Full Press Release Details
reports full-year 2017 financial results - successful first year as a public company
Switzerland, March 20, 2018 - AC Immune SA (NASDAQ: ACIU), a Swiss-based, clinical stage biopharmaceutical company with
a broad pipeline focused on neurodegenerative diseases, today announced financial results and provided a corporate overview for
the year ended December 31, 2017, its first full year as a public company.
Andrea Pfeifer, CEO of AC Immune, commented: "AC Immune made significant progress in
2017 - our first full year as a public company. Our lead asset, crenezumab, entered a second pivotal Phase 3 trial in Alzheimer's
disease with our partner Genentech. There were important developments with our other assets, and a new collaboration with Essex
Biotechnology in Asia. We continue to invest in each of the company's three strategic pillars - Alzheimer's
disease, neuro-orphan indications and diagnostics - and we believe that precision medicine will significantly improve patients'
lives. During 2017 we were pleased to strengthen our relationships with the investment community. We look forward to sharing some
key value inflection points in 2018, like for example the recently announced development of potentially the first selective alpha-synuclein
PET tracer for earlier and more accurate diagnosis of Parkinson's disease."
Financial Highlights 2017
| 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 period 1 | (20.6) | (9.2) | (11.4) |
| Non-IFRS EPS - basic and diluted 1 | (0.36) | (0.18) | (0.18) |
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) |
& Development Highlights 2017
Second Phase 3 study commenced
a member of the Roche Group, started a second Phase 3 clinical trial of the Alzheimer's disease therapy crenezumab, an anti-Abeta
antibody. This new trial, CREAD2, will recruit 750 patients with prodromal or mild Alzheimer's disease. The trial will complement
the current Phase 3 CREAD1 trial of 750 participants with prodromal or mild Alzheimer's disease, expected to read out in 2020.
Antibody moved into Phase 2 Trial for Alzheimer's disease triggering CHF 14 million milestone payment
a member of the Roche Group, has dosed the first patient in a Phase 2 clinical trial for Alzheimer's disease (AD) with an anti-Tau
monoclonal antibody known as RO7105705. This investigational medicine was discovered and humanized as part of the company's collaboration
with Genentech. Upon the dosing of the first patient in the Phase 2 clinical trial, AC Immune became eligible to receive a milestone
payment of CHF 14 million, which was paid in the fourth quarter of 2017. This is the third milestone payment under the 2012 strategic
collaboration and licensing agreement with Genentech for anti-Tau antibodies for the treatment of AD and other neurodegenerative
expansion with new antibodies active against alpha-synuclein and TDP-43
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 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 Roche
Group, in Phase 3 for Alzheimer's disease.
ACI-24 - anti-Abeta vaccine
for AD is advancing to Phase 2
Phase 1/2a clinical study to evaluate safety, tolerability, immunogenicity and biomarker endpoints in patients with mild to moderate
AD was conducted in Europe. Due to the observed favorable safety profile, the treatment free
safety follow-up period of the Phase 1 was shortened to one year and is currently ongoing. Antibody responses
were observed in the two higher dose groups, indicating a dose dependent effect of the vaccine. While
the study was not powered to examine efficacy, a dose-dependent trend of reduction in brain amyloid measured by PET imaging was
also observed in these groups. Due to the promising safety profile and potential dose dependent reduction of amyloid plaques,
we plan to move this program forward into a Phase 2 clinical trial.
- anti-Abeta vaccine in Phase 1b in individuals with Down syndrome
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 The US National Institute on Aging and an additional
grant from the LuMind Research Down Syndrome Foundation. Interim results are expected in 2018.
ACI-35 - anti-Tau vaccine
for AD partnered with Janssen Pharmaceuticals
clinical study to evaluate the safety, tolerability and immunogenicity of ACI-35 in patients with mild to moderate AD was conducted
in Europe. An interim analysis showed a dose-dependent and target-specific antibody response to pTau. For an optimal long-term
and potentially preventive application, new formulations of the Anti-Tau vaccine were developed in collaboration with Janssen
Pharmaceuticals. Due to the encouraging data, AC Immune and Janssen jointly decided to advance the anti-Tau vaccine program to
the next stage of development.
Biotechnology Collaboration
Immune and Essex Bio-Technology Limited (HKEX: 1061), which specializes in biopharmaceutical drug development based on
recombinant DNA technology, entered into a research collaboration agreement to undertake the pre-clinical and clinical
co-development of a novel biological
therapeutic for the treatment of neurodegenerative diseases and neuroinflammation.
of 2015 Grant from The Michael J. Fox Foundation for Parkinson's Research
has been awarded a continuation of a February 2015 research grant from the Michael J. Fox Foundation for Parkinson's Research
(MJFF). This provides funds for the development of PET tracers for the alpha-synuclein protein, to support the early diagnosis
and clinical management of Parkinson's disease. AC Immune has been collaborating on this biomarker program with Biogen since
April 2016 and expects to initiate a first in human study in the second half of 2018.
shared insights from Key Opinion Leader Meeting focused on Tau as a Therapeutic and Diagnostic Target in Alzheimer's disease
and other Neurodegenerative Diseases
2017 the company shared top level insights from a Key Opinion Leader (KOL) luncheon-meeting addressing the importance of Tau as
a target in Alzheimer's disease and other neurodegenerative diseases. Michael Rafii, MD, PhD (UC San Diego and University of Southern
California, USC) discussed the importance of the Tau biomarker which can readily be studied in the Down syndrome population as
well as other populations that display early signs of Alzheimer's disease. This potentially aids in early Alzheimer's
disease diagnosis and treatment.
Khalid Iqbal, PhD (Professor and
Chairman, Department of Neurochemistry at the New York State Institute for Basic Research in Developmental Disabilities, Staten
Island, New York) highlighted the critical importance of Tau as a therapeutic target in Alzheimer's disease and other neurodegenerative
diseases. He also addressed inhibition and prevention of Tau pathology, which may potentially disrupt the progression of Alzheimer's
disease and improve cognitive impairment.
Prof. Andrea Pfeifer, PhD, CEO,
AC Immune provided a general corporate overview of AC Immune's vision and progress followed by Dr. Andreas Muhs, Chief Scientific
Officer of AC Immune, who highlighted AC Immune's relevant Tau programs:
development pipeline
| Product candidate | Target | Target Indication | Partner | Status | |
| 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 | ||
| ACI-24 (Anti-Abeta vaccine) | Abeta | Down syndrome 1 | 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 | ||
| 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 |
a member of the Roche group
and cognitive impairment associated with Down syndrome
of Financial Statements for 12 month period ended December 31, 2017
Research & Development (R&D) Expenses
General & Administrative (G&A) Expenses
to our operating results, as calculated in accordance with International Financial Reporting Standards, or IFRS, as adopted by
the International Accounting Standards Board, we use Adjusted Income/(Loss) and Adjusted Earnings/(Loss) per share when monitoring
and evaluating our operational performance. Adjusted Income/(Loss) is defined as income/(loss) for the relevant period, as adjusted
for certain items that we believe are not indicative of our ongoing operating performance. Adjusted Earnings/(Loss) per share
is defined as Adjusted Income/(Loss) for the relevant period divided by the weighted-average number of shares for such period.
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 AC Immune's financial statements prepared in accordance with IFRS.
The most directly comparable IFRS measure to these non-IFRS measures is net income/(loss) and earnings/(loss) per share. The following
table reconciles net income/(loss) and earnings/(loss) per share to Adjusted Net Earnings/(Loss) and Adjusted Net Earnings/(Loss)
per share for the periods presented: