Full Press Release Details
AC Immune Reports Full-Year 2019 Financial
Provides 2020 R&D Outlook
Lausanne, Switzerland, March 30, 2020
- AC Immune SA (NASDAQ: ACIU), a Swiss-based, clinical-stage biopharmaceutical company with a broad pipeline focused on neurodegenerative
diseases, today announced financial results for the year ended December 31, 2019, and provided a business and 2020 research and
development outlook.
Prof. Andrea Pfeifer, CEO of AC Immune
SA, commented: "AC Immune is building on clinical and business accomplishments in 2019, and anticipates multiple clinical,
value-creating milestones in 2020. We anticipate reporting data from two studies of our proprietary anti-Abeta vaccine program,
ACI-24 as well as Phase 1 results for the small molecule Morphomer Tau aggregation inhibitor, ACI-3024, in partnership with
Eli Lilly and Company.
Prof. Pfeifer continued: "In
parallel, our heritage as a leader in delivering cutting-edge science enables our Company
to advance novel preclinical therapeutic and diagnostic candidates focused on emerging targets and neuroinflammation towards the
clinic, setting the stage for additional value creation and partnership opportunities. AC Immune's leading position
in the field is built upon our proprietary discovery technology platforms, SupraAntigenTM and MorphomerTM,
as well as our personalized medicine approach and exceptional development execution."
and Q1 2020 Research & Development Highlights
Successful execution in preclinical and
clinical development during 2019 resulted in a stronger pipeline.
during Q3 2019 and CHF 10 million in Q1 2020; and, AC Immune now is eligible
for a new additional milestone payment of CHF 60 million within 60 days after dosing of the first patient in the first Phase 2
clinical trial of a Morphomer Tau in the United States or European Union. The amendment to the financial terms increases
the total deal value by CHF 40 million to CHF 1.86 billion, up from CHF 1.82 billion.
2020 Research & Development Outlook
The coming years will be transformational
for the field of neuroscience and AC Immune is poised to make significant clinical contributions, capturing substantial interest
and value in 2020 and beyond. The Company will deliver multiple near-term catalysts, including results from five clinical trials.
The Company's sustained growth is driven by its industry-leading Roadmap to Successful Therapies
for Neurodegenerative Diseases, and is fueled by its proprietary technology platforms, SupraAntigenTM
and MorphomerTM, which continue to generate therapeutic antibody, small molecule and vaccine candidates.
2020 Clinical Readouts
2020 Preclinical Milestones
concluded: "In summary, 2020 begins a decade with the potential for major neuroscience advances. With AC Immune's
remarkably broad development pipeline focused on neurodegenerative diseases we have multiple opportunities to contribute to the
advancement of this field from a business, clinical and human perspective."
Financial Statements for the year ended December 31, 2019
antibody and a CHF 0.7 million increase for manufacturing and preparation of the Phase 2 study for ACI-24 for DS. Additionally,
the personnel costs increased by CHF 1.6 million through the addition of 16 FTEs with remaining increases of CHF 2.8 million in
the area of consumables, depreciation of R&D equipment and regulatory and quality assurance
2020, the Company expects its total cash burn to range between CHF 65 80 million at constant exchange rates.
Immune SA is a Nasdaq-listed clinical-stage biopharmaceutical company, which aims to become a global leader in precision medicine
for neurodegenerative diseases. The Company utilizes two proprietary platforms, SupraAntigenTM and MorphomerTM,
to design, discover and develop small molecule and biological therapeutics as well as diagnostic products intended to diagnose,
prevent and modify neurodegenerative diseases caused by misfolding proteins. The Company's pipeline features nine therapeutic and
three diagnostic product candidates, with six currently in clinical trials. It has collaborations with major pharmaceutical companies
including Roche/Genentech, Lilly and Janssen.
For further information, please contact:
| Head of Investor Relations Joshua Drumm AC Immune Phone: +1 917 809 0814 Email: joshua.drumm@acimmune.com | US Media Katie Gallagher LaVoieHealthScience Phone: +1 617 792 3937 Email: kgallagher@lavoiehealthscience.com |
| Global Head of Communications Judith Moore AC Immune Phone: +41 79 826 63 82 Email: judith.moore@acimmune.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. 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, 2019 | As of December 31, 2018 | |||||||
| ASSETS | ||||||||
| Non-current assets | ||||||||
| Property, plant and equipment | 3,917 | 3,324 | ||||||
| Right-of-use assets | 2,255 | - | ||||||
| Long-term financial assets | 304 | 304 | ||||||
| Total non-current assets | 6,476 | 3,628 | ||||||
| Current assets | ||||||||
| Prepaid expenses | 2,788 | 2,364 | ||||||
| Accrued income | 1,095 | 3,667 | ||||||
| Finance receivable | - | 199 | ||||||
| Other current receivables | 304 | 236 | ||||||
| Short-term financial assets | 95,000 | 30,000 | ||||||
| Cash and cash equivalents | 193,587 | 156,462 | ||||||
| Total current assets | 292,774 | 192,928 | ||||||
| Total assets | 299,250 | 196,556 | ||||||
| SHAREHOLDERS' EQUITY AND LIABILITIES | ||||||||
| Shareholders' equity | ||||||||
| Share capital | 1,437 | 1,351 | ||||||
| Share premium | 346,526 | 298,149 | ||||||
| Accumulated losses | (75,521 | ) | (121,877 | ) | ||||
| Total shareholders' equity | 272,442 | 177,623 | ||||||
| Non-current liabilities | ||||||||
| Long-term financing obligation | - | 186 | ||||||
| Long-term lease liabilities | 1,813 | - | ||||||
| Net employee defined benefit liabilities | 7,485 | 5,665 | ||||||
| Total non-current liabilities | 9,298 | 5,851 | ||||||
| Current liabilities | ||||||||
| Trade and other payables | 142 | 1,979 | ||||||
| Accrued expenses | 11,797 | 10,420 | ||||||
| Short-term deferred income | 4,477 | 351 | ||||||
| Short-term financing obligation | 652 | 332 | ||||||
| Short-term lease liabilities | 442 | - | ||||||
| Total current liabilities | 17,510 | 13,082 | ||||||
| Total liabilities | 26,808 | 18,933 | ||||||
| Total shareholders' equity and liabilities | 299,250 | 196,556 |
Statements of Income/(Loss)
(in CHF thousands except for per share data)
| For the years ended December 31, | ||||||||||||
| 2019 | 2018 | 2017 | ||||||||||
| Revenue | ||||||||||||
| Contract revenue | 111,026 | 7,194 | 20,255 | |||||||||
| Total revenue | 111,026 | 7,194 | 20,255 | |||||||||
| Operating expenses | ||||||||||||
| Research & development expenses | (50,432 | ) | (44,277 | ) | (32,663 | ) | ||||||
| General & administrative expenses | (16,058 | ) | (12,467 | ) | (10,131 | ) | ||||||
| Total operating expenses | (66,490 | ) | (56,774 | ) | (42,794 | ) | ||||||
| Operating income/(loss) | 44,536 | (49,550 | ) | (22,539 | ) | |||||||
| Finance income / (expense), net | (2,046 | ) | (1,132 | ) | (4,055 | ) | ||||||
| Change in fair value of conversion feature | 4,542 | - | - | |||||||||
| Interest income | 304 | 29 | 330 | |||||||||
| Interest expense | (1,894 | ) | (298 | ) | (147 | ) | ||||||
| Finance result, net | 906 | (1,401 | ) | (3,872 | ) | |||||||
| Income/(loss) before tax | 45,442 | (50,951 | ) | (26,411 | ) | |||||||
| Income tax expense | - | - | - | |||||||||
| Income/(loss) for the period | 45,442 | (50,951 | ) | (26,411 | ) | |||||||
| Income/(loss) per share (EPS): | ||||||||||||
| Basic income/(loss) for the period attributable to equity holders | 0.64 | (0.82 | ) | (0.46 | ) | |||||||
| Diluted income/(loss) for the period attributable to equity holders | 0.64 | (0.82 | ) | (0.46 | ) |
Statements of Comprehensive Income/(Loss)
| For the years ended December 31, | ||||||||||||
| 2019 | 2018 | 2017 | ||||||||||
| Income/(loss) for the period | 45,442 | (50,951 | ) | (26,411 | ) | |||||||
| Other comprehensive income/(loss) not to be reclassified to income or loss in subsequent periods (net of tax): | ||||||||||||
| Re-measurement losses on defined benefit plans (net of tax) | (1,304 | ) | (302 | ) | (780 | ) | ||||||
| Total comprehensive income/(loss), net of tax | 44,138 | (51,253 | ) | (27,191 | ) |
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) | 2019 | 2018 | 2017 | |||||||||
| Income/(Loss) | 45,442 | (50,951 | ) | (26,411 | ) | |||||||
| Adjustments: | ||||||||||||
| Non-cash share-based payments (a) | 2,834 | 2,518 | 1,579 | |||||||||
| Foreign currency (gains)/losses (b) | 826 | 1,179 | 4,168 | |||||||||
| Effective interest expense (c) | 1,355 | - | - | |||||||||
| Change in fair value of conversion feature (d) | (4,542 | ) | - | - | ||||||||
| Adjusted Income/(Loss) | 45,915 | (47,254 | ) | (20,664 | ) | |||||||
| Earnings/(Loss) per share - basic | 0.64 | (0.82 | ) | (0.46 | ) | |||||||
| Earnings/(Loss) per share - diluted | 0.64 | (0.82 | ) | (0.46 | ) | |||||||
| Adjustment to earnings/(loss) per share - basic | 0.01 | 0.06 | 0.10 | |||||||||
| Adjustment to earnings/(loss) per share - diluted | 0.00 | 0.06 | 0.10 | |||||||||
| Adjusted earnings/(loss) per share - basic | 0.65 | (0.76 | ) | (0.36 | ) | |||||||
| Adjusted earnings/(loss) per share - diluted | 0.64 | (0.76 | ) | (0.36 | ) | |||||||
| Weighted-average number of shares used to compute Adjusted Loss per share - basic | 70,603,611 | 61,838,228 | 57,084,295 | |||||||||
| Weighted-average number of shares used to compute Adjusted Loss per share - diluted | 71,103,341 | 61,838,228 | 57,084,295 |
Adjustments for the years ended December
31, 2019, 2018 and 2017, were CHF 0.4 million in net gains, CHF 3.7 million in net losses and CHF 5.7 million in net losses, respectively.
The Company recorded CHF 2.8 million, CHF 2.5 million and CHF 1.6 million for the years ended December 31, 2019, 2018 and 2017,
respectively, for share-based compensation expenses. There were foreign currency remeasurement losses of CHF 0.8 million, CHF 1.2
million, CHF 4.2 million for the years ended December 31, 2019, 2018 and 2017, 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 and gains in 2018 nor 2017, respectively.