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Exhibit 99.1

 

 

Condensed Interim Consolidated Financial Statements

As at SEPTEMBER 30, 2022 and for the THREE- AND NINE-MONTH periodS ended SEPTEMBER 30, 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)

 

           
   September 30, 2022   December 31, 2021 
   $   $ 
ASSETS          
Current assets          
Cash and cash equivalents   53,816    65,300 
Trade and other receivables (note 4)   777    1,314 
Inventory   238    73 
Income taxes receivable   1,305    2,361 
Prepaid expenses and other current assets (note 5)   2,474    1,772 
Total current assets   58,610    70,820 
Restricted cash equivalents   300    335 
Right of use assets   85    150 
Property, plant and equipment   40    42 
Identifiable intangible assets   537    625 
Goodwill   7,034    8,130 
Total Assets   66,606    80,102 
LIABILITIES          
Current liabilities          
Payables and accrued liabilities (note 6)   2,287    2,672 
Current portion of provisions   25    34 
Income taxes payable   99    115 
Current portion of deferred revenues (note 3)   3,484    4,815 
Current portion of lease liabilities   73    130 
Total current liabilities   5,968    7,766 
Deferred revenues (note 3)   1,462    1,493 
Deferred gain   85    98 
Lease liabilities   16    31 
Employee future benefits (note 7)   9,458    17,485 
Provisions   199    243 
Total liabilities   17,188    27,116 
SHAREHOLDERS’ EQUITY          
Share capital (note 8)   293,410    293,410 
Warrants (note 8)   5,085    5,085 
Other capital (note 8)   90,291    89,788 
Deficit   (338,664)   (334,619)
Accumulated other comprehensive loss (“AOCI”)   (704)   (678)
Total shareholders’ equity   49,418    52,986 
Total liabilities and shareholders’ equity   66,606    80,102 

 

Commitments (note 12)

 

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 NINE months ended SEPTEMBER 30, 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 (loss)   Total 
Balance - January 1, 2022   4,855,876    293,410    5,085    89,788    (334,619)    (678)    52,986 
Net loss                   (10,276)        (10,276) 
Other comprehensive loss:                                   
Foreign currency translation adjustments                       (26)    (26) 
Actuarial gain on defined benefit plans and Remeasurement of the net defined benefit liability (note 7)                   6,231        6,231 
Comprehensive loss                   (4,045)    (26)    (4,071) 
Share-based compensation costs               503            503 
Balance – September 30, 2022   4,855,876    293,410    5,085    90,291    (338,664)    (704)    49,418 

 

   Common shares (number of)   Share capital   Warrants   Other capital   Deficit   Accumulated other comprehensive income (loss)   Total 
       $   $   $   $   $   $ 
Balance - January 1, 2021   2,507,145    235,008    12,402    89,505    (322,659)   (1,045)   13,211 
Net loss (as restated note 1)                   (5,474)       (5,474)
Other comprehensive loss:                                   
Foreign currency translation adjustments                       460    460 
Actuarial gain on defined benefit plans                   133        133 
Comprehensive loss                   (5,341)   460    (4,881)
Issuance of common shares, net of transaction costs   943,448    29,081    1,897                30,978 
Exercise of warrants   1,400,447    29,770    (9,728)               20,042 
Transfer of warrant issuance costs upon 2021 exercise of warrants (note 8)       (532)   532                 
Exercise of deferred share units (note 8)   840    20        (28)           (8)
Share-based compensation costs               292            292 
Balance – September 30, 2021   4,851,880    293,347    5,103    89,769    (328,000)   (585)   59,634 

 

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

 

3
 

 

 

Condensed Interim Consolidated Statements of Comprehensive Loss

For the three AND NINE months ended SEPTEMBER 30, 2022 and 2021

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

(Unaudited)

 

                     
   Three months ended   Nine months ended 
   September 30,   September 30, 
   2022   2021   2022   2021 
       (As restated-
Note 1)
       (As restated-
Note 1)
 
   $   $   $   $ 
Revenues (note 3)                    
License fees   605    293    831    1,309 
Development Services   1,202    684    2,091    2,809 
Product sales           57     
Royalties   14    20    57    47 
Supply chain   39    55    119    139 
Total revenues   1,860    1,052    3,155    4,304 
Operating expenses                    
Cost of sales   14    31    106    72 
Research and development expenses   3,293    1,485    8,081    4,711 
General and administrative expenses   2,057    1,228    5,396    4,137 
Selling expenses   217    360    822    924 
Total operating expenses   5,581    3,104    14,405    9,844 
Loss from operations   (3,721)   (2,052)   (11,250)   (5,540)
Gain (loss) due to changes in foreign currency exchange rates   301    124    977    (42)
Other finance costs       (4)   (3)   (21)
Net finance income (costs)   301    120    974    (63)
Loss before income taxes   (3,420)   (1,932)   (10,276)   (5,603)
Income tax recovery               129 
Net loss   (3,420)   (1,932)   (10,276)   (5,474)
Other comprehensive loss:                    
Items that may be reclassified subsequently to profit or loss:                    
Foreign currency translation adjustments   (105)   39    (26)   460 
Items that will not be reclassified to profit or loss:                    
Actuarial gain (loss) on defined benefit plans and remeasurement of the net defined benefit liability (note 7)   (1,794)   219    6,231    133 
Comprehensive loss   (5,319)   (1,674)   (4,071)   (4,881)
Net loss per share [basic and diluted]   (0.70)   (0.40)   (2.12)   (1.21)
Weighted average number of shares outstanding (note 11):                    
Basic   4,855,876    4,851,880    4,855,876    4,509,731 
Diluted   4,855,876    4,851,880    4,855,876    4,509,731 

 

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 AND NINE MONTHS ENDED SEPTEMBER 30, 2022 AND 2021

(In thousands of US dollars)

(Unaudited)

 

                     
   Three months ended   Nine months ended 
   September 30,   September 30, 
   2022   2021   2022   2021 
       (As restated-       (As restated-  
       Note 1)       Note 1) 
    $    $    $    $ 
Cash flows from operating activities                    
Net loss for the period   (3,420)   (1,932)   (10,276)   (5,474)
Items not affecting cash and cash equivalents:                    
Provision   7    19    12    39 
Depreciation and amortization   33    33    104    105 
Share-based compensation costs   443    19    503    292 
Employee future benefits (note 7)   69    50    266    149 
Amortization of deferred revenues   (1,248)   (527)   (1,952)   (1,601)
Foreign exchange on items denominated in foreign currencies       (45)       82 
Gain on disposal of property, plant and equipment               (1)
Interest accretion on lease liabilities   3    2    3    5 
Refund (payment) of income taxes       (426)   830    (2,067)
Other asset       (25)       (107)
Changes in operating assets and liabilities (note 9)   168    1,344    254    2,410 
Net cash used in operating activities   (3,945)   (1,488)   (10,256)   (6,168)
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)               20,042 
Payments on lease liabilities   (33)   (31)   (101)   (95)
Net cash provided by (used in) financing activities   (33)   (31)   (101)   50,926 
Cash flows from investing activities                    
Proceeds from disposal of property, plant and equipment               1 
Purchase of intangible assets               (490)
Purchase of property and equipment   (9)   (5)   (57)   (25)
Change in restricted cash equivalents   4    (20)   4    (20)
Net cash used in investing activities   (5)   (25)   (53)   (534)
Effect of exchange rate changes on cash and cash equivalents   (358)   (322)   (1,074)   (493)
Net change in cash and cash equivalents   (4,341)   (1,866)   (11,484)   43,731 
Cash and cash equivalents – Beginning of period   58,157    69,868    65,300    24,271 
Cash and cash equivalents – End of period   53,816    68,002    53,816    68,002 

 

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

 

5
 

 

 

NOTES TO CONDENSED INTERIM CONSOLIDATED FINANCIAL STATEMENTS

AS AT SEPTEMBER 30, 2022 AND FOR THE THREE AND NINE MONTHS ENDED SEPTEMBER 30, 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 (“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 several 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 November 2, 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 used in these condensed interim consolidated financial statements are consistent with those presented in the Company’s annual consolidated financial statements, with the addition 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.

 

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 September 30, 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. During the quarter ended June 30, 2022, management determined that the recruitment for the DETECT-trial and the remaining development services under the Novo Amendment 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. It is expected that the delays associated with COVID-19 and the Russia/Ukraine conflict will result in additional costs to the program. As such, this change in estimate resulted in reversal of revenue in both the license fees and development services for the quarter ended June 30, 2022. During the quarter ended September 30, 2022, Novo provided the Company with a notice of termination of the Novo Amendment. Refer to note 3 for further details on the Novo Amendment. 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.

 

6
 

 

 

NOTES TO CONDENSED INTERIM CONSOLIDATED FINANCIAL STATEMENTS

AS AT SEPTEMBER 30, 2022 AND FOR THE THREE AND NINE MONTHS ENDED SEPTEMBER 30, 2022 AND 2021

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

 

Restatement of comparative period figures

 

At the end of the prior fiscal year 2021, 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. 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 September 30, 2022. The impacts of the September 30, 2021 restatements are as follows (amounts in thousands, except for basic and diluted loss per share):

 

 

   Previously   Effect of     
   reported   restatement   Amended 
   $   $   $ 
             
Consolidated interim statement of loss and comprehensive loss for the three-month period ended September 30, 2021               
License fees   527    (234)   293 
Development service revenues       684    684 
Research and development expenses   801    684    1,485 
Net loss   (1,698)   (234)   (1,932)
Total comprehensive loss   (1,440)   (234)   (1,674)
Basic and diluted loss per share   (0.35)   (0.05)   (0.40)
                
Consolidated interim statement of loss and comprehensive loss for the nine-month period ended September 30, 2021               
License fees   1,601    (292)   1,309 
Development service revenues       2,809    2,809 
Research and development expenses   1,902    2,809    4,711 
Net loss   (5,182)   (292)   (5,474)
Total comprehensive loss   (4,589)   (292)   (4,881)
Basic and diluted loss per share   (1.07)   (0.06)   (1.21)
                
Consolidated interim statement of financial position as of September 30, 2021               
Prepaid expenses and other current assets   3,431    600    4,031 
Current portion of deferred revenues   2,075    943    3,018 
Deficit   (327,708)   (292)   (328,000)

 

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 years ended December 31, 2021 and December 31, 2020.

 

7
 

 

 

NOTES TO CONDENSED INTERIM CONSOLIDATED FINANCIAL STATEMENTS

AS AT SEPTEMBER 30, 2022 AND FOR THE THREE AND NINE MONTHS ENDED SEPTEMBER 30, 2022 AND 2021

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

 

3. License and supply arrangements

 

Novo Nordisk Health Care AG

 

On November 16, 2020, the Company, through AEZS Germany, entered into the Novo Amendment of its existing License Agreement with Novo related to the development and commercialization of macimorelin. The Company earns product sales, royalties and supply chain revenue, in addition to license fees and development service revenue from conducting the DETECT-trial, from Novo.

 

On August 26, 2022, Novo provided the Company with a notice of termination of the Novo Amendment. Under the terms of the Novo Amendment, the termination is effective May 23, 2023 upon the completion of a 270 day notice period (“notice period”). Upon termination, the rights and licenses granted by the Company to Novo under the Novo Amendment are returned to the Company, and the Company has full rights to continue the clinical development and future commercialization of Macrilen™. Following the notice of termination and throughout the 270 day notice period, Novo will continue to fund all DETECT-trial costs up to $8.6 million (€9 million), and any additional DETECT-trial costs incurred over $8.6 million (€9 million) up to $9.2 million (€9.8 million) will be shared equally between Novo and Aeterna.

 

The Company concluded that the notice of termination represents a contract modification for accounting purposes. The Company further concluded that upon receipt of the notice of termination, the remaining goods and services to be performed during the notice period are considered distinct goods and services and therefore, the contract modification is to be accounted for prospectively. As of the date of receipt of the notice of termination from Novo, the Company had recognized total license fees associated with the Pediatric Indication of $1,615 (€1,880) and total development services revenue of $3,865 (€4,448). Subsequent to the receipt of the notice of termination, management estimated the combined transaction price of the remaining services to be performed as $7,937 (€7,776), comprised of Pediatric Indication license fees of $2,872 (€2,814) and development services revenue of $5,065 (€4,962). Revenue associated with this combined performance obligation will be recognized as pediatric development services are incurred during the notice period, until the date of termination on May 23, 2023, using the cost-to-cost method. As such, all amounts in deferred revenue are classified as current as at September 30, 2022 to reflect the revised timing. Management will continue to reevaluate the transaction price at the end of each reporting period.

 

MegaPharm Ltd

 

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 September 30, 2022, there have been no products supplied under this agreement.

 

Consilient Healthcare

 

On December 7, 2020, the Company entered into an exclusive licensing agreement with “CH” for the commercialization of macimorelin in the European Economic Area and the United Kingdom (the “CH License Agreement”). The Company earns licenses fees and product sale revenue from CH.

 

NK Meditech Limited

 

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 September 30, 2022, there have been no products supplied under this agreement.

 

The following table provides a summary of deferred revenue balances:

 

   September 30, 2022 
   Current   Non-Current   Total 
   $   $   $ 
Novo Amendment   3,466        3,466 
CH License Agreement   18    1,345    1,363 
NK License Agreement       117    117 
Total   3,484    1,462    4,946 

 

8
 

 

 

NOTES TO CONDENSED INTERIM CONSOLIDATED FINANCIAL STATEMENTS

AS AT SEPTEMBER 30, 2022 AND FOR THE THREE AND NINE MONTHS ENDED SEPTEMBER 30, 2022 AND 2021

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

 

   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 

 

4. Trade and other receivables

 

           
   September 30, 2022   December 31, 2021 
   $   $ 
Trade accounts receivable (net of expected credit losses of $55 (December 31, 2021 – $55)   383    877 
Value-added tax   162    372 
Grant receivable   201     
Other   31    65 
Trade and other receivables   777    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. The CoV-2 grant is related to R&D expenditures incurred in 2021 and during 2022. The Neuromyelitis Optica grant is related to expenditures incurred in 2021 and during 2022.

 

5. Prepaid expenses and other current assets

 

           
   September 30, 2022   December 31, 2021 
   $   $ 
Prepaid insurance   839    421 
Prepaid research and development   1,561    1,329 
Other   74    22 
Prepaid expenses and other current assets   2,474    1,772 

 

9
 

 

 

NOTES TO CONDENSED INTERIM CONSOLIDATED FINANCIAL STATEMENTS

AS AT SEPTEMBER 30, 2022 AND FOR THE THREE AND NINE MONTHS ENDED SEPTEMBER 30, 2022 AND 2021

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

 

6. Payables and accrued liabilities

 

           
   September 30, 2022   December 31, 2021 
   $   $ 
Trade accounts payable   720    934 
Salaries, employment taxes and benefits   89    531 
Accrued research and development costs   855    596 
Other accrued liabilities   623    611 
 Payables and accrued liabilities   2,287    2,672 

 

7. Employee future benefits

 

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

 

                     
   Nine months ended September 30, 2022   Year ended December 31, 2021 
   Pension     Other       
   benefit plans   benefit plans   Total   Total 
   $   $   $   $ 
Change in plan liabilities                    
Balances – Beginning of the period   29,313    99    29,412    15,435 
Current service cost   48    8    56    65 
Interest cost   209    1    210    88 
Employee contributions   10        10     
Actuarial gain arising from changes in financial assumptions   (8,528)       (8,528)   (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   (513)   (1)   (514)   (511)
Impact of foreign exchange rate changes   (3,032)   (14)   (3,046)   (1,228)
Balances – End of the period   17,507    93    17,600    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   (2,297)       (2,297)    
Employer contributions   40        40     
Employee contributions   10        10     
Benefits paid   (182)       (182)    
Impact of foreign exchange rate changes   (1,356)       (1,356)   (36)
Balances – End of the period   8,142        8,142    11,927 
                     
Net liability of the unfunded plans   8,170    93    8,263    12,749 
Net liability of the funded plans   1,195        1,195    4,736 
Net amount recognized as Employee future benefits   9,365    93    9,458    17,485 
                     
Amounts recognized:                    
In net loss   257    9    266    (153)
In other comprehensive (gain) loss   (7,907)   (14)   (7,921)   (2,408)

 

The calculation of the pension benefit obligation is sensitive to the discount rate assumption and other assumptions such as the rate of the pension benefit increase. Discount rates were 1.1% at December 31, 2021, 3.25% at June 30, 2022 and 3.70% at September 30, 2022 and the pension benefits increase rates were 0.50% at December 31, 2021 and June 30, 2022 and 1.0% at September 30, 2022 causing the variances in the actuarial (gain) loss on defined benefit plan during the quarter and the nine-months ended September 30, 2022.

 

10
 

 

 

NOTES TO CONDENSED INTERIM CONSOLIDATED FINANCIAL STATEMENTS

AS AT SEPTEMBER 30, 2022 AND FOR THE THREE AND NINE MONTHS ENDED SEPTEMBER 30, 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.

 

On July 15, 2022, the Company’s shareholders and board of directors approved an amendment to the Company’s articles of amendment to effect a 1-for-25 reverse stock split of the Company’s common shares, DSU and Warrants. The Company’s outstanding stock options were also adjusted to reflect the 1-for-25 reverse stock split of the Company’s common shares. Accordingly, all common shares, DSU and Warrants, stock options and per share amounts in these condensed interim consolidated financial statements have been retroactively adjusted for all periods presented to give effect to the reverse stock split. Outstanding stock options were proportionately reduced and the respective exercise prices, if applicable, were proportionately increased. The reverse stock split was effected in the markets on July 21, 2022.

 

2021

 

On February 19, 2021, the Company completed an underwritten public offering of 820,390 common shares at $36.25 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 123,058 additional common shares at a price of $36.25 per common share (the “Underwriter Option”). Additionally, the Company issued warrants underlying 57,427 common shares to the Underwriter, with each warrant bearing an exercise price of $45.31 (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 123,058 common shares in exchange for gross proceeds to the Company of $4,461. Upon exercise of the Underwriter Option, the Underwriter also an additional 8,614 February 2021 Placement Agent Warrants.

 

11
 

 

 

NOTES TO CONDENSED INTERIM CONSOLIDATED FINANCIAL STATEMENTS

AS AT SEPTEMBER 30, 2022 AND FOR THE THREE AND NINE MONTHS ENDED SEPTEMBER 30, 2022 AND 2021

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

 

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   57,427    37    45.31    0.59%   119.18%   4.99    0%
February 2021 Placement agent warrants – Underwriter Option   8,614    37    45.31    0.59%   119.57%   4.98    0%

 

  (i) During the nine-month period ended September 30, 2021, warrants were exercised as follows:
  (ii) Based on United States Treasury Government Bond interest rates with a term that is consistent with the expected life of the warrants.
  (iii) Based on the historical volatility of the Company’s stock price over the most recent period consistent with the expected life of the warrants.
  (iv) Based upon time to expiry from the issuance date.

 

During the nine-month period ended September 30, 2021, warrants were exercised as follows:

  

    Warrants exercised (number of underlying common shares)    Exercise Price    Aggregate proceeds to the Company  
   Warrants exercised (number of underlying common shares)   Exercise Price   Aggregate proceeds to the Company 
September 2019 Investor warrants   80,000   $41.25   $3,300 
February 2020 Investor warrants   69,565    30.00    2,087 
July 2020 Investor warrants   841,822    11.25    9,471 
July 2020 Placement Agent warrants   74,667    14.06    1,050 
August 2020 Investor warrants   303,595    11.75    3,567 
August 2020 Placement Agent warrants   34,798    17.60    612 
    1,404,447        $20,087 

 

Other capital

 

   Nine months ended September 30, 2022 
   Stock options   Weighted average exercise
price
   DSUs 
   (Number)   ($)   (Number) 
Balance – January 1, 2022   43,455    22.00    16,920 
Granted   2,000    8.88    80,000 
Expired            
Exercised            
Balance – September 30, 2022   45,455    21.42    96,920 

 

12
 

 

 

NOTES TO CONDENSED INTERIM CONSOLIDATED FINANCIAL STATEMENTS

AS AT SEPTEMBER 30, 2022 AND FOR THE THREE AND NINE MONTHS ENDED SEPTEMBER 30, 2022 AND 2021

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

 

   Year ended December 31, 2021 
   Stock options   Weighted average exercise price   DSUs 
   (Number)   ($)   (Number) 
Balance – January 1, 2021   20,256    36    6,920 
Granted   23,200    10.5    11,200 
Expired   (1)   14,756.25     
Exercised           (1,200) 
Balance – December 31, 2021   43,455    22    16,920 

 

The DSU compensation expense for the three months ended September 30, 2022 was $402 (2021 - $nil) and the nine months ended September 30, 2022 was $402 (2021 – $244) recognized over the vesting period. Vested DSUs cannot be redeemed until the holder is no longer a member of the Board.

 

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.

 

                
       Nine Months Ended   Year Ended 
       September 30,   December 31, 
       2022   2021 
Expected dividend yield   (a)    0.00%   0.00%
Expected volatility   (b)    115.75%   115.80%
Risk-free annual interest rate   (c)    1.59%   1.23%
Expected life (years)   (d)    5.72    5.71 
Weighted average share price       $8.88   $10.50 
Weighted average exercise price       $8.88   $10.50 
Weighted average grant date fair value       $7.47   $8.82 

 

  (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. Supplemental disclosure of cash flow information

 

                     
   Three months ended   Nine months ended 
   September 30, 2022   September 30, 2022 
   2022   2021   2022   2021 
   $   $   $   $ 
Changes in operating assets and liabilities:                    
Trade and other receivables   205    563    425    666 
Inventory   41        (165)   (39)
Prepaid expenses and other current assets   (481)   233    (1,240)   548 
Payables and accrued liabilities   (133)   298    (14)   (17)
Taxes payable   210        210    (129)
Deferred revenues   595    318    1,425    1,606 
Employee future benefits   (269)   (68)   (387)   (225)
Changes in operating assets and liabilities   168    1,344    254    2,410 

 

13
 

 

 

NOTES TO CONDENSED INTERIM CONSOLIDATED FINANCIAL STATEMENTS

AS AT SEPTEMBER 30, 2022 AND FOR THE THREE AND NINE MONTHS ENDED SEPTEMBER 30, 2022 AND 2021

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

 

10. Segment information

 

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

 

11. 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   Nine months ended 
   September 30,   September 20, 
   2022   2021   2022   2021 
   $   $   $   $ 
Net loss   (3,420)   (1,932)   (10,276)   (5,474)
Basic weighted average number of shares outstanding   4,855,876    4,851,880    4,855,876    4,509,731 
Net loss income per share (basic)   (0.70)   (0.40)   (2.12)   (1.21)
                     
Dilutive effect of stock options and DSUs                
Dilutive effect of warrants                
Diluted weighted average number of shares outstanding   4,855,876    4,851,880    4,855,876    4,509,731 
Net loss per share (diluted)   (0.70)   0.40    (2.12)   (1.21)
                     
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   142,375    37,176    142,375    37,176 
Warrants   457,649    461,649    457,649    461,649 

 

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.

 

12. Commitments

 

   Service and manufacturing  

R&D

contracts

   TOTAL 
   $   $   $ 
Less than 1 year   7,006    1,870    8,876 
1 - 3 years   2,089    629    2,718 
4 - 5 years   46        46 
More than 5 years            
Total   9,141    2,499    11,640 

 

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.

 

Based on the closing exchange rates at September 30, 2022, the Company expects to pay $8,527 including $6,394 (€6.5 million), and $1,283 (£1.2 million) and $850 USD, in R&D milestone payments and up to $37,438, including $27,043 (€27.6 million); $1,395 (£1.3 million) and $9,000 USD, 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   24        24 
1 - 3 years   198        198 
4 - 5 years   1,243        1,243 
More than 5 years   7,062    37,438    44,500 
Total   8,527    37,438    45,965 

 

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.

 

14