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 UNDER THE SECURITIES EXCHANGE ACT OF 1934

 

For the month of March 2020

 

Commission File Number: 001-38064

 

Aeterna Zentaris Inc.

(Translation of registrant’s name into English)

 

315 Sigma Drive, Summerville, South Carolina, USA 29486

(Address of principal executive office)

 

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): [  ]

 

Indicate by check mark whether the registrant by furnishing the information contained in this Form is also thereby furnishing the information to the Commission pursuant to Rule 12g3-2(b) under the Securities Exchange Act of 1934. Yes [  ] No [X]

 

If “Yes” is marked, indicate below the file number assigned to the registrant in connection with Rule 12g3-2(b): 82-

 

 

 

 

 

 

This Report on Form 6-K, including exhibits 99.1 and 99.2 hereto, shall be deemed incorporated by reference into the Registrant’s Registration Statements on Form F-3 (File No. 333-232935) and Forms S-8 (File Nos. 333-224737, 333-210561, 333-200834) and to be a part thereof from the date on which this Report is filed, to the extent not superseded by documents or Reports subsequently filed or furnished.

 

Exhibits

 

Exhibit No.   Description
99.1  

The Registrant’s Annual Audited Consolidated Financial Statements as at December 31, 2019 and December 31, 2018 and for the years ended December 31, 2019, 2018 and 2017

     
99.2   The Registrant’s Management’s Discussion and Analysis of Financial Condition and Results of Operations for the financial year ended December 31, 2019
     
99.3   Press release dated March 30, 2020

 

 

 

 

SIGNATURE

 

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.

 

Date: March 30, 2020 AETERNA ZENTARIS INC.
   
  /s/ Leslie Auld
  Leslie Auld
  Senior Vice President and Chief Financial Officer

 

 

 

Exhibit 99.1

 

Aeterna Zentaris Inc.

 

Consolidated Financial Statements

As at December 31, 2019 and December 31, 2018 and for the years ended

December 31, 2019, 2018 and 2017

(presented in thousands of U.S. dollars)

 

     
 

 

Aeterna Zentaris Inc.

Consolidated Financial Statements

As at December 31, 2019 and December 31, 2018 and years ended December 31, 2019, 2018 and 2017

 

Consolidated Statements of Financial Position 4
Consolidated Statements of Changes in Shareholders’ (Deficiency) Equity 6
Consolidated Statements of Comprehensive (Loss) Income 8
Consolidated Statements of Cash Flows 9
Notes to Consolidated Financial Statements 10

 

(2)
 

 

Report of Independent Registered Public Accounting Firm

 

To the Board of Directors and Shareholders of Aeterna Zentaris Inc.

 

Opinion on the Financial Statements

 

We have audited the accompanying consolidated statements of financial position of Aeterna Zentaris Inc. and its subsidiaries (together, the Company) as of December 31, 2019 and 2018, and the related consolidated statements of changes in shareholders’ (deficiency) equity, comprehensive (loss) income, and cash flows for each of the three years in the period ended December 31, 2019, including the related notes (collectively referred to as the consolidated financial statements). In our opinion, the consolidated financial statements present fairly, in all material respects, the financial position of the Company as of December 31, 2019 and 2018, and its financial performance and its cash flows for each of the three years in the period ended December 31, 2019 in conformity with International Financial Reporting Standards as issued by the International Accounting Standards Board.

 

Substantial Doubt About the Company’s Ability to Continue as a Going Concern

 

The accompanying consolidated financial statements have been prepared assuming that the Company will continue as a going concern. As discussed in Note 1 to the consolidated financial statements, the Company has suffered recurring losses from operations and has a net capital deficiency that raises substantial doubt about its ability to continue as a going concern. Management’s plans in regard to these matters are also described in Note 1. The financial statements do not include any adjustments that might result from the outcome of this uncertainty.

 

Basis for Opinion

 

These consolidated financial statements are the responsibility of the Company’s management. Our responsibility is to express an opinion on the Company’s consolidated financial statements based on our audits. We are a public accounting firm registered with the Public Company Accounting Oversight Board (United States) (PCAOB) and are required to be independent with respect to the Company in accordance with the U.S. federal securities laws and the applicable rules and regulations of the Securities and Exchange Commission and the PCAOB.

 

We conducted our audits of these consolidated financial statements in accordance with the standards of the PCAOB. Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the consolidated financial statements are free of material misstatement, whether due to error or fraud. The Company is not required to have, nor were we engaged to perform, an audit of its internal control over financial reporting. As part of our audits we are required to obtain an understanding of internal control over financial reporting but not for the purpose of expressing an opinion on the effectiveness of the Company’s internal control over financial reporting. Accordingly, we express no such opinion.

 

Our audits included performing procedures to assess the risks of material misstatement of the consolidated financial statements, whether due to error or fraud, and performing procedures that respond to those risks. Such procedures included examining, on a test basis, evidence regarding the amounts and disclosures in the consolidated financial statements. Our audits also included evaluating the accounting principles used and significant estimates made by management, as well as evaluating the overall presentation of the consolidated financial statements. We believe that our audits provide a reasonable basis for our opinion.

 

“/s/ PricewaterhouseCoopers LLP”

 

Chartered Professional Accountants, Licensed Public Accountants

 

Toronto, Canada

March 30, 2020

 

We have served as the Company’s auditor since 1993.

 

(3)
 

 

Aeterna Zentaris Inc.
Consolidated Statements of Financial Position
(in thousands of US dollars)

 

    December 31, 2019     December 31, 2018  
    $     $  
ASSETS                
Current assets                
Cash and cash equivalents (note 7)     7,838       14,512  
Trade and other receivables (note 8)     658       294  
Inventory (note 9)     1,203       240  
Prepaid expenses and other current assets (note 10)     1,211       1,210  
Total current assets     10,910       16,256  
Restricted cash equivalents (note 11)     364       418  
Right of use assets (note 5(a))     582        
Property, plant and equipment (note 12)     35       65  
Identifiable intangible assets (note 13)     40       62  
Goodwill (note 14)     8,050       8,210  
Total Assets     19,981       25,011  
LIABILITIES                
Current liabilities                
Payables and accrued liabilities (note 15)     2,148       2,791  
Provision for restructuring and other costs (note 16)     418       887  
Income taxes (note 22)     1,448       1,669  
Current portion of deferred revenues (note 6(a)(ii) and 6(a)(iv))     991       249  
Current portion of lease liabilities (note 5(a))     648        
Current portion of warrant liability (note 17)     6        
Total current liabilities     5,659       5,596  
Deferred revenues (note 6(a)(ii))     185       258  
Lease liabilities (note 5(a))     255        
Warrant liability (note 17)     2,249       3,634  
Employee future benefits (note 18)     13,788       13,205  
Non-current portion of provision for restructuring and other costs (note 16)     308       411  
Total liabilities     22,444       23,104  
SHAREHOLDERS’ (DEFICIENCY) EQUITY                
Share capital (note 19)     224,528       222,335  
Other capital (note 19)     89,806       89,342  
Deficit     (316,891 )     (309,781 )
Accumulated other comprehensive income     94       11  
Total shareholders’ (deficiency) equity     (2,463 )     1,907  
Total liabilities and shareholders’ (deficiency) equity     19,981       25,011  

 

Going concern (note 1)

Commitments and contingencies (note 27)

Subsequent events (note 29)

 

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

 

(4)
 

 

Aeterna Zentaris Inc.
Consolidated Statements of Financial Position
(in thousands of US dollars)

 

Approved by the Board of Directors

 

/s/ Carolyn Egbert   /s/ Gérard Limoges

Carolyn Egbert

Chair of the Board

 

Gérard Limoges

Director

 

(5)
 

 

Aeterna Zentaris Inc.
Consolidated Statements of Changes in Shareholders’ (Deficiency) Equity
For the years ended December 31, 2019, 2018 and 2017
(in thousands of US dollars, except share data)

 

    Common shares (number of) 1     Share capital     Other capital     Deficit     Accumulated other comprehensive income     Total  
          $     $     $     $     $  
Balance - January 1, 2019     16,440,760       222,335       89,342       (309,781 )     11       1,907  
Net loss                       (6,042 )           (6,042 )
Other comprehensive (loss) income:                                                
Foreign currency translation adjustments                             83       83  
Actuarial (loss) on defined benefit plans (note 18)                       (1,068 )           (1,068 )
Comprehensive loss                       (7,110 )     83       (7,027 )
Share issuance from the exercise of warrants, stock options and deferred share units     228,750       906       (329 )                 577  
Issuance of common shares and warrants, net (notes 17 and 19)     3,325,000       1,287                         1,287  
Share-based compensation costs                 793                   793  
Balance - December 31, 2019     19,994,510       224,528       89,806       (316,891 )     94       (2,463 )

 

 

1 Issued and paid in full.

 

    Common shares (number of) 1     Share capital     Other capital     Deficit     Accumulated other comprehensive income     Total  
          $     $     $     $     $  
Balance - January 1, 2018     16,440,760       222,335       88,772       (314,161 )     271       (2,783 )
Net income                       4,187             4,187  
Other comprehensive income (loss):                                                
Foreign currency translation adjustments                             (260 )     (260 )
Actuarial gain on defined benefit plans (note 18)                       193             193  
Comprehensive income                       4,380       (260 )     4,120  
Share-based compensation costs                 570                   570  
Balance - December 31, 2018     16,440,760       222,335       89,342       (309,781 )     11       1,907  

 

 

1 Issued and paid in full.

 

(6)
 

 

Aeterna Zentaris Inc.
Consolidated Statements of Changes in Shareholders’ (Deficiency) Equity
For the years ended December 31, 2019, 2018 and 2017
(in thousands of US dollars, except share data)

 

   

Common shares

(number of) 1

    Share capital    

Pre-

funded warrants

    Other capital     Deficit     Accumulated other comprehensive income (loss)     Total  
          $     $     $     $     $     $  
Balance - January 1, 2017     12,917,995       213,980             88,590       (298,059 )     1,701       6,212  
Net loss                             (16,796 )           (16,796 )
Other comprehensive (loss) income:                                                        
Foreign currency translation adjustments                                   (1,430 )     (1,430 )
Actuarial gain on defined benefit plans (note 18)                             694             694  
Comprehensive loss                             (16,102 )     (1,430 )     (17,532 )
Share issuances pursuant to the exercise of pre-funded warrants     301,343       977                               977  
Share issuances in connection with “at-the-market” drawdowns (note 19)     3,221,422       7,378                               7,378  
Share-based compensation costs                         182                   182  
Balance - December 31, 2017     16,440,760       222,335             88,772       (314,161 )     271       (2,783 )

 

 

1 Issued and paid in full.

 

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

 

(7)
 

 

Aeterna Zentaris Inc.
Consolidated Statements of Comprehensive (Loss) Income
For the years ended December 31, 2019, 2018 and 2017
(in thousands of US dollars, except share and per share data)

 

    Years Ended December 31,  
    2019     2018     2017  
    $     $     $  
Revenues (note 6)                        
License fees     74       24,325       458  
Product sales     129       2,167        
Royalty income     45       184        
Sales commission           110       465  
Supply chain     284       95        
Total revenues     532       26,881       923  
Operating expenses (note 20)                        
Cost of sales     410       2,104        
Research and development costs     1,837       2,932       10,704  
General and administrative expenses     6,615       8,894       8,198  
Selling expenses     1,214       3,109       5,095  
Restructuring costs (note 16)     507              
Impairment of right of use asset (note 5a)     22              
Impairment of prepaid asset (note 10)     169              
Total operating expenses     10,774       17,039       23,997  
(Loss) income from operations     (10,242 )     9,842       (23,074 )
Settlements (note 27)           (1,400 )      
Gain due to changes in foreign currency exchange rates     87       656       502  
Change in fair value of warrant liability (note 17)     4,518       263       2,222  
Other finance (costs) income     (593 )     278       75  
Net finance income     4,012       1,197       2,799  
(Loss) income before income taxes     (6,230 )     9,639       (20,275 )
Income tax recovery (expense) (note 22)     188       (5,452 )     3,479  
Net (loss) income     (6,042 )     4,187       (16,796 )
Other comprehensive (loss) income:                        
Items that may be reclassified subsequently to profit or loss:                        
Foreign currency translation adjustments     83       (260 )     (1,430 )
Items that will not be reclassified to profit or loss:                        
Actuarial (loss) gain on defined benefit plans     (1,068 )     193       694  
Comprehensive (loss) income     (7,027 )     4,120       (17,532 )
Net (loss) income per share (basic) (note 26)     (0.35 )     0.25       (1.12 )
Net (loss) income per share (diluted) (note 26)     (0.35 )     0.24       (1.12 )
Weighted average number of shares outstanding (note 26)                        
Basic     17,494,472       16,440,760       14,958,704  
Diluted     17,494,472       17,034,812       14,958,704  

 

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

 

(8)
 

 

Aeterna Zentaris Inc.
Consolidated Statements of Cash Flows
For the years ended December 31, 2019, 2018 and 2017
(in thousands of US dollars)

 

    Years Ended December 31,  
    2019     2018     2017  
    $     $     $  
Cash flows from operating activities                        
Net (loss) income for the year     (6,042 )     4,187       (16,796 )
Items not affecting cash and cash equivalents:                        
Change in fair value of warrant liability (note 17)     (4,518 )     (263 )     (2,222 )
Transaction costs of warrants issued, expensed as finance cost     550              
Provision for restructuring and other costs (note 16)     511       (136 )     3,083  
Impairment of right of use asset (note 5(a))     22              
Impairment of prepaid asset (note 10)     169              
Recapture of inventory previously written off                 (643 )
Depreciation and amortization (notes 5,12 and 13)     315       58       94  
Deferred income taxes (note 22)           3,479       (3,479 )
Share-based compensation costs (note 20)     793       570       182  
Employee future benefits (note 18)     262       316       246  
Amortization of deferred revenues (note 6)     (74 )     (609 )     (458 )
Foreign exchange gain on items denominated in foreign currencies     (87 )     (652 )     (553 )
Loss (gain) on disposal of property, plant and equipment     10       (9 )     (136 )
Other non-cash items     (126 )     35       (19 )
Interest accretion on lease liabilities (note 5)     (66 )            
Changes in operating assets and liabilities (note 21)     (2,444 )     (151 )     (2,212 )
Net cash (used in) provided by operating activities     (10,725 )     6,825       (22,913 )
Cash flows from financing activities                        
Proceeds from issuances of common shares and warrants (note 19)     4,988             8,038  
Transaction costs     (795 )           (250 )
Proceeds from exercise of warrants, stock options and deferred share units     314             242  
Payments on lease liabilities (note 5)     (614 )            
Net cash provided by financing activities     3,893             8,030  
Cash flows from investing activities                        
Purchase of property, plant and equipment (note 12)           (9 )     (4 )
Proceeds for disposals of property, plant and equipment (note 12)           24       161  
Cash provided by (used in) restricted cash equivalents     50       (50 )     150  
Net cash provided by (used in) investing activities     50       (35 )     307  
Effect of exchange rate changes on cash and cash equivalents     108       (58 )     357  
Net change in cash and cash equivalents     (6,674 )     6,732       (14,219 )
Cash and cash equivalents – beginning of year (note 7)     14,512       7,780       21,999  
Cash and cash equivalents – end of year (note 7)     7,838       14,512       7,780  

 

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

 

(9)
 

 

Aeterna Zentaris Inc.
Notes to Consolidated Financial Statements
As at December 31, 2019 and December 31, 2019 and for the years ended December 31, 2019, 2018 and 2017
(tabular amounts in thousands of US dollars, except share/option/warrant/DSU and per share/option/warrant/DSU data and as otherwise noted)

 

1 Going concern

 

Aeterna Zentaris Inc. (“Aeterna Zentaris” or the “Company”) has incurred significant expenses in its efforts to develop and co-promote products. Consequently, the Company has incurred operating losses and negative cash flow from operations historically and in each of the last several years except for the year ended December 31, 2018 when the Company earned revenue from the sale of a license for the adult indication of Macrilen™ (macimorelin) in the United States and Canada (note 6(a)). As at December 31, 2019, the Company had an accumulated deficit of $316,891. The Company also had a net loss of $6,042 for the year ended December 31, 2019, and negative cash flow from operations of $10,725.

 

Management has evaluated whether material uncertainties exist relating to events or conditions that may cast substantial doubt about the Company’s ability to continue as a going concern and has considered the following in making that critical judgment.

 

The ability of the Company to realize its assets and meet its obligations as they come due is dependent on earning sufficient revenues under the License Agreement, developing opportunities for Macrilen™ (macimorelin) in the rest of the world, realizing other monetizing transactions, and raising additional sources of funding, the outcome of which cannot be predicted at this time. The revenue provided under the License Agreement was $45 for the year ended December 31, 2019 and as at December 31, 2019, the Company had cash of $7,838. In September 2019, the Company closed an equity financing which provided $4,193 in net cash proceeds. On February 21, 2020, the Company closed an equity financing for approximately $3,920 in net cash proceeds.

 

A significant portion of the Company’s cash is held in AEZS Germany, the Company’s principle operating subsidiary. AEZS Germany is the counter-party to the License Agreement described above with Novo, and as such, for generating future revenue earned under the License Agreement. As such, management considers the cash resources available to AEZS Germany in executing its obligations under the License Agreement. In the event the current and medium term liabilities of AEZS Germany exceeds the fair values ascribed to its assets, under German solvency laws, it may no longer be possible for AEZS Germany’s operations to continue or for AEZS Germany to transfer cash to Aeterna Zentaris Inc or its U.S. subsidiary. This imposes additional and material uncertainties on the Company when evaluating liquidity and the going concern assumption.

 

The Company has some discretion to manage its planned research and development costs, administrative expenses and capital expenditures in order to manage its cash liquidity, particularly in AEZS Germany. Furthermore, AEZS Germany is focused on opportunities to either license or sell the European or worldwide rights to Macrilen™ (macimorelin) to third parties. As of the date of issuance of these consolidated financial statements, there are no assurances that cash will be generated from such arrangements. As such, management may also need to consider other sources of financing in order to continue its planned operations.

 

Management has assessed the Company’s ability to continue as a going concern and concluded that additional capital will be required. There can be no assurance that the Company will be able to execute license or purchase agreements or to obtain equity or debt financing, or on terms acceptable to it. Factors within and outside the Company’s control could have a significant bearing on its ability to obtain additional financing (note 29). As a result, management has determined that there are material uncertainties that may cast significant doubt upon the Company’s ability to continue as a going concern.

 

(10)
 

 

Aeterna Zentaris Inc.
Notes to Consolidated Financial Statements
As at December 31, 2019 and December 31, 2019 and for the years ended December 31, 2019, 2018 and 2017
(tabular amounts in thousands of US dollars, except share/option/warrant/DSU and per share/option/warrant/DSU data and as otherwise noted)

 

These financial statements have been prepared on a going concern basis, which asserts the Company has the ability in the near term to continue to realize its assets and discharge its liabilities and commitments in a planned manner giving consideration to the above and expected possible outcomes. Conversely, if the going concern assumption is not appropriate, adjustments to the carrying amounts of the Company’s assets, liabilities, revenues, expenses and balance sheet classifications may be necessary, and these adjustments could be material.

 

2 Business overview

 

Summary of business

 

Aeterna Zentaris is a specialty biopharmaceutical company commercializing and developing therapeutics and diagnostic tests. The Company’s lead product, Macrilen™ (macimorelin), is the first and only United States Food and Drug Administration (“FDA”) and European Commission approved oral test indicated for the diagnosis of patients with adult growth hormone deficiency (“AGHD”). Macrilen™ (macimorelin) is currently marketed in the U.S. through a license and assignment agreement (the “License Agreement”) with Novo. Aeterna Zentaris is also pursuing the development of macimorelin for the diagnosis of child-onset growth hormone deficiency (CGHD), an area of significant unmet need. In addition, we are actively pursuing business development opportunities for the commercialization of macimorelin in Europe and the rest of the world in addition to other non-strategic assets to monetize their value

 

The Company’s principal focus is on the commercialization of Macrilen™ (macimorelin) and it currently does not have any other approved products. Under the terms of License Agreement (as defined below), Novo Nordisk A/S (“Novo”) is funding 70% of the pediatric clinical trial submitted to the EMA and FDA, the Company’s sole development activity. In November 2019, Novo contracted Aeterna Zentaris GmbH (“AEZS Germany”), our wholly owned German subsidiary, to provide supply chain services for the manufacture of Macrilen™ (macimorelin).

 

Reporting entity

 

The accompanying consolidated financial statements include the accounts of Aeterna Zentaris Inc., an entity incorporated under the Canada Business Corporations Act, and its wholly-owned subsidiaries (collectively referred to as the “Group”). Aeterna Zentaris Inc. is the ultimate parent company of the Group. The Company currently has three wholly-owned direct and indirect subsidiaries, AEZS Germany, based in Frankfurt, Germany, Zentaris IVF GmbH, a wholly-owned subsidiary of AEZS Germany, based in Frankfurt, Germany, and Aeterna Zentaris, Inc., an entity incorporated in the state of Delaware and with offices in Summerville, South Carolina, in the U.S.

 

The registered office of the Company is located at 5300 Commerce Court West, 199 Bay Street, Toronto, Ontario M5L 1B9, Canada and its principal place of business is 315 Sigma Drive, Summerville, South Carolina 29486.

 

The Company’s common shares are listed on both the Toronto Stock Exchange (the “TSX”) and on the NASDAQ Capital Market (the “NASDAQ”).

 

Basis of presentation

 

  (a) Statement of compliance

 

These consolidated financial statements as at December 31, 2019 and December 31, 2018 and for the years ended December 31, 2019, 2018 and 2017 have been prepared in accordance with International Financial Reporting Standards (“IFRS”) as issued by the International Accounting Standards Board (“IASB”).

 

These consolidated financial statements were approved by the Company's Board of Directors subject to confirmation by the Audit Committee of the Board of Directors, which confirmation was received on March 27, 2020.

 

The preparation of financial statements in accordance with IFRS requires the use of certain critical accounting estimates and the exercise of management’s judgment in applying the Company’s accounting policies. Areas involving a high degree of judgment or complexity and areas where assumptions and estimates are significant to the Company’s consolidated financial statements are discussed in note 4 - Critical accounting estimates and judgments.

 

(11)
 

 

Aeterna Zentaris Inc.
Notes to Consolidated Financial Statements
As at December 31, 2019 and December 31, 2019 and for the years ended December 31, 2019, 2018 and 2017
(tabular amounts in thousands of US dollars, except share/option/warrant/DSU and per share/option/warrant/DSU data and as otherwise noted)

 

  (b) Basis of measurement

 

The consolidated financial statements have been prepared under a historical cost convention except for warrant liability which is measured at fair value through profit or loss.

 

  (c) Principles of consolidation

 

These consolidated financial statements include any entity in which the Company directly or indirectly holds more than 50% of the voting rights or over which the Company exercises control. The Company controls an entity when the Company is exposed to, or has rights to, variable returns from its involvement with the entity and has the ability to affect those returns through its power over the entity. An entity is included in the consolidation from the date that control is transferred to the Company, while any entities that are sold are excluded from the consolidation from the date that control ceases. All inter-company balances and transactions are eliminated on consolidation.

 

  (d) Foreign currency

 

Items included in the financial statements of the Group’s entities are measured using the currency of the primary economic environment in which the entities operate (the “functional currency”) which is U.S. dollars for the Company and its U.S. subsidiary, Aeterna Zentaris, Inc. and Euro (“EUR”) for its German subsidiaries.

 

Assets and liabilities of the German subsidiaries are translated from EUR balances at the period-end exchange rates, and the results of operations are translated from EUR amounts at average rates of exchange for the period. The resulting translation adjustments are included in accumulated other comprehensive income within shareholders’ (deficiency) equity.

 

Foreign currency transactions are translated into the functional currency using the exchange rates prevailing at the dates of the underlying transaction. Foreign exchange gains and losses resulting from the settlement of such transactions and from the translation of monetary assets and liabilities not denominated in the functional currency are recognized in the consolidated statement of comprehensive (loss) income.

 

3 Summary of significant accounting policies

 

The accounting policies set out below have been applied consistently to all years presented in these consolidated financial statements except for the adoption of those standards in 2019 (note 5) and have been applied consistently by all Group entities.

 

Cash and cash equivalents

 

Cash and cash equivalents consist of unrestricted cash on hand and balances with banks, as well as short-term interest-bearing deposits, such as money market accounts, that are readily convertible to known amounts of cash and are subject to an insignificant risk of changes in value, with a maturity of three months or less from the date of acquisition.

 

Inventories

 

Inventories are valued at the lower of cost or net realizable value. Cost is determined using the first-in, first-out method for all inventories. The Company’s policy is to write down inventory that has become obsolete and inventory that has a cost basis in excess of its expected net realizable value. Increases in the reserve are recorded as charges in cost of sales. For product candidates that have not been approved by the FDA, inventory used in clinical trials is written down at the time of production and recorded as research and development (“R&D”) costs. For products that have been approved by the FDA, inventory used in clinical trials is expensed at the time the inventory is packaged for the clinical trial. All direct manufacturing costs incurred after approval are capitalized into inventory.

 

(12)
 

 

Aeterna Zentaris Inc.
Notes to Consolidated Financial Statements
As at December 31, 2019 and December 31, 2019 and for the years ended December 31, 2019, 2018 and 2017
(tabular amounts in thousands of US dollars, except share/option/warrant/DSU and per share/option/warrant/DSU data and as otherwise noted)

 

Restricted cash equivalents

 

Restricted cash equivalents are comprised of bank deposits, related to a guarantee for a long-term operating lease obligation and for a corporate credit card program that cannot be used for current purposes.

 

Leases

 

The Company assesses, at the inception of a contract, whether a contract is, or contains, a lease. A lease is a contract in which the right to control the use of an identified asset is granted for an agreed upon period of time in exchange for consideration. The Company assessed whether a contract conveys the right to control the use of an identified asset when there is both the right to direct the use of the asset and obtain substantially all the economic benefits from that use. Effective January 1, 2019, the Company recognizes a right of use and a lease liability at the lease commencement date.

 

The lease liability is initially measured at the present value of the non-cancellable lease payments over the lease term and discounted at the rate implicit in the lease. If that rate cannot be determined, the Company’s incremental borrowing rate is used, being the rate that Company would have to pay to borrow the funds necessary to obtain an asset of similar value in a similar economic environment with similar terms and conditions. Lease payments include fixed payments and such variable payments that depend on an index or a rate; less any lease incentives receivable.

 

The lease liability is subsequently measured at amortized cost using the effective interest method. It is remeasured when there is a change in future lease payments arising from a change in an index or rate, if there is a change in the Company’s estimate of the amount expected to be payable under a residual value guarantee, or if the Company changes its assessment of whether it will exercise a purchase, extension or termination option. When the lease liability is remeasured, a corresponding adjustment is made to the carrying amount of the right of use asset, with any difference recorded in the statement of comprehensive (loss) income.

 

The right of use assets are measured at cost which comprises the initial lease liability, lease payments made at or before the lease commencement date, initial direct costs and restoration obligations less lease incentives. The right of use assets are subsequently measured at amortized cost. The assets are depreciated over the shorter of the assets’ useful life and the lease terms on a straight-line basis, less any accumulated impairment losses and adjusted for any remeasurement of the lease liability. The lease term includes periods covered by an option to extend if the Company is reasonably certain to exercise that option. The right of use assets are assessed for impairment in accordance with the requirements of IAS 36 Impairment of Assets.

 

Payments associated with short-term leases and leases of low-value assets are recognized on a straight-line basis as an expense in the statement of comprehensive (loss) income.

 

Property, plant and equipment and depreciation

 

Items of property, plant and equipment are recorded at cost, net of accumulated depreciation and impairment charges. Depreciation is calculated using the following methods, annual rates and period:

 

    Methods   Annual rates and period
Equipment   Declining balance and straight-line   20%
Furniture and fixtures   Declining balance and straight-line   10% and 20%
Computer equipment   Straight-line   25% and 331/3%
Leasehold improvements   Straight-line   Remaining lease term

 

Depreciation expense, which is recorded in the consolidated statement of comprehensive (loss) income, is allocated to the appropriate functional expense categories to which the underlying items of property, plant and equipment relate.

 

Identifiable intangible assets and amortization

 

Identifiable intangible assets with finite useful lives consist of in-process R&D acquired in business combinations, patents and trademarks. In-process R&D acquired in business combinations is recognized at fair value at the acquisition date. Patents and trademarks are comprised of costs, including professional fees incurred in connection with the filing of patents and the registration of trademarks for product marketing and manufacturing purposes net of related government grants, impairment losses, where applicable, and accumulated amortization. Identifiable intangible assets with finite useful lives are amortized, from the time at which the assets are available for use, on a straight-line basis over their estimated useful lives of eight to fifteen years for in-process R&D and patents and ten years for trademarks. Amortization expense, which is recorded in the consolidated statement of comprehensive (loss) income, is allocated to the appropriate functional expense categories to which the underlying identifiable intangible assets relate.

 

(13)
 

 

Aeterna Zentaris Inc.
Notes to Consolidated Financial Statements
As at December 31, 2019 and December 31, 2019 and for the years ended December 31, 2019, 2018 and 2017
(tabular amounts in thousands of US dollars, except share/option/warrant/DSU and per share/option/warrant/DSU data and as otherwise noted)

 

Goodwill

 

Goodwill is recognized as the fair value of the consideration transferred including the recognized amount of any non-controlling interest in the acquiree, less the fair value of the net identifiable assets acquired and liabilities assumed, as of the acquisition date. Subsequent to initial recognition, goodwill is measured at cost less accumulated impairment losses. Goodwill acquired in business combinations is allocated to groups of cash generating units (“CGU”) that are expected to benefit from the synergies of the combination.

 

Impairment of assets

 

Items of property, plant and equipment and identifiable intangible assets with finite lives subject to depreciation or amortization, respectively, are reviewed for impairment whenever events or changes in circumstances indicate that the carrying amounts of the assets may not be recoverable. Management is required to assess at each reporting date whether there is any indication that an asset may be impaired. Where such an indication exists, the asset’s recoverable amount is compared to its carrying value, and an impairment loss is recognized for the amount by which the asset’s carrying amount exceeds its recoverable amount. The recoverable amount is the higher of an asset’s fair value less costs to sell and value in use. For the purpose of assessing impairment, assets are grouped at the lowest levels for which there are separately identifiable cash flows, or CGU. In determining value in use of a given asset or CGU, estimated future cash flows are discounted to their present value using a pre-tax discount rate that reflects current market assessments of the time value of money and the risks specific to the asset. Impairment losses are allocated to the appropriate functional expense categories to which the underlying identifiable intangible assets relate, and are recorded in the consolidated statement of comprehensive (loss) income.

 

Items of property, plant and equipment and amortizable identifiable intangible assets with finite lives that suffered impairment are reviewed for possible reversal of the impairment if there has been a change, since the date of the most recent impairment test, in the estimates used to determine the impaired asset’s recoverable amount. However, an asset’s carrying amount, increased due to the reversal of a prior impairment loss, must not exceed the carrying amount that would have been determined, net of depreciation or amortization, had the original impairment not occurred.

 

Goodwill is not subject to amortization and instead is tested for impairment annually or more often if there is an indication that the CGU to which the goodwill has been allocated may be impaired. Impairment is determined for goodwill by assessing whether the carrying value of a CGU, including the allocated goodwill, exceeds its recoverable amount, which is the higher of fair value less costs to sell and value in use. In the event that the carrying amount of goodwill exceeds its recoverable amount, an impairment loss is recognized in an amount equal to the excess. Impairment losses related to goodwill are not subsequently reversed.

 

Share purchase warrants

 

Share purchase warrants are classified as liabilities when the Company does not have the unconditional right to avoid delivering cash to the holders in the future. Each of the Company’s share purchase warrants contains a written put option, arising upon the occurrence of a fundamental transaction, as that term is defined in the share purchase warrants, including a change of control. As a result of the existence of these put options, and despite the fact that the repurchase feature is conditional on a defined contingency, the share purchase warrants are required to be classified as a financial liability, since such contingency could ultimately result in the transfer of assets by the Company.

 

(14)
 

 

Aeterna Zentaris Inc.
Notes to Consolidated Financial Statements
As at December 31, 2019 and December 31, 2019 and for the years ended December 31, 2019, 2018 and 2017
(tabular amounts in thousands of US dollars, except share/option/warrant/DSU and per share/option/warrant/DSU data and as otherwise noted)

 

The warrant liability is initially measured at fair value, and any subsequent changes in fair value are recognized as gains or losses through profit or loss. Any transaction costs related to the share purchase warrants are expensed as incurred.

 

The warrant liability is classified as non-current, unless the underlying share purchase warrants will expire or be settled within 12 months from the end of a given reporting period.

 

Employee benefits

 

Salaries and other short-term benefits

 

Salaries and other short-term benefit obligations are measured on an undiscounted basis and are recognized in the consolidated statement of comprehensive (loss) income over the related service period or when the Company has a present legal or constructive obligation to make payments as a result of past events and when the amount payable can be estimated reliably.

 

Post-employment benefits

 

AEZS Germany maintains defined contribution and unfunded defined benefit plans, as well as other benefit plans for its employees. For defined benefit pension plans and other post-employment benefits, net periodic pension expense is actuarially determined on a quarterly basis using the projected unit credit method. The cost of pension and other benefits earned by employees is determined by applying certain assumptions, including discount rates, the projected age of employees upon retirement, the expected rate of future compensation and employee turnover.

 

The employee future benefits liability is recognized at its present value, which is determined by discounting the estimated future cash outflows using interest rates of high-quality corporate bonds that are denominated in the currency in which the benefits will be paid and that have terms to maturity approximating the terms of the related future benefit liability. Actuarial gains and losses that arise in calculating the present value of the defined benefit obligation are recognized in other comprehensive (loss) income, net of tax, and simultaneously reclassified in the deficit in the consolidated statement of financial position in the year in which the actuarial gains and losses arise and without recycling to the consolidated statement of comprehensive (loss) income in subsequent periods.

 

For defined contribution plans, expenses are recorded in the consolidated statement of comprehensive (loss) income as incurred–namely, over the period that the related employee service is rendered.

 

Termination benefits

 

Termination benefits are recognized in the consolidated statement of comprehensive (loss) income when the Company is demonstrably committed, without the realistic possibility of withdrawal, to a formal detailed plan to terminate employment earlier than originally expected. Termination benefit liabilities expected to be settled after 12 months from the end of a given reporting period are discounted to their present value, where material.

 

Financial instruments

 

The Company classifies its financial instruments in the following categories: “Financial assets at fair value through profit or loss (“FVTPL”); “Financial assets at amortized cost”; “Financial liabilities at “FVTPL”; and “Financial liabilities at amortized cost”.

 

Financial assets at FVTPL: Financial assets carried at FVTPL are initially recorded at fair value and transaction costs are expensed in the statement of comprehensive (loss) income. Realized and unrealized gains and losses arising from changes in the fair value of the financial assets held at FVTPL are included in the statement of comprehensive (loss) income in the period in which they arise.

 

(15)
 

 

Aeterna Zentaris Inc.
Notes to Consolidated Financial Statements
As at December 31, 2019 and December 31, 2019 and for the years ended December 31, 2019, 2018 and 2017
(tabular amounts in thousands of US dollars, except share/option/warrant/DSU and per share/option/warrant/DSU data and as otherwise noted)

 

Financial liabilities at FVTPL: These financial liabilities are initially recognized at fair value, and transaction costs directly attributable to issuing the warrants are expensed in the statement of comprehensive (loss) income. Financial liabilities that are required to be measured at FVTPL have all fair value movements, excluding those related to changes in the credit risk of the liability which are recorded in other comprehensive (loss) income, recognized in the statement of comprehensive (loss) income.

 

Financial assets at fair value through other comprehensive income (FVTOCI): Investments in equity instruments at FVTOCI are initially recognized at fair value plus transaction costs. Subsequently they are measured at fair value, with gains and losses arising from changes in fair value recognized in other comprehensive income (loss) in the period in which they arise.

 

Financial assets at amortized cost: A financial asset is measured at amortized cost if the objective of the business model is to hold the financial asset for the collection of contractual cash flows, and the asset’s contractual cash flows are comprised solely of payments of principal and interest. They are classified as current assets or non-current assets based on their maturity date, and are initially recognized at fair value and subsequently carried at amortized cost less any impairment.

 

Impairment of financial assets at amortized cost: The Company recognizes a loss allowance for expected credit losses on financial assets that are measured at amortized cost.

 

Share capital

 

Common shares are classified as equity. Incremental costs that are directly attributable to the issuance of common shares and stock options are recognized as a deduction from equity, net of any tax effects.

 

Where offerings result in the issuance of units (where each unit is comprised of a common share of the Company and a share purchase warrant, exercisable in order to purchase a common share or fraction thereof), proceeds received in connection with those offerings are allocated between share capital and share purchase warrants based on the residual method. Proceeds are allocated to warrant liability based on the fair value of the share purchase warrants, and the residual amount of proceeds is allocated to share capital. Transaction costs in connection with such offerings are allocated to the liability and equity unit components in proportion to the allocation of proceeds.

 

Provisions

 

Provisions represent liabilities to the Company for which the amount or timing is uncertain. Provisions are recognized when the Company has a present legal or constructive obligation as a result of past events, such as organizational restructuring, when it is probable that an outflow of resources will be required to settle the obligation and where the amount can be reliably estimated. Provisions are not recognized for future operating losses.

 

Provisions are made for any contracts which are deemed onerous. A contract is onerous if the unavoidable costs of meeting the obligations under the contract exceed the economic benefits expected to be received under it. Provisions for onerous contracts are measured at the present value of the lower of the expected cost of terminating the contract and the expected net cost of continuing with the contract. Present value is determined based on expected future cash flows that are discounted at a pre-tax rate that reflects current market assessments of the time value of money and the risks specific to the liability. The unwinding of the discount is recognized in finance costs.

 

(16)
 

 

Aeterna Zentaris Inc.
Notes to Consolidated Financial Statements
As at December 31, 2019 and December 31, 2019 and for the years ended December 31, 2019, 2018 and 2017
(tabular amounts in thousands of US dollars, except share/option/warrant/DSU and per share/option/warrant/DSU data and as otherwise noted)

 

Revenue recognition

 

Effective January 1, 2018, the Company adopted IFRS 15, Revenue from Contracts with Customers (“IFRS 15”). The standard was applied using a modified retrospective approach. The adoption of IFRS 15 did not have a significant impact on the timing or measurement of the Company’s revenue and no adjustment to the opening balance of deficit as at January 1, 2018 has been recorded as result of adopting IFRS 15.

 

License fees

 

License fees represent non-refundable payments received at the time of executing the license agreements. The Company’s promise to grant a license provides its customer with either a right to access the Company’s intellectual property (“IP”) or a right to use the Company’s IP. Revenue from a license that provides a customer the right to use the Company’s IP is recognized at a point in time when the transfers to the licensee is completed and the license period begins. Revenue from a license that provides access to the Company’s IP over a license term is considered to be a performance obligation satisfied over time and, therefore, revenue is recognized over the term of the license arrangement.

 

Royalty and milestone income

 

Royalty income earned through a license is recognized when the underlying sales have occurred. Milestone income is recognized at the point in time when it is highly probable that the respective milestone event criteria are met, and the risk of reversal of revenue recognition is remote.

 

The Company has not recognized any such milestone revenue in these consolidated financial statements

 

Product sales

 

The Company recognizes revenue from the sale of certain active pharmaceutical ingredients (“API”) and semi-finished goods upon delivery of such items to its customer.

 

Supply chain revenue

 

The Company recognizes revenue, from the achievement of performance obligations with respect to The Company also provides oversight support services for supervision of stability studies and/or development activities with respect to the API batch production as specified in related contracts with customers. These services are contracted with fixed-fees and are provided Revenues from sales commission are recognized from the achievement of performance obligations over a period of time equal to one year. The Company recognizes revenue on a straight-line basis over time as it best represents the pattern of performance of the services. Amounts are invoiced on a quarterly basis in accordance with agreed upon contractual terms

 

CostsWhile providing services, the Company incurs certain direct costs for subcontractors and other expenses that are recoverable directly from its customers. The recoverable amounts of these direct costs are included in the Company’s operating expenses as the Company controls the services before they are transferred to the customer and acts as a principal in these arrangements.

 

Where the Company incurs costs to fulfil the contract, such costs are capitalized if all of the following criteria are met:

 

  · the costs relate directly to a contract or a specifically-anticipated contract;
     
  · the costs generate or enhance company resources that will be used in satisfying future performance obligations; and
     
  · the costs are expected to be recovered.

 

Sales commission revenue

 

Revenues from sales commission are recognized when the products are sold and the related performance obligation is complete as defined in the contract for the promotion of certain products, there is certainty about receipt of the consideration and all related costs have been incurred. The customer contracts for sales commission were terminated in 2017 and 2018.

 

Share-based compensation costs

 

The Company operates an equity-settled share-based compensation plan under which the Company receives services from directors, senior executives, employees and other collaborators as consideration for equity instruments of the Company.

 

The Company accounts for all forms of share-based compensation using the fair value-based method. Fair value of stock options is determined at the date of grant using the Black-Scholes option pricing model, which includes estimates of the number of awards that are expected to vest over the vesting period. Where granted share options vest in installments over the vesting period (defined as graded vesting), the Company treats each installment as a separate share option grant. Share-based compensation expense is recognized over the vesting period, or as specified vesting conditions are satisfied, and credited to other capital.

 

(17)
 

 

Aeterna Zentaris Inc.
Notes to Consolidated Financial Statements
As at December 31, 2019 and December 31, 2019 and for the years ended December 31, 2019, 2018 and 2017
(tabular amounts in thousands of US dollars, except share/option/warrant/DSU and per share/option/warrant/DSU data and as otherwise noted)

 

Any consideration received by the Company in connection with the exercise of stock options is credited to share capital. Any other capital component of the share-based compensation is transferred to share capital upon the issuance of shares.

 

Current and deferred income tax

 

Income tax on profit or loss comprises current and deferred tax. Tax is recognized in profit or loss, except that a change attributable to an item of income or expense recognized as other comprehensive (loss) income or directly in equity is also recognized directly in other comprehensive (loss) income or directly in equity. Management periodically evaluates positions taken in tax returns with respect to situations in which applicable tax regulation is subject to interpretation and establishes provisions where appropriate on the basis of amounts expected to be paid to the tax authorities.

 

The current income tax charge is calculated in accordance with tax rates and laws that have been enacted or substantively enacted by the reporting date in the countries where the Company’s subsidiaries operate and generate taxable income.

 

Deferred income tax is recognized on temporary differences (other than, where applicable, temporary differences associated with unremitted earnings from foreign subsidiaries and associates to the extent that the investment is essentially permanent in duration, and temporary differences associated with the initial recognition of goodwill) arising between the tax bases of assets and liabilities and their carrying amounts in the consolidated financial statements and on unused tax losses or R&D non-refundable tax credits in the Group. Deferred income tax is determined using tax rates and laws that have been enacted or substantively enacted by the reporting date.

 

Deferred income tax assets are recognized only to the extent that it is probable that future taxable profit will be available against which the temporary differences can be utilized.

 

Deferred income tax assets and liabilities are offset when there is a legally enforceable right to offset current tax assets against current tax liabilities and when the deferred income taxes assets and liabilities relate to income taxes levied by the same taxation authority on either the same taxable entity or different taxable entities where there is an intention to settle the balances on a net basis.

 

Research and development costs

 

Research costs are expensed as incurred. Development costs are expensed as incurred, except for those that meet the criteria for deferral, in which case the costs are capitalized and amortized to operations over the estimated period of benefit. No development costs have been capitalized during any of the periods presented.

 

Net (loss) income per share

 

Basic net (loss) income per share is calculated using the weighted average number of common shares outstanding during the year.

 

Diluted net (loss) income per share is calculated based on the weighted average number of common shares outstanding during the year, plus the effects of dilutive common share equivalents, such as stock options and share purchase warrants. This method requires that diluted net (loss) income per share be calculated using the treasury stock method, as if all common share equivalents had been exercised at the beginning of the reporting period, or period of issuance, as the case may be, and that the funds obtained thereby were used to purchase common shares of the Company at the average trading price of the common shares during the period.

 

(18)
 

 

Aeterna Zentaris Inc.
Notes to Consolidated Financial Statements
As at December 31, 2019 and December 31, 2019 and for the years ended December 31, 2019, 2018 and 2017
(tabular amounts in thousands of US dollars, except share/option/warrant/DSU and per share/option/warrant/DSU data and as otherwise noted)

 

4 Critical accounting estimates and judgments

 

The preparation of 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 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 consolidated financial statements are presented fairly and in accordance with IFRS. Revisions to accounting estimates are recognized in the period in which the estimates are revised and in any future periods affected.

 

  (a) Critical accounting estimates and assumptions

 

Critical accounting estimates and assumptions are those that have a significant risk of causing material adjustment and are often applied to matters or outcomes that are inherently uncertain and subject to change. As such, management cautions that future events often vary from forecasts and expectations and that estimates routinely require adjustment.

 

The following discusses the most significant accounting estimates and assumptions that the Company has made in the preparation of the consolidated financial statements.

 

Going concern assessment

 

Management has evaluated whether material uncertainty exists relating to events or conditions that may cast substantial doubt about the Company’s ability to continue as a going concern and has made critical judgements as described in note 1.

 

Accounting for the MacrilenLicense Agreement

 

See the performance obligations further described in note 6 - Licensing arrangements.

 

Fair value of the warrant liability and stock options

 

Determining the fair value of the warrant liability and stock options requires judgment related to the selection of the most appropriate pricing model, the estimation of stock price volatility and the expected term of the underlying instruments. Any changes in the estimates or inputs utilized to determine fair value could result in a significant impact on the Company’s future operating results, liabilities or other components of shareholders’ equity. Fair value assumptions used are described in note 17 - Warrant liability and 19 - Share and other capital.

 

Impairment of goodwill

 

The annual impairment assessment related to goodwill requires management to estimate the recoverable amount, which has been determined using fair value less cost of disposal. The Company has one reportable segment, and management monitors goodwill based on an overall entity basis. The carrying amount of its consolidated net deficit is compared to its overall market capitalization. Based on this calculation, and given the Company has a net deficit, management determined that goodwill was not impaired. Future events could cause the assumptions utilized in the impairment tests to change, resulting in a potentially adverse effect on the Company’s future results due to increased impairment charges.

 

(19)
 

 

Aeterna Zentaris Inc.
Notes to Consolidated Financial Statements
As at December 31, 2019 and December 31, 2019 and for the years ended December 31, 2019, 2018 and 2017
(tabular amounts in thousands of US dollars, except share/option/warrant/DSU and per share/option/warrant/DSU data and as otherwise noted)

 

Employee future benefits

 

The determination of expenses and obligations associated with employee future benefits requires the use of assumptions, such as the discount rate to measure obligations, the projected age of employees upon retirement, the expected rate of future compensation and estimated employee turnover. Because the determination of the cost and obligations associated with employee future benefits requires the use of various assumptions, there is measurement uncertainty inherent in the actuarial valuation process. Actual results will differ from results that are estimated based on the aforementioned assumptions. Additional information is included in note 18 - Employee future benefits.

 

Income taxes

 

The estimation of income taxes includes evaluating the recoverability of deferred tax assets based on an assessment of Group entities’ ability to utilize the underlying future tax deductions against future taxable income prior to expiry of those deductions. Management assesses whether it is probable that some or all of the deferred income tax assets will not be realized. The ultimate realization of deferred tax assets is dependent upon the generation of future taxable income, which in turn is dependent upon the successful commercialization of the Company’s products. To the extent that management’s assessment of any Group entity’s ability to utilize future tax deductions changes, the Company would be required to recognize more or fewer deferred tax assets, and future income tax provisions or recoveries could be affected. Additional information is included in note 22 - Income taxes.

 

5 Recent accounting pronouncements

 

Impact of adoption of significant new IFRS standards in 2019

 

The following new IFRS standards have been adopted by the Company effective January 1, 2019:

 

(a) IFRS 16, Leases

 

The Company has adopted IFRS 16 on a modified retrospective basis from January 1, 2019 with no restatement of comparatives, as permitted under the specific transitional provisions in the standard.

 

Overall impact from adoption

 

The change in accounting policy affected the following items in the balance sheet on January 1, 2019:

 

  Right of use assets - increase by $859
  Provision of onerous lease contracts - decrease by $663
  Lease liabilities - increase by $1,522

 

(Loss) income per share for the three and twelve months to December 31, 2019 was not affected as a result of the adoption of IFRS 16.

 

(ii) Practical expedients applied

 

In applying IFRS 16 for the first time, the Company has used the following practical expedients permitted by the standard:

 

  the use of a single discount rate to a portfolio of leases with reasonably similar characteristics
  reliance on previous assessments on whether leases are onerous
  the exclusion of initial direct costs for the measurement of the right of use asset at the date of initial application; and
  the use of hindsight in determining the lease term where the contract contains options to extend or terminate the lease.

 

(20)
 

 

Aeterna Zentaris Inc.
Notes to Consolidated Financial Statements
As at December 31, 2019 and December 31, 2019 and for the years ended December 31, 2019, 2018 and 2017
(tabular amounts in thousands of US dollars, except share/option/warrant/DSU and per share/option/warrant/DSU data and as otherwise noted)

 

The Company has also elected not to reassess whether a contract is or contains a lease at the date of initial application. Instead, for contracts entered into before the transition date, the Company relied on its assessment made applying IAS 17 and IFRIC 4 Determining whether an Arrangement contains a Lease.

 

(iii) The Company’s leasing activities and how these are accounted for

 

The Company leases various office and lab premises (building), cars and equipment. The building lease was originally for 10 years with one five-year extension, such extension is ending on April 30, 2021. Car lease contracts are typically made for fixed periods of three to four years while the equipment lease is for five years ending April 30, 2020. Lease terms are negotiated on an individual basis and contain a wide range of different terms and conditions. and the lease agreements do not impose any covenants, but leased assets may not be used as security for borrowing purposes.

 

Until the 2018 financial year, leases of property, plant and equipment were classified as operating leases. Payments made under operating leases (net of any incentives received from the lessor) were charged to statement of comprehensive (loss) income on a straight-line basis over the period of the lease.

 

(iv) Adjustments recognized on adoption of IFRS 16

 

Lease liabilities

 

The Company has operating leases for building, cars and equipment leases at its location in Frankfurt. Upon adoption of IFRS 16, the Company recognized lease liabilities in relation to leases which had previously been classified as ‘operating leases’ under the principles of IAS 17 Leases. Under IFRS 16, these liabilities were measured at the present value of the remaining lease payments excluding renewal options as they are not expected to be exercised, discounted using the Company’s incremental borrowing rate as of January 1, 2019. The Company’s incremental annual borrowing rate applied to the lease liabilities on January 1, 2019 were:

 

  Building lease 5.5%
  Vehicle leases ranging from 4.84% to 5.32%
  Equipment leases 3.88%

 

The weighted average incremental borrowing rate applied to lease liabilities recognized in the statement of financial position at January 1, 2019 was 5.45%.

 

    2019  
       
Operating lease commitments disclosed as at December 31, 2018 (revised)     1,669  
Discounted using the lessee’s incremental borrowing rate of at the date of initial application:     (147 )
Lease liability recognized as at January 1, 2019     1,522  
Current lease liabilities     629  
Non-current lease liabilities     893  
         
During the year ended December 31, 2019        
Interest paid as charged to comprehensive (loss) income as other finance income     66  
Payment against lease liabilities     614  
Foreign exchange     62  
         
Lease liability recognized as at December 31, 2019     903  
Current lease liabilities     648  
Non-current lease liabilities     255  

 

(21)
 

 

Aeterna Zentaris Inc.
Notes to Consolidated Financial Statements
As at December 31, 2019 and December 31, 2019 and for the years ended December 31, 2019, 2018 and 2017
(tabular amounts in thousands of US dollars, except share/option/warrant/DSU and per share/option/warrant/DSU data and as otherwise noted)
 

The Company’s lease liabilities come due, as at December 31, 2019, as follows:

 

    $  
Less than 1 year     648  
1 - 3 years     253  
4 - 5 years     2  
More than 5 years      
Total     903  

 

Right of use assets

 

The Company’s related right of use assets were measured at the amount equal to the lease liability at the date of initial application. Only the building right of use asset was further adjusted by the application of $663 in related onerous lease provision to the value at inception.

 

    Building     Vehicles and equipment     Total  
    $     $     $  
Cost                        
At January 1, 2019     735       124       859  
Additions     45       32       77  
Disposals     (7 )     (43 )     (50 )
Impact of foreign exchange rate changes     (16 )     (7 )     (23 )
At December 31, 2019     757       106       863  

 

    Building     Vehicles and equipment     Total  
    $     $     $  
Accumulated Depreciation                        
At January 1, 2019                  
Disposals     (2 )     (12 )     (14 )
Depreciation     227       51       278  
Impairment     22             22  
Impact of foreign exchange rate changes     (5 )           (5 )
At December 31, 2019     242       39       281  

 

    Building     Vehicles and equipment     Total  
    $     $     $  
Carrying amount                        
At December 31, 2019     515       67       582  

 

During the three-month period ended March 31, 2019, management continued its search for a sub-lessee. However, there were delays which led to a reassessment of its onerous lease provision as the Company has determined that its plan to exit its building lease, in full, as at December 31, 2019 was not probable. As such, the Company recognized an impairment of its right of use building asset of $337 in the statement of comprehensive (loss) income during the first quarter of 2019. In light of the June 2019 restructuring of the German operations (note 16), management recognized an additional impairment of $64 as office and lab space was expected to become vacant or underutilized. During the third quarter of 2019, a new sub-lessee signed a 6-month lease for certain lab and office space; management reversed the impairment of its building right of use asset by $125. During the fourth quarter of 2019, an existing sub-lease agreement was renewed, and the amount of rented space was expanded; management then reversed the impairment of its building right of use asset by $254.

 

(22)
 

 

Aeterna Zentaris Inc.
Notes to Consolidated Financial Statements
As at December 31, 2019 and December 31, 2019 and for the years ended December 31, 2019, 2018 and 2017
(tabular amounts in thousands of US dollars, except share/option/warrant/DSU and per share/option/warrant/DSU data and as otherwise noted)

 

The Company had $31 in short term lease payments which were not capitalized.

 

(b) IFRIC 23, “Uncertainty over Income Tax Treatment” (“IFRIC 23”)

 

In June 2017, IFRIC 23, was issued and it provides guidance on how to value uncertain income tax positions based on the probability of whether the relevant tax authorities will accept the company’s tax treatments. A company is to assume that a taxation authority with the right to examine any amounts reported to it will examine those amounts and will have full knowledge of all relevant information when doing so. IFRIC 23 is effective for annual periods beginning on or after January 1, 2019. The adoption of this interpretation did not have a significant impact on the Company’s consolidated financial statements.

 

(c) Amendments in Plan Amendment, Curtailment or Settlement (Amendments to IAS 19)

 

In June 2015, the IASB published ED/2015/5 Remeasurement on a Plan Amendment, Curtailment or Settlement/Availability of a Refund from a Defined Benefit Plan (Proposed amendments to IAS 19 and IFRIC 14) combining two issues submitted separately to the IFRS Interpretations Committee into a single package of narrow-scope amendments to IAS 19 Employee Benefits and IFRIC 14 IAS 19 - The Limit on a Defined Benefit Asset, Minimum Funding Requirements and their Interaction. However, in April 2017 the IASB decided to pursue the amendments to IAS 19 and in September 2017 confirmed it would do so despite putting off the amendments to IFRIC 14. The amendments in Plan Amendment, Curtailment or Settlement (Amendments to IAS 19) are: (i) if a plan amendment, curtailment or settlement occurs, it is now mandatory that the current service cost and the net interest for the period after the remeasurement are determined using the assumptions used for the remeasurement and (ii) amendments have been included to clarify the effect of a plan amendment, curtailment or settlement on the requirements regarding the asset ceiling. An entity applies the amendments to plan amendments, curtailments or settlements occurring on or after the beginning of the first annual reporting period that begins on or after January 1, 2019. The adoption of these amendments did not have a significant impact on the Company’s consolidated financial statements.

 

Accounting standards issued but not yet adopted

 

(d) IAS 1 Presentation of Financial Statements and IAS 8 Accounting policies, changes in accounting estimates and errors (amendment)

 

In October 2018, the IASB issued Definition of Material (Amendments to IAS 1 and IAS 8) to clarify the definition of ‘material’ and to align the definition used in the Conceptual Framework and the standards themselves. The amendments are effective annual reporting periods beginning on or after January 1, 2020. The Company is currently evaluating the new guidance and does not expect it to have a significant impact on its consolidated financial statements.

 

(e) Conceptual Framework for Financial Reporting

 

Together with the revised Conceptual Framework published in March 2018, the IASB also issued Amendments to References to the Conceptual Framework in IFRS Standards. The amendments are effective for annual periods beginning on or after January 1, 2020. The Company is currently evaluating the new guidance and does not expect it to have a significant impact on its consolidated financial statements.

 

6 Licensing arrangements

 

(a) MacrilenLicense Agreement

 

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, which provides for (i) the “right to use” license relating to the Adult Indication; (ii) the sale of the right to acquire a license of a future FDA-approved Pediatric Indication; (iii) the licensee to fund 70% of the costs of a pediatric clinical trial submitted for approval to the EMA and FDA to be run by the Company with customary oversight from a joint steering committee; and (iv) for a Supply Arrangement. 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. In 2019, the Supply Arrangement was concluded and Novo contracted AEZS Germany to provide supply chain services for the manufacture of Macrilen™ (macimorelin).

 

(23)
 

 

Aeterna Zentaris Inc.
Notes to Consolidated Financial Statements
As at December 31, 2019 and December 31, 2019 and for the years ended December 31, 2019, 2018 and 2017
(tabular amounts in thousands of US dollars, except share/option/warrant/DSU and per share/option/warrant/DSU data and as otherwise noted)

 

(i) Adult Indication

 

Under the terms of the License Agreement, and for as long as Macrilen™ (macimorelin) is patent-protected, the Company will be entitled to a 15% royalty on annual net sales up to $75,000 and an 18% royalty on annual net sales above $75,000. Following the end of patent protection in United States or Canada for Macrilen™ (macimorelin), the Company will be entitled to a 5% royalty on net sales in that country. In addition, the Company will also receive one-time payments ranging from $4,000 to $100,000 upon the achievement of commercial milestones going from $25,000 annual net sales up to $500,000 annual net sales.

 

In January 2018, the Company received a cash payment of $24,000 from Strongbridge and on July 23, 2018, Strongbridge launched product sales of Macrilen™ (macimorelin) in the U.S.

 

Royalty income earned under the License Agreement for the year ended December 31, 2019 was $45 (2018- $184).

 

(ii) Pediatric Indication

 

Upon approval by the FDA of a pediatric indication for Macrilen™ (macimorelin), the Company will receive a one-time milestone payment of $5,000. This amount will be recognized once it is probable that it will be received.

 

Transaction price

 

Analysis of the total discounted cash flows of both the $24,000 payment and the $5,000 payment upon FDA approval of the Pediatric Instance demonstrates that 84% of the future revenue streams would be derived from the Adult Indication and 16% from the Pediatric Indication. On a relative fair value basis, the Company has allocated the transaction price to the performance obligations resulting in $23.600 being allocated to the Adult Indication and being recognized as license fee revenue in the consolidated statements of comprehensive (loss) income effective January 2018, and $400 being allocated to the right to a future Pediatric Indication, which is recognized as deferred revenue on the consolidated statements of financial position and amortized monthly beginning January 2018, over a period of 5.4 years, into the consolidated statements of comprehensive (loss) income.

 

(iii) PIP Study

 

During 2019, the Company invoiced its licensee $979 (2018 – $358) as its share of the costs incurred by the Company under the PIP. The Company considers the funding arrangement under the PIP to be a collaboration arrangement under IFRS 11 and has accounted for the invoicing as a reduction of costs incurred during the period. This amount is presented in the consolidated statement of financial position as trade and other receivables and has been fully collected.

 

(iv) Supply Chain Arrangement

 

The Company agreed, in the Interim Supply Arrangement to the License Agreement, to supply ingredients for the manufacture of Macrilen™ (macimorelin) during an interim period at a price that is set ‘at cost’ without any profit margin. The Company believes the stand-alone selling price of the manufacturing ingredients to be their cost, as that approximates the amount at which Novo would be able to procure those same goods with other suppliers. In November 2019, Novo contracted with AEZS Germany, to provide supply chain services including provision of supervision of stability studies (support services) as well as API batch production and delivery of certain API and semi-finished goods. The Company has determined the stand-alone selling price of the support services and API batch production and delivery to be their respective cost, as those approximate the amount at which Novo would be able to procure those same goods and services with other suppliers.

 

For all supply arrangement activities, either under the Interim Supply Agreement or the Supply Agreement with Novo, in 2019, the Company invoiced $1,159 (2018 – $2,167) and has received payment in full for these invoices. These items are presented in the consolidated statements of comprehensive (loss) income as product sales; supply chain, sales commissions and other revenue and as cost of sales when the performance obligations have been met and deferred revenue on the consolidated statements of financial position when payments have been received in advance of revenue recognition.

 

(24)
 

 

Aeterna Zentaris Inc.
Notes to Consolidated Financial Statements
As at December 31, 2019 and December 31, 2019 and for the years ended December 31, 2019, 2018 and 2017
(tabular amounts in thousands of US dollars, except share/option/warrant/DSU and per share/option/warrant/DSU data and as otherwise noted)

 

(b) Zoptrex™ License Agreement

 

On December 1, 2014, the Company entered into an exclusive master collaboration agreement, a technology transfer and technical assistance agreement (“TTA”) and a license agreement with Sinopharm A-Think Pharmaceuticals Co., Ltd. (“Sinopharm”) for the development, manufacture and commercialization of Zoptrex™ in all human uses, in the People’s Republic of China, including Hong Kong and Macau. Under the terms of the TTA, Sinopharm made a one-time, non-refundable payment of $1,000 to the Company in consideration for the transfer of technical documentation and materials, know-how and technical assistance services. At December 31, 2017, the Company had deferred revenues net of amortization of $541 relating to non-refundable upfront payments and, due to events that occurred in 2017, the Company does not anticipate development of Zoptrex™ under the licensing agreements. In the first quarter of 2018, the Company recognized this amount as revenue.

 

7 Cash and cash equivalents

 

    December 31,  
    2019     2018  
    $     $  
Cash on hand and balances with banks     4,801       3,501  
Interest-bearing deposits with maturities of three months or less     3,037       11,011  
      7,838       14,512  

 

8 Trade and other receivables

 

    December 31,  
    2019     2018  
    $     $  
Trade accounts receivable (net of expected credit losses of $55 (2018 - $55))     210       142  
Value added tax     254       49  
Other receivables     194       103  
      658       294  

 

See note 24 - Financial instruments and financial risk management for discussion of credit losses.

 

9 Inventory

 

    December 31,  
    2019     2018  
    $     $  
Raw Materials     204        
Work in process     999       240  
      1,203       240  

 

The Company recognized $101 of inventory costs and $106 as impairment in drug product for the European market as cost of sales in the consolidated statements of comprehensive (loss) income for the year ended December 31, 2019 (2018 - $2,087 and $nil and 2017 - $nil and $nil).

 

(25)
 

 

Aeterna Zentaris Inc.
Notes to Consolidated Financial Statements
As at December 31, 2019 and December 31, 2019 and for the years ended December 31, 2019, 2018 and 2017
(tabular amounts in thousands of US dollars, except share/option/warrant/DSU and per share/option/warrant/DSU data and as otherwise noted)

 

10 Prepaid expenses and other current assets

 

    December 31,  
   

2019

    2018  
      $       $  
Prepaid insurance     791       832  
Prepaid inventory     175       175  
Other     245       203  
      1,211       1,210  

 

During 2019, the Company evaluated the recoverability of $169 paid in a prior year to the Company’s change partner for the serialization of Macrilen™ (macimorelin) sachet and packaging subject to a repayment arrangement. As the timing and amount of such partner’s future ability to repay could not be reasonably estimated, the full amount was written off and the Company expects to recognize any associated revenues in the period in which cash, if any, is received.  

 

11 Restricted cash equivalents

 

The Company had restricted cash equivalents amounting to $364 at December 31, 2019 (2018 - $418). These balances consist of certificates of deposit that are used as collateral for corporate credit cards and leases.

 

12 Property, plant and equipment

 

Components of the Company’s property, plant and equipment are summarized below.

 

    Cost  
    Equipment     Furniture and fixtures     Computer equipment     Leasehold improvements     Total  
    $     $     $     $     $  
At January 1, 2018     2,268       19       790       42       3,119  
Additions     1             8             9  
Disposals / Retirements     (758 )           (137 )           (895 )
Reclassifications     11       (11 )                  
Impact of foreign exchange rate changes     (64 )     (1 )     (24 )     (2 )     (91 )
At December 31, 2018     1,458       7       637       40       2,142  
Disposals / Retirements     (1,019 )           (311 )     (5 )     (1,335 )
Impact of foreign exchange rate changes     (17 )           (12 )     (1 )     (30 )
At December 31, 2019     422       7       314       34       777  

 

(26)
 

 

Aeterna Zentaris Inc.
Notes to Consolidated Financial Statements
As at December 31, 2019 and December 31, 2019 and for the years ended December 31, 2019, 2018 and 2017
(tabular amounts in thousands of US dollars, except share/option/warrant/DSU and per share/option/warrant/DSU data and as otherwise noted)

 

    Accumulated depreciation  
    Equipment     Furniture and fixtures     Computer equipment     Leasehold improvements     Total  
    $     $     $     $     $  
At January 1, 2018     2,210       4       769       35       3,018  
Disposals / Retirements     (752 )           (137 )           (889 )
Depreciation expense     19       1       14       1       35  
Impact of foreign exchange rate changes     (63 )           (22 )     (2 )     (87 )
At December 31, 2018     1,414       5       624       34       2,077  
Disposals / Retirements     (1,009 )           (311 )     (5 )     (1,325 )
Depreciation expense     9       2       6             17  
Impact of foreign exchange rate changes     (14 )           (12 )     (1 )     (27 )
At December 31, 2019     400       7       307       28       742  

 

    Carrying amount  
    Equipment     Furniture and fixtures     Computer equipment     Leasehold improvements     Total  
    $     $     $     $     $  
At December 31, 2018     44       2       13       6       65  
At December 31, 2019     22             7       6       35  

 

Depreciation of $17 ($35 in 2018 and $100 in 2017) is presented in the consolidated statement of comprehensive (loss) income as follows: $10 ($20 in 2018 and $69 in 2017) in R&D costs, $7 ($10 in 2018 and $10 in 2017) in general and administrative (“G&A”) expenses and $nil ($5 in 2018 and $21 in 2017) in selling expenses. During 2019, the Company recognized net loss on disposal of $5 (2018 - $nil and 2017 - $nil) in the consolidated statement of comprehensive (loss) income.

 

13 Identifiable intangible assets

 

Identifiable intangible assets with finite useful lives consist entirely of in-process R&D costs, patents and trademarks with such assets expected to be fully amortized by 2021. Changes in the carrying value of the Company’s identifiable intangible assets with finite useful lives are summarized below.

 

    Year ended December 31, 2019     Year ended December 31, 2018  
    Cost     Accumulated amortization     Carrying value     Cost     Accumulated amortization     Carrying value  
    $     $     $     $     $     $  
Balances – Beginning of the year     32,643       (32,581 )     62       34,246       (34,156 )     90  
Additions                                    
Retirement     (466 )     466                          
Recurring amortization expense           (20 )     (20 )           (23 )     (23 )
Impact of foreign exchange rate changes     (755 )     753       (2 )     (1,603 )     1,598       (5 )
Balances – End of the year     31,422       (31,382 )     40       32,643       (32,581 )     62  

 

During 2019, the Company recognized a retirement of $466 on expired patents and trademarks (2018 - $nil).

 

(27)
 

 

Aeterna Zentaris Inc.
Notes to Consolidated Financial Statements
As at December 31, 2019 and December 31, 2019 and for the years ended December 31, 2019, 2018 and 2017
(tabular amounts in thousands of US dollars, except share/option/warrant/DSU and per share/option/warrant/DSU data and as otherwise noted)

 

14 Goodwill

 

The change in carrying value is as follows:

 

    Cost     Accumulated impairment loss     Carrying amount  
    $     $     $  
At January 1, 2018     8,613             8,613  
Impact of foreign exchange rate changes     (403 )           (403 )
At December 31, 2018     8,210             8,210  
Impact of foreign exchange rate changes     (160 )           (160 )
At December 31, 2019     8,050             8,050  

 

Management’s evaluation of impairment in goodwill is based on fair value less costs of disposal based on the Company’s market capitalization at December 31, 2019, its issued and outstanding common shares less estimated cost of disposal of approximately $1,100. In the prior year the Company’s methodology incorporated estimates of its licensee’s projected sales of Macrilen™ (both units and selling price), annual revenue growth rate, growth in operating expenses, the effect of future costs of the PIP and discount rate for generating the Company’s net present value. There was no impairment assessed at December 31, 2019.

 

15 Payables and accrued liabilities

 

    December 31,  
    2019     2018  
    $     $  
Trade accounts payable     1,087       1,282  
Accrued research and development costs           26  
Salaries, employment taxes and benefits     64       183  
Financing of insurance premiums     4       738  
PIP study payables     118        
Accrued severance     427       148  
Other accrued liabilities     448       414  
      2,148       2,791  

 

16 Provision for restructuring and other costs

 

In the third quarter of 2017, AEZS Germany and its Works Council approved a restructuring program (the “2017 German Restructuring”), which was rolled out as a part of the continued strategy to transition into a commercially operating specialty biopharmaceutical organization focused on the commercialization of Macrilen™ (macimorelin). On June 6, 2019, the Company announced that it was further reducing the size of its German workforce to more closely reflect the Company’s ongoing commercial activities in Frankfurt. AEZS Germany and its Works Council approved a restructuring that affects 8 employees and was completed on January 31, 2020.

 

(28)
 

 

Aeterna Zentaris Inc.
Notes to Consolidated Financial Statements
As at December 31, 2019 and December 31, 2019 and for the years ended December 31, 2019, 2018 and 2017
(tabular amounts in thousands of US dollars, except share/option/warrant/DSU and per share/option/warrant/DSU data and as otherwise noted)

 

The changes in the Company’s provision for restructuring and other costs can be summarized as follows:

 

    Other provision     Cetrotide(R) onerous contracts     2017 German Restructuring: onerous lease     German Restructuring: severance     Total  
          $     $     $     $  
January 1, 2018     9       473       1,208       1,807       3,497  
Provision recognized           317                   317  
Utilization of provision     (9 )     (222 )     (467 )     (1,202 )     (1,900 )
Change in the provision                 (21 )     (432 )     (453 )
Unwinding of discount and impact of foreign exchange rate changes           (21 )     (57 )     (85 )     (163 )
December 31, 2018           547       663       88       1,298  
Adoption of IFRS 16 (note 5a)                 (663 )           (663 )
Provision recognized                       507       507  
Utilization of provision           (137 )           (252 )     (389 )
Change in the provision           4                   4  
Unwinding of discount and impact of foreign exchange rate changes           (18 )           (13 )     (31 )
December 31, 2019           396             330       726  
Less: current portion           (88 )           (330 )     (418 )
Non-current portion           308                   308  

 

17 Warrant liability

 

The change in the Company’s warrant liability can be summarized as follows:

 

    Years ended December 31,  
    2019     2018     2017  
    $     $     $  
Balance – Beginning of the year     3,634       3,897       6,854  
Share purchase warrants issued during the year (note 19)     3,457              
Share purchase warrants exercised during the year     (318 )           (735 )
Change in fair value of share purchase warrants     (4,518 )     (263 )     (2,222 )
Balance - End of the year     2,255       3,634       3,897  
Less: current portion     (6 )            
Non-current portion     2,249       3,634       3,897  

 

(29)
 

 

Aeterna Zentaris Inc.
Notes to Consolidated Financial Statements
As at December 31, 2019 and December 31, 2019 and for the years ended December 31, 2019, 2018 and 2017
(tabular amounts in thousands of US dollars, except share/option/warrant/DSU and per share/option/warrant/DSU data and as otherwise noted)

 

A summary of the activity related to the Company’s share purchase warrants is provided below.

 

    Years ended December 31,  
    2019     2018     2017  
    Number     Weighted average exercise price ($)     Number     Weighted average exercise price ($)     Number     Weighted average exercise price ($)  
Balance – Beginning of the year     3,391,844       6.23       3,417,840       7.59       3,779,245       9.66  
Issued (note 19)     3,325,000       1.65                          
Exercised     (87,700 )     1.07                   (331,730 )*     1.07  
Expired (note 19)                 (25,996 )     185.00       (29,675 )     345.00  
Balance – End of the year     6,629,144       4.00       3,391,844       6.23       3,417,840       7.59  

 

 

  * portion of the Series A warrants was exercised using the cashless feature. Therefore, the total number of equivalent shares issued was 301,343.

 

The warrants issued in March 2015 expired unexercised on March 10, 2020.See note 29, for warrants issued after December 31, 2019.

 

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 all warrants outstanding as at December 31, 2019.

 

    Number of equivalent shares    

Market-value per share price

($)

    Weighted average exercise price
($)
    Risk-free annual interest rate
(a)
   

Expected volatility


(b)

    Expected life (years)
(c)
   

Expected dividend yield


(d)

 
March 2015 Series A Warrants (e)     28,144       0.91       1.07       1.58 %     53.18 %     0.19       0.00 %
December 2015 Warrants     2,331,000       0.91       7.10       1.58 %     78.30 %     0.96       0.00 %
November 2016 Warrants (f)     945,000       0.91       4.70       1.58 %     75.89 %     0.33       0.00 %
September 2019 Warrants (g)     3,325,000       0.91       1.65       1.67 %     117.60 %     4.73       0.00 %

 

 

  (a) Based on United States Treasury Government Bond interest rates with a term that is consistent with the expected life of the warrants.
  (b) Based on the historical volatility of the Company’s stock price over the most recent period consistent with the expected life of the warrants, as well as on future expectations.
  (c) Based upon time to expiry from the reporting period date.
  (d) The Company has not paid dividends and it does not intend to pay dividends in the foreseeable future.
  (e) For the March 2015 Series A Warrants, the inputs and assumptions applied to the Black-Scholes option pricing model have been further adjusted to take into consideration the value attributed to certain anti-dilution provisions. Specifically, the weighted average exercise price is subject to adjustment (note 19).
  (f) For the November 2016 Warrants, the Company reduced the fair value of these warrants to take into consideration the fair value of the $10 call option, which was also calculated using the Black-Scholes pricing model. (note 19).
  (g) For the September 2019 Warrants, the Company, used the Black-Scholes pricing model to fair value the warrants and allocated the gross proceeds. The remaining gross proceeds were allocated to share capital (note 19)

 

(30)
 

 

Aeterna Zentaris Inc.
Notes to Consolidated Financial Statements
As at December 31, 2019 and December 31, 2019 and for the years ended December 31, 2019, 2018 and 2017
(tabular amounts in thousands of US dollars, except share/option/warrant/DSU and per share/option/warrant/DSU data and as otherwise noted)

 

18 Employee future benefits

 

AEZS Germany provides unfunded defined benefit pension plans and unfunded post-employment benefit plans for certain groups of employees. Provisions for pension obligations are established for benefits payable in the form of retirement, disability and surviving dependent pensions.

 

The unfunded defined benefit pension plans are final salary pension plans, which provide benefits to members (or to their surviving dependents) in the form of a guaranteed level of pension payable for life. The level of benefits provided depends on the member’s length of service and on his or her base salary in the final years leading up to retirement. Current pensions vary in accordance with applicable statutory requirements, which foresee an adjustment every three years on an individual basis that is based on inflationary increases or in relation to salaries of comparable groups of active employees in the Company. An adjustment may be denied by the Company if the Company’s financial situation does not allow for an increase in pensions. These plans are unfunded, and the Company meets benefit payment obligations as they fall due.

 

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

 

    Pension benefit plans
Years ended December 31,
    Other benefit plans
 Years ended December 31,
 
    2019     2018     2017     2019     2018     2017  
      $       $       $       $       $       $  
Balances – Beginning of the year     13,100       14,145       13,197       105       84       217  
Current service cost     41       66       107       8       6       14  
Interest cost     239       224       237       2       1       3  
Actuarial loss (gain) arising from changes in financial assumptions     1,068       (193 )     (694 )     (28 )     19       (115 )
Benefits paid     (483 )     (492 )     (485 )           (2 )     (66 )
Impact of foreign exchange rate changes     (261 )     (650 )     1,783       (3 )     (3 )     31  
Balances – End of the year     13,704       13,100       14,145       84       105       84  
Amounts recognized:                                                
In net loss     (280 )     (290 )     (344 )     18       (26 )     98  
In other comprehensive (loss) income     (807 )     843       (1,089 )     (3 )     3       (31 )

 

The cumulative amount of actuarial net losses recognized in other comprehensive (loss) income as at December 31, 2019 is $5,143 ($4,084 as at December 31, 2018 and $4,277 as at December 31, 2017).

 

The significant actuarial assumptions applied to determine the Company’s accrued benefit obligations are as follows:

 

    Pension benefit plans     Other benefit plans  
    Years ended December 31,     Years ended December 31,  
Actuarial assumptions   2019     2018     2017     2019     2018     2017  
    %     %     %     %     %     %  
Discount rate     1.10       1.90       1.70       1.90       1.90       1.70  
Pension benefits increase     1.50       1.80       1.80       1.50       1.80       1.80  
Rate of compensation increase     2.00       2.00       2.00       2.00       2.00       2.00  

 

(31)
 

 

Aeterna Zentaris Inc.
Notes to Consolidated Financial Statements
As at December 31, 2019 and December 31, 2019 and for the years ended December 31, 2019, 2018 and 2017
(tabular amounts in thousands of US dollars, except share/option/warrant/DSU and per share/option/warrant/DSU data and as otherwise noted)

 

The calculation of the pension benefit obligation is sensitive to the discount rate assumption. Throughout 2019, management has reduced the discount rate assumption on a quarterly basis from 1.9% at December 31, 2018 to 1.1% as at December 31, 2019.

 

Assumptions regarding future mortality are set based on actuarial advice in accordance with published statistics and experience in Germany. These assumptions translate into an average remaining life expectancy in years for a pensioner retiring at age 65:

 

    2019     2018     2017  
Retiring at the end of the reporting period:                        
Male     20       20       20  
Female     24       24       24  
Retiring 20 years after the end of the reporting period:                        
Male     28       28       22  
Female     31       31       26  

 

The most recent actuarial reports give effect to the pension and post-employment benefit obligations as at December 31, 2019. The next actuarial reports are planned for December 31, 2020.

 

In accordance with the assumptions used as at December 31, 2019, undiscounted defined pension benefits expected to be paid, in Euro, are as follows:

 

      $  
2020     456  
2021     459  
2022     462  
2023     469  
2024     478  
Thereafter     12,583  
      14,907  

 

The weighted average duration of the defined benefit obligation is 15.6 years.

 

Total expenses for the Company’s defined contribution plan in its German subsidiary amounted to approximately $54 for the year ended December 31, 2019 (2018 - $75 and 2017 - $119).

 

If variations in the following assumptions had occurred during 2018, the impact on the Company’s pension benefit obligation of $13,704 as at December 31, 2019 would have been as follows:

 

Assumption   Increase     Decrease  
             
Change interest rate by 0.25%     (506 )     538  
Change salary rate by 0.25%     17       (17 )
Change pension by 0.25%     391       (374 )
Change mortality by 1 year     519       (518 )

 

(32)
 

 

Aeterna Zentaris Inc.
Notes to Consolidated Financial Statements
As at December 31, 2019 and December 31, 2019 and for the years ended December 31, 2019, 2018 and 2017
(tabular amounts in thousands of US dollars, except share/option/warrant/DSU and per share/option/warrant/DSU data and as otherwise noted)

 

19 Share 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 September 20, 2019, the Company entered into a securities purchase agreement with U.S. institutional investors to purchase $4,988 (before total transaction costs of $795) of its common shares in a registered direct offering and warrants with a cashless exercise feature (see note 17) to purchase common shares in a concurrent private placement (together, the “Offering”). The combined purchase price for one common share and one warrant was $1.50. Under the terms of the securities purchase agreement, the Company sold 3,325,000 common shares. The gross proceeds of $4,988 was allocated as $3,457 to warrants based on the ascribed fair value (note 17) and the remaining gross proceeds of $1,531 were allocated to share capital. The transaction costs of $795 were allocated between share capital and warrants based on their relative fair values. The fair value of the share capital was recorded within equity net of the allocated transaction costs. The transaction costs of $550 allocated to the warrant liability were recorded as expense in the statement of comprehensive (loss) income.

 

In April 2019, there were 87,850 stock options, 23,000 deferred share units and 87,700 warrants exercised for gross proceeds of $314 with 191,650 common shares issued. In September 2019, 53,000 deferred share units were exercised with 37,100 common shares being issued.

 

Common shares issued in connection with “At-the-Market” (“ATM”) drawdowns

 

March 2017 ATM Program

 

On March 28, 2017, the Company commenced a new ATM offering pursuant to its existing ATM Sales Agreement, dated April 1, 2016, under which the Company was able, at its discretion, from time to time, to sell up to a maximum of 3 million common shares through ATM issuances on the NASDAQ, up to an aggregate amount of $9.0 million (the “March 2017 ATM Program”). The common shares were to be sold at market prices prevailing at the time of the sale of the common shares and, as a result, sale prices varied.

 

Between March 28, 2017 and April 18, 2017, the Company issued a total of 597,994 common shares under the March 2017 ATM Program at an average issuance price of $2.97 per share for aggregate gross proceeds of $1,780,000 less cash transaction costs of $55 and previously deferred financing costs of $65.

 

April 2017 ATM Program

 

On April 27, 2017, the Company entered into a New ATM Sales Agreement and filed with the SEC a prospectus supplement (the “April 2017 ATM Prospectus Supplement” or “April 2017 ATM Program”) related to sales and distributions of up to a maximum of 2.24 million common shares through ATM issuances on the NASDAQ, up to an aggregate amount of $6.9 million under the New ATM Sales Agreement. The common shares will be sold at market prices prevailing at the time of the sale of the common shares and, as a result, prices may vary. The New ATM Sales Agreement and the April 2017 ATM Program superseded and replaced the March 2017 ATM Program, which itself superseded and replaced the April 2016 ATM Program. The April 2017 ATM Prospectus Supplement supplements the base prospectus included in the Company’s Shelf Registration Statement on Form F-3, as amended (the “2017 Shelf Registration Statement”), which was declared effective by the SEC on April 27, 2017. The 2017 Shelf Registration Statement allowed the Company to offer up to $50 million of common shares and is effective for a three-year period.

 

Between May 30, 2017 and December 31, 2017, the Company issued a total of 1,805,758 common shares under the April 2017 ATM Program at an average issuance price of $2.08 per share for aggregate gross proceeds of $3,761,000 less cash transaction costs of $115 and previously deferred financing costs of $285. Because of these issuances, the exercise price of the Series A warrants issued in March 2015 was adjusted to $1.07 pursuant to the anti-dilution provisions contained in such warrants.

 

(33)
 

 

Aeterna Zentaris Inc.
Notes to Consolidated Financial Statements
As at December 31, 2019 and December 31, 2019 and for the years ended December 31, 2019, 2018 and 2017
(tabular amounts in thousands of US dollars, except share/option/warrant/DSU and per share/option/warrant/DSU data and as otherwise noted)

 

Shareholder rights plan

 

Effective May 8, 2019, the shareholders re-approved the Company’s shareholder rights plan (the “Rights Plan”) that provides the board of directors and the Company’s shareholders with additional time to assess any unsolicited take-over bid for the Company and, where appropriate, to pursue other alternatives for maximizing shareholder value. Under the Rights Plan, one right has been issued for each currently issued common share, and one right will be issued with each additional common share that may be issued from time to time.

 

Other capital

 

The Company accounts for costs associated with share-based compensation from security grants under its long-term incentive plan and stock option plans as other capital in its consolidated statements of changes in shareholders’ (deficiency) equity and as general and administrative expenses in its consolidated statements of comprehensive (loss) income.

 

Long-term incentive plan

 

At the 2018 annual and special meeting of shareholders, the Company’s shareholders approved the adoption of the 2018 long-term incentive plan (the “LTIP”), which allows the Board of Directors to issue up to 11.4% of the total issued and outstanding common shares at any given time to eligible individuals at an exercise price to be determined by the Board of Directors at the time of the grant, subject to a ceiling, as stock options, stock appreciation rights, stock awards, stock units, performance shares, performance units, and other stock-based awards. This LTIP replaces the stock option plan (the “Stock Option Plan”) for its directors, senior executives, employees and other collaborators who provide services to the Company. The Company’s Board of Directors amended the Stock Option Plan on March 20, 2014 and the Company’s Shareholders approved, ratified and confirmed the Stock Option Plan on May 10, 2016. Options granted under the Stock Option Plan prior to the 2014 amendment expire after a maximum period of 10 years following the date of grant. Options granted after the 2014 amendment expire after a maximum period of seven years following the date of grant.

 

During 2019 and 2018, the Company granted Deferred Share Units (“DSU”) and stock options under the LTIP, and stock options under the Stock Option Plan in 2017, as follows:

 

    Years ended December 31,  
    2019     2018     2017  
US dollar-denominated grants   Number     Weighted average exercise price (US$)     Number     Weighted average exercise price (US$)     Number     Weighted average exercise price (US$)  
Balance – Beginning of the year     888,816       3.66       712,415       4.66       966,539       7.23  
Granted     335,000       2.00       426,000       1.74       390,000       2.05  
Exercised     (163,850 )     2.42                          
Canceled/Forfeited     (6,000 )     13.39       (249,599 )     3.23       (643,271 )     6.02  
Expired     (100,850 )     2.24                   (853 )     704.88  
Balance – End of period     953,116      

3.38

      888,816       3.66       712,415       4.66  

 

(34)
 

 

Aeterna Zentaris Inc.
Notes to Consolidated Financial Statements
As at December 31, 2019 and December 31, 2019 and for the years ended December 31, 2019, 2018 and 2017
(tabular amounts in thousands of US dollars, except share/option/warrant/DSU and per share/option/warrant/DSU data and as otherwise noted)

 

    Years ended December 31,  
    2019     2018     2017  
Canadian dollar-denominated stock options   Number     Weighted average exercise price (CAN$)     Number     Weighted average exercise price (CAN$)     Number     Weighted average exercise price (CAN$)  
Balance – Beginning of the year     869       743.56       1,503       605.84       1,858       820.27  
Forfeited                 (104 )     668.65              
Expired     (428 )     570.00       (530 )     367.70       (355 )     1,728.15  
Balance – End of the year     441       912.00       869       743.56       1,503       605.84  

 

    Options outstanding     Options exercisable  
Range of US dollar-denominated options exercise price   Number (#)    

Weighted average remaining contractual life

(years)

   

Weighted average exercise price

($)

    Number (#)    

Weighted average remaining contractual life

(years)

   

Weighted average exercise price

($)

 
0.87 to 1.45     160,000       7.57       0.91                    
1.46 to 1.79     142,000       7.26       1.67       108,667       7.88       1.74  
1.80 to 2.11     370,000       5.67       2.07       213,334       5.23       2.06  
2.12 to 3.50     253,948       7.03       3.18       228,948       6.74       3.30  
3.51 to 1,044.00     27,168       2.79       46.56       27,168       2.79       46.56  
      953,116       6.50       3.38       578,117       6.21       4.58  

 

    Canadian dollar options outstanding and exercisable as at December 31, 2019  
Exercise price
(CAN$)
  Number     Weighted average remaining
contractual life (years)
    Weighted average exercise price
(CAN$)
 
0 to 912.00     441       0.87       912.00  
      441       0.87       912.00  

 

As at December 31, 2019, the total compensation cost related to unvested US dollar stock options not yet recognized amounted to $101 (2018 - $198). This amount is expected to be recognized over a weighted average period of 1.21 years (2018 - 1.15 years).

 

The Company settles stock options exercised through the issuance of new common shares as opposed to purchasing common shares on the market to settle stock option exercises.

 

Fair value input assumptions for US dollar-denominated 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.

 

(35)
 

 

Aeterna Zentaris Inc.
Notes to Consolidated Financial Statements
As at December 31, 2019 and December 31, 2019 and for the years ended December 31, 2019, 2018 and 2017
(tabular amounts in thousands of US dollars, except share/option/warrant/DSU and per share/option/warrant/DSU data and as otherwise noted)

 

        Years ended December 31,  
        2019     2018  
Expected dividend yield   (a)     0.00 %     0.00 %
Expected volatility   (b)     110.02 %     129.23 %
Risk-free annual interest rate   (c)     1.86 %     2.51 %
Expected life (years)   (d)     5.94       3.6  
Weighted average share price       $ 2.00     $ 1.74  
Weighted average exercise price       $ 2.00     $ 1.74  
Weighted average grant date fair value       $ 1.73     $ 1.39  

 

  (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.

 

(36)
 

 

Aeterna Zentaris Inc.
Notes to Consolidated Financial Statements
As at December 31, 2019 and December 31, 2019 and for the years ended December 31, 2019, 2018 and 2017
(tabular amounts in thousands of US dollars, except share/option/warrant/DSU and per share/option/warrant/DSU data and as otherwise noted)

 

20 Operating expenses

 

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

 

    Years ended December 31,  
    2019     2018     2017  
      $       $       $  
Key management personnel compensation(1)                        
Salaries and short-term employee benefits     1,705       2,388       2,081  
Consultants fees     194       62        
Termination benefits     503       356        
Post-employment benefits     257       147       59  
Share-based compensation costs     784       462       87  
      3,443       3,415       2,227  
Other employees compensation:                        
Salaries and short-term employee benefits     1,257       1,325       3,584  
Termination benefits                 1,806  
Post-employment benefits     78       275       441  
Share-based compensation costs     9       108       95  
      1,344       1,708       5,926  
Cost of inventory used and services provided     309       2,104        
Write down of inventory     101              
Professional fees     2,599       6,421       7,153  
Insurance     890       1,303       949  
Third-party R&D     322       498       3,758  
Consulting fees     144              
Restructuring costs     507              
Contracted sales force           256       22  
Travel     154       256       831  
Marketing services     18       176       698  
Laboratory supplies     23       139       2  
Other goods and services     137       342       162  
Leasing costs, net of sublease receipts of $214 in 2019, $121 in 2018(2) and $359 in 2017(2)     247       344       2,247  
Impairment of prepaid asset     169              
Depreciation and amortization of property, equipment and intangibles     37       60       138  
Depreciation - right to use assets     278              
Impairment losses     22             (44 )
Operating foreign exchange losses (gains)     30       17       (72 )
      5,987       9,812       15,844  
      10,774       17,039       23,997  

 

 

  (1) Key management includes the Company’s executive management team and directors.
  (2) Leasing costs also include changes in the onerous lease provision in 2018 and 2017 (note 16) other than those costs attributable to the unwinding of the discount.

 

(37)
 

 

Aeterna Zentaris Inc.
Notes to Consolidated Financial Statements
As at December 31, 2019 and December 31, 2019 and for the years ended December 31, 2019, 2018 and 2017
(tabular amounts in thousands of US dollars, except share/option/warrant/DSU and per share/option/warrant/DSU data and as otherwise noted)

 

Most of the employment agreements entered into between the Company and its executive officers include termination provisions, whereby the executive officers would be entitled to receive benefits that would be payable if the Company were to terminate the executive officers’ employment without cause or if their employment is terminated following a change of control. Separation benefits generally are calculated based on an agreed-upon multiple of applicable base salary and incentive compensation and, in certain cases, other benefit amounts.

 

21 Supplemental disclosure of cash flow information

 

    Years ended December 31,  
    2019     2018     2017  
      $       $       $  
Changes in operating assets and liabilities:                        
Trade and other receivables     (371 )     (95 )     158  
Inventory     (971 )     314        
Prepaid expenses and other current assets     (170 )     448       (343 )
Other non-current assets           150       39  
Payables and accrued liabilities     (615 )     (586 )     (1,080 )
Taxes payable     (188 )     1,669        
Deferred revenues     743       400        
Provision for restructuring and other costs (note 16)     (389 )     (1,957 )     (435 )
Employee future benefits (note 18)     (483 )     (494 )     (551 )
      (2,444 )     (151 )     (2,212 )

 

22 Income taxes

 

Significant components of current and deferred income tax recovery (expense) are as follows:

 

    Years ended December 31,  
    2019     2018     2017  
      $       $       $  
Current income tax recovery (expense)                  
Deferred tax:                        
Origination and reversal of temporary differences     2,943     (4,003 )     6,395  
Adjustments in respect of prior years         742       (149 )
Change in unrecognized tax assets     (2,755 )      (2,191 )     (2,767 )
Total income tax recovery (expense)     188       (5,452 )     3,479  

 

(38)
 

 

Aeterna Zentaris Inc.
Notes to Consolidated Financial Statements
As at December 31, 2019 and December 31, 2019 and for the years ended December 31, 2019, 2018 and 2017
(tabular amounts in thousands of US dollars, except share/option/warrant/DSU and per share/option/warrant/DSU data and as otherwise noted)

 

The reconciliation of the combined Canadian federal and provincial income tax rate to the income tax expense is provided below:

 

    Years ended December 31,  
    2019     2018     2017  
Combined Canadian federal and provincial statutory income tax rate     26.5 %     26.8 %     26.9 %

 

    Years ended December 31,  
    2019     2018     2017  
      $       $       $  
Income tax (expense) recovery based on combined statutory income tax rate     1,615     (2,574 )     5,434  
Change in unrecognized tax assets     (3,160 )      (1,963 )     (2,701 )
Change in unrecognized tax assets related to OCI     340     (188 )     (228 )
Share issuance costs     65     (40 )     164  
Permanent difference attributable to the use of local currency for tax reporting     35       792       (71 )
Change in enacted rates used     (27 )      (58 )     (358 )
Permanent difference attributable to net change in fair value of warrant liability     1,197     70       595  
Share-based compensation costs     (210 )     (152 )     (49 )
Difference in statutory income tax rate of foreign subsidiaries     321     (917 )     768  
Adjustments in respect of prior years           (372 )     (149 )
Other     12       (50 )     74  
      188       (5,452 )     3,479  

 

Deferred income tax assets are recognized to the extent that the realization of the related tax benefit through reversal of temporary differences and future taxable profits is probable.

 

(Loss) income before income taxes

 

(Loss) income before income taxes is attributable to the Company’s tax jurisdictions as follows:

 

    Years ended December 31,  
    2019     2018     2017  
      $       $       $  
Germany     (6,010 )     16,297       (13,950 )
Canada     812       (5,504 )     (5,592 )
United States     (1,032 )     (1,154 )     (733 )
      (6,230 )     9,639       (20,275 )

 

(39)
 

 

Aeterna Zentaris Inc.
Notes to Consolidated Financial Statements
As at December 31, 2019 and December 31, 2019 and for the years ended December 31, 2019, 2018 and 2017
(tabular amounts in thousands of US dollars, except share/option/warrant/DSU and per share/option/warrant/DSU data and as otherwise noted)

 

Significant components of deferred tax assets and liabilities are as follows:

 

    December 31,  
    2019     2018  
      $       $  
Deferred tax assets                
Current:                
Operating losses carried forward            
Non-current:                
Operating losses carried forward     691       764  
Intangible assets     2,639       3,646  
      3,330       4,410  
Deferred tax liabilities                
Current:                
Deferred revenues           38  
Restricted cash     52       153  
Payables and accrued liabilities           95  
      52       286  
Non-current:                
Property, plant and equipment     184       3  
Deferred revenues     3,047       4,074  
Other     47       47  
      3,278       4,124  
      3,330       4,410  
Deferred tax assets (liabilities), net            

 

Significant components of unrecognized deferred tax assets are as follows:

 

    December 31,  
    2019     2018  
      $       $  
Deferred tax assets                
Current:                
Deferred revenues and other provisions     550       649  
      550       649  
Non-current:                
Deferred revenues            
Operating losses carried forward     83,699       81,731  
SR&ED Pool     9,138       9,148  
Unused tax credits     5,149       5,894  
Employee future benefits     2,303       2,048  
Property, plant and equipment     480       448  
Share issuance expenses     342       467  
Other     272       241  
      101,383       99,977  
Unrecognized deferred tax assets     101,933       100,626  

 

(40)
 

 

Aeterna Zentaris Inc.
Notes to Consolidated Financial Statements
As at December 31, 2019 and December 31, 2019 and for the years ended December 31, 2019, 2018 and 2017
(tabular amounts in thousands of US dollars, except share/option/warrant/DSU and per share/option/warrant/DSU data and as otherwise noted)

 

As at December 31, 2019, amounts and expiry dates of tax attributes to be deferred for which no deferred tax asset was recognized were as follows:

 

    Canada  
    Federal     Provincial  
      $       $  
2028     8,008       6,622  
2029     4,791       4,773  
2030     4,104       4,089  
2031     1,753       1,737  
2032     4,250       4,250  
2033     3,721       3,721  
2034     4,153       4,153  
2035     10,418       10,452  
2036     10,592       10,592  
2037     7,343       7,343  
2038     6,557       6,557  
2039     3,501       3,501  
      69,191       67,790  

 

The Company has non-refundable R&D investment tax credits of approximately $7,005 which can be carried forward to reduce Canadian federal income taxes payable and which expire at dates ranging from 2019 to 2035. Furthermore, the Company has unrecognized tax assets in respect of operating losses to be carried forward in Germany and in the U.S. The federal tax losses amount to approximately $200,707 in Germany (EUR 178,883) for which there is no expiry date, and to $4,044 in the U.S., which expire as follows:

 

    United States  
    $  
2028     369  
2029     178  
2034     151  
2035     447  
2036     195  
2037     709  
2038     1,224  
2039     771  
      4,044  

 

The operating loss carryforwards and the tax credits claimed are subject to review, and potential adjustment, by tax authorities. Other deductible temporary differences for which tax assets have not been booked are not subject to a time limit, except for share issuance expenses which are amortizable over five years.

 

23 Capital disclosures

 

The Company’s objective in managing capital, consisting of shareholders’ (deficiency) equity, with cash and cash equivalents and restricted cash equivalents being its primary components, is to ensure sufficient liquidity to fund R&D costs, selling expenses, G&A expenses and working capital requirements.

 

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Aeterna Zentaris Inc.
Notes to Consolidated Financial Statements
As at December 31, 2019 and December 31, 2019 and for the years ended December 31, 2019, 2018 and 2017
(tabular amounts in thousands of US dollars, except share/option/warrant/DSU and per share/option/warrant/DSU data and as otherwise noted)

 

Over the past several years, the Company has raised capital via public equity offerings and issuances under various ATM sales programs as its primary source of liquidity, as discussed in note 19 - share and other capital.

 

The capital management objective of the Company remains the same as that in previous periods. The policy on dividends is to retain cash to keep funds available to finance the activities required to advance the Company’s product development portfolio and to pursue appropriate commercial opportunities as they may arise.

 

The Company is not subject to any capital requirements imposed by any regulators or by any other external source.

 

24 Financial instruments and financial risk management

 

Financial assets (liabilities) as at December 31, 2019 and December 31, 2018 are presented below.

 

December 31, 2019

   

Financial assets at amortized cost

     

Financial liabilities at FVTPL

      Financial liabilities at amortized cost       Total  
      $       $       $       $  
Cash and cash equivalents (note 7)     7,838                   7,838  
Trade and other receivables (note 8)     404                   404  
Restricted cash equivalents (note 11)     364                   364  
Payables and accrued liabilities (note 15)                 2,148       2,148  
Lease liability (note 5)                 903       903  
Warrant liability (note 17)           2,255             2,255  
      8,606       2,255       3,051       3,300  

 

December 31, 2018   Financial assets at amortized cost     Financial liabilities at FVTPL     Financial liabilities at amortized cost     Total  
      $       $       $       $  
Cash and cash equivalents (note 7)     14,512                   14,512  
Trade and other receivables (note 8)     245                   245  
Restricted cash equivalents (note 11)     418                   418  
Payables and accrued liabilities (note 15)                 2,791       2,791  
Warrant liability (note 17)           3,634             3,634  
      15,175       3,634       2,791       8,750  

 

Fair value

 

The Black-Scholes valuation methodology uses “Level 2” inputs in calculating fair value, as defined in IFRS 13, which establishes a hierarchy that prioritizes the inputs used to measure fair value. The hierarchy gives the highest priority to unadjusted quoted prices in active markets for identical assets or liabilities (Level 1 measurement) and the lowest priority to unobservable inputs (Level 3 measurement).

 

The input levels discussed in IFRS 13 are:

 

Level 1 –       Unadjusted quoted prices in active markets for identical assets or liabilities.

 

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Aeterna Zentaris Inc.
Notes to Consolidated Financial Statements
As at December 31, 2019 and December 31, 2019 and for the years ended December 31, 2019, 2018 and 2017
(tabular amounts in thousands of US dollars, except share/option/warrant/DSU and per share/option/warrant/DSU data and as otherwise noted)

 

  Level 2 – Inputs other than quoted prices included within Level 1 that are observable for an asset or liability, either directly (i.e. prices) or indirectly (i.e. derived from prices).
     
  Level 3 – Inputs for an asset or liability that are not based on observable market data (unobservable inputs).

 

The carrying values of the Company’s cash and cash equivalents, trade and other receivables, restricted cash equivalents, payables and accrued liabilities and provision for restructuring and other costs approximate their fair values due to their short-term maturities or to the prevailing interest rates of the related instruments, which are comparable to those of the market.

 

Financial risk factors

 

The following provides disclosures relating to the nature and extent of the Company’s exposure to risks arising from financial instruments, including credit risk, liquidity risk, market risk (share price risk) and foreign exchange risk and how the Company manages those risks.

 

  (a) Credit risk

 

Credit risk is the risk of an unexpected loss if a customer or counterparty to a financial instrument fails to meet its contractual obligations. The Company regularly monitors credit risk exposure and takes steps to mitigate the likelihood of this exposure resulting in losses. The Company’s exposure to credit risk currently relates to the financial assets at amortized cost in the table above. The Company holds its available cash in amounts that are readily convertible to known amounts of cash and deposits its cash balances with financial institutions that have an investment grade rating of at least “P-2” or the equivalent. This information is supplied by independent rating agencies where available and, if not available, the Company uses publicly available financial information to ensure that it invests its cash in creditworthy and reputable financial institutions. Once there are indicators that there is no reasonable expectation of recovery, such financial assets are written off but are still subject to enforcement activity.

 

As at December 31, 2019, trade accounts receivable for an amount of approximately $265 were with four counterparties of which $55 was past due and impaired and fully provided for (2018 - $197 with four counterparties and $55 past due and impaired and fully provided for). The licensee is obligated to pay its quarterly royalties, 60 days after quarter-end.

 

Generally, the Company does not require collateral or other security from customers for trade accounts receivable; however, credit is extended following an evaluation of creditworthiness. In addition, the Company performs ongoing credit reviews of all of its customers and determines expected credit losses. On this basis, as at December 31, 2019, the Company has provided for all outstanding and unpaid amounts relating to its operations before its licensing of MacrilenTM(macimorelin). The licensee has paid all amounts owing within 90 days of invoicing.

 

The maximum exposure to credit risk approximates the amount recognized in the Company’s consolidated statement of financial position.

 

  (b) Liquidity risk

 

Liquidity risk is the risk that the Company will not be able to meet its financial obligations as they become due. As indicated in note 23, the Company manages this risk through the management of its capital structure. It also manages liquidity risk by continuously monitoring actual and projected cash flows as further discussed in note 1. The Board of Directors reviews and approves the Company’s operating and capital budgets, as well as any material transactions occurring outside of the ordinary course of business. The Company has adopted an investment policy in respect of the safety and preservation of its capital to ensure the Company’s liquidity needs are met. The instruments are selected with regard to the expected timing of expenditures and prevailing interest rates.

 

(43)
 

Aeterna Zentaris Inc.
Notes to Consolidated Financial Statements
As at December 31, 2019 and December 31, 2019 and for the years ended December 31, 2019, 2018 and 2017
(tabular amounts in thousands of US dollars, except share/option/warrant/DSU and per share/option/warrant/DSU data and as otherwise noted)

 

All of the Company’s financial liabilities except lease liabilities are current liabilities with expected settlement dates within one year. The maturity analysis for lease liabilities is disclosed in note 5.

  (c) Market risk

 

Share price risk

 

The change in fair value of the Company’s warrant liability, which is measured at FVTPL, results from the periodic “mark-to-market” revaluation as further described in note 17 as it applies to its outstanding share purchase warrants. The valuation models are impacted, among other inputs, by the market price of the Company’s common shares. As a result, the change in fair value of the warrant liability, which is reported in the consolidated statements of comprehensive income (loss), has been and may continue in future periods to be materially affected most notably by changes in the Company’s common share closing price, which on the NASDAQ ranged from $0.77 to $5.43 during the year ended December 31, 2019.

 

If variations in the market price of our common shares of -30% and +30% were to occur, the impact on the Company’s net loss related to the warrant liability held at December 31, 2019 would be $771 to $(806), respectively.

 

  (d) Foreign exchange risk

 

Entities using the Euro as their functional currency

 

The Company is exposed to foreign exchange risk due to its investments in foreign operations whose functional currency is the Euro. As at December 31, 2019, if the US dollar had increased or decreased by 10% against the Euro, with all variables held constant, net loss for the year ended December 31, 2019 would have been lower or higher by approximately $841 (net income for 2018 - $1,134).

 

25 Segment information

 

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

 

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Aeterna Zentaris Inc.
Notes to Consolidated Financial Statements
As at December 31, 2019 and December 31, 2019 and for the years ended December 31, 2019, 2018 and 2017
(tabular amounts in thousands of US dollars, except share/option/warrant/DSU and per share/option/warrant/DSU data and as otherwise noted)

 

Geographical information

 

Revenues by geographical area are detailed as follows:

 

    Years ended December 31,  
    2019     2018     2017  
    $     $     $  
Ireland     74       24,910        
United States           1,416       452  
China           275       262  
Denmark     413              
British Virgin Islands           280       206  
Other     45             3  
      532       26,881       923  

 

Revenues have been allocated to geographic regions based on the country of residence of the Company’s external customers or licensees.

 

Non-current assets include restricted cash equivalents, right of use assets, property, plant and equipment, identifiable intangible assets and goodwill and are detailed by geographical area as follows:

 

    December 31,  
    2019     2017  
    $     $  
Germany     8,969       8,599  
United States     101       153  
Canada     1       3  
      9,071       8,755  

 

Major customers representing 10% or more of the Company’s revenues in each of the last three years are as follows:

 

    Years ended December 31,  
    2019    

2018

    2017  
    $     $     $  
Company 1     74       26,127        
Company 2     458              
Company 3           275       262  
Company 4                 323  
Company 5                 129  
Company 6           280       206  

 

(45)
 

Aeterna Zentaris Inc.
Notes to Consolidated Financial Statements
As at December 31, 2019 and December 31, 2019 and for the years ended December 31, 2019, 2018 and 2017
(tabular amounts in thousands of US dollars, except share/option/warrant/DSU and per share/option/warrant/DSU data and as otherwise noted)

 

26 Net (loss) income per share

 

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

 

    Years ended December 31,  
    2019     2018     2017  
    $     $     $  
Net (loss) income     (6,042 )     4,187       (16,796 )
Basic weighted average number of shares outstanding     17,494,472       16,440,760       14,958,704  
Diluted weighted average number of shares outstanding     17,494,472       17,034,812       14,958,704  
Items excluded from the calculation of diluted net (loss) income 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     953,557       889,685       713,918  
Share purchase warrants     6,629,144       3,391,844       3,417,840  

 

Net (loss) income per share is calculated by dividing net (loss) income 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 share purchase warrants. In periods with reported net losses, all stock options and share purchase 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 share purchase warrants have not been included in the computation of net loss per share because to do so would be anti-dilutive.

 

27 Commitments and contingencies

 

    Service and
manufacturing
 
    $  
Less than 1 year     1,600  
1 - 3 years     11  
4 - 5 years     5  
More than 5 years     5  
Total     1,621  

 

Contingencies

 

In the normal course of operations, the Company may become involved in various claims and legal proceedings related to, for example, contract terminations and employee-related and other matters.

 

(46)
 

Aeterna Zentaris Inc.
Notes to Consolidated Financial Statements
As at December 31, 2019 and December 31, 2019 and for the years ended December 31, 2019, 2018 and 2017
(tabular amounts in thousands of US dollars, except share/option/warrant/DSU and per share/option/warrant/DSU data and as otherwise noted)

 

Securities class action lawsuit

 

On March 9, 2020, the Company settled the previously disclosed class-action lawsuit against it pending in the U.S. District Court for New Jersey. The settlement payment of $6,500 will be funded entirely by the Company’s insurers. The class-action lawsuit alleged that the Company and certain of its former officers and directors violated the Securities Exchange Act of 1934 in connection with certain public statements between August 30, 2011 and November 6, 2014, regarding the safety and efficacy of Macrilen™ (macimorelin) and the prospects for the approval of the Company’s NDA for the product by the FDA. This settlement remains subject to execution of final settlement documents and approval by the U.S. District Court for the District of New Jersey.

 

Previously settled lawsuits

 

On December 21, 2018, the Company settled a dispute with its former President and Chief Executive Officer and with its former Senior Vice President, Chief Administrative Officer, General Counsel and Corporate Secretary with the Company agreeing to make a payment in the amount of $775.

 

On November 5, 2018, the Company settled a dispute with Cogas Consulting, LLC with the Company agreeing to make a payment of $625.

 

28 Reclassifications on comparative figures

 

To consolidate the presentation of similar items, during 2019, the Company reclassified certain of its prior year comparative balance sheet items as follows:

 

Payables and accrued liabilities and current portion of deferred revenues

 

The $175 in payables and accrued liabilities has been reclassified to deferred revenue to be recognized on the sale of inventory to our licensee in 2020.

 

29 Subsequent events

 

  (a) On February 21, 2020, the Company closed a registered direct offering for 3,478,261 common shares, at a purchase price of $1.29 per share, priced at-the-market. Additionally, the Company issued to the investors unregistered warrants to purchase up to an aggregate of 2,608,696 common shares in a concurrent private placement. The warrants have an exercise price of $1.20 per common share, are exercisable immediately and will expire five and one-half years following the date of issuance. The gross proceeds of the offering were $4,500. The net cash proceeds to the Company from the offering totaled approximately $3,920. The Company also issued 243,478 warrants to the placement agent with an exercise price of $1.61719 per common share, which are exercisable immediately and will expire five years following the date of issuance.

 

  (b) Subsequent to year end, the COVID-19 pandemic began causing significant financial market declines and social dislocation. The situation is dynamic with various cities and countries around the world responding in different ways to address the outbreak. The spread of COVID-19 may impact our operations, including the potential interruption of our clinical trial activities and our supply chain. For example, the COVID-19 outbreak may delay enrollment in our pediatric clinical trial due to prioritization of hospital resources toward the outbreak, and some patients may be unwilling to enroll in our trials or be unable to comply with clinical trial protocols if quarantines impede patient movement or interrupt healthcare services, which would delay our ability to conduct clinical trials or release clinical trial results and could delay our ability to obtain regulatory approval and commercialize our product candidates. The spread of an infectious disease, including COVID-19, may also result in the inability of our suppliers to deliver components or raw materials on a timely basis or at all. In addition, hospitals may reduce staffing and reduce or postpone certain treatments in response to the spread of an infectious disease. Such events may result in a period of business disruption and, in reduced operations, doctors or medical providers may be unwilling to participate in our clinical trials, any of which could materially affect our business, financial condition or results of operations.  The significant spread of COVID-19 within the U.S., Canada, Germany and elsewhere resulted in a widespread health crisis and has had adverse effects on local, national and global economies generally, the markets that we serve, our operations and the market price of our Common Shares.The Company’s impairment test for various assets including goodwill and intangibles is based on fair value models which are based on cash flows from operations or other market dependent models. Accordingly, as required by IFRS we have not reflected these subsequent conditions in the recoverable value of the  estimate of these assets at December 31, 2019.
     
    Uncertain factors, including the duration of the outbreak, the severity of the disease and the actions to contain or treat its impact, could impair our operations including, among other things, employee mobility and productivity, availability of our facilities, conduct of our clinical trials and the availability and the productivity of third-party product and service suppliers.

 

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Exhibit 99.2

 

2019 Annual MD&A

 

Management’s Discussion and Analysis of Financial Condition and Results of Operations

 

Introduction

 

This Management’s Discussion and Analysis (“MD&A”) provides a review of the results of operations, financial condition and cash flows of Aeterna Zentaris Inc. for the year ended December 31, 2019. In this MD&A, “Aeterna Zentaris”, the “Company”, “we”, “us” and “our” mean Aeterna Zentaris Inc. and its subsidiaries. This discussion should be read in conjunction with the information contained in the Company’s consolidated audited financial statements and the accompanying notes thereto as at December 31, 2019 and December 31, 2018 and for the years ended December 31, 2019, 2018 and 2017. Our consolidated audited financial statements have been prepared in accordance with International Financial Reporting Standards (“IFRS”) as issued by the International Accounting Standards Board (“IASB”).

 

The Company’s common shares are listed on both the NASDAQ Capital Market (“NASDAQ”) and on the Toronto Stock Exchange (“TSX”) under the symbol “AEZS”.

 

All amounts in this MD&A are presented in U.S. dollars, except for share, option and share purchase warrant data, or as otherwise noted.

 

This MD&A was approved by the Company’s Board of Directors subject to confirmation by the Audit Committee of the Board of Directors, which confirmation was received on March 27, 2020. This MD&A is dated March 30, 2020 and should be read in conjunction with the December 31, 2019 audited consolidated financial statements and related notes of the Company.

 

Company Overview

 

Aeterna Zentaris is a specialty biopharmaceutical company commercializing and developing therapeutics and diagnostic tests. The Company’s lead product, Macrilen™ (macimorelin), is the first and only United States Food and Drug Administration (“FDA”) and European Commission approved oral test indicated for the diagnosis of patients with adult growth hormone deficiency (“AGHD”). Macrilen™ (macimorelin) is currently marketed in the U.S. through a license and assignment agreement (the “License Agreement”) with Novo. Aeterna Zentaris is also pursuing the development of macimorelin for the diagnosis of child-onset growth hormone deficiency (CGHD), an area of significant unmet need. In addition, we are actively pursuing business development opportunities for the commercialization of macimorelin in Europe and the rest of the world in addition to other non-strategic assets to monetize their value.

 

The Company’s principal focus is on the commercialization of Macrilen™ (macimorelin) and it currently does not have any other approved products. Under the terms of License Agreement (as defined below), Novo Nordisk A/S (“Novo”) is funding 70% of the pediatric clinical trial submitted to the EMA and FDA, the Company’s sole development activity. In November 2019, Novo contracted Aeterna Zentaris GmbH (“AEZS Germany”), our wholly owned German subsidiary, to provide supply chain services for the manufacture of Macrilen™ (macimorelin).

 

About Forward-Looking Statements

 

This document contains forward-looking statements (as defined by applicable securities legislation) made pursuant to the safe-harbor provision of the U.S. Securities Litigation Reform Act of 1995, which reflect our current expectations regarding future events. Forward-looking statements may include, but are not limited to statements preceded by, followed by, or that include the words “will,” “expects,” “believes,” “intends,” “would,” “could,” “may,” “anticipates,” and similar terms that relate to future events, performance, or our results. Forward-looking statements involve known and unknown risks and uncertainties, including those discussed in this press release and in our Annual Report on Form 20-F, under the caption “Key Information - Risk Factors” filed with the relevant Canadian securities regulatory authorities in lieu of an annual information form and with the U.S. Securities and Exchange Commission. Known and unknown risks and uncertainties could cause our actual results to differ materially from those in forward-looking statements. Such risks and uncertainties include, among others, our ability to raise capital and obtain financing to continue our currently planned operations, our ability to continue to list our Common Shares on the NASDAQ, our ability to continue as a going concern is dependent, in part, on our ability of to transfer cash from Aeterna Zentaris GmbH (“AEZS Germany”) to Aeterna Zentaris and the U.S. subsidiary and secure additional financing, our now heavy dependence on the success of Macrilen™ (macimorelin) and related out-licensing arrangements and the continued availability of funds and resources to successfully commercialize the product, including our heavy reliance on the success of the License Agreement with Novo, our ability to enter into out-licensing, development, manufacturing, marketing and distribution agreements with other pharmaceutical companies and keep such agreements in effect, our reliance on third parties for the manufacturing and commercialization of Macrilen™ (macimorelin), , potential disputes with third parties, leading to delays in or termination of the manufacturing, development, out-licensing or commercialization of our product candidates, or resulting in significant litigation or arbitration, uncertainties related to the regulatory process, unforeseen global instability, including the instability due to the global pandemic of the novel coronavirus or COVID-19, our ability to efficiently commercialize or out-license Macrilen™ (macimorelin), our reliance on the success of the pediatric clinical trial in the European Union (“E.U.”) and U.S. for Macrilen™ (macimorelin), the degree of market acceptance of Macrilen™ (macimorelin), our ability to obtain necessary approvals from the relevant regulatory authorities to enable us to use the desired brand names for our product, our ability to successfully negotiate pricing and reimbursement in key markets in the E.U. for Macrilen™ (macimorelin), any evaluation of potential strategic alternatives to maximize potential future growth and shareholder value may not result in any such alternative being pursued, and even if pursued, may not result in the anticipated benefits, our ability to take advantage of business opportunities in the pharmaceutical industry, our ability to protect our intellectual property, and the potential of liability arising from shareholder lawsuits and general changes in economic conditions. Investors should consult our quarterly and annual filings with the Canadian and U.S. securities commissions for additional information on risks and uncertainties. Given these uncertainties and risk factors, readers are cautioned not to place undue reliance on these forward-looking statements. We disclaim any obligation to update any such factors or to publicly announce any revisions to any of the forward-looking statements contained herein to reflect future results, events or developments, unless required to do so by a governmental authority or applicable law.

 

(1)

2019 Annual MD&A

 

About Material Information

 

This MD&A includes information that we believe to be material to investors after considering all circumstances. We consider information and disclosures to be material if they result in, or would reasonably be expected to result in, a significant change in the market price or value of our securities, or where it is likely that a reasonable investor would consider the information and disclosures to be important in making an investment decision.

 

We are a reporting issuer under the securities legislation of all of the provinces of Canada, and our securities are registered with the SEC. We are therefore required to file or furnish continuous disclosure information, such as interim and annual financial statements, MD&A, proxy or information circulars, annual reports on Form 20-F, material change reports and press releases with the appropriate securities regulatory authorities. Copies of these documents may be obtained free of charge upon request from our Corporate Secretary or on the Internet at the following addresses: www.zentaris.com, www.sedar.com and www.sec.gov.

 

Key Developments

 

Financing activities

 

On September 20, 2019, the Company entered into a securities purchase agreement with U.S. institutional investors to purchase $5.0 million (before total transaction costs of $0.8 million) of its common shares in a registered direct offering and warrants with a cashless exercise feature to purchase common shares in a concurrent private placement. The combined purchase price for one common share and one warrant was $1.50. Under the terms of the securities purchase agreement, the Company sold 3,325,000 common shares. In a concurrent private placement, the Company issued warrants to purchase up to an aggregate of 3,325,000 common shares. The warrants are exercisable commencing six months from the date of issuance, have an exercise price of $1.65 per share and expire five years following the date of issuance.

 

Subsequent to 2019, on February 21, 2020, the Company closed a registered direct offering for 3,478,261 common shares, at a purchase price of $1.29375 per share, priced at-the-market. Additionally, the Company issued to the investors unregistered warrants to purchase up to an aggregate of 2,608,696 common shares in a concurrent private placement. The warrants have an exercise price of $1.20 per common share, are exercisable immediately and will expire five and one-half years following the date of issuance. The net cash proceeds to the Company from the offering totaled approximately $3.9 million. The Company issued 243,478 warrants to the placement agent with an exercise price of $1.61719 per common share, which are exercisable immediately and will expire five years following the date of issuance.

 

Commercialization of Macrilen™ (macimorelin) in U.S. and Canada

 

On January 16, 2018, the Company through AEZS Germany entered into the 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, which provides for (i) the “right to use” license relating to the Adult Indication; (ii) the sale of the right to acquire a license of a future pediatric indication approved by the. FDA; (iii) the licensee to fund 70% of the costs of a pediatric clinical trial submitted for approval to the EMA and FDA (the “PIP Study”) to be run by the Company with customary oversight from a joint steering committee (the “JSC”); and (iv) for a Supply Arrangement. 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. In 2019, the Supply Arrangement was concluded and Novo contracted AEZS Germany to provide supply chain services for the manufacture of Macrilen™ (macimorelin).

 

(2)

2019 Annual MD&A

 

Following Novo’s acquisition of the U.S. and Canadian rights to Macrilen™ (macimorelin), the JSC met in January, May, August and December 2019 to discuss Novo’s commercialization plan for the U.S. and Canada, their supply chain needs and the enrollment of patients and protocols of the PIP study. The Company expects that quarterly meetings will continue as forecasts for sales, inventory build and needs for the PIP study progresses.

 

On December 18, 2019, the Company announced that the American Association of Clinical Endocrinologists (“AACE”) and American College of Endocrinology (“ACE”) recently published the new ‘Guidelines for Management of Growth Hormone Deficiency in Adults and Patients transitioning from Pediatric to Adult Care’. These AACE/ACE 2019 Guidelines (publicly available at (https://journals.aace.com/doi/10.4158/GL-2019-0405) identify macimorelin as a “shorter and simpler alternative” compared to the traditionally available growth hormone stimulation tests (“GHSTs”). For further details, refer to the text of the guideline. Full citation: AMERICAN ASSOCIATION OF CLINICAL ENDOCRINOLOGISTS AND AMERICAN COLLEGE OF ENDOCRINOLOGY GUIDELINES FOR MANAGEMENT OF GROWTH HORMONE DEFICIENCY IN ADULTS AND PATIENTS TRANSITIONING FROM PEDIATRIC TO ADULT CARE Kevin C. J. Yuen, Beverly M. K. Biller, Sally Radovick, John D. Carmichael, Sina Jasim, Kevin M. Pantalone, and Andrew R. Hoffman Endocrine Practice 2019 25:11, 1191-1232

 

Royalty income earned under the License Agreement for the twelve-month period ending December 31, 2019 was $0.05 million (2018 - $0.2 million) and, during the twelve-month period ended December 31, 2019, the Company invoiced Novo $1.0 million for its share of PIP study costs (2018 - $0.4 million) and has received payment in full for these invoices.

 

The Company agreed, in the Interim Supply Arrangement to the License Agreement, to supply ingredients for the manufacture of Macrilen™ (macimorelin) during an interim period at a price that is set ‘at cost’ without any profit margin. In November 2019, Novo contracted with AEZS Germany, to provide supply chain services including provision of supervision of stability studies (support services) as well as provision of supervision of stability studies (support services) as well as API batch production and delivery of certain API and semi-finished goods.In 2019, the Company invoiced $1.2 million (2018 – $2.2 million) and has received payment in full for these invoices.

 

Rest of the world commercialization of macimorelin

 

On January 16, 2019, we announced that the European Commission granted marketing authorization for macimorelin for the diagnosis of AGHD. We believe that this marks an important development in our European commercialization strategy based on research evaluating the potential number of GHSTs in adults in Europe. We are in discussions with a variety of companies regarding licensing and/or distribution opportunities in the rest of the world, although there can be no assurances that any such discussions will result in any definitive licensing and/or distribution arrangements.

 

(3)

2019 Annual MD&A

 

Pediatric clinical trial for Macrilen™ (macimorelin)

 

Subsequent to 2019, on January 28, 2020, the Company announced the successful completion of patient recruitment for the first pediatric study of macimorelin as a GHST for the evaluation of growth hormone deficiency (“GHD”) in children. This study, AEZS-130-P01 (“Study P01”), is the first of two studies as agreed with the European Medicines Agency in the Company’s PIP for macimorelin. Macimorelin, a ghrelin agonist, is an orally active small molecule that stimulates the secretion of growth hormone from the pituitary gland into the circulatory system. The goal of Study P01is to establish a dose that can both be safely administered to pediatric patients and cause a clear rise in growth hormone concentration in subjects ultimately diagnosed as not having GHD. The recommended dose derived from Study P01 will be evaluated in the pivotal second study AEZS-130-P02 (“Study P02”) on diagnostic efficacy and safety. Study P01 is an international, multicenter study which is being conducted in Hungary, Poland, Ukraine, Serbia, and Russia. Study P01 is an open label, group comparison, dose escalation trial designed to investigate the safety, tolerability, and pharmacokinetic/pharmacodynamic(“PK/PD”) of macimorelin acetate after ascending single oral doses of macimorelin at 0.25, 0.5, and 1.0 mg per kg body weight in pediatric patients from 2 to less than 18 years of age with suspected GHD. The Company enrolled a total of 24 pediatric patients across the three cohorts of the study. Per study protocol, all enrolled patients will complete four study visits after successful completion of the screening period. At Visit 1 and Visit 3, a provocative GH stimulation test will be conducted according to the study sites’ local practices. At Visit 2, the macimorelin test will be performed: following the oral administration of the macimorelin solution, blood samples will be taken at predefined times for PK/PD assessment. Visit 4 is a safety follow-up visit at study end. For more information about Study P01, please visit EU Clinical Trials Register and reference EudraCT #2018-001988-23.

 

Study P01 is the first of two studies as agreed with the EMA in the Company’s PIP for macimorelin as a GHD diagnostic. Study P01 final study results are expected in the second quarter of 2020. Thereafter, we plan to proceed with the pivotal Study P02 with expected start date in the fourth quarter of 2020 and an expected completion date in July 2022, according to the PIP agreement with EMA.

 

Changes in personnel 

 

On June 6, 2019, the Company announced that it was reducing the size of its German workforce and operations to more closely reflect the Company’s ongoing commercial activities. AEZS Germany and its Works Council approved a restructuring that affected 8 employees and was completed on January 31, 2020, resulting in approximately $0.6 million in severance costs.

 

In July 2019, Michael Ward resigned as managing director of AEZS Germany and Dr. Klaus Paulini assumed this role. In August 2019, Jonathan Pollack resigned as a director and, in September 2019, Brian Garrison, resigned as a Senior Vice President, Global Commercial Operations of Aeterna Zentaris. On October 4, 2019, the Company announced the appointment of Dr. Klaus Paulini as President and Chief Executive Officer of the Aeterna Zentaris Inc., replacing Michael Ward. Dr. Paulini was also appointed as a director of Aeterna Zentaris Inc. at that time.

 

On December 16, 2019, the Company announced changes to its director composition planned for the first quarter of 2020. Mr. Gilles Gagnon (M.Sc., MBA, ICD.D) joined the Board of the Company on January 1, 2020. Mr. Gérard Limoges, who has served on the Board of Company since 2004, is planning to retire from the Board on March 31, 2020, and upon his retirement, Mr. Pierre-Yves Desbiens (CPA, CA, CF, MBA) is joining the Board on April 1, 2020 and replaces Mr. Limoges as Chair of the Audit Committee.

 

NASDAQ notifications

 

On January 8, 2020, the Company announced that it had received a notification letter from NASDAQ indicating that, because the closing bid price of the Company’s common stock for 30 consecutive business days was below $1.00 per share, the Company no longer meets the minimum bid price requirement set forth in NASDAQ Listing Rule5550(a)(2). NASDAQ Listing Rule 5810(c)(3)(A) provides that a failure to meet the minimum bid price requirement exists if the deficiency continues for a period of 30 consecutive business days. On January 23, 2020, the Company received a letter from NASDAQ stating that because the Company’s shares had a closing bid price at $1.00 per share or greater for a minimum of ten (10) consecutive business days, Aeterna Zentaris’ stock has regained compliance with the Bid Price Rule and NASDAQ considers the matter closed. As of the date of this MD&A, the Company’s closing bid price was below $1.00. For more information, please see the Risk Factor entitled “Our Common Shares may be delisted from the NASDAQ or the TSX, which could affect their market price and liquidity. If our Common Shares were to be delisted, investors may have difficulty in disposing their Common Shares” in our Annual Report on Form 20-F for the year ended December 31, 2019.

 

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2019 Annual MD&A

 

Settlement of Class-Action Lawsuit

 

On March 9, 2020, the Company settled the previously disclosed class-action lawsuit against it pending in the U.S. District Court for New Jersey. The settlement payment of $6.5 million will be funded entirely by our insurers. The class-action lawsuit alleged that the Company and certain of its former officers and directors violated the Securities Exchange Act of 1934 in connection with certain public statements between August 30, 2011 and November 6, 2014, regarding the safety and efficacy of Macrilen™ (macimorelin) and the prospects for the approval of the Company’s NDA for the product by the FDA. This settlement remains subject to execution of final settlement documents and approval by the U.S. District Court for the District of New Jersey.

 

Exposure to Epidemic or Pandemic Outbreak

 

As of March 25, 2020, coronavirus or COVID-19, a contagious disease that has been characterized by the World Health Organization as a pandemic, is affecting the global community and is adversely affecting our business operations, which at this time cannot currently be fully determined or quantified. Aeterna Zentaris has developed protocols and procedures should they be required to deal with any potential epidemics and pandemics, and has put these protocols and procedures in place to address the current COVID-19 pandemic. Despite appropriate steps being taken to mitigate such risks, there can be no assurance that existing policies and procedures will ensure that the Company’s operations will not be adversely affected.

 

The COVID-19 pandemic has resulted in a widespread health crisis that has adversely affected the economies and financial markets of many regions and countries. While the COVID-19 outbreak may still be in its early stages, international stock markets have begun to reflect the uncertainty associated with the potential economic impact of the outbreak and the significant declines in the TSX Composite Index, the NASDAQ and other major indices around the world in the latter part of February and in March 2020 has largely been attributed to the effects of COVID-19. There can be no assurance that a disruption in financial markets, regional economies and the world economy would not negatively affect Aeterna Zentaris’ access to capital or the financial performance of the Company.

 

Uncertain factors, including the duration of the outbreak, the severity of the disease and the actions to contain or treat its impact, could impair our operations including, among other things, employee mobility and productivity, availability of our facilities, conduct of our clinical trials and the availability and the productivity of third party product and service suppliers. Please see the Risk Factor entitled “The economic effects of a pandemic, epidemic or outbreak of an infectious disease could adversely affect our operations or the market price of our Common Shares” in our Annual Report on Form 20-F for the year ended December 31, 2019.

 

Monetization of non-strategic assets

 

Opportunities for the Company to monetize non-strategic assets include preclinical work done on AEZS-120, a prostate cancer vaccine and preclinical and clinical work done on AEZS-108 (zoptarelin doxorubicin) and AEZS-104 (perifosine).

 

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2019 Annual MD&A

 

Condensed Consolidated Statements of Comprehensive Loss Information

 

    Three months ended
December 31,
    Years ended
December 31,
 
(in thousands, except share and per share data)   2019     2018     2019     2018     2017  
    $     $     $     $     $  
Revenues                                        
License fees     19       (332 )     74       24,325       458  
Product sales           1,446       129       2,167        
Royalty income     16       184       45       184        
Sales commission                       110       465  
Supply chain     (17 )     94       284       95        
Total revenues     18       1,392       532       26,881       923  
Operating expenses                                        
Cost of sales     309       1,413       410       2,104        
Research and development costs     263       767       1,837       2,932       10,704  
General and administrative expenses     1,691       1,665       6,615       8,894       8,198  
Selling expenses     38       588       1,214       3,109       5,095  
Restructuring costs     (266 )           507              
Impairment of right of use asset     (254 )           22              
Impairment of prepaid asset                 169              
Total operating expenses     1,781       4,433       10,774       17,039       23,997  
(Loss) income from operations     (1,763 )     (3,041 )     (10,242 )     9,842       (23,074 )
Settlements           (1,400 )           (1,400 )      
Gain due to changes in foreign currency exchange rates     26       64       87       656       502  
Change in fair value of warrant liability     533       (1,489 )     4,518       263       2,222  
Other finance (costs) income     10       104       (593 )     278       75  
Net finance income (costs)     569       (1,321 )     4,012       1,197       2,799  
(Loss) income before income taxes     (1,194 )     (5,762 )     (6,230 )     9,639       (20,275 )
Income tax recovery (expense)     188       636       188       (5,452 )     3,479  
Net (loss) income     (1,006 )     (5,126 )     (6,042 )     4,187       (16,796 )
Other comprehensive (loss) income:                                        
Foreign currency translation adjustments     (268 )     (13 )     83       (260 )     (1,430 )
Actuarial gain (loss) on defined benefit plans     959       (418 )     (1,068 )     193       694  
Comprehensive (loss) income     (315 )     (5,557 )     (7,027 )     4,120       (17,532 )
Net loss per share (basic)     (0.05 )     (0.31 )     (0.35 )     0.25       (1.12 )
Net loss per share (diluted)     (0.05 )     (0.31 )     (0.35 )     0.24       (1.12 )

 

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2019 Annual MD&A

 

Condensed Statement of Financial Position Information

 

    December 31,  
(in thousands)   2019     2018  
    $     $  
Cash and cash equivalents     7,838       14,512  
Trade and other receivables and other current assets     1,869       1,504  
Inventory     1,203       240  
Restricted cash equivalents     364       418  
Property, plant and equipment     35       65  
Right of use assets     582        
Other non-current assets     8,090       8,272  
Total assets     19,981       25,011  
Payables and accrued liabilities and income taxes payable     3,596       4,635  
Current portion of provision for restructuring and other costs     418       887  
Current portion of deferred revenues     991       74  
Lease liabilities     903        
Warrant liability     2,255       3,634  
Non-financial non-current liabilities (1)     14,281       13,874  
Total liabilities     22,444       23,104  
Shareholders’ (deficiency) equity     (2,463 )     1,907  
Total liabilities and shareholders’ (deficiency) equity     19,981       25,011  

 

 

(1) Comprised mainly of employee future benefits, provisions for restructuring and other costs and non-current portion of deferred revenues.

 

Critical Accounting Policies, Estimates and Judgments

 

Our consolidated financial statements as at December 31, 2019 and December 31, 2018 and for the years ended December 31, 2019, 2018 and 2017 have been prepared in accordance with IFRS as issued by the IASB.

 

The preparation of consolidated financial statements in accordance with IFRS requires management to make judgments, estimates and assumptions that affect the reported amounts of our 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 when our 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 consolidated financial statements are presented fairly and in accordance with IFRS. Revisions to accounting estimates are recognized in the period in which the estimates are revised and in any future periods affected.

 

Critical accounting estimates and assumptions, as well as critical judgments used in applying accounting policies in the preparation of our interim condensed consolidated financial statements were the same as those that applied to our annual consolidated financial statements as of December 31, 2019 and December 31, 2018 and for the years ended December 31, 2019, 2018 and 2017.

 

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2019 Annual MD&A

 

Recent Accounting Pronouncements

 

(a) IFRS 16, Leases

 

The Company has adopted IFRS 16 on a modified retrospective basis from January 1, 2019 with no restatement of comparatives, as permitted under the specific transitional provisions in the standard.

 

The Company has operating leases for building, cars and equipment leases at its location in Frankfurt. Upon adoption of IFRS 16, the Company recognized lease liabilities in relation to leases which had previously been classified as ‘operating leases’ under the principles of IAS 17 Leases. Under IFRS 16, these liabilities were measured at the present value of the remaining lease payments excluding renewal options as they are not expected to be exercised, discounted using the Company’s incremental borrowing rate as of January 1, 2019.

 

The Company’s related right of use assets were measured at the amount equal to the lease liability at the date of initial application. Only the building right of use asset was further adjusted by the application of $0.7 million in related onerous lease provision to the value at inception.

 

During the three-month period ended March 31, 2019, management continued its search for a sub-lessee. However, there were delays which led to a reassessment of its onerous lease provision as the Company has determined that its plan to exit its building lease, in full, as at December 31, 2019 was not probable. As such, the Company recognized an impairment of its right of use building asset of $0.3 million in the statement of comprehensive (loss) income during the first quarter of 2019. In light of the June 2019 restructuring of the German operations, management recognized an additional impairment of $0.1 million as office and lab space was expected to become vacant or underutilized. During the third quarter of 2019, a new sub-lessee signed a 6-month lease for certain lab and office space; management reversed the impairment of its building right of use asset by $0.1 million. During the fourth quarter of 2019, an existing sub-lease agreement was renewed, and the amount of rented space was expanded; management then reversed the impairment of its building right of use asset by $0.3 million.

 

(b) IFRIC 23, “Uncertainty over Income Tax Treatment” (“IFRIC 23”)

 

In June 2017, IFRIC 23, was issued and it provides guidance on how to value uncertain income tax positions based on the probability of whether the relevant tax authorities will accept the company’s tax treatments. A company is to assume that a taxation authority with the right to examine any amounts reported to it will examine those amounts and will have full knowledge of all relevant information when doing so. IFRIC 23 is effective for annual periods beginning on or after January 1, 2019. The adoption of this interpretation did not have a significant impact on the Company’s consolidated financial statements.

 

(c) Amendments in Plan Amendment, Curtailment or Settlement (Amendments to IAS 19)

 

In June 2015, the IASB published ED/2015/5 Remeasurement on a Plan Amendment, Curtailment or Settlement/Availability of a Refund from a Defined Benefit Plan (Proposed amendments to IAS 19 and IFRIC 14) combining two issues submitted separately to the IFRS Interpretations Committee into a single package of narrow-scope amendments to IAS 19 Employee Benefits and IFRIC 14 IAS 19 - The Limit on a Defined Benefit Asset, Minimum Funding Requirements and their Interaction. However, in April 2017 the IASB decided to pursue the amendments to IAS 19 and in September 2017 confirmed it would do so despite putting off the amendments to IFRIC 14. The amendments in Plan Amendment, Curtailment or Settlement (Amendments to IAS 19) are: (i) if a plan amendment, curtailment or settlement occurs, it is now mandatory that the current service cost and the net interest for the period after the remeasurement are determined using the assumptions used for the remeasurement and (ii) amendments have been included to clarify the effect of a plan amendment, curtailment or settlement on the requirements regarding the asset ceiling. An entity applies the amendments to plan amendments, curtailments or settlements occurring on or after the beginning of the first annual reporting period that begins on or after January 1, 2019. The adoption of these amendments did not have a significant impact on the Company’s consolidated financial statements.

 

Financial Risk Factors and Other Instruments

 

The nature and extent of our exposure to risks arising from financial instruments, including credit risk, liquidity risk and market risk (share price risk) and how we manage those risks are described in note 24 to the Company’s annual audited consolidated financial statements as at December 31, 2019 and 2018 and for the years ended December 31, 2019, 2018 and 2017.

 

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2019 Annual MD&A

 

Results of operations for the three-month period ended December 31, 2019

 

For the three-month period ended December 31, 2019, we reported a consolidated net loss of $1.0 million, or $0.05 loss per common share (basic), as compared with a consolidated net loss of $5.1 million, or $0.31 loss per common share, for the three-month period ended December 31, 2018. The $4.1 million improvement in net results is primarily from a gain in fair value of warrant liability of $2.0 million and a decline in operating expenses of $2.7 million.

 

Revenues

 

Our total revenue for the three-month period ended December 31, 2019 was $0.02 million as compared with $1.4 million for the same period in 2018, representing a decrease of $1.4 million. The 2019 revenue was comprised of $0.02 million in royalty revenue (2018 - $0.2 million), $nil in product sales (2018 - $1.4 million), ($0.02) million in supply chain revenue (2018 - $0.1 million) and $0.02 million in licensing revenue (2018 – ($0.3) million). The product sales in 2018 represented sales of Macrilen™ (macimorelin). There were no sales of Macrilen™ (macimorelin) in the fourth quarter of 2019.

 

Operating expenses

 

Our total operating expense for the three-month period ended December 31, 2019 was $1.8 million as compared with $4.4 million for the same period in 2018, representing a decrease of $2.7 million. This decrease arises primarily from a $1.1 million decline in cost of sales, a $0.5 million decline in research and development costs, a $0.5 million decline in general and administrative expenses, a $0.3 million reversal of restructuring costs and a $0.3 impairment in right of use assets. The decline in cost of sales arose from there being no sales of Macrilen™ (macimorelin in the fourth quarter of 2019 as compared to the fourth quarter of 2019, during which there were sales of Macrilen™ (macimorelin). The decline in research and development costs are attributed to the difference phases of activity of Study P01. In the fourth quarter of 2018, study activities included study start with document development, medication manufacturing, study feasibility testing at different sites and clinical trial applications in Hungary, Poland, Belarus, Russia, Ukraine and Serbia, while in 2019, the focus was on the clinical conduct. The expense amounts in the fourth quarter of 2019 reflect that most sites had completed their enrollment and clinical activities. The decline in general and administrative expenses is due primarily to our cost control measures implemented in 2018 and the decline in selling expenses arises from a reclassification of costs to cost of sales, in accordance with the signed supply agreement with Novo.

 

Settlements

 

In prior year’s fourth quarter, $1.4 million was classified as settlements as compared with nil in the same period in 2019. The costs in the fourth quarter of 2018 were to settle a lawsuit against the Company from two of its former executives. There were no settlements in 2019.

 

Net finance income (costs)

 

Our net finance income for the three-month period ended December 31, 2019 was $0.6 million as compared with a net finance costs of $1.3 million for the same period in 2018, representing an increase of $1.9 million. This is primarily due to a $2.0 million change in fair value of warrant liability offset by increased finance costs of $0.1 million. Such a non-cash change in fair value results from the periodic “mark-to-market” revaluation, which occurs through the application of our pricing model, of our outstanding share purchase warrants. 

 

Results of operations for the twelve-month period ended December 31, 2019

 

For the twelve-month period ended December 31, 2019, we reported a consolidated net loss of $6.0 million, or $0.35 loss per common share (basic), as compared with a consolidated net income of $4.2 million, or $0.25 income per common share (basic), for the twelve-month period ended December 31, 2018. The $10.2 million decline in net results is primarily from a reduction of $26.3 million in revenue offset by $5.6 million in tax expense, $6.3 million decline in operating expenses, $2.8 million increase in net finance income and $1.4 million decline in settlements.

 

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2019 Annual MD&A

 

Revenues

 

Our total revenue for the twelve-month period ended December 31, 2019 was $0.5 million as compared with $26.9 million for the same period in 2018, representing a decline of $26.4 million. The 2019 revenue was comprised of $0.05 million in royalty income (2018 - $0.2 million), $0.1 million in product sales (2018 - $2.2 million), $0.3 million in supply chain revenue (2018 - $0.1 million) and $0.1 million in licensing revenue (2018 - $24.3 million). There was no sales commission revenue in 2019. The decline in total revenue in 2019 relates primarily to the one-time $24.0 million cash payment received from executing the License Agreement in January 2018 and the initial delivery of Macrilen™ (macimorelin) to our licensee.

 

Operating expenses

 

Our total operating expense for the twelve-month period ended December 31, 2019 was $10.8 million as compared with $17.0 million for the same period in 2018, representing a decrease of $6.2 million. This decline arises primarily from a $2.3 million reduction in general and administration expenses, a $1.9 million reduction in selling costs, a $1.7 million decline in cost of sales and a $1.1 million reduction in research and development costs, offset by $0.5 million increase in restructuring costs, $0.02 million impairment in right to use assets and $0.2 million write-off of other current assets. The decline in general and administrative expenses and in selling expenses reflects the cost control improvements implemented in late 2018, the impact of the restructuring in June 2019 and the settlement of lawsuits in 2018 (thereby reducing legal expenses). In 2019, our licensee purchased less Macrilen™ (macimorelin) product than they did in 2018.

 

Settlements

 

In 2018, $1.4 million was classified as settlements. These were costs to settle a lawsuit against the Company from two of its former executives. There were no settlements in 2019.

 

Net finance income

 

Our net finance income for the twelve-month period ended December 31, 2019 was $4.0 million as compared with $1.2 million for the same period in 2018, representing an increase of $2.8 million. This is primarily due to a $4.3 million increase change in fair value of warrant liability, offset by a reduction in gain due to foreign currency exchange rates of $0.6 million and a $0.9 million increase in other finance costs. Such a non-cash change in fair value results from the periodic “mark-to-market” revaluation, which occurs through the application of our pricing model, of our outstanding share purchase warrants. Increased finance costs result primarily from $0.5 million in transaction costs from the issuance of warrants in the September 2019 financing and $0.1 million in costs from exploring other potential financings.

 

Selected quarterly financial data

 

(in thousands, except for per share data)   Three months ended  
    December 31,
2019
    September 30,
2019
    June 30,
2019
    March 31,
2019
 
    $     $     $     $  
Revenues     18       283       194       37  
Net (loss) income     (1,006 )     (331 )     206       (4,911 )
Net (loss) income per share [basic]*     (0.05 )     (0.02 )     0.01       (0.30 )
Net (loss) income per share [diluted]*     (0.05 )     (0.02 )     0.01       (0.30 )

 

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2019 Annual MD&A

 

(in thousands, except for per share data)   Three months ended  
    December 31,
2018
    September 30,
2018
    June 30,
2018
    March 31,
2018
 
    $     $     $     $  
Revenues     1,392       663       168       24,658  
Net (loss) income     (5,126 )     (2,509 )     (2,602 )     14,424  
Net (loss) income per share [basic]*     (0.31 )     (0.15 )     (0.16 )     0.88  
Net loss per share [basic and diluted]*     (0.31 )     (0.15 )     (0.16 )     0.87  

 

 

* Net loss per share is based on the weighted average number of shares outstanding during each reporting period, which may differ on a quarter-to-quarter basis. As such, the sum of the quarterly net loss per share amounts may not equal full-year net loss per share.

 

Historical quarterly results of operations and net (loss) income cannot be taken as reflective of recurring revenue or expenditure patterns of predictable trends, largely given the non-recurring nature of certain components of our historical revenues, due most notably to unpredictable quarterly variations in net finance income, which are impacted by periodic “mark-to-market” revaluations of our warrant liability and of foreign exchange gains and losses. In addition, we cannot predict what the revenues from royalties will be from the License Agreement.

 

Use of proceeds

 

We began 2019 with $14.5 million in cash and cash equivalents. During the twelve-month period ended December 31, 2019, our operating activities consumed $10.7 million, our financing activities provided $3.9 million and the effect of exchange rates on cash and cash equivalents accounted for $0.1 million. As at December 31, 2019 we had $7.8 million of cash and cash equivalents.

 

Liquidity and capital reserves

 

Our operations and capital expenditures have been generally been financed through certain transactions impacting our cash flows from operating activities, public equity offerings and issuances under various ATM programs. In 2018, we used the $24.0 million up front payment received from Strongbridge to fund operations and capital expenditures.

 

(in thousands)   Years ended December 31,  
    2019     2018     2017  
    $     $     $  
Cash and cash equivalents - beginning of period     14,512       7,780       21,999  
Cash (used in) provided by operating activities     (10,725 )     6,825       (22,913 )
Cash flows provided by financing activities     3,893             8,030  
Cash flows provided by (used in) investing activities     50       (35 )     307  
Effect of exchange rate changes on cash and cash equivalents     108       (58 )     357  
Cash and cash equivalents - end of period     7,838       14,512       7,780  

 

Operating Activities

 

Cash (used by) operating activities totaled ($10.7) million for the twelve months ended December 31, 2019, as compared to $6.8 million provided by operating activities in the same period in 2018. In the twelve-month period ended December 31, 2019, the Company had net loss of $6.0 million as compared with net income of $4.2 million in the same period in 2018. In 2019, the Company did not have significant royalty or licensing revenues, while, in the same period in 2018, the Company received a $24.0 million cash payment from executing the License Agreement in January 2018.

 

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2019 Annual MD&A

 

Financing Activities

 

Cash provided by financing activities totaled $3.9 million for the twelve months ended December 31, 2019, as compared with $nil in the same period in 2018. On September 20, 2019, the Company entered into a securities purchase agreement with U.S. institutional investors to purchase $5.0 million (before transaction costs of $0.8 million) of its common shares in a registered direct offering and warrants to purchase common shares in a concurrent private placement. The combined purchase price for one common share and one warrant was $1.50. Under the terms of the securities purchase agreement, the Company sold 3,325,000 common shares. In a concurrent private placement, the Company issued warrants to purchase up to an aggregate of 3,325,000 common shares. The warrants are exercisable commencing six months from the date of issuance, have an exercise price of $1.65 per share and expire 5 years following the date of issuance. In addition, the Company received $0.3 million from the exercise of warrants, options and deferred share units and paid $0.6 million in lease liabilities subsequent to adoption of IFRS 16 in January 2019.

 

Investing Activities

 

Cash provided by investing activities totaled $0.05 million for the twelve months ended December 31, 2019, as compared with ($0.04 million) used by investing activities in the same period in 2018. In 2019, the Company received $0.05 million in restricted cash when it closed out certain banking arrangements, while in 2018, the Company sold certain property, plant and equipment and added $0.05 million in restricted cash.

 

Common shares

 

As at March 25, 2020 we had 23,472,771 Common Shares issued and outstanding, as well as 953,557 stock options and Deferred Share Units (“DSUs”) outstanding. Share purchase warrants outstanding as at March 25, 2020 represented a total of 9,453,174 equivalent common shares.

 

Warrants as at March 25, 2020

 

    Warrants     Exercise Price      
    #     $     Expiry date
December 2015 registered direct offering     2,331,000       7.10     December 13, 2020
November 2016 registered direct offering     945,000       4.70     May 1, 2020
September 2019 registered direct offering     3,325,000       1.65     September 24, 2024
February 2020 registered direct offering     2,608,696       1.20     August 21, 2025
February 2020 registered direct offering     243,478       1.61719     February 19, 2025
      9,453,174              

 

On March 10, 2020, we had 28,144 share purchase warrants expire, each with an exercise price of $1.07.

 

Long-term incentive and stock option plan

 

There were 953,116 stock options and deferred share units outstanding at December 31, 2019, with exercise prices denominated in U.S. dollars (December 31, 2018 - 888,816). During the twelve-month period ended December 31, 2019, 163,859 of these securities were exercised, 335,000 securities were granted, 6,000 stock options were forfeited or canceled and 100,850 expired (twelve-month period ended December 31, 2018 - nil, 426,000 securities, 249,599 and nil, respectively).

 

Adequacy of financial resources

 

Since inception, we have incurred significant expenses in its efforts to develop and co-promote products. Consequently, the Company has incurred operating losses and negative cash flow from operations historically and in each of the last several years except for the year ended December 31, 2018 when the Company earned revenue from the sale of a license for the adult indication of Macrilen™ (macimorelin) in the United States and Canada. As at December 31, 2019, the Company had an accumulated deficit of $317 million. The Company also had a net loss of $6 million for the year ended December 31, 2019, and negative cash flow from operations of $10.7 million.

 

(12)

2019 Annual MD&A

 

The Company’s principal focus is on the commercialization of Macrilen™ (macimorelin) and it currently does not have any other approved products. Under the terms of License and Assignment Agreement (“License Agreement”) (as defined below), Novo Nordisk A/S (“Novo”) is funding 70% of the pediatric clinical trial submitted to the EMA and FDA, the Company’s sole development activity. In November 2019, Novo contracted Aeterna Zentaris GmbH (“AEZS Germany”), our wholly owned German subsidiary, to provide supply chain services for the manufacture of Macrilen™ (macimorelin).

 

Management has evaluated whether material uncertainties exist relating to events or conditions that may cast substantial doubt about the Company’s ability to continue as a going concern and has considered the following in making that critical judgment.

 

The ability of the Company to realize its assets and meet its obligations as they come due is dependent on earning sufficient revenues under the License Agreement, developing opportunities for Macrilen™ (macimorelin) in the rest of the world, realizing other monetizing transactions, and raising additional sources of funding, the outcome of which cannot be predicted at this time. The revenue provided under the License Agreement was $45,000 for the year ended December 31, 2019 and as at December 31, 2019, the Company had cash of $7,838,000. In September 2019, the Company closed an equity financing which provided $4,193,000 in net cash proceeds. On February 21, 2020, the Company closed an equity financing for approximately $3,920,000 in net cash proceeds.

 

A significant portion of the Company’s cash is held in AEZS Germany, the Company’s principle operating subsidiary. AEZS Germany is the counter-party to the License Agreement described above with Novo, and as such, for generating future revenue earned under the License Agreement. As such, management considers the cash resources available to AEZS Germany in executing its obligations under the License Agreement. In the event the current and medium term liabilities of AEZS Germany exceeds the fair values ascribed to its assets, under German solvency laws, it may no longer be possible for AEZS Germany’s operations to continue or for AEZS Germany to transfer cash to Aeterna Zentaris Inc or its U.S. subsidiary. This imposes additional and material uncertainties on the Company when evaluating liquidity and the going concern assumption.

 

The Company has some discretion to manage its planned research and development costs, administrative expenses and capital expenditures in order to manage its cash liquidity, particularly in AEZS Germany. Furthermore, AEZS Germany is focused on opportunities to either license or sell the European or worldwide rights to Macrilen™ (macimorelin) to third parties. As of the date of issuance of these consolidated financial statements, there are no assurances that cash will be generated from such arrangements. As such, management may also need to consider other sources of financing in order to continue its planned operations.

 

Management has assessed the Company’s ability to continue as a going concern and concluded that additional capital will be required. There can be no assurance that the Company will be able to execute license or purchase agreements or to obtain equity or debt financing, or on terms acceptable to it. Factors within and outside the Company’s control could have a significant bearing on its ability to obtain additional financing. As a result, management has determined that there are material uncertainties that may cast significant doubt upon the Company’s ability to continue as a going concern.

 

Contractual obligations and commitments

 

(in thousands)   Service and
manufacturing
 
    $  
Less than 1 year     1,600  
1 - 3 years     11  
4 - 5 years     5  
More than 5 years     5  
Total     1,621  

 

(13)

2019 Annual MD&A

 

Contingencies

 

In the normal course of operations, the Company may become involved in various claims and legal proceedings related to, for example, contract terminations and employee-related and other matters.

 

Securities class action lawsuit

 

On March 9, 2020, the Company settled the previously disclosed class-action lawsuit against us pending in the U.S. District Court for New Jersey. This settlement remains subject to execution of final settlement documents and approval by the U.S. District Court for the District of New Jersey.

 

Previously settled lawsuits

 

On December 21, 2018, the Company settled a dispute with its former President and Chief Executive Officer and with its former Senior Vice President, Chief Administrative Officer, General Counsel and Corporate Secretary with the Company agreeing to make a payment in the amount of $0.8 million.

 

On November 5, 2018, the Company settled a dispute with Cogas Consulting, LLC with the Company agreeing to make a payment of $0.6 million.

 

Related Party Transactions and Off-Balance Sheet Arrangements

 

Other than employment agreements and indemnification agreements with our management, there are no related party transactions.

 

As at December 31, 2019, we did not have any interests in special purpose entities or any other off-balance sheet arrangements.

 

Risk Factors and Uncertainties

 

An investment in our securities involves a high degree of risk. In addition to the other information included in this MD&A and in the related consolidated financial statements, investors are urged to carefully consider the risks described under the caption “Risk Factors and Uncertainties” in our most recent Annual Report on Form 20-F for the year ended December 31, 2019 for a discussion of the various risks that may materially affect our business. The risks and uncertainties not presently known to us or that we currently deem immaterial may also materially harm our business, operating results and financial condition and could result in a complete loss of your investment.

 

Our most recent Annual Report on Form 20-F was filed with the relevant Canadian securities regulatory authorities in lieu of an annual information form at www.sedar.com and with the SEC at www.sec.gov, and investors are urged to consult such risk factors.

 

Disclosure Controls and Procedures

 

Under the supervision and with the participation of our management, including the Chief Executive Officer and the Chief Financial Officer, we have evaluated the effectiveness of our disclosure controls and procedures as at December 31, 2019. Based on that evaluation, the Chief Executive Officer and Chief Financial Officer have concluded that these disclosure controls and procedures were effective as at December 31, 2019.

 

(14)

2019 Annual MD&A

 

Management’s Annual Report on Internal Control over Financial Reporting

 

Our management is responsible for establishing and maintaining adequate internal control over financial reporting. Our internal control over financial reporting is a process designed to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with IFRS as issued by the IASB.

 

Our internal control over financial reporting includes those policies and procedures that: (i) pertain to the maintenance of records that, in reasonable detail, accurately and fairly reflect the transactions and dispositions of the assets of Aeterna Zentaris; (ii) provide reasonable assurance that transactions are recorded as necessary to permit preparation of financial statements in accordance with IFRS, and that receipts and expenditures of the Company are being made only in accordance with authorizations of Company management; and (iii) provide reasonable assurance regarding prevention or timely detection of unauthorized acquisition, use or disposition of Company assets that could have a material effect on the financial statements.

 

Because of its inherent limitations, internal control over financial reporting may not prevent or detect misstatements. Also, projections of any evaluation of effectiveness to future periods are subject to the risk that controls may become inadequate because of changes in conditions, or that the degree of compliance with the policies or procedures may deteriorate.

 

Management conducted an evaluation of the effectiveness of our internal control over financial reporting based on the criteria established in Internal Control – Integrated Framework: 2013 issued by the Committee of Sponsoring Organizations of the Treadway Commission. Based on this evaluation, management has concluded that our internal control over financial reporting was effective as at December 31, 2019.

 

Changes in Internal Controls over Financial Reporting

 

There were no changes in our internal control over financial reporting during the year ended December 31, 2019 that materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.

 

The design of any system of controls and procedures is based in part upon certain assumptions about the likelihood of certain events. There can be no assurance that any design will succeed in achieving its stated goals under all potential future conditions, including conditions that are remote.

 

(15)

 

 

Exhibit 99.3

 

 

Aeterna Zentaris Reports fourth quarter and full-year 2019 financial and operating results AND PROVIDES BUSINESS UPDATE

 

Strengthened cash position with recently closed financing as well as royalty payments from Novo Nordisk for U.S. sales of Macrilen™

 

Robust ongoing business development discussions to secure a commercialization partner for macimorelin in Europe and other key global markets

 

Leveraging clinical success of macimorelin for AGHD and expertise of Novo Nordisk in pediatric clinical development of macimorelin to address significant market opportunity

 

Closely monitoring COVID-19 and its impact on our business and operations

 

CHARLESTON, S.C., March 30, 2020 — Aeterna Zentaris Inc. (NASDAQ: AEZS) (TSX: AEZS) (“Aeterna” or the “Company”), a specialty biopharmaceutical company commercializing and developing therapeutics and diagnostic tests, today reported its financial and operating results for the fourth quarter and year ended December 31, 2019.

 

The Company also provided an update on its clinical program to develop macimorelin for the diagnosis of child-onset growth hormone deficiency (CGHD), an area of significant unmet need, and its plans to expand macimorelin for the diagnosis of adult growth hormone deficiency (AGHD) in Europe.

 

“We have been working diligently with our U.S. and Canadian commercialization partner, Novo Nordisk, to increase the awareness and access to Macrilen™ (macimorelin) for the diagnosis of AGHD and are pleased with the progress made in this regard over the fourth quarter of 2019. The inclusion of macimorelin in the American Association of Clinical Endocrinologists 2019 Guidelines was an important milestone that reflects the hard work of both teams and we intend to build on this momentum,” commented Dr. Klaus Paulini, Chief Executive Officer of Aeterna Zentaris. “Additionally, our business development efforts to secure a marketing partner for macimorelin for the diagnosis of AGHD in Europe and other key markets remain ongoing.”

 

Recent Highlights

 

Closed $4.5 million registered direct offering priced at-the-market;
Announced the completion of patient recruitment in the AEZS-130-P01 (“Study P01”) dose-finding pediatric study of macimorelin; and
Announced the inclusion of macimorelin in the American Association of Clinical Endocrinologists (AACE) and American College of Endocrinology (ACE) 2019 Guidelines for Management of Growth Hormone Deficiency in Adults and Patients Transitioning from Pediatric to Adult Care.

 

 

 

 

 

Dr. Paulini continued, “We also see a significant opportunity in the use of macimorelin for the diagnosis of CGHD and with the upcoming results of the P01 study expected early next quarter, we believe we will be well positioned with a validated dose to move into our planned P02 study, an efficacy and safety registration study.”

 

For more information about Study P01, please visit EU Clinical Trials Register and reference EudraCT #2018-001988-23.

 

Macimorelin

 

The Company’s lead product, macimorelin, is the only FDA approved oral drug indicated for the diagnosis of AGHD and is currently marketed in the United States under the tradename Macrilen™, by Novo Nordisk. Aeterna is currently developing macimorelin for the diagnosis of CGHD, an area of significant unmet need, in collaboration with Novo Nordisk.

 

Upcoming Anticipated Program Milestones

 

Announce results of CGHD dose-ranging study (AEZS-130-P01) in Q2 2020;
Commence CGHD safety and efficacy study (AEZS-130-P02: multi-national, including U.S.); and
Advance business development efforts to secure a marketing partner for macimorelin for the diagnosis of AGHD in Europe and other key markets.

 

The Company is closely monitoring the evolving situation with coronavirus, or COVID-19, and is following guidance from health authorities. COVID-10 is affecting the global community and is adversely affecting our business operations, in a manner which at this time cannot be fully determined or quantified. The situation with coronavirus is rapidly evolving and the impact of COVID-19, including travel and business restrictions, and other impediments to undertaking clinical studies, may significantly affect our business, operations, results, projected timelines and market price for our common shares. Like many of our peers, we have put into place a robust risk mitigation plan to ensure the safety of our employees, partners and community. For more information, please see the Risk Factor entitled “The economic effects of a pandemic, epidemic or outbreak of an infectious disease could adversely affect our operations or the market price of our Common Shares” in our Annual Report on Form 20-F for the year ended December 31, 2019.

 

Summary of Full Year 2019 Financial Results

 

All amounts are in U.S. dollars

 

For the twelve-month period ended December 31, 2019, the Company reported a consolidated net loss of $6.0 million, or $0.35 loss per common share (basic), as compared with a consolidated net income of $4.2 million, or $0.25 income per common share (basic), for the twelve-month period ended December 31, 2018. The $10.2 million decline in net results is primarily from a reduction of $26.3 million in revenue offset by $5.6 million in tax expense, $6.3 million decline in operating expenses, $2.8 million increase in net finance income and $1.4 million decline in settlements.

 

 

 

 

 

Revenues

 

The Company reported total revenue for the twelve-month period ended December 31, 2019 of $0.5 million as compared with $26.9 million for the same period in 2018, representing a decline of $26.4 million. The decline in total revenue in 2019 relates primarily to the one-time $24.0 million cash payment received from executing the License Agreement in January 2018 and the initial delivery of Macrilen™ (macimorelin) to our licensee.

 

Operating Expenses

 

The Company reported total operating expense for the twelve-month period ended December 31, 2019 of $10.8 million as compared with $17.0 million for the same period in 2018, representing a decrease of $6.2 million. This net decline arises primarily from a $2.3 million reduction in general and administration expenses, a $1.9 million reduction in selling costs, a $1.7 million decline in cost of sales and a $1.1 million reduction in research and development costs, offset by $0.5 million increase in restructuring costs, $0.02 million impairment in right to use asset[s] and $0.2 million write-off of other current assets.

 

Net Finance Income

 

The Company reported net finance income for the twelve-month period ended December 31, 2019 of $4.0 million as compared with $1.2 million for the same period in 2018, representing an increase of $2.8 million. This is primarily due to a $4.3 million increase change in fair value of warrant liability, offset by a reduction in gain due to foreign currency exchange rates of $0.6 million and a $0.9 million increase in other finance costs.

 

Consolidated Financial Statements and Management’s Discussion and Analysis

 

For reference, the Management’s Discussion and Analysis of Financial Condition and Results of Operations for the fourth quarter and fiscal 2019, as well as the Company’s audited consolidated financial statements as at December 31, 2019, 2018 and for the years ended December 31, 2019, 2018 and 2017 will be available at www.zentaris.com in the “Investors” section or at the Company’s profile at www.sedar.com and www.sec.gov.

 

About Aeterna Zentaris Inc.

 

Aeterna Zentaris Inc. 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. FDA and European Commission approved oral test indicated for the diagnosis of adult growth hormone deficiency (AGHD). Macrilen™ is currently marketed in the United States through a license agreement with Novo Nordisk. Aeterna Zentaris retains its rights to macimorelin outside of the U.S. and Canada.

 

Aeterna Zentaris is also leveraging the clinical success and compelling safety profile of macimorelin to develop it for the diagnosis of child-onset growth hormone deficiency (CGHD), an area of significant unmet need.

 

The Company is actively pursuing business development opportunities for the commercialization of macimorelin in Europe and the rest of the world, in addition to other non-strategic assets to monetize their value. For more information, please visit the Company’s website at www.zentaris.com.

 

 

 

 

 

Condensed Consolidated Statements of Comprehensive Loss Information

 

    Three months ended December 31,     Years ended December 31,  
(in thousands, except share and per share data)   2019     2018     2019     2018     2017  
    $     $     $     $     $  
Revenues                                        
License fees     19       (332 )     74       24,325       458  
Product sales           1,446       129       2,167        
Royalty income     16       184       45       184        
Sales commission                       110       465  
Supply chain     (17 )     94       284       95        
Total revenues     18       1,392       532       26,881       923  
Operating expenses                                        
Cost of sales     309       1,413       410       2,104        
Research and development costs     263       767       1,837       2,932       10,704  
General and administrative expenses     1,691       1,665       6,615       8,894       8,198  
Selling expenses     38       588       1,214       3,109       5,095  
Restructuring costs     (266 )           507              
Impairment of right of use asset     (254 )           22              
Write-off of other current assets                 169              
Total operating expenses     1,781       4,433       10,774       17,039       23,997  
(Loss) income from operations     (1,763 )     (3,041 )     (10,242 )     9,842       (23,074 )
Settlements           (1,400 )           (1,400 )      
Gain due to changes in foreign currency exchange rates     26       64       87       656       502  
Change in fair value of warrant liability     533       (1,489 )     4,518       263       2,222  
Other finance (costs) income     10       104       (593 )     278       75  
Net finance income (costs)     569       (1,321 )     4,012       1,197       2,799  
(Loss) income before income taxes     (1,194 )     (5,762 )     (6,230 )     9,639       (20,275 )
Income tax recovery (expense)     188       636       188       (5,452 )     3,479  
Net (loss) income     (1,006 )     (5,126 )     (6,042 )     4,187       (16,796 )
Other comprehensive (loss) income:                                        
Foreign currency translation adjustments     (268 )     (13 )     83       (260 )     (1,430 )
Actuarial gain (loss) on defined benefit plans     959       (418 )     (1,068 )     193       694  
Comprehensive (loss) income     (315 )     (5,557 )     (7,027 )     4,120       (17,532 )
Net loss per share (basic)     (0.05 )     (0.31 )     (0.35 )     0.25       (1.12 )
Net loss per share (diluted)     (0.05 )     (0.31 )     (0.35 )     0.24       (1.12 )

 

 

 

 

 

Condensed Statement of Financial Position Information

 

    December 31,  
(in thousands)   2019     2018  
      $       $  
Cash and cash equivalents     7,838       14,512  
Trade and other receivables and other current assets     1,869       1,504  
Inventory     1,203       240  
Restricted cash equivalents     364       418  
Property, plant and equipment     35       65  
Right of use assets     582        
Other non-current assets     8,090       8,272  
Total assets     19,981       25,011  
Payables and accrued liabilities and income taxes payable     3,596       4,635  
Current portion of provision for restructuring and other costs     418       887  
Current portion of deferred revenues     991       74  
Lease liabilities     903        
Warrant liability     2,255       3,634  
Non-financial non-current liabilities (1)     14,281       13,874  
Total liabilities     22,444       23,104  
Shareholders’ (deficiency) equity     (2,463 )     1,907  
Total liabilities and shareholders’ (deficiency) equity     19,981       25,011  

 

 

  (1) Comprised mainly of employee future benefits, provisions for restructuring and other costs and non-current portion of deferred revenues.

 

 

 

 

 

Forward-Looking Statements

 

This press release contains forward-looking statements (as defined by applicable securities legislation) made pursuant to the safe-harbor provision of the U.S. Securities Litigation Reform Act of 1995, which reflect our current expectations regarding future events. Forward-looking statements include those relating to the intended use of proceeds and may include, but are not limited to statements preceded by, followed by, or that include the words “will,” “expects,” “believes,” “intends,” “would,” “could,” “may,” “anticipates,” and similar terms that relate to future events, performance, or our results. Forward-looking statements involve known and unknown risks and uncertainties, including those discussed in this press release and in our Annual Report on Form 20-F, under the caption “Key Information - Risk Factors” filed with the relevant Canadian securities regulatory authorities in lieu of an annual information form and with the U.S. Securities and Exchange Commission. Known and unknown risks and uncertainties could cause our actual results to differ materially from those in forward-looking statements. Such risks and uncertainties include, among others, our ability to raise capital and obtain financing to continue our currently planned operations, our ability to continue to list our Common Shares on the NASDAQ, our ability to continue as a going concern is dependent, in part, on our ability to transfer cash from Aeterna Zentaris GmbH to Aeterna Zentaris and the U.S. subsidiary and secure additional financing, our now heavy dependence on the success of Macrilen™ (macimorelin) and related out-licensing arrangements and the continued availability of funds and resources to successfully commercialize the product, including our heavy reliance on the success of the License Agreement with Novo, the global instability due to the global pandemic of COVID-19, and its unknown potential effect on our planned operations, including studies, our ability to enter into out-licensing, development, manufacturing, marketing and distribution agreements with other pharmaceutical companies and keep such agreements in effect, our reliance on third parties for the manufacturing and commercialization of Macrilen™ (macimorelin), potential disputes with third parties, leading to delays in or termination of the manufacturing, development, out-licensing or commercialization of our product candidates, or resulting in significant litigation or arbitration, uncertainties related to the regulatory process, unforeseen global instability, including the instability due to the global pandemic of the novel coronavirus, our ability to efficiently commercialize or out-license Macrilen™ (macimorelin), our reliance on the success of the pediatric clinical trial in the European Union (“E.U.”) and U.S. for Macrilen™ (macimorelin), the degree of market acceptance of Macrilen™ (macimorelin), our ability to obtain necessary approvals from the relevant regulatory authorities to enable us to use the desired brand names for our product, our ability to successfully negotiate pricing and reimbursement in key markets in the E.U. for Macrilen™ (macimorelin), any evaluation of potential strategic alternatives to maximize potential future growth and shareholder value may not result in any such alternative being pursued, and even if pursued, may not result in the anticipated benefits, our ability to take advantage of business opportunities in the pharmaceutical industry, our ability to protect our intellectual property, and the potential of liability arising from shareholder lawsuits and general changes in economic conditions. Investors should consult our quarterly and annual filings with the Canadian and U.S. securities commissions for additional information on risks and uncertainties. Given these uncertainties and risk factors, readers are cautioned not to place undue reliance on these forward-looking statements. We disclaim any obligation to update any such factors or to publicly announce any revisions to any of the forward-looking statements contained herein to reflect future results, events or developments, unless required to do so by a governmental authority or applicable law.

 

Investor Contact:

 

Jenene Thomas
JTC Team
T (US): +1 (833) 475-8247
E: aezs@jtcir.com