Lausanne, Switzerland, May 15, 2019 - AC Immune SA (NASDAQ: ACIU), a Swiss-based, biopharmaceutical company with a broad clinical-stage pipeline focused on pioneering Precision Medicine in neurodegenerative diseases, today announced financial results for the first quarter ended March 31, 2019.
Prof. Andrea Pfeifer, Ph.D., CEO of AC Immune, commented: "Our CHF 300 million cash position, funds operations through Q3 2023, allowing us to achieve multiple potentially transformative goals. This is thanks to SupraAntigenTM and MorphomerTM, our proprietary discovery platforms, which already have generated multiple clinical and preclinical product-candidates and about CHF 300 million in partnering revenues for rights to our industry-leading therapeutic candidates to treat neurodegenerative diseases. We expect multiple developments in 2019, including initiation of a Phase 1 trial of small molecule Tau MorphomerTM, as we advance our new partnership with Eli Lilly, and the interim Phase 1b data on ACI-24 to treat Alzheimer's disease (AD) in Down syndrome."
"Our key near- to medium-term focus is on developing our Tau therapies to treat early and moderate AD based on the growing body of clinical evidence that Tau pathology drives disease progression," added Dr Pfeifer. "As the key opinion leaders have advised, we also are continuing testing of Abeta therapeutics, like ACI-24 and crenezumab, in carefully selected more homogeneous populations for early treatment and prevention, such as AD in Down syndrome patients and familial AD, respectively. The Roadmap to successful therapies for neurodegenerative diseases like Alzheimer's requires that we treat earlier in the course of disease and select more homogenous populations using Precision Medicine and, as soon as practical, combination therapies."
Financial Highlights Q1 2019
Research & Development Highlights Q1 2019
Analysis of Financial Statements for the Three Months Ended March 31, 2019
Revenues
Research & Development (R&D) Expenses
General & Administrative (G&A) Expenses
IFRS Income/(Loss) for the period
Balance Sheet
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 neurodegenerative diseases. The Company is utilizing two proprietary discovery 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 five currently in clinical trials. It has collaborations with major pharmaceutical companies including Roche/Genentech, Lilly and Janssen.
For further information, please contact:
U.S. Investors Lisa Sher AC Immune Investor Relations Phone: +1 970 987 26 54 E-mail: lisa.sher@acimmune.com | U.S. Media Katie Gallagher LaVoieHealthScience Phone: +1 617 792 3937 E-mail: kgallagher@lavoiehealthscience.com |
European Investors & Media Chris Maggos LifeSci Advisors Phone: +41 79 367 6254 E-mail: 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.
Balance Sheets
As of | As of December 31, | |
in CHF thousands | ||
ASSETS | ||
Non-current assets | ||
Property, plant and equipment............................................................ | 3,570 | 3,324 |
Right-of-use assets............................................................................ | 2,082 | - |
Long-term financial assets.................................................................. | 304 | 304 |
Total non-current assets.................................................................... | 5,956 | 3,628 |
Current assets | ||
Prepaid expenses............................................................................... | 3,000 | 2,364 |
Accrued income................................................................................. | 813 | 3,667 |
Finance receivable ............................................................................. | 201 | 199 |
Other current receivables..................................................................... | 784 | 236 |
Short-term financial assets.................................................................. | 80,000 | 30,000 |
Cash and cash equivalents.................................................................. | 222,138 | 156,462 |
Total current assets........................................................................... | 306,936 | 192,928 |
Total assets....................................................................................... | 312,892 | 196,556 |
SHAREHOLDERS' EQUITY AND LIABILITIES | ||
Shareholders' equity | ||
Share capital...................................................................................... | 1,361 | 1,351 |
Share premium................................................................................... | 298,259 | 298,149 |
Accumulated losses........................................................................... | (57,766) | (121,877) |
Total shareholders' equity................................................................. | 241,854 | 177,623 |
Non-current liabilities | ||
Long-term financing obligation............................................................ | 225 | 186 |
Long-term lease liabilities.................................................................... | 1,666 | - |
Long-term deferred income................................................................. | 2,628 | - |
Net employee defined benefit liabilities................................................ | 5,809 | 5,665 |
Total non-current liabilities............................................................... | 10,328 | 5,851 |
Current liabilities | ||
Trade and other payables.................................................................... | 829 | 1,979 |
Accrued expenses.............................................................................. | 8,800 | 10,420 |
Short-term deferred income................................................................. | 3,546 | 351 |
Convertible loan................................................................................. | 46,740 | - |
Liability related to conversion feature................................................... | 43 | - |
Short-term debt obligation.................................................................. | 336 | 332 |
Short-term lease liabilities................................................................... | 416 | - |
Total current liabilities...................................................................... | 60,710 | 13,082 |
Total liabilities.................................................................................. | 71,038 | 18,933 |
Total shareholders' equity and liabilities........................................... | 312,892 | 196,556 |
Statement of Income/(Loss)
For the Three Months | |||
2019 | 2018 | ||
in CHF thousands except for share and per share data | |||
Revenue | |||
Contract revenue......................................................................... | 75,042 | 1,458 | |
Total revenue............................................................................. | 75,042 | 1,458 | |
Operating expenses | |||
Research & development expenses.............................................. | (11,592) | (10,069) | |
General & administrative expenses............................................... | (3,294) | (2,711) | |
Total operating expenses........................................................... | (14,886) | (12,780) | |
Operating income/(loss)............................................................. | 60,156 | (11,322) | |
Finance expense, net................................................................... | (80) | (281) | |
Change in fair value of conversion feature.................................... | 4,505 | - | |
Interest income............................................................................ | 89 | 1 | |
Interest expense.......................................................................... | (1,096) | (12) | |
Finance result, net..................................................................... | 3,418 | (292) | |
Income/(loss) before tax............................................................. | 63,574 | (11,614) | |
Income tax expense................................................................... | - | - | |
Income/(loss) for the period....................................................... | 63,574 | (11,614) | |
Income/(loss) per share (EPS): | |||
Basic income/(loss) for the period attributable to equity holders.... | 0.94 | (0.20) | |
Diluted income/(loss) for the period attributable to equity holders.. | 0.91 | (0.20) |
Statements of Comprehensive Income/(Loss) | For the Three Months | |
2019 | 2018 | |
in CHF thousands | ||
Income/(loss) for the period ............................................................................ | 63,574 | (11,614) |
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 ............................................ | - | - |
Total comprehensive income/(loss), net of tax................................................... | 63,574 | (11,614) |
Reconciliation of Income/(Loss) to Adjusted Income/(Loss) and
Earnings/(Loss) Per Share to Adjusted Earnings/(Loss) Per Share
For the Three Months | |||
2019 | 2018 | ||
in CHF thousands except for share and per share data | |||
Income/(Loss)............................................................................ | 63,574 | (11,614) | |
Adjustments: | |||
Non-cash share-based payments (a) ............................................ | 584 | 602 | |
Foreign currency losses (b) ......................................................... | 45 | 202 | |
Effective interest expense (c) ...................................................... | 991 | - | |
Change in fair value of conversion feature (d)............................... | (4,505) | - | |
Adjusted Income/(Loss) ............................................................ | 60,689 | (10,810) | |
|
| ||
Earnings/(Loss) per share - basic.............................................. | 0.94 | (0.20) | |
Earnings/(Loss) per share - diluted............................................ | 0.91 | (0.20) | |
Adjustment to earnings/(loss) per share - basic......................... | (0.05) | 0.01 | |
Adjustment to earnings/(loss) per share - diluted...................... | (0.06) | 0.01 | |
Adjusted earnings/(loss) per share - basic................................. | 0.89 | (0.19) | |
Adjusted earnings/(loss) per share - diluted.............................. | 0.85 | (0.19) | |
Weighted-average number of shares used to compute Adjusted earnings/(loss) per share - basic.................................................. | 67,922,939 | 57,368,015 | |
Weighted-average number of shares used to compute Adjusted earnings/(loss) per share - diluted................................................ | 71,276,000 | 57,368,015 |
(a) Reflects 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.
(b) Reflects foreign currency remeasurement gains and losses for the period, predominantly impacted by the change in the exchange rate between the US Dollar and the Swiss Franc.
(c) Effective interest expense for the period relates to the accretion of the Company's convertible loan in accordance with the effective interest method.
(d) Change in fair value of conversion feature that is bifurcated from the convertible loan host debt with Lilly.
Adjustments for the three months ended March 31, 2019 and March 31, 2018 were CHF 2.9 million in net gains compared to CHF 0.8 million in net losses. The Company recorded CHF 0.6 million for the three months, respectively, for share-based compensation expenses. There were foreign currency remeasurement losses of CHF 45 thousand and CHF 0.2 million, respectively, predominantly related to the reduced foreign currency cash balance of the Company and reduced exposure to foreign currency fluctuations. The Company recorded CHF 1.0 million for amortization of effective interest for the three months ended March 31, 2019. Finally, the Company recognized a CHF 4.5 million gain for the change in fair value of the liability related to the conversion feature.