ACADIA Pharmaceuticals Inc. (NASDAQ: ACAD), a biopharmaceutical
company focused on the development and commercialization of
innovative medicines that address unmet medical needs in
neurological and related central nervous system disorders, today
announced its unaudited financial results for the second quarter
ended June 30, 2014.
ACADIA reported a net loss of $21.5 million, or $0.22 per common
share, for the second quarter of 2014 compared to a net loss of
$9.1 million, or $0.11 per common share, for the second quarter of
2013. Net losses for the second quarters of 2014 and 2013 included
$4.3 million and $1.1 million, respectively, in non-cash,
stock-based compensation expense. For the six months ended June 30,
2014, ACADIA reported a net loss of $39.3 million, or $0.41 per
common share, compared to a net loss of $15.2 million, or $0.19 per
common share, for the comparable period of 2013. Net losses for the
six-month periods ended June 30, 2014 and 2013 included $7.5
million and $1.6 million, respectively, in non-cash, stock-based
compensation expense.
At June 30, 2014, ACADIA’s cash, cash equivalents, and
investment securities totaled $354.5 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.
“During the first half of the year, we continued to make
important progress in advancing our lead program with pimavanserin
toward registration, significantly strengthened our financial
position through a follow-on offering, and made key additions to
our team, including the recent appointment of Steve Davis as our
Executive Vice President, Chief Financial Officer and Chief
Business Officer,” said Uli Hacksell, Ph.D., ACADIA’s Chief
Executive Officer. “This is an exciting time as we focus on the
planned submission of our NDA for pimavanserin in Parkinson’s
disease psychosis near the end of this year and continue building
the commercial infrastructure necessary to support the planned
launch of pimavanserin. Given the demonstrated antipsychotic
effects, benefits on sleep, and favorable safety profile we’ve
observed in the clinic to date, we are also very excited about the
opportunity to advance pimavanserin in other indications. To that
end, we continue to advance enrollment of our ongoing Phase II
study of pimavanserin in Alzheimer’s disease psychosis and prepare
for additional studies to evaluate the clinical utility of
pimavanserin in other areas of significant unmet medical need.”
Research and development expenses increased to $13.8 million for
the second quarter of 2014, including $1.1 million in stock-based
compensation expense, from $7.1 million for the comparable quarter
of 2013, including $473,000 in stock-based compensation expense.
This increase was primarily due to an increase of $5.0 million in
external service costs, including costs associated with
NDA-enabling clinical and manufacturing activities in our
pimavanserin development program. Increases in costs associated
with our expanded research and development organization, including
$820,000 in increased personnel costs and $616,000 in increased
stock-based compensation expense, also contributed to the
quarter-over-quarter increase.
General and administrative expenses increased to $8.0 million
for the second quarter of 2014, including $3.2 million in
stock-based compensation expense, from $2.5 million for the
comparable quarter of 2013, including $591,000 in stock-based
compensation expense. This increase was primarily due to $2.6
million in increased stock-based compensation expense, including
$1.1 million in stock-based compensation expense associated with
the retirement of our former Chief Financial Officer. Also
contributing to the quarter-over-quarter increase in general and
administrative expenses was a $2.0 million increase in external
service costs largely related to ACADIA’s preparations for the
planned launch of pimavanserin and $559,000 in increased personnel
costs.
Conference Call and Webcast Information
ACADIA management will review its second 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 866-578-5771 for participants in the United
States or Canada and 617-213-8055 for international callers
(reference passcode 94851179). A telephone replay of the conference
call may be accessed through August 19, 2014 by dialing
888-286-8010 for callers in the United States or Canada and
617-801-6888 for international callers (reference passcode
56603137). 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 August 19, 2014.
About ACADIA Pharmaceuticals
ACADIA is a biopharmaceutical company focused on the development
and commercialization of innovative medicines that address unmet
medical needs in neurological and related central nervous system
disorders. ACADIA has a pipeline of product candidates led by
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. We are currently completing NDA-enabling clinical
and manufacturing activities for pimavanserin and are planning to
submit an NDA with the FDA near the end of 2014. 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 pimavanserin, the potential
for pimavanserin to be the first drug approved in the United States
for Parkinson’s disease psychosis and the potential timing of such
approval, if approved at all; ACADIA’s ongoing pre-commercial
activities and plans to commercially launch pimavanserin; 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, and the clinical
utility to be derived from ACADIA’s product candidates, including
the potential benefits of pimavanserin seen in clinical trials for
Parkinson’s disease psychosis to be applicable to other
indications, including Alzheimer’s disease psychosis and other
indications in which it has not yet been studied; and the progress
of ACADIA’s NDA-enabling clinical and manufacturing activities.
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 EndedJune 30,
Six Months EndedJune 30,
2014
2013 2014
2013
Collaborative revenues $ 28 $ 451 $ 58 $ 868 Operating
expenses Research and development (includes stock-based
compensation expense of $1,089, $473, $2,095, and $727,
respectively) 13,799 7,112 25,467 11,542 General and administrative
(includes stock-based compensation expense of $3,242, $591, $5,398,
and $919, respectively)
7,952
2,496 14,272
4,647 Total operating expenses
21,751 9,608
39,739 16,189 Loss
from operations (21,723 ) (9,157 ) (39,681 ) (15,321 ) Interest
income, net
228 76
358 117
Net loss
$ (21,495 )
$ (9,081 ) $
(39,323 ) $
(15,204 ) Net loss per common share,
basic and diluted
$ (0.22 )
$ (0.11 ) $
(0.41 ) $ (0.19
) Weighted average common shares outstanding, basic
and diluted
99,048
83,410 96,042
81,105
ACADIA PHARMACEUTICALS INC.
CONDENSED CONSOLIDATED BALANCE
SHEETS
(in thousands)
(Unaudited)
June 30,
2014
December 31,
2013(1)
Assets Cash, cash equivalents, and investment
securities $ 354,453 $ 185,790 Prepaid expenses, interest, and
other receivables
4,401
2,570 Total current assets 358,854 188,360 Other
non-current assets
611 758
Total assets
$ 359,465 $
189,118 Liabilities and stockholders’ equity
Total liabilities $ 9,357 $ 6,987 Stockholders’ equity
350,108 182,131 Total liabilities
and stockholders’ equity
$ 359,465
$ 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.
ACADIA Pharmaceuticals Inc.Steve Davis, Executive Vice
President,Chief Financial Officer and Chief Business OfficerLisa
Barthelemy, Director of Investor Relations(858) 558-2871
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