ACADIA Pharmaceuticals Inc. (NASDAQ: ACAD), a biopharmaceutical
company focused on the development and commercialization of
innovative medicines to address unmet medical needs in neurological
and related central nervous system disorders, today announced its
unaudited financial results for the third quarter ended September
30, 2014 and provided an update on the timing of its NUPLAZID™
(pimavanserin) New Drug Application (NDA) submission.
ACADIA plans to submit its NUPLAZID NDA for Parkinson’s disease
psychosis in the first quarter of 2015. The company had previously
planned to submit the NDA near the end of 2014. The decision to
move back the planned submission is based on additional time
required to complete preparations needed to support the U.S. Food
and Drug Administration’s (FDA) review of NUPLAZID. The change in
submission timing is not a result of any change to NUPLAZID’s
clinical or safety profile, nor is it a result of any interaction
with or request for information from the FDA. Additionally, ACADIA
reported that it has successfully completed its drug-drug
interaction program and its registration stability program.
“While we had hoped to submit our NDA for NUPLAZID near the end
of this year, we believe it is prudent to push back our planned
submission to the first quarter of 2015,” said Uli Hacksell, Ph.D.,
Chief Executive Officer of ACADIA. “We are confident in our safety
and efficacy data package supporting the NUPLAZID NDA and are
working diligently on completing preparations for the NDA
submission and review.
“Additionally, the recent decision by the FDA to grant
Breakthrough Therapy designation for NUPLAZID reinforces the large
unmet medical need for the treatment of Parkinson’s disease
psychosis and the importance of the NUPLAZID program. With no
FDA-approved treatment for Parkinson’s disease psychosis, NUPLAZID
has the potential to transform the treatment landscape for patients
with this debilitating disorder.”
Third Quarter Financial Results
ACADIA reported a net loss of $24.8 million, or $0.25 per common
share, for the third quarter of 2014 compared to a net loss of
$10.7 million, or $0.12 per common share, for the third quarter of
2013. Net losses for the third quarters of 2014 and 2013 included
$3.9 million and $1.9 million, respectively, in non-cash,
stock-based compensation expense. For the nine months ended
September 30, 2014, ACADIA reported a net loss of $64.1 million, or
$0.66 per common share, compared to a net loss of $25.9 million, or
$0.31 per common share, for the comparable period of 2013. Net
losses for the nine-month periods ended September 30, 2014 and 2013
included $11.4 million and $3.5 million, respectively, in non-cash,
stock-based compensation expense.
At September 30, 2014, ACADIA’s cash, cash equivalents, and
investment securities totaled $337.8 million compared to
$185.8 million at December 31, 2013. This increase was
primarily due to $196.8 million in net proceeds raised from a
public offering of common stock in March 2014, offset in part by
cash used to fund ACADIA’s operations.
Research and development expenses increased to $17.0 million for
the third quarter of 2014, including $1.4 million in stock-based
compensation expense, from $7.3 million for the comparable quarter
of 2013, including $690,000 in stock-based compensation expense.
This increase was primarily due to an increase of $8.4 million in
external service costs, including increased development costs
incurred in our Phase III program for NUPLAZID. Increases in costs
associated with our expanded research and development organization,
including $882,000 in increased personnel costs and $668,000 in
increased stock-based compensation expense, also contributed to the
quarter-over-quarter increase.
General and administrative expenses increased to $8.1 million
for the third quarter of 2014, including $2.5 million in
stock-based compensation expense, from $3.8 million for the
comparable quarter of 2013, including $1.2 million in stock-based
compensation expense. This increase was due to a $1.4 million
increase in external service costs largely related to ACADIA’s
commercial preparations for the planned launch of NUPLAZID. Also
contributing to the quarter-over-quarter increase in general and
administrative expenses was a $1.4 million increase in personnel
expenses largely related to ACADIA’s preparations for the planned
launch of NUPLAZID, as well as a $1.3 million increase in
stock-based compensation expense.
Conference Call and Webcast Information
ACADIA management will review its third quarter financial
results and development programs via conference call and webcast
later today at 5:00 p.m. Eastern Time. The conference call may be
accessed by dialing 866-318-8615 for participants in the United
States or Canada and 617-399-5134 for international callers
(reference passcode 86826740). A telephone replay of the conference
call may be accessed through November 24, 2014 by dialing
888-286-8010 for callers in the United States or Canada and
617-801-6888 for international callers (reference passcode
62605343). The conference call also will be webcast live on
ACADIA’s website, www.acadia-pharm.com, under the investors section and will be
archived there through November 24, 2014.
About NUPLAZID™ (pimavanserin)
NUPLAZID is ACADIA’s proprietary small molecule that is a
selective serotonin inverse agonist preferentially targeting 5-HT2A
receptors that play an important role in psychosis. ACADIA has
reported positive Phase III trial results with NUPLAZID, which has
the potential to be the first drug approved in the United States
for psychosis associated with Parkinson’s disease. NUPLAZID is
administered orally once-a-day. ACADIA discovered NUPLAZID and
holds worldwide rights to this new chemical entity. The trade name
NUPLAZID has been provisionally accepted by the FDA.
About ACADIA Pharmaceuticals
ACADIA is a biopharmaceutical company focused on the development
and commercialization of innovative medicines to address unmet
medical needs in neurological and related central nervous system
disorders. ACADIA has a pipeline of product candidates led by
NUPLAZID (pimavanserin), for which we have reported positive Phase
III trial results in Parkinson’s disease psychosis and which has
the potential to be the first drug approved in the United States
for this disorder. Pimavanserin is also in Phase II development for
Alzheimer’s disease psychosis and has successfully completed a
Phase II trial in schizophrenia. ACADIA also has clinical-stage
programs for chronic pain and glaucoma in collaboration with
Allergan, Inc. and two preclinical programs directed at Parkinson’s
disease and other neurological disorders. All product candidates
are small molecules that emanate from internal discoveries. ACADIA
maintains a website at www.acadia-pharm.com to which we regularly
post copies of our press releases as well as additional information
and through which interested parties can subscribe to receive
e-mail alerts.
Forward-Looking Statements
Statements in this press release that are not strictly
historical in nature are forward-looking statements. These
statements include but are not limited to statements related to the
timing of the submission of an NDA for NUPLAZID (pimavanserin); the
potential for pimavanserin to be the first drug approved in the
United States for Parkinson’s disease psychosis (PDP) and the
potential timing of such approval, if approved at all; the
importance of the NUPLAZID program based on the Breakthrough
Therapy designation; the potential for NUPLAZID to transform the
treatment landscape for patients with PDP; ACADIA’s ongoing
pre-commercial activities and plans to commercially launch
pimavanserin; and the progress, timing and results of ACADIA’s drug
discovery and development programs, either alone or with a partner,
including the progress and expected timing of clinical trials.
These statements are only predictions based on current information
and expectations and involve a number of risks and uncertainties.
Actual events or results may differ materially from those projected
in any of such statements due to various factors, including the
risks and uncertainties inherent in drug discovery, development,
approval, and commercialization, and collaborations with others,
and the fact that past results of clinical trials may not be
indicative of future trial results. For a discussion of these and
other factors, please refer to ACADIA’s annual report on Form 10-K
for the year ended December 31, 2013 as well as ACADIA’s
subsequent filings with the Securities and Exchange Commission. You
are cautioned not to place undue reliance on these forward-looking
statements, which speak only as of the date hereof. This caution is
made under the safe harbor provisions of the Private Securities
Litigation Reform Act of 1995. All forward-looking statements are
qualified in their entirety by this cautionary statement and ACADIA
undertakes no obligation to revise or update this press release to
reflect events or circumstances after the date hereof, except as
required by law.
ACADIA PHARMACEUTICALS INC.
CONDENSED CONSOLIDATED STATEMENTS OF
OPERATIONS
(in thousands, except per share
amounts)
(Unaudited)
Three Months Ended
September 30,
Nine Months Ended
September 30,
2014
2013 2014
2013 Collaborative
revenues $ 15 $ 240 $ 72 $ 1,108 Operating expenses Research
and development (includes stock-based compensation expense of
$1,358, $690, $3,452, and $1,417, respectively) 16,952 7,254 42,420
18,797 General and administrative (includes stock-based
compensation expense of $2,544, $1,201, $7,942, and $2,120,
respectively)
8,057
3,797 22,328
8,444 Total operating expenses
25,009 11,051
64,748 27,241 Loss
from operations (24,994 ) (10,811 ) (64,676 ) (26,133 ) Interest
income, net
208 116
567 234
Net loss
$ (24,786 )
$ (10,695 ) $
(64,109 ) $
(25,899 ) Net loss per common share,
basic and diluted
$ (0.25 )
$ (0.12 ) $
(0.66 ) $ (0.31
) Weighted average common shares outstanding, basic
and diluted
99,497
89,504 97,210
83,946
ACADIA PHARMACEUTICALS INC.
CONDENSED CONSOLIDATED BALANCE
SHEETS
(in thousands)
(Unaudited)
September 30,
2014
December 31,
2013(1)
Assets Cash, cash equivalents, and investment
securities $ 337,799 $ 185,790 Prepaid expenses, interest, and
other receivables
3,266
2,570 Total current assets 341,065 188,360 Other
non-current assets
698 758
Total assets
$ 341,763 $
189,118 Liabilities and stockholders’ equity
Total liabilities $ 11,274 $ 6,987 Stockholders’ equity
330,489 182,131 Total liabilities
and stockholders’ equity
$ 341,763
$ 189,118
(1)
The condensed consolidated balance sheet
at December 31, 2013 has been derived from the audited financial
statements at such date but does not include all of the information
and footnotes required by accounting principles generally accepted
in the United States for complete financial statements.
Investor Contacts:ACADIA Pharmaceuticals Inc.Steve Davis,
Executive Vice President,Chief Financial Officer and Chief Business
OfficerLisa Barthelemy, Director of Investor Relations(858)
558-2871orMedia Contact:Russo PartnersDavid Schull(212) 845-4271 or
(858) 717-2310david.schull@russopartnersllc.com
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