- Strong cash position of CHF 124.2 million provides resources
to advance pipeline of seven therapeutic and three diagnostic
candidates
- Increased R&D investment across three pillars of
Alzheimer`s disease, neuro-orphan indications and
diagnostics
- Entered into first Asian collaboration for neurodegenerative
diseases and neuroinflammation with Essex Bio-Technology
Lausanne, Switzerland, August 9, 2017 -
AC Immune SA (NASDAQ: ACIU), a Swiss-based, clinical stage
biopharmaceutical company with a broad pipeline focused on
neurodegenerative diseases, today announced financial results for
the second quarter ended June 30, 2017.
Prof. Andrea Pfeifer, CEO of AC Immune,
commented: "Our second quarter was highlighted by the exciting
agreement with Essex Biotechnology, in which we plan to leverage
our mutual expertise in the areas of neurodegeneration and
neuroinflammation to develop therapeutic candidates for Alzheimer's
disease and frontotemporal dementia. This partnership marks AC
Immune's first R&D collaboration in Asia. As we continue to
invest and build value in each of the three pillars of our business
-- Alzheimer's disease, neuro-orphan indications, and diagnostics
-- we expect to see continued news-flow across these areas during
the second half of 2017."
Key Financial Data - Unaudited (CHF million1)
|
For the Three Months Ended June 30 |
For the Six Months Ended June 30 |
|
2017 |
2016 |
2017 |
2016 |
Revenues |
0.8 |
19.9 |
2.8 |
20.4 |
R&D expenses |
6.8 |
5.6 |
14.3 |
11.0 |
G&A expenses |
2.2 |
1.9 |
4.5 |
2.8 |
Income (Loss) for the period |
(12.3) |
12.9 |
(21.8) |
6.8 |
Adjustments:Non-Cash share-based compensationForeign currency
remeasurement (Gains)/Losses |
0.2 4.0 |
0.1 (0.6) |
0.3 5.6 |
0.2 (0.2) |
Adjusted Income (Loss) 2 |
(8.2) |
12.5 |
(15.9) |
6.7 |
EPS - basic |
(0.22) |
0.27 |
(0.38) |
0.14 |
EPS - diluted |
(0.22) |
0.25 |
(0.38) |
0.13 |
Adjusted EPS - basic2 |
(0.14) |
0.26 |
(0.28) |
0.14 |
Adjusted EPS - diluted2 |
(0.14) |
0.24 |
(0.28) |
0.13 |
|
As of |
|
June 30, 2017 |
Dec 31, 2016 |
Cash and cash equivalents |
124.2 |
152.2 |
Total shareholders' equity |
120.9 |
142.4 |
1Key financial data in CHF million except for share and per
share data. 2Adjusted Income (Loss) and Adjusted EPS are non-IFRS
measures. See "Non-IFRS Financial Measures" below for further
information.
RevenuesRevenues fluctuate as a result of
the timing of signing new collaboration agreements, the timing of
milestone achievements, and the size of each milestone payment.
AC Immune generated revenues of CHF 0.8 million in the three
months ended June 30, 2017, a decrease of CHF 19.2 million over the
comparable period in 2016. For the six months ended June 30, 2017,
AC Immune saw a CHF 17.7 million decrease in revenues from CHF 20.4
million to CHF 2.8 million.
For the three and six months ended June 30, 2017, the decrease
in collaboration revenues was principally due to the recognition of
two milestones reached in Q2 2016 related to the anti-Tau antibody
agreement with Genentech and the anti-Tau vaccine agreement with
Janssen. Revenues in the first six months of 2017 were mainly
driven by a EUR 1 million (CHF 1.1 million) milestone from Piramal
Imaging for the initiation of the Phase 1 clinical trial in the
orphan indication of Progressive Supranuclear Palsy (PSP), and the
recognition of CHF 1.8 million in research contribution revenues
related to the alpha-synuclein and TDP-43 PET tracer collaboration
with Biogen.
Research & Development (R&D)
ExpensesFor the three and six months ended June 30, 2017,
research and development expenses totaled CHF 6.8 million and CHF
14.3 million, respectively, compared with CHF 5.6 million and CHF
11.0 million for the same periods in 2016.
This increase was primarily attributable to
further investment in the two anti-Abeta ACI-24 vaccine programs in
Alzheimer's disease and Down syndrome, in programs focused on
Parkinson's disease such as alpha-synuclein PET imaging, and in
discovery programs for neurodegenerative orphan indications. The
R&D investment also reflects the addition of new hires brought
on board to accelerate the development of proprietary and partnered
pipeline candidates.
General and Administrative (G&A)
ExpensesGeneral and administrative expenses amounted to CHF 2.2
million and CHF 4.5 million in the three and six months ended June
30, 2017 compared with CHF 1.9 million and CHF 2.8 million in the
same periods in 2016, respectively. The increase is predominantly
due to increased operating expenses during the three and six months
ended June 30, 2017, as the Company was publicly traded for the
first half of 2017 and not in the comparable 2016 period.
IFRS Loss for the periodFor the three and
six months ended June 30, 2017, the Company had a net loss after
taxes of CHF 12.3 million and CHF 21.8 million compared with net
income of CHF 12.9 million and CHF 6.8 million for the same periods
in 2016. The decline in profitability is attributable to the
decreased revenues for the periods as a result of prior milestone
achievements and an increase in R&D and G&A expenses as
outlined above.
Cash positionAs of June 30, 2017 AC
Immune had total cash of CHF 124.2 million compared to CHF 152.2
million as of December 31, 2016. The decrease of CHF 28 million is
principally due to the net loss of CHF 21.8 million for the 6-month
period. Net cash flows used in operating activities were CHF 20.9
million, due to the higher investments in our major discovery and
development programs and the strengthening of the Company's
infrastructure, systems and organization during our first year as a
publicly traded company. Further details are available in our
corresponding Statements of Cash Flows filed with our Form 6-K.
H1 2017 Company HighlightsResearch
partnership with Essex Bio-TechnologyIn May 2017, AC Immune and
Essex Bio-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. This
collaboration provides powerful synergies in technologies and
expertise for the two companies and marks AC Immune's first R&D
collaboration in Asia.
Crenezumab - anti-Abeta antibody for
Alzheimer's disease (AD) partnered with Genentech in Phase
3During the first quarter, AC Immune's partner Genentech/Roche
started a second pivotal Phase 3 clinical trial, CREAD 2, in 750
prodromal or mild Alzheimer's disease. Similar to the CREAD 1 Phase
3 clinical trial, which has been ongoing since Q1 2016, this second
study will evaluate the effect of crenezumab on the composite
endpoint Clinical Dementia Rating-Sum of Boxes (CDR-SB) Score.
Tau-PET imaging agent - AD diagnostic
partnered with PiramalNew insights into the Tau-PET imaging
tracer, being developed in collaboration with Piramal Imaging, were
provided at the International Conference on Alzheimer's and
Parkinson's Diseases (AD/PD) in March 2017. The results included
its excellent preclinical properties, human dosimetry and first
encouraging clinical data which show a distinct, specific pattern
of binding in patients with Alzheimer's disease and Progressive
Supranuclear Palsy.
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. 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). The following
table reconciles net income (loss) to Adjusted Net Earnings (Loss)
and Adjusted Net Earnings (Loss) per share for the periods
presented:
Reconciliation of Income/(Loss) to Adjusted Income/(Loss)
andEarnings/(Loss) Per Share to Adjusted Earnings/(Loss) Per
Share
|
For the Three MonthsEnded June 30, |
For the Six Months Ended June
30, |
|
2017 |
2016 |
2017 |
2016 |
in
CHF thousands except for share and per share data |
|
|
|
Income/(Loss)..................... |
(12,327) |
12,944 |
(21,782) |
6,774 |
Adjustments: |
|
|
|
|
Non-cash share-based payments (a) |
154 |
98 |
254 |
150 |
Foreign currency (gains)/losses
(b).................................... |
3,997 |
(589) |
5,615 |
(207) |
Adjusted Income/(loss) |
(8,176) |
12,453 |
(15,913) |
6,717 |
|
|
|
|
|
Earnings/(Loss) per share - basic |
(0.22) |
0.27 |
(0.38) |
0.14 |
Earnings/(Loss) per share - diluted |
(0.22) |
0.25 |
(0.38) |
0.13 |
Adjustment to earnings/(loss) per share - basic |
0.08 |
(0.01) |
0.10 |
0.00 |
Adjustment to earnings/(loss) per share - diluted |
0.08 |
(0.01) |
0.10 |
0.00 |
Adjusted Earnings (Loss) per share - basic |
(0.14) |
0.26 |
(0.28) |
0.14 |
Adjusted Earnings(Loss) per share - diluted |
(0.14) |
0.24 |
(0.28) |
0.13 |
Weighted-average number of shares used to compute Adjusted Earnings
(Loss) per share - basic............................ |
57,048,187 |
48,017,453 |
56,951,306 |
47,209,976 |
Weighted-average number of shares used to compute Adjusted Earnings
(Loss) per share - diluted......................... |
57,048,187 |
51,096,175 |
56,951,306 |
50,465,568 |
(a) 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.
(b) 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
three and six months ended June 30, 2017 were CHF 4.1 million and
CHF 5.9 million, respectively. These were largely due to foreign
currency remeasurement losses of CHF 4.0 million and CHF 5.6
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. The Company also recorded CHF 0.15 million and CHF
0.25 million for the three and six months, respectively, for
share-based compensation expenses.
About AC ImmuneAC Immune is a clinical
stage Swiss-based biopharmaceutical company focused on
neurodegenerative diseases with four 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 seven
therapeutic and three diagnostic product candidates. The most
advanced of these is crenezumab, an anti-Abeta antibody in phase 3
clinical studies that is being advanced by the collaboration
partner Genentech, Inc., a wholly owned subsidiary of Roche. Other
business partners 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:
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 Cabinet Privé de Conseils s.a.Phone: +41 22 552 46 46
E-mail: miles@cpc-pr.com |
In the USTed AgneThe Communications Strategy Group
Inc.Phone: +1 781 631 3117E-mail: edagne@comstratgroup.com
|
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