COSCIENS Biopharma Inc 6-K, filed Mar 27, 2024
COSCIENS Biopharma Inc. (CSCIF)
About this 6-K
COSCIENS Biopharma Inc filed this 6-K on March 27, 2024.
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 6-K
REPORT OF FOREIGN PRIVATE ISSUER
PURSUANT TO RULE 13a-16 OR 15d-16 OF THE SECURITIES EXCHANGE ACT OF 1934
For the month of March 2024
Commission File Number: 001-38064
Aeterna Zentaris Inc.
(Translation of registrant’s name into English)
c/o Norton Rose Fulbright Canada, LLP, 222 Bay Street, Suite 3000, PO Box 53, Toronto ON M5K 1E7
(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 ☒ 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):
On March 26, 2024, the registrant filed in Canada its consolidated financial statements and Management’s Discussion and Analysis as of December 31, 2023 and 2022 and for the years ended December 31, 2023, 2022 and 2021, with the Canadian Securities Administration.
DOCUMENTS INDEX
| (2) |
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.
| AETERNA ZENTARIS INC. | ||||
| Date: | March 26, 2024 | By: | /s/ Klaus Paulini | |
| Klaus Paulini | ||||
| President and Chief Executive Officer | ||||
| (3) |
Exhibit 99.1
Aeterna Zentaris Inc.
Consolidated Financial Statements
As of December 31, 2023 and 2022 and for the years ended December 31, 2023, 2022 and 2021
| 1 |
Report of Independent Registered Public Accounting Firm
To the Shareholders and the Board of Directors of
Aeterna Zentaris Inc.
Opinion on the Financial Statements
We have audited the accompanying consolidated statement of financial position of Aeterna Zentaris Inc. and subsidiaries (the “Company”) as of December 31, 2023, the related consolidated statements of changes in shareholders’ equity, loss and comprehensive loss, and cash flows, for the year ended December 31, 2023, and the related notes (collectively referred to as the “financial statements”). In our opinion, the financial statements present fairly, in all material respects, the financial position of the Company as of December 31, 2023, and its financial performance and its cash flows for the year ended December 31, 2023, in accordance with International Financial Reporting Standards as issued by the International Accounting Standards Board.
Basis for Opinion
These financial statements are the responsibility of the Company’s management. Our responsibility is to express an opinion on the Company’s financial statements based on our audit. 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 audit 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 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 audit, 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 audit included performing procedures to assess the risks of material misstatement of the 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 financial statements. Our audit also included evaluating the accounting principles used and significant estimates made by management, as well as evaluating the overall presentation of the financial statements. We believe that our audit provides a reasonable basis for our opinion.
Critical Audit Matter
The critical audit matter communicated below is a matter arising from the current-period audit of the financial statements that was communicated or required to be communicated to the audit committee and that (1) relates to accounts or disclosures that are material to the financial statements and (2) involved our especially challenging, subjective, or complex judgments. The communication of critical audit matters does not alter in any way our opinion on the financial statements, taken as a whole, and we are not, by communicating the critical audit matter below, providing a separate opinion on the critical audit matter or on the accounts or disclosures to which it relates.
| 2 |
Research and development (“R&D”) accruals – Refer to Notes 3, 8 and 12 of the financial statements
Critical Audit Matter Description
The Company carries out R&D activities including contracts with clinical research organizations and contract manufacturing organizations. Management applies judgment when reviewing open contracts and purchase orders, communicating with the Company’s personnel to identify services that have been performed on the Company’s behalf and estimating the level of service performed and the associated cost incurred for the service when the Company has not yet been invoiced or otherwise notified of the actual cost. The Company adjusts the accrued or prepaid expense balance accordingly.
We identified the estimation of R&D accruals as a critical audit matter due to the judgment made by management. This resulted in an increased extent of audit effort.
How the Critical Audit Matter Was Addressed in the Audit
Our audit procedures related to the evaluation of R&D accruals included the following, among others:
| ● | For a sample of open contracts and purchase orders: |
| - | Assessed the Company’s estimates of the activities completed to date by (i) inspecting original contract terms, change orders and the expected timeline for the related study, (ii) obtaining third party reports detailing progress of the study, and (iii) discussing the status of the study with certain members of management and project teams; |
| ● | For a sample of subsequent disbursements related to R&D expenses: |
| - | Assessed whether the related purchase orders were properly accrued for as at year-end; |
| ● | Inspecting (i) publicly available information (such as press releases and investor presentations) and (ii) board of directors’ materials, as available, regarding the status of the studies and assess any contradictory evidence over the advancement of the studies. |
/s/ Deloitte LLP
Chartered Professional Accountants
Montreal, Canada
March 26, 2024
We have served as the Company’s auditor since 2023.
| 3 |
Report of Independent Registered Public Accounting Firm
To the Shareholders and the Board of Directors of
Aeterna Zentaris Inc.
Opinion on the Financial Statements
We have audited the accompanying consolidated statement of financial position of Aeterna Zentaris Inc. (the Company) as of December 31, 2022, the related consolidated statements of changes in shareholders’ equity, loss and comprehensive loss, and cash flows, for each of the two years in the period ended December 31, 2022, and 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, 2022, and its financial performance and its cash flows for each of the two years in the period ended December 31, 2022, in conformity with International Financial Reporting Standards (IFRSs) as issued by the International Accounting Standards Board.
Basis for Opinion
These financial statements are the responsibility of the Company’s management. Our responsibility is to express an opinion on the Company’s 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 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 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 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 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/ Ernst & Young LLP
We served as the Company’s auditor from 2021 to 2023.
Montreal, Canada
March 22, 2023
| 4 |
Aeterna Zentaris Inc.
Consolidated Statements of Financial Position
As of December 31, 2023 and 2022
(in thousands of US dollars)
| 2023 | 2022 | |||||||
| $ | $ | |||||||
| ASSETS | ||||||||
| Current assets | ||||||||
| Cash and cash equivalents (note 6) | 34,016 | 50,611 | ||||||
| Trade and other receivables (note 7) | 222 | 732 | ||||||
| Inventory | 66 | 229 | ||||||
| Income taxes receivable | 121 | 1,428 | ||||||
| Prepaid expenses and other current assets (note 8) | 1,942 | 2,488 | ||||||
| Total current assets | 36,367 | 55,488 | ||||||
| Non-current assets | ||||||||
| Restricted cash equivalents (note 6) | 332 | 322 | ||||||
| Property and equipment (note 9) | 317 | 216 | ||||||
| Total non-current assets | 649 | 538 | ||||||
| Total assets | 37,016 | 56,026 | ||||||
| LIABILITIES | ||||||||
| Current liabilities | ||||||||
| Payables and accrued liabilities (note 12) | 3,622 | 3,828 | ||||||
| Provisions (note 13) | 429 | 45 | ||||||
| Income taxes payable | 111 | 108 | ||||||
| Deferred revenues (note 5) | 218 | 2,949 | ||||||
| Lease liabilities (note 14) | 160 | 114 | ||||||
| Total current liabilities | 4,540 | 7,044 | ||||||
| Non-current liabilities | ||||||||
| Deferred revenues (note 5) | 1,544 | 1,684 | ||||||
| Deferred gain | - | 110 | ||||||
| Lease liabilities (note 14) | 119 | 65 | ||||||
| Employee future benefits (note 15) | 12,617 | 11,159 | ||||||
| Provisions | - | 188 | ||||||
| Total non-current liabilities | 14,280 | 13,206 | ||||||
| Total liabilities | 18,820 | 20,250 | ||||||
| Shareholders’ equity | ||||||||
| Share capital (note 16) | 293,410 | 293,410 | ||||||
| Warrants (note 17) | 5,085 | 5,085 | ||||||
| Contributed surplus (note 18) | 90,710 | 90,332 | ||||||
| Deficit | (369,831 | ) | (352,084 | ) | ||||
| Accumulated other comprehensive loss | (1,178 | ) | (967 | ) | ||||
| Total Shareholders’ equity | 18,196 | 35,776 | ||||||
| Total liabilities and shareholders’ equity | 37,016 | 56,026 | ||||||
Commitments (note 26)
Subsequent event (note 28)
The accompanying notes are an integral part of these consolidated financial statements.
Approved by the Board of Directors
| /s/ Carolyn Egbert | /s/ Dennis Turpin | |
| Carolyn Egbert, Chair of the Board | Dennis Turpin, Director |
| 5 |
Aeterna Zentaris Inc.
Consolidated Statements of Changes in Shareholders’ Equity
For the years ended December 31, 2023, 2022 and 2021
(in thousands of US dollars)
| Share capital | Warrants | Contributed Surplus | Deficit | Accumulated other comprehensive income (loss) | Total | |||||||||||||||||||
| $ | $ | $ | $ | $ | $ | |||||||||||||||||||
| Balance - January 1, 2021 | 235,008 | 12,402 | 89,505 | (322,659 | ) | (1,045 | ) | 13,211 | ||||||||||||||||
| Net loss | - | - | - | (8,368 | ) | - | (8,368 | ) | ||||||||||||||||
| Other comprehensive loss: | ||||||||||||||||||||||||
| Foreign currency translation adjustments | - | - | - | - | 367 | 367 | ||||||||||||||||||
| Actuarial loss on defined benefit plans and remeasurement of the net defined benefit liability | - | - | - | (3,592 | ) | - | (3,592 | ) | ||||||||||||||||
| Comprehensive loss | - | - | - | (11,960 | ) | 367 | (11,593 | ) | ||||||||||||||||
| Issuance of common shares and warrants, net of transaction costs (note 16) | 29,082 | 1,897 | - | - | - | 30,979 | ||||||||||||||||||
| Exercise of warrants (note 17) | 29,833 | (9,746 | ) | - | - | - | 20,087 | |||||||||||||||||
| Transfer of warrant issuance costs on exercise of warrants (note 17) | (532 | ) | 532 | - | - | - | - | |||||||||||||||||
| Exercise of deferred share units | 19 | - | (28 | ) | - | - | (9 | ) | ||||||||||||||||
| Share-based compensation costs | - | - | 311 | - | - | 311 | ||||||||||||||||||
| Balance - December 31, 2021 | 293,410 | 5,085 | 89,788 | (334,619 | ) | (678 | ) | 52,986 | ||||||||||||||||
| Net loss | - | - | - | (22,727 | ) | - | (22,727 | ) | ||||||||||||||||
| Other comprehensive loss: | ||||||||||||||||||||||||
| Foreign currency translation adjustments | - | - | - | - | (289 | ) | (289 | ) | ||||||||||||||||
| Actuarial gain on defined benefit plans and remeasurement of the net defined benefit liability (note 15) | - | - | - | 5,262 | - | 5,262 | ||||||||||||||||||
| Comprehensive loss | - | - | - | (17,465 | ) | (289 | ) | (17,754 | ) | |||||||||||||||
| Share-based compensation costs | - | - | 544 | - | - | 544 | ||||||||||||||||||
| Balance – December 31, 2022 | 293,410 | 5,085 | 90,332 | (352,084 | ) | (967 | ) | 35,776 | ||||||||||||||||
| Net loss | - | - | - | (16,552 | ) | - | (16,552 | ) | ||||||||||||||||
| Other comprehensive loss: | ||||||||||||||||||||||||
| Foreign currency translation adjustments | - | - | - | - | (211 | ) | (211 | ) | ||||||||||||||||
| Actuarial loss on defined benefit plans and remeasurement of the net defined benefit liability (note 15) | - | - | - | (1,195 | ) | - | (1,195 | ) | ||||||||||||||||
| Comprehensive loss | - | - | - | (17,747 | ) | (211 | ) | (17,958 | ) | |||||||||||||||
| Share-based compensation costs | - | - | 378 | - | - | 378 | ||||||||||||||||||
| Balance – December 31, 2023 | 293,410 | 5,085 | 90,710 | (369,831 | ) | (1,178 | ) | 18,196 | ||||||||||||||||
The accompanying notes are an integral part of these consolidated financial statements.
| 6 |
Aeterna Zentaris Inc.
Consolidated Statements of Loss and Comprehensive Loss
For the years ended December 31, 2023, 2022 and 2021
(in thousands of US dollars, except share and per share data)
| Years ended December 31, | ||||||||||||
| 2023 | 2022 | 2021 | ||||||||||
| $ | $ | $ | ||||||||||
| Revenues (note 5) | 4,498 | 5,640 | 5,260 | |||||||||
| Expenses | ||||||||||||
| Cost of sales | 222 | 157 | 90 | |||||||||
| Research and development | 13,560 | 12,506 | 6,574 | |||||||||
| Selling, general and administrative | 8,724 | 8,230 | 7,267 | |||||||||
| Impairment of intangible assets (note 10) | - | 584 | - | |||||||||
| Impairment of goodwill (note 11) | - | 7,642 | - | |||||||||
| Impairment of other assets (note 7) | - | 124 | - | |||||||||
| Total expenses | 22,506 | 29,243 | 13,931 | |||||||||
| Loss from operations | (18,008 | ) | (23,603 | ) | (8,671 | ) | ||||||
| (Loss) gain due to changes in foreign currency exchange rates | (206 | ) | 879 | 215 | ||||||||
| Gain on sale of intangible asset (note 10) | 549 | - | - | |||||||||
| Interest income | 1,126 | - | - | |||||||||
| Net other costs | (13 | ) | (3 | ) | (21 | ) | ||||||
| Net other income (costs) | 1,456 | 876 | 194 | |||||||||
| Loss before income taxes | (16,552 | ) | (22,727 | ) | (8,477 | ) | ||||||
| Income tax recovery | - | - | 109 | |||||||||
| Net loss | (16,552 | ) | (22,727 | ) | (8,368 | ) | ||||||
| Other comprehensive loss: | ||||||||||||
| Items that may be reclassified subsequently to profit or loss: | ||||||||||||
| Foreign currency translation adjustments | (211 | ) | (289 | ) | 367 | |||||||
| Items that will not be reclassified to profit or loss: | ||||||||||||
| Actuarial (loss) gain on defined benefit plans (note 15) | (1,195 | ) | 5,262 | (3,592 | ) | |||||||
| Comprehensive loss | (17,958 | ) | (17,754 | ) | (11,593 | ) | ||||||
| Basic and diluted loss per share (note 25) | (3.41 | ) | (4.68 | ) | (1.82 | ) | ||||||
The accompanying notes are an integral part of these consolidated financial statement
| 7 |
Aeterna Zentaris Inc.
Consolidated Statements of Cash Flows
For the years ended December 31, 2023, 2022 and 2021
(in thousands of US dollars)
| Years ended December 31, | ||||||||||||
| 2023 | 2022 | 2021 | ||||||||||
| $ | $ | $ | ||||||||||
| Cash flows from operating activities | ||||||||||||
| Net loss | (16,552 | ) | (22,727 | ) | (8,368 | ) | ||||||
| Items not affecting cash and cash equivalents: | ||||||||||||
| Amortization of deferred revenues | (1,607 | ) | (1,704 | ) | (1,670 | ) | ||||||
| Share-based compensation costs | 378 | 544 | 311 | |||||||||
| Movement in provisions | 224 | (28 | ) | 23 | ||||||||
| Depreciation and amortization | 169 | 135 | 145 | |||||||||
| Employee future benefits | 520 | 295 | 161 | |||||||||
| Gain on disposal of property and equipment | - | - | (1 | ) | ||||||||
| Gain on sale of intangible asset (note 10) | (549 | ) | - | - | ||||||||
| Interest accretion on lease liabilities | 13 | 4 | 7 | |||||||||
| Net foreign exchange differences | (7 | ) | 16 | (179 | ) | |||||||
| Impairment of intangible assets (note 10) | - | 584 | - | |||||||||
| Impairment of goodwill (note 11) | - | 7,642 | - | |||||||||
| Impairment of other assets | - | 124 | - | |||||||||
| Other non-cash items | - | - | 95 | |||||||||
| Refund (payment) of income taxes | 1,329 | 831 | (1,605 | ) | ||||||||
| Changes in operating assets and liabilities (note 20) | (1,036 | ) | 604 | 2,500 | ||||||||
| Net cash (used in) provided by operating activities | (17,118 | ) | (13,680 | ) | (8,581 | ) | ||||||
| Cash flows from financing activities | ||||||||||||
| Proceeds from issuances of common shares and warrants (note 16) | - | - | 34,200 | |||||||||
| Transaction costs | - | - | (3,221 | ) | ||||||||
| Proceeds from exercise of warrants | - | - | 20,087 | |||||||||
| Proceeds on deferred gain | - | 16 | 98 | |||||||||
| Payments on lease liabilities | (151 | ) | (134 | ) | (127 | ) | ||||||
| Net cash (used in) provided by financing activities | (151 | ) | (118 | ) | 51,037 | |||||||
| Cash flows from investing activities | ||||||||||||
| Purchase of intangible assets | - | - | (609 | ) | ||||||||
| Purchase of property and equipment | (19 | ) | (11 | ) | (30 | ) | ||||||
| Proceeds from disposals of property and equipment | - | - | 1 | |||||||||
| Proceeds from sale of intangible asset (note 10) | 549 | - | - | |||||||||
| Decrease in restricted cash equivalents | (2 | ) | (1 | ) | (20 | ) | ||||||
| Net cash provided by (used in) investing activities | 528 | (12 | ) | (658 | ) | |||||||
| Effect of exchange rate changes on cash and cash equivalents | 146 | (879 | ) | (769 | ) | |||||||
| Net change in cash and cash equivalents | (16,595 | ) | (14,689 | ) | 41,029 | |||||||
| Cash and cash equivalents – beginning of year | 50,611 | 65,300 | 24,271 | |||||||||
| Cash and cash equivalents – end of year | 34,016 | 50,611 | 65,300 | |||||||||
The accompanying notes are an integral part of these consolidated financial statements.
| 8 |
Aeterna Zentaris Inc.
Notes to Consolidated Financial Statements
As of December 31, 2023 and 2022 and for the years ended December 31, 2023, 2022 and 2021
(in thousands of US dollars, except share and per share data and where otherwise noted)
| 1. | Business overview |
Summary of business
Aeterna Zentaris (“Aeterna” or the “Company”) is a specialty biopharmaceutical company commercializing and developing therapeutics and diagnostic tests. The Company’s lead product, Macrilen® (macimorelin), is the first and only U.S. Food and Drug Administration (“FDA”) and European Medicines Agency (“EMA”) approved oral test indicated for the diagnosis of patients with adult growth hormone deficiency (“AGHD”). Macimorelin is currently marketed under the tradename Ghryvelin™ in the European Economic Area and the United Kingdom through an exclusive licensing agreement with Pharmanovia. The Company’s several other license and commercialization partners are also seeking approval for commercialization of macimorelin in Israel and the Palestinian Authority, the Republic of Korea, Turkey and several non-European Union Balkan countries. The Company is actively pursuing business development opportunities for the commercialization of macimorelin in North America, Asia and the rest of the world.
The Company is also dedicated to the development of therapeutic assets and has taken steps to establish a pre-clinical pipeline to potentially address unmet medical needs across several indications with a focus on rare or orphan indications.
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 (the “Group”). Aeterna Zentaris Inc. is the ultimate parent company of the Group. The Company currently has three wholly owned direct and indirect subsidiaries, Aeterna Zentaris GmbH (“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 US.
The registered office of the Company is located at 222 Bay Street, Suite 3000, P.O. Box 53, Toronto, Ontario M5K 1E7, Canada.
The Company’s common shares are listed on both the Toronto Stock Exchange and on the NASDAQ Capital Market.
Basis of presentation
(a) Statement of compliance
These consolidated financial statements as of December 31, 2023, and 2022 and for the years ended December 31, 2023, 2022 and 2021 have been prepared in accordance with International Financial Reporting Standards as issued by the International Accounting Standards Board (“IFRS”).
These consolidated financial statements were approved by the Company’s Board of Directors on March 26, 2024.
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 3 - Critical accounting estimates and judgments.
| 9 |
Aeterna Zentaris Inc.
Notes to Consolidated Financial Statements
As of December 31, 2023 and 2022 and for the years ended December 31, 2023, 2022 and 2021
(in thousands of US dollars, except share and per share data and where otherwise noted)
(b) Basis of measurement
The consolidated financial statements have been prepared under a historical cost convention.
(c) Principles of consolidation
These consolidated financial statements include any entity for which the Company has power over, through existing rights providing the current ability to direct the relevant activities . 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
The consolidated financial statements are presented in United States Dollars. 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 the US dollar for the Company and its US subsidiary, Aeterna Zentaris, Inc., and the Euro (“EUR” or “€”) 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 loss within shareholders’ 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 statements of loss and comprehensive loss.
| 2. | Summary of material accounting policies |
The accounting policies set out below have been applied consistently to all years presented in these consolidated financial statements 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.
Goodwill
Goodwill is recognized as the fair value of the consideration transferred, in a business combination, 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.
| 10 |
Aeterna Zentaris Inc.
Notes to Consolidated Financial Statements
As of December 31, 2023 and 2022 and for the years ended December 31, 2023, 2022 and 2021
(in thousands of US dollars, except share and per share data and where otherwise noted)
Impairment of long-lived assets
Items of property and equipment and identifiable intangible assets with finite lives that are 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. Intangible assets that are not subject to amortization are tested when there are indications that their carrying value may not be recoverable, or, at a minimum, annually.
Goodwill is not subject to amortization, but instead is tested for impairment annually or more often if there is an indication that the group of CGUs to which the goodwill has been allocated may be impaired. Impairment is determined for goodwill by assessing whether the carrying value of the group of CGUs, including the allocated goodwill, exceeds the group of CGU’s recoverable amount, which is the higher of fair value less costs of disposal and the group of CGU’s value in use. Fair value less costs of disposal is determined based on a market approach and also derived from market data, including, information from market participants regarding the price that the Company could receive in a sale of the group of CGUs. Value in use is determined based on cash flow projections from financial budgets approved by senior management covering a five-year period. The estimated future cash flows are discounted to their present value using a pre-tax discount rate that reflects current market assessments of the time value of money and the risks specific to the group of CGUs. In the event that the carrying amount of the group of CGU’s, including the allocated goodwill exceeds its recoverable amount, an impairment loss is recognized in an amount equal to the excess. Impairment losses related to goodwill, which are recorded in the consolidated statement of loss and comprehensive loss, are not subsequently reversed.
Post-employment benefits
The Company has partially funded and unfunded defined benefit multi-employer pension plans, namely the DUPK pension plan and the RUK 1990 and 2006 pension plans, (the “Pension Benefit Plans”) and unfunded post-employment benefit plans in Germany. Provisions for pension obligations are established for benefits payable in the form of retirement, disability and surviving dependent pensions. The Company also provides defined contribution plans to some of 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, rate of pension benefit increases, the projected age of employees upon retirement and the expected rate of future compensation.
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, 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 loss and comprehensive loss in subsequent periods.
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.
| 11 |
Aeterna Zentaris Inc.
Notes to Consolidated Financial Statements
As of December 31, 2023 and 2022 and for the years ended December 31, 2023, 2022 and 2021
(in thousands of US dollars, except share and per share data and where otherwise noted)
The Company grants deferred share units (“DSUs”) to members of its Board of Directors who are not employees or officers of the Company. DSUs cannot be redeemed until the holder is no longer a director of the Company and are considered equity-settled instruments. Under the terms of the DSU agreement, the DSUs vest immediately upon grant. The value attributable to the DSUs is based on the market value of the share price at the time of grant and share based compensation expense is recognized in general and administrative expenses in the consolidated statement of loss and comprehensive loss. At the time of redemption, each DSU may be exchanged for one common share of the Company, net of applicable holding taxes. Any consideration received by the Company in connection with the exercise of DSUs is credited to share capital. Any other capital component of the share-based compensation is transferred to share capital upon the issuance of shares.
Revenue recognition
The Company generates revenue from license and collaboration agreements with customers (license fees, milestone revenue, royalties), the provision of development services, the sale of certain active pharmaceutical ingredients (“API”), semi-finished goods and finished goods, and from certain supply chain activities, which are comprised largely of oversight or supervisory support services related to stability studies or development activities carried out with respect to API batch production as specified in underlying contracts with customers.
IFRS 15 prescribes a five-step framework through which revenue is recognized when control of promised goods or services is transferred to a customer at an amount that reflects the consideration to which the entity expects to be entitled in exchange for those goods or services. Goods and services that are determined not to be distinct are combined with other promised goods or services until a distinct bundle is identified. The Company allocates the transaction price (the amount of consideration to which the Company expects to be entitled in exchange for the promised goods or services) to each performance obligation and recognizes the associated revenue when (or as) each performance obligation is satisfied. The Company’s estimate of the transaction price for each contract includes all variable consideration to which the Company expects to be entitled, and that estimate is reassessed at the end of each reporting period. When two or more contracts are entered into with the same customer at or near the same time, the Company evaluates the contracts to determine whether the contracts should be accounted for as a single arrangement.
The transaction price is allocated among the performance obligations on a relative standalone selling price basis, and the applicable revenue recognition criteria are applied to each of the separate performance obligations. Standalone selling prices may be estimated via methods that include, but are not limited to, an adjusted market assessment approach, an expected cost-plus-margin approach or a residual approach. Determining the standalone selling price for performance obligations requires significant judgment.
The Company records deferred revenues when payments are received or due in advance of its performance. Deferred revenues are primarily from the Company’s services arrangements and are recognized as revenues over the periods when services are performed.
The Company applies judgment in determining whether a combined performance obligation is satisfied at a point in time or over time, and, for performance obligations satisfied over time, in concluding upon the appropriate method of measuring progress to be applied for purposes of recognizing revenue. The Company evaluates the measure of progress each reporting period and, as estimates related to the measure of progress change, related revenue recognition is adjusted accordingly. Changes in the Company’s estimated measure of progress are accounted for on a cumulative catch-up basis as a change in accounting estimate and are recorded in the consolidated statement of loss and comprehensive loss in the period of adjustment.
| 12 |
Aeterna Zentaris Inc.
Notes to Consolidated Financial Statements
As of December 31, 2023 and 2022 and for the years ended December 31, 2023, 2022 and 2021
(in thousands of US dollars, except share and per share data and where otherwise noted)
License fees
If the license to the Company’s intellectual property is determined to be distinct from the other promises or performance obligations identified in the arrangement, the Company recognizes revenue from non-refundable, upfront fees allocated to the license when the license is transferred to the customer and the customer is able to use and benefit from the license. In assessing whether a license is distinct from the other promises, the Company considers whether the collaboration partner can benefit from the license for its intended purpose without the receipt of the remaining promises, whether the value of the license is dependent on the unsatisfied promises, whether there are other vendors that could provide the remaining promises and whether it is separately identifiable from the remaining promises. For licenses that are combined with other promises, the Company utilizes judgment to assess the nature of the combined performance obligation and whether the license is the predominant promise within the combined performance obligation to determine whether the combined performance obligation is satisfied over time or at a point in time and, if over time, the appropriate method of measuring progress for purposes of recognizing revenue.
Development services
Arrangements that include a promise for the Company to provide development services are assessed to determine whether the services are capable of being distinct, are not highly interdependent or do not significantly modify one another, and if so, the services are accounted for as a separate performance obligation as the services are provided to the customer. Otherwise, when development services are determined not to be capable of being distinct, such services are added to the performance obligation that includes the underlying license. For development services that are combined with other promises, the Company applies judgment to assess the nature of the combined performance obligation to determine whether the combined performance obligation is satisfied over time or at a point in time. The Company utilizes judgment to determine the appropriate method of measuring progress for purposes of recognizing revenue, which is generally an input measure such as costs incurred.
Milestone payments
At the inception of any contracts with a customer that includes milestone payments, which are oftentimes payable upon the successful achievement of development or regulatory events, the Company evaluates whether the milestones are considered probable of being reached and estimates the amount to be included in the transaction price using the most likely amount method. If the Company concludes it is highly probable that a significant revenue reversal will not occur, the associated milestone payment is included in the transaction price. Milestone payments that are not within the control of the Company or the licensee, such as regulatory approvals, are generally not considered probable of being achieved until those approvals are received. The transaction price is then allocated to each performance obligation on a relative stand-alone selling price basis, for which the Company recognizes revenue when (or as) the performance obligations under the contract are satisfied. At the end of each subsequent reporting period, the Company reassesses the probability of achievement of milestones and any related constraints, and, if necessary, adjusts the estimate of the overall transaction price on a cumulative catch-up basis.
Royalty payments
For arrangements that include sales-based royalties, including milestone payments based on the level of sales, and when the license is deemed to be the predominant item to which the royalties relate, the Company recognizes revenue at the later of (a) when the related sales occur, or (b) when the performance obligation to which some or all of the royalty has been allocated has been satisfied or partially satisfied.
Product sales
The Company recognizes revenue from the sale of certain API and semi-finished goods, including MacrilenTM, upon delivery of such items to its customer.
Supply chain revenue
Supply chain services are contracted with fixed fees and are provided over a period of time. The Company recognizes revenue on a straight-line basis over time as it best represents the pattern of performance of the services.
| 13 |
Aeterna Zentaris Inc.
Notes to Consolidated Financial Statements
As of December 31, 2023 and 2022 and for the years ended December 31, 2023, 2022 and 2021
(in thousands of US dollars, except share and per share data and where otherwise noted)
Research and development expenses
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 per share
Basic net loss per share is calculated using the weighted average number of common shares outstanding during the year.
Diluted net loss 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, warrants and similar instruments. The number of shares included with respect to options, warrants and similar instruments is computed using the treasury stock method. Diluted net loss per share is equal to the basic net loss per share as the Company is in a loss position and all securities, comprised of options and warrants, would be anti-dilutive.
| 3. | 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.
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.
Accounting for contract modification
The Novo notice of termination of the Novo Amendment received on August 26, 2022, as defined and discussed in note 5, was determined to be a contract modification pursuant to the provisions of IFRS 15, requiring management to apply significant judgments, including the assessment of any changes to the scope of the license agreement and assessment of whether the remaining goods or services are distinct from goods or services transferred before the modification. Any changes in the judgments or assumptions applied to account for this agreement could have a significant impact on the Company’s revenue and deferred revenue.
| 14 |
Aeterna Zentaris Inc.
Notes to Consolidated Financial Statements
As of December 31, 2023 and 2022 and for the years ended December 31, 2023, 2022 and 2021
(in thousands of US dollars, except share and per share data and where otherwise noted)
License and collaboration arrangements with multiple elements
The Company enters into licensing and supply agreements related to the licensing, development, supply and distribution for macimorelin in various territories. Each agreement may contain specific terms or clauses that require careful analysis by management under IFRS 15 in order to ensure the appropriate accounting treatment is reached. The agreements may include non-refundable upfront payments and licensing fees, the provision of development services, pre- and post-commercialization milestone payments, royalties on future product sales derived from such license agreements, and supply arrangements. Management analyzes each agreement and applies significant judgment to determine whether contracts entered into at or near the same time should be accounted for as a single arrangement, whether all parts of the contract are scoped into IFRS 15, to identify all performance obligations, determine whether a performance obligation is distinct or should be combined with other promised goods and services, determine and allocate the transaction price on a relative stand-alone selling price basis, determine whether a combined performance obligation is satisfied at a point in time or over time, and, for performance obligations satisfied over time, in concluding upon the appropriate method of measuring progress to be applied for purposes of recognizing revenue. Any changes in the judgments or assumptions applied can give rise to a significant impact on the Company’s revenues and deferred revenues.
Impairment of goodwill
The annual impairment assessment related to goodwill requires management to estimate the recoverable amount, which is the higher of an asset’s fair value less costs of disposal and value in use. Management has determined that using fair value less cost of disposal results in the higher estimated recoverable value. The carrying amount of its consolidated net assets is compared to the fair value less cost of disposal. Based on this calculation, management determined that goodwill was impaired in the year ended December 31, 2022, see note 11.
Employee future benefits
The determination of expenses, obligations and the Company’s share of the multi-employer plan assets associated with employee future benefits requires the use of assumptions, such as the discount rate to measure obligations, rate of pension benefit increases, the projected age of employees upon retirement and the expected rate of future compensation. Because the determination of the costs, obligations and the Company’s share of the multi-employer plan assets 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 15 - Employee future benefits.
Research and development accruals
As part of the process of preparing our financial statements, management is required to estimate accrued expenses including those pertaining to the Company’s research and development expenses. This process involves reviewing open contracts and purchase orders, communicating with our personnel to identify services that have been performed on the Company’s behalf and estimating the level of service performed and the associated cost incurred for the service when the Company has not yet been invoiced or otherwise notified of the actual cost. If the actual timing of the performance of services or the level of effort varies from management’s estimate, the Company adjusts the accrued or prepaid expense balance accordingly. Although the Company does not expect estimates to be materially different from amounts actually incurred, if those estimates of the status and timing of services performed differ from the actual status and timing of services performed, the Company may report amounts that are too high or too low in any particular period.
| 15 |
Aeterna Zentaris Inc.
Notes to Consolidated Financial Statements
As of December 31, 2023 and 2022 and for the years ended December 31, 2023, 2022 and 2021
(in thousands of US dollars, except share and per share data and where otherwise noted)
| 4. | Recent accounting pronouncements |
New standards and amendments
The Company applied for the first-time certain standards and amendments, which are effective for annual periods beginning on or after January 1, 2023 (unless otherwise stated). The Company has not early adopted any other standard, interpretation or amendment that has been issued but is not yet effective.
Disclosure of Accounting Policies - Amendments to IAS 1 and IFRS Practice Statement 2
The amendments to IAS 1 and IFRS Practice Statement 2 Making Materiality Judgements provide guidance and examples to help entities apply materiality judgements to accounting policy disclosures. The amendments aim to help entities provide accounting policy disclosures that are more useful by replacing the requirement for entities to disclose their ‘significant’ accounting policies with a requirement to disclose their ‘material’ accounting policies and adding guidance on how entities apply the concept of materiality in making decisions about accounting policy disclosures. The amendments have had an impact on the Company’s disclosures of accounting policies, but not on the measurement, recognition or presentation of any items in the Company’s financial statements.
Definition of Accounting Estimates - Amendments to IAS 8
The amendments to IAS 8 clarify the distinction between changes in accounting estimates, changes in accounting policies and the correction of errors. They also clarify how entities use measurement techniques and inputs to develop accounting estimates. The amendments had no impact on the Company’s consolidated financial statements.
Deferred Tax related to Assets and Liabilities arising from a Single Transaction – Amendments to IAS 12
The amendments to IAS 12 Income Tax narrow the scope of the initial recognition exception, so that it no longer applies to transactions that give rise to equal taxable and deductible temporary differences such as leases and decommissioning liabilities. The amendments had no impact on the Company’s consolidated financial statements.
New standards and interpretations not yet adopted
Certain amendments to accounting standards have been published that are not mandatory for December 31, 2023 reporting periods and have not been early adopted by the Company. These amendments are not expected to have a material impact on the Company in future reporting periods and on foreseeable future transactions.
| 16 |
Aeterna Zentaris Inc.
Notes to Consolidated Financial Statements
As of December 31, 2023 and 2022 and for the years ended December 31, 2023, 2022 and 2021
(in thousands of US dollars, except share and per share data and where otherwise noted)
| 5. | Revenue |
Disaggregation of revenue
The Company derives revenue from the transfer of goods and services over time and at a point in time in the following categories:
| Years ended December 31, | ||||||||||||
| 2023 | 2022 | 2021 | ||||||||||
| $ | $ | $ | ||||||||||
| License fees | 1,607 | 1,704 | 1,670 | |||||||||
| Development services | 2,741 | 3,617 | 3,337 | |||||||||
| Product sales | 66 | 57 | - | |||||||||
| Royalties | 31 | 101 | 68 | |||||||||
| Supply chain | 53 | 161 | 185 | |||||||||
| 4,498 | 5,640 | 5,260 | ||||||||||
Revenues of approximately $4,328 (2022 – $5,555 and 2021 - $5,260) are derived from Novo Nordisk.
The Company recorded revenue for the transfer of services over time for the year ended December 31, 2023 of $4,401 (2022 – $5,482 and 2021 - $5,192). Revenue recorded at a point in time for the year ended December 31, 2023, was $97 (2022 – $158 and 2021 - $68).
License, supply and distribution arrangements
Novo Nordisk Health Care AG (“Novo”) - Macrilen™ - United States and Canada
In January 2018, the Company entered into a License Agreement with Novo for the development and commercialization of macimorelin in the U.S. and Canada, which provided for, among others; a right to use license relating to the adult indication; a license for a future FDA-approved pediatric indication; and the licensee to fund costs of a pediatric clinical trial (the “DETECT-trial”) to be run by the Company with oversight from a joint steering committee. The Company was also entitled to receive a milestone payment of $5,000 upon FDA approval of the pediatric indication.
On November 16, 2020, the Company entered into an amendment (the “Novo Amendment”) of its existing License Agreement with Novo related to the development and commercialization of macimorelin. Under the Novo Amendment, Aeterna continued to retain all rights to macimorelin outside of the U.S. and Canada and Novo agreed to make an additional upfront payment to Aeterna of $6,109 (€5,000), which the Company received in December 2020. The royalty payment Aeterna received on sales of macimorelin in the U.S. and Canada was reduced from 15% to 8.5% for annual net sales up to $40,000 and returned to 15% for annual net sales over $40,000. Additionally, the milestone payment to be received upon FDA approval of the pediatric indication was waived. Novo and Aeterna agreed that solely Aeterna will conduct the pivotal DETECT-trial in partnership with a contract research organization (“CRO”) and that Novo was required to reimburse Aeterna for 100% of costs up to €9,000 (approximately $9,600). Any additional external DETECT-trial costs incurred over €9,000 that were jointly approved were shared equally between Novo and Aeterna.
Novo was also granted co-ownership of the U.S. and Canadian patents and trademarks owned by Aeterna on macimorelin but will be required to transfer co-ownership in those patents back to Aeterna on the occurrence of certain termination events. The Novo Amendment also confirmed that Aeterna has the right to use the results from the DETECT-trial, if successful, to support Aeterna seeking regulatory approval and ongoing efforts to seek partnering opportunities for macimorelin in other regions outside of the two countries licensed to Novo, the U.S. and Canada.
The Company allocated $550 (€470) of the additional upfront payment received to the adult indication which was recognized in revenues for the year ended December 31, 2020. The remaining $5,559 (€4,530) was deferred and allocated to the combined performance obligation consisting of the license for the pediatric indication and the development services for the DETECT-trial. The modified transaction price amounted to $5,754 (€4.7 million), which comprised of an unamortized pre-Novo Amendment balance of $195 (€0.2 million) and $5,559 (€4.5 million) which was allocated for the Novo Amendment. Revenue associated with the combined pediatric indication performance obligation was recognized as pediatric development services are incurred using a cost-to-cost measure of progress method based on the cost of the DETECT-trial. The transfer of control to Novo occurred over time, and as such, in management’s judgment, this input method is the best measure of progress towards satisfying the performance obligation and reflects a faithful depiction of the transfer of goods and services.
Notice of termination
On August 26, 2022, Novo provided the Company with a notice of termination of the Novo Amendment. Under the terms of the Novo Amendment, the termination was effective May 23, 2023 upon the completion of a 270 day notice period (“notice period”). Upon termination, the rights and licenses granted by the Company to Novo under the Novo Amendment were returned to the Company, and the Company regained full rights to continue the clinical development and future commercialization of Macrilen™. Following the notice of termination and throughout the 270-day notice period, as per the terms of the Novo Amendment, Novo continued to fund all DETECT-trial costs up to $9.6 million (€9 million), and any additional DETECT-trial costs incurred over $9.6 million (€9 million) up to $10.5 million (€9.8 million) were shared equally between Novo and the Company.
The Company concluded that the notice of termination represents a contract modification for accounting purposes. The Company further concluded that upon receipt of the notice of termination, the remaining goods and services to be performed during the notice period are considered distinct goods and services and therefore, the contract modification is to be accounted for prospectively. As of the date of receipt of the notice of termination from Novo, the Company had recognized total license fees associated with the pediatric indication of $1,615 (€1,880) and total development services revenue of $3,865 (€4,448). Subsequent to the receipt of the notice of termination, management estimated the combined transaction price of the remaining services to be performed as $7,937 (€7,776), comprised of pediatric indication license fees of $2,872 (€2,814) and development services revenue of $5,065 (€4,962). Revenue associated with this combined performance obligation was recognized as pediatric development services were incurred during the notice period, until the date of termination on May 23, 2023, using the cost-to-cost method.
| 17 |
Aeterna Zentaris Inc.
Notes to Consolidated Financial Statements
As of December 31, 2023 and 2022 and for the years ended December 31, 2023, 2022 and 2021
(in thousands of US dollars, except share and per share data and where otherwise noted)
Pharmanovia and Consilient Health Limited
On December 7, 2020, the Company entered into an exclusive licensing agreement with Consilient Health Limited (“CH”) for the commercialization of macimorelin (the “Licensed Product”) in the European Economic Area and the United Kingdom (the “CH License Agreement”).
Under the terms of the CH License Agreement, CH agreed to make a non-refundable, non-creditable upfront payment to the Company of $1,209 (€1.0 million), which the Company received in January 2021. The Company also is eligible to receive additional consideration, including regulatory milestones related to agreed-upon pricing and reimbursement parameters; net sales milestones; and royalties, ranging from 10%-20% of net sales of macimorelin, subject to reduction in certain cases, or sublicense income recorded by CH. Also on December 7, 2020, the Company and CH entered into an exclusive supply agreement, pursuant to which the Company agreed to provide the Licensed Product to CH, with such Licensed Product to be manufactured by third-party manufacturers for a period of ten years, subject to renewal (the “CH Supply Agreement”).
The total transaction price associated with the CH Agreement is $1,209 (€1.0 million), which consists of the non-refundable, non-creditable upfront payment, discussed above. At the inception of the contract, all other contractual consideration to which the Company may be entitled represents variable consideration, including the regulatory milestones, which were determined to be zero, based on management’s estimate of the most likely amount, given that the achievement of the underlying milestones is uncertain and highly susceptible to factors outside of the Company’s control.
| 18 |
Aeterna Zentaris Inc.
Notes to Consolidated Financial Statements
As of December 31, 2023 and 2022 and for the years ended December 31, 2023, 2022 and 2021
(in thousands of US dollars, except share and per share data and where otherwise noted)
The Company allocated the transaction price to the combined performance obligation of the license agreement and the supply agreement for the adult and pediatric indication, using the application of an adjusted market assessment approach. Revenue will be recognized over time using an outputs method based on units of Licensed Product supplied. The total units that the Company expects to supply pursuant to the CH Agreement is an estimate, based on current projections and anticipated market demand, and therefore will be a significant judgment that will be relied upon when using the outputs method to recognize revenue.
During the year ended December 31, 2021, the Company has received a milestone payment of $226 (€0.2 million) relating to a list price in the United Kingdom. During the year ended December 31, 2022, the Company received aggregate milestone payments of $319 (€0.3 million) relating to list price approvals in Germany and Spain. All payments were allocated to the Adult license performance obligation and deferred to the consolidated statement of financial position.
On March 15, 2023, with the Company’s consent, CH entered into an assignment agreement with Pharmanovia to transfer the current licensing agreement for the commercialization of macimorelin in the European Economic Area and the United Kingdom to Pharmanovia, as well as the current supply agreement pursuant to which the Company agreed to provide the licensed product (together, the “Assignment Agreement”). Also on March 15, 2023, the Company and Pharmanovia entered into an amendment agreement, pursuant to which the Company provided its acknowledgement and consent to the Assignment Agreement and agreed to certain amended terms which do not materially differ from the previous license and supply agreement with CH.
The aggregate amount of the transaction price allocated to the Company’s unsatisfied or partially unsatisfied performance obligations under the Pharmanovia Agreement as of December 31, 2023 was $1,629 (2022 - $1,591). The Company expects to recognize the balance of the relevant deferred revenue over the remaining period of nine years, subject to extension based on the outcome of the ongoing clinical development related to the Pediatric Indication and related patent application initiatives.
For the year ended December 31, 2023, the Company recognized $52 (2022 - $18, 2021 - $nil) as license fee revenue associated with the Pharmanovia Agreement.
Liabilities related to contracts with customers
The Company has recognized the following deferred revenue balances related to contracts with customers:
| December 31, 2023 | ||||||||||||
| Current | Non-Current | Total | ||||||||||
| $ | $ | $ | ||||||||||
| Novo Nordisk Health Care | - | - | - | |||||||||
| Pharmanovia | 209 | 1,420 | 1,629 | |||||||||
| NK Meditech Limited | 9 | 124 | 133 | |||||||||
| 218 | 1,544 | 1,762 | ||||||||||
| December 31, 2022 | ||||||||||||
| Current | Non-Current | Total | ||||||||||
| $ | $ | $ | ||||||||||
| Novo Nordisk Health Care | 2,914 | - | 2,914 | |||||||||
| Consilient Healthcare Limited | 35 | 1,556 | 1,591 | |||||||||
| NK Meditech Limited | - | 128 | 128 | |||||||||
| 2,949 | 1,684 | 4,633 | ||||||||||
| 19 |
Aeterna Zentaris Inc.
Notes to Consolidated Financial Statements
As of December 31, 2023 and 2022 and for the years ended December 31, 2023, 2022 and 2021
(in thousands of US dollars, except share and per share data and where otherwise noted)
| 6. | Cash and cash equivalents |
| December 31, | ||||||||
| 2023 | 2022 | |||||||
| $ | $ | |||||||
| Cash on hand and balances with banks | 34,016 | 50,611 | ||||||
| 34,016 | 50,611 | |||||||
The Company had restricted cash equivalents amounting to $332 at December 31, 2023 (2022 - $322). These balances consist of certificates of deposit that are used as collateral for corporate credit cards and leases.
| 7. | Trade and other receivables |
| December 31, | ||||||||
| 2023 | 2022 | |||||||
| $ | $ | |||||||
| Trade accounts receivable | 67 | 403 | ||||||
| Value added tax | 103 | 275 | ||||||
| Other receivables | 52 | 54 | ||||||
| 222 | 732 | |||||||
During the year ended December 31, 2023, the Company recorded a write-down within other receivables of $nil (2022 - $124).
| 8. | Prepaid expenses and other current assets |
| December 31, | ||||||||
| 2023 | 2022 | |||||||
| $ | $ | |||||||
| Prepaid insurance | 250 | 428 | ||||||
| Prepaid research and development | 1,633 | 1,998 | ||||||
| Other | 59 | 62 | ||||||
| 1,942 | 2,488 | |||||||
| 20 |
Aeterna Zentaris Inc.
Notes to Consolidated Financial Statements
As of December 31, 2023 and 2022 and for the years ended December 31, 2023, 2022 and 2021
(in thousands of US dollars, except share and per share data and where otherwise noted)
| 9. | Property and equipment |
Components of the Company’s property and equipment are summarized below.
| Cost | ||||||||||||||||||||
| Equipment | Computer Equipment | Right of use building | Right of use vehicles | Total | ||||||||||||||||
| $ | $ | $ | $ | $ | ||||||||||||||||
| At January 1, 2022 | 199 | 268 | 623 | 87 | 1,177 | |||||||||||||||
| Additions | - | 11 | - | 38 | 49 | |||||||||||||||
| Remeasurement | - | - | 98 | 18 | 116 | |||||||||||||||
| Disposals | - | (1 | ) | (10 | ) | - | (11 | ) | ||||||||||||
| Impact of foreign exchange rate changes | (11 | ) | (13 | ) | (26 | ) | (7 | ) | (57 | ) | ||||||||||
| At December 31, 2022 | 188 | 265 | 685 | 136 | 1,274 | |||||||||||||||
| Additions | 6 | 14 | - | 134 | 154 | |||||||||||||||
| Remeasurement | - | - | 103 | 6 | 109 | |||||||||||||||
| Disposals | (1 | ) | - | - | (94 | ) | (95 | ) | ||||||||||||
| Impact of foreign exchange rate changes | 6 | 7 | 22 | 4 | 39 | |||||||||||||||
| At December 31, 2023 | 199 | 286 | 810 | 186 | 1,481 | |||||||||||||||
| Accumulated Depreciation | ||||||||||||||||||||
| Equipment | Computer Equipment | Right of use building | Right of use vehicles | Total | ||||||||||||||||
| $ | $ | $ | $ | $ | ||||||||||||||||
| At January 1, 2022 | 181 | 244 | 493 | 67 | 985 | |||||||||||||||
| Disposals | - | (1 | ) | (10 | ) | - | (11 | ) | ||||||||||||
| Depreciation | 2 | 9 | 94 | 25 | 130 | |||||||||||||||
| Impact of foreign exchange rate changes | (10 | ) | (12 | ) | (21 | ) | (3 | ) | (46 | ) | ||||||||||
| At December 31, 2022 | 173 | 240 | 556 | 89 | 1,058 | |||||||||||||||
| Disposals | - | - | - | (94 | ) | (94 | ) | |||||||||||||
| Depreciation | 3 | 13 | 103 | 50 | 169 | |||||||||||||||
| Impact of foreign exchange rate changes | 5 | 7 | 17 | 2 | 31 | |||||||||||||||
| At December 31, 2023 | 181 | 260 | 676 | 47 | 1,164 | |||||||||||||||
| Carrying amount | ||||||||||||||||||||
| Equipment | Computer Equipment | Right of use building | Right of use vehicles | Total | ||||||||||||||||
| $ | $ | $ | $ | $ | ||||||||||||||||
| At December 31, 2022 | 15 | 25 | 129 | 47 | 216 | |||||||||||||||
| At December 31, 2023 | 18 | 26 | 134 | 139 | 317 | |||||||||||||||
On September 30, 2023, the Company and its landlord mutually agreed to a one-year plus 6 months’ notice extension to its existing building lease agreement for its German subsidiary, continuing such terms until March 31, 2025, resulting in a remeasurement of the building right of use asset in the amount of $103 (2022 - $98).
| 21 |
Aeterna Zentaris Inc.
Notes to Consolidated Financial Statements
As of December 31, 2023 and 2022 and for the years ended December 31, 2023, 2022 and 2021
(in thousands of US dollars, except share and per share data and where otherwise noted)
| 10. | Intangible assets |
Sale of Cetrotide trademarks to Merck
On August 10, 2021, the Company entered into a trademark maintenance and assignment option agreement with ARES Trading SA, a subsidiary of Merck KGaA (“Merck”), with respect to the trademarks owned by the Company on Cetrotide® (cetrorelix acetate for injection). As consideration for having been granted the option, Merck agreed to pay the Company a total of $549 (€0.5 million). During the year ended December 31, 2023, Merck exercised the option agreement, and the Company accordingly transferred all trademarks to Merck, after which the Company no longer has any ownership in or obligations related to the Cetrotide trademarks.
Impairment of intangible assets
In 2022, the Company ceased its development of both the COVID-19 and Chlamydia vaccine trials. The previously capitalized upfront payments for licenses relating to these two trials of $212 was fully impaired. Furthermore, as part of the Company’s annual goodwill and intangible asset impairment assessment, the Company identified the need for an additional impairment of $372 to intangible assets, as discussed in note 11.
| 11. | Goodwill |
| December 31, | ||||||||
| 2023 | 2022 | |||||||
| $ | $ | |||||||
| Balance – Beginning of year | - | 8,130 | ||||||
| Impairment of goodwill | - | (7,642 | ) | |||||
| Impact of foreign exchange rate changes | - | (488 | ) | |||||
| Balance – End of year | - | - | ||||||
As of December 31, 2022, the market capitalization of the Company was below the carrying value of its shareholders’ equity, indicating a potential impairment of goodwill and impairment of the assets of the group of CGUs. The recoverable amount of the group of CGUs was determined based on a fair value less cost of disposal (“FVLCD”) model. FVLCD was determined based on a market approach and also derived from market data, including, information from market participants regarding the price that the Company could receive in a sale of the group of CGUs. The fair value measurement is categorized as a level 2 fair value based on the inputs in the valuation techniques used. Management determined that value-in-use resulted in a lower estimated recoverable value than FVLCD. Based on the Company’s assessment, the recoverable amount of the group of CGUs was lower than the carrying value and therefore an impairment charge was recorded on its goodwill and intangible assets for an amount of $7,642 and $372 respectively.
| 22 |
Aeterna Zentaris Inc.
Notes to Consolidated Financial Statements
As of December 31, 2023 and 2022 and for the years ended December 31, 2023, 2022 and 2021
(in thousands of US dollars, except share and per share data and where otherwise noted)
| 12. | Payables and accrued liabilities |
| December 31, | ||||||||
| 2023 | 2022 | |||||||
| $ | $ | |||||||
| Trade accounts payable | 1,866 | 2,038 | ||||||
| Accrued research and development costs | 804 | 751 | ||||||
| Accrued employee benefits | 343 | 325 | ||||||
| Payroll tax and other statutory liabilities | 78 | 74 | ||||||
| Other accrued liabilities | 531 | 640 | ||||||
| 3,622 | 3,828 | |||||||
| 13. | Provisions |
| December 31, | ||||||||
| 2023 | 2022 | |||||||
| $ | $ | |||||||
| Balance – Beginning of year | 233 | 277 | ||||||
| Provision recognized | 404 | - | ||||||
| Utilization of provision | (40 | ) | (28 | ) | ||||
| Change in the provision | (174 | ) | - | |||||
| Unwinding of discount and impact of foreign exchange rate changes | 6 | (16 | ) | |||||
| Balances – End of the year | 429 | 233 | ||||||
| Current liabilities | 429 | 45 | ||||||
| Non-current liabilities | - | 188 | ||||||
In 2023, the Company recognized a provision of $404 related to estimated exit costs for certain contracts with suppliers. It is anticipated that these costs will be incurred in the next financial year.
| 23 |
Aeterna Zentaris Inc.
Notes to Consolidated Financial Statements
As of December 31, 2023 and 2022 and for the years ended December 31, 2023, 2022 and 2021
(in thousands of US dollars, except share and per share data and where otherwise noted)
| 14. | Lease liabilities |
| December 31, | ||||||||
| 2023 | 2022 | |||||||
| $ | $ | |||||||
| Balance – Beginning of year | 179 | 161 | ||||||
| Additions | 134 | 38 | ||||||
| Interest paid as charged to net loss as other finance costs | (13 | ) | (4 | ) | ||||
| Payment against lease liabilities | (151 | ) | (134 | ) | ||||
| Modification of lease liability | 108 | 114 | ||||||
| Impact of foreign exchange rate changes | 22 | 4 | ||||||
| Balances – End of the year | 279 | 179 | ||||||
| Current lease liabilities | 160 | 114 | ||||||
| Non-current lease liabilities | 119 | 65 | ||||||
The Company and its landlord mutually agreed to a one-year plus 6 months’ notice extension to its existing building lease agreement for its German subsidiary, continuing such terms until March 31, 2025, resulting in a remeasurement of the lease liability in the amount of $103 (2022 - $98).
Future lease payments as of December 31, 2023, are as follows:
| Amount | ||||
| $ | ||||
| Less than 1 year | 160 | |||
| 1 – 3 years | 102 | |||
| 4 – 5 years | 17 | |||
| 279 | ||||
| 15. | Employee future benefits |
The Company has partially funded and unfunded defined benefit multi-employer pension plans and unfunded post-employment benefit plans in Germany. The 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 members’ length of service and their salary in the final years leading up to retirement.
These plans are governed by the employment laws of Germany, which generally require final salary payments of each plan to be adjusted every third year for either an inflationary increase or a set 1% increase per annum. The form of increase varies for each plan and was an election made by each plan when it was initially established.
Since the pension liability is adjusted for either an increase in inflation or a set 1% increase per annum, the pension plan is exposed to the Company’s inflation, interest rate risks and changes in the life expectancy for pensioners. As the plan assets include significant investments in listed equity shares of entities and real estate, the Company is also exposed to equity market and property market risk. A decrease in corporate bond yields will also increase plan liabilities, although this will be partially offset by an increase in the value of the plans’ bond holdings.
| 24 |
Aeterna Zentaris Inc.
Notes to Consolidated Financial Statements
As of December 31, 2023 and 2022 and for the years ended December 31, 2023, 2022 and 2021
(in thousands of US dollars, except share and per share data and where otherwise noted)
The change in the Company’s accrued benefit obligations associated with the employee future benefit obligation is summarized for the years ended:
| December 31, | ||||||||||||||||
| 2023 | 2022 | |||||||||||||||
| Pension | Other | |||||||||||||||
| benefit plans | benefit plans | Total | Total | |||||||||||||
| $ | $ | $ | $ | |||||||||||||
| Change in plan liabilities | ||||||||||||||||
| Balances – Beginning of the year | 21,657 | 93 | 21,750 | 29,412 | ||||||||||||
| Current service cost (residual value) | 123 | (3 | ) | 120 | 142 | |||||||||||
| Interest cost | 803 | 4 | 807 | 295 | ||||||||||||
| Actuarial loss (gain) arising from changes in financial assumptions | 1,210 | 3 | 1,213 | (5,915 | ) | |||||||||||
| Benefits paid | (814 | ) | (1 | ) | (815 | ) | (752 | ) | ||||||||
| Impact of foreign exchange rate changes | 643 | 2 | 645 | (1,432 | ) | |||||||||||
| Balances – End of the year | 23,622 | 98 | 23,720 | 21,750 | ||||||||||||
| Change in plan assets | ||||||||||||||||
| Balances – Beginning of the year | 10,591 | - | 10,591 | 11,927 | ||||||||||||
| Interest income from plan assets | 396 | - | 396 | 120 | ||||||||||||
| Employer contributions | 36 | - | 36 | 45 | ||||||||||||
| Employee contributions | 13 | - | 13 | 10 | ||||||||||||
| Benefits paid | (266 | ) | - | (266 | ) | (247 | ) | |||||||||
| Remeasurement of plan assets | 15 | - | 15 | (641 | ) | |||||||||||
| Impact of foreign exchange rate changes | 318 | - | 318 | (623 | ) | |||||||||||
| Balances – End of the year | 11,103 | - | 11,103 | 10,591 | ||||||||||||
| Net liability of the unfunded plans | 11,584 | 98 | 11,682 | 10,787 | ||||||||||||
| Net liability of the funded plans | 935 | - | 935 | 372 | ||||||||||||
| Net amount recognized as Employee future benefits | 12,519 | 98 | 12,617 | 11,159 | ||||||||||||
| Amounts recognized: | ||||||||||||||||
| In net loss | 517 | 3 | 520 | 295 | ||||||||||||
| Actuarial gain (loss) on defined benefit plans and remeasurement of the net defined benefit liability in other comprehensive (gain) loss | (1,195 | ) | - | (1,195 | ) | 5,262 | ||||||||||
| 25 |
Aeterna Zentaris Inc.
Notes to Consolidated Financial Statements
As of December 31, 2023 and 2022 and for the years ended December 31, 2023, 2022 and 2021
(in thousands of US dollars, except share and per share data and where otherwise noted)
The fair values of each major class of the Company’s proportionate share of the multi-employer pension plan assets are as follows:
| December 31, | ||||||||
| 2023 | 2022 | |||||||
| $ | $ | |||||||
| Cash and cash equivalents (level 1) | 225 | 46 | ||||||
| Debt instruments (level 1) | 6,357 | 6,302 | ||||||
| Equity instruments (level 1) | 1,219 | 846 | ||||||
| Real estate (level 3) | 2,692 | 2,079 | ||||||
| Other (level 3) | 610 | 1,318 | ||||||
| 11,103 | 10,591 | |||||||
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 | 2023 | 2022 | 2021 | 2023 | 2022 | 2021 | ||||||||||||||||||
| % | % | % | % | % | % | |||||||||||||||||||
| Discount rate | 3.30 | 3.75 | 1.10 | 3.30 | 3.75 | 1.10 | ||||||||||||||||||
| Pension benefits increase | 2.00 | 2.00 | 0.50 | 2.00 | 2.00 | 0.50 | ||||||||||||||||||
| Rate of compensation increase | 2.50 | 2.50 | 2.50 | 2.50 | 2.50 | 2.50 | ||||||||||||||||||
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:
| December 31, | ||||||||||||
| 2023 | 2022 | 2021 | ||||||||||
| Years | Years | Years | ||||||||||
| Retiring at the end of the reporting period: | ||||||||||||
| Male | 21 | 21 | 21 | |||||||||
| Female | 24 | 24 | 24 | |||||||||
| 26 |
Aeterna Zentaris Inc.
Notes to Consolidated Financial Statements
As of December 31, 2023 and 2022 and for the years ended December 31, 2023, 2022 and 2021
(in thousands of US dollars, except share and per share data and where otherwise noted)
In accordance with the assumptions used as of December 31, 2023, undiscounted defined pension benefits expected to be paid are as follows:
| Amount | ||||
| $ | ||||
| 2024 | 871 | |||
| 2025 | 881 | |||
| 2026 | 923 | |||
| 2027 | 1,098 | |||
| 2028 | 1,123 | |||
| Thereafter | 36,144 | |||
| 41,040 | ||||
The weighted average duration of the defined benefit obligation is 14.5 years (2022 – 14.4 years).
If variations in the following assumptions had occurred during 2023, the impact on the Company’s pension benefit obligation of $23,622 as of December 31, 2023, would have been as follows:
| Assumption | Increase | Decrease | ||||||
| Change in discount rate of 0.25% | (809 | ) | 855 | |||||
| Change in salary rate of 0.25% | 17 | (16 | ) | |||||
| Change in pension rate assumption by 0.25% | 506 | (485 | ) | |||||
| Change mortality by one year | 1,160 | (1,160 | ) | |||||
Total expenses for the defined benefit plan that the Company accounts for as a defined contribution plan amounted to approximately $18 for the year ended December 31, 2023 (2022 - $20 and 2021 - $45).
| 16. | Share Capital |
Authorized
The Company has unlimited number of 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.
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.
| 27 |
Aeterna Zentaris Inc.
Notes to Consolidated Financial Statements
As of December 31, 2023 and 2022 and for the years ended December 31, 2023, 2022 and 2021
(in thousands of US dollars, except share and per share data and where otherwise noted)
| Issued and outstanding | Common shares | Amount | ||||||
| # | $ | |||||||
| Balance – December 31, 2020 | 2,507,145 | 235,008 | ||||||
| Issuance of common shares, net of transaction costs | 943,448 | 29,082 | ||||||
| Exercise of warrants, net of issuance costs upon exercise | 1,404,443 | 29,301 | ||||||
| Exercise of deferred share units | 840 | 19 | ||||||
| Balance – December 31, 2021 | 4,855,876 | 293,410 | ||||||
| - | - | |||||||
| Balance – December 31, 2022 | 4,855,876 | 293,410 | ||||||
| - | - | |||||||
| Balance – December 31, 2023 | 4,855,876 | 293,410 | ||||||
On July 15, 2022, the Company’s shareholders and board of directors approved an amendment to the Company’s articles of incorporation to effect a 1-for-25 share consolidation (reverse split) of the Company’s common shares. The Company’s outstanding stock options, DSUs and warrants were also adjusted to reflect the 1-for-25 share consolidation (reverse split) of the Company’s common shares. Accordingly, all common shares, DSU, warrants, stock options and per share amounts in these consolidated financial statements have been retroactively adjusted for all years presented to give effect to the share consolidation (reverse split). Outstanding warrant and stock options were proportionately reduced and the respective exercise prices, if applicable, were proportionately increased. The share consolidation (reverse split) was affected on July 21, 2022.
2021
On February 19, 2021, the Company completed an underwritten public offering of 820,390 common shares at $36.25 per common share, resulting in aggregate gross proceeds of $29,739, less underwriting discounts, commissions and offering expenses of $2,837 (the “February 2021 Financing”). The Company also granted to the underwriter and placement agent (the “Underwriter”), a 30-day over-allotment option to purchase up to 123,058 additional common shares at a price of $36.25 per common share (the “Underwriter Option”). Additionally, the Company issued warrants underlying 57,427 common shares to the Underwriter, with each warrant bearing an exercise price of $45.31 (the “February 2021 Placement Agent Warrants”). The February 2021 Placement Agent Warrants expire on February 17, 2026.
On February 22, 2021, the Underwriter exercised the Underwriter Option and received 123,058 common shares in exchange for gross proceeds to the Company of $4,461. Upon exercise of the Underwriter Option, the Underwriter also received an additional 8,614 February 2021 Placement Agent Warrants. Aggregate gross proceeds received in connection with the February 2021 Financing totaled $34,200, less cash transaction costs of $3,221 and non-cash transaction costs, which represent the issue-date fair value of the February 2021 Placement Agent Warrants, of $1,897.
| 28 |
Aeterna Zentaris Inc.
Notes to Consolidated Financial Statements
As of December 31, 2023 and 2022 and for the years ended December 31, 2023, 2022 and 2021
(in thousands of US dollars, except share and per share data and where otherwise noted)
| 17. | Warrants |
Warrant activity for the years ended December 31, 2023, 2022 and 2021, was as follows:
| Number | Weighted average exercise price | Amount | ||||||||||
| # | $ | $ | ||||||||||
| December 31, 2020 | 1,796,050 | 17.79 | 12,402 | |||||||||
| Granted | 66,041 | 45.31 | 1,897 | |||||||||
| Exercised | (1,404,443 | ) | 14.31 | (9,746 | ) | |||||||
| Allocation of transaction costs to share capital | - | - | 532 | |||||||||
| December 31, 2021 | 457,648 | 21.76 | 5,085 | |||||||||
| - | - | - | ||||||||||
| December 31, 2022 | 457,648 | 21.76 | 5,085 | |||||||||
| - | - | - | ||||||||||
| December 31, 2023 | 457,648 | 21.76 | 5,085 | |||||||||
The fair values of warrants are estimated using the Black-Scholes option pricing model. The weighted average assumptions used in the Black-Scholes valuation model for the year presented were as follows:
December 31, 2021 | ||||
| Expected dividend yield | - | |||
| Expected volatility | 119.18 | % | ||
| Risk-free annual interest rate | 0.59 | % | ||
| Expected life (years) | 4.99 | |||
| Weighted average share price | $ | 37.00 | ||
| Weighted average exercise price | $ | 45.31 | ||
The expected volatility of these warrants was determined using historical volatility rates and the expected life was determined based on time to expiry from the issuance date.
At December 31, 2023, the following warrants were outstanding:
| Warrant issuance | Number | Weighted average remaining contractual life | Weighted average exercise price | |||||||||
| # | years | $ | ||||||||||
| September 2019 | 53,000 | 0.73 | 41.25 | |||||||||
| February 2020 | 44,521 | 1.64 | 32.28 | |||||||||
| July 2020 | 224,845 | 1.51 | 11.25 | |||||||||
| August 2020 | 69,241 | 2.10 | 11.75 | |||||||||
| February 2021 | 66,041 | 2.14 | 45.31 | |||||||||
| 457,648 | 1.61 | 21.76 | ||||||||||
| 29 |
Aeterna Zentaris Inc.
Notes to Consolidated Financial Statements
As of December 31, 2023 and 2022 and for the years ended December 31, 2023, 2022 and 2021
(in thousands of US dollars, except share and per share data and where otherwise noted)
| 18. | Contributed Surplus |
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, deferred stock units (“DSUs”), 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. Options granted under the LTIP expire after seven years following the date of grant, vest over three years, beginning one year after date of grant. 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.
Stock options
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.
The compensation expense for the year end December 31, 2023, was $94 (2022 – $142 and 2021 – $107) recognized over the vesting period. Option activity for the years ended December 31, 2023, 2022 and 2021, was as follows:
| Number | Weighted average exercise price | |||||||
| # | $ | |||||||
| December 31, 2020 | 20,256 | 36.43 | ||||||
| Granted | 23,200 | 10.51 | ||||||
| Expired | (1 | ) | 14,000.00 | |||||
| December 31, 2021 | 43,455 | 21.95 | ||||||
| Granted | 2,000 | 8.88 | ||||||
| Canceled/Forfeited | (2,900 | ) | 14.49 | |||||
| Expired | (525 | ) | 165.08 | |||||
| December 31, 2022 | 42,030 | 20.05 | ||||||
| Granted | 14,000 | 3.75 | ||||||
| Expired | (2,630 | ) | 86.37 | |||||
| December 31, 2023 | 53,400 | 12.51 | ||||||
On January 17, 2023, the Company granted 14,000 stock options under the LTIP. The stock options will be exercisable at $3.75 per share, have a term of seven years and vest over a period of three years.
| 30 |
Aeterna Zentaris Inc.
Notes to Consolidated Financial Statements
As of December 31, 2023 and 2022 and for the years ended December 31, 2023, 2022 and 2021
(in thousands of US dollars, except share and per share data and where otherwise noted)
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.
| December 31, | ||||||||||||
| 2023 | 2022 | 2021 | ||||||||||
| Expected dividend yield | - | - | - | |||||||||
| Expected volatility | 104.46 | % | 115.75 | % | 115.80 | % | ||||||
| Risk-free annual interest rate | 3.56 | % | 1.59 | % | 1.23 | % | ||||||
| Expected life (years) | 5.45 | 5.72 | 5.71 | |||||||||
| Weighted average share price | $ | 3.75 | $ | 8.88 | $ | 10.51 | ||||||
| Weighted average exercise price | $ | 3.75 | $ | 8.88 | $ | 10.51 | ||||||
| Weighted average grant date fair value | $ | 2.99 | $ | 7.47 | $ | 8.82 | ||||||
The expected volatility of these stock options was determined using historical volatility rates and the expected life was determined using the weighted average life of past options issued.
At December 31, 2023, the following options were outstanding:
| Options outstanding | Options exercisable | |||||||||||||||||||||||
| Range of stock option exercise prices | Number | Weighted average remaining contractual life | Weighted average exercise price | Number | Weighted average remaining contractual life | Weighted average exercise price | ||||||||||||||||||
| # | years | $ | # | years | $ | |||||||||||||||||||
| 3.75 to 8.87 | 14,000 | 6.05 | 3.75 | - | ||||||||||||||||||||
| 8.88 to 10.00 | 8,800 | 4.20 | 9.09 | 7,467 | 4.05 | 9.13 | ||||||||||||||||||
| 10.01 to 20.00 | 21,200 | 4.96 | 10.51 | 14,141 | 4.96 | 10.51 | ||||||||||||||||||
| 20.01 to 30.00 | 6,000 | 2.91 | 22.68 | 6,000 | 2.91 | 22.68 | ||||||||||||||||||
| 30.01 to 53.75 | 3,400 | 1.21 | 51.99 | 3,400 | 1.21 | 51.99 | ||||||||||||||||||
| 53,400 | 4.65 | 12.51 | 31,008 | 3.94 | 17.08 | |||||||||||||||||||
Deferred share units
The compensation expense for the year end December 31, 2023, was $284 (2022 – $402 and 2021 – $204) and is presented in selling, general and administrative expenses. DSU activity for the years ended December 31 are:
| December 31, | ||||||||||||
| 2023 | 2022 | 2021 | ||||||||||
| # | # | # | ||||||||||
| Balance – Beginning of the year | 96,920 | 16,920 | 6,920 | |||||||||
| Granted | 100,000 | 80,000 | 11,200 | |||||||||
| Exercised | - | - | (1,200 | ) | ||||||||
| Balance – End of the year | 196,920 | 96,920 | 16,920 | |||||||||
| 31 |
Aeterna Zentaris Inc.
Notes to Consolidated Financial Statements
As of December 31, 2023 and 2022 and for the years ended December 31, 2023, 2022 and 2021
(in thousands of US dollars, except share and per share data and where otherwise noted)
| 19. | Expenses by nature |
| December 31, | ||||||||||||
| 2023 | 2022 | 2021 | ||||||||||
| $ | $ | $ | ||||||||||
| Inventory expensed during the year | 45 | 54 | - | |||||||||
| Provision for obsolete inventory | 133 | 32 | - | |||||||||
| Third-party research and development | 11,664 | 11,244 | 5,534 | |||||||||
| Salaries, wages and benefits | 4,260 | 3,563 | 3,037 | |||||||||
| Professional and consulting fees | 3,504 | 2,475 | 2,570 | |||||||||
| Insurance | 1,184 | 1,687 | 1,077 | |||||||||
| Stock-based compensation | 378 | 544 | 311 | |||||||||
| Software and IT services | 523 | 386 | 387 | |||||||||
| Depreciation and amortization | 170 | 135 | 144 | |||||||||
| Marketing, communications and investor relations | 274 | 317 | 289 | |||||||||
| Travel, meals and entertainment | 276 | 225 | 111 | |||||||||
| Office, rent and telecommunications | 171 | 120 | 162 | |||||||||
| License fees | 10 | 19 | 139 | |||||||||
| Other | (86 | ) | 92 | 170 | ||||||||
| Impairment of goodwill | - | 7,642 | - | |||||||||
| Impairment of other assets | - | 124 | - | |||||||||
| Impairment of intangible assets | - | 584 | - | |||||||||
| 22,506 | 29,243 | 13,931 | ||||||||||
| 20. | Supplemental disclosure of cash flow information |
| December 31, | ||||||||||||
| 2023 | 2022 | 2021 | ||||||||||
| $ | $ | $ | ||||||||||
| Changes in operating assets and liabilities: | ||||||||||||
| Trade and other receivables | 147 | 592 | 120 | |||||||||
| Inventory | 162 | (161 | ) | (56 | ) | |||||||
| Prepaid expenses and other current assets | 589 | (783 | ) | (750 | ) | |||||||
| Payables and accrued liabilities | 76 | 1,076 | 634 | |||||||||
| Income taxes payable | - | - | (109 | ) | ||||||||
| Deferred revenues | (1,313 | ) | 441 | 3,010 | ||||||||
| Deferred gain | (110 | ) | - | - | ||||||||
| Provisions | (14 | ) | (2 | ) | - | |||||||
| Employee future benefits | (573 | ) | (559 | ) | (349 | ) | ||||||
| (1,036 | ) | 604 | 2,500 | |||||||||
| 32 |
Aeterna Zentaris Inc.
Notes to Consolidated Financial Statements
As of December 31, 2023 and 2022 and for the years ended December 31, 2023, 2022 and 2021
(in thousands of US dollars, except share and per share data and where otherwise noted)
| 21. | Income taxes |
Significant components of the current and deferred income tax recovery for the years ended December 31, 2023, 2022 and 2021 are as follows:
| December 31, | ||||||||||||
| 2023 | 2022 | 2021 | ||||||||||
| $ | $ | $ | ||||||||||
| Current income tax recovery | - | - | 109 | |||||||||
| Deferred tax: | ||||||||||||
| Origination and reversal of temporary differences | 3,706 | 2,885 | 1,291 | |||||||||
| Change in unrecognized tax assets | (3,706 | ) | (2,885 | ) | (1,291 | ) | ||||||
| Total income tax recovery | - | - | 109 | |||||||||
From time to time, the Company is subject to tax audits. While the Company believes that its filing positions are appropriate and supportable, periodically, certain matters are challenged by tax authorities. Although the Company believes its tax provisions are adequate, the final determination of tax audits and any related disputes could be materially different from historical income tax provisions and accruals. In 2019, AEZS Germany underwent a tax audit regarding the taxation years 2013 to 2016. As of December 31, 2023 and 2022, the tax authorities concluded the audit for those years. The subsequent years remain unaudited, and the Company has accrued $108 as an uncertain tax provision for those years.
The reconciliation of the combined Canadian federal and provincial corporate income tax rate to the income tax expense for the years ended December 31, 2023, 2022 and 2021 is provided below:
| December 31, | ||||||||||||
| 2023 | 2022 | 2021 | ||||||||||
| Combined Canadian federal and provincial statutory income tax rate | 26.50 | % | 26.50 | % | 26.50 | % | ||||||
| December 31, | ||||||||||||
| 2023 | 2022 | 2021 | ||||||||||
| $ | $ | $ | ||||||||||
| Income tax recovery based on combined statutory income tax rate | 4,273 | 6,023 | 2,246 | |||||||||
| Change in unrecognized tax assets | (3,706 | ) | (2,885 | ) | (1,291 | ) | ||||||
| Share issuance costs | - | - | 367 | |||||||||
| Permanent difference attributable to impairment of goodwill | - | (2,407 | ) | - | ||||||||
| Impact of expiring investment tax credits | (1,156 | ) | (1,559 | ) | (1,724 | ) | ||||||
| Provision to filed return adjustments | - | 106 | 151 | |||||||||
| Share-based compensation costs | (100 | ) | (144 | ) | (82 | ) | ||||||
| Difference in statutory income tax rate of foreign subsidiaries | 521 | 902 | 226 | |||||||||
| Other | 168 | (36 | ) | 216 | ||||||||
| - | - | 109 | ||||||||||
| 33 |
Aeterna Zentaris Inc.
Notes to Consolidated Financial Statements
As of December 31, 2023 and 2022 and for the years ended December 31, 2023, 2022 and 2021
(in thousands of US dollars, except share and per share data and where otherwise noted)
Loss before income taxes is attributable to the Company’s tax jurisdictions for the years ended December 31, 2023, 2022 and 2021. as follows:
| December 31, | ||||||||||||
| 2023 | 2022 | 2021 | ||||||||||
| $ | $ | $ | ||||||||||
| Germany | (10,935 | ) | (16,756 | ) | (4,383 | ) | ||||||
| Canada | (5,371 | ) | (5,679 | ) | (3,860 | ) | ||||||
| United States | (246 | ) | (292 | ) | (234 | ) | ||||||
| (16,552 | ) | (22,727 | ) | (8,477 | ) | |||||||
Significant components of deferred tax assets and liabilities are as follows:
| December 31, | ||||||||
| 2023 | 2022 | |||||||
| $ | $ | |||||||
| Deferred tax assets | ||||||||
| Operating losses carried forward | 143 | 582 | ||||||
| 143 | 582 | |||||||
| Deferred tax liabilities | ||||||||
| Payables and accrued liabilities | - | 450 | ||||||
| Property and equipment | 86 | 55 | ||||||
| Other | 57 | 77 | ||||||
| 143 | 582 | |||||||
| Deferred tax assets (liabilities), net | - | - | ||||||
Significant components of unrecognized deferred tax assets and losses are as follows:
| December 31, | ||||||||
| 2023 | 2022 | |||||||
| $ | $ | |||||||
| Deferred revenues and other provisions | 53 | 1,475 | ||||||
| Operating losses carried forward | 96,866 | 87,445 | ||||||
| Capital losses carried forward | 210 | 210 | ||||||
| SR&ED Pool | 9,138 | 9,138 | ||||||
| Unused tax credits | 1,788 | 1,559 | ||||||
| Employee future benefits | 1,784 | 1,317 | ||||||
| Property and equipment | 524 | 524 | ||||||
| Intangible assets | 104 | 95 | ||||||
| Share issuance expenses | 453 | 781 | ||||||
| Other | 388 | 294 | ||||||
| 111,768 | 102,838 | |||||||
| 34 |
Aeterna Zentaris Inc.
Notes to Consolidated Financial Statements
As of December 31, 2023 and 2022 and for the years ended December 31, 2023, 2022 and 2021
(in thousands of US dollars, except share and per share data and where otherwise noted)
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. Based on the current forecasted future taxable profits and reversal of temporary differences, the company does not believe it will have sufficient future earnings to offset the deferred tax assets and has an unrecognized deferred tax asset balance of $111,768.
As of December 31, 2023, the Company has a total accumulated non-capital losses of $90,436 federally and $89,114 provincially, which may be carried forward for twenty years and used to reduce taxable income in future years. The Company has not recognized deferred tax assets on any of the non-capital losses, due to the uncertainty that there will be sufficient taxable income or that the taxable temporary differences will be reversing in the same reporting period and jurisdiction. The losses will be expiring as follows:
Canada Federal | Canada Provincial | |||||||
| $ | $ | |||||||
| 2028 | 8,054 | 6,668 | ||||||
| 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 | ||||||
| 2040 | 3,808 | 3,808 | ||||||
| 2041 | 4,822 | 4,822 | ||||||
| 2042 | 6,367 | 6,367 | ||||||
| 2043 | 6,202 | 6,202 | ||||||
| 90,436 | 89,114 | |||||||
| 35 |
Aeterna Zentaris Inc.
Notes to Consolidated Financial Statements
As of December 31, 2023 and 2022 and for the years ended December 31, 2023, 2022 and 2021
(in thousands of US dollars, except share and per share data and where otherwise noted)
The Company has non-refundable R&D investment tax credits of approximately $1,778 which can be carried forward to reduce Canadian federal income taxes payable and which expire at dates ranging from 2023 to 2035. Furthermore, the Company has unrecognized tax assets in respect of operating losses to be carried forward in Germany and in the US. The federal tax losses amount to approximately $225,296 in Germany (€ 203,833) for which there is no expiry date, and to $5,342 in the US. The losses in the US will be expiring as follows:
| United States | ||||
| $ | ||||
| 2028 | 369 | |||
| 2029 | 178 | |||
| 2034 | 151 | |||
| 2035 | 447 | |||
| 2036 | 195 | |||
| 2037 | 709 | |||
| Indefinite | 1,224 | |||
| indefinite | 771 | |||
| indefinite | 516 | |||
| indefinite | 244 | |||
| Indefinite | 292 | |||
| indefinite | 246 | |||
| 5,342 | ||||
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.
| 22. | Capital management |
The Company’s objective in managing capital, consisting of shareholders’ 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, general and administrative expenses and working capital requirements. Historically, the Company has raised capital via public and private equity offerings and issuances as its primary source of liquidity, as discussed in note 23. 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.
| 36 |
Aeterna Zentaris Inc.
Notes to Consolidated Financial Statements
As of December 31, 2023 and 2022 and for the years ended December 31, 2023, 2022 and 2021
(in thousands of US dollars, except share and per share data and where otherwise noted)
| 23. | Financial instruments and financial risk management |
Financial assets and liabilities as of December 31, 2023, and 2022 are presented below.
| December 31, 2023 | Financial assets at amortized cost | Financial liabilities at amortized cost | ||||||
| $ | $ | |||||||
| Cash and cash equivalents | 34,016 | - | ||||||
| Trade and other receivables | 67 | - | ||||||
| Restricted cash equivalents | 332 | - | ||||||
| Payables and accrued liabilities | - | 3,544 | ||||||
| Lease liability | - | 160 | ||||||
| 34,415 | 3,704 | |||||||
| December 31, 2022 | Financial assets at amortized cost | Financial liabilities at amortized cost | ||||||
| $ | $ | |||||||
| Cash and cash equivalents | 50,611 | - | ||||||
| Trade and other receivables | 457 | - | ||||||
| Restricted cash equivalents | 322 | - | ||||||
| Payables and accrued liabilities | - | 3,752 | ||||||
| Lease liability | - | 179 | ||||||
| 51,390 | 3,931 | |||||||
The Company assessed that the fair values of cash and cash equivalents, trade receivables and other receivables, restricted cash equivalents, payables and accrued liabilities and lease liability approximate their carrying amounts largely due to the short-term maturities of these instruments.
Assets and liabilities, such as value added taxes, that are not contractual and that arise as a result of statutory requirements imposed by governments, do not meet the definition of financial assets or financial liabilities and are, therefore, excluded from trade and other receivables and payables and accrued liabilities.
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 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.
| 37 |
Aeterna Zentaris Inc.
Notes to Consolidated Financial Statements
As of December 31, 2023 and 2022 and for the years ended December 31, 2023, 2022 and 2021
(in thousands of US dollars, except share and per share data and where otherwise noted)
As of December 31, 2023, two counterparties included in trade accounts receivable comprised a total receivable of approximately $67 (2022 - three counterparties for $403) of which $nil (2022 - $nil) was past due, considered to be impaired and fully provided for.
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 of December 31, 2023, the Company has provided for all outstanding and unpaid amounts relating to its operations.
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. The Company manages this risk through the management of its capital structure by monitoring rolling forecasts of the Company’s cash and cash equivalents on the basis of expected cash flows.
Management concluded that the Company has sufficient cash on hand to meet its obligations as they become due for the next 12 months, considering the Company’s planned research and development activities, selling, general and administrative expenses and working capital requirements. The Company has the ability to scale its research and development activities, and will do so as necessary, based on cash availability. While the Company has $34,016 in cash and cash equivalents at December 31, 2023, it continues to have an ongoing need for additional capital resources to research and develop, commercialize and manufacture its products and technologies.
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 14.
(c) 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 of December 31, 2023, if the US dollar had increased or decreased by 10% against the Euro, with all other variables held constant, net loss for the year ended December 31, 2023, would have been lower or higher by approximately $1,055 (2022 - $823 and 2021 - $300).
| 38 |
Aeterna Zentaris Inc.
Notes to Consolidated Financial Statements
As of December 31, 2023 and 2022 and for the years ended December 31, 2023, 2022 and 2021
(in thousands of US dollars, except share and per share data and where otherwise noted)
| 24. | Segment information |
The Company operates in a single operating segment, being the biopharmaceutical segment.
Geographical information
Revenues by geographical area have been allocated to geographic regions based on the country of residence of the Company’s external customers or licensees and are detailed as follows:
| Years ended December 31, | ||||||||||||
| 2023 | 2022 | 2021 | ||||||||||
| $ | $ | $ | ||||||||||
| Switzerland | 4,317 | 5,395 | 5,075 | |||||||||
| Ireland | 122 | 82 | - | |||||||||
| Denmark | 11 | 160 | 185 | |||||||||
| Other | 48 | 3 | - | |||||||||
| 4,498 | 5,640 | 5,260 | ||||||||||
Non-current assets include restricted cash equivalents and property and equipment, and are detailed by geographical area as follows:
| December 31, | ||||||||
| 2023 | 2022 | |||||||
| $ | $ | |||||||
| Germany | 575 | 463 | ||||||
| Canada | 3 | 4 | ||||||
| United States | 71 | 71 | ||||||
| 649 | 538 | |||||||
| 39 |
Aeterna Zentaris Inc.
Notes to Consolidated Financial Statements
As of December 31, 2023 and 2022 and for the years ended December 31, 2023, 2022 and 2021
(in thousands of US dollars, except share and per share data and where otherwise noted)
| 25. | Net loss per share |
The following table sets forth pertinent data relating to the computation of basic and diluted net loss per share attributable to common shareholders.
| Years ended December 31, | ||||||||||||
| 2023 | 2022 | 2021 | ||||||||||
| $ | $ | $ | ||||||||||
| Net loss | (16,552 | ) | (22,727 | ) | (8,368 | ) | ||||||
| Basic and diluted weighted-average number of shares outstanding | 4,855,876 | 4,855,876 | 4,596,980 | |||||||||
| Basic and diluted loss per share | (3.41 | ) | (4.68 | ) | (1.82 | ) | ||||||
| Items excluded from the calculation of diluted net loss per share due to their anti-dilutive effect: | ||||||||||||
| Stock options and DSUs | 250,320 | 138,950 | 60,375 | |||||||||
| Share purchase warrants | 457,648 | 457,648 | 457,648 | |||||||||
| 26. | Commitments |
Significant expenditure contracted for at the end of the reporting period but not recognized as liabilities is as follows:
| Amount | ||||
| $ | ||||
| Less than 1 year | 5,634 | |||
| 1 – 5 years | 71 | |||
| 5,705 | ||||
In 2021, the Company executed various agreements including in-licensing and similar arrangements with development partners. Such agreements may require the Company to make payments on achievement of stages of development, launch or revenue milestones, although the Company generally has the right to terminate these agreements at no penalty. The Company may have to pay up to $39,373 upon achieving certain sales volumes, regulatory or other milestones related to specific products.
| 40 |
Aeterna Zentaris Inc.
Notes to Consolidated Financial Statements
As of December 31, 2023 and 2022 and for the years ended December 31, 2023, 2022 and 2021
(in thousands of US dollars, except share and per share data and where otherwise noted)
| 27. | Related party disclosures |
Compensation of key management
Key management includes the Company’s Directors, Chief Executive Officer, Chief Financial Officer, Chief Scientific Officer and Chief Medical Officer. Compensation awarded to key management is summarized as follows:
| December 31, | ||||||||||||
| 2023 | 2022 | 2021 | ||||||||||
| $ | $ | $ | ||||||||||
| Salaries and short-term benefits | 2,025 | 1,848 | 1,646 | |||||||||
| Consultant’s fees | - | 17 | 163 | |||||||||
| Post-retirement benefits | 37 | 63 | 70 | |||||||||
| Stock-based compensation | 284 | 460 | 295 | |||||||||
| 2,346 | 2,388 | 2,174 | ||||||||||
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.
| 28. | Subsequent event |
On December 14, 2023, the Company and Ceapro Inc. (“Ceapro”) jointly announced the signing of a definitive agreement to combine their operations in an all-stock merger of equals. Pursuant to the agreement, the transaction will be effected by way of a plan of arrangement under the Canada Business Corporations Act pursuant to which, at closing, each outstanding Ceapro common share will be exchanged for 0.09439 of an Aeterna common share with the result that Ceapro will become a wholly-owned subsidiary of Aeterna (the “Transaction”). If completed, the Transaction will be considered a reverse acquisition and the historical financial statements following the business combination will be those of Ceapro. Additionally, as part of the Transaction, Aeterna will issue to its shareholders immediately prior to the closing of the transaction, 0.47698 of a share purchase warrant (“Transaction Warrants”) for each Aeterna common share held as of such date. Holders of Aeterna’s currently outstanding warrants will also be issued transaction warrants in accordance with the anti-dilution provisions of such warrants. Each whole transaction warrant will be exercisable to purchase one common share of Aeterna at a nominal exercise price of $0.01. The transaction also provides the outstanding options to acquire Ceapro common shares to be replaced by options allowing current holders to acquire common shares of Aeterna on similar terms, as adjusted by the exchange ratio in the transaction. Following the closing of the Transaction, the former shareholders of Ceapro will own 50% of Aeterna and the pre-transaction securityholders of Aeterna will own the remaining 50%, assuming the exercise of all Transaction Warrants. The transaction required the approval of shareholders of both Companies, which was obtained on March 12, 2024, and is subject to closing conditions customary for transactions of this nature, including Alberta court approval and applicable stock exchange approvals. It is anticipated that the transaction will close in the second quarter of 2024, subject to the satisfaction of the conditions of the agreement.
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Exhibit 99.2
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, 2023. In this MD&A, “Aeterna Zentaris”, “Aeterna”, 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 audited consolidated financial statements and the notes thereto as of December 31, 2023 and 2022 and for the years ended December 31, 2023, 2022 and 2021. Our audited consolidated financial statements have been prepared in accordance with International Financial Reporting Standards as issued by the International Accounting Standards Board (“IFRS”).
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 thousands of United States (“U.S.”) dollars, except for share and per share data, or as otherwise noted. This MD&A was approved by the Company’s Board of Directors (the “Board”) on March 26, 2024. This MD&A is dated March 26, 2024.
About Forward-Looking Statements
This document contains statements that may constitute forward-looking statements within the meaning of U.S. and Canadian securities legislation and regulations, and such statements are made pursuant to the safe-harbor provision of the U.S. Private Securities Litigation Reform Act of 1995. In some cases, these forward-looking statements can be identified by words or phrases such as “forecast”, “may”, “will”, “expect”, anticipate”, “estimate”, “intend”, “plan”, “indicate”, “believe”, “direct”, or “likely”, or the negative of these terms, or other similar expressions intended to identify forward-looking statements. In addition, any statements that refer to expectations, intentions, projections and other characterizations of future events or circumstances contain forward-looking information.
Forward-looking statements are based on the opinions and estimates of the Company as of the date of this MD&A, and they are subject to known and unknown risks, uncertainties, assumptions and other factors that may cause the actual results, level of activity, performance or achievements to be materially different from those expressed or implied by such forward-looking statements, including but not limited to the factors described under Item 3, D. – “Risk factors” in this Annual Report on Form 20-F and those relating to: Aeterna’s expectations with respect to the DETECT-trial (as defined below) (including the enrollment of subjects in the DETECT-trial, the application of the macimorelin growth hormone stimulation tests and the completion of the DETECT-trial); Aeterna’s expectations regarding conducting pre-clinical research to identify and characterize an AIM Biologicals-based development candidate for the treatment of neuromyelitis optica spectrum disorder (“NMOSD”), as well as Parkinson’s disease (“PD”), and developing a manufacturing process for selected candidates; Aeterna’s expectations regarding conducting assessments in relevant PD models; the University of Queensland’s undertaking a subsequent investigator initiated clinical trial evaluating macimorelin as a potential therapeutic for the treatment of amyotrophic lateral sclerosis (“ALS”), also known as Lou Gehrig’s disease, and Aeterna’s formulating a pre-clinical development plan for same; the commencement of Aeterna’s formal pre-clinical development of AEZS-150 (as a potential therapeutic in chronic hypoparathyroidism as defined below) in preparation for a potential investigational new drug (“IND”) filing for conducting the first in-human clinical study of AEZS-150; and the impacts associated with the termination of the license agreement with Novo Nordisk Healthcare AG (“Novo Nordisk” or “Novo”), as discussed below.
Forward-looking statements involve known and unknown risks and uncertainties and other factors which may cause the actual results, performance or achievements stated herein to be materially different from any future results, performance or achievements expressed or implied by the forward-looking information. Such risks and uncertainties include, among others: our reliance on the success of the pediatric clinical trial in the European Union and U.S. for Macrilen® (macimorelin); potential delays associated with the completion of the DETECT-trial; we may be unable to enroll the expected number of subjects in the DETECT-trial, and the result of the DETECT-trial may not support receipt of regulatory approval in childhood-onset growth hormone deficiency (“CGHD”); results from ongoing or planned pre-clinical studies of macimorelin by the University of Queensland or for our other products under development may not be successful or may not support advancing the product to human clinical trials; our ability to raise capital and obtain financing to continue our currently planned operations; our dependence on the success of Macrilen® (macimorelin) and related out-licensing arrangements, including the continued availability of funds and resources to successfully commercialize the product; our ability to enter into additional out-licensing, development, manufacturing, marketing and distribution agreements with other pharmaceutical companies and to keep such agreements in effect; and our ability to continue to list our common shares on the Nasdaq or the TSX. These risk factors are not intended to represent a complete list of the risk factors that could affect the Company. These factors and assumptions, however, should be considered carefully. More detailed information about these and other factors is included under Item 3, D. – “Risk factors” in this Annual Report on Form 20-F.
| 1 |
Although the Company has attempted to identify important factors that could cause actual results to differ materially from those contained in forward-looking statements, there may be other factors that cause results not to be as anticipated, estimated or intended. Many of these factors are beyond our control. There can be no assurance that such statements will prove to be accurate, as actual results and future events could differ materially from those anticipated in such statements. Accordingly, readers should not place undue reliance on forward-looking statements. The Company does not undertake to update any forward-looking statements contained herein, except as required by applicable securities laws. New factors emerge from time to time, and it is not possible for the Company to predict all of these factors, or to assess in advance the impact of each such factor on the Company’s business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statement.
Certain forward-looking statements contained herein about prospective results of operations, financial position or cash flows may constitute a financial outlook. Such statements are based on assumptions about future events, are given as of the date hereof and are based on economic conditions, proposed courses of action and management’s assessment of currently available relevant information. The Company’s management has approved the financial outlook as of the date hereof. Readers are cautioned that such financial outlook information contained herein should not be used for purposes other than for which it is disclosed herein.
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 U.S. Securities and Exchange Commission (“SEC”). We are therefore required to file or furnish continuous disclosure information, such as interim and annual financial statements, management’s discussion and analysis, proxy or information circulars, annual reports on Form 20-F, material change reports and press releases with the appropriate securities regulatory authorities. Additional information about the Company and 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.sedarplus.ca and www.sec.gov.
| 2 |
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 U.S. Food and Drug Administration (“FDA”) and European Medicines Agency (“EMA”) approved oral test indicated for the diagnosis of patients with adult growth hormone deficiency (“AGHD”). Macimorelin is currently marketed under the tradename Ghryvelin™ in the European Economic Area and under the tradename “Macimorelin 60 mg granules for oral suspension in sachet” in the United Kingdom through an exclusive licensing agreement with Pharmanovia. The Company’s several other license and commercialization partners have already received or are seeking approval for commercialization of macimorelin in Israel and the Palestinian Authority, the Republic of Korea, Turkey and several non-European Union Balkan countries. The Company is actively pursuing business development opportunities for the commercialization of macimorelin in North America, Asia and the rest of the world. We are also leveraging the clinical success and compelling safety profile of macimorelin to develop the compound for the diagnosis of CGHD, an area of significant unmet need.
The Company is also dedicated to the development of therapeutic assets and has established a pre-clinical development pipeline to potentially address unmet medical needs across a number of indications, with a focus on rare and/or orphan indications, including, Neuromyelitis Optica Spectrum Disorder (NMOSD), Parkinson’s disease (PD), chronic hypoparathyroidism (DC-PTH) and ALS (Lou Gehrig’s disease).
Plan of Arrangement with Ceapro
On December 14, 2023, Aeterna Zentaris entered into an arrangement agreement (the “Arrangement Agreement”) with Ceapro Inc. (“Ceapro”) which was subsequently amended on January 16, 2024, pursuant to which Aeterna Zentaris and Ceapro agreed that, subject to the terms and conditions set forth in the Arrangement Agreement, including the receipt of the approval of the securityholders of Aeterna Zentaris and Ceapro which was obtained on March 12 2024, the final order of the Court of King’s Bench of Alberta and certain regulatory and exchange approvals described below, Aeterna Zentaris will acquire 100 percent of the common shares of Ceapro (the “Ceapro Shares”) pursuant to a court-approved plan of arrangement under the Canada Business Corporations Act such that Ceapro will become a wholly-owned subsidiary of Aeterna Zentaris and Aeterna Zentaris will continue the operations of Aeterna Zentaris and Ceapro on a combined basis (the “Arrangement”). Additionally, as part of the Arrangement, Aeterna Zentaris will issue to its shareholders immediately prior to the closing of the Arrangement, 0.47698 of a share purchase warrant (“Aeterna Zentaris New Warrant”) for each Aeterna Zentaris common share held as of such date. The terms of the Arrangement Agreement were the result of arm’s length negotiation between Aeterna Zentaris and Ceapro and their respective advisors.
On the closing of the Arrangement, existing shareholders of Aeterna Zentaris and former shareholders of Ceapro would own approximately 50% of the outstanding Aeterna Zentaris common shares assuming the exercise of all of the Aeterna Zentaris New Warrants and based on the number of Aeterna Zentaris common shares and Ceapro Shares issued and outstanding as of market close on December 13, 2023. If completed, the Arrangement will be considered a reverse acquisition and the historical financial statements following the business combination will be those of Ceapro.
Aeterna Zentaris has applied to list all of its common shares issuable upon the exercise of the Aeterna Zentaris New Warrants on the TSX and has filed an initial listing application with the Nasdaq as the exchange has determined that the Arrangement constitutes a “change of control” under its rules and regulations. The parties intend to rely upon the exemption from the registration requirements of the U.S. Securities Act pursuant to Section 3(a)(10) thereof and applicable state securities laws with respect to the issuance of the Aeterna Zentaris common shares and the replacement options pursuant to the Arrangement.
Following closing, Aeterna Zentaris and Ceapro have agreed to use their commercially reasonable efforts to delist the Ceapro Shares from the TSXV. Aeterna Zentaris and Ceapro also intend to apply for a decision for Ceapro to cease to be a reporting issuer under the securities laws of each jurisdiction of Canada in which Ceapro is a reporting issuer, if permitted by applicable laws.
| 3 |
The Arrangement Agreement contains customary representations and warranties and is subject to customary conditions to closing and other restrictive covenants, including, but not limited to, the following:
| ● | Directors and Officers: Upon the closing of the Arrangement, certain directors of Aeterna Zentaris will resign, the number of director seats on the Aeterna Zentaris Board will be increased by four and Ronald W. Miller, Ulrich Kosciessa, Geneviève Foster and William Li, each a nominee of Ceapro, will be appointed to fill such vacancies on the Aeterna Zentaris board, to the extent permitted by law. The Chief Executive Officer of the combined company will be Gilles Gagnon, the current Chief Executive Officer of Ceapro and a director of Aeterna Zentaris and the Chief Financial Officer of the combined company will be Giuliano La Fratta, the Chief Financial Officer of Aeterna Zentaris. | |
| ● | Non-Solicitation: Subject to certain exceptions, neither party will solicit or assist in the initiation of proposals that could result in an Acquisition Proposal (as defined in the Arrangement Agreement) by a third-party. | |
| ● | Notification of Proposals: A party that receives an acquisition solicitation has to notify the other party within 24 hours of its receipt of such solicitation and must provide certain information and details relating to such acquisition solicitation. | |
| ● | Superior Proposal: Notwithstanding other restrictions contained in the Arrangement Agreement, in the event a party receives a superior proposal from a third-party, such party may, subject to compliance with the terms of the Arrangement Agreement, enter into a definitive agreement with a party providing for an Acquisition Proposal so long as such Acquisition Proposal constitutes a Superior Proposal (as defined in the Arrangement Agreement). | |
| ● | Termination of Arrangement Agreement: The parties may terminate the Arrangement Agreement upon the occurrence of certain conditions, and in any event, if the effective date has not occurred on or before June 14, 2024. | |
| ● | Termination Fees: Upon the occurrence of certain termination events pursuant to the terms of the Arrangement Agreement, Aeterna Zentaris shall be entitled to a fee of US$0.5 million to be paid by Ceapro within the time(s) specified in the Arrangement Agreement in respect to each termination event. |
For additional information with respect to the Arrangement and the representations and warranties, conditions to closing and other terms in the Arrangement Agreement please refer to the section entitled “The Plan of Arrangement – Principal Terms of the Plan of Arrangement” in the Company’s Registration Statement on Form F-1 filed with the SEC on February 15, 2024 and to the Arrangement Agreement incorporated by reference as Exhibit 2.1 to the Registration Statement on Form F-1. Further information is also available in the management information circular dated February 9, 2024 which is available on the Company’s SEDAR+ profile at www.sedarplus.com.
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Key Operational Developments
Macimorelin Commercialization Program
On March 15, 2023, with the Company’s consent, Consilient Health Limited (“Consilient” or “CH”) entered into an assignment agreement with Atnahs Pharma UK Ltd. (Pharmanovia) to transfer the current licensing agreement for the commercialization of macimorelin in the European Economic Area and the United Kingdom to Pharmanovia, as well as the current supply agreement pursuant to which the Company agreed to provide the licensed product. Also on March 15, 2023, the Company and Pharmanovia entered into an amendment agreement, pursuant to which the Company provided its acknowledgement and consent to the Assignment Agreement and agreed to certain amended terms which do not materially differ from the previous license and supply agreement with CH. To date, we have received total pricing milestone payments from CH of $0.5 million (€0.5 million) relating to Ghryvelin™/Macimorelin 60 mg approved list prices in the United Kingdom, Germany and Spain. We shipped initial batches of macimorelin (Ghryvelin™/Macimorelin 60 mg) to Consilient in the first quarter of 2022. Consilient launched the product meanwhile in the United Kingdom, Sweden, Denmark, Finland, Germany and Austria. More EU countries will follow pending re-imbursement negotiations. On April 19, 2022, we announced that the European Patent Office had issued a patent providing intellectual property protection of macimorelin in 27 countries within the European Union as well as additional European non-EU countries, such as the UK and Turkey, for macimorelin for use to diagnose GHD in adults. In the meantime, the related PCT patent application has been granted in Canada, Japan, South Korea, Eurasia and New Zealand.
On May 9, 2023, the USPTO issued patent US11,644,474 to the Company protecting the use of macimorelin for the diagnosis of GHD in pediatrics.
Since November 2020, Novo marketed macimorelin under the tradename Macrilen® through a license agreement and an amended license agreement (collectively the “Novo Amendment”) for the diagnosis of AGHD. On August 26, 2022, the Company announced that Novo had exercised its right to terminate the Novo Amendment. Following a 270-day notice period, Aeterna regained full rights to Macrilen® in the U.S. and Canada on May 23, 2023, and the sales of Macrilen® are temporarily discontinued in the U.S. commercial market for the diagnosis of AGHD, until an anticipated re-launch with an alternate commercialization partner. The Company continues to actively strategize and seek alternate development and commercialization partners for Macrilen® in the U.S. and other territories. The decision to temporarily discontinue sales of Macrilen® in the United States does not have any impact on the sales and commercialization efforts in the UK and European Economic Area.
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On June 25, 2020, we announced that we entered into an exclusive distribution and related quality agreement with MegaPharm Ltd., a leading Israel-based biopharmaceutical company, for the commercialization in Israel and in the Palestinian Authority of macimorelin, to be used in the diagnosis of patients with AGHD and in clinical development for the diagnosis of CGHD. Under the terms of the agreement, MegaPharm Ltd. will be responsible for obtaining registration to market macimorelin in Israel and the Palestinian Authority, while the Company will be responsible for manufacturing, product supply, quality assurance and control, regulatory support, and maintenance of the relevant intellectual property. In June 2021, MegaPharm Ltd. filed an application to the Ministry of Health of Israel for regulatory approval of macimorelin in Israel, which received the Israeli license in November 2022 and final approval in February 2024.
We entered into license and supply agreements with NK Meditech Ltd. (“NK”), a subsidiary of PharmBio Korea, effective November 30, 2021, and a distribution and commercialization agreement with ER Kim Pharmaceuticals Bulgaria Eood (“ER-Kim”), effective February 1, 2022. The agreements with NK are related to the development and commercialization of macimorelin for the diagnosis of AGHD and CGHD in the Republic of Korea, while the agreement with ER-Kim is related to the commercialization of macimorelin for the diagnosis of growth hormone deficiency in children and adults in Turkey and some non-European Union Balkan countries. The South Korean marketing authorization was granted in September 2023.
Macimorelin Clinical Program
On January 28, 2020, we announced the successful completion of patient recruitment for the first pediatric study of macimorelin as a growth hormone stimulation test for the evaluation of GHD in children. This study, AEZS-130-P01 (“Study P01”), was the first of two studies as agreed with the EMA in our Pediatric Investigation Plan (the “PIP”) for macimorelin as a GHD diagnostic. 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 P01 was 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 is being evaluated in the pivotal second study, Study P02, on diagnostic efficacy and safety (the “DETECT-trial”). Study P01 was an international, multicenter study, which was conducted in Hungary, Poland, Ukraine, Serbia, Belarus and Russia. Study P01 was 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 milligram per kilogram body weight in pediatric patients from 2 to less than 18 years of age with suspected CGHD. We enrolled a total of 24 pediatric patients across the three cohorts of the study. Per study protocol, all enrolled patients completed four study visits after successful completion of the screening period. At Visit 1 and Visit 3, a provocative growth hormone stimulation test was conducted according to the study sites’ local practices. At Visit 2, the macimorelin test was performed, and following the oral administration of the macimorelin solution, blood samples were taken at predefined times for PK/PD assessment. Visit 4 was a safety follow-up visit at study end.
The final study results from Study P01 were published in the second quarter of 2020 indicating positive safety and tolerability data for use of macimorelin in CGHD, as well as PK/PD data observed in a range as expected from the adult studies.
On April 7, 2020, we announced the decision of the EMA to accept our modification request of our PIP as originally approved in March 2017, which covered the conduct of two pediatric studies and defined relevant key elements in the outline of these studies. We believe this EMA decision supports the development of one globally harmonized study protocol for test validation, specifically Study P02, which we expect to be accepted both in Europe and the U.S.
In late 2020, we entered into the start-up phase for the clinical safety and efficacy study, AEZS-130-P02 (“DETECT-trial”), evaluating macimorelin for the diagnosis of CGHD. The DETECT-trial is an open-label, single dose, multicenter and multinational study expected to enroll approximately 100 subjects worldwide (incl. sites in U.S: and EU), with at least 40 pre-pubertal and 40 pubertal subjects. The study design is expected to be suitable to support a claim for potential stand-alone testing, if successful. On April 22, 2021, the U.S. FDA Investigational New Drug Application associated with this clinical trial became active, (see: https://clinicaltrials.gov/ct2/show/NCT04786873), and on May 13, 2021, we announced the opening of the first clinical site in the U.S. Under the Novo Amendment, and following Novo’s notice to terminate the Novo Amendment, Novo has funded DETECT-trial costs up to $10.1 million (€9.4 million). Any additional trial costs incurred over $10.1 million (€9.4 million) will be paid by Aeterna.
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On January 26, 2022, we announced that the DETECT-trial had experienced unavoidable delays in site initiation and patient enrollment due to the rise of the Omicron variant in the COVID-19 pandemic. Furthermore, in February 2022, due to the Russian invasion of Ukraine, the clinical trial activities planned in both Russia and Ukraine were halted and consequently, no patients have been enrolled in either of these countries’ clinical sites to date. On January 17, 2023, we provided a business update, highlighting that bolstered enrollment was expected by the engagement of an additional Clinical Research Organization (CRO) and the replacement of inactive countries and sites with three new countries (Armenia, Slovakia, and Turkey) as well as additional sites in the U.S. In March 2023, we received approval for and activated our first site in Slovakia. Sites in Armenia and Turkey were approved and activated in early 2024. With enrollment in the DETECT-trial now completed, we expect the conclusion of the active part of the trial in Q2 2024 and top-line results in Q3 2024.
Pipeline Expansion Opportunities
AIM Biologicals: Targeted, highly specific autoimmunity modifying therapeutics for the potential treatment of neuromyelitis optica spectrum disorder (NMOSD) and Parkinson’s disease
AIM Biologicals are based on a natural process during pregnancy, which induces immunogenic tolerance of the maternal immune system to the partially foreign fetal antigens. Fetal proteins are processed and presented on certain immunosuppressive major histocompatibility complex class I molecules to induce this tolerance. In an autoimmune disease, the immune system is misdirected and targets the body’s own protein. With AIM Biologicals, we aim to restore the tolerance against such proteins to treat autoimmune diseases. Our AIM Biologics program is focused on the rare and orphan indication NMOSD and on the second most common neurodegenerative disorder, Parkinson’s disease.
In January 2021, we entered into an exclusive patent license and research agreement with the University of Wuerzburg, Germany, for worldwide rights to develop, manufacture, and commercialize AIM Biologicals for the potential treatment of NMOSD. Additionally, we have engaged Prof. Dr. Joerg Wischhusen from the University Hospital in Wuerzburg as well as neuro-immunologist Dr. Michael Levy from the Massachusetts General Hospital (“MGH”) in Boston as consultants for scientific support and advice in the field of inflammatory central nervous system “CNS” disorders, autoimmune diseases of the nervous system, and NMOSD. In September 2021, we entered into an additional exclusive license with the University of Wuerzburg for early pre-clinical development towards the potential treatment of Parkinson’s disease. On May 12, 2022 we announced positive pre-clinical results in an innovative mouse model of Parkinson’s disease, where treatment with α-Synuclein specific AIM Biologicals showed a trend towards improved motoric function, as well as significant induction of regulatory T cells and rescue of substantia nigra neurons. The data were presented at IMMUNOLOGY2022™, the annual event of the American Association of Immunologists, held on May 6-10, 2022 in Portland, Oregon. On June 13, 2022, we announced that we had achieved proof-of-concept for the treatment of NMOSD in both in-vitro and in mouse models. These findings were presented at the 13th International Congress on Autoimmunity on June 10-13, 2022, in Athens, Greece. In October 2022, we entered into a research and development agreement with MGH in Boston and Dr. Michael Levy, to conduct pre-clinical ex-vivo and in-vivo studies in NMOSD.
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NMOSD is an autoimmune disease targeting the protein aquaporin 4, primarily found in optic nerves and the spinal cord. The disease leading to blindness and paralysis has a prevalence of 0.7-10 in 100,000, more common in persons with Asian or African compared to European ancestors, and nine times more prevalent among women compared to men. NMOSD progresses in often life-threatening relapses, which are aggressively treated with high-dose steroids and plasmapheresis. Current treatment options include treatment with immunosuppressive monoclonal antibodies, which carries risk of serious infections. Our pre-clinical plans include expanding the already available proof-of-concept data for the treatment of NMOSD in both in-vitro and in-vivo assessments to select an AIM Biologicals-based development candidate; and manufacturing process development for the selected candidate.
Parkinson’s disease is a neurological disease commonly associated with motoric problems with a slow and fast progression form. It is the second most common neurodegenerative disease affecting 10 million people worldwide. The hallmark of PD is the neuronal inclusion of mainly α-synuclein protein (αSyn) associated with the death of dopamine-producing cells. Dopaminergic medication is the mainstay treatment of PD symptoms. Up to now there is no pharmacological therapy available to prevent or delay disease progression. Alternate treatments, such as deep brain stimulation with short electric bursts, are being investigated for the treatment of symptoms. For the development of AIM Biologicals as potential PD therapeutics, Aeterna utilizes, among others, an innovative animal model on neurodegeneration by α-synuclein-specific T cells in AAV-A53T-α-synuclein Parkinson’s disease mice, which has recently been published by University of Wuerzburg researchers. We are continuing in-vitro and in-vivo testing of antigen-specific AIM Biologics candidate molecules for the potential treatment of Parkinson’s disease.
AEZS-150 - Delayed Clearance (“DC”) Parathyroid Hormone (“PTH”) (“DC-PTH”) Fusion Polypeptides: Potential treatment for chronic hypoparathyroidism
On March 11, 2021, we entered into an exclusive license agreement with The University of Sheffield, United Kingdom, for the intellectual property relating to PTH fusion polypeptides covering the field of human use, which will initially be studied by Aeterna for the potential therapeutic treatment of chronic hypoparathyroidism (“HypoPT”). Under the terms of the exclusive patent and know-how license agreement entered into with the University of Sheffield, we obtained worldwide rights to develop, manufacture and commercialize PTH fusion polypeptides covered by the licensed patent applications for all human uses for an up-front cash payment, and milestone payments to be paid upon the achievement of certain development, regulatory and sales milestones, as well as low single digit royalty payments on net sales of those products and certain fees payable in connection with sublicensing. We will be responsible for the further development, manufacturing, approval, and commercialization of the licensed products. We also engaged the University of Sheffield under a research contract to conduct certain research activities to be funded by Aeterna, the results of which will be included within the scope of the license granted to Aeterna.
The researchers at the University of Sheffield have developed a method to increase the serum clearance time of peptides, which the Company is applying to the development of a treatment for HypoPT. HypoPT is an orphan disease where the PTH level is abnormally low or absent, with a prevalence per 100,000 of 37 in the U.S., 22 in Denmark, 9.4 in Norway, and 5.3 to 27 in Italy. Standard treatment is calcium and vitamin D supplementation. In consultation with The University of Sheffield, Aeterna has selected AEZS-150 as the lead candidate in its DC-PTH program. AEZS-150 is being developed to provide a weekly treatment option of chronic hypoparathyroidism in adults. Recent progress includes the successful verification and reproduction of previous in-vivo data from the University of Sheffield, in a rat model of hypoparathyroidism, as well as ongoing development of the manufacturing process for AEZS-150 with the Company’s contract development and manufacturing organization, establishment of a master cell bank for a cell line expressing AEZS-150 and the development of a production process suitable for larger scale good manufacturing practices. Our next steps include working with The University of Sheffield to continue with in depth characterization of development candidate (in-vitro and in-vivo); meeting with regulatory authorities to formalize the pre-clinical development of AEZS-150 in preparation for a potential IND filing for conducting the first in-human clinical study.
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AEZS-130 - Macimorelin Pre-clinical Program
On January 13, 2021, we entered into a material transfer agreement with Queensland University to provide macimorelin for the conduct of preclinical and clinical studies evaluating macimorelin as a therapeutic for the treatment of ALS. ALS is a rare progressive neurological disease primarily affecting the neurons controlling voluntary movement, leading to the disability to control movements such as walking, talking, and chewing. Most people with ALS die from respiratory failure, usually between 3-5 years after diagnosis. Currently there is no cure for ALS and no effective treatment to halt or reverse the progression of the disease. Ghrelin is a hormone with wide-ranging biological actions, most known for stimulating growth hormone release, which is demonstrating emerging evidence as therapeutic for ALS. As a ghrelin agonist, macimorelin has the potential as a treatment for ALS, which is evaluated in this research collaboration.
In July 2022, we entered a research and option to license agreement with UniQuest Pty Ltd., the commercialization company of The University of Queensland (UQ), Brisbane, Australia, to advance the development of macimorelin as a potential therapeutic for the treatment of ALS. We have developed an alternative formulation suitable for use in ALS patients and are accumulating data for positive effects of AEZS-130 treatment on survival of motor-neurons. We are continuing to evaluate AEZS-130 in transgenic mouse ALS models as well as in human patient-derived neuron cultures to demonstrate the therapeutic potential of macimorelin in this indication. Our next steps include completion of the ongoing toxicology and safety studies to support treatment over prolonged periods and following potential achievement of proof-of-concept, scientific advice with regulatory authorities to discuss program development to support first in human studies.
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Results of operations
The following is a discussion of our financial condition and results of operations for the years ended December 31, 2023, and 2022. This
discussion should be read in conjunction with the consolidated financial statements and related notes thereto. Comparisons between 2022
and 2021 have been omitted from this MD&A but can be found in “Operating and Financial Review and Prospects” under Item
5 our Form 20-F for the year ended December 31, 2022 which was filed on March 23, 2023.
Consolidated Statements of Loss and Comprehensive Loss Information
| Three months ended | Twelve months ended | |||||||||||||||||||
| December 31, | December 31, | |||||||||||||||||||
| 2023 | 2022 | 2023 | 2022 | 2021 | ||||||||||||||||
| $ | $ | $ | $ | $ | ||||||||||||||||
| Revenues | 121 | 2,485 | 4,498 | 5,640 | 5,260 | |||||||||||||||
| Expenses | ||||||||||||||||||||
| Cost of sales | 55 | 51 | 222 | 157 | 90 | |||||||||||||||
| Research and development | 3,868 | 4,425 | 13,560 | 12,506 | 6,574 | |||||||||||||||
| Selling, general and administrative | 2,594 | 2,012 | 8,724 | 8,230 | 7,267 | |||||||||||||||
| Impairment of intangible assets | - | 584 | - | 584 | - | |||||||||||||||
| Impairment of goodwill | - | 7,642 | - | 7,642 | - | |||||||||||||||
| Impairment of other assets | - | 124 | - | 124 | - | |||||||||||||||
| Total expenses | 6,517 | 14,838 | 22,506 | 29,243 | 13,931 | |||||||||||||||
| Loss from operations | (6,396 | ) | (12,353 | ) | (18,008 | ) | (23,603 | ) | (8,671 | ) | ||||||||||
| (Loss) gain due to changes in foreign currency exchange rates | (162 | ) | (98 | ) | (206 | ) | 879 | 215 | ||||||||||||
| Gain on sale of intangible asset | 549 | - | 549 | - | - | |||||||||||||||
| Interest income | 387 | - | 1,126 | - | - | |||||||||||||||
| Net other costs | (13 | ) | - | (13 | ) | (3 | ) | (21 | ) | |||||||||||
| Net other income (costs) | 761 | (98 | ) | 1,456 | 876 | 194 | ||||||||||||||
| Loss before income taxes | (5,635 | ) | (12,451 | ) | (16,552 | ) | (22,727 | ) | (8,477 | ) | ||||||||||
| Income tax recovery | - | - | - | - | 109 | |||||||||||||||
| Net loss | (5,635 | ) | (12,451 | ) | (16,552 | ) | (22,727 | ) | (8,368 | ) | ||||||||||
| Other comprehensive loss: | ||||||||||||||||||||
| Items that may be reclassified subsequently to profit or loss: | ||||||||||||||||||||
| Foreign currency translation adjustments | (367 | ) | (263 | ) | (211 | ) | (289 | ) | 367 | |||||||||||
| Items that will not be reclassified to profit or loss: | ||||||||||||||||||||
| Actuarial gain on defined benefit plans | (2,108 | ) | (969 | ) | (1,195 | ) | 5,262 | (3,592 | ) | |||||||||||
| Comprehensive loss | (8,110 | ) | (13,683 | ) | (17,958 | ) | (17,754 | ) | (11,593 | ) | ||||||||||
| Basic and diluted loss per share | (1.16 | ) | (2.56 | ) | (3.41 | ) | (4.68 | ) | (1.82 | ) | ||||||||||
| 10 |
Consolidated Statements of Financial Position Data
| December 31, | ||||||||||||
| 2023 | 2022 | 2021 | ||||||||||
| (in thousands) | $ | $ | $ | |||||||||
| Cash and cash equivalents | 34,016 | 50,611 | 65,300 | |||||||||
| Trade and other receivables and other current assets | 2,285 | 4,648 | 5,447 | |||||||||
| Inventory | 66 | 229 | 73 | |||||||||
| Restricted cash equivalents | 332 | 322 | 335 | |||||||||
| Property and equipment | 317 | 216 | 192 | |||||||||
| Other non-current assets (1) | - | - | 8,755 | |||||||||
| Total assets | 37,016 | 56,026 | 80,102 | |||||||||
| Payables and accrued liabilities and income taxes payable | 3,733 | 3,936 | 2,787 | |||||||||
| Current portion of provisions | 429 | 45 | 34 | |||||||||
| Current portion of deferred revenues | 218 | 2,949 | 4,815 | |||||||||
| Lease liabilities | 279 | 179 | 161 | |||||||||
| Non-financial non-current liabilities (2) | 14,161 | 13,141 | 19,319 | |||||||||
| Total liabilities | 18,820 | 20,250 | 27,116 | |||||||||
| Shareholders’ equity | 18,196 | 35,776 | 52,986 | |||||||||
| Total liabilities and shareholders’ equity | 37,016 | 56,026 | 80,102 | |||||||||
(1) Comprised of goodwill and intangible assets.
(2) Comprised mainly of employee future benefits, deferred gain, non-current portion of deferred revenues and provisions.
Critical Accounting Estimates and Judgments
Critical accounting estimates and judgements are described in Note 3 to our audited consolidated financial statements as of December 31, 2023, and 2022 and for the years ended December 31, 2023, 2022 and 2021.
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Recent Accounting Pronouncements
New standards and amendments
The Company applied for the first-time certain standards and amendments, which are effective for annual periods beginning on or after January 1, 2023 (unless otherwise stated). The Company has not early adopted any other standard, interpretation or amendment that has been issued but is not yet effective.
Disclosure of Accounting Policies - Amendments to IAS 1 and IFRS Practice Statement 2
The amendments to IAS 1 and IFRS Practice Statement 2 Making Materiality Judgements provide guidance and examples to help entities apply materiality judgements to accounting policy disclosures. The amendments aim to help entities provide accounting policy disclosures that are more useful by replacing the requirement for entities to disclose their ‘significant’ accounting policies with a requirement to disclose their ‘material’ accounting policies and adding guidance on how entities apply the concept of materiality in making decisions about accounting policy disclosures. The amendments have had an impact on the Company’s disclosures of accounting policies, but not on the measurement, recognition or presentation of any items in the Company’s financial statements.
Definition of Accounting Estimates - Amendments to IAS 8
The amendments to IAS 8 clarify the distinction between changes in accounting estimates, changes in accounting policies and the correction of errors. They also clarify how entities use measurement techniques and inputs to develop accounting estimates. The amendments had no impact on the Company’s consolidated financial statements.
Deferred Tax related to Assets and Liabilities arising from a Single Transaction – Amendments to IAS 12
The amendments to IAS 12 Income Tax narrow the scope of the initial recognition exception, so that it no longer applies to transactions that give rise to equal taxable and deductible temporary differences such as leases and decommissioning liabilities. The amendments had no 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 and how we manage those risks are described in Note 23 to our audited consolidated financial statements as of December 31, 2023 and 2022 and for the years ended December 31, 2023, 2022 and 2021.
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Revenues
We generate revenue from license and collaboration agreements with customers (license fees, milestone revenue, royalties), the provision of development services, the sale of certain active pharmaceutical ingredients (“API”), semi-finished goods and finished goods, and from certain supply chain activities, which are comprised largely of oversight or supervisory support services related to stability studies or development activities carried out with respect to API batch production as specified in underlying contracts with customers.
| Three months ended December 31, | ||||||||||||||||
| (in thousands) | 2023 | 2022 | Change | Change | ||||||||||||
| $ | $ | $ | % | |||||||||||||
| License fees | 53 | 873 | (820 | ) | -94 | % | ||||||||||
| Development services | - | 1,526 | (1,526 | ) | -100 | % | ||||||||||
| Product sales | 66 | - | 66 | 100 | % | |||||||||||
| Royalty income | 2 | 44 | (42 | ) | -95 | % | ||||||||||
| Supply chain | - | 42 | (42 | ) | -100 | % | ||||||||||
| Total revenues | 121 | 2,485 | (2,364 | ) | -95 | % | ||||||||||
Our total revenue for the three-month period ended December 31, 2023, was $0.1 million as compared to $2.5 million for the same period in 2022, representing a decrease of $2.4 million. This decrease is primarily due to a $2.5 million decrease due to the termination of the Company’s amended agreement with Novo Nordisk Healthcare in May 2023. This was partially offset by an increase in product sales of $0.1 million to our UK and European partner, Pharmanovia.
| Twelve months ended December 31, | ||||||||||||||||
| (in thousands) | 2023 | 2022 | Change | Change | ||||||||||||
| $ | $ | $ | % | |||||||||||||
| License fees | 1,607 | 1,704 | (97 | ) | -6 | % | ||||||||||
| Development services | 2,741 | 3,617 | (876 | ) | -24 | % | ||||||||||
| Product sales | 66 | 57 | 9 | 16 | % | |||||||||||
| Royalty income | 31 | 101 | (70 | ) | -69 | % | ||||||||||
| Supply chain | 53 | 161 | (108 | ) | -67 | % | ||||||||||
| Total revenues | 4,498 | 5,640 | (1,142 | ) | -20 | % | ||||||||||
Our total revenue for the twelve-month period ended December 31, 2023, was $4.5 million as compared to $5.6 million for the same period in 2022, representing a decrease of $1.1 million, which is due primarily to the termination of the Company’s amended agreement with Novo Nordisk Healthcare in May 2023.
| 13 |
Research and development expenses
The following table summarizes our research and development expenses incurred during the periods indicated:
| Three months ended December 31, | ||||||||||||||||
| (in thousands) | 2023 | 2022 | Change | Change | ||||||||||||
| $ | $ | $ | % | |||||||||||||
| Direct research and development expenses: | ||||||||||||||||
| Macimorelin pediatric DETECT-trial | 1,216 | 1,297 | (81 | ) | -6 | % | ||||||||||
| AEZS-130 – Macimorelin ALS | 303 | 1,004 | (701 | ) | -70 | % | ||||||||||
| AEZS-150 – DC-PTH | 973 | 697 | 276 | 40 | % | |||||||||||
| Aim Biologics - Parkinson’s Disease | 297 | 155 | 142 | 92 | % | |||||||||||
| Aim Biologics - NMOSD | 425 | 320 | 105 | 33 | % | |||||||||||
| Bacterial Vaccine Platform - Covid-19 | - | 222 | (222 | ) | -100 | % | ||||||||||
| Bacterial Vaccine Platform - Chlamydia | - | 295 | (295 | ) | -100 | % | ||||||||||
| Additional programs | 25 | 27 | (2 | ) | -7 | % | ||||||||||
| Total direct research and development expenses | 3,239 | 4,017 | (778 | ) | -19 | % | ||||||||||
| Employee-related expenses | 593 | 311 | 282 | 91 | % | |||||||||||
| Other | 36 | 97 | (61 | ) | -63 | % | ||||||||||
| Total | 3,868 | 4,425 | (557 | ) | -13 | % | ||||||||||
Our total research and development expenses for the three-month period ended December 31, 2023, were $3.9 million as compared to $4.4 million for the same period in 2022, a decrease of $0.5 million. Direct research and development expenses include expenses incurred under arrangements with third parties, such as contract research organizations, contract manufacturers, and consultants.
The decrease in research and development expenses was primarily attributable to:
| ● | a $0.7 million decrease in spending on the Company’s ALS trial driven by the timing of various pre-clinical activities associated with the project; | |
| ● | a $0.5 million decrease in the Company’s Bacterial Vaccine platform projects as the Company ceased development of both the COVID-19 and Chlamydia vaccine trials in Q1, 2023; offset by | |
| ● | a $0.5 million increase in costs related to the DETECT, DC-PTH and AIM Biologics projects due to the timing of various pre-clinical activities and the advancement of these projects; and | |
| ● | a net increase in the employee-related and other expenses of $0.2 million due primarily to an increase in the number of full-time employees. |
| 14 |
The following table summarizes our research and development expenses incurred during the periods indicated:
| Twelve months ended December 31, | ||||||||||||||||
| (in thousands) | 2023 | 2022 | Change | Change | ||||||||||||
| $ | $ | $ | % | |||||||||||||
| Direct research and development expenses: | ||||||||||||||||
| Macimorelin pediatric DETECT-trial | 4,672 | 3,818 | 854 | 22 | % | |||||||||||
| AEZS-130 – Macimorelin ALS | 2,270 | 2,514 | (244 | ) | -10 | % | ||||||||||
| AEZS-150 – DC-PTH | 2,312 | 1,999 | 313 | 16 | % | |||||||||||
| Aim Biologics - Parkinson’s Disease | 816 | 657 | 159 | 24 | % | |||||||||||
| Aim Biologics - NMOSD | 1,147 | 637 | 510 | 80 | % | |||||||||||
| Bacterial Vaccine Platform - Covid-19 | 113 | 527 | (414 | ) | -79 | % | ||||||||||
| Bacterial Vaccine Platform - Chlamydia | 221 | 623 | (402 | ) | -65 | % | ||||||||||
| Additional programs | 188 | 262 | (74 | ) | -28 | % | ||||||||||
| Total direct research and development expenses | 11,739 | 11,037 | 702 | 6 | % | |||||||||||
| Employee-related expenses | 1,546 | 1,199 | 347 | 29 | % | |||||||||||
| Other | 275 | 270 | 5 | 2 | % | |||||||||||
| Total | 13,560 | 12,506 | 1,054 | 8 | % | |||||||||||
Our total research and development expenses for the twelve-month period ended December 31, 2023, were $13.6 million as compared to $12.5 million for the same period in 2022, an increase of $1.1 million. The $1.1 million increase was primarily due to:
| ● | a $0.9 million increase in costs for the DETECT-trial as the Company saw an increase in the number of testing sites opened and the recruitment of patients for the DETECT-trial leading to the increase in cost from the previous year; | |
| ● | a $0.5 million and $0.1 million increase in the Company’s AIM Biologicals programs for NMOSD and Parkinson’s disease respectively, driven by the timing of various pre-clinical activities and the advancement of these projects; | |
| ● | a net $0.1 million increase in spending on the Company’s ALS, DC-PTH and other programs due to timing of various pre-clinical activities; and | |
| ● | a $0.3 million increase in employee-related expenses due to an increase in the number of full-time employees; | |
| ● | offset by a $0.8 million decrease in the Company’s Bacterial Vaccine platform projects as the Company ceases development of both the COVID-19 and Chlamydia vaccine trials in Q1, 2023. |
| 15 |
Selling, general, and administrative expenses
| Three months ended December 31, | ||||||||||||||||
| (in thousands) | 2023 | 2022 | Change | Change | ||||||||||||
| $ | $ | $ | % | |||||||||||||
| Salaries & benefits | 645 | 882 | (237 | ) | -27 | % | ||||||||||
| Insurance | 250 | 420 | (170 | ) | -40 | % | ||||||||||
| Professional fees | 1,485 | 311 | 1,174 | 377 | % | |||||||||||
| Other | 214 | 399 | (185 | ) | 46 | % | ||||||||||
| 2,594 | 2,012 | 582 | 29 | % | ||||||||||||
Our total Selling, general and administrative expenses for the three-month period ended December 31, 2023, were $2.6 million as compared to $2.0 million for the same period in 2022. This increase of $0.6 million was primarily attributable to the following:
| ● | a $1.2 million increase in professional fees due primarily to an increase in payments made to the Company’s legal and financial advisors to assist in strategic review and the Plan of Arrangement, which is described above under “Plan of Arrangement with Ceapro”; offset by | |
| ● | a $0.2 million decrease in salaries & benefits expenses primarily due to a decrease in the cost of the defined benefit pension; | |
| ● | a $0.2 million decrease in other expenses primarily due to the reversal of a provision for future estimated patent costs upon the sale of Cetrotide trademarks to Merck; and | |
| ● | a $0.2 million decrease in insurance expenses as the Company negotiated a lower premium for the current year. |
| Twelve months ended December 31, | ||||||||||||||||
| (in thousands) | 2023 | 2022 | Change | Change | ||||||||||||
| $ | $ | $ | % | |||||||||||||
| Salaries & benefits | 3,124 | 2,994 | 130 | 4 | % | |||||||||||
| Insurance | 1,176 | 1,678 | (502 | ) | -30 | % | ||||||||||
| Professional fees | 2,981 | 1,845 | 1,136 | 62 | % | |||||||||||
| Other | 1,443 | 1,713 | (270 | ) | -16 | % | ||||||||||
| 8,724 | 8,230 | 494 | 6 | % | ||||||||||||
Our total Selling, general and administrative expenses for the twelve-month period ended December 31, 2023, were $8.7 million as compared to $8.2 million for the same period in 2022. This increase of $0.5 million was primarily attributable to the following:
| ● | a $1.1 million increase in professional fees due primarily to an increase in payments made to the Company’s legal and financial advisors to assist in strategic review and the Plan of Arrangement, which is described above under “Plan of Arrangement with Ceapro”; and | |
| ● | a $0.1 million increase in salaries & benefits expenses primarily due to an increase in the number of full time employees; offset by | |
| ● | a $0.5 million decrease in insurance expenses as the Company negotiated a lower premium for the current year; and | |
| ● | a $0.3 million decrease in other expenses primarily due to the reversal of a provision for future estimated patent costs upon the sale of Cetrotide trademarks to Merck. |
| 16 |
Impairment of goodwill and intangible assets
In the prior year ended December 31, 2022, the Company ceased its development of both the COVID-19 and Chlamydia vaccine trials. The previously capitalized upfront payments for licenses relating to these two trials of $212 was fully impaired. In addition, as part of the Company’s annual goodwill impairment assessment, the recoverable amount of the group of cash generating units (“CGUs”) that goodwill was allocated to was determined based on a fair value less cost of disposal (“FVLCD”) model. FVLCD was determined based on a market approach and also derived from market data including information from market participants regarding the price that the Company could receive in a sale of the group of CGUs. Based on the Company’s assessment, the recoverable amount of the group of CGUs was lower than the carrying value and therefore an impairment charge was recorded on its goodwill and intangible assets for an amount of $7,642 and $372 respectively, as discussed in note 11 of the Company’s audited consolidated financial statements.
Net other income (costs)
For the three-month period ended December 31, 2023, our net other income was $0.8 million as compared to a net other loss of $0.1 million for the three-month period ended December 31, 2022, an increase of $0.9 million. This increase was primarily due to a $0.4 million increase in interest income and the gain on sale of intangible asset of $0.5 million.
Net other income for the twelve-month period ended December 31, 2023, was $1.5 million as compared to $0.9 million for the same period in 2022, an increase of $0.6 million. This increase was primarily due to a $1.1 million increase in interest income and the gain on sale of intangible asset of $0.5 million, partially offset by an increase in loss due to changes in foreign currency exchange rates of $1.0 million.
Net loss
For the three-month period ended December 31, 2023, we reported a consolidated net loss of $5.6 million, or $1.16 loss per common share (basic and diluted), as compared to a consolidated net loss of $12.5 million, or $2.56 loss per common share (basic and diluted) for the three-month period ended December 31, 2022. The $6.9 million decrease in net loss is primarily attributable to:
| ● | a $8.3 million decrease in expense from the impairment of goodwill and intangible assets in 2022; | |
| ● | a $0.6 million decrease in cost of sales and R&D costs, offset by $0.6 million increase in SG&A costs, primarily associated with the announced plan of arrangement between the Company and Ceapro Inc | |
| ● | a $0.4 million increase in interest revenue; and | |
| ● | a $0.5 million gain on the sale of trademarks due to the sale of the Cetrotide trademarks to Merck; | |
| ● | offset by a $2.3 million decrease in revenue as a result of the termination of the Novo Amended agreement in May 2023; |
For the twelve-month period ended December 31, 2023, we reported a consolidated net loss of $16.6 million, or $3.41 loss per common share (basic and diluted), as compared to a consolidated net loss of $22.7 million, or $4.68 loss per common share (basic and diluted), for the year ended December 31, 2022. The $6.1 million decrease in net loss is primarily attributable to:
| ● | a $8.3 million decrease in expense from the impairment of goodwill and intangible assets in 2022; | |
| ● | a $0.5 million gain on the sale of trademarks due to the sale of the Cetrotide trademarks to Merck; and | |
| ● | a $1.1 million increase in interest income; | |
| ● | offset by a $1.1 million decrease in revenue as a result of the termination of the Novo Amended agreement in May 2023; | |
| ● | a $1.1 million increase in R&D costs as previously described and a $0.5 million increase in SG&A costs primarily associated with the announced plan of arrangement between the Company and Ceapro Inc; and | |
| ● | a $1.1 million increase in loss due to changes in foreign currency exchange rates. |
| 17 |
Selected quarterly financial data
| Three months ended | ||||||||||||||||
| (in thousands, except for per share data) | Dec 31, 2023 | Sept 30, 2023 | Jun 30, 2023 | Mar 31, 2023 | ||||||||||||
| $ | $ | $ | $ | |||||||||||||
| Revenues | 121 | 3 | 2,246 | 2,128 | ||||||||||||
| Net loss | (5,635 | ) | (4,145 | ) | (2,518 | ) | (4,255 | ) | ||||||||
| Net loss per share (basic and diluted)(1) | (1.16 | ) | (0.85 | ) | (0.52 | ) | (0.88 | ) | ||||||||
Three months ended | ||||||||||||||||
| (in thousands, except for per share data) | Dec 31, 2022 | Sept 30, 2022 | Jun 30, 2022 | Mar 31, 2022 | ||||||||||||
| $ | $ | $ | $ | |||||||||||||
| Revenues | 2,485 | 1,860 | (222 | ) | 1,517 | |||||||||||
| Net loss | (12,451 | ) | (3,420 | ) | (4,216 | ) | (2,640 | ) | ||||||||
| Net loss per share (basic and diluted)(1) | (2.56 | ) | (0.70 | ) | (0.87 | ) | (0.54 | ) | ||||||||
| (1) | 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 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 revenues, unpredictable quarterly variations in net finance income and of foreign exchange gains and losses.
The decrease in revenue in Q3, 2023 and Q4, 2023 in contrast to the other quarterly periods presented, is due to the termination of the Company’s amended agreement with Novo Nordisk Healthcare in May 2023 and as a result, no license fee or development services revenue was recognized in Q3 or Q4, 2023.
The increase in net loss for the three-month period ended December 31, 2022 in contrast to the other quarterly periods presented, was due to the recording of an impairment charge on the Company’s goodwill and intangible assets for an amount of $7,642 and $372 respectively.
The decrease in revenue and increase in net loss for the three months ended June 30, 2022, was driven by the reversal of revenue of $0.4 million in license fees and $0.8 million in development services which took place in Q2, 2022 as a result of a change in management’s best estimate of additional costs associated to the DETECT-trial.
| 18 |
Liquidity and capital resources
The Company’s objective in managing capital, consisting of shareholders’ equity, with cash and cash equivalents being its primary components, is to ensure sufficient liquidity to fund research and development costs, selling, general and administrative expenses and working capital requirements. Over the past several years, we have raised capital via public and private equity offerings and issuances and have entered into licensing and collaborative arrangements, consideration from which, together with proceeds from equity issuances, has been our primary source of liquidity. During the year, the Company’s total assets decreased primarily due to funding research and development and selling, general and administrative expenses, while total liabilities decreased primarily due to the recognition of deferred revenue resulting from the termination of the Novo Amended agreement, resulting in an overall reduction in the working capital available. 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.
Cash flows
The following table shows a summary of our consolidated cash flows for the periods indicated:
| December 31, | ||||||||||||
| (in thousands) | 2023 | 2022 | 2021 | |||||||||
| $ | $ | $ | ||||||||||
| Cash and cash equivalents - beginning of year | 50,611 | 65,300 | 24,271 | |||||||||
| Cash used in operating activities | (17,118 | ) | (13,680 | ) | (8,581 | ) | ||||||
| Cash flows (used in) provided by financing activities | (151 | ) | (118 | ) | 51,037 | |||||||
| Cash flows provided (used in) by investing activities | 528 | (12 | ) | (658 | ) | |||||||
| Effect of exchange rate changes on cash and cash equivalents | 146 | (879 | ) | (769 | ) | |||||||
| Cash and cash equivalents - end of year | 34,016 | 50,611 | 65,300 | |||||||||
Operating activities
Cash used by operating activities totaled $17.1 million for the twelve-month period ended December 31, 2023, as compared to $13.7 million in the same period in 2022. This $3.4 million increase in operating cash outflows is attributed primarily to:
| ● | a decrease in development services, product sales, royalty and supply chain revenues of $1.1 million; | |
| ● | an increase in R&D and SG&A expenses of $1.6 million, as described above; and | |
| ● | an increase in other operating cash and working capital outflows of $1.9 million, primarily related to the recognition of deferred revenue upon termination of the Novo Amendment agreement; offset by | |
| ● | an increase in interest received on cash deposits of $1.2 million. |
Financing activities
Cash spent on financing activities totaled $0.2 million for the twelve months ended December 31, 2023, as compared to cash provided by financing activities of $0.1 million in the same period in 2022 and primarily related to building and car lease payments for our German subsidiary.
Investing activities
Cash provided by investing activities totaled $0.5 million for the twelve months ended December 31, 2023, as compared to $0. million in the same period in 2022. The $0.5 million increase is primarily related to the proceeds from the sale of an intangible asset.
| 19 |
Adequacy of financial resources
Since inception, the Company has incurred significant expenses in its efforts to develop and co-promote products. Our current business focus is to: investigate further therapeutic uses of Macrilen™, expand pipeline development activities, further expand the commercialization of macimorelin in available territories and fund ongoing clinical trial costs. Consequently, the Company has incurred operating losses and has generated negative cash flow from operations 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™ in the U.S. and Canada. The Company expects to incur significant expenses and operating losses for the foreseeable future as it advances its product candidates through preclinical and clinical development, seeks regulatory approval and pursues commercialization of any approved product candidates. We expect that our research and development costs will increase in connection with our planned research and development activities.
As of December 31, 2023, the Company had an accumulated deficit of $369.8 million. The Company also had a net loss of $16.6 million and negative cash flows from operations of $17.1 million for the year ended December 31, 2023 We believe that our existing cash on hand will be sufficient to fund our anticipated operating and capital expenditure requirements for the next 12 months. We plan to finance our future operations and capital expenditures primarily through cash on hand. We also believe that our existing cash on hand will be sufficient to fund our anticipated operating and capital expenditure requirements beyond the next 12 months and through 2025. We have based this estimate on assumptions that may prove to be wrong, and we could exhaust our capital resources sooner than we expect. We may also require additional capital to pursue in-licenses or acquisitions of other product candidates.
Our forecast of the period of time through which our financial resources will be adequate to support our operations is a forward-looking statement that involves risks and uncertainties, and actual results could vary materially as a result of a number of factors. Our future capital requirements are difficult to forecast and will depend on many factors, including:
| ● | the terms and timing of any other collaboration, licensing, and other arrangements that we may establish; | |
| ● | the initiation, progress, timing, and completion of preclinical studies and clinical trials for our current and future potential product candidates; | |
| ● | our alignment with the FDA on regulatory approval requirements; | |
| ● | the number and characteristics of product candidates that we pursue; | |
| ● | the outcome, timing, and cost of regulatory approvals; | |
| ● | delays that may be caused by changing regulatory requirements; | |
| ● | the cost and timing of hiring new employees to support our continued growth; | |
| ● | the costs involved in filing and prosecuting patent applications and enforcing and defending patent claims; | |
| ● | the costs of filing and prosecuting intellectual property rights and enforcing and defending any intellectual property-related claims; | |
| ● | the costs of responding to and defending ourselves against complaints and potential litigation; | |
| ● | the costs and timing of procuring clinical and commercial supplies for our product candidates; and | |
| ● | the extent to which we acquire or in-license other product candidates and technologies. |
| 20 |
Contractual obligations and commitments
The following is a summary of our contractual obligations as of December 31, 2023:
| Amount | ||||
| $ | ||||
| Less than 1 year | 5,634 | |||
| 1 – 5 years | 71 | |||
| 5,705 | ||||
In 2021, the Company executed various agreements including in-licensing and similar arrangements with development partners. Such agreements may require the Company to make payments on achievement of stages of development, launch or revenue milestones, although the Company generally has the right to terminate these agreements at no penalty. The Company may have to pay up to $39,373 upon achieving certain sales volumes, regulatory or other milestones related to specific products.
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.
Related Party Transactions
Other than ordinary course employment agreements and indemnification agreements with our management, which are disclosed in Note 27 of our consolidated financial statements for the years ending December 31, 2023, and 2022, there were no other related party transactions.
Off-Balance Sheet Arrangements
As of December 31, 2023, 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 in our annual information form under the heading “Risk Factors” 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 at www.sedarplus.ca and with the SEC at www.sec.gov, and investors are urged to consult such risk factors.
| 21 |
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 of December 31, 2023. Our disclosure controls and procedures are designed to ensure that information required to be disclosed in the reports we file or submit under the Securities Exchange Act of 1934 is recorded, processed, summarized and reported within the time periods specified in the Securities and Exchange Commission’s rules and forms, and that such information is accumulated and communicated to our management, including the Chief Executive Officer and the Chief Financial Officer, to allow timely decisions regarding required disclosures.
Any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving the desired control objective and management necessarily applies its judgment in evaluating the cost-benefit relationship of possible controls and procedures. Based on this evaluation, the Chief Executive Officer and Chief Financial Officer have concluded that these disclosure controls and procedures were effective as of December 31, 2023.
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.
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.
Remediation of Previously Reported Material Weakness
As previously disclosed in our annual report Item 15 – “Controls and Procedures” in our Annual Report on Form 20-F for the year ended December 31, 2021, our management identified a material weakness in our control over financial reporting that resulted from a failure in the design and implementation of review controls over the accounting for license and collaboration agreements under IFRS and the related revenue recognition. Due to remediation measures taken by us during 2022 to implement and subsequently test newly established policies, procedures, and control activities designed to address the material weakness, management has concluded that this material weakness was remediated as of December 31, 2022.
Our management assessed our internal control over financial reporting as of December 31, 2023. Management based its assessment on criteria established in “Internal Control—Integrated Framework (2013)” issued by the Committee of Sponsoring Organizations of the Treadway Commission. Based on management’s assessment of our internal control over financial reporting, management concluded that, as of December 31, 2023, our internal control over financial reporting was effective.
Changes in Internal Controls over Financial Reporting
There were no changes in our internal control over financial reporting during the year ended December 31, 2023, that materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.
| 22 |