AC Immune reports full-year 2017 financial results - successful first year as a public company
Prof.
Financial Highlights 2017
- Strategic R&D expenditures rose by
CHF 6.9 million (+27%) supporting an ongoing ramp-up in R&D activities primarily driven by investments in our Diagnostics and New Discovery programs and pipeline advancements in our proprietary and partnered key vaccine programs - Ongoing strong financial position with
CHF 124.4 million in cash, allowing the company to be fully financed through Q2 2019, excluding potential incoming milestones - Increase in property and equipment to enhance our research facilities by
CHF 1.8 million (+55%), as well as increase in R&D personnel expenses ofCHF 1.8 million with increase of 15 FTEs (+28%) in 2017 - IFRS net operating loss of
CHF 26.4 million and adjusted (Non-IFRS) loss ofCHF 20.6 million 1
Key Financial Results
| For the year ended December 31, | ||||
| 2017 | 2016 | Change | ||
| (in CHF million except per share data) | ||||
| Contract revenue | 20.3 | 23.2 | (2.9) | |
| R&D expenses | (32.7) | (25.8) | (6.9) | |
| G&A expenses | (10.1) | (7.9) | (2.2) | |
| IFRS (Loss) for the period | (26.4) | (7.1) | (19.3) | |
| IFRS EPS - basic and diluted | (0.46) | (0.14) | (0.32) | |
| Non-IFRS (Loss) for the period1 | (20.6) | (9.2) | (11.4) | |
| Non-IFRS EPS - basic and diluted1 | (0.36) | (0.18) | (0.18) | |
| 1 Adjusted (Loss) and Adjusted EPS are non-IFRS measures. See "Non-IFRS Financial Measures" below for further information. | ||||
| As of December 31, |
|
||
| 2017 | 2016 | Change | |
| (in CHF million) | |||
| Cash and cash equivalents | 124.4 | 152.2 | (27.8) |
| Total shareholder's equity | 116.8 | 142.4 | (25.6) |
Research & Development Highlights 2017
- Crenezumab: initiated a second pivotal Phase 3 trial CREAD in 750 subjects with prodromal to mild Alzheimer's disease
- Received a
CHF 14 million milestone payment from Genentech for the first dosing in a Phase 2 clinical trial for Alzheimer's disease with an anti-Tau antibody - Completed recruitment for low-dose cohort of participants in a Phase 1 trial targeting Alzheimer's disease-like characteristics in individuals with Down syndrome
- Discovered next-generation antibodies for two targets that are important in the pathogenesis of significant neurodegenerative and neuro-orphan diseases (TDP-43 and alpha-synuclein)
- Discovered potentially the first selective alpha-synuclein positron emission tomography (PET) tracer for Parkinson's disease
- Signed a research collaboration agreement with
Essex Bio-Technology to develop a novel biological therapeutic for the treatment of neurodegenerative diseases and neuroinflammation; the company's first R&D base inAsia - Awarded a continuation grant from
The Michael J. Fox Foundation for Parkinson's Research for the development of an alpha-synuclein PET tracer - Hosted a Key Opinion Leader (KOL) event focused on Tau as a Therapeutic and Diagnostic Target in Alzheimer's and other Neurodegenerative Diseases
Milestones achieved in 2017
Crenezumab: Second Phase 3 study commenced
Genentech, a member of the
Anti-Tau Antibody moved into Phase 2 Trial for Alzheimer's disease triggering
Genentech, a member of the
Pipeline expansion with new antibodies active against alpha-synuclein and TDP-43
This discovery marks the advancement of our business strategy by targeting pathological proteins involved in Alzheimer's disease and Parkinson's disease, beyond Abeta and Tau. These two antibodies may potentially also address significant neurodegenerative and orphan indications. Alpha-synuclein is an established target for Parkinson's disease and other Lewy body diseases while TDP-43 is a recently identified target of growing interest for neuro-orphan indications such as Frontotemporal Lobar Degeneration. Both antibodies were discovered using the company's proprietary SupraAntigen(TM) platform which has already generated four products in clinical development including crenezumab, our lead product candidate that is partnered with Genentech, a member of the
ACI-24 - anti-Abeta vaccine for AD is advancing to Phase 2
The Phase 1/2a clinical study to evaluate safety, tolerability, immunogenicity and biomarker endpoints in patients with mild to moderate AD was conducted in
ACI-24 - anti-Abeta vaccine in Phase 1b in individuals with Down syndrome
Together with our prestigious clinical partners, recruitment was completed for the low-dose cohort in a Phase 1b trial targeting Alzheimer's disease-like characteristics in individuals with Down syndrome. The study evaluates the safety, tolerability and immunogenicity of the anti-Abeta vaccine ACI-24 and is being funded through a grant from
ACI-35 - anti-Tau vaccine for AD partnered with
A Phase 1b clinical study to evaluate the safety, tolerability and immunogenicity of ACI-35 in patients with mild to moderate AD was conducted in
Essex Biotechnology Collaboration
Continuation of 2015 Grant from
The company has been awarded a continuation of a
In
Prof.
- ACI-35, an anti-Tau vaccine in Phase 1b and developed in collaboration with
Janssen Pharmaceuticals under a 2014 licensing agreement - RO7105705, an anti-Tau antibody in Phase 2 and developed in collaboration with Genentech under a 2012 licensing agreement
- Morphomer Tau, a small molecule in pre-clinical development and developed in-house
- PI-2620, a Tau-PET imaging agent developed in collaboration with Piramal Imaging under a 2014 licensing agreement
Clinical development pipeline
| Product candidate | Target | Target Indication | Partner | Status | |
| Alzheimer's disease |
Crenezumab (Anti-Abeta antibody) |
Abeta | AD treatment | Genentech* | Phase 3 |
| Crenezumab (Anti-Abeta antibody) |
Abeta | AD prevention | Genentech* | Phase 2 | |
| ACI-24 (Anti-Abeta vaccine) |
Abeta | AD treatment | Advancing to Phase 2 | ||
| ACI-35 (Anti-pTau vaccine) |
Tau | AD treatment | Janssen Pharmaceuticals | Phase 1b | |
| Anti-Tau antibody | Tau | AD treatment | Genentech* | Phase 2 | |
| Morphomer Tau (Tau inhibitor) |
Tau | AD treatment | Pre-clinical | ||
| Non-AD / Neuro-orphan |
ACI-24 (Anti-Abeta vaccine) |
Abeta | Down syndrome1 | Phase 1b | |
| Morphomer Abeta (Abeta inhibitor) |
Abeta | Glaucoma | Pre-clinical | ||
| Morphomer alpha-syn (alpha-syn inhibitor) |
alpha-synuclein | Parkinson's disease | Discovery | ||
| Anti-alpha-syn antibody | alpha-synuclein | alpha-synuclein Pathologies | Discovery | ||
| Anti-TDP-43 antibody |
TDP-43 | TDP-43 Pathologies | Discovery | ||
| Diagnostics |
Tau-PET imaging agent | Tau | AD and Progressive supranuclear palsy (PSP) | Piramal Healthcare | Advancing to longitudinal study |
| In-vitro diagnostics (Tau, Abeta) |
Abeta; Tau | AD | Pre-clinical | ||
| Alpha-syn-PET imaging agent |
alpha-synuclein | Parkinson's disease | Biogen | Pre-clinical |
AD = Alzheimer's disease
* Genentech, a member of the
1 AD and cognitive impairment associated with Down syndrome
Analysis of Financial Statements for 12 month period ended
- Revenues for 2017 were
CHF 20.3 million , which constitutes a decrease ofCHF 2.9 million (12.7%) compared to 2016 - Our revenues fluctuate as a result of our collaborations with current and potentially new partners, the timing of milestone achievements and the size of each milestone payment. In 2017 we received:
CHF 14 million milestone payment from Genentech for dosing the first patient in a Phase 2 clinical trial for Alzheimer's diseaseCHF 3.4 million for research and collaboration services as part of our Biogen collaborationCHF 1.1 million milestone payment fromPiramal related to the initiation of "Part B" of the first-in-man Phase 1 clinical trial for PSP (Progressive Supranuclear Palsy)
Research & Development (R&D) Expenses
- Total R&D expenditures in 2017 were
CHF 32.7 million , upCHF 6.9 million (+27%) compared to 2016 - The company increased Non-Alzheimer's disease, diagnostics and new discovery programs spending by
CHF 4.7 million , withCHF 3.3 million related to finalizing the proof-of-concept and manufacturing activities for studies related to our lead compounds in the Anti-Tau Morphomer program. The Company continued to incur costs in ACI-24 for the Phase 1b clinical study in Down syndrome and spending increased for the Company's alpha-synuclein and TDP-43 PET tracer programs - Increase in R&D personnel expenses of
CHF 1.8 million was linked to an augmentation of 15 FTEs (+28%) in 2017
General & Administrative (G&A) Expenses
- G&A expenditures were
CHF 10.1 million in 2017, upCHF 2.2 million (28%) compared to 2016 - Increase was driven by personnel expenses including share-based compensation and higher professional service costs, such as legal and audit fees, related to
AC Immune's US public listing on Nasdaq
IFRS Loss for the period
- Net loss after taxes was
CHF 26.4 million in 2017 compared with net loss ofCHF 7.1 million in 2016
Balance Sheet
- The company had a total cash balance of
CHF 124.4 million atDecember 31, 2017 , compared toCHF 152.2 million at year end 2016. The decrease ofCHF 27.8 million was principally due to the net loss ofCHF 26.4 million for the year. Further details are available in our Statements of Cash flows in the Form 20-F, published on the company website - The cash balance is strong and provides liquidity for the Company through Q2 2019, excluding potential incoming milestones. The company continued to be debt-free through 2017
- The total shareholders' equity position decreased year-over-year to
CHF 116.8 million as ofDecember 31, 2017 , fromCHF 142.4 million at year end 2016. Further details are available in our corresponding Financial Statements filed in the Form 20-F, published on the company website
Non-IFRS Financial Measures
In addition to our operating results, as calculated in accordance with International Financial Reporting Standards, or IFRS, as adopted by the
We believe that these measures assist our shareholders because they enhance comparability of our results each period and provide more useful insight into operational results for the period. The company's executive management uses these non-IFRS measures to evaluate our operational performance. These non-IFRS financial measures are not meant to be considered alone or substitute for our IFRS financial measures and should be read in conjunction with
Reconciliation of Income/(Loss) to Adjusted Income/(Loss) and Earnings/(Loss) Per Share to Adjusted Earnings/(Loss) Per Share (unaudited)
| |
For the year ended December 31 |
Change | |
| 2017 | 2016 | CHF | |
| (in CHF millions except per share data) | |||
| Income/(Loss) | (26.4) | (7.1) | (19.3) |
| Adjustments: Non-Cash share-based compensation1 Foreign currency remeasurement (Gains)/Losses2 |
1.6 4.2 |
1.3 (3.4) |
0.3 7.6 |
| Adjusted Income (Loss) for the period | (20.6) | (9.2) | (11.4) |
| EPS - basic and diluted | (0.46) | (0.14) | (0.32) |
| Adjustment to EPS - basic and diluted | 0.10 | (0.04) | 0.14 |
| Adjusted EPS - basic and diluted2 | (0.36) | (0.18) | (0.18) |
| Weighted-average number of shares used to compute Adjusted Earnings (Loss) per share - basic and diluted | 57,084,295 | 50,096,859 | 6,987,436 |
- 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.
Non-IFRS Expenditures
Adjustments for the years ended
2018 Financial Guidance
For the full year 2018, the company expects a total cash burn of
About
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
For further information, please contact:
| In Europe Beatrix Benz AC Immune Corporate Communications Phone: +41 21 345 91 34 E-mail: beatrix.benz@acimmune.com |
In the US Lisa Sher AC Immune Investor Relations Phone: +1 970 987 26 54 E-mail: lisa.sher@acimmune.com |
| Nick Miles /Toomas Kull Cabinet Privé de Conseils s.a. Phone: +41 22 552 46 46 E-mail: miles@cpc-pr.com kull@cpc-pr.com |
Ted Agne The Communications Strategy Group Inc. Phone: +1 781 631 3117 E-mail: edagne@comstratgroup.com |
Attachment:
http://www.globenewswire.com/NewsRoom/AttachmentNg/0fa884e5-383a-4a6b-aa52-47aa6eafe156