AC Immune Reports Q1 2019 Financial Results and Business Update
Prof.
“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
- Enhanced cash position of more than
CHF 300 million as of Q1 2019, following receipt ofCHF 80 million upfront payment andUSD 50 million convertible equity note as a result of license agreement withEli Lilly , effective inJanuary 2019 . - Strategic R&D expenditures increased by
CHF 1.5 million (+15%) supporting an ongoing ramp-up in R&D activities, primarily driven by investments in our neurodegenerative disease therapeutics development and discovery programs, most notably ACI-35. - IFRS net income of
CHF 63.6 million and Non-IFRS income ofCHF 60.7 million .
Research & Development Highlights Q1 2019
- License agreement signed with Lilly to research and develop Tau aggregation inhibitor small molecules for the potential treatment of Alzheimer’s disease and other neurodegenerative diseases. The terms include upfront payment of
CHF 80 million ,USD 50 million convertible equity note,CHF 60 million in potential near-term milestones, as well as other milestones up to approximatelyCHF 1.68 billion , and tiered royalty payments in the low double digits. - Presented new data on alpha-synuclein PET Tracer at the Alzheimer’s and Parkinson’s
Diseases Congress (AD/PD)™ Lisbon,Portugal , March 26–31, 2019. - New clinical data on
AC Immune's novel next generation Tau PET-Tracer presented by licensing partner, Life Molecular Imaging, at AD/PD™. - Genentech, a member of
Roche Group , commenced recruitment for a second Phase 2 trial of AC Immune’s anti-Tau monoclonal antibody, RG6100 (MTAAU9937A, RO7105705), in moderate AD, supplementing a separate Phase 2 trial to evaluate its efficacy and safety in participants with prodromal to mild AD. Roche discontinued CREAD 1 and CREAD 2, Phase 3 studies of crenezumab and presented an interim analysis of CREAD studies at AD/PD™ onMarch 27, 2019 .- The landmark Alzheimer's Prevention Initiative (API) trial of crenezumab, for which data are expected in Q1 of 2022, is continuing in cognitively healthy individuals in
Colombia with an autosomal dominant mutation who are at high risk of developing familial AD.
Analysis of Financial Statements for the Three Months Ended
Revenues
- Revenues for the first quarter of 2019 increased
CHF 73.6 million compared to 2018, driven by recognition ofCHF 73.9 million from the right-of-use license and research and development activities. Revenues fluctuate as a result of payments associated with our collaborations with current and potentially new partners, the timing of milestone achievements and the size of each milestone payment.
Research & Development (R&D) Expenses
- Total R&D expenditures increased
CHF 1.5 million (+15%) for the three months endedMarch 31, 2019 compared to 2018.
General & Administrative (G&A) Expenses
- For the three months ended
March 31, 2019 , G&A increasedCHF 0.6 million (+22%) toCHF 3.3 million . Increase driven by rental and personnel expenses.
IFRS Income/(Loss) for the period
AC Immune had net income after taxes ofCHF 63.6 million in 2019 compared with a net loss ofCHF 11.6 million for the comparable period in 2018.
Balance Sheet
- The Company had a total cash balance of
CHF 302.1 million comprised ofCHF 222.1 million in cash and cash equivalents andCHF 80.0 million in short-term financial assets. This compares toCHF 186.5 million as ofDecember 31, 2018 . The increase ofCHF 115.6 million is principally due to theCHF 80 million upfront payment andUSD 50 million convertible equity note with Lilly. Further details are available in our Statements of Cash flows on the accompanying Form 6-K. - The Company’s strong cash balance provides enough capital resources to progress through at least Q3 2023, not considering any incoming milestones.
- The total shareholders’ equity position increased from
December 31, 2018 toCHF 241.9 million fromCHF 177.6 million . Further details are available in our corresponding Financial Statements filed on the accompanying Form 6-K.
About
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
Balance Sheets
As of March 31, 2019 |
As of December 31, 2018 |
|||
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 Ended March 31, |
||||||
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 ended March 31, |
|||
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 Ended March 31, |
|||||||
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 |
- 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.
- 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.
- Effective interest expense for the period relates to the accretion of the Company’s convertible loan in accordance with the effective interest method.
- Change in fair value of conversion feature that is bifurcated from the convertible loan host debt with Lilly.
Adjustments for the three months ended