AC IMMUNE reports Full year 2016 financial
results and R&D update
- Strong cash position of CHF 152.2 million provides resources
to advance pipeline of seven therapeutic and three diagnostic
candidates
- Successful IPO on NASDAQ raised net proceeds of CHF
69.4 million
- Important data on crenezumab supporting 60mg/kg dose in
partner Genentech's CREAD Phase 3 trial for Alzheimer's
disease
- Phase 1 clinical trial of anti-Tau antibody program started
by partner Genentech
- Entered R&D collaboration in neurodegenerative diseases
with Biogen
- Started Phase 1 clinical trial of anti-Abeta vaccine ACI-24
in people with Down syndrome
Lausanne,
Switzerland, March 17, 2017 - AC Immune SA (NASDAQ: ACIU), a
Swiss-based, clinical stage biopharmaceutical company focused on
neurodegenerative diseases, today announced financial results for
the full year ended December 31, 2016. In addition, the company
provided highlights of its R&D achievements in 2016.
Prof. Andrea Pfeifer, CEO of AC Immune,
commented: "AC Immune had an exceptional 2016, highlighted by
our successful IPO on NASDAQ giving us the financial resources to
support our next growth phase. There was important progress made in
several of our programs, such as our partnership with Genentech on
crenezumab in Phase 3 and with the anti-Tau antibody in Phase 1. We
entered a new broad diagnostic collaboration with Biogen, and
started our own Phase 1 trial vaccine in people with Down syndrome.
I am convinced that our world-leading science, strong partnerships
and new financial backing, puts AC Immune in the fore-front of life
science companies tackling neurodegenerative diseases."
Key Financial Data - (IFRS in CHF million, except for share
and per share data)1
|
For the Year Ended December 31, |
|
2016 |
2015 |
Total revenues |
23.2 |
39.1 |
R&D expenses |
25.8 |
17.1 |
G&A expenses |
7.9 |
3.4 |
Income / (loss) for the period |
(7.1) |
20.3 |
Basic EPS/CHF |
(0.14) |
0.47 |
Diluted EPS/CHF |
(0.14) |
0.44 |
Weighted-average no of shares basic |
50,096,859 |
43,412,250 |
Weighted-average no of shares fully diluted |
50,096,859 |
46,043,198 |
|
As of |
|
Dec 31, 2016 |
Dec 31, 2015 |
Cash and cash equivalents |
152.2 |
76.5 |
Total current assets |
154.9 |
79.3 |
Total shareholder's equity |
142.4 |
71.0 |
1This summary table should be read in
conjunction with our financial statements included in our Annual
Report on Form 20-F for the year ended December 31, 2016, including
the accompanying notes which form an integral part of the financial
statements. These financial statements are available on our
website under the tab labelled "Investors - Financial
Information".
RevenuesOur revenues experience
significant fluctuations as a result of securing new collaboration
agreements, the timing of milestone achievements and the size of
each milestone payment.
AC Immune generated revenues of CHF 23.2 million
in the twelve months ended December 31, 2016, compared to CHF 39.1
million in the same period 2015.
Revenues in 2016 resulted primarily from the
recognition of a CHF 4.9 million clinical milestone payment and CHF
1.5 million recognized for research contributions received related
to ACI-35 pursuant to our collaboration agreement with Janssen, the
recognition of a CHF 14 million clinical milestone payment for the
commencement of phase 1 clinical studies for our anti-Tau antibody
candidate under collaboration with Genentech, the recognition of an
approximately CHF 1.0 million share of the Biogen upfront payment
received in April 2016 that we are recognizing over a twelve-month
period and a CHF 1.1 million research contribution payments related
to the Biogen collaboration.
In 2015, we recognized revenue from two
collaboration agreements, including a $25 million milestone (CHF
24.3 million) payment related to our collaboration with Genentech
for crenezumab and a CHF 14 million milestone payment
associated with the Genentech collaboration agreement for our
anti-Tau antibody candidate.
Research & Development (R&D)
ExpensesFor the full year ended December 31, 2016, the Company
incurred R&D expenses of CHF 25.8 million compared with CHF
17.1 million in fiscal 2015. This increase is primarily
attributable to the increased spending on ACI-35, our two ACI-24
programs, new discovery areas and the alpha-synuclein and TDP-43
PET imaging programs. The R&D investment reflects the
growth of the Company's research and development organization to
accelerate the development of its proprietary and partnered
pipeline candidates, which we believe will help us maintain a
scientific leadership position in neurodegenerative diseases.
General and Administrative (G&A)
ExpensesG&A expenses amounted to CHF 7.9 million in the
twelve months ended December 31, 2016, compared with CHF 3.4
million in the same period in 2015. The increase in G&A
expenses is largely related to higher professional service costs,
such as legal costs, associated with the Company becoming a public
company, as well as remuneration expenses.
Income / (loss) for the period For the
twelve months ended December 31, 2016, AC Immune had a net loss of
CHF 7.1 million compared with a
profit of CHF 20.3 million in the twelve months period ended
December 31, 2015. The decline in profitability is mostly
attributable to the decline in revenues and increased R&D and
G&A expenses outlined above.
Balance SheetAs at December 31, 2016, AC
Immune had total cash of CHF 152.2 million which includes CHF 69.4
million in net proceeds, prior to transaction costs, received from
the sale of 6.9 million shares at $11.00 per share in the Company's
IPO on the NASDAQ in September 2016. Earlier in 2016, the Company
also completed its Financing Round E which raised CHF 42.7
million.
Share CapitalThe total shareholders'
equity increased to CHF 142.4 million as at December 31, 2016,
reflecting the issuance of new shares for the IPO.
On December 31, 2016 the Company had
approximately 56.8 million common shares outstanding, which
includes the issuance of 6.9 million common shares as part of the
September IPO.
For a more detailed review of our financial
performance, please refer to "Item 5. Operating and Financial
Review and Prospects" in our Annual Report on Form 20-F filed today
with the U.S. Securities and Exchange Commission and on our website
under the tab labelled "Investors - Financial Information".
Full Year 2016 Highlights of R&D
ProgramsCrenezumab - anti-Abeta antibody for Alzheimer's
disease (AD) partnered with Genentech in Phase 3
- At the Clinical Trials on Alzheimer's Disease (CTAD) meeting
our partner Genentech presented results from a Phase 1b
dose-escalation study and an exposure-response model, which support
the 60mg/kg dose in CREAD Phase 3.
- Scientific publication in Cell Reports describing the crystal
structure of crenezumab targeting Abeta oligomers, the most toxic
type of Abeta.
- Second CREAD Phase 3 trial to be started by partner Genentech
with 750 patients with prodromal or mild Alzheimer's disease
(announced February 28, 2017).
ACI-24 - anti-Abeta vaccine for AD in Phase 1/2aThe Phase
1/2a clinical study to evaluate safety, tolerability,
immunogenicity and biomarker endpoints in patients with mild to
moderate AD is ongoing in Europe. An interim analysis of the first
three doses (cohort 1-3) revealed positive safety and tolerability.
The study was not powered to examine efficacy but a trend towards
reduction in the accumulation of brain amyloid measured by PET
imaging was observed in cohort 3. A similar pattern of reduction of
clinical decline assessed by the Clinical Dementia Rating Scale Sum
of Boxes (CDR-SB) was observed in cohort 3 compared to placebo at
week 52 although this did not reach statistical significance. After
further analysis of the results including the ongoing cohort 4, a
decision for the design of a potential next clinical trial will be
made in the next months.
ACI-24 - anti-Abeta vaccine in people with Down Syndrome in
Phase 1
- First-ever clinical trial of an anti-Abeta vaccine in people
with Down syndrome started in collaboration with University of
California San Diego.
- Scientific publication shows encouraging data on brain Abeta
reduction and memory enhancement of our anti-Abeta vaccine in a
pre-clinical model for people with Down syndrome.
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 is ongoing in Finland and the United
Kingdom. The study includes five cohorts with escalating doses and
different dosing schedules. To date, safety and tolerability is
considered satisfactory as assessed by the Data Safety Monitoring
Board. An interim analysis showed a dose-dependent and
target-specific antibody response to pTau. Further results, which
we expect to have completed in the second half of fiscal 2017, will
be the basis for the program's future development. Janssen is
expected to assume responsibility for the clinical development of
Phase 2 and beyond, as well as the regulatory approval,
manufacturing and commercialization of ACI-35.
Tau-PET imaging agent - AD diagnostic
partnered with PiramalWe commenced a Phase 1 clinical study of
our Tau-PET imaging agent in the fourth quarter of fiscal year 2016
under a collaboration agreement with Piramal Imaging.
New R&D Collaboration with BiogenWe
entered into a new R&D collaboration with Biogen to develop
PET-ligands for two protein targets involved in the pathogenesis of
neurodegenerative diseases - alpha-synuclein and TDP43.
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:
Prof. Andrea PfeiferChief Executive OfficerPhone: +41-21-345 91
21E-mail:andrea.pfeifer@acimmune.com |
Eva SchierCorporate Communications ManagerPhone: +41-21-345 91
34Mobile: +41 79 926 66 03E-mail: eva.schier@acimmune.com
|
Nick Miles/ Toomas Kull Cabinet Privé de Conseils Phone : +41
22 321 45 40E-mail : miles@cpc-pr.com kull@cpc-pr.com
|
In the USTed AgneThe Communications Strategy Group
Inc.Phone: +1 781 631 3117E-mail: edagne@comstratgroup.com
|
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