UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 20-F ☐ Registration Statement Pursuant to Section 12(b) or 12(g) of The Securities Exchange Act of 1934 OR ☒ Annual Report Pursuant to Section 13 or 15(d) of The Securities Exchange Act of 1934 for the fiscal year ended December 31, 2022 OR ☐ Transition Report Pursuant to Section 13 or 15(d) of The Securities Exchange Act of 1934 OR ☐ Shell Company Report Pursuant to Section 13 or 15(d) of The Securities Exchange Act of 1934 Commis ...

Exhibit 99.1 Aeterna Zentaris Inc. Consolidated Financial Statements As of December 31, 2022 and 2021 and for the years ended December 31, 2022, 2021 and 2020 | Report of Independent Registered Public Accounting Firm (PCAOB ID:1263) | 2 | | --- | --- | | Report of Predecessor Independent Registered Public Accounting Firm (PCAOB ID:271) | 4 | | Consolidated Statements of Financial Position | 5 | | Consolidated Statements of Changes in Shareholders' Equity | 6 | | Consolidated Statements of Loss and Comprehen ...

[Condensed Interim Consolidated Financial Statements](index=1&type=section&id=Condensed%20Interim%20Consolidated%20Financial%20Statements) [Condensed Interim Consolidated Statements of Financial Position](index=2&type=section&id=Condensed%20Interim%20Consolidated%20Statements%20of%20Financial%20Position) As of March 31, 2022, total assets decreased to $76.3 million from $80.1 million, driven by reduced cash and current assets, while total liabilities also decreased to $23.2 million from $27.1 million, leading to stable shareholders' equity at $53.2 million Consolidated Statement of Financial Position (in thousands of US$) | Account | March 31, 2022 | December 31, 2021 | | :--- | :--- | :--- | | **Total Current Assets** | **67,097** | **70,820** | | Cash and cash equivalents | 63,596 | 65,300 | | **Total Assets** | **76,344** | **80,102** | | **Total Current Liabilities** | **5,666** | **7,766** | | **Total Liabilities** | **23,185** | **27,116** | | **Total Shareholders' Equity** | **53,159** | **52,986** | | **Total Liabilities and Shareholders' Equity** | **76,344** | **80,102** | [Condensed Interim Consolidated Statements of Changes in Shareholders' Equity](index=3&type=section&id=Condensed%20Interim%20Consolidated%20Statements%20of%20Changes%20in%20Shareholders%27%20Equity) For Q1 2022, total shareholders' equity increased slightly to $53.2 million, driven by comprehensive income offsetting a net loss, contrasting with Q1 2021's significant equity increase from financing activities Changes in Shareholders' Equity - Q1 2022 (in thousands of US$) | Description | Amount | | :--- | :--- | | Balance - January 1, 2022 | 52,986 | | Net loss | (2,640) | | Other comprehensive income | 2,786 | | Share-based compensation costs | 27 | | **Balance – March 31, 2022** | **53,159** | - In Q1 2021, the company raised significant capital, with **$30.98 million** from the issuance of common shares and **$19.99 million** from the exercise of warrants, which dramatically increased shareholders' equity[6](index=6&type=chunk)[66](index=66&type=chunk) [Condensed Interim Consolidated Statements of Comprehensive Income (Loss)](index=4&type=section&id=Condensed%20Interim%20Consolidated%20Statements%20of%20Comprehensive%20Income%20%28Loss%29) The company reported a net loss of $2.64 million for Q1 2022, up from $1.46 million in Q1 2021, driven by increased operating expenses, particularly research and development, despite a slight revenue decrease Q1 2022 vs Q1 2021 Performance (in thousands of US$) | Metric | Q1 2022 | Q1 2021 (Restated) | | :--- | :--- | :--- | | Total Revenues | 1,517 | 1,668 | | Research and development expenses | 2,390 | 1,458 | | Total operating expenses | 4,330 | 2,997 | | Loss from operations | (2,813) | (1,329) | | Net loss | (2,640) | (1,458) | | Comprehensive income (loss) | 146 | (29) | | Net loss per share (basic and diluted) | (0.02) | (0.02) | [Condensed Interim Consolidated Statements of Cash Flows](index=5&type=section&id=Condensed%20Interim%20Consolidated%20Statements%20of%20Cash%20Flows) In Q1 2022, net cash used in operating activities increased to $1.46 million, while financing activities used $34,000, contrasting with Q1 2021's $50.9 million cash provided by financing, leading to a $1.7 million decrease in cash and equivalents Cash Flow Summary (in thousands of US$) | Activity | Q1 2022 | Q1 2021 (Restated) | | :--- | :--- | :--- | | Net cash used in operating activities | (1,461) | (1,045) | | Net cash (used in) provided by financing activities | (34) | 50,933 | | Net cash used in investing activities | (6) | (507) | | **Net change in cash and cash equivalents** | **(1,704)** | **49,100** | | **Cash and cash equivalents – End of period** | **63,596** | **73,371** | - Financing activities in Q1 2021 included **$34.2 million** from the issuance of common shares and **$19.99 million** from the exercise of warrants, which were absent in Q1 2022[11](index=11&type=chunk)[71](index=71&type=chunk) [Notes to Condensed Interim Consolidated Financial Statements](index=6&type=section&id=Notes%20to%20Condensed%20Interim%20Consolidated%20Financial%20Statements) [Note 1: Business Overview](index=6&type=section&id=1.%20Business%20overview) This note details the company's biopharmaceutical business, IFRS basis of financial statement preparation, and the impact of external factors like COVID-19 and the Russia/Ukraine conflict, which delayed the DETECT-trial into 2023 and necessitated restatement of prior period figures [Summary of Business, Basis of Presentation, and Government Assistance](index=6&type=section&id=Summary%20of%20business%2C%20Basis%20of%20presentation%2C%20and%20Government%20assistance) Aeterna Zentaris is a biopharmaceutical company focused on therapeutics and diagnostics, with Macrilen™ as its lead product for AGHD, and is developing a pre-clinical pipeline for rare indications, with financial statements prepared under IFRS - The company's lead product is **Macrilen™ (macimorelin)**, an oral test for Adult Growth Hormone Deficiency (AGHD), marketed in the US by Novo Nordisk and in Europe/UK by Consilient Healthcare[13](index=13&type=chunk)[73](index=73&type=chunk) - The company is also focused on developing a pre-clinical pipeline for rare or orphan indications, with potential for pediatric use[13](index=13&type=chunk)[73](index=73&type=chunk) - Financial statements are prepared in accordance with **IFRS**, and the company has adopted **IAS 20** for accounting for government grants[14](index=14&type=chunk)[74](index=74&type=chunk) [COVID-19 & Russia and Ukraine Conflict](index=7&type=section&id=COVID-19%20%26%20Russia%20and%20Ukraine%20conflict) The COVID-19 pandemic and Russia/Ukraine conflict have delayed the DETECT-trial's recruitment into 2023, leading to a **$1.2 million** reclassification of deferred revenue from current to long-term - The **DETECT-trial** has experienced delays in site initiation and patient enrollment due to the COVID-19 pandemic and the Russia/Ukraine conflict[16](index=16&type=chunk)[76](index=76&type=chunk) - As a result of the delays, the recruitment for the DETECT-trial is now expected to continue into **2023**, revised from the previous estimate of late 2022[16](index=16&type=chunk)[76](index=76&type=chunk) - Due to the revised timeline, **$1.2 million** of deferred revenue has been reclassified from current to long-term as of March 31, 2022[16](index=16&type=chunk)[76](index=76&type=chunk) [Restatement of Comparative Period Figures](index=7&type=section&id=Restatement%20of%20comparative%20period%20figures) The company restated its 2021 interim financial statements due to a re-evaluation of the DETECT-trial arrangement with Novo Nordisk, reclassifying charges from R&D expenses to development services revenue under IFRS 15 - The company restated its condensed consolidated interim financial statements for the three, six, and nine-month periods of **2021**[18](index=18&type=chunk)[78](index=78&type=chunk) - The restatement stemmed from a re-evaluation of the **DETECT-trial** activities with Novo Nordisk, which were determined to no longer be a joint operation under **IFRS 11**[18](index=18&type=chunk)[78](index=78&type=chunk) - Consequently, charges to Novo were reclassified from research and development expenses to development services revenue, and related license fees and deferred revenues were also adjusted[18](index=18&type=chunk)[78](index=78&type=chunk) [Note 2: Critical Accounting Estimates and Judgements](index=8&type=section&id=2.%20Critical%20accounting%20estimates%20and%20judgements) Management's preparation of financial statements requires significant judgments, estimates, and assumptions, which remain consistent with those applied in the annual financial statements for the year ended December 31, 2021 - Management is required to make judgments, estimates, and assumptions that affect the reported amounts of assets, liabilities, revenues, and expenses[21](index=21&type=chunk)[81](index=81&type=chunk) - The critical accounting estimates and judgments applied in these interim statements are the same as those applied in the annual financial statements for the year ended **December 31, 2021**[22](index=22&type=chunk)[82](index=82&type=chunk) [Note 3: License and Supply Arrangements](index=8&type=section&id=3.%20License%20and%20supply%20arrangements) The company generates revenue from Macrilen™ license and supply agreements with key partners like Novo Nordisk and Consilient Health, with total deferred revenue at **$5.37 million** as of March 31, 2022, down from **$6.31 million** at year-end 2021 - The company has key licensing agreements for **Macrilen™** with Novo Nordisk (U.S./Canada), Consilient Health (Europe/UK), MegaPharm (Israel), and NK Meditech (Korea)[23](index=23&type=chunk)[24](index=24&type=chunk)[25](index=25&type=chunk) Deferred Revenue from License Agreements (in thousands of US$) | Agreement | March 31, 2022 | December 31, 2021 | | :--- | :--- | :--- | | Novo Amendment | 3,908 | 4,814 | | CH License Agreement | 1,324 | 1,358 | | NK License Agreement | 133 | 136 | | **Total** | **5,365** | **6,308** | [Note 4: Trade and Other Receivables](index=10&type=section&id=4.%20Trade%20and%20other%20receivables) Trade and other receivables decreased to **$693,000** as of March 31, 2022, from **$1.31 million** at year-end 2021, including a new **$146,000** grant receivable for pre-clinical programs Trade and Other Receivables Breakdown (in thousands of US$) | Item | March 31, 2022 | December 31, 2021 | | :--- | :--- | :--- | | Trade accounts receivable (net) | 302 | 877 | | Value-added tax | 193 | 372 | | Grant receivable | 146 | — | | Other | 52 | 65 | | **Total** | **693** | **1,314** | - In March 2022, the company was awarded a monetary subsidy of **$146,000** under a German tax incentive act for R&D on a SARS-CoV-2 vaccine and a treatment for neuromyelitis optica[29](index=29&type=chunk)[89](index=89&type=chunk) [Note 5: Prepaid Expenses and Other Current Assets](index=10&type=section&id=5.%20Prepaid%20expenses%20and%20other%20current%20assets) Prepaid expenses and other current assets decreased to **$1.05 million** as of March 31, 2022, from **$1.77 million** at year-end 2021, primarily due to reductions in prepaid research and development and prepaid insurance Prepaid Expenses Breakdown (in thousands of US$) | Item | March 31, 2022 | December 31, 2021 | | :--- | :--- | :--- | | Prepaid insurance | — | 421 | | Prepaid research and development | 907 | 1,329 | | Other | 143 | 22 | | **Total** | **1,050** | **1,772** | [Note 6: Payables and Accrued Liabilities](index=10&type=section&id=6.%20Payables%20and%20accrued%20liabilities) Payables and accrued liabilities slightly increased to **$2.80 million** as of March 31, 2022, from **$2.67 million** at year-end 2021, primarily comprising trade accounts payable, accrued R&D costs, and salaries Payables and Accrued Liabilities Breakdown (in thousands of US$) | Item | March 31, 2022 | December 31, 2021 | | :--- | :--- | :--- | | Trade accounts payable | 1,022 | 934 | | Salaries, employment taxes and benefits | 517 | 531 | | Accrued research and development costs | 695 | 596 | | Other accrued liabilities | 561 | 611 | | **Total** | **2,795** | **2,672** | [Note 7: Employee Future Benefits](index=11&type=section&id=7.%20Employee%20future%20benefits) The net liability for employee future benefits decreased to **$14.39 million** as of March 31, 2022, from **$17.49 million** at year-end 2021, primarily due to a **$3.19 million** actuarial gain from an increased discount rate - The net liability for employee future benefits decreased from **$17.49 million** at Dec 31, 2021 to **$14.39 million** at March 31, 2022[34](index=34&type=chunk)[94](index=94&type=chunk) - The reduction was largely due to an actuarial gain of **$3.19 million** arising from changes in financial assumptions, specifically an increase in the discount rate from **1.1%** to **1.7%**[34](index=34&type=chunk)[94](index=94&type=chunk) [Note 8: Share Capital, Warrants and Other Capital](index=12&type=section&id=8.%20Share%20capital%2C%20warrants%20and%20other%20capital) This note details the company's capital structure, highlighting **$34.2 million** raised from a public offering and **$20.0 million** from warrant exercises in Q1 2021, with **1,136,368** stock options and **423,000** DSUs outstanding as of March 31, 2022 - In February 2021, the company completed an underwritten public offering, raising aggregate gross proceeds of **$34.2 million**[38](index=38&type=chunk)[39](index=39&type=chunk)[99](index=99&type=chunk) - During the three months ended March 31, 2021, the exercise of **34,888,965** warrants generated aggregate proceeds of **$19.99 million**[41](index=41&type=chunk)[42](index=42&type=chunk)[101](index=101&type=chunk) - As of March 31, 2022, there were **1,136,368** stock options and **423,000** DSUs outstanding, with **50,000** new stock options granted during the quarter[43](index=43&type=chunk)[103](index=103&type=chunk) [Note 9: Operating Expenses](index=14&type=section&id=9.%20Operating%20expenses) Total operating expenses for Q1 2022 significantly increased to **$4.33 million** from **$3.00 million** in Q1 2021, primarily driven by higher research and development costs and increased employee benefits across R&D and G&A functions Operating Expenses Breakdown (in thousands of US$) | Expense Category | Q1 2022 | Q1 2021 | | :--- | :--- | :--- | | R&D - Employee benefits | 406 | 289 | | R&D - Professional services | 1,975 | 1,147 | | R&D - Government grant | (146) | — | | G&A - Employee benefits | 511 | 351 | | **Total Operating Expenses** | **4,330** | **2,997** | [Note 10: Supplemental Disclosure of Cash Flow Information](index=16&type=section&id=10.%20Supplemental%20disclosure%20of%20cash%20flow%20information) This note details changes in operating assets and liabilities affecting cash flow, showing a net positive change of **$1.13 million** for Q1 2022, mainly from decreases in trade receivables and prepaid expenses Changes in Operating Assets and Liabilities (in thousands of US$) | Item | Q1 2022 | Q1 2021 | | :--- | :--- | :--- | | Trade and other receivables | 474 | 650 | | Inventory | (206) | (40) | | Prepaid expenses and other current assets | 711 | (93) | | Payables and accrued liabilities | 159 | 115 | | Deferred revenues | 8 | 1,227 | | **Total** | **1,126** | **1,647** | [Note 11: Segment Information](index=16&type=section&id=11.%20Segment%20information) The company operates solely within the biopharmaceutical segment - The Company operates in a single operating segment, the biopharmaceutical segment[53](index=53&type=chunk)[113](index=113&type=chunk) [Note 12: Net Loss Per Share](index=16&type=section&id=12.%20Net%20loss%20per%20share) Net loss per share remained stable at **($0.02)** for Q1 2022, despite an increase in weighted average shares outstanding to **121.4 million**, with all stock options and warrants excluded from diluted EPS due to the net loss Net Loss Per Share Calculation (in thousands of US$) | Metric | Q1 2022 | Q1 2021 | | :--- | :--- | :--- | | Net loss (in thousands of US$) | (2,640) | (1,458) | | Basic weighted average shares | 121,397,007 | 95,444,990 | | Diluted weighted average shares | 121,397,007 | 95,444,990 | | **Net loss per share (basic & diluted)** | **(0.02)** | **(0.02)** | - In periods with reported net losses, all stock options and warrants are deemed anti-dilutive and are excluded from the calculation of diluted net loss per share[56](index=56&type=chunk)[116](index=116&type=chunk) [Note 13: Commitments](index=17&type=section&id=13.%20Commitments) The company has total contractual commitments of **$3.84 million**, with **$2.57 million** due within one year, and potential future milestone payments of up to **$41.07 million** for R&D and revenue, with uncertain timing Contractual Commitments (in thousands of US$) | Period | Service and manufacturing | R&D contracts | TOTAL | | :--- | :--- | :--- | :--- | | Less than 1 year | 518 | 2,056 | 2,574 | | 1 - 3 years | 638 | 630 | 1,268 | | 4 - 5 years | 1 | — | 1 | | **Total** | **1,157** | **2,686** | **3,843** | - The company has potential future milestone payments of up to **$8.76 million** for R&D and **$32.31 million** for revenue, totaling **$41.07 million**[59](index=59&type=chunk)[119](index=119&type=chunk) - The timing of milestone payments is not risk-adjusted and is based on the company's best estimate, acknowledging that pharmaceutical development is a complex and risky process[59](index=59&type=chunk)[119](index=119&type=chunk)

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 20-F ☐ Registration Statement Pursuant to Section 12(b) or 12(g) of The Securities Exchange Act of 1934 OR ☒ Annual Report Pursuant to Section 13 or 15(d) of The Securities Exchange Act of 1934 for the fiscal year ended December 31, 2021 OR ☐ Transition Report Pursuant to Section 13 or 15(d) of The Securities Exchange Act of 1934 OR ☐ Shell Company Report Pursuant to Section 13 or 15(d) of The Securities Exchange Act of 1934 Commis ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION ☐ Shell Company Report Pursuant to Section 13 or 15(d) of The Securities Exchange Act of 1934 Commission file number 0-30752 Washington, D.C. 20549 FORM 20-F ☐ Registration Statement Pursuant to Section 12(b) or 12(g) of The Securities Exchange Act of 1934 OR ☒ Annual Report Pursuant to Section 13 or 15(d) of The Securities Exchange Act of 1934 for the fiscal year ended December 31, 2019 OR ☐ Transition Report Pursuant to Section 13 or 15(d) of The Securities ...

PART I [Key Information](index=7&type=section&id=Item%203.%20Key%20Information) Provides selected historical financial data and comprehensive risk factors, such as operating losses and product dependence [Selected Financial Data](index=7&type=section&id=A.%20Selected%20financial%20data) Presents audited consolidated financial data for 2014-2018, prepared under IFRS, with no dividends declared - The selected financial data is derived from audited consolidated financial statements prepared in accordance with **International Financial Reporting Standards (IFRS)** as issued by the IASB. The company has declared or paid **no dividends** during the periods presented[9](index=9&type=chunk)[10](index=10&type=chunk) Consolidated Statements of Comprehensive Income (Loss) Information (2014-2018) | Indicator | 2018 ($) | 2017 ($) | 2016 ($) | 2015 ($) | 2014 ($) | | :--- | :--- | :--- | :--- | :--- | :--- | | **Total Revenues** | 26,881 | 923 | 911 | 545 | 11 | | **Income (loss) from operations** | 9,842 | (23,074) | (29,476) | (34,884) | (37,395) | | **Net (loss) income** | 4,187 | (16,796) | (24,959) | (50,143) | (16,564) | | **Comprehensive (loss) income** | 4,120 | (17,532) | (25,869) | (47,790) | (19,555) | | **Basic Net (loss) income per share** | 0.25 | (1.12) | (2.41) | (18.14) | (28.06) | | **Diluted Net (loss) income per share** | 0.24 | (1.12) | (2.41) | (18.14) | (28.06) | Consolidated Statement of Financial Position Information (2014-2018) | Indicator | 2018 ($) | 2017 ($) | 2016 ($) | 2015 ($) | 2014 ($) | | :--- | :--- | :--- | :--- | :--- | :--- | | **Cash and cash equivalents** | 14,512 | 7,780 | 21,999 | 41,450 | 34,931 | | **Total assets** | 25,011 | 22,195 | 31,659 | 51,498 | 47,435 | | **Shareholders' (deficiency) equity** | 1,907 | (2,783) | 6,212 | 21,615 | 14,484 | [Risk Factors](index=11&type=section&id=D.%20Risk%20factors) Identifies key risks including historical operating losses, reliance on Macrilen™, regulatory compliance, and litigation - The company has a history of operating losses, with an accumulated deficit of approximately **$310 million** as of December 31, 2018. Its ability to continue as a **going concern** depends on increasing revenue and/or securing additional funding[16](index=16&type=chunk)[17](index=17&type=chunk)[18](index=18&type=chunk) - The company's business is heavily dependent on the successful commercialization and out-licensing of its primary product, **Macrilen™ (macimorelin)**. Failure to do so would materially harm the business[23](index=23&type=chunk)[24](index=24&type=chunk) - Aeterna Zentaris relies on third parties, currently **Novo Nordisk** (following its acquisition of rights from Strongbridge), for the commercialization of **Macrilen™** in the U.S. and Canada. Potential revenue is largely contingent on their performance[34](index=34&type=chunk)[35](index=35&type=chunk)[37](index=37&type=chunk) - The company is subject to stringent ongoing government regulation for its products, and failure to comply with requirements from bodies like the **FDA** and **EMA** could result in significant sanctions, penalties, or withdrawal of approvals[46](index=46&type=chunk)[47](index=47&type=chunk)[49](index=49&type=chunk) - The company is a defendant in a **securities class-action lawsuit** alleging false and misleading statements regarding Macrilen™ between 2011 and 2014. While the company considers the claims to be without merit, an adverse outcome could materially affect its financial position[103](index=103&type=chunk)[104](index=104&type=chunk)[105](index=105&type=chunk) - The company's common shares are at risk of being **delisted** from **NASDAQ** or **TSX** if they fail to meet continuing listing requirements, such as maintaining a minimum bid price of **$1.00 per share** on NASDAQ[130](index=130&type=chunk)[131](index=131&type=chunk)[133](index=133&type=chunk) [Information on the Company](index=43&type=section&id=Item%204.%20Information%20on%20the%20Company) Details Aeterna Zentaris's history, Macrilen™-focused strategy, product pipeline, competitive landscape, and IP [History and Development of the Company](index=43&type=section&id=A.%20History%20and%20development%20of%20the%20Company) Outlines the company's incorporation, key acquisitions, share consolidation, and stock exchange listings - Aeterna Zentaris Inc. was incorporated on **September 12, 1990**, under the Canada Business Corporations Act. It acquired **Zentaris AG** in 2002, which became its German subsidiary (AEZS Germany) responsible for drug development[153](index=153&type=chunk)[154](index=154&type=chunk)[155](index=155&type=chunk) - On November 17, 2015, the company executed a **100-to-1 share consolidation** (reverse stock split)[156](index=156&type=chunk) - The company's common shares are listed on both the **NASDAQ Capital Market** and the **Toronto Stock Exchange (TSX)** under the symbol "**AEZS**"[157](index=157&type=chunk) [Business Overview](index=46&type=section&id=B.%20Business%20overview) Describes the company's core strategy, focusing on Macrilen™ development, regulatory approvals, and commercialization - The company's primary business strategy is the development, manufacturing, registration, and commercialization of **Macrilen™ (macimorelin)**, an oral diagnostic test for **Adult Growth Hormone Deficiency (AGHD)**, through out-licensing agreements[160](index=160&type=chunk) - **Macrilen™** received **FDA marketing approval** on **December 20, 2017**, and **EMA marketing authorization** on **January 16, 2019**, for the diagnosis of AGHD[181](index=181&type=chunk)[184](index=184&type=chunk) - On January 16, 2018, the company entered into a **License and Assignment Agreement** with **Strongbridge Ireland Limited** for the commercialization of Macrilen™ in the U.S. and Canada. These rights were subsequently sold by Strongbridge to **Novo Nordisk A/S** on December 19, 2018[182](index=182&type=chunk)[186](index=186&type=chunk) - The company discontinued the development of its oncology drug candidate, **Zoptrex™ (zoptarelin doxorubicin)**, in **May 2017** after its pivotal **Phase 3 ZoptEC study** failed to meet its primary endpoint[194](index=194&type=chunk) - The company holds **worldwide rights** to **macimorelin** through an exclusive license agreement. Key patents covering the compound and its method of use expire between **2021 and 2027** in the U.S., Europe, and other jurisdictions[228](index=228&type=chunk)[231](index=231&type=chunk) [Operating and Financial Review and Prospects](index=66&type=section&id=Item%205.%20Operating%20and%20Financial%20Review%20and%20Prospects) Analyzes financial condition and operating results, highlighting Macrilen™ license impact on 2018 revenue and 2019 outlook [Operating Results](index=71&type=section&id=A.%20Operating%20results) Compares fiscal years 2018 and 2017 financial performance, detailing revenue drivers, cost changes, and quarterly results Comparison of Fiscal Years 2018 and 2017 (in thousands of U.S. dollars) | Metric | 2018 | 2017 | Change | Reason for Change | | :--- | :--- | :--- | :--- | :--- | | **Total Revenues** | $26,881 | $923 | +$25,958 | Primarily due to the $24.3M license fee from the Macrilen™ agreement | | **R&D Costs** | $2,932 | $10,704 | -$7,772 | Decrease due to the discontinuation of the Zoptrex™ study and focus on the less costly PIP study for Macrilen™ | | **Selling Expenses** | $3,109 | $5,095 | -$1,986 | Termination of the North American sales team and co-promotion activities in late 2017 | | **Net Income (Loss)** | $4,187 | ($16,796) | +$20,983 | Driven by the significant increase in revenue and reduction in operating expenses | - In 2018, the company incurred **$1.4 million** in settlement costs related to lawsuits with former executives and a former sales agent, which was not present in 2017[281](index=281&type=chunk) 2018 Quarterly Results (in thousands, except per share data) | Quarter | Revenues ($) | Net Income (Loss) ($) | Net Income (Loss) per Share [basic] ($) | | :--- | :--- | :--- | :--- | | **Q1 2018** | 24,658 | 14,424 | 0.88 | | **Q2 2018** | 168 | (2,602) | (0.16) | | **Q3 2018** | 663 | (2,509) | (0.15) | | **Q4 2018** | 1,392 | (5,126) | (0.31) | [Liquidity and Capital Resources](index=80&type=section&id=B.%20Liquidity%20and%20capital%20resources) Examines the company's liquidity sources, cash position, and management's assessment of future funding needs - The company's primary source of liquidity in 2018 was the **$24.0 million** upfront payment from the **Macrilen™ license agreement**. As of December 31, 2018, cash and cash equivalents were **$14.5 million**[307](index=307&type=chunk)[309](index=309&type=chunk) - Management believes it has **sufficient liquidity** to fund operations and planned expenses for at least the **next twelve months** from the report's issuance date, supported by existing cash and expected royalty income[309](index=309&type=chunk)[310](index=310&type=chunk) Consolidated Cash Flow Summary (in thousands of U.S. dollars) | Activity | 2018 | 2017 | 2016 | | :--- | :--- | :--- | :--- | | **Net cash from operating activities** | 6,825 | (22,913) | (29,010) | | **Net cash from financing activities** | — | 8,030 | 9,924 | | **Net cash from investing activities** | (35) | 307 | (314) | | **Net change in cash** | 6,732 | (14,219) | (19,451) | | **Cash at end of period** | 14,512 | 7,780 | 21,999 | [Trend Information](index=85&type=section&id=D.%20Trend%20information) Outlines the 2019 outlook, focusing on Macrilen™ commercialization, out-licensing, and strategic options - The company's **2019 outlook** is focused on the commercialization of **macimorelin** in the U.S. and Canada by its partner, **Novo Nordisk**, and pursuing out-licensing opportunities for other global territories[340](index=340&type=chunk)[344](index=344&type=chunk)[345](index=345&type=chunk) - On **March 12, 2019**, the board formed a **Special Committee** to review **strategic options**, including licensing, monetization of macimorelin, or a potential sale of the company[343](index=343&type=chunk) 2019 Operating Expenditure Forecasts | Expense Category | Forecasted Amount (USD) | | :--- | :--- | | **Research and Development Costs** | Up to $2.0 million | | **General and Administrative Expenses** | $6.5 million to $7.5 million | [Directors, Senior Management and Employees](index=89&type=section&id=Item%206.%20Directors%2C%20Senior%20Management%20and%20Employees) Details the company's leadership, including Board members, senior management, compensation, and employee base [Directors and Senior Management](index=90&type=section&id=A.%20Directors%20and%20senior%20management) Identifies key leadership positions as of March 29, 2019, including CEO, CFO, and Chair of the Board - As of **March 29, 2019**, the company's leadership included **Michael V. Ward** as **President and Chief Executive Officer**, **Leslie Auld** as **Senior Vice President, Chief Financial Officer**, and **Carolyn Egbert** as **Chair of the Board of Directors**[353](index=353&type=chunk) [Compensation](index=96&type=section&id=B.%20Compensation) Outlines executive compensation, including director retainers and summary compensation for named executive officers - The executive compensation program is designed to be market-based and competitive, targeting the **50th percentile** for small-cap biopharmaceutical companies. It comprises base salary, an annual performance-based bonus, and long-term equity incentives[382](index=382&type=chunk)[385](index=385&type=chunk) 2018 Annual Retainers for Outside Directors | Position | Annual Retainer ($) | | :--- | :--- | | **Chair of the Board** | 80,000 | | **Board Member** | 40,000 | | **Audit Committee Chair** | 20,000 | | **Audit Committee Member** | 5,000 | | **NGCC Chair** | 15,000 | | **NGCC Member** | 3,000 | 2018 Summary Compensation for Named Executive Officers | Name and Position | Salary ($) | Option Awards ($) | Annual Incentive Plan ($) | All Other Compensation ($) | Total ($) | | :--- | :--- | :--- | :--- | :--- | :--- | | **Michael V. Ward**, President & CEO | 325,000 | 227,241 | 35,000 | — | 587,241 | | **James Clavijo**, Former CFO | 190,574 | 130,240 | — | 137,500 | 458,314 | | **Leslie Auld**, SVP, CFO | 62,385 | — | — | — | 62,385 | | **Richard Sachse**, Former CSO/CMO | 403,297 | — | — | — | 403,297 | | **Brian Garrison**, SVP, Global Commercial Ops | 235,015 | 3,550 | 35,000 | — | 273,565 | | **Eckhard Guenther**, VP, Alliance Mgmt | 191,242 | — | 13,154 | 3,298 | 207,694 | [Employees](index=120&type=section&id=D.%20Employees) Provides a breakdown of the company's workforce by location and functional area as of December 31, 2018 - As of December 31, 2018, the company had **22 active employees**. Of these, **18** were based in Frankfurt, Germany, and **4** in the United States, with the CFO based in Canada[459](index=459&type=chunk) - The workforce is primarily engaged in R&D (**12 employees**), commercial operations (**4 employees**), and administration (**6 employees**)[459](index=459&type=chunk) [Major Shareholders and Related Party Transactions](index=121&type=section&id=Item%207.%20Major%20Shareholders%20and%20Related%20Party%20Transactions) Identifies major shareholders, with J. Goldman & Co., L.P. holding over 5%, and confirms no significant related party transactions - As of **March 29, 2019**, **J. Goldman & Co., L.P.** and its affiliates were the only major shareholders, beneficially owning **997,494 common shares**, which represents **6.07%** of the outstanding shares[462](index=462&type=chunk)[463](index=463&type=chunk) - As of **March 7, 2019**, approximately **99.8%** of the company's outstanding common shares were held by two registered holders with addresses in the United States, primarily in broker "street names"[466](index=466&type=chunk) [Financial Information](index=124&type=section&id=Item%208.%20Financial%20Information) Confirms the location of full consolidated financial statements and reports no significant changes since their issuance - The full consolidated financial statements are presented under **Item 18** of this Annual Report on Form 20-F[469](index=469&type=chunk) - **No significant changes** have occurred since the date of the annual consolidated financial statements included in this report[470](index=470&type=chunk) [The Offer and Listing](index=124&type=section&id=Item%209.%20The%20Offer%20and%20Listing) Details the company's common share listings on NASDAQ and TSX, including historical high and low closing prices Common Share Price History (High/Low Closing Prices) | Period | NASDAQ (US$) High | NASDAQ (US$) Low | TSX (CAN$) High | TSX (CAN$) Low | | :--- | :--- | :--- | :--- | :--- | | **2018** | 3.87 | 1.19 | 5.10 | 1.53 | | **2017** | 3.65 | 0.84 | 4.81 | 1.13 | [Additional Information](index=125&type=section&id=Item%2010.%20Additional%20Information) Provides supplementary corporate, legal, and financial details, including articles, material contracts, and shareholder tax [Memorandum and Articles of Association](index=126&type=section&id=B.%20Memorandum%20and%20articles%20of%20association) Details the company's governing act, authorized share capital, shareholder rights plan, and advance notice provisions - The company is governed by the **Canada Business Corporations Act (CBCA)**. Its authorized share capital consists of an **unlimited number of Common Shares** and two classes of Preferred Shares (First and Second), issuable in series[475](index=475&type=chunk)[491](index=491&type=chunk) - The company has an amended and restated **shareholder rights plan**, approved in **2016** and updated in **2019**, designed to ensure fair treatment of all shareholders in the event of an unsolicited take-over bid[497](index=497&type=chunk)[500](index=500&type=chunk) - The bylaws include an **advance notice provision** requiring shareholders to provide timely notice (**30-65 days** before an annual meeting) for director nominations[538](index=538&type=chunk)[539](index=539&type=chunk) [Material Contracts](index=144&type=section&id=C.%20Material%20contracts) Summarizes key agreements, including the Macrilen™ license agreement with Novo Nordisk and executive employment contracts - The key material contract is the **License and Assignment Agreement** for **Macrilen™ (macimorelin)** in the U.S. and Canada, originally with Strongbridge and now held by **Novo Nordisk**. The agreement provides for a **15-18% royalty** on net sales, plus potential commercial milestones ranging from **$4 million to $100 million**[552](index=552&type=chunk)[553](index=553&type=chunk)[554](index=554&type=chunk) - The company has **employment and change of control agreements** with its Named Executive Officers, which include provisions for **severance payments** upon termination without cause or for good reason following a change of control[568](index=568&type=chunk)[571](index=571&type=chunk)[574](index=574&type=chunk) [Taxation](index=152&type=section&id=E.%20Taxation) Discusses U.S. and Canadian tax implications for shareholders, including Passive Foreign Investment Company (PFIC) risk - For U.S. Holders, there is a risk that the company could be classified as a **Passive Foreign Investment Company (PFIC)**. The company believes it was a PFIC in **2015** but not in **2016, 2017, or 2018**. PFIC status could result in adverse U.S. federal income tax consequences[117](index=117&type=chunk)[118](index=118&type=chunk)[612](index=612&type=chunk) - Dividends paid to non-resident holders are subject to **Canadian withholding tax** at a rate of **25%**, which may be reduced by an applicable tax treaty (e.g., to **15%** for qualifying U.S. residents under the Canada-U.S. Tax Convention)[594](index=594&type=chunk)[630](index=630&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=165&type=section&id=Item%2011.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) Identifies primary market risks including share price volatility affecting warrant liability and foreign exchange risk - The company is exposed to **share price risk**, as changes in its stock price materially affect the fair value of its **warrant liability**, which is reported in the income statement. The stock price on NASDAQ ranged from **$1.19 to $3.87** during 2018[651](index=651&type=chunk)[895](index=895&type=chunk) Sensitivity of Net Income to Share Price Changes via Warrant Liability (as of Dec 31, 2018) | Change in Market Price | Impact on Net Income (in thousands of U.S. dollars) | | :--- | :--- | | **-30%** | +$1,792 | | **+30%** | -$1,504 | - The company is exposed to **foreign exchange risk** from its German subsidiary, whose functional currency is the Euro. A **10% change** in the USD/EUR exchange rate would have impacted 2018 net income by approximately **$1.1 million**[896](index=896&type=chunk) [Controls and Procedures](index=169&type=section&id=Item%2015.%20Controls%20and%20Procedures) Management concluded disclosure controls and internal control over financial reporting were effective as of December 31, 2018 - Based on an evaluation as of **December 31, 2018**, the Chief Executive Officer and Chief Financial Officer concluded that the company's **disclosure controls and procedures were effective**[654](index=654&type=chunk) - Management concluded that the company's **internal control over financial reporting was effective** as of **December 31, 2018**, based on the criteria established in the Internal Control – Integrated Framework (2013) by **COSO**[658](index=658&type=chunk) [Corporate Governance and Other Matters](index=171&type=section&id=Item%2016.%20Corporate%20Governance%20and%20Other%20Matters) Covers corporate governance, including audit committee financial expert, Code of Conduct, accountant fees, and NASDAQ compliance - The Board has determined that **Mr. Gérard Limoges**, Chairman of the Audit Committee, qualifies as an "**audit committee financial expert**"[663](index=663&type=chunk) - The company is not in compliance with the **NASDAQ quorum requirement** of **33 1/3%** for shareholder meetings, as its bylaws set the quorum at **10%**. It benefits from a **home country practice exemption** as this complies with Canadian law and TSX rules[673](index=673&type=chunk) Principal Accountant Fees (PricewaterhouseCoopers LLP) | Fee Category | 2018 ($) | 2017 ($) | | :--- | :--- | :--- | | **Audit Fees** | 563,558 | 506,309 | | **Audit-related Fees** | 37,663 | 113,430 | | **Tax Fees** | 36,224 | 5,426 | | **All Other Fees** | 0 | 0 | PART III [Financial Statements](index=176&type=section&id=Item%2018.%20Financial%20Statements) Presents audited consolidated financial statements for 2016-2018, prepared under IFRS, including key financial statements Consolidated Statement of Financial Position (in thousands of U.S. dollars) | | Dec 31, 2018 | Dec 31, 2017 | | :--- | :--- | :--- | | **Total current assets** | 16,256 | 9,381 | | **Total Assets** | 25,011 | 22,195 | | **Total current liabilities** | 5,596 | 5,769 | | **Total Liabilities** | 23,104 | 24,978 | | **Total shareholders' equity (deficiency)** | 1,907 | (2,783) | Consolidated Statement of Comprehensive Income (Loss) (in thousands of U.S. dollars) | | 2018 | 2017 | 2016 | | :--- | :--- | :--- | :--- | | **Total revenues** | 26,881 | 923 | 911 | | **Gross income** | 24,777 | 923 | 911 | | **Total operating expenses** | 14,935 | 23,997 | 30,387 | | **Income (loss) from operations** | 9,842 | (23,074) | (29,476) | | **Net income (loss)** | 4,187 | (16,796) | (24,959) | | **Comprehensive income (loss)** | 4,120 | (17,532) | (25,869) | Consolidated Statement of Cash Flows (in thousands of U.S. dollars) | | 2018 | 2017 | 2016 | | :--- | :--- | :--- | :--- | | **Net cash from operating activities** | 6,825 | (22,913) | (29,010) | | **Net cash from financing activities** | — | 8,030 | 9,924 | | **Net cash from investing activities** | (35) | 307 | (314) | | **Cash and cash equivalents – end of year** | 14,512 | 7,780 | 21,999 | [Exhibits](index=253&type=section&id=Item%2019.%20Exhibits) Indexes all exhibits, including corporate governance documents, material contracts, and Sarbanes-Oxley certifications - The exhibit list includes key corporate governance documents, such as the **Restated Articles of Incorporation (1.1)**, **Amended and Restated By-Law One (1.4)**, and the **Shareholder Rights Plan Agreement (2.1)**[917](index=917&type=chunk) - Material contracts filed as exhibits include the **2018 Long-Term Incentive Plan (4.2)**, the **License and Assignment Agreement for Macrilen™ (4.3)**, and various **executive employment agreements (4.4-4.8)**[917](index=917&type=chunk)