0001193125-20-108359.txt : 20200416 0001193125-20-108359.hdr.sgml : 20200416 20200415202759 ACCESSION NUMBER: 0001193125-20-108359 CONFORMED SUBMISSION TYPE: 20-F PUBLIC DOCUMENT COUNT: 119 CONFORMED PERIOD OF REPORT: 20191231 FILED AS OF DATE: 20200416 DATE AS OF CHANGE: 20200415 FILER: COMPANY DATA: COMPANY CONFORMED NAME: MEDICURE INC CENTRAL INDEX KEY: 0001133519 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] IRS NUMBER: 000000000 FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 20-F SEC ACT: 1934 Act SEC FILE NUMBER: 001-31995 FILM NUMBER: 20794884 BUSINESS ADDRESS: STREET 1: SUITE 2 STREET 2: 1250 WAVERLEY STREET CITY: WINNIPEG STATE: A2 ZIP: R3T 6C6 BUSINESS PHONE: 204-487-7412 MAIL ADDRESS: STREET 1: SUITE 2 STREET 2: 1250 WAVERLEY STREET CITY: WINNIPEG STATE: A2 ZIP: R3T 6C6 20-F 1 d913663d20f.htm 20-F 20-F
Table of Contents

 

UNITED STATES

Securities and Exchange Commission

Washington, D.C. 20549

 

FORM 20-F

 

REGISTRATION STATEMENT PURSUANT TO SECTION 12(b) OR (g) OF THE SECURITIES EXCHANGE ACT OF 1934

or

ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the fiscal year ended: December 31, 2019 

or 

TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

or

SHELL COMPANY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

 

Commission file number: 001-31995

 

MEDICURE INC.

_________________________________________________________________________________

 

(Exact name of registrant as specified in its charter)

 

Canada

_________________________________________________________________________________

(Jurisdiction of incorporation or organization)

 

2 - 1250 Waverley Street, Winnipeg, Manitoba, Canada R3T 6C6

 

_________________________________________________________________________________

(Address of principal executive offices)

 

Dr. Albert D. Friesen, Tel: (204) 487-7412, Fax: (204) 488-9823

2 - 1250 Waverley Street, Winnipeg, Manitoba, Canada R3T 6C6

_________________________________________________________________________________

 

(Name, Telephone, E-mail and/or Facsimile number and Address of Company Contact Person)

 

Securities registered or to be registered pursuant to Section 12(b) of the Act: None

 

Securities registered or to be registered pursuant to Section 12(g) of the Act:

 

Common Shares, without par value

_________________________________________________________________________________

(Title of Class)

Securities for which there is a reporting obligation pursuant to Section 15(d) of the Act: None

 

Indicate the number of outstanding shares of each of the issuer’s classes of capital or common stock as of the close of the period covered by the annual report:

 

At December 31, 2019 the registrant had 10,804,013 common shares issued and outstanding

 

 

 

Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act.

 

  Yes ______ No      ✓     

 

If this report is an annual or transition report, indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934.

 

  Yes ______ No      ✓     

 

Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.

 

  Yes      ✓      No ______

 

Indicate by check mark whether the registrant has submitted electronically and posted on its Web site, if any, every Interactive Data File required to be submitted and posted pursuant to Rule 405 of Regulation S-T during the preceding 12 months (or for such shorter period that the registrant was required to submit and post such files).

 

  Yes      ✓      No ______

 

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, or a non-accelerated filer. See definition of “accelerated filer and large accelerated filer” in Rule 12b-2 of the Exchange Act. (Check one):

 

Large Accelerated Filer ______ Accelerated Filer ______ Non-Accelerated Filer      ✓     
     
    Emerging Growth Company _______

 

If an emerging growth company that prepares its financial statements in accordance with U.S. GAAP, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards1 provided pursuant to Section 13(a) of the Exchange act. ___

 

1 The term “new or revised financial accounting standard” refers to any update issued by the Financial Accounting Standards Board to its Accounting Standards Codification after April 5, 2012.

 

Indicate by check mark which basis of accounting the registrant has used to prepare the financial statements included in this filing:

 

US GAAP ______ International Financial Reporting Other ______
  Standards as issued by the International  
  Accounting Standards Board      ✓       

 

If “Other” has been checked in response to the previous question, indicate by check mark which financial statement item the registrant has elected to follow:

 

ii

 

 

  Item 17 _______ Item 18 _______

 

If this is an annual report, indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act).

 

  Yes ______ No      ✓     

 

iii

 

 

TABLE OF CONTENTS

 

GENERAL 1
GLOSSARY OF TERMS 1
FORWARD LOOKING STATEMENTS 2
PART I 5
ITEM 1. IDENTITY OF DIRECTORS, SENIOR MANAGEMENT AND ADVISERS 5
A. Directors and Senior Management 5
B. Advisers 5
C. Auditors 5
ITEM 2. OFFER STATISTICS AND EXPECTED TIMETABLE 5
ITEM 3. KEY INFORMATION 5
A. Selected Financial Data 5
B. Capitalization and Indebtedness 9
C. Reasons for the Offer and Use of Proceeds 9
D. Risk Factors 9
ITEM 4. INFORMATION ON THE COMPANY 32
A. History and Development of the Company 32
B. Business Overview 36
C. Organizational Structure 55
D. Property, Plant and Equipment 56
ITEM 4A. UNRESOLVED STAFF COMMENTS 56
ITEM 5. OPERATING AND FINANCIAL REVIEW AND PROSPECTS 56
A. Operating Results 62
B. Liquidity and Capital Resources 70
C. Research and Development, Patents and Licenses, Etc. 71
D. Trend Information 76
E. Off-balance Sheet Arrangements 77
F. Contractual Obligations 78
ITEM 6. DIRECTORS, SENIOR MANAGEMENT AND EMPLOYEES 81
A. Directors and Senior Management 81
B. Compensation 84
C. Board Practices 86
D. Employees 98
E. Share Ownership 99
ITEM 7. MAJOR SHAREHOLDERS AND RELATED PARTY TRANSACTIONS 101
A. Major Shareholders 101
B. Related Party Transactions 102
C. Interests of Experts and Counsel 106
ITEM 8. FINANCIAL INFORMATION 106
A. Consolidated Statements or Other Financial Information 106
B. Significant Changes 108
ITEM 9. THE OFFERING AND LISTING 108
A. Listing Details 108
B. Plan of Distribution 109
C. Markets 109
D. Selling Shareholders 109
E. Dilution 109

 

iv

 

 

   
F. Expenses of the Issue 110
ITEM 10. ADDITIONAL INFORMATION 110
A. Share Capital 110
B. Memorandum and Articles of Association 110
C. Material Contracts 114
D. Exchange Controls 115
E. Taxation 115
F. Dividends and Paying Agents 124
G. Statement by Experts 125
H. Documents on Display 125
I. Subsidiary Information 125
ITEM 11. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK 125
ITEM 12. DESCRIPTION OF SECURITIES OTHER THAN EQUITY SECURITIES 125
PART II 126
ITEM 13. DEFAULTS, DIVIDEND ARREARAGES AND DELINQUENCIES 126
ITEM 14. MATERIAL MODIFICATIONS TO THE RIGHTS OF SECURITY HOLDERS AND USE OF PROCEEDS 126
ITEM 15. CONTROLS AND PROCEDURES 126
ITEM 16. RESERVED 127
ITEM 16A. AUDIT COMMITTEE FINANCIAL EXPERT 128
ITEM 16B. CODE OF ETHICS 128
ITEM 16C. PRINCIPAL ACCOUNTANT FEES AND SERVICES 128
ITEM 16D. EXEMPTIONS FROM THE LISTING STANDARDS FOR AUDIT COMMITTEES 129
ITEM 16E. PURCHASES OF EQUITY SECURITIES BY THE ISSUER AND AFFILIATED PURCHASERS 129
ITEM 16F. CHANGE IN REGISTRANT’S CERTIFYING ACCOUNTANT 131
ITEM 16G. CORPORATE GOVERNANCE 132
ITEM 16H. MINE SAFETY DISCLOSURE 132
PART III 132
ITEM 17. FINANCIAL STATEMENTS 132
ITEM 18. FINANCIAL STATEMENTS 132
ITEM 19. EXHIBITS 179

 

v

 

GENERAL

 

As used in this Annual Report, the “Corporation” or “Company” refers to Medicure Inc., a Canadian public company existing under the Canada Business Corporations Act.

 

The Company uses the Canadian dollar as its reporting currency. Unless otherwise indicated, all references to dollar amounts in this Annual Report are to Canadian dollars. As of December 31, 2019, the rate for Canadian dollars was US $1.00 for CND $1.2988. See also Item 3 – Key Information for more detailed currency and conversion information.

 

Except as noted, the information set forth in this Annual Report is as of April 15, 2020 and all information included in this document should only be considered correct as of such date.

 

GLOSSARY OF TERMS

 

The following words and phrases shall have the meanings set forth below:

 

2014 Apicore Transaction” means the transaction occurring on July 3, 2014, whereby the Company acquired a minority interest in Apicore.

 

2016 Apicore Transaction” means the transaction occurring on December 1, 2016, whereby the Company acquired a majority interest in Apicore.

 

2017 Apicore Transaction” means the transaction occurring on July 12, 2017 whereby the Company acquired additional interests in Apicore.

 

“angioplasty” means a surgical procedure to repair a damaged blood vessel or unblock an artery;

 

ANDA” means abbreviated new drug application, which is submitted to the FDA;

 

“Apicore” means any one or more of Apicore LLC, Apicore US LLC, Apicore Inc., Apigen Investments Limited, and Apicore Pharmaceuticals PVT Ltd., including any of their affiliates and subsidiaries, and if the context requires, the pharmaceutical manufacturing business carried on by this group of companies;

 

Apicore Sale Transaction” means the transaction occurring on October 2, 2017, whereby the Company sold its interests in the Apicore business.

 

DEA” means the United States Drug Enforcement Administration;

 

DMF” means drug master file, which is submitted to the FDA;

 

“FDA” means the United States Food and Drug Administration;

 

GPIs” means glycoprotein GP IIb/IIIa inhibitors, which are injectable platelet inhibitors used to treat acute coronary syndromes and related conditions and procedures;

 

“myocardial infarction” means destruction of heart tissue resulting from obstruction of the blood supply to the heart muscle;

 

NDA” means new drug application, which is submitted to the FDA;

 

1  

 

ReDS“means the ReDS™ point of care system;

 

sNDA” means supplemental new drug application, which is submitted to the FDA;

 

SNP” means Sodium Nitroprusside Injection;

 

STEMI” means ST Segment Elevation Myocardial Infarction, a type of heart attack

 

“TSXV” means the TSX Venture Exchange.

 

FORWARD LOOKING STATEMENTS

 

Medicure Inc. cautions readers that certain important factors (including without limitation those set forth in this Form 20-F) may affect the Company’s actual results in the future and could cause such results to differ materially from any forward-looking statements that may be deemed to have been made in this Form 20-F annual report, or that are otherwise made by or on behalf of the Company. This Annual Report contains forward-looking statements and information which may not be based on historical fact, which may be identified by the words “believes,” “may,” “plan,” “will,” “estimate,” “continue,” “anticipates,” “intends,” “expects,” and similar expressions and the negative of such expressions. Such forward-looking statements include, without limitation, statements regarding:

 

The Company’s expectations in regards to the extent and impact of COVID 19 including the timing surrounding these impacts;

 

the Company’s intention to sell and market its acute care cardiovascular drug, AGGRASTAT®, in the United States and its territories through its U.S. subsidiary, Medicure Pharma Inc.;

 

the Company’s intention to sell and market its cardiovascular drug, ZYPITAMAGTM, in the United States and its territories through its U.S. subsidiary, Medicure Pharma Inc.;

 

the Company’s intention to sell and market the ReDSPRO system in the United States and its territories through its U.S. subsidiary, Medicure Pharma Inc.;

 

the Company’s intention to sell and market its cardiovascular drug, SNP, in the United States and its territories through its U.S. subsidiary, Medicure Pharma Inc.;

 

the Company’s intention to develop and implement clinical, regulatory and other plans to generate an increase in the value of AGGRASTAT®;

 

the Company’s intention to expand or otherwise improve the approved indications and/or dosing information contained within AGGRASTAT®’s approved prescribing information;

 

the Company’s intention to increase sales of AGGRASTAT®;

 

the Company’s intention to increase sales of ZYPITAMAGTM;

 

the Company’s intention to increase sales of the ReDS™;

 

the Company’s intention to increase sales of the Company’s generic version of SNP;

 

the Company’s intention to launch PREXXARTAN® (valsartan) oral solution (“PREXXARTAN®”), which is currently on hold pending resolution of the dispute between Carmel Biosciences Inc. (“Carmel”) and the third-party manufacturer of PREXXARTAN®;

 

2  

 

the Company’s intention to develop pyridoxal 5 phosphate (“P5P”) or TARDOXALTM, formerly MC-1, for neurological disorders or other applications;

 

the Company’s intention to investigate and advance certain other product opportunities;

 

the Company’s intention to develop and commercialize additional cardiovascular generic drug products;

 

the Company’s intention and ability to obtain regulatory approval for its products and potential products;

 

the Company’s expectations with respect to the cost of the testing and commercialization of its products and potential products;

 

the Company’s sales and marketing strategy;

 

the Company’s anticipated sources of revenue;

 

the Company’s intentions regarding the protection of its intellectual property;

 

the Company’s intention to identify, negotiate and complete business development transactions (e.g. the sale, purchase, or license of pharmaceutical products or services);

 

the Company’s business strategy; and

 

the Company’s expectation that it will not pay dividends in the foreseeable future.

 

Such forward-looking statements and information involve a number of assumptions as well as known and unknown risks, uncertainties and other factors that may cause the actual results, events or developments to be materially different from any future results, events or developments expressed or implied by such forward-looking statements and information including, without limitation:

 

general business and economic conditions;

 

the extent and impact of the COVID 19 outbreak on our business including any impact on our customers, contract manufacturers and other third-party service providers;

 

the impact of changes in Canadian-U.S. dollar and other foreign exchange rates on the Company’s revenues, costs and results;

 

the timing of the receipt of regulatory and governmental approvals for the Company’s research and development projects;

 

the availability of financing for the Company’s commercial operations and/or research and development projects, or the availability of financing on reasonable terms;

 

results of current and future clinical trials;

 

the uncertainties associated with the acceptance and demand for new products;

 

clinical trials not being unreasonably delayed and expenses not increasing substantially;

 

government regulation not imposing requirements that significantly increase expenses or that delay or impede the Company’s ability to bring new products to market;

 

the Company’s ability to attract and retain skilled management and staff;

 

 

3  

 

the Company’s ability, amid circumstances and decisions that are out of the Company’s control, to maintain adequate supply of product for commercial sale;

 

inaccuracies and deficiencies in the scientific understanding of the interaction and effects of pharmaceutical treatments when administered to humans;

 

market competition;

 

tax benefits and tax rates; and

 

the Company’s ongoing relations with its employees and with its business partners.

 

These factors should be considered carefully and readers are cautioned not to place undue reliance on such forward-looking statements and information. The Company disclaims any obligation to update any such factors or to publicly announce the result of any revisions to any of the forward-looking statements and information contained herein to reflect future results, events or developments, except as otherwise required by applicable law. Additional risks and uncertainties relating to the Company and its business can be found in the “Risk Factors” section of this Annual Report.

 

4  

 

PART I

 

ITEM 1. IDENTITY OF DIRECTORS, SENIOR MANAGEMENT AND ADVISERS

 

A. Directors and Senior Management

 

Not applicable

 

B. Advisers

 

Not applicable

 

C. Auditors

 

Not applicable

 

ITEM 2. OFFER STATISTICS AND EXPECTED TIMETABLE

 

Not applicable

 

ITEM 3. KEY INFORMATION

 

A. Selected Financial Data

 

The selected financial data of the Company as at December 31, 2019 and 2018, and for the fiscal years ended December 31, 2019, 2018 and 2017, was extracted from the audited consolidated financial statements of the Company included in this Annual Report on Form 20-F. The information contained in the selected financial data is qualified in its entirety by reference to the more detailed consolidated financial statements and related notes included in Item 18 - Financial Statements, and should be read in conjunction with such financial statements and with the information appearing in Item 5 - Operating and Financial Review and Prospects. The selected financial data of the Company as at December 31, 2017 and 2016 and 2015 and for the year ended December 31, 2016 and 2015 was extracted from the audited financial statements of the Company not included in this Annual Report.

 

5  

 

Under International Financial Reporting Standards (in Canadian dollars):

                     
Statement of Financial Position Data   December 31,
2019

 

 

December 31,

2018

 

 

December 31,

2017

 

 

December 31,

2016

 

 

December 31,

2015

 

(as at period end) 

  $     $     $     $     $  
Current Assets     31,364,000       89,587,000       114,558,882       55,211,748       17,448,554  
Property and Equipment     1,282,000       316,000       221,622       10,300,639       230,162  
Intangible Assets     9,599,000       1,705,000       1,756,300       100,864,817       1,411,992  
Goodwill     -       -       -       47,485,572       -  
Other Assets     39,000       12,153,000       12,394,881       862,891       2,166,170  
Total Assets     42,284,000       103,761,000       128,931,685       214,725,667       21,256,878  
Current Liabilities     11,662,000       16,931,000       43,673,908       61,560,600       10,352,462  
Non-current Liabilities     3,680,000       3,236,000       4,548,617       114,881,163       6,442,865  
Total Liabilities     15,342,000       20,167,868       48,222,525       176,441,763       16,795,327  
Net Assets / (Deficiency)     26,942,000       83,594,000       80,709,160       36,193,904       4,461,551  
Capital Stock, Warrants and Contributed Surplus     95,341,000       132,464,000       134,579,798       133,476,698       128,304,590  
Accumulated Other Comprehensive Income     (5,751,000 )     1,268,000       673,264       681,992       1,071,735  
Deficit     (62,648,000 )     (50,138,000 )     (54,543,902 )     (97,964,786 )     (124,947,427 )
Non-controlling Interest     -       -       -       2,090,000       -  

Statement of Net (Loss) Income 

(for the fiscal year ended on) 

                                       
Product Sales     20,173,000       29,109,000       27,133,000       29,304,800       22,083,128  
Loss on Settlement of Debt     -       -       -       -       (60,595 )
Net (Loss) Income for the Period from continuing operations     (19,786,000 )     3,926,000       11,497,000       3,624,323       1,668,429  
Net income for the Period from discontinued operations     -       -       31,924,000       23,358,318       -  
Comprehensive (Loss) Income for the Period     (26,805,000 )     4,521,000       43,412,000       26,560,245       2,474,488  
(Loss) Income Per Share from continuing operations                                        
Basic     (1.32 )     0.25       0.74       0.24       0.12  
Diluted     (1.32 )     0.24       0.63       0.21       0.11  
Income                                        
Per Share from discontinued operations                                        

 

6  

 

Basic     -       -       2.04       1.56       -  
Diluted     -       -       1.76       1.35       -  
(Loss) Income                                        
Per Share                                        
Basic     (1.32 )     0.25       2.78       1.80       0.12  
Diluted     (1.32 )     0.24       2.39       1.56       0.11  
Weighted-Average Number of Common Shares Outstanding – Continuing Operations                                        
 Basic     14,998,540       15,791,396       15,636,853       15,002,005       13,461,609  
 Diluted     14,998,540       16,563,663       18,138,080       17,316,401       15,765,570  
Weighted-Average Number of Common Shares Outstanding – Discontinued Operations                                        
 Basic     14,998,540       15,791,396       15,636,853       15,002,005       13,461,609  
 Diluted     14,998,540       16,563,663       18,138,080       17,316,401       15,765,570  
Weighted-Average Number of Common Shares Outstanding                                        
 Basic     14,998,540       15,791,396       15,636,853       15,002,005       13,461,609  
 Diluted     14,998,540       16,563,663       18,138,080       17,316,401       15,765,570  

7  

 

Dividends

 

No cash dividends have been declared nor are any intended to be declared in the foreseeable future. The Company is not subject to legal restrictions respecting the payment of dividends except that they may not be paid if the Company is, or would after the payment be, insolvent. Dividend policy will be based on the Company’s cash resources and needs and it is anticipated that all available cash will be required to further the Company’s research and development activities for the foreseeable future.

 

Exchange Rates

 

Unless otherwise indicated, all reference to dollar amounts are to Canadian dollars. On April 14, 2020, the rate of exchange of the Canadian dollar, based on the daily exchange rate in Canada as published by the Bank of Canada, was US$1.00 = Canadian $1.3904. The exchange rates published by the Bank of Canada and made available on its website, www.bankofcanada.ca, are nominal quotations — not buying or selling rates — and are intended for statistical or analytical purposes.

 

The following tables set out the exchange rates, based on the daily noon rates in Canada as published by the Bank of Canada for the conversion of Canadian Dollars into U.S. Dollars, for the periods indicated:

 

   

December 31,

2019

 

 

December 31,

2018

 

December 31,

2017

 

 

December 31,

2016

 

 

December 31,

2015

 

                     
Period End     1.2988       1.3642       1.2545       1.3427       1.3840  
Average for the Period*     1.3269       1.2957       1.2986       1.3248       1.2787  
High for the Period     1.3600       1.3642       1.3743       1.4590       1.4004  
Low for the Period     1.2988       1.2288       1.2128       1.2544       1.1680  

 

* The average rate for each period is the average of the daily closing rates on the last day of each month during the period.

 

Month   High   Low
March 2020       1.4496       1.3421  
February 2020       1.3429       1.3224  
January 2020       1.3233       1.2970  
December 2019       1.3302       1.2988  
November 2019       1.3307       1.3148  
October 2019       1.3330       1.3056  
September 2019       1.3343       1.3153  
August 2019       1.3325       1.3217  
July 2019       1.3182       1.3038  
June 2019       1.3527       1.3087  
May 2019       1.3527       1.3410  
April 2019       1.3493       1.3316  
March 2019       1.3438       1.3260  
February 2019       1.3298       1.3095  
January 2019       1.3600       1.3144  

 

8  

 

B. Capitalization and Indebtedness

 

Not applicable

 

C. Reasons for the Offer and Use of Proceeds

 

Not applicable

 

D. Risk Factors

 

An investment in the Company’s common shares is highly speculative and subject to a number of risks. Only those persons who can bear the risk of the entire loss of their investment should participate. An investor should carefully consider the risks described below and the other information that the Company furnishes to, or files with, the Securities and Exchange Commission and with Canadian securities regulators before investing in the Company’s common shares.

 

Uncertainties and risks include, but are not limited to, the risk that the Company may face with respect to importing raw materials, increased competition, acquisitions, contract manufacturing arrangements, delays or failure in obtaining product approvals from the FDA, general business and economic conditions, market trends, product development, regulatory, and other approvals and marketing.

 

The following are significant factors known to us that could materially harm our business, financial position, or operating results or could cause our actual results to differ materially from our anticipated results or other expectations, including those expressed in any forward-looking statement made in this report. The risks described are not the only risks facing us. Additional risks and uncertainties not currently known to us, or that we currently deem to be immaterial, also may adversely affect our business, financial position, and operating results. If any of these risks actually occur, our business, financial position, and operating results could suffer significantly. As a result, the market price of our common stock could decline and investors could lose all or part of their investment.

 

Disease outbreaks may negatively impact the performance of the Company

 

A local, regional, national or international outbreak of a contagious disease, including the COVID 19 coronavirus, Middle East Respiratory Syndrome, Severe Acute Respiratory Syndrome, H1N1 influenza virus, avian flu or any other similar illness, could interrupt supplies and other services from third parties upon which the Company relies (including contract manufacturers, marketing and transportation and logistics providers), decrease demand for our products, decrease the general willingness of the general population to travel, cause staff shortages, reduced customer demand, and increased government regulation, all of which may materially and negatively impact the business, financial condition and results of operations of the Company. In particular, if the current outbreak of the COVID 19 coronavirus continues or increases in severity, the Company could experience difficulty in executing it strategic plans and the marketing, sales, production, logistics and distribution of its products could be severely disrupted. These events could materially and adversely affect the Company’s business and could have a material adverse effect on the Company’s liquidity and its financial results.

 

The fact that the Company currently derives nearly all of its revenue from a single product, AGGRASTAT®, exposes the Company to the risks inherent in the establishment and maintenance of a developing business enterprise, such as those related to product acceptance, competition and viable operations management, and the long-term profitability of the Company remains uncertain.

 

9  

 

At December 31, 2019, the Company had AGGRASTAT®, ZYPITAMAGTM, ReDSTM, and SNP available for sale commercially, but 96% of the Company’s revenues were derived from AGGRASTAT®. The remainder of the Company’s commercial products are in the development stage and accordingly, its business operations are subject to all of the risks inherent in the establishment and maintenance of a developing business enterprise, such as those related to product acceptance, competition and viable operations management.

 

The long-term profitability of the Company’s operations is uncertain, and any profitability may not be sustained. The Company’s long-term profitability will depend in significant part on its ability to maintain or expand sales of AGGRASTAT®, increase sales of ZYPITAMAGTM, ReDSTM, and SNP and to acquire and/or develop other commercially viable drug products. This in turn depends on numerous factors which remain uncertain, including the following:

 

(a) the success of the Company’s research and development activities;

(b) obtaining regulatory approvals to market any of its development products;

(c) the ability to contract for the manufacture of the Company’s products according to schedule and within budget, given the Company’s limited experience and lack of internal capabilities for manufacturing;

(d) the ability to develop, implement and maintain appropriate systems and structures to market and operate within applicable regulatory, industry and legal guidelines;

(e) the ability to identify, negotiate and complete business development transactions (e.g. the sale, purchase, or license of pharmaceutical products or services) with third parties;

(f) the ability to maintain current or higher pricing and margins for the Company’s products;

(g) the ability to successfully prosecute and defend its patents and other intellectual property; and

(h) the ability to successfully market the Company’s products, including AGGRASTAT®, given that it has limited resources.

 

Further, if the Company does achieve sustained profitability, it may not be able to increase profitability in the future.

 

There is no assurance that the Company will be successful in growing the sales of ZYPITAMAGTM in the United States and its territories, and its failure to do so could have a material adverse effect on the Company’s long-term profitability.

 

On September 30, 2019 the Company announced that through its subsidiary, Medicure International Inc., it has acquired the ownership of ZYPITAMAGTM from Zydus for U.S. and Canadian markets. Under terms of the agreement, Zydus will receive an upfront payment of U.S. $5.0 million and U.S. $2.0 million in deferred payments to be made over the next four years, as well as contingent payments on achievement of milestones and royalties related to net sales. With this acquisition Medicure obtained full control of marketing and pricing negotiations for the product.

 

10  

 

Previously, on December 14, 2017, the Company acquired from Zydus, an exclusive license to sell and market ZYPITAMAGTM (pitavastatin magnesium), a branded cardiovascular drug, in the United States and its territories for a term of seven years with extensions to the term available. ZYPITAMAGTM is used for the treatment of patients with primary hyperlipidemia or mixed dyslipidemia and was approved in July 2017 by the FDA for sale and marketing in the United States. On May 1, 2018 ZYPITAMAGTM became commercially available in retail pharmacies throughout the United States. The Company’s product launch utilized its existing commercial infrastructure and while not an in-hospital product like AGGRASTAT®, ZYPITAMAGTM added to the Company’s cardiovascular portfolio and expanded the Company’s reach to new patients. ZYPITAMAGTM contributed revenue of $183,000 to Company for the year ended December 31, 2019 and $652,000 of revenue to the Company during the year ended December 31, 2018. ZYPITAMAGTM is still in the early stages of its commercialization and the Company continues to work towards growing the ZYPITAMAGTM brand, usage of the product and revenues from ZYPITAMAGTM. The 2018 revenues were higher than those earned in 2019 due to the initial ordering by wholesaler customers of the product.

 

ZYPITAMAG competes in a highly competitive class of products and to date, the rate of uptake of ZYPITAMAGTM has been slow resulting in low sales of ZYPITAMAGTM recorded for the year ended December 31, 2019. There is no assurance that the Company will be successful in growing the sales of ZYPITAMAGTM in 2020 and beyond as there is no assurance that a viable market for ZYPITAMAGTM will develop. The failure of the Company to grow sales of ZYPITAMAGTM, or to establish a viable market for the product, could have a material adverse effect on the Company’s long-term profitability.

 

There is no assurance that the Company will be successful in launching SNP and growing its revenues in the United States and its territories, and its failure to do so could have a material adverse effect on the Company’s long-term profitability.

 

On August 13, 2018, the Company announced that the FDA approved its ANDA for SNP. SNP is indicated for the immediate reduction of blood pressure for adult and pediatric patients in hypertensive crisis. The product is also indicated for producing controlled hypotension in order to reduce bleeding during surgery and for the treatment of acute congestive heart failure. The filing of the ANDA was previously announced by the Company on December 13, 2016. Medicure’s SNP has recently become available in the United States with the initial sales from SNP being recorded subsequent to December 31, 2019 in January of 2020.

 

SNP was launched into a genericized market with several competitors already selling generic versions of the product and as such there is no assurance that the Company will be successful in growing its sales of SNP in 2020 and beyond. The failure of the Company to successfully launch and grow sales of SNP, or to establish a viable market for the Company’s version of the product, could have a material adverse effect on the Company’s long-term profitability.

 

There is no assurance that the Company will be successful in marketing ReDSTM and growing sales from the product in the United States and its territories, and its failure to do so could have a material adverse effect on the Company’s long-term profitability.

 

On January 28, 2019, the Company entered into an agreement with Sensible Medical Innovations Inc. (“Sensible”) to become the exclusive marketing partner for ReDS™ in the United States. ReDS™ is a non-invasive, FDA-cleared medical device that provides an accurate, actionable and absolute measurement of lung fluid which is important in the management of congestive heart failure. ReDS™ was already being marketed to United States hospitals by Sensible and the Company has begun marketing ReDS™ immediately using its existing commercial organization. Under the terms of the agreement, Medicure will receive a percentage of total U.S. sales revenue of the device and must meet minimum annual sales quotas.

 

11  

 

At the time of the signing of the marketing agreement, ReDSTM was available commercially in the United States, however, there is no assurance that the Company will be successful in its marketing efforts regarding ReDSTM and achieve significant sales growth in 2020 and beyond as planned, or at all. Further, there is no assurance that a viable market for ReDSTM will develop in 2020 and beyond. The failure of the Company to successfully market and grow sales of ReDSTM, or to establish a viable market for the product, could have a material adverse effect on the Company’s long-term profitability.

 

The Company has considered indicators of impairment as at December 31, 2019 and recorded a write-down of intangible assets related to the ReDSTM license during the year ended December 31, 2019 totaling $6.3 million as a result of uncertainties with ReDSTM being experienced in regards to the length of the sales cycle and uptake of the product with customers, resulting in the Company’s sales being below the committed amounts required by the exclusive marketing and distribution agreement regarding ReDSTM. Additionally, a loss of $6.3 million was recorded within other comprehensive loss from the revaluation of the investment in Sensible made during the year ended December 31, 2019. Despite recording this impairment on the license over ReDSTM and the investment in Sensible Medical, the Company continues to market ReDS™ PRO and continues to work to safeguard or monetize the Company’s investment.

 

The commercial launch and marketing of PREXXARTAN® (valsartan) oral solution has been placed on hold by the Company and the Company may not commercially launch the product.

 

On October 31, 2017, the Company announced that it had acquired an exclusive license to sell and market PREXXARTAN®, which treats hypertension, in the U.S. and its territories from Carmel for a seven-year term with extensions to the term available. Medicure acquired the license rights for an upfront payment of U.S.$100,000, with an additional U.S.$400,000 payable on final FDA approval. Carmel would also be entitled to receive royalties and milestone payments from the net revenues of PREXXARTAN®. PREXXARTAN® had been granted tentative approval by the FDA and the tentative approval was converted to final approval on December 19, 2017.

 

As announced on March 19, 2018 and up-dated on March 28, 2018, all PREXXARTAN® related activities were placed on hold by the Company pending the resolution of a dispute that Medicure became aware of between the owner of the New Drug Application (“NDA”), Carmel and the third-party manufacturer of the product. The Company was also named in a civil claim in Florida between the third-party manufacturer and Carmel. The claim disputed the rights granted to Medicure by Carmel in regards to PREXXARTAN®. More recently the claim against the Company has been withdrawn, however the dispute between Carmel and the third-party manufacturer continues.

 

Medicure had intended to launch PREXXARTAN® during the first half of 2018 and to date, only an up-front payment of U.S.$100,000, has been made to Carmel in regards to PREXXARTAN® and the Company has reserved all of its rights under the license agreement with Carmel for PREXXARTAN®.

 

As a result of the uncertainty surrounding the marketing rights for PREXXARTAN®, marketing activities remain on hold in regards to the product. There can be no assurances that the Company launches the product commercially in 2020 or future years. Further, there is no assurance that the Company will be successful in its launching PREXXARTAN® and achieve sales results as planned, or at all. Further, there is no assurance that a viable market for PREXXARTAN® will develop if the marketing efforts begin.

 

The Company may never receive regulatory approval in the United States, Canada or abroad for any of its products in development. Therefore, the Company may not be able to sell any therapeutic products currently under development.

 

12  

 

The Company’s failure to maintain or obtain necessary regulatory approvals to fully market its current and future development stage products in one or more significant markets may adversely affect its business, financial condition and results of operations. The process involved in obtaining regulatory approval from the competent authorities to market therapeutic products is long and costly and may delay product development. The approval to market a product may be applicable to a limited extent only or it may be refused entirely.

 

While the Company’s approved product portfolio has grown during 2019 to AGGRASTAT®, ZYPITAMAGTM, PREXXARTAN®, which is currently on hold, ReDSTM and SNP, the Company still has products that are currently in the research and development stages. The Company may never develop another commercially viable drug product approved for marketing. To obtain regulatory approvals for its products and to achieve commercial success, human clinical trials must demonstrate that the new chemical entities are safe for human use and that they show efficacy, and generic drug products under development need to show analytical equivalence and /or bioequivalence to the referenced product on the market. Unsatisfactory results obtained from a particular study or clinical trial relating to one or more of the Company’s products may cause the Company to reduce or abandon its commitment to that program.

 

If the Company fails to successfully complete its development projects, it will not obtain approval from the FDA and other international regulatory agencies, to market its these products. Regulatory approvals also may be subject to conditions that could limit the market its products can be sold in or make either products more difficult or expensive to sell than anticipated. Also, regulatory approvals may be revoked at any time for various reasons, including for failure to comply with regulatory requirements or poor performance of its products in terms of safety and effectiveness.

 

The Company’s business, financial condition and results of operations are likely to be adversely affected if it fails to maintain or obtain regulatory approvals in the United States, Canada and abroad to market and sell its current or future drug products, including any limitations imposed on the marketing of such products.

 

If the Company fails to acquire and develop additional product candidates or approved products, it will impair the Company’s ability to grow its business and to increase value for shareholders.

 

For the year ended December 31, 2019, the Company generated its commercial product revenue from AGGRASTAT®, ZYPITAMAGTM and ReDSTM with initial revenue from SNP being earned beginning in 2020. A component of the Company’s plan to generate additional revenue is its intention to develop and/or to acquire or license, and then develop and/or market, additional product candidates or approved products. The success of this growth strategy depends upon the Company’s ability to identify, select and then to develop, acquire or license products that meet the criteria it has established. Due to the fact the Company has limited financial capacity, and limited value in its equity, relative to other companies in the industry, it has a limited number of product opportunities to choose from. Moreover, the Company’s ability to research and develop its own, or other acquired/licensed products, is limited by the extent of its internal scientific research capabilities. In addition, proposing, negotiating and implementing an economically viable acquisition or license is a lengthy and complex process. Other companies, including those with substantially greater financial, marketing and sales resources, may compete with the Company for the acquisition or license of product candidates and approved products. The Company may not be able to acquire or license the rights to additional product candidates and approved products on terms that it finds acceptable, or at all. Moreover, the Company may not have the human, technical, financial, manufacturing and/or clinical resources to successfully develop additional products.

 

13  

 

The Company may not receive regulatory approval in the United States to further expand or otherwise improve the approved indications and/or dosing information contained within AGGRASTAT®’s prescribing information. Therefore, the Company may not be able to continue to materially increase sales of AGGRASTAT®.

 

In fiscal 2014 the Company was able to obtain revisions to AGGRASTAT®’s prescribing information and these revisions have had a positive, material impact on sales of AGGRASTAT®. The Company believes that further revisions to AGGRASTAT®’s prescribing information will put the Company in a better position to maximize the revenue potential for AGGRASTAT®. To make such changes, the Company may need to conduct appropriate clinical trials, obtain positive results from those trials, or otherwise provide support in order to obtain regulatory approval for the proposed indications and dosing regimens. The Company’s failure to obtain additional regulatory approvals from the FDA to expand or otherwise improve the approved indications and/or dosing information contained within AGGRASTAT®’s prescribing information may adversely affect the Company’s ability to materially increase sales. The process involved in obtaining such regulatory approval is long and costly and may require additional investments that may not be reasonably achievable by the Company. The regulatory authorities have substantial discretion in the approval process and may refuse to accept any application. Varying interpretations of the data obtained from pre-clinical and clinical testing could delay, limit or prevent regulatory approval of a new indication for a product. Furthermore, the approval to modify the prescribing information may be applicable to a limited extent only or it may be refused entirely.

 

The current approved prescribing information for AGGRASTAT® does not include all of the dosing information and therapeutic indications for which a physician may wish to use the product. Although health care professionals may utilize a product at doses and for indications outside of the approved prescribing information, the Company is prohibited from promoting such uses.

 

To obtain regulatory approvals to modify the prescribing information, the Company must supply sufficient information supporting the safety and efficacy of such uses to the FDA, which in turn must review and deem this information to be sufficient to modify the label in the agreed upon fashion. Unsatisfactory or insufficient results obtained from any particular study or clinical trial relating to the Company’s products may cause the Company to reduce or abandon its efforts to expand or otherwise improve the approved indications and/or dosing information contained within AGGRASTAT®’s prescribing information.

 

If the Company does not comply with federal, state and foreign laws and regulations relating to the health care business, it could face substantial penalties.

 

The Company and its customers are subject to extensive regulation by the United States federal government, and the governments of the states in which the business is conducted. In the United States, the laws that directly or indirectly affect the Company’s ability to operate its business include the following:

 

the Federal Anti-Kickback Law, which prohibits persons from knowingly and willfully soliciting, offering, receiving or providing remuneration, directly or indirectly, in cash or in kind, to induce either the referral of an individual or furnishing or arranging for a good or service for which payment may be made under federal health care programs such as Medicare and Medicaid;

other Medicare laws and regulations that prescribe the requirements for coverage and payment for services performed by the Company’s customers, including the amount of such payment;

the Federal False Claims Act, which imposes civil and criminal liability on individuals and entities who submit, or cause to be submitted, false or fraudulent claims for payment to the government;

 

14  

 

the Federal False Statements Act, which prohibits knowingly and willfully falsifying, concealing or covering up a material fact or making any materially false statement in connection with delivery of or payment for health care benefits, items or services; and

various state laws that impose similar requirements and liability with respect to state healthcare reimbursement and other programs.

 

If the Company’s operations are found to be in violation of any of the laws and regulations described above or any other law or governmental regulation to which the Company or its customers are or will be subject, the Company may be subject to civil and criminal penalties, damages, fines, exclusion from the Medicare and Medicaid programs and the curtailment or restructuring of its operations. Similarly, if the Company’s customers are found to be non-compliant with applicable laws, they may be subject to sanctions, which could also have a negative impact on the Company. Any penalties, damages, fines, curtailment or restructuring of the Company’s operations would adversely affect its ability to operate its business and financial results. Any action against the Company for violation of these laws, even if the Company is able to successfully defend against it, could cause it to incur significant legal expenses, divert management’s attention from the operation of the business and damage the Company’s reputation.

 

Due to the fact that a material amount of the use of AGGRASTAT® is outside of the FDA approved indications contained within AGGRASTAT®’s prescribing information, the Company may be at a greater risk than would be the case if the product was almost exclusively used within the approved prescribing information.

 

AGGRASTAT® must compete with a variety of existing drugs, including generic versions of those existing drugs, and may in the future have to compete with new drugs, which may limit the use of AGGRASTAT® and adversely affect the Company’s revenue.

 

Due to the incidence and severity of cardiovascular diseases, the market for anticoagulant and antiplatelet therapies is large and competition is intense. There are a number of anticoagulant and antiplatelet drugs recently approved, currently on the market, awaiting regulatory approval or in development. AGGRASTAT® must compete with these drugs, and may in the future have to compete with new drugs, to the extent that AGGRASTAT® and such drugs are approved for the same or similar indications.

 

AGGRASTAT® competes primarily with other platelet inhibitors, in particular the other GP IIb/IIIa inhibitors, ReoPro® (abciximab) (sold by Eli Lilly and Company) and Integrilin® (eptifibatide) (a branded drug sold by Merck & Co., Inc.), in addition to generic eptifibatide sold by other companies. It also competes with a number of oral platelet inhibitors, which can be used alone or in conjunction with anticoagulants, most notably with heparin (sold generically by a number of companies), and with a recently approved injectable platelet inhibitor, Kengreal® (cangrelor) (sold by Chiesi Farmaceutics S.p.A. Inc.). In addition, some alternative methods of treatment, such as the use of Angiomax® (bivalirudin) (sold by The Medicines Company, Inc.), also compete with AGGRASTAT®. These competing products are all marketed by large pharmaceutical companies with significantly more resources and experience than the Company.

 

There still remains many hospitals in the United States where AGGRASTAT® is not available on the hospital formulary, and it can be very difficult and time consuming to have AGGRASTAT® added to formulary for use by health care professionals. In many cases, competing treatment approaches may have FDA approval for dosing regimens and/or therapeutic indications that are outside of AGGRASTAT®’s approved prescribing information. The risk of bleeding associated with AGGRASTAT® may cause physicians to choose an alternative therapy. Although AGGRASTAT® is positioned as a relatively low-cost therapy, in certain circumstances other treatment approaches are lower cost and may for this reason be preferred by health care professionals - in particular where oral antiplatelet agents are deemed suitable.

 

15  

 

ZYPITAMAGTM competes with a variety of existing drugs and may compete against other new drugs, which may limit the use of ZYPITAMAGTM and potentially affect the Company’s revenue.

 

Due to the incidence and severity of cardiovascular diseases, the market for antihyperlipidemics is large and competition is intense. There are a number of approved antihyperlipidemic drugs approved, currently on the market, awaiting regulatory approval or in development. ZYPITAMAGTM will compete with these drugs to the extent ZYPITAMAGTM and any of these drugs are approved for the same or similar indications.

 

Although ZYPITAMAGTM is positioned as a relatively low-cost therapy, in certain circumstances, other treatment approaches are lower cost and may for this reason be preferred by health care professionals.

 

The development of generic treatment options may decrease or eliminate the cost advantage that AGGRASTAT® currently enjoys, which could negatively impact the Company’s sales.

 

AGGRASTAT® is a branded pharmaceutical product for which there is currently no generic alternative available in the Company’s market. AGGRASTAT®’s reduced cost relative to other products was one of the advantages being used by the Company to promote and increase sales of AGGRASTAT®. Distributors of generic products typically price products significantly below the branded alternative, and these distributors are always seeking to introduce these generic alternatives of pharmaceuticals. There is a risk that new generic products will be introduced that compete with AGGRASTAT® and that their low pricing would reduce AGGRASTAT®’s relative cost advantage, and therefore negatively impact the maintenance and growth of sales by the Company. As at December 31, 2019, there are generic versions of a competing product, eptifibatide, that are commercially available and are now competing directly against AGGRASTAT®. Additional generic competitors are expected to enter the market in the months and years ahead, and it is anticipated that these will result in further reductions to the price of eptifibatide.

 

Moreover, due to the previously seen growth in sales of AGGRASTAT®, there is increased probability that generic companies will attempt to enter the U.S. market before the last AGGRASTAT® patent expires. If this occurs, the Company will have to defend its patent position and market exclusivity for AGGRASTAT® against larger, better funded and more experienced generic companies. The entry of a generic version of AGGRASTAT® into the market would have a major negative effect on both the volume and profitability of the Company’s AGGRASTAT® sales.

 

Further to this, as announced on November 16, 2018, the Company filed a patent infringement action against Gland Pharma Ltd. (“Gland”) in the U.S. District Court for the District of New Jersey, alleging infringement of U.S. Patent No. 6,770,660 (“the ‘660 patent”).

 

The patent infringement action was in response to Gland’s filing of an ANDA seeking approval from the FDA to market a generic version of AGGRASTAT® before the expiration of the ‘660 patent. The ‘660 patent is listed in FDA’s Orange Book for AGGRASTAT®. Medicure vigorously defend the ‘660 patent and pursued the patent infringement action against Gland and all other legal options available to protect its patent rights.

 

On August 21, 2019 the Company announced that its subsidiary, Medicure International Inc., settled its ongoing patent infringement action against Gland. As part of the settlement, Gland has acknowledged that the ‘660 patent is valid, enforceable and infringed. The settlement resulted in the Company entering into a license agreement with Gland with an anticipated launch date for Gland’s generic product of March 1, 2023. The remaining terms of the settlement are confidential.

 

16  

 

Additionally, the Company announced it had filed a patent infringement action against Nexus Pharmaceuticals, Inc. (“Nexus”) in the U.S. District Court for the Northern District of Illinois, alleging infringement of the ‘660 patent.

 

The patent infringement action is in response to Nexus’ filing of an ANDA seeking approval from the FDA to market a generic version of AGGRASTAT® (tirofiban hydrochloride) injection before the expiration of the ‘660 patent. Medicure will vigorously defend the ‘660 patent and will pursue the patent infringement action against Nexus and all other legal options available to protect its product.

 

The Company may not be able to hire or retain the qualified scientific, technical and management personnel it requires.

 

The Company’s business prospects and operations depend on the continued contributions of certain of the Company’s executive officers and other key management and technical personnel, certain of whom would be difficult to replace.

 

The Company’s subsidiary, Medicure International, Inc., contracts with third parties to perform a significant amount of its research and development activities. Because of the specialized scientific nature of the Company’s business, the loss of services of any one or more of these parties may require the Company to attract and retain replacement qualified scientific, technical and management personnel. Competition in the biotechnology industry for such personnel is intense and the Company may not be able to hire or retain a sufficient number of qualified personnel, which may compromise the viability, pace and success of its research and development activities.

 

Also, certain of the Company’s management personnel are officers and/or directors of other companies and organizations, some publicly-traded, and will only devote part of their time to the Company. Although the Company has key person insurance for Dr. Albert Friesen, Chief Executive Officer, the Company does not have key person insurance in effect in the event of a loss of any other management, scientific or other key personnel. The loss of the services of one or more of the Company’s current executive officers or key personnel or the inability to continue to attract qualified personnel could have a material adverse effect on the Company’s business prospects, financial results and financial condition.

 

The Company faces substantial technological competition from many biotechnology and pharmaceutical companies with much greater resources, and it may not be able to effectively compete.

 

Technological and scientific competition in the pharmaceutical and biotechnology industry is intense. The Company competes with other companies in Canada, the United States and abroad to develop products designed to treat similar conditions. Most of these other companies have substantially greater financial, technical and scientific research and development resources, manufacturing and production and sales and marketing capabilities than the Company. Smaller companies may also prove to be significant competitors, whether acting independently or through collaborative arrangements with large pharmaceutical and biotechnology companies. Developments by other companies may adversely affect the competitiveness of the Company’s products or technologies or the commitment of its research and marketing collaborators to its programs or even render its products obsolete.

 

17  

 

The pharmaceutical and biotechnology industry is characterized by extensive drug discovery and drug research efforts and rapid technological and scientific change. Competition can be expected to increase as technological advances are made and commercial applications for biopharmaceutical products increase. The Company’s competitors may use different technologies or approaches to develop products similar to the products which it is developing, or may develop new or enhanced products or processes that may be more effective, less expensive, safer or more readily available before or after the Company obtains approval of its products. The Company may not be able to successfully compete with its competitors or their products and, if it is unable to do so, the Company’s business, financial condition and results of operations may suffer.

 

The Company may be unable to establish collaborative and commercial relationships with third parties, in which case the Company’s business, financial position and operating results could be materially adversely affected.

 

The Company’s success may depend to some extent on its ability to enter into and to maintain various arrangements with corporate partners, licensors, licensees and others for the research, development, clinical trials, manufacturing, marketing, sales and commercialization of its products. These relationships are crucial to the Company’s intention to license to or contract with other pharmaceutical companies for the manufacturing, marketing, sales and/or distribution of any its current or future products. There can be no assurance that any licensing or other agreements will be established on favourable terms, if at all. The failure to establish successful collaborative arrangements may negatively impact the Company’s ability to develop and commercialize its products, and may adversely affect its business, financial condition and results of operations.

 

The Company is currently dependent on third parties for the production of AGGRASTAT®, and the loss of or other disruption to such third-party relationships could have a material adverse effect on the Company’s business, financial position and operating results.

 

The Company’s subsidiary, Medicure International, Inc., has a supply contract for raw materials (active pharmaceutical ingredient) used in the manufacture of AGGRASTAT® with a contract manufacturer which was approved by the FDA as the approved source of the raw material for AGGRASTAT®.

 

The Company’s subsidiary, Medicure Pharma, Inc., has both vial and bag manufacturers of final product that are approved by the FDA.

 

If either the supply of raw material or the final product manufacturing agreement for AGGRASTAT® is terminated or interrupted, or if, in the event of termination, the Company and its subsidiaries are unable to find a replacement raw material supplier or manufacturer, or obtain regulatory approval for commercial use of product made by a new raw material supplier or a new finished product manufacturer, the Company’s business, financial position and operating results could be materially adversely affected. It is also important to note that the establishment of new manufacturing sources of pharmaceutical raw materials or finished products takes a prolonged period of time.

 

The Company is currently dependent on a third-party manufacturer for the supply of ZYPITAMAGTM, and the loss or other disruption to the supply arrangement could have a material adverse effect on the Company’s business, financial position and operating results.

 

The Company’s subsidiary, Medicure Pharma, Inc., has entered into a supply arrangement with a third-party manufacturer of ZYPITAMAGTM which will expire on September 19, 2029.

 

18  

 

If the supply arrangement is interrupted, or if the Company and Medicure Pharma, Inc. are unable to renew or replace the supply arrangement, or if the Company and Medicure Pharma, Inc. are unable to obtain regulatory approval for commercial use of product made by a new supplier, the Company’s business, financial position and operating results could be materially adversely affected. It is also important to note that the establishment of new manufacturing sources of pharmaceutical raw materials or finished products takes a prolonged period of time.

 

The Company is currently dependent on third parties for the production of SNP, and the loss of or other disruption to such third-party relationships could have a material adverse effect on the Company’s business, financial position and operating results.

 

The Company’s subsidiary, Medicure International, Inc., has a supply contract for raw materials (active pharmaceutical ingredient) used in the manufacture of SNP with a contract manufacturer which was approved by the FDA as the approved source of the raw material for SNP.

 

The Company’s subsidiary, Medicure Pharma, Inc., has a contracted manufacturer of final product that is approved by the FDA.

 

If either the supply of raw material or the final product manufacturing agreement for SNP is terminated or interrupted, or if, in the event of termination, the Company and its subsidiaries are unable to find a replacement raw material supplier or manufacturer, or obtain regulatory approval for commercial use of product made by a new raw material supplier or a new finished product manufacturer, the Company’s business, financial position and operating results could be materially adversely affected. It is also important to note that the establishment of new manufacturing sources of pharmaceutical raw materials or finished products takes a prolonged period of time.

 

ReDSTM will be manufactured by Sensible, the Company’s partner in regards to the technology and as a result the Company is dependent on their manufacturing for the supply of ReDSTM devices and the loss or other disruption to this supply could have a material adverse effect on the Company’s business, financial position and operating results.

 

The Company’s subsidiary, Medicure Pharma, Inc., has entered into a marketing agreement regarding the sale of ReDSTM in the United States.

 

If the supply of product is interrupted, or if the Company and Sensible, are unable to find replacement suppliers, the Company’s business, financial position and operating results could be materially adversely affected.

 

Loss of product inventory could have a material adverse effect on the Company’s financial results and financial condition.

 

If the Company’s existing inventories of AGGRASTAT® and/or ZYPITAMAGTM are contaminated, exhausted due to stock-out, or otherwise lost, the Company’s financial results and financial condition could be adversely affected, particularly if the third-party suppliers of raw materials or final product are unable to meet any additional demands that may be placed on them by the Company in its efforts to make up depleted inventory.

 

Consolidation and the formation of strategic partnerships among and between wholesale distributors, chain drug stores, and group purchasing organizations has resulted in a smaller number of companies, each controlling a larger share of pharmaceutical distribution channels.

 

19  

 

Drug wholesalers and retail pharmacy chains, which represent an essential part of the distribution chain for generic pharmaceutical products, have undergone, and are continuing to undergo, significant consolidation. This consolidation may result in declines in the Company’s sales volumes if a customer is consolidated into another company that purchases products from a competitor. In addition, the consolidation of drug wholesalers and retail pharmacy chains could result in these groups gaining additional purchasing leverage and consequently increasing the product pricing pressures facing the Company’s business and enabling those groups to charge the Company increased fees. Additionally, the emergence of large buying groups representing independent retail pharmacies and the prevalence and influence of managed care organizations and similar institutions potentially enable those groups to extract price discounts on the Company’s products. The result of these developments may have a material adverse effect on the Company’s business, financial position, and operating results.

 

The use of legal, regulatory, and legislative strategies by competitors, both branded and generic, including “authorized generics,” citizen’s petitions, and legislative proposals, may increase the costs to develop and market the Company’s generic products, could delay or prevent new product introductions, and could reduce significantly the Company’s profit potential. These factors could have a material adverse effect on the Company’s business, financial position, and operating results.

 

The Company’s competitors, both branded and generic, often pursue legal, regulatory, and/or legislative strategies to prevent or delay competition from generic alternatives to branded products. These strategies include, but are not limited to:

 

entering into agreements whereby other generic companies will begin to market an authorized generic, a generic equivalent of a branded product, at the same time generic competition initially enters the market;

launching a generic version of their own branded product at the same time generic competition initially enters the market;

filing citizen petitions with the FDA or other regulatory bodies, including timing the filings so as to thwart generic competition by causing delays of generic product approvals;

seeking to establish regulatory and legal obstacles that would make it more difficult to demonstrate bioequivalence or meet other approval requirements;

initiating legislative and regulatory efforts to limit the substitution of generic versions of branded pharmaceuticals;

filing suits for patent infringement that may delay regulatory approval of generic products;

introducing “next-generation” products prior to the expiration of market exclusivity for the reference product, which often materially reduces the demand for the first generic product;

obtaining extensions of market exclusivity by conducting clinical trials of branded drugs in pediatric populations or by other potential methods;

persuading regulatory bodies to withdraw the approval of branded name drugs for which the patents are about to expire, thus allowing the branded company to obtain new patented products serving as substitutes for the products withdrawn; and

seeking to obtain new patents on drugs for which patent protection is about to expire.

 

If the Company cannot compete with such strategies, its business, financial position, and operating results could be adversely impacted.

 

The pharmaceutical industry is subject to regulation by various federal authorities, including the FDA and the DEA, and state governmental authorities. Failure to comply with applicable legal and regulatory requirements can lead to sanctions which could have a material adverse effect on the Company’s business, financial position and operating results.

 

20  

 

Federal and state statutes and regulations govern or influence the testing, manufacturing, packing, labeling, storage, record keeping, safety, approval, advertising, promotion, sale, and distribution of the Company’s products. Noncompliance with applicable legal and regulatory requirements can trigger action by various federal authorities, including the FDA and the DEA, as well as state governmental authorities. This can lead to a broad range of consequences which could have a material adverse effect on the Company’s business, financial position and operating results. The potential sanctions include warning letters, fines, seizure of products, product recalls, total or partial suspension of production and distribution, refusal to approve NDAs/ANDAs or other applications or revocation of approvals previously granted, withdrawal of product from marketing, injunctions, withdrawal of licenses or registrations necessary to conduct business, disqualification from supply contracts with the government, civil penalties, debarment, and criminal prosecution.

 

The Company’s research, product development, and manufacturing activities involve the controlled use of hazardous materials, and it may incur significant costs in complying with numerous laws and regulations.

 

The Company is subject to laws and regulations enforced by the FDA and the DEA, and other regulatory statutes including the Occupational Safety and Health Act (“OSHA”), the Environmental Protection Act, the Toxic Substances Control Act, the Resource Conservation and Recovery Act, and other current and potential federal, state, local, and foreign laws and regulations governing the use, manufacture, storage, handling, and disposal of its products, materials used to develop and manufacture such products, and resulting waste products.

 

The Company cannot completely eliminate the risk of contamination or injury, by accident or as the result of intentional acts, from these materials. In the event of an accident, the Company could be held liable for any damages that result, and any resulting liability could exceed its resources. The Company may also incur significant costs in complying with environmental laws and regulations in the future. The Company is also subject to laws generally applicable to businesses, including but not limited to, federal, state, and local regulations relating to wage and hour matters, employee classification, mandatory healthcare benefits, unlawful workplace discrimination, and whistle-blowing. Any actual or alleged failure to comply with any regulation applicable to our business or any whistle-blowing claim, even if without merit, could result in costly litigation, regulatory action or otherwise harm our business, financial position, and operating results.

 

The Company relies on third parties to assist with its research and development projects and clinical studies. If these third parties do not perform as required or expected, we may not be able to obtain regulatory approval for or commercialize the subject products.

 

The Company relies on third parties to assist with its clinical studies. If these third parties do not perform as required or expected, or if they are not in compliance with FDA rules and regulations, our clinical studies may be extended, delayed or terminated, or may need to be repeated, and we may not be able to obtain regulatory approval for or commercialize the products being tested in such studies. Further, we may be required to audit or redo previously completed trials or recall already-approved commercial products.

 

The Company may fail to obtain acceptable prices or appropriate reimbursement for its products and its ability to successfully commercialize its products may be impaired as a result.

 

21  

 

Government and insurance reimbursements for healthcare expenditures play an important role for all healthcare providers, including physicians, medical device companies, pharmaceutical companies, medical supply companies, and companies, such as the Company, that offer or plan to offer various products in the United States and other countries. The Company’s ability to earn sufficient returns on its products will depend in part on the extent to which reimbursement for the costs of such products, related therapies and related treatments will be available from government health administration authorities, private health coverage insurers, managed care organizations, and other organizations. In the United States, the Company’s ability to have its products and related treatments and therapies eligible for Medicare or private insurance reimbursement is and will remain an important factor in determining the ultimate success of its products. If, for any reason, Medicare or the insurance companies decline to provide reimbursement for the Company’s products and related treatments, the Company’s ability to commercialize its products would be adversely affected. There can be no assurance that the Company’s products and related treatments will be eligible for reimbursement.

 

There has been a trend toward declining government and private insurance expenditures for many healthcare items. Third-party payers are increasingly challenging the price of medical products and services.

 

If purchasers or users of the Company’s products and related treatments are not able to obtain appropriate reimbursement for the cost of using such products and related treatments, they may forgo or reduce such use. Even if the Company’s products and related treatments are approved for reimbursement by Medicare and private insurers, as is the case with AGGRASTAT®, the amount of reimbursement may be reduced at times, or even eliminated. This would have a material adverse effect on the Company’s business, financial condition, and results of operations.

 

Significant uncertainty exists as to the reimbursement status of newly approved healthcare products, and there can be no assurance that adequate third-party coverage will be available for new products developed or acquired by the Company.

 

The Company does not have significant manufacturing experience and has limited marketing resources and may never be able to successfully manufacture or market certain of its products.

 

The Company has limited experience in commercial manufacturing and has limited resources for marketing or selling its products. The Company may never be able to successfully manufacture and market certain of its development products. If any other of its development products are approved for sale, the Company intends to contract with and rely on third parties to manufacture, and possibly also to market and sell its products. Accordingly, the quality, timing and commercial success of such products may be outside of the Company’s control. Failure of, or delays by, a third-party manufacturer to comply with good manufacturing practices or similar quality control regulations or satisfy regulatory inspections may have a material adverse effect on the Company and its products. Failure of, or delays by, a third party in the marketing or selling of the Company’s products or failure of the Company to successfully market and sell such products likewise may have a material adverse effect on the Company and its products.

 

The Company has limited product liability insurance and may not be able to obtain adequate product liability insurance in the future.

 

22  

 

The sale and use of the Company’s commercial and development products, and the conduct of clinical studies involving human subjects, entails product and professional liability risks that are inherent in the testing, production, marketing and sale of pharmaceuticals to humans. While the Company has taken, and intends to continue to take, what it believes are appropriate precautions, there can be no assurance that it will avoid significant liability exposure. Although the Company currently carries product liability insurance, there can be no assurance that it has sufficient coverage, or can in the future obtain sufficient coverage at a reasonable cost. An inability to obtain insurance on economically feasible terms or to otherwise protect against potential product liability claims could inhibit or prevent the commercialization of products developed by the Company. The obligation to pay any product liability claim or recall for a product may have a material adverse effect on its business, financial condition and future prospects. In addition, even if a product liability claim is not successful, adverse publicity and the time and expense of defending such a claim may significantly impact the Company’s business.

 

If the Company is unable to successfully protect its intellectual proprietary rights, its competitive position will be adversely affected.

 

The patent positions of pharmaceutical companies are generally uncertain and involve complex legal, scientific and factual issues. The Company’s success depends significantly on its ability to:

 

a) obtain and maintain U.S. and foreign patents, including defending those patents against adverse claims;

b) secure patent term extensions for the patents covering its approved products;

c) protect trade secrets;

d) operate without infringing the proprietary rights of others; and

e) prevent others from infringing its proprietary rights.

 

The Company’s success will depend to a significant degree on its ability to obtain and protect its patents and protect its proprietary rights in unpatented trade secrets.

 

The Company owns or jointly owns numerous patents from the United States Patent Office and other jurisdictions. The Company has additional pending United States patent applications along with applications pending in other jurisdictions. The Company’s pending and any future patent applications may not be accepted by the United States Patent and Trademark Office or any other jurisdiction in which applications may be filed. Also, processes or products that may be developed by the Company in the future may not be patentable. Errors or ill-advised decisions by Company staff and/or contracted patent agents may also affect the Company’s ability to obtain or maintain valid patent protection.

 

The patent protection afforded to biotechnology and pharmaceutical companies is uncertain and involves many complex legal, scientific and factual questions. There is no clear law or policy involving the degree of protection afforded under patents. As a result, the scope of patents issued to the Company may not successfully prevent third parties from developing similar or competitive products. Competitors may develop similar or competitive products that do not conflict with the Company’s patents. Litigation may be commenced by the Company to prevent infringement of its patents. Litigation may also commence against the Company to challenge its patents that, if successful, may result in the narrowing or invalidating of such patents. It is not possible to predict how any patent litigation will affect the Company’s efforts to develop, manufacture or market its products. However, the cost of litigation to prevent infringement or uphold the validity of any patents issued to the Company may be significant, in which case its business, financial condition and results of operations may suffer. Patents provide protection for only a limited period of time, and much of such time can occur well before commercialization commences.

 

23  

 

The U.S. Congress is considering patent reform legislation. In addition, the U.S. Supreme Court has ruled on several patent cases in recent years, either narrowing the scope of patent protection available in certain circumstances or weakening the rights of patent owners in certain situations. This combination of events has created uncertainty with respect to the value of patents, once obtained, and the Company’s ability to obtain patents in the future. Depending on decisions by the U.S. Congress, the federal courts, and the United States Patent and Trademark Office, the laws and regulations governing patents could change in unpredictable ways that would weaken the Company’s ability to obtain new patents or to enforce its existing patents and patents that it might obtain in the future.

 

Disclosure and use of the Company’s proprietary rights in unpatented trade secrets not otherwise protected by patents are generally controlled by written agreements. However, such agreements will not provide the Company with adequate protection if they are not honoured, others independently develop an equivalent technology, disputes arise concerning the ownership of intellectual property, or its trade secrets are disclosed improperly. To the extent that consultants or other research collaborators use intellectual property owned by others in their work with the Company, disputes may also arise as to the rights to related or resulting know-how or inventions.

 

Others could claim that the Company infringes on their proprietary rights, which may result in costly, complex and time-consuming litigation.

 

The Company’s success will depend partly on its ability to operate without infringing upon the patents and other proprietary rights of third parties. The Company is not currently aware that any of its products or processes infringes the proprietary rights of third parties. However, despite its best efforts, the Company may be sued for infringing on the patent or other proprietary rights of third parties at any time in the future.

 

Such litigation, with or without merit, is time-consuming and costly and may significantly impact the Company’s financial condition and results of operations, even if it prevails. If the Company does not prevail, it may be required to stop the infringing activity or enter into a royalty or licensing agreement, in addition to any damages it may have to pay. The Company may not be able to obtain such a license or the terms of the royalty or license may be burdensome for it, which may significantly impair the Company’s ability to market its products and adversely affect its business, financial condition and results of operations.

 

The Company is subject to stringent governmental regulation, in the future may become subject to additional regulations and if it is unable to comply, its business may be materially harmed.

 

Pharmaceutical companies operate in a high-risk regulatory environment. The FDA and other national health agencies can be very slow to approve a product and can also withhold product approvals. In addition, these health agencies also oversee many other aspects of the Company’s operations, such as research and development, manufacturing, and testing and safety regulation of products. As a result, regulatory risk is normally higher than in other industry sectors.

 

The Company is or may become subject to various federal, provincial, state and local laws, regulations and recommendations. The Company and third parties providing manufacturing, research and/or development services to the Company is subject to various laws and regulations, relating to product emissions, use and disposal of hazardous or toxic chemicals or potentially hazardous substances, infectious disease agents and other materials, and laboratory and manufacturing practices used in connection with the activities. If the Company, or its contracted third party, fails to comply with these regulations, the Company may be fined or suffer other consequences that could materially affect the Company’s business, financial condition or results of operations.

 

24  

 

The pharmaceutical sales and marketing industry within which the Company operates is a complex legal and regulatory environment. The failure to comply with applicable laws, rules and regulations may result in civil and criminal legal proceedings. As those rules and regulations change or as governmental interpretation of those rules and regulations evolve, prior conduct may be called into question. The Company may become subject of federal and/or state governmental investigations into pricing, marketing, and reimbursement of its prescription drug product. Any such investigation could result in related restitution or civil litigation on behalf of the federal or state governments, as well as related proceedings initiated against the Company by or on behalf of consumers and private payers. Such proceedings may result in trebling of damages awarded or fines in respect of each violation of law. Criminal proceedings may also be initiated against the Company. Any of these consequences could materially and adversely affect the Company’s financial results.

 

The Company is unable to predict the extent of future government regulations or industry standards; however, it should be assumed that government regulations or standards will increase in the future. New regulations or standards may result in increased costs, including costs for obtaining permits, delays or fines resulting from loss of permits or failure to comply with regulations.

 

The Company’s products may not gain market acceptance, and as a result it may be unable to generate significant revenues.

 

As at December 31, 2019, the Company has several products in development which do not have the required manufacturing approvals or capabilities, clinical data and regulatory approvals necessary to be marketed in any jurisdiction; future clinical or preclinical results may be negative or insufficient to allow the Company to successfully market any of its products under development; and obtaining needed data and results may take longer than planned, and may not be obtained at all.

 

Even if the Company’s products under development are approved for sale, they may not be successful in the marketplace. Market acceptance of any of the Company’s products will depend on a number of factors, including: demonstration of clinical effectiveness and safety; the potential advantages of its products over alternative treatments; the availability of acceptable pricing and adequate third-party reimbursement; and the effectiveness of marketing and distribution methods for the products. Providers, payors or patients may not accept the Company’s products, even if they prove to be safe and effective and are approved for marketing by the FDA and other national regulatory authorities. The Company’s initial development product, SNP, became commercially available during the third quarter of 2019 in the United States with initial sales beginning in early 2020. If the Company’s products do not gain market acceptance among physicians, patients, and others in the medical community, its ability to generate significant revenues from its products would be limited.

 

The Company may not achieve its projected development and commercial goals in the time frames it announces and expects.

 

25  

 

The Company sets goals for and may from time to time make public statements regarding timing of the accomplishment of objectives related to AGGRASTAT®, ZYPITAMAGTM ReDSTM, SNP and/or its products under development, that are material to the Company’s success, such as the commencement and completion of clinical trials, anticipated regulatory approval dates, and timing of product launches. The actual timing of these events can vary dramatically due to factors such as delays or failures in the Company’s clinical trials, the uncertainties inherent in the regulatory approval process, and delays in achieving product development, manufacturing or marketing milestones. There can be no assurance that the Company’s clinical trials will be completed, that it will make regulatory submissions or receive regulatory approvals as planned, or that it will be able to adhere to its current schedule for the scale-up of manufacturing and launch of any of its products. If the Company fails to achieve one or more of these milestones as planned, that could materially affect its business, financial condition or results of operations.

 

The Company’s business involves the use of hazardous material, which requires it to comply with environmental regulations.

 

The Company’s research and development processes and commercial activities may involve the controlled storage, use, and disposal of hazardous materials and hazardous biological materials. The Company and the third-party service providers conducting manufacturing, research and development for the Company, are subject to laws and regulations governing the use, manufacture, storage, handling, and disposal of such materials and certain waste products. Although the Company believes that its safety procedures for handling and disposing of such materials comply with the standards prescribed by such laws and regulations, the risk of accidental contamination or injury from these materials cannot be completely eliminated. In the event of such an accident, the Company could be held liable for any damages that result, and any such liability could exceed its resources. There can be no assurance that the Company will not be required to incur significant costs to comply with current or future environmental laws and regulations, or that its business, financial condition, and results of operations will not be materially or adversely affected by current or future environmental laws or regulations.

 

The Company’s insurance may not provide adequate coverage with respect to environmental matters.

 

Environmental regulations could have a material adverse effect on the results of the Company’s operations and its financial position.

 

The Company is subject to a broad range of environmental regulations imposed by federal, state, provincial, and local governmental authorities. Such environmental regulation relates to, among other things, the handling and storage of hazardous materials, the disposal of waste, and the discharge of contaminants into the environment. Although the Company believes that it is in material compliance with applicable environmental regulation, as a result of the potential existence of unknown environmental issues and frequent changes to environmental regulation and the interpretation and enforcement thereof, there can be no assurance that compliance with environmental regulation or obligations imposed thereunder will not have a material adverse effect on the Company in the future.

 

The Company operates in an industry that is more susceptible to legal proceedings. The Company may become involved in litigation.

 

26  

 

The Company operates in an industry consisting of firms that are more susceptible to legal proceedings than firms in other industries. This susceptibility is due to several factors, including but not limited to, the fact that the Company’s shares and those of its competitors are publicly traded, and the uncertainty and complex regulatory environment involved in the development and sale of pharmaceuticals. The Company intends to vigorously defend such actions if and when they arise. Defense and prosecution of legal claims can be expensive and time consuming, may adversely affect the Company regardless of the outcome due to the diversion of financial, management and other resources away from the Company’s primary operations, and could impact the Company’s ability to continue as a going concern in the longer term. In addition, a negative judgment against the Company, even if the Company is planning to appeal such a decision, or even a settlement in a case, could negatively affect the cash reserves of the Company, and could have a material negative effect on the development and sale of its products.

 

Indemnification obligations to the Company’s directors and senior management may adversely affect its financial condition.

 

The Company has entered into agreements pursuant to which it will indemnify the directors and senior management in respect of certain claims made against them while acting in their capacity as such. If the Company is called upon to perform its indemnity obligations, the Company’s financial condition will be adversely affected. The Company is not currently aware of any matters pending or under consideration that may result in indemnification payments to any of its present or former directors or senior management.

 

The Company is exposed to foreign exchange movements since all of its sales are denominated in U.S. currency.

 

The majority of the Company’s sales revenues and a substantial portion of its selling, general and administrative expenses are denominated in U.S. dollars. The Company does not utilize derivatives, such as foreign currency forward contracts and futures contracts, to manage its exposure to currency risk and as a result a change in the value of the Canadian dollar against the U.S. dollar could have a negative impact on the Company’s business prospects, financial results and financial condition. In the future, the Company may begin to utilize foreign exchange rate mitigation and management strategies, however any such efforts, if they are not based on accurate predictions of future fluctuations in foreign exchange rates, may actually have a negative impact on the Company.

 

The Company may need to raise additional capital through the sale of its securities, resulting in dilution to its existing shareholders. Such funds may not be available, or may not be available on reasonable terms, adversely affecting the Company’s operations.

 

To meet future cash needs or product acquisition requirements the Company may need to rely on the taking on of debt and/or the sale of such securities for future financing, resulting in dilution to its existing shareholders. The Company’s long-term capital requirements may be significant and will depend on many factors, including revenue and revenue growth, continued scientific progress in its product discovery and development program, progress in the maintenance and expansion of its sales and marketing capabilities, progress in its pre-clinical and clinical evaluation of products and product candidates, time and expense associated with filing, prosecuting and enforcing its patent claims and costs associated with obtaining regulatory approvals. In order to meet such capital requirements, the Company will consider contract fees, collaborative research and development arrangements, debt financing, public financing or additional private financing (including the issuance of additional equity securities) to fund all or a part of particular programs.

 

The Company is exposed to risks given its significant dependence on revenue from the sale of AGGRASTAT®.

 

27  

 

The Company is largely dependent upon revenue from the sale of AGGRASTAT®. If revenue from the sale of AGGRASTAT® is not maintained, the Company may have to reduce substantially or eliminate expenditures for research and development, testing, production and marketing of its proposed products, or obtain funds through arrangements with corporate partners that require it to relinquish rights to certain of its technologies, assets or products.

 

The Company’s effective tax rates could increase.

 

The Company has operations in various countries that have differing tax laws and rates. The Company’s tax reporting is supported by current domestic tax laws in the countries in which the Company operates and the application of tax treaties between the various countries in which the Company operates. The Company’s income tax reporting is subject to audit by domestic and foreign authorities. The effective tax rate of the Company may change from year to year based on changes in the mix of activities and income earned among the different jurisdictions in which the Company operates, changes in tax laws in these jurisdictions, changes in the tax treaties between various countries in which the Company operates, changes in the Company’s eligibility for benefits under those tax treaties and changes in the estimated values of tax provisions and deferred tax assets. Tax laws, regulations and administrative practices in various jurisdictions may be subject to significant change, with or without notice, due to economic, political and other conditions, and significant judgment is required in evaluating and estimating our provision and accruals for these taxes. Such changes could result in a substantial increase in the effective tax rate on all or a portion of the Company’s income.

 

The Company’s provision for income taxes is based on certain estimates and assumptions made by management. The Company’s consolidated income tax rate is affected by the amount of pre-tax income earned in our various operating jurisdictions, the availability of benefits under tax treaties, and the rates of taxes payable in respect of that income. The Company enters into many transactions and arrangements in the ordinary course of business in respect of which the tax treatment is not entirely certain. The Company therefore makes estimates and judgements based on knowledge and understanding of the applicable tax laws and tax treaties and the application of those tax laws and tax treaties to the Company’s business, in determining the Company’s consolidated tax provision. For example, certain countries could seek to tax a greater share of income than the Company will allocate to the business in such countries. The final outcome of any audits by taxation authorities may differ from the estimates and assumptions that the Company may use in determining our consolidated tax provisions and accruals. This could result in a material adverse effect on the Company’s consolidated income tax provision, financial condition and the net income for the period in which such determinations are made.

 

The Company’s provision for tax liabilities, deferred tax assets and any related valuation allowances are effect by events and transactions arising in the ordinary course of business, acquisitions of assets and businesses and non recurring items. The assessment of the appropriate amount of valuation allowance against the deferred tax assets is dependent upon several factors, including estimates of the realization of deferred income tax assets, which realization will be primarily based on future taxable income, including the reversal of existing taxable temporary differences. Significant judgement is applied to determine the appropriate amount of valuation allowance to record. Changes in the amount of any valuation allowance required could materially increase or decrease our provision for income taxes in a given period.

 

Future issuance of the Company’s common shares will result in dilution to its existing shareholders. Additionally, future sales of the Company’s common shares into the public market may lower the market price which may result in losses to its shareholders.

 

28  

 

As of December 31, 2019, the Company had 10,804,013 common shares issued and outstanding. A further 1,428,408 common shares are issuable upon exercise of outstanding stock options (of which 1,059,308 were exercisable at December 31, 2019) and another 900,000 common shares are issuable upon exercise of share purchase warrants, all of which may be exercised in the future resulting in dilution to the Company’s shareholders. The Company’s stock option plan allowed for the issuance of stock options to purchase up to a maximum of 20% of the outstanding common shares at the time of the approval of the stock option plan, which resulted in a fixed number of stock options allowed to be granted totaling 2,934,403.

 

By Articles of Amendment filed by the Company under the Canada Business Corporations Act on November 1, 2012, a consolidation of shares was completed to reduce the total number of outstanding shares.

 

On May 16, 2018, the Company announced that the TSX-V accepted the Company’s notice of its intention to make a normal course issuer bid (the “2018 NCIB”). Under the terms of the 2018 NCIB, the Company could have acquired up to an aggregate of 794,088 common shares, representing five percent of the common shares outstanding at the time of the application, over the twelve-month period that the 2018 NCIB was in place. The 2018 NCIB commenced on May 28, 2018 and ended on May 27, 2019. During the twelve months of the 2018 NCIB, the Company purchased and cancelled 771,900 common shares for a total cost of $5.1 million. The prices that the Company paid for the common shares purchased was the market price of the shares at the time of purchase.

 

On May 30, 2019, the Company announced that the TSX-V accepted the Company’s notice of intention to make an additional normal course issuer bid (the “2019 NCIB”). Under the terms of the 2019 NCIB, the Company may acquire up to an aggregate of 761,141 common shares, representing five percent of the common shares outstanding at the time of the application, over the twelve-month period that the 2019 NCIB is in place. The 2019 NCIB commenced on May 30, 2019 and will end on May 29, 2020, or on such earlier date as the Company may complete its maximum purchases allowed under the 2019 NCIB. From the commencement of the 2019 NCIB, the Company purchased and cancelled 421,300 common shares for a total cost of $2.1 million. The prices that the Company paid or will pay for common shares purchased was or will be the market price of the shares at the time of purchase.

 

During the year ended December 31, 2019, the Company repurchased and cancelled 751,800 (2018 – 441,400), common shares as a result of the 2018 NCIB and 2019 NCIB. The aggregate price paid for these common shares totaled $4.1 million (2018 - $3.0 million). During the year ended December 31, 2019 the Company recorded $1.8 million (2018 - $480,000) directly in its retained deficit representing the difference between the aggregate price paid for these common shares and a reduction of the Company’s share capital totaling $6.0 million (2018 - $3.5 million).

 

On December 20, 2019, the Company completed a Substantial Issuer Bid (“SIB”) pursuant to which the Company purchased 4,000,000 of its common shares for cancellation at a set purchase price of $6.50 per common share for a total purchase price of $26.0 million in cash. The Company incurred an additional $139,000 on transaction costs related to the SIB for a total aggregate purchase price paid of $26.1 million. During the year ended December 31, 2019, the Company recorded $5.5 million directly in its deficit representing the difference between the aggregate price paid for these common shares and a reduction of the Company’s share capital totaling $31.6 million.

 

However, as described above, the Company may from time to time be required to finance its operations through the sale of equity securities. In addition, it may be required to issue equity securities as consideration for services or asset acquisition transactions. Sales of substantial amounts of the Company’s common shares into the public market, or even the perception by the market that such sales may occur, may lower the market price of its common shares.

 

29  

 

The Company’s common shares may experience extreme price and volume volatility which may result in losses to its shareholders.

 

The Company’s common shares historically have been subject to extreme price and volume volatility. For example, during the period from January 1, 2019 to December 31, 2019, the high and low closing trading prices of the Company’s common shares on the TSX-V were CDN$6.85 and CDN$3.05 respectively, with a total trading volume of 1,979,700 shares. Daily trading volume on the TSX-V of the Company’s common shares for the period from January 1, 2019 to December 31, 2019 has fluctuated, with a high of 323,400 shares and a low of no shares traded, averaging approximately 7,887 shares per trading day.

 

The Company expects that the trading price of its common shares will continue to be subject to wide fluctuations in response to a variety of factors including announcement of material events by the Company, such as the dependence of revenue on a single product, the status of required regulatory approvals for its products, competition by new products or new innovations, fluctuations in its operating results, general and industry-specific economic conditions and developments pertaining to patent and proprietary rights. The trading price of the Company’s common shares may be subject to wide fluctuations in response to a variety of factors and/or announcements concerning such factors, including:

 

actual or anticipated period-to-period fluctuations in financial results;

 

litigation or threat of litigation;

 

failure to achieve, or changes in, financial estimates of individual investors and/or by securities analysts;

 

new or existing products or generic equivalents to products or services or technological innovations by the Company or its competitors;

 

comments or opinions by securities analysts or major shareholders;

 

conditions or trends in the pharmaceutical, biotechnology and life science industries;

 

significant acquisitions, strategic partnerships, joint ventures or capital commitments;

 

results of, and developments in, the Company’s manufacturing, research and development efforts, including results and adequacy of, and developments in, its manufacturing activities, development activities, clinical trials and applications for regulatory approval;

 

additions or departures of key personnel;

 

sales of the Company’s common shares, including by holders of the notes on conversion or repayment by the Company in common shares;

 

economic and other external factors or disasters or crises;

 

limited daily trading volume; and

 

developments regarding the Company’s patents or other intellectual property or that of its competitors.

 

30  

 

In addition, the securities markets in the United States and Canada have recently experienced a high level of price and volume volatility, and the market price of securities of pharmaceutical companies have experienced wide fluctuations in price which have not necessarily been related to the operating performance, underlying asset values or prospects of such companies.

 

There may not be an active, liquid market for the Company’s common shares.

 

There is no guarantee that an active trading market for the Company’s common shares will be maintained on the TSX-V. Investors may not be able to sell their shares quickly or at the latest market price if trading in its common shares is not active.

 

If there are substantial sales of the Company’s common shares, the market price of its common shares could decline.

 

Sales of substantial numbers of the Company’s common shares could cause a decline in the market price of its common shares. The Company has two significant shareholders that each own more than 10% of the outstanding common shares of the Company as of December 31, 2019. Any sales by existing shareholders or holders of options or warrants may have an adverse effect on the Company’s ability to raise capital and may adversely affect the market price of its common shares.

 

The Company has no history of paying dividends, does not intend to pay dividends in the foreseeable future and may never pay dividends.

 

Since incorporation, the Company has not paid any cash or other dividends on its common shares and does not expect to pay such dividends in the foreseeable future as all available funds will be invested to finance the growth of its business. The Company will need to achieve significant and prolonged profitability prior to any dividends being declared, which may never happen.

 

If the Company is classified as a “passive foreign investment company” for United States federal income tax purposes, it could have significant and adverse tax consequences to United States holders of its common shares.

 

The Company believes it was a “passive foreign investment company” (“PFIC”) in one or more previous taxable years, but does not believe that it was a PFIC for the taxable years ended December 31, 2019 or December 31, 2018, and does not expect that it will be a PFIC for the taxable year ending December 31, 2020. (See more detailed discussion in Item 10E – Taxation). However, there can be no assurance that the United States Internal Revenue Service (“IRS”) will not challenge the determination made by the Company concerning its PFIC status or that the Company will not be a PFIC for the current taxable year or any subsequent taxable year. U.S. Holders who own common shares of the Company while it is a PFIC could have significant and adverse tax consequences.

 

Risks associated with material weaknesses within the Company’s financial reporting and review process

 

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In connection with its review of the Company’s Internal Control over Financial Reporting, the Company has identified material weaknesses with the Company’s financial reporting and review process, involving the accounting and reporting for complex transactions, due to limited staff not allowing for appropriate reviews of such transactions. Any failure to remediate the material weaknesses, to implement the required new or improved control, or difficulties encountered in the implementation, could cause the Company to fail to meet its reporting obligations on a timely basis or result in material misstatements in the annual or interim financial statements. Inadequate internal control over financial reporting could also cause investors to lose confidence in the Company’s reported financial information, which could cause the Company’s stock price to decline.

 

New risks emerge from time to time. It is not possible for the Company’s management to predict all risks. The forward-looking statements contained in this document are made only as of the date of this document. The Company undertakes no obligation to update or revise any forward-looking statement, whether as a result of new information, future events, or otherwise.

 

ITEM 4. INFORMATION ON THE COMPANY

 

A. History and Development of the Company

 

On December 22, 1999, the Company was formed by the amalgamation of Medicure Inc. with Lariat Capital Inc. pursuant to the provisions of the Business Corporations Act (Alberta). The Company was continued from Alberta to the federal jurisdiction by Certificate of Continuance issued pursuant to the provisions of the Canada Business Corporations Act on February 23, 2000.

 

The Company’s current legal and commercial name is Medicure Inc. and its current registered office and head office is 2-1250 Waverley Street, Winnipeg, Manitoba, Canada, R3T 6C6.

 

In August 2006, the Company acquired the U.S. rights to its first commercial product, AGGRASTAT® Injection (tirofiban hydrochloride) in the United States and its territories (Puerto Rico, Virgin Islands and Guam) for U.S. $19.0 million.

 

In September 2007, the Company monetized a percentage of its current and potential future commercial revenues by entering into a debt financing agreement with Birmingham Associates Ltd. (“Birmingham”), an affiliate of Elliott Associates, L.P. (“Elliott”) for proceeds of US$25 million. This debt was subsequently settled in July 2011 for consideration that included a royalty payable by the Company to Birmingham based on future commercial AGGRASTAT® sales until 2023. The royalty is based on four percent of the first $2.0 million of quarterly AGGRASTAT® sales, six percent on the portion of quarterly sales between $2.0 million and $4.0 million and eight percent on the portion of quarterly sales exceeding $4.0 million payable within 60 days of the end of the preceding quarter.

 

In February 2008, the Company announced that its pivotal Phase III MEND-CABG II clinical trials with MC-1 did not meet the primary endpoint and as a result was not sufficient to support the filings. As a result, the Company announced a restructuring plan that resulted in the organization reducing its head count by approximately 50 employees and full-time consultants. The restructuring and downsizing in March 2008 conserved capital for ongoing operations.

 

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Since March 2008, the Company has continued to focus on the sale and marketing of AGGRASTAT®. The Company has also explored and implemented a number of cost savings measures and has further downsized its operations. All these measures were initiated due to the restructuring plan announced towards the end of fiscal 2008. These activities assisted in further reducing the Company’s use of capital, in particular its investment in research and development programs, but have moved forward certain programs on a limited and focused fashion such as the development and implementation of a new clinical, product and regulatory strategy for AGGRASTAT® and the development of additional generic cardiovascular products.

 

During calendar years 2014, 2015 and 2016, as a part of its effort to expand sales of AGGRASTAT®, the Company began to significantly increase the number of employees and otherwise increase expenses related to sales and marketing of AGGRASTAT®, and related to General and Administrative costs of the Company.

 

On December 14, 2017 and subsequently up-dated on March 7, 2018, the Company announced it had acquired, from Zydus Cadila (“Zydus”), an exclusive license to sell and market a branded cardiovascular drug, ZYPITAMAGTM (pitavastatin magnesium) in the United States and its territories for a term of seven years with extensions to the term available. ZYPITAMAGTM is used for the treatment of patients with primary hyperlipidemia or mixed dyslipidemia and was approved earlier in 2017 by the FDA for sale and marketing in the United States. The Company launched the product using its existing commercial infrastructure during May 2018.

 

On January 28, 2019, the Company entered into an agreement with Sensible Medical Innovations Inc. (“Sensible”) to become the exclusive marketing partner for ReDS™ in the United States. ReDS™ is a non-invasive, FDA-cleared medical device that provides an accurate, actionable and absolute measurement of lung fluid which is important in the management of congestive heart failure. ReDS™ was already being marketed to United States hospitals by Sensible and the Company has begun marketing ReDS™ immediately using its existing commercial organization. Under the terms of the agreement, Medicure will receive a percentage of total U.S. sales revenue of the device and must meet minimum annual sales quotas.

 

The Company received approval in August of 2018 from the FDA for its first ANDA for SNP and Medicure’s product became available during the third quarter of 2019 in the United States with initial sales beginning in early 2020. As well, the Company is focused on the development of additional cardiovascular generic drugs which is expected to transform the Company’s commercial suite of products to more than five approved products in 2021.

 

In 2020, the Company plans to further maintain selling, general and administrative expenditure levels as it continues to focus on the sale of AGGRASTAT®, ZYPITAMAGTM, ReDSTM, and SNP and the development of additional generic cardiovascular products.

 

The Company’s future operations are dependent upon its ability to maintain sales of AGGRASTAT®, to increase sales of ZYPITAMAGTM, ReDSTM and SNP and the development and/or acquisition of new products and/or secure additional capital, which may not be available under favorable terms or at all.

 

If the Company is unable to maintain sales of AGGRASTAT®, grow sales of ZYPITAMAGTM, ReDSTM and SNP and develop and/or acquire new products, and/or raise additional capital, management will consider other strategies including cost curtailments, delays of research and development activities, asset divestures and/or monetization of certain intangible assets.

 

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On July 18, 2011, the Company borrowed $5,000,000 from the Government of Manitoba, under the Manitoba Industrial Opportunities Program (“MIOP”), to assist with settling the Company’s debt to Birmingham. Effective August 1, 2013, the Company renegotiated this debt and received an additional two-year deferral of principal repayments. Under the renegotiated terms, the loan continued to be interest only until August 1, 2015, when blended payments of principal and interest commenced, and the loan maturity date was extended to July 1, 2018. On November 6, 2017, the Company repaid the MIOP loan from funds on hand from the proceeds of the Apicore Sale Transaction.

 

On July 3, 2014, the Company and its newly formed and wholly owned subsidiary, Medicure U.S.A. Inc. (“Medicure USA”), entered into an arrangement whereby they acquired a minority interest in a pharmaceutical manufacturing business known as Apicore, along with an option to acquire all of the remaining issued shares within the next three years. Specifically, the Company and Medicure USA acquired a 6.09% equity interest (5.33% on a fully-diluted basis) in two newly formed holding companies of which Apicore LLC and Apicore US LLC were to be wholly-owned operating subsidiaries. The Company’s equity interest and certain other rights, including the option rights were obtained by the Company for services provided in its lead role in structuring a US$22.5 million majority interest purchase and financing of Apicore. There was no cash outflow in connection with the acquisition of the minority interest in Apicore. The business and operations of Apicore were distinct from the Company, and the Company’s primary operating focus continued to remain on the sale and marketing of AGGRASTAT®.

 

On November 17, 2016, in connection with the exercise of the Company’s acquisition of the controlling ownership in Apicore, the Company received a term loan (the “Term Loan”) from Crown Capital Fund IV LP, an investment fund managed by Crown Capital Partners Inc. (“Crown”) (TSX: CRN) for $60.0 million of which $30.0 million was syndicated to the Ontario Pension Board (“OPB”) a limited partner in Crown’s funds. Under the terms of the loan agreement with Crown, the loan bears interest at a fixed rate of 9.5% per annum, compounded monthly and payable on an interest only basis, maturing in 48 months, and is repayable in full upon maturity. On November 17, 2017, the Company repaid the Crown loan from funds on hand from the proceeds of the Apicore Sale Transaction. Additionally, the Company incurred an early prepayment penalty of $2.4 million relating to the early repayment of the Term Loan.

 

The Term Loan was used by the Company, acting through its wholly owned subsidiary, Medicure Mauritius Limited, to exercise the Company’s option rights to purchase interests in Apicore, Inc. and Apicore LLC. The 2016 Apicore Transaction was closed on December 1, 2016. Apicore, Inc. and Apicore LLC are affiliated entities that together operate the Apicore pharmaceutical business and are referred to together as “Apicore”. Apicore is a process research and development and Active Pharmaceutical Ingredients (“APIs”) manufacturing service provider for the worldwide pharmaceutical industry. The acquisition brought the Company’s indirect ownership interests in Apicore, Inc. to 64% (or approximately 59% on a fully diluted basis), and the Company’s indirect ownership in Apicore LLC. to 64% (basic and fully-diluted). Five percent of Medicure’s ownership in Apicore LLC was then held by Apigen Investments Limited (“Apigen”), a Company which owned 100 percent of Apicore LLC, before the Acquisition.

 

Medicure continued to have additional option rights until July 3, 2017 to acquire additional shares in Apicore, Inc. and Apicore LLC at predetermined prices consistent with the value reflected in the 2016 Apicore Transaction. On July 3, 2017, the Company announced that its option to acquire additional shares in Apicore, which otherwise would have expired, had been extended. The option covered an additional minority interest in Apicore (the “Minority Interest”) representing approximately 32% of the fully diluted shares of Apicore.

 

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On July 10, 2017, the Company, acting through Medicure Mauritius Limited, exercised the Company’s option rights to acquire the Minority Interest in Apicore Inc. and Apicore LLC from Apicore’s founding shareholders. The 2017 Apicore Transaction closed on July 12, 2017 and allowed for the acquisition of all of the shares of Apicore Inc. and Apicore LLC held by the founding shareholders (representing approximately 32% of the fully diluted ownership of Apicore) for US$24.5 million, being the price provided for under the option. This acquisition brought Medicure’s ownership in Apicore Inc. to approximately 98% (94% on a fully diluted basis).

 

On July 10, 2017, the Company announced that Apicore repaid the U.S.$9.8 million secured loan previously provided to Apicore by Medicure. Additionally, Apicore provided a U.S.$14.8 million loan to Medicure bearing interest at 12% per annum with a term of three years. These funds were obtained from Apicore’s current business which includes API sales, ANDA development partnership payments, and royalty and upfront payments from ANDA commercial partnerships. The loan proceeds were used by Medicure to help satisfy the purchase price of the 2017 Apicore Transaction.

 

During the year ended December 31, 2017, employees and former directors of Apicore exercised 292,500 stock options to acquire 292,500 Class E common shares of Apicore for gross proceeds to the company of U.S.$280,000. These shares, as well as 112,500 Class E common shares previously issued for gross proceeds of U.S.$48,000 were then purchased by the Company upon the employees and former directors exercising their put right to the Company. This resulted in the Company acquiring 405,000 Class E common shares of Apicore for a total cost of U.S.$2.0 million during 2017. As a result of the employees and former directors exercising their put right to the Company, the liability to repurchase Apicore Class E common shares on the statement of financial position in the Company’s consolidated financial statements was reduced.

 

On October 3, 2017, the Company announced that it sold its interests in Apicore (the “Sales Transaction”) to an arm’s length, pharmaceutical company (the “Buyer”). Under the Apicore Sale Transaction, the Company would receive net proceeds of approximately U.S.$105.0 million of which approximately U.S.$55.0 million was received on October 3, 2017, with the remainder to be received in early 2018. These funds received and to be received by the Company were after payment of all transaction costs, the cashing in of Apicore’s employee stock options, the redemption of the remaining shares of Apicore not owned by Medicure and other adjustments. Over the 18 months following the close of the transaction, additional payments could have become payable under the Apicore Sale Transaction, in the form of contingent payments, including an earn out payment based on the achievement of certain financial results by Apicore following closing and other customary adjustments.

 

On February 1, 2018, the Company announced that it had received the deferred purchase price proceeds of approximately U.S.$50.0 million from the Buyer as a result of the Apicore Sale Transaction. The U.S.$50.0 million was included in the total net proceeds of U.S.$105.0 million described earlier. The Company did not receive any contingent payments based on an earn out formula as certain financial results within the Apicore business were not met following the Apicore Sale Transaction.

 

On February 13, 2019, the Company announced that it had received notice from the purchaser of Medicure’s interests in Apicore of potential claims against funds held back in respect of representations and warranties under the Apicore sale agreement. The notice did not contain sufficiently detailed information to enable Medicure to assess the merits of the claims with the maximum exposure of the claims being the total holdback receivable. The Company continued to proceed diligently to investigate the potential claims and attempt to satisfactorily resolve them with a view to having the holdback funds released. In conjunction with the sale of Medicure’s interests in Apicore, representation and warranty insurance was obtained by the purchaser that could result in mitigation of the potential claims.

 

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On December 5, 2019, the Company announced that it had reached a settlement agreement with the purchaser of the Company’s interests in Apicore with respect to the amounts heldback under the Apicore sale agreement. A settlement agreement was reached under which Medicure will receive a net payment of U.S. $5.1 million in relation to the holdback.

 

The funds received from the Apicore sales transaction will be invested and used for business and product development purposes and to fund operations as needed as well as funding the purchase of common shares under the Company’s recently completed substantial issuer bid.

 

B. Business Overview

 

Plan of Operation

 

Medicure is a pharmaceutical company focused on the development and commercialization of therapies for the United States cardiovascular market. The Company’s present focus is the sale and marketing of its cardiovascular products, AGGRASTAT®, ZYPITAMAGTM and SNP and the sale and marketing of the ReDS PRO medical device. The products are distributed in the United States and its territories through the Company’s U.S. subsidiary, Medicure Pharma, Inc. The Company’s registered office and head office is located at 2-1250 Waverley Street, Winnipeg, Manitoba, R3T 6C6.

 

On September 30, 2019 the Company announced that through its subsidiary, Medicure International Inc., it has acquired the ownership of ZYPITAMAGTM from Zydus for U.S. and Canadian markets. Under terms of the agreement, Zydus will receive an upfront payment of U.S. $5.0 million and U.S. $2.0 million in deferred payments to be made over the next four years, as well as contingent payments on achievement of milestones and royalties related to net sales. With this acquisition Medicure obtained full control of marketing and pricing negotiations for the product.

 

Previously, on December 14, 2017, the Company acquired from Zydus, an exclusive license to sell and market ZYPITAMAGTM, a branded cardiovascular drug, in the United States and its territories for a term of seven years with extensions to the term available. ZYPITAMAGTM is used for the treatment of patients with primary hyperlipidemia or mixed dyslipidemia and was approved in July 2017 by the FDA for sale and marketing in the United States. On May 1, 2018 ZYPITAMAGTM became commercially available in retail pharmacies throughout the United States. The Company’s product launch utilized its existing commercial infrastructure and while not an in-hospital product like AGGRASTAT®, ZYPITAMAGTM added to the Company’s cardiovascular portfolio and expanded the Company’s reach to new patients. ZYPITAMAGTM contributed revenue of $183,000 to Company for the year ended December 31, 2019 and $652,000 of revenue to the Company during the year ended December 31, 2018. ZYPITAMAGTM is still in the early stages of its commercialization and the Company continues to work towards growing the ZYPITAMAGTM brand, usage of the product and revenues from ZYPITAMAGTM. The 2018 revenues were higher than those earned in 2019 due to the initial ordering by wholesaler customers of the product.

 

The Company received approval in August of 2019 from the FDA for its first ANDA for SNP and Medicure’s product became available during the third quarter of 2019 in the United States with initial sales beginning in early 2020.

 

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On January 28, 2019 the Company announced it had entered into an agreement with Sensible to become the exclusive marketing partner for ReDS™ in the United States. ReDSTM is a non-invasive, FDA-cleared medical device that provides an accurate, actionable and absolute measurement of lung fluid which is important in the management of congestive heart failure. The lung fluid measurements are used in guiding treatment and monitoring a heart failure patient’s condition and may lead to a significant decrease in readmissions and hospital costs. Clinical studies have shown an 87% reduction in heart failure readmission rates for patients using the ReDS system at home for three months post-discharge versus those who were treated with usual care alone. ReDS was already being marketed to U.S. hospitals by Sensible and Medicure began marketing ReDS immediately using its existing commercial organization. Under the terms of the agreement, Medicure receives a percentage of total U.S. sales revenue of the device and must meet minimum annual sales quotas.

 

In addition, Medicure invested U.S. $10 million in Sensible for a 7.71% equity stake on a fully diluted basis and in connection with this investment the Company acquired the license for ReDS™ in the United States. In connection with the investment, Medicure’s Chief Executive Officer, Dr. Albert Friesen, was appointed to the Board of Directors of Sensible.

 

The Company has considered indicators of impairment as at December 31, 2019 and recorded a write-down of intangible assets related to the ReDSTM license during the year ended December 31, 2019 totaling $6.3 million as a result of uncertainties with ReDSTM being experienced in regards to the length of the sales cycle and uptake of the product with customers, resulting in the Company’s sales being below the committed amounts required by the exclusive marketing and distribution agreement regarding ReDSTM. Additionally, a loss of $6.3 million was recorded within other comprehensive loss from the revaluation of the investment in Sensible made during the year ended December 31, 2019. Despite recording this impairment on the license over ReDSTM and the investment in Sensible Medical, the Company continues to market ReDS™ PRO and continues to work to safeguard or monetize the Company’s investment

 

The Company’s research and development program is focused on making selective research and development investments in certain additional acute cardiovascular generic and reformulation product opportunities, as well as continuing the development and implementation of its regulatory, brand and life cycle management strategy for AGGRASTAT®. The Company is also continuing to explore neurological treatment applications of its legacy product P5P (MC-1, TARDOXALTM). The Company is focused on the development of additional cardiovascular generic drugs which is expected to transform the Company’s commercial suite of products to five or more approved products in 2021.

 

The increased sales of AGGRASTAT® that was experienced over recent years and the staged acquisition and subsequent sale of the Apicore business completed in 2016 and 2017 dramatically improved the Company’s financial position compared to previous years. The Company completed a SIB in December of 2019 where it purchased and cancelled 4.0 million common shares at a set purchase price of $6.50 per common share resulting in the payment $26.0 million. After the closing of the transaction and despite lower cash balances and working capital levels, the Company’s financial position remains strong..

 

The ongoing focus of the Company includes the sale of AGGRASTAT®, ZYPITAMAGTM, ReDSPRO and SNP and the development of additional cardiovascular products. In parallel with the Company’s ongoing commitment to support AGGRASTAT®, its valued customers and the continuing efforts of the commercial organization, the Company is in the process of developing and further implementing its regulatory, brand and life cycle management strategy for AGGRASTAT®. The objective of this effort is to further expand AGGRASTAT®’s share of the glycoprotein GP IIb/IIIa (“GPI”) inhibitor market in the United States. GPIs are injectable platelet inhibitors used in the treatment of patients with acute coronary syndrome (“ACS”). The marketing and sales of ZYPITAMAGTM became a key focus of the Company during 2018 and throughout 2019 and the marketing and sales of ReDSTM became a key focus of the Company during the first quarter of 2019.

 

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The Company has historically financed its operations principally through the net revenue received from the sale of AGGRASTAT®, ZYPITAMAGTM and ReDSTM, the sale of its equity securities, the issuance and subsequent exercises of warrants and stock options, interest on excess funds held and the issuance of debt. As announced on October 3, 2017, the Company sold the Apicore business for net proceeds to Medicure of approximately U.S. $105.0 million, as well as additional contingent payments. The funds generated from the sale of Apicore were partially used to repay the Company’s long-term debt, fund the recently completed SIB and the remaining funds will continue to be used to finance the Company’s operations, development and growth moving forward.

 

Recent Developments

 

COVID-19

 

Subsequent to December 31, 2019, the outbreak of the novel strain of coronavirus, specifically identified as COVID-19, has resulted in governments worldwide enacting emergency measures to combat the spread of the virus. These measures, which include the implementation of travel bans, self-imposed quarantine periods and social distancing, have caused material disruption to businesses globally resulting in an economic slowdown. Global equity markets have experienced significant volatility and weakness. Governments and central banks have reacted with significant monetary and fiscal interventions designed to stabilize economic conditions. The duration and impact of the COVID-19 outbreak is unknown at this time, as is the efficacy of the government and central bank interventions. It is not possible to reliably estimate the length and severity of these developments and the impact on the liquidity, financial results and condition of the Company and its operating subsidiaries in future periods.

 

Substantial issuer bid

 

On November 4, 2019 the Company announced its intention to commence a SIB (the “Offer”) pursuant to which the Company offered to purchase up to 4.0 million of its common shares (the “Common Shares”) for cancellation at a set purchase price of $6.50 per Common Share for a total purchase price of up to $26.0 million in cash. The Offer commenced on November 13, 2019 and expired at 5:00 p.m. (Eastern Standard Time) on December 19, 2019.

 

A total of 10,154,952 Common Shares were properly deposited under the Offer and not withdrawn. As the Offer was oversubscribed, the Company purchased Common Shares deposited on a pro rata basis following the determination of the final results of the Offer. Tendering shareholders had approximately 39.4% of their tendered Common Shares purchased by the Company under the Offer. The Common Shares that were purchased under the Offer represented approximately 27.0% of the outstanding Common Shares as at the time that the Offer was commenced. After giving effect to the Offer, the Company had 10,804,013 Common Shares outstanding.

 

The Offer was funded from the Company’s existing cash on hand. The Company believed Medicure’s underlying value and its long-term growth prospects were not reflected in the trading price of its Common Shares prior to the announcement of the SIB. As such, Medicure believes that the purchase of Common Shares under the Offer represented a reasonable use of a portion of its significant cash resources resulting from the Company’s successful purchase and subsequent sale of the Apicore business.

 

During the ten months ended October 31, 2019, the closing prices of the Common Shares on the TSX Venture Exchange (“TSXV”) ranged from a low of $3.00 to a high of $6.85. The closing price of the Common Shares on the TSXV on November 1, 2019 (the last full trading day before the announcement of the SIB) was $3.22. The purchase price of $6.50 per Common Share represented a 101.9% premium over the closing price of the Common Shares on the TSXV on November 1, 2019.

 

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The Offer was optional for all shareholders, who were free to choose whether to participate and how many Common Shares to tender. Shareholders who did not deposit their Common Shares (or whose Common Shares were not purchased under the Offer) realized a proportionate increase in their equity interest in the Company.

 

As more than 4.0 million Common Shares were properly tendered to the Offer, Medicure took-up and paid for the tendered Common Shares on a pro-rata basis according to the number of Common Shares tendered (with adjustments to avoid the purchase of fractional Common Shares). The Offer was not conditional upon any minimum number of Common Shares being tendered but was subject to various other conditions disclosed in the Offer Documents.

 

Neither the Company nor its board of directors made any recommendation to any shareholder whether to tender or refrain from tendering Common Shares. Shareholders were strongly urged to read and carefully evaluate all information in the Offer Documents and to consult their own broker or other financial and tax advisors prior to making any decision with respect to the Offer.

 

The Company suspended its existing normal course issuer bid (“NCIB”) in connection with the commencement of the Offer and no subsequent purchases were completed under such NCIB prior to completion of the Offer.

 

The Company had engaged Computershare Trust Company of Canada to act as the depositary (the “Depository”) for the Offer. Any Common Shares deposited under the Offer but not purchased, including any Common Shares invalidly deposited, were returned to the depositing shareholders by the Depositary.

 

The full details of the Offer were described in the Company’s offer to purchase and issuer bid circular dated November 1, 2019, as well as the related letter of transmittal and notice of guaranteed delivery, copies of which are available on SEDAR under the Company’s profile at www.sedar.com and on EDGAR at www.sec.com.

 

Completion of SAVI-PCI study

 

On December 17, 2019, the Company announced the completion of the Shortened AGGRASTAT® (tirofiban hydrochloride) injection versus Integrilin® (eptifibatide) in Percutaneous Coronary Intervention (SAVI-PCI) Clinical Trial.

 

SAVI-PCI was a randomized, multicenter, open-label study enrolling 535 patients at thirteen sites in the United States, which compared tirofiban high-dose bolus injection followed by a maintenance infusion for 1-2 hours post-PCI to label-dosing eptifibatide (double bolus followed by 12-18 hour maintenance infusion). Comparisons to a long-infusion tirofiban arm (high-dose bolus injection followed by 12-18 hour maintenance infusion post-PCI) were also performed. The primary endpoint of the study was to assess whether the short infusion tirofiban regimen in patients undergoing PCI was non-inferior to the aforementioned eptifibatide regimen. The primary endpoint was a composite rate of death, periprocedural myonecrosis, urgent target vessel revascularization (uTVR) or in-hospital, non-CABG related major bleeding within 48 hours following PCI or hospital discharge, whichever comes first, quantified according to REPLACE-2 criteria. This study was sponsored by Medicure.

 

Topline results of the SAVI-PCI trial will be communicated in 2020.

 

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Completion of enrolment of the FABOLUS-FASTER trial

 

On December 12, 2019, the Company announced the completion of the FABOLUS-FASTER Phase 4 trial, a randomized, open-label, multi-center trial assessing different regimens of intravenous platelet inhibitors, notably tirofiban and cangrelor (an IV P2Y12 inhibitor) in the early phase of primary PCI. The study enrolled 120 patients. The Company expects to release top-line data in 2020.

 

FABOLUS-FASTER was funded by a grant from the Company. This study does not imply comparable efficacy, safety, or product interchangeability. Please note that the use of AGGRASTAT® in STEMI patients has not been approved by the FDA. As of this time, neither AGGRASTAT® nor any of the GP IIb/IIIa inhibitors are indicated for the use in STEMI patients. AGGRASTAT® is approved for use in NSTE-ACS patients.

 

Topline results of the FABOLUS-FASTER Phase 4 trial will be communicated in 2020.

 

Settlement of holdback receivable

 

On February 13, 2019, the Company announced that it had received notice from the purchaser of Medicure’s interests in Apicore of potential claims against funds held back in respect of representations and warranties under the Apicore sale agreement. The notice did not contain sufficiently detailed information to enable Medicure to assess the merits of the claims with the maximum exposure of the claims being the total holdback receivable. The Company continued to proceed diligently to investigate the potential claims and attempt to satisfactorily resolve them with a view to having the holdback funds released. In conjunction with the sale of Medicure’s interests in Apicore, representation and warranty insurance was obtained by the purchaser that could result in mitigation of the potential claims.

 

On December 5, 2019, the Company announced that it had reached a settlement agreement with the purchaser of the Company’s interests in Apicore with respect to the amounts heldback under the Apicore sale agreement. A settlement agreement was reached under which Medicure received a net payment of U.S. $5.1 million in relation to the holdback receivable.

 

Patent infringement filing

 

On December 5, 2019, the Company announced it had filed a patent infringement action against Nexus in the U.S. District Court for the Northern District of Illinois, alleging infringement of ‘660 patent.

 

The patent infringement action is in response to Nexus’ filing of an ANDA seeking approval from the FDA to market a generic version of AGGRASTAT® (tirofiban hydrochloride) injection before the expiration of the ‘660 patent.

 

The ‘660 patent is listed in FDA’s Orange Book for AGGRASTAT®. Medicure will vigorously defend the ‘660 patent and will pursue the patent infringement action against Nexus and all other legal options available to protect its product.

 

SMILE-HF study demonstrates use of ReDSTM results in reductions in hospital readmission rates

 

On October 15, 2019 the Company announced the primary results of the late-breaking SMILETM-Heart Failure (“SMILE-HF”) Clinical Trial which was presented at the Heart Failure Society of America (“HFSA”) conference in Philadelphia, Pennsylvania by Dr. William T. Abraham, the SMILE-HF national principal investigator.

 

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The SMILE-HF trial demonstrated that when used as intended, ReDS™ treatment guided heart failure management prevented 58% of heart failure readmission(s). Data was collected from 268 patients by 43 centers across the United States, constituting the largest randomized control trial to date on the impact of ReDS™ on managing heart failure. Patients were recruited for the study during hospitalization and followed for up to nine months at home. Daily measurements were taken using ReDS™ with the goal of keeping lung fluid content within the normal range of 20-35%. Data aggregated in the cloud was sent to physicians to monitor and adjust medication with the goal to keep each patient’s fluid status balanced and avoid hospital readmission.

 

Preferred pricing agreement for ZYPITAMAGTM with the ADAP Crisis Task Force

 

On October 3, 2019, the Company announced that it reached a preferred pricing agreement with the AIDS Drug Assistance Program (“ADAP”) Crisis Task Force for ZYPITAMAGTM. The agreement will open access to ZYPITAMAGTM tablets to low income, underinsured and uninsured Americans who qualify for ADAP coverage in states where ZYPITAMAGTM has been adopted onto the ADAP formulary.

 

The ADAP Crisis Task Force negotiates reduced drug prices for all ADAP formularies. ADAP formularies provide HIV treatment to low income, uninsured, and underinsured individuals living with HIV/AIDS in all 50 states and the US territories. The ADAP Crisis Task Force was formed in 2002, and is currently comprised of representatives from Arizona, California, Florida, Illinois, Massachusetts, New York, North Carolina, Tennessee, Texas, Virginia, and Washington state HIV/AIDS divisions.

 

Acquisition of full US ownership of ZYPITAMAGTM

 

On September 30, 2019 the Company announced that through its subsidiary, Medicure International Inc., it acquired the ownership of ZYPITAMAGTM from Cadila Healthcare Ltd., India (“Zydus”) for the U.S. and Canadian markets. Under terms of the agreement, Zydus will receive an upfront payment of U.S. $5.0 million and U.S. $2.0 million in deferred payments to be made over the next four years, as well as contingent payments on the achievement of milestones and royalties related to net sales.

 

Medicure previously had acquired U.S. marketing rights with a profit-sharing arrangement. With this acquisition Medicure obtained full control of marketing and pricing negotiations for the product.

 

Launch of ReDSTM PRO

 

On September 17, 2019 the Company announced the launch of the ReDSTM PRO (“ReDSTM PRO”) system, the next generation of lung fluid management technology for heart failure. The debut of the new system took place at the HFSA conference in Philadelphia, Pennsylvania. ReDSTM PRO is optimized for the point-of-care market, designed for use in hospitals and sub-acute facilities. ReDSTM PRO utilizes non-invasive low energy radio frequency technology that produces reliable fluid volume readings after only 45 seconds of measurement. The ReDSTM PRO can be utilized across the continuum of hospital care, from the emergency department to discharge and subacute rehabilitation.

 

Medicure previously announced, on January 28, 2019, that it had entered an agreement with Sensible to become the exclusive marketing partner for the ReDS™ point of care system in the United States, a non-invasive, FDA-cleared medical device that provides an accurate, actionable and absolute measurement of lung fluid which is important in the management of congestive heart failure. The ReDSTM PRO represents the next generation of this device.

 

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An impairment on the license over ReDSTM and the Company’s investment in Sensible was recorded during the year ended December 31, 2019, as a result of uncertainties with ReDSTM being experienced in regards to the length of the sales cycle and uptake of the product with customers, resulting in the Company’s sales being below the committed amounts required by the exclusive marketing and distribution agreement regarding ReDSTM. The Company is continuing to market the ReDS™ PRO for the clinical management of congestive heart failure and working to safeguard or monetize the investment in Sensible.

 

Settlement of Patent Infringement Action

 

On August 21, 2019 the Company announced that its subsidiary, Medicure International Inc., settled its ongoing patent infringement action against Gland in the U.S. District Court for the District of New Jersey, which alleged infringement of the ‘660 patent. As part of the settlement, Gland has acknowledged that the ‘660 patent is valid, enforceable and infringed. The settlement resulted in the Company entering into a license agreement with Gland with an anticipated launch date for Gland’s generic product of March 1, 2023. The remaining terms of the settlement are confidential.

 

The Company had filed the patent infringement action against Gland alleging infringement of the ‘660 patent. The patent infringement action was in response to Gland’s filing of an ANDA seeking approval from the FDA to market a generic version of AGGRASTAT® before the expiration of the ‘660 patent. The ‘660 patent is listed in the FDA’s orange book with an expiry date of May 1, 2023.

 

Grant of Stock Options

 

On June 26, 2019, the Company announced that the Board of Directors approved the grant of an aggregate of 262,000 stock options to certain directors, officers, employees and management company employees of the Company pursuant to its stock option plan. These options, which were subject to the approval of the TSX Venture Exchange, are set to expire on the fifth anniversary of the date of grant and were issued at an exercise price of $4.95 per share.

 

Appointment of President and Chief Operating Officer

 

On June 26, 2019, the Company announced that Dr. Neil Owens has been appointed President and Chief Operating Officer of the Company effective July 1, 2019. In this capacity, Dr. Owens will be responsible for implementing the Company’s strategic plans, and overseeing day-to-day operations, including the advancement and management of new and existing pharmaceutical products. Dr. Albert Friesen had served as the Company’s President since May of 2016 and will continue to serve as Chief Executive Officer of the Company and as Chair of its Board of Directors.

 

Normal Course Issuer Bid

 

On May 30, 2019, the Company announced that the TSXV has accepted the Company’s notice of intention to make a NCIB (the “2019 NCIB”).

 

Under the terms of the 2019 NCIB, Medicure could acquire up to an aggregate of 761,141 common shares. In the opinion of the Company, its common shares had been trading at prices that did not reflect its underlying value. Accordingly, Medicure believed that purchasing its common shares for cancellation, at the then present pricing, represented an opportunity to enhance value for its shareholders.

 

As of May 29, 2019, the Company had 15,222,813 common shares outstanding, of which 6,758,666 common shares represented the public float of Medicure. Under TSXV policies, Medicure was entitled to purchase up to the maximum of 761,141 common shares, representing 5% of the then common shares outstanding, over the 12-month period that the 2019 NCIB is in place.

 

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The 2019 NCIB commenced on May 30, 2019 and will end on May 29, 2020, or on such earlier date as Medicure may complete its maximum purchases under the 2019 NCIB. The actual number of common shares which will be purchased, if any, and the timing of such purchases will be determined by the Company. All common shares purchased by the Company will be purchased on the open market through the facilities of TSXV by PI Financial Corp. (“PI”) acting on behalf of the Company in accordance with the policies of the TSXV and will be surrendered by the Company to its transfer agent for cancellation. The prices that the Company paid or will pay for common shares purchased will be the market price of the shares at the time of purchase.

 

The Company also announced that it had entered into an automatic share purchase plan with PI (the “Plan”) in order to facilitate repurchases of its common shares under the 2019 NCIB. Under the Plan, PI may purchase common shares under the 2019 NCIB at times when the Company would ordinarily not be permitted to do so, due to regulatory restrictions or self-imposed blackout periods.

 

Purchases under the Plan will be made by PI based upon parameters prescribed by the TSXV, applicable Canadian securities laws and terms of the Plan.

 

During the year ended December 31, 2019, the Company purchased and cancelled 421,300 of its common shares between May 30, 2019 and December 31, 2019 for a total cost to the Company of $2.1 million under the 2019 NCIB.

  

The Company suspended the 2019 NCIB in connection with its commencement of the SIB and no subsequent purchases were completed under the 2019 NCIB for the remainder of 2019.

 

Under the Company’s previous NCIB, which expired on May 27, 2019, the Company purchased and cancelled 771,900 of its common shares between May 28, 2018 and May 27, 2019 for a total cost to the Company of $5.1 million.

 

Appointment of Ms. Manon Harvey to the Company’s Board of Directors

 

On May 15, 2019, the Company announced the appointment of Manon Harvey CPA, CA, to the Board of Directors. Ms. Harvey is a CPA, CA, and holds a Bachelor of Commerce (summa cum laude) from the University of Ottawa. Additionally, Ms. Harvey has her ICD.D designation from the Institute of Corporate Directors. In January 2019, she joined the University of British Columbia’s Okanagan Campus as Director, Integrated Planning and Chief Budget Officer where she is responsible for supporting the University’s mission through long range financial planning, financial advice and effective resource allocation strategies. For the prior 21 years as Vice-President, Finance and Corporate Services for the Canada Foundation for Innovation (“CFI”), Ms. Harvey was responsible for the finance function, human resources, information technology, and administrative services. She was an Officer of the CFI Board of Directors, and served as the Secretary and Treasurer. For over 10 years, until June 2014, she was both a member of the Board of Directors, as well as Chair of the Audit Committee, for Hydro Ottawa. She is an external member of the Departmental Audit Committee of the Royal Canadian Mounted Police.

 

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Agreement to Market ReDS Device

 

On January 28, 2019 the Company announced it had entered into an agreement with Sensible to become the exclusive marketing partner for ReDS™ in the United States. ReDSTM is a non-invasive, FDA-cleared medical device that provides an accurate, actionable and absolute measurement of lung fluid which is important in the management of congestive heart failure. The lung fluid measurements are used in guiding treatment and monitoring a heart failure patient’s condition and may lead to a significant decrease in readmissions and hospital costs. Clinical studies have shown an 87% reduction in heart failure readmission rates for patients using the ReDS system at home for three months post-discharge versus those who were treated with usual care alone. ReDS was already being marketed to U.S. hospitals by Sensible and Medicure began marketing ReDS immediately using its existing commercial organization. Under the terms of the agreement, Medicure receives a percentage of total U.S. sales revenue of the device and must meet minimum annual sales quotas.

 

In addition, Medicure invested U.S. $10.0 million in Sensible for a 7.71% equity stake on a fully diluted basis and in connection with this investment the Company acquired the license for ReDS™ in the United States. In connection with the investment, Medicure’s Chief Executive Officer, Dr. Albert Friesen, was appointed to the Board of Directors of Sensible.

 

An impairment on the license over ReDSTM and the Company’s investment in Sensible was recorded during the year ended December 31, 2019, as a result of uncertainties with ReDSTM being experienced in regards to the length of the sales cycle and uptake of the product with customers, resulting in the Company’s sales being below the committed amounts required by the exclusive marketing and distribution agreement regarding ReDSTM. The Company is continuing to market the ReDS™ PRO for the clinical management of congestive heart failure and working to safeguard or monetize the investment in Sensible.

 

Commercial:

 

In fiscal 2007, the Company through its wholly owned Barbadian subsidiary, Medicure International Inc., acquired the U.S. rights to its first commercial product, AGGRASTAT®, in the United States and its territories (Puerto Rico, Virgin Islands, and Guam). AGGRASTAT®, a GPI, is used for the treatment of ACS, including UA, which is characterized by chest pain when one is at rest, and non Q wave MI. AGGRASTAT® is indicated to reduce the rate of thrombotic cardiovascular events (combined endpoint of death, myocardial infarction, or refractory ischemia/repeat cardiac procedure) in patients with non ST elevation acute coronary syndrome (“NSTE ACS”). Under a contract with Medicure International Inc., the Company’s wholly owned U.S. subsidiary, Medicure Pharma Inc., continues to support, market and distribute the product.

 

Net AGGRASTAT® product sales for year ended December 31, 2019 were $19.4 million compared to $28.5 million during the year ended December 31, 2018.

 

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The Company currently sells finished AGGRASTAT® to drug wholesalers. These wholesalers subsequently sell AGGRASTAT® to hospitals where health care providers administer the drug to patients. Wholesaler management decisions to increase or decrease their inventory of AGGRASTAT® may result in sales of AGGRASTAT® to wholesalers that do not track directly with demand for the product at hospitals.

 

Hospital demand for AGGRASTAT® was lower during 2019 than the prior year however the number of new hospital customers using AGGRASTAT® continued to increase leading to patient market share held by the product increasing to approximately 67% as at December 31, 2019. The Company’s commercial team continues to work on expanding its customer base, however this continued increase in the customer base for AGGRASTAT® has not directly resulted in corresponding revenue increases as the Company continues to face increased competition resulting from further genericizing of the Integrilin market which has created pricing pressures on AGGRASTAT® combined with lower hospital demand for the product. The Company continues to expect strong performance from the AGGRASTAT® brand, due primarily to its patient market share, however diversifying revenues away from a single product became increasingly important to the Company.

 

The number of new customers reviewing and implementing AGGRASTAT® increased sharply since October 11, 2013 as a result of FDA approval of the High Dose Bolus (“HDB”) regimen for AGGRASTAT® and due to the increased marketing and promotional efforts of the Company.

 

As all of the Company’s sales are denominated in U.S. dollars and the U.S. dollar improved in value against the Canadian dollar when comparing the year ended December 31, 2019 with the year ended December 31, 2018, this led to increased AGGRASTAT® revenues, however this was offset by the increasing price pressures facing AGGRASTAT® when comparing the two periods as well as decreases in demand.

 

On December 5, 2019, the Company announced it had filed a patent infringement action against Nexus in the U.S. District Court for the Northern District of Illinois, alleging infringement of the ‘660 patent.

 

The patent infringement action is in response to Nexus’ filing of an ANDA seeking approval from the FDA to market a generic version of AGGRASTAT® before the expiration of the ‘660 patent.

 

The ‘660 patent is listed in the FDA’s orange book with an expiry date of May 1, 2023. Medicure will vigorously defend the ‘660 patent and will pursue the patent infringement action against Nexus and all other legal options available to protect its product.

 

Previously, on November 16, 2018, the Company filed a patent infringement action against Gland in the U.S. District Court for the District of New Jersey, alleging infringement of the ‘660 patent.

 

The patent infringement actions were in response to Gland’s filing of an ANDA seeking approval from the FDA to market a generic version of AGGRASTAT® before the expiration of the ‘660 patent.

 

On August 21, 2019 the Company announced that its subsidiary, Medicure International Inc., has settled this ongoing patent infringement action. As part of the settlement, Gland has acknowledged that the ‘660 patent is valid, enforceable and infringed. The settlement resulted in the Company entering into a license agreement with Gland with an anticipated launch date for Gland’s generic product of March 1, 2023. The remaining terms of the settlement are confidential.

 

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On September 30, 2019 the Company announced that through its subsidiary, Medicure International Inc., it has acquired the ownership of ZYPITAMAGTM from Zydus for U.S. and Canadian markets. Under terms of the agreement, Zydus will receive an upfront payment of U.S. $5.0 million and U.S. $2.0 million in deferred payments to be made over the next four years, as well as contingent payments on achievement of milestones and royalties related to net sales. With this acquisition Medicure obtained full control of marketing and pricing negotiations for the product.

 

Previously, on December 14, 2017, the Company acquired from Zydus, an exclusive license to sell and market ZYPITAMAGTM, a branded cardiovascular drug, in the United States and its territories for a term of seven years with extensions to the term available. ZYPITAMAGTM is used for the treatment of patients with primary hyperlipidemia or mixed dyslipidemia and was approved in July 2017 by the FDA for sale and marketing in the United States. On May 1, 2018 ZYPITAMAGTM became commercially available in retail pharmacies throughout the United States. The Company’s product launch utilized its existing commercial infrastructure and while not an in-hospital product like AGGRASTAT®, ZYPITAMAGTM added to the Company’s cardiovascular portfolio and expanded the Company’s reach to new patients. ZYPITAMAGTM contributed revenue of $183,000 to Company for the year ended December 31, 2019 and $652,000 of revenue to the Company during the year ended December 31, 2018. ZYPITAMAGTM is still in the early stages of its commercialization and the Company continues to work towards growing the ZYPITAMAGTM brand, usage of the product and revenues from ZYPITAMAGTM. The 2018 revenues were higher than those earned in 2019 due to the initial ordering by wholesaler customers of the product.

 

On October 3, 2019, the Company announced that it has reached a preferred pricing agreement with the ADAP Crisis Task Force for ZYPITAMAGTM. The agreement will open access to ZYPITAMAGTM tablets to low income, underinsured and uninsured Americans who qualify for ADAP coverage in states where ZYPITAMAGTM has been adopted onto the ADAP formulary.

 

The ADAP Crisis Task Force negotiates reduced drug prices for all ADAP formularies. ADAP formularies provide HIV treatment to low income, uninsured, and underinsured individuals living with HIV/AIDS in all 50 states and the US territories. The ADAP Crisis Task Force was formed in 2002, and is currently comprised of representatives from Arizona, California, Florida, Illinois, Massachusetts, New York, North Carolina, Tennessee, Texas, Virginia, and Washington state HIV/AIDS divisions.

 

On January 28, 2019 the Company entered into an agreement with Sensible to become the exclusive marketing partner for ReDS™ in the United States. ReDS is a non-invasive, FDA-cleared medical device that provides an accurate, actionable and absolute measurement of lung fluid which is important in the management of congestive heart failure. The lung fluid measurements are used in guiding treatment and monitoring a heart failure patient’s condition and may lead to a significant decrease in readmissions and hospital costs. Clinical studies have shown an 87% reduction in heart failure readmission rates for patients using the ReDS system at home for three months post-discharge versus those who were treated with usual care alone. ReDS is already marketed to U.S. hospitals by Sensible and Medicure expects to begin marketing ReDSimmediately using its existing commercial organization. Under the terms of the agreement, Medicure will receive a percentage of total U.S. sales revenue of the device and must meet minimum annual sales quotas.

 

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On September 17, 2019 the Company announced the launch of the ReDSTM PRO system, the next generation of lung fluid management technology for heart failure. The debut of the new system took place at the HFSA conference in Philadelphia, Pennsylvania. ReDSTM PRO is optimized for the point-of-care market, designed for use in hospitals and sub-acute facilities. ReDSTM PRO utilizes non-invasive low energy radio frequency technology that produces reliable fluid volume readings after only 45 seconds of measurement. The ReDSTM PRO can be utilized across the continuum of hospital care, from the emergency department to discharge and subacute rehabilitation. The ReDSTM PRO represents the next generation of ReDSTM.

 

On October 15, 2019 the Company announced the primary results of the late-breaking SMILE-HF Clinical Trial which was presented at the HFSA conference in Philadelphia, Pennsylvania by Dr. William T. Abraham, the SMILE-HF national principal investigator.

 

The SMILE-HF trial demonstrated that when used as intended, ReDS™ treatment guided heart failure management prevented 58% of heart failure readmission(s). Data was collected from 268 patients by 43 centers across the United States, constituting the largest randomized control trial to date on the impact of ReDS™ on managing heart failure. Patients were recruited for the study during hospitalization and followed for up to nine months at home. Daily measurements were taken using ReDS™ with the goal of keeping lung fluid content within the normal range of 20-35%. Data aggregated in the cloud was sent to physicians to monitor and adjust medication with the goal to keep each patient’s fluid status balanced and avoid hospital readmission.

 

The Company has considered indicators of impairment as at December 31, 2019 and recorded a write-down of intangible assets related to the ReDSTM license during the year ended December 31, 2019 totaling $6.3 million as a result of uncertainties with ReDSTM being experienced in regards to the length of the sales cycle and uptake of the product with customers, resulting in the Company’s sales being below the committed amounts required by the exclusive marketing and distribution agreement regarding ReDSTM. Additionally, a loss of $6,336 was recorded within other comprehensive loss from the revaluation of the investment in Sensible made during the year ended December 31, 2019. Despite recording the impairment on the license over ReDSTM and the investment in Sensible Medical, the Company continues to market ReDS™ PRO and continues to work to safeguard or monetize the Company’s investment.

 

On August 13, 2018, the Company announced that the FDA has approved its ANDA for SNP. SNP is indicated for the immediate reduction of blood pressure for adult and pediatric patients in hypertensive crisis. The product is also indicated for producing controlled hypotension in order to reduce bleeding during surgery and for the treatment of acute congestive heart failure. The filing of the ANDA was previously announced by the Company on December 13, 2016. Medicure’s SNP has recently become available in the United States with the initial sales from SNP being recorded subsequent to December 31, 2019 in January of 2020.

 

On October 31, 2017, the Company acquired an exclusive license to sell and market PREXXARTAN®, which treats hypertension, in the U.S. and its territories from Carmel for a seven-year term with extensions to the term available. Medicure acquired the license rights for an upfront payment of U.S.$100,000, with an additional U.S.$400,000 payable on final FDA approval. Carmel would also be entitled to receive royalties and milestone payments from the net revenues of PREXXARTAN®. PREXXARTAN® had been granted tentative approval by the FDA and the tentative approval was converted to final approval on December 19, 2017.

 

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As announced on March 19, 2018 and up-dated on March 28, 2018, all PREXXARTAN® related activities were placed on hold by the Company pending the resolution of a dispute that Medicure became aware of between the owner of the New Drug Application (“NDA”), Carmel and the third-party manufacturer of the product. The Company was also named in a civil claim in Florida between the third-party manufacturer and Carmel. The claim disputed the rights granted to Medicure by Carmel in regards to PREXXARTAN®. More recently the claim against the Company was withdrawn, however the dispute between Carmel and the third-party manufacturer continues.

 

Medicure had intended to launch PREXXARTAN® during the first half of 2018. To date, only an up-front payment of U.S.$100,000, has been made to Carmel in regards to PREXXARTAN® and the Company has reserved all of its rights under the license agreement with Carmel for PREXXARTAN®.

 

Going forward and contingent on sufficient finances being available, the Company intends to further expand revenue through marketing and promotional activities, strategic investments related to AGGRASTAT® and ZYPITAMAGTM, the sales and marketing of ReDSTM and SNP, as well as the licensing, acquisition and/or development of other cardiovascular products that fit the commercial organization.

 

Research and Development:

 

The Company’s research and development activities are predominantly conducted by its wholly-owned Barbadian subsidiary, Medicure International Inc.

 

AGGRASTAT®

 

One of the primary ongoing research and development activities is the continued development and further implementation of a new regulatory, brand and life cycle management strategy for AGGRASTAT®. The extent to which the Company is able to invest in this plan is dependent upon the availability of sufficient finances and the expected returns from those investments.

 

An important aspect of the AGGRASTAT® strategy was the revision of its approved prescribing information. On October 11, 2013, the Company announced that the FDA approved the AGGRASTAT® HDB regimen, as requested under Medicure’s sNDA. The AGGRASTAT® HDB regimen (25 mcg/kg within 5 minutes, followed by 0.15 mcg/kg/min) has become the recommended dosing for the reduction of thrombotic cardiovascular events in patients with NSTE ACS.

 

The Company believes that further expanded indications and dosing regimens could provide added value to further maximize the revenue potential for AGGRASTAT®. The Company is currently exploring the potential to make such changes, and the Company may need to conduct appropriate clinical trials, obtain positive results from those trials, or otherwise provide support in order to obtain regulatory approval for such proposed indications and dosing regimens.

 

On April 23, 2015, the Company announced that the FDA approved a revision to the duration of the bolus delivery for the AGGRASTAT® HDB regimen. The dosing change and label modification was requested by the Company to help health care professionals more efficiently meet patient-specific administration needs and to optimize the implementation of AGGRASTAT® at new hospitals. The newly approved labeling supplement now allows the delivery duration of the AGGRASTAT® HDB (25 mcg/kg) to occur anytime within 5 minutes, instead of the previously specified duration of 3 minutes. This change was part of the Company’s ongoing regulatory strategy to expand the applications for AGGRASTAT®.

 

On September 10, 2015, the Company announced that it submitted a sNDA to the FDA to expand the label for AGGRASTAT® to include the treatment of patients presenting with STEMI. If approved for STEMI, AGGRASTAT® would be the first in its class of GPIs to receive such a label in the United States.

 

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In previous communication with the Company, the FDA’s Division of Cardiovascular and Renal Drug Products indicated its willingness to review and evaluate this label change request based substantially on data from the On-TIME 2 study, with additional support from published studies and other data pertinent to the use of the AGGRASTAT® HDB regimen in the treatment of STEMI. The efficacy and safety of the HDB regimen in STEMI has been evaluated in more than 20 clinical studies involving over 11,000 patients and is currently recommended by the ACCF/AHA Guideline for the Management of STEMI.

 

On July 7, 2016, the Company received a Complete Response Letter (“CRL”) from the FDA for its sNDA requesting an expanded indication for patients presenting with STEMI. The FDA issued the CRL to communicate that its initial review of the application was completed; however, it could not approve the application in its present form and requested additional information. The Company continues to work directly with the FDA to address these comments and explore other options available.

 

The sNDA filing was accompanied by a mandatory U.S. $1.2 million user fee paid by Medicure International Inc. to the FDA. In December 2016, the Company received a waiver and full refund of the user fee which had been paid and expensed during fiscal 2015.

 

On September 1, 2016, the Company announced that it had received approval from the FDA for its bolus vial product format for AGGRASTAT®.

 

This product format is a concentrated, 15 ml vial containing sufficient drug to administer the FDA approved, HDB of 25 mcg/kg given at the beginning of treatment. AGGRASTAT® is also sold in two other sizes, a 100 ml vial and a 250 ml bag. The existing, pre-mixed products continue to be available, providing a convenient concentration for administering the post-HDB maintenance infusion of 0.15 mcg/kg/min. (Approved Dosing: Administer intravenously 25 mcg/kg within 5 minutes and then 0.15 mcg/kg/min for up to 18 hours). Commercial launch of the bolus vial occurred during the fourth quarter of 2016 and the Company continues to believe this product format will have a positive impact on hospital utilization of AGGRASTAT®.

 

Another aspect of the AGGRASTAT® strategy is to advance studies related to the contemporary use and future regulatory positioning of the product. On May 10, 2012, the Company announced the commencement of enrolment in a clinical trial of AGGRASTAT® entitled SAVI-PCI. SAVI-PCI is a randomized, open-label study enrolling patients undergoing PCI at sites across the United States. The study was designed to evaluate whether patients receiving the HDB regimen of AGGRASTAT® (25 mcg/kg bolus over 3 minutes) followed by an infusion of 0.15 mcg/kg/min for a shortened duration of 1 to 2 hours will have outcomes that are similar, or “non-inferior,” to patients receiving a 12 to 18-hour infusion of Integrilin® (eptifibatide) (Merck & Co., Inc.) at its FDA approved dosing regimen.

 

The primary objective of SAVI-PCI is to demonstrate AGGRASTAT® is non-inferior to Integrilin with respect to the composite endpoint of death, PCI-related myocardial infarction, urgent target vessel revascularization, or major bleeding within 48 hours following PCI or hospital discharge. The secondary objectives of this study include the assessment of safety as measured by the incidence of major bleeding.

 

The first patient was enrolled in June 2012. Enrolment was completed during the fourth quarter of 2018 and on December 17, 2019, the Company announced the completion of the Shortened AGGRASTAT® (tirofiban hydrochloride) injection versus Integrilin® (eptifibatide) in Percutaneous Coronary Intervention (SAVI-PCI) Clinical Trial. Topline results of the SAVI-PCI trial will be communicated in 2020.

 

The Company is also providing funding for a number of investigator sponsored research projects targeting contemporary utilization of AGGRASTAT® relative to its competitors. On December 12, 2019, the Company announced the completion of the FABOLUS-FASTER Phase 4 trial, a randomized, open-label, multi-center trial assessing different regimens of intravenous platelet inhibitors, notably tirofiban and cangrelor (an IV P2Y12 inhibitor) in the early phase of primary PCI. The study enrolled 120 patients. The Company expects to release top-line data in 2020.

 

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FABOLUS-FASTER was funded by a grant from the Company. This study does not imply comparable efficacy, safety, or product interchangeability. Please note that the use of AGGRASTAT® in STEMI patients has not been approved by the FDA. As of this time, neither AGGRASTAT® nor any of the GP IIb/IIIa inhibitors are indicated for the use in STEMI patients. AGGRASTAT® is approved for use in NSTE-ACS patients.

 

Cardiovascular Generic and Reformulation Products

 

Through an ongoing research and development investment, the Company is exploring new product opportunities in the interest of developing future sources of revenue and growth.

 

On August 13, 2018, the Company announced that the FDA has approved its ANDA for SNP. SNP is indicated for the immediate reduction of blood pressure for adult and pediatric patients in hypertensive crisis. The product is also indicated for producing controlled hypotension in order to reduce bleeding during surgery and for the treatment of acute congestive heart failure. The filing of the ANDA was previously announced by the Company on December 13, 2016. Medicure’s SNP has recently become available in the United States with the initial sales from SNP being recorded subsequent to December 31, 2019 in January of 2020.

 

The Company is focused on the development of two additional cardiovascular generic drugs. When combined with the ANDA described above and the acquisition of ZYPITAMAGTM and the marketing partnership for ReDSTM, the Company expects to transform its commercial suite of products to at least five approved products in 2021.

 

The Company had been devoting a modest amount of resources to its research and development programs, including, but not limited to the development of TARDOXALTM (pyridoxal 5 phosphate (“P5P”) formerly known as MC-1) for neurological conditions such as Tardive Dyskinesia. This work included, but was not limited to, working with the FDA to better understand and refine the next steps in development of the product. The advancement of TARDOXALTM is currently on hold. The Company changed its focus from TARDOXALTM to other uses of P5P and continues to devote time and resources to the advancement of P5P development.

 

The following table summarizes the Company’s research and development programs, their therapeutic focus and their stage of development.

 

Product Candidate Therapeutic focus Stage of Development
AGGRASTAT® Acute Cardiology Approved/Marketed – Additional studies underway
ZYPITAMAGTM Primary Hyperlipidemia or Mixed Dyslipidemia Approved/Marketed
ReDSTM Heart Failure – Medical Device Approved/Marketed
PREXXARTAN® Hypertension Approved – Commercial launch on hold
SNP Acute Cardiology ANDA approved/Marketed
Generic ANDA 2 Acute Cardiology ANDA filed
Generic ANDA 3 Acute Cardiology Formulation development underway
TARDOXALTM/P5P TD/Neurological indications

TARDOXAL TM – On hold

P5P - Regulatory and clinical planning underway

 

 

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Other Products

 

The Company is investing in the research and development of other new product development opportunities. The Company is also exploring opportunities to grow the business through acquisition. The Company has evaluated and continues to evaluate the acquisition or license of other approved commercial products with the objective of further broadening its product portfolio and generating additional revenue.

 

As at December 31, 2019, the Company had numerous issued United States patents (see Item 5 – Operating and Financial Review and Prospects – C. Research and Development, Patents and Licenses, Etc. below).

 

Competitors’ Current Products

 

AGGRASTAT®, is owned by the Company’s subsidiary, Medicure International, Inc., and is sold in the United States of America through the Company’s subsidiary, Medicure Pharma, Inc. AGGRASTAT® is indicated to reduce the rate of thrombotic cardiovascular events (combined endpoint of death, myocardial infarction, or refractory ischemia/repeat cardiac procedure) in patients with non-ST elevation acute coronary syndrome (NSTE-ACS).

 

AGGRASTAT® competes in a market segment commonly referred to as the anti-thrombotic market (treatments to remove or prevent formation of blood clots). More specifically, AGGRASTAT® is an antiplatelet drug which affects thrombus (blood clot) formation by preventing the aggregation of platelets in the blood stream. Of the different classes of antiplatelet drugs, AGGRASTAT® is a representative of the glycoprotein IIB/IIIA inhibitors drug class. There are three of these agents approved for use, including abciximab (ReoPro®), eptifibatide (Integrilin®), and tirofiban (AGGRASTAT®). All three are proprietary drugs and only eptifibatide has generic equivalents, which were introduced beginning in December 2015. Of the two directly competing agents, AGGRASTAT® is most closely comparable to eptifibatide (Integrilin) as they are both highly potent, small molecule drugs that have reversible antiplatelet effects.

 

The launch of the injectable antiplatelet agent, cangrelor (KengrealTM), by The Medicines Company, occurred in 2015 and has had some impact on the use and sale of GPIs, including AGGRASTAT®.

 

The initial launch of generic versions of eptifibatide (Integrilin) occurred in December 2015 and could impact the utilization of AGGRASTAT® in the future.

 

Due to the incidence and severity of cardiovascular diseases, the market for antihyperlipidemics is large and competition is intense. There are a number of approved antihyperlipidemic drugs, currently on the market, awaiting regulatory approval or in development. ZYPITAMAGTM will compete with these drugs to the extent ZYPITAMAGTM and any of these drugs are approved for the same or similar indications.

 

Although ZYPITAMAGTM would be positioned as a relatively low-cost therapy, in certain circumstances, other treatment approaches are lower cost and may for this reason be preferred by health care professionals.

 

SNP was launched into a genericized market with several competitors already selling generic versions of the product and as such there is no assurance that the Company will be successful in launching SNP in 2020 and growing sales for the product. The failure of the Company to successfully launch and grow sales of SNP, or to establish a viable market for the Company’s version of the product, could have a material adverse effect on the Company’s long-term profitability.

 

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Competitors’ Products in Development

 

At present the Company is not aware of any other glycoprotein IIb/IIIa inhibitors in mid to late stage clinical development. However, the choice and use of AGGRASTAT® may be affected by the continued advancement of new antithrombotic and antiplatelet agents, including the recently approved oral antiplatelet agents, ticagrelor (Brilinta®) and prasugrel (Effient®). Any future launch of generic version of AGGRASTAT® and/or of other competitive drugs may also be expected to impact utilization of the Company’s drug. Many companies, including large pharmaceutical and biotechnology companies, are conducting development of products that are intended to address the same or a similar medical need. Many of these companies have much larger financial and other resources than the Company does, including those related to research and development, manufacturing, and sales and marketing. The Company also faces competition in recruiting scientific personnel from colleges, universities, agencies, and research organizations who seek patent protection and licensing agreements for the technologies they develop.

 

There are a number of approved antihyperlipidemic drugs, currently on the market, awaiting regulatory approval or in development. ZYPITAMAGTM will compete with these drugs to the extent ZYPITAMAGTM and any of these drugs are approved for the same or similar indications.

 

SNP is being sold into a genericized market with several competitors already selling generic versions of the product and as such there is no assurance that the Company will be successful at growing sales of its SNP in 2020. The failure of the Company to successfully launch and grow sales of SNP, or to establish a viable market for the Company’s version of the product, could have a material adverse effect on the Company’s long-term profitability.

 

Divesture of Apicore

 

On October 3, 2017, the Company sold its interests in Apicore (the “Apicore Sale Transaction”) to an arm’s length, pharmaceutical company (the “Buyer”). Under the Apicore Sale Transaction, the Company received net proceeds of approximately U.S. $105.0 million of which approximately U.S. $55.0 million was received on October 3, 2017, with the remainder received in early 2018. There is also a holdback that was to be received in 2019 as per the terms of the agreements. These funds received by the Company were after payment of all transaction costs, the compensation paid to holders of Apicore’s employee stock options, the redemption of the remaining shares of Apicore not owned by Medicure and other adjustments.

 

On February 1, 2018, the Company received the deferred purchase price proceeds of approximately U.S. $50.0 million from the Buyer as a result of the Apicore Sale Transaction. The U.S. $50.0 million was included in the total net proceeds of U.S. $105.0 million described earlier. The Company did not receive any contingent payments based on an earn out formula as certain financial results within the Apicore business were not met following the Apicore Sale Transaction.

 

On February 13, 2019, the Company announced that it had received notice from the purchaser of Medicure’s interests in Apicore of potential claims against funds held back in respect of representations and warranties under the Apicore sale agreement. The notice did not contain sufficiently detailed information to enable Medicure to assess the merits of the claims with the maximum exposure of the claims being the total holdback receivable. The Company continued to proceed diligently to investigate the potential claims and attempt to satisfactorily resolve them with a view to having the holdback funds released. In conjunction with the sale of Medicure’s interests in Apicore, representation and warranty insurance was obtained by the purchaser that could result in mitigation of the potential claims.

 

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On December 5, 2019, the Company announced that it had reached a settlement agreement with the purchaser of the Company’s interests in Apicore with respect to the amounts heldback under the Apicore sale agreement. A settlement agreement was reached under which Medicure will receive a net payment of U.S. $5.1 million in relation to the holdback receivable.

 

Competitive Strategy and Position

 

The Company is primarily focusing on:

 

Maintaining and growing AGGRASTAT® sales in the United States

 

The Company continues to work to expand the sales of AGGRASTAT® in the United States. The use of AGGRASTAT® is recommended by the AHA and ACC Guidelines for the treatment of ACS. AGGRASTAT® has been shown, to reduce the rate of thrombotic cardiovascular events (combined endpoint of death, myocardial infarction, or refractory ischemia/repeat cardiac procedure) in patients with NSTE ACS.

 

As stated previously, one of the Company’s primary ongoing research and development activities is the continued development and further implementation of a new regulatory, brand and life cycle management strategy for AGGRASTAT®.

 

An important aspect of the AGGRASTAT® strategy was the revision of its approved prescribing information. On October 11, 2013, the Company announced that the FDA approved the AGGRASTAT® HDB regimen, as requested under Medicure’s sNDA. The AGGRASTAT® HDB regimen (25 mcg/kg within 5 minutes, followed by 0.15 mcg/kg/min) has become the recommended dosing for the reduction of thrombotic cardiovascular events in patients with NSTE ACS.

 

The Company believes that further expanded indications and dosing regimens could provide added value to further maximize the revenue potential for AGGRASTAT®. The Company is currently exploring the potential to make such changes, and the Company may need to conduct appropriate clinical trials, obtain positive results from those trials, or otherwise provide support in order to obtain regulatory approval for such proposed indications and dosing regimens.

 

On September 1, 2016, the Company announced that it had received approval from the FDA for its bolus vial product format for AGGRASTAT®. The product format is a concentrated, pre-mixed, 15 ml vial designed specifically for convenient delivery of the AGGRASTAT® bolus dose (25 mcg/kg). Development of the bolus vial was in response to feedback from interventional cardiologists and catheterization lab nurses from across the United States. Commercial launch of the bolus vial took place in October of 2016 and the Company continues to believe this product format will have a positive impact on hospital utilization of AGGRASTAT®.

 

The Company is also providing funding for a number of investigator sponsored research projects targeting contemporary utilization of AGGRASTAT® relative to its competitors. On December 12, 2019, the Company announced the completion of the FABOLUS-FASTER Phase 4 trial, a randomized, open-label, multi-center trial assessing different regimens of intravenous platelet inhibitors, notably tirofiban and cangrelor (an IV P2Y12 inhibitor) in the early phase of primary PCI. The study enrolled 120 patients. The Company expects to release top-line data in 2020.

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Growing sales of ZYPITAMAGTM in the United States

 

On September 30, 2019 the Company announced that through its subsidiary, Medicure International Inc., it has acquired the ownership of ZYPITAMAGTM from Zydus for U.S. and Canadian markets. Under terms of the agreement, Zydus will receive an upfront payment of U.S. $5,000 and U.S. $2,000 in deferred payments to be made over the next four years, as well as contingent payments on achievement of milestones and royalties related to net sales.

 

Previously, on December 14, 2017, the Company acquired from Zydus, an exclusive license to sell and market ZYPITAMAGTM, a branded cardiovascular drug, in the United States and its territories for a term of seven years with extensions to the term available. ZYPITAMAGTM is used for the treatment of patients with primary hyperlipidemia or mixed dyslipidemia and was approved in July 2017 by the FDA for sale and marketing in the United States. On May 1, 2018 ZYPITAMAGTM became commercially available in retail pharmacies throughout the United States. The Company’s product launch utilized its existing commercial infrastructure and while not an in-hospital product like AGGRASTAT®, ZYPITAMAGTM added to the Company’s cardiovascular portfolio and expanded the Company’s reach to new patients. ZYPITAMAGTM contributed revenue of $183,000 to Company for the year ended December 31, 2019 and $652,000 of revenue to the Company during the year ended December 31, 2018. ZYPITAMAGTM is still in the early stages of its commercialization and the Company continues to work towards growing the ZYPITAMAGTM brand, usage of the product and revenues from ZYPITAMAGTM. The 2018 revenues were higher than those earned in 2019 due to the initial ordering by wholesaler customers of the product.

 

Growing sales of ReDSTM in the United States

 

On January 28, 2019 the Company entered into an agreement with Sensible to become the exclusive marketing partner for ReDS™ in the United States. ReDS is a non-invasive, FDA-cleared medical device that provides an accurate, actionable and absolute measurement of lung fluid which is important in the management of congestive heart failure. The lung fluid measurements are used in guiding treatment and monitoring a heart failure patient’s condition and may lead to a significant decrease in readmissions and hospital costs.  Clinical studies have shown an 87% reduction in heart failure readmission rates for patients using the ReDS system at home for three months post-discharge versus those who were treated with usual care alone. ReDS is already marketed to U.S. hospitals by Sensible and Medicure expects to begin marketing ReDSimmediately using its existing commercial organization.  Under the terms of the agreement, Medicure will receive a percentage of total U.S. sales revenue of the device and must meet minimum annual sales quotas.  

 

On September 17, 2019 the Company announced the launch of the ReDSTM PRO system, the next generation of lung fluid management technology for heart failure. The debut of the new system took place at the HFSA conference in Philadelphia, Pennsylvania. ReDSTM PRO is optimized for the point-of-care market, designed for use in hospitals and sub-acute facilities. ReDSTM PRO utilizes non-invasive low energy radio frequency technology that produces reliable fluid volume readings after only 45 seconds of measurement. The ReDSTM PRO can be utilized across the continuum of hospital care, from the emergency department to discharge and subacute rehabilitation. The ReDSTM PRO represents the next generation of ReDSTM.

 

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The Company has considered indicators of impairment as at December 31, 2019 and recorded a write-down of intangible assets related to the ReDSTM license during the year ended December 31, 2019 totaling $6.3 million as a result of uncertainties with ReDSTM being experienced in regards to the length of the sales cycle and uptake of the product with customers, resulting in the Company’s sales being below the committed amounts required by the exclusive marketing and distribution agreement regarding ReDSTM. Additionally, a loss of $6.3 million was recorded within other comprehensive loss from the revaluation of the investment in Sensible made during the year ended December 31, 2019. Despite recording this impairment on the license over ReDSTM and the investment in Sensible Medical, the Company continues to market ReDS™ PRO and continues to work to safeguard or monetize the Company’s investment

 

Acquisitions, licensing or marketing partnerships for new commercial products

 

The Company continues to explore additional opportunities for the acquisition or licensing of other cardiovascular products that fit the commercial organization.

 

Developing additional cardiovascular generic and reformulation products

 

On August 13, 2018, the Company announced that the FDA has approved its ANDA for SNP. SNP is indicated for the immediate reduction of blood pressure for adult and pediatric patients in hypertensive crisis. The product is also indicated for producing controlled hypotension in order to reduce bleeding during surgery and for the treatment of acute congestive heart failure) The filing of the ANDA had been previously announced by the Company on December 13, 2016. Medicure’s SNP has recently become available in the United States with the initial sales from SNP being recorded subsequent to December 31, 2019 in January of 2020.

 

Medicure is also developing two additional generic versions of acute cardiovascular drugs and is exploring other potential opportunities.

 

C. Organizational Structure

 

Medicure International, Inc., a wholly owned subsidiary of the Company, was incorporated pursuant to the laws of Barbados, West Indies, on May 23, 2000. Medicure International, Inc.’s registered office is located at Whitepark House, White Park Road, Bridgetown, Barbados. Medicure International Inc.’s head office is located at 1st Floor Limegrove Centre Holetown, St. James, Barbados.

 

Medicure Pharma, Inc., a wholly owned subsidiary of the Company, was incorporated pursuant to the laws of the State of Delaware, United States of America, on September 30, 2005. Medicure Pharma Inc.’s registered office is 2711 Centerville Road, Suite 400, Wilmington, Delaware, 19808. Medicure Pharma, Inc.’s head office is located at 116 Village Blvd. Suite 202, Princeton, NJ, 08540.

 

Medicure U.S.A., Inc., a wholly owned subsidiary of the Company, was incorporated pursuant to the laws of the State of Delaware, United States of America, on June 23, 2014. Medicure U.S.A. Inc.’s registered office is 2711 Centerville Road, Suite 400, Wilmington, Delaware, 19808.

 

Medicure Mauritius Limited, a wholly owned subsidiary of the Company was incorporated pursuant to the laws of the Republic of Mauritius on November 17, 2016. Medicure Mauritius Limited’s registered office is 6th floor, Tower A, 1 CyberCity, Ebene, Mauritius.

 

Apigen Investments Limited, a wholly owned subsidiary of the Company, was incorporated pursuant to the laws of the Republic of Mauritius on June 27, 2014. Apigen Investments Limited’s registered office is 4th floor, Tower A, 1 CyberCity, Ebene, Mauritius.

 

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Medicure Pharma Europe Limited, a wholly owned subsidiary of the Company, was incorporated pursuant to the laws of Ireland on October 17, 2017. Medicure Pharma Europe Limited’s registered office is Block 3, Harcourt Centre, Harcourt Road, Dublin 2.

 

D. Property, Plant and Equipment

 

Office Space

 

Included within the business and administration services agreement entered into with Genesys Venture Inc. (see Item 5F - Contractual Obligations), is the use of office space at Genesys Venture Inc.’s head office located at 1250 Waverley Street in Winnipeg, Manitoba, Canada. As at December 31, 2019, the Company had use of approximately 14,720 square feet.

 

ITEM 4A. UNRESOLVED STAFF COMMENTS

 

Not applicable

 

ITEM 5. OPERATING AND FINANCIAL REVIEW AND PROSPECTS

 

This section contains forward-looking statements involving risks and uncertainties. The Company’s actual results could differ materially from those anticipated in these forward-looking statements as a result of certain factors, including those set forth under part Item 3D - Risk Factors. The following discussion of the financial condition, changes in financial conditions and results of operations of the Company for the years ended December 31, 2019 and December 31, 2018 should be read in conjunction with the consolidated financial statements of the Company. The Company’s consolidated financial statements are presented in Canadian dollars and have been prepared in accordance with IFRS included under Item 18 to this Annual Report.

 

Critical Accounting Policies and Estimates

 

The preparation of these consolidated financial statements in conformity with IFRS requires management to make estimates and assumptions that affect the application of accounting policies and the reported amounts of assets, liabilities, revenue and expenses. Actual results may differ from these estimates.

 

Estimates and underlying assumptions are reviewed on an ongoing basis. Revisions to accounting estimates are recognized in the period in which the estimates are revised and in any future periods affected.

 

Areas where management has made critical judgments in the process of applying accounting policies and that have the most significant effect on the amounts recognized in the consolidated financial statements include the determination of the Company’s and its subsidiaries’ functional currencies.

 

Information about key assumptions and estimation uncertainties that have a significant risk of resulting in a material adjustment to the carrying amount of assets and liabilities within the next financial year are included in the following notes to the consolidated financial statements for the year ended December 31, 2019:

 

The valuation of the investment in Sensible Medical

 

The valuation of the royalty obligation

 

The provisions for returns, chargebacks, rebates and discounts

 

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The measurement of intangible assets

 

The measurement of the amount and assessment of the recoverability of income tax assets and income tax provisions

 

Valuation of financial instruments

 

Financial Assets

 

Initial recognition and measurement

 

Upon recognition of a financial asset, classification is made based on the business model for managing the asset and the asset’s contractual cash flow characteristics. The financial asset is initially recognized at its fair value and subsequently classified and measured as (i) amortized cost; (ii) FVOCI; or (iii) FVTPL. Financial assets are classified as FVTPL if they have not been classified as measured at amortized cost or FVOCI. Upon initial recognition of an equity instrument that is not held-for-trading, the Company may irrevocably designate the presentation of subsequent changes in the fair value of such equity instrument as FVTPL

 

Subsequent measurement

 

The subsequent measurement of financial assets depends on their classification as follows:

 

Financial assets measured at amortized cost

 

A financial asset is subsequently measured at amortized cost, using the effective interest method and net of any impairment allowance, if the asset is held within a business whose objective is to hold assets in order to collect contractual cash flows; and the contractual terms of the financial asset give rise, on specified dates, to cash flows that are solely payments of principal and interest. Cash and cash equivalents, short-term investments and accounts receivable are classified within this category.

 

Financial assets at FVTPL

 

Financial assets measured at FVTPL are carried in the statement of financial position at fair value with changes in fair value therein recognized in the statement of net (loss) income. The holdback receivable was classified within this category.

 

Financial assets at FVOCI

 

Financial assets measured at FVOCI are carried in the statement of financial position at fair value with changes in fair value therein recognized in the statement of comprehensive (loss) income. The Investment in Sensible Medical was classified within this category.

 

Derecognition

 

A financial asset or, where applicable a part of a financial asset or part of a group of similar financial assets is derecognized when the contractual rights to receive cash flows from the asset have expired; or the Company has transferred its rights to receive cash flows from the asset or has assumed an obligation to pay the received cash flows in full without material delay to a third party under a ‘pass-through’ arrangement; and either (a) the Company has transferred substantially all the risks and rewards of the asset, or (b) the Company has neither transferred nor retained substantially all the risks and rewards of the asset, but has transferred control of the asset.

 

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Financial liabilities

 

Initial recognition and measurement

 

The Company recognizes a financial liability on the trade date in which it becomes a party to the contractual provisions of the instrument at fair value plus any directly attributable costs. Financial liabilities are subsequently measured at amortized cost or FVTPL, and are not subsequently reclassified. The Company’s financial liabilities are accounts payable and accrued liabilities, royalty obligation and acquisition payable which are recognized on an amortized cost basis.

 

The royalty obligation was recorded at its fair value at the date at which the liability was incurred and subsequently measured at amortized cost using the effective interest rate method at each reporting date. Estimating fair value for this liability required determining the most appropriate valuation model which was dependent on its underlying terms and conditions. This estimate also required determining expected revenue from AGGRASTAT® sales and an appropriate discount rate and making assumptions about them.

 

The acquisition payable was recorded at its fair value at the date at which the liability was incurred and subsequently measured at amortized cost using the effective interest rate method at each reporting date. Estimating fair value for this liability required determining an appropriate discount rate.

 

Offsetting of financial instruments

 

Financial assets and financial liabilities are offset, and the net amount reported in the statement of financial position if, and only if, there is a currently enforceable legal right to offset the recognized amounts and there is an intention to settle on a net basis, or to realize the assets and settle the liabilities simultaneously.

 

Fair value of financial instruments

 

Fair value is determined based on the price that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants. Fair value is measured using the assumptions that market participants would use when pricing an asset or liability. Typically, fair value is determined by using quoted prices in active markets for identical or similar assets or liabilities. When quoted prices in active markets are not available, fair value is determined using valuation techniques that maximize the use of observable inputs. When observable valuation inputs are not available, significant judgement is required through determining the valuation technique to apply, the valuation techniques such as discounted cash flow analysis and selecting inputs. The use of alternative valuation techniques or valuation inputs may result in a different fair value.

 

Transaction costs

 

Transaction costs for all financial instruments measured at amortized cost, the transaction costs are included in the initial measurement of the financial asset or financial liability and are amortized using the effective interest rate method over a period that corresponds with the term of the financial instruments. Transaction costs for financial instruments classified as FVTPL are recognized as an expense in professional fees, in the period the cost was incurred.

 

Embedded Derivatives

 

For financial liabilities measured at amortized cost, under certain conditions, an embedded derivative must be separated from its host contract and accounted for as a derivative. An embedded derivative causes some or all of the cash flows that otherwise would be required by the contract to be modified according to a specified interest rate, financial instrument price, commodity price, foreign exchange rate, index of prices or rates, a credit rating or credit index, or other variable, provided in the case of a non-financial variable that the variable is not specific to a party to the contract. For financial assets at FVTPL, any embedded derivatives are not separated from its host contract.

 

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Provision for returns, chargebacks, rebates and discounts

 

The Company has three commercially available products that generated revenue for the year ended December 31, 2019, AGGRASTAT®, ZYPITAMAG™ and ReDSTM (the “Products”) which it sells to United States customers. AGGRASTAT® and ZYPITAMAG™ are sold to wholesalers for resale; with AGGRASTAT® primarily being sold by the wholesalers to hospitals, while ZYPITAMAG™ is primarily sold by wholesalers to pharmacies. The Company sells ReDSTM directly to end users. Revenue from the sale of AGGRASTAT® and ZYPITAMAG™ is recognized upon the receipt of goods by the wholesaler, the point in time in which title and control of the transferred goods pass from the Company to the wholesale customer. At this point in time, the wholesaler has gained the sole ability to route the goods, and there are no unfulfilled obligations that could affect the wholesaler’s acceptance of the goods. Delivery of the product occurs when the goods have been received at the wholesaler in accordance with the terms of the sale. Revenue from the sale of ReDSTM is recognized upon the receipt of goods by the end user, the point in time in which title and control of the transferred goods pass from the Company to the customer. At this point in time, the customer has gained the sole ability to benefit from the product, and there are no unfulfilled obligations that could affect the customer’s acceptance of the goods. Delivery of the product occurs when the goods have been shipped to the customer and the customer has accepted the products in accordance with the terms of the sale.

 

Sales are made subject to certain discounts available for prompt payment, volume discounts, rebates or chargebacks. Revenue from these sales is recognized based on the price specified per the pricing terms of the sales invoices, net of the estimated discounts, rebates or chargebacks. Variable consideration is based on historical information, using the expected value method. Revenue is only recognized to the extent that it is highly probable that a significant reversal will not occur. A liability is included within accounts payable and accrued liabilities and is measured for expected payments that will be made to the customers for the discounts in which they are entitled. Sales do not contain an element of financing as sales are made with credit terms within the normal operating cycle of the date of the invoice, which is consistent with market practice.

 

The measurement of intangible assets

 

Intangible assets that are acquired separately are measured at cost less accumulated amortization and accumulated impairment losses. Subsequent expenditures are capitalized only when they increase the future economic benefits embodied in the specific asset to which they relate. All other expenditures are recognized in profit or loss as incurred.

 

Licenses are amortized on a straight-line basis over the contractual term of the acquired license. Patents and drug approvals are amortized on a straight-line basis over the legal life of the respective patent, ranging from five to twenty years, or its economic life, if shorter. Trademarks are amortized on a straight-line basis over the legal life of the respective trademark, being ten years, or its economic life, if shorter. Customer lists are amortized on a straight-line basis over approximately twelve years, or its economic life, if shorter.

 

Amortization on licenses commences when the intangible asset is available for use, which would typically be in connection with the commercial launch of the associated product under the license.

 

Following initial recognition, intangible assets are carried at cost less accumulated amortization and accumulated impairment losses. The cost of servicing the Company’s patents and trademarks are expensed as incurred.

 

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The amortization method and amortization period of an intangible asset with a finite useful life are reviewed at least annually. Changes in the expected useful life or the expected pattern of consumption of future economic benefits embodied in the asset are accounted for by changing the amortization period or method, as appropriate, and are treated as changes in accounting estimates in the consolidated statements of net (loss) income and comprehensive (loss) income.

 

The measurement of the amount and assessment of the recoverability of income tax assets

 

The Company and its subsidiaries are generally taxable under the statutes of their country of incorporation.

 

Income tax expense comprises current and deferred taxes. Current taxes and deferred taxes are recognized in profit or loss except to the extent that they relate to a business combination, or items recognized directly in equity or in other comprehensive income.

 

Current taxes are the expected tax receivable or payable on the taxable income or loss for the year, using tax rates enacted or substantively enacted at the reporting date, and any adjustment to tax receivable or payable in respect of previous years.

 

The Company follows the liability method of accounting for deferred taxes. Under this method, deferred taxes are recognized in respect of temporary differences between the carrying amounts of assets and liabilities for financial reporting purposes and the amounts used for taxation purposes. Deferred taxes are not recognized for the following temporary differences: the initial recognition of assets or liabilities in a transaction that is not a business combination and that affects neither accounting nor taxable profit or loss, and differences relating to investments in subsidiaries and jointly controlled entities to the extent that it is probable that they will not reverse in the foreseeable future. In addition, deferred taxes are not recognized for taxable temporary differences arising on the initial recognition of goodwill. Deferred taxes are measured at the tax rates that are expected to be applied to temporary differences when they reverse, based on the tax laws that have been enacted or substantively enacted by the reporting date. Deferred tax assets and liabilities are offset if there is a legally enforceable right to offset current tax assets and liabilities, and they relate to income taxes levied by the same tax authority on the same taxable entity, or on different tax entities, but they intend to settle current tax assets and liabilities on a net basis or their tax assets and liabilities will be realized simultaneously.

 

A deferred tax asset is recognized for unused tax losses, tax credits and deductible temporary differences, to the extent that it is probable that future taxable profits will be available against which they can be utilized. Deferred tax assets are reviewed at each reporting date and are reduced to the extent that it is no longer probable that the related tax benefit will be realized.

 

The Company has provided for income taxes, including the impacts of tax legislation in various jurisdictions, in accordance with guidance issued by accounting regulatory bodies, the Canada Revenue Agency, the U.S. Internal Revenue Service, the Barbados Revenue Authority, the Mauritius Revenue Authority, as well as other state and local governments through the date of the issuance of these consolidated financial statements. Additional guidance and interpretations can be expected and such guidance, if any, could impact future results. While management continues to monitor these matters, the ultimate impact, if any, as a result of the application of any guidance issued in the future cannot be determined at this time.

 

The Company and its subsidiaries file federal income tax returns in Canada, the United States, Barbados and other foreign jurisdictions, as well as various provinces and states in Canada and the United States, respectively. The Company and its subsidiaries have open tax years, primarily from 2010 to 2019, with significant taxing jurisdictions, including Canada, the United States and Barbados. These open years contain certain matters that could be subject to differing interpretations of applicable tax laws and regulations and tax treaties, as they relate to the amount, timing or inclusion of revenues and expenses, or the sustainability of income tax positions of the Company and its subsidiaries. Certain of these tax years may remain open indefinitely.

 

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Tax benefits acquired as part of a business combination, but not satisfying the criteria for separate recognition at that date, would be recognized subsequently if information about facts and circumstances changed. The adjustment would either be treated as a reduction to goodwill if it occurred during the measurement period or in profit or loss, when it occurs subsequent to the measurement period.

 

NEW ACCOUNTING STANDARDS AND INTERPRETATIONS

 

Set out below is the impact of the mandatory adoption of the new accounting standard:

 

IFRS 16, Leases (“IFRS 16”)

 

Effective January 1, 2019, the Company has adopted IFRS 16 using the modified retrospective approach, recognizing a right of use asset equal to the lease liability at the date of initial application, and prior periods were not restated. IFRS 16 which requires lessees to recognize assets and liabilities for most leases, with exemptions available for leases with a term that is twelve (12) months or less, or where the underlying asset is of a low value.

 

Unless exempted, as noted above, upon inception of a lease, lessees will be required to recognize a right-of use (“ROU”) asset, representing the Company’s right to use the underlying asset and a lease liability representing its obligation for lease payments due to the lessor. ROU assets and the corresponding liability are initially measured at the present value of non-cancellable payments, including those made in accordance with an option period when the Company expects to exercise an option period to extend or not terminate a lease.

 

Effective November 1, 2014, the Company entered into a sub-lease with Genesys Venture Inc. (“GVI”), a related party, to lease office space at a rate of $170,000 per annum for three years ending October 31, 2017, with an 18-month renewal period available. The lease was amended on May 1, 2016 and increased the leased area covered under the lease agreement at a rate of $212,000 per annum until October 31, 2019 with an 18-month renewal period available. The leased area covered under the lease was again increased, effective November 1, 2018 at a rate of $306,000 per annum until the end of the term of the lease. The discount rate used by the Company in calculating the lease obligation relating to the ROU asset is five percent.

 

The impact of the adoption of IFRS 16 on the Company’s statement of financial position at January 1, 2019 is as follows:

 

    December 31, 2018     Impact of transition to IFRS 16     January 1, 2019  
Assets                        
Property and equipment   $ 316,000     $ 677,000     $ 993,000  
                         
Current liabilities                        
Lease obligation   $ -     $ 300,000     $ 300,000  
                         
Non-current liabilities                        
Lease obligation   $ -     $ 377,000     $ 377,000  
    $ 316,000     $ -     $ 316,000  

 

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The impact of the adoption of the Company’s operating lease commitments to the lease obligations recognized as a result of the adoption of IFRS 16 is as follows:

 

Operating lease commitments, including renewal options, as at December 31, 2018   $ 715,000  
Adjustment of lease commitments to present value of lease liability     (38,000 )
Lease obligation as at January 1, 2019   $ 677,000  

 

Effective November 1, 2019, the Company modified and extended its sub-lease with GVI to lease a reduced amount of office space at a rate of $238,000 per annum for three years ending October 31, 2022 with an 18-month renewal period available. This resulted in an increase to the ROU asset of $685,000. As at December 31, 2019, the lease obligation of the statement of financial position totaled $1.1 million with $240,000 recorded as the current portion of the lease obligation.

 

NEW ACCOUNTING STANDARD NOT YET ADOPTED

 

Amendments to IFRS 3 – definition of a business:

 

In October 2018, the International Accounting Standards Board (“IASB”) issued amendments to IFRS 3 Business Combinations, that seek to clarify whether a transaction results in an asset or a business acquisition. The amendments include an election to use a concentration test. This is a simplified assessment that results in an asset acquisition if substantially all of the fair value of the gross assets is concentrated in a single identifiable asset or a group of similar identifiable assets. The amendments apply to businesses acquired in annual reporting periods beginning on or after January 1, 2020. The Company does not expect the amendments to have a significant impact on the consolidated financial statements upon adoption.

 

A. Operating Results

 

General

 

Through 2019, the Company was focused on maintaining and growing the sales AGGRASTAT® and ZYPITAMAGTM and the commercial launch of ReDSTM. The Company earned its initial revenue from SNP in January of 2020.

 

Historically, the Company concentrated primarily on research and development and continues to invest a significant amount of funds in research and development activities. To date, the Company has yet to and may never derive any revenues from its research and development products.

 

The Company has a limited operating history and its prospects must be considered in light of the risks, expenses and difficulties frequently encountered with the establishment of a business in a highly competitive industry, characterized by frequent new product introductions.

 

Twelve Months Ended December 31, 2019 Compared to the Twelve Months Ended December 31, 2018

 

Net AGGRASTAT® product sales for year ended December 31, 2019 were $19.4 million compared to $28.5 million during the year ended December 31, 2018.

 

The Company currently sells finished AGGRASTAT® to drug wholesalers. These wholesalers subsequently sell AGGRASTAT® to hospitals where health care providers administer the drug to patients. Wholesaler management decisions to increase or decrease their inventory of AGGRASTAT® may result in sales of AGGRASTAT® to wholesalers that do not track directly with demand for the product at hospitals.

 

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Hospital demand for AGGRASTAT® was lower during 2019 than the prior year however the number of new hospital customers using AGGRASTAT® continued to increase leading to patient market share held by the product increasing to approximately 67% as at December 31, 2019. The Company’s commercial team continues to work on expanding its customer base, however this continued increase in the customer base for AGGRASTAT® has not directly resulted in corresponding revenue increases as the Company continues to face increased competition resulting from further genericizing of the Integrilin market which has created pricing pressures on AGGRASTAT® combined with lower hospital demand for the product. The Company continues to expect strong performance from the AGGRASTAT® brand, due primarily to its patient market share, however diversifying revenues away from a single product has become increasingly important to the Company.

 

As all of the Company’s sales are denominated in U.S. dollars and the U.S. dollar improved in value against the Canadian dollar when comparing the year ended December 31, 2019 with the year ended December 31, 2018, which led to increased AGGRASTAT® revenues, however this was offset by the increasing price pressures facing AGGRASTAT® when comparing the two periods and decreased demand.

 

During the year ended December 31, 2019, ReDSTM contributed revenue of $618,000 from the sale of the product in the United States.

 

Net ZYPITAMAGTM product sales for year ended December 31, 2019 were $183,000 compared to $652,000 during the year ended December 31, 2018.

 

The Company currently sells ZYPITAMAGTM to drug wholesalers. These wholesalers subsequently sell ZYPITAMAGTM to pharmacies who in turn sell the product to patients. The decrease in ZYPITAMAGTM product sales for the year ended December 31, 2019 is a result of initial stocking at the wholesale level during the year ended December 31, 2018. The Company expects ZYPITAMAGTM revenues to grow throughout 2020 and beyond.

 

Cost of goods sold represents direct product costs associated with AGGRASTAT®, ZYPITAMAGTM, ReDSTM and SNP including write-downs for obsolete inventory, amortization of the related intangible assets and royalties paid on ZYPITAMAGTM.

 

AGGRASTAT® cost of goods sold for the year ended December 31, 2019 was $3.6 million compared to $3.7 million for the year ended December 31, 2018. The decrease to cost of goods sold is the result of lower volume of AGGRASTAT product sold, as well as a higher percentage of 250 ml bags sold versus the other AGGRASTAT® formats.

 

ReDSTM cost of goods sold for the year ended December 31, 2019 totaled $904,000 and consisted of $263,000 paid to Sensible in relation to ReDSTM from the revenue sharing arrangement relating to product sold by the Company during 2019 and $641,000 related to the amortization of the ReDSTM license, which was recorded on the statement of financial position within intangible assets, prior to the impairment recorded over the ReDSTM intangible assets.

 

ZYPITAMAGTM cost of goods sold for the year ended December 31, 2019 totaled $1.9 million and includes $34,000 relating to product sold to the Company’s wholesale customers, $1.0 million relating to a write-down of ZYPITAMAGTM product inventory, $797,000 from amortization of the ZYPITAMAGTM license and $2,000 relating to royalties on the sale of ZYPITAMAGTM resulting from the acquisition of the product in September of 2019.

 

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The cost of goods sold related to SNP relates to an impairment loss on the write-down of inventory of $940,000 recorded during the year ended December 31, 2019 as a result of reduced selling prices for the product experienced in the market pertaining to SNP.

 

Selling expenses include salaries and related costs for those employees involved in the commercial operations of the Company, as well as costs associated with marketing, promotion, distribution of the Company’s products as well as market access activities and other commercial activities. The expenditures are required to support sales and marketing efforts of AGGRASTAT®, ZYPITAMAGTM, ReDSTM and SNP.

 

Selling expenses for the year ended December 31, 2019 were $13.4 million compared to $15.6 million for the year ended December 31, 2018.

 

Commercial sales expenses decreased during the year ended December 31, 2019 as compared to the prior year due to commercial launch costs relating to ZYPITAMAGTM being incurred during the year ended December 31, 2018 as well as cost reductions implemented by the Company during 2019.

 

General and administrative expenses include the cost of administrative salaries, ongoing business development and corporate stewardship activities and professional fees such as legal, audit, investor and public relations.

 

General and administrative expenses for the year ended December 31, 2019 were $3.4 million compared to $3.9 million for the year ended December 31, 2018. The decrease in general and administrative expenses is primarily related to lower share-based compensation expenses during the year ended December 31, 2019 as compared to the year ended December 31, 2018.

 

Research and development expenditures include costs associated with the Company’s clinical development and preclinical programs including salaries, monitoring and other research costs. The Company expenses all research costs and has not had any development costs that meet the criteria for capitalization under IFRS. Prepaid research and development costs represent advance payments under contractual arrangements for clinical activity outsourced to research centers.

 

Net research and development expenditures for the year ended December 31, 2019 were $4.3 million compared to $6.7 million for the year ended December 31, 2018. Research and development expenditures include costs associated with the Company’s on-going AGGRASTAT® development, clinical development and preclinical programs including salaries, research centered costs and monitoring costs, as well as research and development costs associated with the development projects being undertaken to develop additional cardiovascular products. The decrease experienced during the year ended December 31, 2019 when compared to the year ended December 31, 2018 is a result of the timing of expenses pertaining to the Company’s development projects, particularly the Company’s additional ANDA development projects.

 

On February 13, 2019, the Company announced that it had received notice from the purchaser of Medicure’s interests in Apicore of potential claims against funds held back in respect of representations and warranties under the Apicore sale agreement. The notice did not contain sufficiently detailed information to enable Medicure to assess the merits of the claims with the maximum exposure of the claims being the total holdback receivable. The Company continued to proceed diligently to investigate the potential claims and attempt to satisfactorily resolve them with a view to having the holdback funds released. In conjunction with the sale of Medicure’s interests in Apicore, representation and warranty insurance was obtained by the purchaser that could result in mitigation of the potential claims.

 

In consideration of the uncertainty associated with the potential claims asserted by the Buyer, the Company reduced the carrying value of the holdback receivable by $1.5 million on the statement of financial position as at December 31, 2018.

 

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On December 5, 2019, the Company reached a settlement agreement with the Buyer in the Apicore Sales Transaction with respect to the amounts heldback under the Apicore Sales Transaction. A settlement agreement was reached under which the Company received U.S. $5.1 million (CDN$6.7 million) in relation to the holdback receivable. In connection with this settlement the amounts owing to former President and Chief Executive Officer of Apicore which were recorded within other long-term liabilities were settled by the Buyer. Immediately prior to the settlement, the Company reduced the carrying value on the statement of financial position of the holdback receivable by $3.6 million to the net recoverable value from the negotiated settlement.

 

Intangible assets are reviewed for impairment on an ongoing basis whenever events or changes in circumstances indicate that the carrying amount may not be recoverable.

 

The amount and timing of impairments and write-downs may vary substantially from period to period depending on the business and research activities being undertaken at any one time and changes in the Company’s commercial strategy.

 

The Company has considered indicators of impairment as at December 31, 2019 and 2018. The Company recorded a write-down of intangible assets related to the ReDSTM license during the year ended December 31, 2019 totaling $6.3 million as a result of uncertainties with ReDSTM being experienced in regards to the length of the sales cycle and uptake of the product with customers, resulting in the Company’s sales being below the committed amounts required by the exclusive marketing and distribution agreement regarding ReDSTM. The Company did not record any write-down of intangible assets during the year ended December 31, 2018.

 

With respect to the intangible asset related to ZYPITAMAGTM, management calculated its fair value less costs to sell using a discounted cash flow model (Level 3 in the fair value hierarchy) based upon financial forecasts prepared by management using a discount rate of 13.25%, a cumulative aggregate growth rate of 300% over four years and a nominal terminal value. The Company has concluded that there was no impairment as a result of the analysis for the year ended December 31, 2019 as the recoverable amount exceeded the carrying amount by approximately $1.6 million at the high end of the reasonable range. However, the assessment identified that a reasonably possible change in the key assumption of the sales growth rate forecast results in the recoverable amount being less than the carrying value.  A seven percent reduction in the sales growth forecast per year would result in the carrying value of the intangible asset exceeding the reasonable range of the recoverable amount.

 

The finance income for the year ended December 31, 2019 relates to interest on cash and investments held by the Company and a recovery from accretion on the Company’s royalty obligation, partially offset by bank changes, accretion of the Company’s acquisition payable and other interest incurred during the year ended December 31, 2019. This compares to finance income for the year ended December 31, 2018, which relates to interest on cash and investments held by the Company, offset primarily by accretion on the Company’s royalty obligation.

 

The foreign exchange loss for the year ended December 31, 2019 compared to a gain for year ended December 31, 2018 relates to decrease in the US dollar exchange rate between December 31, 2018 and December 31, 2019, which led to the foreign exchange loss as it applies to the significant US dollar cash held by the Company as at the end of both periods.

 

The income tax expense of $145,000 during the year ended December 30, 2019 is primarily related to changes to the Company’s tax loss carryforwards in Barbados during the period compared to income tax expense of $897,000 during the year ended December 31, 2018, which resulted from taxable income in the United States from the Company’s commercial business during the period. 

 

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For the year ended December 31, 2019, the Company recorded a net loss of $19.8 million or $1.32 per share ($1.32 per share diluted) compared to net income of $3.9 million or $0.25 per share ($0.24 per share diluted) for the year ended December 31, 2018. As discussed above, the main factors contributing to the net loss were the impairment loss recorded on the ReDSTM license, impairment losses recorded in regards to inventories of ZYPITAMAGTM and SNP, a loss recorded upon the settlement of the holdback receivable, lower revenues and foreign exchange losses experienced during the year ended December 31, 2019.

 

For the year ended December 31, 2019, the Company recorded a total comprehensive loss of $26.8 million compared to total comprehensive income of $4.5 million for the year ended December 31, 2018. The change in comprehensive loss results from the factors described above resulting in the net loss for the year ended December 31, 2019 as well as a loss of $6.3 million from the revaluation of the investment in Sensible Medical made during the year ended December 31, 2019. During the year ended December 31, 2019, the Company recorded other comprehensive loss of $6.3 million associated with the change in fair value of the investment in Sensible Medical. This resulted in a carrying value as at December 31, 2019 of one dollar. The change in the fair value of the investment in Sensible Medical is as a result of uncertainties with ReDSTM being experienced in regards to the length of the sales cycle and uptake of the product with customers resulting in lower than expected amounts being paid to Sensible Medical under the exclusive marketing and distribution agreement.

 

The weighted average number of common shares outstanding used to calculate basic (loss) income per share for the year ended December 31, 2019 and 2018 was 14,998,540 and 15,791,396, respectively.

 

The weighted average number of common shares outstanding used to calculate diluted (loss) income per share for the year ended December 31, 2019 and 2018 was 14,998,540 and 16,563,663, respectively.

 

As at December 31, 2019, the Company had 10,804,013 common shares outstanding, 900,000 warrants to purchase common shares and 1,428,408 stock options, of which 1,059,308 were exercisable, to purchase common shares outstanding.

 

As at April 15, 2020, the Company had 10,804,013 common shares outstanding, 900,000 warrants to purchase common shares and 1,394,208 stock options, of which 1,074,708 were exercisable, to purchase common shares outstanding.

 

Twelve Months Ended December 31, 2018 Compared to the Twelve Months Ended December 31, 2017

 

Net AGGRASTAT® product sales for year ended December 31, 2018 were $28.5 million compared to $27.1 million during the year ended December 31, 2017.

 

The Company currently sells finished AGGRASTAT® to drug wholesalers. These wholesalers subsequently sell AGGRASTAT® to the hospitals where health care providers administer the drug to patients. Wholesaler management decisions to increase or decrease their inventory of AGGRASTAT® may result in sales of AGGRASTAT® to wholesalers that do not track directly with demand for the product at hospitals.

 

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Hospital demand for AGGRASTAT® continued to increase compared to the prior year with the number of new hospital customers using AGGRASTAT® continuing to increase leading to patient market share held by the product increasing to over 50% during the year ended December 31, 2017 and to approximately 65% as at December 31, 2018. The Company’s commercial team continues to work on expanding its customer base, however this continued increase in the customer base for AGGRASTAT® has not directly resulted in corresponding revenue increases as the Company continues to face increased competition resulting from further genericizing of the Integrilin market which has created pricing pressures on AGGRASTAT®. The Company continues to expect strong performance from the AGGRASTAT® brand, due primarily to its patient market share, however diversifying revenues away from a single product became increasingly important for the Company during 2018 and continues to occur during 2019.

 

The number of new customers reviewing and implementing AGGRASTAT® increased sharply since October 11, 2013 as a result of FDA approval of the High Dose Bolus (“HDB”) regimen for AGGRASTAT® and due to the increased marketing and promotional efforts of the Company.

 

As all of the Company’s sales are denominated in U.S. dollars and the U.S. dollar improved in value against the Canadian dollar during the second half of 2018 when compared to the 2017, Canadian dollar revenue growth increased, however it was offset by the increasing price pressures facing AGGRASTAT® when comparing the two periods. Net revenue from AGGRASTAT® in U.S. dollars for 2018 totaled $21.9 million compared to $20.9 million in 2017.

 

ZYPITAMAGTM contributed $652,000 of revenue to the Company during the year ended December 31, 2018 and although early into the commercial availability of the product the Company continues to work towards growing the ZYPITAMAGTM brand.

 

Cost of goods sold represents direct product costs associated with AGGRASTAT® and ZYPITAMAGTM, including write-downs for obsolete inventory and amortization of the related intangible assets.

 

AGGRASTAT® cost of goods sold for the year ended December 31, 2018 was $3.7 million compared to $3.5 million for the comparable period in the prior year. For the year ended December 31, 2018, the increases to cost of goods sold is the result of higher volume of AGGRASTAT product sold offset by a significant write-down of expired inventory during the year ended December 31, 2017. During the year ended December 31, 2018, the Company wrote-off inventory of $3,000 that had expired or was otherwise unusable, compared to $385,000 during the year ended December 31, 2017.

 

ZYPITAMAGTM cost of goods sold for the year ended December 31, 2018 is $142,000 relating to the cost of the ZYPITAMAGTM product sold to the Company’s wholesale customers and $196,000 pertaining to the amortization of the ZYPITAMAGTM license for the periods, which is recorded on the statement of financial position within intangible assets and $92,000 relating to a write-down of inventory that had expired or was otherwise unusable.

 

Selling expenses include salaries and related costs for those employees involved in the commercial operations of the Company, as well as costs associated with marketing, promotion, distribution of the Company’s products as well as market access activities and other commercial activities. The expenditures are required to support sales and marketing efforts of AGGRASTAT® and ZYPITAMAGTM.

 

Selling expenses for the year ended December 31, 2018 were $15.6 million compared to $11.5 million for the year ended December 31, 2017.

 

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Commercial sales expenses increased during the year ended December 31, 2018 as compared to the prior year as sales and marketing costs including the size of the Company’s commercial team increased between the two periods to support the launch of ZYPITAMAGTM as well as on going sales efforts of the commercial team in regards to the Company’s products.

 

General and administrative expenses include the cost of administrative salaries, ongoing business development and corporate stewardship activities and professional fees such as legal, audit, investor and public relations.

 

General and administrative expenses for the year ended December 31, 2018 were $3.9 million compared to $3.4 million for the year ended December 31, 2017. General and administrative expenses increased for the year ended December 31, 2018 as compared to the year ended December 31, 2017 primarily as a result of $1.0 million of stock-based compensation recorded during the year ended December 31, 2018 compared to $491,000 for the year ended December 31, 2017.

 

Research and development expenditures include costs associated with the Company’s clinical development and preclinical programs including salaries, monitoring and other research costs. The Company expenses all research costs and has not had any development costs that meet the criteria for capitalization under IFRS. Prepaid research and development costs represent advance payments under contractual arrangements for clinical activity outsourced to research centers.

 

Net research and development expenditures for the year ended December 31, 2018 were $6.7 million, compared to $5.1 million for the year ended December 31, 2017. Research and development expenditures include costs associated with the Company’s on-going AGGRASTAT® development, clinical development and preclinical programs including salaries, research centered costs and monitoring costs, as well as research and development costs associated with the development projects being undertaken to develop additional cardiovascular products. The increase in research and development expenditures for the year ended December 31, 2018 when compared to the year ended December 31, 2017 is as a result of the timing of expenses and work associated with each development project undertaken by the Company, primarily the Company’s development of additional generic ANDA cardiovascular products.

 

Subsequent to December 31, 2018, on February 13, 2019, the Company received notice from the Buyer in the Apicore Sales Transaction of potential claims against the holdback receivable in respect of representations and warranties under the Apicore Sales Transaction, with the maximum exposure of the claims being the total holdback receivable. The notice did not contain sufficiently detailed information to enable the Company to assess the merits of the claims. The Company will proceed diligently to investigate the potential claims and attempt to satisfactorily resolve them with a view to having the holdback receivable released.

 

In consideration of the uncertainty associated with the potential claims asserted by the Buyer, the Company reduced the carrying value of the holdback receivable by $1.5 million on the statement of financial position as at December 31, 2018. The Buyer did not make the required payments on the holdback receivable in February and April 2019.

 

Intangible assets are reviewed for impairment on an ongoing basis whenever events or changes in circumstances indicate that the carrying amount may not be recoverable.

 

The Company recorded an impairment loss of $636,000 for the year ended December 31, 2017 pertaining to a write-down in the value of the intangible assets relating to the license acquired for PREXXARTAN® due to the on-going litigation surrounding the product.

 

The amount and timing of impairments and write-downs may vary substantially from period to period depending on the business and research activities being undertaken at any one time and changes in the Company’s commercial strategy.

 

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The finance income for the year ended December 31, 2018 relates primarily to interest on cash and investments held by the Company during 2018 partially offset by accretion on the Company’s royalty obligation, which compares to finance expense for the year ended December 31, 2017 which primarily related to accretion on the Company’s royalty obligation and interest on the Company’s long-term debt. The Company repaid its long-term debt during the fourth quarter of 2017.

 

The increase in the foreign exchange gain for the year ended December 31, 2018 when compared to the year ended December 31, 2017 relates to increases in the US dollar exchange rate between the two periods combined with the significant increase in US dollar cash and short-term investments held by the Company during the year ended December 31, 2018.

 

The income tax expense of $897,000 during the year ended December 31, 2018 is primarily related to taxable income in the United States during the year ended December 31, 2018. Income tax recovery of $9.1 million during the year ended December 31, 2017 was primarily the result of the utilization of Canadian tax losses as part of the sale of the Apicore business and other credits offset by taxable income in the United States.

 

The loss from discontinued operations for the year ended December 31, 2017 relates to the Apicore business, which was divested through the Apicore Sale Transaction which was completed on October 2, 2017. As the Apicore business was divested during 2017, there is no income or loss from discontinued operations for the year ended December 31, 2018.

 

For the year ended December 31, 2018, the Company recorded consolidated net income from continuing operations of $3.9 million or $0.25 per share ($0.24 per share diluted) compared to consolidated net income from continuing operations of $11.5 million or $0.74 per share ($0.63 per share diluted) for the year ended December 31, 2017. As discussed above, the main factors contributing to the net income decrease was higher selling, general and administrative expenses and research and development expenses for the year ended December 31, 2018 when compared to the year ended December 31, 2017 and the revaluation of the holdback receivable, offset by higher foreign exchange gains and finance income, net. For the year ended December 31, 2018, the Company did not record any net income or loss from discontinued operations related to the Apicore business compared to income from discontinued operations of $31.9 million or $2.04 per share ($1.76 per share diluted) in the year ended December 31, 2017. For the year ended December 31, 2018, the Company recorded net income of $3.9 million or $0.25 per share ($0.24 per share diluted) compared to net income of $43.4 million or $2.78 per share ($2.39 per share diluted) for the year ended December 31, 2017.

 

For the year ended December 31, 2018, the Company recorded a total comprehensive income of $4.5 million compared to total comprehensive income of $43.4 million for the year ended December 31, 2017. The change in comprehensive income results from the factors described above and the fluctuations in the US dollar exchange rate during the periods.

 

The weighted average number of common shares outstanding used to calculate basic income per share for the years ended December 31, 2018 and 2017 was 15,791,396 and 15,636,853, respectively. The weighted average number of common shares outstanding used to calculate diluted income per share for the years ended December 31, 2018 and 2017 was 16,563,663 and 18,138,080, respectively.

 

As at December 31, 2018, the Company had 15,547,812 common shares outstanding, 900,000 warrants to purchase common shares and 1,394,642 stock options, of which 1,044,892 were exercisable, to purchase common shares outstanding.

 

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B. Liquidity and Capital Resources

 

Since the Company’s inception, it has financed operations primarily from net revenue received from the sale of AGGRASTAT®, ZYPITAMAGTM and ReDSTM, the sale of its equity securities, the issue and subsequent exercises of warrants and stock options, interest on excess funds held and the issuance of debt.

 

On October 3, 2017, the Company announced the completion of the Apicore Sale Transaction to the Buyer. Under the Apicore Sale Transaction, the Company received net proceeds of approximately U.S. $105.0 million of which approximately U.S. $55.0 million was received on October 3, 2017, with the remainder received in early 2018. There is also a holdback receivable of U.S. $10.0 million that is due in 2019. These funds received and yet to be received by the Company were after payment of all transaction costs, the compensation paid to holders of Apicore’s employee stock options, the redemption of the remaining shares of Apicore not owned by Medicure and other adjustments.

 

On February 1, 2018, the Company announced that it had received the deferred purchase price proceeds of approximately U.S. $50.0 million from the Buyer as a result of the Apicore Sale Transaction. The U.S. $50.0 million was included in the total net proceeds of U.S. $105.0 million described earlier. The Company did not receive any contingent payments based on an earn out formula as certain financial results within the Apicore business were not met following the Apicore Sale Transaction.

 

On December 5, 2019, the Company announced that it had reached a settlement agreement with the purchaser of the Company’s interests in Apicore with respect to the amounts heldback under the Apicore sale agreement. A settlement agreement was reached under which Medicure received a net payment of U.S. $5.1 million in relation to the holdback receivable.

 

The funds received from the Apicore sales transaction were invested and used for business and product development purposes and to fund operations as needed as well as funding the purchase of common shares under the Company’s recently completed SIB.

 

Cash used in operating activities for the year ended December 31, 2019 was $14.6 million compared to cash from operations of $742,000 for the comparable period in the prior year. The decrease in cash from operating activities is primarily due to the net loss incurred during the year ended December 31, 2019.

 

Cash from investing activities for the year ended December 31, 2019 totaled $34.3 million primarily from the conversion of short-term investments into cash which totaled $47.7 million and $6.7 million was received in relation to the proceeds from the holdback receivable. Offsetting this where payments made by the Company during the year ended December 31, 2019 in regards to the acquisition of ZYPITAMAGTM which totaled $6.6 million and the acquisition of ReDSTM intangible assets for $7.0 million and the investment in Sensible Medical Innovations Ltd. of $6.3 million. Additionally, $186,000 was spent regarding the acquisition of property, plant and equipment during the year ended December 31, 2019. For the year ended December 31, 2018, $65.2 million was received as proceeds from the Apicore Sale Transaction, $44.1 million was used to acquire short-term investments, $1.3 million was paid for the acquisition of the ZYPITAMAGTM license and $197,000 was spent regarding the acquisition of property, plant and equipment resulting in cash from investing activities of $19.7 million during the year ended December 31, 2018.

 

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Cash used in financing activities for the year ended December 31, 2019 totaled $30.3 million and related to cash paid to acquire the Company’s common shares under the SIB which totaled $26.1 million, cash paid to acquire the Company’s common shares under the NCIB which totaled $4.1 million, offset by the receipt of $20,000 from employees exercising stock options during the year. Cash used in financing activities for the year ended December 31, 2018 totaled $2.7 million and related to cash paid to acquire the Company’s common shares under the NCIB which totaled $3.0 million, offset by the receipt of $363,000 from employees exercising stock options during the year.

 

As at December 31, 2019, the Company had unrestricted cash totaling $13.0 million compared to $24.1 million as of December 31, 2018. The Company did not have any short-term investments as at December 31, 2019. At December 31, 2018, the Company had short-term investments in the form of term deposits with maturities of greater than three months and less than one year which totaled $47.7 million. As at December 31, 2019, the Company had working capital of $19.7 million compared to $72.7 million as at December 31, 2018.

 

During the year ended December 31, 2019, the Company repurchased and cancelled 751,800 (2018 – 441,400), common shares as a result of the 2018 NCIB and 2019 NCIB. The aggregate price paid for these common shares totaled $4.1 million (2018 - $3.0 million). During the year ended December 31, 2019 the Company recorded $1.8 million (2018 - $480,000) directly in its deficit representing the difference between the aggregate price paid for these common shares and a reduction of the Company’s share capital totaling $6.0 million (2018 - $3.5 million).

 

On December 20, 2019, the Company completed a SIB pursuant to which the Company purchased 4,000,000 of its common shares for cancellation at a set purchase price of $6.50 per common share for a total purchase price of $26.0 million in cash. The Company incurred an additional $139,000 on transaction costs related to the SIB for a total aggregate purchase price paid of $26.1 million. During the year ended December 31, 2019, the Company recorded $5.5 million directly in its retained deficit representing the difference between the aggregate price paid for these common shares and a reduction of the Company’s share capital totaling $31.6 million.

 

The Company did not have any long-term debt recorded in its consolidated financial statements as at December 31, 2019.

 

C. Research and Development, Patents and Licenses, Etc.

 

Research and Development

 

The Company’s research and development activities are predominantly conducted by its wholly-owned Barbadian subsidiary, Medicure International Inc.

 

AGGRASTAT®

 

One of the primary ongoing research and development activities is the continued development and further implementation of a new regulatory, brand and life cycle management strategy for AGGRASTAT®. The extent to which the Company is able to invest in this plan is dependent upon the availability of sufficient finances and the expected returns from those investments.

 

An important aspect of the AGGRASTAT® strategy was the revision of its approved prescribing information. On October 11, 2013, the Company announced that the FDA approved the AGGRASTAT® HDB regimen, as requested under Medicure’s sNDA. The AGGRASTAT® HDB regimen (25 mcg/kg within 5 minutes, followed by 0.15 mcg/kg/min) has become the recommended dosing for the reduction of thrombotic cardiovascular events in patients with NSTE ACS.

 

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The Company believes that further expanded indications and dosing regimens could provide added value to further maximize the revenue potential for AGGRASTAT®. The Company is currently exploring the potential to make such changes, and the Company may need to conduct appropriate clinical trials, obtain positive results from those trials, or otherwise provide support in order to obtain regulatory approval for such proposed indications and dosing regimens.

 

On April 23, 2015, the Company announced that the FDA approved a revision to the duration of the bolus delivery for the AGGRASTAT® HDB regimen. The dosing change and label modification was requested by the Company to help health care professionals more efficiently meet patient-specific administration needs and to optimize the implementation of AGGRASTAT® at new hospitals. The newly approved labeling supplement now allows the delivery duration of the AGGRASTAT® HDB (25 mcg/kg) to occur anytime within 5 minutes, instead of the previously specified duration of 3 minutes. This change was part of the Company’s ongoing regulatory strategy to expand the applications for AGGRASTAT®.

 

On September 10, 2015, the Company announced that it submitted a sNDA to the FDA to expand the label for AGGRASTAT® to include the treatment of patients presenting with STEMI. If approved for STEMI, AGGRASTAT® would be the first in its class of GPIs to receive such a label in the United States.

 

In previous communication with the Company, the FDA’s Division of Cardiovascular and Renal Drug Products indicated its willingness to review and evaluate this label change request based substantially on data from the On-TIME 2 study, with additional support from published studies and other data pertinent to the use of the AGGRASTAT® HDB regimen in the treatment of STEMI. The efficacy and safety of the HDB regimen in STEMI has been evaluated in more than 20 clinical studies involving over 11,000 patients and is currently recommended by the ACCF/AHA Guideline for the Management of STEMI.

 

On July 7, 2016, the Company received a Complete Response Letter (“CRL”) from the FDA for its sNDA requesting an expanded indication for patients presenting with STEMI. The FDA issued the CRL to communicate that its initial review of the application was completed; however, it could not approve the application in its present form and requested additional information. The Company continues to work directly with the FDA to address these comments and explore other options available.

 

The sNDA filing was accompanied by a mandatory U.S. $1.2 million user fee paid by Medicure International Inc. to the FDA. In December 2016, the Company received a waiver and full refund of the user fee which had been paid and expensed during fiscal 2015.

 

On September 1, 2016, the Company announced that it had received approval from the FDA for its bolus vial product format for AGGRASTAT®.

 

This product format is a concentrated, 15 ml vial containing sufficient drug to administer the FDA approved, HDB of 25 mcg/kg given at the beginning of treatment. AGGRASTAT® is also sold in two other sizes, a 100 ml vial and a 250 ml bag. The existing, pre-mixed products continue to be available, providing a convenient concentration for administering the post-HDB maintenance infusion of 0.15 mcg/kg/min. (Approved Dosing: Administer intravenously 25 mcg/kg within 5 minutes and then 0.15 mcg/kg/min for up to 18 hours). Commercial launch of the bolus vial occurred during the fourth quarter of 2016 and the Company continues to believe this product format will have a positive impact on hospital utilization of AGGRASTAT®.

 

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Another aspect of the AGGRASTAT® strategy is to advance studies related to the contemporary use and future regulatory positioning of the product. On May 10, 2012, the Company announced the commencement of enrolment in a clinical trial of AGGRASTAT® entitled SAVI-PCI. SAVI-PCI is a randomized, open-label study enrolling patients undergoing PCI at sites across the United States. The study was designed to evaluate whether patients receiving the HDB regimen of AGGRASTAT® (25 mcg/kg bolus over 3 minutes) followed by an infusion of 0.15 mcg/kg/min for a shortened duration of 1 to 2 hours will have outcomes that are similar, or “non-inferior,” to patients receiving a 12 to 18-hour infusion of Integrilin® (eptifibatide) (Merck & Co., Inc.) at its FDA approved dosing regimen.

 

The primary objective of SAVI-PCI is to demonstrate AGGRASTAT® is non-inferior to Integrilin with respect to the composite endpoint of death, PCI-related myocardial infarction, urgent target vessel revascularization, or major bleeding within 48 hours following PCI or hospital discharge. The secondary objectives of this study include the assessment of safety as measured by the incidence of major bleeding.

 

The first patient was enrolled in June 2012. Enrolment was completed during the fourth quarter of 2018 and on December 17, 2019, the Company announced the completion of the Shortened AGGRASTAT® (tirofiban hydrochloride) injection versus Integrilin® (eptifibatide) in Percutaneous Coronary Intervention (SAVI-PCI) Clinical Trial. Topline results of the SAVI-PCI trial will be communicated in 2020.

 

The Company is also providing funding for a number of investigator sponsored research projects targeting contemporary utilization of AGGRASTAT® relative to its competitors. On December 12, 2019, the Company announced the completion of the FABOLUS-FASTER Phase 4 trial, a randomized, open-label, multi-center trial assessing different regimens of intravenous platelet inhibitors, notably tirofiban and cangrelor (an IV P2Y12 inhibitor) in the early phase of primary PCI. The study enrolled 120 patients. The Company expects to release top-line data in 2020.

 

FABOLUS-FASTER was funded by a grant from the Company. This study does not imply comparable efficacy, safety, or product interchangeability. Please note that the use of AGGRASTAT® in STEMI patients has not been approved by the FDA. As of this time, neither AGGRASTAT® nor any of the GP IIb/IIIa inhibitors are indicated for the use in STEMI patients. AGGRASTAT® is approved for use in NSTE-ACS patients.

 

Cardiovascular Generic and Reformulation Products

 

Through an ongoing research and development investment, the Company is exploring new product opportunities in the interest of developing future sources of revenue and growth.

 

On August 13, 2018, the Company announced that the FDA has approved its ANDA for SNP. SNP is indicated for the immediate reduction of blood pressure for adult and pediatric patients in hypertensive crisis. The product is also indicated for producing controlled hypotension in order to reduce bleeding during surgery and for the treatment of acute congestive heart failure. The filing of the ANDA was previously announced by the Company on December 13, 2016. Medicure’s SNP has recently become available in the United States with the initial sales from SNP being recorded subsequent to December 31, 2019 in January of 2020.

 

The Company is focused on the development of two additional cardiovascular generic drugs. When combined with the ANDA described above and the acquisition of ZYPITAMAGTM and the marketing partnership for ReDSTM, the Company expects to transform its commercial suite of products to at least five approved products in 2021.

 

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The Company had been devoting a modest amount of resources to its research and development programs, including, but not limited to the development of TARDOXALTM (pyridoxal 5 phosphate (“P5P”) formerly known as MC-1) for neurological conditions such as Tardive Dyskinesia. This work included, but was not limited to, working with the FDA to better understand and refine the next steps in development of the product. The advancement of TARDOXALTM is currently on hold. The Company changed its focus from TARDOXALTM to other uses of P5P and continues to devote time and resources to the advancement of P5P development.

 

The following table summarizes the Company’s research and development programs, their therapeutic focus and their stage of development.

 

Product Candidate Therapeutic focus Stage of Development
AGGRASTAT® Acute Cardiology Approved/Marketed – Additional studies underway
ZYPITAMAGTM Primary Hyperlipidemia or Mixed Dyslipidemia Approved/Marketed
ReDSTM Heart Failure – Medical Device Approved/Marketed
PREXXARTAN® Hypertension Approved – Commercial launch on hold
SNP Acute Cardiology ANDA approved/Marketed
Generic ANDA 2 Acute Cardiology ANDA filed
Generic ANDA 3 Acute Cardiology Formulation development underway
TARDOXALTM/P5P TD/Neurological indications

TARDOXALTM – On hold

P5P - Regulatory and clinical planning underway

 

Other Products

 

The Company is investing in the research and development of other new product development opportunities. The Company is also exploring opportunities to grow the business through acquisition. The Company has evaluated and continues to evaluate the acquisition or license of other approved commercial products with the objective of further broadening its product portfolio and generating additional revenue.

 

As at December 31, 2019, the Company had numerous issued United States patents (see Item 5 – Operating and Financial Review and Prospects – C. Research and Development, Patents and Licenses, Etc. below).

 

Patents and Licenses

 

In addition to a number of pending patent applications, the Company has 1 issued patent from the United States Patent Office providing protection for AGGRASTAT® and related its current and historic development compounds. The Company will continue to file patents related to its research and development activities. The United States patents currently issued to the Company are as follows:

 

Patent Number Issue Date Title
6,770,660 August 3, 2004 Method for Inhibiting Platelet Aggregation

 

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Patents 5,965,581, 5,972,967, 5,978,698, 6,136,794, 6,538,112 and 6,770,660 were purchased by the Company from MGI GP, INC. (a Delaware corporation doing business as MGI PHARMA and its Affiliate, Artery, LLC). Pursuant to an Asset Purchase Agreement dated August 8, 2006, MGI GP, INC. sold the exclusive use of the patents to the Company in the specified territory (the United States of America including the Commonwealth of Puerto Rico; Guam; and the United States Virgin Islands). Pursuant to the Asset Purchase Agreement the Company agreed to pay MGI GP, INC. a one-time fee for the procurement of the acquired assets. The Asset Purchase Agreement was executed August 8, 2006.

 

Much of the work, including some of the research methods, that is important to the success of the Company’s business is germane to the industry and may not be patentable. For this reason, all employees, contracted researchers and consultants are bound by non-disclosure agreements.

 

Given that the patent applications for these technologies involve complex legal, scientific and factual questions, there can be no assurance that patent applications relating to the technology used by the Company will result in patents being issued, or that, if issued, the patents will provide a competitive advantage or will afford protection against competitors with similar technology, or will not be challenged successfully or circumvented by competitors.

 

The Company has filed patents in accordance with the Patent Cooperation Treaty (the ‘‘PCT’’). The PCT is a multilateral treaty that was concluded in Washington in 1970 and entered into force in 1978. It is administered by the International Bureau of the World Intellectual Property Organization (the ‘‘WIPO’’), headquartered in Geneva, Switzerland. The PCT facilitates the obtaining of protection for inventions where such protection is sought in any or all of the PCT contracting states (total of 104 at July 1999). It provides for the filing of one patent application (the ‘‘international application’’), with effect in several contracting states, instead of filing several separate national and/or regional patent applications. At the present time, an international application may include designation for regional patents in respect of contracting states party to any of the following regional patent treaties: The Protocol on Patents and Industrial Designs within the framework of the African Regional Industrial Property Organization, the Eurasian Patent Convention, the European Patent Convention, and the Agreement Establishing the African Intellectual Property Organization. The PCT does not eliminate the necessity of prosecuting the international application in the national phase of processing before the national or regional offices, but it does facilitate such prosecution in several important respects by virtue of the procedures carried out first on all international applications during the international phase of processing under the PCT. The formalities check, the international search and (optionally) the international preliminary examination carried out during the international phase, as well as the automatic deferral of national processing which is entailed; give the applicant more time and a better basis for deciding whether and in what countries to further pursue the application. Further information may be obtained from the official WIPO internet website (http://www.wipo.int).

 

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Although the Company is no longer developing MC-1 for cardiovascular indications, the Company does have a royalty bearing agreement with its subsidiary in regards to this development program. On June 1, 2000, the Company entered into the Medicure International Licensing Agreement whereby it licensed the world-wide development and marketing rights for MC-1, except for Canada, to its wholly owned subsidiary, Medicure International, Inc. As consideration for the grant of the license, Medicure International, Inc. agreed to pay the Company a fee of $1.00 upon the completion of specified milestones in the development process, together with a variable royalty of 7% to 9% of net sales of MC-1 (if any sales are ever in fact made). The term of the Medicure International Licensing Agreement will expire on the date of expiration of the last to expire patent on MC-1, or in the absence of any such patent, on the 10th anniversary of the date of the first commercial sale of MC-1 in the country where it was last introduced (if it is ever so introduced). The Medicure International Licensing Agreement may be terminated under a number of circumstances and, in any event, by either party at any time by providing the other with at least 90 days prior written notice of its intention to terminate the Medicure International Licensing Agreement.

 

Medicure International, Inc. subsequently entered into a development agreement with CanAm on June 1, 2000 to perform research and development of MC-1 and other compounds at cost, plus a reasonable mark-up not to exceed ten percent of any amount invoiced. The parties to the development agreements have agreed that the aggregate amount of all invoiced expenditures shall not exceed $30,000,000 over the term of each agreement. The term of the CanAm development agreement is to expire on the completion of all research and development activities by CanAm and the written acknowledgment by CanAm and Medicure International, Inc. that no further research projects will be undertaken. CanAm continues to perform work on AGGRASTAT®, TARDOXALTM and other projects under this agreement, however there is no ongoing research activity related to MC-1.

 

The development agreements may be terminated under a number of circumstances and, in any event, by Medicure International, Inc. at any time by providing CanAm with at least 30 days prior written notice of its intention to terminate, or by CanAm at any time by providing Medicure International, Inc., with at least 90 days prior written notice of its intention to terminate the development agreement.

 

The agreements provide that all confidential information developed or made known during the course of the relationship with the Company is to be kept confidential except in specific circumstances.

 

D. Trend Information

 

Net AGGRASTAT® product sales for year ended December 31, 2019 were $19.4 million compared to $28.5 million during the year ended December 31, 2018.

 

The Company currently sells finished AGGRASTAT® to drug wholesalers. These wholesalers subsequently sell AGGRASTAT® to hospitals where health care providers administer the drug to patients. Wholesaler management decisions to increase or decrease their inventory of AGGRASTAT® may result in sales of AGGRASTAT® to wholesalers that do not track directly with demand for the product at hospitals.

 

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Hospital demand for AGGRASTAT® was lower during 2019 than the prior year however the number of new hospital customers using AGGRASTAT® continued to increase leading to patient market share held by the product increasing to approximately 67% as at December 31, 2019. The Company’s commercial team continues to work on expanding its customer base, however this continued increase in the customer base for AGGRASTAT® has not directly resulted in corresponding revenue increases as the Company continues to face increased competition resulting from further genericizing of the Integrilin market which has created pricing pressures on AGGRASTAT® combined with lower hospital demand for the product. The Company continues to expect strong performance from the AGGRASTAT® brand, due primarily to its patient market share, however diversifying revenues away from a single product became increasingly important to the Company.

 

The number of new customers reviewing and implementing AGGRASTAT® increased sharply since October 11, 2013 as a result of FDA approval of the High Dose Bolus (“HDB”) regimen for AGGRASTAT® and due to the increased marketing and promotional efforts of the Company.

 

As all of the Company’s sales are denominated in U.S. dollars and the U.S. dollar improved in value against the Canadian dollar when comparing the year ended December 31, 2019 with the year ended December 31, 2018, this led to increased AGGRASTAT® revenues, however this was offset by the increasing price pressures facing AGGRASTAT® when comparing the two periods as well as decreases in demand.

 

During the year ended December 31, 2019, ReDSTM contributed revenue of $618,000 from the sale of the product in the United States.

 

Net ZYPITAMAGTM product sales for year ended December 31, 2019 were $183,000 compared to $652,000 during the year ended December 31, 2018. The 2018 revenues were higher than those earned in 2019 due to the initial ordering by wholesaler customers of the product.

 

The Company currently sells ZYPITAMAGTM to drug wholesalers. These wholesalers subsequently sell ZYPITAMAGTM to pharmacies who in turn sell the product to patients. The decrease in ZYPITAMAGTM product sales for the year ended December 31, 2019 is a result of initial stocking at the wholesale level during the year ended December 31, 2018. The Company expects ZYPITAMAGTM revenues to grow throughout 2020 and beyond.

 

The Company is not aware of any other trends, uncertainties, demands, commitments or events which are reasonably likely to have a material effect upon the Company’s net sales or revenues, income from continuing operations, profitability, liquidity or capital resources, or that would cause reported financial information not necessarily to be indicative of future operating results or financial condition.

 

E. Off-balance Sheet Arrangements

 

As of December 31, 2019, the Company does not have any off-balance sheet arrangements, other than those disclosed below.

 

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F. Contractual Obligations

 

The following tables set forth the Company’s contractual obligations as of December 31, 2019:

 

    Contractual Obligations Payment Due By Period (in Thousands)
(in thousands of CDN$)   Total   2020   2021   2022   2023   2024   Thereafter
Accounts Payable and Accrued Liabilities     9,384       9,384       -       -       -       -       -  
Income Taxes Payable     517       517       -       -       -       -       -  
Lease Obligation     1,230       238       238       238       238       238       40  
Acquisition Payable     2,596       649       649       649       649       -       -  
Purchase Agreement Commitments     5,919       3,043       1,243       1,243       195       195       -  
Total   $ 19,646     $ 13,831     $ 2,130     $ 2,130     $ 1,082     $ 433     $ 40  

 

Payments in connection with the Company’s royalty obligation, as described below, are excluded from the table above.

 

Commitments

 

The Company has entered into a manufacturing and supply agreement to purchase a minimum quantity of AGGRASTAT® unfinished product inventory totaling U.S.$150,000 annually (based on current pricing) until 2024 and a minimum quantity of AGGRASTAT® finished product inventory totaling U.S.$218,000 annually (based on current pricing) until 2022 and €525,000 annually (based on current pricing) until 2022.

 

Effective January 1, 2019, the Company renewed its business and administration services agreement with GVI, under which the Company is committed to pay $7,000 per month or $85,000 per year for a one-year term.

 

Contracts with contract research organizations are payable over the terms of the associated agreements and clinical trials and timing of payments is largely dependent on various milestones being met, such as the number of patients recruited, number of monitoring visits conducted, the completion of certain data management activities, trial completion, and other trial related activities.

 

On October 31, 2017, the Company acquired an exclusive license to sell and market PREXXARTAN® (valsartan) oral solution in the United States and its territories with a seven-year term, with extensions to the term available, which had been granted tentative approval by the U.S. Food and Drug Administration (“FDA”), and which was converted to final approval during 2017. The Company acquired the exclusive license rights for an upfront payment of U.S.$100,000, with an additional U.S.$400,000 payable on final FDA approval and will be obligated to pay royalties and milestone payments from the net revenues of PREXXARTAN®. The U.S.$400,000 payment is on hold pending resolution of the dispute between the licensor and the third-party manufacturer of PREXXARTAN® described in note 16(d) to the Company’s consolidated financial statements and is recorded within accounts payable and accrued liabilities on the consolidated statements of financial position.

 

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On December 14, 2017 the Company acquired an exclusive license to sell and market a branded cardiovascular drug, ZYPITAMAGTM (pitavastatin magnesium) in the United States and its territories for a term of seven years with extensions to the term available. The Company had entered into a profit-sharing arrangement resulting in a portion of the net profits from ZYPITAMAGTM being paid to the licensor. No amounts are due and/or payable pertaining to profit sharing on this product and the profit-sharing arrangement was eliminated with the Company’s acquisition of ZYPITAMAGTM on September 30, 2019 as described in note 9 to the Company’s consolidated financial statements.

 

The Company periodically enters into research agreements with third parties that include indemnification provisions customary in the industry. These guarantees generally require the Company to compensate the other party for certain damages and costs incurred as a result of claims arising from research and development activities undertaken on behalf of the Company. In some cases, the maximum potential amount of future payments that could be required under these indemnification provisions could be unlimited. These indemnification provisions generally survive termination of the underlying agreement. The nature of the indemnification obligations prevents the Company from making a reasonable estimate of the maximum potential amount it could be required to pay. Historically, the Company has not made any indemnification payments under such agreements and no amount has been accrued in the consolidated financial statements with respect to these indemnification obligations. 

As a part of the Birmingham debt settlement described in note 12 to the Company’s consolidated financial statements, beginning on July 18, 2011, the Company is obligated to pay a royalty to Birmingham based on future commercial AGGRASTAT® sales until 2023. The royalty is based on 4% of the first $2.0 million of quarterly AGGRASTAT® sales, 6% on the portion of quarterly sales between $2.0 million and $4.0 million and 8% on the portion of quarterly sales exceeding $4.0 million payable within 60 days of the end of the preceding three-month periods ended February 28, May 31, August 31 and November 30. Birmingham has a one-time option to switch the royalty payment from AGGRASTAT® to a royalty on the sale of MC-1. Management has determined there is no value to the option to switch the royalty to MC-1 as the product is not commercially available for sale and the extended long-term development timeline associated with commercialization of the product. Royalties for the year ended December 31, 2019 totaled $1.0 million (2018 $1.7 million) with payments made during the year ended December 31, 2019 of $1.4 million (2018 $1.5 million).

 

Beginning with the acquisition of ZYPITAMAGTM, completed on September 30, 2019, the Company is obligated to pay royalties on any commercial net sales of ZYPITAMAGTM to Zydus subsequent to the acquisition date. During the three months ended December 31, 2019, the Company accrued $2,000 in royalties in regards to ZYPITAMAGTM which is recorded within cost of goods sold on the statement of net (loss) income and comprehensive (loss) income and within accounts payable and accrued liabilities on the statement of financial position as at December 31, 2019.

 

The Company is obligated to pay royalties on any future commercial net sales of PREXXARTAN® to the licensor of PREXXARTAN®. To date, no royalties are due and/or payable.

 

In the normal course of business, the Company may from time to time be subject to various claims or possible claims. Although management currently believes there are no claims or possible claims that if resolved would either individually or collectively result in a material adverse impact on the Company’s financial position, results of operations, or cash flows, these matters are inherently uncertain and management’s view of these matters may change in the future.

 

During 2018, the Company was named in a civil claim in Florida from the third-party manufacturer of PREXXARTAN® against the licensor. The claim disputed the rights granted by the licensor to the Company with respect to PREXXARTAN®. The claim against the Company has since been withdrawn, however the dispute between the licensor and the third-party manufacturer continues.

 

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On September 10, 2015, the Company submitted a supplemental New Drug Application (“sNDA”) to the FDA to expand the label for AGGRASTAT®. The label change is being reviewed and evaluated based substantially on data from published studies. If the label change submission were to be successful, the Company will be obligated to pay €300,000 over the course of a three-year period in equal quarterly instalments following approval. On July 7, 2016, the Company announced it received a Complete Response Letter stating the sNDA cannot be approved in its present form and requested additional information. The payments are contingent upon the success of the filing and as such the Company has not recorded any amount in the consolidated statements of net (loss) income and comprehensive (loss) income pertaining to this contingent liability.

 

During 2015, the Company began a development project of a cardiovascular generic drug in collaboration with Apicore. The Company has entered into a supply and development agreement under which the Company holds all commercial rights to the drug. In connection with this project, the Company is obligated to pay Apicore 50% of net profit from the sale of this drug. On August 13, 2018, the Company announced that the FDA has approved its ANDA for SNP, a generic intravenous cardiovascular product and the product became available commercially during the third quarter of 2019. To date, no amounts are due and/or payable pertaining to profit sharing on this product.

 

Claims and Possible Claims

 

In the normal course of business, the Company may from time to time be subject to various claims or possible claims. Although management currently believes that aside from the information noted below, there are no claims or possible claims that if resolved would either individually or collectively result in a material adverse impact on the Company’s financial position, results of operations, or cash flows, these matters are inherently uncertain and management’s view of these matters may change in the future.

 

On February 13, 2019, the Company received notice from the Buyer in the Apicore Sales Transaction of potential claims against the holdback receivable in respect of representations and warranties under the Apicore Sales Transaction, with the maximum exposure of the claims being the total holdback receivable. The notice did not contain sufficiently detailed information to enable the Company to assess the merits of the claims. The Company will proceed diligently to investigate the potential claims and attempt to satisfactorily resolve them with a view to having the holdback receivable released.

 

On December 5, 2019, the Company announced that it had reached a settlement agreement with the purchaser of the Company’s interests in Apicore with respect to the amounts heldback under the Apicore sale agreement. A settlement agreement was reached under which Medicure received a net payment of US$5.1 million in relation to the holdback receivable.

 

During 2018, the Company was named in a civil claim in Florida from the third-party manufacturer of PREXXARTAN® against Carmel. The claim disputed the rights granted by Carmel to the Company with respect to PREXXARTAN®.  The Company believed the claim against it was without merit and intended to defend itself against the claim. The claim against the Company has been subsequently withdrawn, however the dispute between the third-party manufacturer and Carmel continues.

 

G. Safe Harbor

 

Statements in Item 5.E and Item 5.F of this Annual Report on Form 20-F that are not statements of historical fact, constitute “forward-looking statements.” See “Forward-Looking Statements” on page 1 of this Annual Report. Our Company is relying on the safe harbor provided in Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, in making such forward-looking statements.

 

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ITEM 6. DIRECTORS, SENIOR MANAGEMENT AND EMPLOYEES

 

A. Directors and Senior Management

 

Directors and Senior Management

 

The members of the board of directors and senior officers of the Company including a brief biography of each are as follows:

 

Dr. Albert D. Friesen, Winnipeg, Manitoba, Canada - Director, Chairman and Chief Executive Officer

 

The founder, President, CEO and Chair of the Board of Medicure Inc., Dr. Friesen holds a Ph.D. in protein chemistry from the University of Manitoba.  Dr. Friesen played a key role in founding several health industry companies including the first employee and President of the Winnipeg Rh Institute for over 20 years, where he oversaw the development of WinRho (then acquired by Cangene Inc. and more recently by Emergent BioSolutions), ABI Biotechnology (acquired by Apotex Inc.), Viventia Biotech Inc., Genesys Pharma Inc., Waverley Pharma Inc. DiaMedica Inc, Miraculins Inc., Kane Biotech Inc. and KAM Scientific Inc.  Dr. Friesen has experience in the establishment of pharmaceutical production facilities and has also managed and initiated the research and clinical development of several pharmaceutical candidates.  Dr. Friesen is a founder of the Industrial Biotechnology Association of Canada (IBAC) and past Chairman of its board of directors and former member of the Industrial Advisory Committee to the Biotechnology Research Institute in Montreal.  In addition to his role with the Company, Dr. Friesen is currently the President and Chairman of Genesys Venture Inc., a biotech incubator, based in Winnipeg and a member of the Board of Directors of Waverley Pharma Inc, a TSX-V listed company.  Dr. Friesen provides his services to the Company through A.D. Friesen Enterprises Ltd., his private consulting corporation.  Dr. Friesen served as both CEO and President of Medicure Inc. Dr. Friesen’s date of birth is May 19, 1947.

 

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Dr. Arnold Naimark, Winnipeg, Manitoba, Canada - Director

 

Dr. Arnold Naimark, O.C., O.M., M.D., L.L.D., F.R.C.P.(C), F.R.S.C, FCAHS, FAAAS,. has had a distinguished career in biomedical research, medicine and higher education.  He is President Emeritus and Dean of Medicine Emeritus and Professor of Medicine and Physiology at the University of Manitoba.  He is currently Director of the Centre for the Advancement of Medicine, Chair of Genome Prairie Immediate Past-Chair of CancerCare Manitoba.  Dr. Naimark serves on the National Statistics Council of Canada and is Vice-Chair of the Statistics Canada Audit Committee. He was formerly on the Research Council of the Canadian Institute for Advanced Research, Chair of Health Canada’s Ministerial Science Advisory Board, Member of the International Advisory Committee on Research of the Alberta Cancer Board, Vice-Chair of the Manitoba Health Research Council and Director of the Robarts Research Institute. He is the founding Chairman of the North Portage Development Corporation, the Canadian Health Services Research Foundation and the Canadian Biotechnology Advisory Committee. He has served as President of several academic bodies including, the Canadian Physiological Society, the Canadian Society for Clinical Investigation, the Association of Canadian Medical Colleges, the Association of Universities and Colleges of Canada and as Chairman of the Association of Commonwealth Universities.  Dr. Naimark is an Officer of the Order of Canada, a Member of the Order of Manitoba and a Fellow of the Royal College of Physicians and Surgeons of Canada, the Royal Society of Canada, and the Canadian Academy of Health Sciences.  He is recipient of the G. Malcolm Brown Award of the Royal College of Physicians and Surgeons and Medical Research Council of Canada, the Osler Award, the Distinguished Service Award of Ben Gurion University, the Symons Award of the Association of Commonwealth Universities; and of honorary doctorates from Mount Allison University and the University of Toronto, and of several other awards and distinctions related to his professional, academic and civic activities. Date of birth is August 24, 1933.

 

Gerald P. McDole, Mississauga, Ontario, Canada, MBA – Director

 

Mr. McDole is currently a director of one Canadian healthcare company. Mr. McDole is Past President of AstraZeneca Canada Inc. He was named President and CEO of AstraZeneca Canada Inc.’s pharmaceutical operations in 1999 and immediately led the merger of Astra Pharma and Zeneca Pharma Inc. Prior to this, Mr. McDole was president and CEO of Astra Pharma Inc., a position he assumed in 1985 after having served as Executive Vice-President. Mr. McDole is a member of the Canadian Healthcare Marketing Hall of Fame, and has been recognized by Canadian Healthcare Manager Magazine with the Who’s Who in Healthcare Award in the pharmaceutical category. In recognition of Mr. McDole’s outstanding contributions to the biotech and pharmaceutical industries, the University of Manitoba established The Gerry McDole Fellowship in Health Policy and Economic Growth. Mr. McDole holds a Bachelor of Science and a Certificate of Business Management from the University of Manitoba, an MBA from Simon Fraser University, and a Business Administration diploma from the University of Toronto. Date of birth is January 25, 1940.

 

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Peter Quick, Mill Neck, New York, USA - Director

 

Peter Quick has over 30 years experience in the securities and financial services industries. He is a recognized leader in the securities industry with experience in the domestic and international equities market, equities market making, market structure reform, trading technology and clearing operations. Mr. Quick is a Partner of Burke and Quick Partners Holdings LLP, the parent company of Burke & Quick Partners LLC a broker dealer. Mr. Quick was President at the American Stock Exchange from 2000 to 2005. Prior to joining the American Stock Exchange, he served as President of Quick & Reilly Inc., a Quick & Reilly subsidiary and a national discount brokerage firm. He also served as President of Quick & Reilly/Fleet Securities. Mr. Quick is a graduate from the University of Virginia with a B.S. in Engineering and attended Stanford University’s Graduate School of Petroleum Engineering. He served four years active duty from 1978 to 1982 as an Officer in the United States Navy. He is the former Chairman and a current member of the Board of Directors of Gain Capital (GCAP: NYSE) and a member of the Boards of Trustees of First of Long Island Corporation (FLIC: NASDAQ) and First National Bank of Long Island. He is a member of the Board of Directors of Fund for the Poor. Mr. Quick serves as the Mayor of the Incorporated Village of Mill Neck, NY. He is a former member of the Board of Alliance Capital Money Market Fund, Chicago Stock Exchange Inc (CHX), The Depository Trust & Clearing Corporation (DTCC), The Midwest Trust Company, Securities Industry Automation Corporation (SIAC), National Security Clearing Corporation, The American Stock Exchange and the National Association of Security Dealers Inc), Quick & Reilly, Inc., (NYSE: BQR), Reckson Associates Realty Corp (NYSE: RX) and The Bear Stearns Current Yield Fund (AMEX:YYY). He is a former Chairman of the Board of Governors of St. Francis Hospital, Roslyn, NY and Mercy Medical Center, Rockville Centre, NY. Date of birth is February 11, 1956.

 

Brent Fawkes, Winnipeg, Manitoba, Canada - Director

 

Mr. Fawkes is a Chartered Professional Accountant with over 20 years of experience in accounting and finance. Mr. Fawkes is currently the Vice President of Finance with Standard Aero Limited, one of the world’s largest independent providers of a variety of aerospace services serving a diverse array of customers in business and general aviation, airline, military, helicopter, components and energy markets. In his current role, Mr. Fawkes is responsible for the oversight of the finance department including external reporting, budgeting and planning and treasury management.  Date of birth is December 21, 1969.

 

Manon Harvey, Kelowna, British Columbia, Canada - Director

 

Ms. Manon Harvey joined the UBC Okanagan Campus as Director, Integrated Planning and Chief Budget Officer in January 2019 where she is responsible for supporting the University’s mission through long range financial planning, financial advice and effective resource allocation strategies. For the prior 21 years as Vice-President, Finance and Corporate Services for the Canada Foundation for Innovation, Manon was responsible for the finance function, human resources, information technology, and administrative services. She was an Officer of the CFI Board of Directors, and served as the Secretary and Treasurer. Ms Harvey is a CPA, CA, with membership in British Columbia. She has her ICD.D designation from the Institute of Corporate Directors. Manon holds a Bachelor of Commerce (summa cum laude) from the University of Ottawa. For over 10 years, until June 2014, she was both a member of the Board of Directors, as well as the Chair of the Audit Committee, for Hydro Ottawa. She is an external member of the Departmental Audit Committee (DAC) of the RCMP.

 

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Neil Owens – President and Chief Operating Officer

 

Dr. Neil Owens is responsible for implementing Medicure’s strategic plans and overseeing day-to-day operations including the advancement and management of new and existing pharmaceutical products. Dr. Owens has worked with Medicure since 2014, serving in various positions of escalating responsibility within Medical Affairs, and most recently as Director, Scientific Affairs. His responsibilities have included providing scientific input and expertise to support manufacturing, product development and clinical studies, as well as KOL engagement and team management. Dr. Owens holds a Bachelor of Science and a Ph.D. in Chemistry from the University of Manitoba and has Postdoctoral experience with the European Institute of Chemistry and Biology (Bordeaux, France). His research background has focused on organic & medicinal chemistry, and the overall application of science towards solving health-related issues.

 

James Kinley – Chief Financial Officer

 

Effective September 21, 2011 Mr. James Kinley was appointed as CFO of the Company, replacing Dawson Reimer, who has served as Chief Financial Officer in an interim capacity since July 15, 2011 until Mr. Kinley’s appointment. Mr. Kinley’s services are provided to the Company through a Consulting Agreement. Previous to his time at Genesys Venture Inc. and the Company, he was Manager, Financial Reporting at Manitoba Telecom Services Inc. and was involved in all aspects of financial reporting, including publicly filed documents such as their financial statements. James is a CPA, CA and holds a Bachelor of Commerce (Hons.) degree from the University of Manitoba. Date of birth is July 9, 1978.

 

Management

 

Dr. Albert D. Friesen - Chairman, Chief Executive Officer and Director: Dr. Friesen directs the overall business management of the Company (see “Directors and Senior Management” under this item).

 

Dr. Neil Owens - President and Chief Operating Officer: Dr. Owens is responsible for the day to day operations of the Company (see “Directors and Senior Management” under this item).

 

James Kinley - Chief Financial Officer: Mr. Kinley is responsible for the Company’s financial management and accounting practices (see “Directors and Senior Management” under this item).

 

B. Compensation

 

Compensation paid to the directors, and executive officers of the Company during the year ended December 31, 2019, is described below and stock-based compensation described in Item 6(E) below:

 

The Company recorded $66,000 in fees paid or payable to Board members for attendance at meetings between January 1, 2019 and December 31, 2019 and the chairs of the Audit and Finance Committee and executive compensation, nominating and corporate governance committee were paid an additional $5,000 each for services as committee chairs.

 

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On October 1, 2001, a compensation agreement was entered into between the Company and A.D. Friesen Enterprises Ltd., a corporation owned by Dr. Friesen and subsequently amended on October 1, 2003, October 1, 2005, October 1, 2006, October 1, 2007, July 18, 2011, July 18, 2016, January 1, 2017 and January 1, 2019. For the years ended December 31, 2019 and 2018, the Company recorded payable to A.D. Friesen Enterprises Ltd., $331,000 and 315,000, respectively, in consulting compensation, including taxable benefits. Dr. Friesen is eligible for an annual bonus, if certain objectives of the Company are met, as determined by the Board of Directors. During the year ended December 31, 2017, a bonus of $125,000 was accrued to Dr. Friesen, which was paid to him during the year ended December 31, 2018. During the year ended December 31, 2018, a bonus of $31,500 was accrued to Dr. Friesen, which was paid to him during the year ended December 31, 2019. No bonus has been accrued as at December 31, 2019.

 

Dawson Reimer served as the Company’s as President and Chief Operating Officer and received a salary of $205,000 payable in equal semi-monthly installments and a bonus at the discretion of the Board of Directors of the Company. On May 9, 2016, the Company announced that the employment agreement with the Company’s President and Chief Operating Officer had been terminated, effective immediately. Mr. Reimer was paid $73,000 up to the date of his termination and $222,000 pertaining to severance during the year ended December 31, 2016. All amounts pertaining to this severance were paid during 2016 and there is no additional liability in this regard.

 

Effective January 1, 2016, the business and administration services agreement with GVI no longer included the Chief Financial Officer’s services and the Company signed a consulting agreement with its Chief Financial Officer, through JFK Enterprises Ltd., a company owned by the Chief Financial Officer, for a one-year term, at a rate of $135,000 annually. During the year ended December 31, 2016, the Company recorded a bonus of $10,000 to its Chief Financial Officer. Effective January 1, 2017, consulting agreement with the Chief Financial Officer, through JFK Enterprises Ltd., a company owned by the Chief Financial Officer, was renewed for a one-year term, at a rate of $155,000 annually. During the year ended December 31, 2017, the Company recorded a bonus of $200,000 to its Chief Financial Officer. Effective January 1, 2018, the Company renewed its consulting agreement with its Chief Financial Officer, through JFK Enterprises Ltd., for a one-year term, at a rate of $155,000 annually. Effective June 1, 2018, this consulting agreement was converted into an employment agreement with the Chief Financial Officer. For the year ended December 31, 2019, the Chief Financial Officer received a salary of $185,000.

 

Neil Owens serves the Company as President and Chief Operating Officer beginning on July 1, 2019 and received a salary of $68,000 for during the year ended December 31, 2019 in relation to the portion of the year he was the President and Chief Operating Officer.

 

Graeme Merchant served the Company as Vice President, Commercial Operations until the conclusion of his employment in September 2017 and received a salary of $161,000 during the year ended December 31, 2016.

 

During the year ended December 31, 2018, the Company paid directors a total of Nil (December 31, 2017: Nil; December 31, 2016: Nil, December 31, 2015: Nil and December 31, 2014: Nil) for consulting fees.

 

The Company has agreed to provide its independent directors $2,000 for each quarterly board meeting they personally attend ($1,000 via telephone), and $1,500 for each quarterly executive compensation, nominating and corporate governance committee meeting or audit and finance committee meeting they attend that is not held in conjunction with a regular Board meeting.

 

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For fiscal 2011 and prior, due to the Company’s financial position, the board had offered and committed not to request, and has therefore not received, any compensation for their services as independent directors. Subsequent to the debt settlement that occurred on July 18, 2011, the Company began paying the Board members this amount owing and had paid $54,000 during fiscal 2013 relating to these accrued amounts. During fiscal 2013, the members of the Board of Directors agreed to further defer payments on amounts owing. Beginning on February 22, 2013 and until June 30, 2015, these amounts bore interest at a rate of 5.5% per annum. For the year ended December 31, 2015, $5,000 (seven months ended December 31, 2014 –$10,000 and year ended May 31, 2014 – $15,000) was recorded within finance expense in relation to these amounts payable to the members of the Company’s Board of Directors. No interest was paid or recorded pertaining to amounts owing to the Board of Directors for the year ended December 31, 2019. As at December 31, 2018, the Company had $1,000 of accrued compensation owing to the independent members of the Board of Directors relating to Directors fees.

 

On July 11, 2014, the Company announced that, subject to all necessary regulatory approvals, it has entered into shares for debt agreements with certain members of the Board of Directors, pursuant to which the Company issued 106,490 of its common shares at a deemed price of $1.98 per common share to satisfy $211,000 of outstanding amounts owing to the Company’s Board of Directors. The shares were issued on January 9, 2015.

 

On January 27, 2015, the Company announced that, subject to all necessary regulatory approvals, it has entered into shares for debt agreements with certain members of the Board of Directors, pursuant to which the Company issued 75,472 of its common shares at a deemed price of $1.44 per common share to satisfy $109,000 of outstanding amounts owing to these individuals. The shares were issued on March 20, 2015.

 

The Company does not provide any cash compensation for its directors who are also officers of the Company for their services as directors.

 

No pension, retirement fund and other similar benefits have been set aside for the officers and directors of the Company.

 

C. Board Practices

 

The Board of Directors presently consists of five directors, who were all elected at the Company’s annual general meeting of the shareholders held on June 26, 2019. Each director holds office until the next annual general meeting of the Company or until his successor is elected or appointed, unless his office is earlier vacated in accordance with the By-Laws of the Company, or pursuant to the provisions of the Canada Business Corporations Act.

 

Dr. Albert D. Friesen has served as a director of the Company since September 1997. Dr. Arnold Naimark has served as a director of the Company since March 2000. Gerald McDole has served as a director of the Company since January 2004. Peter Quick has served as a director of the Company since November 2005. Brent Fawkes has served as a director of the Company since January 2013. Manon Harvey has served as a director of the Company since May 2019.

 

As discussed in more detail below, the Board of Directors maintains an Audit and Finance Committee and an Executive Compensation, Nominating and Corporate Governance Committee.

 

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Corporate Governance

 

The Canadian Securities Administrators (the “CSA”) have adopted National Policy 58-201 Corporate Governance Guidelines, which provides non-prescriptive guidelines on corporate governance practices for reporting issuers such as the Company. In addition, the CSA have implemented National Instrument NI 58-101 Disclosure of Corporate Governance Practices, which prescribes certain disclosure by the Company of its corporate governance practices. The Company’s approach to corporate governance is set forth below.

 

The Board believes that a clearly defined system of corporate governance is essential to the effective and efficient operation of the Company. The system of corporate governance should reflect the Company’s particular circumstances, having always as its ultimate objective, the best long-term interests of the Company and the enhancement of value for all shareholders.

 

Directors are considered to be independent if they have no direct or indirect material relationship with the Company. A “material relationship” is a relationship which could, in the view of the Company’s board of directors, be reasonably expected to interfere with the exercise of a director’s independent judgment.

 

The Executive Compensation, Nominating and Corporate Governance Committee has reviewed the independence of each director on the basis of the definition in section 1.4 of National Instrument 52-110 – Audit Committees (“NI 52-110”). The Board has determined, after reviewing the roles and relationships of each of the directors, that Dr. Arnold Naimark, Brent Fawkes, Gerald McDole, Manon Harvey and Peter Quick are independent from the Company. Only Dr. Albert Friesen is deemed to not be independent from the Company. As part of every regularly scheduled Board and committee meeting, the independent directors are given the opportunity to meet separately from management and the non-independent director. Board committees are entirely composed of independent directors who meet without management when required.

 

The Board has an orientation program in place for new directors which the Board feels is appropriate having regard to the current makeup of the Board. Each director receives relevant corporate and business information on the Company, the Board, and its committees. The directors regularly meet with Management and are given periodic presentations on relevant business issues and developments.

 

Presentations are made to the Board from time to time to educate and keep it informed of changes within the Company and of regulatory and industry requirements and standards.

 

The Company’s Board has adopted a Code of Ethics applicable to directors, officers and employees, copies of which are available on the Company’s website (www.medicure.com). A copy may also be obtained upon request to the Secretary of the Company at its head office, 2-1250 Waverley Street, Winnipeg, Manitoba, R3T 6C6. The ECNCG Committee regularly monitors compliance with the Code of Ethics and also ensures that Management encourages and promotes a culture of ethical business conduct.

 

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Audit and Finance Committee

 

Pursuant to Section 171 of the Canada Business Corporations Act (the “Act”), the Company is required to have an Audit Committee. Section 171(1) of the Act requires the directors of a reporting corporation to elect from among their number a committee composed of not fewer than three directors, of whom a majority must not be officers or employees of the corporation or an affiliate of the corporation. Section 171(3) of the Act provides that, before financial statements are approved by the directors, they must be submitted to the audit committee for review. Section 171(4) of the Act provides that the auditor must be given notice of, and has the right to appear before and to be heard at, every meeting of the audit committee, and must appear before the audit committee when requested to do so by the committee. Finally, section 171(5) of the Act provides that on the request of the auditor, the audit committee must convene a meeting of the audit committee to consider any matters the auditor believes should be brought to the attention of the directors or members.

 

Pursuant to section 6.1 of NI 52-110, the Company is exempt from the requirements of Parts 3 and 5 of NI 52-110 for the year ended December 31, 2018, by virtue of the Company being a “venture issuer” (as defined in NI 52-110).

 

Part 3 of NI 52-110 prescribes certain requirements for the composition of audit committees of non-exempt companies that are reporting issuers under Canadian provincial securities legislation. Part 3 of NI 52-110 requires, among other things that an audit committee be comprised of at three directors, each of whom, is, subject to certain exceptions, independent and financially literate in accordance with the standards set forth in NI 52-110.

 

Part 5 of NI 52-110 requires an annual information form that is filed by a non-exempt reporting issuer under National Instrument 51-102 – Continuous Disclosure Obligations, as adopted the CSA, to include certain disclosure about the issuer’s audit committee, including, among other things: the text of the audit committee’s charter; the name of each audit committee member and whether or not the member is independent and financially literate; whether a recommendation of the audit committee to nominate or compensate an external auditor was not adopted by the issuer’s board of directors, and the reasons for the board’s decision; a description of any policies and procedures adopted by the audit committee for the engagement of non-audit services; and disclosure of the fees billed by the issuer’s external auditor in each of the last two fiscal years for audit, tax and other services.

 

Notwithstanding the exemption available under section 6.1 of NI 52-110, as at the date hereof, the Audit and Finance Committee is comprised of four independent directors: Brent Fawkes (Chair), Gerald McDole, Dr. Arnold Naimark, Manon Harvey and Peter Quick. The relevant experience of each member is described above. (See “Item 6 - Directors, Senior Management and Employees”.)

 

As a result of their education and experience, each member of the audit committee has familiarity with, an understanding of, or experience in:

 

the accounting principles used by the Company to prepare its financial statements, and the ability to assess the general application of those principles in connection with estimates, accruals and reserves;

 

reviewing or evaluating financial statements that present a breadth and level of complexity of accounting issues that are generally comparable to the breadth and complexity of issues that can reasonably be expected to be raised by the Company’s financial statements, and

 

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an understanding of internal controls and procedures for financial reporting.

 

Under the Sarbanes-Oxley Act of 2002, the independent auditor of a public Company is prohibited from performing certain non-audit services. The Audit and Finance Committee has adopted procedures and policies for the pre-approval of non-audit services, as described in the Audit and Finance Committee Charter reproduced below.

 

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AUDIT AND FINANCE COMMITTEE CHARTER

 

GENERAL FUNCTIONS, AUTHORITY, AND ROLE

 

The purpose of the Audit and Finance Committee (the “Committee”) is to oversee the accounting, financial reporting and disclosure processes of the Company and the audits of its financial statements, and thereby assist the Board of Directors of the Company (the “Board”) in monitoring the following:

 

(1) the integrity of the financial statements of the Company;

 

(2) compliance by the Company with ethical policies and legal and regulatory requirements related to financial reporting and disclosure;

 

(3) the appointment, compensation, qualifications, independence and performance of the Company’s internal and external auditors;

 

(4) the performance of the Company’s independent auditors;

 

(5) performance of the Company’s internal controls and financial reporting and disclosure processes; and

 

(6) that management of the Company has assessed areas of potential significant financial risk to the Company and taken appropriate measures.

 

The Committee has the power to conduct or authorize investigations into any matters within its scope of responsibilities, with full access to all books, records, facilities and personnel of the Company, its auditors and its legal advisors. In connection with such investigations or otherwise in the course of fulfilling its responsibilities under this charter, the Committee has the authority to independently retain, and set and pay compensation to, special legal, accounting, or other consultants to advise it, and may request any officer or employee of the Company, its independent legal counsel or independent auditor to attend a meeting of the Committee or to meet with any members of, or consultants to, the Committee. The Committee has the power to create specific sub-committees with all of the power to conduct or authorize investigations into any matters within the scope of the mandate of the sub-committee, with full access to all books, records, facilities and personnel of the Company, its auditors and its legal advisors.

 

In the course of fulfilling its specific responsibilities hereunder, the Committee has authority to, and must, maintain free and open communication between the Company’s independent auditor, Board and Company management. The responsibilities of a member of the Committee are in addition to such member’s duties as a member of the Board.

 

While the Committee has the responsibilities and powers set forth in this charter, it is not the duty of the Committee to plan or conduct audits or to determine that the Company’s financial statements are complete, accurate, and in accordance with International Financial Reporting Standards (“IFRS”). This is the responsibility of management and the independent auditor. Nor is it the duty of the Committee to conduct investigations, to resolve disagreements, if any, between management and the independent auditor or to assure compliance with laws and regulations and the Company’s Code of Ethics. Any responsibilities that the Committee has the power to act upon, may be recommended to the Board to act upon.

 

MEMBERSHIP

 

The membership of the Committee will be as follows:

 

The Committee shall consist of a minimum of three members of the Board, appointed from time to time, each of whom is affirmatively confirmed as independent by the Board in accordance with the definition of independence for audit committee members set out in Appendix I hereto, with such affirmation

 

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disclosed in the Company’s Management Information Circular for its annual meeting of shareholders. All members of the Committee should be “financially literate”, as defined in Appendix I, and at least one of the members shall be an “audit committee financial expert” as defined in as defined in Appendix I.

 

The Board will elect, by a majority vote, one member as chairperson. In the absence of the Chair of the Committee, the members shall appoint an acting Chair.

 

The members of the Committee shall meet all independence and financial literacy requirements of The TSX Venture Exchange, and the requirements of such other securities exchange or quotations system or regulatory agency as may from time to time apply to the Company.

 

Any member of the Committee may be removed and replaced at any time by the Board and will automatically cease to be a member of the Committee as soon as such member ceases to be a Director. The Board may fill vacancies in the Committee by election from among the members of the Board. If and whenever a vacancy exists on the Committee, the remaining members may exercise all its powers so long as a quorum remains in office.

 

A quorum shall be a majority of the members provided that if the number of members is an even number, one half of the number plus one shall constitute a quorum.

 

A member of the Committee may not, other than in his or her capacity as a member of the Committee, the Board, or any other Board committee, accept any consulting, advisory, or other compensatory fee from the Company, and may not be an affiliated person of the Company or any subsidiary thereof.

 

RESPONSIBILITIES

 

The responsibilities of the Committee shall be as follows:

 

Frequency of Meetings

 

Meet quarterly or more often as may be deemed necessary or appropriate in its judgment, either in person or telephonically.

 

The Committee will meet with the independent auditor at least annually, either in person or telephonically.

 

Reporting Responsibilities

 

Provide to the Board proper Committee minutes.

 

Report Committee actions to the Board with such recommendations as the Committee may deem appropriate.

 

Committee and Charter Evaluation

 

The Committee shall annually review, discuss and assess its own performance. In addition, the Committee shall periodically review its role and responsibilities.

 

Annually review and reassess the adequacy of this Charter and recommend any proposed changes to the Board for approval.

 

Whistleblower Mechanism

 

Adopt and review annually a procedure through which employees and others can confidentially and anonymously inform the Committee regarding any concerns about the Company’s accounting, internal

 

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accounting controls or auditing matters. The procedure shall include responding to and the retention of, any such complaints.

 

Legal Responsibilities

 

Perform such functions as may be assigned by law, by the Company’s certificate of incorporation, memorandum, articles or similar documents, or by the Board.

 

INDEPENDENT AUDITOR

 

Nomination, Compensation and Evaluation

 

The Company’s independent auditor is ultimately accountable to the Committee and the Board and shall report directly to the Committee. The Committee shall review the independence and performance of the auditor and annually recommend to the Board the appointment and compensation of the independent auditor or approve any discharge of auditor when circumstances warrant.

 

Review of Work

 

The Committee is directly responsibility for overseeing the work of the independent auditor engaged to prepare or issue an audit report or perform other audit, review or attest services for the Company, including the resolution of disagreements between management and the independent auditor regarding financial reporting.

 

Approval in Advance of Related Party Transactions

 

Pre-approval of all “related party transactions,” which are transactions or loans between the Company and a related party involving goods, services, or tangible or intangible assets that are:

 

(1) material to the Company or the related party; or

 

(2) unusual in their nature or conditions.

 

A related party includes an affiliate, major shareholder, officer, other key management personnel or director of the Company, a company controlled by any of those parties or a family member of any of those parties.

 

Engagement Procedures for Audit and Non-Audit Services

 

Approve in advance all audit services to be provided by the independent auditor. Establish policies and procedures that establish a requirement for approval in advance of the engagement of the independent auditor to provide permitted non-audit services provided to the Company or its subsidiary entities and to prohibit the engagement of the independent auditor for any activities or services not permitted by any of the Canadian provincial securities commissions, the Securities Exchange Commission (“SEC”) or any securities exchange on which the Company’s shares are traded including any of the following non-audit services:

 

Bookkeeping or other services related to accounting records or financial statements of the Company;

 

Financial information systems design and implementation consulting services;

 

Appraisal or valuation services, fairness opinions, or contributions-in-kind reports;

 

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Actuarial services;

 

Internal audit outsourcing services;

 

Any management or human resources function;

 

Broker, dealer, investment advisor, or investment banking services;

 

Legal services;

 

Expert services related to the auditing service; and

 

Any other service the Board determines is not permitted.

 

Hiring Practices

 

Review and approve the Company’s hiring policy regarding the partners, employees and former partners and employees of the present and former independent auditor of the Company. Ensure that no individual who is, or in the past three years has been, affiliated with or employed by a present or former auditor of the Company or an affiliate, is hired by the Company as a senior officer until at least three years after the end of either the affiliation or the auditing relationship.

 

Independence Test

 

Take reasonable steps to confirm the independence of the independent auditor, which shall annually include:

 

Ensuring receipt from the independent auditor of a formal written statement delineating all relationships between the independent auditor and the Company, consistent with the Independence Standards Board Standard No. 1 and related Canadian regulatory body standards;

 

Considering and discussing with the independent auditor any relationships or services provided to the Company, including non-audit services, that may impact the objectivity and independence of the independent auditor; and

 

As necessary, taking, or recommending that the Board take, appropriate action to oversee the independence of the independent auditor and evaluate whether it is appropriate to rotate the independent auditor on a regular basis.

 

Audit and Finance Committee Meetings

 

Notify the independent auditor of every Committee meeting and permit the independent auditor to appear and speak at those meetings.

 

At the request of the independent auditor, convene a meeting of the Committee to consider matters the auditor believes should be brought to the attention of the directors or shareholders.

 

Keep minutes of its meetings and report to the Board for approval of any actions taken or recommendations made.

 

Restrictions

 

Confirm with management and the independent auditor that no restrictions are placed on the scope of the auditors’ review and examination of the Company’s accounts.

 

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OTHER PROFESSIONAL CONSULTING SERVICES

 

Engagement Review

 

As necessary, consider with management the rationale and selection criteria for engaging professional consulting services firms.

 

Ultimate authority and responsibility to select, evaluate and approve professional consulting services engagements.

 

AUDIT AND REVIEW PROCESS AND RESULTS

 

Scope

 

Consider, in consultation with the independent auditor, the audit scope, staffing and planning of the independent auditor.

 

Review Process and Results

 

Consider and review with the independent auditor the matters required to be discussed by such auditing standards as may be applicable.

 

Review and discuss with management and the independent auditor at the completion of annual and quarterly examinations, if any:

 

The Company’s audited and unaudited financial statements and related notes;

 

The Company’s Management Discussion & Analysis (“MD&A”) and news releases related to financial results;

 

The Company’s management certifications of the financial statements and accompanying MD&A as required under applicable securities laws;

 

The Company’s annual information form (“AIF”), if one is prepared and filed.

 

The independent auditor’s audit of the financial statements and its report thereon;

 

Any significant changes required in the independent auditor’s audit plan;

 

The appropriateness of the presentation of any non-IFRS related financial information;

 

Any serious difficulties or disputes with management encountered during the course of the audit; and

 

Other matters related to the conduct of the audit, which are to be communicated to the Committee under generally accepted auditing standards.

 

Review the management letter, if any, delivered by the independent auditor in connection with the audit.

 

Following such review and discussion, if so determined by the Committee, recommend to the Board that the annual financial statements be included in the Company’s annual report.

 

Review and discuss with management and the independent auditor the adequacy of the Company’s internal accounting and financial controls that management and the Board have established and the

 

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effectiveness of those systems, and inquire of management and the independent auditor about significant financial risks or exposures and the steps management has taken to minimize such risks to the Company.

 

Meet separately with the independent auditor and management, as necessary or appropriate, to discuss any matters that the Committee or any of these groups believe should be discussed privately with the Committee.

 

Review and discuss with management and the independent auditor the accounting policies which may be viewed as critical, including all alternative treatments for financial information within IFRS that have been discussed with management, and review and discuss any significant changes in the accounting policies of the Company and industry accounting and regulatory financial reporting proposals that may have a significant impact on the Company’s financial reports.

 

Review with management and the independent auditor the effect of regulatory and accounting initiatives as well as off-balance sheet structures, if any, on the Company’s financial statements.

 

Review with management and the independent auditor any correspondence with regulators or governmental agencies and any employee complaints or published reports which raise material issues regarding the Company’s financial statements or accounting policies.

 

Review with the Company’s legal counsel legal matters that may have a material impact on the financial statements, the Company’s financial compliance policies and any material reports or inquiries received from regulators or governmental agencies related to financial matters.

 

SECURITIES REGULATORY FILINGS

 

Review filings with the Canadian provincial securities commissions and the SEC and other published documents containing the Company’s financial statements.

 

Review, with management, prior to public disclosure, the Company’s financial statements and MD&A and related press releases. The chairperson of the Committee may represent the entire Committee for purposes of this review.

 

Ensure that adequate procedures are in place for the review of the Company’s public disclosure of financial information extracted or derived from the Company’s financial statements, other than the disclosure stated above, and periodically assess the adequacy of those procedures.

 

RISK ASSESSMENT

 

Meet periodically with management to review the Company’s major financial risk exposures and the steps management has taken to monitor and control such exposures.

 

Assess risk areas and policies to manage risk including, without limitation, environmental risk, insurance coverage and other areas as determined by the Board from time to time.

 

Review and discuss with management, and approve changes to, the Company’s Corporate Investment Policy.

 

LIMITATION ON DUTIES OF AUDIT AND FINANCE COMMITTEE

 

In contributing to the Committee’s discharging of its duties under this charter, each member of the Committee shall be obliged only to exercise the care, diligence and skill that a reasonably prudent person would exercise in comparable circumstances. Nothing in this charter is intended, or may be construed,

 

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to impose on any member of the Committee a standard of care or diligence that is in any way more onerous or extensive than the standard to which all Board members are subject.

 

ADOPTION OF CHARTER

 

This charter was originally adopted by the Board on August 23, 2004 and revised on January 17, 2012.

 

APPENDIX I

 

GLOSSARY OF TERMS

 

“Independent” means a director who has no direct or indirect material relationship with the Company or its subsidiaries.

 

A “material relationship” is a relationship which could, in the view of the Board of the Company, be reasonably expected to interfere with the exercise of the person’s independent judgment.

 

For greater certainty, certain individuals will be deemed not to be independent:

 

a) an individual who is, or has been within the last three years, an employee or executive officer of the Company;

 

b) an individual whose immediate family member is, or has been within the last three years, an executive officer of the Company;

 

c) an individual who is a partner of, or employed by the Company’s internal or external auditor or who was, within the last three years, a partner or employee of that audit firm and personally worked on the Company’s audit within that time. For this purpose, “partner” does not include a fixed income partner;

 

d) an individual whose child or stepchild shares a home with the individual or whose spouse, is a partner of the Company’s internal or external auditor, or is an employee of the audit firm and participates in its audit, assurance or tax compliance practice or who was within the last three years a partner or employee of the audit firm and personally worked on the Company’s audit within that time. For this purpose, “partner” does not include a fixed income partner;

 

e) an individual who, or whose immediate family member, is or has been within the last three years, an executive officer of an entity if any of the Company’s current executive officers serve or served at the same time on the entity’s compensation committee; and

 

f) an individual who received, or whose immediate family member who is employed as an executive officer of the Company received, more than $75,000 in direct compensation from the Company during any 12 month period within the last three years. For purposes hereof, direct compensation does not include remuneration for acting as a member of the Board or of any Board committee or remuneration consisting of fixed amounts of compensation under a retirement plan for prior service provided that such compensation is not contingent on any way on continued service.

 

For purposes hereof, “Company” includes Medicure Inc. and any subsidiaries thereof.

 

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Notwithstanding the foregoing, a person will not be considered to have a material relationship with the Company solely because he or she:

 

a) has previously acted as an interim chief executive officer of the issuer, or

 

b) acts, or has previously acted, as a chair or vice-chair of the Board or any Board committee, on a part-time basis.

 

Meaning Of “Independence” For Audit Committees

 

In addition to the requirement of being an Independent Director as described above, members of the Audit Committee will not be considered “independent” for that purpose where the individual:

 

a) accepts, directly or indirectly, any consulting, advisory or other compensatory fee from the Company or subsidiary of the Company, other than as remuneration for acting in his or her capacity as a member of the Board or any Board committee, or as a part-time or vice-chair of the Board or any Board Committee; or

 

b) is an affiliated entity (as defined in National Instrument 52-110 Audit Committees) of the Company or any of its subsidiaries.

 

For purposes hereof, indirect acceptance by an individual of any consulting, advisory or other compensatory fee includes acceptance of a fee by (i) an individual’s spouse, minor child or stepchild, or child or stepchild who shares the individual’s home, or (ii) an entity in which such individual is a partner, member, executive officer or managing director (or comparable position) and which provides accounting, consulting, legal, investment banking or financial advisory services to the Company or any subsidiary of the Company. Notwithstanding the foregoing, compensatory fees do not include receipt of fixed amounts of compensation under a retirement plan (including deferred compensation) for prior service with the issuer if the compensation is not contingent in any way on continued service.

 

Meaning of “financially literate”

 

For purposes hereof, an individual is financially literate if he or she has the ability to read and understand a set of financial statements that present a breadth and level of complexity of accounting issues that are generally comparable to the breadth and complexity of the issues that can reasonably be expected to be raised by the Company’s financial statements.

 

Meaning of “audit committee financial expert”

 

An “audit committee financial expert” means a person who has the following attributes:

 

(1) An understanding of generally accepted accounting principles and financial statements;

 

(2) The ability to assess the general application of such principles in connection with the accounting for estimates, accruals and reserves;

 

(3) Experience preparing, auditing, analyzing or evaluating financial statements that present a breadth and level of complexity of accounting issues that are generally comparable to the breadth and complexity of issues that can reasonably be expected to be raised by the Company’s financial statements, or experience actively supervising one or more persons engaged in such activities;

 

(4) An understanding of internal controls over financial reporting;

 

(5) An understanding of audit committee functions.

 

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A person shall have acquired such attributes through:

 

(1) Education and experience as a principal financial officer, principal accounting officer, controller, public accountant or auditor or experience in one or more positions that involve the performance of similar functions;

 

(2) Experience actively supervising a principal financial officer, principal accounting officer, controller, public accountant, auditor or person performing similar functions;

 

(3) Experience overseeing or assessing the performance of companies or public accountants with respect to the preparation, auditing or evaluation of financial statements; or

 

(4) Other relevant experience.

 

Executive Compensation, Nominating and Corporate Governance Committee

 

The Executive Compensation, Nominating and Corporate Governance Committee is responsible for determining the compensation of executive officers of the Company. The current members of the Committee are Dr. Arnold Naimark (Chair), Gerald McDole, Manon Harvey, Peter Quick and Brent Fawkes, none of whom is a current or former executive officer of the Company. The Committee meets at least once a year.

 

The Committee has developed a policy to govern the Company’s approach to corporate governance issues and provides a forum for concerns of individual directors about matters not easily or readily discussed in a full board meeting, e.g., the performance of management. The Committee ensures there is a clear definition and separation of the responsibilities of the Board, the Committees of the Board, the Chief Executive Officer and other management employees. It also ensures there is a process in place for the orientation and education of new directors and for continuing education of the Board. The Committee also assesses the effectiveness of the Board and its committees on an ongoing ad hoc basis. It also reviews at least annually the Company’s responsiveness to environmental impact, health and safety and other regulatory standards.

 

The Committee reviews the objectives, performance and compensation of the Chief Executive Officer at least annually and makes recommendations to the Board for change. The Committee makes recommendations based upon the Chief Executive Officer’s suggestions regarding the salaries and incentive compensation for senior officers of the Company. The Committee also reviews significant changes to compensation, benefits and human resources policies and compliance with current human resource management practices, such as pay equity, performance review and staff development. The Committee is responsible for reviewing and recommending changes to the compensation of directors as necessary.

 

The charter of the Executive Compensation, Nominating and Corporate Governance Committee can be found on the Company’s website at www.medicure.com.

 

D. Employees

 

In addition to the individuals disclosed in Section A. Directors and Senior Management of this item, the Company has 45 employees through Medicure as at December 31, 2019. During the year ended December 31, 2019, the Company’s total employment decreased from the previous year as part of the Company’s cost curtailment activities.

 

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E. Share Ownership

 

The following table discloses the number of shares (each share possessing identical voting rights), stock options and percent of the shares outstanding held by the directors and officers of the Company, and their respective affiliates, directly and indirectly, at December 31, 2019.

 

Title of Class Identity of Person or Group Amount Owned Percentage of Class
       
Common shares Dr. Albert D. Friesen(1) 2,273,227(1) 21.04%
Common shares Dr. Arnold Naimark 39,194 0.36%
Common shares Gerald P. McDole 48,950 0.45%
Common shares Peter Quick 28,150 0.26%
Common shares Brent Fawkes 12,376 0.11%
Common shares Manon Harvey - -
Common shares Dr. Neil Owens - -
Common shares James Kinley 47,100 0.44%

 

(1) Dr. Albert D. Friesen holds 721,267 shares personally or in an RRSP, a Canadian individual retirement plan. The rest of the shares are held by ADF Family Holding Corp. ADF Enterprises Inc., his wife Mrs. Leona M. Friesen, and CentreStone Ventures Limited Partnership Fund. Dr. Friesen is the General Partner of CentreStone Ventures Limited Partnership Fund.

 

Incentive Stock Options

 

The Company has established an Incentive Stock Option Plan (the ‘‘Plan’’) for its directors, key officers, employees and consultants. Options granted pursuant to the Plan will not exceed a term of ten years and are granted at an option price and on other terms which the directors determine is necessary to achieve the goal of the Plan and in accordance with regulatory requirements, including those of the TSX Venture Exchange. Each option entitles the holder thereof to purchase one (1) Common Share of the Company on the terms set forth in the Plan and in such purchaser’s specific stock option agreement. The option price may be at a discount to market price, which discount will not, in any event, exceed that permitted by any stock exchange on which the Company’s Common Shares are listed for trading.

 

The number of Common Shares allocated to the Plan, the exercise period for the options, and the vesting provisions for the options will be determined by the board of directors of the Company from time to time. The Company’s stock option plan allowed for the issuance of stock options to purchase up to a maximum of 20% of the outstanding common shares at the time of approval of the stock option plan, which resulted in a fixed number of stock options allowed to be granted totaling 2,934,403. The Plan was adopted by the shareholders of the Company on June 22, 2016.

 

The Common Shares issued pursuant to the exercise of options, when fully paid for by a participant, are not included in the calculation of Common Shares allocated to or within the Plan. Should a participant cease to be eligible due to the loss of corporate office (being that of an officer or director) or employment, the option shall cease for varying periods not exceeding 90 days. Loss of eligibility for consultants is regulated by specific rules imposed by the directors when the option is granted to the appropriate consultant. The Plan also provides that estates of deceased participants can exercise their options for a period not exceeding one year following death.

 

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The following table discloses the stock options beneficially held by the directors and officers of the Company, and their respective affiliates, directly and indirectly, as of December 31, 2019. The stock options are subject to the Plan and are for shares of Common Stock of the Company.

 

Name of Person

Number of Shares Subject to Issuance Exercise Price per Share

Expiry Date

Dr. Albert D. Friesen

5,000

414,000

15,000

100,000

15,000

7,500

9,000

$6.16

$1.50

$7.20

$7.30

$4.95

$1.90

$1.90

April 7, 2021

July 18, 2021

December 19, 2022

January 31, 2023

June 26, 2024

July 7, 2024

March 27, 2025

Dr. Arnold Naimark

4,000

5,000

45,000

5,000

4,500

7,200

$6.16

$7.20

$0.30

$4.95

$1.90

$1.90

April 7, 2021

December 19, 2022

May 10, 2023

June 26, 2024

July 7, 2024

March 27, 2025

Gerald P. McDole

4,000

5,000

45,000

5,000

4,500

7,200

$6.16

$7.20

$0.30

$4.95

$1.90

$1.90

April 7, 2021

December 19, 2022

May 10, 2023

June 26, 2024

July 7, 2024

March 27, 2025

Peter Quick

4,000

5,000

45,000

5,000

4,500

7,200

$6.16

$7.20

$0.30

$4.95

$1.90

$1.90

April 7, 2021

December 19, 2022

May 10, 2023

June 26, 2024

July 7, 2024

March 27, 2025

Brent Fawkes

4,000

5,000

45,000

5,000

4,500

7,200

$6.16

$7.20

$0.30

$4.95

$1.90

$1.90

April 7, 2021

December 19, 2022

May 10, 2023

June 26, 2024

July 7, 2024

March 27, 2025

Manon Harvey 15,000 $4.95 June 26, 2024
Dr. Neil Owens

3,000

1,050

4,000

100,000

3,500

1,350

$3.90

$6.16

$7.20

$4.95

$1.90

$1.90

November 25, 2020

April 7, 2021

December 19, 2022

June 26, 2024

July 7, 2024

March 27, 2025

James Kinley

4,000

100,000

15,000

7,500

7,200

$6.16

$7.20

$4.95

$1.90

$1.90

April 7, 2021

December 19, 2022

June 26, 2024

July 7, 2024

March 27, 2025

 

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On June 26, 2019, the Company announced that the Board of Directors had approved the grant of an aggregate of 262,000 stock options to certain directors, officers, employees and management company employees of the Company pursuant to its stock option plan. These options, which were subject to the approval of the TSX Venture Exchange, are set to expire on the fifth anniversary of the date of grant and were issued at an exercise price of $4.95 per share. Of the stock options granted 180,000 were granted to officers and directors of the Company.

 

On February 1, 2018, the Company announced that its Board of Directors had approved the grant of 100,000 stock options to an officer of the Company pursuant to its stock option plan. These options, which were subject to the approval of the TSX-V, are set to expire on the fifth anniversary of the date of grant and were issued at an exercise price of $7.30 per share. 

 

During the year ended December 31, 2019, Gerald McDole, Arnold Naimark and Peter Quick each exercised 667 stock options to acquire 667 common shares of the Company each at an exercise price of $0.60.

 

During the year ended December 31, 2018, James Kinley exercised 45,000 stock options to acquire 45,000 common shares of the Company at an exercise price of $0.30.

 

ITEM 7. MAJOR SHAREHOLDERS AND RELATED PARTY TRANSACTIONS

 

A. Major Shareholders

 

As of December 31, 2019, the following table sets forth the beneficial ownership of the Company’s common shares by each person known by the Company to own beneficially more than 5% of the issued and outstanding common shares of the Company. Information as to shares beneficially owned, directly or indirectly, by each nominee or over which each nominee exercises control or direction, not being within the knowledge of the Company, has been furnished by the respective nominees individually. The Company does not know the majority of the ultimate beneficial owners of these common shares.

 

Title of Class Identity of Person or Group Amount Owned (3) Percentage of Class
       
Common shares

Dr. Albert D. Friesen

Winnipeg, Manitoba

2,273,227 (1) 21.04%
       
Common shares MM Asset Management Inc. 2,410,567 22.31%
  Toronto, Ontario    
       
Common shares PenderFund Capital Management Ltd 1,150,597 10.65%
       

Notes:

(1) Dr. Albert Friesen holds 781,267 shares personally or in an RRSP. The rest of the shares are held by ADF Family Holding Corp., his wife Mrs. Leona M. Friesen, and CentreStone Ventures Limited Partnership Fund. Dr. Friesen is the General Partner of CentreStone Ventures Limited Partnership Fund.

 

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To the best of the Company’s knowledge, it is not owned or controlled, directly or indirectly, by another Company, by any foreign government or by any other natural or legal person severally or jointly.

 

As of December 31, 2019, the total number of issued and outstanding common shares of the Company beneficially owned by the directors and executive officers of the Company as a group was 2,448,997 (or 22.67% of common shares).

 

To the best of the Company’s knowledge, there are no arrangements, the operation of which at a subsequent date will result in a change in control of the Company.

 

The major shareholders do not have any special voting rights.

 

Insider Reports under Canadian Securities Legislation

 

Since the Company a reporting issuer under the Securities Acts of each of the provinces of Canada, certain “insiders” of the Company (including its directors, certain executive officers, and persons who directly or indirectly beneficially own, control or direct more than 10% of its common shares) are generally required to file insider reports of changes in their ownership of the Company’s common shares five days following the trade under National Instrument 55-104 – Insider Reporting Requirements and Exemptions, as adopted by the Canadian Securities Administrators. Insider reports must be filed electronically five days following the date of the trade at www.sedi.ca. The public is able to access these reports at www.sedi.ca.

 

The U.S. rules governing the ownership threshold above which shareholder ownership must be disclosed are more stringent than those discussed above. Section 13 of the Exchange Act imposes reporting requirements on persons who acquire beneficial ownership (as such term is defined in the Rule 13d-3 under the Exchange Act) of more than 5 per cent of a class of an equity security registered under Section 12 of the Exchange Act. In general, such persons must file, within 10 days after such acquisition, a report of beneficial ownership with the Securities and Exchange Commission containing the information prescribed by the regulations under Section 13 of the Exchange Act. This information is also required to be sent to the issuer of the securities and to each exchange where the securities are traded.

 

B. Related Party Transactions

 

Except as disclosed below, the Company has not, since January 1, 2015, and does not at this time propose to:

 

(1) enter into any transactions which are material to the Company or a related party or any transactions unusual in their nature or conditions involving goods, services or tangible or intangible assets to which the Company or any of its former subsidiaries was a party;

 

(2) make any loans or guarantees directly or through any of its former subsidiaries to or for the benefit of any of the following persons:

 

(a) enterprises directly or indirectly through one or more intermediaries, controlling or controlled by or under common control with the Company;

 

(b) associates of the Company (unconsolidated enterprises in which the Company has significant influence or which has significant influence over the Company) including shareholders beneficially owning 10% or more of the outstanding shares of the Company;

  

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(c) individuals owning, directly or indirectly, shares of the Company that gives them significant influence over the Company and close members of such individuals families;

 

(d) key management personnel (persons having authority in responsibility for planning, directing and controlling the activities of the Company including directors and senior management and close members of such directors and senior management); or

 

(e) enterprises in which a substantial voting interest is owned, directly or indirectly, by any person described in (c) or (d) or over which such a person is able to exercise significant influence.

 

On July 18, 2011, the Company entered into a consulting agreement with A.D. Friesen Enterprises Ltd. pursuant to which Dr. Albert Friesen serves the Company as its Chief Executive Officer. The agreement is for a term of five years, at a rate of $180,000 annually. Dr. Friesen is also eligible for a yearly merit/performance bonus, if any, that the Company’s board of directors, in its sole discretion, may authorize. Effective July 18, 2016, the Company renewed its consulting agreement with its Chief Executive Officer, through A.D. Friesen Enterprises Ltd., a company owned by the Chief Executive Officer. for a term of five years, at a rate of $300,000 annually, increasing to $315,000 annually, effective January 1, 2017 and increasing to $331,000 annually, effective January 1, 2019. The Company may terminate this agreement at any time upon 120 days’ written notice. As at December 31, 2019 and 2018, there were no amounts included in accounts payable and accrued liabilities payable to A. D. Friesen Enterprises Ltd. as a result of this consulting agreement. Any amounts payable to A. D. Friesen Enterprises Ltd. are unsecured, payable on demand and non-interest bearing.

 

During the year ended December 31, 2018, the Company recorded a bonus of $32,000 to its Chief Executive Officer which was recorded within general and administrative expenses. During the year ended December 31, 2017, the Company recorded a bonus of $125,000 to its Chief Executive Officer which is recorded within the gain on the sale of Apicore, which was paid during fiscal 2018. During the year ended December 31, 2016, the Company recorded a bonus of $54,000 to its Chief Executive Officer which is recorded within selling, general and administrative expenses. During the year ended December 31, 2015, the Company recorded a bonus of $100,000 to its Chief Executive Officer which is recorded within selling, general and administrative expenses.

 

On July 11, 2014, the Company announced that, subject to all necessary regulatory approvals, it has entered into shares for debt agreements with its Chief Executive Officer, Dr. Albert Friesen and certain members of the Board of Directors, pursuant to which the Company will issue 205,867 of its common shares at a deemed price of $1.98 per common share to satisfy $408,000 of outstanding amounts owing to CEO and members of the Company’s Board of Directors. The shares were issued on January 9, 2015.

 

The Company may terminate the consulting agreement with the CEO for any reason and at any time upon 120 days’ written notice. In relation to the consulting agreement with A.D. Friesen Enterprises Ltd. the Company recorded consulting fees payable to A.D. Friesen Enterprises Ltd. During the year ended December 31, 2019, the Company recorded a total of $331,000 to A.D. Friesen Enterprises Ltd. During the year ended December 31, 2018 and 2017, the Company recorded a total of $315,000, respectively, to A.D. Friesen Enterprises Ltd. During the year ended December 31, 2016, the Company recorded a total of $300,000 to A.D. Friesen Enterprises Ltd. During the year ended December 31, 2015, the Company recorded a total of $186,000 to A.D. Friesen Enterprises Ltd.

 

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Dr. Friesen, a director, the Chairman and the Chief Executive Officer of the Company is also the majority shareholder in a management services company, Genesys Venture Inc. (“GVI”) which entered into a management services agreement with the Company as of October 1, 2010. Effective January 1, 2012, the Company entered into a new business and administration services agreement with GVI under which the Company is committed to pay $15,833.33 per month or $190,000 per annum along with an additional $500 per month for each office space it requests and is given access to by GVI. The agreement was for an initial term of one year and shall be automatically renewed for succeeding terms of one year. Either party may terminate the agreement at any time after June 30, 2012, upon 90 days written notice to the other party. The Chief Financial Officer's services, accounting, payroll, human resources, and information technology are provided pursuant to this agreement. The agreement was renewed for the 2013 and 2014 calendar years. Effective November 1, 2014, the business and administration services agreement was renegotiated for a further 14 month term ending December 31, 2015 at a rate of $17,917 per month, or $215,000 per year. Effective January 1, 2016, the Company entered into a new business and administration services agreement with GVI, under which the Company is committed to paying $7,000 per month or $85,000 per year for a one year term and the agreement no longer includes the services of the Chief Financial Officer. Effective January 1, 2017, the Company renewed its business and administration services agreement with GVI, under which the Company is committed to pay $7,000 per month or $85,000 per year for a one-year term and effective January 1, 2018, this agreement was renewed for an additional one-year term. Effective January 1, 2019, this agreement was renewed for an additional one-year term.

Effective November 1, 2014, the Company entered into a sub-lease with GVI to lease office space at a rate of $170,000 per annum for three years ending October 31, 2017. The lease was amended on May 1, 2016 and increased the leased area covered under the lease agreement at a rate of $212,000 per annum until October 31, 2019. The leased area covered under the lease was again increased, effective November 1, 2018 at a rate of $306,000 per annum until the end of the term of the lease. Effective November 1, 2019, the Company modified and extended its sub-lease with GVI to lease a reduced amount of office space at a rate of $238,000 per annum for three years ending October 31, 2022 with an 18-month renewal period available.

During the year ended December 31, 2019 the Company paid GVI, a company controlled by the Chief Executive Officer, a total of $85,000 (2018 – $85,000; 2017 – $85,000; 2016 $85,000, 2015 - $215,000) for business administration services, $295,000 (2018 - $228,000, 2017 – $212,000; 2016 – $223,000; 2015 - $176,000) in rental costs and $47,000 (2018 - $47,000, 2017 – $44,000; 2016 – $42,000; 2015 $34,000) for commercial and information technology support services. As described in note 17(b) to the Company’s audited consolidated financial statements included in this annual report, the business administration services summarized above are provided to the Company through a consulting agreement with GVI. The business administration services summarized above are provided to the Company through a consulting agreement with GVI. Until December 31, 2015, the GVI agreement included the Chief Financial Officer's services to the Company, as well as accounting, payroll, human resources and some information technology services. The business and administration services agreement entered into effective January 1, 2016 and subsequently no longer includes the Chief Financial Officer's services, which effective January 1, 2016, have been paid directly by the Company through a consulting agreement.

 

Dr. Friesen, a director, the Chairman and the Chief Executive Officer of the Company also owns a clinical research organization, GVI Clinical Development Solutions Inc. (“GVI CDS”) which entered into the following clinical research contracts with the Company;

 

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Nature of Agreement Effective Date Terms
Regulatory affairs support June 22, 2009 Services provided as needed on an hourly basis
Pharmacovigilance and medical affairs support January 1, 2014 Monthly retainer of $2,000, plus hourly charges for pharmacovigilance services outside base services.
Pharmacovigilance and medical affairs support January 1, 2014 Monthly retainer of $1,250, plus hourly charges for pharmacovigilance services outside base services.
Quality assurance support June 1, 2010 Services provided as needed on an hourly basis.
Clincial services May 1, 2010 Services provided as needed on an hourly basis.

 

During the year ended December 31, 2019, the Company paid GVI CDS $406,000 (2018 - $858,000, 2017 – $716,000; 2016 – $592,000, 2015 - $331,000) for clinical research services.

 

The Company also has a consulting agreement with CanAm Bioresearch Inc. (“CanAm”), a company controlled by a close family member of Dr. Friesen’s to provide contract research services. During the year ended December 31, 2019, the Company paid CanAm $133,000 (2018 - $393,000, 2017 – $458,000; 2016 – $560,000; 2015 - $400,000) for research and development services.

 

These transactions have been measured at the exchange amount, which is the amount of consideration established and agreed to by the related parties.

 

Beginning on February 22, 2013 and until June 30, 2015, the amounts owing to GVI, GVI CDS and CanAm bore interest at a rate of 5.5% per annum. For the year ended December 31, 2017 and 2016, there was no interest charged on these amounts payable to related parties. For the year ended December 31, 2015 $5,000 was recorded within finance expense in relation to these amounts payable to related parties.

Beginning with the acquisition of Apicore (the “Acquisition”) on December 1, 2016 and ending with the Apicore Sales Transaction on October 2, 2017, as described in note 5 of the consolidated financial statements, the Company incurred rental charges pertaining to leased manufacturing facilities and office space from Dap Dhaduk II LLC (“Dap Dhaduk”), an entity controlled by a minority shareholder and member of the board of directors of Apicore Inc. Included within discontinued operations on the consolidated statements of net income and comprehensive income is payments to Dap Dhaduk totaling $263,000 and $30,000 for the years ended December 31, 2017 and 2016, respectively.

Beginning with the Acquisition on December 1, 2016 and ending with the Apicore Sales Transaction on October 2, 2017, as described in note 5 of the consolidated financial statements, the Company purchased inventory from Aktinos Pharmaceuticals Private Limited and Aktinos HealthCare Private Limited (together, “Aktinos”), an entity significantly influenced by a close family member of the Chief Executive Officer of Apicore Inc. For the year ended December 31, 2017, the Company paid Aktinos $1.6 million (2016 – $217,000) for purchases of inventory, which were included in assets of the Apicore business sold (note 5) in connection with the Apicore Sales Transaction.

 

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Beginning with the Acquisition on December 1, 2016 and ending with the Apicore Sales Transaction on October 2, 2017, as described in note 5 of the consolidated financial statements, the Company incurred research and development charges from Omgene Life Sciences Pvt. Ltd. (“Omgene”), an entity significantly influenced by a close family member of the Chief Executive Officer of Apicore Inc. Included within discontinued operations on the consolidated statements of net income and comprehensive income is payments to Omgene totaling $26,000 and nil for the years ended December 31, 2017 and 2016, respectively.

 

Beginning with the Acquisition on December 1, 2016 and ending with the Apicore Sales Transaction on October 2, 2017, as described in note 5 of the consolidated financial statements,, the Company incurred pharmacovigilance charges from 4C Pharma Solutions LLC (“4C Pharma”), an entity significantly influenced by a close family member of the Chief Executive Officer of Apicore Inc. Included within discontinued operations on the consolidated statements of net income and comprehensive income is payments to 4C Pharma totaling $6,000 and nil for the years ended December 31, 2017 and 2016, respectively.

 

As at December 31, 2019, included in accounts payable and accrued liabilities is $95,000 (2018 - $17,000) payable to GVI, $56,000 (2018 $134,000) payable to GVI CDS, and no amounts (2018 $40,000) payable to CanAm. These amounts are unsecured, payable on demand and non-interest bearing. In addition, the other long-term liability totaling $1.2 million as at December 31, 2018 (2017 - $1.1 million) is payable to the former President and Chief Executive Officer of Apicore upon receipt of the holdback receivable.

As at December 31, 2019, the Company did not have any amounts payable (2018 $5,000) recorded within accounts payable and accrued liabilities relating to amounts payable to the members of the Company's Board of Directors for services provided.

Effective January 1, 2018, the Company renewed its consulting agreement with its Chief Financial Officer, through JFK Enterprises Ltd., a company owned by the Chief Financial Officer of the Company, for a one-year term, at a rate of $155,000 annually. The agreement could have been terminated by either party, at any time, upon 30 days written notice. Any amounts payable to JFK Enterprises Ltd. were unsecured, payable on demand and non-interest bearing. Effective June 1, 2018, this consulting agreement was converted into an employment agreement with the Chief Financial Officer.

 

C. Interests of Experts and Counsel

 

Not applicable

 

ITEM 8. FINANCIAL INFORMATION

 

A. Consolidated Statements or Other Financial Information

 

financial Statements

 

The consolidated financial statements of the Company as at December 31, 2019 and 2018 and for the years ended December 31, 2019, 2018 and 2017 have been prepared in accordance with IFRS, as issued by the IASB, and are included under Item 18 of this Annual Report. The consolidated financial statements including related notes are accompanied by the report of the Company’s independent registered public accounting firm, PricewaterhouseCoopers LLP as at and for the years ended December 2019 and 2018 and Ernst & Young LLP for the year ended December 31, 2017.

 

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Legal Proceedings 

On February 13, 2019, the Company announced that it had received notice from the purchaser of Medicure's interests in Apicore of potential claims against funds held back in respect of representations and warranties under the Apicore sale agreement. The notice did not contain sufficiently detailed information to enable Medicure to assess the merits of the claims with the maximum exposure of the claims being the total holdback receivable. The Company continued to proceed diligently to investigate the potential claims and attempt to satisfactorily resolve them with a view to having the holdback funds released. In conjunction with the sale of Medicure's interests in Apicore, representation and warranty insurance was obtained by the purchaser that could result in mitigation of the potential claims.

On December 5, 2019, the Company announced that it had reached a settlement agreement with the purchaser of the Company’s interests in Apicore with respect to the amounts heldback under the Apicore sale agreement. A settlement agreement was reached under which Medicure received a net payment of US$5.1 million in relation to the holdback receivable.

 

On December 5, 2019, the Company announced it had filed a patent infringement action against in the U.S. District Court for the Northern District of Illinois, alleging infringement of the ‘660 patent.

 

The patent infringement action is in response to Nexus’ filing of an ANDA seeking approval from the FDA to market a generic version of AGGRASTAT® before the expiration of the ’660 patent.

 

The ’660 patent is listed in FDA’s orange book with an expiry date of May 1, 2023. Medicure will vigorously defend the ’660 patent and will pursue the patent infringement action against Nexus and all other legal options available to protect its product.

 

Previously, on November 16, 2018, the Company filed a patent infringement action against Gland in the U.S. District Court for the District of New Jersey, alleging infringement of the ‘660 patent.

 

The patent infringement actions were in response to Gland’s filing of an ANDA seeking approval from the FDA to market a generic version of AGGRASTAT® before the expiration of the ’660 patent.

 

On August 21, 2019 the Company announced that its subsidiary, Medicure International Inc., has settled this ongoing patent infringement action. As part of the settlement, Gland has acknowledged that the ‘660 patent is valid, enforceable and infringed. The settlement resulted in the Company entering into a license agreement with Gland with an anticipated launch date for Gland’s generic product of March 1, 2023. The remaining terms of the settlement are confidential.

During 2018, the Company was named in a civil claim in Florida from the third-party manufacturer of PREXXARTAN® against Carmel. The claim disputed the rights granted by Carmel to the Company with respect to PREXXARTAN®.  The Company believed the claim against it was without merit and intended to defend itself against the claim. The claim against the Company has been subsequently withdrawn, however the dispute between the third-party manufacturer and Carmel continues.

 

Aside from the above, there are no additional legal or arbitration proceedings, including those relating to bankruptcy, receivership or similar proceedings and those involving any third party, which may have, or have had in the recent past, significant effects on the Company’s financial position or profitability. There are no additional significant legal proceedings to which the Company is a party, nor to the best of the knowledge of the Company’s management are any legal proceedings contemplated.

 

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Dividend Policy

 

The Company has not paid dividends in the past and it has no present intention of paying dividends on its shares as it anticipates that all available funds will be invested to finance the growth of its business. The directors of the Company will determine if and when dividends should be declared and paid in the future based upon the Company’s financial position at the relevant time. All of the Company’s Shares are entitled to an equal share of any dividends declared and paid.

 

B. Significant Changes

 

There have been no significant changes to the accompanying financial statements since December 31, 2018, except as disclosed in this Annual Report on Form 20-F.

 

ITEM 9. THE OFFERING AND LISTING

 

A. Listing Details

 

On October 24, 2011, the Company’s common shares commenced trading on the TSX-V under the symbol “MPH”.

 

By Articles of Amendment filed by the Company under the Canada Business Corporations Act on November 1, 2012, the Company’s issued and outstanding common shares were consolidated on the basis of one post-consolidation common share for every fifteen pre-consolidation common shares. The Company’s name and trading symbol did not change as a result of the consolidation. The Company’s common shares were reduced from 182,947,595 to 12,196,508 issued and outstanding as a result of the consolidation. The trading prices presented here have not been adjusted to reflect the consolidation.

 

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The following table sets forth for the periods indicated the price history of the Company’s common shares on the TSX-V.

 

  TSX-V TSX-V
  High ($) Low ($)
     
Fiscal Quarter Ended  
December 31, 2019  5.24 3.00
September 30, 2019 5.02 4.15
June 30, 2019 6.35 4.68
March 31, 2019  6.90 5.95
December 31, 2018  7.15 5.71
September 30, 2018 7.38 6.60
June 30, 2018 7.55 5.90
March 31, 2018  7.40 6.70
December 31, 2017  8.71 6.90
September 30, 2017 8.45 7.50
June 30, 2017 9.82 6.50
March 31, 2017 10.55 8.52
December 31, 2016 10.67 5.48
September 30, 2016 7.20 5.49
June 30, 2016 6.98 4.73
March 31, 2016 7.29 4.18

 

B. Plan of Distribution

 

Not applicable.

 

C. Markets

 

The Company’s common shares are listed for trading on the TSX-V under the symbol “MPH”. Certain market makers also trade the Company’s common shares on the OTC Pink Market, under the symbol “MCUJF”.

 

D. Selling Shareholders

 

Not applicable.

 

E. Dilution

 

Not applicable.

 

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F. Expenses of the Issue

 

Not applicable.

 

ITEM 10. ADDITIONAL INFORMATION

 

A. Share Capital

 

Not applicable

 

B. Memorandum and Articles of Association

 

1. Objects and Purposes of the Company

 

The Articles of Continuance (as amended, the “Articles”) and the By-Laws of the Company place no restrictions upon the Company’s objects and purposes.

 

2. Directors

 

Under applicable Canadian law, the directors and officers of the Company, in exercising their powers and discharging their duties, must act honestly and in good faith with a view to the best interests of the Company. The directors and officers must also exercise the care, diligence and skill that a reasonably prudent person would exercise in comparable circumstances.

 

Section 4.18 of By-Law No.1A of the Company (the “By-Law”) provides that a director shall not be disqualified by reason of his office from contracting with the Company or a subsidiary thereof. Subject to the provisions of the Canada Business Corporations Act (the “Act”), a director shall not by reason only of his office be accountable to the Company or its shareholders for any profit or gain realized from a contract or transaction in which he has an interest. Such contract or transaction shall not be voidable by reason only of such interest, or by reason only of the presence of a director so interested at a meeting, or by reason only of his presence being counted in determining a quorum at a meeting of the directors at which such a contract or transaction is approved, provided that a declaration and disclosure of such interest shall have been made at the time and in the manner prescribed by section 120 of the Act, and the director so interested shall have refrained from voting as a director on the resolution approving the contract or transaction (except as permitted by the Act) and such contract shall have been reasonable and fair to the Company and shall have been approved by the directors or shareholders of the Company as required by section 120 of the Act.

 

The Company’s Articles provide that the Company’s board shall consist of a minimum of one and a maximum of 15 directors. The exact number of directors to form the board, between the minimum and maximum number of directors prescribed by the Articles, is determined from time to time by the board. Section 4.01 of the By-Law states that the quorum of the board shall be a majority of the board, or such other number of directors as the board may from time to time determine. No business shall be transacted at a meeting unless a quorum is present.

 

Section 3.01 of the By-Law states that the board may, without the authorization of the shareholders:

 

i) borrow money upon the credit of the Company;

ii) issue, reissue, sell or pledge debt obligations of the Company, including bonds, debentures, notes or other evidences of indebtedness or guarantees, whether secured or unsecured;

 

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iii) subject to section 44 of the Act, give a guarantee on behalf of the Company to secure performance of any present or future indebtedness, liability or obligation of any person; and

iv) mortgage, hypothecate, pledge or otherwise create a security interest in all or any property of the Company, owned or subsequently acquired, to secure any obligation of the Company.

 

The borrowing powers of the directors can be varied by amending the By-Law of the Company.

 

There is no provision in the By-Law imposing a requirement for retirement or non-retirement of directors under an age limit requirement.

 

Section 4.02 of the By-law states that a director need not be a shareholder to be qualified as a director. However, section 4.02 also provides that at least 25% of the directors shall be resident Canadians unless the Company has less than four directors, in which case at least one director must be a resident Canadian.

 

Under section 4.03 of the By-law, directors are to be elected yearly by ordinary resolution to hold office until the close of the next annual meeting of shareholder. If directors fail to be elected at any such meeting of shareholders, then the incumbent directors continue in office until their successors are elected.

 

3. Shares

 

The Articles of the Company provide that the Company is authorized to issue an unlimited number of shares designated as Common Shares, Class A Common Shares and Preferred Shares. Except for meetings at which only holders of another specified class or series of shares of the Company are entitled to vote separately as a class or series, each holder of the Common and Class A shares is entitled to receive notice of, to attend and to vote at all meetings of the shareholders of the Company. Subject to the rights, privileges, restrictions and conditions attached to any other class of shares of the Company, the holders of the Common and Class A shares are also entitled to receive dividends if, as and when declared by the directors of the Company and are entitled to share equally in the remaining property of the Company upon liquidation, dissolution or winding-up of the Company.

 

The Preferred Shares may from time to time be issued in one or more series and, subject to the following provisions, and subject to the sending of articles of amendment in respect thereof, the directors may fix from time to time and before issue a series of Preferred Shares, the number of shares which are to comprise that series and the designation, rights, privileges, restrictions and conditions to be attached to that series of Preferred Shares including, without limiting the generality of the foregoing, the rate or amount of dividends or the method of calculating dividends, the dates of payment of dividends, the redemption, purchase and/or conversion, and any sinking fund or other provisions.

 

The Preferred Shares of each series shall, with respect to the payment of dividends and the distribution of assets or return of capital in the event of liquidation, dissolution or winding-up of the Company, whether voluntary or involuntary, or any other return of capital or distribution of the assets of the Company among its shareholders for the purpose of winding-up its affairs, rank on a parity with the Preferred Shares of every other series and be entitled to preference over the Common and Class A Common Shares and over any other shares of the Company ranking junior to the Preferred Shares. The Preferred Shares of any series may also be given other preferences, not inconsistent with these articles, over the Common Shares and Class A Common Shares and any other shares of the Company ranking junior to the Preferred Shares of a series as may be fixed in accordance with terms outlined above.

 

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If any cumulative dividends or amounts payable on the return of capital in respect of a series of Preferred Shares are not paid in full, all series of Preferred Shares shall participate rateably in respect of accumulated dividends and return of capital.

 

Unless the directors otherwise determine in the articles of amendment designating a series of Preferred Shares, the holder of each share or a series of Preferred Shares shall not, as such, be entitled to receive notice of or vote at any meeting of shareholders, except as otherwise specifically provided in the Act.

 

4. Rights of Shareholders

 

Under the Act, shareholders of the Company are entitled to examine, during its usual business hours, the Company’s articles and by-laws, notices of directors and change of directors, any unanimous shareholder agreements, the minutes of meetings and resolutions of shareholders and the list of shareholders.

 

Shareholders of the Company may obtain a list of shareholders upon payment of a reasonable fee and sending an affidavit to the Company or its transfer agent stating, among other things, that the list of shareholders will not be used by any person except in connection with an effort to influence the voting of shareholders of the Company, an offer to acquire shares of the Company or any other matter relating to the affairs of the Company.

 

Under the Act, shareholders of the Company may apply to a court having jurisdiction directing an investigation to be made of the Company. If it appears to the court that the formation, business or affairs of the Company were conducted for fraudulent or unlawful purposes, or that the powers of the directors were exercised in a manner that is oppressive or unfairly disregards the interests of the shareholders, the court may order an investigation to be made of the Company.

 

To change the rights of holders of stock, where such rights are attached to an issued class or series of shares, requires the consent by a separate resolution of the holders of the class or series of shares, as the case may be, requiring a majority of two-thirds of the votes cast.

 

The Company is organized under the laws of Canada. The majority of the Company’s directors, officers, and affiliates of the Company, as well as the experts named in this registration statement, are residents of Canada and, to the best of the Company’s knowledge, all or a substantial portion of their assets and all of the Company’s assets are located outside of the United States. As a result, it may be difficult for shareholders of the Company in the United States to effect service of process on the Company or these persons above within the United States, or to realize in the United States upon judgments rendered against the Company or such persons. Additionally, a shareholder of the Company should not assume that the courts of Canada (i) would enforce judgments of U.S. courts obtained in actions against the Company or such persons predicated upon the civil liability provisions of the U.S. federal securities laws or other laws of the United States, or (ii) would enforce, in original actions, liabilities against the Company or such persons predicated upon the U.S. federal securities laws or other laws of the United States.

 

Laws in the United States and judgments of U.S. courts would generally be enforced by a court of Canada unless such laws or judgments are contrary to public policy in Canada, are or arise from foreign penal laws or laws that deal with taxation or the taking of property by a foreign government and are not in compliance with applicable laws in Canada regarding the limitation of actions. Further, a judgment obtained in a U.S. court would generally be recognized by a court of Canada, except under the following examples:

 

i) the judgment was rendered in a U.S. court that had no jurisdiction according to applicable laws in Canada;

 

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ii) the judgment was subject to ordinary remedy (appeal, judicial review and any other judicial proceeding which renders the judgment not final, conclusive or enforceable under the laws of the applicable state) or not final, conclusive or enforceable under the laws of the applicable state;

iii) the judgment was obtained by fraud or in any manner contrary to natural justice or rendered in contravention of fundamental principles of procedure; and

iv) a dispute between the same parties, based on the same subject matter has given rise to a judgment rendered in a court of Canada or has been decided in a third country and the judgment meets the necessary conditions for recognition in a court of Canada.

 

5. Meetings

 

Subject to the provisions of the Act, the annual general meeting of the shareholders shall be on such date in each year as the board of directors may determine, and a special meeting of the shareholders may be convened at any time by order of the President or by the board on their own motion or on the requisition of shareholders as provided for in the Act. Notice of the time and place of each meeting of shareholders shall be given not less than 21 days nor more than 60 days before the date of the meeting to each director and shareholder. A meeting of shareholders may be held without notice at any time and at any place provided a waiver of notice is obtained in accordance with section 136 of the Act. The quorum for the transaction of business at meetings of the shareholders shall consist of not less than two shareholders present or represented by proxy and holding in all not less than 10% percent of the outstanding shares entitled to vote at the meeting. At any meeting of shareholders, every person shall be entitled to vote who, at the time of the taking of a vote (or, if there is a record date for voting, at the close of business on such record date) is entered in the register of shareholders as the holder of one or more shares carrying the right to vote at such meeting, subject to the provisions of the Act.

 

6. Ownership of Securities

 

There are no limitations imposed by the Act, or by the Articles or By-Law or any other constituent document of the Company on the right of non-resident or foreign shareholders to own or vote securities of the Company. However, the Investment Canada Act (Canada) will prohibit implementation, or if necessary, require divestiture of an investment deemed “reviewable” under the Investment Canada Act (Canada) by an investor that is not a “Canadian” as defined in the Investment Canada Act (Canada), unless after review the Minister responsible for the Investment Canada Act (Canada) is satisfied that the “reviewable” investment is likely to be of net benefit to Canada.

 

The following discussion summarizes the principal features of the Investment Canada Act for a non-Canadian who proposes to acquire common shares of the Company. The discussion is general only; it is not a substitute for independent legal advice from an investor’s own adviser; and, except where expressly noted, it does not anticipate statutory or regulatory amendments.

 

The Investment Canada Act is a federal statute of broad application regulating the establishment and acquisition of Canadian businesses by non-Canadians, including individuals, governments or agencies thereof, corporations, partnerships, trusts or joint ventures, Investments by non-Canadians to acquire control over existing Canadian businesses or to establish new ones are either reviewable or notifiable under the Investment Canada Act. If an investment by a non-Canadian to acquire control over an existing Canadian business is reviewable under the Investment Canada Act, the Investment Canada Act generally prohibits implementation of the investment unless, after review, the Minister of Industry is satisfied that the investment is likely to be of net benefit to Canada.

 

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An investment in the Company’s common shares by a non-Canadian, who is not a resident of a World Trade Organization (“WTO”) member, would be reviewable under the Investment Canada Act (Canada) if it was an investment to acquire control of the Company and the value of the assets of the Company was CAN $5 million or more. An investment in common shares of the Company by a resident of a WTO member would be reviewable only if it was an investment to acquire control of the Company and the enterprise value of the assets of the Company was equal to or greater than a specified amount, which is published by the Minister after its determination for any particular year. This amount is currently CAN $1 billion (unless the WTO member is party to one of a list of certain free trade agreements, in which case the amount is currently CAN $1.5 billion); beginning January 1, 2019, both thresholds will be adjusted annually by a GDP (Gross Domestic Product) based index.

 

A non-Canadian would be deemed to acquire control of the Company for the purposes of the Investment Canada Act if the non-Canadian acquired a majority of the outstanding common shares (or less than a majority but controlled the Company in fact through the ownership of one-third or more of the outstanding common shares) unless it could be established that, on the acquisition, the Company is not controlled in fact by the acquirer through the ownership of such common shares. Certain transactions in relation to the Company’s common shares would be exempt from review under the Investment Canada Act, including, among others, the following:

 

a) the acquisition of voting shares or other voting interests by any person in the ordinary course of that person’s business as a trader or dealer in securities;

 

ii) the acquisition of control of the Company in connection with the realization of security granted for a loan or other financial assistance and not for any purpose related to the provisions of the Investment Canada Act (Canada), if the acquisition is subject to approval under the Bank Act (Canada), the Cooperative Credit Associations Act (Canada), the Insurance Companies Act (Canada) or the Trust and Loan Companies Act (Canada); and

 

iii) the acquisition of control of the Company by reason of an amalgamation, merger, consolidation or corporate reorganization following which the ultimate direct or indirect control of the Company, through the ownership of voting interests, remains unchanged.

 

7. Change in Control of Company

 

No provision of the Company’s Articles or By-Law would have the effect of delaying, deferring, or preventing a change in control of the Company, and operate only with respect to a merger, acquisition or corporate restructuring of the Company or any of its subsidiaries. The Company no longer has a shareholder rights plan.

 

C. Material Contracts

 

The following are the material contracts of the Company, other than those mentioned elsewhere in this Form, to which the Company or any member of the group is a party, for the two years immediately preceding publication of this registration statement.

 

None

 

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D. Exchange Controls

 

There is no law or governmental decree or regulation in Canada that restricts the export or import of capital, or affects the remittance of dividends, interest or other payments to a non-resident holder of Common Shares, other than withholding tax requirements. Any such remittances to United States residents are generally subject to withholding tax, however no such remittances are likely in the foreseeable future. (See “Item 10E - Taxation”, below.)

 

Except as provided in the Investment Canada Act (Canada), which has rules regarding certain acquisitions of shares by non-residents, there is no limitation imposed by Canadian law, or by the Company’s Articles or By-Law, or by any other constituent documents of the Company, on the right of a non-resident to hold or vote the Company’s common shares. Investment Canada Act is a Canadian federal statute of broad application regulating the establishment and acquisition of Canadian businesses by non-Canadians, including individuals, governments or agencies thereof, corporations, partnerships, trusts or joint ventures. Investments by non-Canadians to acquire control over existing Canadian businesses or to establish new ones are either reviewable or notifiable under the Investment Canada Act. If an investment by a non-Canadian to acquire control over an existing Canadian business is reviewable under the Investment Canada Act, the Investment Canada Act generally prohibits implementation of the investment unless, after review, the Minister of Industry is satisfied that the investment is likely to be of net benefit to Canada.

 

E. Taxation

 

Material U.S. Federal Income Tax Considerations

 

The following is a summary of the anticipated material U.S. federal income tax considerations applicable to a U.S. Holder (as defined below) arising from and relating to the acquisition, ownership, and disposition of the Company’s common shares (“Common Shares”).

 

This summary is for general information purposes only and does not purport to be a complete analysis or listing of all potential U.S. federal income tax considerations that may apply to a U.S. Holder as a result of the acquisition, ownership, and disposition of Common Shares. In addition, this summary does not take into account the individual facts and circumstances of any particular U.S. Holder that may affect the U.S. federal income tax consequences of the acquisition, ownership, and disposition of Common Shares for such U.S. Holder. Accordingly, this summary is not intended to be, and should not be construed as, legal or U.S. federal income tax advice with respect to any particular U.S. Holder. Except as specifically set forth below, this summary does not discuss applicable tax reporting requirements. Each U.S. Holder should consult its own tax advisor regarding the U.S. federal, U.S. state and local, and non-U.S. tax consequences of the acquisition, ownership, and disposition of Common Shares.

 

No opinion from U.S. legal counsel or ruling from the Internal Revenue Service (the “IRS”) has been requested, or will be obtained, regarding the U.S. federal income tax consequences of the acquisition, ownership and disposition of Common Shares. This summary is not binding on the IRS, and the IRS is not precluded from taking a position that is different from, or contrary to, any position taken in this summary. In addition, because the authorities upon which this summary is based are subject to various interpretations, the IRS and the U.S. courts could disagree with one or more of the positions taken in this summary.

 

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Scope of this Summary

 

Authorities

 

This summary is based on the Internal Revenue Code of 1986, as amended (the “Code”), Treasury Regulations (whether final, temporary, or proposed), published rulings of the IRS, published administrative positions of the IRS, the Convention Between Canada and the United States of America with Respect to Taxes on Income and on Capital, signed September 26, 1980, as amended (the “Canada-U.S. Tax Convention”), and U.S. court decisions that are applicable and, in each case, as in effect and available, as of the date of this Annual Report. Any of the authorities on which this summary is based could be changed in a material and adverse manner at any time, and any such change could be applied on a retroactive basis, which could affect the U.S. federal income tax consequences described in this summary. This summary does not discuss the potential effects, whether adverse or beneficial, of any proposed legislation that, if enacted, could be applied on a retroactive basis.

 

U.S. Holders

 

For purposes of this summary, a “U.S. Holder” is a beneficial owner of Common Shares that, for U.S. federal income tax purposes, is (a) an individual who is a citizen or resident of the U.S., (b) a corporation, or any other entity classified as a corporation for U.S. federal income tax purposes, that is created or organized in or under the laws of the U.S., any state in the U.S., or the District of Columbia, (c) an estate if the income of such estate is subject to U.S. federal income tax regardless of the source of such income, or (d) a trust if (i) such trust has validly elected to be treated as a U.S. person for U.S. federal income tax purposes or (ii) a U.S. court is able to exercise primary supervision over the administration of such trust and one or more U.S. persons have the authority to control all substantial decisions of such trust.

 

Non-U.S. Holders

 

For purposes of this summary, a “non-U.S. Holder” is a beneficial owner of Common Shares other than a U.S. Holder. This summary does not address the U.S. federal income tax consequences of the acquisition, ownership, and disposition of Common Shares to non-U.S. Holders. Accordingly, a non-U.S. Holder should consult its own tax advisor regarding the U.S. federal, U.S. state and local, and non-U.S. tax consequences (including the potential application of and operation of any tax treaties) of the acquisition, ownership, and disposition of Common Shares.

 

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U.S. Holders Subject to Special U.S. Federal Income Tax Rules Not Addressed

 

This summary does not address the U.S. federal income tax consequences of the acquisition, ownership, and disposition of Common Shares to U.S. Holders that are subject to special provisions under the Code, including the following U.S. Holders: (a) U.S. Holders that are tax-exempt organizations, qualified retirement plans, individual retirement accounts, or other tax-deferred accounts; (b) U.S. Holders that are financial institutions, underwriters, insurance companies, real estate investment trusts, or regulated investment companies; (c) U.S. Holders that are dealers in securities or currencies or U.S. Holders that are traders in securities or currencies that elect to apply a mark-to-market accounting method; (d) U.S. Holders that have a “functional currency” other than the U.S. dollar; (e) U.S. Holders that are liable for the alternative minimum tax under the Code; (f) U.S. Holders that own Common Shares as part of a straddle, hedging transaction, conversion transaction, constructive sale, or other arrangement involving more than one position; (g) U.S. Holders that are subject to Section 451(b) of the Code; (h) U.S. Holders that acquired Common Shares in connection with the exercise of employee stock options or otherwise as compensation for services; (i) U.S. Holders that hold Common Shares other than as capital assets within the meaning of Section 1221 of the Code (generally, property held for investment purposes); (j) U.S. Holders who are U.S. expatriates or former long-term residents of the United States; (k) U.S. Holders that own (directly, indirectly, or by attribution) 10% or more of the total combined voting power or value of the outstanding shares of the Company; or (l) corporations that accumulate earnings to avoid U.S. federal income tax. U.S. Holders that are subject to special provisions under the Code, including U.S. Holders described immediately above, should consult their own tax advisors regarding the U.S. federal, U.S. state and local, and non-U.S. tax consequences of the acquisition, ownership, and disposition of Common Shares.

 

If an entity that is classified as a partnership (or other “pass-through” entity) for U.S. federal income tax purposes holds Common Shares, the U.S. federal income tax consequences to such partnership (or other “pass-through” entity) and the partners of such partnership (or owners of such other “pass-through” entity) generally will depend on the activities of the partnership (or other “pass-through” entity) and the status of such partners (or owners). This summary does not address the U.S. federal income tax consequences for any such partner or partnership (or other “pass-through” entity or owner). Partners of entities that are classified as partnerships (or owners of other “pass-through” entities) for U.S. federal income tax purposes should consult their own tax advisors regarding the U.S. federal tax consequences of the acquisition, ownership, and disposition of Common Shares.

 

Tax Consequences Other than U.S. Federal Income Tax Consequences Not Addressed

 

This summary does not address the U.S. state and local, U.S. federal estate and gift, U.S. Medicare contribution, or non-U.S. tax consequences to U.S. Holders of the acquisition, ownership, and disposition of Common Shares. Each U.S. Holder should consult its own tax advisor regarding the U.S. state and local, U.S. federal estate and gift, U.S. Medicare contribution, and non-U.S. tax consequences of the acquisition, ownership, and disposition of Common Shares. (See “Taxation—Canadian Federal Income Tax Considerations for U.S. Residents” below).

 

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U.S. Federal Income Tax Consequences of the Acquisition, Ownership, and Disposition of Common Shares

 

Distributions on Common Shares

 

General Taxation of Distributions

 

Subject to the “passive foreign investment company” rules discussed below, a U.S. Holder that receives a distribution, including a constructive distribution, with respect to Common Shares will be required to include the amount of such distribution in gross income as a dividend (without reduction for any Canadian income tax withheld from such distribution) to the extent of the current or accumulated “earnings and profits” of the Company, as computed for U.S. federal income tax purposes. To the extent that a distribution exceeds the current and accumulated “earnings and profits” of the Company, such distribution will be treated (a) first, as a tax-free return of capital to the extent of a U.S. Holder’s tax basis in the Common Shares, and (b) thereafter, as gain from the sale or exchange of such Common Shares. (See more detailed discussion at “Disposition of Common Shares” below). The Company may not maintain calculations of earnings and profits in accordance with U.S. federal income tax principles, and each U.S. Holder should therefore assume that any distribution by the Company with respect to Common Shares will constitute a dividend.

 

Reduced Tax Rates for Certain Dividends

 

A dividend paid by the Company generally will be taxed at the preferential tax rates applicable to long-term capital gains if (a) the Company is a “qualified foreign corporation” (as defined below), (b) the U.S. Holder receiving such dividend is an individual, estate, or trust, and (c) such dividend is paid on Common Shares that have been held by such U.S. Holder for at least 61 days during the 121-day period beginning 60 days before the “ex-dividend date.” The Company generally will be a “qualified foreign corporation” under Section 1(h)(11) of the Code (a “QFC”) if (a) the Company is eligible for the benefits of the Canada-U.S. Tax Convention, or (b) Common Shares are readily tradable on an established securities market in the U.S.

 

However, even if the Company satisfies one or more of such requirements, the Company will not be treated as a QFC if the Company is a “passive foreign investment company,” or “PFIC” (as defined below) for the taxable year during which the Company pays a dividend or for the preceding taxable year.

 

As discussed below, the Company does not believe that it was a PFIC for the taxable year ended December 31, 2019, and does not expect that it will be a PFIC for the taxable year ending December 31, 2020. (See more detailed discussion at “Additional Rules that May Apply to U.S. Holders” below). However, there can be no assurance that the IRS will not challenge the determination made by the Company concerning its PFIC status or that the Company will not be a PFIC for the current taxable year or any subsequent taxable year.

 

Accordingly, although the Company expects that it may be a QFC for the taxable year ending December 31, 2020, there can be no assurance that the IRS will not challenge the determination made by the Company concerning its QFC status, or that the Company will be a QFC for the taxable year ending December 31, 2020, or any subsequent taxable year.

 

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If the Company is not a QFC, subject to the PFIC rules discussed below, a dividend paid by the Company to a U.S. Holder, including a U.S. Holder that is an individual, estate, or trust, generally will be taxed at ordinary income tax rates (and not at the preferential tax rates applicable to long-term capital gains). The dividend rules are complex, and each U.S. Holder should consult its own tax advisor regarding the dividend rules.

 

 

Distributions Paid in Foreign Currency

 

The amount of a distribution paid to a U.S. Holder in foreign currency generally will be equal to the U.S. dollar value of such distribution based on the exchange rate applicable on the date of receipt. A U.S. Holder that does not convert foreign currency received as a distribution into U.S. dollars on the date of receipt generally will have a tax basis in such foreign currency equal to the U.S. dollar value of such foreign currency on the date of receipt. Such a U.S. Holder generally will recognize ordinary income or loss on the subsequent sale or other taxable disposition of such foreign currency (including an exchange for U.S. dollars).

 

Dividends Received Deduction

 

Dividends paid on Common Shares generally will not be eligible for the “dividends received deduction.” The availability of the dividends received deduction is subject to complex limitations that are beyond the scope of this discussion, and a U.S. Holder that is a corporation should consult its own tax advisor regarding the dividends received deduction.

 

Disposition of Common Shares

 

Subject to the PFIC rules discussed below, a U.S. Holder will recognize capital gain or loss on the sale or other taxable disposition of Common Shares in an amount equal to the difference, if any, between (a) the amount of cash plus the fair market value of any property received and (b) such U.S. Holder’s tax basis in the Common Shares sold or otherwise disposed of. A U.S. Holder’s tax basis in Common Shares generally will be such U.S. Holder’s U.S. dollar cost for such Common Shares. Such gain or loss will be long-term capital gain or loss if the Common Shares have been held for more than one year at the time of sale or other taxable disposition. Gain or loss recognized by a U.S. Holder on the sale or other taxable disposition of Common Shares generally will be treated as “U.S. source” for purposes of applying the U.S. foreign tax credit rules.

 

Preferential tax rates apply to long-term capital gains of a U.S. Holder that is an individual, estate, or trust. There are currently no preferential tax rates for long-term capital gains of a U.S. Holder that is a corporation. Deductions for capital losses are subject to significant limitations under the Code.

 

The amount realized on a sale or other taxable disposition of Common Shares for an amount in foreign currency will generally be the U.S. dollar value of this amount on the date of sale or disposition. On the settlement date, the U.S. Holder will recognize U.S. source foreign currency gain or loss (taxable as ordinary income or loss) equal to the difference (if any) between the U.S. dollar value of the amount received based on the exchange rates in effect on the date of sale or other disposition and the settlement date.

 

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Foreign Tax Credit

 

A U.S. Holder that pays (whether directly or through withholding) Canadian income tax with respect to dividends paid on Common Shares or gain from the sale or other taxable disposition of Common Shares generally will be entitled, at the election of such U.S. Holder, to receive either a deduction or a credit for such Canadian income tax paid. Generally, a credit will reduce a U.S. Holder’s U.S. federal income tax liability on a dollar-for-dollar basis, whereas a deduction will reduce a U.S. Holder’s income subject to U.S. federal income tax. This election is made on a year-by-year basis and applies to all foreign taxes paid (whether directly or through withholding) by a U.S. Holder during a year.

 

Complex limitations apply to the foreign tax credit, including the general limitation that the credit cannot exceed the proportionate share of a U.S. Holder’s U.S. federal income tax liability that such U.S. Holder’s “foreign source” taxable income bears to such U.S. Holder’s worldwide taxable income. In applying this limitation, a U.S. Holder’s various items of income and deduction must be classified, under complex rules, as either “foreign source” or “U.S. source.” In addition, this limitation is calculated separately with respect to specific categories of income. Dividends paid by the Company generally will constitute “foreign source” income and generally will be categorized as “passive income.” The foreign tax credit rules are complex, and each U.S. Holder should consult its own tax advisor regarding the foreign tax credit rules.

 

Information Reporting; Backup Withholding Tax

 

Payments made within the U.S., or by a U.S. payor or U.S. middleman, of distributions with respect to, or proceeds arising from the sale or other taxable disposition of, Common Shares generally will be subject to information reporting and backup withholding tax, at the rate of 24%, if a U.S. Holder (a) fails to furnish such U.S. Holder’s correct U.S. taxpayer identification number (generally on IRS Form W-9), (b) furnishes an incorrect U.S. taxpayer identification number, (c) is notified by the IRS that such U.S. Holder has previously failed to properly report items subject to backup withholding tax, or (d) fails to certify, under penalty of perjury, that such U.S. Holder has furnished its correct U.S. taxpayer identification number and that the IRS has not notified such U.S. Holder that it is subject to backup withholding tax. However, U.S. Holders that are corporations generally are excluded from these information reporting and backup withholding tax rules. Backup withholding is not an additional tax. Any amounts withheld under the U.S. backup withholding tax rules will be allowed as a credit against a U.S. Holder’s U.S. federal income tax liability, if any, or will be refunded, if such U.S. Holder furnishes required information to the IRS in a timely manner. Each U.S. Holder should consult its own tax advisor regarding the information reporting and backup withholding tax rules.

 

Additional Rules that May Apply to U.S. Holders

 

The Company believes it was a PFIC in one or more previous taxable years. If the Company is or becomes a PFIC, or U.S. Holders held Common Shares while the Company was a PFIC, the preceding sections of this summary may not describe the U.S. federal income tax consequences to U.S. Holders of the acquisition, ownership, and disposition of Common Shares.

 

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Passive Foreign Investment Company

 

The Company generally will be a PFIC if, for a taxable year, (a) 75% or more of the gross income of the Company for such taxable year is passive income (“income test”) or (b) on average for such taxable year, 50% or more of the assets held by the Company either produce passive income or are held for the production of passive income (“asset test”), based on the fair market value of such assets. Passive income includes, for example, dividends, interest, certain rents and royalties, certain gains from the sale of stock and securities, and certain gains from commodities transactions. Passive income does not include any interest, dividends, rents, or royalties that are received or accrued by the Company from a “related person” (as defined in Section 954(d)(3) of the Code), to the extent such items are properly allocable to the income of such related person that is not passive income. Assets that produce or are held for the production of passive income generally include cash, even if held as working capital or raised in a public offering, marketable securities and other assets that may produce passive income.

 

For purposes of the income test and asset test, if the Company owns, directly or indirectly, 25% or more of the total value of the outstanding shares of another corporation, the Company will be treated as if it (a) held a proportionate share of the assets of such other corporation and (b) received directly a proportionate share of the income of such other corporation. , In addition, if the Company is a PFIC and owns shares of another foreign corporation that also is a PFIC (“subsidiary PFIC”), a disposition of the shares of such other foreign corporation or a distribution received from such other foreign corporation generally will be treated as an indirect disposition by a U.S. Holder or an indirect distribution received by a U.S. Holder, subject to the rules of Section 1291 of the Code discussed below. Accordingly, U.S. Holders should be aware that they could be subject to tax even if no distributions are received and no redemptions or other dispositions of Common Shares are made. To the extent that gain recognized on the actual disposition by a U.S. Holder of Common Shares or income recognized by a U.S. Holder on an actual distribution received on Common Shares was previously subject to U.S. federal income tax under these indirect ownership rules, such amount generally should not be subject to U.S. federal income tax.

 

If the Company is a PFIC, or a U.S. Holder held Common Shares while the Company was a PFIC, the U.S. federal income tax consequences to a U.S. Holder of the acquisition, ownership, and disposition of Common Shares will depend on whether such U.S. Holder makes an election to treat the Company and any subsidiary PFIC as a “qualified electing fund” or “QEF” under Section 1295 of the Code (a “QEF Election”) or a mark-to-market election for the Company under Section 1296 of the Code (a “Mark-to-Market Election”). A U.S. Holder that does not make either a QEF Election or a Mark-to-Market Election is referred to in this summary as a “Non-Electing U.S. Holder.”

 

Under Section 1291 of the Code, any gain recognized on the sale or other taxable disposition of Common Shares, and any “excess distribution” (as defined in Section 1291(b) of the Code) paid on the Common Shares, must be ratably allocated to each day in a Non-Electing U.S. Holder’s holding period for the Common Shares. The amount of any such gain or excess distribution allocated to the current year and any year prior to the first year in which the Company was a PFIC generally will be subject to U.S. federal income tax as ordinary income in the current year. The amount of any such gain or excess distribution allocated to other years generally will be subject to U.S. federal income tax in the current year at the highest tax rate applicable to ordinary income in each such prior year, and a Non-Electing U.S. Holder will be required to pay interest on the resulting tax liability for each such prior year, calculated as if such tax liability had been due in each such prior year.

 

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A U.S. Holder that makes a QEF Election generally will not be subject to the rules of Section 1291 of the Code discussed above. Instead, a U.S. Holder that makes a QEF Election generally will be subject to U.S. federal income tax on such U.S. Holder’s pro rata share of (a) the “net capital gain” of the Company, which will be taxed as long-term capital gain to such U.S. Holder, and (b) the “ordinary earnings” of the Company, which will be taxed as ordinary income to such U.S. Holder. A U.S. Holder that makes a QEF Election will be subject to U.S. federal income tax on such amounts for each taxable year in which the Company is a PFIC, regardless of whether such amounts are actually distributed to such U.S. Holder by the Company. Taxable gains on the disposition of Common Shares by a U.S. Holder that has made a timely and effective QEF Election are generally capital gains. Each U.S. Holder should consult its own tax advisor regarding the availability and desirability of, and procedure for, making a timely and effective QEF Election for the Company and any subsidiary PFIC.

 

A U.S. Holder that makes a Mark-to-Market Election generally will not be subject to the rules of Section 1291 of the Code discussed above. A U.S. Holder may make a Mark-to-Market Election only if Common Shares are “marketable stock” (as defined in Section 1296(e) of the Code). A U.S. Holder that makes a Mark-to-Market Election will include in gross income, as ordinary income, for each taxable year in which the Company is a PFIC, an amount equal to the excess, if any, of (a) the fair market value of the Common Shares as of the close of such taxable year over (b) such U.S. Holder’s tax basis in such Common Shares. A U.S. Holder that makes a Mark-to-Market Election will, subject to certain limitations, be allowed a deduction in an amount equal to the excess, if any, of (a) such U.S. Holder’s adjusted tax basis in the Common Shares over (b) the fair market value of such Common Shares as of the close of such taxable year. Any gain recognized upon a disposition of Common Shares by a U.S. Holder who has made a Mark-to-Market Election generally will be treated as ordinary income, and any loss recognized upon a disposition generally will be treated as an ordinary loss to the extent of net mark-to-market income recognized for all prior taxable years. Any loss recognized in excess thereof will be taxed as a capital loss. Capital losses are subject to significant limitations under the Code. A Mark-to-Market election may not be made with respect to the stock of any subsidiary PFIC because such stock is not “marketable stock.” Hence, a Mark-to-Market Election will not be effective to eliminate the application of the default rules of Section 1291 of the Code, described above, with respect to deemed dispositions of subsidiary PFIC stock or excess distributions with respect to a subsidiary PFIC. Each U.S. Holder should consult its own tax advisor regarding the availability and desirability of, and procedure for, making a timely and effective Mark-to-Market Election with respect to Common Shares.

 

The Company believes it was a PFIC in one or more prior taxable years but does not believe that it was a PFIC for the taxable years ended December 31, 2019 and December 31, 2018, and, based on current operations and financial projections, does not expect that it will be a PFIC for the taxable year ending December 31, 2020. The determination of whether the Company was, or will be, a PFIC for a taxable year depends, in part, on the application of complex U.S. federal income tax rules, which are subject to differing interpretations. In addition, whether the Company will be a PFIC for the taxable year ending December 31, 2020, and each subsequent taxable year depends on the assets and income of the Company over the course of each such taxable year and, as a result, cannot be predicted with certainty as of the date of this Annual Report. Accordingly, there can be no assurance that the IRS will not challenge the determination made by the Company concerning its PFIC status or that the Company was not, or will not be, a PFIC for any taxable year.

 

If the Company meets the income test or asset test for any taxable year during which a U.S. Holder owns Common Shares, the Company will be treated as a PFIC with respect to such U.S. Holder for that taxable year and for all subsequent taxable years, regardless of whether the Company meets the PFIC income test or asset test for such subsequent taxable years, unless the U.S. Holder elects to recognize any unrealized gain in the Common Shares or makes a timely and effective QEF Election or Mark-to-Market Election.

 

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The PFIC rules are complex, and each U.S. Holder should consult its own tax advisor regarding the PFIC rules and how the PFIC rules may affect the U.S. federal income tax consequences of the acquisition, ownership, and disposition of Common Shares.

 

THE ABOVE SUMMARY IS NOT INTENDED TO CONSTITUTE A COMPLETE ANALYSIS OF ALL U.S. FEDERAL INCOME TAX CONSIDERATIONS APPLICABLE TO U.S. HOLDERS WITH RESPECT TO THE ACQUISITION, OWNERSHIP, AND DISPOSITION OF COMMON SHARES. U.S. HOLDERS SHOULD CONSULT THEIR OWN TAX ADVISORS AS TO THE TAX CONSIDERATIONS APPLICABLE TO THEM IN THEIR PARTICULAR CIRCUMSTANCES.

 

Canadian Federal Income Tax Considerations for United States Residents

 

The following, as of the date hereof, is a summary of the principal Canadian federal income tax considerations generally applicable to the holding and disposition of common shares by a holder (a) who, for the purposes of the Income Tax Act (Canada) (the “Tax Act”) and at all relevant times, is not resident or deemed to be resident in Canada, deals at arm’s length and is not affiliated with the Company, holds the common shares as capital property and does not use or hold, and is not deemed to use or hold, the common shares in the course of carrying on, or otherwise in connection with, a business in Canada, and (b) who, for the purposes of the Canada - United States Income Tax Convention (the “Convention”) and at all relevant times, is a resident solely of the United States, has never been a resident of Canada, has not held or used (and does not hold or use) common shares in connection with a permanent establishment or fixed base in Canada, and who otherwise qualifies for the full benefits of the Convention. The Canada Revenue Agency has introduced special forms to be used in order to substantiate eligibility for benefits under the Convention, and affected holders should consult with their own advisers with respect to these forms and all relevant compliance matters.

 

Holders who meet all such criteria in clauses (a) and (b) above are referred to in this summary as a “U.S. Holder” or “U.S. Holders”, and this summary only addresses such U.S. Holders. The summary does not deal with special situations, such as particular circumstances of traders or dealers, limited liability companies, tax-exempt entities, insurers, financial institutions (including those to which the mark-to-market provisions of the Tax Act apply), entities considered fiscally transparent under applicable law, or otherwise.

 

This summary is based on the current provisions of the Tax Act, and the regulations thereunder, all proposed amendments to the Tax Act and regulations publicly announced by the Minister of Finance (Canada) to the date hereof, the current provisions of the Convention and our understanding of the current administrative practices of the Canada Revenue Agency. It has been assumed that all currently proposed amendments to the Tax Act and regulations will be enacted as proposed and that there will be no other relevant change in any governing law, the Convention or administrative policy, although no assurance can be given in these respects. This summary does not take into account provincial, U.S. or other foreign income tax considerations, which may differ significantly from those discussed herein.

 

This summary is not exhaustive of all possible Canadian income tax consequences. It is not intended as legal or tax advice to any particular U.S. Holder and should not be so construed. The tax consequences to a U.S. Holder will depend on that U.S. Holder’s particular circumstances. All holders, including U.S. Holders or prospective U.S. Holders as defined above, should consult their own tax advisors with respect to the tax consequences applicable to them having regard to their own particular circumstances. The discussion below is qualified accordingly.

 

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For the purposes of the Tax Act, all amounts relating to the acquisition, holding or disposition of the common shares must be converted into Canadian dollars based on the relevant exchange rate applicable thereto.

 

Dividends

 

Dividends paid or deemed to be paid or credited by the Company to a U.S. Holder are subject to Canadian withholding tax. In general terms, the Tax Act provides for withholding at the rate of 25% unless the holder is able to substantiate a reduced rate under an applicable tax treaty or convention.

 

The rate of withholding tax on dividends paid to a U.S. Holder who can substantiate eligibility for benefits under the Convention is generally limited to 15% of the gross amount of the dividends (or 5%, if the beneficial owner of the dividends is a company that owns at least 10% of the voting stock of the Company).

 

Dispositions

 

A U.S. Holder is generally not subject to tax under the Tax Act in respect of a capital gain realized on the disposition of a common share in the open market, unless the share is “taxable Canadian property” to the holder thereof and the U.S. Holder is not entitled to relief under the Convention.

 

Provided that the Company’s common shares are listed on a “designated stock exchange” for purposes of the Tax Act (which currently includes the TSX Venture) at the time of disposition, a common share will generally not constitute taxable Canadian property to a U.S. Holder unless, at any time during the 60 month period ending at the time of disposition, (i) the U.S. Holder, persons with whom the U.S. Holder did not deal at arm’s length, partnerships in which the U.S. Holder or such non-arm’s length persons holds a membership interest directly or indirectly, or the U.S. Holder together with any of the foregoing, owned 25% or more of the issued shares of any class or series of the Company AND (ii) more than 50% of the fair market value of the share was derived directly or indirectly from certain types of assets, including real or immoveable property situated in Canada, Canadian resource properties or timber resource properties, and options, interests or rights in respect of any of the foregoing. Common shares may also be deemed to be taxable Canadian property under the Tax Act in certain other circumstances. A U.S. Holder who may hold common shares as taxable Canadian property should consult with the U.S. Holder’s own tax advisors in advance of any disposition or deemed disposition of common shares under the Tax Act in order to determine whether any relief from tax under the Tax Act may be available by virtue of the Convention, and any related compliance procedures.

 

While intended to address material Canadian federal income tax considerations relevant to the holding or disposition of common shares by U.S. Holders, this summary is for general information purposes only, and is not intended to be, nor should it be construed to be, legal or tax advice to any holder or prospective holder of common shares. No opinion was requested by the Company, or is provided by its legal counsel and/or auditors. Accordingly, holders and prospective holders of common shares (including U.S. Holders as defined above) should consult their own tax advisors regarding the consequences of purchasing, owning, and disposing of common shares of the Company.

 

F. Dividends and Paying Agents

 

Not applicable

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G. Statement by Experts

 

Not applicable

 

H. Documents on Display

 

Exhibits attached to this Annual Report are available for viewing on EDGAR, or may be inspected at the head office of Company at 2 – 1250 Waverley Street, Winnipeg, Manitoba, Canada R3T 6C6, during normal business hours. Copies of the Company’s financial statements and other continuous disclosure documents required under Canadian securities legislation are available for viewing on the internet at www.sedar.com.

 

I. Subsidiary Information

 

Not applicable

 

ITEM 11. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK

 

INTEREST RATE RISK

 

The primary objective of the Company’s investment activities is to preserve principal by maximizing the income the Company receives from such activities without significantly increasing risk. Securities that the Company invests in are generally highly liquid short-term investments such as term deposits with terms to maturity of less than one year.

 

Interest rate risk is the risk that the future cash flows of a financial instrument will fluctuate because of changes in market interest rates. The Company is not exposed to any significant interest rate risk as it does not have any variable rate borrowings.

 

FOREIGN EXCHANGE RISK

 

The Company’s primary currency of operations is the Canadian dollar. Its wholly-owned operating subsidiaries primary currency of operations is the US dollar. The Company has expenditures and holds investments denominated in US dollars.  During the year ended December 31, 2019, it is estimated that approximately 60% of the Company’s consolidated expenditures were denominated in a foreign currency, primarily being the US dollar and 100% of the Company’s consolidated product revenues were denominated in the US dollar. To date the Company has not entered into any future or forward contracts, or other derivative instruments, for either hedging or speculative purposes, to mitigate the impact of foreign exchange fluctuations on these costs or revenues. Based on the above net exposures as at December 31, 2019, assuming that all other variables remain constant, a 5% appreciation or deterioration of the Canadian dollar against the U.S. dollar would result in a corresponding increase or decrease, respectively on the Company's net (loss) income of approximately $448,000. 

ITEM 12. DESCRIPTION OF SECURITIES OTHER THAN EQUITY SECURITIES

 

Not applicable

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PART II

 

ITEM 13. DEFAULTS, DIVIDEND ARREARAGES AND DELINQUENCIES

 

Not applicable

 

ITEM 14. MATERIAL MODIFICATIONS TO THE RIGHTS OF SECURITY HOLDERS AND USE OF PROCEEDS

 

Not applicable

 

ITEM 15. CONTROLS AND PROCEDURES

 

Disclosure Controls and Procedures

 

The Company’s disclosure controls and procedures, as such term is defined in Rules 13(a)-13(e) and 15(d)-15(e) of the Exchange Act are designed to provide reasonable assurance that all relevant information is communicated to senior management, including the Chief Executive Officer (“CEO”) and the Chief Financial Officer (“CFO”), to allow timely decisions regarding required disclosure. We carried out an evaluation, under the supervision and with the participation of our management, including our CEO and CFO. Based on this evaluation these officers concluded that as of the end of the period covered by this Annual Report on Form 20-F, our disclosure controls and procedures were not effective to ensure that the information required to be disclosed by our company in reports it files or submits under the Exchange Act is recorded, processed, summarized and reported within the time periods specified in the rules and forms of the Securities and Exchange Commission. These disclosure controls and procedures include controls and procedures designed to ensure that such information is accumulated and communicated to the Company’s management, including our company’s principal executive officer and principal financial officer, to allow timely decisions regarding required disclosure. The conclusion that the disclosure controls and procedures were not effective was due to the presence of a material weakness in internal control over financial reporting as identified below under the heading “Internal Controls over Financial Reporting Procedures”. Management anticipates that such disclosure controls and procedures will not be effective until the material weakness is remediated.

 

Management’s Annual Report on Internal Control over Financial Reporting

 

The management of the Company, including the CEO and CFO, is responsible for establishing and maintaining adequate internal controls over financial reporting (as defined in Rule 13a-15(f) under the Exchange Act). The Company’s internal control system was designed to provide reasonable assurance to the Company’s management and the board of directors regarding the reliability of financial reporting and preparation and fair presentation of published financial statements for external purposes in accordance with IFRS. Internal control over financial reporting includes those policies and procedures that:

 

1. pertain to the maintenance of records that in reasonable detail accurately and fairly reflect the transactions and dispositions of the assets of the Company;

 

2. provide reasonable assurance that transactions are recorded as necessary to permit preparation of financial statements in accordance with IFRS, and that receipts and expenditures of the Company are being made only in accordance with authorizations of management and directors of the Company; and

 

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3. provide reasonable assurance regarding prevention or timely detection of unauthorized acquisition, use or disposition of the Company’s assets that could have a material effect on the financial statements.

 

All internal control systems, no matter how well designed, have inherent limitations. Therefore, even those systems determined to be effective can provide only reasonable assurance with respect to financial statement preparation and presentation. Because of its inherent limitations, internal control over financial reporting may not prevent or detect misstatements. Projections of any evaluation of effectiveness to future periods are subject to the risk that controls may become inadequate because of changes in conditions or that the degree of compliance with the policies or procedures may deteriorate.

 

Under the supervision and with the participation of our management, including our CEO and CFO, we conducted an evaluation of the design and operation of internal control over financial reporting as of December 31, 2019, based on the framework set forth in Internal Control – Integrated Framework, issued by the Committee of Sponsoring Organizations of the Treadway Commission (COSO). Based on this evaluation, management concluded that the Company’s ICFR was not effective as at December 31, 2019 due to the following material weaknesses:

 

Due to the limited number of staff with an appropriate level of technical accounting knowledge, experience and training and the inability to attract outside expert advice on a cost-effective basis, there is a risk of material misstatements related to the accounting and reporting for complex accounting and income tax transactions. This control deficiency creates a reasonable possibility that a material misstatement of the annual financial statements would not have been prevented or detected in a timely manner.

 

Attestation Report of the Registered Public Accounting Firm

 

This Annual Report does not include an attestation report of the Company’s registered public accounting firm regarding internal control over financial reporting. Management’s report is not subject to attestation by the Company’s registered public accounting firm pursuant to rules of the Securities and Exchange Commission that permit the Company to provide only management’s report in this Annual Report.

 

Changes in Internal Control over Financial Reporting and Planned Remediation Activities

 

There have been no changes in the Company’s internal controls identified in connection with the evaluation described in the preceding paragraph that occurred during the period covered by this Annual Report on Form 20-F which have materially affected, or are reasonably likely to materially affect, the Company’s internal controls over financial reporting.

 

No remediation activities have been undertaken to date in fiscal 2020. Due to resource constraints and the present stage of the Company’s development the Company does not have sufficient size and scale to warrant the hiring of additional staff to correct this material weakness at this time.

 

ITEM 16. RESERVED

 

Not applicable

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ITEM 16A. AUDIT COMMITTEE FINANCIAL EXPERT

 

As of December 31, 2019, Mr. Brent Fawkes CPA, CA, a non-employee director, was a member of the audit committee of the Company. The board of directors of the Company has determined that Mr. Fawkes (i) qualifies as an audit committee financial expert pursuant to Items 16A(b) and (c) of Form 20-F and (ii) is independent as defined in section 803 of the NYSE American Company Guide and Rule 10A-3 of the Exchange Act. In addition, all members of the audit committee are considered financially literate under applicable Canadian laws.

 

ITEM 16B. CODE OF ETHICS

 

On August 23, 2004, the Company adopted a written Code of Business Conduct and Ethics (“Code of Ethics”) that applies to the Company’s principal executive officer, principal financial officer and to all its other employees. These standards are a guide to help ensure that all of the Company’s employees live up to high ethical standards. A copy of the Code of Ethics is maintained on the Company’s website at www.medicure.com.

 

During the most recently completed fiscal year, the Company has neither: (a) amended its Code of Ethics; nor (b) granted any waiver (including any implicit waiver) form any provision of its Code of Ethics.

 

ITEM 16C. PRINCIPAL ACCOUNTANT FEES AND SERVICES.

 

 

On November 21, 2018, the Company changed its auditors from Ernst & Young LLP to PricewaterhouseCoopers LLP.

 

In accordance with the requirements of the Sarbanes-Oxley Act of 2002 and the Audit Committee’s charter, all audit and audit-related work and all non-audit work performed by the chartered accountants, Ernst & Young LLP and PricewaterhouseCoopers LLP, is approved in advance by the Audit Committee, including the proposed fees for such work. The Audit Committee is informed of each service actually rendered that was approved through its pre-approval process.

 

For the fiscal year ended December 31, 2018, the Company did not incur any fees from PricewaterhouseCoopers LLP, however $140,000 of audit fees were accrued at December 31, 2018. As at December 31, 2019, the Company has accrued $162,000 in relation to audit fees from PricewaterhouseCoopers LLP.

 

(a)  Audit fees 2019 2018
  $ 146,000 $ -

Audit fees consist of fees billed for the audit of the Company’s annual financial statements.

 

 

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(b)  Audit-related fees 2019 2018
  $ - $ -

Audit-related fees consist of fees billed for accounting consultations.

 

(c)  Tax fees 2019 2018
  $ - $ -
     
(d)  All other fees 2019 2018
  $ - $ -

  

(e) Audit Committee’s Pre-approval Policies

 

All PricewaterhouseCoopers LLP services and fees are approved by the Audit Committee.

 

ITEM 16D. EXEMPTIONS FROM THE LISTING STANDARDS FOR AUDIT COMMITTEES

 

Not applicable

 

ITEM 16E. PURCHASES OF EQUITY SECURITIES BY THE ISSUER AND AFFILIATED PURCHASERS

 

On May 16, 2018, the Company announced that the TSXV accepted the Company's notice of intention to make a NCIB. In the opinion of the Company, its common shares were trading at prices that did not reflect its underlying value. Accordingly, the Company believed that purchasing its common shares for cancellation, at the then present pricing, represented an opportunity to enhance value for its shareholders.

 

Under the terms of the NCIB, the Company could have acquired up to an aggregate of 794,088 common shares. The NCIB commenced on May 28, 2018 and ended on May 27, 2019. The actual number of common shares that could have been purchased, if any, and the timing of such purchases was determined by the Company. All common shares purchased by the Company were purchased on the open market through the facilities of TSXV by PI Financial Corp. ("PI") acting on behalf of the Company in accordance with the policies of the TSXV and were surrendered by the Company to its transfer agent for cancellation. The prices that the Company paid for common shares purchased was the market price of the shares at the time of purchase.

 

The Company also announced that it had entered into an automatic share purchase plan with PI (the “Plan”) in order to facilitate repurchases of its common shares under the NCIB. Under the Plan, PI could purchase common shares under the NCIB at times when the Company would ordinarily not be permitted to do so, due to regulatory restrictions or self-imposed blackout periods.

 

Purchases under the Plan were made by PI based upon parameters prescribed by the TSXV, applicable Canadian securities laws and terms of the Plan.

During the year ended December 31, 2018 the Company repurchased and cancelled 441,400 common shares. The aggregate price paid for these common shares totaled $3.0 million. As a result of the NCIB, during the year ended December 31, 2018 the Company recorded $480,000 directly in its retained deficit representing the difference between the aggregate price paid for these common shares and a reduction of the Company’s share capital totaling $3.5 million.

On May 30, 2019, the Company announced that the TSXV has accepted the Company's notice of intention to make a NCIB (the “2019 NCIB”).

 

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Under the terms of the 2019 NCIB, Medicure may acquire up to an aggregate of 761,141 common shares. In the opinion of the Company, its common shares had been trading at prices that did reflect its underlying value. Accordingly, Medicure believed that purchasing its common shares for cancellation, at the then present pricing, represented an opportunity to enhance value for its shareholders.

 

As of May 29, 2019, the Company had 15,222,813 common shares outstanding, of which 6,758,666 common shares represented the public float of Medicure. Under TSXV policies, Medicure is entitled to purchase up to the maximum of 761,141 common shares, representing 5% of the common shares outstanding, over the 12 month period that the 2019 NCIB is in place.

 

The 2019 NCIB commenced on May 30, 2019 and will end on May 29, 2020, or on such earlier date as Medicure may complete its maximum purchases under the 2019 NCIB. The actual number of common shares which will be purchased, if any, and the timing of such purchases will be determined by the Company. All common shares purchased by the Company will be purchased on the open market through the facilities of TSXV by PI acting on behalf of the Company in accordance with the policies of the TSXV and will be surrendered by the Company to its transfer agent for cancellation. The prices that the Company will pay for common shares purchased will be the market price of the shares at the time of purchase.

 

The Company also announced that it had entered into an automatic share purchase plan with PI (the “Plan”) in order to facilitate repurchases of its common shares under the 2019 NCIB. Under the Plan, PI may purchase common shares under the 2019 NCIB at times when the Company would ordinarily not be permitted to do so, due to regulatory restrictions or self-imposed blackout periods.

 

Purchases under the Plan will be made by PI based upon parameters prescribed by the TSXV, applicable Canadian securities laws and terms of the Plan.

 

During the year ended December 31, 2019, the Company purchased and cancelled 421,300 of its common shares between May 30, 2019 and December 31, 2019 for a total cost to the Company of $2.1 million under the 2019 NCIB.

 

The Company suspended the 2019 NCIB in connection with its commencement of a SIB and no subsequent purchases were completed under the 2019 NCIB for the remainder of 2019.

 

On November 4, 2019 the Company announced its intention to commence a SIB (the “Offer”) pursuant to which the Company offered to purchase up to 4.0 million of its common shares (the “Common Shares”) for cancellation at a set purchase price of $6.50 per Common Share for a total purchase price of up to $26.0 million in cash. The Offer commenced on November 13, 2019 and expired at 5:00 p.m. (Eastern Standard Time) on December 19, 2019.

 

A total of 10,154,952 Common Shares were properly deposited under the Offer and not withdrawn. As the Offer was oversubscribed, the Company purchased Common Shares deposited on a pro rata basis following the determination of the final results of the Offer. Tendering shareholders had approximately 39.4% of their tendered Common Shares purchased by the Company under the Offer. The Common Shares that were purchased under the Offer represented approximately 27.0% of the outstanding Common Shares as at the time that the Offer was commenced. After giving effect to the Offer, the Company had 10,804,013 Common Shares outstanding.

 

130  

The Offer was funded from the Company’s existing cash on hand. The Company believed Medicure’s underlying value and its long-term growth prospects were not reflected in the trading price of its Common Shares prior to the announcement of the SIB. As such, Medicure believes that the purchase of Common Shares under the Offer represented a reasonable use of a portion of its significant cash resources resulting from the Company’s successful purchase and subsequent sale of the Apicore business.

 

During the ten months ended October 31, 2019, the closing prices of the Common Shares on the TSX Venture Exchange (“TSXV”) ranged from a low of $3.00 to a high of $6.85. The closing price of the Common Shares on the TSXV on November 1, 2019 (the last full trading day before the announcement of the SIB) was $3.22. The purchase price of $6.50 per Common Share represents a 101.9% premium over the closing price of the Common Shares on the TSXV on November 1, 2019.

 

The Offer was optional for all shareholders, who were free to choose whether to participate and how many Common Shares to tender. Shareholders who did not deposit their Common Shares (or whose Common Shares were not purchased under the Offer) realized a proportionate increase in their equity interest in the Company.

 

As more than 4.0 million Common Shares were properly tendered to the Offer, Medicure took-up and paid for the tendered Common Shares on a pro-rata basis according to the number of Common Shares tendered (with adjustments to avoid the purchase of fractional Common Shares). The Offer was not conditional upon any minimum number of Common Shares being tendered but was subject to various other conditions disclosed in the Offer Documents.

 

Neither the Company nor its board of directors made any recommendation to any shareholder whether to tender or refrain from tendering Common Shares. Shareholders were strongly urged to read and carefully evaluate all information in the Offer Documents and to consult their own broker or other financial and tax advisors prior to making any decision with respect to the Offer.

 

The Company had engaged Computershare Trust Company of Canada to act as the depositary (the “Depository”) for the Offer. Any Common Shares deposited under the Offer but not purchased, including any Common Shares invalidly deposited, were returned to the depositing shareholders by the Depositary.

 

The full details of the Offer were described in the Company’s offer to purchase and issuer bid circular dated November 1, 2019, as well as the related letter of transmittal and notice of guaranteed delivery, copies of which are available on SEDAR under the Company’s profile at www.sedar.com and on EDGAR at www.sec.com.

 

On December 20, 2019, the Company completed the SIB pursuant to which the Company purchased 4.0 million of its common shares for cancellation at a set purchase price of $6.50 per common share for a total purchase price of $26 million in cash. The Company incurred an additional $139,000 on transaction costs related to the SIB for a total aggregate purchase price paid of $26.1 million. During the year ended December 31, 2019, the Company recorded $5.5 million directly in its deficit representing the difference between the aggregate price paid for these common shares and a reduction of the Company’s share capital totaling $31.6 million.

 

ITEM 16F. CHANGE IN REGISTRANT’s CERTIFYING ACCOUNTANT

 

Not applicable.

131  

 

 

ITEM 16G. CORPORATE GOVERNANCE

 

Not applicable.

 

ITEM 16H. MINE SAFETY DISCLOSURE

 

Not applicable.

 

PART III

 

ITEM 17. FINANCIAL STATEMENTS

 

Not applicable. See “Item 18 – Financial Statements”.

 

 

ITEM 18. FINANCIAL STATEMENTS

 

The consolidated financial statements were prepared in accordance with IFRS, as issued by the IASB, and are presented in thousands of Canadian dollars.

 

The consolidated financial statements are in the following order:

 

1. Reports of Independent Registered Public Accounting Firms;

2. Consolidated Statements of Financial Position;

3. 3. Consolidated Statements of Net (Loss) Income and Comprehensive (Loss) Income;

4. Consolidated Statements of Changes in Equity

5. Consolidated Statements of Cash Flows; and

6. Notes to Consolidated Financial Statements.

 

132  

 



Consolidated Financial Statements 

(Expressed in thousands of Canadian Dollars, except per share amounts)

 

MEDICURE INC. 

 

Year ended December 31, 2019

 

133  

 

 

MANAGEMENT REPORT

 

The accompanying consolidated financial statements have been prepared by management and approved by the Board of Directors of Medicure Inc. (the “Company”). Management is responsible for the information and representations contained in these consolidated financial statements.

 

These consolidated financial statements have been prepared in accordance with International Financial Reporting Standards as issued by the International Accounting Standards Board. The significant accounting policies, which management believes are appropriate for the Company, are described in note 3 to these consolidated financial statements. The Company maintains a system of internal control and processes intended to provide reasonable assurance that assets are safeguarded and to ensure that relevant and reliable financial information is produced.

 

The Board of Directors is responsible for reviewing and approving these consolidated financial statements and overseeing management’s performance of its financial reporting responsibilities. An Audit Committee of non-management Directors is appointed by the Board. The Audit Committee reviews the consolidated financial statements, audit process and financial reporting with management and with the external auditors and reports to the Board of Directors prior to the approval of the audited consolidated financial statements for publication.

 

PricewaterhouseCoopers LLP, the Company’s external auditors for the year ended December 31, 2019, who are appointed by the shareholders, audited the consolidated financial statements in accordance with the standards of the Public Company Accounting Oversight Board (United States) to enable them to express to the shareholders their opinion on these consolidated financial statements as at and for the years ended December 31, 2019 and 2018. Ernst & Young LLP, the Company’s external auditors for the year ended December 31, 2017, who were appointed by the shareholders, audited the consolidated financial statements in accordance with the standards of the Public Company Accounting Oversight Board (United States) to enable them to express to the shareholders their opinion on these consolidated financial statements for the year ended December 31, 2017. The reports of PricewaterhouseCoopers LLP and Ernst & Young LLP follow.

 

/s/ Albert Friesen   /s/ James Kinley  
Dr. Albert D. Friesen   Mr. James F. Kinley CPA CA  
Chief Executive Officer   Chief Financial Officer  

  

April 15, 2020

  

134  

 

 

Report of Independent Registered Public Accounting Firm

 

To the Shareholders and Board of Directors of Medicure Inc.

 

 

Opinion on the Financial Statements

We have audited the accompanying consolidated statements of financial position of Medicure Inc. and its subsidiaries (together, the Company) as of December 31, 2019 and 2018, and the related consolidated statements of net (loss) income and comprehensive (loss) income, changes in equity and cash flows for the years then ended, including the related notes (collectively referred to as the consolidated financial statements). In our opinion, the consolidated financial statements present fairly, in all material respects, the financial position of the Company as of December 31, 2019 and 2018, and its financial performance and its cash flows for the years then ended in conformity with International Financial Reporting Standards as issued by the International Accounting Standards Board.

Basis for Opinion

These consolidated financial statements are the responsibility of the Company’s management. Our responsibility is to express an opinion on the Company’s consolidated financial statements based on our audits. We are a public accounting firm registered with the Public Company Accounting Oversight Board (United States) (PCAOB) and are required to be independent with respect to the Company in accordance with the U.S. federal securities laws and the applicable rules and regulations of the Securities and Exchange Commission and the PCAOB.

We conducted our audits of these consolidated financial statements in accordance with the standards of the PCAOB. Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the consolidated financial statements are free of material misstatement, whether due to error or fraud. The Company is not required to have, nor were we engaged to perform, an audit of its internal control over financial reporting. As part of our audits we are required to obtain an understanding of internal control over financial reporting but not for the purpose of expressing an opinion on the effectiveness of the Company’s internal control over financial reporting. Accordingly, we express no such opinion.

PricewaterhouseCoopers LLP

One Lombard Place, Suite 2300, Winnipeg, Manitoba, Canada R3B 0X6

T: +1 204 926 2400, F: +1 204 944 1020

 

“PwC” refers to PricewaterhouseCoopers LLP, an Ontario limited liability partnership.

 

 

135  

 

 

 

Our audits included performing procedures to assess the risks of material misstatement of the consolidated financial statements, whether due to error or fraud, and performing procedures that respond to those risks. Such procedures included examining, on a test basis, evidence regarding the amounts and disclosures in the consolidated financial statements. Our audits also included evaluating the accounting principles used and significant estimates made by management, as well as evaluating the overall presentation of the consolidated financial statements. We believe that our audits provide a reasonable basis for our opinion.

 

Chartered Professional Accountants

Winnipeg, Canada

April 15, 2020

We have served as the Company's auditor since 2018.

 

136  

 

 

 

Report of independent registered public accounting firm

 

 

 

 

To the Shareholders of

Medicure Inc.

 

Opinion on the Consolidated Financial Statements

We have audited the accompanying consolidated financial statements of Medicure Inc. [the “Company”], which comprise the consolidated statement of net income and comprehensive income, changes in equity and cash flows for the year ended December 31, 2017, and the related notes, comprising a summary of significant accounting policies and other explanatory information.

 

In our opinion, the consolidated financial statements present fairly, in all material respects, the consolidated financial performance of the Company and its consolidated cash flows for the year ended December 31, 2017, in accordance with International Financial Reporting Standards [“IFRSs”] as issued by the International Accounting Standards Board.

 

Basis for Opinion

Management’s Responsibility for the Consolidated Financial Statements

Management is responsible for the preparation and fair presentation of these consolidated financial statements in accordance with International Financial Reporting Standards [“IFRSs”] as issued by the International Accounting Standards Board, and for such internal control as management determines is necessary to enable the preparation of consolidated financial statements that are free from material misstatement, whether due to fraud or error.

 

Auditors’ Responsibility

Our responsibility is to express an opinion on these consolidated financial statements based on our audit. We conducted our audit in accordance with Canadian generally accepted auditing standards and the standards of the Public Company Accounting Oversight Board (United States) [“PCAOB”]. Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the consolidated financial statements are free from material misstatement, whether due to error or fraud. Those standards also require that we comply with ethical requirements, including independence. We are required to be independent with respect to the Company in accordance with the ethical requirements that are relevant to our audit of the consolidated financial statements in Canada, the U.S. federal securities laws and the applicable rules and regulations of the Securities and Exchange Commission and the PCAOB. We are a public accounting firm registered with the PCAOB.

 

An audit includes performing procedures to assess the risks of material misstatements of the consolidated financial statements, whether due to error or fraud, and performing procedures to respond to those risks. Such procedures included obtaining and examining, on a test basis, audit evidence regarding the amounts and disclosures in the consolidated financial statements. The procedures selected depend on our judgment, including the assessment of the risks of material misstatement of the consolidated financial statements, whether due to fraud or error. In making those risk assessments, we consider internal control relevant to the Company’s preparation and fair presentation of the consolidated financial statements in order to design audit procedures that are appropriate in the circumstances, but not for the purpose of expressing an opinion on the effectiveness of the Company’s internal control. The Company is not required to have, nor were we engaged to perform, an audit of its internal control over financial reporting. Accordingly, we express no such opinion.

 

137  

 

 

 

– 2 –

 

 

 

 

An audit also includes evaluating the appropriateness of accounting policies and principles used and the reasonableness of accounting estimates made by management, as well as evaluating the overall presentation of the consolidated financial statements.

 

We believe that the audit evidence we have obtained in our audit is sufficient and appropriate to provide a reasonable basis for our audit opinion.

 

We served as the Company’s auditor from 2013 to 2017.

 

 

Winnipeg, Canada Chartered Professional Accountants

May 1, 2018

 

138  

 

Consolidated Statements of Financial Position

(expressed in thousands of Canadian dollars, except per share amounts)

As at December 31   Note     2019     2018  
Assets                        
Current assets:                        
Cash and cash equivalents           $ 12,965     $ 24,139  
Short-term investments             -       47,747  
Accounts receivable     6       10,216       10,765  
Inventories     7       6,328       4,239  
Prepaid expenses             1,855       2,697  
Total current assets             31,364       89,587  
Non-current assets:                        
Property, plant and equipment     4 & 8       1,282       316  
Intangible assets     9       9,599       1,705  
Holdback receivable     5 & 10       -       11,909  
Other assets             39       117  
Deferred tax assets     14       -       127  
Total non-current assets             10,920       14,174  
Total assets           $ 42,284     $ 103,761  
                         

Liabilities and Equity

                       
Current liabilities:                        
Accounts payable and accrued liabilities           $ 9,384     $ 14,377  
Current portion of royalty obligation     12       872       1,496  
Current portion of acquisition payable     9       649       -  
Current income taxes payable     14       517       1,058  
Current portion of lease obligation     4       240       -  
Total current liabilities             11,662       16,931  
Non-current liabilities                        
Royalty obligation     12       1,176       2,035  
Acquisition payable     9       1,655       -  
Lease obligation     4       849       -  
Other long-term liabilities     5 & 10       -       1,201  
Total non-current liabilities             3,680       3,236  
Total liabilities             15,342       20,167  
Equity:                        
Share capital     13(b)     85,364       122,887  
Warrants     13(d)     1,949       1,949  
Contributed surplus             8,028       7,628  
Accumulated other comprehensive income             (5,751 )     1,268  
Deficit             (62,648 )     (50,138 )
Total Equity             26,942       83,594  
Total liabilities and equity           $ 42,284     $ 103,761  
Commitments and contingencies     16(a) & 16(d)                
Subsequent events     22                

 

On behalf of the board 

“Dr. Albert D. Friesen”

 

“Mr. Brent Fawkes”

 
Director   Director  

 

See accompanying notes to the consolidated financial statements.

 

139  

 

 

Consolidated Statements of Net (Loss) Income and Comprehensive (Loss) Income

(expressed in thousands of Canadian dollars, except per share amounts)

For the year ended December 31   Note     2019     2018     2017  
Revenue, net                                
Product sales, net           $ 20,173     $ 29,109     $ 27,133  
Cost of goods sold     7 & 9       7,272       4,152       3,465  
Gross profit             12,901       24,957       23,668  
                                 
Expenses                                
Selling             13,399       15,580       11,515  
General and administrative             3,395       3,922       3,353  
Research and development             4,349       6,681       5,148  
              21,143       26,183       20,016  
                                 
Other expense (income):                                
Revaluation of holdback receivable     10       3,623       1,473       (83 )
Impairment loss on intangible assets     9       6,321       -       636  
              9,944       1,473       553  
Finance (income) costs:                                
Finance (income) expense, net     15       (1,115 )     (1,061 )     837  
Foreign exchange (gain) loss, net             2,570       (6,461 )     (175 )
              1,455       (7,522 )     662  
Net (loss) income before income taxes           $ (19,641 )   $ 4,823     $ 2,437  
Income tax (expense) recovery                                
Current     14       (22 )     (678 )     9,393  
Deferred     14       (123 )     (219 )     (333 )
              (145 )     (897 )     9,060  
Net (loss) income before discontinued operations           $ (19,786 )   $ 3,926     $ 11,497  
Net income from discontinued operations, net of tax     5       -       -       31,924  
Net (loss) income           $ (19,786 )   $ 3,926     $ 43,421  
Item that may be reclassified to profit or loss                                
Exchange differences on translation of foreign subsidiaries:                                
Continuing operations             (683 )     595       (30 )
Discontinued operations             -       -       21  
Item that will not be reclassified to profit and loss                                
Revaluation of investment in Sensible Medical at FVOCI     11       (6,336 )     -       -  
Comprehensive (loss) income           $ (26,805 )   $ 4,521     $ 43,412  
                                 
(Loss) earnings per share from continuing operations                                
Basic     13(e)     $ (1.32 )   $ 0.25     $ 0.74  
Diluted     13(e)     $ (1.32 )   $ 0.24     $ 0.63  
                         
Earnings per share from discontinued operations                        
Basic     13(e)     $ -     $ -     $ 2.04  
Diluted     13(e)     $ -     $ -     $ 1.76  
                         
(Loss) earnings per share                        
Basic     13(e)     $ (1.32 )   $ 0.25     $ 2.78  
Diluted     13(e)     $ (1.32 )   $ 0.24     $ 2.39  

 

See accompanying notes to the consolidated financial statements.

 

140  

 

 

Consolidated Statements of Changes in Equity

(expressed in thousands of Canadian dollars, except per share amounts)

          Attributable to shareholders of the Company              
    Note     Share
Capital
    Warrants     Contributed
Surplus
   

Accumulated

other

comprehensive income

(loss)

    Equity
(Deficit)
    Total     Non-
Controlling
Interest
   

 

 

Total

Equity

 
Balance, December 31, 2018           $ 122,887     $ 1,949     $ 7,628     $ 1,268     $ (50,138 )   $ 83,594     $ -     $ 83,594  
Net loss for the year ended
December 31, 2019
            -       -       -       -       (19,786 )     (19,786 )     -       (19,786 )
Other comprehensive income for the year ended December 31, 2019             -       -       -       (7,019 )     -       (7,019 )     -       (7,019 )
                                                                         
Transactions with owners, recorded directly in equity                                                                        
Buy-back of common shares under normal course issuer bid     13 (b)     (5,955 )     -       -       -       1,810       (4,145 )     -       (4,145 )
Buy-back of common shares under substantial issuer bid     13 (b)     (31,605 )     -       -       -       5,466       (26,139 )     -       (26,139 )
Stock options exercised     13 (c)     37       -       (17 )     -       -       20       -       20  
Share-based compensation     13 (c)     -       -       417       -       -       417       -       417  
Total transactions with owners             (37,523 )     -       400       -       7,276       (29,847 )     -       (29,847 )
Balance, December 31, 2019           $ 85,364     $ 1,949     $ 8,028     $ (5,751 )   $ (62,648 )   $ 26,942     $ -     $ 26,942  

  

(continued on next page)

 

See accompanying notes to the consolidated financial statements.

 

141  

 

 

Consolidated Statements of Changes in Equity (continued)

(expressed in thousands of Canadian dollars, except per share amounts)

          Attributable to shareholders of the Company              
    Note     Share
Capital
    Warrants     Contributed
Surplus
   

Accumulated

other

comprehensive income

    Equity
(Deficit)
    Total     Non-
Controlling
Interest
   

 

 

Total

Equity

 
Balance, December 31, 2017           $ 125,734     $ 1,949     $ 6,897     $ 673     $ (54,544 )   $ 80,709     $ -     $ 80,709  
Net income for the year ended
December 31, 2018
            -       -       -       -       3,926       3,926       -       3,926  
Other comprehensive income for the year ended December 31, 2018             -       -       -       595       -       595       -       595  
Transactions with owners, recorded directly in equity                                                                        
Buy-back of common shares under normal course issuer bid     13 (b)     (3,501 )     -       -       -       480       (3,021 )     -       (3,021 )
Stock options exercised     13 (c)     654       -       (291 )     -       -       363       -       363  
Share-based compensation     13 (c)     -       -       1,022       -       -       1,022       -       1,022  
Total transactions with owners             (2,847 )     -       731       -       480       (1,636 )     -       (1,636 )
Balance, December 31, 2018           $ 122,887     $ 1,949     $ 7,628     $ 1,268     $ (50,138 )   $ 83,594     $ -     $ 83,594  

          Attributable to shareholders of the Company              
    Note     Share
Capital
    Warrants     Contributed
Surplus
   

Accumulated

other

comprehensive income (loss)

    Equity
(Deficit)
    Total     Non-
Controlling
Interest
   

 

 

 

 

Total

Equity

 
Balance, December 31, 2016           $ 124,700     $ 2,021     $ 6,756     $ 682     $ (97,965 )   $ 36,194     $ 2,090     $ 38,284  
Net income for the year ended
 December 31, 2017
            -       -       -       -       43,421       43,421       -       43,421  
Other comprehensive loss for the year ended December 31, 2017             -       -       -       (9 )     -       (9 )     -       (9 )
Disposition of non-controlling interests             -       -       -       -       -       -       (2,090 )     (2,090 )
Transactions with owners, recorded directly in equity                                                                        
Stock options exercised     13 (c)     870       -       (350 )     -       -       520       -       520  
Warrants exercised     13 (d)     164       (72 )     -       -       -       92       -       92  
Share-based compensation     13 (c)     -       -       491       -       -       491       -       491  
Total transactions with owners             1,034       (72 )     141       -       -       1,103       -       1,103  
Balance, December 31, 2017           $ 125,734     $ 1,949     $ 6,897     $ 673     $ (54,544 )   $ 80,709     $ -     $ 80,709  

 

See accompanying notes to the consolidated financial statements.

 

142  

 

 

Consolidated Statements of Cash Flows

(expressed in thousands of Canadian dollars, except per share amounts)

For the year ended December 31   Note     2019     2018     2017  
Cash (used in) provided by:                                
Operating activities:                                
Net (loss) income from continuing operations for the year           $ (19,786 )   $ 3,926     $ 11,497  
Net income from discontinued operations for the year     5       -       -       31,924  
              (19,786 )     3,926       43,421  
Adjustments for:                                
Gain on sale of Apicore     5       -       -       (55,254 )
Current income tax expense (recovery)     14       22       678       (9,393 )
Deferred income tax expense (recovery)     14       123       219       (1,514 )
Impairment of intangible assets     9       6,321       -       636  
Impairment of property, plant and equipment     8       95       -       -  
Revaluation of holdback receivable     10       3,623       1,473       (83 )
Amortization of property, plant and equipment     8       485       103       1,173  
Amortization of intangible assets     9       1,438       196       6,634  
Share-based compensation     13(c)     417       1,022       623  
Write-down of inventories     7       1,983       95       385  
Finance (income) expense, net     15       (1,115 )     (1,061 )     837  
Unrealized foreign exchange (gain) loss             362       (5,323 )     271  
Change in the following:                                
Accounts receivable             (318 )     (1,341 )     (3,713 )
Inventories             (4,072 )     (1,259 )     145  
Prepaid expenses             842       (1,793 )     77  
Other assets             78       -       33  
Accounts payable and accrued liabilities             (4,992 )     7,132       48,398  
Deferred revenue             -       -       (621 )
Other long-term liabilities             -       -       77  
Interest received (paid), net     15       1,685       255       (7,486 )
Income taxes paid     14       (477 )     (2,041 )     (894 )
Royalties paid     12       (1,355 )     (1,539 )     (1,829 )
Cash flows (used in) from operating activities             (14,641 )     742       21,923  
Investing activities:                                
Investment in Sensible Medical     11       (6,337 )     -       -  
Proceeds from Apicore Sale Transaction     5       -       65,235       89,720  
Receipt of holdback receivable funds     10       6,719       -       -  
Redemptions (purchase) of short-term investments             47,747       (44,100 )     -  
Acquisition of Class C common shares of Apicore     5       -       -       (31,607 )
Acquisition of Class E common shares of Apicore     5       -       -       (2,641 )
Acquisition of property, plant and equipment     8       (186 )     (197 )     (1,195 )
Acquisition of intangible assets     9       (13,660 )     (1,281 )     (127 )
Cash flows from investing activities             34,283       19,657       54,150  

  

(continued on next page)

 

See accompanying notes to the consolidated financial statements.

 

143  

 

 

Consolidated Statements of Cash Flows (Continued)

(expressed in thousands of Canadian dollars, except per share amounts)

For the year ended December 31   Note     2019     2018     2017  
Financing activities:                                
Repurchase of common shares under substantial issuer bid     13 (b)     (26,139 )     -       -  
Repurchase of common shares under normal course issuer bid     13 (b)     (4,145 )     (3,021 )     -  
Proceeds from exercise of stock options     13 (c)     20       363       520  
Proceeds from exercise of Apicore stock options     13 (c)     -       -       422  
Proceeds from exercise of warrants     13 (d)     -       -       92  
Repayment of long-term debt             -       -       (75,181 )
Repayment of note payable to Apicore     5     -       -       (18,507 )
Increase in short-term borrowings             -       -       162  
Decrease in cash held in escrow             -       -       12,809  
Finance lease payments             -       -       (102 )
Payment of due to vendor     5     -       -       (3,186 )
Cash flows used in financing activities             (30,264 )     (2,658 )     (82,971 )
Foreign exchange (loss) gain on cash held in foreign currency             (552 )     1,138       (108 )
(Decrease) increase in cash             (11,174 )     18,879       (7,006 )
Cash and cash equivalents, beginning of period             24,139       5,260       12,266  
Cash and cash equivalents, end of period           $ 12,965     $ 24,139     $ 5,260  

 

See accompanying notes to the consolidated financial statements.

 

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Notes to the Consolidated Financial Statements 

(expressed in thousands of Canadian dollars, except per share amounts)

 

 

1. Reporting entity

 

Medicure Inc. (the “Company”) is a company domiciled and incorporated in Canada and as of October 24, 2011, its Common Shares are listed on the TSX Venture Exchange (“TSX-V”). Prior to October 24, 2011 and beginning on March 29, 2010, the Company’s Common Shares were listed on the NEX board of the TSX-V. Prior to March 29, 2010, the Company’s Common Shares were listed on the Toronto Stock Exchange. Additionally, the Company’s shares were listed on the American Stock Exchange (later called NYSE Amex and now called NYSE MKT) on February 17, 2004 and the shares ceased trading on the NYSE Amex effective July 3, 2008. The Company remains a U.S. Securities and Exchange Commission registrant. The address of the Company’s registered office is 2-1250 Waverley Street, Winnipeg, Manitoba, Canada, R3T 6C6.

 

The Company is a biopharmaceutical company engaged in the research, development and commercialization of human therapeutics. Through its subsidiary Medicure International, Inc., the Company has rights to the commercial product AGGRASTAT® Injection (tirofiban hydrochloride) in the United States and its territories (Puerto Rico, U.S. Virgin Islands, and Guam). AGGRASTAT®, a glycoprotein GP IIb/IIIa receptor antagonist, is used for the treatment of acute coronary syndrome including unstable angina, which is characterized by chest pain when one is at rest, and non-Q-wave myocardial infarction.

 

On September 30, 2019 the Company acquired ownership of ZYPITAMAGTM from Cadila Healthcare Ltd., India (“Zydus”) for the U.S. and Canadian markets. Under terms of the agreement, the Company previously had acquired U.S. marketing rights with a profit-sharing arrangement on December 14, 2017. With this acquisition the Company obtained full control of the product including marketing and pricing negotiation for ZYPITAMAGTM. ZYPITAMAGTM is used for the treatment of patients with primary hyperlipidemia or mixed dyslipidemia and was approved in July 2017 by the U.S. Food and Drug Administration (“FDA”) for sale and marketing in the United States. On May 1, 2018 ZYPITAMAGTM was made available in retail pharmacies throughout the United States.

 

On January 28, 2019, the Company became the exclusive marketing partner for the ReDS™ point of care system (“ReDS™”) in the United States. ReDS™ is a non-invasive, FDA-cleared medical device that provides an accurate, actionable and absolute measurement of lung fluid which is important in the management of congestive heart failure.

 

The Company’s ongoing research and development activities include the continued development and further implementation of a new regulatory, brand and life cycle management strategy for AGGRASTAT® and the development of additional cardiovascular products. The Company continues to seek to acquire or license additional cardiovascular products.

 

During 2017, the Company, through Apicore, was involved in the manufacturing, development, marketing, and selling of Active Pharmaceutical Ingredients (“API”) to generic pharmaceutical customers and providing custom synthesis for early phase pharmaceutical research of branded products. Through these subsidiaries, the Company also participated in collaborations with other parties in the research and development stages of specific products. In October 2017 and January 2018, respectively, the Company sold its interests in Apicore’s U.S. business and Apicore’s Indian business and the Company no longer participates in this line of business.

 

2. Basis of preparation of financial statements

 

(a) Statement of compliance

 

These consolidated financial statements of the Company and its subsidiaries were prepared in accordance with International Financial Reporting Standards (“IFRS”) as issued by the International Accounting Standards Board (“IASB”).

 

The consolidated financial statements were authorized for issue by the Board of Directors on April 15, 2020.

 

(b) Basis of presentation

 

The consolidated financial statements have been prepared on the historical cost basis except for the following items:

 

Derivative financial instruments are measured at fair value.

 

Financial instruments at fair value through profit or loss (“FVTPL”) are measured at fair value.

 

Financial instruments at fair value through other comprehensive income (“FVOCI”) are measured at fair value.

 

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Notes to the Consolidated Financial Statements 

(expressed in thousands of Canadian dollars, except per share amounts)

 

 

2. Basis of preparation of financial statements (continued)

 

(c) Functional and presentation currency

 

The consolidated financial statements are presented in Canadian dollars, which is the Company’s functional currency. All financial information presented has been rounded to the nearest thousand dollar except where indicated otherwise. The Company has rounded comparative figures, which were previously presented as rounded to the nearest dollar, to the nearest thousand dollar to conform to current year presentation. Additionally, certain of the comparative figures have been reclassified to conform with the current year presentation, namely for the current year presentation selling expenses have been presented separately from general and administration expenses on the statements of net (loss) income and comprehensive (loss) income.

 

(d) Use of estimates and judgments

 

The preparation of these consolidated financial statements in conformity with IFRS requires management to make estimates and assumptions that affect the application of accounting policies and the reported amounts of assets, liabilities, revenue and expenses. Actual results may differ from these estimates.

 

Estimates and underlying assumptions are reviewed on an ongoing basis. Revisions to accounting estimates are recognized in the period in which the estimates are revised and in any future periods affected.

 

Areas where management has made critical judgments in the process of applying accounting policies and that have the most significant effect on the amounts recognized in the consolidated financial statements include the determination of the Company’s and its subsidiaries’ functional currencies.

 

Information about key assumptions and estimation uncertainties that have a significant risk of resulting in a material adjustment to the carrying amount of assets and liabilities within the next financial year are included in the following notes to the consolidated financial statements for the year ended December 31, 2019:

 

Note 3(c)(i): The valuation of the investment in Sensible Medical

 

Note 3(c)(iii): The valuation of the royalty obligation

 

Note 3(e): The provisions for returns, chargebacks, rebates and discounts

 

Note 3(j): The measurement of intangible assets

 

Note 3(p): The measurement of the amount and assessment of the recoverability of income tax assets and income tax provisions

 

3. Significant accounting policies

 

The accounting policies set out below have been applied consistently to all periods presented in these consolidated financial statements, unless otherwise indicated.

 

(a) Basis of consolidation

 

These consolidated financial statements include the accounts of the Company and its subsidiaries. Subsidiaries are entities controlled by the Company. Control exists when the Company has power over the investee and when the Company is exposed, or has the rights, to variable returns from the investee. Subsidiaries are included in the consolidated financial results of the Company from the effective date of acquisition up to the effective date of disposition or loss of control and include wholly owned subsidiaries, Medicure International Inc., Medicure Pharma Inc., Medicure U.S.A. Inc., Medicure Mauritius Limited, Medicure Pharma Europe Limited and Apigen Investments Limited. Additionally, the December 31, 2017 comparative figures include, from the date of acquisition (note 5), the accounts of subsidiaries that are controlled by the Company including, Apicore Inc., Apicore US LLC, Apicore LLC and Apicore Pharmaceuticals Private Limited. These additional subsidiaries were classified as discontinued operations for 2017 and Apicore Inc. and Apicore US LLC were sold during 2017 as described in note 5. The financial statements of the subsidiaries are prepared for the same reporting period as the parent company, using consistent accounting policies. All intercompany transactions and balances and unrealized gains and losses from intercompany transactions have been eliminated.

 

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Notes to the Consolidated Financial Statements 

(expressed in thousands of Canadian dollars, except per share amounts)

 

 

3. Significant accounting policies (continued)

 

(b) Foreign currency

 

Items included in the financial statements of each of the Company’s consolidated subsidiaries are measured using the currency of the primary economic environment in which the subsidiary operates (the functional currency). The consolidated financial statements are presented in Canadian dollars, which is the Company’s functional and presentation currency.

 

Foreign currency transactions are translated into the respective functional currencies of the Company and its subsidiaries using the exchange rates prevailing at the dates of the transactions. Foreign exchange gains and losses resulting from the settlement of such transactions and from the translation at period-end exchange rates of monetary assets and liabilities denominated in foreign currencies are recognized in profit or loss. Non-monetary items that are not carried at fair value are translated using the exchange rates as at the date of the initial transaction. Non-monetary items measured at fair value in a foreign currency are translated using the exchange rates at the date when the fair value is determined.

 

The results and financial position of the Company’s foreign operations that have a functional currency different from the Company’s functional and presentation currency are translated into Canadian dollars as follows:

 

(i) assets and liabilities of foreign operations are translated at the closing rate at the date of the consolidated statement of financial position;

 

(ii) revenue and expenses of foreign operations for each year are translated at average exchange rates (unless this is not a reasonable approximation of the cumulative effect of the rates prevailing on the transaction dates, in which case revenue and expenses are translated at the dates of the transactions); and

 

(iii) all resulting exchange differences for foreign operations are recognized in other comprehensive income in the cumulative translation account.

 

When a foreign operation is disposed of, the component of other comprehensive income relating to that particular foreign operation is recognized in the consolidated statements of net income and comprehensive income, as part of the gain or loss on sale where applicable.

 

(c) Financial instruments

 

(i) Financial Assets

 

Initial recognition and measurement

 

Upon recognition of a financial asset, classification is made based on the business model for managing the asset and the asset’s contractual cash flow characteristics. The financial asset is initially recognized at its fair value and subsequently classified and measured as (i) amortized cost; (ii) FVOCI; or (iii) FVTPL. Financial assets are classified as FVTPL if they have not been classified as measured at amortized cost or FVOCI. Upon initial recognition of an equity instrument that is not held-for-trading, the Company may irrevocably designate the presentation of subsequent changes in the fair value of such equity instrument as FVTPL

 

Subsequent measurement

 

The subsequent measurement of financial assets depends on their classification as follows:

 

Financial assets measured at amortized cost

 

A financial asset is subsequently measured at amortized cost, using the effective interest method and net of any impairment allowance, if the asset is held within a business whose objective is to hold assets in order to collect contractual cash flows; and the contractual terms of the financial asset give rise, on specified dates, to cash flows that are solely payments of principal and interest. Cash and cash equivalents, short-term investments and accounts receivable are classified within this category.

 

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(GRAPHIC) 

 

Notes to the Consolidated Financial Statements 

(expressed in thousands of Canadian dollars, except per share amounts)

 

 

3. Significant accounting policies (continued)

 

(c) Financial instruments (continued)

 

Financial assets at FVTPL

 

Financial assets measured at FVTPL are carried in the statement of financial position at fair value with changes in fair value therein recognized in the statement of net (loss) income. The holdback receivable was classified within this category.

 

Financial assets at FVOCI

 

Financial assets measured at FVOCI are carried in the statement of financial position at fair value with changes in fair value therein recognized in the statement of comprehensive (loss) income. The Investment in Sensible Medical was classified within this category.

 

(ii) Derecognition

 

A financial asset or, where applicable a part of a financial asset or part of a group of similar financial assets is derecognized when the contractual rights to receive cash flows from the asset have expired; or the Company has transferred its rights to receive cash flows from the asset or has assumed an obligation to pay the received cash flows in full without material delay to a third party under a ‘pass-through’ arrangement; and either (a) the Company has transferred substantially all the risks and rewards of the asset, or (b) the Company has neither transferred nor retained substantially all the risks and rewards of the asset, but has transferred control of the asset.

 

(iii) Financial liabilities

 

Initial recognition and measurement

 

The Company recognizes a financial liability on the trade date in which it becomes a party to the contractual provisions of the instrument at fair value plus any directly attributable costs. Financial liabilities are subsequently measured at amortized cost or FVTPL, and are not subsequently reclassified. The Company’s financial liabilities are accounts payable and accrued liabilities, royalty obligation and acquisition payable which are recognized on an amortized cost basis.

 

The royalty obligation was recorded at its fair value at the date at which the liability was incurred and subsequently measured at amortized cost using the effective interest rate method at each reporting date. Estimating fair value for this liability required determining the most appropriate valuation model which was dependent on its underlying terms and conditions. This estimate also required determining expected revenue from AGGRASTAT® sales and an appropriate discount rate and making assumptions about them.

 

The acquisition payable was recorded at its fair value at the date at which the liability was incurred and subsequently measured at amortized cost using the effective interest rate method at each reporting date. Estimating fair value for this liability required determining an appropriate discount rate.

 

(iv) Offsetting of financial instruments

 

Financial assets and financial liabilities are offset, and the net amount reported in the statement of financial position if, and only if, there is a currently enforceable legal right to offset the recognized amounts and there is an intention to settle on a net basis, or to realize the assets and settle the liabilities simultaneously.

 

(v) Fair value of financial instruments

 

Fair value is determined based on the price that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants. Fair value is measured using the assumptions that market participants would use when pricing an asset or liability. Typically, fair value is determined by using quoted prices in active markets for identical or similar assets or liabilities. When quoted prices in active markets are not available, fair value is determined using valuation techniques that maximize the use of observable inputs. When observable valuation inputs are not available, significant judgement is required through determining the valuation technique to apply, the valuation techniques such as discounted cash flow analysis and selecting inputs. The use of alternative valuation techniques or valuation inputs may result in a different fair value.

 

148  

 

(GRAPHIC) 

 

Notes to the Consolidated Financial Statements 

(expressed in thousands of Canadian dollars, except per share amounts)

 

 

3. Significant accounting policies (continued)

 

(c) Financial instruments (continued)

 

(vi) Transaction costs

 

Transaction costs for all financial instruments measured at amortized cost, the transaction costs are included in the initial measurement of the financial asset or financial liability and are amortized using the effective interest rate method over a period that corresponds with the term of the financial instruments. Transaction costs for financial instruments classified as FVTPL are recognized as an expense in professional fees, in the period the cost was incurred.

 

(vii) Embedded Derivatives

 

For financial liabilities measured at amortized cost, under certain conditions, an embedded derivative must be separated from its host contract and accounted for as a derivative. An embedded derivative causes some or all of the cash flows that otherwise would be required by the contract to be modified according to a specified interest rate, financial instrument price, commodity price, foreign exchange rate, index of prices or rates, a credit rating or credit index, or other variable, provided in the case of a non-financial variable that the variable is not specific to a party to the contract. For financial assets at FVTPL, any embedded derivatives are not separated from its host contract.

 

(d) Impairment of financial assets

 

An “expected credit loss” impairment model applies to financial assets which requires a loss allowance to be recorded on financial assets measured at amortized cost based on their expected credit losses. An estimate is made to determine the present value of future cash flows associated with the asset, and if required, an impairment loss is recorded. The impairment loss reduces the carrying value of the impaired financial asset to the value of the estimated present value of the future cash flows associated with the asset, discounted at the financial asset’s original effective interest rate is recorded either directly or through the use of an allowance account and the resulting impairment loss is recorded in profit or loss.

 

Impairment losses on financial assets carried at amortized cost are reversed in subsequent periods if the amount of the loss decreases and the decrease can be related objectively to an event occurring after the impairment was recognized.

 

(e) Revenue from contracts with customers

 

The Company has three commercially available products that generated revenue for the year ended December 31, 2019, AGGRASTAT®, ZYPITAMAG™ and ReDSTM (the “Products“) which it sells to United States customers. AGGRASTAT® and ZYPITAMAG™ are sold to wholesalers for resale; with AGGRASTAT® primarily being sold by the wholesalers to hospitals, while ZYPITAMAG™ is primarily sold by wholesalers to pharmacies. The Company sells ReDSTM directly to end users. Revenue from the sale of AGGRASTAT® and ZYPITAMAG™ is recognized upon the receipt of goods by the wholesaler, the point in time in which title and control of the transferred goods pass from the Company to the wholesale customer. At this point in time, the wholesaler has gained the sole ability to route the goods, and there are no unfulfilled obligations that could affect the wholesaler’s acceptance of the goods. Delivery of the product occurs when the goods have been received at the wholesaler in accordance with the terms of the sale. Revenue from the sale of ReDSTM is recognized upon the receipt of goods by the end user, the point in time in which title and control of the transferred goods pass from the Company to the customer. At this point in time, the customer has gained the sole ability to benefit from the product, and there are no unfulfilled obligations that could affect the customer’s acceptance of the goods. Delivery of the product occurs when the goods have been shipped to the customer and the customer has accepted the products in accordance with the terms of the sale.

 

Sales are made subject to certain discounts available for prompt payment, volume discounts, rebates or chargebacks. Revenue from these sales is recognized based on the price specified per the pricing terms of the sales invoices, net of the estimated discounts, rebates or chargebacks. Variable consideration is based on historical information, using the expected value method. Revenue is only recognized to the extent that it is highly probable that a significant reversal will not occur. A liability is included within accounts payable and accrued liabilities and is measured for expected payments that will be made to the customers for the discounts in which they are entitled. Sales do not contain an element of financing as sales are made with credit terms within the normal operating cycle of the date of the invoice, which is consistent with market practice.

 

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(GRAPHIC) 

 

Notes to the Consolidated Financial Statements 

(expressed in thousands of Canadian dollars, except per share amounts)

 

 

3. Significant accounting policies (continued)

 

(f) Cash and cash equivalents

 

The Company considers all liquid investments purchased with a maturity of three months or less at acquisition to be cash and cash equivalents, which are carried and classified at amortized cost.

 

(g) Short-term investments

 

The Company considers all liquid investments purchased with a maturity greater than three months and less than one year at acquisition to be short-term investments, which are carried and classified at amortized cost.

 

(h) Inventories

 

Inventories consist of unfinished product (raw material in the form of API and packaging materials) and finished commercial product, which are available for sale and are measured at the lower of cost and net realizable value.

 

The cost of inventories is based on the first-in first-out principle, and includes expenditures incurred in acquiring the inventories, production or conversion costs and other costs incurred in bringing them to their existing location and condition.

 

Inventories are written down to net realizable value when the cost of inventories is estimated to be unrecoverable due to obsolescence, damage, or declining selling prices.  Net realizable value is the estimated selling price in the ordinary course of business, less the estimated costs of completion and selling expenses. When the circumstances that previously caused inventories to be written down below cost no longer exist, or when there is clear evidence of an increase in selling prices, the amount of the write-down previously recorded is reversed.

 

(i) Property plant and equipment

 

(i) Recognition and measurement

 

Items of property, plant and equipment are measured at cost less accumulated amortization and accumulated impairment losses and reversals. When parts of an item of property, plant and equipment have different useful lives, they are accounted for as separate items (major components) of property, plant and equipment. The costs of the day-to-day servicing of property, plant and equipment are recognized in the consolidated statements of net (loss) income and comprehensive (loss) income in the period in which they are incurred.

 

(ii) Amortization

 

Amortization is recognized in profit or loss over the estimated useful lives of each part of an item of property, plant and equipment in a manner that most closely reflects the expected pattern of consumption of the future economic benefits embodied in the asset. The estimated useful lives for the current and comparative periods are as follows:

 

Asset Basis Rate
Computers, office equipment, furniture and fixtures Straight-line 20% to 25%
Leasehold improvements Straight-line Term of lease
ReDS™ demonstration units Straight-line 33%
Right of use assets Straight-line Term of lease

 

Amortization methods, useful lives and residual values are reviewed at each period end and adjusted if appropriate.

 

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Notes to the Consolidated Financial Statements 

(expressed in thousands of Canadian dollars, except per share amounts)

 

 

3. Significant accounting policies (continued

 

(j) Intangible assets

 

Intangible assets that are acquired separately are measured at cost less accumulated amortization and accumulated impairment losses. Subsequent expenditures are capitalized only when they increase the future economic benefits embodied in the specific asset to which they relate. All other expenditures are recognized in profit or loss as incurred.

 

Licenses are amortized on a straight-line basis over the contractual term of the acquired license. Patents and drug approvals are amortized on a straight-line basis over the legal life of the respective patent, ranging from five to twenty years, or its economic life, if shorter. Trademarks are amortized on a straight-line basis over the legal life of the respective trademark, being ten years, or its economic life, if shorter. Customer lists are amortized on a straight-line basis over approximately twelve years, or its economic life, if shorter.

 

Amortization on licenses commences when the intangible asset is available for use, which would typically be in connection with the commercial launch of the associated product under the license.

 

Following initial recognition, intangible assets are carried at cost less accumulated amortization and accumulated impairment losses. The cost of servicing the Company’s patents and trademarks are expensed as incurred.

 

The amortization method and amortization period of an intangible asset with a finite useful life are reviewed at least annually. Changes in the expected useful life or the expected pattern of consumption of future economic benefits embodied in the asset are accounted for by changing the amortization period or method, as appropriate, and are treated as changes in accounting estimates in the consolidated statements of net (loss) income and comprehensive (loss) income.

 

(k) Research and development

 

Expenditure on research activities, undertaken with the prospect of gaining new scientific or technical knowledge and understanding, is recognized in profit or loss as incurred.

 

Development activities involve a plan or design for the production of new or substantially improved products and processes. Development expenditures are capitalized only if development costs can be measured reliably, the product or process is technically and commercially feasible, future economic benefits are probable, and the Company intends to and has sufficient resources to complete development and to use or sell the asset. No development costs have been capitalized to date.

 

Research and development expenses include all direct and indirect operating expenses supporting the products in development.

 

Clinical trial expenses are a component of the Company’s research and development costs. These expenses include fees paid to contract research organizations, clinical sites, and other organizations who conduct research and development activities on the Company’s behalf. The amount of clinical trial expenses recognized in a period related to clinical agreements are based on estimates of the work performed using an accrual basis of accounting. These estimates incorporate factors such as patient enrolment, services provided, contractual terms, and prior experience with similar contracts.

 

(l) Government assistance

 

Government assistance, in the form of grants, is recognized at fair value where there is reasonable assurance that the grant will be received and all attaching conditions will be complied with. Government assistance toward current expenses is recorded as a reduction of the related expenses in the period the expenses are incurred. Government assistance towards property, plant and equipment is deducted from the cost of the related property, plant and equipment. The benefits of investment tax credits for scientific research and experimental development expenditures (“SR&ED”) incurred directly by the Company are recognized in the period the qualifying expenditure is made, provided there is reasonable assurance of recoverability. SR&ED investment tax credits receivable are recorded at their net realizable value.

 

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Notes to the Consolidated Financial Statements 

(expressed in thousands of Canadian dollars, except per share amounts)

 

 

3. Significant accounting policies (continued)

 

(m) Impairment of non-financial assets

 

The Company assesses at each reporting period whether there is an indication that a non-financial asset may be impaired. An impairment loss is recognized when the carrying amount of an asset, or its CGU, exceeds its recoverable amount. Impairment losses are recognized in net income and comprehensive income. A CGU is the smallest identifiable group of assets that generates cash inflows that are largely independent of the cash inflows from other assets or groups of assets. The recoverable amount is the greater of the asset’s or CGU’s fair value less costs to sell and value in use. In assessing value in use, the estimated future cash flows are discounted to their present value using a pre-tax discount rate that reflects current market assessments of the time value of money and the risks specific to the asset or CGU. In determining fair value less costs to sell, an appropriate valuation model is used. For an asset that does not generate largely independent cash inflows, the recoverable amount is determined for the CGU to which the asset belongs.

 

For assets other than goodwill, impairment losses recognized in prior periods are assessed at each reporting date for any indications that the loss has decreased or no longer exists. An impairment loss is reversed if there has been a change in the estimates used to determine the recoverable amount. An impairment loss is reversed only to the extent that the asset’s carrying amount does not exceed the carrying amount that would have been determined, net of amortization, if no impairment loss had been recognized.

 

Goodwill is tested for impairment annually and when circumstances indicate that the carrying value may be impaired. Impairment is determined for goodwill by assessing the recoverable amount of each CGU to which the goodwill relates. When the recoverable amount of the CGU is less than its carrying amount, an impairment loss is recognized. Impairment losses relating to goodwill are not reversed in future periods.

 

(n) Employee benefits

 

(i) Short-term employee benefits

 

Short-term employee benefit obligations are measured on an undiscounted basis and are expensed as the related service is provided.

 

(ii) Share-based payment transactions

 

The grant date fair value of share-based payment awards granted to employees is recognized as a personnel expense, with a corresponding increase in equity, over the period that the employees unconditionally become entitled to the awards. The amount recognized as an expense is adjusted to reflect the number of awards for which the related service and non-market vesting conditions are expected to be met, such that the amount ultimately recognized as an expense is based on the number of awards that do meet the related service and non-market performance conditions at the vesting date. For share-based payment awards with non-vesting conditions, the grant date fair value of the share-based payment is measured to reflect such conditions and there is no true-up for differences between expected and actual outcomes.

 

Share-based payment arrangements in which the Company receives goods or services as consideration for its own equity instruments are accounted for as equity-settled share-based payment transactions. In situations where equity instruments are issued and some or all of the goods or services received by the entity as consideration cannot be specifically identified, they are measured at fair value of the share-based payment.

 

For share-based payment arrangements with non-employees, the expense is recorded over the service period until the options vest. Once the options vest, services are deemed to have been received.

 

Where the terms of an equity-settled transaction award are modified, the minimum expense recognized is the expense as if the terms had not been modified, if the original terms of the award are met. An additional expense is recognized for any modification that increases the total fair value of the share-based payment transaction or is otherwise beneficial to the employee as measured at the date of modification.

 

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Notes to the Consolidated Financial Statements 

(expressed in thousands of Canadian dollars, except per share amounts)

 

 

3. Significant accounting policies (continued)

 

(n) Employee benefits (continued)

 

(ii) Share-based payment transactions (continued)

 

Where an equity-settled award is cancelled, it is treated as if it vested on the date of the cancellation and any expense not yet recognized for the award (being the total expense as calculated at the grant date) is recognized immediately. This includes any awards where vesting conditions within the control of either the Company or the employee are not met. However, if a new award is substituted for the cancelled award, and designated as a replacement award on the date that it is granted, the cancelled award and new awards are treated as if they were a modification of the original awards.

 

(o) Finance income and finance costs

 

Finance costs comprise interest expense on borrowings which are recognized in net income and comprehensive income using the effective interest rate method, accretion on the royalty obligation, prepayment fees on the early repayment of long-term debt and amortization of deferred debt issue costs using the effective interest rate method, offset by any finance income which is comprised of interest income on funds invested and is recognized as it accrues in net income and comprehensive income, using the effective interest rate method.

 

Foreign currency gains and losses are reported on a net basis.

 

(p) Income taxes

 

The Company and its subsidiaries are generally taxable under the statutes of their country of incorporation.

 

Income tax expense comprises current and deferred taxes. Current taxes and deferred taxes are recognized in profit or loss except to the extent that they relate to a business combination, or items recognized directly in equity or in other comprehensive income.

 

Current taxes are the expected tax receivable or payable on the taxable income or loss for the year, using tax rates enacted or substantively enacted at the reporting date, and any adjustment to tax receivable or payable in respect of previous years.

 

The Company follows the liability method of accounting for deferred taxes. Under this method, deferred taxes are recognized in respect of temporary differences between the carrying amounts of assets and liabilities for financial reporting purposes and the amounts used for taxation purposes. Deferred taxes are not recognized for the following temporary differences: the initial recognition of assets or liabilities in a transaction that is not a business combination and that affects neither accounting nor taxable profit or loss, and differences relating to investments in subsidiaries and jointly controlled entities to the extent that it is probable that they will not reverse in the foreseeable future. In addition, deferred taxes are not recognized for taxable temporary differences arising on the initial recognition of goodwill. Deferred taxes are measured at the tax rates that are expected to be applied to temporary differences when they reverse, based on the tax laws that have been enacted or substantively enacted by the reporting date. Deferred tax assets and liabilities are offset if there is a legally enforceable right to offset current tax assets and liabilities, and they relate to income taxes levied by the same tax authority on the same taxable entity, or on different tax entities, but they intend to settle current tax assets and liabilities on a net basis or their tax assets and liabilities will be realized simultaneously.

 

A deferred tax asset is recognized for unused tax losses, tax credits and deductible temporary differences, to the extent that it is probable that future taxable profits will be available against which they can be utilized. Deferred tax assets are reviewed at each reporting date and are reduced to the extent that it is no longer probable that the related tax benefit will be realized.

 

153  

 

  (GRAPHIC)

 

Notes to the Consolidated Financial Statements 

(expressed in thousands of Canadian dollars, except per share amounts)

 

 

3. Significant accounting policies (continued)

 

(p) Income taxes (continued)

 

The Company has provided for income taxes, including the impacts of tax legislation in various jurisdictions, in accordance with guidance issued by accounting regulatory bodies, the Canada Revenue Agency, the U.S. Internal Revenue Service, the Barbados Revenue Authority, the Mauritius Revenue Authority, as well as other state and local governments through the date of the issuance of these consolidated financial statements. Additional guidance and interpretations can be expected and such guidance, if any, could impact future results. While management continues to monitor these matters, the ultimate impact, if any, as a result of the application of any guidance issued in the future cannot be determined at this time.

 

The Company and its subsidiaries file federal income tax returns in Canada, the United States, Barbados and other foreign jurisdictions, as well as various provinces and states in Canada and the United States, respectively. The Company and its subsidiaries have open tax years, primarily from 2010 to 2019, with significant taxing jurisdictions, including Canada, the United States and Barbados. These open years contain certain matters that could be subject to differing interpretations of applicable tax laws and regulations and tax treaties, as they relate to the amount, timing or inclusion of revenues and expenses, or the sustainability of income tax positions of the Company and its subsidiaries. Certain of these tax years may remain open indefinitely.

 

Tax benefits acquired as part of a business combination, but not satisfying the criteria for separate recognition at that date, would be recognized subsequently if information about facts and circumstances changed. The adjustment would either be treated as a reduction to goodwill if it occurred during the measurement period or in profit or loss, when it occurs subsequent to the measurement period.

 

(q) Earnings per share

 

The Company presents basic earnings per share (“EPS”) data for its common voting shares. Basic EPS is calculated by dividing the profit or loss attributable to common voting shareholders of the Company by the weighted average number of common voting shares outstanding during the period, adjusted for the Company’s own shares held. Diluted EPS is computed similar to basic EPS except that the weighted average shares outstanding are increased to include additional shares for the assumed exercise of stock options and warrants, if dilutive. The number of additional shares is calculated by assuming that outstanding stock options and warrants were exercised and that the proceeds from such exercise were used to acquire common shares at the average market price during the reporting periods.

 

(r) Business combinations and goodwill

 

Business combinations are accounted for using the acquisition method. The consideration for an acquisition is measured at the fair values of the assets transferred, the liabilities assumed and the equity interests issued at the acquisition date. Transaction costs that are incurred in connection with a business combination, other than costs associated with the issuance of debt or equity securities, are expensed as incurred. Identified assets acquired and liabilities and contingent liabilities assumed are measured initially at fair values at the date of acquisition. On an acquisition-by-acquisition basis, any non-controlling interest is measured either at fair value of the non-controlling interest or at the fair value of the proportionate share of the net assets acquired.

 

Contingent consideration is measured at fair value on acquisition date and is included as part of the consideration transferred. The fair value of the contingent consideration liability is remeasured at each reporting date with the corresponding gain or loss being recognized in profit or loss.

 

Goodwill is initially measured at cost, being the excess of fair value of the cost of the business combinations over the Company’s share in the net fair value of the acquiree’s identifiable assets, liabilities and contingent liabilities. Any negative difference is recognized directly in the consolidated statements of net income and comprehensive income. If the fair values of the assets, liabilities and contingent liabilities can only be calculated on a provisional basis, the business combination is recognized using provisional values. Any adjustments resulting from the completion of the measurement process are recognized within twelve months of the date of the acquisition.

 

154  

 

(GRAPHIC) 

 

Notes to the Consolidated Financial Statements 

(expressed in thousands of Canadian dollars, except per share amounts)

 

 

3. Significant accounting policies (continued)

 

(s) New standard not yet adopted

 

Amendments to IFRS 3 – definition of a business:

 

In October 2018, the International Accounting Standards Board (“IASB”) issued amendments to IFRS 3 Business Combinations, that seek to clarify whether a transaction results in an asset or a business acquisition. The amendments include an election to use a concentration test. This is a simplified assessment that results in an asset acquisition if substantially all of the fair value of the gross assets is concentrated in a single identifiable asset or a group of similar identifiable assets. The amendments apply to businesses acquired in annual reporting periods beginning on or after January 1, 2020. The Company does not expect the amendments to have a significant impact on the consolidated financial statements upon adoption.

 

4. New standards and interpretations

 

IFRS 16, Leases (“IFRS 16”)

 

Effective January 1, 2019, the Company has adopted IFRS 16 using the modified retrospective approach, recognizing a right of use asset equal to the lease liability at the date of initial application, and prior periods were not restated. IFRS 16 which requires lessees to recognize assets and liabilities for most leases, with exemptions available for leases with a term that is twelve months or less, or where the underlying asset is of a low value.

 

Unless exempted, as noted above, upon inception of a lease, lessees will be required to recognize a right-of use (“ROU”) asset, representing the Company’s right to use the underlying asset and a lease liability representing its obligation for lease payments due to the lessor. ROU assets and the corresponding liability are initially measured at the present value of non-cancellable payments, including those made in accordance with an option period when the Company expects to exercise an option period to extend or not terminate a lease.

 

Effective November 1, 2014, the Company entered into a sub-lease with Genesys Venture Inc. (“GVI”), a related party as described in note 17(b), to lease office space at a rate of $170 per annum for three years ending October 31, 2017, with an 18-month renewal period available. The lease was amended on May 1, 2016 and increased the leased area covered under the lease agreement at a rate of $212 per annum until October 31, 2019 with an 18-month renewal period available. The leased area covered under the lease was again increased, effective November 1, 2018 at a rate of $306 per annum until the end of the term of the lease. The discount rate used by the Company in calculating the lease obligation relating to the ROU asset is five percent.

 

The impact of the adoption of IFRS 16 on the Company’s statement of financial position at January 1, 2019 is as follows:

 

      December 31, 2018       Impact of transition to IFRS 16       January 1, 2019  
Assets                        
Property and equipment   $ 316     $ 677     $ 993  
                         
Current liabilities                        
Lease obligation   $ -     $ 300     $ 300  
                         
Non-current liabilities                        
Lease obligation   $ -     $ 377     $ 377  
    $ 316     $ -     $ 316  

 

155  

 

(GRAPHIC) 

 

Notes to the Consolidated Financial Statements 

(expressed in thousands of Canadian dollars, except per share amounts)

 

 

4. New standards and interpretations (continued)

 

IFRS 16, Leases (“IFRS 16”) (continued)

 

The impact of the adoption of the Company’s operating lease commitments to the lease obligations recognized as a result of the adoption of IFRS 16 is as follows:

 

Operating lease commitments, including renewal options, as at December 31, 2018   $ 715  
Adjustment of lease commitments to present value of lease liability     (38 )
Lease obligation as at January 1, 2019   $ 677  

 

Effective November 1, 2019, the Company modified and extended its sub-lease with GVI to lease a reduced amount of office space at a rate of $238 per annum for three years ending October 31, 2022 with an 18-month renewal period available. This resulted in an increase to the ROU asset of $685. As at December 31, 2019, the lease obligation of the statement of financial position totaled $1,089 with $240 recorded as the current portion of the lease obligation.

 

5. Discontinued operations

 

On October 2, 2017, the Company sold its interests in Apicore (the “Apicore Sale Transaction”) to an arm’s-length, pharmaceutical company (the “Buyer”). The Company acquired Apicore in a series of transactions occurring between July 3, 2014 and July 12, 2017.

 

Under the Apicore Sale Transaction, the Company received a payment of US$57,623 (CDN - $72,058) upon the closing of the transaction. Additional working capital and deferred payments of US$52,887 (CDN - $65,235) were received subsequent to December 31, 2017 as part of the Apicore Sales Transaction and were recorded as consideration receivable as at December 31, 2017. Additionally, a contingent payment in the form of an earn-out based on the achievement of certain financial results by Apicore for the year ended December 31, 2017 could have been received, however the financial results specified under the Apicore Sales Transaction were not achieved. As a result, no amount has been recorded in the consolidated financial statements pertaining to this potential earn-out payment. Additionally, under the Apicore Sale Transaction, the Buyer held an option to acquire Apicore’s Indian operations for a fixed price until December 31, 2017. This option lapsed without exercise and the Company sold Apicore’s Indian operations, to a company owned by the former President and Chief Executive Officer of Apicore Inc. in January of 2018 with the net assets held for sale being released from accounts payable and accrued liabilities at that time.

 

Set out below is the financial performance for years ended December 31, 2019, 2018 and 2017 relating to the Apicore business:

 

Year ended December 31     2019       2018       2017  
Revenue   $ -     $ -     $ 22,759  
Expenses     -       -       (47,936 )
Loss from discontinued operations   $ -     $ -     $ (25,177 )
Income tax recovery     -       -       1,847  
Loss after income tax recovery   $ -     $ -       (23,330 )
Gain on disposition of the Apicore business     -       -       55,254  
Income from discontinued operations   $ -     $ -     $ 31,924  

 

156  

 

(GRAPHIC) 

 

Notes to the Consolidated Financial Statements 

(expressed in thousands of Canadian dollars, except per share amounts)

 

 

5. Discontinued operations (continued)

 

As previously described, the Company retained ownership in Apicore’s Indian operations until the lapse of the Buyer Option and during January of 2018, Apicore’s Indian operations were sold to a company owned by the former President and Chief Executive Officer of Apicore Inc.

 

Immediately before the classification as discontinued operations, the recoverable amount was estimated for certain items and no impairment loss was identified. As at December 31, 2017, a write-down of $1,791 was recognized to reduce the carrying amount of the assets in the disposal group to their fair value less costs to sell, which totaled $7,077. This impairment was recognized in discontinued operations in the statements net income and comprehensive income for the year ended December 31, 2017.

 

Set out below is the cash flow information for the years ended December 31, 2019, 2018 and 2017 relating to the Apicore business:

 

Year ended December 31   2019     2018     2017  
Net cash flows from operating activities   $ -     $ -     $ 5,210  
Net cash flows from investing activities     -       -       54,326  
Net cash flows used in financing activities     -       -       (80,944 )
Net cash flows used in discontinued operations   $ -     $ -     $ (21,408 )

 

6. Accounts receivable

 

As at December 31   2019     2018  
Trade accounts receivable   $ 10,136     $ 9,678  
Other accounts receivable     80       1,087  
    $ 10,216     $ 10,765  

 

As at December 31, 2019, there were three customers with amounts owing greater than 10% of the Company’s accounts receivable which totaled 96% in aggregate (Customer A – 41%, Customer B – 28%, Customer C – 27%).

 

As at December 31, 2018, there were three customers with amounts owing greater than 10% of the Company’s accounts receivable which totaled 91% in aggregate (Customer A – 47%, Customer B – 22%, Customer C – 22%).

 

7. Inventories

 

As at December 31   2019     2018  
Finished product available-for-sale   $ 5,273     $ 2,937  
Unfinished product and packaging materials     1,055       1,302  
    $ 6,328     $ 4,239  

 

Inventories expensed as part of cost of goods sold during the year ended December 31, 2019 amounted to $3,585 (2018 – $3,862; 2017 – $3,079). During the year ended December 31, 2019, the Company wrote-off inventory of $1,983 (2018 – $95; 2017 – $385) that had expired or was otherwise unusable through cost of goods sold on the statement of (loss) income and comprehensive (loss) income.

 

157  

 

(GRAPHIC) 

 

Notes to the Consolidated Financial Statements 

(expressed in thousands of Canadian dollars, except per share amounts)

 

 

8. Property, plant and equipment

 

Cost   Computer
and office
equipment
    Leasehold
improvements
    ReDS™ Demonstration
units
    Right of use
assets
    Total  
At December 31, 2017   $ 428     $ 156     $ -     $ -     $ 584  
Additions     186       12       -       -       198  
Effect of movements in exchange rates     12       -       -       -       12  
Dispositions     (156 )     -       -       -       (156 )
At December 31, 2018   $ 470     $ 168     $ -     $ -     $ 638  
Impact of adoption of IFRS 16 (Note 4)     -       -       -       677       677  
Additions     50       2       134       685       871  
Impairment     -       -       (130 )     -       (130 )
Effect of movements in exchange rates     -       -       (4 )     -       (4 )
At December 31, 2019   $ 520     $ 170     $ -     $ 1,362     $ 2,052  

 

Accumulated amortization and impairment losses     Computer
and office
equipment
      Leasehold
improvements
     

ReDS™ Demonstration

units

     

Right of use

assets

      Total  
At December 31, 2017   $ 281     $ 82     $ -     $ -     $ 363  
Amortization     75       28       -       -       103  
Effect of movements in exchange rates     12       -       -       -       12  
Dispositions     (156 )     -       -       -       (156 )
At December 31, 2018   $ 212     $ 110     $ -     $ -     $ 322  
Amortization     111       60       37       277       485  
Impairment     -       -       (35 )     -       (35 )
Effect of movements in exchange rates     -       -       (2 )     -       (2 )
At December 31, 2019   $ 323     $ 170     $ -     $ 277     $ 770  

 

Carrying amounts     Computer
and office
equipment
      Leasehold
improvements
     

ReDS™ Demonstration 

units 

     

Right of use 

assets 

      Total  
At December 31, 2018   $ 258     $ 58     $ -     $ -     $ 316  
At December 31, 2019   $ 197     $ -     $ -     $ 1,085     $ 1,282  

 

During the year ended December 31, 2019, amortization of property, plant and equipment totaling $485 (2018 – $103; 2017 – $98) is included within general and administrative expenses on the consolidated statements of net (loss) income and comprehensive (loss) income. For the year ended December 31, 2017, amortization of property, plant and equipment totaling $1,075 is recorded within discontinued operations.

 

During the year ended December 31, 2019, an impairment of property, plant and equipment totaling $95 is included within general and administrative expenses on the consolidated statements of net (loss) income and comprehensive (loss) income pertaining to an impairment of ReDSTM demonstration units in connection with the impairment of the ReDSTM license as described in note 9.

 

158  

 

 

 

Notes to the Consolidated Financial Statements 

(expressed in thousands of Canadian dollars, except per share amounts)

 

 

9. Intangible assets

 

Cost   Licenses     Patents and
Drug
Approvals
    Trademarks     Customer
list
    Total
At December 31, 2017   $ 1,756     $ 14,239     $ 4,014     $ 708     $ 20,717
Effect of movements in exchange rates     154       1,245       351       62       1,812
At December 31, 2018   $ 1,910     $ 15,484     $ 4,365     $ 770     $ 22,529
Additions (note 11)     7,038       8,930       -       -       15,968
Impairment     (6,959)     -       -       -       (6,959)
Transfers within intangible assets     (1,854)     1,457       -       -       (397)
Effect of movements in exchange rates     (135)     (942)     (209)     (37)     (1,323)
At December 31, 2019   $ -     $ 24,929     $ 4,156     $ 733     $ 29,818
                                       
Accumulated amortization and
impairment losses
    Licenses   Patents and
Drug
Approvals
    Trademarks     Customer
list
    Total
At December 31, 2017   $ -     $ 14,239     $ 4,014     $ 708     $ 18,961
Amortization     196       -       -       -       196
Effect of movements in exchange rates     9       1,245       351       62       1,667
At December 31, 2018   $ 205     $ 15,484     $ 4,365     $ 770     $ 20,824
Amortization     841       597       -       -       1,438
Impairment     (638)     -       -       -       (638)
Transfers within intangible assets     (397)     -       -       -       (397)
Effect of movements in exchange rates     (11)     (751)     (209)     (37)     (1,008)
At December 31, 2019   $ -     $ 15,330     $ 4,156     $ 733     $ 20,219
                                       
Carrying amounts   Licenses     Patents and
Drug
Approvals
    Trademarks     Customer
list
    Total
At December 31, 2018   $ 1,705     $ -     $ -     $ -     $ 1,705
At December 31, 2019   $ -     $ 9,599     $ -     $ -     $ 9,599

 

On September 30, 2019 the Company acquired ownership of ZYPITAMAGTM for the U.S. and Canadian markets. Under terms of the agreement, Zydus will receive an upfront payment of U.S. $5,000 (CDN $6,622) and U.S. $2,000 (CDN $2,649) in deferred payments to be paid in equal instalments annually over the next four years, as well as contingent payments on the achievement of milestones and royalties related to net sales. The Company previously had acquired U.S. marketing rights with a profit-sharing arrangement. With this acquisition the Company obtained full control of marketing and pricing negotiation for ZYPITAMAGTM. Upon completion of the acquisition $8,930 was recorded within patents and drug approvals relating to the upfront and deferred payments and $1,457 was transferred from licenses to patents and drug approvals pertaining to the cost of the previously acquired license over ZYPITAMAGTM. The fair value of the deferred payments of $649 and $1,655 is recorded on the statement of financial position within current portion of acquisition payable and acquisition payable, respectively. The initial amortization period pertaining to the ZYPITAMAGTM intangible assets was 4.3 years with the remaining amortization period being 4.1 years as at December 31, 2019.

 

As at December 31, 2018, the Company had recorded $546 within accounts payable and accrued liabilities relating to the current portion of license fees payable relating to the ZYPITAMAGTM license acquired during the year ended December 31, 2017. This balance was paid during the year ended December 31, 2019.

 

159  

 

 

 

Notes to the Consolidated Financial Statements 

(expressed in thousands of Canadian dollars, except per share amounts)

 

 

9. Intangible assets

 

The Company has considered indicators of impairment as at December 31, 2019 and 2018. The Company recorded a write-down of intangible assets related to the ReDSTM license during the year ended December 31, 2019 totaling $6,321 as a result of uncertainties with ReDSTM being experienced in regards to the length of the sales cycle and uptake of the product with customers, resulting in the Company’s sales being below the committed amounts required by the exclusive marketing and distribution agreement regarding ReDSTM. The Company did not record any write-down of intangible assets during the year ended December 31, 2018. The Company recorded a write-down of intangible assets during the year ended December 31, 2017 totaling $636 pertaining to a license acquired during the year, which was under litigation as described in note 16(d). As at December 31, 2019, intangible assets pertaining to AGGRASTAT® intangible were fully amortized.

 

With respect to the intangible asset related to ZYPITAMAGTM, management calculated its fair value less costs to sell using a discounted cash flow model (Level 3 in the fair value hierarchy) based upon financial forecasts prepared by management using a discount rate of 13.25%, a cumulative aggregate growth rate of 300% over four years and a nominal terminal value. The Company has concluded that there was no impairment as a result of the analysis for the year ended December 31, 2019 as the recoverable amount exceeded the carrying amount by approximately $1,600 at the high end of the reasonable range. However, the assessment identified that a reasonably possible change in the key assumption of the sales growth rate forecast results in the recoverable amount being less than the carrying value.  A seven percent reduction in the sales growth forecast per year would result in the carrying value of the intangible asset exceeding the reasonable range of the recoverable amount.

 

For the year ended December 31, 2019, amortization of intangible assets totaling $1,438 (2018 - $196) is recorded within cost of goods sold. For the years ended December 31 2017, there was no amortization of intangible recorded within net income from continuing operations. For the year ended December 31, 2017, amortization of the acquired intangible assets totaling $6,634 was recognized within loss from discontinued operations.

 

10. Holdback receivable

 

The holdback receivable of US$10 million, originated on October 2, 2017 as a part of the Apicore Sale Transaction described in note 5. The holdback receivable was initially recorded at its fair value of $11,941 and subsequently was measured at FVTPL. The other long-term liability was payable to the former President and Chief Executive Officer of Apicore upon receipt of the holdback receivable.

 

On February 13, 2019, the Company received notice from the Buyer in the Apicore Sales Transaction of potential claims against the holdback receivable in respect of representations and warranties under the Apicore Sales Transaction, with the maximum exposure of the claims being the total holdback receivable. The Company proceeded diligently to investigate the potential claims and attempt to satisfactorily resolve them with a view to having the holdback receivable released. The Buyer did not make the required payments on the holdback receivable in February 2019 and April 2019.

 

In consideration of the uncertainty associated with the potential claims asserted by the Buyer, the Company reduced the carrying value of the holdback receivable by $1,473 on the consolidated statement of financial position as at December 31, 2018.

 

On December 5, 2019, the Company reached a settlement agreement with the Buyer in the Apicore Sales Transaction with respect to the amounts heldback under the Apicore Sales Transaction. A settlement agreement was reached under which the Company received US$5,100 (CDN$6,719) in relation to the holdback receivable. In connection with this settlement the amounts owing to former President and Chief Executive Officer of Apicore totaling US$880 (CDN$1,165) which were recorded within other long-term liabilities were settled by the Buyer. Immediately prior to the settlement, the Company reduced the carrying value on the statement of financial position of the holdback receivable by $3,623 to the net recoverable value from the negotiated settlement.

 

11. Investment in Sensible Medical

 

On January 24, 2019, the Company acquired a 9.36% equity interest (7.71% on a fully-diluted basis) in Sensible Medical Innovations Ltd. (“Sensible”), and concurrently entered into an exclusive marketing and distribution agreement with Sensible to market ReDSTM in the United States. The Company acquired the rights for US$10,000 (CDN$13,351) plus US$68 (CDN$91) in directly attributable costs.

 

160  

 

 

 

Notes to the Consolidated Financial Statements 

(expressed in thousands of Canadian dollars, except per share amounts)

 

 

11. Investment in Sensible Medical (continued)

 

On completion of the transaction, the Company recorded the initial fair value assigned to the investment in Sensible Medical at $6,337 with the remainder attributed to the rights associated with the distribution agreement accounted for within intangible assets and ReDS™ demonstration units which are recorded within property and equipment, $7,038 was recorded within intangible assets relating to the license acquired through the exclusive marketing and distribution agreement and $67 was recorded within property and equipment pertaining to ReDS™ demonstration devices acquired as part of the agreement.

 

The Company made an irrevocable election at initial recognition to recognize changes in the fair value of the investment in Sensible Medial through other comprehensive income (loss), as this is a strategic investment, and the Company considers this classification to be more relevant. As noted above, the initial fair value assigned to the investment upon initial recognition was $6,337. During the year ended December 31, 2019, the Company recorded other comprehensive loss of $6,336 associated with the change in fair value of the investment in Sensible Medical. This resulted in a carrying value as at December 31, 2019 of one dollar. The change in the fair value of the investment in Sensible Medical is as a result of uncertainties with ReDSTM being experienced in regards to the length of the sales cycle and uptake of the product with customers resulting in lower than expected amounts being paid to Sensible Medical under the exclusive marketing and distribution agreement.

 

The license was being amortized over the term of the license agreement which was equal to ten years. During the year ended December 31, 2019, amortization of $641 was recorded within cost of goods sold. The Company recorded a write-down of intangible assets related to the ReDSTM license during the year ended December 31, 2019 totaling $6,321.

 

The exclusive marketing and distribution agreement with Sensible included a period of co-exclusivity, whereby Sensible may sell, market, and distribute products directly to customers in select states of the United States using its own sales force. The Company is currently eligible to receive 20% of the revenue earned by Sensible from such sales during the co-exclusivity period, and may be eligible to receive up to 35% of the revenue earned by Sensible upon certain conditions being met. During the year ended December 31, 2019, the Company recorded revenue of $289 relating to the payments from Sensible from sales made by their sales force.

 

12. Royalty obligation

 

On July 18, 2011, the Company settled its then existing long-term debt with Birmingham Associates Ltd. (“Birmingham”), an affiliate of Elliott Associates L.P., in exchange for i) $4,750 in cash; ii) 2,176,003 common shares of the Company; and iii) a royalty on future AGGRASTAT® sales until May 1, 2023. The royalty is based on 4% of the first $2,000 of quarterly AGGRASTAT® sales, 6% on the portion of quarterly sales between $2,000 and $4,000 and 8% on the portion of quarterly sales exceeding $4,000 payable within 60 days of the end of the preceding three-month periods ended February 28, May 31, August 31 and November 30. Birmingham has a one-time option to switch the royalty payment from AGGRASTAT® to a royalty on the sale of MC-1. Management determined there is no value to the option to switch the royalty to MC-1 as the product is not commercially available for sale and the extended long-term development timelines associated with commercialization of the product.

 

In accordance with the terms of the agreement, if the Company were to dispose of its AGGRASTAT® rights, the acquirer would be required to assume the obligations under the royalty agreement.

 

The royalty obligation was recorded at its fair value at the date at which the liability was incurred, estimated to be $902, and subsequently measured at amortized cost using the effective interest rate method at each reporting date. This resulted in a carrying value as at December 31, 2019 of $2,048 (2018 $3,531) of which $872 (2018 $1,496) represents the current portion of the royalty obligation. The net change in the royalty obligation for the year ended December 31, 2019 of a recovery of $316 (2018 expense of $355; 2017 expense of $748) is recorded within finance (income) expense on the consolidated statements of net (loss) income and comprehensive (loss) income. Royalties for the year ended December 31, 2019 totaled $1,023 (2018 $1,654; 2017 $1,243) with payments made during the year ended December 31, 2019 of $1,355 (2018 $1,539; 2017 $1,829).

 

161  

 

 

 

Notes to the Consolidated Financial Statements 

(expressed in thousands of Canadian dollars, except per share amounts)

 

 

13. Capital Stock

 

(a) Authorized

 

The Company has authorized share capital of an unlimited number of common voting shares, an unlimited number of Class A common shares and an unlimited number of preferred shares. The preferred shares may be issued in one or more series, and the directors may fix prior to each series issued, the designation, rights, privileges, restrictions and conditions attached to each series of preferred shares.

 

(b) Shares issued and outstanding

 

Shares issued and outstanding are as follows:

 

    Number of Common Shares     Amount
Balance, December 31, 2017   15,782,327     $ 125,734
Shares issued upon exercise of stock options (13(c))   206,885       654
Shares repurchased and cancelled under a normal course issuer bid(1)   (441,400)     (3,501)
Balance, December 31, 2018   15,547,812     $ 122,887
Shares issued upon exercise of stock options (13(c))   8,001       37
Shares repurchased and cancelled under a normal course issuer bid(1)   (751,800)     (5,955)
Shares repurchased and cancelled under a substantial issuer bid(2)   (4,000,000)     (31,605)
Balance, December 31, 2019   10,804,013     $ 85,364

 

(1) On May 16, 2018, the Company announced that the TSX-V accepted the Company’s notice of its intention to make a normal course issuer bid (the “2018 NCIB”). Under the terms of the 2018 NCIB, the Company could have acquired up to an aggregate of 794,088 common shares, representing five percent of the common shares outstanding at the time of the application, over the twelve-month period that the 2018 NCIB was in place. The 2018 NCIB commenced on May 28, 2018 and ended on May 27, 2019. During the twelve months of the 2018 NCIB, the Company purchased and cancelled 771,900 common shares for a total cost of $5,085. The prices that the Company paid for the common shares purchased was the market price of the shares at the time of purchase.

 

On May 30, 2019, the Company announced that the TSX-V accepted the Company’s notice of intention to make an additional normal course issuer bid (the “2019 NCIB”). Under the terms of the 2019 NCIB, the Company may acquire up to an aggregate of 761,141 common shares, representing five percent of the common shares outstanding at the time of the application, over the twelve-month period that the 2019 NCIB is in place. The 2019 NCIB commenced on May 30, 2019 and will end on May 29, 2020, or on such earlier date as the Company may complete its maximum purchases allowed under the 2019 NCIB. From the commencement of the 2019 NCIB, the Company purchased and cancelled 421,300 common shares for a total cost of $2,081. The prices that the Company paid or will pay for common shares purchased was or will be the market price of the shares at the time of purchase.

 

During the year ended December 31, 2019, the Company repurchased and cancelled 751,800 (2018 – 441,400), common shares as a result of the 2018 NCIB and 2019 NCIB. The aggregate price paid for these common shares totaled $4,145 (2018 - $3,021). During the year ended December 31, 2019 the Company recorded $1,810 (2018 - $480) directly in its deficit representing the difference between the aggregate price paid for these common shares and a reduction of the Company’s share capital totaling $5,955 (2018 - $3,501).

 

(2) On December 20, 2019, the Company completed a Substantial Issuer Bid (“SIB”) pursuant to which the Company purchased 4,000,000 of its common shares for cancellation at a set purchase price of $6.50 per common share for a total purchase price of $26,000 in cash. The Company incurred an additional $139 on transaction costs related to the SIB for a total aggregate purchase price paid of $26,139. During the year ended December 31, 2019, the Company recorded $5,466 directly in its deficit representing the difference between the aggregate price paid for these common shares and a reduction of the Company’s share capital totaling $31,605.

 

162  

 

 

 

Notes to the Consolidated Financial Statements 

(expressed in thousands of Canadian dollars, except per share amounts)

 

 

13. Capital Stock (continued)

 

(c) Stock option plan

 

The Company has a stock option plan which is administered by the Board of Directors of the Company with stock options granted to directors, management, employees and consultants as a form of compensation. The number of common shares reserved for issuance of stock options is limited to a maximum of 2,934,403 common shares of the Company at any time. The stock options generally have a maximum term of between five and ten years and vest within a five-year period from the date of grant.

 

Changes in the number of options outstanding during the year ended December 31, 2019 is as follows:

 

Year ended December 31, 2019   Options     Weighted
average
exercise
price
Balance, beginning of period   1,394,642     $ 3.91
Granted   262,000       4.95
Exercised   (8,001)     (2.45)
Forfeited, cancelled or expired   (220,233)     (6.75)
Balance, end of period   1,428,408     $ 3.67
Options exercisable, end of period   1,059,308     $ 2.88

 

Changes in the number of options outstanding during the years ended December 31, 2018 and 2017 are as follows:

 

Year ended December 31   2018     2017
    Options     Weighted
average
exercise
price
    Options     Weighted
average
exercise
price
Balance, beginning of period   1,602,127     $ 3.58     1,387,000     $ 2.37
Granted   200,000       7.25     476,000       7.20
Exercised   (206,885)       (1.76)     (207,950)       (2.50)
Forfeited, cancelled or expired   (200,600)       (6.85)     (52,923)       (8.58)
Balance, end of period   1,394,642     $ 3.91     1,602,127     $ 3.58
Options exercisable, end of period   1,044,892     $ 2.80     1,231,127     $ 2.50

 

Options outstanding at December 31, 2019 consist of the following:

 

Range of
exercise prices
  Number
outstanding
   

Weighted
average
remaining
contractual life

    Options outstanding
weighted average
exercise price
    Number
exercisable
$0.30   185,000     3.35 years     $ 0.30     185,000
$1.01 - $3.00   539,433     2.30 years     $ 1.59     539,433
$3.01 - $4.00   29,000     0.90 years     $ 3.90     29,000
$4.01 - $5.00   262,000     4.49 years     $ 4.95     52,400
$5.01 - $7.30   412,975     2.76 years     $ 7.08     253,475
$0.30 - $7.30   1,428,408     2.94 years     $ 3.67     1,059,308

 

163  

 

 

 

Notes to the Consolidated Financial Statements 

(expressed in thousands of Canadian dollars, except per share amounts)

 

 

13. Capital Stock (continued)

 

(c) Stock option plan (continued)

 

Compensation expense related to stock options granted during the year or from previous periods under the stock option plan for the year ended December 31, 2019 is $417 (2018 – $1,022; 2017 – $491). The compensation expense was determined based on the fair value of the options at the date of measurement using the Black-Scholes option pricing model. The expected life of stock options is based on historical data and current expectations and is not necessarily indicative of exercise patterns that may occur. The expected volatility reflects the assumption that the historical volatility over a period similar to the life of the options is indicative of future trends, which may not necessarily be the actual outcome.

 

The compensation expense for the years ended December 31, 2019, 2018, and 2017 was determined based on the fair value of the options at the date of measurement using the Black-Scholes option pricing model:

 

Years ended December 31: 2019 2018 2017
Expected option life 4.4 years 4.4 years 4.5 years
Risk free interest rate 1.40% 1.92%-2.04% 1.71%
Dividend yield nil nil nil
Expected volatility 47.10% 85.14%-93.72% 80.44%

 

Additionally, prior to its disposal Apicore had a stock option plan and at the December 1, 2016 acquisition date, there were 897,500 options to purchase Class E common stock of Apicore Inc. outstanding. 497,500 options became fully vested on the change in control with the right to put the outstanding Apicore Class E shares and options to the Company upon the change in control. The remaining Apicore stock options outstanding of 400,000 were unaffected by the change of control and fully vested during 2017. The value of the put option was initially recorded as a liability to repurchase Apicore Class E shares on the consolidated statements of financial position and the value of the remaining options was recorded as non-controlling interest within equity.

 

During the year ended December 31, 2017, employees and former directors of Apicore exercised 292,500 stock options to acquire 292,500 Class E common shares of Apicore for gross proceeds to the Company of US$280. These shares, as well as 112,500 Class E common shares previously issued for gross proceeds of US$48 were then purchased by the Company upon the employees and former directors exercising their put right to the Company. This resulted in the Company acquiring 405,000 Class E common shares of Apicore for a total cost of US$1,975 (CDN - $2,690) during 2017. As a result of the employees and former directors exercising their put right to the Company, the liability to repurchase Apicore Class E common shares on the consolidated statements of financial position was reduced.

 

On July 3, 2017, the remaining employee put options over 117,500 Class E shares, to be issued upon the exercise of stock options, of Apicore expired without being exercised by the employees and the value of these options, totaling $615, was reclassified as a non-controlling interest. As a result, there remained 517,500 stock options in Apicore Inc. outstanding prior to the sale transaction which occurred on October 2, 2017.

 

During the year ended December 31, 2017, the Company recorded $132 of stock-based compensation expense within the loss from discontinued operations on the consolidated statements of net income and comprehensive income relating to stock options in Apicore.

 

(d) Warrants

 

On November 17, 2016 in connection with a term loan entered into to fund an acquisition, the Company issued 900,000 warrants to the lenders, exercisable for a 48-month period following the issuance of the loan at a price of $6.50 per share. The fair value of the warrants issued in connection with the loan was $2,066 net of its pro-rata share of financing costs of $117 and were recorded in equity with a corresponding balance recorded as deferred financing costs which is netted against the associated long-term debt on the consolidated statements of financial position as at December 31, 2017.

 

164  

 

 

 

Notes to the Consolidated Financial Statements 

(expressed in thousands of Canadian dollars, except per share amounts)

 

 

13. Capital Stock (continued)

 

(d) Warrants (continued)

 

Changes in the number of Canadian dollar denominated warrants outstanding during the years ended December 31, 2019, 2018, and 2017 are as follows:

 

Years ended December 31   2019     2018     2017
    Warrants     Weighted
average
exercise
price
    Warrants     Weighted
average
exercise
price
    Warrants     Weighted
average
exercise
price
Balance, beginning of period   900,000     $ 6.50     900,000     $ 6.50     941,969     $ 6.31
Exercised   -       -     -       -     (41,969)     (2.20)
Balance, end of period   900,000     $ 6.50     900,000     $ 6.50     900,000     $ 6.50
Warrants exercisable, end of period   900,000     $ 6.50     900,000     $ 6.50     900,000     $ 6.50

 

(e) Per share amounts

 

The following table reflects the calculation of basic (loss) earnings per share for the years ended December 31, 2019, 2018 and 2017:

 

Year ended December 31   2019     2018     2017
Net (loss) earnings before discontinued operations   $ (1.32)   $ 0.25     $ 0.74
Earnings from discontinued operations, net of tax     -       -       2.04
    $ (1.32)   $ 0.25     $ 2.78

 

The following table reflects the calculation of diluted (loss) earnings per share for the years ended December 31, 2019, 2018 and 2017:

 

Year ended December 31   2019     2018     2017
Net (loss) earnings before discontinued operations   $ (1.32)   $ 0.24     $ 0.63
Earnings from discontinued operations, net of tax     -       -       1.76
    $ (1.32)   $ 0.24     $ 2.39

 

The following table reflects the (loss) income used in the basic (loss) earnings per share computations for the years ended December 31, 2019, 2018 and 2017:

 

Year ended December 31   2019     2018     2017
Net (loss) earnings before discontinued operations   $ (19,786)   $ 3,926     $ 11,497
Earnings from discontinued operations, net of tax     -       -       31,924
    $ (19,786)   $ 3,926     $ 43,421

 

165  

 

 

 

Notes to the Consolidated Financial Statements 

(expressed in thousands of Canadian dollars, except per share amounts)

 

 

13. Capital Stock (continued)

 

(e) Per share amounts (continued)

 

The following table reflects the share data used in the denominator of the basic and diluted (loss) earnings per share computations for the years ended December 31, 2019, 2018 and 2017:

 

Year ended December 31     2019       2018       2017
Weighted average shares outstanding for basic (loss) earnings per share     14,998,540       15,791,396       15,636,853
Effects of dilution from:                      
Stock options     -       772,267       1,601,227
Warrants     -       -       900,000
Weighted average shares outstanding for diluted (loss) earnings per share     14,998,540       16,563,663       18,138,080

 

Effects of dilution from 1,428,408 stock options (2018 – 622,375, 2017 – 900) and 900,000 warrants (2018 - 900,000, 2017 – nil) were excluded in the calculation of weighted average shares outstanding for diluted (loss) earnings per share before discontinued operations for the year ended December 31, 2019 as they are anti-dilutive.

 

14. Income taxes

 

The Company recognized current income tax expense of $22 for the year ended December 31, 2019 (2018 – expense of $678; 2017 – recovery of $9,393) and a deferred income tax expense of $123 for the year ended December 31, 2019 (2018 – $219, 2017 – $333).

 

As at December 31, 2019 and 2018, deferred tax assets and liabilities have been recognized with respect to the following items:

 

As at December 31   2019     2018
Deferred tax assets              
Non-capital loss carryforwards   $ -     $ 127
Total deferred tax assets   $ -     $ 127

 

As at December 31, 2019 and 2018, Canadian deferred tax assets have not been recognized with respect to the following table. The scientific research and experimental development deferred tax assets expire between 2025 and 2028.

 

As at December 31   2019     2018
Deferred tax assets              
Scientific research and experimental development   $ 2,640     $ 3,237
Investment in Sensible     855       -
Holdback receivable     688       199
Other     1,781       159
Non-capital losses     207       -
Total deferred tax assets   $ 6,171     $ 3,595

 

166  

 

 

 

Notes to the Consolidated Financial Statements 

(expressed in thousands of Canadian dollars, except per share amounts)

 

 

14. Income taxes (continued)

 

The reconciliation of the Canadian statutory rate to the income tax rate applied to the net income before discontinued operations for the years ended December 31, 2019, 2018 and 2017 to the income tax expense is as follows:

 

Year ended December 31   2019     2018     2017
(Loss) Income for the year                      
Canadian   $ (7,013)   $ 3,440     $ (2,178)
Foreign     (12,628)     1,383       4,615
    $ (19,641)   $ 4,823     $ 2,437

 

Year ended December 31   2019     2018     2017

Canadian federal and provincial income taxes at 27% (2018 – 27%; 2017 – 27%)

  $ 5,303     $ (1,302)   $ (658)
Permanent differences and other items     (330)     26       (335)
Foreign tax rate in foreign jurisdictions     (1,308)     85       656
Change in unrecognized deferred tax assets     (3,810)     294       9,397
    $ (145)   $ (897)   $ 9,060

 

The foreign tax rate differential is the difference between the Canadian federal and provincial statutory income tax rate and the tax rates in Barbados (2.50%), Mauritius (15.00%), Ireland (12.50%) and the United States (21.00%) that is applicable to income or losses incurred by the Company’s subsidiaries.

 

At December 31, 2019, the Company has the following United States losses available for application in future years:

 

2039     $ 243
      $ 243

 

At December 31, 2019, the Company has the following Barbados losses available for application in future years:

 

2020     $ 1,210
2021       1,275
2022       3,752
      $ 6,237

 

167  

 

 

 

Notes to the Consolidated Financial Statements 

(expressed in thousands of Canadian dollars, except per share amounts)

 

 

15. Finance income (expense)

 

During the years ended December 31, 2019, 2018 and 2017 the Company earned finance income (incurred finance expense) as follows:

 

Year ended December 31   2019     2018     2017
Interest income   $ 886     $ 1,115     $ 47
Accretion of royalty obligation     316       (355)       (748)
Accretion of acquisition payable     (41)       -       -
Bank charges and other interest     (24)       (25)       (30)
Finance expense from lease obligation     (22)       -       -
Accretion on holdback receivable     -       326       -
Interest on MIOP loan     -       -       (106)
    $ 1,115     $ 1,061     $ (837)

 

During the years ended December 31, 2019, 2018 and 2017, the Company received (paid) finance income (expense) as follows:

 

Year ended December 31   2019     2018     2017
Interest received   $ 1,731     $ 279     $ 47
Other interest, net and banking fees     (46)     (24)     (31)
Interest paid on MIOP loan     -       -       (89)
    $ 1,685     $ 255     $ (73)

 

16. Commitments and contingencies

 

(a) Commitments

 

As at December 31, 2019, and in the normal course of business, the Company has obligations to make future payments representing contracts and other commitments that are known and committed as follows:

 

2020   $ 3,043
2021     1,243
2022     1,243
2023     195
2024     195
    $ 5,919

 

The Company has entered into a manufacturing and supply agreement to purchase a minimum quantity of AGGRASTAT® unfinished product inventory totaling US$150 annually (based on current pricing) until 2024 and a minimum quantity of AGGRASTAT® finished product inventory totaling US$218 annually (based on current pricing) until 2022 and €525 annually (based on current pricing) until 2022.

 

Effective January 1, 2019, the Company renewed its business and administration services agreement with GVI, as described in note 17(b), under which the Company is committed to pay $7 per month or $85 per year for a one-year term.

 

168  

 

 

 

Notes to the Consolidated Financial Statements 

(expressed in thousands of Canadian dollars, except per share amounts)

 

 

16. Commitments and contingencies (continued)

 

(a) Commitments (continued)

 

Contracts with contract research organizations are payable over the terms of the associated agreements and clinical trials and timing of payments is largely dependent on various milestones being met, such as the number of patients recruited, number of monitoring visits conducted, the completion of certain data management activities, trial completion, and other trial related activities.

 

On October 31, 2017, the Company acquired an exclusive license to sell and market PREXXARTAN® (valsartan) oral solution in the United States and its territories with a seven-year term, with extensions to the term available, which had been granted tentative approval by the U.S. Food and Drug Administration (“FDA”), and which was converted to final approval during 2017. The Company acquired the exclusive license rights for an upfront payment of US$100, with an additional US$400 payable on final FDA approval and will be obligated to pay royalties and milestone payments from the net revenues of PREXXARTAN®. The US$400 payment is on hold pending resolution of the dispute between the licensor and the third-party manufacturer of PREXXARTAN® described in note 16(d) and is recorded within accounts payable and accrued liabilities on the consolidated statements of financial position.

 

On December 14, 2017 the Company acquired an exclusive license to sell and market a branded cardiovascular drug, ZYPITAMAGTM (pitavastatin magnesium) in the United States and its territories for a term of seven years with extensions to the term available. The Company had entered into a profit-sharing arrangement resulting in a portion of the net profits from ZYPITAMAGTM being paid to the licensor. No amounts are due and/or payable pertaining to profit sharing on this product and the profit-sharing arrangement was eliminated with the Company’s acquisition of ZYPITAMAGTM on September 30, 2019 as described in note 9.

 

(b) Guarantees

 

The Company periodically enters into research agreements with third parties that include indemnification provisions customary in the industry. These guarantees generally require the Company to compensate the other party for certain damages and costs incurred as a result of claims arising from research and development activities undertaken on behalf of the Company. In some cases, the maximum potential amount of future payments that could be required under these indemnification provisions could be unlimited. These indemnification provisions generally survive termination of the underlying agreement. The nature of the indemnification obligations prevents the Company from making a reasonable estimate of the maximum potential amount it could be required to pay. Historically, the Company has not made any indemnification payments under such agreements and no amount has been accrued in the consolidated financial statements with respect to these indemnification obligations.

 

(c) Royalties

 

As a part of the Birmingham debt settlement described in note 12, beginning on July 18, 2011, the Company is obligated to pay a royalty to Birmingham based on future commercial AGGRASTAT® sales until 2023. The royalty is based on 4% of the first $2,000 of quarterly AGGRASTAT® sales, 6% on the portion of quarterly sales between $2,000 and $4,000 and 8% on the portion of quarterly sales exceeding $4,000 payable within 60 days of the end of the preceding three-month periods ended February 28, May 31, August 31 and November 30. Birmingham has a one-time option to switch the royalty payment from AGGRASTAT® to a royalty on the sale of MC-1. Management has determined there is no value to the option to switch the royalty to MC-1 as the product is not commercially available for sale and the extended long-term development timeline associated with commercialization of the product. Royalties for the year ended December 31, 2019 totaled $1,023 (2018 $1,654; 2017 $1,243) with payments made during the year ended December 31, 2019 of $1,355 (2018 $1,539; 2017 $1,829).

 

Beginning with the acquisition of ZYPITAMAGTM (note 9), completed on September 30, 2019, the Company is obligated to pay royalties on any commercial net sales of ZYPITAMAGTM to Zydus subsequent to the acquisition date. During the three months ended December 31, 2019, the Company accrued $2 in royalties in regards to ZYPITAMAGTM which is recorded within cost of goods sold on the statement of net (loss) income and comprehensive (loss) income and within accounts payable and accrued liabilities on the statement of financial position as at December 31, 2019.

 

The Company is obligated to pay royalties on any future commercial net sales of PREXXARTAN® to the licensor of PREXXARTAN®. To date, no royalties are due and/or payable.

 

169  

 

 

 

Notes to the Consolidated Financial Statements 

(expressed in thousands of Canadian dollars, except per share amounts)

 

 

16. Commitments and contingencies (continued)

 

(d) Contingencies

 

In the normal course of business, the Company may from time to time be subject to various claims or possible claims. Although management currently believes there are no claims or possible claims that if resolved would either individually or collectively result in a material adverse impact on the Company’s financial position, results of operations, or cash flows, these matters are inherently uncertain and management’s view of these matters may change in the future.

 

During 2018, the Company was named in a civil claim in Florida from the third-party manufacturer of PREXXARTAN® against the licensor. The claim disputed the rights granted by the licensor to the Company with respect to PREXXARTAN®. The claim against the Company has since been withdrawn, however the dispute between the licensor and the third-party manufacturer continues.

 

On September 10, 2015, the Company submitted a supplemental New Drug Application (“sNDA”) to the FDA to expand the label for AGGRASTAT®. The label change is being reviewed and evaluated based substantially on data from published studies. If the label change submission were to be successful, the Company will be obligated to pay €300 over the course of a three-year period in equal quarterly instalments following approval. On July 7, 2016, the Company announced it received a Complete Response Letter stating the sNDA cannot be approved in its present form and requested additional information. The payments are contingent upon the success of the filing and as such the Company has not recorded any amount in the consolidated statements of net (loss) income and comprehensive (loss) income pertaining to this contingent liability.

 

During 2015, the Company began a development project of a cardiovascular generic drug in collaboration with Apicore. The Company has entered into a supply and development agreement under which the Company holds all commercial rights to the drug. In connection with this project, the Company is obligated to pay Apicore 50% of net profit from the sale of this drug. On August 13, 2018, the Company announced that the FDA has approved its ANDA for SNP, a generic intravenous cardiovascular product and the product became available commercially during the third quarter of 2019. To date, no amounts are due and/or payable pertaining to profit sharing on this product.

 

17. Related party transactions

 

(a) Key management personnel compensation

 

Key management personnel are those persons having authority and responsibility for planning, directing and controlling the activities of the Company. The Board of Directors, President and Chief Executive Officer and Chief Financial Officer are key management personnel for all periods. Beginning on July 1, 2019, the Company appointed a new President and Chief Operating Officer who was considered key management personnel beginning with this appointment. The then existing President retains the title of Chief Executive Officer and remains included in key management personnel for all periods. The Vice-President, Commercial Operations was considered key management personnel until the conclusion of his employment in September 2017 and for the 2018 and 2019 periods, a new Vice-President, Commercial Operations was hired effective January 8, 2018 and is included in key management personnel from the effective date of his hire until the conclusion of his employment on June 30, 2019.

 

Beginning in December 2016 and ending of October 2, 2017, the President and Chief Executive Officer of Apicore, was considered key management personnel. The compensation pertaining to the President and Chief Executive Officer of Apicore has been included in the income from discontinued operations in the consolidated statements of net income and comprehensive income for the year ended December 31, 2017 and his compensation has been excluded from the table below. Included in the table below is $750,000 relating to transaction bonuses paid to key management personnel which is included within the income from discontinued operations for the year ended December 31, 2017 on the consolidated statement net income and comprehensive income.

 

170  

 

 

 

Notes to the Consolidated Financial Statements 

(expressed in thousands of Canadian dollars, except per share amounts)

 

 

17. Related party transactions (continued)

 

(a) Key management personnel compensation (continued)

 

In addition to their salaries, the Company also provides non-cash benefits and participation in the Stock Option Plan. The following table details the compensation paid to key management personnel:

 

Year ended December 31   2019     2018       2017
Salaries, fees and short-term benefits   $ 781     $ 770     $ 1,463
Share-based payments     208       669       139
    $ 989     $ 1,439     $ 1,602

 

As at December 31, 2019, the Company did not have any amounts (2018 $5) recorded within accounts payable and accrued liabilities relating to amounts payable to the members of the Company’s Board of Directors for services provided.

 

(b) Transactions with related parties

 

Directors and key management personnel control 23% of the voting shares of the Company as at December 31, 2019 (2018 – 17%).

 

During the year ended December 31, 2019 the Company paid GVI, a company controlled by the Chief Executive Officer, a total of $85 (2018 – $85; 2017 – $85) for business administration services, $295 (2018 – $228; 2017 – $212) in rental costs and $47 (2018 – $47; 2017 – $44) for information technology support services. As described in note 16(a), the business administration services summarized above are provided to the Company through a consulting agreement with GVI.

 

Clinical research services are provided through a consulting agreement with GVI Clinical Development Solutions Inc. (“GVI CDS”), a company controlled by the Chief Executive Officer. Pharmacovigilance and safety, regulatory support, quality control and clinical support are provided to the Company through the GVI CDS agreement. During the year ended December 31, 2019, the Company paid GVI CDS $406 (2018 – $858; 2017 – $716) for clinical research services.

 

Research and development services are provided through a consulting agreement with CanAm Bioresearch Inc. (“CanAm”), a company controlled by a close family member of the President and Chief Executive Officer. During the year ended December 31, 2019, the Company paid CanAm $133 (2018 – $393; 2017 – $458) for research and development services.

 

Beginning with the acquisition of Apicore (the “Acquisition”) on December 1, 2016 and ending with the Apicore Sales Transaction on October 2, 2017 (note 5), the Company incurred rental charges pertaining to leased manufacturing facilities and office space from Dap Dhaduk II LLC (“Dap Dhaduk”), an entity controlled by a minority shareholder and member of the board of directors of Apicore Inc. Included within discontinued operations on the consolidated statements of net income and comprehensive income is payments to Dap Dhaduk totaling $263 for the year ended December 31, 2017.

 

Beginning with the Acquisition on December 1, 2016 and ending with the Apicore Sales Transaction on October 2, 2017 (note 5), the Company purchased inventory from Aktinos Pharmaceuticals Private Limited and Aktinos HealthCare Private Limited (together, “Aktinos”), an entity significantly influenced by a close family member of the Chief Executive Officer of Apicore Inc. For the year ended December 31, 2017, the Company paid Aktinos $1,599 for purchases of inventory, which were included in assets of the Apicore business sold (note 5) in connection with the Apicore Sales Transaction.

 

Beginning with the Acquisition on December 1, 2016 and ending with the Apicore Sales Transaction on October 2, 2017 (note 5), the Company incurred research and development charges from Omgene Life Sciences Pvt. Ltd. (“Omgene”), an entity significantly influenced by a close family member of the Chief Executive Officer of Apicore Inc. Included within discontinued operations on the consolidated statements of net income and comprehensive income is payments to Omgene totaling $26 for the year ended December 31, 2017.

 

171  

 

 

 

Notes to the Consolidated Financial Statements 

(expressed in thousands of Canadian dollars, except per share amounts)

 

 

17. Related party transactions (continued)

 

(b) Transactions with related parties (continued)

 

Beginning with the Acquisition on December 1, 2016 and ending with the Apicore Sales Transaction on October 2, 2017 (note 5), the Company incurred pharmacovigilance charges from 4C Pharma Solutions LLC (“4C Pharma”), an entity significantly influenced by a close family member of the Chief Executive Officer of Apicore Inc. Included within discontinued operations on the consolidated statements of net income and comprehensive income is payments to 4C Pharma totaling $6 for the year ended December 31, 2017.

 

These transactions have been measured at the exchange amount, which is the amount of consideration established and agreed to by the related parties.

 

As at December 31, 2019, included in accounts payable and accrued liabilities is $95 (2018 $17) payable to GVI, $56 (2018 $134) payable to GVI CDS, and no amounts (2018 $40) payable to CanAm. These amounts are unsecured, payable on demand and non-interest bearing.

 

Effective July 18, 2016, the Company renewed its consulting agreement with its Chief Executive Officer, through A.D. Friesen Enterprises Ltd., a company owned by the Chief Executive Officer, for a term of five years, at a rate of $300 annually, increasing to $315 annually, effective January 1, 2017 and increasing to $331 annually, effective January 1, 2019. The Company may terminate this agreement at any time upon 120 days’ written notice. There were not any amounts payable to A.D. Friesen Enterprises Ltd. as a result of this consulting agreement as at December 31, 2019 or 2018. Any amounts payable to A.D. Friesen Enterprises Ltd. are unsecured, payable on demand and non-interest bearing.

 

Effective January 1, 2018, the Company renewed its consulting agreement with its Chief Financial Officer, through JFK Enterprises Ltd., a company owned by the Chief Financial Officer of the Company, for a one-year term, at a rate of $155 annually. The agreement could have been terminated by either party, at any time, upon 30 days written notice. Any amounts payable to JFK Enterprises Ltd. were unsecured, payable on demand and non-interest bearing. Effective June 1, 2018, this consulting agreement was converted into an employment agreement with the Chief Financial Officer.

 

18. Expenses by nature

 

Expenses incurred for the years ended December 31, 2019, 2018 and 2017 from continuing operations are as follows:

 

Year ended December 31   2019     2018     2017
Personnel expenses                    
Salaries, fees and short-term benefits   $ 6,394     $ 7,696   $ 5,904
Share-based payments     417       1,022     491
      6,811       8,718     6,395
Depreciation, amortization and impairment     2,017       299     98
Research and development     2,887       5,306     3,539
Manufacturing     752       765     955
Inventory material costs     3,851       3,862     3,079
Write-down of inventory     1,983       95     385
Medical affairs     718       1,026     1,108
Administration     821       1,505     1,725
Selling and logistics     6,997       8,019     5,395
Professional fees     1,578       740     802
    $ 28,415     $ 30,335     $23,481

 

172  

 

 

 

Notes to the Consolidated Financial Statements 

(expressed in thousands of Canadian dollars, except per share amounts)

 

 

19. Financial instruments

 

(a) Financial assets and liabilities

 

Set out below is a comparison by class of the carrying amounts and fair value of the Company’s financial instruments as at December 31, 2019 and 2018:

 

As at December 31   2019     2018
    Carrying
amount
    Fair
value
    Carrying
amount
    Fair
value
Financial assets                              
Financial assets measured at amortized cost                              
Cash and cash equivalents   $ 12,965     $ 12,965     $ 24,139     $ 24,139
Short-term investments     -       -       47,747       47,747
Accounts receivable     10,216       10,216       10,765       10,765
Investment in Sensible Medical     -       -       -       -
Holdback receivable     -       -       11,909       11,909
                               
Financial liabilities                              
Financial liabilities measured at amortized cost:                              
Accounts payable and accrued liabilities   $ 9,384     $ 9,384     $ 14,377     $ 14,377
Current portion of royalty obligation     872       872       1,496       1,496
Current portion of acquisition payable     649       649       -       -
Current portion of lease obligation     240       240       -       -
Royalty obligation     1,176       1,176       2,035       2,035
Acquisition payable     1,655       1,655       -       -
Lease obligation     849       849       -       -
Other long-term liability     -       -       1,201       1,201

 

The Company has determined the estimated fair values of its financial instruments based on appropriate valuation methodologies. The carrying values of current monetary assets and liabilities approximate their fair values due to their relatively short periods to maturity. The royalty obligation, and acquisition payable are carried at amortized cost. The holdback receivable was carried at FVTPL and the other long-term liability was carried at amortized cost.

 

The investment in Sensible Medical is carried at FVOCI. During the year ended December 31, 2019, the Company recorded other comprehensive loss of $6,336 associated with the change in fair value of the investment in Sensible Medical. This resulted in a carrying value as at December 31, 2019 of one dollar.

 

IFRS 13, Fair Value Measurement, establishes a fair value hierarchy that reflects the significance of the inputs used in measuring fair value. The fair value hierarchy has the following levels:

 

Level 1 – Quoted prices (unadjusted) in active markets for identical assets or liabilities;

 

Level 2 – Inputs other than quoted prices included within Level 1 that are either directly or indirectly observable;

 

Level 3 – Unobservable inputs in which little or no market activity exists, therefore requiring an entity to develop its own assumptions about the assumptions that market participants would use in pricing.

 

173  

 

 

 

Notes to the Consolidated Financial Statements 

(expressed in thousands of Canadian dollars, except per share amounts)

 

 

19. Financial instruments (continued)

 

(a) Financial assets and liabilities (continued)

 

The fair value hierarchy of the following financial assets and liabilities on the consolidated statements of financial position as at December 31, 2019 is as follows:

 

    Level 1     Level 2     Level 3
Financial assets                      
           Investment in Sensible Medical   $ -     $ -     $ -
                       
Financial liabilities                      
Current portion of royalty obligation   $ -     $ -     $ 872
Current portion of acquisition payable     -       -       649
Royalty obligation     -       -       1,176
Acquisition payable     -       -       1,655

 

The fair value hierarchy of the following financial assets and liabilities on the consolidated statements of financial position as at December 31, 2018 is as follows:

 

    Level 1     Level 2     Level 3
Financial assets                      
Holdback receivable   $ -     $ -     $ 11,909
                       
Financial liabilities                      
Accounts payable and accrued liabilities   $ -     $ -     $ 546
Current portion of royalty obligation     -       -       1,496
Royalty obligation     -       -       2,035
Other long-term liability     -       -       1,201

 

Included in accounts payable and accrued liabilities as at December 31, 2018 is the current portion of the license fee payable of $546.

 

Investment in Sensible Medical: The investment in Sensible Medical requires determining the most appropriate valuation model and determining the most appropriate inputs to the valuation model, including publicly traded companies similar to Sensible Medical to use as a proxy in the valuation model, a discount rate for lack of marketability of the investment and estimated costs to dispose of the investment.

 

Royalty obligation: The royalty obligation requires determining expected revenue from AGGRASTAT® sales and an appropriate discount rate and making assumptions about them. If the expected revenue from AGGRASTAT® sales were to change by 10%, then the royalty obligation liability recorded as at December 31, 2019 would change by approximately $257 (2018 - $211). If the discount rate used in calculating the fair value of the royalty obligation of 20% were to change by 1%, the royalty obligation liability recorded as at December 31, 2019 would change by approximately $15 (2018 - $22).

 

Acquisition payable: The acquisition payable requires determining an appropriate discount rate and making assumptions about it. If the discount rate used in calculating the fair value of the acquisition payable of 10% were to change by 1%, the acquisition payable recorded as at December 31, 2019 would change by approximately $28.

 

For assets and liabilities that are recognized in the consolidated financial statements on a recurring basis, the Company determines whether transfers have occurred between levels in the hierarchy by reassessing categorization (based on the lowest level input that is significant to the fair value measurement as a whole) at the end of each reporting period. During the years ended December 31, 2019, 2018 and 2017 there were no transfers between Level 1 and Level 2 fair value measurements.

 

174  

 

 

 

Notes to the Consolidated Financial Statements 

(expressed in thousands of Canadian dollars, except per share amounts)

 

 

19. Financial instruments (continued)

 

(b) Risks arising from financial instruments and risk management

 

The Company’s activities expose it to a variety of financial risks; market risk (including foreign exchange and interest rate risks), credit risk and liquidity risk. Risk management is the responsibility of the Company, which identifies, evaluates and, where appropriate, mitigates financial risks.

 

(i) Market risk

 

(a) Foreign exchange risk is the risk that the fair value of future cash flows for financial instruments will fluctuate because of changes in foreign exchange rates. The Company is exposed to currency risks primarily due to its U.S dollar denominated cash and cash equivalents, accounts receivable, other assets, accounts payable and accrued liabilities, income taxes payable, royalty obligation and acquisition payable. The Company has not entered into any foreign exchange hedging contracts.

 

The Company is exposed to U.S. dollar currency risk through the following U.S. denominated financial assets and liabilities:

 

As at December 31

(Expressed in U.S. Dollars)

  2019     2018  
Cash   $ 9,518     $ 17,428  
Short-term investments     -       35,000  
Accounts receivable     7,817       7,725  
Holdback receivable     -       8,730  
Other assets     30       -  
Accounts payable and accrued liabilities     (6,714 )     (9,903 )
Income taxes payable     (398 )     (776 )
Current portion of royalty obligation     (671 )     (1,096 )
Current portion of acquisition payable     (500 )     -  
Royalty obligation     (906 )     (1,492 )
Acquisition payable     (1,275 )     -  
Other long-term liability     -       (880 )
    $ 6,901     $ 54,736  

 

Based on the above net exposures as at December 31, 2019, assuming that all other variables remain constant, a 5% appreciation or deterioration of the Canadian dollar against the U.S. dollar would result in a corresponding increase or decrease, respectively on the Company’s net income of approximately $448 (2018 – $3,700).

 

The Company is also exposed to currency risk on the Euro, however management estimates such risk relating to an appreciation or deterioration of the Canadian dollar against the Euro would have limited impact on the operations of the Company.

 

(b) Interest rate risk is the risk that the future cash flows of a financial instrument will fluctuate because of changes in market interest rates. Based on the Company’s exposures as at December 31, 2019, as a result of the balance of cash and cash equivalents held by the Company, assuming that all other variables remain constant, a 1% appreciation or deterioration in interest rates would result in a corresponding increase or decrease, respectively on the Company’s net income of approximately $130 (2018 - $720).

 

175  

 

 

 

Notes to the Consolidated Financial Statements 

(expressed in thousands of Canadian dollars, except per share amounts)

 

 

19. Financial instruments (continued)

 

(b) Risks arising from financial instruments and risk management (continued)

 

(ii) Credit risk

 

Credit risk is the risk of financial loss to the Company if a partner or counterparty to a financial instrument fails to meet its contractual obligation and arises principally from the Company’s cash and accounts receivable. The carrying amounts of the financial assets represents the maximum credit exposure.

 

The Company limits its exposure to credit risk on cash by placing these financial instruments with high-credit quality financial institutions.

 

The Company is subject to a concentration of credit risk related to its accounts receivable as 96% of the balance of amounts owing are from three customers. The Company has historically had low impairment in regards to its accounts receivable. As at December 31, 2019, none of the outstanding accounts receivable were outside of the normal payment terms and the Company did not record any bad debt expenses (2018 – nil; 2017 – nil). As at December 31, 2019 and 2018, the expected credit lifetime credit losses for accounts receivable aged as current were nominal amounts.

 

(iii) Liquidity risk

 

Liquidity risk is the risk that the Company will not be able to meet its financial obligations as they come due. The Company manages its liquidity risk by continuously monitoring forecasted and actual cash flows, as well as anticipated investing and financing activities and to ensure that it will have sufficient liquidity to meet its liabilities and commitments when due and to fund future operations.

 

The majority of the Company’s accounts payable and accrued liabilities are due within the current operating period.

 

(c) Capital management

 

The Company manages its capital structure and makes adjustments to it, based on the funds available to the Company, in order to continue the business of the Company. The Company, upon approval from its Board of Directors, will balance its overall capital structure through new share and warrant issuances, granting of stock options, the issuance of debt or by undertaking other activities as deemed appropriate under the specific circumstance. The Board of Directors does not establish a quantitative return on capital criteria for management, but rather relies on the expertise of the Company’s management to sustain future development of the business.

 

The Company’s objectives when managing capital are to safeguard the Company’s ability to continue as a going concern and to provide capital to pursue the development and commercialization of its products. In the management of capital, the Company includes cash, long-term debt, capital stock, stock options, warrants and contributed surplus. The Company manages the capital structure and makes adjustments to it in light of changes in economic conditions and the risk characteristics of the underlying assets. To maintain or adjust the capital structure, the Company may attempt to issue new shares or new debt.

 

At the current stage of the Company’s development, in order to maximize its current business activities, the Company does not pay out dividends. Management reviews its capital management approach on an ongoing basis and believes that this approach, given the relative size of the Company, is reasonable.

 

The Company’s overall strategy with respect to capital risk management remains unchanged for the year ended December 31, 2019.

 

176  

 

 

 

Notes to the Consolidated Financial Statements 

(expressed in thousands of Canadian dollars, except per share amounts)

 

 

20. Determination of fair values

 

A number of the Company’s accounting policies and disclosures require the determination of fair value, for both financial and non-financial assets and liabilities. Fair values have been determined for measurement and/or disclosure purposes based on the following models. When applicable, further information about the assumptions made in determining fair values is disclosed in the notes specific to that asset or liability.

 

(a) Intangible assets

 

The fair value of intangible assets is based on the discounted cash flows expected to be derived from the use and eventual sale of the assets.

 

(b) Investment in Sensible Medical

 

The investment in Sensible Medical is the fair value associated with the Company’s equity investment in Sensible Medical and is classified as FVOCI. The change in the Investment in Sensible Medical is recorded through other comprehensive (loss) income in the consolidated statement of net (loss) income and comprehensive (loss) income. The investment in Sensible Medical was recorded at fair value at the date at which it was acquired and subsequently revalued at each reporting date. Estimating fair value for this asset requires determining the most appropriate valuation model and determining the most appropriate inputs to the valuation model, including publicly traded companies similar to Sensible Medical to use as a proxy in the valuation model, a discount rate for lack of marketability of the investment and estimated costs to dispose of the investment.

 

(c) Share-based payment transactions

 

The fair value of the employee share options is measured using the Black-Scholes option pricing model. Measurement inputs include share price on measurement date, exercise price of the instrument, expected volatility (based on weighted average historical volatility adjusted for changes expected due to publicly available information), weighted average expected life of the instruments (based on historical experience and general option holder behavior), expected dividends, and the risk-free interest rate (based on government bonds). Service and non-market performance conditions attached to the transactions are not taken into account in determining fair value.

 

(d) Royalty obligation

 

The royalty obligation is recorded at its fair value at the date at which the liability was incurred and subsequently measured at amortized cost using the effective interest rate method at each reporting date. Estimating fair value for this liability requires determining the most appropriate valuation model which is dependent on its underlying terms and conditions. This estimate also requires determining expected revenue from AGGRASTAT® sales and an appropriate discount rate and making assumptions about them.

 

(e) Acquisition payable

 

The acquisition payable is recorded at its fair value at the date at which the liability was incurred and subsequently measured at amortized cost using the effective interest rate method at each reporting date. Estimating fair value for this liability requires determining the most appropriate valuation model which is dependent on its underlying terms and conditions. This estimate also requires determining an appropriate discount rate and making assumptions about it.

 

(f) Holdback receivable

 

The holdback receivable was recorded at its fair value at the date of acquisition and subsequently measured at fair value at each reporting date. Estimating fair value for this asset required determining the most appropriate valuation model which is dependent on its underlying terms and conditions. This estimate also required determining expected cash flows from this receivable including potential claims from the Buyer in the Apicore Sale Transaction (Note 10) and an appropriate discount rate and making assumptions about them.

 

177  

 

 

 

Notes to the Consolidated Financial Statements 

(expressed in thousands of Canadian dollars, except per share amounts)

 

 

21. Segmented information

 

Prior to October 2, 2017, the operations of the Company were classified into two industry segments: the marking and distribution of commercial products (AGGRASTAT®) and the manufacturing and distribution of API, which was classified as held for sale and discontinued operations in 2017 (note 5). No operating segments were aggregated to form these reportable operating segments. Since the sale of API on October 2, 2017, the Company operates under one segment.

 

Revenue generated from external customers from the marketing and distribution of commercial products for the years ended December 31, 2019, 2018 and 2017 was 100% from sales to customers in the United States.

 

During the year ended December 31, 2019, 100% of total revenue was generated from thirteen customers. Customer A accounted for 38%, Customer B accounted for 28%, Customer C accounted for 28% and the remaining ten customers accounted for approximately 6% of revenue.

 

During the year ended December 31, 2018, 100% of total revenue was generated from eight customers. Customer A accounted for 33%, Customer B accounted for 28%, Customer C accounted for 33% and Customer D accounted for 6% and the remaining five customers accounted for less than 1% of revenue.

 

During the year ended December 31, 2017, 100% of total revenue was generated from nine customers. Customer A accounted for 33%, Customer B accounted for 30%, Customer C accounted for 30% and Customer D accounted for 6% and the remaining five customers accounted for less than 1% of revenue.

 

Property, plant and equipment and intangible assets are located in the following countries:

 

As at December 31   2019     2018
Canada   $ 1,282     $ 316
Barbados     9,599       1,705
    $ 10,881     $ 2,021

 

22. Subsequent events

 

Since December 31, 2019, the outbreak of the novel strain of coronavirus, specifically identified as “COVID-19”, has resulted in governments worldwide enacting emergency measures to combat the spread of the virus. These measures, which include the implementation of travel bans, self-imposed quarantine periods and social distancing, have caused material disruption to businesses globally resulting in an economic slowdown. Global equity markets have experienced significant volatility and weakness. Governments and central banks have reacted with significant monetary and fiscal interventions designed to stabilize economic conditions. The duration and impact of the COVID-19 outbreak is unknown at this time, as is the efficacy of the government and central bank interventions. It is not possible to reliably estimate the length and severity of these developments and the impact on the liquidity, financial results and condition of the Company and its operating subsidiaries in future periods.

 

178  

 

ITEM 19. EXHIBITS

 

Number Exhibit

 

1. Articles of Incorporation and Bylaws:

 

1.1 Medicure’s Articles of Incorporation dated September 15, 1997 [1]

1.2 Lariat’s Articles of Incorporation dated June 3, 1997 [1]

1.3 Medicure’s Certificate of Continuance from Manitoba to Alberta dated December 3, 1999 [1]

1.4 Certificate of Amalgamation for Medicure and Lariat dated December 22, 1999 [1]

1.5 Medicure’s Certificate of Continuance from Alberta to Canada dated February 23, 2000 [1]

1.6 Amended Certificate of Continuance and Articles of Continuance dated February 20, 2003 [3]

1.7 Certificate of Amendment dated November 1, 2012 [10]

1.8 Bylaw No. 1A [10]

1.9 Bylaw No. 2 [8]

 

4. Material Contracts and Agreements:

 

4.1 Transfer Agency Agreement between Montreal Trust Company of Canada and the Company dated as of January 26, 2000, whereby Montreal Trust Company of Canada agreed to act as transfer agent and registrar with respect to the Shares [1]

 

4.2 Medicure International Licensing Agreement between the Company and Medicure International Inc. dated June 1, 2000, wherein the Company granted Medicure International, Inc. a license with regard to certain intellectual property [1]

 

4.3 Development Agreement between Medicure International, Inc. and CanAm Bioresearch Inc. dated June 1, 2000, wherein CanAm Bioresearch Inc. agreed to conduct research and development activities for Medicure International, Inc. [1]

 

4.4 Amendment to the Consulting Services Agreement dated February 1, 2002 between A.D. Friesen Enterprises Ltd. and the Company whereby consulting services will be provided to the Company by Dr. Albert D. Friesen [2]

 

4.5 Stock Option Plan approved February 4, 2002 [3]

 

4.5 Amendment dated March 1, 2002 to the Development Agreement between Medicure International, Inc. and CanAm Bioresearch Inc. [5]

 

4.7 Amendment dated August 7, 2003 to the Development Agreement between Medicure International, Inc. and CanAm Bioresearch Inc. [3]

 

4.8 Amendment to the Consulting Services Agreement dated October 1, 2003 between A.D. Friesen Enterprises Ltd. and the Company whereby consulting services will be provided to the Company by Dr. Albert D. Friesen [4]

 

4.9 Employment Agreement with Dawson Reimer dated October 1, 2001 [4]

 

179  

 

4.10 Amendment to Employment Agreement dated April 5, 2005 between A.D. Friesen Enterprises Ltd. and the Company [5]

 

4.11 Amendment to Employment Agreement dated April 5, 2005 between Dawson Reimer and the Company [5]

 

4.12 Amendment to Employment Agreement dated April 5, 2005 between Derek Reimer and the Company [5]

 

4.13 Amendment dated July 8, 2005 to the Development Agreement between Medicure International, Inc. and CanAm Bioresearch Inc. [5]

 

4.14 Amendment to Employment Agreement dated October 1, 2005 between A.D. Friesen Enterprises Ltd. and the Company [6]

 

4.15 Amendment to Development Agreement dated June 1, 2000 between CanAm Bioresearch Inc. and Medicure International, Inc. dated July 4, 2006 [6]

 

4.16 Amended Stock Option Plan approved October 25, 2005 [6]

 

4.17 Amendment to Employment Agreement dated October 1, 2006 between A.D. Friesen Enterprises Ltd. and the Company [7]

 

4.18 Amended License Agreement between Medicure and the University of Manitoba dated November 24, 2006, originally dated August 30, 1999, wherein the University of Manitoba granted to Medicure an exclusive license with regard to certain intellectual property (the “U of M Licensing Agreement”) [7]

 

4.19 Amendment to Employment Agreement dated October 1, 2007 between A.D. Friesen Enterprises Ltd. and the Company [8]

 

4.20 Amended Stock Option Plan approved October 2, 2007 [9]

 

4.21 Employment Agreement with Dwayne Henley June 10, 2008 [8]

 

4.22 Debt financing agreement between Birmingham Associates Ltd. and the Company dated September 17, 2007 [8]

 

4.23 Stock Option Plan amended and restated as of November 30, 2012 [14]

 

4.24 Stock Option Plan amended and restated as of November 4, 2014 [11]

 

4.25 Stock Option Plan amended and restated as of June 22, 2016 [12]

 

8.1 List of Significant Subsidiaries and Consolidated Affiliated Entity *

 

11.1 Code of Ethics [4]

 

12.1 Certification of CEO pursuant to Section 302 of the Sarbanes-Oxley Act of 2002 *

 

180  

 

12.2 Certification of CFO pursuant to Section 302 of the Sarbanes-Oxley Act of 2002 *

 

13.1 Certification of CEO and CFO pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 **
     
  23.1 Consents of Independent Registered Pubic Accounting Firms *

 

Notes:

 

[1] Herein incorporated by reference as previously included in the Company’s Form 20-F registration statement filed on January 30, 2001.

 

[2] Herein incorporated by reference as previously included in the Company’s Form 20-F annual report filed on December 31, 2002.

 

[3] Herein incorporated by reference as previously included in the Company’s Form 20-F annual report filed on October 20, 2003.

 

[4] Herein incorporated by reference as previously included in the Company’s Form 20-F annual report filed on September 15, 2004.

 

[5] Herein incorporated by reference as previously included in the Company’s Form 20-F annual report filed on August 24, 2005.

 

[6] Herein incorporated by reference as previously included in the Company’s Form 20-F annual report filed on August 16, 2006.

 

[7] Herein incorporated by reference as previously included in the Company’s Form 20-F annual report filed on August 27, 2007.

 

[8] Herein incorporated by reference as previously included in the Company’s Form 20-F annual report filed on August 29, 2008.

 

[9] Herein incorporated by reference as previously included in the Company’s Registration Statement on Form S-8, filed on October 9, 2007 (SEC File No. 333-146574).

 

[10] Herein incorporated by reference as previously included in the Company’s Form 20-F annual report filed on September 11, 2014.

 

[11] Herein incorporated by reference as previously included in the Company’s Form 20-F annual report filed on April 14, 2015.

 

[12] Herein incorporated by reference as previously included in the Company’s Form 20-F annual report filed on March 31, 2016.

 

[13] Herein incorporated by reference as previously included in the Company’s Form 20-F annual report filed on April 27, 2017.

 

181  

 

[14] Herein incorporated by reference as previously included in the Company’s Form 20-F annual report filed on May 1, 2018.

 

[15] Herein incorporated by reference as previously included in the Company’s Form 20-F annual report filed on April 29, 2019.

 

*          Filed herewith 

**       Furnished herewith

 

182  

 

SIGNATURE PAGE

 

Pursuant to the requirements of Section 12 of the Securities Exchange Act of 1934, the Company certifies that it meets all of the requirements for filing on Form 20-F and has duly caused this Annual Report to be signed on its behalf by the undersigned, thereunto duly authorized.

 

Dated: April 15, 2020

 

ON BEHALF OF THE CORPORATION, 

MEDICURE INC.

 

per:

 

/s/ Albert D. Friesen  
   
Albert D. Friesen, Ph.D.   
Chairman, & CEO   

 

183  

 

EX-8.1 2 d913663dex81.htm EX-8.1 EX-8.1

Exhibit 8.1 – List of Significant Subsidiaries and
Consolidated Affiliated Entity 

 

LIST OF SIGNIFICANT SUBSIDIARIES AND
CONSOLIDATED AFFILIATED ENTITIES

 

Significant Subsidiaries

 

Name of Company Jurisdiction of Incorporation Percentage of Equity Owned
Medicure International, Inc. Barbados 100%
Medicure Pharma Inc. United States (Delaware) 100%
Medicure U.S.A. Inc. United States (Delaware) 100%
Medicure Pharma Europe Ltd Ireland 100%
Medicure Mauritius Limited Mauritius 100%
Apigen Investments Limited Mauritius 100%

 

All significant subsidiaries do business under their respective legal names.

 

 

 

EX-12.1 3 d913663dex121.htm EX-12.1 EX-12.1

Exhibit 12.1 – Certification of CEO pursuant to Section 302
OF THE sARBANES-OXLEY ACT OF 2002 

 

CERTIFICATION

 

I, Albert D. Friesen, certify that:

 

1. I have reviewed this Annual Report on Form 20-F of Medicure Inc.;

 

2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;

 

3. Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the company as of, and for, the periods presented in this report;

 

4. The company’s other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15(d)-(15)(f)) for the company and have:

 

  (a) Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the company, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;

 

(b) Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;

 

(c) Evaluated the effectiveness of the company’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and

 

(d) Disclosed in this report any change in the company’s internal control over financial reporting that occurred during the period covered by the annual report that has materially affected, or is reasonably likely to materially affect, the company’s internal control over financial reporting; and

 

5. The company’s other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the company’s auditors and the audit committee of the company’s board of directors (or persons performing the equivalent functions):

 

(a) All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the company’s ability to record, process, summarize and report financial information; and

 

(b) Any fraud, whether or not material, that involves management or other employees who have a significant role in the company’s internal control over financial reporting.

 

Date April 15, 2020 /s/ Albert D. Friesen  
  Chief Executive Officer
  (Principal Executive Officer)

 

 

 

EX-12.2 4 d913663dex122.htm EX-12.2 EX-12.2

Exhibit 12.2 – Certification of CFO pursuant to Section 302
OF THE sARBANES-OXLEY ACT OF 2002 

 

CERTIFICATION

 

I, James F. Kinley, certify that:

 

1. I have reviewed this Annual Report on Form 20-F of Medicure Inc.;

 

2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;

 

3. Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the company as of, and for, the periods presented in this report;

 

4. The company’s other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15(d)-(15)(f)) for the company and have:

 

(a) Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the company, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;

 

(b) Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;

 

(c) Evaluated the effectiveness of the company’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and

 

(d) Disclosed in this report any change in the company’s internal control over financial reporting that occurred during the period covered by the annual report that has materially affected, or is reasonably likely to materially affect, the company’s internal control over financial reporting; and

 

5. The company’s other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the company’s auditors and the audit committee of the company’s board of directors (or persons performing the equivalent functions):

 

(a) All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the company’s ability to record, process, summarize and report financial information; and

 

(b) Any fraud, whether or not material, that involves management or other employees who have a significant role in the company’s internal control over financial reporting.

 

Date: April 15, 2020 /s/ James F. Kinley  
  Chief Financial Officer
  (Principal Financial Officer)

 

 

 

EX-13.1 5 d913663dex131.htm EX-13.1 EX-13.1

Exhibit 13.1 – Certification of ceo and cfo pursuant to
section 906 OF THE sARBANES-OXLEY ACT OF 2002 

 

CERTIFICATION OF PRINCIPAL EXECUTIVE OFFICER AND
PRINCIPAL FINANCIAL OFFICER
PURSUANT TO 18 U.S.C. SECTION 1350,
AS ADOPTED PURSUANT TO
SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002

 

Pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, each of the undersigned officers of Medicure Inc. (the “Company”), does hereby certify with respect to the Annual Report of the Company on Form 20-F for the year ended December 31, 2019, as filed with the Securities and Exchange Commission on the date hereof (the “Form 20-F”), that, to the best of his knowledge:

 

(1) the Form 20-F fully complies with the requirements of section 13(a) or 15(d) of the Securities Exchange Act of 1934; and

 

(2) the information contained in the Form 20-F fairly presents, in all material respects, the financial condition and results of operations of the Company.

 

Date: April 15, 2020 /s/ Albert D. Friesen  
    Albert D. Friesen Ph D., Chief Executive Officer
    (Principal Executive Officer)
     
     
Date: April 15, 2020 /s/ James F. Kinley  
    James F. Kinley CA, Chief Financial Officer
    (Principal Financial Officer)

 

A signed original of this written statement required by Section 906, or other document authenticating, acknowledging, or otherwise adopting the signature that appears in typed form within the electronic version of this written statement required by Section 906, has been provided to the Company and will be retained by the Company and furnished to the Securities and Exchange Commission or its staff upon request.

 

 

 

EX-23.1 6 d913663dex231.htm EX-23.1 EX-23.1

Exhibit 23.1 – consent of independent registered public accounting firm 

 

Consent of Independent Registered Public Accounting Firm

 

We hereby consent to the incorporation by reference in the Registration Statement on Form S-8 (No. 333-146574) of Medicure Inc., of our report dated April 15, 2020 which is incorporated in this Form 20-F.

 

/s/ PricewaterhouseCoopers LLP

 

Chartered Professional Accountants

 

Winnipeg, Canada

April 15, 2020

     

 

 

Consent of Independent Registered Public Accounting Firm

 

 

We consent to the incorporation by reference in the Registration Statement (File No. 333-146574) on Form S-8 of Medicure Inc. (“the Company”) of our audit report dated May 1, 2018 with respect to the consolidated financial statements of the Company comprising the consolidated statement of net income and comprehensive income, changes in equity and cash flows for the year ended December 31, 2017, included in the Annual Report on Form 20-F of the Company, as filed with the Securities and Exchange Commission.

 

 

Winnipeg, Canada,

April 15, 2020 Chartered Professional Accountants

 

 

     

 

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</div></div></div></td></tr></table><div style="clear: both; max-height: 0px;"></div><div style="clear: both; max-height: 0px;"></div><div style="clear: both; max-height: 0px;"></div><div style="clear: both; max-height: 0px;"></div><div style="clear: both; max-height: 0px;"></div><div style="clear: both; max-height: 0px; background: none;"></div><div style="font-family: times new roman; font-size: 10pt; margin-top: 6pt; margin-bottom: 0pt; margin-left: 4%;">Medicure Inc. (the &#8220;Company&#8221;) is a company domiciled and incorporated in Canada and as of October&#160;24, 2011, its Common Shares are listed on the TSX Venture Exchange <div style="white-space: nowrap; letter-spacing: 0px; top: 0px;;display:inline;">(&#8220;TSX-V&#8221;).</div> Prior to October&#160;24, 2011 and beginning on March&#160;29, 2010, the Company&#8217;s Common Shares were listed on the NEX board of the <div style="white-space: nowrap; letter-spacing: 0px; top: 0px;;display:inline;">TSX-V.</div> Prior to March&#160;29, 2010, the Company&#8217;s Common Shares were listed on the Toronto Stock Exchange. Additionally, the Company&#8217;s shares were listed on the American Stock Exchange (later called NYSE Amex and now called NYSE MKT) on February&#160;17, 2004 and the shares ceased trading on the NYSE Amex effective July&#160;3, 2008. The Company remains a U.S. Securities and Exchange Commission registrant. The address of the Company&#8217;s registered office is <div style="white-space: nowrap; letter-spacing: 0px; top: 0px;;display:inline;">2-1250</div> Waverley Street, Winnipeg, Manitoba, Canada, R3T 6C6.</div><div style="font-family: times new roman; font-size: 10pt; margin-top: 6pt; margin-bottom: 0pt; margin-left: 4%;">The Company is a biopharmaceutical company engaged in the research, development and commercialization of human therapeutics. Through its subsidiary Medicure International, Inc., the Company has rights to the commercial product AGGRASTAT<div style="font-size: 7.4pt; vertical-align: top; line-height: 5.476pt;;vertical-align: super;font-size: smaller;display:inline;">&#174;</div> Injection (tirofiban hydrochloride) in the United States and its territories (Puerto Rico, U.S. Virgin Islands, and Guam). AGGRASTAT<div style="font-size: 7.4pt; vertical-align: top; line-height: 5.476pt;;vertical-align: super;font-size: smaller;display:inline;">&#174;</div>, a glycoprotein GP IIb/IIIa receptor antagonist, is used for the treatment of acute coronary syndrome including unstable angina, which is characterized by chest pain when one is at rest, and <div style="white-space: nowrap; letter-spacing: 0px; top: 0px;;display:inline;"><div style="white-space: nowrap;;display:inline;">non-Q-wave</div></div> myocardial infarction.</div><div style="font-family: times new roman; font-size: 10pt; margin-top: 6pt; margin-bottom: 0pt; margin-left: 4%;"><div style="font-family: &quot;times new roman&quot;; font-size: 10pt; letter-spacing: 0px; top: 0px;;display:inline;">On September&#160;30, 2019 the Company acquired ownership of ZYPITAMAG<div style="font-size: 7.4pt; vertical-align: top; line-height: 5.476pt;;vertical-align: super;font-size: smaller;display:inline;">TM</div> from Cadila Healthcare Ltd., India (&#8220;Zydus&#8221;) for the U.S. and Canadian markets. 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font-size: 10pt; letter-spacing: 0px; top: 0px;;display:inline;">These consolidated financial statements include the accounts of the Company and its subsidiaries. Subsidiaries are entities controlled by the Company. Control exists when the Company has power over the investee and when the Company is exposed, or has the rights, to variable returns from the investee. Subsidiaries are included in the consolidated financial results of the Company from the effective date of acquisition up to the effective date of disposition or loss of control and include wholly owned subsidiaries, Medicure International Inc., Medicure Pharma Inc., Medicure U.S.A. Inc., Medicure Mauritius Limited, Medicure Pharma Europe Limited and Apigen Investments Limited. Additionally, the December&#160;31, 2017 comparative figures include, from the date of acquisition (note 5), the accounts of subsidiaries that are controlled by the Company including, Apicore Inc., Apicore US LLC, Apicore LLC and Apicore Pharmaceuticals Private Limited. These additional subsidiaries were classified as discontinued operations for 2017 and Apicore Inc. and Apicore US LLC were sold during 2017 as described in note 5. The financial statements of the subsidiaries are prepared for the same reporting period as the parent company, using consistent accounting policies. 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Foreign exchange gains and losses resulting from the settlement of such transactions and from the translation at <div style="white-space: nowrap; letter-spacing: 0px; top: 0px;;display:inline;">period-end</div> exchange rates of monetary assets and liabilities denominated in foreign currencies are recognized in profit or loss. <div style="white-space: nowrap; letter-spacing: 0px; top: 0px;;display:inline;">Non-monetary</div> items that are not carried at fair value are translated using the exchange rates as at the date of the initial transaction. <div style="white-space: nowrap; letter-spacing: 0px; top: 0px;;display:inline;">Non-monetary</div> items measured at fair value in a foreign currency are translated using the exchange rates at the date<div style="letter-spacing: 0px; top: 0px;;display:inline;">&#160;</div>when the fair value is determined.</div><div style="font-family: times new roman; font-size: 10pt; margin-top: 6pt; margin-bottom: 0pt; margin-left: 9%;"><div style="font-family: &quot;times new roman&quot;; 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The holdback receivable was classified within this category. </div></div></div><div style="font-family: times new roman; font-size: 10pt; margin-top: 6pt; margin-bottom: 0pt; margin-left: 9%;"><div style="letter-spacing: 0px; top: 0px;;display:inline;"><div style="font-family: &quot;times new roman&quot;; font-size: 10pt; letter-spacing: 0px; top: 0px;;display:inline;">Financial assets at FVOCI </div></div></div><div style="font-family: times new roman; font-size: 10pt; margin-top: 6pt; margin-bottom: 0pt; margin-left: 9%;"><div style="letter-spacing: 0px; top: 0px;;display:inline;"><div style="font-family: &quot;times new roman&quot;; font-size: 10pt; letter-spacing: 0px; top: 0px;;display:inline;">Financial assets measured at FVOCI are carried in the statement of financial position at fair value with changes in fair value therein recognized in the statement of comprehensive (loss) income. 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Financial liabilities are subsequently measured at amortized cost or FVTPL, and are not subsequently reclassified. The Company&#8217;s financial liabilities are accounts payable and accrued liabilities, royalty obligation and acquisition payable which are recognized on an amortized cost basis. </div></div><div style="font-family: times new roman; font-size: 10pt; margin-top: 6pt; margin-bottom: 0pt; margin-left: 9%;"><div style="font-family: &quot;times new roman&quot;; font-size: 10pt; letter-spacing: 0px; top: 0px;;display:inline;">The royalty obligation was recorded at its fair value at the date at which the liability was incurred and subsequently measured at amortized cost using the effective interest rate method at each reporting date. Estimating fair value for this liability required determining the most appropriate valuation model which was dependent on its underlying terms and conditions. This estimate also required determining expected revenue from AGGRASTAT<div style="font-size: 7.4pt; vertical-align: top; line-height: 5.476pt;;vertical-align: super;font-size: smaller;display:inline;">&#174;</div> sales and an appropriate discount rate and making assumptions about them. </div></div><div style="font-family: times new roman; font-size: 10pt; margin-top: 6pt; margin-bottom: 0pt; margin-left: 9%;"><div style="font-family: &quot;times new roman&quot;; font-size: 10pt; letter-spacing: 0px; top: 0px;;display:inline;">The acquisition payable was recorded at its fair value at the date at which the liability was incurred and subsequently measured at amortized cost using the effective interest rate method at each reporting date. Estimating fair value for this liability required determining an appropriate discount rate. </div></div><div style="font-family: times new roman; font-size: 10pt; margin-top: 6pt; margin-bottom: 0pt; margin-left: 9%;"><div style="font-family: &quot;times new roman&quot;; font-size: 10pt; letter-spacing: 0px; top: 0px;;display:inline;">(iv) Offsetting of financial instruments </div></div><div style="font-family: times new roman; font-size: 10pt; margin-top: 6pt; margin-bottom: 0pt; margin-left: 9%;"><div style="font-family: &quot;times new roman&quot;; font-size: 10pt; letter-spacing: 0px; top: 0px;;display:inline;">Financial assets and financial liabilities are offset, and the net amount reported in the statement of financial position if, and only if, there is a currently enforceable legal right to offset the recognized amounts and there is an intention to settle on a net basis, or to realize the assets and settle the liabilities simultaneously. </div></div><div style="font-family: times new roman; font-size: 10pt; margin-top: 6pt; margin-bottom: 0pt; margin-left: 9%;"><div style="font-family: &quot;times new roman&quot;; font-size: 10pt; letter-spacing: 0px; top: 0px;;display:inline;">(v) Fair value of financial instruments </div></div><div style="font-family: times new roman; font-size: 10pt; margin-top: 6pt; margin-bottom: 0pt; margin-left: 9%;"><div style="font-family: &quot;times new roman&quot;; font-size: 10pt; letter-spacing: 0px; top: 0px;;display:inline;">Fair value is determined based on the price that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants. Fair value is measured using the assumptions that market participants would use when pricing an asset or liability. Typically, fair value is determined by using quoted prices in active markets for identical or similar assets or liabilities. When quoted prices in active markets are not available, fair value is determined using valuation techniques that maximize the use of observable inputs. When observable valuation inputs are not available, significant judgement is required through determining the valuation technique to apply, the valuation techniques such as discounted cash flow analysis and selecting inputs. The use of alternative valuation techniques or valuation inputs may result in a different fair value. </div></div><div style="font-family: &quot;times new roman&quot;; font-size: 10pt; margin-top: 6pt; margin-bottom: 0pt; margin-left: 9%; line-height: 12pt;"><div style="font-family: &quot;times new roman&quot;; font-size: 10pt; letter-spacing: 0px; top: 0px;;display:inline;">(vi) Transaction costs </div></div><div style="font-family: times new roman; font-size: 10pt; margin-top: 6pt; margin-bottom: 0pt; margin-left: 9%;"><div style="font-family: &quot;times new roman&quot;; font-size: 10pt; letter-spacing: 0px; top: 0px;;display:inline;">Transaction costs for all financial instruments measured at amortized cost, the transaction costs are included in the initial measurement of the financial asset or financial liability and are amortized using the effective interest rate method over a period that corresponds with the term of the financial instruments. Transaction costs for financial instruments classified as FVTPL are recognized as an expense in professional fees, in the period the cost was incurred. </div></div><div style="font-family: times new roman; font-size: 10pt; margin-top: 6pt; margin-bottom: 0pt; margin-left: 9%;"><div style="font-family: &quot;times new roman&quot;; font-size: 10pt; letter-spacing: 0px; top: 0px;;display:inline;">(vii) Embedded Derivatives </div></div><div style="font-family: times new roman; font-size: 10pt; margin-top: 6pt; margin-bottom: 0pt; margin-left: 9%;">For financial liabilities measured at amortized cost, under certain conditions, an embedded derivative must be separated from its host contract and accounted for as a derivative. An embedded derivative causes some or all of the cash flows that otherwise would be required by the contract to be modified according to a specified interest rate, financial instrument price, commodity price, foreign exchange rate, index of prices or rates, a credit rating or credit index, or other variable, provided in the case of a <div style="white-space: nowrap; letter-spacing: 0px; top: 0px;;display:inline;">non-financial</div> variable that the variable is not specific to a party to the contract. 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An estimate is made to determine the present value of future cash flows associated with the asset, and if required, an impairment loss is recorded. The impairment loss reduces the carrying value of the impaired financial asset to the value of the estimated present value of the future cash flows associated with the asset, discounted at the financial asset&#8217;s original effective interest rate is recorded either directly or through the use of an allowance account and the resulting impairment loss is recorded in profit or loss. </div></div><div style="font-family: times new roman; font-size: 10pt; margin-top: 6pt; margin-bottom: 0pt; margin-left: 9%;"><div style="font-family: &quot;times new roman&quot;; font-size: 10pt; letter-spacing: 0px; top: 0px;;display:inline;">Impairment losses on financial assets carried at amortized cost are reversed in subsequent periods if the amount of the loss decreases and the decrease can be related objectively to an event occurring after the impairment was recognized. </div></div> <table border="0" style="width:100%; table-layout:fixed;" cellspacing="0" cellpadding="0"><tr><td></td></tr></table> <table border="0" cellpadding="0" cellspacing="0" style="font-family: &quot;times new roman&quot;; font-size: 10pt; border-spacing: 0px; table-layout: fixed;;width:100%;"><tr style="page-break-inside: avoid;"><td style="width:4%;">&#160;</td><td style="text-align:left;;vertical-align:top;;width:5%;"><div style="font-weight:bold;display:inline;"><div style="font-style:italic;display:inline;;font-style:italic;display:inline;">(e)</div></div></td><td style="font-size: 10pt;;text-align:left;;vertical-align:top;"><div style="font-family: &quot;times new roman&quot;; font-size: 10pt; margin-top: 0pt; margin-bottom: 0pt; line-height: normal;"><div style="font-family: &quot;times new roman&quot;; font-size: 10pt; letter-spacing: 0px; top: 0px;;display:inline;"><div style="font-weight:bold;display:inline;"><div style="font-style:italic;display:inline;;font-style:italic;display:inline;">Revenue from contracts with customers</div></div> </div></div></td></tr></table><div style="clear: both; max-height: 0px;"></div><div style="clear: both; max-height: 0px;"></div><div style="clear: both; max-height: 0px;"></div><div style="clear: both; max-height: 0px;"></div><div style="clear: both; max-height: 0px;"></div><div style="clear: both; max-height: 0px;"></div><div style="clear: both; max-height: 0px;"></div><div style="clear: both; max-height: 0px;"></div><div style="clear: both; max-height: 0px; background: none;"></div><div style="font-family: times new roman; font-size: 10pt; margin-top: 6pt; margin-bottom: 0pt; margin-left: 9%;"><div style="letter-spacing: 0px; top: 0px;;display:inline;"><div style="font-family: &quot;times new roman&quot;; font-size: 10pt; letter-spacing: 0px; top: 0px;;display:inline;">The Company has three commercially available products that generated revenue for the year ended December&#160;31, 2019, AGGRASTAT<div style="font-size: 7.4pt; vertical-align: top; line-height: 5.476pt;;vertical-align: super;font-size: smaller;display:inline;">&#174;</div>, ZYPITAMAG<div style="font-size: 7.4pt; vertical-align: top; line-height: 5.476pt;;vertical-align: super;font-size: smaller;display:inline;">&#8482;</div> and ReDS<div style="font-size: 7.4pt; vertical-align: top; line-height: 5.476pt;;vertical-align: super;font-size: smaller;display:inline;">TM </div>(the &#8220;<div style="font-weight:bold;display:inline;">Products</div>&#8221;) which it sells to United States customers. 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A liability is included within accounts payable and accrued liabilities and is measured for expected payments that will be made to the customers for the discounts in which they are entitled. 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When parts of an item of property, plant and equipment have different useful lives, they are accounted for as separate items (major components) of property, plant and equipment. 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An impairment loss is recognized when the carrying amount of an asset, or its CGU, exceeds its recoverable amount. Impairment losses are recognized in net income and comprehensive income. A CGU is the smallest identifiable group of assets that generates cash inflows that are largely independent of the cash inflows from other assets or groups of assets. The recoverable amount is the greater of the asset&#8217;s or CGU&#8217;s fair value less costs to sell and value in use. In assessing value in use, the estimated future cash flows are discounted to their present value using a <div style="white-space: nowrap; letter-spacing: 0px; top: 0px;;display:inline;">pre-tax</div> discount rate that reflects current market assessments of the time value of money and the risks specific to the asset or CGU. In determining fair value less costs to sell, an appropriate valuation model is used. 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The amount recognized as an expense is adjusted to reflect the number of awards for which the related service and <div style="white-space: nowrap; letter-spacing: 0px; top: 0px;;display:inline;">non-market</div> vesting conditions are expected to be met, such that the amount ultimately recognized as an expense is based on the number of awards that do meet the related service and <div style="white-space: nowrap; letter-spacing: 0px; top: 0px;;display:inline;">non-market</div> performance conditions at the vesting date. 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This includes any awards where vesting conditions within the control of either the Company or the employee are not met. 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Under this method, deferred taxes are recognized in respect of temporary differences between the carrying amounts of assets and liabilities for financial reporting purposes and the amounts used for taxation purposes. Deferred taxes are not recognized for the following temporary differences: the initial recognition of assets or liabilities in a transaction that is not a business combination and that affects neither accounting nor taxable profit or loss, and differences relating to investments in subsidiaries and jointly controlled entities to the extent that it is probable that they will not reverse in the foreseeable future. In addition, deferred taxes are not recognized for taxable temporary differences arising on the initial recognition of goodwill. Deferred taxes are measured at the tax rates that are expected to be applied to temporary differences when they reverse, based on the tax laws that have been enacted or substantively enacted by the reporting date. Deferred tax assets and liabilities are offset if there is a legally enforceable right to offset current tax assets and liabilities, and they relate to income taxes levied by the same tax authority on the same taxable entity, or on different tax entities, but they intend to settle current tax assets and liabilities on a net basis or their tax assets and liabilities will be realized simultaneously. </div></div><div style="font-family: times new roman; font-size: 10pt; margin-top: 6pt; margin-bottom: 0pt; margin-left: 9%;"><div style="font-family: &quot;times new roman&quot;; font-size: 10pt; letter-spacing: 0px; top: 0px;;display:inline;">A deferred tax asset is recognized for unused tax losses, tax credits and deductible temporary differences, to the extent that it is probable that future taxable profits will be available against which they can be utilized. 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Additional guidance and interpretations can be expected and such guidance, if any, could impact future results. While management continues to monitor these matters, the ultimate impact, if any, as a result of the application of any guidance issued in the future cannot be determined at this time. </div></div><div style="font-family: times new roman; font-size: 10pt; margin-top: 6pt; margin-bottom: 0pt; margin-left: 9%;"><div style="font-family: &quot;times new roman&quot;; font-size: 10pt; letter-spacing: 0px; top: 0px;;display:inline;">The Company and its subsidiaries file federal income tax returns in Canada, the United States, Barbados and other foreign jurisdictions, as well as various provinces and states in Canada and the United States<div style="letter-spacing: 0px; top: 0px;;display:inline;">, respectively</div>. The Company and its subsidiaries have open tax years, primarily from 20<div style="letter-spacing: 0px; top: 0px;;display:inline;">1</div>0&#160;to 201<div style="letter-spacing: 0px; top: 0px;;display:inline;">9</div>, with significant taxing jurisdictions, including Canada, the United States and Barbados. These open years contain certain matters that could be subject to differing interpretations of applicable tax laws and regulations and tax treaties, as they relate to the amount, timing or inclusion of revenues and expenses, or the sustainability of income tax positions of the Company and its subsidiaries. Certain of these tax years may remain open indefinitely. </div></div><div style="font-family: times new roman; font-size: 10pt; margin-top: 6pt; margin-bottom: 0pt; margin-left: 9%;"><div style="font-family: &quot;times new roman&quot;; font-size: 10pt; letter-spacing: 0px; top: 0px;;display:inline;">Tax benefits acquired as part of a business combination, but not satisfying the criteria for separate recognition at that date, would be recognized subsequently if information about facts and circumstances changed. The adjustment would either be treated as a reduction to goodwill if it occurred during the measurement period or in profit or loss, when it occurs subsequent to the measurement period. </div></div> <table border="0" style="width:100%; table-layout:fixed;" cellspacing="0" cellpadding="0"><tr><td></td></tr></table> <table border="0" cellpadding="0" cellspacing="0" style="font-family: &quot;times new roman&quot;; font-size: 10pt; border-spacing: 0px; table-layout: fixed;;width:100%;"><tr style="page-break-inside: avoid;"><td style="width:4%;">&#160;</td><td style="text-align:left;;vertical-align:top;;width:5%;"><div style="font-weight:bold;display:inline;"><div style="font-style:italic;display:inline;;font-style:italic;display:inline;">(q)</div></div></td><td style="font-size: 10pt;;text-align:left;;vertical-align:top;"><div style="font-family: &quot;times new roman&quot;; font-size: 10pt; margin-top: 0pt; margin-bottom: 0pt; line-height: normal;"><div style="font-family: &quot;times new roman&quot;; font-size: 10pt; letter-spacing: 0px; top: 0px;;display:inline;"><div style="font-weight:bold;display:inline;"><div style="font-style:italic;display:inline;;font-style:italic;display:inline;">Earnings per share </div></div></div></div></td></tr></table><div style="clear: both; max-height: 0px;"></div><div style="clear: both; max-height: 0px;"></div><div style="clear: both; max-height: 0px;"></div><div style="clear: both; max-height: 0px;"></div><div style="clear: both; max-height: 0px;"></div><div style="clear: both; max-height: 0px; background: none;"></div><div style="font-family: times new roman; font-size: 10pt; margin-top: 6pt; margin-bottom: 0pt; margin-left: 9%;"><div style="font-family: &quot;times new roman&quot;; font-size: 10pt; letter-spacing: 0px; top: 0px;;display:inline;">The Company presents basic earnings per share (&#8220;EPS&#8221;) data for its common voting shares. Basic EPS is calculated by dividing the profit or loss attributable to common voting shareholders of the Company by the weighted average number of common voting shares outstanding during the period, adjusted for the Company&#8217;s own shares held. Diluted EPS is computed similar to basic EPS except that the weighted average shares outstanding are increased to include additional shares for the assumed exercise of stock options and warrants, if dilutive. The number of additional shares is calculated by assuming that outstanding stock options and warrants were exercised and that the proceeds from such exercise were used to acquire common shares at the average market price during the reporting periods. </div></div> <table border="0" style="width:100%; table-layout:fixed;" cellspacing="0" cellpadding="0"><tr><td></td></tr></table> <table border="0" cellpadding="0" cellspacing="0" style="font-family: &quot;times new roman&quot;; font-size: 10pt; border-spacing: 0px; table-layout: fixed;;width:100%;"><tr style="page-break-inside: avoid;"><td style="width:4%;">&#160;</td><td style="text-align:left;;vertical-align:top;;width:5%;"><div style="font-weight:bold;display:inline;"><div style="font-style:italic;display:inline;;font-style:italic;display:inline;">(r)</div></div></td><td style="font-size: 10pt;;text-align:left;;vertical-align:top;"><div style="font-family: &quot;times new roman&quot;; font-size: 10pt; margin-top: 0pt; margin-bottom: 0pt; line-height: normal;"><div style="font-family: &quot;times new roman&quot;; font-size: 10pt; letter-spacing: 0px; top: 0px;;display:inline;"><div style="font-weight:bold;display:inline;"><div style="font-style:italic;display:inline;;font-style:italic;display:inline;">Business combinations and goodwill </div></div></div></div></td></tr></table><div style="clear: both; max-height: 0px;"></div><div style="clear: both; max-height: 0px;"></div><div style="clear: both; max-height: 0px;"></div><div style="clear: both; max-height: 0px;"></div><div style="clear: both; max-height: 0px;"></div><div style="clear: both; max-height: 0px; background: none;"></div><div style="font-family: times new roman; font-size: 10pt; margin-top: 6pt; margin-bottom: 0pt; margin-left: 9%;">Business combinations are accounted for using the acquisition method. The consideration for an acquisition is measured at the fair values of the assets transferred, the liabilities assumed and the equity interests issued at the acquisition date. Transaction costs that are incurred in connection with a business combination, other than costs associated with the issuance of debt or equity securities, are expensed as incurred. Identified assets acquired and liabilities and contingent liabilities assumed are measured initially at fair values at the date of acquisition. 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margin-bottom: 0pt; border-top: 3px double rgb(0, 0, 0); line-height: normal;"><div style="letter-spacing: 0px; top: 0px; white-space: nowrap;;display:inline;">&#160;</div></div></td><td style="padding-right: 0pt;;vertical-align:bottom;"><div style="margin-top: 0pt; margin-bottom: 0pt; border-top: 3px double rgb(0, 0, 0); line-height: normal;"><div style="letter-spacing: 0px; top: 0px; white-space: nowrap;;display:inline;">&#160;</div></div></td><td style="font-family: &quot;times new roman&quot;; padding-right: 0pt;">&#160;</td></tr></table><div style="clear: both; max-height: 0px;"></div><div style="clear: both; max-height: 0px;"></div><div style="clear: both; max-height: 0px;"></div><div style="clear: both; max-height: 0px;"></div><div style="clear: both; max-height: 0px;"></div><div style="clear: both; max-height: 0px;"></div><div style="clear: both; max-height: 0px;"></div> <div style="font-family: times new roman; font-size: 10pt; margin-top: 6pt; margin-bottom: 0pt; margin-left: 4%;"><div style="font-family: &quot;times new roman&quot;; font-size: 10pt; letter-spacing: 0px; top: 0px;;display:inline;">During the year ended December&#160;31, 2019, amortization of property, plant and equipment totaling $485 (2018 &#8211; $103; 2017 &#8211; $98) is included within general and administrative expenses on the consolidated statements of net (loss) income and comprehensive (loss) income. 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The Company recorded a write-down of intangible assets during the year ended December&#160;31, 2017 totaling $636 pertaining to a license acquired during the year, which was under litigation as described in note&#160;16(d). As at December&#160;31, 2019, intangible assets pertaining to AGGRASTAT<div style="font-size: 7.4pt; vertical-align: top; line-height: 5.476pt;;vertical-align: super;font-size: smaller;display:inline;">&#174;</div> intangible were fully amortized. </div><div style="letter-spacing: 0px; top: 0px;;display:inline;"> </div></div><div style="font-family: times new roman; font-size: 10pt; margin-top: 6pt; margin-bottom: 0pt; margin-left: 4%;"><div style="display:inline;"><div style="font-family: &quot;times new roman&quot;; font-size: 10pt; letter-spacing: 0px; top: 0px;;display:inline;">With respect to the intangible asset related to ZYPITAMAGTM, management calculated its fair value less costs to sell using a discounted cash flow model (Level&#160;3 in the fair value hierarchy) based upon financial forecasts prepared by management using a discount rate of</div></div><div style="letter-spacing: 0px; top: 0px;;display:inline;"><div style="font-family: &quot;times new roman&quot;; font-size: 10pt; letter-spacing: 0px; top: 0px;;display:inline;"> 13.25%, a cumulative aggregate growth rate of 300% over four years and a nominal terminal value. 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top: 0px;;display:inline;">&#160;</div></td><td style="padding-bottom: 0.5pt;;vertical-align:bottom;;width:;"><div style="letter-spacing: 0px; top: 0px;;display:inline;">&#160;&#160;</div></td><td colspan="2" style="border-bottom-color: rgb(0, 0, 0); border-bottom-width: 1pt; border-bottom-style: solid;;text-align:center;;vertical-align:bottom;;width:;"><div style="letter-spacing: 0px; top: 0px;;display:inline;">2018</div></td><td style="padding-bottom: 0.5pt;;vertical-align:bottom;;width:;"><div style="letter-spacing: 0px; top: 0px;;display:inline;">&#160;</div></td></tr><tr style="font-family: times new roman; font-size: 10pt; page-break-inside: avoid;"><td style="font-size: 10pt; background-color: rgb(204, 238, 255); width: 82%;;vertical-align:top;"><div style="text-indent: -1em; font-family: &quot;times new roman&quot;; font-size: 10pt; margin-top: 0pt; margin-bottom: 0pt; margin-left: 1em; line-height: normal;"><div style="letter-spacing: 0px; top: 0px;;display:inline;"><div style="font-family: &quot;times new roman&quot;; font-size: 10pt; letter-spacing: 0px; top: 0px;;display:inline;">Deferred tax assets</div></div></div></td><td style="background-color: rgb(204, 238, 255); width: 3%;;vertical-align:bottom;"><div style="letter-spacing: 0px; top: 0px;;display:inline;">&#160;&#160;</div></td><td style="background-color: rgb(204, 238, 255);;vertical-align:bottom;">&#160;</td><td style="background-color: rgb(204, 238, 255);;vertical-align:bottom;">&#160;</td><td style="background-color: rgb(204, 238, 255);;vertical-align:bottom;">&#160;</td><td style="background-color: rgb(204, 238, 255); width: 3%;;vertical-align:bottom;"><div style="letter-spacing: 0px; top: 0px;;display:inline;">&#160;&#160;</div></td><td style="background-color: rgb(204, 238, 255);;vertical-align:bottom;">&#160;</td><td style="background-color: rgb(204, 238, 255);;vertical-align:bottom;">&#160;</td><td style="background-color: rgb(204, 238, 255);;vertical-align:bottom;">&#160;</td></tr><tr><td style="font-size: 10pt; background-color: rgb(255, 255, 255); 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background-color: rgb(255, 255, 255);;vertical-align:bottom;"><div style="letter-spacing: 0px; top: 0px;;display:inline;">&#160;</div></td></tr><tr style="font-size: 1px;"><td style="background-color: rgba(255, 255, 255, 0); width: 82%;;vertical-align:bottom;">&#160;</td><td style="background-color: rgba(255, 255, 255, 0); width: 3%;;vertical-align:bottom;"><div style="letter-spacing: 0px; top: 0px;;display:inline;">&#160;&#160;</div></td><td style="background-color: rgba(255, 255, 255, 0);;vertical-align:bottom;"><div style="margin-top: 0pt; margin-bottom: 0pt; border-top: 1px solid rgb(0, 0, 0); line-height: normal;"><div style="letter-spacing: 0px; top: 0px;;display:inline;"><div style="letter-spacing: 0px; top: 0px;;display:inline;">&#160;</div></div></div></td><td style="background-color: rgba(255, 255, 255, 0);;vertical-align:bottom;"><div style="margin-top: 0pt; margin-bottom: 0pt; border-top: 1px solid rgb(0, 0, 0); line-height: normal;"><div style="letter-spacing: 0px; top: 0px;;display:inline;"><div style="letter-spacing: 0px; top: 0px;;display:inline;">&#160;</div></div></div></td><td style="background-color: rgba(255, 255, 255, 0);"><div style="letter-spacing: 0px; top: 0px;;display:inline;">&#160;</div></td><td style="background-color: rgba(255, 255, 255, 0); width: 3%;;vertical-align:bottom;"><div style="letter-spacing: 0px; top: 0px;;display:inline;">&#160;&#160;</div></td><td style="background-color: rgba(255, 255, 255, 0);;vertical-align:bottom;"><div style="margin-top: 0pt; margin-bottom: 0pt; border-top: 1px solid rgb(0, 0, 0); line-height: normal;"><div style="letter-spacing: 0px; top: 0px;;display:inline;"><div style="letter-spacing: 0px; top: 0px;;display:inline;">&#160;</div></div></div></td><td style="background-color: rgba(255, 255, 255, 0);;vertical-align:bottom;"><div style="margin-top: 0pt; margin-bottom: 0pt; border-top: 1px solid rgb(0, 0, 0); line-height: normal;"><div style="letter-spacing: 0px; top: 0px;;display:inline;"><div style="letter-spacing: 0px; top: 0px;;display:inline;">&#160;</div></div></div></td><td style="background-color: rgba(255, 255, 255, 0);"><div style="letter-spacing: 0px; 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font-size: 8pt; page-break-inside: avoid;"><td style="padding-bottom: 0.5pt; font-family: 'times new roman';;vertical-align:bottom;"><div style="letter-spacing: 0px; top: 0px;;display:inline;">&#160;</div></td><td style="padding-bottom: 0.5pt; font-family: 'times new roman';;vertical-align:bottom;"><div style="letter-spacing: 0px; top: 0px;;display:inline;">&#160;&#160;</div></td><td colspan="2" style="border-bottom-color: rgb(0, 0, 0); border-bottom-width: 1pt; border-bottom-style: solid;;text-align:center;;vertical-align:bottom;"><div style="letter-spacing: 0px; top: 0px;;display:inline;"><div style="font-weight:bold;display:inline;">Level&#160;1</div></div></td><td style="padding-bottom: 0.5pt; font-family: 'times new roman';;vertical-align:bottom;"><div style="letter-spacing: 0px; top: 0px;;display:inline;">&#160;</div></td><td style="padding-bottom: 0.5pt; font-family: 'times new roman';;vertical-align:bottom;"><div style="letter-spacing: 0px; top: 0px;;display:inline;">&#160;&#160;</div></td><td colspan="2" style="border-bottom-color: rgb(0, 0, 0); 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margin-top: 0px; margin-bottom: 0px;"><div style="letter-spacing: 0px; top: 0px;;display:inline;"><div style="letter-spacing: 0px; top: 0px;;display:inline;">&#160;</div></div></div></td><td style="padding: 0px; font-family: 'times new roman'; background-color: rgb(255, 255, 255);;vertical-align:bottom;"><div style="letter-spacing: 0px; top: 0px;;display:inline;"><div style="letter-spacing: 0px; top: 0px;;display:inline;">$</div></div></td><td style="padding: 0px 5pt 0px 0px; text-align: right; font-family: 'times new roman'; background-color: rgb(255, 255, 255);;vertical-align:bottom;"><div style="letter-spacing: 0px; top: 0px;;display:inline;">&#8212;</div></td><td style="padding: 0px; font-family: 'times new roman'; background-color: rgb(255, 255, 255);;vertical-align:bottom;"></td><td style="font-family: 'times new roman'; background-color: rgb(255, 255, 255);;vertical-align:bottom;"><div style="line-height: normal; margin-top: 0px; margin-bottom: 0px;"><div style="letter-spacing: 0px; top: 0px;;display:inline;"><div style="letter-spacing: 0px; top: 0px;;display:inline;">&#160;</div></div></div></td><td style="padding: 0px; font-family: 'times new roman'; background-color: rgb(255, 255, 255);;vertical-align:bottom;"><div style="letter-spacing: 0px; top: 0px;;display:inline;"><div style="letter-spacing: 0px; top: 0px;;display:inline;">$</div></div></td><td style="padding: 0px 5pt 0px 0px; text-align: right; font-family: 'times new roman'; background-color: rgb(255, 255, 255);;vertical-align:bottom;"><div style="letter-spacing: 0px; top: 0px;;display:inline;">&#8212;</div></td><td style="padding: 0px; font-family: 'times new roman'; background-color: rgb(255, 255, 255);;vertical-align:bottom;"></td></tr><tr style="font-family: times new roman; font-size: 10pt; page-break-inside: avoid;"><td style="font-size: 10pt; background-color: rgb(204, 238, 255);;vertical-align:top;"><div style="line-height: normal; text-indent: -1em; font-family: 'times new roman'; font-size: 10pt; margin-top: 0px; margin-bottom: 0px; margin-left: 1em;"><div style="letter-spacing: 0px; top: 0px;;display:inline;"><div style="top: 0px; letter-spacing: 0px; font-family: 'times new roman'; font-size: 10pt;;display:inline;"><div style="font-weight:bold;display:inline;">Financial liabilities</div></div></div></div></td><td style="font-family: 'times new roman'; background-color: rgb(204, 238, 255);;vertical-align:bottom;"><div style="letter-spacing: 0px; top: 0px;;display:inline;">&#160;&#160;</div></td><td style="padding: 0px; font-family: 'times new roman'; background-color: rgb(204, 238, 255);;vertical-align:bottom;"></td><td style="padding: 0px; font-family: 'times new roman'; background-color: rgb(204, 238, 255);;vertical-align:bottom;"></td><td style="padding: 0px; font-family: 'times new roman'; background-color: rgb(204, 238, 255);;vertical-align:bottom;"></td><td style="font-family: 'times new roman'; background-color: rgb(204, 238, 255);;vertical-align:bottom;"><div style="letter-spacing: 0px; top: 0px;;display:inline;">&#160;&#160;</div></td><td style="padding: 0px; font-family: 'times new roman'; background-color: rgb(204, 238, 255);;vertical-align:bottom;"></td><td style="padding: 0px; font-family: 'times new roman'; background-color: rgb(204, 238, 255);;vertical-align:bottom;"></td><td style="padding: 0px; font-family: 'times new roman'; background-color: rgb(204, 238, 255);;vertical-align:bottom;"></td><td style="font-family: 'times new roman'; background-color: rgb(204, 238, 255);;vertical-align:bottom;"><div style="letter-spacing: 0px; top: 0px;;display:inline;">&#160;&#160;</div></td><td style="padding: 0px; font-family: 'times new roman'; background-color: rgb(204, 238, 255);;vertical-align:bottom;"></td><td style="padding: 0px; font-family: 'times new roman'; background-color: rgb(204, 238, 255);;vertical-align:bottom;"></td><td style="padding: 0px; font-family: 'times new roman'; background-color: rgb(204, 238, 255);;vertical-align:bottom;"></td></tr><tr style="font-family: times new roman; font-size: 10pt; page-break-inside: avoid;"><td style="font-size: 10pt; background-color: rgb(255, 255, 255);;vertical-align:top;"><div style="line-height: normal; text-indent: -1em; font-family: 'times new roman'; font-size: 10pt; margin-top: 0px; margin-bottom: 0px; margin-left: 3em;"><div style="letter-spacing: 0px; top: 0px;;display:inline;"><div style="top: 0px; letter-spacing: 0px; font-family: 'times new roman'; font-size: 10pt;;display:inline;">Current portion of royalty obligation</div></div></div></td><td style="font-family: 'times new roman'; background-color: rgb(255, 255, 255);;vertical-align:bottom;"><div style="letter-spacing: 0px; top: 0px;;display:inline;">&#160;&#160;</div></td><td style="white-space: nowrap; background-color: rgb(255, 255, 255);;vertical-align:bottom;"><div style="letter-spacing: 0px; top: 0px;;display:inline;"><div style="font-weight:bold;display:inline;">$</div></div></td><td style="padding: 0pt 5pt 0pt 0pt; width: 2%; height: 15px; white-space: nowrap; 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top: 0px;;display:inline;"><div style="font-weight:bold;display:inline;">&#8212;</div></div></td><td style="white-space: nowrap; background-color: rgb(255, 255, 255);;vertical-align:bottom;"><div style="letter-spacing: 0px; top: 0px;;display:inline;"><div style="font-weight:bold;display:inline;">&#160;</div></div></td><td style="font-family: 'times new roman'; background-color: rgb(255, 255, 255);;vertical-align:bottom;"><div style="letter-spacing: 0px; top: 0px;;display:inline;">&#160;&#160;</div></td><td style="background-color: rgb(255, 255, 255);;vertical-align:bottom;"><div style="letter-spacing: 0px; top: 0px;;display:inline;"><div style="font-weight:bold;display:inline;">$</div></div></td><td style="background-color: rgb(255, 255, 255);;text-align:right;;vertical-align:bottom;"><div style="letter-spacing: 0px; top: 0px;;display:inline;"><div style="font-weight:bold;display:inline;">872</div></div></td><td style="white-space: nowrap; background-color: rgb(255, 255, 255);;vertical-align:bottom;"><div style="letter-spacing: 0px; top: 0px;;display:inline;"><div style="font-weight:bold;display:inline;">&#160;</div></div></td></tr><tr style="font-family: times new roman; font-size: 10pt; page-break-inside: avoid;"><td style="font-size: 10pt; background-color: rgb(204, 238, 255);;vertical-align:top;"><div style="line-height: normal; text-indent: -1em; font-family: 'times new roman'; font-size: 10pt; margin-top: 0px; margin-bottom: 0px; margin-left: 3em;"><div style="letter-spacing: 0px; top: 0px;;display:inline;"><div style="top: 0px; letter-spacing: 0px; font-family: 'times new roman'; font-size: 10pt;;display:inline;">Current portion of acquisition payable</div></div></div></td><td style="font-family: 'times new roman'; background-color: rgb(204, 238, 255);;vertical-align:bottom;"><div style="letter-spacing: 0px; top: 0px;;display:inline;">&#160;&#160;</div></td><td style="white-space: nowrap; background-color: rgb(204, 238, 255);;vertical-align:bottom;"><div style="letter-spacing: 0px; top: 0px;;display:inline;"><div style="font-weight:bold;display:inline;">&#160;</div></div></td><td style="padding: 0pt 5pt 0pt 0pt; width: 2%; height: 15px; white-space: nowrap; background-color: rgb(204, 238, 255);;text-align:right;;vertical-align:bottom;"><div style="letter-spacing: 0px; top: 0px;;display:inline;"><div style="font-weight:bold;display:inline;">&#8212;</div></div></td><td style="white-space: nowrap; background-color: rgb(204, 238, 255);;vertical-align:bottom;"><div style="letter-spacing: 0px; top: 0px;;display:inline;"><div style="font-weight:bold;display:inline;">&#160;</div></div></td><td style="font-family: 'times new roman'; background-color: rgb(204, 238, 255);;vertical-align:bottom;"><div style="letter-spacing: 0px; top: 0px;;display:inline;">&#160;&#160;</div></td><td style="white-space: nowrap; background-color: rgb(204, 238, 255);;vertical-align:bottom;"><div style="letter-spacing: 0px; top: 0px;;display:inline;"><div style="font-weight:bold;display:inline;">&#160;</div></div></td><td style="padding: 0pt 5pt 0pt 0pt; width: 3%; height: 15px; white-space: nowrap; background-color: rgb(204, 238, 255);;text-align:right;;vertical-align:bottom;"><div style="letter-spacing: 0px; top: 0px;;display:inline;"><div style="font-weight:bold;display:inline;">&#8212;</div></div></td><td style="white-space: nowrap; background-color: rgb(204, 238, 255);;vertical-align:bottom;"><div style="letter-spacing: 0px; top: 0px;;display:inline;"><div style="font-weight:bold;display:inline;">&#160;</div></div></td><td style="font-family: 'times new roman'; background-color: rgb(204, 238, 255);;vertical-align:bottom;"><div style="letter-spacing: 0px; top: 0px;;display:inline;">&#160;&#160;</div></td><td style="background-color: rgb(204, 238, 255);;vertical-align:bottom;"><div style="letter-spacing: 0px; top: 0px;;display:inline;"><div style="font-weight:bold;display:inline;">&#160;</div></div></td><td style="background-color: rgb(204, 238, 255);;text-align:right;;vertical-align:bottom;"><div style="letter-spacing: 0px; top: 0px;;display:inline;"><div style="font-weight:bold;display:inline;">649</div></div></td><td style="white-space: nowrap; background-color: rgb(204, 238, 255);;vertical-align:bottom;"><div style="letter-spacing: 0px; top: 0px;;display:inline;"><div style="font-weight:bold;display:inline;">&#160;</div></div></td></tr><tr style="font-family: times new roman; font-size: 10pt; page-break-inside: avoid;"><td style="font-size: 10pt; background-color: rgb(255, 255, 255);;vertical-align:top;"><div style="line-height: normal; text-indent: -1em; font-family: 'times new roman'; font-size: 10pt; margin-top: 0px; margin-bottom: 0px; margin-left: 3em;"><div style="letter-spacing: 0px; top: 0px;;display:inline;"><div style="top: 0px; letter-spacing: 0px; font-family: 'times new roman'; font-size: 10pt;;display:inline;">Royalty obligation</div></div></div></td><td style="font-family: 'times new roman'; background-color: rgb(255, 255, 255);;vertical-align:bottom;"><div style="letter-spacing: 0px; top: 0px;;display:inline;">&#160;&#160;</div></td><td style="white-space: nowrap; background-color: rgb(255, 255, 255);;vertical-align:bottom;"><div style="letter-spacing: 0px; top: 0px;;display:inline;"><div style="font-weight:bold;display:inline;">&#160;</div></div></td><td style="padding: 0pt 5pt 0pt 0pt; width: 2%; height: 15px; white-space: nowrap; background-color: rgb(255, 255, 255);;text-align:right;;vertical-align:bottom;"><div style="letter-spacing: 0px; top: 0px;;display:inline;"><div style="font-weight:bold;display:inline;">&#8212;</div></div></td><td style="white-space: nowrap; background-color: rgb(255, 255, 255);;vertical-align:bottom;"><div style="letter-spacing: 0px; top: 0px;;display:inline;"><div style="font-weight:bold;display:inline;">&#160;</div></div></td><td style="font-family: 'times new roman'; background-color: rgb(255, 255, 255);;vertical-align:bottom;"><div style="letter-spacing: 0px; top: 0px;;display:inline;">&#160;&#160;</div></td><td style="white-space: nowrap; background-color: rgb(255, 255, 255);;vertical-align:bottom;"><div style="letter-spacing: 0px; top: 0px;;display:inline;"><div style="font-weight:bold;display:inline;">&#160;</div></div></td><td style="padding: 0pt 5pt 0pt 0pt; width: 3%; height: 15px; white-space: nowrap; background-color: rgb(255, 255, 255);;text-align:right;;vertical-align:bottom;"><div style="letter-spacing: 0px; top: 0px;;display:inline;"><div style="font-weight:bold;display:inline;">&#8212;</div></div></td><td style="white-space: nowrap; background-color: rgb(255, 255, 255);;vertical-align:bottom;"><div style="letter-spacing: 0px; top: 0px;;display:inline;"><div style="font-weight:bold;display:inline;">&#160;</div></div></td><td style="font-family: 'times new roman'; background-color: rgb(255, 255, 255);;vertical-align:bottom;"><div style="letter-spacing: 0px; top: 0px;;display:inline;">&#160;&#160;</div></td><td style="background-color: rgb(255, 255, 255);;vertical-align:bottom;"><div style="letter-spacing: 0px; top: 0px;;display:inline;"><div style="font-weight:bold;display:inline;">&#160;</div></div></td><td style="background-color: rgb(255, 255, 255);;text-align:right;;vertical-align:bottom;"><div style="letter-spacing: 0px; top: 0px;;display:inline;"><div style="font-weight:bold;display:inline;">1,176</div></div></td><td style="white-space: nowrap; background-color: rgb(255, 255, 255);;vertical-align:bottom;"><div style="letter-spacing: 0px; 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When applicable, further information about the assumptions made in determining fair values is disclosed in the notes specific to that asset or liability.</div><div style="font-size: 6pt; margin-top: 0pt; margin-bottom: 0pt;"><div style="font-size: 6pt; letter-spacing: 0px; top: 0px;;display:inline;">&#160;</div></div><table border="0" cellpadding="0" cellspacing="0" style="font-family: &quot;times new roman&quot;; font-size: 10pt; border-collapse: collapse; border-spacing: 0px; table-layout: fixed;;width:100%;"><tr style="page-break-inside: avoid;"><td style="width:4%;">&#160;</td><td style="text-align:left;;vertical-align:top;;width:5%;"><div style="font-weight:bold;display:inline;"><div style="font-style:italic;display:inline;;font-style:italic;display:inline;">(a)</div></div></td><td style="font-size: 10pt;;text-align:left;;vertical-align:top;"><div style="font-family: &quot;times new roman&quot;; font-size: 10pt; margin-top: 0pt; margin-bottom: 0pt; line-height: normal;"><div style="font-family: &quot;times new roman&quot;; font-size: 10pt; letter-spacing: 0px; top: 0px;;display:inline;"><div style="font-weight:bold;display:inline;"><div style="font-style:italic;display:inline;;font-style:italic;display:inline;">Intangible assets </div></div></div></div></td></tr></table><div style="clear: both; max-height: 0px;"></div><div style="clear: both; max-height: 0px;"></div><div style="clear: both; max-height: 0px; background: none;"></div><div style="font-family: times new roman; font-size: 10pt; margin-top: 6pt; margin-bottom: 0pt; margin-left: 9%;"><div style="font-family: &quot;times new roman&quot;; font-size: 10pt; letter-spacing: 0px; top: 0px;;display:inline;">The fair value of intangible assets is based on the discounted cash flows expected to be derived from the use and eventual sale of the assets. </div></div><div style="font-size: 6pt; margin-top: 0pt; margin-bottom: 0pt;">&#160;</div><table border="0" cellpadding="0" cellspacing="0" style="font-family: &quot;times new roman&quot;; font-size: 10pt; border-collapse: collapse; border-spacing: 0px; table-layout: fixed;;width:100%;"><tr style="page-break-inside: avoid;"><td style="width:4%;">&#160;</td><td style="text-align:left;;vertical-align:top;;width:5%;"><div style="display:inline;"><div style="font-weight:bold;display:inline;"><div style="font-style:italic;display:inline;;font-style:italic;display:inline;">(b)</div></div></div></td><td style="font-size: 10pt;;text-align:left;;vertical-align:top;"><div style="font-family: &quot;times new roman&quot;; font-size: 10pt; margin-top: 0pt; margin-bottom: 0pt; line-height: normal;"><div style="display:inline;"><div style="font-family: &quot;times new roman&quot;; font-size: 10pt; letter-spacing: 0px; top: 0px;;display:inline;"><div style="font-weight:bold;display:inline;"><div style="font-style:italic;display:inline;;font-style:italic;display:inline;">Investment in Sensible Medical </div></div></div></div></div></td></tr></table><div style="clear: both; max-height: 0px;"></div><div style="clear: both; max-height: 0px; background: none;"></div><div style="font-family: times new roman; font-size: 10pt; margin-top: 6pt; margin-bottom: 0pt; margin-left: 9%;"><div style="display:inline;"><div style="font-family: &quot;times new roman&quot;; font-size: 10pt; letter-spacing: 0px; top: 0px;;display:inline;">The investment in Sensible Medical is the fair value associated with the Company&#8217;s equity investment in Sensible Medical and is classified as FVOCI. The change in the Investment in Sensible Medical is recorded through other comprehensive (loss) income in the consolidated statement of net (loss) income and comprehensive (loss) income. The investment in Sensible Medical was recorded at fair value at the date at which it was acquired and subsequently revalued at each reporting date. Estimating fair value for this asset requires determining the most appropriate valuation model and determining the most appropriate inputs to the valuation model, including publicly traded companies similar to Sensible Medical to use as a proxy in the valuation model, a discount rate for lack of marketability of the investment and estimated costs to dispose of the investment. </div></div></div><div style="font-size: 6pt; margin-top: 0pt; margin-bottom: 0pt;"><div style="font-size: 6pt; letter-spacing: 0px; top: 0px;;display:inline;">&#160;</div></div><table border="0" cellpadding="0" cellspacing="0" style="font-family: &quot;times new roman&quot;; font-size: 10pt; border-collapse: collapse; border-spacing: 0px; table-layout: fixed;;width:100%;"><tr style="page-break-inside: avoid;"><td style="width:4%;">&#160;</td><td style="text-align:left;;vertical-align:top;;width:5%;"><div style="font-weight:bold;display:inline;"><div style="font-style:italic;display:inline;;font-style:italic;display:inline;">(<div style="display:inline;">c</div>)</div></div></td><td style="font-size: 10pt;;text-align:left;;vertical-align:top;"><div style="font-family: &quot;times new roman&quot;; font-size: 10pt; margin-top: 0pt; margin-bottom: 0pt; line-height: normal;"><div style="font-family: &quot;times new roman&quot;; font-size: 10pt; letter-spacing: 0px; top: 0px;;display:inline;"><div style="font-weight:bold;display:inline;"><div style="font-style:italic;display:inline;;font-style:italic;display:inline;">Share-based payment transactions </div></div></div></div></td></tr></table><div style="clear: both; max-height: 0px;"></div><div style="clear: both; max-height: 0px;"></div><div style="clear: both; max-height: 0px; background: none;"></div><div style="font-family: times new roman; font-size: 10pt; margin-top: 6pt; margin-bottom: 0pt; margin-left: 9%;">The fair value of the employee share options is measured using the <div style="white-space: nowrap; letter-spacing: 0px; top: 0px;;display:inline;">Black-Scholes</div> option pricing model. Measurement inputs include share price on measurement date, exercise price of the instrument, expected volatility (based on weighted average historical volatility adjusted for changes expected due to publicly available information), weighted average expected life of the instruments (based on historical experience and general option holder behavior), expected dividends, and the <div style="white-space: nowrap; letter-spacing: 0px; top: 0px;;display:inline;">risk-free</div> interest rate (based on government bonds). 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Estimating fair value for this liability requires determining the most appropriate valuation model which is dependent on its underlying terms and conditions. This estimate also requires determining expected revenue from AGGRASTAT<div style="font-size: 7.4pt; vertical-align: top; line-height: 5.476pt;;vertical-align: super;font-size: smaller;display:inline;">&#174;</div> sales and an appropriate discount rate and making assumptions about them. </div></div><div style="font-size: 6pt; margin-top: 0pt; margin-bottom: 0pt;"><div style="font-size: 6pt; letter-spacing: 0px; top: 0px;;display:inline;">&#160;</div></div><table border="0" cellpadding="0" cellspacing="0" style="font-family: &quot;times new roman&quot;; font-size: 10pt; border-collapse: collapse; border-spacing: 0px; table-layout: fixed;;width:100%;"><tr style="page-break-inside: avoid;"><td style="width:4%;">&#160;</td><td style="text-align:left;;vertical-align:top;;width:5%;"><div style="font-weight:bold;display:inline;"><div style="font-style:italic;display:inline;;font-style:italic;display:inline;">(<div style="display:inline;">e</div>)</div></div></td><td style="font-size: 10pt;;text-align:left;;vertical-align:top;"><div style="font-family: &quot;times new roman&quot;; font-size: 10pt; margin-top: 0pt; margin-bottom: 0pt; line-height: normal;"><div style="font-family: &quot;times new roman&quot;; font-size: 10pt; letter-spacing: 0px; top: 0px;;display:inline;"><div style="font-weight:bold;display:inline;"><div style="font-style:italic;display:inline;;font-style:italic;display:inline;">Acquisition payable </div></div></div></div></td></tr></table><div style="clear: both; max-height: 0px;"></div><div style="clear: both; max-height: 0px;"></div><div style="clear: both; max-height: 0px; background: none;"></div><div style="font-family: times new roman; font-size: 10pt; margin-top: 6pt; margin-bottom: 0pt; margin-left: 9%;"><div style="font-family: &quot;times new roman&quot;; font-size: 10pt; letter-spacing: 0px; top: 0px;;display:inline;">The acquisition payable is recorded at its fair value at the date at which the liability was incurred and subsequently measured at amortized cost using the effective interest rate method at each reporting date. Estimating fair value for this liability requires determining the most appropriate valuation model which is dependent on its underlying terms and conditions. This estimate also requires determining an appropriate discount rate and making assumptions about it. </div></div><div style="font-size: 6pt; margin-top: 0pt; margin-bottom: 0pt;"><div style="font-size: 6pt; letter-spacing: 0px; top: 0px;;display:inline;">&#160;</div></div><table border="0" cellpadding="0" cellspacing="0" style="font-family: &quot;times new roman&quot;; font-size: 10pt; border-collapse: collapse; border-spacing: 0px; table-layout: fixed;;width:100%;"><tr style="page-break-inside: avoid;"><td style="width:4%;">&#160;</td><td style="text-align:left;;vertical-align:top;;width:5%;"><div style="font-weight:bold;display:inline;"><div style="font-style:italic;display:inline;;font-style:italic;display:inline;">(<div style="display:inline;">f</div>)</div></div></td><td style="font-size: 10pt;;text-align:left;;vertical-align:top;"><div style="font-family: &quot;times new roman&quot;; font-size: 10pt; margin-top: 0pt; margin-bottom: 0pt; line-height: normal;"><div style="font-family: &quot;times new roman&quot;; font-size: 10pt; letter-spacing: 0px; top: 0px;;display:inline;"><div style="font-weight:bold;display:inline;"><div style="font-style:italic;display:inline;;font-style:italic;display:inline;">Holdback receivable </div></div></div></div></td></tr></table><div style="clear: both; max-height: 0px;"></div><div style="clear: both; max-height: 0px;"></div><div style="clear: both; max-height: 0px; background: none;"></div><div style="font-family: times new roman; font-size: 10pt; margin-top: 6pt; margin-bottom: 0pt; margin-left: 9%;"><div style="font-family: &quot;times new roman&quot;; font-size: 10pt; letter-spacing: 0px; top: 0px;;display:inline;">The holdback receivable was recorded at its fair value at the date of acquisition and subsequently measured at fair value at each reporting date. Estimating fair value for this asset required determining the most appropriate valuation model which is dependent on its underlying terms and conditions. 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(&#8220;Sensible&#8221;), and concurrently entered into an exclusive marketing and distribution agreement with Sensible to <div style="display:inline;">m</div></div><div style="letter-spacing: 0px; top: 0px;;display:inline;"><div style="font-family: &quot;times new roman&quot;; font-size: 10pt; letter-spacing: 0px; top: 0px;;display:inline;">arket ReDS<div style="font-size: 7.4pt; vertical-align: top; line-height: 5.476pt;;vertical-align: super;font-size: smaller;display:inline;">&#8482;</div></div></div><div style="font-family: &quot;times new roman&quot;; font-size: 10pt; letter-spacing: 0px; top: 0px;;display:inline;"> in the United States. 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top: 0px;;display:inline;"><div style="font-weight:bold;display:inline;">&#8212;</div></div></td><td style="white-space: nowrap; background-color: rgb(255, 255, 255);;vertical-align:bottom;"><div style="letter-spacing: 0px; top: 0px;;display:inline;"><div style="font-weight:bold;display:inline;">&#160;</div></div></td><td style="font-family: 'times new roman'; background-color: rgb(255, 255, 255);;vertical-align:bottom;"><div style="letter-spacing: 0px; top: 0px;;display:inline;">&#160;&#160;</div></td><td style="background-color: rgb(255, 255, 255);;vertical-align:bottom;"><div style="letter-spacing: 0px; top: 0px;;display:inline;"><div style="font-weight:bold;display:inline;">$</div></div></td><td style="background-color: rgb(255, 255, 255);;text-align:right;;vertical-align:bottom;"><div style="letter-spacing: 0px; top: 0px;;display:inline;"><div style="font-weight:bold;display:inline;">872</div></div></td><td style="white-space: nowrap; background-color: rgb(255, 255, 255);;vertical-align:bottom;"><div style="letter-spacing: 0px; 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top: 0px;;display:inline;"><div style="font-weight:bold;display:inline;">&#8212;</div></div></td><td style="white-space: nowrap; background-color: rgb(204, 238, 255);;vertical-align:bottom;"><div style="letter-spacing: 0px; top: 0px;;display:inline;"><div style="font-weight:bold;display:inline;">&#160;</div></div></td><td style="font-family: 'times new roman'; background-color: rgb(204, 238, 255);;vertical-align:bottom;"><div style="letter-spacing: 0px; top: 0px;;display:inline;">&#160;&#160;</div></td><td style="background-color: rgb(204, 238, 255);;vertical-align:bottom;"><div style="letter-spacing: 0px; top: 0px;;display:inline;"><div style="font-weight:bold;display:inline;">&#160;</div></div></td><td style="background-color: rgb(204, 238, 255);;text-align:right;;vertical-align:bottom;"><div style="letter-spacing: 0px; top: 0px;;display:inline;"><div style="font-weight:bold;display:inline;">649</div></div></td><td style="white-space: nowrap; background-color: rgb(204, 238, 255);;vertical-align:bottom;"><div style="letter-spacing: 0px; 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width: 2%; height: 15px; white-space: nowrap; background-color: rgb(255, 255, 255);;text-align:right;;vertical-align:bottom;"><div style="letter-spacing: 0px; top: 0px;;display:inline;"><div style="font-weight:bold;display:inline;">&#8212;</div></div></td><td style="white-space: nowrap; background-color: rgb(255, 255, 255);;vertical-align:bottom;"><div style="letter-spacing: 0px; top: 0px;;display:inline;"><div style="font-weight:bold;display:inline;">&#160;</div></div></td><td style="font-family: 'times new roman'; background-color: rgb(255, 255, 255);;vertical-align:bottom;"><div style="letter-spacing: 0px; top: 0px;;display:inline;">&#160;&#160;</div></td><td style="white-space: nowrap; background-color: rgb(255, 255, 255);;vertical-align:bottom;"><div style="letter-spacing: 0px; top: 0px;;display:inline;"><div style="font-weight:bold;display:inline;">&#160;</div></div></td><td style="padding: 0pt 5pt 0pt 0pt; width: 3%; height: 15px; white-space: nowrap; background-color: rgb(255, 255, 255);;text-align:right;;vertical-align:bottom;"><div style="letter-spacing: 0px; top: 0px;;display:inline;"><div style="font-weight:bold;display:inline;">&#8212;</div></div></td><td style="white-space: nowrap; background-color: rgb(255, 255, 255);;vertical-align:bottom;"><div style="letter-spacing: 0px; top: 0px;;display:inline;"><div style="font-weight:bold;display:inline;">&#160;</div></div></td><td style="font-family: 'times new roman'; background-color: rgb(255, 255, 255);;vertical-align:bottom;"><div style="letter-spacing: 0px; top: 0px;;display:inline;">&#160;&#160;</div></td><td style="background-color: rgb(255, 255, 255);;vertical-align:bottom;"><div style="letter-spacing: 0px; top: 0px;;display:inline;"><div style="font-weight:bold;display:inline;">&#160;</div></div></td><td style="background-color: rgb(255, 255, 255);;text-align:right;;vertical-align:bottom;"><div style="letter-spacing: 0px; top: 0px;;display:inline;"><div style="font-weight:bold;display:inline;">1,176</div></div></td><td style="white-space: nowrap; background-color: rgb(255, 255, 255);;vertical-align:bottom;"><div style="letter-spacing: 0px; 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width: 2%; height: 15px; white-space: nowrap; background-color: rgb(204, 238, 255);;text-align:right;;vertical-align:bottom;"><div style="letter-spacing: 0px; top: 0px;;display:inline;"><div style="font-weight:bold;display:inline;">&#8212;</div></div></td><td style="white-space: nowrap; background-color: rgb(204, 238, 255);;vertical-align:bottom;"><div style="letter-spacing: 0px; top: 0px;;display:inline;"><div style="font-weight:bold;display:inline;">&#160;</div></div></td><td style="font-family: 'times new roman'; background-color: rgb(204, 238, 255);;vertical-align:bottom;"><div style="letter-spacing: 0px; top: 0px;;display:inline;">&#160;&#160;</div></td><td style="white-space: nowrap; background-color: rgb(204, 238, 255);;vertical-align:bottom;"><div style="letter-spacing: 0px; top: 0px;;display:inline;"><div style="font-weight:bold;display:inline;">&#160;</div></div></td><td style="padding: 0pt 5pt 0pt 0pt; width: 3%; height: 15px; white-space: nowrap; background-color: rgb(204, 238, 255);;text-align:right;;vertical-align:bottom;"><div style="letter-spacing: 0px; top: 0px;;display:inline;"><div style="font-weight:bold;display:inline;">&#8212;</div></div></td><td style="white-space: nowrap; background-color: rgb(204, 238, 255);;vertical-align:bottom;"><div style="letter-spacing: 0px; top: 0px;;display:inline;"><div style="font-weight:bold;display:inline;">&#160;</div></div></td><td style="font-family: 'times new roman'; background-color: rgb(204, 238, 255);;vertical-align:bottom;"><div style="letter-spacing: 0px; top: 0px;;display:inline;">&#160;&#160;</div></td><td style="background-color: rgb(204, 238, 255);;vertical-align:bottom;"><div style="letter-spacing: 0px; top: 0px;;display:inline;"><div style="font-weight:bold;display:inline;">&#160;</div></div></td><td style="background-color: rgb(204, 238, 255);;text-align:right;;vertical-align:bottom;"><div style="letter-spacing: 0px; top: 0px;;display:inline;"><div style="font-weight:bold;display:inline;">1,655</div></div></td><td style="white-space: nowrap; background-color: rgb(204, 238, 255);;vertical-align:bottom;"><div style="letter-spacing: 0px; 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border-top-style: double;"><div style="letter-spacing: 0px; top: 0px;;display:inline;"><div style="top: 0px; letter-spacing: 0px;;display:inline;">&#160;</div></div></div></td><td style="font-family: 'times new roman'; background-color: rgb(255, 255, 255);"><div style="letter-spacing: 0px; top: 0px;;display:inline;">&#160;</div></td><td style="font-family: 'times new roman'; background-color: rgb(255, 255, 255);;vertical-align:bottom;"><div style="letter-spacing: 0px; top: 0px;;display:inline;">&#160;&#160;</div></td><td style="background-color: rgb(255, 255, 255);;vertical-align:bottom;"><div style="line-height: normal; margin-top: 0px; margin-bottom: 0px; border-top-color: rgb(0, 0, 0); border-top-width: 3px; border-top-style: double;"><div style="letter-spacing: 0px; top: 0px;;display:inline;"><div style="top: 0px; letter-spacing: 0px;;display:inline;">&#160;</div></div></div></td><td style="background-color: rgb(255, 255, 255);;vertical-align:bottom;"><div style="line-height: normal; 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The Investment in Sensible Medical was classified within this category. </div></div></div><div style="font-family: times new roman; font-size: 10pt; margin-top: 6pt; margin-bottom: 0pt; margin-left: 9%;"><div style="letter-spacing: 0px; top: 0px;;display:inline;"><div style="font-family: &quot;times new roman&quot;; font-size: 10pt; letter-spacing: 0px; top: 0px;;display:inline;">(ii) Derecognition </div></div></div><div style="font-family: times new roman; font-size: 10pt; margin-top: 6pt; margin-bottom: 0pt; margin-left: 9%;"><div style="font-family: &quot;times new roman&quot;; font-size: 10pt; letter-spacing: 0px; top: 0px;;display:inline;">A financial asset or, where applicable a part of a financial asset or part of a group of similar financial assets is derecognized when the contractual rights to receive cash flows from the asset have expired; or the Company has transferred its rights to receive cash flows from the asset or has assumed an obligation to pay the received cash flows in full without material delay to a third party under a &#8216;pass-through&#8217; arrangement; and either (a)&#160;the Company has transferred substantially all the risks and rewards of the asset, or (b)&#160;the Company has neither transferred nor retained substantially all the risks and rewards of the asset, but has transferred control of the asset. </div></div><div style="font-family: times new roman; font-size: 10pt; margin-top: 6pt; margin-bottom: 0pt; margin-left: 9%;"><div style="font-family: &quot;times new roman&quot;; font-size: 10pt; letter-spacing: 0px; top: 0px;;display:inline;">(iii) Financial liabilities </div></div><div style="font-family: times new roman; font-size: 10pt; margin-top: 6pt; margin-bottom: 0pt; margin-left: 9%;"><div style="font-family: &quot;times new roman&quot;; font-size: 10pt; letter-spacing: 0px; top: 0px;;display:inline;">Initial recognition and measurement </div></div><div style="font-family: times new roman; font-size: 10pt; margin-top: 6pt; margin-bottom: 0pt; margin-left: 9%;"><div style="font-family: &quot;times new roman&quot;; font-size: 10pt; letter-spacing: 0px; top: 0px;;display:inline;">The Company recognizes a financial liability on the trade date in which it becomes a party to the contractual provisions of the instrument at fair value plus any directly attributable costs. 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This estimate also required determining expected revenue from AGGRASTAT<div style="font-size: 7.4pt; vertical-align: top; line-height: 5.476pt;;vertical-align: super;font-size: smaller;display:inline;">&#174;</div> sales and an appropriate discount rate and making assumptions about them. </div></div><div style="font-family: times new roman; font-size: 10pt; margin-top: 6pt; margin-bottom: 0pt; margin-left: 9%;"><div style="font-family: &quot;times new roman&quot;; font-size: 10pt; letter-spacing: 0px; top: 0px;;display:inline;">The acquisition payable was recorded at its fair value at the date at which the liability was incurred and subsequently measured at amortized cost using the effective interest rate method at each reporting date. Estimating fair value for this liability required determining an appropriate discount rate. </div></div><div style="font-family: times new roman; font-size: 10pt; margin-top: 6pt; margin-bottom: 0pt; margin-left: 9%;"><div style="font-family: &quot;times new roman&quot;; font-size: 10pt; letter-spacing: 0px; top: 0px;;display:inline;">(iv) Offsetting of financial instruments </div></div><div style="font-family: times new roman; font-size: 10pt; margin-top: 6pt; margin-bottom: 0pt; margin-left: 9%;"><div style="font-family: &quot;times new roman&quot;; font-size: 10pt; letter-spacing: 0px; top: 0px;;display:inline;">Financial assets and financial liabilities are offset, and the net amount reported in the statement of financial position if, and only if, there is a currently enforceable legal right to offset the recognized amounts and there is an intention to settle on a net basis, or to realize the assets and settle the liabilities simultaneously. </div></div><div style="font-family: times new roman; font-size: 10pt; margin-top: 6pt; margin-bottom: 0pt; margin-left: 9%;"><div style="font-family: &quot;times new roman&quot;; font-size: 10pt; letter-spacing: 0px; top: 0px;;display:inline;">(v) Fair value of financial instruments </div></div><div style="font-family: times new roman; font-size: 10pt; margin-top: 6pt; margin-bottom: 0pt; margin-left: 9%;"><div style="font-family: &quot;times new roman&quot;; font-size: 10pt; letter-spacing: 0px; top: 0px;;display:inline;">Fair value is determined based on the price that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants. Fair value is measured using the assumptions that market participants would use when pricing an asset or liability. Typically, fair value is determined by using quoted prices in active markets for identical or similar assets or liabilities. When quoted prices in active markets are not available, fair value is determined using valuation techniques that maximize the use of observable inputs. When observable valuation inputs are not available, significant judgement is required through determining the valuation technique to apply, the valuation techniques such as discounted cash flow analysis and selecting inputs. 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An embedded derivative causes some or all of the cash flows that otherwise would be required by the contract to be modified according to a specified interest rate, financial instrument price, commodity price, foreign exchange rate, index of prices or rates, a credit rating or credit index, or other variable, provided in the case of a <div style="white-space: nowrap; letter-spacing: 0px; top: 0px;;display:inline;">non-financial</div> variable that the variable is not specific to a party to the contract. 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An estimate is made to determine the present value of future cash flows associated with the asset, and if required, an impairment loss is recorded. The impairment loss reduces the carrying value of the impaired financial asset to the value of the estimated present value of the future cash flows associated with the asset, discounted at the financial asset&#8217;s original effective interest rate is recorded either directly or through the use of an allowance account and the resulting impairment loss is recorded in profit or loss. </div></div><div style="font-family: times new roman; font-size: 10pt; margin-top: 6pt; margin-bottom: 0pt; margin-left: 9%;"><div style="font-family: &quot;times new roman&quot;; font-size: 10pt; letter-spacing: 0px; top: 0px;;display:inline;">Impairment losses on financial assets carried at amortized cost are reversed in subsequent periods if the amount of the loss decreases and the decrease can be related objectively to an event occurring after the impairment was recognized. </div></div> <div style="font-size: 6pt; margin-top: 0pt; margin-bottom: 0pt;"><div style="font-size: 6pt; letter-spacing: 0px; top: 0px;;display:inline;">&#160;</div></div> <table border="0" cellpadding="0" cellspacing="0" style="font-family: &quot;times new roman&quot;; font-size: 10pt; border-spacing: 0px; table-layout: fixed;;width:100%;"><tr style="page-break-inside: avoid;"><td style="width:4%;">&#160;</td><td style="text-align:left;;vertical-align:top;;width:5%;"><div style="font-weight:bold;display:inline;"><div style="font-style:italic;display:inline;;font-style:italic;display:inline;">(e)</div></div></td><td style="font-size: 10pt;;text-align:left;;vertical-align:top;"><div style="font-family: &quot;times new roman&quot;; font-size: 10pt; margin-top: 0pt; margin-bottom: 0pt; line-height: normal;"><div style="font-family: &quot;times new roman&quot;; font-size: 10pt; letter-spacing: 0px; top: 0px;;display:inline;"><div style="font-weight:bold;display:inline;"><div style="font-style:italic;display:inline;;font-style:italic;display:inline;">Revenue from contracts with customers</div></div> </div></div></td></tr></table><div style="clear: both; max-height: 0px;"></div><div style="clear: both; max-height: 0px;"></div><div style="clear: both; max-height: 0px;"></div><div style="clear: both; max-height: 0px;"></div><div style="clear: both; max-height: 0px;"></div><div style="clear: both; max-height: 0px;"></div><div style="clear: both; max-height: 0px;"></div><div style="clear: both; max-height: 0px;"></div><div style="clear: both; max-height: 0px; background: none;"></div><div style="font-family: times new roman; font-size: 10pt; margin-top: 6pt; margin-bottom: 0pt; margin-left: 9%;"><div style="letter-spacing: 0px; top: 0px;;display:inline;"><div style="font-family: &quot;times new roman&quot;; font-size: 10pt; letter-spacing: 0px; top: 0px;;display:inline;">The Company has three commercially available products that generated revenue for the year ended December&#160;31, 2019, AGGRASTAT<div style="font-size: 7.4pt; vertical-align: top; line-height: 5.476pt;;vertical-align: super;font-size: smaller;display:inline;">&#174;</div>, ZYPITAMAG<div style="font-size: 7.4pt; vertical-align: top; line-height: 5.476pt;;vertical-align: super;font-size: smaller;display:inline;">&#8482;</div> and ReDS<div style="font-size: 7.4pt; vertical-align: top; line-height: 5.476pt;;vertical-align: super;font-size: smaller;display:inline;">TM </div>(the &#8220;<div style="font-weight:bold;display:inline;">Products</div>&#8221;) which it sells to United States customers. 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A liability is included within accounts payable and accrued liabilities and is measured for expected payments that will be made to the customers for the discounts in which they are entitled. 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Current taxes and deferred taxes are recognized in profit or loss except to the extent that they relate to a business combination, or items recognized directly in equity or in other comprehensive income. </div></div><div style="font-family: times new roman; font-size: 10pt; margin-top: 6pt; margin-bottom: 0pt; margin-left: 9%;"><div style="font-family: &quot;times new roman&quot;; font-size: 10pt; letter-spacing: 0px; top: 0px;;display:inline;">Current taxes are the expected tax receivable or payable on the taxable income or loss for the year, using tax rates enacted or substantively enacted at the reporting date, and any adjustment to tax receivable or payable in respect of previous years. </div></div><div style="font-family: times new roman; font-size: 10pt; margin-top: 6pt; margin-bottom: 0pt; margin-left: 9%;"><div style="font-family: &quot;times new roman&quot;; font-size: 10pt; letter-spacing: 0px; top: 0px;;display:inline;">The Company follows the liability method of accounting for deferred taxes. Under this method, deferred taxes are recognized in respect of temporary differences between the carrying amounts of assets and liabilities for financial reporting purposes and the amounts used for taxation purposes. Deferred taxes are not recognized for the following temporary differences: the initial recognition of assets or liabilities in a transaction that is not a business combination and that affects neither accounting nor taxable profit or loss, and differences relating to investments in subsidiaries and jointly controlled entities to the extent that it is probable that they will not reverse in the foreseeable future. In addition, deferred taxes are not recognized for taxable temporary differences arising on the initial recognition of goodwill. Deferred taxes are measured at the tax rates that are expected to be applied to temporary differences when they reverse, based on the tax laws that have been enacted or substantively enacted by the reporting date. Deferred tax assets and liabilities are offset if there is a legally enforceable right to offset current tax assets and liabilities, and they relate to income taxes levied by the same tax authority on the same taxable entity, or on different tax entities, but they intend to settle current tax assets and liabilities on a net basis or their tax assets and liabilities will be realized simultaneously. </div></div><div style="font-family: times new roman; font-size: 10pt; margin-top: 6pt; margin-bottom: 0pt; margin-left: 9%;"><div style="font-family: &quot;times new roman&quot;; font-size: 10pt; letter-spacing: 0px; top: 0px;;display:inline;">A deferred tax asset is recognized for unused tax losses, tax credits and deductible temporary differences, to the extent that it is probable that future taxable profits will be available against which they can be utilized. 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Additional guidance and interpretations can be expected and such guidance, if any, could impact future results. While management continues to monitor these matters, the ultimate impact, if any, as a result of the application of any guidance issued in the future cannot be determined at this time. </div></div><div style="font-family: times new roman; font-size: 10pt; margin-top: 6pt; margin-bottom: 0pt; margin-left: 9%;"><div style="font-family: &quot;times new roman&quot;; font-size: 10pt; letter-spacing: 0px; top: 0px;;display:inline;">The Company and its subsidiaries file federal income tax returns in Canada, the United States, Barbados and other foreign jurisdictions, as well as various provinces and states in Canada and the United States<div style="letter-spacing: 0px; top: 0px;;display:inline;">, respectively</div>. 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Although management currently believes there are no claims or possible claims that if resolved would either individually or collectively result in a material adverse impact on the Company&#8217;s financial position, results of operations, or cash flows, these matters are inherently uncertain and management&#8217;s view of these matters may change in the future. </div></div><div style="font-family: times new roman; font-size: 10pt; margin-top: 6pt; margin-bottom: 0pt; margin-left: 9%;"><div style="font-family: &quot;times new roman&quot;; font-size: 10pt; letter-spacing: 0px; top: 0px;;display:inline;">During 2018, the Company was named in a civil claim in Florida from the third-party manufacturer of PREXXARTAN<div style="font-size: 7.4pt; vertical-align: top; line-height: 5.476pt;;vertical-align: super;font-size: smaller;display:inline;">&#174;</div>&#160;against the licensor. 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The label change is being reviewed and evaluated based substantially on data from published studies. If the label change submission were to be successful, the Company will be obligated to pay &#8364;300 over the course of a three-year period in equal quarterly instalments following approval. 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XML 19 R41.htm IDEA: XBRL DOCUMENT v3.20.1
Expenses by nature (Tables)
12 Months Ended
Dec. 31, 2019
Expenses by nature [abstract]  
Schedule of expenses incurred
 
Year ended December 31
  
2019
   2018   2017 
Personnel expenses
      
Salaries, fees and short-term benefits
  
$
6,394
 
  $7,696   $5,904 
Share-based
payments
  
 
417
 
   1,022    491 
  
 
 
   
 
 
   
 
 
 
  
 
6,811
 
   8,718    6,395 
Depreciation, amortization and impairment
  
 
2,017
 
   299    98 
Research and development
  
 
2,887
 
   5,306    3,539 
Manufacturing
  
 
752
 
   765    955 
Inventory material costs
  
 
3,851
 
   3,862    3,079 
Write-down of inventory
  
 
1,983
 
   95    385 
Medical affairs
  
 
718
 
   1,026    1,108 
Administration
  
 
821
 
   1,505    1,725 
Selling and logistics
  
 
6,997
 
   8,019    5,395 
Professional fees
  
 
1,578
 
   740    802 
  
 
 
   
 
 
   
 
 
 
  
$
28,415
 
  $30,335   $23,481 
  
 
 
   
 
 
   
 
 
 
XML 20 R45.htm IDEA: XBRL DOCUMENT v3.20.1
New standards and interpretations (Detail Textuals) - CAD ($)
$ in Thousands
Nov. 01, 2019
Nov. 01, 2014
Dec. 31, 2019
Jan. 01, 2019
Nov. 01, 2018
Disclosure of initial application of standards or interpretations [line items]          
Discount rate used in lease obligations       0.00%  
Lease obligation     $ 1,089    
Current lease obligation     240    
Sublease Agreement With Gvi [Member]          
Disclosure of initial application of standards or interpretations [line items]          
Term of agreement 3 years 3 years      
Sublease rent upto 30th April, 2016     170    
Sublease rent from 1st May, 2016     $ 212   $ 306
Reduced sublease rent per annum $ 238        
Increase in right of use asset $ 685        
XML 21 R49.htm IDEA: XBRL DOCUMENT v3.20.1
Discontinued operations (Details 1) - Apicore - CAD ($)
$ in Thousands
12 Months Ended
Dec. 31, 2019
Dec. 31, 2018
Dec. 31, 2017
Disclosure Of Detailed Information Discontinued Operations [Line Items]      
Net cash flows from operating activities $ 5,210
Net cash flows from investing activities 54,326
Net cash flows used in financing activities (80,944)
Net cash flows used in discontinued operations $ (21,408)
XML 22 R96.htm IDEA: XBRL DOCUMENT v3.20.1
Segmented information (Detail Textuals 1) - Customer
12 Months Ended
Dec. 31, 2019
Dec. 31, 2018
Dec. 31, 2017
Disclosure of operating segments [line items]      
Percentage of total revenue 100.00% 100.00% 100.00%
Number of customers 13 8 9
Number of remaining customers accounted for less than 1% revenue 10 5 5
Customer A      
Disclosure of operating segments [line items]      
Percentage of total revenue 38.00% 33.00% 33.00%
Customer B      
Disclosure of operating segments [line items]      
Percentage of total revenue 28.00% 28.00% 30.00%
Customer C      
Disclosure of operating segments [line items]      
Percentage of total revenue 28.00% 33.00% 30.00%
Customer D      
Disclosure of operating segments [line items]      
Percentage of total revenue 6.00% 6.00% 6.00%
XML 23 R66.htm IDEA: XBRL DOCUMENT v3.20.1
Capital Stock (Details 4)
12 Months Ended
Dec. 31, 2019
shares
$ / shares
Dec. 31, 2018
shares
$ / shares
Dec. 31, 2017
shares
$ / shares
Warrants      
Balance, beginning of period | shares 900,000 900,000 941,969
Exercised | shares (41,969)
Balance, end of period | shares 900,000 900,000 900,000
Warrants exercisable, end of period | shares 900,000 900,000 900,000
Weighted average exercise price      
Balance, beginning of period | $ / shares $ 6.50 $ 6.50 $ 6.31
Exercised | $ / shares (2.20)
Balance, end of period | $ / shares 6.50 6.50 6.50
Warrants exercisable, end of period | $ / shares $ 6.50 $ 6.50 $ 6.50
XML 24 R62.htm IDEA: XBRL DOCUMENT v3.20.1
Capital Stock (Details) - CAD ($)
12 Months Ended
Dec. 20, 2019
May 30, 2019
Dec. 31, 2019
Dec. 31, 2018
Dec. 31, 2017
Number of common shares          
Shares repurchased and cancelled under a normal course issuer bid   (421,300) (751,800) (441,400)  
Shares repurchased and cancelled under a substantial issuer bid 4,000,000        
Amount of common shares          
Balance     $ 83,594,000 $ 80,709,000 $ 38,284,000
Shares issued upon exercise of stock options     20,000 363,000 520,000
Balance     $ 26,942,000 $ 83,594,000 $ 80,709,000
Shares repurchased and cancelled under a substantial issuer bid $ 26,000,000        
Share Capital          
Number of common shares          
Balance     15,547,812 15,782,327  
Shares issued upon exercise of stock options     8,001 206,885  
Shares repurchased and cancelled under a normal course issuer bid [1]     (751,800) (441,400)  
Balance     10,804,013 15,547,812 15,782,327
Shares repurchased and cancelled under a substantial issuer bid [2]     (4,000,000)    
Amount of common shares          
Balance     $ 122,887,000 $ 125,734,000 $ 124,700,000
Shares issued upon exercise of stock options     37,000 654,000 870,000
Shares repurchased and cancelled under a normal course issuer bid [1]     (5,955,000) (3,501,000)  
Balance     85,364,000 $ 122,887,000 $ 125,734,000
Shares repurchased and cancelled under a substantial issuer bid [2]     $ (31,605,000)    
[1] On May 16, 2018, the Company announced that the TSX-V accepted the Company’s notice of its intention to make a normal course issuer bid (the “2018 NCIB”). Under the terms of the 2018 NCIB, the Company could have acquired up to an aggregate of 794,088 common shares, representing five percent of the common shares outstanding at the time of the application, over the twelve-month period that the 2018 NCIB was in place. The 2018 NCIB commenced on May 28, 2018 and ended on May 27, 2019. During the twelve months of the 2018 NCIB, the Company purchased and cancelled 771,900 common shares for a total cost of $5,085. The prices that the Company paid for the common shares purchased was the market price of the shares at the time of purchase.
[2] On December 20, 2019, the Company completed a Substantial Issuer Bid (“SIB”) pursuant to which the Company purchased 4,000,000 of its common shares for cancellation at a set purchase price of $6.50 per common share for a total purchase price of $26,000 in cash. The Company incurred an additional $138 on transaction costs related to the SIB for a total aggregate purchase price paid of $26,138. During the year ended December 31, 2019, the Company recorded $5,466 directly in its retained deficit representing the difference between the aggregate price paid for these common shares and a reduction of the Company’s share capital totaling $31,605.
XML 25 R92.htm IDEA: XBRL DOCUMENT v3.20.1
Financial instruments (Details 2)
$ in Thousands, $ in Thousands
Dec. 31, 2019
CAD ($)
Dec. 31, 2019
USD ($)
Dec. 05, 2019
CAD ($)
Dec. 31, 2018
CAD ($)
Dec. 31, 2018
USD ($)
Disclosure of nature and extent of risks arising from financial instruments [line items]          
Accounts receivable $ 10,216     $ 10,765  
Holdback receivable     $ 3,623 11,909  
Other assets 39     117  
Accounts payable and accrued liabilities (9,384)     (14,377)  
Income taxes payable (517)     (1,058)  
Current portion of royalty obligation (872)     (1,496)  
Current portion of acquisition payable (649)        
Royalty obligation (1,176)     $ (2,035)  
Acquisition payable $ (1,655)        
U.S. dollar currency risk          
Disclosure of nature and extent of risks arising from financial instruments [line items]          
Cash   $ 9,518     $ 17,428
Short-term investments   0     35,000
Accounts receivable   7,817     7,725
Holdback receivable   0     8,730
Other assets   30     0
Accounts payable and accrued liabilities   (6,714)     (9,903)
Income taxes payable   (398)     (776)
Current portion of royalty obligation   (671)     (1,096)
Current portion of acquisition payable   (500)     0
Royalty obligation   (906)     (1,492)
Acquisition payable   (1,275)     0
Other long-term liability   0     (880)
Derivative financial assets liabilities   $ 6,901     $ 54,736
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Significant accounting policies (Policies)
12 Months Ended
Dec. 31, 2019
Disclosure Of Significant Accounting Policies [Abstract]  
Basis of consolidation
 
(a)
Basis of consolidation
These consolidated financial statements include the accounts of the Company and its subsidiaries. Subsidiaries are entities controlled by the Company. Control exists when the Company has power over the investee and when the Company is exposed, or has the rights, to variable returns from the investee. Subsidiaries are included in the consolidated financial results of the Company from the effective date of acquisition up to the effective date of disposition or loss of control and include wholly owned subsidiaries, Medicure International Inc., Medicure Pharma Inc., Medicure U.S.A. Inc., Medicure Mauritius Limited, Medicure Pharma Europe Limited and Apigen Investments Limited. Additionally, the December 31, 2017 comparative figures include, from the date of acquisition (note 5), the accounts of subsidiaries that are controlled by the Company including, Apicore Inc., Apicore US LLC, Apicore LLC and Apicore Pharmaceuticals Private Limited. These additional subsidiaries were classified as discontinued operations for 2017 and Apicore Inc. and Apicore US LLC were sold during 2017 as described in note 5. The financial statements of the subsidiaries are prepared for the same reporting period as the parent company, using consistent accounting policies. All intercompany transactions and balances and unrealized gains and losses from intercompany transactions have been eliminat
e
d.
 
Foreign currency
 
(b)
Foreign currency
Items included in the financial statements of each of the Company’s consolidated subsidiaries are measured using the currency of the primary economic environment in which the subsidiary operates (the functional currency). The consolidated financial statements are presented in Canadian dollars, which is the Company’s functional and presentation currency.
Foreign currency transactions are translated into the respective functional currencies of the Company and its subsidiaries using the exchange rates prevailing at the dates of the transactions. Foreign exchange gains and losses resulting from the settlement of such transactions and from the translation at
period-end
exchange rates of monetary assets and liabilities denominated in foreign currencies are recognized in profit or loss.
Non-monetary
items that are not carried at fair value are translated using the exchange rates as at the date of the initial transaction.
Non-monetary
items measured at fair value in a foreign currency are translated using the exchange rates at the date
 
when the fair value is determined.
The results and financial position of the Company’s foreign operations that have a functional currency different from the Company’s functional and presentation currency are translated into Canadian dollars as follows:
(i)
assets and liabilities of foreign operations are translated at the closing rate at the date of the consolidated statement of financial position;
(ii)
revenue and expenses of foreign operations for each year are translated at average exchange rates (unless this is not a reasonable approximation of the cumulative effect of the rates prevailing on the transaction dates, in which case revenue and expenses are translated at the dates of the transactions); and
(iii)
all resulting exchange differences for foreign operations are recognized in other comprehensive income in the cumulative translation account.
When a foreign operation is disposed of, the component of other comprehensive income relating to that particular foreign operation is recognized in the consolidated statements of net income and comprehensive income, as part of the gain or loss on sale where applicable.
Financial instruments
 
(c)
Financial instruments
(i) Financial Assets
Initial recognition and measurement
Upon recognition of a financial asset, classification is made based on the business model for managing the asset and the asset’s contractual cash flow characteristics. The financial asset is initially recognized at its fair value and subsequently classified and measured as (i) amortized cost; (ii) FVOCI; or (iii) FVTPL. Financial assets are classified as FVTPL if they have not been classified as measured at amortized cost or FVOCI. Upon initial recognition of an equity instrument that is not
held-for-trading,
the Company may irrevocably designate the presentation of subsequent changes in the fair value of such equity instrument as FVTPL
Subsequent measurement
The subsequent measurement of financial assets depends on their classification as follows:
Financial assets measured at amortized cost
A financial asset is subsequently measured at amortized cost, using the effective interest method and net of any impairment allowance, if the asset is held within a business whose objective is to hold assets in order to collect contractual cash flows; and the contractual terms of the financial asset give rise, on specified dates, to cash flows that are solely payments of principal and interest. Cash and cash equivalents, short-term investments and accounts receivable are classified within this category.
 
Financial assets at FVTPL
Financial assets measured at FVTPL are carried in the statement of financial position at fair value with changes in fair value therein recognized in the statement of net (loss) income. The holdback receivable was classified within this category.
Financial assets at FVOCI
Financial assets measured at FVOCI are carried in the statement of financial position at fair value with changes in fair value therein recognized in the statement of comprehensive (loss) income. The Investment in Sensible Medical was classified within this category.
(ii) Derecognition
A financial asset or, where applicable a part of a financial asset or part of a group of similar financial assets is derecognized when the contractual rights to receive cash flows from the asset have expired; or the Company has transferred its rights to receive cash flows from the asset or has assumed an obligation to pay the received cash flows in full without material delay to a third party under a ‘pass-through’ arrangement; and either (a) the Company has transferred substantially all the risks and rewards of the asset, or (b) the Company has neither transferred nor retained substantially all the risks and rewards of the asset, but has transferred control of the asset.
(iii) Financial liabilities
Initial recognition and measurement
The Company recognizes a financial liability on the trade date in which it becomes a party to the contractual provisions of the instrument at fair value plus any directly attributable costs. Financial liabilities are subsequently measured at amortized cost or FVTPL, and are not subsequently reclassified. The Company’s financial liabilities are accounts payable and accrued liabilities, royalty obligation and acquisition payable which are recognized on an amortized cost basis.
The royalty obligation was recorded at its fair value at the date at which the liability was incurred and subsequently measured at amortized cost using the effective interest rate method at each reporting date. Estimating fair value for this liability required determining the most appropriate valuation model which was dependent on its underlying terms and conditions. This estimate also required determining expected revenue from AGGRASTAT
®
sales and an appropriate discount rate and making assumptions about them.
The acquisition payable was recorded at its fair value at the date at which the liability was incurred and subsequently measured at amortized cost using the effective interest rate method at each reporting date. Estimating fair value for this liability required determining an appropriate discount rate.
(iv) Offsetting of financial instruments
Financial assets and financial liabilities are offset, and the net amount reported in the statement of financial position if, and only if, there is a currently enforceable legal right to offset the recognized amounts and there is an intention to settle on a net basis, or to realize the assets and settle the liabilities simultaneously.
(v) Fair value of financial instruments
Fair value is determined based on the price that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants. Fair value is measured using the assumptions that market participants would use when pricing an asset or liability. Typically, fair value is determined by using quoted prices in active markets for identical or similar assets or liabilities. When quoted prices in active markets are not available, fair value is determined using valuation techniques that maximize the use of observable inputs. When observable valuation inputs are not available, significant judgement is required through determining the valuation technique to apply, the valuation techniques such as discounted cash flow analysis and selecting inputs. The use of alternative valuation techniques or valuation inputs may result in a different fair value.
(vi) Transaction costs
Transaction costs for all financial instruments measured at amortized cost, the transaction costs are included in the initial measurement of the financial asset or financial liability and are amortized using the effective interest rate method over a period that corresponds with the term of the financial instruments. Transaction costs for financial instruments classified as FVTPL are recognized as an expense in professional fees, in the period the cost was incurred.
(vii) Embedded Derivatives
For financial liabilities measured at amortized cost, under certain conditions, an embedded derivative must be separated from its host contract and accounted for as a derivative. An embedded derivative causes some or all of the cash flows that otherwise would be required by the contract to be modified according to a specified interest rate, financial instrument price, commodity price, foreign exchange rate, index of prices or rates, a credit rating or credit index, or other variable, provided in the case of a
non-financial
variable that the variable is not specific to a party to the contract. For financial assets at
FVTPL
, any embedded derivatives are not separated from its host contract.
Impairment of financial assets
 
(d)
Impairment of financial assets
An “expected credit loss” impairment model applies to financial assets which requires a loss allowance to be recorded on financial assets measured at amortized cost based on their expected credit losses. An estimate is made to determine the present value of future cash flows associated with the asset, and if required, an impairment loss is recorded. The impairment loss reduces the carrying value of the impaired financial asset to the value of the estimated present value of the future cash flows associated with the asset, discounted at the financial asset’s original effective interest rate is recorded either directly or through the use of an allowance account and the resulting impairment loss is recorded in profit or loss.
Impairment losses on financial assets carried at amortized cost are reversed in subsequent periods if the amount of the loss decreases and the decrease can be related objectively to an event occurring after the impairment was recognized.
Revenue from contracts with customers
 
(e)
Revenue from contracts with customers
The Company has three commercially available products that generated revenue for the year ended December 31, 2019, AGGRASTAT
®
, ZYPITAMAG
and ReDS
TM
(the “
Products
”) which it sells to United States customers. AGGRASTAT
®
and ZYPITAMAG
are sold to wholesalers for resale; with AGGRASTAT
®
primarily being sold by the wholesalers to hospitals, while ZYPITAMAG
is primarily sold by wholesalers to pharmacies. The Company sells ReDS
TM
directly to end users. Revenue from the sale of AGGRASTAT
®
and ZYPITAMAG
is recognized upon the receipt of goods by the wholesaler, the point in time in which title and control of the transferred goods pass from the Company to the wholesale customer. At this point in time, the wholesaler has gained the sole ability to route the goods, and there are no unfulfilled obligations that could affect the wholesaler’s acceptance of the goods. Delivery of the product occurs when the goods have been received at the wholesaler in accordance with the terms of the sale. Revenue from the sale of ReDS
TM
is recognized upon the receipt of goods by the end user, the point in time in which title and control of the transferred goods pass from the Company to the customer. At this point in time, the customer has gained the sole ability to benefit from the product, and there are no unfulfilled obligations that could affect the customer’s acceptance of the goods. Delivery of the product occurs when the goods have been shipped to the customer and the customer has accepted the products in accordance with the terms of the sale.
Sales are made subject to certain discounts available for prompt payment, volume discounts, rebates or chargebacks. Revenue from these sales is recognized based on the price specified per the pricing terms of the sales invoices, net of the estimated discounts, rebates or chargebacks. Variable consideration is based on historical information, using the expected value method. Revenue is only recognized to the extent that it is highly probable that a significant reversal will not occur. A liability is included within accounts payable and accrued liabilities and is measured for expected payments that will be made to the customers for the discounts in which they are entitled. Sales do not contain an element of finan
c
ing as sales are made with credit terms within the normal operating cycle of the date of the invoice, which is consistent with market practice.
 
Cash and cash equivalents
 
(f)
Cash and cash equivalents
The Company considers all liquid investments purchased with a maturity of three months or less at acquisition to be cash and cash equivalents, which are carried and classified at amortized cost.
Short-term investments
 
(g)
Short-term investments
The Company considers all liquid investments purchased with a maturity greater than three months and less than one year at acquisition to be short-term investments, which are carried and classified at amortized cost.
Inventories
 
(h)
Inventories
Inventories consist of unfinished product (raw material in the form of API and packaging materials) and finished commercial product, which are available for sale and are measured at the lower of cost and net realizable value.
The cost of inventories is based on the
first-in
first-out
principle, and includes expenditures incurred in acquiring the inventories, production or conversion costs and other costs incurred in bringing them to their existing location and condition.
Inventories are written down to net realizable value when the cost of inventories is estimated to be unrecoverable due to obsolescence, damage, or declining selling prices. Net realizable value is the estimated selling price in the ordinary course of business, less the estimated costs of completion and selling expenses. When the circumstances that previously caused inventories to be written down below cost no longer exist, or when there is clear evidence of an increase in selling prices, the amount of the write-down previously recorded is reversed.
Property plant and equipment
 
(i)
Property plant and equipment
 
 
(i)
Recognition and measurement
Items of property, plant and equipment are measured at cost less accumulated amortization and accumulated impairment losses and reversals. When parts of an item of property, plant and equipment have different useful lives, they are accounted for as separate items (major components) of property, plant and equipment. The costs of the
day-to-day
servicing of property, plant and equipment are recognized in the consolidated statements of net
(loss) 
income and comprehensive
(loss) 
income in the period in which they are incurred.
 
 
(ii)
Amortization
Amortization is recognized in profit or loss over the estimated useful lives of each part of an item of property, plant and equipment in a manner that most closely reflects the expected pattern of consumption of the future economic benefits embodied in the asset. The estimated useful lives for the current and comparative periods are as follows:
 
Asset
  Basis   Rate 
Computers, office equipment, furniture and fixtures
   
Straight-line
    20% to 25
Leasehold improvements
   Straight-line    Term of lease 
ReDS
demonstration units
   Straight-line    33
Right of use assets
   Straight-line    Term of lease 
Amortization methods, useful lives and residual values are reviewed at each period end and adjusted if appropriate.
Intangible assets
 
(j)
Intangible assets
Intangible assets that are acquired separately are measured at cost less accumulated amortization and accumulated impairment losses. Subsequent expenditures are capitalized only when they increase the future economic benefits embodied in the specific asset to which they relate. All other expenditures are recognized in profit or loss as incurred.
Licenses are amortized on a straight-line basis over the contractual term of the acquired license. Patents and drug approvals are amortized on a
straight-line
basis over the legal life of the respective patent, ranging from five to twenty years, or its economic life, if shorter. Trademarks are amortized on a
straight-line
basis over the legal life of the respective trademark, being ten years, or its economic life, if shorter. Customer lists are amortized on a
straight-line
basis over approximately twelve years, or its economic life, if shorter.
Amortization on licenses commences when the intangible asset is available for use, which would typically be in connection with the commercial launch of the associated product under the license.
Following initial recognition, intangible assets are carried at cost less accumulated amortization and accumulated impairment losses. The cost of servicing the Company’s patents and trademarks are expensed as incurred.
The amortization method and amortization period of an intangible asset with a finite useful life are reviewed at least annually. Changes in the expected useful life or the expected pattern of consumption of future economic benefits embodied in the asset are accounted for by changing the amortization period or method, as appropriate, and are treated as changes in accounting estimates in the consolidated statements of net
(loss) 
income and comprehensive
(loss) 
income.
 
Research and development
 
(k)
Research and development
Expenditure on research activities, u
n
dertaken with the prospect of gaining new scientific or technical knowledge and understanding, is recognized in profit or loss as incurred.
Development activities involve a plan or design for the production of new or substantially improved products and processes. Development expenditures are capitalized only if development costs can be measured reliably, the product or process is technically and commercially feasible, future economic benefits are probable, and the Company intends to and has sufficient resources to complete development and to use or sell the asset. No development costs have been capitalized to date.
Research and development expenses include all direct and indirect operating expenses supporting the products in development.
Clinical trial expenses are a component of the Company’s research and development costs. These expenses include fees paid to contract research organizations, clinical sites, and other organizations who conduct research and development activities on the Company’s behalf. The amount of clinical trial expenses recognized in a period related to clinical agreements are based on estimates of the work performed using an accrual basis of accounting. These estimates incorporate factors such as patient enrolment, services provided, contractual terms, and prior experience with similar contracts.
Government assistance
 
(l)
Government assistance
Government assistance, in the form of grants, is recognized at fair value where there is reasonable assurance that the grant will be received and all attaching conditions will be complied with. Government assistance toward current expenses is recorded as a reduction of the related expenses in the period the expenses are incurred. Government assistance towards property, plant and equipment is deducted from the cost of the related property, plant and equipment. The benefits of investment tax credits for scientific research and experimental development expenditures (“SR&ED”) incurred directly by the Company are recognized in the period the qualifying expenditure is made, provided there is reasonable assurance of recoverability. SR&ED investment tax credits receivable are recorded at their net realizable value.
Impairment of non-financial assets
 
(m)
Impairment of
non-financial
assets
The Company assesses at each reporting period whether there is an indication that a
non-financial
asset may be impaired. An impairment loss is recognized when the carrying amount of an asset, or its CGU, exceeds its recoverable amount. Impairment losses are recognized in net income and comprehensive income. A CGU is the smallest identifiable group of assets that generates cash inflows that are largely independent of the cash inflows from other assets or groups of assets. The recoverable amount is the greater of the asset’s or CGU’s fair value less costs to sell and value in use. In assessing value in use, the estimated future cash flows are discounted to their present value using a
pre-tax
discount rate that reflects current market assessments of the time value of money and the risks specific to the asset or CGU. In determining fair value less costs to sell, an appropriate valuation model is used. For an asset that does not generate largely independent cash inflows, the recoverable amount is determined for the CGU to which the asset belongs.
For assets other than goodwill, impairment losses recognized in prior periods are assessed at each reporting date for any indications that the loss has decreased or no longer exists. An impairment loss is reversed if there has been a change in the estimates used to determine the recoverable amount. An impairment loss is reversed only to the extent that the asset’s carrying amount does not exceed the carrying amount that would have been determined, net of amortization, if no impairment loss had been recognized.
Goodwill is tested for impairment annually and when circumstances indicate that the carrying value may be impaired. Impairment is determined for goodwill by assessing the recoverable amount of each CGU to which the goodwill relates. When the recoverable amount of the CGU is less than its carrying amount, an impairment loss is recognized. Impairment losses relating to goodwill are not reversed in future periods.
Employee benefits
 
(n)
Employee benefits
 
 
(i)
Short-term employee benefits
Short-term
employee benefit obligations are measured on an undiscounted basis and are expensed as the related service is provided.
 
 
(ii)
Share-based payment transactions
The grant date fair value of
share-based
payment awards granted to employees is recognized as a personnel expense, with a corresponding increase in equity, over the period that the employees unconditionally become entitled to the awards. The amount recognized as an expense is adjusted to reflect the number of awards for which the related service and
non-market
vesting conditions are expected to be met, such that the amount ultimately recognized as an expense is based on the number of awards that do meet the related service and
non-market
performance conditions at the vesting date. For
share-based
payment awards with
non-vesting
conditions, the grant date fair value of the
share-based
payment is measured to reflect such conditions and there is no
true-up
for differences between expected and actual outcomes.
Share-based
payment arrangements in which the Company receives goods or services as consideration for its own equity instruments are accounted for as
equity-settled
share-based
payment transactions. In situations where equity instruments are issued and some or all of the goods or services received by the entity as consideration cannot be specifically identified, they are measured at fair value of the
share-based
payment.
For
share-based
payment arrangements with
non-employees,
the expense is recorded over the service period until the options vest. Once the options vest, services are deemed to have been received.
Where the terms of an equity-settled transaction award are modified, the minimum expense recognized is the expense as if the terms had not been modified, if the original terms of the award are met. An additional expense is recognized for any modification that increases the total fair value of the share-based payment transaction or is otherwise beneficial to the employee as measured at the date of modification.
 
Where an equity-settled award is cancelled, it is treated as if it vested on the date of the cancellation and any expense not yet recognized for the award
(
being the total expense as calculated at the grant date
)
is recognized immediately. This includes any awards where vesting conditions within the control of either the Company or the employee are not met. However, if a new award is substituted for the cancelled award, and designated as a replacement award on the date that it is granted, the cancelled award and new awards are treated as if they were a modification of the original awards.
 
Finance income and finance costs
 
(o)
Finance income and finance costs
Finance costs comprise interest expense on borrowings which are recognized in net income and comprehensive income using the effective interest rate method, accretion on the royalty obligation, prepayment fees on the early repayment of long-term debt and amortization of deferred debt issue costs using the effective interest rate method, offset by any finance income which is comprised of interest income on funds invested and is recognized as it accrues in net income and comprehensive income, using the effective interest rate method.
Foreign currency gains and losses are reported on a net basis.
Income taxes
 
(p)
Income taxes
The Company and its subsidiaries are generally taxable under the statutes of their country of incorporation.
Income tax expense comprises current and deferred taxes. Current taxes and deferred taxes are recognized in profit or loss except to the extent that they relate to a business combination, or items recognized directly in equity or in other comprehensive income.
Current taxes are the expected tax receivable or payable on the taxable income or loss for the year, using tax rates enacted or substantively enacted at the reporting date, and any adjustment to tax receivable or payable in respect of previous years.
The Company follows the liability method of accounting for deferred taxes. Under this method, deferred taxes are recognized in respect of temporary differences between the carrying amounts of assets and liabilities for financial reporting purposes and the amounts used for taxation purposes. Deferred taxes are not recognized for the following temporary differences: the initial recognition of assets or liabilities in a transaction that is not a business combination and that affects neither accounting nor taxable profit or loss, and differences relating to investments in subsidiaries and jointly controlled entities to the extent that it is probable that they will not reverse in the foreseeable future. In addition, deferred taxes are not recognized for taxable temporary differences arising on the initial recognition of goodwill. Deferred taxes are measured at the tax rates that are expected to be applied to temporary differences when they reverse, based on the tax laws that have been enacted or substantively enacted by the reporting date. Deferred tax assets and liabilities are offset if there is a legally enforceable right to offset current tax assets and liabilities, and they relate to income taxes levied by the same tax authority on the same taxable entity, or on different tax entities, but they intend to settle current tax assets and liabilities on a net basis or their tax assets and liabilities will be realized simultaneously.
A deferred tax asset is recognized for unused tax losses, tax credits and deductible temporary differences, to the extent that it is probable that future taxable profits will be available against which they can be utilized. Deferred tax assets are reviewed at each reporting date and are reduced to the extent that it is no longer probable that the related tax benefit will be realized.
 
The Company has provided for income taxes, including the impacts of tax legislation in various jurisdictions, in accordance with guidance issued by accounting regulatory bodies, the Canada Revenue Agency, the U.S. Internal Revenue Service, the Barbados Revenue Authority, the Mauritius Revenue Authority, as well as other state and local governments through the date of the issuance of these consolidated financial statements. Additional guidance and interpretations can be expected and such guidance, if any, could impact future results. While management continues to monitor these matters, the ultimate impact, if any, as a result of the application of any guidance issued in the future cannot be determined at this time.
The Company and its subsidiaries file federal income tax returns in Canada, the United States, Barbados and other foreign jurisdictions, as well as various provinces and states in Canada and the United States
, respectively
. The Company and its subsidiaries have open tax years, primarily from 20
1
0 to 201
9
, with significant taxing jurisdictions, including Canada, the United States and Barbados. These open years contain certain matters that could be subject to differing interpretations of applicable tax laws and regulations and tax treaties, as they relate to the amount, timing or inclusion of revenues and expenses, or the sustainability of income tax positions of the Company and its subsidiaries. Certain of these tax years may remain open indefinitely.
Tax benefits acquired as part of a business combination, but not satisfying the criteria for separate recognition at that date, would be recognized subsequently if information about facts and circumstances changed. The adjustment would either be treated as a reduction to goodwill if it occurred during the measurement period or in profit or loss, when it occurs subsequent to the measurement period.
Earnings per share
 
(q)
Earnings per share
The Company presents basic earnings per share (“EPS”) data for its common voting shares. Basic EPS is calculated by dividing the profit or loss attributable to common voting shareholders of the Company by the weighted average number of common voting shares outstanding during the period, adjusted for the Company’s own shares held. Diluted EPS is computed similar to basic EPS except that the weighted average shares outstanding are increased to include additional shares for the assumed exercise of stock options and warrants, if dilutive. The number of additional shares is calculated by assuming that outstanding stock options and warrants were exercised and that the proceeds from such exercise were used to acquire common shares at the average market price during the reporting periods.
Business combinations and goodwill
 
(r)
Business combinations and goodwill
Business combinations are accounted for using the acquisition method. The consideration for an acquisition is measured at the fair values of the assets transferred, the liabilities assumed and the equity interests issued at the acquisition date. Transaction costs that are incurred in connection with a business combination, other than costs associated with the issuance of debt or equity securities, are expensed as incurred. Identified assets acquired and liabilities and contingent liabilities assumed are measured initially at fair values at the date of acquisition. On an
acquisition-by-acquisition
basis, any
non-controlling
interest is measured either at fair value of the
non-controlling
interest or at the fair value of the proportionate share of the net assets acquired.
Contingent consideration is measured at fair value on acquisition date and is included as part of the consideration transferred. The fair value of the contingent consideration liability is remeasured at each reporting date with the corresponding gain or loss being recognized in profit or loss.
Goodwill is initially measured at cost, being the excess of fair value of the cost of the business combinations over the Company’s share in the net fair value of the acquiree’s identifiable assets, liabilities and contingent liabilities. Any negative difference is recognized directly in the consolidated statements of net income and comprehensive income. If the fair values of the assets, liabilities and contingent liabilities can only be calculated on a provisional basis, the business combination is recognized using provisional values. Any adjustments resulting from the completion of the measurement process are recognized within twelve months of the date of the acquisition.
New standard not yet adopted
 
(s)
New standard not yet adopted
Amendments to IFRS 3 – definition of a business:
In October 2018, the International Accounting Standards Board (“IASB”) issued amendments to IFRS 3 Business Combinations, that seek to clarify whether a transaction results in an asset or a business acquisition. The amendments include an election to use a concentration test. This is a simplified assessment that results in an asset acquisition if substantially all of the fair value of the gross assets is concentrated in a single identifiable asset or a group of similar identifiable assets. The amendments apply to businesses acquired in annual reporting periods beginning on or after January 1, 2020. The Company does not expect the amendments to have a significant impact on the consolidated financial statements upon adoption.
 

XML 28 R24.htm IDEA: XBRL DOCUMENT v3.20.1
Financial instruments
12 Months Ended
Dec. 31, 2019
Disclosure of detailed information about financial instruments [abstract]  
Financial instruments
19.
Financial instruments
 
 
(a)
Financial assets and liabilities
Set out below is a comparison by class of the carrying amounts and fair value of the Company’s financial instruments as at December 31, 2019 and 2018:
 
As at December 31
  
2019
   2018 
   
Carrying
amount
   
Fair
value
   Carrying
amount
   Fair
value
 
Financial assets
        
Financial assets measured at amortized cost
        
Cash and cash equivalents
  $12,965   $12,965   $24,139   $24,139 
Short-term investments
           47,747    47,747 
Accounts receivable
   10,216    10,216    10,765    10,765 
Investment in Sensible Medical
 
 
 
 
 
 
 
 
 
 
 
 
 
Holdback receivable
           11,909    11,909 
Financial liabilities
        
Financial liabilities measured at amortized cost:
        
Accounts payable and accrued liabilities
  $9,384   $9,384   $14,377   $14,377 
Current portion of royalty obligation
   872    872    1,496    1,496 
Current portion of acquisition payable
   649    649         
Current portion
of lease o
bl
igation
 
 
 
240
 
 
 
240
 
 
 
 
 
 
 
Royalty obligation
   1,176    1,176    2,035    2,035 
Acquisition payable
   1,655    1,655         
Lease obligat
ion
 
 
 
849
 
 
 
849
 
 
 
 
 
 
 
Other long-term liability
           1,201    1,201 
  
 
 
   
 
 
   
 
 
   
 
 
 
 
The Company has determined the estimated fair values of its financial instruments based on appropriate valuation methodologies. The carrying values of current monetary assets and liabilities approximate their fair values due to their relatively short periods to maturity. The royalty obligation, and acquisition payable are carried at amortized cost. The holdback receivable was carried at FVTPL and the other long-term liability was carried at amortized cost.
The investment in Sensible Medical is carried at FVOCI. During the year ended December 31, 2019, the Company recorded other comprehensive loss of $6,336 associated with the change in fair value of the investment in Sensible Medical. This resulted in a carrying value as at December 31, 2019 of one dollar.
IFRS 13,
Fair Value Measurement
, establishes a fair value hierarchy that reflects the significance of the inputs used in measuring fair value. The fair value hierarchy has the following levels:
 
  
Level 1 – Quoted prices (unadjusted) in active markets for identical assets or liabilities;
 
  
Level 2 – Inputs other than quoted prices included within Level 1 that are either directly or indirectly observable;
 
  
Level 3 – Unobservable inputs in which little or no market activity exists, therefore requiring an entity to develop its own assumptions about the assumptions that market participants would use in pricing.
The fair value hierarchy of the following financial assets and liabilities on the consolidated statements of financial position as at December 31, 2019 is as follows:
 
 
  
Level 1
 
  
Level 2
 
  
Level 3
 
Financial
assets
 
 
 
 
Investment in
Sensible Medical
 
 
$
 
$
 
$
Financial liabilities
  
  
  
Current portion of royalty obligation
  
$
 
  
$
 
  
$
872
 
Current portion of acquisition payable
  
 
 
  
 
 
  
 
649
 
Royalty obligation
  
 
 
  
 
 
  
 
1,176
 
Acquisition payable
  
 
 
  
 
 
  
 
1,655
 
  
 
 
 
  
 
 
 
  
 
 
 
The fair value hierarchy of the following financial assets and liabilities on the consolidated statements of financial position as at December 31, 2018 is as follows:
 
   
Level 1
   
Level 2
   
Level 3
 
Financial assets
      
Holdback receivable
  $   $   $11,909 
Financial liabilities
      
Accounts payable and accrued liabilities
  $   $   $546 
Current portion of royalty obligation
           1,496 
Royalty obligation
           2,035 
Other long-term liability
           1,201 
  
 
 
   
 
 
   
 
 
 
Included in accounts payable and accrued liabilities as at December 31, 2018 is the current portion of the license fee payable of $546.
Investment in Sensible Medical:
The investment in Sensible Medical requires determining the most appropriate valuation model and determining the most appropriate inputs to the valuation model, including publicly traded companies similar to Sensible Medical to use as a proxy in the valuation model, a discount rate for lack of marketability of the investment and estimated costs to dispose of the investment.
Royalty obligation:
The royalty obligation requires determining expected revenue from AGGRASTAT
®
sales and an appropriate discount rate and making assumptions about them. If the expected revenue from AGGRASTAT
®
sales were to change by 10%, then the royalty obligation liability recorded as at December 31, 2019 would change by approximately $
257 (2018 – $211
)
. If the discount rate used in calculating the fair value of the royalty obligation of 20% were to change by 1%, the royalty obligation liability recorded as at December 31, 2019 would change by approximately $
15 (2018 – $22)
.
 
Acquisition payable:
The acquisition payable requires determining an appropriate discount rate and making assumptions about it. If the discount rate used in calculating the fair value of the acquisition payable of 10% were to change by 1%, the acquisition payable recorded as at December 31, 2019 would change by approximately $28.
For assets and liabilities that are recognized in the consolidated financial statements on a recurring basis, the Company determines whether transfers have occurred between levels in the hierarchy by reassessing categorization (based on the lowest level input that is significant to the fair value measurement as a whole) at the end of each reporting period. During the years ended December 31, 2019, 2018 and 2017 there were no transfers between Level 1 and Level 2 fair value measurements.
 
 
(b)
Risks arising from financial instruments and risk management
The Company’s activities expose it to a variety of financial risks; market risk (including foreign exchange and interest rate risks), credit risk and liquidity risk. Risk management is the responsibility of the Company, which identifies, evaluates and, where appropriate, mitigates financial risks.
 
 
(i)
Market risk
(a)
Foreign exchange risk is the risk that the fair value of future cash flows for financial instruments will fluctuate because of changes in foreign exchange rates. The Company is exposed to currency risks primarily due to its U.S dollar denominated cash and cash equivalents, accounts receivable, other assets, accounts payable and accrued liabilities, income taxes payable, royalty obligation and acquisition payable. The Company has not entered into any foreign exchange hedging contracts.
The Company is exposed to U.S. dollar currency risk through the following U.S. denominated financial assets and liabilities:
 
As at December 31
(Expressed in U.S. Dollars)
  
2019
   2018 
Cash
  $9,518   $17,428 
Short-term investments
  
 
 
   35,000 
Accounts receivable
  
 
7,817
 
   7,725 
Holdback receivable
  
 
 
   8,730 
Other assets
  
 
30
 
    
Accounts payable and accrued liabilities
  
 
(6,714
   (9,903
Income taxes payable
  
 
(398
   (776
Current portion of royalty obligation
  
 
(671
   (1,096
Current portion of acquisition payable
  
 
(500
    
Royalty obligation
  
 
(906
   (1,492
Acquisition payable
  
 
(1,275
    
Other long-term liability
  
 
 
   (880
  
 
 
   
 
 
 
  
$
6,901
 
  $54,736 
  
 
 
   
 
 
 
Based on the above net exposures as at December 31, 2019, assuming that all other variables remain constant, a 5% appreciation or deterioration of the Canadian dollar against the U.S. dollar would result in a corresponding increase or decrease, respectively on the Company’s net income of approximately $448 (2018 – $3,700).
The Company is also exposed to currency risk on the Euro, however management estimates such risk relating to an appreciation or deterioration of the Canadian dollar against the Euro would have limited impact on the operations of the Company.
 
(b)
Interest rate risk is the risk that the future cash flows of a financial instrument will fluctuate because of changes in market interest rates. Based on the Company’s exposures as at December 31, 201
9
, as a result of the
balance of
cash and cash equivalents held by the Company, assuming that all other variables remain constant, a 1% appreciation or deterioration in interest rates would result in a corresponding increase or decrease, respectively on the Company’s net income of approximately $130 (2018
 
 
$720)
.
 
 
(ii)
Credit risk
Credit risk is the risk of financial loss to the Company if a partner or counterparty to a financial instrument fails to meet its contractual obligation and arises principally from the Company’s cash
 and
 accounts receivable. The carrying amounts of the financial assets represents the maximum credit exposure.
The Company limits its exposure to credit risk on cash by placing these financial instruments with
high-credit
quality financial institutions.
The Company is subject to a concentration of credit risk related to its accounts receivable as 96% of the balance of amounts owing are from three customers. The Company has historically had low impairment in regards to its accounts receivable. As at December 31, 2019, none of the outstanding accounts receivable were outside of the normal payment terms and the Company did not record any bad debt expenses (2018 – nil; 2017 – nil).
 As at December 31, 2019 and 2018, the expected credit lifetime credit losses for accounts receivable aged as current were nominal amounts.
 
 
(iii)
Liquidity risk
Liquidity risk is the risk that the Company will not be able to meet its financial obligations as they come due. The Company manages its liquidity risk by continuously monitoring forecasted and actual cash flows, as well as anticipated investing and financing activities and to ensure that it will have sufficient liquidity to meet its liabilities
and
commit
ments
when due and to fund future operations.
The majority of the Company’s accounts payable and accrued liabilities are due within the current operating period.
 
 
(c)
Capital management
The Company manages its capital structure and makes adjustments to it, based on the funds available to the Company, in order to continue the business of the Company. The Company, upon approval from its Board of Directors, will balance its overall capital structure through new share and warrant issuances, granting of stock options, the issuance of debt or by undertaking other activities as deemed appropriate under the specific circumstance. The Board of Directors does not establish a quantitative return on capital criteria for management, but rather relies on the expertise of the Company’s management to sustain future development of the business.
The Company’s objectives when managing capital are to safeguard the Company’s ability to continue as a going concern and to provide capital to pursue the development and commercialization of its products. In the management of capital, the Company includes cash,
long-term
debt, capital stock, stock options, warrants and contributed surplus. The Company manages the capital structure and makes adjustments to it in light of changes in economic conditions and the risk characteristics of the underlying assets. To maintain or adjust the capital structure, the Company may attempt to issue new shares or new debt.
At the current stage of the Company’s development, in order to maximize its current business activities, the Company does not pay out dividends. Management reviews its capital management approach on an ongoing basis and believes that this approach, given the relative size of the Company, is reasonable.
The Company’s overall strategy with respect to capital risk management remains unchanged for the year ended December 31, 2019.
XML 29 R20.htm IDEA: XBRL DOCUMENT v3.20.1
Finance income (expense)
12 Months Ended
Dec. 31, 2019
Disclosure Of Finance Cost Income [Abstract]  
Finance income (expense)
15.
Finance income (expense)
During the years ended December 31, 2019, 2018 and 2017 the Company earned finance income (incurred finance expense) as follows:
 
Year ended December 31
  
2019
   2018   2017 
Interest income
  
$
886
 
  $1,115   $47 
Accretion of royalty obligation
  
 
316
 
   (355   (748
Accretion of acquisition payable
  
 
(41
        
Bank charges and other interest
  
 
(24
   (25   (30
Finance expense from lease obligation
  
 
(22
        
Accretion on holdback receivable
  
 
 
   326     
Interest on MIOP loan
  
 
 
       (106
  
 
 
   
 
 
   
 
 
 
  
$
1,115
 
  $1,061   $(837
  
 
 
   
 
 
   
 
 
 
During the years ended December 31, 2019, 2018 and 2017, the Company received (paid) finance income (expense) as follows:
 
Year ended December 31
  
2019
   2018   2017 
Interest received
  
$
1,731
 
  $279   $47 
Other interest, net and banking fees
  
 
(46
   (24   (31
Interest paid on MIOP loan
  
 
 
       (89
  
 
 
   
 
 
   
 
 
 
  
$
1,685
 
  $255   $(73
  
 
 
   
 
 
   
 
 
 
XML 30 R16.htm IDEA: XBRL DOCUMENT v3.20.1
Investment in Sensible Medical
12 Months Ended
Dec. 31, 2019
Disclosure of detailed information about investment property [abstract]  
Disclosure of Investment in Sensible Medical
11.
Investment in Sensible Medical
On January 24, 2019, the Company acquired a 9.36% equity interest (7.71% on a fully-diluted basis) in Sensible Medical Innovations Ltd. (“Sensible”), and concurrently entered into an exclusive marketing and distribution agreement with Sensible to
m
arket ReDS
in the United States. The Company acquired the rights for US$10,000 (CDN$13,351) plus US$68 (CDN$91) in directly attributable costs.
On completion of the transaction, the Company recorded the initial fair value assigned to the investment in Sensible Medical at $6,337 with the remainder attributed to the rights associated with the distribution agreement accounted for within intangible assets and
ReDS
TM
demonstration units which are recorded within property and equipment, $7,038 was recorded within intangible assets relating to the license acquired through the exclusive marketing and distribution agreement and $67 was recorded within property and equipment pertaining to
ReDS
TM
demonstration devices acquired as part of the agreement.
The Company made an irrevocable election at initial recognition to recognize changes in the fair value of the investment in Sensible Medial through other comprehensive income (loss), as this is a strategic investment, and the Company considers this classification to be more relevant. As noted above, the initial fair value assigned to the investment upon initial recognition was $6,337. During the year ended December 31, 2019, the Company recorded other comprehensive loss of $6,336 associated with the change in fair value of the investment in Sensible Medical. This resulted in a carrying value as at December 31, 2019 of
one
dollar. The change in the fair value of the investment in Sensible Medical is as a result of uncertainties with ReDS
TM
being experienced in regards to the length of the sales cycle and uptake of the product with customers resulting in lower than expected amounts being paid to Sensible Medical under the exclusive marketing and distribution agreement.
The license was being amortized over the term of the license agreement which was equal to ten years. During the year ended December 31, 2019, amortization of $641 was recorded within cost of goods sold. The Company recorded a write-down of intangible assets related to the ReDS
TM
license during the year ended December 31, 2019 totaling $6,321.
The exclusive marketing and distribution agreement with Sensible included a period of
co-exclusivity,
whereby Sensible may sell, market, and distribute products directly to customers in select states of the United States using its own sales force. The Company is currently eligible to receive 20% of the revenue earned by Sensible from such sales during the
co-exclusivity
period, and may be eligible to receive up to 35% of the revenue earned by Sensible upon certain conditions being met. During the year ended December 31, 2019, the Company recorded revenue of $289 relating to the payments from Sensible from sales made by their sales force.
XML 31 R12.htm IDEA: XBRL DOCUMENT v3.20.1
Inventories
12 Months Ended
Dec. 31, 2019
Disclosure Of Inventories [Abstract]  
Inventories
7.
Inventories
 
As at December 31
  
2019
   2018 
Finished product
available-for-sale
  
$
5,273
 
  $2,937 
Unfinished product and packaging materials
  
 
1,055
 
   1,302 
  
 
 
   
 
 
 
  
$
6,328
 
  $4,239 
  
 
 
   
 
 
 
Inventories expensed as part of cost of goods sold during the year ended December 31, 2019 amounted to $3,585 (2018 – $3,862; 2017 – $3,079). During the year ended December 31, 2019, the Company
wrote-off
inventory of $1,983 (2018 – $95; 2017 –
 
$385) that had expired or was otherwise unusable
 
through cost of goods sold on the statement of (loss) income and comprehensive (loss) income.
XML 32 R31.htm IDEA: XBRL DOCUMENT v3.20.1
Discontinued operations (Tables)
12 Months Ended
Dec. 31, 2019
Discontinued Operations [Abstract]  
Schedule of financial performance relating to the Apicore business
Year ended December 31
  
2019
   2018   2017 
Revenue
  $   $
   $22,759 
Expenses
           (47,936
  
 
 
   
 
 
   
 
 
 
Loss from discontinued operations
  
$
 
  $   $(25,177
Income tax recovery
  
 
 
  
 
 
   1,847 
  
 
 
   
 
 
   
 
 
 
Loss after income tax recovery
  
$
 
  $
    (23,330
Gain on disposition of the Apicore business
  
 
 
  
 
 
   55,254 
  
 
 
   
 
 
   
 
 
 
Income from discontinued operations
  
$
 
  $
   $31,924 
  
 
 
   
 
 
   
 
 
 
Schedule of cash flow information of Apicore business
Year ended December 31
  
2019
   2018   2017 
Net cash flows from operating activities
  
$
 
  $
   $5,210 
Net cash flows from investing activities
  
 
 
  
 
 
   54,326 
Net cash flows used in financing activities
  
 
 
  
 
 
   (80,944
  
 
 
   
 
 
   
 
 
 
Net cash flows used in discontinued operations
  
$
 
  $
   $(21,408
  
 
 
   
 
 
   
 
 
 
XML 33 R35.htm IDEA: XBRL DOCUMENT v3.20.1
Intangible assets (Tables)
12 Months Ended
Dec. 31, 2019
Disclosure of detailed information about intangible assets [abstract]  
Schedule of intangible assets
Cost
  Licenses  Patents and
Drug
Approvals
  Trademarks  Customer
list
  Total 
At December 31, 2017
  $1,756  $14,239  $4,014  $708  $20,717 
Effect of movements in exchange rates
   154   1,245   351   62   1,812 
  
 
 
  
 
 
  
 
 
  
 
 
  
 
 
 
At December 31, 2018
  $1,910  $15,484  $4,365  $770  $22,529 
Additions (note 1
1
)
  
 
7,038
 
 
 
8,930
 
 
 
 
 
 
 
 
 
15,968
 
Impairment
 
 
(6,959
)
 
 
 
 
 
 
 
 
 
 
 
(6,959
)
Transfers within intangible assets
  
 
(1,854
 
 
1,457
 
 
 
—  
 
 
 
—  
 
 
 
(397
Effect of movements in exchange rates
  
 
(135
 
 
(942
 
 
(209
 
 
(37
 
 
(1,323
  
 
 
  
 
 
  
 
 
  
 
 
  
 
 
 
At December 31, 2019
  
$
 
 
$
24,929
 
 
$
4,156
 
 
$
733
 
 
$
29,818
 
  
 
 
  
 
 
  
 
 
  
 
 
  
 
 
 
 
Accumulated amortization and
impairment losses
  Licenses  Patents and
Drug
Approvals
  Trademarks  Customer
list
  Total 
At December 31, 2017
  $  $14,239  $4,014  $708  $18,961 
Amortization
   196            196 
Effect of movements in exchange rates
   9   1,245   351   62   1,667 
  
 
 
  
 
 
  
 
 
  
 
 
  
 
 
 
At December 31, 2018
  $205  $15,484  $4,365  $770  $20,824 
Amortization
  
 
841
 
 
 
597
 
 
 
 
 
 
 
 
 
1,438
 
Imp
airment
 
 
(638
)
 
 
 
 
 
 
 
 
 
 
 
(638
)
Transfers within intangible assets
  
 
(397
 
 
—  
 
 
 
—  
 
 
 
—  
 
 
 
(397
Effect of movements in exchange rates
  
 
(11
 
 
(751
 
 
(209
 
 
(37
 
 
(1,008
  
 
 
  
 
 
  
 
 
  
 
 
  
 
 
 
At December 31, 2019
  
$
 
 
$
15,330
 
 
$
4,156
 
 
$
733
 
 
$
20,219
 
  
 
 
  
 
 
  
 
 
  
 
 
  
 
 
 
 
Carrying amounts
  Licenses   Patents and
Drug
Approvals
   Trademarks   Customer
list
   Total 
At December 31, 2018
  $1,705   $   $   $   $1,705 
At December 31, 2019
  
$
 
  
$
9,599
 
  
$
 
  
$
 
  
$
9,599
 
  
 
 
   
 
 
   
 
 
   
 
 
   
 
 
 
XML 34 R39.htm IDEA: XBRL DOCUMENT v3.20.1
Commitments and contingencies (Tables)
12 Months Ended
Dec. 31, 2019
Disclosure Of Commitment And Contingencies [Abstract]  
Schedule of commitments and contingencies
2020
  $3,043 
2021
   1,243 
2022
   1,243 
2023
   195 
2024
   195 
  
 
 
 
  $5,919 
  
 
 
 
XML 35 R58.htm IDEA: XBRL DOCUMENT v3.20.1
Intangible assets (Detail Textuals)
$ in Thousands, $ in Thousands
12 Months Ended
Sep. 30, 2019
CAD ($)
Dec. 31, 2019
CAD ($)
Dec. 31, 2018
CAD ($)
Dec. 31, 2017
CAD ($)
Sep. 30, 2019
USD ($)
Disclosure of detailed information about intangible assets [line items]          
Amortization of the acquired intangible assets   $ 1,438 $ 196 $ 6,634  
Fair value of deferred payment payable current   649      
Fair value of deferred payment payable   $ 1,655      
Initial amortization period of intangible assets   4 years 3 months 18 days      
Remaining amortization period of intangible assets   4 years 1 month 6 days      
Write-down of intangible assets   $ 6,321   636  
Percentage of intangible asset discount rate   20.00%      
Zydus [Member]          
Disclosure of detailed information about intangible assets [line items]          
Upfront payment $ 6,622       $ 5,000
Deferred payment 2,649       $ 2,000
Percentage of intangible asset discount rate   13.25%      
Percentage of cumulative aggregate growth rate   300.00%      
Cumulative aggregate growth term   4 years      
Intangible asset recoverable amount   $ 1,600      
Accumulated amortization and impairment losses          
Disclosure of detailed information about intangible assets [line items]          
Amortization of the acquired intangible assets   1,438 196    
Transfers within intangible assets   (397)      
Write-down of intangible assets   (638)      
Acquired intangible assets          
Disclosure of detailed information about intangible assets [line items]          
Amortization of the acquired intangible assets       $ 6,634  
Licences          
Disclosure of detailed information about intangible assets [line items]          
Amount payable for services provided recorded within accounts payable and accrued liabilities     546    
Additions   7,038      
Licences | Accumulated amortization and impairment losses          
Disclosure of detailed information about intangible assets [line items]          
Amortization of the acquired intangible assets   841 $ 196    
Transfers within intangible assets   (397)      
Write-down of intangible assets   $ (638)      
Patents And Drug Approval [Member]          
Disclosure of detailed information about intangible assets [line items]          
Additions 8,930        
Transfers within intangible assets $ 1,457        
XML 36 R4.htm IDEA: XBRL DOCUMENT v3.20.1
Consolidated Statements of Changes in Equity - CAD ($)
$ in Thousands
Total
Share Capital
Warrants
Contributed Surplus
Accumulated other comprehensive income (loss)
Equity (Deficit)
Total
Non-Controlling Interest
Balance at Dec. 31, 2016 $ 38,284 $ 124,700 $ 2,021 $ 6,756 $ 682 $ (97,965) $ 36,194 $ 2,090
Net income for the year ended 43,421         43,421 43,421  
Other comprehensive (loss) income for the year ended (9)       (9)   (9)  
Disposition of non-controlling interests (2,090)             $ (2,090)
Transactions with owners, recorded directly in equity                
Stock options exercised (Note 13(c)) 520 870   (350)     520  
Warrants exercised (Note 13 (d)) 92 164 (72)       92  
Share-based compensation (Note 13(c)) 491     491     491  
Total transactions with owners 1,103 1,034 (72) 141     1,103  
Balance at Dec. 31, 2017 80,709 125,734 1,949 6,897 673 (54,544) 80,709  
Net income for the year ended 3,926         3,926 3,926  
Other comprehensive (loss) income for the year ended 595       595   595  
Transactions with owners, recorded directly in equity                
Buy-back of common shares under normal course issuer bid 13(b) (3,021) (3,501)       480 (3,021)  
Stock options exercised (Note 13(c)) 363 654   (291)     363  
Share-based compensation (Note 13(c)) 1,022     1,022     1,022  
Total transactions with owners (1,636) (2,847)   731   480 (1,636)  
Balance at Dec. 31, 2018 83,594 122,887 1,949 7,628 1,268 (50,138) 83,594  
Net income for the year ended (19,786)         (19,786) (19,786)  
Other comprehensive (loss) income for the year ended (7,019)       (7,019)   (7,019)  
Transactions with owners, recorded directly in equity                
Buy-back of common shares under normal course issuer bid (Note 13(b)) (4,145) (5,955)       1,810 (4,145)  
Buy-back of common shares under substantial issuer bid (Note 13(b)) (26,139) (31,605)       5,466 (26,139)  
Stock options exercised (Note 13(c)) 20 37   (17)     20  
Share-based compensation (Note 13(c)) 417     417     417  
Total transactions with owners (29,847) (37,523)   400   7,276 (29,847)  
Balance at Dec. 31, 2019 $ 26,942 $ 85,364 $ 1,949 $ 8,028 $ (5,751) $ (62,648) $ 26,942  
XML 37 R54.htm IDEA: XBRL DOCUMENT v3.20.1
Inventories (Detail Textuals) - CAD ($)
$ in Thousands
12 Months Ended
Dec. 31, 2019
Dec. 31, 2018
Dec. 31, 2017
Disclosure Of Inventories [Abstract]      
Cost of goods sold, inventory $ 3,585 $ 3,862 $ 3,079
Wrote-off (reversal) of inventory $ 1,983 $ 95 $ 385
XML 38 R50.htm IDEA: XBRL DOCUMENT v3.20.1
Discontinued operations (Detail Textuals) - Apicore
Oct. 02, 2017
CAD ($)
Oct. 02, 2017
USD ($)
Dec. 31, 2017
CAD ($)
Dec. 31, 2017
USD ($)
Disclosure Of Detailed Information Discontinued Operations [Line Items]        
Closing payment received upon closing of sale transaction $ 72,058 $ 57,623    
Consideration receivable, net of transaction costs     $ 65,235 $ 52,887
XML 39 R8.htm IDEA: XBRL DOCUMENT v3.20.1
Significant accounting policies
12 Months Ended
Dec. 31, 2019
Disclosure Of Significant Accounting Policies [Abstract]  
Significant accounting policies
3.
Significant accounting policies
The accounting policies set out below have been applied consistently to all periods presented in these consolidated financial statements, unless otherwise indicated.
 
 
(a)
Basis of consolidation
These consolidated financial statements include the accounts of the Company and its subsidiaries. Subsidiaries are entities controlled by the Company. Control exists when the Company has power over the investee and when the Company is exposed, or has the rights, to variable returns from the investee. Subsidiaries are included in the consolidated financial results of the Company from the effective date of acquisition up to the effective date of disposition or loss of control and include wholly owned subsidiaries, Medicure International Inc., Medicure Pharma Inc., Medicure U.S.A. Inc., Medicure Mauritius Limited, Medicure Pharma Europe Limited and Apigen Investments Limited. Additionally, the December 31, 2017 comparative figures include, from the date of acquisition (note 5), the accounts of subsidiaries that are controlled by the Company including, Apicore Inc., Apicore US LLC, Apicore LLC and Apicore Pharmaceuticals Private Limited. These additional subsidiaries were classified as discontinued operations for 2017 and Apicore Inc. and Apicore US LLC were sold during 2017 as described in note 5. The financial statements of the subsidiaries are prepared for the same reporting period as the parent company, using consistent accounting policies. All intercompany transactions and balances and unrealized gains and losses from intercompany transactions have been eliminat
e
d.
 
 
(b)
Foreign currency
Items included in the financial statements of each of the Company’s consolidated subsidiaries are measured using the currency of the primary economic environment in which the subsidiary operates (the functional currency). The consolidated financial statements are presented in Canadian dollars, which is the Company’s functional and presentation currency.
Foreign currency transactions are translated into the respective functional currencies of the Company and its subsidiaries using the exchange rates prevailing at the dates of the transactions. Foreign exchange gains and losses resulting from the settlement of such transactions and from the translation at
period-end
exchange rates of monetary assets and liabilities denominated in foreign currencies are recognized in profit or loss.
Non-monetary
items that are not carried at fair value are translated using the exchange rates as at the date of the initial transaction.
Non-monetary
items measured at fair value in a foreign currency are translated using the exchange rates at the date
 
when the fair value is determined.
The results and financial position of the Company’s foreign operations that have a functional currency different from the Company’s functional and presentation currency are translated into Canadian dollars as follows:
(i)
assets and liabilities of foreign operations are translated at the closing rate at the date of the consolidated statement of financial position;
(ii)
revenue and expenses of foreign operations for each year are translated at average exchange rates (unless this is not a reasonable approximation of the cumulative effect of the rates prevailing on the transaction dates, in which case revenue and expenses are translated at the dates of the transactions); and
(iii)
all resulting exchange differences for foreign operations are recognized in other comprehensive income in the cumulative translation account.
When a foreign operation is disposed of, the component of other comprehensive income relating to that particular foreign operation is recognized in the consolidated statements of net income and comprehensive income, as part of the gain or loss on sale where applicable.
 
 
(c)
Financial instruments
(i) Financial Assets
Initial recognition and measurement
Upon recognition of a financial asset, classification is made based on the business model for managing the asset and the asset’s contractual cash flow characteristics. The financial asset is initially recognized at its fair value and subsequently classified and measured as (i) amortized cost; (ii) FVOCI; or (iii) FVTPL. Financial assets are classified as FVTPL if they have not been classified as measured at amortized cost or FVOCI. Upon initial recognition of an equity instrument that is not
held-for-trading,
the Company may irrevocably designate the presentation of subsequent changes in the fair value of such equity instrument as FVTPL
Subsequent measurement
The subsequent measurement of financial assets depends on their classification as follows:
Financial assets measured at amortized cost
A financial asset is subsequently measured at amortized cost, using the effective interest method and net of any impairment allowance, if the asset is held within a business whose objective is to hold assets in order to collect contractual cash flows; and the contractual terms of the financial asset give rise, on specified dates, to cash flows that are solely payments of principal and interest. Cash and cash equivalents, short-term investments and accounts receivable are classified within this category.
 
Financial assets at FVTPL
Financial assets measured at FVTPL are carried in the statement of financial position at fair value with changes in fair value therein recognized in the statement of net (loss) income. The holdback receivable was classified within this category.
Financial assets at FVOCI
Financial assets measured at FVOCI are carried in the statement of financial position at fair value with changes in fair value therein recognized in the statement of comprehensive (loss) income. The Investment in Sensible Medical was classified within this category.
(ii) Derecognition
A financial asset or, where applicable a part of a financial asset or part of a group of similar financial assets is derecognized when the contractual rights to receive cash flows from the asset have expired; or the Company has transferred its rights to receive cash flows from the asset or has assumed an obligation to pay the received cash flows in full without material delay to a third party under a ‘pass-through’ arrangement; and either (a) the Company has transferred substantially all the risks and rewards of the asset, or (b) the Company has neither transferred nor retained substantially all the risks and rewards of the asset, but has transferred control of the asset.
(iii) Financial liabilities
Initial recognition and measurement
The Company recognizes a financial liability on the trade date in which it becomes a party to the contractual provisions of the instrument at fair value plus any directly attributable costs. Financial liabilities are subsequently measured at amortized cost or FVTPL, and are not subsequently reclassified. The Company’s financial liabilities are accounts payable and accrued liabilities, royalty obligation and acquisition payable which are recognized on an amortized cost basis.
The royalty obligation was recorded at its fair value at the date at which the liability was incurred and subsequently measured at amortized cost using the effective interest rate method at each reporting date. Estimating fair value for this liability required determining the most appropriate valuation model which was dependent on its underlying terms and conditions. This estimate also required determining expected revenue from AGGRASTAT
®
sales and an appropriate discount rate and making assumptions about them.
The acquisition payable was recorded at its fair value at the date at which the liability was incurred and subsequently measured at amortized cost using the effective interest rate method at each reporting date. Estimating fair value for this liability required determining an appropriate discount rate.
(iv) Offsetting of financial instruments
Financial assets and financial liabilities are offset, and the net amount reported in the statement of financial position if, and only if, there is a currently enforceable legal right to offset the recognized amounts and there is an intention to settle on a net basis, or to realize the assets and settle the liabilities simultaneously.
(v) Fair value of financial instruments
Fair value is determined based on the price that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants. Fair value is measured using the assumptions that market participants would use when pricing an asset or liability. Typically, fair value is determined by using quoted prices in active markets for identical or similar assets or liabilities. When quoted prices in active markets are not available, fair value is determined using valuation techniques that maximize the use of observable inputs. When observable valuation inputs are not available, significant judgement is required through determining the valuation technique to apply, the valuation techniques such as discounted cash flow analysis and selecting inputs. The use of alternative valuation techniques or valuation inputs may result in a different fair value.
(vi) Transaction costs
Transaction costs for all financial instruments measured at amortized cost, the transaction costs are included in the initial measurement of the financial asset or financial liability and are amortized using the effective interest rate method over a period that corresponds with the term of the financial instruments. Transaction costs for financial instruments classified as FVTPL are recognized as an expense in professional fees, in the period the cost was incurred.
(vii) Embedded Derivatives
For financial liabilities measured at amortized cost, under certain conditions, an embedded derivative must be separated from its host contract and accounted for as a derivative. An embedded derivative causes some or all of the cash flows that otherwise would be required by the contract to be modified according to a specified interest rate, financial instrument price, commodity price, foreign exchange rate, index of prices or rates, a credit rating or credit index, or other variable, provided in the case of a
non-financial
variable that the variable is not specific to a party to the contract. For financial assets at
FVTPL
, any embedded derivatives are not separated from its host contract.
 
 
(d)
Impairment of financial assets
An “expected credit loss” impairment model applies to financial assets which requires a loss allowance to be recorded on financial assets measured at amortized cost based on their expected credit losses. An estimate is made to determine the present value of future cash flows associated with the asset, and if required, an impairment loss is recorded. The impairment loss reduces the carrying value of the impaired financial asset to the value of the estimated present value of the future cash flows associated with the asset, discounted at the financial asset’s original effective interest rate is recorded either directly or through the use of an allowance account and the resulting impairment loss is recorded in profit or loss.
Impairment losses on financial assets carried at amortized cost are reversed in subsequent periods if the amount of the loss decreases and the decrease can be related objectively to an event occurring after the impairment was recognized.
 
 
(e)
Revenue from contracts with customers
The Company has three commercially available products that generated revenue for the year ended December 31, 2019, AGGRASTAT
®
, ZYPITAMAG
and ReDS
TM
(the “
Products
”) which it sells to United States customers. AGGRASTAT
®
and ZYPITAMAG
are sold to wholesalers for resale; with AGGRASTAT
®
primarily being sold by the wholesalers to hospitals, while ZYPITAMAG
is primarily sold by wholesalers to pharmacies. The Company sells ReDS
TM
directly to end users. Revenue from the sale of AGGRASTAT
®
and ZYPITAMAG
is recognized upon the receipt of goods by the wholesaler, the point in time in which title and control of the transferred goods pass from the Company to the wholesale customer. At this point in time, the wholesaler has gained the sole ability to route the goods, and there are no unfulfilled obligations that could affect the wholesaler’s acceptance of the goods. Delivery of the product occurs when the goods have been received at the wholesaler in accordance with the terms of the sale. Revenue from the sale of ReDS
TM
is recognized upon the receipt of goods by the end user, the point in time in which title and control of the transferred goods pass from the Company to the customer. At this point in time, the customer has gained the sole ability to benefit from the product, and there are no unfulfilled obligations that could affect the customer’s acceptance of the goods. Delivery of the product occurs when the goods have been shipped to the customer and the customer has accepted the products in accordance with the terms of the sale.
Sales are made subject to certain discounts available for prompt payment, volume discounts, rebates or chargebacks. Revenue from these sales is recognized based on the price specified per the pricing terms of the sales invoices, net of the estimated discounts, rebates or chargebacks. Variable consideration is based on historical information, using the expected value method. Revenue is only recognized to the extent that it is highly probable that a significant reversal will not occur. A liability is included within accounts payable and accrued liabilities and is measured for expected payments that will be made to the customers for the discounts in which they are entitled. Sales do not contain an element of finan
c
ing as sales are made with credit terms within the normal operating cycle of the date of the invoice, which is consistent with market practice.
 
 
(f)
Cash and cash equivalents
The Company considers all liquid investments purchased with a maturity of three months or less at acquisition to be cash and cash equivalents, which are carried and classified at amortized cost.
 
 
(g)
Short-term investments
The Company considers all liquid investments purchased with a maturity greater than three months and less than one year at acquisition to be short-term investments, which are carried and classified at amortized cost.
 
 
(h)
Inventories
Inventories consist of unfinished product (raw material in the form of API and packaging materials) and finished commercial product, which are available for sale and are measured at the lower of cost and net realizable value.
The cost of inventories is based on the
first-in
first-out
principle, and includes expenditures incurred in acquiring the inventories, production or conversion costs and other costs incurred in bringing them to their existing location and condition.
Inventories are written down to net realizable value when the cost of inventories is estimated to be unrecoverable due to obsolescence, damage, or declining selling prices. Net realizable value is the estimated selling price in the ordinary course of business, less the estimated costs of completion and selling expenses. When the circumstances that previously caused inventories to be written down below cost no longer exist, or when there is clear evidence of an increase in selling prices, the amount of the write-down previously recorded is reversed.
 
 
(i)
Property plant and equipment
 
 
(i)
Recognition and measurement
Items of property, plant and equipment are measured at cost less accumulated amortization and accumulated impairment losses and reversals. When parts of an item of property, plant and equipment have different useful lives, they are accounted for as separate items (major components) of property, plant and equipment. The costs of the
day-to-day
servicing of property, plant and equipment are recognized in the consolidated statements of net
(loss) 
income and comprehensive
(loss) 
income in the period in which they are incurred.
 
 
(ii)
Amortization
Amortization is recognized in profit or loss over the estimated useful lives of each part of an item of property, plant and equipment in a manner that most closely reflects the expected pattern of consumption of the future economic benefits embodied in the asset. The estimated useful lives for the current and comparative periods are as follows:
 
Asset
  Basis   Rate 
Computers, office equipment, furniture and fixtures
   
Straight-line
    20% to 25
Leasehold improvements
   Straight-line    Term of lease 
ReDS
demonstration units
   Straight-line    33
Right of use assets
   Straight-line    Term of lease 
Amortization methods, useful lives and residual values are reviewed at each period end and adjusted if appropriate.
 
(j)
Intangible assets
Intangible assets that are acquired separately are measured at cost less accumulated amortization and accumulated impairment losses. Subsequent expenditures are capitalized only when they increase the future economic benefits embodied in the specific asset to which they relate. All other expenditures are recognized in profit or loss as incurred.
Licenses are amortized on a straight-line basis over the contractual term of the acquired license. Patents and drug approvals are amortized on a
straight-line
basis over the legal life of the respective patent, ranging from five to twenty years, or its economic life, if shorter. Trademarks are amortized on a
straight-line
basis over the legal life of the respective trademark, being ten years, or its economic life, if shorter. Customer lists are amortized on a
straight-line
basis over approximately twelve years, or its economic life, if shorter.
Amortization on licenses commences when the intangible asset is available for use, which would typically be in connection with the commercial launch of the associated product under the license.
Following initial recognition, intangible assets are carried at cost less accumulated amortization and accumulated impairment losses. The cost of servicing the Company’s patents and trademarks are expensed as incurred.
The amortization method and amortization period of an intangible asset with a finite useful life are reviewed at least annually. Changes in the expected useful life or the expected pattern of consumption of future economic benefits embodied in the asset are accounted for by changing the amortization period or method, as appropriate, and are treated as changes in accounting estimates in the consolidated statements of net
(loss) 
income and comprehensive
(loss) 
income.
 
 
(k)
Research and development
Expenditure on research activities, u
n
dertaken with the prospect of gaining new scientific or technical knowledge and understanding, is recognized in profit or loss as incurred.
Development activities involve a plan or design for the production of new or substantially improved products and processes. Development expenditures are capitalized only if development costs can be measured reliably, the product or process is technically and commercially feasible, future economic benefits are probable, and the Company intends to and has sufficient resources to complete development and to use or sell the asset. No development costs have been capitalized to date.
Research and development expenses include all direct and indirect operating expenses supporting the products in development.
Clinical trial expenses are a component of the Company’s research and development costs. These expenses include fees paid to contract research organizations, clinical sites, and other organizations who conduct research and development activities on the Company’s behalf. The amount of clinical trial expenses recognized in a period related to clinical agreements are based on estimates of the work performed using an accrual basis of accounting. These estimates incorporate factors such as patient enrolment, services provided, contractual terms, and prior experience with similar contracts.
 
 
(l)
Government assistance
Government assistance, in the form of grants, is recognized at fair value where there is reasonable assurance that the grant will be received and all attaching conditions will be complied with. Government assistance toward current expenses is recorded as a reduction of the related expenses in the period the expenses are incurred. Government assistance towards property, plant and equipment is deducted from the cost of the related property, plant and equipment. The benefits of investment tax credits for scientific research and experimental development expenditures (“SR&ED”) incurred directly by the Company are recognized in the period the qualifying expenditure is made, provided there is reasonable assurance of recoverability. SR&ED investment tax credits receivable are recorded at their net realizable value.
 
 
(m)
Impairment of
non-financial
assets
The Company assesses at each reporting period whether there is an indication that a
non-financial
asset may be impaired. An impairment loss is recognized when the carrying amount of an asset, or its CGU, exceeds its recoverable amount. Impairment losses are recognized in net income and comprehensive income. A CGU is the smallest identifiable group of assets that generates cash inflows that are largely independent of the cash inflows from other assets or groups of assets. The recoverable amount is the greater of the asset’s or CGU’s fair value less costs to sell and value in use. In assessing value in use, the estimated future cash flows are discounted to their present value using a
pre-tax
discount rate that reflects current market assessments of the time value of money and the risks specific to the asset or CGU. In determining fair value less costs to sell, an appropriate valuation model is used. For an asset that does not generate largely independent cash inflows, the recoverable amount is determined for the CGU to which the asset belongs.
For assets other than goodwill, impairment losses recognized in prior periods are assessed at each reporting date for any indications that the loss has decreased or no longer exists. An impairment loss is reversed if there has been a change in the estimates used to determine the recoverable amount. An impairment loss is reversed only to the extent that the asset’s carrying amount does not exceed the carrying amount that would have been determined, net of amortization, if no impairment loss had been recognized.
Goodwill is tested for impairment annually and when circumstances indicate that the carrying value may be impaired. Impairment is determined for goodwill by assessing the recoverable amount of each CGU to which the goodwill relates. When the recoverable amount of the CGU is less than its carrying amount, an impairment loss is recognized. Impairment losses relating to goodwill are not reversed in future periods.
 
 
(n)
Employee benefits
 
 
(i)
Short-term employee benefits
Short-term
employee benefit obligations are measured on an undiscounted basis and are expensed as the related service is provided.
 
 
(ii)
Share-based payment transactions
The grant date fair value of
share-based
payment awards granted to employees is recognized as a personnel expense, with a corresponding increase in equity, over the period that the employees unconditionally become entitled to the awards. The amount recognized as an expense is adjusted to reflect the number of awards for which the related service and
non-market
vesting conditions are expected to be met, such that the amount ultimately recognized as an expense is based on the number of awards that do meet the related service and
non-market
performance conditions at the vesting date. For
share-based
payment awards with
non-vesting
conditions, the grant date fair value of the
share-based
payment is measured to reflect such conditions and there is no
true-up
for differences between expected and actual outcomes.
Share-based
payment arrangements in which the Company receives goods or services as consideration for its own equity instruments are accounted for as
equity-settled
share-based
payment transactions. In situations where equity instruments are issued and some or all of the goods or services received by the entity as consideration cannot be specifically identified, they are measured at fair value of the
share-based
payment.
For
share-based
payment arrangements with
non-employees,
the expense is recorded over the service period until the options vest. Once the options vest, services are deemed to have been received.
Where the terms of an equity-settled transaction award are modified, the minimum expense recognized is the expense as if the terms had not been modified, if the original terms of the award are met. An additional expense is recognized for any modification that increases the total fair value of the share-based payment transaction or is otherwise beneficial to the employee as measured at the date of modification.
 
Where an equity-settled award is cancelled, it is treated as if it vested on the date of the cancellation and any expense not yet recognized for the award
(
being the total expense as calculated at the grant date
)
is recognized immediately. This includes any awards where vesting conditions within the control of either the Company or the employee are not met. However, if a new award is substituted for the cancelled award, and designated as a replacement award on the date that it is granted, the cancelled award and new awards are treated as if they were a modification of the original awards.
 
 
(o)
Finance income and finance costs
Finance costs comprise interest expense on borrowings which are recognized in net income and comprehensive income using the effective interest rate method, accretion on the royalty obligation, prepayment fees on the early repayment of long-term debt and amortization of deferred debt issue costs using the effective interest rate method, offset by any finance income which is comprised of interest income on funds invested and is recognized as it accrues in net income and comprehensive income, using the effective interest rate method.
Foreign currency gains and losses are reported on a net basis.
 
 
(p)
Income taxes
The Company and its subsidiaries are generally taxable under the statutes of their country of incorporation.
Income tax expense comprises current and deferred taxes. Current taxes and deferred taxes are recognized in profit or loss except to the extent that they relate to a business combination, or items recognized directly in equity or in other comprehensive income.
Current taxes are the expected tax receivable or payable on the taxable income or loss for the year, using tax rates enacted or substantively enacted at the reporting date, and any adjustment to tax receivable or payable in respect of previous years.
The Company follows the liability method of accounting for deferred taxes. Under this method, deferred taxes are recognized in respect of temporary differences between the carrying amounts of assets and liabilities for financial reporting purposes and the amounts used for taxation purposes. Deferred taxes are not recognized for the following temporary differences: the initial recognition of assets or liabilities in a transaction that is not a business combination and that affects neither accounting nor taxable profit or loss, and differences relating to investments in subsidiaries and jointly controlled entities to the extent that it is probable that they will not reverse in the foreseeable future. In addition, deferred taxes are not recognized for taxable temporary differences arising on the initial recognition of goodwill. Deferred taxes are measured at the tax rates that are expected to be applied to temporary differences when they reverse, based on the tax laws that have been enacted or substantively enacted by the reporting date. Deferred tax assets and liabilities are offset if there is a legally enforceable right to offset current tax assets and liabilities, and they relate to income taxes levied by the same tax authority on the same taxable entity, or on different tax entities, but they intend to settle current tax assets and liabilities on a net basis or their tax assets and liabilities will be realized simultaneously.
A deferred tax asset is recognized for unused tax losses, tax credits and deductible temporary differences, to the extent that it is probable that future taxable profits will be available against which they can be utilized. Deferred tax assets are reviewed at each reporting date and are reduced to the extent that it is no longer probable that the related tax benefit will be realized.
 
The Company has provided for income taxes, including the impacts of tax legislation in various jurisdictions, in accordance with guidance issued by accounting regulatory bodies, the Canada Revenue Agency, the U.S. Internal Revenue Service, the Barbados Revenue Authority, the Mauritius Revenue Authority, as well as other state and local governments through the date of the issuance of these consolidated financial statements. Additional guidance and interpretations can be expected and such guidance, if any, could impact future results. While management continues to monitor these matters, the ultimate impact, if any, as a result of the application of any guidance issued in the future cannot be determined at this time.
The Company and its subsidiaries file federal income tax returns in Canada, the United States, Barbados and other foreign jurisdictions, as well as various provinces and states in Canada and the United States
, respectively
. The Company and its subsidiaries have open tax years, primarily from 20
1
0 to 201
9
, with significant taxing jurisdictions, including Canada, the United States and Barbados. These open years contain certain matters that could be subject to differing interpretations of applicable tax laws and regulations and tax treaties, as they relate to the amount, timing or inclusion of revenues and expenses, or the sustainability of income tax positions of the Company and its subsidiaries. Certain of these tax years may remain open indefinitely.
Tax benefits acquired as part of a business combination, but not satisfying the criteria for separate recognition at that date, would be recognized subsequently if information about facts and circumstances changed. The adjustment would either be treated as a reduction to goodwill if it occurred during the measurement period or in profit or loss, when it occurs subsequent to the measurement period.
 
 
(q)
Earnings per share
The Company presents basic earnings per share (“EPS”) data for its common voting shares. Basic EPS is calculated by dividing the profit or loss attributable to common voting shareholders of the Company by the weighted average number of common voting shares outstanding during the period, adjusted for the Company’s own shares held. Diluted EPS is computed similar to basic EPS except that the weighted average shares outstanding are increased to include additional shares for the assumed exercise of stock options and warrants, if dilutive. The number of additional shares is calculated by assuming that outstanding stock options and warrants were exercised and that the proceeds from such exercise were used to acquire common shares at the average market price during the reporting periods.
 
 
(r)
Business combinations and goodwill
Business combinations are accounted for using the acquisition method. The consideration for an acquisition is measured at the fair values of the assets transferred, the liabilities assumed and the equity interests issued at the acquisition date. Transaction costs that are incurred in connection with a business combination, other than costs associated with the issuance of debt or equity securities, are expensed as incurred. Identified assets acquired and liabilities and contingent liabilities assumed are measured initially at fair values at the date of acquisition. On an
acquisition-by-acquisition
basis, any
non-controlling
interest is measured either at fair value of the
non-controlling
interest or at the fair value of the proportionate share of the net assets acquired.
Contingent consideration is measured at fair value on acquisition date and is included as part of the consideration transferred. The fair value of the contingent consideration liability is remeasured at each reporting date with the corresponding gain or loss being recognized in profit or loss.
Goodwill is initially measured at cost, being the excess of fair value of the cost of the business combinations over the Company’s share in the net fair value of the acquiree’s identifiable assets, liabilities and contingent liabilities. Any negative difference is recognized directly in the consolidated statements of net income and comprehensive income. If the fair values of the assets, liabilities and contingent liabilities can only be calculated on a provisional basis, the business combination is recognized using provisional values. Any adjustments resulting from the completion of the measurement process are recognized within twelve months of the date of the acquisition.
 
 
(s)
New standard not yet adopted
Amendments to IFRS 3 – definition of a business:
In October 2018, the International Accounting Standards Board (“IASB”) issued amendments to IFRS 3 Business Combinations, that seek to clarify whether a transaction results in an asset or a business acquisition. The amendments include an election to use a concentration test. This is a simplified assessment that results in an asset acquisition if substantially all of the fair value of the gross assets is concentrated in a single identifiable asset or a group of similar identifiable assets. The amendments apply to businesses acquired in annual reporting periods beginning on or after January 1, 2020. The Company does not expect the amendments to have a significant impact on the consolidated financial statements upon adoption.
 
XML 40 R83.htm IDEA: XBRL DOCUMENT v3.20.1
Commitments and contingencies (Detail Textuals 1)
€ in Thousands, $ in Thousands
3 Months Ended 12 Months Ended
Dec. 31, 2019
CAD ($)
Dec. 31, 2019
CAD ($)
Dec. 31, 2019
EUR (€)
Dec. 31, 2018
CAD ($)
Dec. 31, 2017
CAD ($)
Commitments And Contingencies [Line Items]          
Royalty expense   $ 1,023   $ 1,654 $ 1,243
Royalty payment   $ (1,355)   (1,539) (1,829)
Payment for expansion of label | €     € 300    
Period over which contingent liability is payable   3 years 3 years    
Royalty expenditure   $ 1,023   $ 1,654 $ 1,243
ZYPITAMAG | Zydus          
Commitments And Contingencies [Line Items]          
Royalty expense $ 2        
Royalty expenditure 2        
Current portion of the royalty obligation $ 2 $ 2      
Birmingham Associates Ltd | AGGRASTAT          
Commitments And Contingencies [Line Items]          
Terms of quarterly sales   60 days 60 days    
Birmingham Associates Ltd | AGGRASTAT | Upto 200000          
Commitments And Contingencies [Line Items]          
Percentage of royalty 4.00% 4.00%      
Birmingham Associates Ltd | AGGRASTAT | Between 200000 and 400000          
Commitments And Contingencies [Line Items]          
Percentage of royalty 6.00% 6.00%      
Birmingham Associates Ltd | AGGRASTAT | Above 400000          
Commitments And Contingencies [Line Items]          
Percentage of royalty 8.00% 8.00%      
XML 41 R73.htm IDEA: XBRL DOCUMENT v3.20.1
Income taxes (Details) - CAD ($)
$ in Thousands
Dec. 31, 2019
Dec. 31, 2018
Deferred tax assets    
Non-capital loss carryforwards $ 0 $ 127
Total deferred tax assets $ 0 $ 127
XML 43 R77.htm IDEA: XBRL DOCUMENT v3.20.1
Income taxes (Detail Textuals) - CAD ($)
$ in Thousands
12 Months Ended
Dec. 31, 2019
Dec. 31, 2018
Dec. 31, 2017
Income Taxes [Abstract]      
Current income tax expense $ 22 $ 678 $ (9,393)
Deferred income tax expense (recovery) $ 123 $ 219 $ 333
XML 44 R87.htm IDEA: XBRL DOCUMENT v3.20.1
Related party transactions (Detail Textuals 2) - CAD ($)
$ in Thousands
12 Months Ended
Dec. 31, 2019
Dec. 31, 2018
Dec. 31, 2017
Disclosure of amounts incurred by entity for provision of key management personnel services provided by separate management entities [line items]      
Research and development expense $ 4,349 $ 6,681 $ 5,148
GVI clinical development solutions Inc      
Disclosure of amounts incurred by entity for provision of key management personnel services provided by separate management entities [line items]      
Accounts payable and accrued liabilities 56 134  
GVI clinical development solutions Inc | Consulting agreement      
Disclosure of amounts incurred by entity for provision of key management personnel services provided by separate management entities [line items]      
Research and development expense 406 858 716
CanAm Bioresearch Inc      
Disclosure of amounts incurred by entity for provision of key management personnel services provided by separate management entities [line items]      
Accounts payable and accrued liabilities 0 40  
CanAm Bioresearch Inc | Consulting agreement      
Disclosure of amounts incurred by entity for provision of key management personnel services provided by separate management entities [line items]      
Research and development expense 133 393 458
Dap Dhaduk II LLC      
Disclosure of amounts incurred by entity for provision of key management personnel services provided by separate management entities [line items]      
Rental expenses which are recorded within loss from discontinued operations     263
Aktinos      
Disclosure of amounts incurred by entity for provision of key management personnel services provided by separate management entities [line items]      
Purchases of inventory, which were included in assets     1,599
4C Pharma Solutions LLC.      
Disclosure of amounts incurred by entity for provision of key management personnel services provided by separate management entities [line items]      
Services provided which are recorded within loss from discontinued operations     6
Genesys Venture Inc      
Disclosure of amounts incurred by entity for provision of key management personnel services provided by separate management entities [line items]      
Rental expenses which are recorded within loss from discontinued operations 295 228 $ 212
Accounts payable and accrued liabilities $ 95 $ 17  
XML 45 R17.htm IDEA: XBRL DOCUMENT v3.20.1
Royalty obligation
12 Months Ended
Dec. 31, 2019
Royalty Obligation [Abstract]  
Royalty obligation
12.
Royalty obligation
On July 18, 2011, the Company settled its then existing
long-term
debt with Birmingham Associates Ltd. (“Birmingham”), an affiliate of Elliott Associates L.P., in exchange for i) $4,750 in cash; ii) 2,176,003 common shares of the Company; and iii) a royalty on future AGGRASTAT
®
sales until May 1, 2023. The royalty is based on 4% of the first $2,000 of quarterly AGGRASTAT
®
sales, 6% on the portion of quarterly sales between $2,000 and $4,000 and 8% on the portion of quarterly sales exceeding $4,000 payable within 60 days of the end of the preceding three-month periods ended February 28, May 31, August 31 and November 30. Birmingham has a
one-time
option to switch the royalty payment from AGGRASTAT
®
to a royalty on the sale of
MC-1.
Management determined there is no value to the option to switch the royalty to
MC-1
as the product is not commercially available for sale and the extended long-term development timelines associated with commercialization of the product.
In accordance with the terms of the agreement, if the Company were to dispose of its AGGRASTAT
®
rights, the acquirer would be required to assume the obligations under the royalty agreement.
The royalty obligation was recorded at its fair value at the date at which the liability was incurred, estimated to be $902, and subsequently measured at amortized cost using the effective interest rate method at each reporting date. This resulted in a carrying value as at December 31, 2019 of $2,048 (2018 – $3,531) of which $872 (2018 – $1,496) represents the current portion of the royalty obligation. The net change in the royalty obligation for the year ended December 31, 2019 of a recovery of $316 (2018 –
 expense of
$355; 2017 –
 expe
nse of
 $748) is recorded within finance (income) expense on the consolidated statements of net (loss) income and comprehensive (loss) income. Royalties for the year ended December 31, 2019 totaled $1,023 (2018 – $1,654; 2017 – $1,243) with payments made during the year ended December 31, 2019 of $1,355 (2018 – $1,539; 2017 – $1,829).
XML 46 R13.htm IDEA: XBRL DOCUMENT v3.20.1
Property, plant and equipment
12 Months Ended
Dec. 31, 2019
Disclosure of detailed information about property, plant and equipment [abstract]  
Property, plant and equipment
8.
Property, plant and equipment
 
Cost
  Computer
and office
equipment
  Leasehold
improvements
   ReDS

Demonstration
units
  Right of use
assets
   Total 
At December 31, 2017
  $428  $156   $  $   $584 
Additions
   186   12           198 
Effect of movements in exchange rates
   12              12 
Dispositions
   (156             (156
  
 
 
  
 
 
   
 
 
  
 
 
   
 
 
 
At December 31, 2018
  $470  $168   $  $   $638 
Impact of adoption of IFRS 16 (Note 4)
  
 
 
 
 
 
  
 
 
 
 
677
 
  
 
677
 
Additions
  
 
50
 
 
 
2
 
  
 
134
 
 
 
685
 
  
 
871
 
Im
pairment
 
 
 
 
 
 
 
 
(130
)
 
 
 
 
 
(130
)
Effect of movements in exchange rates
  
 
 
 
 
 
  
 
(4
 
 
 
  
 
(4
  
 
 
  
 
 
   
 
 
  
 
 
   
 
 
 
At December 31, 2019
  
$
520
 
 
$
170
 
  
$
 
 
$
1,362
 
  
$
2,052
 
  
 
 
  
 
 
   
 
 
  
 
 
   
 
 
 
 
Accumulated amortization and impairment losses
  Computer
and office
equipment
  Leasehold
improvements
   ReDS

Demonstration
units
  Right of use
assets
   Total 
At December 31, 2017
  $281  $82   $  $   $363 
Amortization
   75   28           103 
Effect of movements in exchange rates
   12              12 
Dispositions
   (156             (156
  
 
 
  
 
 
   
 
 
  
 
 
   
 
 
 
At December 31, 2018
  $212  $110   $  $   $322 
Amortization
  
 
111
 
 
 
60
 
  
 
37
 
 
 
277
 
  
 
485
 
Impairment
 
 
 
 
 
 
 
 
(35
)
 
 
 
 
 
(35
)
Effect of movements in exchange rates
  
 
 
 
 
 
  
 
(2
)
 
 
 
 
  
 
(2
)
 
  
 
 
  
 
 
   
 
 
  
 
 
   
 
 
 
At December 31, 2019
  
$
323
 
 
$
170
 
  
$
 
 
$
277
 
  
$
770
 
  
 
 
  
 
 
   
 
 
  
 
 
   
 
 
 
 
Carrying amounts
  Computer
and office
equipment
   Leasehold
improvements
   ReDS

Demonstration
units
   Right of use
assets
   Total 
At December 31, 2018
  $258   $58   $   $   $316 
At December 31, 2019
  
$
197
 
  
$
 
  
$
 
  
$
1,085
 
  
$
1,282
 
  
 
 
   
 
 
   
 
 
   
 
 
   
 
 
 
During the year ended December 31, 2019, amortization of property, plant and equipment totaling $485 (2018 – $103; 2017 – $98) is included within general and administrative expenses on the consolidated statements of net (loss) income and comprehensive (loss) income. For the year ended December 31, 2017, amortization of property, plant and equipment totaling $1,075 is recorded within discontinued operations.
During the year ended December 31, 2019, an impairment of property, plant and equipment totaling $95 is included within general and administrative expenses on the consolidated statements of net (loss) income and comprehensive (loss) income pertaining to an impairment of ReDS
TM
demonstration units in connection with the impairment of the ReDS
TM
license as described in note 9.
XML 47 R38.htm IDEA: XBRL DOCUMENT v3.20.1
Finance income (expense) (Tables)
12 Months Ended
Dec. 31, 2019
Disclosure Of Finance Cost Income [Abstract]  
Schedule of company's incurred finance income (expense)
Year ended December 31
  
2019
   2018   2017 
Interest income
  
$
886
 
  $1,115   $47 
Accretion of royalty obligation
  
 
316
 
   (355   (748
Accretion of acquisition payable
  
 
(41
        
Bank charges and other interest
  
 
(24
   (25   (30
Finance expense from lease obligation
  
 
(22
        
Accretion on holdback receivable
  
 
 
   326     
Interest on MIOP loan
  
 
 
       (106
  
 
 
   
 
 
   
 
 
 
  
$
1,115
 
  $1,061   $(837
  
 
 
   
 
 
   
 
 
 
Schedule of company's paid finance income (expense)
Year ended December 31
  
2019
   2018   2017 
Interest received
  
$
1,731
 
  $279   $47 
Other interest, net and banking fees
  
 
(46
   (24   (31
Interest paid on MIOP loan
  
 
 
       (89
  
 
 
   
 
 
   
 
 
 
  
$
1,685
 
  $255   $(73
  
 
 
   
 
 
   
 
 
 
XML 48 R30.htm IDEA: XBRL DOCUMENT v3.20.1
New standards and interpretations (Tables)
12 Months Ended
Dec. 31, 2019
Disclosure of initial application of standards or interpretations [abstract]  
Summary of Detailed Information About Adoption Of New Lease Policy And Its Impact On Financial Position
The impact of the adoption of IFRS 16 on the Company’s statement of financial position at January 1, 2019 is as follows:
 
   
December 31, 2018
   
Impact of transition to IFRS 16
   
January 1, 2019
 
Assets
      
Property and equipment
  
$
316
 
  
$
677
 
  
$
993
 
Current liabilities
      
Lease obligation
  
$
—  
 
  
$
300
 
  
$
300
 
Non-current
liabilities
      
Lease obligation
  
$
—  
 
  
$
377
 
  
$
377
 
  
 
 
   
 
 
   
 
 
 
  
$
316
 
  
$
—  
 
  
$
316
 
  
 
 
   
 
 
   
 
 
 
Summary of Detailed Information About Adoption Of New Lease Policy And Its Impact On Operating Lease Commitments
The impact of the adoption of the Company’s operating lease commitments to the lease obligations
recognized
as a result of the adoption of IFRS 16 is as
follows
:
 
Operating lease commitments, including renewal options, as at December 31, 2018
  $715 
Adjustment of lease commitments to present value of lease liability
   (38
  
 
 
 
Lease obligation as at January 1, 2019
  $677 
  
 
 
 
XML 49 R34.htm IDEA: XBRL DOCUMENT v3.20.1
Property, plant and equipment (Tables)
12 Months Ended
Dec. 31, 2019
Disclosure of detailed information about property, plant and equipment [abstract]  
Schedule of property, plant and equipment
Cost
  Computer
and office
equipment
  Leasehold
improvements
   ReDS

Demonstration
units
  Right of use
assets
   Total 
At December 31, 2017
  $428  $156   $  $   $584 
Additions
   186   12           198 
Effect of movements in exchange rates
   12              12 
Dispositions
   (156             (156
  
 
 
  
 
 
   
 
 
  
 
 
   
 
 
 
At December 31, 2018
  $470  $168   $  $   $638 
Impact of adoption of IFRS 16 (Note 4)
  
 
 
 
 
 
  
 
 
 
 
677
 
  
 
677
 
Additions
  
 
50
 
 
 
2
 
  
 
134
 
 
 
685
 
  
 
871
 
Im
pairment
 
 
 
 
 
 
 
 
(130
)
 
 
 
 
 
(130
)
Effect of movements in exchange rates
  
 
 
 
 
 
  
 
(4
 
 
 
  
 
(4
  
 
 
  
 
 
   
 
 
  
 
 
   
 
 
 
At December 31, 2019
  
$
520
 
 
$
170
 
  
$
 
 
$
1,362
 
  
$
2,052
 
  
 
 
  
 
 
   
 
 
  
 
 
   
 
 
 
 
Accumulated amortization and impairment losses
  Computer
and office
equipment
  Leasehold
improvements
   ReDS

Demonstration
units
  Right of use
assets
   Total 
At December 31, 2017
  $281  $82   $  $   $363 
Amortization
   75   28           103 
Effect of movements in exchange rates
   12              12 
Dispositions
   (156             (156
  
 
 
  
 
 
   
 
 
  
 
 
   
 
 
 
At December 31, 2018
  $212  $110   $  $   $322 
Amortization
  
 
111
 
 
 
60
 
  
 
37
 
 
 
277
 
  
 
485
 
Impairment
 
 
 
 
 
 
 
 
(35
)
 
 
 
 
 
(35
)
Effect of movements in exchange rates
  
 
 
 
 
 
  
 
(2
)
 
 
 
 
  
 
(2
)
 
  
 
 
  
 
 
   
 
 
  
 
 
   
 
 
 
At December 31, 2019
  
$
323
 
 
$
170
 
  
$
 
 
$
277
 
  
$
770
 
  
 
 
  
 
 
   
 
 
  
 
 
   
 
 
 
 
Carrying amounts
  Computer
and office
equipment
   Leasehold
improvements
   ReDS

Demonstration
units
   Right of use
assets
   Total 
At December 31, 2018
  $258   $58   $   $   $316 
At December 31, 2019
  
$
197
 
  
$
 
  
$
 
  
$
1,085
 
  
$
1,282
 
  
 
 
   
 
 
   
 
 
   
 
 
   
 
 
 
XML 50 R55.htm IDEA: XBRL DOCUMENT v3.20.1
Property, plant and equipment (Details) - CAD ($)
$ in Thousands
12 Months Ended
Dec. 31, 2019
Dec. 31, 2018
Dec. 31, 2017
Disclosure of detailed information about property, plant and equipment [line items]      
Balance $ 316    
Amortization 485 $ 103 $ 1,173
Impairment (95)    
Balance 1,282 316  
Cost      
Disclosure of detailed information about property, plant and equipment [line items]      
Balance 638 584  
Additions 871 198  
Impairment (130)    
Effect of movements in exchange rates (4) 12  
Dispositions   (156)  
Balance 2,052 638 584
Impact of adoption of IFRS 16 (Note 4) 677    
Accumulated amortization and impairment losses      
Disclosure of detailed information about property, plant and equipment [line items]      
Balance 322 363  
Amortization 485 103  
Impairment (35)    
Effect of movements in exchange rates (2) 12  
Dispositions   (156)  
Balance 770 322 363
Computer And Office Equipment      
Disclosure of detailed information about property, plant and equipment [line items]      
Balance 258    
Balance 197 258  
Computer And Office Equipment | Cost      
Disclosure of detailed information about property, plant and equipment [line items]      
Balance 470 428  
Additions 50 186  
Impairment 0    
Effect of movements in exchange rates 0 12  
Dispositions   (156)  
Balance 520 470 428
Impact of adoption of IFRS 16 (Note 4) 0    
Computer And Office Equipment | Accumulated amortization and impairment losses      
Disclosure of detailed information about property, plant and equipment [line items]      
Balance 212 281  
Amortization 111 75  
Impairment 0    
Effect of movements in exchange rates 0 12  
Dispositions   (156)  
Balance 323 212 281
Leasehold improvements      
Disclosure of detailed information about property, plant and equipment [line items]      
Balance 58    
Balance 0 58  
Leasehold improvements | Cost      
Disclosure of detailed information about property, plant and equipment [line items]      
Balance 168 156  
Additions 2 12  
Impairment 0    
Effect of movements in exchange rates 0 0  
Dispositions   0  
Balance 170 168 156
Impact of adoption of IFRS 16 (Note 4) 0    
Leasehold improvements | Accumulated amortization and impairment losses      
Disclosure of detailed information about property, plant and equipment [line items]      
Balance 110 82  
Amortization 60 28  
Impairment 0    
Effect of movements in exchange rates 0 0  
Dispositions   0  
Balance 170 110 82
ReDS Demonstration Units [Member]      
Disclosure of detailed information about property, plant and equipment [line items]      
Balance 0    
Additions 67    
Balance 0 0  
ReDS Demonstration Units [Member] | Cost      
Disclosure of detailed information about property, plant and equipment [line items]      
Balance 0 0  
Additions 134 0  
Impairment (130)    
Effect of movements in exchange rates (4) 0  
Dispositions   0  
Balance 0 0 0
Impact of adoption of IFRS 16 (Note 4) 0    
ReDS Demonstration Units [Member] | Accumulated amortization and impairment losses      
Disclosure of detailed information about property, plant and equipment [line items]      
Balance 0 0  
Amortization 37 0  
Impairment (35)    
Effect of movements in exchange rates (2) 0  
Dispositions   0  
Balance 0 0 0
Right-of-use assets [member]      
Disclosure of detailed information about property, plant and equipment [line items]      
Balance 0    
Balance 1,085 0  
Right-of-use assets [member] | Cost      
Disclosure of detailed information about property, plant and equipment [line items]      
Balance 0 0  
Additions 685 0  
Impairment 0    
Effect of movements in exchange rates 0 0  
Dispositions   0  
Balance 1,362 0 0
Impact of adoption of IFRS 16 (Note 4) 677    
Right-of-use assets [member] | Accumulated amortization and impairment losses      
Disclosure of detailed information about property, plant and equipment [line items]      
Balance 0 0  
Amortization 277 0  
Impairment 0    
Effect of movements in exchange rates 0 0  
Dispositions   0  
Balance $ 277 $ 0 $ 0
XML 51 R51.htm IDEA: XBRL DOCUMENT v3.20.1
Accounts receivable (Details) - CAD ($)
$ in Thousands
Dec. 31, 2019
Dec. 31, 2018
Trade and other receivables [abstract]    
Trade accounts receivable $ 10,136 $ 9,678
Other accounts receivable 80 1,087
Accounts receivable $ 10,216 $ 10,765
XML 52 R9.htm IDEA: XBRL DOCUMENT v3.20.1
New standards and interpretations
12 Months Ended
Dec. 31, 2019
Disclosure of initial application of standards or interpretations [abstract]  
New standards and interpretations
4.
New standards and interpretations
IFRS 16,
Leases
(“IFRS 16”)
Effective January 1, 2019, the Company has adopted IFRS 16 using the modified retrospective approach, re
co
g
nizing a right of use asse
t
equal to
the 
lease liability at
 the date
o
f initial application, and prior periods
were
not restated. IFRS 16 which requires lessees to recognize assets and liabilities for most leases, with exemptions available for leases with a term that is twelve months or less, or where the underlying asset is of a low value.
Unless exempted, as noted above, upon inception of a lease, lessees will be required to recognize a
right-of
use (“ROU”) asset, representing the Company’s right to use the underlying asset and a lease liability representing its obligation for lease payments due to the lessor. ROU assets and the corresponding liability are initially measured at the present value of
non-cancellable
payments, including those made in accordance with an option period when the Company expects to exercise an option period to extend or not terminate a lease.
Effective November 1, 2014, the Company entered into a
sub-lease
with Genesys Venture Inc.
(“GVI”), a related party as described in note 17(b),
to lease office space at a rate of $170 per annum for three years ending October 31, 2017, with an
18-month
renewal period available. The lease was amended on May 1, 2016 and increased the leased area covered under the lease agreement at a rate of $212 per annum until October 31, 2019 with an
18-month
renewal
period available. The leased area covered under the lease was again increased, effective November 1, 2018 at a rate of $306 per annum until the end of the term of the lease.
 
The discount rate used by the Company in calculatin
g
the lease obligation relating to the ROU asset is five percent. 
The impact of the adoption of IFRS 16 on the Company’s statement of financial position at January 1, 2019 is as follows:
 
   
December 31, 2018
   
Impact of transition to IFRS 16
   
January 1, 2019
 
Assets
      
Property and equipment
  
$
316
 
  
$
677
 
  
$
993
 
Current liabilities
      
Lease obligation
  
$
—  
 
  
$
300
 
  
$
300
 
Non-current
liabilities
      
Lease obligation
  
$
—  
 
  
$
377
 
  
$
377
 
  
 
 
   
 
 
   
 
 
 
  
$
316
 
  
$
—  
 
  
$
316
 
  
 
 
   
 
 
   
 
 
 
The impact of the adoption of the Company’s operating lease commitments to the lease obligations
recognized
as a result of the adoption of IFRS 16 is as
follows
:
 
Operating lease commitments, including renewal options, as at December 31, 2018
  $715 
Adjustment of lease commitments to present value of lease liability
   (38
  
 
 
 
Lease obligation as at January 1, 2019
  $677 
  
 
 
 
 
Effective November 1, 2019, the Company modified and extended its sub-lease with GVI to lease a reduced amount of
office
space at a rate of $238 per annum for three years ending October 31, 2022 with an 18-month renewal period available. This resulted in an increase to the ROU asset of $685. As at December 31, 2019, the lease obligation of the statement of financial position totaled $1,089 with $240 recorded as the current portion of the lease obligation.
XML 53 R59.htm IDEA: XBRL DOCUMENT v3.20.1
Holdback receivable (Detail Textuals)
$ in Thousands, $ in Thousands
12 Months Ended
Dec. 05, 2019
CAD ($)
Dec. 05, 2019
USD ($)
Dec. 31, 2019
CAD ($)
Dec. 31, 2018
CAD ($)
Dec. 31, 2017
CAD ($)
Dec. 05, 2019
USD ($)
Oct. 02, 2017
CAD ($)
Oct. 02, 2017
USD ($)
Disclosure Of Holdback Receivable [Line Items]                
Holdback receivable (Note 5&10) $ 3,623     $ 11,909        
Amount of allowance against the holdback receivable     $ 3,623 1,473 $ (83)      
Other liabilities       $ 1,201        
Receipt of holdback receivable funds 6,719 $ 5,100            
Apicore                
Disclosure Of Holdback Receivable [Line Items]                
Holdback receivable (Note 5&10)             $ 11,941 $ 10,000
Other liabilities $ 1,165         $ 880    
XML 54 R1.htm IDEA: XBRL DOCUMENT v3.20.1
Cover
12 Months Ended
Dec. 31, 2019
shares
Cover [Abstract]  
Entity Registrant Name MEDICURE INC
Entity Central Index Key 0001133519
Trading Symbol mph
Entity Current Reporting Status Yes
Entity Filer Category Non-accelerated Filer
Current Fiscal Year End Date --12-31
Entity Well-known Seasoned Issuer No
Entity Common Stock, Shares Outstanding 10,804,013
Document Type 20-F
Document Period End Date Dec. 31, 2019
Amendment Flag false
Document Fiscal Year Focus 2019
Document Fiscal Period Focus FY
Entity Emerging Growth Company false
Entity Shell Company false
Entity Address, Country CA
Entity Interactive Data Current Yes
Entity Voluntary Filers No
Document Accounting Standard International Financial Reporting Standards
Document Annual Report true
Document Transition Report false
Document Shell Company Report false
Title of 12(g) Security Common Shares
XML 55 R5.htm IDEA: XBRL DOCUMENT v3.20.1
Consolidated Statements of Cash Flows - CAD ($)
$ in Thousands
12 Months Ended
Dec. 31, 2019
Dec. 31, 2018
Dec. 31, 2017
Cash (used in) provided by: Operating activities:      
Net (loss) income from continuing operations for the year $ (19,786) $ 3,926 $ 11,497
Net income from discontinued operations for the year (Note 5)     31,924
Net (loss) income (19,786) 3,926 43,421
Adjustments for:      
Gain on sale of Apicore (Note 5)     (55,254)
Current income tax expense (recovery) (Note 14) 22 678 (9,393)
Deferred income tax expense (recovery) (Note 14) 123 219 (1,514)
Impairment of intangible assets (Note 9) 6,321   636
Impairment of property, plant and equipment (Note 8) 95    
Revaluation of holdback receivable (Note 10) 3,623 1,473 (83)
Amortization of property, plant and equipment (Note 8) 485 103 1,173
Amortization of intangible assets (Note 9) 1,438 196 6,634
Share-based compensation (Note 13(c)) 417 1,022 623
Write-down of inventories (Note 7) 1,983 95 385
Finance (income) expense, net (Note 15) (1,115) (1,061) 837
Unrealized foreign exchange (gain) loss 362 (5,323) 271
Change in the following:      
Accounts receivable (318) (1,341) (3,713)
Inventories (4,072) (1,259) 145
Prepaid expenses 842 (1,793) 77
Other assets 78   33
Accounts payable and accrued liabilities (4,992) 7,132 48,398
Deferred revenue     (621)
Other long-term liabilities     77
Interest received (paid), net (Note 15) 1,685 255 (7,486)
Income taxes paid (Note 14) (477) (2,041) (894)
Royalties paid (Note 12) (1,355) (1,539) (1,829)
Cash flows (used in) from operating activities (14,641) 742 21,923
Investing activities:      
Investment in Sensible Medical (Note 11) (6,337)    
Proceeds from Apicore Sale Transaction (Note 5)   65,235 89,720
Receipt of holdback receivable funds (Note 10) 6,719    
Redemptions (purchase) of short-term investments 47,747 (44,100)  
Acquisition of Class C common shares of Apicore (Note 5)     (31,607)
Acquisition of Class E common shares of Apicore (Note 5)     (2,641)
Acquisition of property, plant and equipment (Note 8) (186) (197) (1,195)
Acquisition of intangible assets (Note 9) (13,660) (1,281) (127)
Cash flows from investing activities 34,283 19,657 54,150
Financing activities:      
Repurchase of common shares under substantial issuer bid (Note 13(b)) (26,139)    
Repurchase of common shares under normal course issuer bid (Note 13(b)) (4,145) (3,021)  
Proceeds from exercise of stock options (Note 13 (c)) 20 363 520
Proceeds from exercise of Apicore stock options (Note 13 (c))     422
Proceeds from exercise of warrants (Note 13 (d))     92
Repayment of long-term debt     (75,181)
Repayment of note payable to Apicore (Note 5)     (18,507)
Increase in short-term borrowings     162
Decrease in cash held in escrow     12,809
Finance lease payments     (102)
Payment of due to vendor (Note 5)     (3,186)
Cash flows used in financing activities (30,264) (2,658) (82,971)
Foreign exchange (loss) gain on cash held in foreign currency (552) 1,138 (108)
(Decrease) increase in cash (11,174) 18,879 (7,006)
Cash and cash equivalents, beginning of period 24,139 5,260 12,266
Cash and cash equivalents, end of period $ 12,965 $ 24,139 $ 5,260
XML 56 R82.htm IDEA: XBRL DOCUMENT v3.20.1
Commitments and contingencies (Detail Textuals)
€ in Thousands, $ in Thousands, $ in Thousands
12 Months Ended
Jan. 01, 2019
CAD ($)
Dec. 31, 2017
USD ($)
Dec. 31, 2019
USD ($)
Dec. 31, 2019
EUR (€)
Commitments And Contingencies [Line Items]        
Unfinished product inventory     $ 218  
Business and administration agreement with GVI        
Commitments And Contingencies [Line Items]        
Term of agreement 1 year      
Amount committed to pay under the agreement, per month $ 7      
Amount committed to pay under the agreement, per year $ 85      
Bottom of range        
Commitments And Contingencies [Line Items]        
Unfinished product inventory | €       € 400
Top of range        
Commitments And Contingencies [Line Items]        
Unfinished product inventory | €       € 525
AGGRASTAT        
Commitments And Contingencies [Line Items]        
Unfinished product inventory     $ 150  
Prexxartan | Exclusive License Agreement        
Commitments And Contingencies [Line Items]        
Term of agreement   7 years    
Upfront payment   $ 100    
Additional amount payable   $ 400    
XML 57 R72.htm IDEA: XBRL DOCUMENT v3.20.1
Capital Stock (Detail Textuals 3) - shares
12 Months Ended
Dec. 31, 2019
Dec. 31, 2018
Dec. 31, 2017
Disclosure Of Capital Stock [Abstract]      
Anti-dilutive stock option excluded from calculation of diluted earnings per share before discontinued operations as exercise price exceeded the share price on TSX Venture Exchange 1,428,408 622,375 900
Anti-dilutive warrants excluded from calculation of diluted earnings per share before discontinued operations as exercise price exceeded the share price on TSX Venture Exchange 900,000 900,000  
XML 58 R76.htm IDEA: XBRL DOCUMENT v3.20.1
Income taxes (Details 3)
$ in Thousands
Dec. 31, 2019
CAD ($)
US [Member]  
Income Tax [Line Items]  
Losses available for application in future years $ 243
2039 | US [Member]  
Income Tax [Line Items]  
Losses available for application in future years 243
Barbados  
Income Tax [Line Items]  
Losses available for application in future years 6,237
Barbados | 2020  
Income Tax [Line Items]  
Losses available for application in future years 1,210
Barbados | 2021  
Income Tax [Line Items]  
Losses available for application in future years 1,275
Barbados | 2022  
Income Tax [Line Items]  
Losses available for application in future years $ 3,752
XML 59 R86.htm IDEA: XBRL DOCUMENT v3.20.1
Related party transactions (Detail Textuals 1) - CAD ($)
$ in Thousands
12 Months Ended
Dec. 31, 2019
Dec. 31, 2018
Dec. 31, 2017
Key management personnel of entity or parent      
Disclosure of amounts incurred by entity for provision of key management personnel services provided by separate management entities [line items]      
Voting shares of Directors and key management personnel control   23.00% 17.00%
Genesys Venture Inc      
Disclosure of amounts incurred by entity for provision of key management personnel services provided by separate management entities [line items]      
Business administration services $ 85 $ 85 $ 85
Rental costs 295 228 212
Commercial and information technology support services $ 47 $ 47 $ 44
XML 60 R48.htm IDEA: XBRL DOCUMENT v3.20.1
Discontinued operations (Details) - CAD ($)
$ in Thousands
12 Months Ended
Dec. 31, 2019
Dec. 31, 2018
Dec. 31, 2017
Disclosure Of Detailed Information Discontinued Operations [Line Items]      
Gain on disposition of the Apicore business     $ 55,254
Income from discontinued operations     31,924
Apicore      
Disclosure Of Detailed Information Discontinued Operations [Line Items]      
Revenue 22,759
Expenses     (47,936)
(Loss) income from discontinued operations     (25,177)
Income tax recovery     1,847
Loss after income tax recovery     (23,330)
Gain on disposition of the Apicore business     55,254
Income from discontinued operations     $ 31,924
XML 61 R40.htm IDEA: XBRL DOCUMENT v3.20.1
Related party transactions (Tables)
12 Months Ended
Dec. 31, 2019
Disclosure of transactions between related parties [abstract]  
Schedule of compensation paid to key management personnel
In addition to their salaries, the Company also provides
non-cash
benefits and participation in the Stock Option Plan. The following table details the compensation paid to key management personnel:
 
Year ended December 31
  
2019
   2018   2017 
Salaries, fees and short-term benefits
  
$
781
 
  $770   $1,463 
Share-based payments
  
 
208
 
   669    139 
  
 
 
   
 
 
   
 
 
 
  
$
989
 
  $1,439   $1,602 
  
 
 
   
 
 
   
 
 
 
XML 62 R44.htm IDEA: XBRL DOCUMENT v3.20.1
Significant accounting policies (Details)
12 Months Ended
Dec. 31, 2019
Computers, office equipment, furniture and fixtures  
Disclosure of detailed information about property, plant and equipment [line items]  
Method of depreciation Straight-line
Depreciation rates 20% to 25
Leasehold improvements  
Disclosure of detailed information about property, plant and equipment [line items]  
Method of depreciation Straight-line
Depreciation rates Term of lease
ReDS Demonstration Units [Member]  
Disclosure of detailed information about property, plant and equipment [line items]  
Method of depreciation Straight-line
Depreciation rates 33
Right-of-use assets [member]  
Disclosure of detailed information about property, plant and equipment [line items]  
Method of depreciation Straight-line
Depreciation rates Term of lease
XML 63 R67.htm IDEA: XBRL DOCUMENT v3.20.1
Capital Stock (Details 6)
12 Months Ended
Dec. 31, 2019
$ / shares
Dec. 31, 2019
$ / shares
Dec. 31, 2018
$ / shares
Dec. 31, 2018
$ / shares
Dec. 31, 2017
$ / shares
Dec. 31, 2017
$ / shares
Basic earnings per share            
Net earnings before discontinued operations $ (1.32)   $ 0.25   $ 0.74  
Earnings from discontinued operations, net of tax | (per share)         2.04 $ 2.04
Total (1.32)   0.25   2.78  
Diluted earnings per share            
Net earnings before discontinued operations | (per share) (1.32) $ (1.32) 0.24 $ 0.24 0.63 0.63
Earnings from discontinued operations, net of tax | (per share)         1.76 1.76
Total | (per share) $ (1.32) $ (1.32) $ 0.24 $ 0.24 $ 2.39 $ 2.39
XML 64 R63.htm IDEA: XBRL DOCUMENT v3.20.1
Capital Stock (Details 1)
12 Months Ended
Dec. 31, 2019
shares
$ / shares
Dec. 31, 2018
shares
$ / shares
Dec. 31, 2017
shares
$ / shares
Options      
Balance | shares 1,394,642 1,602,127 1,387,000
Granted | shares 262,000 200,000 476,000
Exercised | shares (8,001) (206,885) (207,950)
Forfeited, cancelled or expired | shares (220,233) (200,600) (52,923)
Balance | shares 1,428,408 1,394,642 1,602,127
Options exercisable, end of period | shares 1,059,308 1,044,892 1,231,127
Weighted average exercise price      
Balance | $ / shares $ 3.91 $ 3.58 $ 2.37
Granted | $ / shares 4.95 7.25 7.20
Exercised | $ / shares (2.45) (1.76) (2.50)
Forfeited, cancelled or expired | $ / shares (6.75) (6.85) (8.58)
Balance | $ / shares 3.67 3.91 3.58
Options exercisable, end of period | $ / shares $ 2.88 $ 2.80 $ 2.50
XML 65 R93.htm IDEA: XBRL DOCUMENT v3.20.1
Financial instruments (Detail Textuals)
$ in Thousands
12 Months Ended
Dec. 31, 2019
CAD ($)
Customer
Dec. 31, 2018
CAD ($)
Customer
Dec. 31, 2017
CAD ($)
Customer
Disclosure of detailed information about financial instruments [line items]      
Other comprehensive loss in Sensible Medical $ 6,336    
Fair value measurement, Discount rate 20.00%    
Concentration of credit risk, Percentage Of Accounts Receivable 96.00% 91.00% 96.00%
Number of customers owing greater than 10% of accounts receivable | Customer 3 3 3
Bad debt expenses  
Discount rate, measurement input      
Disclosure of detailed information about financial instruments [line items]      
Increase in discount rate for calculating royalty obligation 1.00%    
Discount rate, measurement input | Non Current Portion Of Acquistion Payable [Member]      
Disclosure of detailed information about financial instruments [line items]      
Increase in discount rate for calculating royalty obligation 1.00%    
Fair value measurement, Discount rate 10.00%    
Increase decrease in the fair value of liabilitites due to changes in discount rate $ 28    
Other price risk      
Disclosure of detailed information about financial instruments [line items]      
Amount of Change in net income due to 5% appreciation or deterioration of the Canadian dollar against the U.S. dollar 448 3,700  
Interest rate risk      
Disclosure of detailed information about financial instruments [line items]      
Amount of Change in net income due to 1% appreciation or deterioration of the Canadian dollar against the U.S. dollar 130 720  
AGGRASTAT      
Disclosure of detailed information about financial instruments [line items]      
Amount of Change in royalty obligation liability if the expected revenue from AGGRASTAT sales were to change by 10% 257 211  
Amount of Change in royalty obligation liability if If the discount rate used in calculating the fair value of the royalty obligation of 20% were to change by 1% $ 15 22  
Level 3 | Accounts payable and accrued liabilities      
Disclosure of detailed information about financial instruments [line items]      
Current portion of the license fee payable   $ 546  
XML 66 R25.htm IDEA: XBRL DOCUMENT v3.20.1
Determination of fair values
12 Months Ended
Dec. 31, 2019
Disclosure Of Fair Value Measurement Explanatory [Abstract]  
Determination of fair values
20.
Determination of fair values
A number of the Company’s accounting policies and disclosures require the determination of fair value, for both financial and
non-financial
assets and liabilities. Fair values have been determined for measurement and/or disclosure purposes based on the following models. When applicable, further information about the assumptions made in determining fair values is disclosed in the notes specific to that asset or liability.
 
 
(a)
Intangible assets
The fair value of intangible assets is based on the discounted cash flows expected to be derived from the use and eventual sale of the assets.
 
 
(b)
Investment in Sensible Medical
The investment in Sensible Medical is the fair value associated with the Company’s equity investment in Sensible Medical and is classified as FVOCI. The change in the Investment in Sensible Medical is recorded through other comprehensive (loss) income in the consolidated statement of net (loss) income and comprehensive (loss) income. The investment in Sensible Medical was recorded at fair value at the date at which it was acquired and subsequently revalued at each reporting date. Estimating fair value for this asset requires determining the most appropriate valuation model and determining the most appropriate inputs to the valuation model, including publicly traded companies similar to Sensible Medical to use as a proxy in the valuation model, a discount rate for lack of marketability of the investment and estimated costs to dispose of the investment.
 
 
(
c
)
Share-based payment transactions
The fair value of the employee share options is measured using the
Black-Scholes
option pricing model. Measurement inputs include share price on measurement date, exercise price of the instrument, expected volatility (based on weighted average historical volatility adjusted for changes expected due to publicly available information), weighted average expected life of the instruments (based on historical experience and general option holder behavior), expected dividends, and the
risk-free
interest rate (based on government bonds). Service and
non-market
performance conditions attached to the transactions are not taken into account in determining fair value.
 
 
(
d
)
Royalty obligation
The royalty obligation is recorded at its fair value at the date at which the liability was incurred and subsequently measured at amortized cost using the effective interest rate method at each reporting date. Estimating fair value for this liability requires determining the most appropriate valuation model which is dependent on its underlying terms and conditions. This estimate also requires determining expected revenue from AGGRASTAT
®
sales and an appropriate discount rate and making assumptions about them.
 
 
(
e
)
Acquisition payable
The acquisition payable is recorded at its fair value at the date at which the liability was incurred and subsequently measured at amortized cost using the effective interest rate method at each reporting date. Estimating fair value for this liability requires determining the most appropriate valuation model which is dependent on its underlying terms and conditions. This estimate also requires determining an appropriate discount rate and making assumptions about it.
 
 
(
f
)
Holdback receivable
The holdback receivable was recorded at its fair value at the date of acquisition and subsequently measured at fair value at each reporting date. Estimating fair value for this asset required determining the most appropriate valuation model which is dependent on its underlying terms and conditions. This estimate also required determining expected cash flows from this receivable including potential claims from the Buyer in the Apicore Sale Transaction (Note 10) and an appropriate discount rate and making assumptions about them.
XML 67 R21.htm IDEA: XBRL DOCUMENT v3.20.1
Commitments and contingencies
12 Months Ended
Dec. 31, 2019
Disclosure Of Commitment And Contingencies [Abstract]  
Commitments and contingencies
16.
Commitments and contingencies
 
 
(a)
Commitments
As at December 31, 2019, and in the normal course of business, the Company has obligations to make future payments representing contracts and other commitments that are known and committed as follows:
 
2020
  $3,043 
2021
   1,243 
2022
   1,243 
2023
   195 
2024
   195 
  
 
 
 
  $5,919 
  
 
 
 
The Company has entered into a manufacturing and supply agreement to purchase a minimum quantity of AGGRASTAT
®
unfinished product inventory totaling US$150 annually (based on current pricing) until 2024 and a minimum quantity of AGGRASTAT
®
finished product inventory totaling US$218 annually (based on current pricing) until 2022 and
525 annually (based on current pricing) until 2022.
Effective January 1, 2019, the Company renewed its business and administration services agreement with GVI, as described in note 1
7
(b), under which the Company is committed to pay $7 per month or $85 per year for a
one-year
term.
Contracts with contract research organizations are payable over the terms of the associated agreements and clinical trials and timing of payments is largely dependent on various milestones being met, such as the number of patients recruited, number of monitoring visits conducted, the completion of certain data management activities, trial completion, and other trial related activities.
On October 31, 2017, the Company acquired an exclusive license to sell and market PREXXARTAN
®
(valsartan) oral solution in the United States and its territories with a seven-year term, with extensions to the term available, which had been granted tentative approval by the U.S. Food and Drug Administration (“FDA”), and which was converted to final approval during 2017. The Company acquired the exclusive license rights for an upfront payment of US$100, with an additional US$400 payable on final FDA approval and will be obligated to pay royalties and milestone payments from the net revenues of PREXXARTAN
®
. The US$400 payment is on hold pending resolution of the dispute between the licensor and the third-party manufacturer of PREXXARTAN
®
described in note 16(d) and is recorded within accounts payable and accrued liabilities on the consolidated statements of financial position.
On December 14, 2017 the Company acquired an exclusive license to sell and market a branded cardiovascular drug, ZYPITAMAG
TM
(pitavastatin magnesium) in the United States and its territories for a term of seven years with extensions to the term available. The Company had entered into a profit-sharing arrangement resulting in a portion of the net profits from ZYPITAMAG
TM
being paid to the licensor. No amounts are due and/or payable pertaining to profit sharing on this product and the profit-sharing arrangement was eliminated with the Company’s acquisition of ZYPITAMAG
TM
on September 30, 2019 as described in note 9.
 
 
(b)
Guarantees
The Company periodically enters into research agreements with third parties that include indemnification provisions customary in the industry. These guarantees generally require the Company to compensate the other party for certain damages and costs incurred as a result of claims arising from research and development activities undertaken on behalf of the Company. In some cases, the maximum potential amount of future payments that could be required under these indemnification provisions could be unlimited. These indemnification provisions generally survive termination of the underlying agreement. The nature of the indemnification obligations prevents the Company from making a reasonable estimate of the maximum potential amount it could be required to pay. Historically, the Company has not made any indemnification payments under such agreements and no amount has been accrued in the consolidated financial statements with respect to these indemnification obligations.
 
 
(c)
Royalties
As a part of the Birmingham debt settlement described in note 12, beginning on July 18, 2011, the Company is obligated to pay a royalty to Birmingham based on future commercial AGGRASTAT
®
sales until 2023. The royalty is based on 4% of the first $
2,000
of quarterly AGGRASTAT
®
sales, 6% on the portion of quarterly sales between $
2,000
and $
4,000
and 8% on the portion of quarterly sales exceeding $
4,000
payable within 60 days of the end of the preceding three-month periods ended February 28, May 31, August 31 and November 30. Birmingham has a
one-time
option to switch the royalty payment from AGGRASTAT
®
to a royalty on the sale of
MC-1.
Management has determined there is no value to the option to switch the royalty to
MC-1
as the product is not commercially available for sale and the extended long-term development timeline associated with commercialization of the product. Royalties for the year ended December 31, 2019 totaled $1,023 (2018 – $1,654; 2017 – $1,243) with payments made during the year ended December 31, 2019 of $1,355 (2018 – $1,539; 2017 – $1,829).
Beginning with the acquisition of ZYPITAMAG
TM
(note 9), completed on September 30, 2019, the Company is obligated to pay royalties on any commercial net sales of ZYPITAMAG
TM
to Zydus
subsequent to
the acquisition
 date
. During the three months ended December 31, 2019, the Company accrued $2 in royalties in regards to ZYPITAMAG
TM
which is recorded within cost of goods sold on the statement of net (loss) income and comprehensive (loss) income and within accounts payable and accrued liabilities on the statement of financial position as at December 31, 2019.
The Company is obligated to pay royalties on any future commercial net sales of PREXXARTAN
®
to the licensor of PREXXARTAN
®
. To date, no royalties are due and/or payable.
 
 
(d)
Contingencies
In the normal course of business, the Company may from time to time be subject to various claims or possible claims. Although management currently believes there are no claims or possible claims that if resolved would either individually or collectively result in a material adverse impact on the Company’s financial position, results of operations, or cash flows, these matters are inherently uncertain and management’s view of these matters may change in the future.
During 2018, the Company was named in a civil claim in Florida from the third-party manufacturer of PREXXARTAN
®
 against the licensor. The claim disputed the rights granted by the licensor to the Company with respect to PREXXARTAN
®
. The claim against the Company has since been withdrawn, however the dispute between the licensor and the third-party manufacturer continues.
On September 10, 2015, the Company submitted a supplemental New Drug Application (“sNDA”) to the FDA to expand the label for AGGRASTAT
®
. The label change is being reviewed and evaluated based substantially on data from published studies. If the label change submission were to be successful, the Company will be obligated to pay €300 over the course of a three-year period in equal quarterly instalments following approval. On July 7, 2016, the Company announced it received a Complete Response Letter stating the sNDA cannot be approved in its present form and requested additional information.
The payments are contingent upon the success of the filing and as such the Company has not recorded any amount in the consolidated statements of net (loss) income and comprehensive (loss) income pertaining to this contingent liability.
During 2015, the Company began a development project of a cardiovascular generic drug in collaboration with Apicore. The Company has entered into a supply and development agreement under which the Company holds all commercial rights to the drug. In connection with this project, the Company is obligated to pay Apicore
50
% of net profit from the sale of this drug. On August 13, 2018, the Company announced that the FDA has approved its
A
NDA for SNP, a generic intravenous cardiovascular product and the product became available commercially during the third quarter of 2019. To date, no amounts are due and/or payable pertaining to profit sharing on this product.
XML 68 R29.htm IDEA: XBRL DOCUMENT v3.20.1
Significant accounting policies (Tables)
12 Months Ended
Dec. 31, 2019
Disclosure Of Significant Accounting Policies [Abstract]  
Schedule of estimated useful lives of property, plant and equipment
Asset
  Basis   Rate 
Computers, office equipment, furniture and fixtures
   
Straight-line
    20% to 25
Leasehold improvements
   Straight-line    Term of lease 
ReDS
demonstration units
   Straight-line    33
Right of use assets
   Straight-line    Term of lease 
XML 69 R32.htm IDEA: XBRL DOCUMENT v3.20.1
Accounts receivable (Tables)
12 Months Ended
Dec. 31, 2019
Trade and other receivables [abstract]  
Schedule of accounts receivable
As at December 31
  
2019
   2018 
Trade accounts receivable
  
$
10,136
 
  $9,678 
Other accounts receivable
  
 
80
 
   1,087 
  
 
 
   
 
 
 
  
$
10,216
 
  $10,765 
  
 
 
   
 
 
 
XML 70 R36.htm IDEA: XBRL DOCUMENT v3.20.1
Capital Stock (Tables)
12 Months Ended
Dec. 31, 2019
Disclosure Of Capital Stock [Abstract]  
Schedule of shares issued and outstanding
   Number of Common Shares   Amount 
Balance, December 31, 2017
   15,782,327   $ 125,734 
Shares issued upon exercise of stock options (12(c))
   206,885    654 
Shares repurchased and cancelled under a normal course issuer bid
(*)
   (441,400   (3,501
  
 
 
   
 
 
 
Balance, December 31, 2018
   15,547,812   $122,887 
Shares issued upon exercise of stock options (12(c))
   8,001    37 
Shares repurchased and cancelled under a normal course issuer bid
(*)
   (751,800   (5,955
Shares repurchased and cancelled under a substantial issuer bid
(2)
   (4,000,000   (31,605
  
 
 
   
 
 
 
Balance, December 31, 2019
  
 
10,804,013
 
  
$
85,364
 
  
 
 
   
 
 
 
 
 
(1)
On May 16, 2018, the Company announced that the
TSX-V
accepted the Company’s notice of its intention to make a normal course issuer bid (the “2018 NCIB”). Under the terms of the 2018 NCIB, the Company could have acquired up to an aggregate of 794,088 common shares, representing five percent of the common shares outstanding at the time of the application, over the twelve-month period that the 2018 NCIB was in place. The 2018 NCIB commenced on May 28, 2018 and ended on May 27, 2019. During the twelve months of the 2018 NCIB, the Company purchased and cancelled 771,900 common shares for a total cost of $5,085. The prices that the Company paid for the common shares purchased was the market price of the shares at the time of purchase.
On May 30, 2019, the Company announced that the
TSX-V
accepted the Company’s notice of intention to make an additional normal course issuer bid (the “2019 NCIB”). Under the terms of the 2019 NCIB, the Company may acquire up to an aggregate of 761,141 common shares, representing five percent of the common shares outstanding at the time of the application, over the twelve-month period that the 2019 NCIB is in place. The 2019 NCIB commenced on May 30, 2019 and will end on May 29, 2020, or on such earlier date as the Company may complete its maximum purchases allowed under the 2019 NCIB. From the commencement of the 2019 NCIB, the Company purchased and cancelled 421,300 common shares for a total cost of $2,081. The prices that the Company paid or will pay for common shares purchased was or will be the market price of the shares at the time of purchase.
During the year ended December 31, 2019, the Company repurchased and cancelled 751,800 (2018 – 441,400), common shares as a result of the 2018 NCIB and 2019 NCIB. The aggregate price paid for these common shares totaled $4,145 (2018—$3,021). During the year ended December 31, 2019 the Company recorded $1,812 (2018—$480) directly in its retained deficit representing the difference between the aggregate price paid for these common shares and a reduction of the Company’s share capital totaling $5,958 (2018—$3,501).
 
 
(2)
On December 20, 2019, the Company completed a Substantial Issuer Bid (“SIB”) pursuant to which the Company purchased 4,000,000 of its common shares for cancellation at a set purchase price of $6.50 per common share for a total purchase price of $26,000 in cash. The Company incurred an additional $138 on transaction costs related to the SIB for a total aggregate purchase price paid of $26,138. During the year ended December 31, 2019, the Company recorded $5,466 directly in its retained deficit representing the difference between the aggregate price paid for these common shares and a reduction of the Company’s share capital totaling $31,605.
Schedule of changes in stock options
Year ended December 31, 2019
  Options   Weighted
average
exercise
price
 
Balance, beginning of period
   1,394,642   $3.91 
Granted
   262,000    4.95 
Exercised
   (8,001   (2.45
Forfeited, cancelled or expired
   (220,233   (6.75
  
 
 
   
 
 
 
Balance, end of period
  
 
1,428,408
 
  
$
3.67
 
  
 
 
   
 
 
 
Options exercisable, end of period
  
 
1,059,308
 
  
$
2.88
 
  
 
 
   
 
 
 
 
Year ended December 31
  2018   2017 
   Options   Weighted
average
exercise
price
   Options   Weighted
average
exercise
price
 
Balance, beginning of period
   1,602,127   $3.58    1,387,000   $2.37 
Granted
   200,000    7.25    476,000    7.20 
Exercised
   (206,885   (1.76   (207,950   (2.50
Forfeited, cancelled or expired
   (200,600   (6.85   (52,923   (8.58
  
 
 
   
 
 
   
 
 
   
 
 
 
Balance, end of period
   1,394,642   $3.91    1,602,127   $3.58 
  
 
 
   
 
 
   
 
 
   
 
 
 
Options exercisable, end of period
   1,044,892   $2.80    1,231,127   $2.50 
  
 
 
   
 
 
   
 
 
   
 
 
 
Schedule of contractual life of options outstanding
 
Range of
exercise prices
  Number
outstanding
   Weighted
average
remaining
contractual life
   Options outstanding
weighted average
exercise price
   Number
exercisable
 
$0.30
   185,000    3.35 years   $ 0.30    185,000 
$1.01
-
$3.00
   539,433    2.30 years   $1.59    539,433 
$3.01
-
$4.00
   29,000    0.90 years   $3.90    29,000 
$4.01 - $5.00
   262,000    4.49 years   $4.95    52,400 
$5.01 - $7.30
   412,975    2.76 years   $7.08    253,475 
  
 
 
   
 
 
   
 
 
   
 
 
 
$0.30
-
$7.30
   1,428,408    2.94 years   $3.67    1,059,308 
  
 
 
   
 
 
   
 
 
   
 
 
 
Schedule of fair value of the options using the Black-Scholes option pricing model
Years ended December 31:
  
2019
  2018  2017 
Expected option life
  
 
4.4 years
 
  4.4 years   4.5 years 
Risk free interest rate
  
 
1.40
  
1.92%-2.04
  1.71
Dividend yield
  
 
n
il
 
  
n
il
   nil 
Expected volatility
  
 
47.10
  
85.14%-93.72
  80.44
  
 
 
  
 
 
  
 
 
 
Schedule of changes in warrants outstanding
 
Years ended December 31
  
2019
   2018   2017 
   
Warrants
   
Weighted
average
exercise
price
   Warrants   Weighted
average
exercise
price
   Warrants  Weighted
average
exercise
price
 
Balance, beginning of period
  
 
900,000
 
  
$
6.50
 
   900,000   $6.50    941,969  $6.31 
Exercised
  
 
 
  
 
 
           (41,969  (2.20
  
 
 
   
 
 
   
 
 
   
 
 
   
 
 
  
 
 
 
Balance, end of period
  
 
900,000
 
  
$
6.50
 
   900,000   $6.50    900,000  $6.50 
  
 
 
   
 
 
   
 
 
   
 
 
   
 
 
  
 
 
 
Warrants exercisable, end of period
  
 
900,000
 
  
$
6.50
 
   900,000   $6.50    900,000  $6.50 
  
 
 
   
 
 
   
 
 
   
 
 
   
 
 
  
 
 
 
Schedule of calculation of basic and diluted earnings per share
Year ended December 31
  
2019
   2018   2017 
Net (loss) earnings before discontinued operations
  
$
(1.32
  $0.25   $0.74 
Earnings from discontinued operations, net of tax
  
 
—  
 
   —      2.04 
  
 
 
   
 
 
   
 
 
 
  
$
(1.32
  $0.25   $2.78 
  
 
 
   
 
 
   
 
 
 
Year ended December 31
  
2019
   2018   2017 
Net (loss) earnings before discontinued operations
  
$
(1.32
  $0.24   $0.63 
Earnings from discontinued operations, net of tax
  
 
—  
 
   —      1.76 
  
 
 
   
 
 
   
 
 
 
  
$
(1.32
  $0.24   $2.39 
  
 
 
   
 
 
   
 
 
 
Schedule of basic and diluted earnings per share
Year ended December 31
  
2019
   2018   2017 
Net (loss) earnings before discontinued operations
  
$
(19,786
  $3,926   $11,497 
Earnings from discontinued operations, net of tax
  
 
—  
 
   —      31,924 
  
 
 
   
 
 
   
 
 
 
  
$
(19,786
  $3,926   $43,421 
  
 
 
   
 
 
   
 
 
 
 
Year ended December 31
  
201
9
   2018   2017 
Weighted average shares outstanding for basic (loss) earnings per share
  
 
14,998,540
 
   15,791,396    15,636,853 
Effects of dilution from:
      
Stock options
  
 
—  
 
   772,267    1,601,227 
Warrants
  
 
—  
 
   —      900,000 
  
 
 
   
 
 
   
 
 
 
Weighted average shares outstanding for diluted (loss) earnings per share
  
 
14,998,540
 
   16,563,663    18,138,080 
  
 
 
   
 
 
   
 
 
 
XML 71 R19.htm IDEA: XBRL DOCUMENT v3.20.1
Income taxes
12 Months Ended
Dec. 31, 2019
Income Taxes [Abstract]  
Income taxes
14.
Income taxes
The Company recognized current income tax expense of $22 for the year ended December 31, 2019 (2018 – expense of $678; 2017 – recovery of $9,393) and a deferred income tax expense of $123 for the year ended December 31, 2019 (2018 – $219, 2017 – $333).
As at December 31, 2019 and 2018, deferred tax assets and liabilities have been recognized with respect to the following items:
 
As at December 31
  
2019
   2018 
Deferred tax assets
    
Non-capital
loss carryforwards
  
$
—  
 
  $127 
  
 
 
   
 
 
 
Total deferred tax assets
  
$
 
 
 
  $127 
  
 
 
   
 
 
 
As at December 31, 2019 and 2018, Canadian deferred tax assets have not been recognized with respect to the following table. The scientific research and experimental development deferred tax assets expire between 2025 and 2028.
 
As at December 31
  
2019
 
  
2018
 
Deferred tax assets
  
   
  
   
Scientific research and experimental development
 
 
$
 
2
,
640
 
 
$
3,237
 
Investment in Sensible
  
 
855
 
  
 
 
 
 
Holdback receivable
  
 
688
 
  
 
199
 
Other
  
 
1,781
 
  
 
159
 
Non-capital losses
  
 
207
 
  
 
 
 
 
 
  
 
 
 
  
 
 
 
Total deferred tax assets
  
$
6,171
 
  
$
3,595
 
 
  
 
 
 
  
 
 
 
The reconciliation of the Canadian statutory rate to the income tax rate applied to the net income before discontinued operations for the years ended December 31, 2019, 2018 and 2017 to the income tax expense is as follows:
 
Year ended December 31
  
2019
   2018   2017 
(Loss)
Income for the year
      
Canadian
  
$
(7,013
)
 
  $3,440   $(2,178
Foreign
  
 
(12,628
)
 
   1,383    4,615 
  
 
 
   
 
 
   
 
 
 
  
$
(19,641
)
 
  $4,823   $2,437 
  
 
 
   
 
 
   
 
 
 
 
Year ended December 31
  
2019
   2018   2017 
Canadian federal and provincial income taxes at 27% (2018 – 27%; 2017 – 27%)
  
$
5,303
 
  $(1,302  $(658
Permanent differences and other items
  
 
(330
)
 
   26    (335
Foreign tax rate in foreign jurisdictions
  
 
(1,308
)
 
   85    656 
Change in unrecognized deferred tax assets
  
 
(3,810
)
 
   294    9,397 
  
 
 
   
 
 
   
 
 
 
  
$
(145
  $(897  $9,060 
  
 
 
   
 
 
   
 
 
 
The foreign tax rate differential is the difference between the Canadian federal and provincial statutory income tax rate and the tax rates in Barbados (2.50%), Mauritius (15.00%), Ireland (12.50%) and the United States (21.00%) that is applicable to income or losses incurred by the Company’s subsidiaries.
At December 31, 2019, the Company has the following United States losses available for application in future years:
 
2039
  
$
243
 
 
  
 
 
 
 
  
$
243
 
 
  
 
 
 
At December 31, 2019, the Company has the following Barbados losses available for application in future years:
 
2020
  $1,210 
202
1
   1,275 
2022
   3,752 
  
 
 
 
  
$
6,237 
  
 
 
 
XML 72 R15.htm IDEA: XBRL DOCUMENT v3.20.1
Holdback receivable
12 Months Ended
Dec. 31, 2019
Holdback Receivable [Abstract]  
Holdback receivable
10.
Holdback receivable
The holdback receivable of US$10 million, originated on October 2, 2017 as a part of the Apicore Sale Transaction described in note 5. The holdback receivable was initially recorded at its fair value of $11,941 and subsequently was measured at FVTPL. The other long-term liability was payable to the former President and Chief Executive Officer of Apicore upon receipt of the holdback receivable.
On February 13, 2019, the Company received notice from the Buyer in the Apicore Sales Transaction of potential claims against the holdback receivable in respect of representations and warranties under the Apicore Sales Transaction, with the maximum exposure of the claims being the total holdback receivable. The Company proceeded diligently to investigate the potential claims and attempt to satisfactorily resolve them with a view to having the holdback receivable released. The Buyer did not make the required payments on the holdback receivable in February
2019
and April 2019.
In consideration of the uncertainty associated with the potential claims asserted by the Buyer, the Company reduced the carrying value of the holdback receivable by $1,473 on the
consolidated
statement of financial position as at December 31, 2018.
On December 5, 2019, the Company reached a settlement agreement with the Buyer in the Apicore Sales Transaction with respect to the amounts heldback under the Apicore Sales Transaction. A settlement agreement was reached under which the Company received US$5,100 (CDN$6,719)
in relation to the holdback receivable. In connection with this settlement the amounts owing to former President and Chief Executive Officer of Apicore totaling US$880 (CDN$1,165) which were recorded within other long-term liabilities were settled by the Buyer. Immediately prior to the settlement, the Company reduced the carrying value on the statement of financial position of the holdback receivable by
$3,623 to the net recoverable value from the negotiated settlement.
XML 73 R11.htm IDEA: XBRL DOCUMENT v3.20.1
Accounts receivable
12 Months Ended
Dec. 31, 2019
Trade and other receivables [abstract]  
Accounts receivable
6.
Accounts receivable
 
As at December 31
  
2019
   2018 
Trade accounts receivable
  
$
10,136
 
  $9,678 
Other accounts receivable
  
 
80
 
   1,087 
  
 
 
   
 
 
 
  
$
10,216
 
  $10,765 
  
 
 
   
 
 
 
As at December 31, 2019, there were three customers with amounts owing greater than 10% of the Company’s accounts receivable which totaled 96% in aggregate (Customer A – 41%, Customer B – 28%, Customer C – 27%).
As at December 31, 2018, there were three customers with amounts owing greater than 10% of the Company’s accounts receivable which totaled 91% in aggregate (Customer A – 47%, Customer B – 22%, Customer C – 22%).
XML 74 R80.htm IDEA: XBRL DOCUMENT v3.20.1
Finance income (expense) (Details 1) - CAD ($)
$ in Thousands
12 Months Ended
Dec. 31, 2019
Dec. 31, 2018
Dec. 31, 2017
Schedule For Finance Income And Expense [Line Items]      
Interest received $ 1,731 $ 279 $ 47
Other interest, net and banking fees (46) (24) (31)
Finance income (expense) (paid) received 1,685 255 (73)
MIOP loan      
Schedule For Finance Income And Expense [Line Items]      
Interest paid $ 0 $ 0 $ (89)
XML 75 R70.htm IDEA: XBRL DOCUMENT v3.20.1
Capital Stock (Detail Textuals 1)
$ in Thousands, $ in Thousands
12 Months Ended
Jul. 03, 2017
CAD ($)
shares
Dec. 31, 2019
CAD ($)
shares
Dec. 31, 2018
CAD ($)
shares
Dec. 31, 2017
CAD ($)
shares
Dec. 31, 2017
USD ($)
shares
Dec. 31, 2017
USD ($)
shares
Oct. 02, 2017
Dec. 31, 2016
shares
Dec. 01, 2016
shares
Disclosure of detailed information about business combination [line items]                  
Expense from share-based payment transactions with employees | $   $ 417 $ 1,022 $ 491          
Gross proceeds from sale of options | $   $ 20 $ 363 $ 520          
Number of share options expired without being exercised   220,233 200,600 52,923 52,923        
Number of stock options outstanding   1,428,408 1,394,642 1,602,127   1,602,127   1,387,000  
Apicore entity | Discontinued Operations                  
Disclosure of detailed information about business combination [line items]                  
Expense from share-based payment transactions with employees | $       $ 132          
Apicore                  
Disclosure of detailed information about business combination [line items]                  
Number of shares and options authorized                 497,500
Number of stock options outstanding             517,500    
Number of shares outstanding 117,500                
Non-controlling interests | $ $ 615                
Apicore | Class E common shares                  
Disclosure of detailed information about business combination [line items]                  
Number of shares and options authorized                 400,000
Number of share options expired without being exercised 117,500                
Apicore | Apicore entity | Class E common shares                  
Disclosure of detailed information about business combination [line items]                  
Number of shares and options authorized                 897,500
Employees and former directors | Class E common shares                  
Disclosure of detailed information about business combination [line items]                  
Gross proceeds from sale of options | $         $ 48        
Number of share acquired due to options exercised       405,000 405,000        
Total cost       $ 2,690   $ 1,975      
Number of shares outstanding       112,500   112,500      
Employees and former directors | Apicore entity                  
Disclosure of detailed information about business combination [line items]                  
Gross proceeds from sale of options | $         $ 280        
Employees and former directors | Apicore entity | Class E common shares                  
Disclosure of detailed information about business combination [line items]                  
Number of shares issued under the plan       292,500 292,500        
XML 76 R74.htm IDEA: XBRL DOCUMENT v3.20.1
Income taxes (Details 1) - CAD ($)
$ in Thousands
Dec. 31, 2019
Dec. 31, 2018
Deferred tax assets    
Scientific research and experimental development $ 2,640 $ 3,237
Investment in Sensible 855 0
Holdback receivable 688 199
Other 1,781 159
Non-capital losses 207 0
Total deferred tax assets $ 6,171 $ 3,595
XML 77 R84.htm IDEA: XBRL DOCUMENT v3.20.1
Related party transactions (Details) - CAD ($)
$ in Thousands
12 Months Ended
Dec. 31, 2019
Dec. 31, 2018
Dec. 31, 2017
Disclosure of transactions between related parties [abstract]      
Salaries, fees and short-term benefits $ 781 $ 770 $ 1,463
Share-based payments 208 669 139
Total $ 989 $ 1,439 $ 1,602
XML 78 R88.htm IDEA: XBRL DOCUMENT v3.20.1
Related party transactions (Detail Textuals 3) - CAD ($)
$ in Thousands
1 Months Ended 12 Months Ended
Jul. 18, 2016
Dec. 31, 2018
Dec. 31, 2019
Disclosure of amounts incurred by entity for provision of key management personnel services provided by separate management entities [line items]      
Revised amount payable under agreement     $ 331
A.D. Friesen Enterprises Ltd.,      
Disclosure of amounts incurred by entity for provision of key management personnel services provided by separate management entities [line items]      
Term of agreement 5 years    
Amount payable under agreement $ 300    
Revised amount payable under agreement $ 315    
JFK Enterprises Ltd      
Disclosure of amounts incurred by entity for provision of key management personnel services provided by separate management entities [line items]      
Term of agreement   1 year  
Amount payable under agreement   $ 155  
XML 79 R78.htm IDEA: XBRL DOCUMENT v3.20.1
Income taxes (Detail Textuals 1)
12 Months Ended
Dec. 31, 2019
Dec. 31, 2018
Dec. 31, 2017
Income Tax [Line Items]      
Statutory income tax rate 27.00% 27.00% 27.00%
Barbados      
Income Tax [Line Items]      
Statutory income tax rate 2.50%    
MAURITIUS      
Income Tax [Line Items]      
Statutory income tax rate 15.00%    
IRELAND      
Income Tax [Line Items]      
Statutory income tax rate 12.50%    
United States      
Income Tax [Line Items]      
Statutory income tax rate 21.00%    
XML 80 R57.htm IDEA: XBRL DOCUMENT v3.20.1
Intangible assets (Details) - CAD ($)
$ in Thousands
12 Months Ended
Dec. 31, 2019
Dec. 31, 2018
Dec. 31, 2017
Disclosure of detailed information about intangible assets [line items]      
Beginning balance $ 1,705    
Impairment 6,321   $ 636
Amortization 1,438 $ 196 6,634
Ending balance 9,599 1,705  
Cost      
Disclosure of detailed information about intangible assets [line items]      
Beginning balance 22,529 20,717  
Additions 15,968    
Impairment (6,959)    
Effect of movements in exchange rates (1,323) 1,812  
Ending balance 29,818 22,529 20,717
Transfers within intangible assets (397)    
Accumulated amortization and impairment losses      
Disclosure of detailed information about intangible assets [line items]      
Beginning balance 20,824 18,961  
Impairment (638)    
Amortization 1,438 196  
Effect of movements in exchange rates (1,008) 1,667  
Ending balance 20,219 20,824 18,961
Transfers within intangible assets (397)    
Licences      
Disclosure of detailed information about intangible assets [line items]      
Beginning balance 1,705    
Additions 7,038    
Ending balance 0 1,705  
Licences | Cost      
Disclosure of detailed information about intangible assets [line items]      
Beginning balance 1,910 1,756  
Additions 7,038    
Impairment (6,959)    
Effect of movements in exchange rates (135) 154  
Ending balance 0 1,910 1,756
Transfers within intangible assets (1,854)    
Licences | Accumulated amortization and impairment losses      
Disclosure of detailed information about intangible assets [line items]      
Beginning balance 205 0  
Impairment (638)    
Amortization 841 196  
Effect of movements in exchange rates (11) 9  
Ending balance 0 205 0
Transfers within intangible assets (397)    
Patents      
Disclosure of detailed information about intangible assets [line items]      
Beginning balance 0    
Ending balance 9,599 0  
Patents | Cost      
Disclosure of detailed information about intangible assets [line items]      
Beginning balance 15,484 14,239  
Additions 8,930    
Impairment 0    
Effect of movements in exchange rates (942) 1,245  
Ending balance 24,929 15,484 14,239
Transfers within intangible assets 1,457    
Patents | Accumulated amortization and impairment losses      
Disclosure of detailed information about intangible assets [line items]      
Beginning balance 15,484 14,239  
Impairment 0    
Amortization 597 0  
Effect of movements in exchange rates (751) 1,245  
Ending balance 15,330 15,484 14,239
Trademarks      
Disclosure of detailed information about intangible assets [line items]      
Beginning balance 0    
Ending balance 0 0  
Trademarks | Cost      
Disclosure of detailed information about intangible assets [line items]      
Beginning balance 4,365 4,014  
Additions 0    
Impairment 0    
Effect of movements in exchange rates (209) 351  
Ending balance 4,156 4,365 4,014
Trademarks | Accumulated amortization and impairment losses      
Disclosure of detailed information about intangible assets [line items]      
Beginning balance 4,365 4,014  
Impairment 0    
Amortization 0 0  
Effect of movements in exchange rates (209) 351  
Ending balance 4,156 4,365 4,014
Customer list      
Disclosure of detailed information about intangible assets [line items]      
Beginning balance 0    
Ending balance 0 0  
Customer list | Cost      
Disclosure of detailed information about intangible assets [line items]      
Beginning balance 770 708  
Additions 0    
Impairment 0    
Effect of movements in exchange rates (37) 62  
Ending balance 733 770 708
Customer list | Accumulated amortization and impairment losses      
Disclosure of detailed information about intangible assets [line items]      
Beginning balance 770 708  
Impairment 0    
Amortization 0 0  
Effect of movements in exchange rates (37) 62  
Ending balance $ 733 $ 770 $ 708
XML 81 R53.htm IDEA: XBRL DOCUMENT v3.20.1
Inventories (Details) - CAD ($)
$ in Thousands
Dec. 31, 2019
Dec. 31, 2018
Disclosure Of Inventories [Abstract]    
Finished product available-for-sale $ 5,273 $ 2,937
Unfinished product and packaging materials 1,055 1,302
Current inventories $ 6,328 $ 4,239
XML 82 R3.htm IDEA: XBRL DOCUMENT v3.20.1
Consolidated Statements of Net (Loss) Income and Comprehensive (Loss) Income
$ in Thousands
12 Months Ended
Dec. 31, 2019
CAD ($)
$ / shares
Dec. 31, 2018
CAD ($)
$ / shares
Dec. 31, 2017
CAD ($)
$ / shares
Revenue, net      
Product sales, net $ 20,173 $ 29,109 $ 27,133
Cost of goods sold (Note 7 & 9) 7,272 4,152 3,465
Gross profit 12,901 24,957 23,668
Expenses      
Selling 13,399 15,580 11,515
General and administrative 3,395 3,922 3,353
Research and development 4,349 6,681 5,148
Total expense 21,143 26,183 20,016
Other expense (income):      
Revaluation of holdback receivable (Note 10) 3,623 1,473 (83)
Impairment loss on intangible assets (Note 9) 6,321   636
Total Other (income) expense 9,944 1,473 553
Finance (income) costs:      
Finance (income) expense, net (Note 15) (1,115) (1,061) 837
Foreign exchange (gain) loss, net 2,570 (6,461) (175)
Total Finance costs (income) 1,455 (7,522) 662
Net (loss) income before income taxes (19,641) 4,823 2,437
Income tax (expense) recovery      
Current (Note 14) (22) (678) 9,393
Deferred (Note 14) (123) (219) (333)
Income tax expense (145) (897) 9,060
Net (loss) income before discontinued operations (19,786) 3,926 11,497
Net income from discontinued operations, net of tax (Note 5)     31,924
Net (loss) income (19,786) 3,926 43,421
Item that may be reclassified to profit or loss      
Continuing operations (683) 595 (30)
Discontinued operations     21
Item that will not be reclassified to profit and loss      
Revaluation of investment in Sensible Medical at FVOCI (Note 11) (6,336)    
Comprehensive (loss) income $ (26,805) $ 4,521 $ 43,412
(Loss) earnings per share from continuing operations      
Basic (Note 13(e)) | $ / shares $ (1.32) $ 0.25 $ 0.74
Diluted (Note 13(e)) | (per share) (1.32) 0.24 0.63
Earnings per share from discontinued operations      
Basic (Note 13(e)) | (per share)     2.04
Diluted (Note 13(e)) | (per share)     1.76
(Loss) earnings per share      
Basic (Note 13(e)) | $ / shares (1.32) 0.25 2.78
Diluted (Note 13(e)) | (per share) $ (1.32) $ 0.24 $ 2.39
XML 83 R7.htm IDEA: XBRL DOCUMENT v3.20.1
Basis of preparation of financial statements
12 Months Ended
Dec. 31, 2019
Disclosure Of Basis Of Preparation Of Financial Statements Explanatory [Abstract]  
Basis of preparation of financial statements
2.
Basis of preparation of financial statements
 
 
(a)
Statement of compliance
These consolidated financial statements of the Company and its subsidiaries were prepared in accordance with International Financial Reporting Standards (“IFRS”) as issued by the International Accounting Standards Board (“IASB”).
The consolidated financial statements were authorized for issue by the Board of Directors on
April
15
, 2020.
 
 
(b)
Basis of presentation
The consolidated financial statements have been prepared on the historical cost basis except for the following items:
 
  
Derivative financial instruments are measured at fair value.
 
  
Financial instruments at fair value through profit or loss (“FVTPL”) are measured at fair value.
 
  
Financial instruments at fair value through other comprehensive income (“FVOCI”) are measured at fair value.
 
 
(c)
Functional and presentation currency
The consolidated financial statements are presented in Canadian dollars, which is the Company’s functional currency. All financial information presented has been rounded to the nearest thousand dollar except where indicated otherwise. The Company has rounded comparative figures, which were previously presented as rounded to the nearest dollar, to the nearest thousand dollar to conform to current year presentation. Additionally, certain of the comparative figures have been reclassified to conform with the current year presentation, namely for the current year presentation selling expenses have been presented separately from general and administration expenses on the statements of net (loss) income and comprehensive (loss) income.
 
 
(d)
Use of estimates and judgments
The preparation of these consolidated financial statements in conformity with IFRS requires management to make estimates and assumptions that affect the application of accounting policies and the reported amounts of assets, liabilities, revenue and expenses. Actual results may differ from these estimates.
Estimates and underlying assumptions are reviewed on an ongoing basis. Revisions to accounting estimates are recognized in the period in which the estimates are revised and in any future periods affected.
Areas where management has made critical judgments in the process of applying accounting policies and that have the most significant effect on the amounts recognized in the consolidated financial statements include the determination of the Company’s and its subsidiaries’ functional currencies.
Information about key assumptions and estimation uncertainties that have a significant risk of resulting in a material adjustment to the carrying amount of assets and liabilities within the next financial year are included in the following notes to the consolidated financial statements for the year ended December 31, 2019:
 
  
Note 3(c)(i): The valuation of the investment in Sensible Medical
 
  
Note 3(c)(iii): The valuation of the royalty obligation
 
  
Note 3(e): The provisions for returns, chargebacks, rebates and discounts
 
  
Note 3(j): The measurement of intangible assets
 
  
Note 3(p): The measurement of the amount and assessment of the recoverability of income tax assets and income tax provisions
XML 84 R69.htm IDEA: XBRL DOCUMENT v3.20.1
Capital Stock (Detail Textuals)
12 Months Ended
Dec. 20, 2019
CAD ($)
shares
Dec. 20, 2019
$ / shares
May 30, 2019
CAD ($)
shares
May 16, 2018
CAD ($)
shares
Dec. 31, 2019
CAD ($)
shares
Dec. 31, 2018
CAD ($)
shares
Disclosure of terms and conditions of share-based payment arrangement [line items]            
Stock options vesting term         five-year  
Aggregate percentage of common stock share outstanding       0.00%    
Aggregate common stock share outstanding normal course issuer Bid | shares     761,141 794,088   771,900
Shares repurchased and cancelled under a normal course issuer bid | shares     421,300   751,800 441,400
Repurchase of common shares under normal course issuer Bid     $ 2,081,000 $ 5,085,000 $ 4,145,000 $ 3,021,000
Common stock repurchase price per share | $ / shares   $ 6.50        
Repurchase of common stock additional cost $ 139,000          
Repurchase of common stock aggregate price paid $ 26,139,000          
Shares repurchased and cancelled under a substantial issuer bid | shares 4,000,000          
Shares repurchased and cancelled under a substantial issuer bid $ 26,000,000          
Deficit            
Disclosure of terms and conditions of share-based payment arrangement [line items]            
Buy-back of common shares         1,810,000 480,000
Buy-back of common shares under substantial issuer bid         5,466,000  
Share Capital            
Disclosure of terms and conditions of share-based payment arrangement [line items]            
Shares repurchased and cancelled under a normal course issuer bid [1]         $ 5,955,000 $ 3,501,000
Shares repurchased and cancelled under a normal course issuer bid | shares [1]         751,800 441,400
Shares repurchased and cancelled under a substantial issuer bid | shares [2]         (4,000,000)  
Shares repurchased and cancelled under a substantial issuer bid [2]         $ (31,605,000)  
Top of range            
Disclosure of terms and conditions of share-based payment arrangement [line items]            
Number of common shares reserved for issuance of stock options | shares         2,934,403  
Stock options term         10 years  
Bottom of range            
Disclosure of terms and conditions of share-based payment arrangement [line items]            
Stock options term         5 years  
[1] On May 16, 2018, the Company announced that the TSX-V accepted the Company’s notice of its intention to make a normal course issuer bid (the “2018 NCIB”). Under the terms of the 2018 NCIB, the Company could have acquired up to an aggregate of 794,088 common shares, representing five percent of the common shares outstanding at the time of the application, over the twelve-month period that the 2018 NCIB was in place. The 2018 NCIB commenced on May 28, 2018 and ended on May 27, 2019. During the twelve months of the 2018 NCIB, the Company purchased and cancelled 771,900 common shares for a total cost of $5,085. The prices that the Company paid for the common shares purchased was the market price of the shares at the time of purchase.
[2] On December 20, 2019, the Company completed a Substantial Issuer Bid (“SIB”) pursuant to which the Company purchased 4,000,000 of its common shares for cancellation at a set purchase price of $6.50 per common share for a total purchase price of $26,000 in cash. The Company incurred an additional $138 on transaction costs related to the SIB for a total aggregate purchase price paid of $26,138. During the year ended December 31, 2019, the Company recorded $5,466 directly in its retained deficit representing the difference between the aggregate price paid for these common shares and a reduction of the Company’s share capital totaling $31,605.
XML 85 R95.htm IDEA: XBRL DOCUMENT v3.20.1
Segmented information (Detail Textuals)
12 Months Ended
Dec. 31, 2019
Dec. 31, 2018
Dec. 31, 2017
Disclosure of operating segments [line items]      
Percentage of total revenue 100.00% 100.00% 100.00%
AGGRASTAT | United States      
Disclosure of operating segments [line items]      
Percentage of total revenue 100.00% 100.00% 100.00%
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Capital Stock (Details 3) - yr
12 Months Ended
Dec. 31, 2019
Dec. 31, 2018
Dec. 31, 2017
Disclosure of range of exercise prices of outstanding share options [line items]      
Expected option life (in years) 4.4 4.4 4.5
Risk free interest rate 1.40%   1.71%
Dividend yield 0.00% 0.00% 0.00%
Expected volatility 47.10%   80.44%
Bottom of range      
Disclosure of range of exercise prices of outstanding share options [line items]      
Risk free interest rate   1.92%  
Expected volatility   85.14%  
Top of range      
Disclosure of range of exercise prices of outstanding share options [line items]      
Risk free interest rate   2.04%  
Expected volatility   93.72%  
XML 88 R61.htm IDEA: XBRL DOCUMENT v3.20.1
Royalty obligation (Detail Textuals) - CAD ($)
$ in Thousands
1 Months Ended 12 Months Ended
Jul. 18, 2011
Dec. 31, 2019
Dec. 31, 2018
Dec. 31, 2017
Royalty Obligation [Line Items]        
Fair value of the royalty obligation   $ 902    
Carrying value of the royalty obligation   2,048 $ 3,531  
Current portion of the royalty obligation   872 1,496  
Change in royalty obligation   316 355 $ 748
Royalties received   1,023 1,654 1,243
Royalties paid   $ (1,355) $ (1,539) $ (1,829)
Birmingham Associates Ltd | AGGRASTAT        
Royalty Obligation [Line Items]        
Value of shares issued on debt conversion $ 4,750      
Number of shares issued on debt conversion 2,176,003      
Percentage of first $2,000,000 of quarterly sales 4.00%      
Percentage of quarterly sales between $2,000,000 and $4,000,000 6.00%      
Percentage of portion of quarterly sales exceeding $4,000,000 payable within 60 days 8.00%      
Amount of quarterly product revenue $ 2,000      
Amount of quarterly product revenue 2,000      
Amount of quarterly product revenue 4,000      
Amount of quarterly product revenue $ 4,000      
XML 89 R91.htm IDEA: XBRL DOCUMENT v3.20.1
Financial instruments (Details 1) - CAD ($)
$ in Thousands
Dec. 31, 2019
Dec. 31, 2018
Level 1 | Accounts payable and accrued liabilities    
Disclosure of detailed information about financial instruments [line items]    
Financial liabilities   $ 0
Level 1 | Current portion of royalty obligation    
Disclosure of detailed information about financial instruments [line items]    
Financial liabilities $ 0 0
Level 1 | Royalty obligation    
Disclosure of detailed information about financial instruments [line items]    
Financial liabilities 0 0
Level 1 | Other long-term liabilities    
Disclosure of detailed information about financial instruments [line items]    
Financial liabilities   0
Level 1 | Acquisition payable    
Disclosure of detailed information about financial instruments [line items]    
Financial liabilities 0  
Level 1 | Current portion of acquisition payable    
Disclosure of detailed information about financial instruments [line items]    
Financial liabilities 0  
Level 1 | Investment in Sensible Medical    
Disclosure of detailed information about financial instruments [line items]    
Financial assets 0  
Level 1 | Holdback receivable    
Disclosure of detailed information about financial instruments [line items]    
Financial assets   0
Level 2 | Accounts payable and accrued liabilities    
Disclosure of detailed information about financial instruments [line items]    
Financial liabilities   0
Level 2 | Current portion of royalty obligation    
Disclosure of detailed information about financial instruments [line items]    
Financial liabilities 0 0
Level 2 | Royalty obligation    
Disclosure of detailed information about financial instruments [line items]    
Financial liabilities 0 0
Level 2 | Other long-term liabilities    
Disclosure of detailed information about financial instruments [line items]    
Financial liabilities   0
Level 2 | Acquisition payable    
Disclosure of detailed information about financial instruments [line items]    
Financial liabilities 0  
Level 2 | Current portion of acquisition payable    
Disclosure of detailed information about financial instruments [line items]    
Financial liabilities 0  
Level 2 | Investment in Sensible Medical    
Disclosure of detailed information about financial instruments [line items]    
Financial assets 0  
Level 2 | Holdback receivable    
Disclosure of detailed information about financial instruments [line items]    
Financial assets   0
Level 3 | Accounts payable and accrued liabilities    
Disclosure of detailed information about financial instruments [line items]    
Financial liabilities   546
Level 3 | Current portion of royalty obligation    
Disclosure of detailed information about financial instruments [line items]    
Financial liabilities 872 1,496
Level 3 | Royalty obligation    
Disclosure of detailed information about financial instruments [line items]    
Financial liabilities 1,176 2,035
Level 3 | Other long-term liabilities    
Disclosure of detailed information about financial instruments [line items]    
Financial liabilities   1,201
Level 3 | Acquisition payable    
Disclosure of detailed information about financial instruments [line items]    
Financial liabilities 1,655  
Level 3 | Current portion of acquisition payable    
Disclosure of detailed information about financial instruments [line items]    
Financial liabilities 649  
Level 3 | Investment in Sensible Medical    
Disclosure of detailed information about financial instruments [line items]    
Financial assets $ 0  
Level 3 | Holdback receivable    
Disclosure of detailed information about financial instruments [line items]    
Financial assets   $ 11,909
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Financial instruments (Tables)
12 Months Ended
Dec. 31, 2019
Disclosure of detailed information about financial instruments [abstract]  
Schedule of comparison by class of the carrying amounts and fair value of the company's financial instruments
As at December 31
  
2019
   2018 
   
Carrying
amount
   
Fair
value
   Carrying
amount
   Fair
value
 
Financial assets
        
Financial assets measured at amortized cost
        
Cash and cash equivalents
  $12,965   $12,965   $24,139   $24,139 
Short-term investments
           47,747    47,747 
Accounts receivable
   10,216    10,216    10,765    10,765 
Investment in Sensible Medical
 
 
 
 
 
 
 
 
 
 
 
 
 
Holdback receivable
           11,909    11,909 
Financial liabilities
        
Financial liabilities measured at amortized cost:
        
Accounts payable and accrued liabilities
  $9,384   $9,384   $14,377   $14,377 
Current portion of royalty obligation
   872    872    1,496    1,496 
Current portion of acquisition payable
   649    649         
Current portion
of lease o
bl
igation
 
 
 
240
 
 
 
240
 
 
 
 
 
 
 
Royalty obligation
   1,176    1,176    2,035    2,035 
Acquisition payable
   1,655    1,655         
Lease obligat
ion
 
 
 
849
 
 
 
849
 
 
 
 
 
 
 
Other long-term liability
           1,201    1,201 
  
 
 
   
 
 
   
 
 
   
 
 
 
Schedule of fair value of financial assets and liabilities
The fair value hierarchy of the following financial assets and liabilities on the consolidated statements of financial position as at December 31, 2019 is as follows:
 
 
  
Level 1
 
  
Level 2
 
  
Level 3
 
Financial
assets
 
 
 
 
Investment in
Sensible Medical
 
 
$
 
$
 
$
Financial liabilities
  
  
  
Current portion of royalty obligation
  
$
 
  
$
 
  
$
872
 
Current portion of acquisition payable
  
 
 
  
 
 
  
 
649
 
Royalty obligation
  
 
 
  
 
 
  
 
1,176
 
Acquisition payable
  
 
 
  
 
 
  
 
1,655
 
  
 
 
 
  
 
 
 
  
 
 
 
The fair value hierarchy of the following financial assets and liabilities on the consolidated statements of financial position as at December 31, 2018 is as follows:
 
   
Level 1
   
Level 2
   
Level 3
 
Financial assets
      
Holdback receivable
  $   $   $11,909 
Financial liabilities
      
Accounts payable and accrued liabilities
  $   $   $546 
Current portion of royalty obligation
           1,496 
Royalty obligation
           2,035 
Other long-term liability
           1,201 
  
 
 
   
 
 
   
 
 
 
Schedule for exposure to U.S. dollar currency risk through financial assets and liabilities
 
As at December 31
(Expressed in U.S. Dollars)
  
2019
   2018 
Cash
  $9,518   $17,428 
Short-term investments
  
 
 
   35,000 
Accounts receivable
  
 
7,817
 
   7,725 
Holdback receivable
  
 
 
   8,730 
Other assets
  
 
30
 
    
Accounts payable and accrued liabilities
  
 
(6,714
   (9,903
Income taxes payable
  
 
(398
   (776
Current portion of royalty obligation
  
 
(671
   (1,096
Current portion of acquisition payable
  
 
(500
    
Royalty obligation
  
 
(906
   (1,492
Acquisition payable
  
 
(1,275
    
Other long-term liability
  
 
 
   (880
  
 
 
   
 
 
 
  
$
6,901
 
  $54,736 
  
 
 
   
 
 
 
XML 92 R46.htm IDEA: XBRL DOCUMENT v3.20.1
New standards and interpretations (Details) - CAD ($)
$ in Thousands
Jan. 01, 2019
Dec. 31, 2019
Dec. 31, 2018
Assets      
Property and equipment   $ 1,282 $ 316
Current liabilities      
Lease obligation   240  
Non-current liabilities      
Lease liabilities   $ 1,089  
IFRS 16 [Member]      
Assets      
Property and equipment $ 993   316
Property and equipment 677    
Current liabilities      
Lease obligation 300    
Lease obligation 300    
Non-current liabilities      
Lease liabilities 377    
Lease obligation 377    
Assets (liabilities) $ 316   $ 316
XML 93 R27.htm IDEA: XBRL DOCUMENT v3.20.1
Subsequent events
12 Months Ended
Dec. 31, 2019
Disclosure of non-adjusting events after reporting period [abstract]  
Subsequent events
22.
Subsequent events
Since December 31, 2019, the outbreak of the novel strain of coronavirus, specifically identified as
“COVID-19”,
has resulted in governments worldwide enacting emergency measures to combat the spread of the virus. These measures, which include the implementation of travel bans, self-imposed quarantine periods and social distancing, have caused material disruption to businesses globally resulting in an economic slowdown. Global equity markets have experienced significant volatility and weakness. Governments and central banks have reacted with significant monetary and fiscal interventions designed to stabilize economic conditions. The duration and impact of the COVID-19 outbreak is unknown at this time, as is the efficacy of the government and central bank interventions. It is not possible to reliably estimate the length and severity of these developments and the impact on the
liquidity,
financial results and condition of the Company and its operating subsidiaries in future periods.
XML 94 R23.htm IDEA: XBRL DOCUMENT v3.20.1
Expenses by nature
12 Months Ended
Dec. 31, 2019
Expenses by nature [abstract]  
Expenses by nature
18.
Expenses by nature
Expenses incurred for the years ended December 31, 2019, 2018 and 2017 from continuing operations are as follows:
Year ended December 31
  
2019
   2018   2017 
Personnel expenses
      
Salaries, fees and short-term benefits
  
$
6,394
 
  $7,696   $5,904 
Share-based
payments
  
 
417
 
   1,022    491 
  
 
 
   
 
 
   
 
 
 
  
 
6,811
 
   8,718    6,395 
Depreciation, amortization and impairment
  
 
2,017
 
   299    98 
Research and development
  
 
2,887
 
   5,306    3,539 
Manufacturing
  
 
752
 
   765    955 
Inventory material costs
  
 
3,851
 
   3,862    3,079 
Write-down of inventory
  
 
1,983
 
   95    385 
Medical affairs
  
 
718
 
   1,026    1,108 
Administration
  
 
821
 
   1,505    1,725 
Selling and logistics
  
 
6,997
 
   8,019    5,395 
Professional fees
  
 
1,578
 
   740    802 
  
 
 
   
 
 
   
 
 
 
  
$
28,415
 
  $30,335   $23,481 
  
 
 
   
 
 
   
 
 
 
XML 95 R94.htm IDEA: XBRL DOCUMENT v3.20.1
Segmented information (Details) - CAD ($)
$ in Thousands
Dec. 31, 2019
Dec. 31, 2018
Disclosure of geographical areas [line items]    
Property, plant and equipment, intangible assets and other assets $ 10,881 $ 2,021
Canada    
Disclosure of geographical areas [line items]    
Property, plant and equipment, intangible assets and other assets 1,282 316
Barbados    
Disclosure of geographical areas [line items]    
Property, plant and equipment, intangible assets and other assets $ 9,599 $ 1,705
XML 96 R64.htm IDEA: XBRL DOCUMENT v3.20.1
Capital Stock (Details 2)
12 Months Ended
Dec. 31, 2019
shares
Customer
$ / shares
Dec. 31, 2019
shares
Customer
$ / shares
Dec. 31, 2018
shares
$ / shares
Dec. 31, 2017
shares
$ / shares
Dec. 31, 2016
shares
$ / shares
Disclosure of number and weighted average remaining contractual life of outstanding share options [line items]          
Number outstanding | shares 1,428,408 1,428,408 1,394,642 1,602,127 1,387,000
Options outstanding weighted average exercise price   $ 3.67 $ 3.91 $ 3.58 $ 2.37
Options exercisable, end of period | shares 1,059,308 1,059,308 1,044,892 1,231,127  
$0.30          
Disclosure of number and weighted average remaining contractual life of outstanding share options [line items]          
Range of exercise prices $ 0.30        
Number outstanding | Customer 185,000 185,000      
Weighted average remaining contractual life (in years) 3 years 4 months 6 days        
Options outstanding weighted average exercise price $ 0.30        
Options exercisable, end of period | Customer 185,000 185,000      
$1.01 - $3.00          
Disclosure of number and weighted average remaining contractual life of outstanding share options [line items]          
Number outstanding | Customer 539,433 539,433      
Weighted average remaining contractual life (in years) 2 years 3 months 18 days        
Options outstanding weighted average exercise price $ 1.59        
Options exercisable, end of period | Customer 539,433 539,433      
$1.01 - $3.00 | Bottom of range          
Disclosure of number and weighted average remaining contractual life of outstanding share options [line items]          
Range of exercise prices $ 1.01        
$1.01 - $3.00 | Top of range          
Disclosure of number and weighted average remaining contractual life of outstanding share options [line items]          
Range of exercise prices $ 3.00        
$3.01 - $4.00          
Disclosure of number and weighted average remaining contractual life of outstanding share options [line items]          
Number outstanding | Customer 29,000 29,000      
Weighted average remaining contractual life (in years) 10 months 24 days        
Options outstanding weighted average exercise price $ 3.90        
Options exercisable, end of period | Customer 29,000 29,000      
$3.01 - $4.00 | Bottom of range          
Disclosure of number and weighted average remaining contractual life of outstanding share options [line items]          
Range of exercise prices $ 3.01        
$3.01 - $4.00 | Top of range          
Disclosure of number and weighted average remaining contractual life of outstanding share options [line items]          
Range of exercise prices $ 4.00        
$4.01 - $5.00          
Disclosure of number and weighted average remaining contractual life of outstanding share options [line items]          
Number outstanding | Customer 262,000 262,000      
Weighted average remaining contractual life (in years) 4 years 5 months 26 days        
Options outstanding weighted average exercise price $ 4.95        
Options exercisable, end of period | Customer 52,400 52,400      
$4.01 - $5.00 | Bottom of range          
Disclosure of number and weighted average remaining contractual life of outstanding share options [line items]          
Range of exercise prices $ 4.01        
$4.01 - $5.00 | Top of range          
Disclosure of number and weighted average remaining contractual life of outstanding share options [line items]          
Range of exercise prices $ 5.00        
$5.01 - $7.30          
Disclosure of number and weighted average remaining contractual life of outstanding share options [line items]          
Number outstanding | Customer 412,975 412,975      
Weighted average remaining contractual life (in years) 2 years 9 months 3 days        
Options outstanding weighted average exercise price $ 7.08        
Options exercisable, end of period | Customer 253,475 253,475      
$5.01 - $7.30 | Bottom of range          
Disclosure of number and weighted average remaining contractual life of outstanding share options [line items]          
Range of exercise prices $ 5.01        
$5.01 - $7.30 | Top of range          
Disclosure of number and weighted average remaining contractual life of outstanding share options [line items]          
Range of exercise prices $ 7.30        
$0.30 - $7.30          
Disclosure of number and weighted average remaining contractual life of outstanding share options [line items]          
Number outstanding | Customer 1,428,408 1,428,408      
Weighted average remaining contractual life (in years) 2 years 11 months 8 days        
Options outstanding weighted average exercise price $ 3.67        
Options exercisable, end of period | Customer 1,059,308 1,059,308      
$0.30 - $7.30 | Bottom of range          
Disclosure of number and weighted average remaining contractual life of outstanding share options [line items]          
Range of exercise prices $ 0.30        
$0.30 - $7.30 | Top of range          
Disclosure of number and weighted average remaining contractual life of outstanding share options [line items]          
Range of exercise prices $ 7.30        
XML 97 R60.htm IDEA: XBRL DOCUMENT v3.20.1
Investment in Sensible Medical (Detail Textuals)
$ in Thousands, $ in Thousands
12 Months Ended
Jan. 24, 2019
CAD ($)
Jan. 24, 2019
USD ($)
Dec. 31, 2019
CAD ($)
Dec. 31, 2018
CAD ($)
Dec. 31, 2017
CAD ($)
Disclosure of detailed information about investment property [line items]          
Change in fair value of the investment     $ (6,336)    
Amortization     1,438 $ 196 $ 6,634
Write-down of intangible assets     6,321   $ 636
ReDS Demonstration Units [Member]          
Disclosure of detailed information about investment property [line items]          
Additions to property plant and equipment     67    
Licences [member]          
Disclosure of detailed information about investment property [line items]          
Additions to license     7,038    
Licences [member] | Cost Of Goods Sold [Member]          
Disclosure of detailed information about investment property [line items]          
Amortization     641    
Sensible to Market ReDS [Member]          
Disclosure of detailed information about investment property [line items]          
Rights acquired $ 13,351 $ 10,000      
Directly attributable costs $ 91 $ 68      
Sensible Medical Innovations Ltd [Member]          
Disclosure of detailed information about investment property [line items]          
Voting interest acquired 9.36% 9.36%      
Voting interest acquired on diluted basis 7.71% 7.71%      
Change in fair value of the investment     $ 6,336    
Sensible Medical Innovations Ltd [Member] | Marketing And Distribution Agreement [Member]          
Disclosure of detailed information about investment property [line items]          
Percentage of share of profit     20.00%    
Percentage of share of profit upon certain conditions being met     35.00%    
Revenue     $ 289    
Sensible Medical Innovations Ltd [Member] | At fair value [member]          
Disclosure of detailed information about investment property [line items]          
Investment in sensible medical     $ 6,337    
XML 98 R90.htm IDEA: XBRL DOCUMENT v3.20.1
Financial instruments (Details) - CAD ($)
$ in Thousands
Dec. 31, 2019
Dec. 31, 2018
Accounts payable and accrued liabilities    
Disclosure of detailed information about financial instruments [line items]    
Carrying amount $ 9,384 $ 14,377
Fair value 9,384 14,377
Current portion of royalty obligation    
Disclosure of detailed information about financial instruments [line items]    
Carrying amount 872 1,496
Fair value 872 1,496
Current portion of acquisition payable    
Disclosure of detailed information about financial instruments [line items]    
Carrying amount 649 0
Fair value 649 0
Current Portion Of Lease Obligations    
Disclosure of detailed information about financial instruments [line items]    
Carrying amount 240 0
Fair value 240 0
Royalty obligation    
Disclosure of detailed information about financial instruments [line items]    
Carrying amount 1,176 2,035
Fair value 1,176 2,035
Acquisition payable    
Disclosure of detailed information about financial instruments [line items]    
Carrying amount 1,655 0
Fair value 1,655 0
Lease liabilities    
Disclosure of detailed information about financial instruments [line items]    
Carrying amount 849 0
Fair value 849 0
Other long-term liabilities    
Disclosure of detailed information about financial instruments [line items]    
Carrying amount 0 1,201
Fair value 0 1,201
Cash and cash equivalents    
Disclosure of detailed information about financial instruments [line items]    
Carrying amount 12,965 24,139
Fair value 12,965 24,139
Short-term investments    
Disclosure of detailed information about financial instruments [line items]    
Carrying amount 0 47,747
Fair value 0 47,747
Accounts receivable    
Disclosure of detailed information about financial instruments [line items]    
Carrying amount 10,216 10,765
Fair value 10,216 10,765
Investment in Sensible Medical    
Disclosure of detailed information about financial instruments [line items]    
Carrying amount 0 0
Fair value 0 0
Holdback receivable    
Disclosure of detailed information about financial instruments [line items]    
Carrying amount 0 11,909
Fair value $ 0 $ 11,909
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Capital Stock (Details 7) - CAD ($)
$ in Thousands
12 Months Ended
Dec. 31, 2019
Dec. 31, 2018
Dec. 31, 2017
Disclosure Of Capital Stock [Abstract]      
Net earnings before discontinued operations $ (19,786) $ 3,926 $ 11,497
Net income from discontinued operations, net of tax     31,924
Net (loss) income $ (19,786) $ 3,926 $ 43,421
Weighted average ordinary shares and adjusted weighted average ordinary shares [abstract]      
Weighted average shares outstanding for basic earnings per share 14,998,540 15,791,396 15,636,853
Effects of dilution from:      
Stock options   772,267 1,601,227
Warrants     900,000
Weighted average shares outstanding for diluted earnings per share 14,998,540 16,563,663 18,138,080
XML 100 R43.htm IDEA: XBRL DOCUMENT v3.20.1
Segmented information (Tables)
12 Months Ended
Dec. 31, 2019
Disclosure of operating segments [abstract]  
Schedule of geographical areas of property, plant and equipment and intangible assets
As at December 31
  
2019
   2018 
Canada
  
$
1,282
 
  $316 
Barbados
  
 
9,599
 
   1,705 
  
 
 
   
 
 
 
  
$
10,881
 
  $2,021 
  
 
 
   
 
 
XML 101 R47.htm IDEA: XBRL DOCUMENT v3.20.1
New standards and interpretations (Details 1) - IFRS 16 [Member] - CAD ($)
$ in Thousands
12 Months Ended
Dec. 31, 2018
Dec. 31, 2019
Detailed Information About Adoption Of New Lease Policy And Its Impact On Operating Lease Commitments [Line Items]    
Operatinge Lease Liabilities $ 715 $ 677
Adjustments Of Lease Liabilities To Present Value $ (38)  
XML 102 R26.htm IDEA: XBRL DOCUMENT v3.20.1
Segmented information
12 Months Ended
Dec. 31, 2019
Disclosure of operating segments [abstract]  
Segmented information
21.
Segmented information
Prior to October 2, 2017, the operations of the Company were classified into two industry segments: the marking and distribution of commercial products (AGGRASTAT
®
) and the manufacturing and distribution of API, which was classified as held for sale and discontinued operations in 2017 (note 5). No operating segments were aggregated to form these reportable operating segments. Since the sale of API on October 2, 2017, the Company operates under one segment.
Revenue generated from external customers from the marketing and distribution of commercial products for the years ended December 31, 2019, 2018 and 2017 was 100% from sales to customers in the United States.
During the year ended December 31, 2019, 100% of total revenue was generated from thirteen customers. Customer A accounted for 38%, Customer B accounted for 28%, Customer C accounted for 28% and the remaining ten customers accounted for approximately 6% of revenue.
During the year ended December 31, 2018, 100% of total revenue was generated from eight customers. Customer A accounted for 33%, Customer B accounted for 28%, Customer C accounted for 33% and Customer D accounted for 6% and the remaining five customers accounted for less than 1% of revenue.
During the year ended December 31, 2017, 100% of total revenue was generated from nine customers. Customer A accounted for 33%, Customer B accounted for 30%, Customer C accounted for 30% and Customer D accounted for 6% and the remaining five customers accounted for less than 1% of revenue.
Property, plant and equipment and intangible assets are located in the following countries:
As at December 31
  
2019
   2018 
Canada
  
$
1,282
 
  $316 
Barbados
  
 
9,599
 
   1,705 
  
 
 
   
 
 
 
  
$
10,881
 
  $2,021 
  
 
 
   
 
 
XML 103 R22.htm IDEA: XBRL DOCUMENT v3.20.1
Related party transactions
12 Months Ended
Dec. 31, 2019
Disclosure of transactions between related parties [abstract]  
Related party transactions
17.
Related party transactions
 
 
(a)
Key management personnel compensation
Key management personnel are those persons having authority and responsibility for planning, directing and controlling the activities of the Company. The Board of Directors, President and Chief Executive Officer and Chief Financial Officer are key management personnel for all periods. Beginning on July 1, 2019, the Company appointed a new President and Chief Operating Officer who was considered key management personnel beginning with this appointment. The then existing President retains the title of Chief Executive Officer and remains included in key management personnel for all periods. The Vice-President, Commercial Operations was considered key management personnel until the conclusion of his employment in September 2017 and for the 2018 and 2019 periods, a new Vice-President, Commercial Operations was hired effective January 8, 2018 and is included in key management personnel from the effective date of his hire until the conclusion of his employment on June 30, 2019.
Beginning in December 2016 and ending of October 2, 2017, the President and Chief Executive Officer of Apicore, was considered key management personnel. The compensation pertaining to the President and Chief Executive Officer of Apicore has been included in the income from discontinued operations in the consolidated statements of net income and comprehensive income for the year ended December 31, 2017 and his compensation has been excluded from the table below. Included in the table below is $750,000 relating to transaction bonuses paid to key management personnel which is included within the income from discontinued operations for the year ended December 31, 2017 on the consolidated statement net income and comprehensive income.
In addition to their salaries, the Company also provides
non-cash
benefits and participation in the Stock Option Plan. The following table details the compensation paid to key management personnel:
 
Year ended December 31
  
2019
   2018   2017 
Salaries, fees and short-term benefits
  
$
781
 
  $770   $1,463 
Share-based payments
  
 
208
 
   669    139 
  
 
 
   
 
 
   
 
 
 
  
$
989
 
  $1,439   $1,602 
  
 
 
   
 
 
   
 
 
 
As at December 31, 2019, the Company did not have any amounts (2018 – $5) recorded within accounts payable and accrued liabilities relating to amounts payable to the members of the Company’s Board of Directors for services provided.
 
 
(b)
Transactions with related parties
Directors and key management personnel control 23% of the voting shares of the Company as at December 31, 201
9
(2018 – 17%).
During the year ended December 31, 2019 the Company paid GVI, a company controlled by the Chief Executive Officer, a total of $85 (2018 – $85; 2017 – $85) for business administration services, $295 (2018 – $228; 2017 – $212) in rental costs and $47 (2018 – $47; 2017 – $44) for information technology support services. As described in note 16(a), the business administration services summarized above are provided to the Company through a consulting agreement with GVI.
Clinical research services are provided through a consulting agreement with GVI Clinical Development Solutions Inc. (“GVI CDS”), a company controlled by the Chief Executive Officer. Pharmacovigilance and safety, regulatory support, quality control and clinical support are provided to the Company through the GVI CDS agreement. During the year ended December 31, 2019, the Company paid GVI CDS $406 (2018 – $858; 2017 – $716) for clinical research services.
 
Research and development services are provided through a consulting agreement with CanAm Bioresearch Inc. (“CanAm”), a company controlled by a close family member of the President and Chief Executive Officer. During the year ended December 31, 2019, the Company paid CanAm $133 (2018 – $393; 2017 – $458) for research and development services.
Beginning with the acquisition of Apicore (the “Acquisition”) on December 1, 2016 and ending with the Apicore Sales Transaction on October 2, 2017 (note 5), the Company incurred rental charges pertaining to leased manufacturing facilities and office space from Dap Dhaduk II LLC (“Dap Dhaduk”), an entity controlled by a minority shareholder and member of the board of directors of Apicore Inc. Included within discontinued operations on the consolidated statements of net income and comprehensive income is payments to Dap Dhaduk totaling $263 for the year ended December 31, 2017.
Beginning with the Acquisition on December 1, 2016 and ending with the Apicore Sales Transaction on October 2, 2017 (note 5), the Company purchased inventory from Aktinos Pharmaceuticals Private Limited and Aktinos HealthCare Private Limited (together, “Aktinos”), an entity significantly influenced by a close family member of the Chief Executive Officer of Apicore Inc. For the year ended December 31, 2017, the Company paid Aktinos $1,599 for purchases of inventory, which were included in assets of the Apicore business sold (note 5) in connection with the Apicore Sales Transaction.
Beginning with the Acquisition on December 1, 2016 and ending with the Apicore Sales Transaction on October 2, 2017 (note 5), the Company incurred research and development charges from Omgene Life Sciences Pvt. Ltd. (“Omgene”), an entity significantly influenced by a close family member of the Chief Executive Officer of Apicore Inc. Included within discontinued operations on the consolidated statements of net income and comprehensive income is payments to Omgene totaling $
26
for the year ended December 31, 2017.
Beginning with the Acquisition on December 1, 2016 and ending with the Apicore Sales Transaction on October 2, 2017 (note 5), the Company incurred pharmacovigilance charges from 4C Pharma Solutions LLC (“4C Pharma”), an entity significantly influenced by a close family member of the Chief Executive Officer of Apicore Inc. Included within discontinued operations on the consolidated statements of net income and comprehensive income is payments to 4C Pharma totaling $6 for the year ended December 31, 2017.
These transactions have been measured at the exchange amount, which is the amount of consideration established and agreed to by the related parties.
As at December 31, 2019, included in accounts payable and accrued liabilities is $95 (2018 – $17) payable to GVI, $56 (2018 – $134) payable to GVI CDS, and no amounts (2018 – $40) payable to CanAm. These amounts are unsecured, payable on demand and
non-interest
bearing.
Effective July 18, 2016, the Company renewed its consulting agreement with its Chief Executive Officer, through A.D. Friesen Enterprises Ltd., a company owned by the Chief Executive Officer, for a term of five years, at a rate of $300 annually, increasing to $315 annually, effective January 1, 2017 and increasing to $331 annually, effective January 1, 2019. The Company may terminate this agreement at any time upon 120 days’ written notice. There were not any amounts payable to A.D. Friesen Enterprises Ltd. as a result of this consulting agreement as at December 31, 2019 or 2018. Any amounts payable to A.D. Friesen Enterprises Ltd. are unsecured, payable on demand and
non-interest
bearing.
Effective January 1, 2018, the Company renewed its consulting agreement with its Chief Financial Officer, through JFK Enterprises Ltd., a company owned by the Chief Financial Officer of the Company, for a
one-year
term, at a rate of $155 annually. The agreement could have been terminated by either party, at any time, upon 30 days written notice. Any amounts payable to JFK Enterprises Ltd. were unsecured, payable on demand and
non-interest
bearing. Effective June 1, 2018, this consulting agreement was converted into an employment agreement with the Chief Financial Officer.
XML 104 R33.htm IDEA: XBRL DOCUMENT v3.20.1
Inventories (Tables)
12 Months Ended
Dec. 31, 2019
Disclosure Of Inventories [Abstract]  
Schedule of inventories
As at December 31
  
2019
   2018 
Finished product
available-for-sale
  
$
5,273
 
  $2,937 
Unfinished product and packaging materials
  
 
1,055
 
   1,302 
  
 
 
   
 
 
 
  
$
6,328
 
  $4,239 
  
 
 
   
 
 
 
XML 105 R37.htm IDEA: XBRL DOCUMENT v3.20.1
Income taxes (Tables)
12 Months Ended
Dec. 31, 2019
Income Tax [Line Items]  
Schedule of deferred tax assets and liabilities
As at December 31
  
2019
   2018 
Deferred tax assets
    
Non-capital
loss carryforwards
  
$
—  
 
  $127 
  
 
 
   
 
 
 
Total deferred tax assets
  
$
 
 
 
  $127 
  
 
 
   
 
 
 
Schedule of deferred tax assets not recognized
As at December 31
  
2019
 
  
2018
 
Deferred tax assets
  
   
  
   
Scientific research and experimental development
 
 
$
 
2
,
640
 
 
$
3,237
 
Investment in Sensible
  
 
855
 
  
 
 
 
 
Holdback receivable
  
 
688
 
  
 
199
 
Other
  
 
1,781
 
  
 
159
 
Non-capital losses
  
 
207
 
  
 
 
 
 
 
  
 
 
 
  
 
 
 
Total deferred tax assets
  
$
6,171
 
  
$
3,595
 
 
  
 
 
 
  
 
 
 
Schedule of reconciliation of statutory rate to the income tax rate applied to the net (loss) income
 
Year ended December 31
  
2019
   2018   2017 
(Loss)
Income for the year
      
Canadian
  
$
(7,013
)
 
  $3,440   $(2,178
Foreign
  
 
(12,628
)
 
   1,383    4,615 
  
 
 
   
 
 
   
 
 
 
  
$
(19,641
)
 
  $4,823   $2,437 
  
 
 
   
 
 
   
 
 
 
 
Year ended December 31
  
2019
   2018   2017 
Canadian federal and provincial income taxes at 27% (2018 – 27%; 2017 – 27%)
  
$
5,303
 
  $(1,302  $(658
Permanent differences and other items
  
 
(330
)
 
   26    (335
Foreign tax rate in foreign jurisdictions
  
 
(1,308
)
 
   85    656 
Change in unrecognized deferred tax assets
  
 
(3,810
)
 
   294    9,397 
  
 
 
   
 
 
   
 
 
 
  
$
(145
  $(897  $9,060 
  
 
 
   
 
 
   
 
 
 
UNITED STATES  
Income Tax [Line Items]  
Schedule of losses available for application in future years
 
2039
  
$
243
 
 
  
 
 
 
 
  
$
243
 
 
  
 
 
 
BARBADOS  
Income Tax [Line Items]  
Schedule of losses available for application in future years
2020
  $1,210 
202
1
   1,275 
2022
   3,752 
  
 
 
 
  
$
6,237 
  
 
 
 
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Intangible assets
12 Months Ended
Dec. 31, 2019
Disclosure of detailed information about intangible assets [abstract]  
Intangible assets
9.
Intangible assets
 
Cost
  Licenses  Patents and
Drug
Approvals
  Trademarks  Customer
list
  Total 
At December 31, 2017
  $1,756  $14,239  $4,014  $708  $20,717 
Effect of movements in exchange rates
   154   1,245   351   62   1,812 
  
 
 
  
 
 
  
 
 
  
 
 
  
 
 
 
At December 31, 2018
  $1,910  $15,484  $4,365  $770  $22,529 
Additions (note 1
1
)
  
 
7,038
 
 
 
8,930
 
 
 
 
 
 
 
 
 
15,968
 
Impairment
 
 
(6,959
)
 
 
 
 
 
 
 
 
 
 
 
(6,959
)
Transfers within intangible assets
  
 
(1,854
 
 
1,457
 
 
 
—  
 
 
 
—  
 
 
 
(397
Effect of movements in exchange rates
  
 
(135
 
 
(942
 
 
(209
 
 
(37
 
 
(1,323
  
 
 
  
 
 
  
 
 
  
 
 
  
 
 
 
At December 31, 2019
  
$
 
 
$
24,929
 
 
$
4,156
 
 
$
733
 
 
$
29,818
 
  
 
 
  
 
 
  
 
 
  
 
 
  
 
 
 
 
Accumulated amortization and
impairment losses
  Licenses  Patents and
Drug
Approvals
  Trademarks  Customer
list
  Total 
At December 31, 2017
  $  $14,239  $4,014  $708  $18,961 
Amortization
   196            196 
Effect of movements in exchange rates
   9   1,245   351   62   1,667 
  
 
 
  
 
 
  
 
 
  
 
 
  
 
 
 
At December 31, 2018
  $205  $15,484  $4,365  $770  $20,824 
Amortization
  
 
841
 
 
 
597
 
 
 
 
 
 
 
 
 
1,438
 
Imp
airment
 
 
(638
)
 
 
 
 
 
 
 
 
 
 
 
(638
)
Transfers within intangible assets
  
 
(397
 
 
—  
 
 
 
—  
 
 
 
—  
 
 
 
(397
Effect of movements in exchange rates
  
 
(11
 
 
(751
 
 
(209
 
 
(37
 
 
(1,008
  
 
 
  
 
 
  
 
 
  
 
 
  
 
 
 
At December 31, 2019
  
$
 
 
$
15,330
 
 
$
4,156
 
 
$
733
 
 
$
20,219
 
  
 
 
  
 
 
  
 
 
  
 
 
  
 
 
 
 
Carrying amounts
  Licenses   Patents and
Drug
Approvals
   Trademarks   Customer
list
   Total 
At December 31, 2018
  $1,705   $   $   $   $1,705 
At December 31, 2019
  
$
 
  
$
9,599
 
  
$
 
  
$
 
  
$
9,599
 
  
 
 
   
 
 
   
 
 
   
 
 
   
 
 
 
On September 30, 2019 the Company acquired ownership of ZYPITAMAG
TM
for the U.S. and Canadian markets. Under terms of the agreement, Zydus will receive an upfront payment of U.S. $5,000 (CDN $6,622) and U.S. $2,000 (CDN $2,649) in deferred payments to be paid in equal instalments annually over the next four years, as well as contingent payments on the achievement of milestones and royalties related to net sales. The Company previously had acquired U.S. marketing rights with a profit-sharing arrangement. With this acquisition the Company obtained full control of marketing and pricing negotiation for ZYPITAMAG
TM
. Upon completion of the acquisition $8,930 was recorded within patents and drug approvals relating to the upfront and deferred payments and $1,457 was transferred from licenses to patents and drug approvals pertaining to the cost of the previously acquired license over ZYPITAMAG
TM
. The fair value of the deferred payments of $649 and $1,655 is recorded on the statement of financial position within current portion of acquisition payable and acquisition payable, respectively. The initial amortization period pertaining
to
the ZYPITAMAG
TM
intangible assets was 4.3 years with the remaining amortization period being 4.1 years as at December 31, 2019.
As at December 31, 2018, the Company had recorded $546 within accounts payable and accrued liabilities relating to the current portion of license fees payable relating to the ZYPITAMAG
TM
license acquired during the year ended December 31, 2017. This balance was paid during the year ended December 31, 2019.
The Company has considered indicators of impairment as at December 31, 2019 and 2018. The Company recorded a write-down of intangible assets related to the ReDS
TM
license during the year ended December 31, 2019 totaling $6,321 as a result of uncertainties with ReDS
TM
being experienced in regards to the length of the sales cycle and uptake of the product with customers, resulting in the Company’s sales being below the committed amounts required by the exclusive marketing and distribution agreement regarding ReDS
TM
.
The Company did not record any
write-down
of intangible assets during the year ended December 31, 2018. The Company recorded a write-down of intangible assets during the year ended December 31, 2017 totaling $636 pertaining to a license acquired during the year, which was under litigation as described in note 16(d). As at December 31, 2019, intangible assets pertaining to AGGRASTAT
®
intangible were fully amortized.
With respect to the intangible asset related to ZYPITAMAGTM, management calculated its fair value less costs to sell using a discounted cash flow model (Level 3 in the fair value hierarchy) based upon financial forecasts prepared by management using a discount rate of
13.25%, a cumulative aggregate growth rate of 300% over four years and a nominal terminal value. The Company has concluded that there was no impairment as a result of the analysis for the year ended December 31, 2019 as the recoverable amount exceeded the carrying amount by approximately $1,600 at the high end of the reasonable range. However, the assessment identified that a reasonably possible change in the key assumption of the sales growth rate forecast results in the recoverable amount being less than the carrying value. A seven percent reduction in the sales growth forecast per year would result in the carrying value of the intangible asset exceeding the reasonable range of the recoverable amount.
For the year ended December 31, 2019, amortization of intangible assets totaling $1,438 (2018 – $196) is recorded within cost of goods sold. For the years ended December 31 2017, there was no amortization of intangible recorded within net income from continuing operations. For the year ended December 31, 2017, amortization of the acquired intangible assets totaling $6,634 was recognized within loss from discontinued operations.
XML 108 R10.htm IDEA: XBRL DOCUMENT v3.20.1
Discontinued operations
12 Months Ended
Dec. 31, 2019
Discontinued Operations [Abstract]  
Discontinued operations
5.
Discontinued operations
On October 2, 2017, the Company sold its interests in Apicore (the “Apicore Sale Transaction”) to an
arm’s-length,
pharmaceutical company (the “Buyer”). The Company acquired Apicore in a series of transactions occurring between July 3, 2014 and July 12, 2017.
Under the Apicore Sale Transaction, the Company received a payment of US$57,623 (C
DN
—$72,058) upon the closing of the transaction. Additional working capital and deferred payments of US$52,887 (C
DN
—$65,235) were received subsequent to December 31, 2017 as part of the Apicore Sales Transaction and were recorded as consideration receivable as at December 31, 2017. Additionally, a contingent payment in the form of an
earn-out
based on the achievement of certain financial results by Apicore for the year ended December 31, 2017 could have been received, however the financial results specified under the Apicore Sales Transaction were not achieved. As a result, no amount has been recorded in the consolidated financial statements pertaining to this potential
earn-out
payment. Additionally, under the Apicore Sale Transaction, the Buyer held an option to acquire Apicore’s Indian operations for a fixed price until December 31, 2017. This option lapsed without exercise and the Company sold Apicore’s Indian operations, to a company owned by the former President and Chief Executive Officer of Apicore Inc. in January of 2018 with the net assets held for sale being released from accounts payable and accrued liabilities at that time.
Set out below is the financial performance for years ended December 31, 2019, 2018 and 2017 relating to the Apicore business:
 
Year ended December 31
  
2019
   2018   2017 
Revenue
  $   $
   $22,759 
Expenses
           (47,936
  
 
 
   
 
 
   
 
 
 
Loss from discontinued operations
  
$
 
  $   $(25,177
Income tax recovery
  
 
 
  
 
 
   1,847 
  
 
 
   
 
 
   
 
 
 
Loss after income tax recovery
  
$
 
  $
    (23,330
Gain on disposition of the Apicore business
  
 
 
  
 
 
   55,254 
  
 
 
   
 
 
   
 
 
 
Income from discontinued operations
  
$
 
  $
   $31,924 
  
 
 
   
 
 
   
 
 
 
As previously described, the Company retained ownership in Apicore’s Indian operations until the lapse of the Buyer Option and during January of 2018, Apicore’s Indian operations were sold to a company owned by the former President and Chief Executive Officer of Apicore Inc.
Immediately before the classification as discontinued operations, the recoverable amount was estimated for certain items and no impairment loss was identified. As at December 31, 2017, a write-down of $1,791 was recognized to reduce the carrying amount of the assets in the disposal group to their fair value less costs to sell, which totaled $7,077. This impairment was recognized in discontinued operations in the statements net income and comprehensive income for the year ended December 31, 2017.
Set out below is the cash flow information for the years ended December 31, 2019, 2018 and 2017 relating to the Apicore business:
 
Year ended December 31
  
2019
   2018   2017 
Net cash flows from operating activities
  
$
 
  $
   $5,210 
Net cash flows from investing activities
  
 
 
  
 
 
   54,326 
Net cash flows used in financing activities
  
 
 
  
 
 
   (80,944
  
 
 
   
 
 
   
 
 
 
Net cash flows used in discontinued operations
  
$
 
  $
   $(21,408
  
 
 
   
 
 
   
 
 
 
 
XML 109 R18.htm IDEA: XBRL DOCUMENT v3.20.1
Capital Stock
12 Months Ended
Dec. 31, 2019
Disclosure Of Capital Stock [Abstract]  
Capital Stock
13.
Capital Stock
 
 
(a)
Authorized
The Company has authorized share capital of an unlimited number of common voting shares, an unlimited number of Class A common shares and an unlimited number of preferred shares. The preferred shares may be issued in one or more series, and the directors may fix prior to each series issued, the designation, rights, privileges, restrictions and conditions attached to each series of preferred shares.
 
 
(b)
Shares issued and outstanding
Shares issued and outstanding are as follows:
 
   Number of Common Shares   Amount 
Balance, December 31, 2017
   15,782,327   $125,734 
Shares issued upon exercise of stock options (1
3
(c))
   206,885    654 
Shares repurchased and cancelled under a normal course issuer bid
(1)
   (441,400   (3,501
  
 
 
   
 
 
 
Balance, December 31, 2018
   15,547,812   $122,887 
Shares issued upon exercise of stock options (1
3
(c))
   8,001    37 
Shares repurchased and cancelled under a normal course issuer bid
(1)
   (751,800   (5,955
Shares repurchased and cancelled under a substantial issuer bid
(2)
   (4,000,000   (31,605
  
 
 
   
 
 
 
Balance, December 31, 2019
  
 
10,804,013
 
  
$
85,364
 
  
 
 
   
 
 
 
 
 
(1)
On May 16, 2018, the Company announced that the
TSX-V
accepted the Company’s notice of its intention to make a normal course issuer bid (the “2018 NCIB”). Under the terms of the 2018 NCIB, the Company could have acquired up to an aggregate of 794,088 common shares, representing five percent of the common shares outstanding at the time of the application, over the twelve-month period that the 2018 NCIB was in place. The 2018 NCIB commenced on May 28, 2018 and ended on May 27, 2019. During the twelve months of the 2018 NCIB, the Company purchased and cancelled 771,900 common shares for a total cost of $5,085. The prices that the Company paid for the common shares purchased was the market price of the shares at the time of purchase.
On May 30, 2019, the Company announced that the
TSX-V
accepted the Company’s notice of intention to make an additional normal course issuer bid (the “2019 NCIB”). Under the terms of the 2019 NCIB, the Company may acquire up to an aggregate of 761,141 common shares, representing five percent of the common shares outstanding at the time of the application, over the twelve-month period that the 2019 NCIB is in place. The 2019 NCIB commenced on May 30, 2019 and will end on May 29, 2020, or on such earlier date as the Company may complete its maximum purchases allowed under the 2019 NCIB. From the commencement of the 2019 NCIB, the Company purchased and cancelled 421,300 common shares for a total cost of $2,081. The prices that the Company paid or will pay for common shares purchased was or will be the market price of the shares at the time of purchase.
During the year ended December 31, 2019, the Company repurchased and cancelled 751,800 (2018 – 441,400), common shares as a result of the 2018 NCIB and 2019 NCIB. The aggregate price paid for these common shares totaled $4,145 (2018—$3,021). During the year ended December 31, 2019 the Company recorded $1,810 (2018—$480) directly in its deficit representing the difference between the aggregate price paid for these common shares and a reduction of the Company’s share capital totaling $5,955 (2018—$3,501).
 
 
(2)
On December 20, 2019, the Company completed a Substantial Issuer Bid (“SIB”) pursuant to which the Company purchased 4,000,000 of its common shares for cancellation at a set purchase price of $6.50 per common share for a total purchase price of $26,000 in cash. The Company incurred an additional $139 on transaction costs related to the SIB for a total aggregate purchase price paid of $26,139. During the year ended December 31, 2019, the Company recorded $5,466 directly in its deficit representing the difference between the aggregate price paid for these common shares and a reduction of the Company’s share capital totaling $31,605.
 
 
(c)
Stock option plan
The Company has a stock option plan which is administered by the Board of Directors of the Company with stock options granted to directors, management, employees and consultants as a form of compensation. The number of common shares reserved for issuance of stock options is limited to a maximum of 2,934,403 common shares of the Company at any time. The stock options generally have a maximum term of between five and ten years and vest within a five-year period from the date of grant.
Changes in the number of options outstanding during the year ended December 31, 2019 is as follows:
 
Year ended December 31, 2019
  Options   Weighted
average
exercise
price
 
Balance, beginning of period
  
 
1,394,642
 
  
$
3.91
 
Granted
  
 
262,000
 
  
 
4.95
 
Exercised
  
 
(8,001
  
 
(2.45
Forfeited, cancelled or expired
  
 
(220,233
  
 
(6.75
  
 
 
   
 
 
 
Balance, end of period
  
 
1,428,408
 
  
$
3.67
 
  
 
 
   
 
 
 
Options exercisable, end of period
  
 
1,059,308
 
  
$
2.88
 
  
 
 
   
 
 
 
 
Changes in the number of options outstanding during the years ended December 31, 2018 and 2017 are as follows:
 
Year ended December 31
  2018   2017 
   Options   Weighted
average
exercise
price
   Options   Weighted
average
exercise
price
 
Balance, beginning of period
   1,602,127   $3.58    1,387,000   $2.37 
Granted
   200,000    7.25    476,000    7.20 
Exercised
   (206,885   (1.76   (207,950   (2.50
Forfeited, cancelled or expired
   (200,600   (6.85   (52,923   (8.58
  
 
 
   
 
 
   
 
 
   
 
 
 
Balance, end of period
   1,394,642   $3.91    1,602,127   $3.58 
  
 
 
   
 
 
   
 
 
   
 
 
 
Options exercisable, end of period
   1,044,892   $2.80    1,231,127   $2.50 
  
 
 
   
 
 
   
 
 
   
 
 
 
Options outstanding at December 31, 2019 consist of the following:
 
Range of
exercise prices
  Number
outstanding
   Weighted
average
remaining
contractual life
   Options outstanding
weighted average
exercise price
   Number
exercisable
 
$0.30
   185,000    3.35 years   $0.30    185,000 
$1.01
-
$3.00
   539,433    2.30 years   $1.59    539,433 
$3.01
-
$4.00
   29,000    0.90 years   $3.90    29,000 
$4.01 - $5.00
   262,000    4.49 years   $4.95    52,400 
$5.01 - $7.30
   412,975    2.76 years   $7.08    253,475 
  
 
 
   
 
 
   
 
 
   
 
 
 
$0.30
-
$7.30
   1,428,408    2.94 years   $3.67    1,059,308 
  
 
 
   
 
 
   
 
 
   
 
 
 
Compensation expense related to stock options granted during the year or from previous periods under the stock option plan for the year ended December 31, 2019 is $417 (2018 – $1,022; 2017 – $491). The compensation expense was determined based on the fair value of the options at the date of measurement using the
Black-Scholes
option pricing model. The expected life of stock options is based on historical data and current expectations and is not necessarily indicative of exercise patterns that may occur. The expected volatility reflects the assumption that the historical volatility over a period similar to the life of the options is indicative of future trends, which may not necessarily be the actual outcome.
The compensation expense for the years ended December 31, 2019, 2018, and 2017 was determined based on the fair value of the options at the date of measurement using the
Black-Scholes
option pricing model:
 
Years ended December 31:
  
2019
  2018  2017 
Expected option life
  
 
4.4 years
 
  4.4 years   4.5 years 
Risk free interest rate
  
 
1.40
  
1.92%-2.04
  1.71
Dividend yield
  
 
n
il
 
  
n
il
   nil 
Expected volatility
  
 
47.10
  
85.14%-93.72
  80.44
  
 
 
  
 
 
  
 
 
 
 
Additionally, prior to its disposal Apicore had a stock option plan and at the December 1, 2016 acquisition date, there were 897,500 options to purchase Class E common stock of Apicore Inc. outstanding. 497,500 options became fully vested on the change in control with the right to put the outstanding Apicore Class E shares and options to the Company upon the change in control. The remaining Apicore stock options outstanding of 400,000 were unaffected by the change of control and fully vested during 2017. The value of the put option was initially recorded as a liability to repurchase Apicore Class E shares on the consolidated statements of financial position and the value of the remaining options was recorded as
non-controlling
interest within equity.
During the year ended December 31, 2017, employees and former directors of Apicore exercised 292,500 stock options to acquire 292,500 Class E common shares of Apicore for gross proceeds to the Company of US$280. These shares, as well as 112,500 Class E common shares previously issued for gross proceeds of US$48 were then purchased by the Company upon the employees and former directors exercising their put right to the Company. This resulted in the Company acquiring 405,000 Class E common shares of Apicore for a total cost of US$1,975 (CDN—$2,690) during 2017. As a result of the employees and former directors exercising their put right to the Company, the liability to repurchase Apicore Class E common shares on the consolidated statements of financial position was reduced.
On July 3, 2017, the remaining employee put options over 117,500 Class E shares, to be issued upon the exercise of stock options, of Apicore expired without being exercised by the employees and the value of these options, totaling $615
,
 
was reclassified as a
non-controlling
interest. As a result, there remained 517,500 stock options in Apicore Inc. outstanding prior to the sale transaction which occurred on October 2, 2017.
During the year ended December 31, 2017, the Company recorded $132 of stock-based compensation expense within the loss from discontinued operations on the consolidated statements of net income and comprehensive income relating to stock options in Apicore.
 
 
(d)
Warrants
On November 17, 2016 in connection with a term loan entered into to fund an acquisition, the Company issued 900,000 warrants to the lenders, exercisable for a
48-month
period following the issuance of the loan at a price of $6.50 per share. The fair value of the warrants issued in connection with the loan was $2,066 net of its
pro-rata
share of financing costs of $117 and were recorded in equity with a corresponding balance recorded as deferred financing costs which is netted against the associated long-term debt on the consolidated statements of financial position as at December 31, 2017.
Changes in the number of Canadian dollar denominated warrants outstanding during the years ended December 31, 2019, 2018, and 2017 are as follows:
 
Years ended December 31
  
2019
   2018   2017 
   
Warrants
   
Weighted
average
exercise
price
   Warrants   Weighted
average
exercise
price
   Warrants  Weighted
average
exercise
price
 
Balance, beginning of period
  
 
900,000
 
  
$
6.50
 
   900,000   $6.50    941,969  $6.31 
Exercised
  
 
 
  
 
 
           (41,969  (2.20
  
 
 
   
 
 
   
 
 
   
 
 
   
 
 
  
 
 
 
Balance, end of period
  
 
900,000
 
  
$
6.50
 
   900,000   $6.50    900,000  $6.50 
  
 
 
   
 
 
   
 
 
   
 
 
   
 
 
  
 
 
 
Warrants exercisable, end of period
  
 
900,000
 
  
$
6.50
 
   900,000   $6.50    900,000  $6.50 
  
 
 
   
 
 
   
 
 
   
 
 
   
 
 
  
 
 
 
 
 
(e)
Per share amounts
The following table reflects the calculation of basic (loss) earnings per share for the years ended December 31, 2019, 2018 and 2017:
 
Year ended December 31
  
2019
   2018   2017 
Net (loss) earnings before discontinued operations
  
$
(1.32
  $0.25   $0.74 
Earnings from discontinued operations, net of tax
  
 
—  
 
   —      2.04 
  
 
 
   
 
 
   
 
 
 
  
$
(1.32
  $0.25   $2.78 
  
 
 
   
 
 
   
 
 
 
The following table reflects the calculation of diluted (loss) earnings per share for the years ended December 31, 2019, 2018 and 2017:
 
Year ended December 31
  
2019
   2018   2017 
Net (loss) earnings before discontinued operations
  
$
(1.32
  $0.24   $0.63 
Earnings from discontinued operations, net of tax
  
 
—  
 
   —      1.76 
  
 
 
   
 
 
   
 
 
 
  
$
(1.32
  $0.24   $2.39 
  
 
 
   
 
 
   
 
 
 
The following table reflects the (loss) income used in the basic (loss) earnings per share computations for the years ended December 31, 2019, 2018 and 2017:
 
Year ended December 31
  
2019
   2018   2017 
Net (loss) earnings before discontinued operations
  
$
(19,786
  $3,926   $11,497 
Earnings from discontinued operations, net of tax
  
 
—  
 
   —      31,924 
  
 
 
   
 
 
   
 
 
 
  
$
(19,786
  $3,926   $43,421 
  
 
 
   
 
 
   
 
 
 
The following table reflects the share data used in the denominator of the basic and diluted (loss) earnings per share computations for the years ended December 31, 2019, 2018 and 2017:
 
Year ended December 31
  
201
9
   2018   2017 
Weighted average shares outstanding for basic (loss) earnings per share
  
 
14,998,540
 
   15,791,396    15,636,853 
Effects of dilution from:
      
Stock options
  
 
—  
 
   772,267    1,601,227 
Warrants
  
 
—  
 
   —      900,000 
  
 
 
   
 
 
   
 
 
 
Weighted average shares outstanding for diluted (loss) earnings per share
  
 
14,998,540
 
   16,563,663    18,138,080 
  
 
 
   
 
 
   
 
 
 
Effects of dilution from 1,428,408 stock options (2018 – 622,375, 2017 – 900) and 900,000 warrants (2018
 
 
900,000, 2017 –
nil
) were excluded in the calculation of weighted average shares outstanding for diluted (loss) earnings per share before discontinued operations for the year ended December 31, 2019 as they are anti-dilutive.
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XML 112 R79.htm IDEA: XBRL DOCUMENT v3.20.1
Finance income (expense) (Details) - CAD ($)
$ in Thousands
12 Months Ended
Dec. 31, 2019
Dec. 31, 2018
Dec. 31, 2017
Schedule For Finance Income And Expense [Line Items]      
Interest income $ 886 $ 1,115 $ 47
Accretion of royalty obligation 316 (355) (748)
Accretion of acquisition payable (41)    
Bank charges and other interest (24) (25) (30)
Finance expense from lease obligation (22)    
Accretion on holdback receivable 0 326 0
Total Finance costs (income) 1,115 1,061 (837)
MIOP loan      
Schedule For Finance Income And Expense [Line Items]      
Accretion of acquisition payable   0 0
Finance expense from lease obligation   0 0
Interest on MIOP loan $ 0 $ 0 $ (106)
XML 113 R81.htm IDEA: XBRL DOCUMENT v3.20.1
Commitments and contingencies (Details)
$ in Thousands
Dec. 31, 2019
CAD ($)
Commitments And Contingencies [Line Items]  
Future payable representing contracts and other commitments $ 5,919
2020  
Commitments And Contingencies [Line Items]  
Future payable representing contracts and other commitments 3,043
2021  
Commitments And Contingencies [Line Items]  
Future payable representing contracts and other commitments 1,243
2022  
Commitments And Contingencies [Line Items]  
Future payable representing contracts and other commitments 1,243
2023  
Commitments And Contingencies [Line Items]  
Future payable representing contracts and other commitments 195
2024  
Commitments And Contingencies [Line Items]  
Future payable representing contracts and other commitments $ 195
XML 114 R71.htm IDEA: XBRL DOCUMENT v3.20.1
Capital Stock (Detail Textuals 2) - Apicore - Crown Capital Fund IV LP term loan
1 Months Ended
Nov. 17, 2016
CAD ($)
$ / shares
Dec. 01, 2016
shares
Disclosure of terms and conditions of share-based payment arrangement [line items]    
Number of warrants issued to lenders | shares   900,000
Maturity period of term loans 48 months  
Warrant exercise price issued to lenders | $ / shares $ 6.50  
Fair value assigned to warrants issued $ 2,066  
Pro rata share of financing costs $ 117  
XML 115 R75.htm IDEA: XBRL DOCUMENT v3.20.1
Income taxes (Details 2) - CAD ($)
$ in Thousands
12 Months Ended
Dec. 31, 2019
Dec. 31, 2018
Dec. 31, 2017
Income (loss) for the year      
Canadian $ (7,013) $ 3,440 $ (2,178)
Foreign (12,628) 1,383 4,615
(Loss) Income for the year (19,641) 4,823 2,437
Canadian federal and provincial income taxes at 27% (2017 - 27%; 2016 - 27%) 5,303 (1,302) (658)
Permanent differences and other items (330) 26 (335)
Foreign tax rate in foreign jurisdictions (1,308) 85 656
Change in unrecognized deferred tax assets (3,810) 294 9,397
Income tax expense $ (145) $ (897) $ 9,060
XML 116 R85.htm IDEA: XBRL DOCUMENT v3.20.1
Related party transactions (Detail Textuals) - Key management personnel of entity or parent - CAD ($)
12 Months Ended
Dec. 31, 2017
Dec. 31, 2019
Dec. 31, 2018
Disclosure of transactions between related parties [line items]      
Transaction bonuses included in loss from discontinued operations $ 750,000    
Amount payable for services provided recorded within accounts payable and accrued liabilities   $ 0 $ 5,000
XML 117 R2.htm IDEA: XBRL DOCUMENT v3.20.1
Consolidated Statements of Financial Position - CAD ($)
$ in Thousands
Dec. 31, 2019
Dec. 31, 2018
Current assets:    
Cash and cash equivalents $ 12,965 $ 24,139
Short-term investments   47,747
Accounts receivable (Note 6) 10,216 10,765
Inventories (Note 7) 6,328 4,239
Prepaid expenses 1,855 2,697
Total current assets 31,364 89,587
Non-current assets:    
Property, plant and equipment (Note 4 & 8) 1,282 316
Intangible assets (Note 9) 9,599 1,705
Holdback receivable (Note 5 & 10)   11,909
Other assets 39 117
Deferred tax assets (Note 14) 0 127
Total non-current assets 10,920 14,174
Total assets 42,284 103,761
Current liabilities:    
Accounts payable and accrued liabilities 9,384 14,377
Current portion of royalty obligation (Note 12) 872 1,496
Current portion of acquisition payable (Note 9) 649  
Current income taxes payable (Note 14) 517 1,058
Current portion of lease obligation (Note 4) 240  
Total current liabilities 11,662 16,931
Non-current liabilities    
Royalty obligation (Note 12) 1,176 2,035
Acquisition payable (Note 9) 1,655  
Lease obligation (Note 4) 849  
Other long-term liabilities (Note 5 & 10)   1,201
Total non-current liabilities 3,680 3,236
Total liabilities 15,342 20,167
Equity:    
Share capital (Note 13(b)) 85,364 122,887
Warrants (Note 13(d)) 1,949 1,949
Contributed surplus 8,028 7,628
Accumulated other comprehensive income (5,751) 1,268
Deficit (62,648) (50,138)
Total Equity 26,942 83,594
Total liabilities and equity 42,284 103,761
Commitments and contingencies (Note 16(a) & 16(d))
Subsequent events (Note 22)
XML 118 R6.htm IDEA: XBRL DOCUMENT v3.20.1
Reporting entity
12 Months Ended
Dec. 31, 2019
Nature Of Reporting Entity [Abstract]  
Reporting entity
1.
Reporting entity
Medicure Inc. (the “Company”) is a company domiciled and incorporated in Canada and as of October 24, 2011, its Common Shares are listed on the TSX Venture Exchange
(“TSX-V”).
Prior to October 24, 2011 and beginning on March 29, 2010, the Company’s Common Shares were listed on the NEX board of the
TSX-V.
Prior to March 29, 2010, the Company’s Common Shares were listed on the Toronto Stock Exchange. Additionally, the Company’s shares were listed on the American Stock Exchange (later called NYSE Amex and now called NYSE MKT) on February 17, 2004 and the shares ceased trading on the NYSE Amex effective July 3, 2008. The Company remains a U.S. Securities and Exchange Commission registrant. The address of the Company’s registered office is
2-1250
Waverley Street, Winnipeg, Manitoba, Canada, R3T 6C6.
The Company is a biopharmaceutical company engaged in the research, development and commercialization of human therapeutics. Through its subsidiary Medicure International, Inc., the Company has rights to the commercial product AGGRASTAT
®
Injection (tirofiban hydrochloride) in the United States and its territories (Puerto Rico, U.S. Virgin Islands, and Guam). AGGRASTAT
®
, a glycoprotein GP IIb/IIIa receptor antagonist, is used for the treatment of acute coronary syndrome including unstable angina, which is characterized by chest pain when one is at rest, and
non-Q-wave
myocardial infarction.
On September 30, 2019 the Company acquired ownership of ZYPITAMAG
TM
from Cadila Healthcare Ltd., India (“Zydus”) for the U.S. and Canadian markets. Under terms of the agreement, the Company previously had acquired U.S. marketing rights with a profit-sharing arrangement on December 14, 2017. With this acquisition the Company
obtained
full control of
 
the product
including
 
marketing and pricing negotiation for ZYPITAMAG
TM
. ZYPITAMAG
TM
is used for the treatment of patients with primary hyperlipidemia or mixed dyslipidemia and was approved in July 2017 by the U.S. Food and Drug Administration (“FDA”) for sale and marketing in the United States. On May 1, 2018 ZYPITAMAG
TM
was made available in retail pharmacies throughout the United States.
On January 28, 2019, the Company bec
a
me the exclusive marketing partner for the ReDS
point of care system
(“ReDS
”)
in the United States.
ReDS
is a
non-invasive,
FDA-cleared
medical device that provides an accurate, actionable and absolute measurement of lung fluid which is important in the management of congestive heart failure.
The Company’s ongoing research and development activities include the continued development and further implementation of a new regulatory, brand and life cycle management strategy for AGGRASTAT
®
and the development of additional cardiovascular products. The Company
continues to seek
to acquire or license additional cardiovascular products.
During 2017, the Company, through Apicore, was involved in the manufacturing, development, marketing, and selling of
Active Pharmaceutical Ingredients
(“API”) to generic pharmaceutical customers and providing custom synthesis for early phase pharmaceutical research of branded products. Through these subsidiaries, the Company also participated in collaborations with other parties in the research and development stages of specific products. In October 2017 and January 2018, respectively, the Company sold its interests in Apicore’s U.S. business and Apicore’s Indian business and the Company no longer participates in this line of business.
XML 119 R56.htm IDEA: XBRL DOCUMENT v3.20.1
Property, plant and equipment (Detail Textuals) - CAD ($)
12 Months Ended
Dec. 31, 2019
Dec. 31, 2018
Dec. 31, 2017
Disclosure of detailed information about property, plant and equipment [line items]      
Amortization of property, plant and equipment $ 485,000 $ 103,000 $ 1,173,000
Impairment of property, plant and equipment 95,000    
Discontinued Operations      
Disclosure of detailed information about property, plant and equipment [line items]      
Amortization of property, plant and equipment     1,075
Discontinued Operations | Selling, general and administrative expense      
Disclosure of detailed information about property, plant and equipment [line items]      
Amortization of property, plant and equipment $ 485 $ 103 $ 98
XML 120 R52.htm IDEA: XBRL DOCUMENT v3.20.1
Accounts receivable (Detail Textuals) - Customer
12 Months Ended
Dec. 31, 2019
Dec. 31, 2018
Dec. 31, 2017
Disclosure of major customers [line items]      
Number of customers owing greater than 10% of accounts receivable 3 3 3
Concentration Risk, Percentage Of Accounts Receivable 96.00% 91.00% 96.00%
Customer A      
Disclosure of major customers [line items]      
Concentration Risk, Percentage Of Accounts Receivable 41.00% 47.00%  
Customer B      
Disclosure of major customers [line items]      
Concentration Risk, Percentage Of Accounts Receivable 28.00% 22.00%  
Customer C      
Disclosure of major customers [line items]      
Concentration Risk, Percentage Of Accounts Receivable 27.00% 22.00%  

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A0#% @ ?*./4)^&H;(2 M(P #*X! ! ( !_$4" &UP:"TR,#$Y,3(S,2YX XML 111 R89.htm IDEA: XBRL DOCUMENT v3.20.1
Expenses by nature (Details) - CAD ($)
$ in Thousands
12 Months Ended
Dec. 31, 2019
Dec. 31, 2018
Dec. 31, 2017
Personnel expenses      
Salaries, fees and short-term benefits $ 6,394 $ 7,696 $ 5,904
Share-based payments 417 1,022 491
Employee benefits expense 6,811 8,718 6,395
Depreciation, amortization and impairment 2,017 299 98
Research and development 4,349 6,681 5,148
Manufacturing 752 765 955
Inventory material costs 3,851 3,862 3,079
Write-down of inventories 1,983 95 385
Medical affairs 718 1,026 1,108
Administration 821 1,505 1,725
Selling and logistics 6,997 8,019 5,395
Professional fees 1,578 740 802
Expenses by nature $ 28,415 $ 30,335 $ 23,481