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Exhibit 99.1

 

 

Condensed Interim Consolidated Financial Statements

As at MARCH 31, 2022 and for the three-month periodS ended March 31, 2022 and 2021

(In thousands of US dollars)

(Unaudited)

 

Condensed Interim Consolidated Statements of Financial Position 2
Condensed Interim Consolidated Statements of Changes in Shareholders’ Equity 3
Condensed Interim Consolidated Statements of Comprehensive Loss 4
Condensed Interim Consolidated Statements of Cash Flows 5
Notes to Condensed Interim Consolidated Financial Statements 6

 

(1)

 

 

 

Condensed Interim Consolidated Statements of Financial Position

(In thousands of US dollars)

(Unaudited)

 

   March 31, 2022   December 31, 2021 
    $    $ 
ASSETS          
Current assets          
Cash and cash equivalents   63,596    65,300 
Trade and other receivables (note 4)   693    1,314 
Inventory   278    73 
Income taxes receivable   1,480    2,361 
Prepaid expenses and other current assets (note 5)   1,050    1,772 
Total current assets   67,097    70,820 
Restricted cash equivalents   330    335 
Right of use assets   153    150 
Property, plant and equipment   45    42 
Other non-current assets   130     
Identifiable intangible assets   612    625 
Goodwill   7,977    8,130 
Total Assets   76,344    80,102 
LIABILITIES          
Current liabilities          
Payables and accrued liabilities (note 6)   2,795    2,672 
Current portion of provisions   34    34 
Income taxes payable   112    115 
Current portion of deferred revenues (note 3)   2,582    4,815 
Current portion of lease liabilities   143    130 
Total current liabilities   5,666    7,766 
Deferred revenues (note 3)   2,783    1,493 
Deferred gain   96    98 
Lease liabilities   22    31 
Employee future benefits (note 7)   14,386    17,485 
Provisions   232    243 
Total liabilities   23,185    27,116 
SHAREHOLDERS’ EQUITY          
Share capital (note 8)   293,410    293,410 
Warrants (note 8)   5,085    5,085 
Other capital (note 8)   89,815    89,788 
Deficit   (334,510)   (334,619)
Accumulated other comprehensive loss (“AOCI”)   (641)   (678)
Total shareholders’ equity   53,159    52,986 
Total liabilities and shareholders’ equity   76,344    80,102 

 

Commitments (note 13)

 

The accompanying notes are an integral part of these condensed interim consolidated financial statements.

 

Approved by the Board of Directors

 

/s/ Carolyn Egbert   /s/ Dennis Turpin

Carolyn Egbert

Chair of the Board

 

Dennis Turpin

Director

 

(2)

 

 

 

Condensed Interim Consolidated Statements of Changes in Shareholders’ Equity

For the three months ended march 31, 2022 and 2021

(In thousands of US dollars, except share data, unaudited)  

 

   Common shares (number of)   Share capital   Warrants   Other capital   Deficit   Accumulated other comprehensive income   Total 
       $   $   $   $   $   $ 
Balance - January 1, 2022   121,397,007    293,410    5,085    89,788    (334,619)   (678)   52,986 
Net loss                   (2,640)       (2,640)
Other comprehensive loss:                                   
Foreign currency translation adjustments                       37    37 
Actuarial gain on defined benefit plans (note 7)                   2,749        2,749 
Comprehensive income                   109    37    146 
Share-based compensation costs               27            27 
Balance – March 31, 2022     121,397,007      293,410    5,085    89,815      (334,510)   (641)       53,159 

 

   Common shares (number of)   Share capital   Warrants   Other capital   Deficit   Accumulated other comprehensive income   Total 
       $   $   $   $   $   $ 
Balance - January 1, 2021   62,678,613    235,008    12,402    89,505    (322,659)   (1,045)   13,211 
Net loss (as restated note 1)                   (1,458)       (1,458)
Other comprehensive loss:                                   
Foreign currency translation adjustments                       547    547 
Actuarial gain on defined benefit plans                   882        882 
Comprehensive loss                   (576)   547    (29)
Issuance of common shares, net of transaction costs   23,586,207    29,082    1,897                30,979 
Exercise of warrants   34,888,965    29,691    (9,704)                19,987 
Share-based compensation costs               13            13 
Balance – March 31, 2021     121,153,785      293,781    4,595    89,518      (323,235)   (498)       64,161 

 

The accompanying notes are an integral part of these condensed interim consolidated financial statements.

 

(3)

 

 

 

Condensed Interim Consolidated Statements of Comprehensive INCOME (Loss)

For the three months ended March 31, 2022 and 2021

(In thousands of US dollars, except share and per share data)

(Unaudited)

 

         
   Three months ended 
   March 31 
   2022   2021 
      

(As restated-

Note 1)

 
    $    $ 
Revenues (note 3)          
License fees   432    524 
Development services   966    1,095 
Product sales   57     
Royalties   19    8 
Supply chain   43    41 
Total revenues   1,517    1,668 
Operating expenses          
Cost of sales   79    29 
Research and development expenses   2,390    1,458 
General and administrative expenses   1,558    1,264 
Selling expenses   303    246 
Total operating expenses (note 9)   4,330    2,997 
Loss from operations   (2,813)   (1,329)
Gains (loss) due to changes in foreign currency exchange rates   174    (248)
Other finance costs   (1)   (10)
Net finance income (costs)   173    (258)
Loss before income taxes   (2,640)   (1,587)
Income tax recovery       129 
Net loss   (2,640)   (1,458)
Other comprehensive income (loss):          
Items that may be reclassified subsequently to profit or loss:          
Foreign currency translation adjustments   37    547 
Items that will not be reclassified to profit or loss:          
Actuarial gain on defined benefit plans (note 7)   2,749    882 
Comprehensive income (loss)   146    (29)
Net loss per share [basic and diluted]   (0.02)   (0.02)
Weighted average number of shares outstanding (note 12):          
Basic   121,397,007    95,444,990 
Diluted   121,397,007    95,444,990 

 

The accompanying notes are an integral part of these condensed interim consolidated financial statements.

 

(4)

 

 

 

 

Condensed Interim Consolidated Statements of Cash Flows

For the three months ended March 31, 2022 and 2021

(In thousands of US dollars)

(Unaudited)

 

         
   Three months ended 
   March 31, 
   2022   2021 
       (As restated-
Note 1)
 
    $    $ 
Cash flows from operating activities          
Net loss for the period   (2,640)   (1,458)
Items not affecting cash and cash equivalents:          
Provision   (2)   19 
Depreciation and amortization   36    36 
Share-based compensation costs   27    13 
Employee future benefits (note 7)   99    49 
Amortization of deferred revenues   (828)   (524)
Foreign exchange on items denominated in foreign currencies   (174)   266 
Other non-cash items   14    31 
Receipt of income taxes receivable   881    (1,124)
Changes in operating assets and liabilities (note 10)   1,126    1,647 
Net cash used in operating activities   (1,461)   (1,045)
Cash flows from financing activities          
Issuance of common shares (note 8)       34,200 
Transaction costs (note 8)       (3,221)
Proceeds from exercise of warrants (note 8)       19,987 
Payments on lease liabilities   (34)   (33)
Net cash (used in) provided by financing activities   (34)   50,933 
Cash flows from investing activities          
Purchase of intangible assets       (490)
Purchase of property and equipment   (6)   (17)
Net cash used in investing activities   (6)   (507)
Effect of exchange rate changes on cash and cash equivalents   (203)   (281)
Net change in cash and cash equivalents   (1,704)   49,100 
Cash and cash equivalents – Beginning of period   65,300    24,271 
Cash and cash equivalents – End of period   63,596    73,371 

 

The accompanying notes are an integral part of these condensed interim consolidated financial statements.

 

(5)

 

 

 

 

NOTES TO CONDENSED INTERIM CONSOLIDATED FINANCIAL STATEMENTS

AS AT MARCH 31, 2022 AND FOR THE THREE MONTHS ENDED MARCH 31, 2022 AND 2021

(amounts in thousands of US dollars, except share and per share data and as otherwise noted)

(Unaudited)

 

1. Business overview

 

Summary of business

 

Aeterna Zentaris (the “Company” or “Aeterna”) is a specialty biopharmaceutical company commercializing and developing therapeutics and diagnostic tests. The Company’s lead product, Macrilen™ (macimorelin), is the first and only U.S. Food and Drug Administration (“FDA”) and European Medicines Agency-approved oral test indicated for the diagnosis of patients with adult growth hormone deficiency (“AGHD”). Macrilen™ is currently marketed in the US through a license agreement (the “Novo Amendment”) between the Company and Novo Nordisk Health Care AG (“Novo”) and in the United Kingdom and Europe through a license agreement with Consilient Healthcare Inc (the “Consilient” or “CH”) under the trade name of Ghryvelin®. The Company is also dedicated to the development of therapeutic assets and has recently taken steps to establish a pre-clinical pipeline to potentially address unmet medical needs across a number of indications with a focus on rare or orphan indications and with the potential for pediatric use.

 

These unaudited condensed interim consolidated financial statements were approved by the Board of Directors (the “Board”) on May 10, 2022.

 

Basis of presentation

 

These unaudited condensed interim consolidated financial statements have been prepared in accordance with International Financial Reporting Standards as issued by the International Accounting Standards Board (“IFRS”) applicable to the preparation of interim financial statements, including IAS 34, Interim Financial Reporting. These unaudited condensed interim consolidated financial statements should be read in conjunction with the Company’s annual consolidated financial statements as at and for the year ended December 31, 2021. The accounting policies in these condensed interim consolidated financial statements are consistent with those presented in the Company’s annual consolidated financial statements, with the exception of the Company’s policy with respect to the government assistance which is as follows:

 

Government assistance

 

Amounts received or receivable resulting from government assistance programs, including grants and refundable investment tax credits for research and development, are accounted for in accordance with IAS 20 - Accounting for government grants and disclosure of government assistance and are recognized where there is reasonable assurance that the amount of government assistance will be received, and all attached conditions will be complied with. When the amount relates to an expense item such as research and development costs, it is recognized as income on a systematic basis as a reduction to the costs that it is intended to compensate. When the grant relates to an asset, it reduces the carrying amount of the asset and is then recognized as income over the useful life of the depreciable asset by way of a reduced depreciation charge.

 

(6)

 

 

 

NOTES TO CONDENSED INTERIM CONSOLIDATED FINANCIAL STATEMENTS

AS AT MARCH 31, 2022 AND FOR THE THREE MONTHS ENDED MARCH 31, 2022 AND 2021

(amounts in thousands of US dollars, except share and per share data and as otherwise noted)

(Unaudited)

 

COVID-19 & Russia and Ukraine conflict

 

The rise in COVID-19 variants has caused delays in site initiation and patient enrollment in our DETECT-trial and may be impacting sales activities for Macrilen™ in the US. Further, the continuation of the COVID-19 pandemic and the Russia/Ukraine conflict may also cause some patients to be unwilling to enroll in our trials or be unable to comply with clinical trial protocols if such events impede patient movement or interrupt healthcare services, both of which would delay our ability to conduct clinical trials or release clinical trial results on a timely basis and could delay our ability to obtain regulatory approval and commercialize our product candidates. For the period ended March 31, 2022, the Company assessed the impact of the uncertainties around the COVID-19 pandemic and the Russia/Ukraine conflict on its judgments, estimates, accounting policies and amounts recognized in these unaudited condensed interim consolidated financial statements and determined that no adjustments were required to the carrying value of assets and liabilities. Management determined that the recruitment for the DETECT-trial may now continue until later into 2023 compared to the end of the 2022 year as anticipated at the end of the previous fiscal year. As such, an amount of $1.2 million of deferred revenue has been reclassified from current to long-term portion as of March 31, 2022 to reflect the revised timeline. We are currently assessing with Novo the impact on timelines and study cost.

 

The Company will continue to monitor the impact of the development of the COVID-19 pandemic and Russia/Ukraine conflict in further reporting periods. Actual results could differ from these estimates, and such differences may be material.

 

Restatement of comparative period figures

 

At the end of the prior fiscal year2021, the Company restated its previously reported condensed consolidated interim financial statements for the three-month period ended March 31, 2021 and the three-month and six-month periods ended June 30, 2021 and three-month and nine-month periods ended September 30, 2021 with respect to the recognition of revenue for the Novo Amendment, signed in November 2020. During the fourth quarter of 2021, management reassessed the classification of the development activities associated with the DETECT-trial and concluded that subsequent to the Novo Amendment, the parties no longer shared joint control of these activities and, as such, these development activities no longer met the definition of a joint operation, as defined in IFRS 11 -Joint Arrangements. Therefore, pursuant to the guidance in IFRS 15 -Revenue from Contracts with Customers, the Company reclassified the charges to Novo, from research and development expenses to development services revenue, in the related periods. In addition, the license fees related to the pediatric indication were adjusted to reflect the revised pattern of recognition as the performance obligation for the development services has now been combined with the pediatric license. In addition, the accounting for prepaid expenses and other assets and deferred revenues related the DETECT-trial expenses incurred was restated.

 

(7)

 

 

 

NOTES TO CONDENSED INTERIM CONSOLIDATED FINANCIAL STATEMENTS

AS AT MARCH 31, 2022 AND FOR THE THREE MONTHS ENDED MARCH 31, 2022 AND 2021

(amounts in thousands of US dollars, except share and per share data and as otherwise noted)

(Unaudited)

 

The condensed interim consolidated financial statements were not adjusted and refiled at the time of discovery of the error, rather the comparatives are being corrected now with the filing of the interim financials for the period ended March 31, 2022. The impacts of the March 31, 2021 restatements are as follows (amounts in thousands, except for basic and diluted loss per share):

 

 

 

 

2. Critical accounting estimates and judgements

 

The preparation of condensed interim consolidated financial statements in accordance with IFRS requires management to make judgments, estimates and assumptions that affect the reported amounts of the Company’s assets, liabilities, revenues, expenses and related disclosures. Judgments, estimates and assumptions are based on historical experience, expectations, current trends and other factors that management believes to be relevant at the time at which the Company’s condensed interim consolidated financial statements are prepared.

 

Management reviews, on a regular basis, the Company’s accounting policies, assumptions, estimates and judgments in order to ensure that the condensed interim consolidated financial statements are presented fairly and in accordance with IFRS applicable to interim financial statements. Critical accounting estimates and assumptions, as well as critical judgments used in applying accounting policies in the preparation of the Company’s condensed interim consolidated financial statements, were the same as those applied to the Company’s annual consolidated financial statements as at and for the year ended December 31, 2021 and December 31, 2020 and for the years ended December 31, 2021, and 2020.

 

3. License and supply arrangements

 

On January 16, 2018, the Company, through AEZS Germany, entered into License Agreement with Strongbridge Ireland Limited (“Strongbridge”) to carry out development, manufacturing, registration, regulatory and supply chain services for the commercialization of Macrilen™ (macimorelin) in the U.S. and Canada. Effective December 19, 2018, Strongbridge sold the entity which owned the License Agreement for the U.S. and Canadian rights to Macrilen™ (macimorelin) to Novo Nordisk Biopharm Ltd. Ireland (Novo). In 2019, the Interim Supply Arrangement was concluded and Novo contracted AEZS Germany to provide supply chain services for the manufacture of Macrilen™ (macimorelin). On November 16, 2020, the Company, through AEZS Germany, entered into Novo Amendment of its existing License Agreement with Novo related to the development and commercialization of macimorelin. The Company earns license fees, product sales, royalties and supply chain revenue, in addition to development service revenue from conducting the Study P02, from Novo.

 

(8)

 

 

 

NOTES TO CONDENSED INTERIM CONSOLIDATED FINANCIAL STATEMENTS

AS AT MARCH 31, 2022 AND FOR THE THREE MONTHS ENDED MARCH 31, 2022 AND 2021

(amounts in thousands of US dollars, except share and per share data and as otherwise noted)

(Unaudited)

 

In June 2020, the Company entered into an exclusive distribution and quality agreement with MegaPharm Ltd. (“MegaPharm”) for the commercialization in Israel and in the Palestinian Authority of macimorelin to be used in the diagnosis of patients with adult growth hormone deficiency and in clinical development for the diagnosis of pediatric growth hormone deficiency (the “MegaPharm Agreement”). As of March 31, 2022, there have been no products supplied under this agreement. On December 7, 2020, the Company entered into an exclusive licensing agreement with Consilient Health Limited (“CH”) for the commercialization of macimorelin (the “Licensed Product”) in the European Economic Area and the United Kingdom (the “CH License Agreement”). The Company earns licenses fees and product sale revenue from CH.

 

The Company and NK Meditech Limited (“NK”) entered into a licensing agreement, effective November 30, 2021 and pursuant to which the Company granted to NK the exclusive right to commercialize (including marketing, selling and offering to sell) macimorelin in the Republic of Korea (the “ROK”) and as applicable, in the Democratic People’s Republic of Korea (“DPRK”) to the extent NK is allowed to use the aforementioned licensed rights in the latter (“NK License Agreement”). As of March 31, 2022, there have been no products supplied under this agreement.

 

The following table provides a summary of deferred revenue balances:

   March 31, 2022 
   Current   Non-Current   Total 
   $   $   $ 
Novo Amendment   2,580    1,328    3,908 
CH License Agreement   2    1,322    1,324 
NK License Agreement       133    133 
Total   2,582    2,783    5,365 

 

   December 31, 2021 
   Current   Non-Current   Total 
    $    $    $ 
Novo Amendment   4,791    23    4,814 
CH License Agreement   24    1,334    1,358 
NK License Agreement       136    136 
Total   4,815    1,493    6,308 

 

(9)

 

 

 

 

NOTES TO CONDENSED INTERIM CONSOLIDATED FINANCIAL STATEMENTS

AS AT MARCH 31, 2022 AND FOR THE THREE MONTHS ENDED MARCH 31, 2022 AND 2021

(amounts in thousands of US dollars, except share and per share data and as otherwise noted)

(Unaudited)

 

4. Trade and other receivables

 

  

March 31,

2022

   December 31, 2021 
    $    $ 
Trade accounts receivable (net of expected credit losses of $55 (December 31, 2021 - $55))   302    877 
Value-added tax   193    372 
Grant receivable   146     
Other   52    65 
Trade and other receivables   693    1,314 

 

In March 2022, the Company was awarded a monetary subsidy with respect to two pre-clinical programs—namely, the Company’s development of an oral vaccine against infections with SARS-CoV-2 and the development of a product candidate for the treatment of neuromyelitis optica. The subsidy was awarded pursuant to the provisions of the German Act on Tax Incentives for Research and Development, which provides direct reimbursement of certain qualifying R&D expenditures to eligible entities. CoV-2 grant is related to R&D expenditures incurred in 2021 and during the first quarter of 2022. Neuromyelitis Optica grant is related to expenditures incurred in 2021 and during the first quarter of 2022.

 

5. Prepaid expenses and other current assets

 

  

March 31,

2022

   December 31, 2021 
    $    $ 
Prepaid insurance       421 
Prepaid research and development   907    1,329 
Other   143    22 
Prepaid expenses and other current assets   1,050    1,772 

 

6. Payables and accrued liabilities

 

  

March 31,

2022

   December 31, 2021 
    $    $ 
Trade accounts payable   1,022    934 
Salaries, employment taxes and benefits   517    531 
Accrued research and development costs   695    596 
Other accrued liabilities   561    611 
Payables and accrued liabilities   2,795    2,672 

 

(10)

 

 

 

 

NOTES TO CONDENSED INTERIM CONSOLIDATED FINANCIAL STATEMENTS

AS AT MARCH 31, 2022 AND FOR THE THREE MONTHS ENDED MARCH 31, 2022 AND 2021

(amounts in thousands of US dollars, except share and per share data and as otherwise noted)

(Unaudited)

 

7. Employee future benefits

 

The change in the Company’s accrued benefit obligations is summarized as follows:

 

                     
   Three months ended March 31, 2022   Year ended December 31, 2021 
   Pension benefit plans   Other benefit plans   Total   Total 
    $    $    $    $ 
Change in plan liabilities                    
Balances – Beginning of the period   29,313    99    29,412    15,435 
Current service cost   17    3    20    65 
Interest cost   80        80    88 
Employee Contributions   2        2     
Actuarial gain arising from changes in financial assumptions   (3,194)       (3,194)   (1,130)
Past service cost associated with multi-employer plan               16,137 
Actuarial loss arising from change in current assumptions on funding of future pension increases               556 
Benefits paid   (165)   (1)   (166)   (511)
Impact of foreign exchange rate changes   (551)   (2)   (553)   (1,228)
Balances – End of the period   25,502    99    25,601    29,412 
                     
Change in plan assets                    
Balances – Beginning of the period   11,927        11,927     
Presentation of plan assets as of December 31, 2021               11,963 
Remeasurement of plan assets   (445)       (445)    
Employer contributions   12        12     
Employee contributions   2        2     
Benefits paid   (57)       (57)    
Impact of foreign exchange rate changes   (224)       (224)   (36)
Balances – End of the period   11,215        11,215    11,927 
                     
Net liability of the unfunded plans   10,976    99    11,075    12,749 
Net liability of the funded plans   3,311        3,311    4,736 
Net amount recognized as Employee future benefits   14,287    99    14,386    17,485 
                     
Amounts recognized:                    
In net loss   97    3    100    (153)
In other comprehensive loss   (3,076)   (2)   (3,078)   2,408 

 

The calculation of the pension benefit obligation is sensitive to the discount rate assumption. Discount rates were 1.1% at December 31, 2021 and 1.7% at March 31, 2022 causing much of the gain noted above.

 

(11)

 

 

 

 

NOTES TO CONDENSED INTERIM CONSOLIDATED FINANCIAL STATEMENTS

AS AT MARCH 31, 2022 AND FOR THE THREE MONTHS ENDED MARCH 31, 2022 AND 2021

(amounts in thousands of US dollars, except share and per share data and as otherwise noted)

(Unaudited)

 

8. Share capital, warrants and other capital

 

The Company has an unlimited number of authorized common shares (being voting and participating shares) with no par value, as well as an unlimited number of preferred, first and second ranking shares, issuable in series, with rights and privileges specific to each class, with no par value.

 

2021

 

On February 19, 2021, the Company completed an underwritten public offering of 20,509,746 common shares at $1.45 per common share, resulting in aggregate gross proceeds of $29,739, before deducting underwriting discounts, commissions and offering expenses of $2,837 (the “February 2021 Financing). The Company also granted the underwriter and placement agent (the “Underwriter”), a 30-day over-allotment option to purchase up to 3,076,461 additional common shares at a price of $1.45 per common share (the “Underwriter Option”). Additionally, the Company issued warrants underlying 1,435,682 common shares to the Underwriter, with each warrant bearing an exercise price of $1.8125 (the “February 2021 Placement Agent Warrants”). The February 2021 Placement Agent Warrants expire on February 17, 2026.

 

On February 22, 2021, the underwriter exercised the Underwriter Option in full and received 3,076,461 common shares in exchange for gross proceeds to the Company of $4,461. Upon exercise of the Underwriter Option, the Underwriter also an additional 215,352 February 2021 Placement Agent Warrants.

 

Aggregate gross proceeds received in connection with the February 2021 Financing totaled $34,200, less cash transaction costs of $3,221 and non-cash transaction costs, which represent the issue-date fair value of the February 2021 Placement Agent Warrants, of $1,897.

 

The table presented below shows the inputs and assumptions applied to the Black-Scholes option pricing model in order to determine the fair value of these Placement agent warrants:

   Number of equivalent shares   Market value per share price   Weighted average exercise price   Risk-free annual interest rate   Expected volatility   Expected life (years)   Expected dividend yield 
         ($)    ($)    (i)    (ii)    (iii)    (iv) 
February 2021 Placement agent warrants – public offering   1,435,682    1.48    1.8125    0.58734%   119.18%   4.99    0.00%
February 2021 Placement agent warrants – Underwriter Option   215,352    1.48    1.8125    0.58544%   119.57%   4.98    0.00%

 

 

  (i) Based on United States Treasury Government Bond interest rates with a term that is consistent with the expected life of the warrants.
  (ii) Based on the historical volatility of the Company’s stock price over the most recent period consistent with the expected life of the warrants.
  (iii) Based upon time to expiry from the issuance date.
  (iv) The Company has not paid dividends and it does not intend to pay dividends in the foreseeable future.

 

(12)

 

 

 

NOTES TO CONDENSED INTERIM CONSOLIDATED FINANCIAL STATEMENTS

AS AT MARCH 31, 2022 AND FOR THE THREE MONTHS ENDED MARCH 31, 2022 AND 2021

(amounts in thousands of US dollars, except share and per share data and as otherwise noted)

(Unaudited)

 

During the three-month period ended March 31, 2021, certain warrant holders exercised their warrants as follows:

 

   Warrants exercised (number of underlying common shares)   Exercise Price   Aggregate proceeds to the Company 
September 2019 Investor warrants   2,000,000   $1.65   $3,300 
February 2020 Investor warrants   1,739,130    1.20    2,087 
July 2020 Investor warrants   20,823,333    0.45    9,371 
July 2020 Placement Agent warrants   1,866,667    0.5625    1,050 
August 2020 Investor warrants   7,589,883    0.47    3,567 
August 2020 Placement Agent warrants   869,952    0.7040625    612 
    34,888,965        $19,987 

 

Other capital

 

   Three months ended March 31, 2022 
   Stock options   Weighted average exercise price   DSUs 
   (Number)   ($)   (Number) 
Balance – January 1, 2022   1,086,368    0.88    423,000 
Granted   50,000    0.36     
Expired            
Exercised            
Balance – March 31, 2022   1,136,368    0.85    423,000 

 

   Year ended December 31, 2021 
   Stock options   Weighted average exercise price   DSUs 
   (Number)   ($)   (Number) 
Balance – January 1, 2021   506,400    1.44    173,000 
Granted   580,000    0.42    280,000 
Expired   (32)   590.25     
Exercised           (30,000)
Balance – December 31, 2021   1,086,368    0.88    423,000 

 

(13)

 

 

 

 

NOTES TO CONDENSED INTERIM CONSOLIDATED FINANCIAL STATEMENTS

AS AT MARCH 31, 2022 AND FOR THE THREE MONTHS ENDED MARCH 31, 2022 AND 2021

(amounts in thousands of US dollars, except share and per share data and as otherwise noted)

(Unaudited)

 

Fair value input assumptions for US dollar stock option grants

 

The table below shows the assumptions, or weighted average parameters, applied to the Black-Scholes option pricing model in order to determine share-based compensation costs over the life of the awards.

 

      Three Months Ended   Year Ended 
      March 31,   December 31 
      2022   2021 
Expected dividend yield  (a)   0.00%   0.00%
Expected volatility  (b)   115.80%   115.80%
Risk-free annual interest rate  (c)   1.23%   1.23%
Expected life (years)  (d)   5.71    5.71 
Weighted average share price     $0.42   $0.42 
Weighted average exercise price     $0.42   $0.42 
Weighted average grant date fair value     $0.35   $0.35 

 

  (a) The Company has not paid dividends and it does not intend to pay dividends in the foreseeable future.
     
  (b) Based on the historical volatility of the Company’s stock price over the most recent period consistent with the expected life of the stock options, as well as on future expectations.
     
  (c) Based on United States Treasury Government Bond interest rates with a term that is consistent with the expected life of the stock options.
     
  (d) Based upon historical data related to the exercise of stock options, on post-vesting employment terminations and on future expectations related to exercise behavior.

 

 

9. Operating expenses

 

The nature of the Company’s operating expenses from operations include the following:

 

         
   Three months ended March 31, 
   2022   2021 
    $    $ 
Key management personnel:          
Salaries and short-term employee benefits   355    219 
Consultant fees   17    48 
Share-based compensation costs   16    10 
Post-employment benefits   18    12 
Key management personnel compensation   406    289 
Other employees:          
Salaries and short-term employee benefits   415    310 
Post-employment benefits   85    38 
Share-based compensation costs   11    3 
Other employees compensation   511    351 
Cost of inventory used and services provided   79    29 
Professional fees   647    580 
Consulting fees   260    130 
Insurance   422    227 
Third-party research and development   1,975    1,147 
Grants (note 4)   (146)    
Travel   43    22 
Marketing services   5    97 
Laboratory supplies   87    15 
Other goods and services   45    19 
Leasing costs   (40)   34 
Depreciation and amortization   36    36 
Operating foreign exchange loss       21 
Total operating expenses   4,330    2,997 

 

(14)

 

 

 

NOTES TO CONDENSED INTERIM CONSOLIDATED FINANCIAL STATEMENTS

AS AT MARCH 31, 2022 AND FOR THE THREE MONTHS ENDED MARCH 31, 2022 AND 2021

(amounts in thousands of US dollars, except share and per share data and as otherwise noted)

(Unaudited)

 

10. Supplemental disclosure of cash flow information

         
   Three months ended 
   March 31, 
   2022   2021 
    $    $ 
Changes in operating assets and liabilities:          
Trade and other receivables   474    650 
Inventory   (206)   (40)
Prepaid expenses and other current assets   711    (93)
Payables and accrued liabilities   159    115 
Taxes payable       (129)
Deferred revenues   8    1,227 
Employee future benefits   (20)   (83)
Changes in operating assets and liabilities   1,126    1,647 

 

 

11. Segment information

 

The Company operates in a single operating segment, being the biopharmaceutical segment.

 

12. Net loss per share

 

The following table sets forth pertinent data relating to the computation of basic and diluted net loss per share attributable to common shareholders.

 

           
   Three months ended 
   March 31, 
   2022   2021 
    $    $ 
Net loss   (2,640)   (1,458)
Basic weighted average number of shares outstanding   121,397,007    95,444,990 
Net loss income per share (basic)   (0.02)   (0.02)
           
Dilutive effect of stock options and DSUs        
Dilutive effect of warrants        
Diluted weighted average number of shares outstanding   121,397,007    95,444,990 
Net loss per share (diluted)   (0.02)   (0.02)
           
Items excluded from the calculation of diluted net loss per share because the exercise price was greater than the average market price of the common shares or due to their anti-dilutive effect          
Stock options and DSUs   1,559,368    679,400 
Warrants   11,441,213    11,663,435 

 

(15)

 

 

 

NOTES TO CONDENSED INTERIM CONSOLIDATED FINANCIAL STATEMENTS

AS AT MARCH 31, 2022 AND FOR THE THREE MONTHS ENDED MARCH 31, 2022 AND 2021

(amounts in thousands of US dollars, except share and per share data and as otherwise noted)

(Unaudited)

 

Net loss per share is calculated by dividing net loss by the weighted average number of shares outstanding during the relevant period. Diluted weighted average number of shares reflects the dilutive effect of equity instruments, such as any “in the money” stock options, DSUs and warrants. In periods with reported net losses, all stock options and warrants are deemed anti-dilutive such that basic net loss per share and diluted net loss per share are equal, and thus “in the money” stock options and warrants have not been included in the computation of net loss per share because to do so would be anti-dilutive.

 

13. Commitments

 

   Service and manufacturing  

R&D

contracts

  

 

TOTAL

 
    $    $    $ 
Less than 1 year   518    2,056    2,574 
1 - 3 years   638    630    1,268 
4 - 5 years   1        1 
More than 5 years            
Total   1,157    2,686    3,843 

 

The Company executed various agreements including in-licensing and similar arrangements with development partners. Such agreements may require the Company to make payments on achievement of stages of development, launch or revenue milestones, although the Company generally has the right to terminate these agreements at no penalty. The Company recognizes research and development milestones as an intangible asset once it is committed to the payment, which is generally when the Company reaches a set point in the development cycle.

 

Based on the closing exchange rates at March 31, 2022, the Company expects to pay $2,686, including $2,548 (€2.3 million), and $138 (£0.1 million), in R&D contracts and up to $8,757, including $7,248 (€6.5 million) and $1,509 (£1.2 million), in R&D milestone payments and up to $32,309, including $30,669 (€27.6 million) and $1,640 (£1.3 million), in revenue related milestone payments. The table below contains all potential R&D and revenue-related milestone payments that the Company may be required to make under such agreements:

   Future potential R&D milestone payments  

Future potential revenue milestone

payments

  

 

 

TOTAL

 
    $    $    $ 
Less than 1 year   28        28 
1 - 3 years   111        111 
4 - 5 years   909        909 
More than 5 years   7,709    32,309    40,018 
Total   8,757    32,309    41,066 

 

The future payments that are disclosed represent contract payments and are not discounted and are not risk-adjusted. The development of any pharmaceutical product candidates is a complex and risky process that may fail at any stage in the development process due to a number of factors. The timing of the payments is based on the Company’s current best estimate of achievement of the relevant milestone.

 

(16)