Full Press Release Details
AC Immune Reports Full Year 2022 Financial
Results and Provides Corporate Update
Lausanne, Switzerland,
March 16, 2023 - AC Immune SA (NASDAQ: ACIU), a clinical-stage biopharmaceutical company pioneering precision medicine
for neurodegenerative diseases, today reported results for the year ended December 31, 2022, and provided a corporate update.
Pfeifer, CEO of AC Immune SA, commented: "Thanks to the strong progress by our experienced team over
the past year, we now have highly innovative vaccines targeting neurotoxic species of Abeta, Tau or a-syn in mid- to late-stage development
for Alzheimer's and Parkinson's disease, respectively. This progress was highlighted by ABATE's successful interim
readout in AD, which is enabling the quick and informed transition to this adaptive trial's next cohorts. Importantly, ABATE remains
on track for additional readouts on ACI-24.060's safety and immunogenicity this year, and for interim Abeta PET analyses in 2024
that will provide an opportunity for early de-risking and potentially a rapid transition to a pivotal program."
"Together, our vaccines and the highly
specific diagnostics we are developing against targets such as Tau and a-syn form the cornerstone of our strategy to enable precision
medicine for neurodegenerative diseases. With this strategy, our long-term goal is to identify and treat the multifactorial pathologies
of each patient at their earliest stages, so that we can minimize irreversible neuronal damage and enable disease prevention."
2022 and Subsequent Highlights
Thought Leadership and Collaborations
Key Achieved and Anticipated 2023 Milestones
| ACI-24.060 anti-Abeta vaccine | Reported interim Phase 1b safety and immunogenicity data from first AD cohort of Phase 1b/2 ABATE study Initiation of first DS cohort of ABATE study expected in H1 2023 Submission of an Investigational New Drug (IND) application to enable expansion of ABATE study to the U.S. expected in H1 2023 Additional interim safety and immunogenicity data from AD cohort of ABATE study expected in H2 2023 Interim safety and immunogenicity data from DS cohort of ABATE study expected in H2 2023 |
| ACI-7104 anti-a-syn vaccine | Update from Phase 2 VACSYN study expected in H2 2023 |
| ACI-35.030 anti-pTau vaccine | Initiation of next trial in AD expected in H2 2023 (to be followed by milestone payment) |
| Semorinemab anti-Tau antibody | Results from the open-label extension of the Phase 2 Lauriet trial in mild-to-moderate AD expected in H2 2023 |
| Anti-TDP-43 antibody | Advancement of candidate into preclinical development (tox) expected in H2 2023 |
| a-syn-PET tracer | Declaration of next clinical candidate for development in Parkinson's disease expected in H2 2023 |
| TDP-43-PET tracer | Clinical candidate declaration expected in H1 2023 |
Analysis of Financial
Statements for the Year Ended December 31, 2022
2023 Financial Guidance
AC Immune SA is a clinical-stage biopharmaceutical
company that aims to become a global leader in precision medicine for neurodegenerative diseases, including Alzheimer's disease,
Parkinson's disease, and NeuroOrphan indications driven by misfolded proteins. The Company's two clinically validated technology
platforms, SupraAntigen and Morphomer , fuel its broad and diversified pipeline of first- and best-in-class
assets, which currently features ten therapeutic and three diagnostic candidates, five of which are currently in Phase 2 clinical trials
and one of which is in Phase 3. AC Immune has a strong track record of securing strategic partnerships with leading global
pharmaceutical companies including Genentech, a member of the Roche Group, Eli Lilly and Company, and others, resulting in
substantial non-dilutive funding to advance its proprietary programs and >$3 billion in potential milestone payments.
SupraAntigen is a registered trademark
of AC Immune SA in the following territories: AU, EU, CH, GB, JP, RU, SG and USA. Morphomer is a registered trademark
of AC Immune SA in CN, CH, GB, JP, KR, NO and RU.
The information on our website and any other
websites referenced herein is expressly not incorporated by reference into, and does not constitute a part of, this press release.
For further information, please contact:
| Head of Investor Relations & Corporate Communications Gary Waanders, Ph.D., MBA AC Immune Phone: +41 21 345 91 91 Email: gary.waanders@acimmune.com | U.S. Investors Corey Davis, Ph.D. LifeSci Advisors Phone: +1 212 915 2577 Email: cdavis@lifesciadvisors.com |
| International Media Chris Maggos Cohesion Bureau Phone: +41 79 367 6254 Email: chris.maggos@cohesionbureau.com |
Forward looking statements
This press release contains statements that constitute
"forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of
the Securities Exchange Act of 1934. Forward-looking statements are statements other than historical fact and may include statements
that address future operating, financial or business performance or AC Immune's strategies or expectations. In some cases, you
can identify these statements by forward-looking words such as "may," "might," "will," "should,"
"expects," "plans," "anticipates," "believes," "estimates," "predicts,"
"projects," "potential," "outlook" or "continue," and other comparable terminology. Forward-looking
statements are based on management's current expectations and beliefs and involve significant risks and uncertainties that could
cause actual results, developments and business decisions to differ materially from those contemplated by these statements. These risks
and uncertainties include those described under the captions "Item 3. Key Information - Risk Factors" and "Item
5. Operating and Financial Review and Prospects" in AC Immune's Annual Report on Form 20-F and other filings with the
Securities and Exchange Commission. These include: the impact of Covid-19 on our business, suppliers, patients and employees and any
other impact of Covid-19. Forward-looking statements speak only as of the date they are made, and AC Immune does not undertake any obligation
to update them in light of new information, future developments or otherwise, except as may be required under applicable law. All forward-looking
statements are qualified in their entirety by this cautionary statement.
Consolidated Balance Sheets
| As of December 31, 2022 | As of December 31, 2021 | |||||||
| ASSETS | ||||||||
| Non-current assets | ||||||||
| Property, plant and equipment | 4,259 | 5,116 | ||||||
| Right-of-use assets | 2,808 | 2,914 | ||||||
| Intangible asset | 50,416 | 50,416 | ||||||
| Long-term financial assets | 361 | 363 | ||||||
| Total non-current assets | 57,844 | 58,809 | ||||||
| Current assets | ||||||||
| Prepaid expenses | 4,708 | 3,015 | ||||||
| Accrued income | 408 | 975 | ||||||
| Other current receivables | 392 | 428 | ||||||
| Short-term financial assets | 91,000 | 116,000 | ||||||
| Cash and cash equivalents | 31,586 | 82,216 | ||||||
| Total current assets | 128,094 | 202,634 | ||||||
| Total assets | 185,938 | 261,443 | ||||||
| SHAREHOLDERS' EQUITY AND LIABILITIES | ||||||||
| Shareholders' equity | ||||||||
| Share capital | 1,797 | 1,794 | ||||||
| Share premium | 431,323 | 431,251 | ||||||
| Treasury shares | (124 | ) | (124 | ) | ||||
| Currency translation differences | 10 | - | ||||||
| Accumulated losses | (264,015 | ) | (200,942 | ) | ||||
| Total shareholders' equity | 168,991 | 231,979 | ||||||
| Non-current liabilities | ||||||||
| Long-term lease liabilities | 2,253 | 2,340 | ||||||
| Net employee defined-benefit liabilities | 3,213 | 7,098 | ||||||
| Total non-current liabilities | 5,466 | 9,438 | ||||||
| Current liabilities | ||||||||
| Trade and other payables | 929 | 2,003 | ||||||
| Accrued expenses | 9,417 | 16,736 | ||||||
| Deferred income | 587 | 717 | ||||||
| Short-term lease liabilities | 548 | 570 | ||||||
| Total current liabilities | 11,481 | 20,026 | ||||||
| Total liabilities | 16,947 | 29,464 | ||||||
| Total shareholders' equity and liabilities | 185,938 | 261,443 |
Consolidated Statements of Income/(Loss)
(In CHF thousands, except for per share data)
| For the Year Ended December 31, | ||||||||||||
| 2022 | 2021 | 2020 | ||||||||||
| Revenue | ||||||||||||
| Contract revenue | 3,935 | - | 15,431 | |||||||||
| Total revenue | 3,935 | - | 15,431 | |||||||||
| Operating expenses | ||||||||||||
| Research & development expenses | (60,336 | ) | (62,282 | ) | (59,487 | ) | ||||||
| General & administrative expenses | (15,789 | ) | (17,910 | ) | (18,557 | ) | ||||||
| Other operating income/(expense), net | 1,343 | 1,182 | 1,353 | |||||||||
| Total operating expenses | (74,782 | ) | (79,010 | ) | (76,691 | ) | ||||||
| Operating loss | (70,847 | ) | (79,010 | ) | (61,260 | ) | ||||||
| Financial income | 69 | 6,485 | 78 | |||||||||
| Financial expense | (355 | ) | (581 | ) | (184 | ) | ||||||
| Exchange differences | 393 | 113 | (555 | ) | ||||||||
| Finance result, net | 107 | 6,017 | (661 | ) | ||||||||
| Loss before tax | (70,740 | ) | (72,993 | ) | (61,921 | ) | ||||||
| Income tax expense | (13 | ) | (3 | ) | - | |||||||
| Loss for the period | (70,753 | ) | (72,996 | ) | (61,921 | ) | ||||||
| Loss per share: | ||||||||||||
| Basic and diluted loss for the period attributable to equity holders | (0.85 | ) | (0.97 | ) | (0.86 | ) |
Consolidated Statements of Comprehensive Income/(Loss)
| For the Year Ended December 31, | ||||||||||||
| 2022 | 2021 | 2020 | ||||||||||
| Loss for the period | (70,753 | ) | (72,996 | ) | (61,921 | ) | ||||||
| Items that may be reclassified to income or loss in subsequent periods (net of tax): | ||||||||||||
| Currency translation differences | 10 | - | - | |||||||||
| Items that will not be reclassified to income or loss in subsequent periods (net of tax): | ||||||||||||
| Remeasurement gains on defined-benefit plans (net of tax) | 4,426 | 956 | 726 | |||||||||
| Other comprehensive income | 4,436 | 956 | 726 | |||||||||
| Total comprehensive loss, net of tax | (66,317 | ) | (72,040 | ) | (61,195 | ) |
Reconciliation of loss to adjusted loss and
loss per share to adjusted loss per share
| For the Year Ended December 31, | ||||||||||||
| (In CHF thousands, except for share and per share data) | 2022 | 2021 | 2020 | |||||||||
| Loss | (70,753 | ) | (72,996 | ) | (61,921 | ) | ||||||
| Adjustments: | ||||||||||||
| Non-cash share-based payments 1 | 3,330 | 4,126 | 4,088 | |||||||||
| Foreign currency (gains)/losses 2 | (521 | ) | 70 | 703 | ||||||||
| Change in fair value of derivative financial assets 3 | - | (6,459 | ) | - | ||||||||
| Transaction costs 4 | - | 1,144 | - | |||||||||
| Adjusted loss | (67,944 | ) | (74,115 | ) | (57,130 | ) | ||||||
| Loss per share - basic and diluted | (0.85 | ) | (0.97 | ) | (0.86 | ) | ||||||
| Adjustment to loss per share - basic and diluted | 0.04 | (0.02 | ) | 0.07 | ||||||||
| Adjusted loss per share - basic and diluted | (0.81 | ) | (0.99 | ) | (0.79 | ) | ||||||
| Weighted-average number of shares used to compute adjusted loss per share - basic and diluted | 83,554,412 | 74,951,833 | 71,900,212 |
1Reflects non-cash expenses associated
with share-based compensation for equity awards issued to directors, management and employees of the Company. This expense reflects the
awards' fair value recognized for the portion of the equity award which is vesting over the period.
2Reflects foreign currency re-measurement
gains and losses for the period, predominantly impacted by the change in the exchange rate between the U.S. Dollar and the Swiss Franc.
3Reflects the change in the fair value
of the derivative financial instruments associated with two convertible notes sold to certain Affiris affiliated entities.
4Reflects transaction costs associated
with our asset acquisition for a portfolio of therapeutics targeting alpha-synuclein.