Lausanne, 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.
Prof. 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
- 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 of CHF 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 of CHF 20.6 million1
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 in Asia
- 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
commencedGenentech, 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.
Anti-Tau Antibody moved into Phase 2 Trial
for Alzheimer's disease triggering CHF 14 million milestone
paymentGenentech, 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 diseases.
Pipeline expansion with new antibodies active
against alpha-synuclein and TDP-43This 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 Roche Group, in Phase 3 for Alzheimer's
disease.
ACI-24 - anti-Abeta vaccine for AD is advancing to Phase
2The 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.
ACI-24 - anti-Abeta vaccine in Phase 1b in
individuals with Down syndromeTogether 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 in Phase 1A Phase 1b 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.
Essex Biotechnology CollaborationAC
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.
Continuation of 2015 Grant from The Michael
J. Fox Foundation for Parkinson's ResearchThe company 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.
AC Immune shared insights from Key Opinion
Leader Meeting focused on Tau as a Therapeutic and Diagnostic
Target in Alzheimer's disease and other Neurodegenerative
DiseasesIn December 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:
- 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-PETimaging agent |
alpha-synuclein |
Parkinson's disease |
Biogen |
Pre-clinical |
AD = Alzheimer's disease* Genentech, a member of
the Roche group1 AD and cognitive impairment associated with Down
syndrome
Analysis of Financial Statements for 12 month
period ended December 31, 2017
- Revenues for 2017 were CHF 20.3 million, which constitutes a
decrease of CHF 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
disease
- CHF 3.4 million for research and collaboration services as part
of our Biogen collaboration
- CHF 1.1 million milestone payment from Piramal 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, up
CHF 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, with CHF 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, up CHF 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 of CHF 7.1 million in 2016
Balance Sheet
- The company had a total cash balance of CHF 124.4 million at
December 31, 2017, compared to CHF 152.2 million at year end 2016.
The decrease of CHF 27.8 million was principally due to the net
loss of CHF 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 of December 31, 2017, from
CHF 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 MeasuresIn addition 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.
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 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:
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 compensation1Foreign 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 ExpendituresAdjustments for the
years ended December 31, 2017 and 2016 were CHF 5.8 million in net
losses and CHF 2.1 million in net gains, respectively. These were
largely due to foreign currency remeasurement losses and gains of
CHF 4.2 million and CHF 3.4 million, respectively, predominantly
related to the cash balance of the company as a result of a
weakening of the US Dollar against the Swiss Franc for most of the
first half of 2017. The company also recorded CHF 1.6 million and
CHF 1.3 million for share-based compensation expenses for the years
ended December 31, 2017 and 2016, respectively. Further details are
available in our corresponding Financial Statements filed in the
Form 20-F, published on the company website.
2018 Financial GuidanceFor the full year
2018, the company expects a total cash burn of CHF 55-70 million at
constant exchange rates.
About AC ImmuneAC Immune is a clinical
stage Swiss-based biopharmaceutical company focused on
neurodegenerative diseases with five product candidates in clinical
trials. The Company designs, discovers and develops therapeutic and
diagnostic products intended to prevent and modify diseases caused
by misfolding proteins. AC Immune's two proprietary technology
platforms create antibodies, small molecules and vaccines designed
to address a broad spectrum of neurodegenerative indications, such
as Alzheimer's disease. The Company's pipeline features nine
therapeutic and three diagnostic product candidates. The most
advanced of these is crenezumab, a humanized anti-amyloid-ß
monoclonal IgG4 antibody that targets monomeric and aggregated
forms of amyloid-ß, with highest affinity for neurotoxic oligomers
currently in Phase 3 clinical studies for AD. This global program
is being conducted by the collaboration partner Genentech (a member
of the Roche group). Other collaborations include Biogen, Janssen
Pharmaceuticals, Nestlé Institute of Health Sciences, Piramal
Imaging and Essex Bio-Technology.
Forward looking statementsThis 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.
For further information, please
contact:
In EuropeBeatrix BenzAC Immune Corporate Communications
Phone: +41 21 345 91 34E-mail: beatrix.benz@acimmune.com |
In the USLisa SherAC Immune Investor Relations Phone: +1 970
987 26 54E-mail: lisa.sher@acimmune.com |
Nick Miles /Toomas KullCabinet Privé de Conseils s.a.Phone: +41 22
552 46 46 E-mail: miles@cpc-pr.com kull@cpc-pr.com |
Ted AgneThe Communications Strategy Group Inc.Phone: +1 781 631
3117E-mail: edagne@comstratgroup.com |
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