CHF 300 million cash position as of Q1 2019 funds operations through Q3 2023
Eli Lilly deal validates MorphomerTM platform
Initiation of second Phase 2 trial of Tau antibody by partner Genentech
Multiple other products progressing, key appointments made to executive team
Lausanne, Switzerland, March 21, 2019 - AC Immune SA (NASDAQ: ACIU), a Swiss-based, clinical-stage biopharmaceutical company with a broad pipeline focused on pioneering precision medicine in neuro-degenerative diseases, today announced financial results for the year ended December 31, 2018, and provided a business and clinical update detailing its corporate progress and anticipated milestones.
Prof. Andrea Pfeifer, Ph.D., CEO of AC Immune, commented: "Our two proprietary discovery platforms, SupraAntigenTM and MorphomerTM, have generated multiple product-candidates utilizing different approaches to treating neuro-degenerative diseases. We are advancing five of these through various stages of clinical testing and expect multiple developments in 2019, including data on ACI-24 in Down syndrome and the initiation of a Phase 1 trial of Tau MorphomerTM as we advance our new partnership with Eli Lilly."
"Our partnerships with the global leaders in neuro-degeneration are a testament to our approach and already have generated CHF 292 million in funds, not including potential future milestones and royalties. We are particularly pleased with the recent validation of the small molecule Morphomer discovery platform by Lilly, which licensed rights to Tau Morphomer in December in one of the biggest deals ever for such an early-stage asset. Our cash position, approximately CHF 300 million as of Q1 2019, funds the company through Q3 2023, allowing us to continue and accelerate implementation of our strategy."
Anticipated 2019 Research & Development Outlook
AC Immune's external collaborations and broad, robust pipeline to treat neuro-degenerative diseases are driven by its proprietary technology platforms, which are fueling sustained growth. Successful delivery of external and internal research & development strategies are expected to produce multiple near-term catalysts in FY 2019-2020.
|Data read-outs|| |
|Study initiations|| |
2019 Financial Guidance
For the full year 2019, the company expects total operating expenses to range between CHF 65-80 million, up from CHF 56.8 million in 2018.
Financial Highlights 2018
Analysis of Financial Statements for the 12 months ended December 31, 2018
Key Financial Results
|For the year ended December 31,|
|(in CHF million except per share data)|
|IFRS loss for the period||(50.9)||(26.4)||(24.5)|
|IFRS EPS - basic and diluted||(0.82)||(0.46)||(0.36)|
|Non-IFRS loss for the period1||(47.2)||(20.6)||(26.6)|
|Non-IFRS EPS - basic and diluted1||(0.76)||(0.36)||(0.40)|
|As of December 31,|
|(in CHF million)|
|Cash and cash equivalents||156.5||124.4||32.1|
|Short-term financial assets||30.0||-||30.0|
|Total shareholder's equity||177.6||116.8||60.8|
Research & Development (R&D) Expenses
General & Administrative (G&A) Expenses
IFRS Loss for the period
Non-IFRS Financial Measures
The Company's operating results, as calculated in accordance with International Financial Reporting Standards, or IFRS, as adopted by the International Accounting Standards Board, we use non-IFRS Loss and non-IFRS Loss per share when monitoring and evaluating our operational performance. Non-IFRS Loss is defined as loss for the relevant period, as adjusted for certain items that we believe are not indicative of our ongoing operating performance. Non-IFRS Loss per share is defined as non-IFRS Loss for the relevant period divided by the weighted-average number of shares for such period.
The Company believes that these measures assist shareholders because they enhance comparability and provide more useful insight into operational results for the period. The Company's executive management uses these non-IFRS measures to evaluate operational performance. These non-IFRS financial measures are not meant to be considered alone or substitute for IFRS financial measures and should be read in conjunction with AC Immune's financial statements prepared in accordance with IFRS. The most directly comparable IFRS measure to these non-IFRS measures is net loss and loss per share. The following table reconciles IFRS net loss and IFRS loss per share to non-IFRS net loss and non-IFRS net loss per share for the periods presented:
Reconciliation of Loss to Adjusted Loss and Loss per Share to Adjusted Loss per Share (unaudited)
| || For the year ended |
|(in CHF millions except per share data)|
| Adjustments: |
Non-Cash share-based compensation
Foreign currency remeasurement losses
|IFRS EPS - basic and diluted||(0.82)||(0.46)||(0.36)|
|Adjustment to EPS - basic and diluted||0.06||0.10||(0.04)|
|Non-IFRS EPS - basic and diluted||(0.76)||(0.36)||(0.40)|
|Weighted-average number of shares used to compute Adjusted Earnings (Loss) per share - basic and diluted||61,838,228||57,084,295||4,753,933|
Adjustments for the years ended December 31, 2018 and 2017 were CHF 3.7 million and CHF 5.8 million in net losses, respectively. These were largely due to foreign currency remeasurement losses of CHF 1.2 million and CHF 4.2 million for the years ended December 31, 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. The Company also recorded CHF 2.5 million and CHF 1.6 million for the years ended December 31, 2018 and 2017, respectively, for share-based compensation expenses.
About AC Immune
AC Immune SA is a Nasdaq-listed clinical-stage biopharmaceutical company, which aims to become a global leader in precision medicine for neuro-degenerative diseases. The Company designs, discovers and develops therapeutic as well as diagnostic products intended to prevent and modify diseases caused by misfolding proteins. AC Immune's two proprietary technology platforms create antibodies, small molecules and vaccines designed to address a broad spectrum of neuro-degenerative indications, such as Alzheimer's disease (AD). The Company's pipeline features nine therapeutic and three diagnostic product candidates, with five currently in clinical trials. It has collaborations with major pharmaceutical companies including Roche/Genentech, Lilly, Biogen, Janssen Pharmaceuticals, Nestlé Institute of Health Sciences, Life Molecular Imaging (formerly Piramal Imaging) and Essex Bio-Technology.
For further information, please contact:
| U.S. Investors |
AC Immune Investor Relations
Phone: +1 970 987 26 54
| U.S. Media |
Phone: +1 617 792 3937
| European Investors & Media |
Phone: +41 79 367 6254
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.
 Non-IFRS (Loss) and Non-IFRS EPS are non-IFRS measures. See "Non-IFRS Financial Measures" below for further information
 Liquidity is defined as the cash and cash equivalents plus short-term financial assets. These short-term financial assets are comprised of cash held in fixed-term deposits ranging in maturity from 3-12 months