AC Immune SA — FY2021 Form 20-F
Reporting period: Fiscal year ended December 31, 2021; filed March 22, 2022. Although the request identifies Q4 2021, this is an annual report, not a standalone quarterly filing. Financial statements are IFRS, presented in Swiss francs (CHF).
Business context
AC Immune is a clinical-stage biopharmaceutical company developing therapies and diagnostics for neurodegenerative diseases, principally Alzheimer’s and Parkinson’s disease. Its portfolio uses the SupraAntigen and Morphomer platforms. The company had no approved products and generated no product-sales revenue; it relies on collaboration payments, grants and capital markets.
Key financial metrics
| Metric (CHF millions, except per-share data) | FY2021 | FY2020 |
|---|---|---|
| Revenue | 0.0 | 15.4 |
| Research and development expense | 62.3 | 59.5 |
| General and administrative expense | 17.9 | 18.6 |
| Operating loss | 79.0 | 61.3 |
| Net loss | 73.0 | 61.9 |
| Basic and diluted loss per share | CHF 0.97 | CHF 0.86 |
| Net cash used in operating activities | 65.7 | 59.5 |
| Cash and cash equivalents | 82.2 | 160.9 |
| Short-term financial assets | 116.0 | 65.0 |
| Total liquidity (cash plus short-term financial assets) | 198.2 | 225.9 |
Product margins are not meaningful because the company had no product sales. FY2021’s CHF 6.0 million net finance gain included a CHF 6.5 million fair-value gain on derivative assets associated with Affiris-related convertible notes. Net loss excluding management’s specified adjustments was CHF 74.1 million; this is a non-IFRS measure.
At year-end, total liabilities were CHF 29.5 million, including CHF 2.9 million of lease liabilities; the Affiris-related convertible notes had been converted and settled. The company reported CHF 231.979 million in shareholders’ equity. Operating cash burn increased year over year. Investing cash flow was negative CHF 53.7 million, principally reflecting net purchases of short-term financial assets and CHF 2.6 million in capital expenditures; financing cash flow was positive CHF 40.7 million, including note proceeds, share issuance related to Affiris, and treasury-share sales.
Material changes versus FY2020
- Revenue fell CHF 15.4 million to zero, mainly because Lilly milestone and R&D-services revenue recognized in 2020 did not recur.
- Net loss increased CHF 11.1 million. R&D expense rose CHF 2.8 million, while operating loss also reflected the absence of prior-year contract revenue.
- Liquidity declined CHF 27.7 million overall, although cash fell more sharply as CHF 51.0 million was invested net in short-term financial assets.
- AC Immune acquired Affiris’ alpha-synuclein program portfolio, including ACI-7104/PD01, for shares and CHF 4.6 million in cash. It recognized a CHF 50.4 million in-process R&D asset, which was not impaired at year-end.
Outlook, pipeline and principal risks
- Management estimated existing capital resources, excluding potential milestones, would fund planned operations through at least Q1 2024. This estimate depends on assumptions and spending, trial progress and financing needs could change. Management expects losses and R&D expenses to continue; no product-revenue guidance was provided.
- Key pipeline updates included completion of the ACI-24 Phase 2 AD study, which showed no apparent amyloid-PET effect in the limited study population but evidence of pharmacodynamic target engagement. An optimized ACI-24 formulation’s next study was planned for 2022.
- For semorinemab, the earlier Tauriel Phase 2 study failed its primary efficacy endpoint. Lauriet met one of two co-primary endpoints (ADAS-Cog11), with a reported 42.2% slowing of cognitive decline in the modified intent-to-treat population; the functional co-primary endpoint and other reported functional measures were not met. Safety was reported as acceptable. The clinical meaning and durability of the cognitive finding remain uncertain.
- Crenezumab’s Phase 3 studies in sporadic AD were discontinued in 2019 after an interim analysis indicated the primary endpoint was unlikely to be met. Results from its Colombia prevention study were expected in H1 2022. ACI-7104 Phase 2 initiation was planned for H2 2022; readouts from the ACI-12589 alpha-synuclein PET tracer studies were expected by Q2 2022; and PI-2620 PSP test-retest results were anticipated in H2 2022.
- Material risks include clinical failure or delay, uncertain regulatory approval and reimbursement, dependence on collaboration partners and third-party manufacturers, patent and IP challenges, ongoing cash burn and potential need for additional capital. Currency exposure is unhedged; management disclosed that a hypothetical 10% CHF exchange-rate movement could materially affect results.
- COVID-19 had caused business and trial disruption, though management reported operations had resumed at full capacity with minimal disruption and no projected material impact to key trials at the time of filing. Management also disclosed potential supply-chain and trial risks from geopolitical events; it stated the company had no direct business or clinical activity in Russia or Ukraine.
- The Affiris IPR&D valuation is a significant judgment and a critical audit matter. It uses a risk-adjusted discounted cash-flow model with a 15% discount rate and depends on clinical, regulatory and commercial assumptions; impairment could arise if development is curtailed or value expectations change.
Most important facts for investors to verify
- Whether the reported semorinemab cognitive signal is replicated or translates into functional benefit, given the mixed Lauriet results and prior Tauriel failure.
- Progress, enrollment, safety and actual readouts for the planned 2022 ACI-24, ACI-7104, crenezumab, ACI-12589 and PI-2620 milestones.
- Whether the CHF 198.2 million liquidity position and stated Q1 2024 runway remain supportable against actual operating cash burn and planned development spending.
- Terms, dilution and remaining availability of financing arrangements, including the shelf registration and ATM program; the filing reports 83,479,013 common shares outstanding at period end.
- Assumptions underlying the CHF 50.4 million Affiris IPR&D asset valuation and the potential for impairment; also monitor the status of milestone payments, which are contingent and not assured.