- New total cash position of approximately CHF 210 million
that is expected to extend cash runway to Q3 2021, excluding
potential incoming milestones
- Financial position strengthened after Q2 close due to
issuance of new shares, raising gross proceeds of USD 117.5
million
- Crenezumab: Phase 3 trial CREAD 2 fully recruited in
July 2018; new Phase 2 data analysis provides strong evidence for
principal target engagement of Abeta oligomers
- Selection of small molecules targeting Tau (Tau
MorphomersTM) for clinical development in Alzheimer's
disease
Lausanne, Switzerland, August 8, 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 for
the second quarter and first half ended June 30, 2018.
Prof. Andrea Pfeifer, CEO of AC Immune,
commented: "During the second quarter we announced the
selection of small molecules targeting pathological Tau for
clinical development in Alzheimer's disease. Tau MorphomersTM
inhibit intracellular Tau seeding and provide a strong basis for
combination therapy.
Furthermore, we are excited about recent news around crenezumab
communicated in July. Not only has CREAD 2 been fully recruited
ahead of schedule in July 2018 (CREAD1 completed recruitment in Q4
2017), but also a new exploratory Phase 2 data analysis presented
at the AAIC* 2018 showed that crenezumab significantly reduces
Abeta oligomers in cerebrospinal fluid in patients with Alzheimer's
disease. We are very encouraged about the potential of crenezumab
as a disease-modifying therapy, given its distinct differentiation
from other beta-amyloid antibodies in terms of target specificity
and safety.
In July we also successfully executed a share
capital increase of 10 million common shares resulting in gross
proceeds of USD 117.5 million, with strong support from existing
and new investors."
*Alzheimer's Association International
Conference, Chicago, July 22 - 26, 2018
Key Financial Data - Unaudited (CHF
million)
|
For the three months ended June 30, |
For the six months ended June 30, |
|
|
2018 |
2017 |
2018 |
2017 |
|
|
(in CHF million except per share data) |
(in CHF million except per share data) |
|
Contract revenue |
2.0 |
0.8 |
3.5 |
2.8 |
|
|
|
|
|
|
|
R&D expenses |
(10.5) |
(6.8) |
(20.6) |
(14.3) |
|
G&A expenses |
(3.1) |
(2.2) |
(5.8) |
(4.5) |
|
|
|
|
|
|
|
IFRS (Loss) for the period |
(11.1) |
(12.3) |
(22.8) |
(21.8) |
|
IFRS EPS - basic and diluted |
(0.19) |
(0.22) |
(0.40) |
(0.38) |
|
|
|
|
|
|
|
Non-IFRS (Loss) for the period1 |
(10.8) |
(8.2) |
(21.6) |
(15.9) |
|
Non-IFRS EPS - basic and diluted1 |
(0.19) |
(0.14) |
(0.38) |
(0.28) |
|
|
|
1 Adjusted (Loss) and Adjusted EPS are non-IFRS
measures. See "Non-IFRS Financial Measures" below for further
information and reconciliation to the most directly comparable IFRS
measures. |
|
|
As of June 30, |
As of December 31, |
|
|
|
2018 |
2017 |
Change |
|
|
(in CHF million) |
|
|
Cash and cash equivalents |
102.72 |
124.4 |
(21.7) |
|
Total shareholder's equity |
95.4 |
116.8 |
(21.4) |
|
2 Excludes the impact from the share capital
increase described under the heading "Subsequent events"
below. |
|
Second Quarter 2018 Company
Highlights
Selection of Tau Small Molecules for Clinical
Development in Alzheimer's disease AC Immune has one of the
largest Tau pipelines in the industry comprising antibodies,
vaccines, small molecules and tau PET imaging ligands. Several Tau
small molecule candidates, derived from AC Immune's proprietary
MorphomerTM platform and designed to cross the blood brain barrier,
have demonstrated target-specific reduction of pathological Tau and
cognitive and functional improvement in proof-of-concept studies in
Alzheimer's disease. IND/CTA enabling studies have started and a
Phase 1 study will commence by the end of 2018.
Second Quarter 2018 Financial
Highlights
Revenues 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. AC Immune generated revenues of CHF 2.0
million in the three months ended June 30, 2018, an increase
of CHF 1.3 million over the comparable period in 2017. The major
increases in contract revenues related to CHF 0.5 million for
research and development services performed for the anti-pTau
Vaccine (ACI-35) together with Janssen, CHF°0.2°million related to
the TDP-43 PET Imaging Tracers Biogen collaboration and CHF 0.2
million for research services provided to Essex Bio-Technology. We
also recognized CHF 0.1 million in grant revenue from the Michael
J. Fox Foundation.
We recognized CHF 3.5 million in the six months
ended June 30, 2018, a CHF°0.7°million increase over the comparable
period in 2017. The increase in contract revenues was principally
due to a CHF 0.7 million increase for research and development
services performed for the anti-pTau Vaccine (ACI-35) together with
Janssen, CHF°0.4 million increase for research services provided to
Essex Bio-Technology and CHF 0.3 million increase for research and
development revenues from Biogen. This was offset by a
non-recurring CHF 1.1 million milestone in Q1 2017 from
Piramal.
Research & Development (R&D)
ExpensesFor the three months ended June 30, 2018, AC Immune
invested CHF 10.5 million in research and development, compared
with CHF 6.8 million for the same period in 2017. The increase in
R&D spending is primarily driven by increased investments in
various key programs. This includes a CHF 1.7 million increase for
our Alzheimer's disease programs, including a CHF 0.8 million
increase for our ACI-24 program in Alzheimer's disease (AD) to
start-up the Phase 2 study and CHF 0.9 million for our anti-pTau
Vaccine (ACI-35) program. There was an additional CHF 0.7 million
increase for the Tau°MorphomersTM program to prepare the entry
into Phase 1 development.
For the six months ended June 30, 2018, AC
Immune invested CHF 20.6 million in research and development,
compared with CHF 14.3 million for the same period in 2017. The
increase in R&D spend is primarily driven by increased
investments of CHF°2.5 million in our Alzheimer's disease programs,
specifically a CHF 1.4 million increase for our ACI-24 program in
Alzheimer's disease (AD) to start-up the Phase 2 study. A CHF 1.2
million increase was allocated to our anti-pTau Vaccine (ACI-35)
program. Importantly, we increased our investments in our Discovery
programs by CHF°2.5 million, driven by a CHF 1.5 million increase
for preparing the Phase 1 entry of our lead compounds in the Tau
MorphomersTM program. Additionally, there were CHF°0.2 million
increases related to our vaccine technology program and
CHF°0.4°million for our anti-alpha-Synuclein antibody.
General and Administrative (G&A)
ExpenseGeneral and administrative expenses amounted to CHF 3.1
million in the three months ended June 30, 2018, compared with CHF
2.2 million in the same period in 2017. For the six months ended
June 30, 2018, and 2017, general and administrative expenses were
CHF 5.8 million and CHF 4.5 million, respectively. The increase
predominantly relates to increases in personnel expenses.
IFRS Loss for the periodFor the three
months ended June 30, 2018, the Company had a net loss of
CHF 11.1 million compared with net loss of CHF 12.3
million for the same period in 2017. The decrease in net loss for
this three month period is attributable to the increase in our
Finance result of CHF 4.5 million and our CHF 1.3 million increase
in revenues offset by the CHF 4.6 million increase in R&D and
G&A expenses.
For the six months ended June 30, 2018, the
Company had a net loss of CHF 22.8 million compared with
net loss of CHF 21.8 million for the same period in 2017. The
increase in net loss for this six month period is attributable to
the increase in our Finance result of CHF 5.8 million and our CHF
0.7 million increase in revenues offset by the CHF 7.5 million
increase in R&D and G&A expenses.
Cash position As of June 30, 2018, AC
Immune had total cash of CHF 102.7 million compared to CHF°124.4
million as of December 31, 2017. The decrease of CHF 21.7 million
is principally due to the net loss of CHF 22.8 million for the six
month period. Net cash flows used in operating activities were CHF
20.5 million, due to the higher investments in our major discovery
and development programs, and the continued strengthening of the
Company's infrastructure, systems and organization as a
publicly-traded company.
Subsequent events On July 17, 2018, the
Company announced that it commenced three offerings of up to 10
million new common shares of the Company with a nominal value of
CHF 0.02 per share. On July 19, 2018, the Company announced the
closing of the first subscription rights offering and the
underwritten primary offering of its common shares at a price per
share of USD 11.75. On July 24, 2018, the Company also announced
that the underwriters had exercised in full their option to
purchase an additional 1,108,695°shares. This brought the total
number of common shares sold by the Company to 8,500,000 shares,
resulting in total gross proceeds raised in these two offerings,
before underwriting discounts and estimated expenses, to
approximately USD°99.9 million.
On July 27, 2018, the Company completed its
second subscription rights offering of up to 1,500,000 shares at
the same price per share of USD 11.75. At closing on July 31, 2018,
the Company issued 1,500,000 additional common shares, resulting in
gross proceeds of approximately USD 17.6 million.
At the conclusion of these three offerings, the
Company obtained gross proceeds, before underwriting discounts and
estimated expenses, of approximately USD°117.5 million, or
approximately CHF 116.4 million.
These gross proceeds brought the total cash
position to approximately CHF 210 million, which we believe will
extend our cash runway until Q3 2021, excluding potential incoming
milestones.
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 Loss
and Adjusted Loss per Share when monitoring and evaluating our
operational performance. Adjusted Loss is defined as loss for the
relevant period, as adjusted for certain items that we believe are
not indicative of our ongoing operating performance. Adjusted Loss
per Share is defined as Adjusted Loss for the relevant period
divided by the weighted-average number of shares for such period.
The following table reconciles net loss to Adjusted Loss and
Adjusted Loss per Share for the periods presented:
Reconciliation of Loss to Adjusted Loss
andLoss Per Share to Adjusted Loss Per Share
(unaudited)
|
For the three months ended June 30, |
For the six months ended June 30, |
|
2018 |
2017 |
2018 |
2017 |
|
(in CHF millions except per share data) |
(in CHF millions except per share data) |
Net Income/(Loss) |
(11.1) |
(12.3) |
(22.8) |
(21.8) |
Adjustments:Non-Cash share-based compensation1Foreign currency
remeasurement (Gains)/Losses2 |
0.7 (0.4) |
0.2 4.0 |
1.3 (0.2) |
0.3 5.6 |
Adjusted Income (Loss) for the period |
(10.8) |
(8.2) |
(21.6) |
(15.9) |
|
|
|
|
|
EPS - basic and diluted |
(0.19) |
(0.22) |
(0.40) |
(0.38) |
Adjustment to EPS - basic and diluted |
0.00 |
0.08 |
0.02 |
0.10 |
Adjusted EPS - basic and diluted2 |
(0.19) |
(0.14) |
(0.38) |
(0.28) |
Weighted-average number of shares used to compute Adjusted Earnings
(Loss) per share - basic and diluted |
57,423,650 |
57,048,187 |
57,395,987 |
56,951,306 |
1 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.
2 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, 2018, were CHF 0.3 million and
CHF 1.1 million, respectively. These were largely due to share
based compensation expenses of CHF 0.7 million and CHF 1.3 million,
respectively, predominantly related to the increase in awards since
Q2 2017 which were incurring expenses for the full periods in 2018.
Additionally, for the three and six months ended June 30, 2018, the
Company recorded CHF 0.4 million and CHF 0.2 million in foreign
currency gains on cash balances, respectively, compared to CHF 4.0
million and CHF 5.6 million in foreign currency losses on cash
balances for the comparable periods in 2017, respectively.
About AC ImmuneAC Immune is a
clinical-stage Swiss-based biopharmaceutical company, listed on
Nasdaq, which aims to become a global leader in precision medicine
for neurodegenerative diseases. The Company designs, discovers and
develops therapeutic as well as 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 (AD).
The Company's pipeline features nine therapeutic and three
diagnostic product candidates - with five product candidates
currently in clinical trials. 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. Crenezumab is currently
in two Phase 3 clinical studies for AD, under a global program
conducted by the collaboration partner Roche/Genentech. 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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