0001062993-21-007505.txt : 20210816 0001062993-21-007505.hdr.sgml : 20210816 20210813203256 ACCESSION NUMBER: 0001062993-21-007505 CONFORMED SUBMISSION TYPE: 6-K PUBLIC DOCUMENT COUNT: 7 CONFORMED PERIOD OF REPORT: 20210630 FILED AS OF DATE: 20210816 DATE AS OF CHANGE: 20210813 FILER: COMPANY DATA: COMPANY CONFORMED NAME: NEOVASC INC CENTRAL INDEX KEY: 0001399708 STANDARD INDUSTRIAL CLASSIFICATION: SURGICAL & MEDICAL INSTRUMENTS & APPARATUS [3841] IRS NUMBER: 000000000 STATE OF INCORPORATION: A1 FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 6-K SEC ACT: 1934 Act SEC FILE NUMBER: 001-36458 FILM NUMBER: 211174064 BUSINESS ADDRESS: STREET 1: 2135 13700 Mayfield place CITY: RICHMOND STATE: A1 ZIP: 00000 BUSINESS PHONE: 604-270-4344 MAIL ADDRESS: STREET 1: 2135 13700 Mayfield place CITY: RICHMOND STATE: A1 ZIP: 00000 FORMER COMPANY: FORMER CONFORMED NAME: Medical Ventures Corp DATE OF NAME CHANGE: 20070516 6-K 1 form6k.htm FORM 6-K Neovasc Inc.: Form 6-K - Filed by newsfilecorp.com

UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549

FORM 6-K

REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16
OF THE SECURITIES EXCHANGE ACT OF 1934

For the month of August 2021

Commission File Number: 001-36458

Neovasc Inc.
(Translation of registrant's name into English)

Suite 5138 - 13562 Maycrest Way Richmond, British Columbia, Canada, V6V 2J7
(Address of principal executive offices)

Indicate by check mark whether the Registrant files or will file annual reports under cover of Form 20-F or Form 40-F.

[  ] Form 20-F   [ x ] Form 40-F

Indicate by check mark if the Registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(1): [   ]

Indicate by check mark if the Registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(7): [   ]


SUBMITTED HEREWITH

Exhibits

Exhibit   Description
     
99.1   Condensed Interim Consolidated Financial Statements for the period ended June 30, 2021
99.2   Management’s Discussion and Analysis for the period ended June 30, 2021
99.3   Form 52-109F2 Certification of Interim Filings Full Certificate - CEO
99.4   Form 52-109F2 Certification of Interim Filings Full Certificate - CFO


SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.

  NEOVASC INC.
(Registrant)
     
Date: August 10, 2021 By /s/ Chris Clark
    Chris Clark
    Chief Financial Officer


EX-99.1 2 exhibit99-1.htm EXHIBIT 99.1 Neovasc Inc.: Exhibit 99.1 - Filed by newsfilecorp.com

 

 

 

 

 

 
 

Neovasc Inc.

CONDENSED INTERIM CONSOLIDATED FINANCIAL
STATEMENTS

FOR THE THREE AND SIX MONTHS ENDED

JUNE 30, 2021 AND 2020

(Expressed in U.S. dollars)


 

 

 

 

 

 

 


CONTENTS

  Page
   
Condensed Interim Consolidated Statements of Financial Position 1
   
Condensed Interim Consolidated Statements of Loss and Comprehensive Loss 2
   
Condensed Interim Consolidated Statements of Changes in Equity 3
   
Condensed Interim Consolidated Statements of Cash Flows 4
   
Notes to the Condensed Interim Consolidated Financial Statements 5 - 35


NEOVASC INC.

Condensed Interim Consolidated Statements of Financial Position

(Expressed in U.S. dollars) (Unaudited)

  Notes   June 30,
2021
    December 31,
2020
 
               
ASSETS              
  Current assets              
    Cash and cash equivalents 6 $ 63,294,878   $ 12,935,860  
    Accounts receivable 7   1,213,450     987,057  
    Finance lease receivable 8   93,466     95,849  
    Inventory 9   1,387,718     839,472  
    Research and development supplies 9   11,852     167,378  
    Prepaid expenses and other assets 10   969,740     705,471  
  Total current assets     66,971,104     15,731,087  
               
Non-current assets              
    Restricted cash 11   483,714     470,460  
    Right-of-use asset 12   643,445     830,551  
    Finance lease receivable  8   -     42,841  
    Property and equipment 13   215,024     803,280  
    Deferred loss on 2021 derivative warrant liabilities 16   12,705,147     -  
  Total non-current assets     14,047,330     2,147,132  
               
Total assets   $ 81,018,434   $ 17,878,219  
               
LIABILITIES AND EQUITY              
  Liabilities              
  Current liabilities              
  Accounts payable and accrued liabilities 14 $ 6,422,130   $ 7,243,500  
  Lease liabilities 15   290,957     342,910  
  2019 Convertible notes 16   38,633     38,633  
  2020 Convertible notes, warrants and derivative warrant liabilities 16   37,839     37,525  
  Total current liabilities     6,789,559     7,662,568  
               
  Non-current Liabilities              
  Lease liabilities 15   426,699     596,881  
  2019 Convertible notes 16   6,544,895     6,156,724  
  2020 Convertible notes, warrants and derivative warrant liabilities 16   2,077,415     1,484,529  
  2021 Derivative warrant liabilities 16   1,745,600     -  
Total non-current liabilities     10,794,609     8,238,134  
               
Total liabilities   $ 17,584,168   $ 15,900,702  
               
  Equity              
    Share capital 17 $ 439,679,546   $ 369,775,383  
    Contributed surplus 17   38,783,708     35,045,056  
    Accumulated other comprehensive loss     (8,601,354 )   (7,615,717 )
    Deficit     (406,427,634 )   (395,227,205 )
  Total equity   $ 63,434,266   $ 1,977,517  
               
Total liabilities and equity   $ 81,018,434   $ 17,878,219  

Going Concern and Uncertainty (see Note 1(c) and 5(d))

Contingent Liabilities and Provisions (see Note 23)

Subsequent Events (see Note 24)

See Accompanying Notes to the Condensed Interim Consolidated Financial Statements


NEOVASC INC.

Condensed Interim Consolidated Statements of Loss and Comprehensive Loss
For the three and six months ended June 30, 2021 and 2020
(Expressed in U.S. dollars) (Unaudited)

  Notes   For the three months ended
June 30
    For the six months ended
June 30
 
      2021     2020     2021     2020  
                           
REVENUE 18 $ 633,068   $ 284,047   $ 1,084,862   $ 816,942  
COST OF GOODS SOLD     109,106     74,669     181,499     199,232  
GROSS PROFIT     523,962     209,378     903,363     617,710  
                           
EXPENSES                          
Selling expenses 20   832,812     452,514     1,470,791     1,006,043  
General and administrative expenses 20   5,042,804     3,825,510     10,335,373     6,313,012  
Product development and clinical trials expenses 20   3,740,887     4,589,724     8,362,315     9,113,130  
      9,616,503     8,867,748     20,168,479     16,432,185  
                           
OPERATING LOSS     (9,092,541 )   (8,658,370 )   (19,265,116 )   (15,814,475 )
                           
OTHER INCOME/(EXPENSE)                          
Interest and other income     39,733     24,981     49,753     58,650  
Interest and other expense     (278,154 )   (566,886 )   (318,563 )   (537,550 )
Gain/(loss) on foreign exchange     15,057     (125,002 )   (20,238 )   (125,653 )
Unrealized gain on warrants, derivative liability
warrants and convertible notes
 16   2,809,340     369,849     15,259,393     3,502,831  
Realized gain/(loss) on exercise or conversion of warrants, derivative liability warrants and convertible notes 16   219,307     (835,880 )   (1,895,344 )   (979,630 )
Amortization of deferred loss     (2,761,152 )   (135,082 )   (5,026,442 )   (135,082 )
      44,131     (1,268,020 )   8,048,559     1,783,566  
LOSS BEFORE TAX     (9,048,410 )   (9,926,390 )   (11,216,557 )   (14,030,909 )
                           
Tax refund/(expense)     15,396     1,075     16,128     (5,997 )
LOSS FOR THE PERIOD   $ (9,033,014 ) $ (9,925,315 ) $ (11,200,429 ) $ (14,036,906 )
                           
OTHER COMPREHENSIVE INCOME FOR THE PERIOD                          
Fair market value changes in convertible notes due to changes in own credit risk     (280,051 )   (2,309,141 )   (985,637 )   (870,956 )
LOSS AND OTHER COMPREHENSIVE LOSS FOR THE PERIOD   $ (9,313,065 ) $ (12,234,456 ) $ (12,186,066 ) $ (14,907,862 )
                           
LOSS PER SHARE                          
Basic and diluted loss per share 21 $ (0.13 ) $ (0.81 ) $ (0.19 ) $ (1.21 )

See Accompanying Notes to the Condensed Interim Consolidated Financial Statements


NEOVASC INC.

Condensed Interim Consolidated Statements of Changes in Equity

(Expressed in U.S. dollars) (Unaudited)

  Notes   Share
Capital
    Contributed
Surplus
    Accumulated Other Comprehensive Loss     Deficit     Total Equity  
                                 
Balance at January 1, 2020   $ 328,460,681   $ 29,766,225   $ (6,140,507 ) $ (366,532,164 ) $ (14,445,765 )
Issue of share capital on public offering
(net of share issuance costs)
    15,354,661     3,045,888     -     -     18,400,549  
Issue of share capital on conversion of notes 17(a)   1,293,093     -     -     -     1,293,093  
Issue of Broker warrants 17(a)   (505,268 )   948,545     -     -     443,277  
Issue of shares capital on exchange of warrants 17(b)   1,447,582     (1,447,582 )   -     -     -  
Issue of share capital on exercise of stock options 17(b)   378     (174 )   -     -     204  
Share-based payments 20   -     2,087,437     -     -     2,087,437  
Transactions with owners during the period     17,590,446     4,634,114     -     -     22,224,560  
                                 
Loss for the period     -     -     -     (14,036,906 )   (14,036,906 )
Other comprehensive loss for the period     -     -     (870,956 )   -     (870,956 )
                                 
Balance at June 30, 2020   $ 346,051,127   $ 34,400,340   $ (7,011,463 ) $ (380,569,070 ) $ (7,129,066 )
                                 
                                 
Balance at January 1, 2021   $ 369,775,383   $ 35,045,056   $ (7,615,717 ) $ (395,227,205 ) $ 1,977,517  
Issue of share capital on public offering                                
(net of share issuance costs) 17(a)   66,868,911     -     -     -     66,868,911  
Issue of share capital on exercise of warrants 17(a)   3,704,828     -     -     -     3,704,828  
Issue of share capital on vesting of restricted stock units 17(a)   1,229,383     (1,229,383 )   -     -     -  
Issue of compensation warrants 17(a)   (1,898,959 )   1,898,959     -     -     -  
Share-based payments 20   -     3,069,076     -     -     3,069,076  
Transactions with owners during the period     69,904,163     3,738,652     -     -     73,642,815  
                                 
Loss for the period     -     -     -     (11,200,429 )   (11,200,429 )
Other comprehensive loss for the period     -     -     (985,637 )   -     (985,637 )
                                 
Balance at June 30, 2021   $ 439,679,546   $ 38,783,708   $ (8,601,354 ) $ (406,427,634 ) $ 63,434,266  

See Accompanying Notes to the Condensed Interim Consolidated Financial Statements


NEOVASC INC.

Condensed Interim Consolidated Statements of Cash Flows
For the three and six months ended June 30, 2021 and 2020
(Expressed in U.S. dollars) (Unaudited)

  Notes   For the three months ended
June 30
    For the six months ended
June 30
 
      2021     2020     2021     2020  
OPERATING ACTIVITIES                          
Loss for the period   $ (9,033,014 ) $ (9,925,315 ) $ (11,200,429 ) $ (14,036,906 )
Adjustments for:                          
  Depreciation 20   193,011     187,696     379,300     371,606  
  Share-based payments 20   2,047,119     1,019,114     4,451,076     2,087,437  
  Accretion on collaboration, license and settlement     
    agreement provision
    25,509     48,895     50,469     96,740  
  Unrealized gain on warrants, derivative liability                          
    warrants and convertible notes 16   (2,809,340 )   (369,849 )   (15,259,393 )   (3,502,831 )
  Realized (gain)/loss on exercise or conversion of
    warrants, derivative liability warrants and
    convertible notes
16   (219,307 )   835,880     1,895,344     979,630  
  Amortization of deferred loss     2,761,152     135,082     5,026,442     135,082  
  Legal expenses and underwriters fees from
    financing activity
    -     -     1,546,811     -  
  Gain on disposal of assets     -     (27,864 )   (1,849 )   (27,864 )
  Write down of fixed assets for obsolescence     593,622     -     593,622     -  
  Income tax (refund)/expense     (15,396 )   (1,075 )   (16,128 )   5,997  
  Interest expense     238,421     568,583     270,659     552,952  
      (6,218,223 )   (7,528,853 )   (12,264,076 )   (13,338,157 )
Net change in non-cash working capital items:                          
  Accounts receivable     (149,900 )   147,821     (238,862 )   122,483  
  Inventory     (484,441 )   (22,353 )   (548,246 )   (210,420 )
  Research and development supplies     307,114     87,795     155,526     334,753  
  Prepaid expenses and other assets     (322,159 )   (183,395 )   (265,264 )   (99,846 )
  Accounts payable and accrued liabilities     102,724     426,084     (2,253,840 )   (779,306 )
      (546,662 )   455,952     (3,150,686 )   (632,336 )
Income tax and Interest paid and received:                          
  Income tax recovered/(paid)     15,396     1,075     16,128     (5,997 )
  Interest received     40,394     24,981     29,161     58,650  
      55,790     26,056     45,289     52,653  
Net cash applied to operating activities     (6,709,095 )   (7,046,845 )   (15,369,473 )   (13,917,840 )
                           
INVESTING ACTIVITES                          
  (Increase)/decrease in restricted cash     6,811     (15,884 )   -     22,169  
  Purchase of property, plant and equipment 13   (110,987 )   (6,086 )   (146,058 )   (46,417 )
Net cash applied to investing activities     (104,176 )   (21,970 )   (146,058 )   (24,248 )
                           
FINANCING ACTIVITIES                          
  Proceeds from public offering
    (net of share issuance costs)
17(b)   -     10,084,052     65,322,100     18,843,828  
  Proceeds from private placement     -     5,000,000     -     5,000,000  
  Proceeds from exercise of warrants 17(b)   -     -     1,078,623     -  
  Proceeds from exercise of options     -     -     -     204  
  Repayment of 2017 convertible note     -     (2,897,000 )   -     (2,897,000 )
  Interest payment of 2019 convertible note     (255,371 )   (575,000 )   (255,371 )   (575,000 )
  Payment of lease obligation     (130,374 )   (137,400 )   (270,803 )   (274,596 )
Net cash from financing activities     (385,745 )   11,474,652     65,874,549     20,097,436  
                           
NET CHANGE IN CASH     (7,199,016 )   4,405,837     50,359,018     6,155,348  
CASH AND CASH EQUIVALENTS                          
Beginning of the period     70,493,894     7,042,344     12,935,860     5,292,833  
End of the period   $ 63,294,878   $ 11,448,181     63,294,878   $ 11,448,181  

See Accompanying Notes to the Condensed Interim Consolidated Financial Statements


NEOVASC INC.

Notes to the Condensed Interim Consolidated Financial Statements

For the three and six months ended June 30, 2021 and 2020

(Expressed in U.S. dollars)


1. INCORPORATION AND GOING CONCERN

(a) Business description

Neovasc Inc. ("Neovasc" or the "Company") is a company incorporated and domiciled in Canada. The Company was incorporated as Medical Ventures Corp. under the Company Act (British Columbia) on November 2, 2000 and was continued under the Canada Business Corporations Act on April 19, 2002. On July 1, 2008, the Company changed its name to Neovasc Inc. Neovasc is the parent company.

The condensed interim consolidated financial statements of the Company as at June 30, 2021 and for the three and six months ended June 30, 2021 and 2020, comprise the Company and its subsidiaries, all of which are wholly owned. The Company's principal place of business is located at Suite 5138 - 13562 Maycrest Way, Richmond, British Columbia, V6V 2J7 and the Company's registered office is located at Suite 2600 - 595 Burrard Street, Vancouver, British Columbia, V7X 1L3, Canada. The Company's shares are listed on the Toronto Stock Exchange (TSX: NVCN) and the Nasdaq Capital Market (NASDAQ: NVCN).

Neovasc is a specialty medical device company that develops, manufactures and markets products for the rapidly growing cardiovascular marketplace. Its products include the Neovasc ReducerTM ("Reducer"), for the treatment of refractory angina, which is not currently commercially available in the United States (6 U.S. patients have been treated under Compassionate Use) and has been commercially available in Europe since 2015, and the TiaraTM ("Tiara"), for the transcatheter treatment of mitral valve disease, which is currently under clinical investigation in the United States, Canada, Israel and Europe.

(b) Corporate reorganization

On June 20, 2021, the Company announced that it had paused all product development activities on the Tiara TF device.  Concurrent with this decision the Company terminated 40% of its staff and took a provision for obsolete leasehold improvements and equipment related to these activities.

(c) Going concern and uncertainty

As at June 30, 2021, the Company had approximately $63.3 million in cash and cash equivalents being sufficient cash on hand to extend the operations of the Company for up to three years at the current anticipated burn rate. However, given the FDA's adverse panel decision and "not approvable" letter for the Reducer, and the announcement that the Company is unable to receive a European CE mark ("CE Mark") under the previous Medical Device Directive regulations ("MDD"), it is possible that the Company will initiate programs that will require additional significant expenditures and that the increasing cash needs of the Company could shorten the time the proceeds will meet the requirements of the Company. In addition, COVID-19 has impacted the Company's ability to generate revenue, enroll patients in clinical studies, complete certain Tiara TF bench testing milestones on its expected schedule, and raise capital (the Company can give no assurance that it will be able to obtain the additional funds needed in the future, on terms agreeable to the Company, or at all). These circumstances indicate the existence of material uncertainty and cast substantial doubt about the Company's ability to continue as a going concern.

The Company will re-evaluate the going concern risk at each reporting period and will consider removing the going concern and uncertainty note when the Company can depend on the profitable commercialization of its products or is confident of obtaining additional debt, equity or other financing to fund ongoing operations until profitability is achieved.

These condensed interim consolidated financial statements do not reflect adjustments that would be necessary if the going concern assumption were not appropriate. Should the Company be unable to obtain additional capital in the future and the Company's ability to continue as a going concern be impaired, material adjustments may be necessary to these condensed interim consolidated financial statements.

(d) Share consolidation (reverse stock split)

On September 18, 2018, the Company effected a share consolidation (reverse stock split) of its issued and outstanding common shares in the capital of the Company ("Common Shares") on the basis of one post-consolidation Common Share for every one hundred pre-consolidation Common Shares. On June 25, 2019, the Company effected a share consolidation (reverse stock split) of its issued and outstanding Common Shares the basis of one post-consolidation Common Share for every ten pre-consolidation Common Shares. All references in these condensed interim consolidated financial statements to Common Shares and options have been retroactively adjusted to reflect the share consolidations. The aggregate principal amount of the 2017 Notes and the 2019 Notes (as defined below) were not affected by the consolidations, but the Common Shares issuable upon conversion of the 2017 Notes and 2019 Notes will be adjusted proportionally to each share consolidation ratio.


NEOVASC INC.

Notes to the Condensed Interim Consolidated Financial Statements

For the three and six months ended June 30, 2021 and 2020

(Expressed in U.S. dollars)


1.  INCORPORATION AND GOING CONCERN (continued)

(e) Nasdaq listing

On August 22, 2019, the Company received written notification from the Nasdaq Listing Qualifications Department notifying the Company that it was not in compliance with the $35 million minimum market value requirement set forth in the Nasdaq Marketplace Rules. In accordance with Nasdaq Listing Rule 5810(c)(3)(C), the Company was provided 180 calendar days, or until February 17, 2020, to regain compliance. The Company did not regain compliance by February 17, 2020. On February 19, 2020, the Company received notice from the Listing Qualifications Staff (the "Staff") of The Nasdaq Stock Market LLC ("Nasdaq") indicating that the Staff had determined to delist the Company's common shares from Nasdaq unless the Company requests a hearing before the Nasdaq Hearings Panel. On February 26, 2020, the Company requested such a hearing and the date of the hearing was set by the Nasdaq for April 2, 2020. On April 30, 2020, the Panel granted the Company's request for an extension through August 17, 2020 to evidence compliance with the $35 million minimum market value of listed securities requirement for continued listing on the Nasdaq. On June 25, 2020, the Nasdaq Notice confirmed that the Company had regained compliance with Listing Rule 5550(a)(2) pursuant to Listing Rule 5810 for continued listing on the Nasdaq.

On December 10, 2020, the Company received written notification from the Nasdaq Listing Qualifications Department notifying the Company that it was not in compliance with the $35 million minimum market value requirement set forth in the Nasdaq Marketplace Rules. In accordance with Nasdaq Listing Rule 5810(c)(3)(C), the Company was provided 180 calendar days, or until June 8, 2021, to regain compliance. On February 25, 2021, the Company announced that it had received written notification from the Nasdaq notifying the Company that it had regained compliance with the minimum market value requirement under Nasdaq Listing Rule 5550(b)(2) pursuant to Nasdaq Listing Rule 5810 for continued listing on the Nasdaq.

On December 14, 2020 the Company received written notification from the Nasdaq Listing Qualifications Department notifying the Company that it was not in compliance with the $1.00 minimum bid price requirement set forth in the Nasdaq Marketplace Rules. In accordance with Nasdaq Listing Rule 5810(c)(3)(A), the Company was provided 180 calendar days, or until June 14, 2021, to regain compliance. On February 9, 2021, the Company announced that it had received written notification from the Nasdaq notifying the Company that it had regained compliance with the minimum bid price requirement under Nasdaq Listing Rule 5550(a)(2) pursuant to Nasdaq Listing Rule 5810 for continued listing on the Nasdaq.

On May 25, 2021 the Company received written notification from the Nasdaq Listing Qualifications Department notifying the Company that it was not in compliance with the $1.00 minimum bid price requirement set forth in the Nasdaq Marketplace Rules. In accordance with Nasdaq Listing Rule 5810(c)(3)(A), the Company was provided 180 calendar days, or until November 22, 2021, to regain compliance.

(f) Impacts of COVID-19 pandemic

The Company is subject to risks and uncertainties as a result of the COVID-19 pandemic. The extent of the impact of the COVID-19 pandemic on the Company's business is difficult to predict, as the response to the pandemic evolves on a country by country basis. Furthermore, capital markets and economies worldwide have also been disrupted by the COVID-19 pandemic, and it is possible that it could cause a local and/or global adverse economic events. Such economic disruption could have a material adverse effect on the Company's business.

The severity of the impact of the COVID-19 pandemic on the Company's business will depend on a number of factors, including, but not limited to, the duration and severity of the pandemic and the extent and severity of the impact on the Company's customers, all of which are uncertain and cannot be predicted. As at June 30, 2021, the Company has seen a marked impact on Reducer revenues due to restrictions on elective procedures which included Reducer implants. Furthermore, the Company's recruitment to clinical trials and studies continues to be on temporary hold, or are enrolling slower than expected, due to the pandemic restrictions and the Company's ability to complete certain Tiara bench testing milestones on our expected schedule has been impacted and could be impacted further in the future if COVID restrictions increase again.

The Company's future results of operations and liquidity could be adversely impacted by a decrease in Reducer sales, delays in payments of outstanding receivable amounts beyond normal payment terms, supply chain disruptions and uncertain demand, and the impact of any initiatives or programs that the Company may undertake to address financial and operational challenges faced by its customers. As of the date of issuance of these condensed interim consolidated financial statements, the extent to which the COVID-19 pandemic may further materially impact the Company's financial condition, liquidity, or results of operations is uncertain.


NEOVASC INC.

Notes to the Condensed Interim Consolidated Financial Statements

For the three and six months ended June 30, 2021 and 2020

(Expressed in U.S. dollars)


2. BASIS OF PREPARATION

(a)  Statement of compliance with IFRS

These condensed interim consolidated financial statements are prepared in accordance with International Accounting Standard ("IAS") 34 Interim Financial Reporting, as issued by the International Accounting Standards Board ("IASB"), using the accounting policies consistent with the Company's annual consolidated financial statements for the years ended December 31, 2020, 2019 and 2018. These condensed interim consolidated financial statements should be read in conjunction with the Company's audited annual consolidated financial statements for the years ended December 31, 2020, 2019 and 2018 and the accompanying notes included in those financial statements. For a full description of accounting policies, refer to the audited annual consolidated financial statements of the Company for the years ended December 31, 2020, 2019 and 2018.

The results for the three and six months ended June 30, 2021 may not be indicative of the results that may be expected for the full year or any other period.

(b)  Basis of consolidation

The condensed interim consolidated financial statements include the financial statements of the Company and its wholly-owned subsidiaries, Neovasc Medical Inc., Neovasc Tiara Inc., Neovasc (US) Inc., Neovasc Medical Ltd., B-Balloon Ltd. (which is in the process of being voluntarily liquidated), Neovasc GmbH, and Neovasc Management Inc. All intercompany balances and transactions have been eliminated upon consolidation.

(c)  Presentation of financial statements

The Company has elected to present the 'Statement of Comprehensive Income' in a single statement.

3. SIGNIFICANT ACCOUNTING POLICIES

The condensed interim consolidated financial statements have been prepared in accordance with the accounting policies adopted in the Company's most recent annual consolidated financial statements for the years ended December 31, 2020, 2019 and 2018.

4. MANAGING CAPITAL

The Company's objectives, when managing capital, are to safeguard cash as well as maintain financial liquidity and flexibility in order to preserve its ability to meet financial obligations and deploy capital to grow its business. In the definition of capital, the Company includes equity and the convertible notes. There has been no change in the definition since the prior year.

The Company's financial strategy is designed to maintain a flexible capital structure consistent with the objectives stated above and to respond to business growth opportunities and changes in economic conditions. In order to maintain or adjust its capital structure, the Company may issue new shares, new units or new debt (secured, unsecured, convertible and/or other types of available debt instruments). For the three and six months ended June 30, 2021, there were no changes in the Company's capital management policy.

The capital of the Company is comprised of:

    June 30,
2021
    December 31,
2020
 
2019 Convertible Notes $ 6,583,528   $ 6,195,357  
2020 Convertible notes, warrants and derivative warrant liabilities   2,115,254     1,522,054  
2021 Derivative warrant liabilities   1,745,600     -  
Equity   63,457,764     1,977,517  
Capital $ 73,902,146   $ 9,694,928  


NEOVASC INC.

Notes to the Condensed Interim Consolidated Financial Statements

For the three and six months ended June 30, 2021 and 2020

(Expressed in U.S. dollars)


5. FINANCIAL RISK MANAGEMENT

(a) Fair value estimation

The fair value hierarchy establishes three levels to classify fair value measurements based upon the observability of significant inputs used in the valuation techniques. The three levels of the fair value hierarchy are described below:

Level 1 | Quoted prices (unadjusted) in active markets for identical assets or liabilities

Level 2 | Inputs other than quoted prices included in level 1 that are observable for the asset or liability, either directly (that is, as prices) or indirectly (that is, derived from prices)

Level 3 | Inputs for the assets or liability that are not based on observable market data (that is, unobservable inputs)

The following table sets forth the Company's financial assets and liabilities measured at fair value on a recurring basis by level within the fair value hierarchy as at June 30, 2021 and December 31, 2020. As required by IFRS 13, assets and liabilities are classified in their entirety based on the lowest level of input that is significant to the fair value measurement.

As at December 31, 2020:

    Level 1     Level 2     Level 3     Total  
Financial liabilities at fair value through profit and loss                        
2019 Convertible Notes $ -   $ -   $ 6,195,357   $ 6,195,357  
2020 Convertible notes, warrants and derivative
warrant liabilities
$ -   $ -   $ 9,117,147   $ 9,117,147  

As at June 30, 2021:

    Level 1     Level 2     Level 3     Total  
Financial liabilities at fair value through profit and loss                        
2019 Convertible Notes $ -   $ -   $ 6,583,528   $ 6,583,528  
2020 Convertible notes, warrants and derivative
warrant liabilities
$ -   $ -   $ 7,645,581   $ 7,645,581  
2021 Derivative warrant liabilities $ -   $ -   $ 1,745,600   $ 1,745,600  

Presentation of the fair values of the 2020 Convertible notes, warrants and derivative warrant liabilities and 2021 Derivative warrant liabilities are gross of the deferred loss.

 The carrying amounts of financial assets and financial liabilities in each category are as follows:

    June 30,
2021
    December 31,
2020
 
Assets at amortized cost            
Cash and cash equivalents $ 63,294,878   $ 12,935,860  
Accounts receivable   1,213,450     987,057  
Restricted cash   483,714     470,460  
Assets at amortized cost $ 64,992,042   $ 14,393,377  
             
Other financial liabilities at amortized cost            
Accounts payable and accrued liabilities (current) $ 6,422,130   $ 7,243,500  
             
Financial liabilities at fair value through profit and loss            
2019 Convertible Notes (current) $ 38,633     38,633  
2019 Convertible Notes (non-current)   6,544,895     6,156,724  
2020 Convertible Notes (current)   37,839     37,525  
2020 Convertible notes, warrants and derivative warrant liabilities (non-current)   7,607,742     9,079,622  
2021 Derivative warrant liabilities   1,745,600     -  
  $ 22,396,839   $ 22,556,004  

The carrying amounts of cash and cash equivalents, accounts receivable, restricted cash and accounts payable and accrued liabilities are considered a reasonable approximation of fair value due to their short-term nature.


NEOVASC INC.

Notes to the Condensed Interim Consolidated Financial Statements

For the three and six months ended June 30, 2021 and 2020

(Expressed in U.S. dollars)


5. FINANCIAL RISK MANAGEMENT (continued)

 (b) Foreign exchange risk

A portion of the Company's revenues are derived from product sales in Europe, denominated in Euros. Management has considered the stability of the foreign currency and the impact a change in the exchange rate may have on future earnings during the forecasting process. The Euro represents approximately 47% of revenues for the three and six months ended June 30, 2021, (three and six months ended June 30, 2020: 49%). A 10% change in the foreign exchange rates for the Euro for foreign currency denominated accounts receivable will impact net income as at June 30, 2021 by approximately $12,259  (as at June 30, 2020: $9,199), and a similar change in foreign currency denominated accounts payable, which are denominated in Canadian dollars and Euros will impact net income by approximately $6,730 and $34,695 respectively, as at June 30, 2021 (as at June 30, 2020: $88,314 and $133,168 respectively). A similar change in foreign currency denominated cash and cash equivalents, and restricted cash, which are denominated in Canadian dollars and Euros will impact net income by approximately $101,270 and $74,787, respectively, as at June 30, 2021 (as at June 30, 2020: $126,723 and $45,398 respectively). The Company does not hedge its foreign exchange risk.

(c)  Interest rate risk

The Company is not exposed to material cash flow interest rate risk on fixed rate cash balances, and short-term accounts

receivable, accounts payable, 2019 Notes and 2020 Notes that have fixed interest terms.

(d)  Liquidity risk

As at June 30, 2021, the Company had $63,294,878 in cash and cash equivalents as compared to cash and cash equivalents of $12,935,860 at December 31, 2020. The Company is dependent on the profitable commercialization of its products or obtaining additional debt, equity or other forms of financing to fund ongoing operations until profitability is achieved.

The Company monitors its cash flow on a monthly basis and compares actual performance to the budget for the period. The Company may obtain additional debt, equity or other forms of financing in future periods. Further into the future the Company is dependent on the profitable commercialization of its products or obtaining additional debt, equity or other forms of financing to fund ongoing operations until profitability is achieved.

On February 12, 2021 the Company received aggregate gross proceeds of $72 million from the February 2021 Financing (see Note 17). The proceeds from the February 2021 Financing could be sufficient to extend the operations of the Company for up to three years at the current burn rate. However, it is possible that the Company will initiate programs that were on hold given past cash constraints and that the cash needs of the Company will increase, shortening the time the proceeds will meet the requirements of the Company.

Trade payables were aged as follows as at June 30, 2021 and do not include accrued liabilities. All trades payables are current liabilities:

    Total  
Current $ 1,122,673  
31-60 days   241,625  
Over 60 days   5,381  
  $ 1,369,679  

The following is an analysis of the contractual maturities of the Company's non-derivative accrued liabilities as at June 30, 2021:

    Within One
Year
 
       
Collaboration, license and settlement agreements (undiscounted) $ 1,250,000  
  $ 1,250,000  


NEOVASC INC.

Notes to the Condensed Interim Consolidated Financial Statements

For the three and six months ended June 30, 2021 and 2020

(Expressed in U.S. dollars)


5. FINANCIAL RISK MANAGEMENT (continued)

(e) Credit risk

Credit risk arises from the possibility that the entities to which the Company sells products may experience financial difficulty and be unable to fulfill their contractual obligations. This risk is mitigated by proactive credit management policies that include regular monitoring of the debtor's payment history and performance. The Company does not require collateral from its customers as security for trade accounts receivable but may require certain customers to pay in advance of any work being performed or product being shipped.

The maximum exposure, if all the Company's customers were to default at the same time is the full carrying value of the trade accounts receivable as at June 30, 2021 is $573,891 (as at December 31, 2020: $322,201). As at June 30, 2021, the Company had $192,262 of trade accounts receivable that were overdue according to the customers' credit terms (as at December 31, 2020: $146,658). During the three and six months ended June 30, 2021, the Company wrote down $nil of accounts receivable owed by customers (three and six months ended June 30, 2020: $nil).

The Company may also have credit risk related to its cash and cash equivalents and restricted cash, with a maximum exposure of $63,778,592  as at June 30, 2021 (as at December 31, 2020: $13,406,320). The Company minimizes its risk to cash and cash equivalents and restricted cash by maintaining the majority of its balances with Canadian Chartered Banks.

6. CASH AND CASH EQUIVALENTS

    June 30,
2021
    December 31,
2020
 
Cash held in:            
United States dollars $ 62,018,021   $ 11,631,843  
Canadian dollars   528,984     809,429  
Euros   747,873     494,588  
  $ 63,294,878   $ 12,935,860  

7. ACCOUNTS RECEIVABLE

    June 30,
2021
    December 31,
2020
 
             
Trade accounts receivable $ 573,891   $ 322,201  
Other accounts receivable   108,608     116,905  
Income tax receivable   530,951     547,951  
  $ 1,213,450   $ 987,057  

All the Company's trade and other receivables have been reviewed for impairment. During the three and six months ended June 30, 2021, the Company wrote off $nil, respectively of accounts receivable (the three and six months ended June 30, 2020: $nil).

8. FINANCE LEASE RECEIVABLE

The Company entered into a sublease agreement which has been recognized as a finance lease. Finance lease receivables are presented in the statement of financial position as follows:

    June 30,
2021
    December 31,
2020
 
             
Current $ 93,466   $ 95,849  
Non-current   -     42,841  
  $ 93,466   $ 138,690  

 The following is a detailed maturity analysis of the undiscounted finance lease receivables as at June 30, 2021:

    Total  
Less than 1 year $ 98,203  
Total undiscounted finance lease receivables $ 98,203  


NEOVASC INC.

Notes to the Condensed Interim Consolidated Financial Statements

For the three and six months ended June 30, 2021 and 2020

(Expressed in U.S. dollars)


9. INVENTORY AND RESEARCH AND DEVELOPMENT SUPPLIES

    June 30,
2021
    December 31,
2020
 
             
Raw materials $ 1,221,369   $ 694,043  
Work in progress   30,121     -  
Finished goods   136,228     145,429  
  $ 1,387,718   $ 839,472  
             
Research and development supplies $ 11,852   $ 167,378  

During the three and six months ended June 30, 2021 and 2020, the Company did not write down any inventory. During the three and six months ended June 30, 2021, $109,106 and $181,499 of inventory was expensed in cost of goods sold (three and six months ended June 30, 2020: $74,669 and $199,232).

10.  PREPAID EXPENSES AND OTHER ASSETS

    June 30,
2021
    December 31,
2020
 
             
Prepaid insurance $ 621,245   $ 367,969  
Deposits on rental agreements   122,183     128,680  
Retainers for professional services   46,920     23,000  
Other prepaid expenses and other assets   179,392     185,822  
  $ 969,740   $ 705,471  

11. RESTRICTED CASH

    June 30,
2021
    December 31,
2020
 
             
  $ 483,714   $ 470,460  

Restricted cash as at June 30, 2021 represents $600,000 CAD (December 31, 2020: $600,000 CAD) security held by a Canadian Chartered Bank as a guarantee for the Company's same day electronic processing facility and corporate credit card facility.


NEOVASC INC.

Notes to the Condensed Interim Consolidated Financial Statements

For the three and six months ended June 30, 2021 and 2020

(Expressed in U.S. dollars)


12. RIGHT OF USE ASSET

COST   Total  
Balance at January 1, 2020 $ 1,057,333  
Addition and lease modification   478,281  
Balance as at December 31, 2020 and June 30, 2021 $ 1,535,614  
       
ACCUMULATED DEPRECIATION      
Balance as at January 1, 2020 $ 336,860  
Depreciation for the period   368,203  
Balance as at December 31, 2020   705,063  
Depreciation for the period   187,106  
Balance as at June 30, 2021 $ 892,169  
       
NET BOOK VALUE      
As at January 1, 2020 $ 720,473  
As at December 31, 2020 $ 830,551  
As at June 30, 2021 $ 643,445  

The Company's right-of-use asset relates to the lease of buildings.

The Company entered into an agreement for office space in September 2014 in Richmond, Canada. The agreement did not contain any contingent rent clauses, or purchase options or escalation clauses. The term of the lease was 36 months commencing on October 1, 2014. The lease contained an option to renew for an additional 36 months. In February 2017, the Company renewed the lease and added additional office premises. The term of the combined lease is 60 months commencing June 1, 2017. The amended agreement does not contain any contingent rent clauses, purchase options or escalation clauses.

The Company entered into a sublease agreement for a portion of office space in September 2019. The term for the sublease agreement was 32 months commencing on October 7, 2019 (See Note 8).

The Company entered into an agreement for office space in September 2014 in Minneapolis. The agreement did not contain any contingent rent clauses, purchase options or escalation clauses. The original term of the lease was 66 months commencing on September 1, 2014. Additional office space was added in July 2015 in Minneapolis. The term of the combined lease is 69 months commencing on July 1, 2015. In August 2019, the Company renewed the lease for an additional 36 months commencing June 1, 2020.

The Company entered into an agreement for office space in December 2016 in Richmond, Canada. The agreement does not contain any contingent rent clauses, renewal or purchase options or escalation clauses. The term of the lease is 24 months commencing on December 19, 2016. In December 2018, the Company renewed the lease for another 24 months commencing on December 19, 2018. In October 2020, the Company renewed the lease for another 24 months commencing on December 19, 2020.

The Company entered into an agreement for office space in June 2018 in Richmond, Canada. The agreement does not contain any contingent rent clauses, purchase options or escalation clauses. The term of the lease is 36 months commencing on August 1, 2018. The lease contains an option to renew for an additional 24 months. In June 2020, the Company renewed the lease for an additional 36 months commencing August 1, 2021.


NEOVASC INC.

Notes to the Condensed Interim Consolidated Financial Statements

For the three and six months ended June 30, 2021 and 2020

(Expressed in U.S. dollars)


13. PROPERTY AND EQUIPMENT

    Leasehold
improvements
    Production &
development
equipment
    Computer
hardware
    Computer
software
    Office
equipment
    Total  
COST                                    
Balance as at January 1, 2020 $ 169,938   $ 1,692,127   $ 543,922   $ 693,404   $ 316,085   $ 3,415,476  
Additions during the year   -     202,329     106,149     33,289     -     341,767  
Disposals during the year   -     (88,285 )   -     -     -     (88,285 )
Balance as at December 31, 2020 $ 169,938   $ 1,806,171   $ 650,071   $ 726,693   $ 316,085   $ 3,668,958  
                                     
Additions during the period   -     110,987     -     35,071     -     146,058  
Disposals during the period   -     (40,661 )   -     -     -     (40,661 )
Write downs for obsolescence   (111,390 )   (1,799,123 )   -     -     -     (1,910,513 )
Balance as at June 30, 2021 $ 58,548   $ 77,374   $ 650,071   $ 761,764   $ 316,085   $ 1,863,842  
                                     
ACCUMULATED DEPRECIATION                                    
Balance as at January 1, 2020 $ 107,987   $ 1,133,370   $ 466,587   $ 686,443   $ 253,116   $ 2,647,503  
Depreciation for the year   25,636     184,973     33,815     37,477     12,593     294,494  
Disposals during the year   -     (76,319 )   -     -     -     (76,319 )
Balance as at December 31, 2020 $ 133,623   $ 1,242,024   $ 500,402   $ 723,920   $ 265,709   $ 2,865,678  
                                     
Depreciation for the period   12,818     82,321     22,450     16,000     5,038     138,627  
Disposals during the period   -     (38,596 )   -     -     -     (38,596 )
Write downs for obsolescence   (87,893 )   (1,228,998 )   -     -     -     (1,316,891 )
Balance as at June 30, 2021 $ 58,548   $ 56,751   $ 522,852   $ 739,920   $ 270,747   $ 1,648,818  
                                     
CARRYING AMOUNTS                                    
As at December 31, 2020 $ 36,315   $ 564,147   $ 149,669   $ 2,773   $ 50,376   $ 803,280  
As at June 30, 2021   -   $ 20,623   $ 127,219   $ 21,844   $ 45,338   $ 215,024  

During the second quarter of 2021 the company paused all activities related to the product development of the Tiara TF device (See Note 1(b). As a result of this decision the Company wrote down all the leasehold improvements and equipment that related to these activities and that it now considers to be obsolete.


NEOVASC INC.

Notes to the Condensed Interim Consolidated Financial Statements

For the three and six months ended June 30, 2021 and 2020

(Expressed in U.S. dollars)


14. ACCOUNTS PAYABLE AND ACCRUED LIABILITIES

    June 30,
2021
    December 31,
2020
 
Current accounts payable and accrued liabilities            
Trade payables $ 1,369,679   $ 3,705,626  
Accrued liabilities   1,433,840     1,421,433  
Accrued vacation   452,256     335,681  
Accrued severance provision   245,687     -  
Other accounts payable   242,562     535,124  
Share appreciation rights liability   1,441,037     59,036  
Collaboration, license, and settlement agreements provision (see Note 23)   1,237,069     1,186,600  
Total current accounts payable and accrued liabilities $ 6,422,130   $ 7,243,500  

Included in accounts payable and accrued liabilities as at June 30, 2021 are $495,653 (December 31, 2020: $470,349) related to a licensing and collaboration agreement and $741,416 (December 31, 2020: $716,251) related to a settlement agreement (see Note 23). This represents the calculated net present value of the amounts set out per the agreements with payments due over the next year.

15. LEASE LIABILITY

    Total  
Balance as at January 1, 2020 $ 904,879  
Addition and lease modification   478,280  
Interest expense   106,843  
Lease payments   (550,211 )
Balance as at December 31, 2020 $ 939,791  
       
Lease Liability, current $ 342,910  
Lease Liability, non-current $ 596,881  
       
Balance as at January 1, 2021 $ 939,791  
Interest expense   48,668  
Lease payments   (270,803 )
Balance as at June 30, 2021 $ 717,656  
       
Lease Liability, current $ 290,957  
Lease Liability, non-current $ 426,699  
       
The maturity analysis of the undiscounted contractual balances      
of the lease liabilities is as follows:      
In one year or less $ 431,152  
In more than one year, but not more than five years   463,077  
  $ 894,229  


NEOVASC INC.

Notes to the Condensed Interim Consolidated Financial Statements

For the three and six months ended June 30, 2021 and 2020

(Expressed in U.S. dollars)


16. DERIVATIVE WARRANT LIABILITY FROM FINANCING AND CONVERTIBLE NOTE

(a) Derivative Warrant Liability from Financing

On November 17, 2017, Neovasc completed an underwritten public offering (the "2017 Public Transaction") of 6,609,588 Series A units (the "Series A Units") and 19,066,780 Series B units (the "Series B Units") of the Company, at a price of $1.46 per Unit for gross proceeds of $37,487,497 before deducting the underwriting discounts and commissions and other estimated offering costs.

Each Series A Unit was comprised of:

(i) 0.001 Common Share

(ii) one Series A Common Share purchase warrant of the Company exercisable for 0.001 Common Shares at an exercise price of $1,610 per Series A Warrant Share for a period of five years following issuance (each, a "Series A Warrant"),

(iii) one Series B Common Share purchase warrant of the Company exercisable for 0.001 Common Shares at an exercise price of $1,610 per Series B Warrant Share for a period of two years following issuance (each, a "Series B Warrant"); and

(iv) 0.40 Series C Warrant of the Company to purchase a unit at an exercise price of $1.46 per unit for a period of two years following issuance (each, a "Series C Unit") comprised of 0.001 Common Shares, one Series A Warrant and one Series B Warrant.

Each Series B Unit was comprised of:

(i) either 0.001 Common Shares or one Series D Common Share purchase warrant of the Company exercisable for 0.001 Common Shares (each, a "Series D Warrant") at an exercise price of $1,460 per Series D Warrant Share, all of which were be pre-funded except for a nominal exercise price of $0.001 per Series D Warrant Share for a period of five years following issuance,

(ii) one Series A Warrant,

(iii) one Series B Warrant,

(iv) 0.40 Series C Warrant, and

(v) 1.1765 Series F Common Share purchase warrant of the Company with each warrant exercisable for 0.001 Common Shares at an exercise price of $1,610 per Series F Warrant Share for a period of two years following issuance (each, a "Series F Warrant").

15,493 Common Shares and 3,573,830 Series D Warrants were issued as part of the Series B Unit. Since initial issuance and during the period up to December 31, 2018, all of the 3,573,830 Series D Warrants were exercised for gross proceeds of $35,738 and 3,573 Common Shares were issued from treasury. All the warrants (collectively, the "2017 Warrants") issued pursuant to the 2017 Public Transaction and the 2017 Private Placement (as defined below) included various price adjustment clauses, some of which caused the number of shares to be issued upon exercise to be variable, and therefore do not meet the fixed for fixed test under IAS 32 - Financial instruments; presentation. Accordingly, the warrants have been accounted for as derivative financial liabilities and measured at fair value through profit and loss ("FVTPL"). The fair values of the warrants were calculated using a binomial option pricing model and have been classified as level 3 in the fair value hierarchy.

The total fair value of the warrants issued in connection with the 2017 Public Transaction, together with the Series E Warrants (as defined below) issued in connection with the Private Transaction (as defined below), was $89,470,273 which exceeded the transaction price giving rise to a loss of $45,132,259. Since the fair values of the derivatives were not determined using a valuation that only used data from observable markets, the loss on initial recognition has been recognized in income over the expected term of the instruments on a straight-line basis depending on the term of the warrants.

(b) 2017 Convertible Notes

On November 17, 2017, the Company also completed a brokered private placement (the "2017 Private Placement" and together with the 2017 Public Transaction the "2017 Financings") for the sale of $32,750,000 aggregate principal amount of senior secured convertible notes of the Company (the "2017 Notes") and Series E warrants (the "Series E Warrants") to purchase one Common Share per Series E Warrant for gross proceeds of $27,837,500.

The 2017 Notes were issued with an original issue price of $850 per $1,000 principal amount of note. The 2017 Notes have an 18-month term and carry an interest rate of 0.0% per annum (increasing to 15% upon an event of default) from the closing date of the Private Transaction ("Private Transaction"). On September 12, 2018, the Company and the holders of 2017 Notes amended certain terms of the 2017 Notes, including a one-year extension of the maturity date of the 2017 Notes from May 17, 2019 until May 17, 2020 and certain other amendments. Upon any event of a default, the interest rate applicable to the 2017 Notes would automatically be increased to 15% per annum. Interest on the 2017 Notes, as applicable, will commence accruing on the date of issue, will be computed on the basis of a 360-day year and twelve 30-day months and became payable in cash on January 1, 2018 and on the first day of each calendar quarter thereafter up to, and including, the maturity date.


NEOVASC INC.

Notes to the Condensed Interim Consolidated Financial Statements

For the three and six months ended June 30, 2021 and 2020

(Expressed in U.S. dollars)


16. DERIVATIVE WARRANT LIABILITY FROM FINANCING AND CONVERTIBLE NOTES (continued)

(b) 2017 Convertible Notes (continued)

The conversion option contained within the 2017 Notes contains similar price adjustment characteristics to certain of the warrants, which precludes the 2017 Notes from being recognized within equity. The 2017 Notes contain a future-priced conversion mechanism that allows the holder of a 2017 Notes to replace the conversion price then in effect with a price (the "Alternate Conversion Price") that is 85% of the lowest volume weighted average price ("VWAP") of the Common Shares during the ten consecutive trading day period ending and including the date of delivery of the applicable conversion notice. The 2017 Notes are also subject to full ratchet anti-dilution provisions in certain circumstances.

Accordingly, the Company has elected to measure the 2017 Notes at FVTPL. The Series E Warrants are also classified as derivative financial liabilities and measured at FVTPL. The fair values of the warrants were calculated using a binomial option pricing model and have been classified as level 3 in the fair value hierarchy. The fair value of the convertible debt was $26,100,900 which exceeded the transaction price giving rise to a loss of $5,113,917. Since the fair value of the convertible debt is not determined using a valuation that only uses data from observable markets, the loss on initial recognition has been deferred and will be recognized in income over the expected term of the instrument. As at December 31, 2020 the loss on initial recognition was fully amortized.

On May 26, 2020, the Company made a final payment of $2,897,000 to holders of the 2017 Notes and $1,016,000 in 2017 Notes was converted for the issuance of 500,014 Common Shares. The Company and certain holders of the 2017 Notes have also agreed to a mutual release (the "Settlement") in return for the issuance by the Company, in the aggregate, of 500,000 Settlement Warrants to such holders.

(c) 2019 Convertible Notes

On May 16, 2019, the Company completed a private placement of (i) 15% original issue discount convertible notes ("2019 Notes") with a face value of $11.5 million, for gross proceeds to the Company of $9,775,000, and (ii) 334,951 Common Shares of the Company at a price of $5.15 per Common Share, for gross proceeds to the Company of $1,725,000.

The 2019 Notes have the following key terms:

  • For the first year after the closing date, interest at a rate of 8% of which 5% is payable in cash on or about May 17, 2020 (when the existing 2017 Notes issued by the Company mature). The remainder is deferred and will be due on maturity of the 2019 Notes.
  • After the first year and until maturity, interest at a rate of 10% of which 7% is payable in cash at the end of May and November each year. The remainder is deferred and will be due on maturity of the 2019 Notes.
  • The 2019 Notes were issued at an original discount of $1.725 million. A separate subscription for Common Shares of the Company by the holder of the 2019 Notes was made for this amount (at market price) concurrent with the issuance of the 2019 Notes.
  • The Company has a prepayment option whereby it may voluntarily prepay the 2019 Notes prior to maturity. Prepayment penalties of 3% (if prepaid prior to the 1st anniversary of issuance), 2% (if prepaid between the 1st and 2nd anniversaries of issuance) and 1% (if prepaid after the 2nd anniversary) apply.
  • The 2019 Notes are convertible into Common Shares of the Company at the option of the holder (however, the holder may not own > 19.99% of the total outstanding Common Shares of the Company as a result of the conversion). The conversion price fluctuates from $7.50 per common share (prior to the 2nd anniversary of issuance) to $8.50 between the 2nd and 3rd anniversaries of issuance to $9.70 after the 3rd anniversary of issuance. The conversion price would also be altered subject to certain anti-dilution provisions.

Accordingly, the 2019 Notes contain two embedded derivatives: the conversion option and the prepayment option. Accordingly, the Company has elected to measure the 2019 Notes at FVTPL. The fair values of the 2019 Notes were calculated using the Cox Ross Rubinstein binomial tree model and have been classified as level 3 in the fair value hierarchy.


NEOVASC INC.

Notes to the Condensed Interim Consolidated Financial Statements

For the three and six months ended June 30, 2021 and 2020

(Expressed in U.S. dollars)


16. DERIVATIVE WARRANT LIABILITY FROM FINANCING AND CONVERTIBLE NOTES (continued)

(d) 2020 Convertible Notes

On May 28, 2020, the Company issued senior secured convertible notes ("2020 Notes") with a principal amount of $5 million, convertible at $2.815 per Common Share for 1,776,041 Common Shares and 2,573,959 Warrants ("May 2020 Warrants") exercisable at $2.634 per 2020 Warrant with a 4-year term.

The 2020 Notes have the following key terms:

  • The 2020 Notes will bear interest at the rate of 8% computed on the basis of a 360-day year and twelve 30-day months and shall be payable in additional 2020 Notes on the date that is six-months after issuance and on each six-month period thereafter up to, and including, the maturity date.
  • The 2020 Notes will have a maturity date of 48 months after issuance with the holder's option for early redemption at 24 months.
  • Change of control redemption option with option premia of 125% in the first year, 115% in the second year, 105% in the third year, and 100% thereafter.
  • The 2020 Notes are convertible into Common Shares of the Company at the option of the holder (however, the holder may not own greater than 9.99% of the total outstanding Common Shares of the Company as a result of the conversion).
  • The conversion option caused the number of shares to be issued upon exercise to be variable, and therefore do not meet the fixed of fixed test under IAS 32- Financial instruments - presentation.

Accordingly, the 2020 Notes contain three embedded derivatives: change in control redemption option, the early redemption option and the conversion option but will not be separated from the host debt instrument and the entire hybrid contract will be designated as at fair value through profit or loss. The fair values of the 2020 Notes and 2020 Warrants were calculated using the Cox Ross Rubinstein binomial tree model and have been classified as level 3 in the fair value hierarchy. The fair value of the convertible debt was $6,449,634 which exceeded the transaction price giving rise to a loss of $3,511,670. Since the fair value of the convertible debt is not determined using a valuation that only uses data from observable markets, the loss on initial recognition has been deferred and will be recognized in income over the expected term of the instrument.

(e) Warrants and Convertible Notes Model

Key assumptions used in the valuation of the 2019 Notes at June 30, 2021 and December 31, 2020 are summarized below:

Valuation Date   June 30,
2021
    December 31,
2020
 
Price of Common Shares $ 0.92   $ 0.95  
Dividend Yield   0%     0%  
Historical volatility of Common Shares   100.92%     103.42%  
Historical volatility of index   23.97%     23.11%  
Volatility input   62.44%     63.26%  
Risk-free rate   0.29%     0.19%  
Credit spread   13.02%     18.18%  

Key assumptions used in the valuation of the 2020 Notes and 2020 Warrants at June 30, 2021 and December 31, 2020 are summarized below:

Valuation Date   June 30,
2021
    December 31,
2020
 
Price of Common Shares $ 0.92   $ 0.95  
Dividend Yield   0%     0%  
Historical volatility of Common Shares   103.82%     116.72%  
Historical volatility of index   21.48%     20.74%  
Volatility input   62.65%     68.73%  
Risk-free rate   0.53%     0.26%  
Credit spread   9.26%     14.42%  


NEOVASC INC.

Notes to the Condensed Interim Consolidated Financial Statements

For the three and six months ended June 30, 2021 and 2020

(Expressed in U.S. dollars)


16. DERIVATIVE WARRANT LIABILITY FROM FINANCING AND CONVERTIBLE NOTES (continued)

(e) Warrants and Convertible Notes Model (continued)

The carrying amounts for the 2020 derivative warrant liability from financing are as follows:

    2020 January Warrants  
Inception of the January 2020 Warrants (see Note 17(f))   6,145,620  
Deferred loss   (223,791 )
January 31 exercise 1,241,490 pre-funded warrants   (3,885,746 )
Fair value adjustment, January 31 realized gain   (422,102 )
Derecognition of deferred loss   93,813  
May 28 exercise 1,185,000 Series A; 991,940 Series B   (969,133 )
Fair value adjustment, May 28 realized loss   957,847  
Derecognition of deferred loss   76,473  
Amortization of deferred loss   63,064  
Fair value adjustment, unrealized gain   (1,824,698 )
Balance, December 31, 2020 $ 11,347  
Amortization of deferred loss   5,056  
Fair value adjustment, March 31, 2021 unrealized loss   1,885  
Balance, March 31, 2021 $ 18,288  
Amortization of deferred loss   5,111  
Fair value adjustment, June 30, 2021 unrealized loss   3,865  
Balance, June 30, 2021 $ 27,264  
       
Number of warrants outstanding as of June 30, 2021   249,550  
 
 
  2020 May Warrants  
Inception of the May 2020 Warrants (see Note 17(f))   4,526,732  
Deferred loss   (2,464,696 )
July 23 exercise 1,424,049 warrants   (2,082,598 )
August 17 exercise of 501,000 warrants   (565,221 )
Derecognition of deferred loss   1,843,332  
Amortization of deferred loss   126,997  
Fair value adjustment, unrealized gain   (1,641,185 )
Balance, December 31, 2020 $ (256,639 )
Amortization of deferred loss   34,869  
Fair value adjustment, March 31, 2021 unrealized gain   (44,372 )
Balance, March 31, 2021 $ (266,142 )
Amortization of deferred loss   35,257  
Fair value adjustment, June 30, 2021 unrealized gain   (98,047 )
Balance, June 30, 2021 $ (328,932 )
       
Number of warrants outstanding as of June 30, 2021   648,910  
       
    2020 June Warrants  
Inception of the June 2020 Warrants (see Note 17(f))   2,404,957  
Deferred loss   (448,877 )
Amortization of deferred loss   121,751  
Fair value adjustment, unrealized gain   (2,127,007 )
Balance, December 31, 2020 $ (49,176 )
Amortization of deferred loss   55,341  
Fair value adjustment, March 31, 2021 unrealized loss   129,422  
Balance, March 31, 2021 $ 135,587  
Amortization of deferred loss   55,956  
Fair value adjustment, June 30, 2021 unrealized gain   (218,468 )
Balance, June 30, 2021 $ (26,925 )
       
Number of warrants outstanding as of June 30, 2021   2,912,277  


NEOVASC INC.

Notes to the Condensed Interim Consolidated Financial Statements

For the three and six months ended June 30, 2021 and 2020

(Expressed in U.S. dollars)


16. DERIVATIVE WARRANT LIABILITY FROM FINANCING AND CONVERTIBLE NOTES (continued)

(e) Warrants and Convertible Notes Model (continued)

    2020 August Warrants  
Inception of the August 2020 Warrants (see Note 17(f))   3,511,115  
Deferred loss   (3,167,758 )
Amortization of deferred loss   611,854  
Fair value adjustment, unrealized gain   (3,150,303 )
Balance, December 31, 2020 $ (2,195,092 )
February 12 exercise of 125,000 warrants   (80,856 )
Derecognition of deferred loss   87,118  
Fair value adjustment, February 12 realized gain   (48,244 )
Amortization of deferred loss   383,046  
Fair value adjustment, March 31, 2021 unrealized loss   272,573  
Balance, March 31, 2021 $ (1,581,455 )
Amortization of deferred loss   380,365  
Fair value adjustment, June 30, 2021 unrealized gain   (263,113 )
Balance, June 30, 2021 $ (1,464,203 )
       
Number of warrants outstanding as of June 30, 2021   3,274,579  
       
    2020 December Warrants  
Inception of the December 2020 Warrants (see Note 17(f))   2,051,657  
Deferred loss   (1,278,414 )
Amortization of deferred loss   40,279  
Fair value adjustment, unrealized loss   370,769  
Balance, December 31, 2020 $ 1,184,291  
February 12 exercise of 1,828,479 warrants   (2,545,349 )
Derecognition of deferred loss   341,242  
Fair value adjustment, February 12 realized loss   1,943,274  
Amortization of deferred loss   133,459  
Fair value adjustment, March 31, 2021 unrealized loss   351,808  
Balance, March 31, 2021 $ 1,408,725  
Amortization of deferred loss   112,597  
Fair value adjustment, June 30, 2021 unrealized gain   (669,049 )
Balance, June 30, 2021 $ 852,273  
       
Number of warrants outstanding as of June 30, 2021   4,402,324  
       
    2020 Repayment Warrants  
Inception of the 2020 Repayment Warrants (see Note 17(f))   161,720  
Fair value adjustment, unrealized gain   (152,272 )
Balance, December 31, 2020 $ 9,448  
Fair value adjustment, March 31, 2021 unrealized loss   6,871  
Balance, March 31, 2021 $ 16,319  
Fair value adjustment, June 30, 2021 unrealized gain   (11,945 )
Balance, June 30, 2021 $ 4,374  
       
Number of warrants outstanding as of June 30, 2021   650,296  


NEOVASC INC.

Notes to the Condensed Interim Consolidated Financial Statements

For the three and six months ended June 30, 2021 and 2020

(Expressed in U.S. dollars)


16. DERIVATIVE WARRANT LIABILITY FROM FINANCING AND CONVERTIBLE NOTES (continued)

(e) Warrants and Convertible Notes Model (continued)

    2020 Settlement Warrants  
Inception of the 2020 Settlement Warrants (see Note 17(f))   807,977  
Fair value adjustment, unrealized gain   (606,304 )
Balance, December 31, 2020 $ 201,673  
Fair value adjustment, March 31, 2021 unrealized gain   (20,543 )
Balance, March 31, 2021 $ 181,130  
Fair value adjustment, June 30, 2021 unrealized gain   (83,388 )
Balance, June 30, 2021 $ 97,742  
       
Number of warrants outstanding as of June 30, 2021   500,000  

The carrying amounts for the 2021 derivative warrant liability from financing are as follows:
 
   
    2021 February Warrants  
Inception of the February 2021 Warrants (see Note 17(f))   15,666,819  
Deferred loss   (15,666,819 )
Amortization of deferred loss   1,008,686  
Fair value adjustment, March 31, 2021 unrealized gain   (12,252,740 )
Balance, March 31, 2021 $ (11,244,054 )
Amortization of deferred loss   1,952,986  
Fair value adjustment, June 30, 2021 unrealized gain   (1,668,479 )
Balance, June 30, 2021 $ (10,959,547 )
       
Presented on the consolidated statements of financial position as:      
Deferred loss on 2021 derivative warrant liabilities $ 12,705,147  
2021 Derivative warrant liabilities $ 1,745,600  
       
Number of warrants outstanding as of June 30, 2021   18,000,000  
       
    2019 Convertible Notes  
Balance, convertible notes December 31, 2019 $ 9,265,480  
Re-payment of convertible note July 23 conversion   (3,613,341 )
Re-payment of convertible note August 17 conversion   (1,263,884 )
Fair value adjustment, Repayment warrants   (161,720 )
Fair value adjustment, unrealized loss   39,730  
Fair value adjustment, realized loss   636,154  
Fair value adjustment, unrealized loss due to changes in credit spread   1,292,938  
Balance, convertible notes December 31, 2020 $ 6,195,357  
Fair value adjustment, March 31, 2021 unrealized gain   (290,705 )
Fair value adjustment, March 31, 2021 realized loss   115,898  
Fair value adjustment, unrealized loss due to changes in credit spread   375,632  
Balance, convertible notes March 31, 2021 $ 6,396,182  
Fair value adjustment, June 30, 2021 unrealized loss   77,956  
Fair value adjustment, June 30, 2021 realized gain   (115,898 )
Fair value adjustment, unrealized loss due to changes in credit spread   225,288  
Balance, convertible notes June 30, 2021 $ 6,583,528  
2019 Convertible Notes, current $ 38,633  
2019 Convertible Notes, non-current $ 6,544,895  

NEOVASC INC.

Notes to the Condensed Interim Consolidated Financial Statements

For the three and six months ended June 30, 2021 and 2020

(Expressed in U.S. dollars)


16. DERIVATIVE WARRANT LIABILITY FROM FINANCING AND CONVERTIBLE NOTES (continued)

(e) Warrants and Convertible Notes Model (continued)

    2020 Convertible Notes  
Fair value, May 26, 2020   6,449,634  
Deferred loss   (3,511,670 )
Amortization of deferred loss   516,938  
Fair value adjustment, unrealized gain   (1,075,620 )
Fair value adjustment, realized loss   37,525  
Fair value adjustment, unrealized loss due to changes in credit spread   199,395  
Balance, convertible notes December 31, 2020 $ 2,616,202  
Amortization of deferred loss   216,473  
Fair value adjustment, March 31, 2021 unrealized gain   (604,252 )
Fair value adjustment, March 31, 2021 realized loss   103,723  
Fair value adjustment, unrealized loss due to changes in credit spread   329,953  
Balance, convertible notes March 31, 2021 $ 2,662,099  
Amortization of deferred loss   218,878  
Fair value adjustment, June 30, 2021 unrealized loss   121,326  
Fair value adjustment, June 30, 2021 realized gain   (103,409 )
Fair value adjustment, unrealized loss due to changes in credit spread   54,767  
Balance, convertible notes June 30, 2021 $ 2,953,661  
2020 Convertible Notes, current $ 37,839  
2020 Convertible Notes, non-current $ 2,915,822  

The following table lists 2020 Convertible notes and warrants and derivative warrant liabilities outstanding as at June 30, 2021:

Convertible notes - 2020 Convertible notes   2,953,661  
Derivative liability - 2020 January warrants   27,264  
Derivative liability - 2020 May warrants   (328,932 )
Derivative liability - 2020 June warrants   (26,925 )
Derivative liability - 2020 August warrants   (1,464,203 )
Derivative liability - 2020 December warrants   852,273  
Derivative liability - 2020 Repayment warrants   4,374  
Derivative liability - 2020 Settlement warrants   97,742  
Balance, 2020 Convertible notes and warrants and derivative liabilities June 30, 2021 $ 2,115,254  
2020 Convertible notes and warrants and derivative liabilities, current $ 37,839  
2020 Convertible notes and warrants and derivative liabilities, non-current $ 2,077,415  


NEOVASC INC.

Notes to the Condensed Interim Consolidated Financial Statements

For the three and six months ended June 30, 2021 and 2020

(Expressed in U.S. dollars)


17. SHARE CAPITAL

All Common Shares are equally eligible to receive dividends and the repayment of capital and represent one vote at shareholders' meetings. All Preferred Shares have no voting rights at shareholders' meetings but on liquidation, winding-up or other distribution of the Company's assets are entitled to participate in priority to Common Shares. There are no Preferred Shares issued and outstanding.

(a) Authorized

Unlimited number of Common Shares without par value.

Unlimited number of Preferred Shares without par value.

We may issue our Preferred Shares from time to time in one or more series. The terms of each series of Preferred Shares, including the number of shares, the designation, rights, preferences, privileges, priorities, restrictions, conditions and limitations, will be determined at the time of creation of each such series by our board of directors, without shareholder approval, provided that all Preferred Shares will rank equally within their class as to dividends and distributions in the event of our dissolution, liquidation or winding-up.

All share and per share amounts are net of share issuance costs and have been adjusted to retroactively reflect the impact of the September 18, 2018 reverse stock split on a 1 for 100 basis and the June 25, 2019 reverse stock split on a 1 for 10 basis.

    Common Shares     Contributed  
    Number     Amount     Surplus  
Balance, December 31, 2019   8,706,779   $ 328,460,681   $ 29,766,225  
Common Shares issued from public offerings Series A (i)   1,185,000     4,111,950     -  
Common Shares issued from exercise of Series B
Pre-funded warrants (ii)
  1,241,490     3,885,746     -  
      Transaction costs for both Series A and Series B   -     (462,880 )   -  
      Broker warrants (See Note 17 (f))   -     (82,597 )   82,597  
Common Shares issued on conversion of warrants (iii)   672,937     969,133     -  
Common Shares issued on conversion of notes (iv)   500,014     1,293,093     -  
Common Shares issued from public offering (v)   3,883,036     9,591,099     -  
        Transaction costs for public offering   -     (1,215,274 )   -  
        Broker warrants (See Note 17 (f))   -     (162,467 )   162,467  
Common Shares issued from public offering (vi)   4,532,772     12,238,48     -  
        Transaction costs for public offering   -     (1,057,302 )   -  
        Broker warrants (See Note 17 (f))   -     (242,989 )   242,989  
Common Shares issued from Warrant conversion (vii)   1,925,049     7,718,346     -  
Common Shares issued from public offerings Series A (vii)   6,230,803     5,333,567     -  
        Transaction costs for public offerings Series A   -     (659,410 )   -  
        Broker warrants (See Note 17 (f))   -     (96,114 )   96,114  
Common Shares issued from exercise of restricted share units   50,986     151,938     (151,938 )
Common Shares issued from exercise of stock options   50     378     (174 )
Share-based payments   -     -     4,846,776  
Balance, December 31, 2020   28,928,916   $ 369,775,383   $ 35,045,056  
Common Shares issued from public offering (ix)   36,000,000     72,000,000     -  
        Transaction costs for public offering   -     (5,131,089 )   -  
        Broker warrants (See Note 17 (f))   -     (1,898,959 )   1,898,959  
Common Shares issued from warrant conversion (x)   125,000     417,092     -  
Common Shares issued from warrant conversion (xi)   1,828,479     3,287,736     -  
Common Shares issued from exercise of restricted share units   621,668     1,034,938     (1,034,938 )
Share-based payments   -     -     2,219,993  
Balance, March 31, 2021   67,504,063   $ 439,485,101   $ 38,129,070  
Common Shares issued from exercise of restricted share units   80,349     194,445     (194,445 )
Share-based payments   -     -     849,083  
Balance, June 30, 2021   67,584,412   $ 439,679,546   $ 38,783,708  


NEOVASC INC.

Notes to the Condensed Interim Consolidated Financial Statements

For the three and six months ended June 30, 2021 and 2020

(Expressed in U.S. dollars)


17. SHARE CAPITAL (continued)

(a) Authorized (continued)

(i) On January 6, 2020, the Company completed a registered direct offering of an aggregate of 1,185,000 series A units and 1,241,490 series B units at a price of $4.1351 per series A unit and $4.135 per series B unit for aggregate gross proceeds to the Company of approximately $10,000,000, less $462,880 in underwriting commission, a $82,597 fair value charge for 157,721 broker warrants issued and $185,883 in other share issuance costs.

(ii) During the three months ended March 31, 2020, 1,241,490 Common Shares were issued on the conversion of series B pre-funded warrants from the January 6, 2020 registered direct offering.

(iii) On May 28, 2020, the Company issued an aggregate of 672,937 Common Shares for the surrender and cancellation of 2,176,490 January 2020 Warrants (as defined below) on the basis of approximately 0.3092 of a Common Share for each January 2020 Warrant.

(iv) On May 26, 2020, 500,014 Common Shares were issued on the conversion of $1,016,000 of aggregate principal amount of 2017 Notes. The fair value of 2017 Notes related to this conversion was derecognized at the date of exercise.

(v) On June 16, 2020, the Company completed a registered direct offering of an aggregate 3,883,036 units at a price of $2.973 per unit for aggregate gross proceeds to the Company of approximately $11,500,000 less $1,215,274 in underwriting commission, a $162,467 fair value charge for compensation warrants, and $278,482 in other share issuance costs.

(vi) On August 12, 2020 the Company completed a registered direct offering of an aggregate 4,532,772 units at a price of $2.775 per unit for aggregate gross proceeds to the Company for approximately $12,600,000 less $1,057,302 in underwriting commission, a $242,989 fair value charge for compensation warrants and $109,918 in other share issuance costs.

(vii) On July 23, 2020 and August 12, 2020, 1,925,049 Commons shares were issued on the conversion of May 2020 Warrants (as defined below). Using the exercise proceeds of $4,877,225, the Company has prepaid a portion of the 2019 Note.

(viii) On December 8, 2020, the Company completed a registered direct offering of an aggregate 6,230,803 units at a price of $0.9801 per unit for aggregate gross proceeds to the Company for approximately $6,100,000 less $659,410 in underwriting commission, a $96,114 fair value charge for compensation warrants, and $200,386 in other share issuance costs.

(ix) On February 12, 2021, the Company completed a registered direct offering of an aggregate 36,000,000 units at a price of $2.00 per unit for aggregate gross proceeds to the Company for approximately $72,000,000 less $5,760,000 in underwriting commission, a $1,898,959 fair value charge for compensation warrants, and $917,900 in other share issuance costs.

(x) During the period ending March 31, 2021, 125,000 Common Shares were issued on the exercise of warrants in connection with the August 2020 Financing.

(xi) During the period ending March 31, 2021, 1,828,479 Common Shares were issued on the exercise of warrants in connection with the December 2020 Financing.


NEOVASC INC.

Notes to the Condensed Interim Consolidated Financial Statements

For the three and six months ended June 30, 2021 and 2020

(Expressed in U.S. dollars)


17. SHARE CAPITAL (continued)

(b) Stock options

The Company adopted an equity-settled stock option plan under which the directors of the Company may grant options to purchase Common Shares to directors, officers, employees and service providers (the "optionees") of the Company on terms that the directors of the Company may determine within the limitations set forth in the stock option plan. Effective June 4, 2018, at the Annual General Meeting ("AGM"), the board of directors and shareholders of the Company approved an amendment to the Company's incentive stock option plan to increase the number of options available for grant under the plan to 15% of the number of Common Shares of the Company outstanding at any time.

Options under the Company's stock option plan granted to directors, officers and employees vest immediately on the grant date, unless a vesting schedule is specified by the board. The directors of the Company have discretion within the limitations set forth in the stock option plan to determine other vesting terms on options granted to directors, officers, employees, and others. The minimum exercise price of a stock option cannot be less than the applicable market price of the Common Shares on the date of the grant and the options have a maximum life of ten years from the date of grant. The following table summarizes stock option activity for the respective years as follows:

          Weighted
average
    Average
remaining
 
    Number of
options
    exercise
price
    contractual life
(years)
 
Options outstanding, January 1, 2020   1,051,665   $ 20.63     7.09  
Options exercisable, January 1, 2020   398,596   $ 35.69     6.97  
Granted   2,495,100     2.48        
Exercised   (50 )   4.10        
Forfeited   (468,238 )   23.10        
Expired   (1,329 )   3,498.28        
Options outstanding, December 31, 2020   3,077,148   $ 4.10     7.19  
Options exercisable, December 31, 2020   1,081,760   $ 6.01     6.93  
Granted   3,600,000     1.38        
Forfeited/ cancelled   (930,310 )   2.91        
Expired   (64 )   3,744.68        
Options outstanding, June 30, 2021   5,746,774   $ 2.55     7.26  
Options exercisable, June 30, 2021   2,004,676   $ 3.86     6.89  

The determination of a transaction to be either forfeited or cancelled requires management judgment, which is dependent on the terms and conditions of the transaction.

The following table lists the options outstanding as at June 30, 2021 by exercise price:

 

Exercise price

Options

outstanding

Weighted average
remaining term
(yrs)

Options

exercisable

Weighted average
remaining term (yrs)

$1.38

3,239,600

7.71

719,760

7.71

$2.11

357,500

7.23

116,750

7.23

$2.17

600,000

7.27

161,250

7.27

$2.42

500,875

6.98

266,063

6.98

$3.35

403,700

6.56

221,438

6.56

$4.10

417,450

5.74

325,100

5.74

$4.80

5,000

5.84

3,750

5.84

$5.00

96,325

5.92

75,938

5.92

$5.01 - $1,532.35

126,324

5.33

114,627

5.33

 

5,746,774

 

2,004,676

 



NEOVASC INC.

Notes to the Condensed Interim Consolidated Financial Statements

For the three and six months ended June 30, 2021 and 2020

(Expressed in U.S. dollars)


17. SHARE CAPITAL (continued)

(c)    Stock Options (continued)

The following table lists the options outstanding as at December 31, 2020 by exercise price:

 

Exercise price

Options
outstanding

Weighted average
remaining term (yrs)

Options
exercisable

Weighted average
remaining term (yrs)

$2.11

486,875

7.72

138,125

7.72

$2.17

695,000

7.76

173,750

7.76

$2.27

1,500

7.61

1,500

7.61

$2.42

640,000

7.47

176,032

7.47

$3.35

493,766

7.05

133,495

7.05

$4.10

481,150

6.23

251,550

6.23

$4.11 - $3,878.39

278,857

6.07

207,308

6.01

 

3,077,148

 

1,081,760

 

During the three and six months ended June 30, 2021, the Company recorded $415,984 and $1,642,226, as compensation expense for share-based compensation awarded to eligible optionees (three and six months ended June 30, 2020: $799,284 and $1,722,117). The Company used the Black-Scholes Option Pricing Model to estimate the fair value of the options at each measurement date using the following weighted average assumptions:

    2021     2020  
Weighted average fair value $ 1.04   $ 2.86  
Weighted average exercise price $ 1.38   $ 3.35  
Weighted average share price at grant $ 1.38   $ 3.35  
Dividend yield   nil     nil  
Volatility   119%     143%  
Risk-free interest rate   0.87%     1.60%  
Expected life   4 years     4 years  
Forfeiture rate   7.00%     7.00%  

(d)  Restricted share units

On December 2, 2019, the Company adopted a Restricted Share Unit ("RSU") Plan which provides for RSUs to be awarded to directors, officers, employees and service providers. The maximum number of Common Shares authorized and reserved for issuance under the RSU Plan is equal to 5% of the issued and outstanding Common Shares of the Company. The shareholders of the Company approved the amended RSU Plan at the annual meeting of the shareholders on September 3, 2020, which falls within 12 months of the effective date of the RSU Plan.

The granting of RSUs is considered an equity-settled share-based payment transaction. The fair value of the grant was determined by multiplying the Company's share price at the grant date by the number of RSUs granted and is recognized over the vesting period of the grant. The expense recognized for the three and six months ended June 30, 2021, was $433,098 and $1,426,849 (three and six months ended June 30, 2020: $219,830 and $365,320). As at June 30, 2021, the total remaining unrecognized compensation cost related to RSUs amounted to approximately $2,519,466 which will be amortized over the remaining vesting periods.


NEOVASC INC.

Notes to the Condensed Interim Consolidated Financial Statements

For the three and six months ended June 30, 2021 and 2020

(Expressed in U.S. dollars)


17. SHARE CAPITAL (continued)

(d)  Restricted share units (continued)

RSU transactions are summarized as follows:

    Number of
RSUs
    Weighted Average
Grant Date Fair
Value Per Share
 
Outstanding, January 1, 2020   152,956   $ 2.98  
Granted   706,044   $ 2.72  
Vested/Exercised   (50,986 ) $ 0.85  
Cancelled/Forfeited   (30,000 ) $ 2.74  
Outstanding, December 31, 2020   778,014   $ 2.76  
Granted   2,600,000   $ 1.38  
Vested/Exercised   (702,017 ) $ 1.75  
Cancelled/Forfeited   (251,999 ) $ 1.81  
Outstanding, June 30, 2021   2,423,998   $ 1.72  

(e)  Share appreciation rights

On September 22, 2020, the Company adopted a Share Appreciation Rights ("SAR") Plan which provides for SARs to be awarded to directors, officers, employees and service providers. The granting of SARs is considered a cash-settled payment transaction. The fair value of the SAR is measured applying an option pricing model, taking into account the terms and conditions on which the SARs are granted. The liability of the SAR is measured initially at grant date and at the end of each reporting period until settled. The fair value of the SAR as of June 30, 2021, is $4,962,060 which will be recorded over the vesting period of the SAR. The expense recognized for the three and six months ended June 30, 2021, was $1,198,036 and $1,382,000 (three and six months ended June 30, 2020: $nil).

SAR transactions are summarized as follows:

    Number of
SARs
    Weighted Average
Grant Date Fair
Value Per Share
 
Outstanding, January 1, 2020   -     -  
Granted   1,811,768   $ 0.185  
Outstanding, December 31, 2020   1,811,768   $ 0.185  
Granted   5,400,000   $ 0.000  
Cancelled   (1,811,768 ) $ 0.185  
Outstanding, June 30, 2021   5,400,000   $ 0.000  

(f)  Warrants

On January 6, 2020, the Company completed a registered direct offering of an aggregate of 1,185,000 series A units ("Series A Units") and 1,241,490 series B units ("Series B Units"): Series B Units at a price of $4.1351 per Series A Unit and $4.135 per Series B Unit for aggregate gross proceeds to the Company of approximately $10,000,000. Each Series A Unit consists of one Common Share of Neovasc and one warrant ("January 2020 Warrant"). Each January 2020 Warrant entitles the holder to acquire one Common Share of Neovasc at a price of US$4.1351 at any time prior to four years following the date of issuance. Each Series B Unit consists of one pre-funded warrant ("Pre-Funded Warrant") of Neovasc and one January 2020 Warrant. Each Pre-Funded Warrant entitles the holder to acquire one Common Share of Neovasc at a price of US$0.0001 at any time until the exercise in full of each Pre-Funded Warrant.

All Pre-Funded Warrants were exercised as at December 31, 2020. The January 2020 Warrants include a cashless exercise option which is effective only if the Company does not have an effective registration statement in the United States at the time of the exercise. In accordance with IAS 32 - Financial instruments; presentation, the January 2020 Warrants have been accounted for as derivative financial liabilities and measured at FVTPL. The fair value of $6,145,620 for the January 2020 Warrants and Pre-Funded Warrants was computed using the Black-Scholes pricing model with the following assumptions: a) average risk-free interest rate of 1.60%; b) expected life of 1 years; c) the price of the stock on the grant date of $3.47; d) expected volatility of 70%; and e) no expected dividend payments.


NEOVASC INC.

Notes to the Condensed Interim Consolidated Financial Statements

For the three and six months ended June 30, 2021 and 2020

(Expressed in U.S. dollars)


17. SHARE CAPITAL (continued)

(f)  Warrants (continued)

On May 28, 2020, the Company issued an aggregate of 672,937 Exchange Shares for the surrender and cancellation of 2,176,490 January 2020 Warrants outstanding on the basis of approximately 0.3092 of an Exchange Share for each warrant. Subsequent to the exchange, 250,000 January 2020 Warrants remain outstanding.

On May 26, 2020, the Company granted 2,573,959 warrants with an exercise price of $2.634 and term of 4 years ("the May 2020 Warrants"). The May 2020 Warrants are convertible into Common Shares of the Company at the option of the holder (however, the holder may not own greater than 9.99% of the total outstanding Common Shares of the Company as a result of the conversion). The May 2020 Warrants include a cashless exercise option which is effective only if the Company does not have an effective registration statement in the United States at the time of the exercise. In accordance with IAS 32 - Financial instruments; presentation, the May 2020 Warrants have been accounted for as derivative financial liabilities and measured at FVTPL. The fair values of $4,526,732 of the May 2020 Warrants were calculated using a binomial option pricing model and have been classified as level 3 in the fair value hierarchy. On July 23, 2020 1,424,049 May 2020 Warrants were exercised and on August 17, 2020 501,000 May 2020 Warrants were exercised leaving 648,910 May 2020 Warrants remaining. The total exercise proceeds of $4,877,225 net of interest and prepayment penalty has been applied to the principal of the 2019 Note.

On May 28, 2020 the Company entered into a settlement agreement to issue 500,000 settlement warrants ("2020 Settlement Warrants"). Each Settlement Warrant entitles the holder to purchase one Common Share in the capital of the Company at an exercise price of $2.634 per Settlement Warrant for a period of 4 years following issuance and are subject to transfer/leak-out restrictions, including volume and public float restrictions. The 2020 Settlement Warrants include a cashless exercise option which is effective only if the Company does not have an effective registration statement in the United States at the time of the exercise. In accordance with IAS 32 - Financial instruments; presentation, the 2020 Settlement Warrants have been accounted for as derivative financial liabilities and measured at FVTPL. The fair value of $807,977 of the 2020 Settlement Warrants were calculated using the Cox Ross Rubinstein binomial tree model and have been classified as level 3 in the fair value hierarchy.

On June 16, 2020, the Company completed a registered direct offering of an aggregate 3,883,036 units (the "June 2020 Units") at a price of $2.973 per unit for aggregate gross proceeds to the Company of approximately $11,500,000 less $1,215,274 in underwriting commission, a $162,467 fair value charge for compensation warrants "June 2020 Compensation Warrants" (see Note 17 (a)), and $278,482 in other share issuance costs. Each June 2020 Unit consists of one Common Share of the Company and three-quarters of one warrant (each whole warrant, a "June 2020 Warrant") to purchase one Common Share issuing 2,912,277 June 2020 Warrants in total. Each June 2020 Warrant entitles the holder to acquire one Common Share of the Company at a price of $2.88 at any time prior to June 16, 2025. The June 2020 Warrants include a cashless exercise option which is effective only if the Company does not have an effective registration statement in the United States at the time of the exercise.  In accordance with IAS 32 - Financial instruments; presentation, the June 2020 Warrants have been accounted for as derivative financial liabilities and measured at FVTPL. The fair value of $2,404,957 for the June 2020 Warrants was computed using the Black-Scholes pricing model with the following assumptions: a) average risk-free interest rate of 0.32%; b) expected life of 2 years; c) the price of the stock on the grant date of $2.47; d) expected volatility of 70%; and e) no expected dividend payments.

On July 23, 2020, the Company issued repayment warrants ("July 2020 Repayment Warrants") to purchase up to 481,778 Common Shares at an exercise price of $7.50 per Common Share at any time prior to July 23, 2025. The exercise price is adjusted as the conversion price of the 2019 Note is adjusted. The fair value of $134,718 for the July 2020 Repayment Warrants was computed using the Black-Scholes pricing model with the following assumptions: a) average risk-free interest rate of 0.29%; b) expected life of 2 years; c) the price of the stock on the grant date of $2.54; d) expected volatility of 70.0%; and e) no expected dividend payments.


NEOVASC INC.

Notes to the Condensed Interim Consolidated Financial Statements

For the three and six months ended June 30, 2021 and 2020

(Expressed in U.S. dollars)


17. SHARE CAPITAL (continued)

(f) Warrants (continued)

On August 12, 2020, the Company completed a registered direct offering of an aggregate 4,532,772 units (the August 2020 Units") at a price of $2.775 per unit for aggregate gross proceeds to the Company for approximately $12,600,000 less $1,057,302 in underwriting commission, a $242,989 fair value charge for Compensation Warrants "August 2020 Compensation Warrants" (see Note 17 (a)), and $109,918 in other share issuance costs. Each August 2020 Unit consists of one Common Share of the Company and three-quarters of one warrant (each whole warrant, an "August 2020 Warrant") issuing 3,399,579 August 2020 Warrants in total. Each August 2020 Warrant entitles the holder to acquire one Common Share of the Company at an exercise price of $2.69 per share at any time prior to August 12, 2025. The August 2020 Warrants include a cashless exercise option which is effective only if the Company does not have an effective registration statement in the United States at the time of the exercise. In accordance with IAS 32 - Financial instruments; presentation, the August 2020 Warrants have been accounted for as derivative financial liabilities and measured at FVTPL. The fair value of $3,511,115 for the August 2020 Warrants was computed using the Black-Scholes pricing model with the following assumptions: a) average risk-free interest rate of 0.32%; b) expected life of 2 years; c) the price of the stock on the grant date of $2.70; d) expected volatility of 70%; and e) no expected dividend payments.  125,000 August 2020 Warrants have been exercised and there are 3,274,579 August 2020 Warrants outstanding at June 30, 2021.

On August 17, 2020, the Company issued repayment warrants ("August 2020 Repayment Warrants", the July 2020 Repayment Warrants and the August 2020 Repayment Warrants collectively the "2020 Repayment Warrants") to purchase up to 168,518 Common Shares at an exercise price of $7.50 per Common Share at any time prior to August 17, 2025. The exercise price is adjusted as the conversion price of the 2019 Note is adjusted. The fair value of $27,002 for the August 2020 Repayment Warrants was computed using the Black-Scholes pricing model with the following assumptions: a) average risk-free interest rate of 0.31%; b) expected life of 2 years; c) the price of the stock on the grant date of $2.13; d) expected volatility of 68%; and e) no expected dividend payments.

On December 8, 2020, the Company completed a registered direct offering of an aggregate 3,883,036 units (the "December 2020 Units") at a price of $0.9801 per unit for aggregate gross proceeds to the Company for approximately $6,100,000 less $659,410 in underwriting commission, a $96,114 fair value charge for compensation warrants "December 2020 Compensation Warrants" (see Note 17 (a)), and $178,968 in other share issuance costs. Each December 2020 Unit consists of one Common Share of the Company and one warrant (a "December 2020 Warrant") to purchase one Common Share issuing 6,230,803 December 2020 Warrants in total. Each December Warrant entitles the holder to acquire one Common Share of the Company at an exercise price of $0.86 per share at any time prior to December 8, 2025. The December 2020 Warrants include a cashless exercise option which is effective only if the Company does not have an effective registration statement in the United States at the time of the exercise.  In accordance with IAS 32 - Financial instruments; presentation, the December 2020 Warrants have been accounted for as derivative financial liabilities and measured at FVTPL. The fair value of $2,051,657 for the December 2020 Warrants was computed using the Black-Scholes pricing model with the following assumptions: a) average risk-free interest rate of 0.33%; b) expected life of 2 years; c) the price of the stock on the grant date of $0.86; d) expected volatility of 70%; and e) no expected dividend payments. 3,724,287 December 2020 Warrants have been exercised and there are 2,506,516 December 2020 Warrants outstanding at June 30, 2021.

On February 12, 2021 the Company completed a registered direct offering of an aggregate 36,000,000 units (the February 2021 Units") at a price of $2.00 per unit for aggregate gross proceeds to the Company for approximately $72,000,000 less $5,760,000  in underwriting commission, a $1,898,959 fair value charge for compensation warrants "February 2021 Compensation Warrants" (see Note 17 (a)), and $917,900 in other share issuance costs. February 2021 Unit consists of one Common Share of the Company and one half of one warrant (each whole warrant, a "February 2021 Warrant") issuing 18,000,000 February 2021 Warrants in total. Each February 2021 Warrant entitles the holder to acquire one Common Share of the Company at an exercise price of $2.30 per share at any time prior to February 12, 2026. The February 2021 Warrants include a cashless exercise option which is effective only if the Company does not have an effective registration statement in the United States at the time of the exercise.  In accordance with IAS 32 - Financial instruments; presentation, the February 2021 Warrants have been accounted for as derivative financial liabilities and measured at FVTPL. The fair value of $15,666,819 for the February 2021 Warrants was computed using the Black-Scholes pricing model with the following assumptions: a) average risk-free interest rate of 0.33%; b) expected life of 2 years; c) the price of the stock on the grant date of $2.29; d) expected volatility of 70%; and e) no expected dividend payments.


NEOVASC INC.

Notes to the Condensed Interim Consolidated Financial Statements

For the three and six months ended June 30, 2021 and 2020

(Expressed in U.S. dollars)


17. SHARE CAPITAL (continued)

(g) Broker Warrants

In February and March of 2019, the Company completed two $5 million underwritten public offerings and issued 144,444 broker warrants ("2019 Broker Warrants") as part of the underwriter's commission. The Company uses the Black-Scholes pricing model to calculate the fair value of the 2019 Broker Warrants. The fair value for the February 28, 2019 $5 million public offering and 72,222 2019 Broker Warrants was computed using the Black-Scholes pricing model with the following assumptions: a) average risk-free interest rate of 2.51%; b) expected life of three years; c) the price of the stock on the grant date of $4.50; d) expected volatility of 81%; and e) no expected dividend payments. The fair value for the March 15, 2019 $5 million public offering and 72,222 2019 Broker Warrants was computed using the Black-Scholes pricing model with the following assumptions: a) average risk-free interest rate of 2.43%; b) expected life of three years; c) the price of the stock on the grant date of $4.50; d) expected volatility of 82%; and e) no expected dividend payments.

On January 6, 2020, the Company issued the January 2020 Broker Warrants to purchase up to 157,721 Common Shares at an exercise price of $5.1689 per Common Share at any time prior to January 6, 2023. The fair value of $82,597 for the January 2020 broker warrants was computed using the Black-Scholes pricing model with the following assumptions: a) average risk-free interest rate of 1.60%; b) expected life of one year; c) the price of the stock on the grant date of $3.47; d) expected volatility of 70%; and e) no expected dividend payments.

On June 16, 2020, the Company issued the June 2020 Compensation Warrants to purchase up to 252,397 Common Shares at an exercise price of $3.71 per Common Share at any time prior to June 16, 2025. The fair value of $162,467 for the June 2020 Compensation Warrants was computed using the Black-Scholes pricing model with the following assumptions: a) average risk-free interest rate of 0.32%; b) expected life of two years; c) the price of the stock on the grant date of $2.47; d) expected volatility of 70.0%; and e) no expected dividend payments.

On August 12, 2020, the Company issued the August 2020 Compensation Warrants to purchase up to 294,630 Common Shares at an exercise price of $3.47 per Common Share at any time prior to August 12, 2025. The fair value of $242,989 for the August 2020 Compensation Warrants was computed using the Black-Scholes pricing model with the following assumptions: a) average risk-free interest rate of 0.32%; b) expected life of two years; c) the price of the stock on the grant date of $2.70; d) expected volatility of 70.0%; and e) no expected dividend payments.

On December 8, 2020, the Company issued the December 2020 Compensation Warrants to purchase up to 405,002 Common Shares at an exercise price of $1.22 per Common Share at any time prior to December 8, 2025. The fair value of $96,114 for the December 2020 Compensation Warrants was computed using the Black-Scholes pricing model with the following assumptions: a) average risk-free interest rate of 0.33%; b) expected life of two years; c) the price of the stock on the grant date of $0.86; d) expected volatility of 70.0%; and e) no expected dividend payments.

On February 12, 2021, the Company issued the February 2021 Compensation Warrants to purchase up to 2,340,000 Common Shares at an exercise price of $2.50 per Common Share at any time prior to February 12, 2026. The fair value of $1,898,959 for the February 2021 Compensation Warrants was computed using the Black-Scholes pricing model with the following assumptions: a) average risk-free interest rate of 0.33%; b) expected life of two years; c) the price of the stock on the grant date of $2.29; d) expected volatility of 70.0%; and e) no expected dividend payments.


NEOVASC INC.

Notes to the Condensed Interim Consolidated Financial Statements

For the three and six months ended June 30, 2021 and 2020

(Expressed in U.S. dollars)


18. SEGMENT INFORMATION

The Company's operations are in one business segment: the development, manufacturing and marketing of medical devices. Each of the Company's product lines has similar characteristics, customers, distribution and marketing strategies, and are subject to similar regulatory requirements. Substantially all of the Company's long-lived assets are located in Canada. The Company carries on business in Canada, the United States and Europe. The Company earns revenue from sales to customers in the following geographic locations:

    For the three months ended
June 30,
    For the six months ended
June 30,
 
    2021     2020     2021     2020  
REVENUE                        
Europe $ 598,068   $ 284,047   $ 1,004,862   $ 764,442  
Rest of the World   35,000     -     80,000     52,500  
  $ 633,068   $ 284,047   $ 1,084,862   $ 816,942  

Sales to the Company's three largest customers accounted for approximately 27%, 22%, and 12% of the Company's sales for the six months ended June 30, 2021. Sales to the Company's three largest customers accounted for approximately 14%, 12%, and 11% of the Company's sales for the six months ended June 30, 2020.

19. EMPLOYEE BENEFITS EXPENSE

    For the three months ended
June 30,
    For the six months ended
June 30,
 
    2021     2020     2021     2020  
                         
Salaries and wages $ 2,050,840   $ 3,123,388   $ 4,348,726   $ 5,272,313  
Pension plan and employment insurance   105,411     119,978     279,065     327,423  
Contribution to defined contribution pension plan   36,181     61,174     74,610     110,237  
Health benefits   102,480     145,186     232,735     321,528  
Cash-based employee expenses $ 2,294,912     3,449,726     4,935,136     6,031,501  
                         
Employee termination expense   309,056     -     309,056     -  
                         
Share-based payments   2,047,119     1,019,114     4,451,076     2,087,437  
Total employee expenses $ 4,651,087   $ 4,468,840   $ 9,695,268   $ 8,118,938  

The $309,056 employee termination expense is related to the severance of approximately 40% of the staff as the Company has paused all activity on the Tiara TF devices (see note 1(b).


NEOVASC INC.

Notes to the Condensed Interim Consolidated Financial Statements

For the three and six months ended June 30, 2021 and 2020

(Expressed in U.S. dollars)


20. DEPRECIATION, SHARE-BASED PAYMENTS, EMPLOYEE AND OTHER EXPENSES

    For the three months ended
June 30,
    For the six months ended
June 30,
 
    2021     2020     2021     2020  
                         
EXPENSES                        
Selling expenses                        
Share-based payments $ 251,669   $ 61,113   $ 505,043   $ 111,301  
Cash-based employee expenses   221,842     239,595     447,390     422,863  
Other expenses   359,301     151,806     518,358     471,879  
  $ 832,812   $ 452,514   $ 1,470,791   $ 1,006,043  
                         
General and administrative expenses                        
Depreciation $ 77,109   $ 68,278   $ 151,295   $ 133,781  
Share-based payments   1,689,521     562,377     3,346,025     1,186,070  
Cash-based employee expenses   948,473     1,142,898     1,654,694     1,626,611  
Employee termination expense   309,056     -     309,056     -  
Write down of fixed assets for obsolescence   593,622     -     593,622     -  
Litigation expenses   321,016     -     480,818     -  
Accretion on collaboration, license and settlement
agreements provision
  25,508     48,895     50,468     96,740  
Legal expenses and underwriters fees from financing
activities
  -     -     1,630,124     -  
Other expenses   1,078,499     2,003,062     2,119,271     3,269,810  
  $ 5,042,804   $ 3,825,510   $ 10,335,373   $ 6,313,012  
                         
Product development and clinical trials expenses                        
Depreciation $ 115,902   $ 119,418   $ 228,005   $ 237,825  
Share-based payments   105,929     395,624     600,008     790,066  
Cash-based employee expenses   1,124,597     2,067,233     2,833,052     3,982,027  
Other expenses   2,394,459     2,007,449     4,701,250     4,103,212  
  $ 3,740,887   $ 4,589,724   $ 8,362,315   $ 9,113,130  
                         
TOTAL EXPENSES $ 9,616,503   $ 8,867,748   $ 20,168,479   $ 16,432,185  
                         
Depreciation per Statements of Cash Flows $ 193,011   $ 187,696   $ 379,300   $ 371,606  
                         
Share-based payments per Statements of Cash
Flows
$ 2,047,119   $ 1,019,114   $ 4,451,076   $ 2,087,437  
                         
Cash-based employee expenses (see Note 19) $ 2,294,912   $ 3,449,726   $ 4,935,136   $ 6,031,501  


NEOVASC INC.

Notes to the Condensed Interim Consolidated Financial Statements

For the three and six months ended June 30, 2021 and 2020

(Expressed in U.S. dollars)


21. LOSS PER SHARE

Both the basic and diluted loss per share have been calculated using the loss attributable to shareholders of the Company as the numerator. The weighted average number of Common Shares outstanding used for basic loss per share for the three and six months ended June 30, 2021, amounts to 67,509,361 and 39,768,556 (three and six months ended June 30, 2020: 12,219,739 and 11,575,925).

    For the three months ended
June 30,
    For the six months ended
June 30,
 
    2021     2020     2021     2020  
                         
Weighted average number of Common Shares   67,509,361     12,219,739     39,768,556     11,575,925  
Loss for the period $ (9,033,014 ) $ (9,925,315 ) $ (11,200,429 ) $ (14,036,906 )
Basic and diluted loss per share $ ($0.13 ) $ (0.81 ) $ ($0.19 ) $ (1.21 )

Instruments that could potentially have a dilutive effect on the Company's weighted average shares outstanding include all of the outstanding convertible notes, restricted share units, stock options, stock appreciation rights, and warrants. These instruments are currently excluded from the calculation of diluted earnings per share as they are antidilutive for the periods presented.

22. RELATED PARTY TRANSACTIONS

The Company's key management personnel include members of the board of directors, executive officers, and former executive officers. The Company provides salaries or cash compensation, and other non-cash benefits to directors and executive officers.

    For the three months ended
June 30,
    For the six months ended
June 30,
 
    2021     2020     2021     2020  
Short-term employee benefits                        
Employee salaries and bonuses $ 753,249   $ 872,869   $ 1,135,160   $ 1,277,595  
Directors fees   67,500     63,333     135,000     130,833  
Social security and medical care costs   13,130     17,721     50,898     57,277  
    833,879     953,923     1,321,058     1,465,705  
Post-employment benefits                        
Contributions to defined contribution pension plan   6,646     10,335     15,526     19,029  
                         
Share-based payments   620,426     364,922     2,004,749     932,353  
Total key management remuneration $ 1,460,951   $ 1,329,180   $ 3,341,333   $ 2,417,087  


NEOVASC INC.

Notes to the Condensed Interim Consolidated Financial Statements

For the three and six months ended June 30, 2021 and 2020

(Expressed in U.S. dollars)


23.   CONTINGENT LIABILITIES AND PROVISIONS

Litigation

Litigation resulting from third party claims has been, and may be, costly and time-consuming and could divert the attention of management and key personnel from our business operations. Although we intend to vigorously defend ourselves against any pending claims, and future claims that may occur, we cannot assure that we will succeed in appealing and defending any of these claims and that judgments will not be upheld against us. If we are unsuccessful in our appeal and defense of these claims or unable to settle the claims in a manner satisfactory to us, we may be faced with significant loss of intellectual property rights that could have a material adverse effect on the Company and its financial condition.

Claims by CardiAQ in Germany

On June 23, 2014, Edwards Lifesciences CardiAQ LLC ("CardiAQ") filed a complaint against Neovasc in Munich, Germany (the "German Court") requesting that Neovasc assign its right to one of its European patent applications to CardiAQ. After a hearing held on December 14, 2016, the German Court rendered its decision on June 16, 2017, granting co-ownership of the European patent application to CardiAQ but denying their claim for full entitlement. On July 14, 2017, Neovasc filed a notice of appeal against the German Court's decision with the Appeals Court of Munich (the 'Appeals Court'). On July 20, 2017, CardiAQ filed a notice of appeal with the same court. The decision of the Appeals Court of Munich was rendered on March 21, 2019, wherein it amended the decision of the German Court and dismissed the complaint of CardiAQ in full. On March 30, 2020, the German Supreme Court granted CardiAQ leave to appeal the Appeals Court decision and at a hearing held on August 4, 2020 the German Supreme Court set aside the prior decision of the Appeals Court and remanded the matter back to the Appeals Court for a new hearing and decision. The hearing at the Appeals Court was held on February 25, 2021.

On May 20, 2021, the Appeals Court has upheld the first instance judgment of the German Court of June 16, 2017, in which the court had found that CardiAQ had contributed in part to the invention of the Tiara and awarded to CardiAQ co-entitlement rights to the disputed Tiara European patent application. There are no monetary awards associated with these matters (except for a decision on the statutory costs of the proceedings) and no damages award was recognized. Regarding the statutory costs of the proceedings, both parties bear 50% of the costs of the appeal proceedings before the Appeals Court. Neovasc bears the costs of the 2nd appeal proceedings before the German Supreme Court. Neovasc has not appealed this decision so as to preserve capital and move forward with our new strategic activities. The decision is now final.

Claims by CardiAQ in the United States

On March 24, 2017, CardiAQ filed a related lawsuit in the in the U.S. District Court for the District of Massachusetts (the "Court"), asserting two claims for correction of patent inventorship as to Neovasc's U.S. Patents Nos. 9,241,790 and 9,248,014. On October 4, 2017, CardiAQ amended its pleading to add a third claim for correction of patent inventorship as to Neovasc's U.S. Patent No. 9,770,329. The lawsuit did not seek money damages and would not have prevented the Company from practicing these patents. The Company moved to dismiss the complaint on November 16, 2017, and the Court denied this motion on September 28, 2018. On April 17, 2019, the Company resolved the three claims for correction of patent inventorship and, without reaching conclusion on the merits of the claims, the parties agreed to the correction of patent inventorship and added co-inventors to the three patents in question. Each party will bear its own costs. There were no monetary awards associated with these matters and no damages award was recognized.


NEOVASC INC.

Notes to the Condensed Interim Consolidated Financial Statements

For the three and six months ended June 30, 2021 and 2020

(Expressed in U.S. dollars)


23. CONTINGENT LIABILITIES AND PROVISIONS (continued)

Other Matters

By way of Amended Statement of Claim in Federal Court of Canada Action T-1831-16 (the "Action"), Neovasc Inc. and Neovasc Tiara Inc. (the "Neovasc Defendants") were added as defendants to an existing action commenced by Edwards Lifesciences PVT, Inc. and Edwards Lifesciences (Canada) Inc. (collectively the "Edwards Plaintiffs") against Livanova Canada Corp., Livanova PLC, Boston Scientific and Boston Scientific Ltd. (collectively, the "BSC/Livanova Defendants"). The Action was first filed in October 2016 and first concerned an allegation by the Edwards Plaintiffs that the manufacturing, assembly, use, sale and export of the Lotus Aortic Valve devices by the BSC/Livanova Defendants infringes on the Edwards Plaintiffs' patents. In February 2017, the Neovasc Defendants were added to the Edwards Plaintiffs' claim making related allegations. On January 22, 2019, the Company announced that pursuant to a settlement reached with the Edwards Plaintiffs, the patent infringement action that the Edwards Plaintiffs had previously commenced in the Federal Court of Canada against the Neovasc Defendants, Boston Scientific and Livanova, has been dismissed on a no-costs basis. No damages award was recognized.

On August 3, 2018, the Company announced that it had entered into a collaboration and licensing agreement with Penn Medicine and the Gorman Cardiovascular Research Group at the University of Pennsylvania (collectively, "UPenn"), which resolved certain potential claims against the Company that had been previously disclosed. The collaboration and licensing agreement with UPenn contemplates certain fees being paid by Neovasc to UPenn, including fees in installments totaling $2.65 million over the four years following the agreement's execution. In addition, Neovasc agreed to pay UPenn a royalty of 1.0-1.5% on the annual net sales of the Tiara following the first commercial sale of the Tiara. Also contained in the collaboration and licensing agreement are buy-out clauses that allow Neovasc, or an acquirer of Neovasc or the Tiara assets, to buy out these royalty obligations. As part of the collaboration and licensing agreement, certain potential claims against the Neovasc Defendants were resolved.

When the Company assesses that it is more likely that a present obligation exists at the end of the reporting period and that the possibility of an outflow of economic resources embodying economic benefits is probable, a provision is recognized and contingent liability disclosure is required. The Company has accrued $495,653 as at June 30, 2021 representing the discounted value of future payments anticipated under the settlement agreement with UPenn. The Company has not accrued for any future royalty payments in the settlement agreement with UPenn as the amounts are undeterminable at this time.

On September 7, 2018, Endovalve Inc. and Micro Interventional Devices, Inc. (collectively, "Endovalve") filed a complaint in the United States District Court for the District of New Jersey against the Neovasc Defendants, alleging claims for trade secret misappropriation, breach of contract, and unfair competition. Endovalve alleged that it was a former customer of Neovasc Inc., and that the Neovasc Defendants improperly used trade secrets in the development of Tiara. The complaint sought injunctive relief, money damages, and attorneys' fees. On February 20, 2019, the Company announced that it had entered into a settlement agreement with Endovalve. The settlement agreement with Endovalve contemplates certain fees being paid by Neovasc to Endovalve, including settlement fees in installments totaling $3 million over the two and a half years following the agreement's execution. In addition, Neovasc agreed to pay Endovalve a royalty of 1.3% on the annual net sales of the Tiara following the first commercial sale of the Tiara. Also contained in the settlement agreement are buy-out clauses that allow Neovasc, or an acquirer of Neovasc or the Tiara assets, to buy out these royalty obligations. As part of the settlement agreement, the claims against the Neovasc Defendants were dismissed with prejudice.

When the Company assesses that it is more likely that a present obligation exists at the end of the reporting period and that the possibility of an outflow of economic resources embodying economic benefits is probable, a provision is recognized and contingent liability disclosure is required. The Company has accrued $741,416 as at June 30, 2021 representing the discounted value of future payments anticipated under the settlement agreement with Endovalve. The Company has not accrued for any future royalty payments in the settlement agreement with Endovalve as the amounts are undeterminable at this time.

Shareholder Litigation

On November 5, 2020, a putative shareholder class action lawsuit was filed in the United States District Court for the Southern District of New York against Neovasc Inc. ("Neovasc"), Fred Colen, Neovasc's CEO, and Christopher Clark, Neovasc's CFO: Gonzalez v. Neovasc Inc., et al., Case No. 7:20-cv-09313 (S.D.N.Y.) (the "Gonzalez Action"). The complaint in the Gonzalez Action purports to bring suit on behalf of a class consisting of all persons and entities that purchased or otherwise acquired Neovasc securities between November 1, 2019 and October 27, 2020, inclusive. On November 25, 2020, a second putative shareholder class action lawsuit was filed in the United States District Court for the Southern District of New York against Neovasc and Messrs. Colen and Clark: Siple v. Neovasc Inc., et al., Case No. 1:20-cv-09948 (S.D.N.Y.) (the "Siple Action"). The complaint in the Siple Action purports to bring suit on behalf of a class consisting of all persons and entities that purchased or otherwise acquired Neovasc securities between October 10, 2018 and October 27, 2020, inclusive.


NEOVASC INC.

Notes to the Condensed Interim Consolidated Financial Statements

For the three and six months ended June 30, 2021 and 2020

(Expressed in U.S. dollars)


23. CONTINGENT LIABILITIES AND PROVISIONS (continued)

Shareholder Litigation (continued)

The complaints in both the Gonzalez Action and the Siple Action contain similar allegations that the defendants made materially false and/or misleading statements, as well as failed to disclose material adverse facts about Neovasc's business, operations, and prospects. Specifically, the complaints' allegations relate to the premarket approval process with the U.S. Food and Drug Administration for Neovasc's Reducer medical device for the treatment of refractory angina. Both complaints assert the same two causes of action: (i) a violation of Section 10(b) of the Securities Exchange Act of 1934 ("Exchange Act") and Rule 10b-5 promulgated thereunder against all defendants; and (ii) a violation of Section 20(a) of the Exchange Act against Messrs. Colen and Clark.

On January 26, 2021, the court issued an order consolidating the Gonzalez Action and the Siple Action under a new case style: In re Neovasc Inc. Securities Litigation, Case No. 7:20-cv-09313 (S.D.N.Y.) (the "Consolidated Action"). The order also appointed Pratap Golla as Lead Plaintiff and the law firms of Pomerantz LLP and Holzer & Holzer LLC as Co-Lead Counsel for the Class in the Consolidated Action. The order further directed Lead Plaintiff to file a Consolidated Amended Complaint in the Consolidated Action. On March 19, 2021, Lead Plaintiff filed a Consolidated Amended Complaint.

The Consolidated Amended Complaint names Neovasc, Messrs. Colen and Clark, Bill Little, and Shmuel Banai as defendants.  The Consolidated Amended Complaint purports to bring suit on behalf of a class consisting of all persons and entities that purchased or otherwise acquired Neovasc securities between October 10, 2018 and January 15, 2021, inclusive.  The Consolidated Amended Complaint contains allegations similar to the complaints in the Gonzalez Action and the Siple Action and asserts the same two causes of action: (i) a violation of Section 10(b) of the Exchange Act and Rule 10b-5 promulgated thereunder against all defendants; and (ii) a violation of Section 20(a) of the Exchange Act against Messrs. Colen, Clark, Little, and Banai.

Defendants obtained permission to file a motion to dismiss the Consolidated Amended Complaint, which they served on June 14, 2021. Plaintiff served its opposition to the motion to dismiss on July 17, 2021. Defendants' reply in support of their motion to dismiss was served on August 6, 2021.

24.  SUBSEQUENT EVENTS

On July 13, 2021, the Company announced that it has appointed Lisa Becker as Vice President, Regulatory Affairs, Global Angina Therapies and Sarah Gallagher as Vice President, Clinical Affairs.

25.  AUTHORIZATION OF FINANCIAL STATEMENTS

The condensed interim consolidated financial statements for the three and six months ended June 30, 2021 (including comparatives) were approved by the audit committee on behalf of the board of directors on August 5, 2021.

 
(signed) Chris Clark
 
Chris Clark, Chief Financial Officer
 
 
(signed) Paul Geyer
 
Paul Geyer, Director

 


EX-99.2 3 exhibit99-2.htm EXHIBIT 99.2 Neovasc Inc.: Exhibit 99.2 - Filed by newsfilecorp.com

 

 

 

 

 

 

 
 

Neovasc Inc.
Management’s
Discussion and Analysis

FOR THE THREE AND SIX MONTHS ENDED
JUNE 30, 2021 AND 2020

(Expressed in U.S. Dollars)

 

 

 

 

 

 

Q2
2021

 

 

 

 


MANAGEMENT'S DISCUSSION AND ANALYSIS

This Management's Discussion and Analysis of Financial Condition and Results of Operations ("MD&A") covers the unaudited condensed interim consolidated financial statements of Neovasc Inc. (the "Company", "Neovasc", "we", "us", or "our") for the three and six months ended June 30, 2021 and 2020.

This MD&A should be read in conjunction with the unaudited condensed interim consolidated financial statements and notes thereto for the three and six months ended June 30, 2021 and 2020 (included as part of Neovasc's quarterly filing) as well as the audited consolidated financial statements and notes thereto, the MD&A for the years ended December 31, 2020, 2019 and 2018, the Company's Annual Information Form and Annual Report on Form 40-F.

The Company has prepared this MD&A with reference to National Instrument 51-102 - Continuous Disclosure Obligations of the Canadian Securities Administrators.

The names TiaraTM ("Tiara"), and Neovasc ReducerTM ("Reducer") are our trademarks; other trademarks, product names and Company names appearing herein are the property of their respective owners.

All financial information is prepared in accordance with International Financial Reporting Standards ("IFRS") as issued by the International Accounting Standards Board.  The Company presents its consolidated financial statements in U.S. dollars.

Additional information about the Company, including the Company's audited consolidated financial statements and Annual Information Form, is available on SEDAR at www.sedar.com and in the Company's Annual Report on Form 40-F filed with the U.S. Securities and Exchange Commission (the "SEC") at www.sec.gov.

CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS AND RISK FACTORS

This MD&A contains forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995 and applicable Canadian securities laws.  The words "expect", "anticipate", "plan", "may", "will", "estimate", "continue", "intend", "believe", "target", "potential", "seek", "explore" and other similar words or expressions are intended to identify such forward-looking statements.  Forward-looking statements are necessarily based on estimates and assumptions made by us in light of our experience and perception of historical trends, current conditions and expected future developments, as well as the factors we believe are appropriate. Forward-looking statements in this MD&A include, but are not limited to, statements relating to:

 our ability to continue as a going concern;

 our need for significant additional financing and our estimates regarding our capital requirements and future revenues, expenses and profitability;

 our intended use of the net proceeds from the February 2021 offering (the "February 2021 Offering") of units comprised of one Common Share and one common share purchase warrants (the "February 2021 Units");

 our intended use of the net proceeds from the December 2020 offering (the "December 2020 Offering") of units comprised of one Common Share and one common share purchase warrants (the "December 2020 Units");

 our anticipation that the proceeds from the February 2021 offering could be sufficient to extend operations of the Company for up to three years at the current burn rate and our anticipation that we will likely initiate programs that will require additional significant expenditures and that the cash needs of the Company will likely increase, shortening the time the proceeds will meet the requirements of the Company;

 our estimates regarding our fully diluted share capital and future dilution to shareholders;

 our expectation that our remediation of our material weakness in internal control over financial reporting ("ICFR") as of December 31, 2019, and 2018 will be sufficient;

 our intention to monitor the Company's market value on the Nasdaq and our expectation that the Common Shares will continue to be listed and traded on the Nasdaq;

 our intention to expand the indications for which we may market the Tiara (which does not have regulatory approval and is not commercialized) and the Reducer (which has CE Mark approval for sale in the European Union);

 our clinical development of our products, including the results of current and future clinical trials and studies;

 our anticipation  that the Tiara TA and Tiara TF (if and when Tiara TF development is restarted) will receive CE Mark approval in Europe under the Medical Device Regulation ("MDR");

 the ongoing pause in enrollment of, and the anticipated timing of additional implantations in the TIARA-II trial;

 our plans to develop and commercialize products, including the Tiara and the Reducer, and the timing and cost of these development programs;

 our plans to pause the development and commercialization of the Tiara transfemoral trans-septal system, including our ability to improve current prototypes, until the Company is in a financial position to restart the development, if at all;

 our ability to grow revenues from the Reducer in a timely manner;

 whether we will receive, and the timing and costs of obtaining, regulatory approvals;

 our belief that the U.S. Food and Drug Administration (the "FDA") approval for Reducer in the United States is not likely in the near future following the 'not approvable' letter for the Reducer received on January 15, 2021 and that the Investigational Device Exemption ("IDE") study now being proposed to potentially obtain FDA PMA approval for the Reducer may take three years or more to complete;


 the cost of post-market regulation and commercialization if we receive necessary regulatory approvals and if we decide to commercialize;

 our ability to enroll patients in our clinical trials, studies and compassionate use cases in Canada, the United States, Europe, Israel and other markets;

 our ability to advance and complete a potential COSIRA-II IDE pivotal clinical trial in the event that we restart the Tiara TF program;

 our belief that the full PMA application pathway, while costly and likely to take many years, brings the best chance of success for Tiara in the U.S. and that this pathway is currently paused;

 our belief that the TIARA-I Early Feasibility study demonstrates the safety of the Neovasc transcatheter mitral valve replacement ("TMVR") system;

 our belief that clinical evidence already available or that may be developed in the future will be sufficient to support the availability of Tiara for the treatment of patients in Europe;

 our intention to continue directing a significant portion of our resources into sales expansion;

 our ability to get our products approved for use;

 the benefits and risks of our products as compared to others;

 our ability to find strategic alternatives for adoption of the Reducer, including potential alliances in order to broaden and deepen therapy penetration and potentially advance the COSIRA-II study;

 our plans to increase Reducer implants in Europe in 2021;

 our expectation that in 2021 more German clinics will negotiate and finalize reimbursement negotiations with German insurance companies relating to the Reducer;

 our estimates of the size of the potential markets for our products including the anticipated market opportunities for the Reducer and the Tiara;

 our potential relationships with distributors and collaborators with acceptable development, regulatory and commercialization expertise and the benefits to be derived from such collaborative efforts;

 sources of revenues and anticipated revenues, including contributions from distributors and other third-parties, product sales, license agreements and other collaborative efforts for the development and commercialization of products;

 our ability to meet our financial and organizational restructuring goals to establish a lean and accountable organization with stable capitalization;

 our ability to meet our cash expenditure covenants;

 our creation of an effective direct sales and marketing infrastructure for approved products we elect to market and sell directly;

 the rate and degree of market acceptance of our products;

 the timing and amount of reimbursement for our products;

 the composition and compensation of our management team and board of directors;

 the impact of foreign currency exchange rates; and

 the composition and compensation of our board of directors and senior management team in the future.


Forward-looking statements are based on estimates and assumptions made by the Company in light of its experience and its perception of historical trends, current conditions and expected future developments, as well as other factors that the Company believes are appropriate in the circumstances.  Many factors could cause the Company's actual results, performance or achievements to differ materially from those expressed or implied by the forward-looking statements, including, without limitation:

 the doubt about our ability to continue as a going concern;

 risks related to the recent COVID-19 coronavirus outbreak or other health epidemics, which could significantly impact our operations, sales or ability to raise capital or enroll patients in clinical trials and complete certain Tiara development milestones on our expected schedule;

 risks relating to our need for significant additional future capital and our ability to raise additional funding;

 risks relating to the sale of a significant number of Common Shares;

 risks relating to the Company's conclusion that it did have an effective ICFR as of June 30, 2021 and December 31, 2020, but not December 31, 2019 and 2018;

 risks relating to our Common Share price being volatile;

 risks relating to the possibility that our Common Shares may be delisted from the Nasdaq or the TSX, which could affect their market price and liquidity

 risks relating to the influence of significant shareholders of the Company over our business operations and share price;

 risks relating to our significant indebtedness, and its effect on our financial condition;

 risks relating to lawsuits that we are subject to, which could divert our resources and result in the payment of significant damages and other remedies;

 risks relating to claims by third-parties alleging infringement of their intellectual property rights;

 risks relating to our ability to establish, maintain and defend intellectual property rights in our products;

 risks relating to results from clinical trials of our products, which may be unfavorable or perceived as unfavorable;

 our history of losses and significant accumulated deficit;

 risks associated with product liability claims, insurance and recalls;


 risks relating to use of our products in unapproved circumstances, which could expose us to liabilities;

 risks relating to competition in the medical device industry, including the risk that one or more competitors may develop more effective or more affordable products;

 risks relating to our ability to achieve or maintain expected levels of market acceptance for our products, as well as our ability to successfully build our in-house sales capabilities or secure third-party marketing or distribution partners;

 risks relating to our ability to convince public payors and hospitals to include our products on their approved products lists;

 risks relating to new legislation, new regulatory requirements and the efforts of governmental and third-party payors to contain or reduce the costs of healthcare;

 risks relating to increased regulation, enforcement and inspections of participants in the medical device industry, including frequent government investigations into marketing and other business practices;

 risks relating to the extensive regulation of our products and trials by governmental authorities, as well as the cost and time delays associated therewith;

 risks relating to post-market regulation of our products;

 risks relating to health and safety concerns associated with our products and our industry;

 risks relating to our manufacturing operations, including the regulation of our manufacturing processes by governmental authorities and the availability of two critical components of the Reducer;

 risks relating to the possibility of animal disease associated with the use of our products;

 risks relating to the manufacturing capacity of third-party manufacturers for our products, including risks of supply interruptions impacting the Company's ability to manufacture its own products;

 risks relating to our dependence on limited products for substantially all of our current revenues;

 risks relating to our exposure to adverse movements in foreign currency exchange rates;

 risks relating to the possibility that we could lose our foreign private issuer status under U.S. federal securities laws;

 risks relating to the possibility that we could be treated as a "passive foreign investment company" ("PFIC");

 risks relating to breaches of anti-bribery laws by our employees or agents;

 risks relating to future changes in financial accounting standards and new accounting pronouncements;

 risks relating to our dependence upon key personnel to achieve our business objectives;

 risks relating to our ability to maintain strong relationships with physicians;

 risks relating to the sufficiency of our management systems and resources in periods of significant growth;

 risks relating to consolidation in the health care industry, including the downward pressure on product pricing and the growing need to be selected by larger customers in order to make sales to their members or participants;

 risks relating to our ability to successfully identify and complete corporate transactions on favorable terms or achieve anticipated synergies relating to any acquisitions or alliances;

 risks relating to conflicts of interests among the Company's officers and directors as a result of their involvement with other issuers;

 risks relating to future issuances of equity securities by us, or sales of Common Shares or conversions of convertible notes by our existing security holders, causing the price of our securities to fall;

 risks relating to the broad discretion in our use of proceeds from an offering of our securities;

 risks relating to our intention to not pay dividends in the foreseeable future;

 risks relating to future issuances of equity securities by us, or sales of Common Shares or conversions of convertible notes, and exercise of warrants, options and restricted stock units by our existing security holders, causing the price of our securities to fall;

 risks relating to the broad discretion in our use of proceeds from an offering of our securities;

 risks relating to our intention to not pay dividends in the foreseeable future; and

 risks relating to anti-takeover provisions in our constating documents which could discourage a third-party from making a takeover bid beneficial to our shareholders.

Forward-looking statements reflect our current views with respect to future events and are subject to risks and uncertainties and are necessarily based upon a number of estimates and assumptions that, while considered reasonable by us, are inherently subject to significant business, economic, competitive, political and social uncertainties and contingencies, many of which, with respect to future events, are subject to change.  The material factors and assumptions used by us to develop such forward-looking statements include, but are not limited to:

 our ability to continue as a going concern;

 our regulatory and clinical strategies will be successful;

 our current positive interactions with regulatory agencies will continue;

 our recruitment to clinical trials and studies will continue, specifically once COVID-19 is properly managed;

 the time required to enroll, analyze and report the results of our clinical studies will be consistent with projected timelines;

 our current and future clinical trials and studies will generate the supporting clinical data necessary to achieve approval of marketing authorization applications;

 our current regulatory requirements for approval of marketing authorization applications will be maintained;

 our current good relationships with our suppliers and service providers will be maintained;

 our estimates of market size and reports reviewed by us are accurate;

 our efforts to develop markets and generate revenue from the Reducer will be successful;

 our expectation that genericization of markets for the Tiara and the Reducer will develop;


 our ability to raise additional capital on terms that are favorable to us;

 our ability to retain and attract key personnel, including members of our board of directors and senior management team; and

 our estimates and assumptions about the impact that the COVID-19 crisis will have on the Company

By their very nature, forward-looking statements or information involve known and unknown risks, uncertainties and other factors that may cause our actual results, events or developments, or industry results, to be materially different from any future results, events or developments expressed or implied by such forward-looking statements or information.  In evaluating these statements, prospective purchasers should specifically consider various factors, including the risks outlined herein, under "Risk Factors" in our most recent Annual Information Form, which is available on SEDAR at www.sedar.com and as filed with the SEC at www.sec.gov.  These factors should be considered carefully, and readers should not place undue reliance on the Company's forward-looking statements.  Should one or more of these risks or uncertainties or a risk that is not currently known to us materialize, or should assumptions underlying the forward-looking statements prove incorrect, actual results may vary materially from those described herein. These forward-looking statements are made as of the date of this MD&A and we do not intend, and do not assume any obligation, to update these forward-looking statements, except as required by law.  Investors are cautioned that forward-looking statements are not guarantees of future performance and investors are cautioned not to put undue reliance on forward-looking statements due to their inherent uncertainty.

The Company advises that these cautionary remarks expressly qualify in their entirety all forward looking statements attributable to the Company or persons acting on its behalf.

Date: August 10, 2021

OVERVIEW

Description of the Business

Neovasc is a specialty medical device company that develops, manufactures and markets products for the rapidly growing cardiovascular marketplace. Its products include the Reducer, for the treatment of refractory angina, which is not currently commercially available in the United States (6 U.S. patients have been treated under Compassionate Use) and has been commercially available in Europe since 2015, and Tiara, for the transcatheter treatment of mitral valve disease, which is currently under clinical investigation in the United States, Canada, Israel and Europe. 

Neovasc's business operations started in March 2002, with the acquisition of Neovasc Medical Inc. ("NMI") (formerly PM Devices Inc.). NMI manufactured a line of collagen based surgical patch products. The products are made from chemically treated pericardial tissue.  In 2012, the Company sold the rights to the surgical patch products to LeMaitre Vascular, Inc. ("LeMaitre"), but retained rights to the underlying tissue technology for all other uses.

In May 2003, Neovasc acquired Angiometrx Inc. ("ANG").  ANG developed a technology called the Metricath, a catheter-based device that allowed clinicians to measure artery and stent size and confirm deployment during interventional treatment of coronary and peripheral artery disease.  In 2009, Neovasc ceased all activities related to Metricath and on January 1, 2015 ANG was amalgamated into NMI.

In July 2008, Neovasc acquired two pre-commercial vascular device companies based in Israel: Neovasc Medical Ltd. ("NML") and B-Balloon Ltd. ("BBL").  NML developed and owned intellectual property related to the Reducer.  In 2009, Neovasc ceased all activities related to BBL's technologies and is in the process of voluntarily liquidating BBL.

In late 2009, Neovasc started initial activities to develop novel technologies for the catheter-based treatment of mitral valve disease.  Based on the positive results of these activities, the Company launched a program to develop the Tiara transcatheter mitral valve.

Throughout the years 2014 to 2019, the Company announced a number of developments pertaining to litigation, all as more fully discussed under the heading "Trends, Risks and Uncertainties" and "Contractual Obligations and Contingencies" herein.

In late 2016, Neovasc sold its tissue processing technology and facility for $67,909,800 to Boston Scientific Corporation ("Boston Scientific"), and concurrently, Boston Scientific invested an additional $7,090,200 in Neovasc for a 15% equity interest in the Company. Under the terms of the equity investment, Boston Scientific purchased 11,817 Common Shares of Neovasc at a price of $600 per Common Share, for gross proceeds of $7,090,200. Under the terms of the asset purchase agreement, Neovasc has been granted a license to the purchased assets and access to the sold facilities to allow it to continue its tissue and valve assembly activities for its remaining customers, and continue its own tissue related programs, including advancing the Tiara through its clinical and regulatory pathways.  $70 million of the proceeds were placed in escrow to fund the damages and interest awards in its litigation with Edwards Lifesciences CardiAQ LLC ("CardiAQ") formerly known as CardiAQ Valve Technologies Inc.

In November 2017, Neovasc completed the 2017 underwritten public offering (the "2017 Public Offering") and a private placement (the "2017 Private Placement" and collectively with the 2017 Public Offering, the "2017 Financings") for aggregate gross proceeds of approximately $65 million. The Company used the net proceeds of the 2017 Financings to fully fund the approximately $42 million balance of the damages and interest awards in its litigation with CardiAQ (after subtracting the approximately $70 million that the Company had paid into escrow from the proceeds of the sale of the tissue processing technology to Boston Scientific), with remaining funds being used (i) to partially fund the ongoing Tiara clinical program; (ii) to support the completion of the TIARA-II study; and (iii) for general corporate purposes. For a description of the terms of the 2017 Financings and the securities issued pursuant to the 2017 Financings, see "Operating Results" and "Share Capital" of the Company's Annual Information Form and the prospectus supplement, dated November 10, 2017 and the form of 2017 Notes, each as filed or furnished under the Company's profiles on SEDAR at www.sedar.com and on the SEC's website at www.sec.gov. 


On February 28, 2019, the Company completed an underwritten public offering of 1,111,111 Common Shares, at a price of $4.50 per Common Share, for gross proceeds of approximately $5 million before deducting the underwriting commission and offering expenses payable by the Company ("February 2019 Financing"). As part of the underwriter's compensation in the February 2019 Financing, the Company issued the underwriter warrants (the "February Broker Warrants") to purchase in aggregate up to a 72,222 Common Shares, exercisable at a price per Common Share equal to $5.625 for a period of three years following issuance.

On March 15, 2019, the Company completed an underwritten public offering of 1,111,111 Common Shares, at a price of $4.50 per Common Share, for gross proceeds of approximately $5 million before deducting the underwriting commission and offering expenses payable by the Company ("March 2019 Financing)" and together with the February 2019 Financing and May 2019 Financing, the "2019 Financings". As part of the underwriter's compensation in the March 2019 Financing, the Company issued the underwriter warrants (the "March Broker Warrants", and together with the February Broker Warrants, the "2019 Broker Warrants") to purchase in aggregate up to a 72,222 Common Shares, exercisable at a price per Common Share equal to $5.625 for a period of three years following issuance.

On May 16, 2019, the Company completed an offering of (i) 15% original issue discount convertible notes ("2019 Notes") with a face value of $11.5 million, for gross proceeds to the Company of $9,775,000, and (ii) 334,951 Common Shares at a price of $5.15 per Common Share, for gross proceeds to the Company of $1,725,000 (the "May 2019 Financing").

On June 4, 2019, Dr. William O'Neill resigned from the board of Directors and Fred Colen was elected in his place, and on September 16, 2019, Jane Hsiao resigned from the board of Directors and Norman Radow was appointed in her place.

On January 6, 2020, the Company completed the registered direct January 2020 Offering of an aggregate of 1,185,000 series A units ("Series A Units") and 1,241,490 series B units ("Series B Units") at a price of US$4.1351 per Series A Unit and US$4.1351 per Series B Unit for aggregate gross proceeds to the Company of approximately US$10 million, before deducting placement agent's fees and estimated expenses of the offering payable by the Company. Each Series A Unit consisted of one Common Share and one warrant (a "January 2020 Warrant") to purchase one Common Share. Each January 2020 Warrant entitles the holder to acquire one Common Share of the Company at a price of US$4.1351 at any time prior to the date which is four years following the date of issuance. Each Series B Unit consists of one pre-funded warrant of the Company (each, a "January 2020 Pre-Funded Warrant") and one January 2020 Warrant. Each January 2020 Pre-Funded Warrant entitles the holder to acquire one Common Share of the Company at a price of US$0.0001 at any time until the exercise in full of each Pre-Funded Warrant.

On May 26, 2020, the Company made a final payment of $2,897,000 to holders of the 2017 Notes and $1,016,000 in 2017 Notes was converted for the issuance of 500,014 Common Shares. The Company and certain holders of the 2017 Notes have also agreed to a mutual release (the "Settlement") in return for the issuance by the Company, in the aggregate, of 500,000 settlement warrants (the "Settlement Warrants") to such holders.

On May 28, 2020, the Company completed an offering (the "May Offering") of secured convertible notes (the "2020 Notes") with a principal amount of $5 million, convertible at $2.815 per Common Share for 1,776,041 Common Shares and 2,573,959 warrants ("May 2020 Warrants") exercisable at $2.634 per May 2020 Warrant share with a 4-year term. The May Offering was completed in two tranches comprised of an initial closing of US$4 million aggregate principal amount of 2020 Notes and 2,573,959 May 2020 Warrants and an additional closing of US$1,000,000 aggregate principal amount of 2020 Notes.

On June 16, 2020, the Company completed the registered direct June 2020 Offering of an aggregate 3,883,036 June 2020 Units at a price of $2.973 per unit for aggregate gross proceeds to the Company of approximately $11,500,000 before deducting placement agent's fee and estimated expenses of the June Offering payable by the Company.

On July 23, 2020 Strul Medical Group LLC ("SMG") exercised 1,424,049 of the 2,573,959 May 2020 Warrants at an exercise price of US$2.634 per May 2020 Warrant for aggregate exercise proceeds to the Company of US$3,750,945 (the "Exercise Proceeds"). Using the Exercise Proceeds, the Company has prepaid a portion of the 2019 Notes. The total aggregate amount of the Exercise Proceeds has been applied to the prepayment of the 2019 Note whereby US$3,613,341 has been applied to the US$11,500,000 principal of the 2019 Note, US$72,267 has been paid as a prepayment penalty pursuant to the terms of the 2019 Note and US$65,337 has been paid in accrued interest. In connection with the prepayment of the 2019 Note, the Company also issued to SMG 481,778 common share purchase warrants (the "Repayment Warrants") at an exercise price of US$7.50 per Repayment Warrant in accordance with the terms of the 2019 Note.

On August 12, 2020 the Company completed the registered direct August 2020 Offering of 4,532,772 August 2020 Units at a price of $2.775 per August 2020 Unit, with each August 2020 Unit comprised of one Common Share and three-quarters of one Common Share purchase warrant for aggregate gross proceeds to the Company for approximately $12,600,000 before deducting placement agent's fee and estimated expenses of the August 2020 Offering payable by the Company.


On August 17, 2020 SMG exercised 501,000 of the remaining 1,149,910 May 2020 Warrants at an exercise price of US$2.634 per May 2020 Warrant for aggregate exercise proceeds to the Company of US$1,319,634. Using the Exercise Proceeds, the Company has prepaid a portion of the 2019 Notes. The total aggregate amount of the Exercise Proceeds has been applied to the prepayment of the 2019 Note whereby US$1,263,885 has been applied to the remaining US$7,886,659 principal of the 2019 Note, US$25,278 has been paid as a prepayment penalty pursuant to the terms of the 2019 Note and US$30,472 has been paid in accrued interest. In connection with the prepayment of the 2019 Note, the Company also issued to SMG 168,518 common share purchase warrants at an exercise price of US$7.50 per Repayment Warrant in accordance with the terms of the 2019 Note.

On December 10, 2020 the Company completed the registered direct December 2020 Offering of an aggregate 6,230,803 December 2020 Units at a price of US$0.9801 per unit for aggregate gross proceeds to the Company of approximately US$6,100,000 before deducting placement agent's fee and estimated expenses of the December 2020 Offering payable by the Company.

On August 22, 2019, the Company received written notification (the "Notification Letter") from the Nasdaq Stock Market LLC (the "Nasdaq") notifying the Company that it is not in compliance with the minimum market value requirement set forth in Nasdaq Rules for continued listing on the Nasdaq Capital Market. Nasdaq Listing Rule 5550(b)(2) requires companies to maintain a minimum market value of US$35 million and Listing Rule 5810(c)(3)(C) provides that a failure to meet the market value requirement exists if the deficiency continues for a period of 30 consecutive business days. Based on the market value of the Company for the 30 consecutive business days from July 10, 2019 to August 20, 2019, the Company no longer met the minimum market value requirement. The Notification Letter did not impact the Company's listing on the Nasdaq Capital Market at that time. In accordance with Nasdaq Listing Rule 5810(c)(3)(C), the Company was provided 180 calendar days, or until February 17, 2020, to regain compliance with Nasdaq Listing Rule 5550(b)(2). To regain compliance, the Company's market value must exceed US$35 million for a minimum of 10 consecutive business days. The Company did not regain compliance by February 17, 2020.  On February 19, 2020, the Company received notice from the Listing Qualifications Staff (the "Staff") of the Nasdaq indicating that the Staff had determined to delist the Company's common shares from Nasdaq unless the Company requests a hearing before the Nasdaq Hearings Panel (the "Panel").  On February 26, 2020, the Company requested such a hearing, and the date of the hearing was set by the Nasdaq for April 2, 2020.  This request for a hearing stayed any further action by the Staff and the Company's securities continued to be eligible to trade on Nasdaq at least pending the ultimate conclusion of the hearing process. On April 30, 2020, the Panel granted the Company's request for an extension through August 17, 2020 to evidence compliance with the $35 million minimum market value of listed securities requirement for continued listing on the Nasdaq. On June 25, 2020, the Nasdaq Notice confirmed that the Company had regained compliance with Listing Rule 5550(a)(2) pursuant to Listing Rule 5810 for continued listing on the Nasdaq.

On January 15, 2021, the Company received a "not approvable" letter from the FDA regarding its PMA submission for the Reducer. The FDA reviewed Reducer for treatment of patients with refractory angina pectoris despite guideline directed medical therapy, who are unsuitable for revascularization by coronary artery bypass grafting or by percutaneous coronary intervention.

On February 12, 2021, the Company completed the registered direct February 2021 Offering of 36,000,000 February 2021 Units at a price of $2.00 per February 2021 Unit, with each February 2021 Unit comprised of one Common Share and one-half of one Common Share purchase warrant for aggregate gross proceeds to the Company for approximately $72,000,000 before deducting placement agent's fee and estimated expenses of the February 2021 Offering payable by the Company.

On December 10, 2020 and December 14, 2020, the Company received additional Notification Letters from the Nasdaq notifying that the Company is not currently in compliance with the Nasdaq's continued listing requirements which require that an issuer's listed securities maintain a total market value of US$35 million (the "Market Value Requirements") and a minimum bid price of at least US$1.00 per share (the "Minimum Bid Price Requirements"), respectively.  In accordance with Nasdaq Listing Rules, the Company was given until June 8, 2021 to regain compliance with the Market Value Requirements and until June 14, 2021 to regain compliance with the Minimum Bid Price Requirements. On February 9, 2021, the Company announced that it had received written notification from the Nasdaq notifying the Company that it had regained compliance with the minimum bid price requirement under Nasdaq Listing Rule 5550(a)(2) pursuant to Nasdaq Listing Rule 5810 for continued listing on the Nasdaq. On February 25, 2021, the Company announced that it had received written notification from the Nasdaq notifying the Company that it had regained compliance with the minimum market value requirement under Nasdaq Listing Rule 5550(b)(2) pursuant to Nasdaq Listing Rule 5810 for continued listing on the Nasdaq.

On May 25, 2021 the Company received written notification from the Nasdaq Listing Qualifications Department notifying the Company that it was not in compliance with the $1.00 minimum bid price requirement set forth in the Nasdaq Marketplace Rules. In accordance with Nasdaq Listing Rule 5810(c)(3)(A), the Company was provided 180 calendar days, or until November 22, 2021, to regain compliance.

On June 10, 2021, the Company announced that it had paused all product development activities on the Tiara TF device.  Concurrent with this decision the Company terminated 40% of its staff and took a provision for obsolete leasehold improvements and equipment related to these activities.


The Company and its subsidiaries now operate as follows: Neovasc Inc. is the Canadian public Company and 100% owner of each of the subsidiary entities. NMI and Neovasc (US) Inc. ("NUS") are the operating companies for the group. They hold the majority of the tangible assets and NMI holds the Peripatch tissue license from Boston Scientific. NMI and NUS employ the majority of the employees of the Company. Neovasc Tiara Inc. ("NTI") in Canada holds all the intangible assets related to the Tiara and NML in Israel holds all the intangible assets related to the Reducer program. NMI charges both NTI and NML for the development services performed by its employees to develop the Tiara and the Reducer respectively. NML receives a royalty based on the Reducer revenues generated by NMI and pays royalties to the Office of the Chief Scientist ("OCS") in Israel to repay certain research grants funded by the OCS prior to the acquisition of NML in July 2008.  NUS, charges NMI for development services performed by its employees to develop the Tiara and the Reducer respectively and these are then passed on through NMI to NTI and NML respectively. Neovasc GmbH conducts sales and marketing activities on behalf of NMI as part of the license agreement between NML and NMI for NMI to manufacture, distribute and sell the Reducer on behalf of NML. Neovasc Management Inc. provides executive management services to Neovasc Inc.

Neovasc's Strategy

The Company's core strategy is to i) expand revenue and global reimbursement for Reducer and initiate a U.S. IDE Study and ii) advance the development program for the Tiara TA transapical system. Additionally, the Company is focused on providing minimally invasive medical devices for a cardiovascular market that the Company believes is both growing and under-served by current treatment solutions.

Key elements of this strategy include:

  • Reducer - continuing therapy development of the Reducer, and supplementing the successful COSIRA prospective, multicenter, randomized, double-blind, sham-controlled clinical study of 104 patients (52 of whom were implanted with the Reducer and 52 of whom were randomized to the control arm) with additional clinical experience through the Company's targeted commercial launch of the Reducer in Europe and elsewhere and enrollment in the REDUCER-I, real world post market observational clinical study. Improving revenue growth in Europe by leveraging the renewed NUB 1 status in Germany and by further reimbursement initiatives in other international markets.
  • Following receipt of the "not approvable" letter from FDA, January 15, 2021, the Company does not believe that FDA approval in the United States is likely in the near future, but the Company, working closely with the FDA, intends to initiate  a U.S. IDE study, COSIRA-II.
  • Tiara - with the Company's clinical experience of the Tiara and the clinical data from the TIARA-II multi-center study, the Company has filed for CE Mark under the Medical Device Directive ("MDD"). The Company has been notified by its Notified Body that the Notified Body requires further data from the Company. The Company is in ongoing discussions with its notified body and is pursuing a regulatory decision for Tiara TA under the European Medical Device Regulation rules. Enrollment in the TIARA-I study was closed on November 15, 2019 with a total of 27 patients treated who will be followed out to 5 years.

Neovasc's Products

Tiara

In 2009, Neovasc started initial activities to develop novel technologies for catheter-based treatment of mitral valve disease. In the second quarter of 2011, the Company formally initiated a new project to develop the Tiara, a product for treating mitral valve disease. The transapically delivered Tiara is currently in the clinical trial phase providing a minimally invasive transcatheter device for patients who experience severe Mitral Regurgitation as a result of functional (most patients) or degenerative mitral heart valve disease, combined with an enlarged left ventricle. There are millions of patients worldwide who suffer from severe Mitral Regurgitation, the majority of them with functional Mitral Regurgitation. The unmet medical need in these patients is high. Mitral Regurgitation is often severe and can lead to heart failure and death. Currently, a significant percentage of patients with severe Mitral Regurgitation are not good candidates for conventional surgical repair or replacement due to frailty or comorbidities. Many of these patients are treated today via minimally invasive mitral valve repair procedures; however, these procedures are also complex, can take a long period of time to complete, and the clinical outcomes may not be optimal. Currently there is no transcatheter mitral valve replacement device approved for use in the U.S.

Our clinical experience to date has been with the 35 mm and 40 mm Tiara valves. First clinical use of the 40mm Tiara occurred in the fourth quarter of 2015. These two sizes allow for the treatment of approximately 75% of the annulus sizes in this high-risk patient population, in our TIARA-I and TIARA-II Clinical Studies. Currently, approximately 20% of this high-risk patient population meet all inclusion criteria for the Tiara studies and can be treated.

As of April 25, 2021, 83 patients have been treated with Tiara in either the TIARA-I Early Feasibility Clinical Study, compassionate use cases or in our TIARA-II CE Mark Clinical Study. Neovasc believes that early results have been encouraging. The 30-day survival rate at the time of data cut-off April 5, 2021, for the 83 patients treated with the Tiara is 89% with one patient now more than 7 years post implant. The Tiara has successfully treated both functional and degenerative Mitral Regurgitation patients, as well as patients with pre-existing prosthetic aortic valves and mitral surgical annuloplasty rings. On November 15, 2019, TIARA-I study enrollment was closed with 27 patients treated. This decision was not due to any safety concerns. The objective of the TIARA-I Early Feasibility study was to demonstrate the safety of the Neovasc TMVR system, while gathering preliminary information on device performance and clinical outcomes. With the experience to date, the Company believes it has accomplished this objective. The patients that are in follow-up will continue their follow up assessments, adverse event reporting requirements, etc., as per protocol through their 5-year visits. This decision had no impact on the TIARA-II CE Mark Study. There are currently 16 active sites across Germany, Israel, Spain, the Netherlands and the UK., however due to the COVID-19 pandemic restrictions, enrollment continues to be on temporary hold (sites were notified on April 24, 2020 of the temporary hold). The results from our clinical experience to-date continue to demonstrate the potential benefit for patients who otherwise have no treatment options. 


Neovasc believes that there are several unique attributes of the Tiara that may provide advantages over other approaches to mitral valve replacement, in particular the low profile, its D shape, enabling a better anatomical fit and less risk of left ventricular outflow tract obstruction, and its unique combined skirt and anchoring mechanism. The Tiara has successfully treated 17 patients with previous aortic valves (AVR), including mechanical, bioprosthetic and TAVI, without any LVOT obstruction, no peri-procedural deaths or paravalvular leak. Data on the first 12 patients with previous AVR treated with Tiara was published in 2018 in Circulation: Cardiovascular Interventions.

There are several other transcatheter mitral valve replacement devices in development by third parties, some of which have been implanted in early feasibility type studies, pivotal U.S. studies, and CE Mark studies with varying results. There is no certainty that the Tiara will successfully proceed through clinical evaluation and ultimately receive regulatory approval to treat these patients.

The Tiara valve is manufactured, packaged and labelled in-house by the Company and is made up of two major components: the leaflets which are made from the Peripatch bovine tissue licensed from Boston Scientific, a fabric skirt, and the nitinol frame (to which the leaflets and skirt are attached), which is manufactured by a well-established specialty manufacturer in the medical device industry. If this supplier were unable to provide the nitinol frame in the future, it would seriously impact further development of the Tiara. The Tiara delivery system is manufactured, packaged and labelled in-house by the Company using customized standard catheter construction components that are readily available through vendors.

The TIARA-II study is estimated to cost approximately $15 million. While many challenges remain prior to achieving commercialization (including, but not limited to, positive clinical trial results and obtaining regulatory approval from the relevant authorities), the Company believes the Tiara is being recognized as one of the leading mitral valve replacement devices. Neovasc is managing and conducting the TIARA-II study itself in conjunction with certain service providers who undertake portions of data collection, data management, data analysis, safety and event monitoring and similar functions. The Tiara is currently manufactured for use in these studies by Neovasc at its own facilities following required medical device quality requirements. In the event of a positive outcome from the TIARA-II study and the Company successfully obtaining CE Mark approval, and if the Company decides to commercialize the Tiara TA, the Tiara would be commercially manufactured in the same manner at Neovasc's facility.

Regulatory Status

The Company filed for CE Mark under MDD but was unable to complete the regulatory review process before the expiration of the MDD on May 26, 2021. Therefore, the Company was unable to receive CE Mark under MDD in the first half of 2021. The Company is in ongoing discussions with its notified body and is pursuing a regulatory decision under MDR rules. There is no assurance that European regulatory filing and an approval will be granted in the time frame anticipated by management or granted at any time in the future or that any or all of the sizes will be approved. There is no expectation that this product will be revenue-generating in the near term, although management believes that the product is addressing an important unmet clinical need. The Tiara TA is an early-stage development product without any regulatory approvals in any country. The Company expects ongoing expenses associated with Tiara TA regulatory, clinical and other functional activities.

The Company has paused development activity associated with Tiara TF.  There can be no assurance that the Company will re-start development activity with Tiara TF or that it will maintain the development pause.

Reducer

The Reducer is a treatment for patients with refractory angina, a painful and debilitating condition that occurs when the coronary vasculature delivers an inadequate supply of blood to the heart muscle, despite treatment with standard revascularization or cardiac drug therapies.

Worldwide, coronary artery disease ("CAD") is the leading cause of death. It is the largest contributor to the global burden of disease as reflected in disability-adjusted life years, a measure which combines premature mortality and the prevalence and severity of ill-health. On this measure, the impact of CAD increased by 29% in the period from 1990 to 2010. This reflects the worldwide shift to those chronic diseases associated with an aging global population. The most frequent (and often the first) manifestation of stable CAD is chronic stable angina. As a result, angina is a significant burden on healthcare systems worldwide. There is a clear association between more frequent angina and greater utilization of healthcare resources.

Refractory angina, resulting in continued symptoms despite maximal medical therapy without revascularization options, is estimated to affect 600,000 to 1.8 million Americans, with 50,000 to 100,000 new cases per year. A publication in the Cardiovascular Revascularization Medicine journal by Benck and Henry suggests that the prevalence of No-Option Refractory Disabling Angina (NORDA) in the U.S. population is between 26,000 and 52,000. Another publication in the European Heart Journal by Crea et al., stated persistence of angina caused by incomplete coronary revascularization may occur in up to 30% in the current era, although definitions of incomplete revascularization are heterogeneous.  It further stated that persistent angina is associated with a significant economic burden with healthcare costs almost being two-fold higher among patients with persistent angina post-percutaneous coronary intervention vs. those who become symptom free. Additionally, there is emerging interest in treating patients that have refractory angina despite patent coronary arteries.  Angina with non-obstructive coronary artery disease may affect as many as 39% of patients with chest pain according to a study from Patel et. al, published in the New England Journal of Medicine.  Furthermore, a publication in Circulation by Lee et. al, suggests upwards of 20% of patients with angina and non-obstructive coronary artery disease have evidence of microvascular dysfunction.  Increasing interest in diagnosis and treatment of angina and microvascular dysfunction as evidenced by the 2019 ESC Guidelines for the diagnosis and management of chronic coronary syndromes provides growing support for Reducer treatment.


The pain and shortness of breath associated with refractory angina can make it difficult for patients to engage in routine activities, such as walking or climbing stairs. Clinical studies demonstrate that the Reducer can provide significant relief of chest pain, shortness of breath and other debilitating symptoms in refractory angina patients. A significant proportion of the refractory angina patients in the United States and in Europe are potential candidates for the current Reducer therapy, either because they cannot be revascularized or because they are otherwise poorly managed using conventional medical therapies. These patients represent a substantial potential market opportunity for the Reducer. There continues to be interest from the medical community to explore the use of Reducer for other indications. Further clinical trials will need to be conducted to explore this possibility.

The Reducer is targeting a patient population that has failed to gain relief of their symptoms, despite other medical treatment options. A refractory patient, by definition, is resistant to other existing interventional cardiology therapies and is not receiving adequate relief from available drug regimens to manage their chest pain, shortness of breath and other debilitating symptoms. Neovasc believes that further studies may demonstrate that additional patient populations may benefit from treatment with Reducer and thus could further increase its market potential.

The Reducer is an hourglass-shaped, balloon-expandable, stainless steel, bare metal device, which is implanted in the coronary sinus, creating a restriction in venous outflow from the myocardium (the muscular layer of the heart wall). It is implanted using conventional percutaneous, or needle puncture, techniques. The Reducer is provided sterile and pre-loaded on a balloon catheter system. The system is 9 French sheath compatible and operates over a 0.035 inch guidewire. The implant procedure requires minimal training for experienced interventionalists. Once guidewire access to the coronary sinus is achieved, implantation typically takes less than 20 minutes.

Using a catheter-based procedure, the Reducer is implanted in the coronary sinus (the main vein draining blood from the heart muscle). Following implantation, the Reducer (all but the mid-section) becomes covered with endothelial tissue after about 4-6 weeks. This tissue coverage creates a permanent (but reversible, if necessary) narrowing in the coronary sinus. The coronary sinus is narrowed from a typical diameter of 10-12mm to approximately 3mm at the site of implantation. This focal narrowing provides a backwards pressure elevation in the coronary sinus which is intended to improve blood perfusion to ischemic territories of the heart muscle by forcing redistribution of blood from the less ischemic areas to the more ischemic areas of the heart muscle. This can result in improved perfusion of the endocardium, which helps relieve ischemia and chest pain, shortness of breath and other debilitating symptoms.

The clinical utility of this approach was demonstrated by a number of analogous approaches used in the past that achieved positive clinical outcomes for angina patients by constricting or intermittently blocking the coronary sinus to improve perfusion to the heart muscle. However, these therapies required the use of highly invasive surgery, or leaving a catheter in the heart for a prolonged period, making them impractical or clinically unacceptable for use in modern medical practice. The Reducer was developed to deliver this therapy in a safe, simple and effective manner via a minimally invasive catheter that is consistent with contemporary medical practice.

The Reducer has demonstrated excellent results in multiple animal studies, and a first-in-human clinical trial of 15 patients suffering from chronic refractory angina who were followed out to six months, and then again at three years post implantation. The six-month results from this clinical trial were published in the Journal of the American College of Cardiology and three-year follow-up data were presented at the annual scientific meeting of the American College of Cardiology in March 2010. In this clinical trial, implantation of the Reducer resulted in significant clinical improvements in stress test and perfusion measurements, as well as in overall quality of life in the majority of the patients at six months and these same results were noted at the three year follow up. During this period, the Reducer remained patent with no evidence of migration, and symptom relief was maintained in these patients.

The Company completed the COSIRA trial, a prospective, multicenter, randomized, double-blind, sham-controlled study to assess the safety and effectiveness of the Reducer device in 2013. The COSIRA trial's primary endpoint was a two-class improvement in angina symptoms six months after implantation based on the patients' ratings on the Canadian Cardiovascular Society "CCS" angina grading scale; a four-class functional classification that is widely used to characterize the severity of angina symptoms and disability. Only patients with severe angina, CCS Class III or IV, were enrolled in the COSIRA trial. The COSIRA trial analysis showed that the study met the primary endpoint, with patients receiving the Reducer achieving a statistically significant improvement in CCS scores (two classes or better) compared to patients receiving a sham control (18 of 52 [34.6%] of the Reducer patients improved ≥ 2 CCS classes compared to 8 of 52 [15.4%] of the control patients [p-value = 0.024]). The analysis also showed that patients treated with the Reducer showed a statistically significant improvement of one or more CCS classes compared to the sham control patients (37 of 52 [71.2%] of the Reducer patients showed this improvement compared to 22 of 52 [42.3%] of the control patients [p-value = 0.003]). The COSIRA trial results were published in the New England Journal of Medicine in February 2015.

In 2016, Neovasc initiated the REDUCER-I post market observational study as a multi-center, multi-country, three-arm study collecting long-term data from European patients implanted with the Reducer. The study is expected to enroll up to 400 patients. Currently, 301 patients have been enrolled across 22 centers that are active in Italy, Germany, Austria, Belgium, the Netherlands, the United Kingdom, Spain and Switzerland. Enrollment has been delayed due to the impact of COVID-19.


In 2018 an article by Parikh, et al., was published in the Journal of the American College of Cardiology (JACC) titled, "First-in-Human Use of Coronary Sinus Reducer in Patients with Refractory Angina".  This article describes the long-term structural, anatomic, and clinical durability of the Reducer. Reducers were patent 12 years following implantation, with no signs of strut fractures, dislocation, thrombosis, or migration, and the sustained improvement in angina class seen at six months and three years, was also maintained at the 12-year follow-up.

Hundreds of patients have been enrolled in clinical studies conducted by third parties across Europe and Israel relating to the Reducer. These studies continue to show a strong safety profile and positive clinical results that trend closely to the COSIRA randomized study. Many of these studies have been published and presented in medical forums. It is anticipated that as the commercial use of the Reducer continues to expand, additional third-party studies, investigations and presentations will be undertaken. If the results from such third-party activities continue to show positive results from the product, they may provide additional data to support expanded adoption of the Reducer for the intended patient population. As a result of the clinical evidence from these studies and publications, the Reducer Therapy has now been recognized in the European Society of Cardiology Guidelines as a treatment option for refractory angina.

Included in the numerous publications of clinical results since the COSIRA study was published in the New England Journal of Medicine in 2015, a publication in the European Heart Journal by Gallone, et al., on the "Cost-effectiveness of the coronary sinus Reducer and its impact on the healthcare burden of refractory angina" indicated that the Reducer was consistently cost-effective according to a range of cost-effectiveness thresholds after just one year of implant. 

Following the positive data from the COSIRA trial, the Company initiated a pilot launch of the Reducer in select European markets in early 2015. The Company has signed distribution agreements in multiple jurisdictions across Europe. Direct sales are underway in select centers in Germany.

Based on achieving NUB 1 status in Germany and a general positive reception in the European market, with positive experiences by many physicians from the treatment of their own patients with the Reducer, we are seeing an increase in adoption of the Reducer therapy in Europe. COVID-19 had a marked impact on Reducer revenues and we anticipate that the negative impact will be felt throughout 2021. It is unclear how long the negative impact of COVID-19 will persist.

We are seeing a growing level of enthusiasm in Europe for the Reducer therapy and we believe that the therapy has significant potential. In order to further accelerate the penetration of the therapy, we are open to considering strategic alternatives for the Reducer, including potential alliances in Europe, and the rest of the world.

On September 3, 2019, the Company announced that the European Society of Cardiology included Neovasc Reducer in the European Practice Guidelines for the Diagnosis and Management of Chronic Coronary Syndromes. The Reducer entered at Class 2 B.

On November 1, 2019, the Company announced it had advised the FDA of its decision to submit a PMA application, and on December 31, 2019, the Company announced the submission of a PMA to the FDA for the Reducer.

On July 9, 2020, the Company announced it had received notification of an FDA Circulatory Systems Devices Panel Meeting scheduled for October 27, 2020.

On October 28, 2020, the Company announced results from the FDA Circulatory Systems Devices Panel Meeting at which the Panel voted 14 to 4 "in favor" that the Reducer is safe when used as intended and voted 1 to 17 "against" on the issue of a reasonable assurance of effectiveness. The third vote was 13 to 3 "against" (2 abstained) on whether the relative benefits outweighed the relative risks.

On January 15, 2021, the Company announced that it had received a not-approvable letter from FDA regarding its PMA submission for the Neovasc Reducer.

Regulatory Status

The Reducer received CE Mark designation November 2011. On November 3, 2017, Neovasc received FDA approval for a U.S. IDE clinical trial, COSIRA-II (a trial design similar to the COSIRA study). While the principal investigator and co-principal investigator for this study were already appointed, the Company has not started such a U.S. clinical trial, funding being the largest impediment. The cost of this U.S. clinical trial is expected to be approximately $35 million. The Company expects significant future expenses associated with the clinical studies, and regulatory submissions, for the Reducer.  The Company is in the process of submitting a supplement to the COSIRA-II study.

On October 10, 2018, the Company announced that the FDA had granted "Breakthrough Device Designation" for the Reducer. The FDA grants this designation in order to expedite the development and review of a device that demonstrates compelling potential to provide a more effective treatment or diagnosis for life-threatening or irreversibly debilitating diseases.


On December 20, 2018, Neovasc filed a comprehensive Q-Sub submission to the FDA with all available Reducer Clinical evidence, requesting a Sprint FDA discussion meeting. The Neovasc team, together with two top U.S. Cardiologists, met with the FDA proposing moving forward with a PMA submission using the available Neovasc clinical evidence including the prospective, multicenter, randomized, double-blind, sham controlled study assessing the safety and efficacy of the Reducer in 104 patients in the European Union and Canada (COSIRA), a multi-center, multi-country, three-arm observational post market study (REDUCER-I), and supportive safety and efficacy data from peer-reviewed journals.

On February 20, 2019, the Company announced that the FDA had informed Neovasc that, despite "Breakthrough Device Designation", the FDA review team recommended collection of further pre-market blinded data prior to PMA submission.

On June 26, 2019, the Company and two top U.S. Cardiologists, met with the FDA to further discuss available clinical evidence for the Reducer, to try to reach agreement on potential options to enter the U.S. Market.  The FDA provided the Company with guidance towards potential alternate options, including the HDE pathway for class IV refractory angina patients and/or alternate clinical trial designs for a broader refractory angina patient population.

Following the Sprint discussion held with the FDA on October 9, 2019 and weighing all available options a decision was made by the Company to pursue a PMA application for this Breakthrough medical device. 

On October 27, 2020, the FDA Circulatory Systems Devices Panel Meeting was held.  The Panel voted 14 to 4 "in favor" that the Neovasc Reducer™ is safe when used as intended and voted 1 to 17 "against" on the issue of a reasonable assurance of effectiveness. The third vote was 13 to 3 "against" (2 abstained) on whether the relative benefits outweighed the relative risks.

On January 15, 2021, the Company announced that it had received a not-approvable letter from FDA regarding its PMA submission for the Reducer.

New Products/Components/Cycles

Tiara

The Company has paused development activity associated with Tiara TF.  There can be no assurance that the Company will re-start development activity with Tiara TF or that it will maintain the development pause.

Reducer

The Reducer is a commercial-stage product with European CE Mark approval. The Company initiated a pilot launch of the Reducer in select European markets in 2015. The Company has also initiated Reducer sales in other non-US markets with distribution agreements in several countries.

A well-known and well-established medical device contract manufacturer is manufacturing the Reducer for the Company and we are in the process of transitioning manufacture of the device to another similar contract manufacturer. The majority of the components that make up the Reducer are readily available; however, two critical components of the device are not. The balloon portion of the delivery system is technically challenging to manufacture and the Reducer device, while a basic technology, must be manufactured in Israel due to restrictions on the transfer of intellectual property and manufacturing out of Israel stemming from certain research grants received by NML prior to the acquisition in July 2008.

Peripatch Technology used in our Tiara Mitral Valve

The basic Peripatch technology licensed from Boston Scientific was established over 25 years ago, when the material was used to fashion the leaflets and other components in surgical heart valves.

Neovasc sources its bovine tissue from abattoirs in New Zealand for the manufacture of Tiara devices. There is a degree of capacity constraint related to the supply of raw tissue, but the risk of disruption is minimal, due to the relatively small amounts of tissue required for the current Tiara programs.

While a definitive pattern of demand has not yet been established and the effect is expected to be minimal, the cyclical nature of the meat industry could conceivably have an impact on the quality and availability of raw tissue and could potentially impact the yields and margins for the product over the course of any given year.

TRENDS, RISKS AND UNCERTAINTIES

Losses and Additional Funding Requirements

Neovasc has a limited operating history, which makes it difficult to predict how its business will develop or what its future operating results will be.  The Company has a history of operating losses since its inception and will need to generate significantly greater revenues than it has to date to achieve and maintain profitability.  There is no certainty of future profitability, and results of operations in future periods cannot be predicted based on results of operations in past periods.  The securities of the Company should be considered a highly speculative investment.


The Company has incurred operating losses and comprehensive losses of $9,092,541 and $9,313,065, and $19,265,116 and $12,186,066 for the three and six months ended June 30, 2021, respectively (2020: $8,658,370 and $12,234,456, and $15,814,475 and $14,907,862, respectively) and has a deficit of $406,427,634 as at June 30, 2021 compared to a deficit of $380,569,070 as at June 30, 2020.  As at June 30, 2021 the Company had $63,294,878 in cash and cash equivalents (December 31, 2020: $12,935,860).

During the six months ended June 30, 2021, the Company raised $72 million in a registered direct offering that closed on February 12, 2021 with estimated net proceeds of $65 million to the Company. The proceeds from the February 2021 Financing could be sufficient to extend the operations of the Company for up to three years at the current burn rate. However, given the FDA's recent adverse panel decision and "not approvable" letter for the Reducer, and the recent announcement that the Company is unable to receive a European CE mark ("CE Mark") under the current Medical Device Directive regulations ("MDD"), it is likely that the Company will initiate programs that will require additional significant expenditures and that the increasing cash needs of the Company will likely shorten the time the proceeds will meet the requirements of the Company.

The Company will need to raise additional capital to fund its long-term objectives for the Tiara and the Reducer prior to the successful commercialization of these products in the longer term. There is no certainty that the Company will be able to raise additional capital through debt or equity or other means on terms acceptable to the Company or at all.  There is also no certainty that the programs will be successfully commercialized, or any required funds will be available to the Company at the time needed or on terms acceptable to the Company.  These terms may make it more difficult to obtain additional debt or equity financing in the future.

Given the current nature of the Company's capital structure, the Company can give no assurance that it will be able to obtain additional funds needed in the future, on terms agreeable to the Company, or at all.  These circumstances indicate the existence of material uncertainty and cast substantial doubt about the Company's ability to continue as a going concern at June 30, 2021. The Company will re-evaluate the going concern risk at each reporting period and will remove the going concern and uncertainty note when the Company can depend on the profitable commercialization of its products or is confident of obtaining additional debt, equity or other financing to fund ongoing operations until profitability is achieved. For a description of the risks relating to the Company's need for additional financing see the Company's Annual Information Form, which is available on SEDAR at www.sedar.com and as filed with the SEC at www.sec.gov.

The unaudited condensed interim consolidated financial statements do not reflect adjustments that would be necessary if the going concern assumption were not appropriate.  Material adjustments may be necessary to the unaudited condensed interim consolidated financial statements should these circumstances impair the Company's ability to continue as a going concern.

Litigation Matters

The litigation matters are more fully described in "Contractual Obligations and Contingencies" below.

Operating Risks

The Company may need to raise additional capital prior to the successful commercialization of its products.  There is no certainty that the Company's programs will be successfully commercialized or that any required funds will be available to the Company at the time needed or on terms acceptable to the Company.

Neovasc is subject to risks and uncertainties associated with operating in the life sciences industry and as a Company engaged in significant development, regulatory, production and commercialization activity.  Neovasc cannot anticipate or prevent all of the potential risks to its success, nor predict the impact of any such risk.

Operating risks include but are not limited to: market acceptance of the Company's technologies and products; litigation risk associated with the Company's intellectual property and the Company's defense and protection thereof; securities litigation risk and the Company's defense thereof: the Company's ability to obtain and enforce timely patent protection of its technologies and products; the clinical success of the Tiara; the Company's ability to develop, manufacture and commercialize its products cost-effectively and according to the regulatory standards of numerous governments; the competitive environment and impact of technological change and/or product obsolescence; the Company's ability to conduct and complete successful clinical trials; the Company's ability to garner regulatory approvals for its products in a timely fashion; the Company's ability to attract and retain key personnel, effectively manage growth and smoothly integrate newly acquired businesses or technologies; limitations on third-party reimbursement; instances of product or third-party liability; dependence on a single supplier for some products; animal disease or other factors affecting the quality and availability of raw materials; conflicts of interest among the Company's directors, officers, promoters and members of management; fluctuations in the values of relative foreign currencies; volatility of the Company's share price; fluctuations in quarterly financial results; unanticipated expenses; changes in business strategy; impact of any negative publicity; general political and economic conditions; and acts of god and other unforeseeable events, natural or human-caused.


Risks Relating to Potential Global Pandemics

A global pandemic could cause temporary closure of businesses in regions that are significantly impacted by the health crises, or cause governments to take preventative measures such as the closure of points of entry, including ports and borders. These restrictive measures along with market uncertainty could cause a decrease in the demand or sales for our products. The recent outbreak of the novel coronavirus (COVID-19) has had a negative impact on our operating environment and governmental actions to contain the outbreak may impact our ability to transport or market our products, enroll patients in our clinical studies or adversely affect our ability to raise capital.

FOREIGN OPERATIONS

The majority of the Company's revenues are derived from product sales in Europe, primarily denominated in U.S. dollars and Euros, while the majority of the Company's costs are denominated in Canadian and U.S. dollars.  A decrease in the value of the Euro in relation to the U.S. dollar will have an adverse effect on the Company's results of operations, with lower than expected revenue amounts and gross margins being reported in the Company's U.S. dollar financial statements.  In addition, any decrease in the value of the Euro occurring in between the time a sale is consummated, and the time payment is received by Neovasc will lead to a foreign exchange loss being recognized on the foreign currency denominated trade account receivable.  The fluctuation of foreign exchange may impose an adverse effect on the Company's results of operations and cash flows in the future.  The Company does not conduct any hedging activities to mitigate these foreign exchange risks.  Additionally, Neovasc may be materially and adversely affected by increases in duty rates, exchange or price controls, repatriation restrictions, or other restrictions on foreign currencies.  The Company's international operations are subject to certain other risks common to international operations, including, without limitation: government regulations; import restrictions and, in certain jurisdictions, reduced protection for the Company's intellectual property rights.

Foreign currency translation gains and losses arising from normal business operations are credited to or charged to operations in the period incurred.  To date, Neovasc has not entered into any foreign exchange forward contracts.

SELECTED FINANCIAL INFORMATION

The following discussion should be read in conjunction with the unaudited condensed interim consolidated financial statements for the three and six months ended June 30, 2021 and 2020.

DISCUSSION OF OPERATIONS AND FINANCIAL CONDITION

Results for the three months ended June 30, 2021 and 2020 follow:

Losses

The operating losses and comprehensive losses for the three months ended June 30, 2021 were $9,092,541 and $9,313,065, respectively, or $0.13 basic and diluted loss per share, as compared with $8,658,370 operating losses and $12,234,456 comprehensive loss, or $0.81 basic and diluted loss per share, for the same period in 2020. The increase of $434,171 in operating losses can be explained by a $748,755 increase in operating expenses offset by a $349,021 increase in revenue.

The $2,921,391 decrease in the comprehensive loss incurred for the three months ended June 30, 2021 compared to the same period in 2020 can be substantially explained by a $2,897,698 decease in other loss and other comprehensive loss primarily relating to the accounting treatment of the 2019 Notes, 2020 Notes and the derivative liability warrants.

Revenues

Revenues increased by 123% to $633,068 for the three months ended June 30, 2021, compared to revenues of $284,047 for the same period in 2020. A restriction on elective procedures, which included Reducer implants, was implemented by the hospitals, health authorities or governments of a substantial portion of all our major markets due to COVID-19, which caused Reducer implantations to significantly slow beginning in March 2020. Since March 2020, these restrictions have been increased or decreased on a country-by-country basis depending on the severity of the COVID-19 outbreak in each region at the time. Notably, however, the measures were at their most restrictive during our comparative period and substantially explain the year over year increase in revenues. We continue to work on our reimbursement activities in several countries to further streamline payment of the ongoing implantations. The Company recognizes that future revenues may be unstable before the Reducer becomes widely adopted. The continued success of the commercialization of the Reducer will be dependent on obtaining appropriate reimbursement in various territories and continuing our market development efforts.

Cost of Goods Sold

The cost of goods sold for the three months ended June 30, 2021 was $109,106 compared to $74,669 for the same period in 2020. The overall gross margin for the three months ended June 30, 2021 was 83%, compared to 74% gross margin for the same period in 2020. The Company continues to focus on Germany where the Company sells the Reducer directly to customers for higher margins.


Expenses

Total expenses for the three months ended June 30, 2021 were $9,616,503 compared to $8,867,748 for 2020, representing an increase of $748,755 or 8%. The increase in total expenses for the three months ended June 30, 2021 compared to 2020 can be substantially explained by the following non-cash charges; i) a $1,028,005 increase in non-cash share-based payments, ii) a $593,622 impairment charge due to fixed assets obsolescence, and iii) a $309,056 charge for employee termination expenses (both charges related to the decision to pause the development of the Tiara TF device), offset by a $1,154,814 decrease in employee expenses due to the Company's reduction in force at the end of 2020.

Selling expenses for the three months ended June 30, 2021 were $832,812, compared to $452,514 for 2020, representing an increase of $380,298 or 84%. The increase in selling expenses for the three months ended June 30, 2021 compared to 2020 can be substantially explained by a $190,556 increase in non-cash share-based payments and a $207,495 increase in other expenses incurred for commercialization activities related to the Reducer as the Company increased its selling activities from the COVID-19 driven low point in the comparable period.

General and administrative expenses for the three months ended June 30, 2021 were $5,042,804, compared to $3,825,510 for the same period in 2020, representing an increase of $1,217,294 or 32%. The increase in general and administrative expenses for the three months ended June 30, 2021 compared to 2020 can be substantially explained by the following non-cash charges i) a $1,127,144 increase in non-cash share-based payments, ii) a $593,622 impairment charge due to fixed assets obsolescence iii) a $309,056  charge for employee termination expenses (both charges related to the decision to pause the development of the Tiara TF device), offset by a $924,5643 decrease in other expenses primarily due to higher legal expenses in comparable period related to the retirement and settlement of the 2017 Convertible Notes in 2020 and the issuance of the June 2020 Notes.

Product development and clinical trial expenses for the three months ended June 30, 2021 were $3,740,887 compared to $4,589,724 for 2020, representing an decrease of $848,837 or 18%. The decrease in product development and clinical trial expenses for the three months ended June 30, 2021 can be substantially explained by a $942,636 decrease in employee expenses due to the Company's reduction in force at the end of 2020 and a $289,695 decrease in non-cash share-based payments offset by a $387,010 increase in other product development and clinical trial expenses as the Company continued to incur development costs related to Tiara and Reducer.

The Company's expenses are subject to inflation and cost increases. The Company has not seen a material increase in the price of any of the components used in the manufacture of its products and services.

Other Income

The other income for the three months ended June 30, 2021 was $44,131 compared to other loss of $1,268,020 for the same period in 2020, a change of $1,312,151. The change in the other income can be substantially explained by a $868,608 increase in other income related to the accounting treatment of the 2019 Notes, 2020 Notes and the derivative liability warrants and a $319,629 decrease in interest payment of the 2019 Convertible Note.

Tax Expense

The tax recovery for the three months ended June 30, 2021 was $15,396 compared to $1,075 for the same period in 2020. Neovasc (US) Inc. was established in 2015 to provide clinical trial services to Neovasc Medical Inc. The cross border intercompany charges from Neovasc (US) Inc. to Neovasc Medical Inc. created a taxable profit in Neovasc (US) Inc. and U.S. federal and state taxes were incurred.

Results for the six months ended June 30, 2021 and 2020 follow:

Losses

The operating losses and comprehensive losses for the six months ended June 30,2021 were $19,265,116 and $12,186,066, respectively, or $0.19 basic and diluted loss per share, as compared with $15,814,475 operating losses and $14,907,862 comprehensive loss, or $1.21 basic and diluted loss per share, for the same period in 2020. The increase of $3,450,641 in operating losses can be substantially explained by a $3,736,294 increase in department expenses offset by a $267,920 increase in revenue.

The $2,721,796 decrease in the comprehensive loss incurred for the six months ended June 30, 2021 compared to the same period in 2020 can be substantially explained by a $5,949,488 increase in income related to the accounting treatment of the 2019 Notes, 2020 Notes and the derivative liability warrants and offset by the $3,450,641 increase in operating losses.

Revenues

Revenues increased by 33% to $1,084,862 for the six months ended June 30, 2021, compared to revenues of $816,942 for the same period in 2020. A restriction on elective procedures, which included Reducer implants was implemented by the hospitals, health authorities or governments of a substantial portion of all our major markets due to COVID-19, which caused Reducer implantations to significantly slow beginning in March 2020. Since March 2020, these restrictions have been increased or decreased on a country-by-country basis depending on the severity of the COVID-19 outbreak in each region at the time. Notably, however, the restrictions did not begin until March 2020 and these two COVID-19 free months in our comparative period skew the comparative period and like for like analysis. We continue to work on our reimbursement activities in several countries to further streamline payment of the ongoing implantations. The Company recognizes that future revenues may be unstable before the Reducer becomes widely adopted. The continued success of the commercialization of the Reducer will be dependent on obtaining appropriate reimbursement in various territories and continuing our market development efforts.


Cost of Goods Sold

The cost of goods sold for the six months ended June 30, 2021 was $181,499 compared to $199,232 for the same period in 2020. The overall gross margin for the six months ended June 30, 2021 was 83%, compared to 76% gross margin for the same period in 2020. The Company continues to focus on Germany where the Company sells the Reducer direct for higher margins.

Expenses

Total expenses for the six months ended June 30, 2021 were $20,168,479 compared to $16,432,185 for 2020, representing an increase of $3,736,294 or 23%. The increase in total expenses for the six months ended June 30, 2021 compared to 2020 can be substantially explained by the following non-cash charges; i) $2,363,639 increase in non-cash share-based payments, ii) a $593,622 impairment charge due to fixed assets obsolescence, iii) a $309,056 charge for employee termination expenses (both charges related to the decision to pause the development of the Tiara TF device) and a $1,630,124 expense for legal and underwriting fees related to the February 2021 financing.

Selling expenses for the six months ended June 30, 2021 were $1,470,791, compared to $1,006,043 for 2020, representing an increase of $464,748 or 46%. The increase in selling expenses for the six months ended June 30, 2021 compared to 2020 can be substantially explained by a $393,742 increase in non-cash share-based payments and a $46,479 increase in other expenses incurred for commercialization activities related to the Reducer.

General and administrative expenses for the six months ended June 30, 2021 were $10,335,373, compared to $6,313,012 for the same period in 2020, representing an increase of $4,022,361 or 64%. The increase in general and administrative expenses for the six months ended June 30, 2021 compared to 2020 can be substantially explained by the following non-cash charges; i) a $2,159,955 increase in non-cash share-based payments, ii) a $593,622 impairment charge due to fixed assets obsolescence, iii) a $309,056 charge for employee termination expenses, and a $1,630,124 expense for legal and underwriting fees related to the February 2021 financing.

Product development and clinical trial expenses for the six months ended June 30, 2021 were $8,362,315 compared to $9,113,130 for 2020, representing a decrease of $750,815 or 8%. The decrease in product development and clinical trial expenses for the six months ended June 30, 2021 can be substantially explained by a $1,148,975 decrease in employee expenses due to the Company's reduction in force at the end of 2020 and a $190,058 decrease in non-cash share-based payments offset by a $598,038  increase in other product development and clinical trial as the Company continued to incur development costs related to Tiara and Reducer.

The Company's expenses are subject to inflation and cost increases. The Company has not seen a material increase in the price of any of the components used in the manufacture of its products and services.

Other Loss

The other income for the six months ended June 30, 2021 was $8,048,559 compared to $1,783,566 for the same period in 2020, an increase of $6,264,993. The increase in the other income can be substantially explained by a $5,949,488 increase in income related to the accounting treatment of the 2019 Notes, 2020 Notes and the derivative liability warrants.

Tax Expense

The tax recovery for the six months ended June 30, 2021 was $16,128 compared to a $5,997 expense in 2020. Neovasc (US) Inc. was established in 2015 to provide clinical trial services to Neovasc Medical Inc. The cross border intercompany charges from Neovasc (US) Inc. to Neovasc Medical Inc. created a taxable profit in Neovasc (US) Inc. and U.S. federal and state taxes were incurred.


QUARTERLY INFORMATION

The following is a summary of selected unaudited financial information for the eight fiscal quarters to June 30, 2021:

    June 30,
2021
    March 31,
2021
    December 31,
2020
    September 30,
2020
 
                         
REVENUE $ 633,068   $ 451,794   $ 514,002   $ 626,418  
COST OF GOODS SOLD   109,106     72,393     96,504     150,503  
GROSS PROFIT   523,962     379,401     417,498     475,915  
EXPENSES                        
Selling expenses   832,812     637,979     692,089     498,671  
General and administrative expenses   5,042,804     5,292,569     3,125,162     4,642,979  
Product development and clinical trials expenses   3,740,887     4,621,428     5,785,748     5,502,717  
    9,616,503     10,551,976     9,602,999     10,644,367  
OPERATING LOSS   (9,092,541  )   (10,172,575  )   (9,185,501 )   (10,168,452 )
Other (expense)/income   44,131     8,004,428     4,231,989     (66,225 )
Tax recovery   15,396     732     530,054     -  
LOSS FOR THE PERIOD $ (9,033,014  ) $ (2,167,415  ) $ (4,423,458 ) $ (10,234,677 )
BASIC AND DILLUTED LOSS PER SHARE $ ($0.13 ) $ ($0.04 ) $ (0.18 ) $ (0.51 )

    June 30,
2020
    March 31,
2020
    December 31,
                    2019
    September 30,
                    2019
 
                         
REVENUE $ 284,047   $ 532,895   $ 565,821   $ 500,498  
COST OF GOODS SOLD   74,669     124,563     109,449     137,999  
GROSS PROFIT   209,378     408,332     456,372     362,499  
EXPENSES                        
Selling expenses   452,514     553,529     502,828     380,412  
General and administrative expenses   3,825,510     2,487,502     2,671,418     2,197,922  
Product development and clinical trials expenses   4,589,724     4,523,406     6,855,615     4,777,197  
    8,867,748     7,564,437     10,029,861     7,355,531  
OPERATING LOSS   (8,658,370 )   (7,156,105 )   (9,573,489 )   (6,993,032 )
Other income/(expense)   (1,268,020 )   3,051,586     (2,739,008 )   775,550  
Tax recovery/(expense)   1,075     (7,072 )   (41,688 )   15,505  
LOSS FOR THE PERIOD $ (9,925,315 ) $ (4,111,591 ) $ (12,354,185 ) $ (6,201,977 )
BASIC AND DILLUTED LOSS PER SHARE $ (0.81 ) $ (0.38 ) $ (1.45 ) $ (0.83 )

Selling expenses are expected to generally increase as the Company continues its focused commercialization of the Reducer in select countries in Europe.  General and administrative expenses reached a new peak in the first quarter of 2021 due to the increase in legal expenses and underwriters fees related to the February 2021 financings in that period. We anticipate that product development and clinical trials expenses will be reduced significantly by the decision to pause the Tiara TF development program but will increase significantly on the initiation of the COSIRA-II IDE clinical study. Product development and clinical trials expenses will continue to fluctuate on a quarterly basis as we move through different development cycles of our products.


 

USE OF PROCEEDS

 

PROPOSED USE OF NET
PROCEEDS

ACTUAL USE OF NET PROCEEDS

 

December 2020 $6.2M

Equity Financing 

Use of Proceeds

Remaining to be Spent

Continuing operations

$5,238,911

$5,238,911

$NIL

NET PROCEEDS

$5,238,911

$5,238,911

$NIL


 

PROPOSED USE OF NET
PROCEEDS

ACTUAL USE OF NET PROCEEDS

 

February 2021 $72M

Equity Financing 

Use of Proceeds

Remaining to be Spent

Advancement of Reducer

$35,000,000

$225,329

$34,774,671

Advancement of Tiara

$15,000,000

        $1,226,211

$13,773,789

General corporate and working capital

$15,322,100

$575,682

$14,746,418

NET PROCEEDS

$65,322,100

$2,027,222

$63,294,878

The Company used all the proceeds from the December 2020 Financing for continuing operations. The Company has cash on hand of $63,294,878 as at June 30, 2021.

DISCUSSION OF LIQUIDITY AND CAPITAL RESOURCES

Results for the six months ended June 30, 2021 and 2020 follow:

Neovasc finances its operations and capital expenditures with cash generated from operations and through equity and debt financings. As at June 30, 2021 the Company had cash and cash equivalents of $63,294,878 compared to cash and cash equivalents of $12,935,860 as at December 31, 2020. 

The Company's working capital position is $60,181,545, with current assets of $66,971,104 and current liabilities of $6,789,559. The Company may require additional working capital in order to continue to operate its business and there can be no assurance that such additional working capital will be available on favorable terms, or at all in the future.

Net cash applied to operating activities for the six months ended June 30, 2021 was $15,369,473, compared to $13,917,840, for the same period in 2020. For the six months ended June 30, 2021, cash operating expenses were $12,264,076, compared to $13,338,157 for the same period in 2020, a decrease of $1,074,081 as the Company continues to manage its cash flows while still advancing the commercialization and development of its products.  Net cash applied to the net change in non-cash working capital items for the six months ended June 30, 2021 was $3,150,668, compared to $632,336 in the same period in 2020, a $2,518,332 increase as we sought to decrease our accounts payable following the February 2021 Financing.

During the six months ended June 30, 2021, the Company received net proceeds of $65,322,100 from the February 2021 Financing and $1,078,623 from the exercise of 2020 Warrants compared to the receipt of $18,843,828 from the January 2020 and June 2020 Financings, $616,075 from the exercise of 2017 Warrants and $5,000,000 from the 2020 Notes and derivative liability warrants and repayment of the 2017 Convertible Note for $3,898,000 during the six months ended June 30, 2020.

The majority of the revenue and expenses of the Company are incurred in the parent and in two of its subsidiaries, NMI, which is located in Canada, and Neovasc (US) Inc. which is located in the United States.  There were no significant restrictions on the transfer of funds between these entities during the periods ended June 30, 2021 and 2020 and the Company had no complications in transferring funds to and from its subsidiaries in Israel and the United States.

The Company is exposed to foreign currency fluctuations on $1,760,571 of its cash and cash equivalents and restricted cash held in Canadian dollars and Euros.

SUBSEQUENT EVENTS

On July 13, 2021, the Company announced that it has appointed Lisa Becker as Vice President, Regulatory Affairs, Global Angina Therapies and Sarah Gallagher as Vice President, Clinical Affairs.

OUTSTANDING SHARE DATA

As of August 10, 2021, subsequent to the effect of the share consolidations, the Company had 67,584,412 Common Shares issued and outstanding. The following securities are convertible into Common Shares:


  • 18,000,000 February 2021 Warrants with an exercise price of $2.30, 2,506,516 December 2020 Warrants with an exercise price of $0.86, 3,274,579 August 2020 Warrants with an exercise price of $2.69, 2,912,277 June 2020 Warrants with an exercise price of $2.88, 648,910 May 2020 Warrants with an exercise price of $2.634, 250,000 January 2020 Warrants with an exercise price of $4.14, In addition the Company had 650,296 Repayment Warrants with an exercise price of $7.50 (escalating during the life of the warrant as per the terms of the 2019 Notes) and 500,000 settlement warrants with an exercise price of $2.01. 
  • 144,444 2019 Broker Warrants with an exercise price of $5.63, 157,721 January 2020 Broker Warrants with an exercise price of $5.17, 252,397 June 2020 compensation warrants with an exercise price of $3.72, 294,630 August 2020 compensation warrants with an exercise price of $3.47, 405,002 December 2020 compensation warrants with an exercise price of $1.23 and 2,340,000 February 2021 compensation warrants with an exercise price of $2.50.
  • $6,622,774 principal amount of 2019 Notes and additional accrued interest which could convert into 965,639 Common Shares at $7.50 per share and $5,000,000 principal amount of 2020 Notes and additional accrued interest which could convert into 1,936,434 Common Shares at $2.82 per share.
  • 2,423,998 restricted share units and 5,746,774 incentive options

Our fully diluted share capital as of the same date is 110,994,029, including any payment in kind interest that may be due and convertible into common shares on the outstanding notes.

CONTRACTUAL OBLIGATIONS AND CONTINGENCIES

Contingencies

Litigation

Litigation resulting from third party claims has been, and may be, costly and time-consuming and could divert the attention of management and key personnel from our business operations. Although we intend to vigorously defend ourselves against any pending claims, and future claims that may occur, we cannot assure that we will succeed in appealing and defending any of these claims and that judgments will not be upheld against us. If we are unsuccessful in our appeal and defense of these claims or unable to settle the claims in a manner satisfactory to us, we may be faced with significant loss of intellectual property rights that could have a material adverse effect on the Company and its financial condition.

Claims by CardiAQ in Germany

On June 23, 2014, Edwards Lifesciences CardiAQ LLC ("CardiAQ") filed a complaint against Neovasc in Munich, Germany (the "German Court") requesting that Neovasc assign its right to one of its European patent applications to CardiAQ. After a hearing held on December 14, 2016, the German Court rendered its decision on June 16, 2017, granting co-ownership of the European patent application to CardiAQ but denying their claim for full entitlement. On July 14, 2017, Neovasc filed a notice of appeal against the German Court's decision with the Appeals Court of Munich (the 'Appeals Court'). On July 20, 2017, CardiAQ filed a notice of appeal with the same court. The decision of the Appeals Court of Munich was rendered on March 21, 2019, wherein it amended the decision of the German Court and dismissed the complaint of CardiAQ in full. On March 30, 2020, the German Supreme Court granted CardiAQ leave to appeal the Appeals Court decision and at a hearing held on August 4, 2020 the German Supreme Court set aside the prior decision of the Appeals Court and remanded the matter back to the Appeals Court for a new hearing and decision.  The hearing at the Appeals Court was held on February 25, 2021.

On May 20, 2021, the Appeals Court has upheld the first instance judgment of the German Court of June 16, 2017, in which the court had found that CardiAQ had contributed in part to the invention of the Tiara and awarded to CardiAQ co-entitlement rights to the disputed Tiara European patent application. There are no monetary awards associated with these matters (except for a decision on the statutory costs of the proceedings) and no damages award was recognized. Regarding the statutory costs of the proceedings, both parties bear 50% of the costs of the appeal proceedings before the Appeals Court. Neovasc bears the costs of the 2nd appeal proceedings before the German Supreme Court. Neovasc has not appealed this decision to preserve capital and move forward with our new strategic activities. The decision is now final.

Claims by CardiAQ in the United States

On March 24, 2017, CardiAQ filed a related lawsuit in the in the U.S. District Court for the District of Massachusetts (the "Court"), asserting two claims for correction of patent inventorship as to Neovasc's U.S. Patents Nos. 9,241,790 and 9,248,014. On October 4, 2017, CardiAQ amended its pleading to add a third claim for correction of patent inventorship as to Neovasc's U.S. Patent No. 9,770,329. The lawsuit did not seek money damages and would not have prevented the Company from practicing these patents. The Company moved to dismiss the complaint on November 16, 2017, and the Court denied this motion on September 28, 2018.  On April 17, 2019, the Company resolved the three claims for correction of patent inventorship and, without reaching conclusion on the merits of the claims, the parties agreed to the correction of patent inventorship and added co-inventors to the three patents in question. Each party will bear its own costs. There were no monetary awards associated with these matters and no damages award was recognized.


Other Matters

By way of Amended Statement of Claim in Federal Court of Canada Action T-1831-16 (the "Action"), Neovasc Inc. and Neovasc Tiara Inc. (the "Neovasc Defendants") were added as defendants to an existing action commenced by Edwards Lifesciences PVT, Inc. and Edwards Lifesciences (Canada) Inc. (collectively the "Edwards Plaintiffs") against Livanova Canada Corp., Livanova PLC, Boston Scientific and Boston Scientific Ltd. (collectively, the "BSC/Livanova Defendants"). The Action was first filed in October 2016 and first concerned an allegation by the Edwards Plaintiffs that the manufacturing, assembly, use, sale and export of the Lotus Aortic Valve devices by the BSC/Livanova Defendants infringes on the Edwards Plaintiffs' patents. In February 2017, the Neovasc Defendants were added to the Edwards Plaintiffs' claim making related allegations.  On January 22, 2019, the Company announced that pursuant to a settlement reached with the Edwards Plaintiffs, the patent infringement action that the Edwards Plaintiffs had previously commenced in the Federal Court of Canada against the Neovasc Defendants, Boston Scientific and Livanova, has been dismissed on a no-costs basis.  No damages award was recognized.

On August 3, 2018, the Company announced that it had entered into a collaboration and licensing agreement with Penn Medicine and the Gorman Cardiovascular Research Group at the University of Pennsylvania (collectively, "UPenn"), which resolved certain potential claims against the Company that had been previously disclosed. The collaboration and licensing agreement with UPenn contemplates certain fees being paid by Neovasc to UPenn, including fees in installments totaling $2.65 million over the four years following the agreement's execution. In addition, Neovasc agreed to pay UPenn a royalty of 1.0-1.5% on the annual net sales of the Tiara following the first commercial sale of the Tiara. Also contained in the collaboration and licensing agreement are buy-out clauses that allow Neovasc, or an acquirer of Neovasc or the Tiara assets, to buy out these royalty obligations. As part of the collaboration and licensing agreement, certain potential claims against the Neovasc Defendants were resolved.

When the Company assesses that it is more likely that a present obligation exists at the end of the reporting period and that the possibility of an outflow of economic resources embodying economic benefits is probable, a provision is recognized, and contingent liability disclosure is required. The Company has accrued $482,835 as at June 30, 2021 representing the discounted value of future payments anticipated under the settlement agreement with UPenn. The Company has not accrued for any future royalty payments in the settlement agreement with UPenn as the amounts are undeterminable at this time.

On September 7, 2018, Endovalve Inc. and Micro Interventional Devices, Inc. (collectively, "Endovalve") filed a complaint in the United States District Court for the District of New Jersey against the Neovasc Defendants, alleging claims for trade secret misappropriation, breach of contract, and unfair competition. Endovalve alleged that it was a former customer of Neovasc Inc., and that the Neovasc Defendants improperly used trade secrets in the development of Tiara. The complaint sought injunctive relief, money damages, and attorneys' fees. On February 20, 2019, the Company announced that it had entered into a settlement agreement with Endovalve. The settlement agreement with Endovalve contemplates certain fees being paid by Neovasc to Endovalve, including settlement fees in installments totaling $3 million over the two and a half years following the agreement's execution. In addition, Neovasc agreed to pay Endovalve a royalty of 1.3% on the annual net sales of the Tiara following the first commercial sale of the Tiara. Also contained in the settlement agreement are buy-out clauses that allow Neovasc, or an acquirer of Neovasc or the Tiara assets, to buy out these royalty obligations. As part of the settlement agreement, the claims against the Neovasc Defendants were dismissed with prejudice.

When the Company assesses that it is more likely that a present obligation exists at the end of the reporting period and that the possibility of an outflow of economic resources embodying economic benefits is probable, a provision is recognized, and contingent liability disclosure is required. The Company has accrued $728,725 as at June 30, 2021 representing the discounted value of future payments anticipated under the settlement agreement with Endovalve. The Company has not accrued for any future royalty payments in the settlement agreement with Endovalve as the amounts are undeterminable at this time.

Shareholder Litigation

On November 5, 2020, a putative shareholder class action lawsuit was filed in the United States District Court for the Southern District of New York against Neovasc Inc. ("Neovasc"), Fred Colen, Neovasc's CEO, and Christopher Clark, Neovasc's CFO: Gonzalez v. Neovasc Inc., et al., Case No. 7:20-cv-09313 (S.D.N.Y.) (the "Gonzalez Action").  The complaint in the Gonzalez Action purports to bring suit on behalf of a class consisting of all persons and entities that purchased or otherwise acquired Neovasc securities between November 1, 2019 and October 27, 2020, inclusive.  On November 25, 2020, a second putative shareholder class action lawsuit was filed in the United States District Court for the Southern District of New York against Neovasc and Messrs. Colen and Clark: Siple v. Neovasc Inc., et al., Case No. 1:20-cv-09948 (S.D.N.Y.) (the "Siple Action").  The complaint in the Siple Action purports to bring suit on behalf of a class consisting of all persons and entities that purchased or otherwise acquired Neovasc securities between October 10, 2018 and October 27, 2020, inclusive. 

The complaints in both the Gonzalez Action and the Siple Action contain similar allegations that the defendants made materially false and/or misleading statements, as well as failed to disclose material adverse facts about Neovasc's business, operations, and prospects.  Specifically, the complaints' allegations relate to the premarket approval process with the U.S. Food and Drug Administration for Neovasc's Reducer medical device for the treatment of refractory angina.  Both complaints assert the same two causes of action: (i) a violation of Section 10(b) of the Securities Exchange Act of 1934 ("Exchange Act") and Rule 10b-5 promulgated thereunder against all defendants; and (ii) a violation of Section 20(a) of the Exchange Act against Messrs. Colen and Clark.


On January 26, 2021, the court issued an order consolidating the Gonzalez Action and the Siple Action under a new case style: In re Neovasc Inc. Securities Litigation, Case No. 7:20-cv-09313 (S.D.N.Y.) (the "Consolidated Action").  The order also appointed Pratap Golla as Lead Plaintiff and the law firms of Pomerantz LLP and Holzer & Holzer LLC as Co-Lead Counsel for the Class in the Consolidated Action.  The order further directed Lead Plaintiff to file a Consolidated Amended Complaint in the Consolidated Action.  On March 19, 2021, Lead Plaintiff filed a Consolidated Amended Complaint.

The Consolidated Amended Complaint names Neovasc, Messrs. Colen and Clark, Bill Little, and Shmuel Banai as defendants.  The Consolidated Amended Complaint purports to bring suit on behalf of a class consisting of all persons and entities that purchased or otherwise acquired Neovasc securities between October 10, 2018 and January 15, 2021, inclusive.  The Consolidated Amended Complaint contains allegations similar to the complaints in the Gonzalez Action and the Siple Action and asserts the same two causes of action: (i) a violation of Section 10(b) of the Exchange Act and Rule 10b-5 promulgated thereunder against all defendants; and (ii) a violation of Section 20(a) of the Exchange Act against Messrs. Colen, Clark, Little, and Banai.

Defendants obtained permission to file a motion to dismiss the Consolidated Amended Complaint, which they served on June 14, 2021. Plaintiff served its opposition to the motion to dismiss on July 17, 2021. Defendants' reply in support of their motion to dismiss was served on August 6, 2021.

OFF BALANCE SHEET ARRANGEMENTS

The Company has no off-balance sheet arrangements.

RELATED PARTY TRANSACTIONS

There were no ongoing contractual commitments and transactions with related parties during the six months ended June 30, 2021 and 2020, other than those as described elsewhere herein, and those compensation-based payments disclosed in Note 22 Related Party Transactions of the unaudited condensed interim consolidated financial statements for the six months ended June 30, 2021 and 2020.

RISK FACTORS

A comprehensive list of the risks and uncertainties affecting us can be found in our most recent Annual Information Form, which is available on SEDAR at www.sedar.com and as filed with the SEC at www.sec.gov. Investors are urged to consult and carefully consider these risk factors as an investment in the securities of the Company should be considered a highly speculative investment.

CRITICAL ACCOUNTING ESTIMATES AND MANAGEMENT JUDGMENT

The preparation of unaudited condensed interim consolidated financial statements in conformity with IFRS requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities at the date of the unaudited condensed interim consolidated financial statements and the reported amounts of revenues and expenses during the reporting year.  Actual results may differ from those estimates.

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

Significant areas requiring the use of estimates relate to the determination of the net realizable value of inventory (obsolescence provisions), allowance for doubtful accounts receivable, impairment of non-financial assets, useful lives of depreciable assets and expected life, and volatility and forfeiture rates for share-based payments.

Inventories

The Company estimates the net realizable values of inventories, taking into account the most reliable evidence available at each reporting date.  The future realization of these inventories may be affected by future technology or other market-driven changes that may reduce future selling prices. Reducer research and development supplies are expensed as the supplies are used.

Allowance for doubtful accounts receivable

The Company has established and applied a provision matrix to the trade accounts receivables balances in order to calculate an allowance for doubtful accounts on adoption of IFRS 9.  Actual collectability of customer balances can vary from the Company's estimation.

Impairment of long-lived assets

In assessing impairment, the Company estimates the recoverable amount of each asset or cash generating unit based on expected future cash flows and uses an interest rate to discount them.  Estimation uncertainty relates to assumptions about future operating results and the determination of a suitable discount rate.


Useful lives of depreciable assets

The Company reviews its estimate of the useful lives of depreciable assets at each reporting date, based on the expected utilization of the assets.

Share-based payments

The Company measures the cost of equity-settled transactions by reference to the fair value of the equity instruments at the date at which they are granted.  Estimating fair value for share-based payment transactions requires determining the most appropriate valuation model, which is dependent on the terms and conditions of the grant.  This estimate also requires determining the most appropriate inputs to the valuation model including the expected life of the share option, risk free interest rate, volatility and forfeiture rates and making assumptions about them. The determination of a transaction to be either forfeited or cancelled requires management judgment, which is dependent on the terms and conditions of the transaction.

Determination of functional currency

The Company determines its functional currency as the United States dollar based on the primary economic environment in which it operates.  IAS 21 The Effects of Changes in Foreign Exchange Rates outlines a number of factors to apply in determining the functional currency, which is subject to significant judgment by management.  Management uses a number of factors to determine the primary economic environment in which the Company operates; it is normally the one in which it primarily generates and expends cash.

Deferred tax assets

Deferred tax assets are recognized in respect of tax losses and other temporary differences to the extent probable that there will be taxable income available against which the losses can be utilized.  Judgment is required to determine the amount of deferred tax assets that can be recognized based on estimates of future taxable income.

Contingent Liabilities

Contingent liabilities are assessed continually to determine whether an outflow of resources embodying economic benefits has become probable.  If it becomes probable that an outflow of future economic benefits will be required for an item previously dealt with as a contingent liability, a provision is recognized in the consolidated financial statements of the year in which the change in probability occurs.

Determination of discount rate to measure lease liabilities

The Company enters into leases with third-party landlords and as a consequence the rate implicit in the relevant lease is not readily determinable. Therefore, the Company uses its incremental borrowing rate as the discount rate for determining its lease liabilities at the lease commencement date. The incremental borrowing rate is the rate of interest that the Company would have to pay to borrow over similar terms which requires estimations when no observable rates are available.

Accounting for financing and determination of fair value of derivative liabilities

The determination of the accounting treatment for the financing transactions, most notably for those completed in November 2017, May 2019 and May 2020 is an area of significant management judgment.  In particular, this involved the determination of whether the warrants issued, and the conversion feature associated with the convertible note should be classified as equity or as derivative liabilities.  The difference between the transaction amount and the fair value of the instruments issued in connection with the financing gives rise to a loss which has been deferred as the fair values were not determined using only observable market inputs.  The manner in which the deferred loss will be recognized within income involves management judgment.

The derivative warrant liabilities and convertible notes will be measured at fair value through profit and loss at each year end.  The calculations of the fair value of these instruments involves the use of a number of estimates and a complex valuation model.  The carrying amounts of these liabilities may change significantly as a result of changes to these estimates.  Details of the estimates used as at June 30, 2021 are disclosed in Note 16 of the unaudited condensed interim consolidated financial statements for the six months ended June 30, 2021 and 2020.

FINANCIAL INSTRUMENTS

The Company's financial instruments include its cash and cash equivalents, restricted cash, accounts receivable and accounts payable, derivative warrant liability from financing, convertible notes, and accrued liabilities.

a) Fair value estimation

The fair value hierarchy establishes three levels to classify fair value measurements based upon the observability of significant inputs used in the valuation techniques.  The three levels of the fair value hierarchy are described below:


Level 1 |  Quoted prices (unadjusted) in active markets for identical assets or liabilities

Level 2 |  Inputs other than quoted prices included in level 1 that are observable for the asset or liability, either 

                directly (that is, as prices) or indirectly (that is, derived from prices)

Level 3 |  Inputs for the assets or liability that are not based on observable market data (that is, unobservable inputs)

The following table sets forth the Company's financial assets and liabilities measured at fair value on a recurring basis by level within the fair value hierarchy as at December 31, 2020 and June 30, 2021. As required by IFRS 13, assets and liabilities are classified in their entirety based on the lowest level of input that is significant to the fair value measurement.

              As at December 31, 2020:

    Level 1     Level 2     Level 3     Total  
Financial liabilities at fair value through profit and loss                        
2019 Convertible Notes $ -   $ -   $ 6,195,357   $ 6,195,357  
2020 Convertible notes, warrants and derivative
warrant liabilities
$ -   $ -   $ 9,117,147   $ 9,117,147  

As at June 30, 2021:

    Level 1     Level 2     Level 3     Total  
Financial liabilities at fair value through profit and loss                        
2019 Convertible Notes $ -   $ -   $ 6,583,528   $ 6,583,528  
2020 Convertible notes, warrants and derivative
warrant liabilities
$ -   $ -   $ 7,645,581   $ 7,645,581  
2021 Derivative warrant liabilities $ -   $ -   $ 1,745,600   $ 1,745,600  

Presentation of the fair values of the 2020 Convertible notes, warrants and derivative warrant liabilities and 2021 Derivative warrant liabilities are gross of the deferred loss.

The carrying amounts of financial assets and financial liabilities in each category are as follows:

    June 30,
2021
    December 31,
2020
 
Assets at amortized cost            
Cash and cash equivalents $ 63,294,878   $ 12,935,860  
Accounts receivable   1,213,450     987,057  
Restricted cash   483,714     470,460  
Assets at amortized cost $ 64,992,042   $ 14,393,377  
             
Other financial liabilities at amortized cost            
Accounts payable and accrued liabilities (current) $ 6,422,130   $ 7,243,500  
             
Financial liabilities at fair value through profit and loss            
2019 Convertible Notes (current) $ 38,633     38,633  
2019 Convertible Notes (non-current)   6,544,895     6,156,724  
2020 Convertible Notes (current)   37,839     37,525  
2020 Convertible notes, warrants and derivative warrant liabilities
(non-current)
  7,607,742     9,079,622  
2021 Derivative warrant liabilities   1,745,600     -  
  $ 22,396,839   $ 22,556,004  

The carrying amounts of cash and cash equivalents, accounts receivable, restricted cash and accounts payable and accrued liabilities are considered a reasonable approximation of fair value due to their short-term nature.

(b)  Foreign exchange risk

A portion of the Company's revenues are derived from product sales in Europe, denominated in Euros. Management has considered the stability of the foreign currency and the impact a change in the exchange rate may have on future earnings during the forecasting process. The Euro represents approximately 47% of revenues for the three and six months ended June 30, 2021, (three and six months ended June 30, 2020: 49%). A 10% change in the foreign exchange rates for the Euro for foreign currency denominated accounts receivable will impact net income as at June 30, 2021 by approximately $12,259  (as at June 30, 2020: $9,199), and a similar change in foreign currency denominated accounts payable, which are denominated in Canadian dollars and Euros will impact net income by approximately $6,730 and $34,695 respectively, as at June 30, 2021 (as at June 30, 2020: $88,314 and $133,168 respectively). A similar change in foreign currency denominated cash and cash equivalents, and restricted cash, which are denominated in Canadian dollars and Euros will impact net income by approximately $101,270 and $74,787, respectively, as at June 30, 2021 (as at June 30, 2020: $126,723 and $45,398 respectively). The Company does not hedge its foreign exchange risk.


(c)  Interest rate risk

The Company is not exposed to material cash flow interest rate risk on fixed rate cash balances, and short-term accounts receivable, accounts payable, 2019 Notes and 2020 Notes that have fixed interest terms.

(d)  Liquidity risk

As at June 30, 2021, the Company had $63,294,878 in cash and cash equivalents as compared to cash and cash equivalents of $12,935,860 at December 31, 2020. The Company is dependent on the profitable commercialization of its products or obtaining additional debt or equity financing to fund ongoing operations until profitability is achieved.

The Company monitors its cash flow on a monthly basis and compares actual performance to the budget for the period. The Company may obtain additional debt, equity or other forms of financing in future periods. Further into the future the Company is dependent on the profitable commercialization of its products or obtaining additional debt, equity or other forms of financing to fund ongoing operations until profitability is achieved.

On February 12, 2021 the Company received aggregate gross proceeds of $72 million from the February 2021 Financing (see Note 17). The proceeds from the February 2021 Financing could be sufficient to extend the operations of the Company for up to three years at the current burn rate. However, it is likely that the Company will initiate programs that were on hold given cash constraints and that the cash needs of the Company will increase, shortening the time the proceeds will meet the requirements of the Company.

Trade payables were aged as follows as at June 30, 2021 and do not include accrued liabilities. All trades payables are current liabilities:

    Total  
Current $ 1,122,673  
31-60 days   241,625  
Over 60 days   5,381  
  $ 1,369,679  

The following is an analysis of the contractual maturities of the Company's non-derivative accrued liabilities as at June 30,2021:

    Within One
Year
 
       
Collaboration, license and settlement agreements (undiscounted) $ 1,250,000  
  $ 1,250,000  

(e)  Credit risk

Credit risk arises from the possibility that the entities to which the Company sells products may experience financial difficulty and be unable to fulfill their contractual obligations. This risk is mitigated by proactive credit management policies that include regular monitoring of the debtor's payment history and performance. The Company does not require collateral from its customers as security for trade accounts receivable but may require certain customers to pay in advance of any work being performed or product being shipped.

The maximum exposure, if all the Company's customers were to default at the same time is the full carrying value of the trade accounts receivable as at June 30, 2021 is $573,891 (as at December 31, 2020: $322,201). As at June 30, 2021, the Company had $192,262 of trade accounts receivable that were overdue according to the customers' credit terms (as at December 31, 2020: $146,658). During the three and six months ended June 30, 2021, the Company wrote down $nil of accounts receivable owed by customers (three and six months ended June 30, 2020: $nil).

The Company may also have credit risk related to its cash and cash equivalents and restricted cash, with a maximum exposure of $63,778,592 as at June 30, 2021 (as at December 31, 2020: $13,406,320). The Company minimizes its risk to cash and cash equivalents and restricted cash by maintaining the majority of its balances with Canadian Chartered Banks.


DISCLOSURE CONTROLS AND PROCEDURES

The Company's management, under the supervision of the Chief Executive Officer ("CEO") and Chief Financial Officer ("CFO"), has designed disclosure controls and procedures ("DC&P"). DC&P are defined in Rule 13a-15(e) and Rule 15d-15(e) of the Securities Exchange Act of 1934, as amended (the "Exchange Act") as those controls and procedures designed to ensure that information required to be disclosed in the annual filings and interim filings and other reports filed or submitted by the Company under the Exchange Act is duly recorded, processed, summarized and reported, within the time periods specified in rules and forms of the SEC.

DC&P are designed to provide reasonable assurance that material information relating to the Company is made known to the CEO and CFO during the reporting period and the information required to be disclosed by the Company is recorded, processed, summarized and reported in a timely and appropriate manner. Due to the inherent limitations associated with any such controls and procedures, management recognizes that, no matter how well designed and operated, they may not prevent or detect misstatements on a timely basis.

The Company's management, under the supervision of the CEO and CFO, has evaluated both the design and operating effectiveness of its DC&P and concluded that they are effective in DC&P as at June 30, 2021.

INTERNAL CONTROL OVER FINANCIAL REPORTING

The Company's management, under the supervision of the Chief Executive Officer ("CEO") and Chief Financial Officer ("CFO"), has designed controls and procedures for internal control over financial reporting, based on the Internal Control - Integrated Framework (2013) issued by the Committee of Sponsoring Organizations of the Treadway Commission ("COSO"). ICFR is designed to provide reasonable assurance regarding the reliability of financial reporting for external purposes in accordance with international financial reporting standards. Due to the inherent limitations associated with any such controls and procedures, management recognizes that, no matter how well designed and operated, they may not prevent or detect misstatements on a timely basis.

The Company's management, under the supervision of the CEO and CFO, has evaluated both the design and operating effectiveness of its DC&P and ICFR and concluded that both were ineffective as of December 31, 2019 and 2018 as detailed below.

A material weakness is a significant deficiency, or combination of significant deficiencies, that result in more than a remote likelihood that a material misstatement of the annual or interim financial statements will occur and not be detected by management before the financial statements are published. Controls can potentially be circumvented by the individual acts of some persons, by collusion of two or more people or by management override of the control. The design of any system of controls also is based in part upon certain assumptions about the likelihood of future events, and there can be no assurance that any design will succeed in achieving its stated goals under all potential future conditions. Over time, control may become inadequate because of changes in conditions, or the degree of compliance with the policies or procedures may deteriorate. Because of the inherent limitations in a cost-effective control system, misstatements due to error or fraud may occur and not be detected. Due to the remediation changes in ICFR as at December 31, 2020, management concluded that ICFR was effective as at December 31, 2020 and as at June 30, 2021.

Material Changes in ICFR

On December 31, 2019, the Company identified certain accounting differences requiring restatement of previously issued consolidated financial statements for the years ended December 31, 2018 and 2017. The accounting differences are related to Reducer units purchased for research and development during the year ended December 31, 2017 and recognized as product development and clinical trials expenses during that period. Not all of the units were used for product development and clinical trials and during the year ended December 31, 2019, as Reducer revenue increased, the Company used certain of those units in commercial activities. In order to correctly state the cost of goods sold for the year ended December 31, 2019 and the correct period expense for the years ended December 31, 2019, 2018 and 2017 the Company has restated the years ended December 31, 2018 and 2017 to include those Reducer units as research and development supplies assets with potential future economic value at the end of each of those periods. All references relating to financial information for the years ended December 2018 and 2017 have been adjusted to be reflected in this Annual Report.

Remediation for Material Weakness in ICFR

In light of the aforementioned material weakness, management conducted a thorough review of all research and development supplies and can conclude that ICFR is effective for the six months ended June 30, 2021.  The Company has developed and implemented a remediation plan; the following actions were implemented to improve ICFR included:

  • Flagged all Reducer units scheduled for testing at each period end to ensure they were correctly accounted for as an asset.
  • Reviewed all Reducer units included in period expenses as product development and clinical trials expenses to ensure all the units were correctly used in testing during that period.
  • Deployed an internal control compliance program, in accordance with COSO, designed to identify potential deficiencies in DC&P and ICFR throughout the six months ended June 30, 2021, to ensure that deficiencies are identified and remediated in a timely manner.
  • Further matured DC&P and ICFR practices in addition to enhancing risk assessment, control design assessment and operating effectiveness testing practices throughout the six months ended June 30, 2021.

Management's Report on ICFR

As a result of this process the operating effectiveness of ICFR has been strengthened and management believes that there are no material inaccuracies or omissions of material fact and, to the best its knowledge, believes that the unaudited condensed interim consolidated financial statements for the six months ended June 30, 2021 fairly present in all material respects and the financial condition and results of operations for the Company in conformity with IFRS.

Management has assessed the effectiveness of the Company's internal control over financial reporting as of June 30, 2021. In making this assessment, management used the criteria set forth by COSO in Internal Control-Integrated Framework (2013). Based on this assessment, management determined that the Company maintained effective internal control over financial reporting as of June 30, 2021.

Auditor attestation on ICFR

Non-accelerated filers are exempt from Section 404(b) of the Sarbanes-Oxley Act, which generally requires public companies to provide an independent auditor attestation of management's assessment of the effectiveness of their internal control over financial reporting. The Company qualifies as a non-accelerated filer and therefore has not included an independent auditor attestation of management's assessment of the effectiveness of its internal control over financial reporting in its Annual Report or in its audited consolidated financial statements for the years ended December 31, 2020, 2019 and 2018.

ADDITIONAL INFORMATION

Additional information about the Company, including the Company's Financial Statements and Annual Report on Form 40-F, are available on SEDAR at www.sedar.com and on the website of the SEC at www.sec.gov.

 


EX-99.3 4 exhibit99-3.htm EXHIBIT 99.3 Neovasc Inc.: Exhibit 99.3 - Filed by newsfilecorp.com

Form 52-109F2

Certification of Interim Filings

Full Certificate

I, Fred Colen, the President and Chief Executive Officer of Neovasc Inc., certify the following:

1. Review: I have reviewed the interim financial report and interim MD&A (together, the "interim filings") of Neovasc Inc. (the "issuer") for the interim period ended June 30, 2021.

2. No misrepresentations: Based on my knowledge, having exercised reasonable diligence, the interim filings do not contain any untrue statement of a material fact or omit to state a material fact required to be stated or that is necessary to make a statement not misleading in light of the circumstances under which it was made, with respect to the period covered by the interim filings.

3. Fair presentation: Based on my knowledge, having exercised reasonable diligence, the interim financial report together with the other financial information included in the interim filings fairly present in all material respects the financial condition, financial performance and cash flows of the issuer, as of the date of and for the periods presented in the interim filings.

4. Responsibility: The issuer's other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (DC&P) and internal control over financial reporting (ICFR), as those terms are defined in National Instrument 52-109 Certification of Disclosure in Issuers' Annual and Interim Filings, for the issuer.

5. Design:  Subject to the limitations, if any, described in paragraphs 5.2 and 5.3, the issuer's other certifying officer and I have, as at the end of the period covered by the interim filings

(a) designed DC&P, or caused it to be designed under our supervision, to provide reasonable assurance that

(i) material information relating to the issuer is made known to us by others, particularly during the period in which the interim filings are being prepared; and

(ii) information required to be disclosed by the issuer in its annual filings, interim filings or other reports filed or submitted by it under securities legislation is recorded, processed, summarized and reported within the time periods specified in securities legislation; and

(b) designed ICFR, or caused it 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 the issuer's GAAP.


5.1 Control framework:  The control framework the issuer's other certifying officer and I used to design the issuer's ICFR is the Internal Control - Integrated Framework (COSO Framework) published by The Committee of Sponsoring Organizations of the Treadway Commission (COSO).

5.2 IFCR - material weakness relating to design: N/A.

5.3 Limitation on scope of design: N/A.

6. Reporting changes in ICFR: The issuer has disclosed in its interim MD&A any change in the issuer's ICFR that occurred during the period beginning on April 1, 2021 and ended on June 30, 2021 that has materially affected, or is reasonably likely to materially affect, the issuer's ICFR.

Date: August 10, 2021.

(Signed)"Fred Colen"
Fred Colen
President and Chief Executive Officer


EX-99.4 5 exhibit99-4.htm EXHIBIT 99.4 Neovasc Inc.: Exhibit 99.4 - Filed by newsfilecorp.com

Form 52-109F2

Certification of Interim Filings

Full Certificate

I, Chris Clark, the Chief Financial Officer of Neovasc Inc., certify the following:

1. Review: I have reviewed the interim financial report and interim MD&A (together, the "interim filings") of Neovasc Inc. (the "issuer") for the interim period ended June 30, 2021.

2. No misrepresentations: Based on my knowledge, having exercised reasonable diligence, the interim filings do not contain any untrue statement of a material fact or omit to state a material fact required to be stated or that is necessary to make a statement not misleading in light of the circumstances under which it was made, with respect to the period covered by the interim filings.

3. Fair presentation: Based on my knowledge, having exercised reasonable diligence, the interim financial report together with the other financial information included in the interim filings fairly present in all material respects the financial condition, financial performance and cash flows of the issuer, as of the date of and for the periods presented in the interim filings.

4. Responsibility: The issuer's other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (DC&P) and internal control over financial reporting (ICFR), as those terms are defined in National Instrument 52-109 Certification of Disclosure in Issuers' Annual and Interim Filings, for the issuer.

5. Design:  Subject to the limitations, if any, described in paragraphs 5.2 and 5.3, the issuer's other certifying officer and I have, as at the end of the period covered by the interim filings

(a) designed DC&P, or caused it to be designed under our supervision, to provide reasonable assurance that

(i) material information relating to the issuer is made known to us by others, particularly during the period in which the interim filings are being prepared; and

(ii) information required to be disclosed by the issuer in its annual filings, interim filings or other reports filed or submitted by it under securities legislation is recorded, processed, summarized and reported within the time periods specified in securities legislation; and

(b) designed ICFR, or caused it 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 the issuer's GAAP.


5.1 Control framework:  The control framework the issuer's other certifying officer and I used to design the issuer's ICFR is the Internal Control - Integrated Framework (COSO Framework) published by The Committee of Sponsoring Organizations of the Treadway Commission (COSO).

5.2 IFCR - material weakness relating to design: N/A.

5.3 Limitation on scope of design: N/A.

6. Reporting changes in ICFR: The issuer has disclosed in its interim MD&A any change in the issuer's ICFR that occurred during the period beginning on April 1, 2021 and ended on June 30, 2021 that has materially affected, or is reasonably likely to materially affect, the issuer's ICFR.

Date: August 10, 2021.

(Signed)"Chris Clark"
Chris Clark
Chief Financial Officer


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