AC Immune SA — FY2023 Form 20-F Summary
Reporting period: Fiscal year ended December 31, 2023. This is an annual report, not a standalone 2023 fourth-quarter filing. Financial statements are prepared under IFRS in Swiss francs (CHF).
Business context and reporting period
AC Immune is a clinical-stage biopharmaceutical company developing therapeutics and diagnostics for neurodegenerative diseases, including Alzheimer’s and Parkinson’s disease. It reported 16 therapeutic and diagnostic programs, with one in Phase 3 and five in Phase 2. It has no products approved for sale and has never generated product-sale revenue.
Key financial metrics
| CHF millions, unless stated | FY2023 | FY2022 |
|---|---|---|
| Contract revenue | 14.8 | 3.9 |
| Research and development expense | 54.6 | 60.3 |
| General and administrative expense | 15.3 | 15.8 |
| Operating loss | (53.6) | (70.8) |
| Net loss | (54.2) | (70.8) |
| Basic and diluted loss per share | CHF (0.64) | CHF (0.85) |
| Net cash used in operating activities | (60.4) | (73.6) |
- 2023 contract revenue was principally a CHF 14.8 million Janssen milestone for commencement of the first Phase 2b study of ACI-35.030. The milestone was recorded as a receivable at year-end and received on February 1, 2024. The 2022 revenue was a CHF 3.9 million LMI milestone related to PI-2620.
- At December 31, 2023, cash and cash equivalents were CHF 78.5 million and short-term financial assets CHF 24.6 million, for total liquidity of CHF 103.1 million. Total assets were CHF 182.8 million; shareholders’ equity was CHF 160.6 million; total liabilities were CHF 22.2 million.
- No material borrowings are reported. Lease liabilities were CHF 3.5 million in total, including CHF 0.7 million current and CHF 2.8 million non-current.
- Operating cash outflow improved year over year. Investing activities provided CHF 65.6 million, mainly reflecting maturities of short-term financial assets; financing activities provided CHF 43.3 million, primarily from a December 2023 share offering.
- Gross margin is not meaningful for this development-stage company; the filing does not present a product-sales margin.
Material changes versus the prior comparable period
- Revenue increased CHF 10.9 million, principally due to the Janssen milestone; revenue remains collaboration-based rather than product-based.
- Net loss narrowed by CHF 16.5 million. R&D expense fell CHF 5.7 million, with lower discovery/preclinical and clinical costs, partly offset by higher payroll and share-based compensation. Management attributed some lower clinical spending to ACI-35.030’s transition to Phase 2b, for which Janssen assumes development responsibility from Phase 2b onward, subject to the parties’ cost-sharing terms for the first Phase 2b study.
- Finance result shifted from CHF 0.1 million income to a CHF 0.6 million loss, mainly due to unfavorable foreign-exchange movements, partly offset by higher interest income.
- Cash and short-term financial assets together decreased CHF 19.5 million from year-end 2022. The company raised CHF 40.5 million net in a follow-on offering and received CHF 2.7 million net from sales of treasury shares.
Outlook, management commentary, risks and unusual items
- Management expects losses to continue and R&D expenses to increase as programs advance. It estimates existing capital resources will fund projected operating requirements into Q1 2026, assuming receipt of a further CHF 24.6 million ACI-35.030 enrollment milestone and no other milestones. That milestone is contingent; management cautions that estimates may prove incorrect and additional capital may be needed.
- On January 22, 2024, AC Immune announced it would regain global rights to crenezumab and semorinemab following termination of its Genentech collaborations, effective April 2024. The company said it would review available data before deciding on further development. Semorinemab’s Tauriel Phase 2 study missed its primary endpoint; Lauriet met one of two co-primary endpoints. Crenezumab’s Phase 3 program was discontinued after an interim analysis indicated it was unlikely to meet its primary endpoint.
- Key development updates include ACI-35.030 planned for a Phase 2b study in presymptomatic Alzheimer’s disease; ACI-24.060 in Phase 1b/2, with FDA Fast Track designation for Alzheimer’s disease; ACI-7104.056 in a Phase 2 Parkinson’s study; and PI-2620 in a pivotal Phase 3 imaging study. These are investigational programs, and clinical outcomes and regulatory approval remain uncertain.
- Principal risks include clinical and regulatory failure or delay, patient enrollment and safety issues, reliance on collaboration partners and third-party manufacturers, competition, intellectual-property challenges, and the need for additional capital. The company also reports unhedged foreign-exchange exposure; a hypothetical 10% CHF move against the EUR and USD would have changed net loss by about CHF 2.6 million, all else equal.
- The CHF 50.4 million acquired in-process R&D asset for the Parkinson’s immunotherapy ACI-7104.056 was not impaired at year-end. Its valuation depends on significant assumptions, including clinical success, market uptake, pricing and patent life; the auditor identified valuation of this asset as a critical audit matter. The accounts received an unmodified audit opinion, and the auditor also opined that internal control over financial reporting was effective.
- The company reported no material litigation as of the filing date and has never paid a dividend; it does not expect dividends in the foreseeable future.
Important facts for investors to verify
- Whether the assumed CHF 24.6 million enrollment milestone is achieved and whether the stated Q1 2026 funding runway remains valid under actual spending and clinical timelines.
- Progress, safety and efficacy data from the planned ACI-35.030 Phase 2b study, ACI-24.060, ACI-7104.056 and the PI-2620 Phase 3 study.
- The strategic and financial implications of regaining crenezumab and semorinemab rights, including development costs and any future partnering plans.
- The assumptions supporting the CHF 50.4 million IPR&D asset valuation and the possibility of future impairment.
- Potential dilution and funding needs following the 14.3 million-share offering, together with foreign-exchange sensitivity and collaboration-milestone dependence.