Full Press Release Details
AC Immune Reports Full Year 2021 Financial Results and Provides Corporate Update
Seven clinical data readouts expected in 2022
Three vaccines, targeting Tau, Abeta and alpha-synuclein, advancing in 2022
Semorinemab Phase 2 Lauriet trial: additional fluid biomarker data expected in H2 2022
Initiation of ACI-24 anti-Abeta vaccine Phase 1b/2 trial in patients with Alzheimer's disease (AD) and people living with Down syndrome (DS) expected in H1
AD/PD Conference: ACI-12589 identified as a reliable and accurate PET tracer for
alpha-synucleinopathies (e.g. MSA)
Strong financial position of CHF 198.2 million ensures the Company is fully financed through at least Q1 2024
Lausanne, Switzerland, March 22, 2022 - AC Immune SA (NASDAQ: ACIU), a clinical-stage biopharmaceutical company pioneering precision
medicine for neurodegenerative diseases, today reported its financial results for the year ended December 31, 2021, and provided a corporate update, highlighting progress in its broad pipeline of products to treat and diagnose neurodegenerative
Prof. Andrea Pfeifer, CEO of AC Immune SA, commented: "We are off to a strong start in 2022 with the second of seven clinical data
readouts presented last week at the AD/PD 2022 conference. The first-in-human study of our alpha-synuclein diagnostic, ACI-12589, showed it has strong potential to become the first reliable and accurate PET tracer for alpha-synucleinopathies (e.g.
multiple system atrophy, MSA)."
"Pairing cutting-edge diagnostics with highly targeted and selective therapeutic agents, such as our vaccines targeting alpha-synuclein, phosphorylated-Tau, and Abeta,
which are all advancing into later-stage development this year, we aim to shift the therapeutic paradigm of neurodegenerative diseases towards earlier, more accurate diagnosis, treatment, and prevention," Prof. Pfeifer said.
2021 and Subsequent Highlights
Strenthening Financial Position and Extend Shareholder Base
Strengthening of Board
Thought Leadership and Collaborations
Our strategy for 2022
AC Immune's execution strategy is to advance late-stage AD programs with partners, accelerate its non-AD and NeuroOrphan programs in-house, and advance development of its
suite of potentially best-in-class diagnostics to enable precision medicine. The Company intends to maintain program leadership over its wholly-owned AD and PD vaccine programs until Phase 3 or beyond, and expects to initiate two mid-stage clinical
2022 Clinical Milestones
| ACI-12589 a-syn-PET tracer | Reported results from first-in-human study at AD/PD 2022 conference | ||
| ACI-35.030 anti-pTau vaccine | Reported Phase 1b/2a interim analysis from highest dose group in Q1; disclose future late-stage development plans in H2 | ||
| ACI-24 (optimized) anti-Abeta vaccine | ACI-24 (optimized vaccine formulation) Phase 1b/2a First-Patient-In (AD) in H1 Phase 1b in AD readout and decision to move into DS in H2 | ||
| Crenezumab anti-Abeta antibody | Top line Phase 2 results from AD prevention trial in patients with autosomal dominant AD in H1 | ||
| Semorinemab anti-Tau antibody | Additional fluid biomarker data from the Phase 2 Lauriet study in mild-to-moderate AD in H2 | ||
| PI-2620 Tau-PET tracer | Phase 2 and Phase 1 results in AD and progressive supranuclear palsy (PSP) respectively, in H2 | ||
| ACI-7104 anti-a-syn vaccine | Initiate Phase 2 trial in early PD in H2 |
Analysis of Financial Statements for the year ended December 31, 2021
2022 Financial Guidance
AC Immune SA is 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, six of which are currently in clinical trials. 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 Janssen Pharmaceuticals, Inc., 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 and RU. Morphomer is a
registered trademark of AC Immune SA in CN, CH, GB, JP, and NO.
For further information, please contact:
| Media Relations Saoyuth Nidh AC Immune Phone: +41 21 345 91 34 Email: saoyuth.nidh@acimmune.com | Investor Relations Gary Waanders, Ph.D., MBA AC Immune Phone: +41 21 345 91 91 Email: gary.waanders@acimmune.com |
| U.S. Media Shani Lewis LaVoieHealthScience Phone: +1 609 516 5761 Email: slewis@lavoiehealthscience.com | U.S. Investors Corey Davis, Ph.D. LifeSci Advisors Phone: +1 212 915 2577 Email: cdavis@lifesciadvisors.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, 2021 | As of December 31, 2020 | |||||||
| ASSETS | ||||||||
| Non-current assets | ||||||||
| Property, plant and equipment | 5,116 | 4,416 | ||||||
| Right-of-use assets | 2,914 | 2,223 | ||||||
| Intangible asset | 50,416 | - | ||||||
| Long-term financial assets | 363 | 334 | ||||||
| Total non-current assets | 58,809 | 6,973 | ||||||
| Current assets | ||||||||
| Prepaid expenses | 3,015 | 3,954 | ||||||
| Accrued income | 975 | 1,591 | ||||||
| Other current receivables | 428 | 329 | ||||||
| Short-term financial assets | 116,000 | 65,000 | ||||||
| Cash and cash equivalents | 82,216 | 160,893 | ||||||
| Total current assets | 202,634 | 231,767 | ||||||
| Total assets | 261,443 | 238,740 | ||||||
| SHAREHOLDERS' EQUITY AND LIABILITIES | ||||||||
| Shareholders' equity | ||||||||
| Share capital | 1,794 | 1,538 | ||||||
| Share premium | 431,251 | 346,890 | ||||||
| Treasury shares | (124 | ) | (100 | ) | ||||
| Accumulated losses | (200,942 | ) | (132,850 | ) | ||||
| Total shareholders' equity | 231,979 | 215,478 | ||||||
| Non-current liabilities | ||||||||
| Long-term lease liabilities | 2,340 | 1,780 | ||||||
| Net employee defined-benefit liabilities | 7,098 | 7,464 | ||||||
| Total non-current liabilities | 9,438 | 9,244 | ||||||
| Current liabilities | ||||||||
| Trade and other payables | 2,003 | 2,184 | ||||||
| Accrued expenses | 16,736 | 11,085 | ||||||
| Deferred income | 717 | 306 | ||||||
| Short-term lease liabilities | 570 | 443 | ||||||
| Total current liabilities | 20,026 | 14,018 | ||||||
| Total liabilities | 29,464 | 23,262 | ||||||
| Total shareholders' equity and liabilities | 261,443 | 238,740 |
Consolidated Statements of Income/(Loss)
(In CHF thousands, except for per-share data)
| For the Years Ended December 31, | ||||||||||||
| 2021 | 2020 | 2019 | ||||||||||
| Revenues | ||||||||||||
| Contract revenue | - | 15,431 | 110,456 | |||||||||
| Total revenue | - | 15,431 | 110,456 | |||||||||
| Operating expenses | ||||||||||||
| Research & development expenses | (62,282 | ) | (59,487 | ) | (50,432 | ) | ||||||
| General & administrative expenses | (17,910 | ) | (18,557 | ) | (16,058 | ) | ||||||
| Other operating income/(expense) | 1,182 | 1,353 | 570 | |||||||||
| Total operating expenses | (79,010 | ) | (76,691 | ) | (65,920 | ) | ||||||
| Operating income/(loss) | (79,010 | ) | (61,260 | ) | 44,536 | |||||||
| Financial income | 6,485 | 78 | 303 | |||||||||
| Financial expense | (581 | ) | (184 | ) | (1,926 | ) | ||||||
| Change in fair value of conversion feature | - | - | 4,542 | |||||||||
| Exchange differences | 113 | (555 | ) | (2,013 | ) | |||||||
| Finance result, net | 6,017 | (661 | ) | 906 | ||||||||
| Income/(loss) before tax | (72,993 | ) | (61,921 | ) | 45,442 | |||||||
| Income tax expense | (3 | ) | - | - | ||||||||
| Income/(loss) for the period | (72,996 | ) | (61,921 | ) | 45,442 | |||||||
| Earnings/(loss) per share: | ||||||||||||
| Basic income/(loss) for the period attributable to equity holders | (0.97 | ) | (0.86 | ) | 0.64 | |||||||
| Diluted income/(loss) for the period attributable to equity holders | (0.97 | ) | (0.86 | ) | 0.64 |
Consolidated Statements of Comprehensive Income/(Loss)
| For the Years Ended December 31, | ||||||||||||
| 2021 | 2020 | 2019 | ||||||||||
| Income/(loss) for the period | (72,996 | ) | (61,921 | ) | 45,442 | |||||||
| Items that may be reclassified to income or loss in subsequent periods (net of tax): | ||||||||||||
| Currency translation differences | - | - | - | |||||||||
| Items that will not be reclassified to income or loss in subsequent periods (net of tax): | ||||||||||||
| Re-measurement gains/(losses) on defined-benefit plans | 956 | 726 | (1,304 | ) | ||||||||
| Other comprehensive income/(loss) | 956 | 726 | (1,304 | ) | ||||||||
| Total comprehensive income/(loss), net of tax | (72,040 | ) | (61,195 | ) | 44,138 |
Reconciliation of income/(loss) to adjusted income/(loss) and
earnings/(loss) per share to adjusted earnings/(loss) per share
| For the Years Ended December 31, | ||||||||||||
| (In CHF thousands, except for share and per share data) | 2021 | 2020 | 2019 | |||||||||
| Income/(loss) | (72,996 | ) | (61,921 | ) | 45,442 | |||||||
| Adjustments: | ||||||||||||
| Non-cash share-based payments 1 | 4,126 | 4,088 | 2,834 | |||||||||
| Foreign currency (gains)/losses 2 | 70 | 703 | 826 | |||||||||
| Change in fair value of derivative financial assets 3 | (6,459 | ) | - | - | ||||||||
| Transaction costs 4 | 1,144 | - | - | |||||||||
| Effective interest expenses 5 | - | - | 1,355 | |||||||||
| Change in fair value of conversion feature 6 | - | - | (4,542 | ) | ||||||||
| Adjusted income/(loss) | (74,115 | ) | (57,130 | ) | 45,915 | |||||||
| Earnings/(loss) per share - basic | (0.97 | ) | (0.86 | ) | 0.64 | |||||||
| Earnings/(loss) per share - diluted | (0.97 | ) | (0.86 | ) | 0.64 | |||||||
| Adjustment to earnings/(loss) per share - basic | (0.02 | ) | 0.07 | 0.01 | ||||||||
| Adjustment to earnings/(loss) per share - diluted | (0.02 | ) | 0.07 | 0.00 | ||||||||
| Adjusted earnings/(loss) per share - basic | (0.99 | ) | (0.79 | ) | 0.65 | |||||||
| Adjusted earnings/(loss) per share - diluted | (0.99 | ) | (0.79 | ) | 0.64 | |||||||
| Weighted-average number of shares used to compute adjusted loss per share - basic | 74,951,833 | 71,900,212 | 70,603,611 | |||||||||
| Weighted-average number of shares used to compute adjusted loss per share - diluted | 74,951,833 | 71,900,212 | 71,103,341 |
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 US Dollar and
3 Reflects 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.
5Effective interest expense for the period relates to the accretion of the Company's convertible loan in accordance with the effective interest method.
6Change in fair value of conversion feature that is bifurcated from the convertible loan host debt with Lilly.
Adjustments for the years ended December 31, 2021, 2020 and 2019 increased net loss by CHF 1.1 million, decreased net loss by CHF 4.8 million
and increased net income by CHF 0.5 million, respectively. The Company recorded share-based compensation expenses of CHF 4.1 million, CHF 4.1 million and CHF 2.8 million for the years ended December 31, 2021, 2020 and 2019, respectively. There were
foreign currency re-measurement losses of CHF 0.1 million, CHF 0.7 million and CHF 0.8 million for the years ended December 31, 2021, 2020 and 2019, respectively, predominantly related to the cash balance of the Company as a result of fluctuations
of the US Dollar against the Swiss Franc. The Company recognized a CHF 6.5 million gain on the change in fair value of the derivative financial assets associated with two convertible notes with Affiris affiliated entities in 2021. This gain
did not arise in the comparable prior periods. The Company also incurred CHF 1.1 million in transaction costs associated with its acquisition of a portfolio of therapeutics targeting alpha-synuclein, which did not arise in the comparable prior
periods. Finally, related to the Company's convertible note settled with Lilly in 2019, we recorded CHF 1.4 million for amortization of effective interest for the year ended December 31, 2019 and recognized a CHF 4.5
million gain for the change in fair value of the liability related to the conversion feature in 2019. There were no comparable expenses or gains in 2021 nor 2020.