Full Press Release Details
AC Immune Reports Full-Year 2020 Financial
Results and Provides 2021 R&D Outlook
Lausanne, Switzerland, March 23, 2021
- 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, 2020. The Company also provided an overview of its
execution strategy and anticipated clinical and preclinical milestones for 2021, as well as the strong progress being made across
its broad portfolio of therapeutic and diagnostic product candidates.
Prof. Andrea Pfeifer, CEO of AC
Immune SA, commented: "We began 2021 with strong momentum based on the effective execution of our multi-pronged
clinical development growth strategy. This is exemplified by our anti-pTau vaccine, which recently demonstrated highly potent
immune responses against pathological Tau and remarkable safety in patients with early Alzheimer's disease (AD). We are
also creating future value by accelerating development of our proprietary, first-in-class candidates addressing novel targets
in neurodegeneration, such as our promising alpha-synuclein PET tracer, which will generate initial clinical results this
year, and our highly valued programs targeting the NLRP3 inflammasome. Our strong track record shows that expanding our
efforts to advance these key early-stage programs may lead to multiple future opportunities for strategic partnership as well
as in-house clinical development for select indications. In parallel, we continue to collaborate with our global partners to
advance our later-stage clinical programs toward key inflection points. Looking forward in 2021, we expect to build upon our
successes and continue innovating as a leader in precision medicine for neurodegenerative disease."
2020 and Q1 2021 Research & Development Highlights
Partnership milestone payments and grants
Strengthening of Management
Future Value Creation
strategy to maximize value creation
execution strategy is focused on three key initiatives, which support the Company's overarching goal of enabling precision
medicine for neurodegenerative diseases:
Anticipated 2021 milestones
Preclinical Milestones
Therapeutic and Diagnostic Pipeline Overview
AC Immune also provided a comprehensive
overview highlighting strong progress across its clinical and preclinical development pipeline. This supplemental
material can be viewed and downloaded in the investor section of the Company's website.
Analysis of Financial Statements for
the year ended December 31, 2020
2021, the Company expects its total cash burn to range between CHF 65 million 75 million.
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, SupraAntigenTM and MorphomerTM, fuel
its broad and diversified pipeline of first- and best-in-class assets, which currently features nine 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.
For further information, please contact:
| Head of Investor Relations Joshua Drumm, Ph.D. AC Immune Phone : +1 917 809 0814 Email: joshua.drumm@acimmune.com | U.S. Media Katie Gallagher LaVoie Health Science Phone: +1 617 792 3937 Email: kgallagher@lavoiehealthscience.com |
| European Investors & Media Chris Maggos LifeSci Advisors Phone : +41 79 367 6254 Email : chris@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.
| As of December 31, | ||||||||
| 2020 | 2019 | |||||||
| ASSETS | ||||||||
| Non-current assets | ||||||||
| Property, plant and equipment | 4,416 | 3,917 | ||||||
| Right-of-use assets | 2,223 | 2,255 | ||||||
| Long-term financial assets | 334 | 304 | ||||||
| Total non-current assets | 6,973 | 6,476 | ||||||
| Current assets | ||||||||
| Prepaid expenses | 3,954 | 2,788 | ||||||
| Accrued income | 1,591 | 1,095 | ||||||
| Other current receivables | 329 | 304 | ||||||
| Short-term financial assets | 65,000 | 95,000 | ||||||
| Cash and cash equivalents | 160,893 | 193,587 | ||||||
| Total current assets | 231,767 | 292,774 | ||||||
| Total assets | 238,740 | 299,250 | ||||||
| SHAREHOLDERS' EQUITY AND LIABILITIES | ||||||||
| Shareholders' equity | ||||||||
| Share capital | 1,538 | 1,437 | ||||||
| Share premium | 346,890 | 346,526 | ||||||
| Treasury shares | (100 | ) | - | |||||
| Accumulated losses | (132,850 | ) | (75,521 | ) | ||||
| Total shareholders' equity | 215,478 | 272,442 | ||||||
| Non-current liabilities | ||||||||
| Long-term lease liabilities | 1,780 | 1,813 | ||||||
| Net employee defined benefit liabilities | 7,464 | 7,485 | ||||||
| Total non-current liabilities | 9,244 | 9,298 | ||||||
| Current liabilities | ||||||||
| Trade and other payables | 2,184 | 142 | ||||||
| Accrued expenses | 11,085 | 11,797 | ||||||
| Deferred income | 306 | 4,477 | ||||||
| Short-term financing obligation | - | 652 | ||||||
| Short-term lease liabilities | 443 | 442 | ||||||
| Total current liabilities | 14,018 | 17,510 | ||||||
| Total liabilities | 23,262 | 26,808 | ||||||
| Total shareholders' equity and liabilities | 238,740 | 299,250 |
Statements of Income/(Loss)
(In CHF thousands, except for per-share
| For the Years Ended December 31, | ||||||||||||
| 2020 | 2019 | 2018 | ||||||||||
| Revenues | ||||||||||||
| Contract revenue | 15,431 | 110,456 | 6,912 | |||||||||
| Total revenue | 15,431 | 110,456 | 6,912 | |||||||||
| Operating expenses | ||||||||||||
| Research & development expenses | (59,487 | ) | (50,432 | ) | (44,277 | ) | ||||||
| General & administrative expenses | (18,557 | ) | (16,058 | ) | (12,467 | ) | ||||||
| Other operating income/(expense) | 1,353 | 570 | 282 | |||||||||
| Total operating expenses | (76,691 | ) | (65,920 | ) | (56,462 | ) | ||||||
| Operating income/(loss) | (61,260 | ) | 44,536 | (49,550 | ) | |||||||
| Financial income | 78 | 303 | 127 | |||||||||
| Financial expense | (184 | ) | (1,926 | ) | (334 | ) | ||||||
| Change in fair value of conversion feature | - | 4,542 | - | |||||||||
| Exchange differences | (555 | ) | (2,013 | ) | (1,194 | ) | ||||||
| Finance result, net | (661 | ) | 906 | (1,401 | ) | |||||||
| Income/(loss) before tax | (61,921 | ) | 45,442 | (50,951 | ) | |||||||
| Income tax expense | - | - | - | |||||||||
| Income/(loss) for the period | (61,921 | ) | 45,442 | (50,951 | ) | |||||||
| Earnings/(loss) per share: | ||||||||||||
| Basic income/(loss) for the period attributable to equity holders | (0.86 | ) | 0.64 | (0.82 | ) | |||||||
| Diluted income/(loss) for the period attributable to equity holders | (0.86 | ) | 0.64 | (0.82 | ) |
Statements of Comprehensive Income/(Loss)
| For the Years Ended December 31, | ||||||||||||
| 2020 | 2019 | 2018 | ||||||||||
| Income/(loss) for the period | (61,921 | ) | 45,442 | (50,951 | ) | |||||||
| Other comprehensive income/(loss) not to be reclassified to income or loss in subsequent periods (net of tax) | ||||||||||||
| Remeasurement income/(losses) on defined benefit plans (net of tax) | 726 | (1,304 | ) | (302 | ) | |||||||
| Total comprehensive income/(loss), net of tax | (61,195 | ) | 44,138 | (51,253 | ) |
Reconciliation of income/(loss) to adjusted
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 | 2020 | 2019 | 2018 | |||||||||
| Income/(loss) | (61,921 | ) | 45,442 | (50,951 | ) | |||||||
| Adjustments: | ||||||||||||
| Non-cash share-based payments 1 | 4,088 | 2,834 | 2,518 | |||||||||
| Foreign currency (gains)/losses 2 | 703 | 826 | 1,179 | |||||||||
| Effective interest expenses 3 | - | 1,355 | - | |||||||||
| Change in fair value of conversion feature 4 | - | (4,542 | ) | - | ||||||||
| Adjusted income/(loss) | (57,130 | ) | 45,915 | (47,254 | ) | |||||||
| Earnings/(loss) per share - basic | (0.86 | ) | 0.64 | (0.82 | ) | |||||||
| Earnings/(loss) per share - diluted | (0.86 | ) | 0.64 | (0.82 | ) | |||||||
| Adjustment to earnings/(loss) per share - basic | 0.07 | 0.01 | 0.06 | |||||||||
| Adjustment to earnings/(loss) per share - diluted | 0.07 | 0.00 | 0.06 | |||||||||
| Adjusted earnings/(loss) per share - basic | (0.79 | ) | 0.65 | (0.76 | ) | |||||||
| Adjusted earnings/(loss) per share - diluted | (0.79 | ) | 0.64 | (0.76 | ) | |||||||
| Weighted-average number of shares used to compute adjusted loss per share - basic | 71,900,212 | 70,603,611 | 61,838,228 | |||||||||
| Weighted-average number of shares used to compute adjusted loss per share - diluted | 71,900,212 | 71,103,341 | 61,838,228 |
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.
currency re-measurement gains and losses for the period, predominantly impacted by the change in the exchange rate between the
US Dollar and the Swiss Franc.
interest expense for the period relates to the accretion of the Company's convertible loan in accordance with the effective
in fair value of conversion feature that is bifurcated from the convertible loan host debt with Lilly.
years ended December 31, 2020, 2019 and 2018 decreased net loss by CHF 4.8 million, increased net income by CHF 0.5 million and
decreased net loss by CHF 3.7 million, respectively. The Company recorded share-based compensation expenses of CHF 4.1 million,
CHF 2.8 million and CHF 2.5 million for the years ended December 31, 2020, 2019 and 2018, respectively. There were foreign currency
re-measurement losses of CHF 0.7 million, CHF 0.8 million and CHF 1.2 million for the years ended December 31, 2020, 2019 and 2018,
respectively, predominantly related to the cash balance of the Company as a result of fluctuations of the US Dollar against the
Swiss Franc. 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 2020 nor 2018.