LAUSANNE, Switzerland, Aug. 14, 2019 (GLOBE NEWSWIRE) -- AC Immune SA (NASDAQ: ACIU), a Swiss-based, biopharmaceutical company with a broad clinical-stage pipeline focused on neurodegenerative diseases, today announced its business and clinical plan and strategy, reported consolidated financial results for the second quarter of 2019 and its revised cash guidance.
Prof. Andrea Pfeifer, Ph.D., CEO of AC Immune, commented: “Our business strategy is based on a three-pillar approach in the development of treatments for Alzheimer’s disease, NeuroOrphan therapeutics and diagnostics. Our Roadmap to Successful Therapies for Neurodegenerative Diseases is based on treating earlier, targeting Tau, incorporating homogeneous populations, applying precision medicine and targeting neuroinflammation.”
There is a growing body of clinical evidence that Tau drives disease progression. AC Immune has one of the broadest anti-Tau pipelines with antibodies, small molecules, vaccines and diagnostics, covering five clinical trials and partnerships with four major pharmaceutical companies.
“SupraAntigenTM and MorphomerTM, our proprietary discovery platforms are the foundation for multiple product candidates," added Dr. Pfeifer. “The productivity of these platforms has recently demonstrated significant clinical, value-creating milestones.”
Research & Development Highlights Q2 2019 and Beyond
Anticipated Near-Term Milestones
Analysis of Financial Statements for the Three and Six Months Ended June 30, 2019
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 Pharmaceuticals Inc.
As a strategic leader in the field of neurodegenerative diseases, AC Immune has developed a five point Roadmap to Successful Therapies for Neurodegenerative Diseases that recognizes the importance of treating earlier, targeting Tau, focusing on more homogeneous populations, precision medicine and exploring neuroinflammation as a target.
For further information, please contact:
U.S. Investors Joshua Drumm, Ph.D. AC Immune Investor Relations Phone: +1 646 876 5538 E-mail: joshua.drumm@acimmune.com | U.S. Media Katie Gallagher LaVoieHealthScience Phone: +1 617 792 3937 E-mail: kgallagher@lavoiehealthscience.com |
European Media Judith Moore AC Immune Global Communication Lead Phone: +44 7932 053829 Email: judith.moore@acimmune.com | European Investors 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 June 30, 2019 | As of December 31, 2018 | ||||
in CHF thousands | |||||
ASSETS | |||||
Non-current assets | |||||
Property, plant and equipment | 3,594 | 3,324 | |||
Right-of-use assets | 1,978 | - | |||
Long-term financial assets | 304 | 304 | |||
Total non-current assets | 5,876 | 3,628 | |||
Current assets | |||||
Prepaid expenses | 2,917 | 2,364 | |||
Accrued income | 547 | 3,667 | |||
Finance receivable | 98 | 199 | |||
Other current receivables | 1,049 | 236 | |||
Short-term financial assets | 80,000 | 30,000 | |||
Cash and cash equivalents | 205,735 | 156,462 | |||
Total current assets | 290,346 | 192,928 | |||
Total assets | 296,222 | 196,556 | |||
SHAREHOLDERS’ EQUITY AND LIABILITIES | |||||
Shareholders’ equity | |||||
Share capital | 1,436 | 1,351 | |||
Share premium | 346,024 | 298,149 | |||
Accumulated losses | (74,170 | ) | (121,877 | ) | |
Total shareholders’ equity | 273,290 | 177,623 | |||
Non-current liabilities | |||||
Long-term financing obligation | 256 | 186 | |||
Long-term lease liabilities | 1,559 | - | |||
Long-term deferred income | 1,903 | - | |||
Net employee defined benefit liabilities | 5,954 | 5,665 | |||
Total non-current liabilities | 9,672 | 5,851 | |||
Current liabilities | |||||
Trade and other payables | 156 | 1,979 | |||
Accrued expenses | 8,414 | 10,420 | |||
Short-term deferred income | 3,941 | 351 | |||
Short-term debt obligation | 329 | 332 | |||
Short-term lease liabilities | 420 | - | |||
Total current liabilities | 13,260 | 13,082 | |||
Total liabilities | 22,932 | 18,933 | |||
Total shareholders’ equity and liabilities | 296,222 | 196,556 | |||
Statements of Income/(Loss)
For the Three Months Ended June 30, | For the Six Months Ended June 30, | ||||||||||
2019 | 2018 | 2019 | 2018 | ||||||||
(in CHF thousands except for per share data) | |||||||||||
Revenue | |||||||||||
Contract revenue | 1,511 | 2,028 | 76,553 | 3,486 | |||||||
Total revenue | 1,511 | 2,028 | 76,553 | 3,486 | |||||||
Operating expenses | |||||||||||
Research & development expenses | (12,700 | ) | (10,533 | ) | (24,293 | ) | (20,604 | ) | |||
General & administrative expenses | (3,585 | ) | (3,065 | ) | (6,879 | ) | (5,770 | ) | |||
Total operating expenses | (16,285 | ) | (13,598 | ) | (31,172 | ) | (26,374 | ) | |||
Operating income/(loss) | (14,774 | ) | (11,570 | ) | 45,381 | (22,888 | ) | ||||
Finance income / (expense), net | (1,732 | ) | 447 | (1,812 | ) | 165 | |||||
Change in fair value of conversion feature | 36 | — | 4,542 | — | |||||||
Interest income | 75 | 2 | 164 | 3 | |||||||
Interest expense | (504 | ) | (22 | ) | (1,601 | ) | (35 | ) | |||
Finance result, net. | (2,125 | ) | 427 | 1,293 | 133 | ||||||
Income/(loss) before tax | (16,899 | ) | (11,143 | ) | 46,674 | (22,755 | ) | ||||
Income tax expense | — | — | — | — | |||||||
Income/(loss) for the period | (16,899 | ) | (11,143 | ) | 46,674 | (22,755 | ) | ||||
Income/(loss) per share (EPS): | |||||||||||
Basic income/(loss) for the period attributable to equity holders | (0.24 | ) | (0.19 | ) | 0.67 | (0.40 | ) | ||||
Diluted income/(loss) for the period attributable to equity holders | (0.24 | ) | (0.19 | ) | 0.67 | (0.40 | ) | ||||
Statements of Comprehensive Income/(Loss)
For the Three Months Ended June 30, | For the Six Months Ended June 30, | |||||||||
2019 | 2018 | 2019 | 2018 | |||||||
(in CHF thousands) | ||||||||||
Income/(loss) for the period | (16,899 | ) | (11,143 | ) | 46,674 | (22,755 | ) | |||
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 | (16,899 | ) | (11,143 | ) | 46,674 | (22,755 | ) | |||
Reconciliation of Income/(Loss) to Adjusted Income/(Loss) and
Earnings/(Loss) Per Share to Adjusted Earnings/(Loss) Per Share
For the Three Months Ended June 30, | For the Six Months Ended June 30, | ||||||||||
2019 | 2018 | 2019 | 2018 | ||||||||
(in CHF thousands except for share and per share data) | |||||||||||
Income/(Loss) | (16,899 | ) | (11,143 | ) | 46,674 | (22,755 | ) | ||||
Adjustments: | |||||||||||
Non-cash share-based payments (a) | 561 | 712 | 1,146 | 1,314 | |||||||
Foreign currency losses (b) | 513 | (397 | ) | 558 | (195 | ) | |||||
Effective interest expense (c) | 364 | — | 1,355 | — | |||||||
Change in fair value of conversion feature (d) | (36 | ) | — | (4,542 | ) | — | |||||
Adjusted Income/(Loss) | (15,497 | ) | (10,828 | ) | 45,191 | (21,636 | ) | ||||
Earnings/(Loss) per share – basic | (0.24 | ) | (0.19 | ) | 0.67 | (0.40 | ) | ||||
Earnings/(Loss) per share – diluted | (0.24 | ) | (0.19 | ) | 0.67 | (0.40 | ) | ||||
Adjustment to earnings/(loss) per share – basic | 0.02 | 0.00 | (0.02 | ) | 0.02 | ||||||
Adjustment to earnings/(loss) per share – diluted | 0.02 | 0.00 | (0.02 | ) | 0.02 | ||||||
Adjusted earnings/(loss) per share – basic | (0.22 | ) | (0.19 | ) | 0.65 | (0.38 | ) | ||||
Adjusted earnings/(loss) per share – diluted. | (0.22 | ) | (0.19 | ) | 0.65 | (0.38 | ) | ||||
Weighted-average number of shares used to compute Adjusted earnings/(loss) per share – basic | 70,764,091 | 57,423,650 | 69,351,363 | 57,395,987 | |||||||
Weighted-average number of shares used to compute Adjusted earnings/(loss) per share – diluted | 70,764,091 | 57,423,650 | 69,845,858 | 57,395,987 |
(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.
For the three and six months ended June 30, 2019, adjustments decreased net loss and net income by CHF 1.4 million and CHF 1.5 million compared with decreases to the net losses by CHF 0.3 million and CHF 1.1 million for the comparable periods in 2018, respectively. The Company recorded CHF 0.6 million and CHF 1.1 million for the three and six months, respectively, for share-based compensation expenses. There were foreign currency remeasurement losses of CHF 0.5 million and 0.6 million, respectively, predominantly related to foreign currency fluctuations. The Company recorded CHF 0.4 million and CHF 1.4 million for amortization of effective interest for the three and six months ended June 30, 2019, respectively. Finally, the Company recognized less than a CHF 0.1 million and a CHF 4.5 million gain for the change in fair value of the liability related to the conversion feature.