- Announced important clinical milestones for ACI-24 vaccine
in Alzheimer's disease and Down Syndrome
- Company record high, period end cash position of
approximately CHF 200 million that is expected to extend our cash
runway to Q3 2021, excluding potential incoming milestones
- Successfully issued 10 million new shares via three
offerings to raise gross proceeds of USD 117.5 (CHF 116.3)
million
Lausanne, Switzerland, November 13, 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 three and nine months ended September 30, 2018.
Prof. Andrea Pfeifer, CEO of AC Immune,
commented: "During the third quarter we raised USD 117.5
million, and broadened our shareholder base with 11 new
institutional investors. We are grateful for the continued support
of our existing shareholders who also participated. These proceeds
are expected to fund our three pillar strategy through at least
2021, excluding potential incoming milestones. This capital raise,
and the established investors who participated, are a strong
endorsement of our scientific pipeline and business model."
"We also continued to advance key assets in our
pipeline, announcing both the start and dosing of the first patient
in the Phase 2 trial with ACI-24 in patients with mild Alzheimer's
disease and completing recruitment for the high-dose cohort of the
Phase 1b study with ACI-24 for Abeta-related cognitive decline in
individuals with Down Syndrome. Vaccines are potentially an
important option for the treatment and prevention of
neurodegenerative diseases and are one of our main targets for
clinical development.A new exploratory Phase 2 data analysis
presented at the AAIC 2018 showed that our lead product candidate
crenezumab significantly reduces Abeta oligomers in cerebrospinal
fluid in patients with Alzheimer's disease. We are encouraged about
crenezumab's potential as a disease modifying therapy, particularly
given its distinct differentiation from other beta-amyloid
antibodies in terms of both target specificity and safety."
Key Financial Data - Unaudited (CHF
million)
|
For the three months ended September 30, |
For the nine months ended September 30, |
|
2018 |
2017 |
2018 |
2017 |
|
(in CHF million except per share data) |
(in CHF million except per share data) |
Total revenue |
2.3 |
1.1 |
5.8 |
3.8 |
|
|
|
|
|
R&D expenses |
(11.5) |
(8.2) |
(32.2) |
(22.5) |
G&A expenses |
(2.9) |
(2.5) |
(8.7) |
(7.0) |
|
|
|
|
|
IFRS Loss for the period |
(13.5) |
(8.8) |
(36.3) |
(30.6) |
IFRS Loss per Share - basic and diluted |
(0.21) |
(0.15) |
(0.61) |
(0.54) |
|
|
|
|
|
Adjusted Loss for the period1 |
(11.6) |
(9.0) |
(33.3) |
(25.0) |
Adjusted Loss Share - basic and diluted1 |
(0.18) |
(0.16) |
(0.56) |
(0.44) |
|
1 Adjusted (Loss) and Adjusted Loss per Share are non-IFRS
measures. See "Non-IFRS Financial Measures" below for further
information and reconciliation to the most directly comparable IFRS
measures. |
|
As of September 30, |
As of December 31, |
|
|
2018 |
2017 |
Change |
|
(in CHF million) |
|
Cash and cash equivalents |
199.1 |
124.4 |
74.7 |
Total shareholder's equity |
192.0 |
116.8 |
75.2 |
Third Quarter 2018 Company Highlights
ACI-24 Vaccine for Alzheimer's DiseaseAC
Immune has started the Phase 2 study with ACI-24 in patients with
mild Alzheimer's disease (AD). The aim of this double-blind,
randomized, placebo-controlled study with an adaptive design is to
assess the safety, tolerability, immunogenicity, target engagement,
biomarkers and clinical efficacy of ACI-24. The trial will seek to
confirm the positive trends on Abeta PET imaging and clinical
measurement (CDR-SB) of the previous Phase 1 safety study. The
Phase 2 trial will be conducted in several European countries and
the first patients have been screened.
ACI-24 in Down SyndromeAC Immune has
completed recruitment for the high-dose cohort of the ACI-24 Phase
1b study for the treatment of Alzheimer's disease-like
characteristics in adults with Down Syndrome (DS), a condition
affecting approximately one in 700 newborns. The first low-dose and
the second high-dose cohorts have been fully recruited in August
2017 and in July 2018 respectively, and interim results of the low
dose cohort are expected later in 2018. In addition to cognitive
dysfunction beginning in childhood, individuals with DS are
genetically-predisposed to develop Abeta-related cognitive decline
at a much younger age and with much greater probability than the
general population.
Closing of Three Primary Offerings for
10,000,000 Common SharesIn July, the Company completed three
offerings, totaling 10,000,000 new common shares at a price per
share of USD 11.75, from which the Company obtained gross proceeds
of approximately USD 117.5 million (CHF 116.3 million). Net
underwriting fees and transaction costs totaled CHF 6.8 million,
yielding net proceeds of CHF 109.5 million.
Third Quarter 2018 Financial
Highlights
RevenuesOur 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 2.3 million
in the three months ended September 30, 2018, an increase of
CHF 1.2 million over the comparable period in 2017. Contract
revenues improved due to an incremental CHF 0.8 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 0.1
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 5.8 million in the nine months
ended September 30, 2018, a CHF°2.0°million increase over the
comparable period in 2017. Contract revenues improved principally
due to increases of CHF 1.6 million for research and development
services performed for the anti-pTau Vaccine (ACI-35) together with
Janssen, CHF°0.5 million for research services provided to Essex
Bio-Technology and CHF 0.5 million for research and development
revenues from Biogen. The Company also recorded CHF 0.3 million in
grant revenue from the Michael J. Fox Foundation. This was offset
by a non-recurring CHF 1.1 million milestone in Q1 2017 from Life
Molecular Imaging (formerly Piramal Imaging).
Research & Development (R&D)
ExpensesFor the three months ended September 30, 2018, AC
Immune invested CHF 11.5 million in research and development,
compared with CHF 8.2 million for the same period in 2017. The
increase in R&D spending was primarily driven by investments in
a variety of our programs. In our Alzheimer's disease programs,
this includes an incremental CHF 1.6 million for our anti-pTau
Vaccine (ACI-35) program. The increase in our discovery programs of
CHF 1.4 million was driven by a variety of projects including CHF
0.3 million related to the continued proof of concept studies and
additional manufacturing activities of our lead compounds in the
Tau Morphomers and a CHF 0.4 million increase related to
manufacturing activities in our vaccine technology program.
For the nine months ended September 30, 2018, AC
Immune invested CHF 32.2 million in research and development,
compared with CHF 22.5 million for the same period in 2017. The
increase in R&D spending was primarily driven by investments of
CHF°3.8 million in our Alzheimer's disease programs, specifically a
CHF 1.2 million increase for our ACI-24 program in Alzheimer's
disease (AD) to start-up the Phase 2 study. We also invested an
incremental CHF 2.8 million for our anti-pTau Vaccine (ACI-35)
program. Importantly, we increased our investments in our Discovery
programs by CHF°3.9 million, driven by a CHF 1.8 million increase
for preparing the Phase 1 entry of our lead compounds in the Tau
MorphomersTM program. Additionally, there were CHF°0.6 million
increases related to our vaccine technology program and
CHF°0.5°million for our anti-alpha-Synuclein antibody.
General and Administrative (G&A)
ExpensesGeneral and administrative expenses amounted to CHF 2.9
million in the three months ended September 30, 2018, compared with
CHF 2.5 million in the same period in 2017. For the nine months
ended September 30, 2018, and 2017, general and administrative
expenses were CHF 8.7 million and CHF 7.0 million, respectively.
The changes predominantly related to increases in personnel
expenses.
IFRS Loss for the periodFor the three
months ended September 30, 2018, the Company had a net loss of
CHF 13.5 million compared with net loss of CHF 8.8
million for the same period in 2017. The increased net loss for
this three month period was partly attributable to the CHF 3.8
million increase in R&D and G&A expenses and CHF 2.2
million decrease in Finance result offset by the CHF 1.2 million in
revenues additional revenues.
For the nine months ended September 30, 2018,
the Company had a net loss of CHF 36.3 million compared
with net loss of CHF 30.6 million for the same period in 2017. The
increase in net loss for this nine month period was attributable to
the increased spending of CHF 11.3 million in R&D and G&A
expenses offset by gains in our Finance result of CHF 3.6 million
and CHF 2.0 million in revenues.
Cash positionAs of September 30, 2018, AC
Immune had total cash and cash equivalents of CHF 199.1 million
compared to CHF°124.4 million as of December 31, 2017. This CHF
74.7 million increase was principally due to the Company's three
follow on offerings which yielded a CHF 109.5 million in proceeds,
after deducting underwriting fees and transaction costs. Net cash
flows used in operating activities of CHF 32.3 million offset this
cash increase, 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.
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 and
Loss Per Share to Adjusted Loss Per Share (unaudited)
|
For the three months ended September 30, |
For the nine months ended September 30, |
|
2018 |
2017 |
2018 |
2017 |
|
(in CHF millions except per share data) |
(in CHF millions except per share data) |
Net Loss |
(13.5) |
(8.8) |
(36.3) |
(30.6) |
Adjustments:Non-Cash share-based compensation1Foreign currency
remeasurement (Gains)/Losses2 |
0.6 1.3 |
0.6 (0.8) |
1.9 1.1 |
0.8 4.8 |
Adjusted Loss for the period |
(11.6) |
(9.0) |
(33.3) |
(25.0) |
|
|
|
|
|
Loss per Share - basic and diluted |
(0.21) |
(0.15) |
(0.61) |
(0.54) |
Adjustment to Loss per Share - basic and diluted |
0.03 |
(0.01) |
0.05 |
0.10 |
Adjusted Loss per Share - basic and diluted2 |
(0.18) |
(0.16) |
(0.56) |
(0.44) |
Weighted-average number of shares used to compute Adjusted Loss per
Share - basic and diluted |
64,862,822 |
57,164,145 |
59,912,283 |
57,023,032 |
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 nine months ended
September 30, 2018, were CHF 1.9 million and CHF 3.0 million,
respectively. These were largely due to foreign currency
remeasurement losses of CHF 1.3 million and CHF 1.1 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 third quarter. The Company also
recorded CHF 0.6 million and CHF 1.9 million for the three and nine
months, respectively, for share-based compensation expenses. The
latter represented a CHF 1.0 million increase compared to the nine
months ended September 30, 2017.
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, Life Molecular Imaging (formerly
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 RelationsPhone: +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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