SAN DIEGO--(BUSINESS WIRE)--Nov. 5, 2015--
ACADIA Pharmaceuticals Inc. (NASDAQ: ACAD), a biopharmaceutical company
focused on the development and commercialization of innovative medicines
to address unmet medical needs in central nervous system disorders,
today announced its unaudited financial results for the third quarter
ended September 30, 2015.
ACADIA reported a net loss of $38.9 million, or $0.39 per common share,
for the third quarter of 2015 compared to a net loss of $24.8 million,
or $0.25 per common share, for the third quarter of 2014. Net losses for
the third quarters of 2015 and 2014 included $9.2 million and $3.9
million, respectively, in non-cash stock-based compensation expense. For
the nine months ended September 30, 2015, ACADIA reported a net loss of
$118.7 million, or $1.18 per common share, compared to a net loss of
$64.1 million, or $0.66 per common share, for the comparable period of
2014. Net losses for the nine-month periods ended September 30, 2015 and
2014 included $31.3 million and $11.4 million, respectively, in
non-cash, stock-based compensation expense. At September 30, 2015,
ACADIA’s cash, cash equivalents and investment securities totaled $240.7
million, compared to $322.5 million at December 31, 2014.
“Our third quarter was highlighted by the September submission to the
FDA of our New Drug Application for the use of NUPLAZID™ in the
treatment of Parkinson’s disease psychosis, a condition for which there
is no FDA-approved therapy,” said Steve Davis, ACADIA’s President and
Chief Executive Officer. “We’re pleased by the FDA’s recent decision to
grant Priority Review status to our NUPLAZID application, resulting in a
projected accelerated timeline for review and an FDA goal of May 1, 2016
for taking action under the Prescription Drug User Fee Act, or PDUFA. We
continue to advance our preparations for the planned commercial launch
of NUPLAZID in the United States and to lay the foundation for
additional development with pimavanserin in other areas of significant
unmet medical need.”
Research and development expenses increased to $18.7 million for the
third quarter of 2015, including $3.9 million in stock-based
compensation expense, from $17.0 million for the comparable quarter of
2014, including $1.4 million in stock-based compensation expense. This
increase was primarily due to an increase in personnel and related costs
of $4.9 million associated with ACADIA’s expanded research and
development organization, largely offset by pimavanserin manufacturing
development costs incurred during the third quarter of 2014 that were
not incurred during the third quarter of 2015.
General and administrative expenses increased to $20.3 million for the
third quarter of 2015, including $5.3 million in stock-based
compensation expense, from $8.1 million for the comparable quarter of
2014, including $2.5 million in stock-based compensation expense. This
increase was due to increases in personnel and related costs of $7.0
million and increases in external services costs of $5.2 million, all
largely related to ACADIA’s commercial preparations for the planned
launch of NUPLAZID.
Conference Call and Webcast Information
ACADIA management will review its third quarter financial results and
operations via conference call and webcast later today at 5:00 p.m.
Eastern Time. The conference call may be accessed by dialing
844-821-1109 for participants in the U.S. or Canada and 830-865-2550 for
international callers (reference passcode 69545890). A telephone replay
of the conference call may be accessed through November 19, 2015 by
dialing 855-859-2056 for callers in the U.S. or Canada and 404-537-3406
for international callers (reference passcode 69545890). 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 until November
19, 2015.
About ACADIA Pharmaceuticals
ACADIA is a biopharmaceutical company focused on the development and
commercialization of innovative medicines to address unmet medical needs
in central nervous system disorders. ACADIA has a pipeline of product
candidates led by NUPLAZID™ (pimavanserin), for which we have submitted
a New Drug Application (NDA) in Parkinson’s disease psychosis to the FDA
and which has the potential to be the first drug approved in the United
States for this condition. The FDA has classified the NUPLAZID NDA as
having Priority Review status. 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 glaucoma and, in collaboration with
Allergan, Inc., for chronic pain. 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 potential for NUPLAZID
(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, by the FDA; ACADIA’s progress in preparing
to commercially launch NUPLAZID; 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,
including additional planned trials for pimavanserin; and the benefits
to be derived from ACADIA’s product candidates, including pimavanserin.
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 and past regulatory decisions may not be
indicative of future trial results or future regulatory decisions,
respectively. 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,
2014 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,
|
|
|
|
|
2015
|
|
|
|
2014
|
|
|
|
2015
|
|
|
|
2014
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Collaborative revenues
|
|
|
|
$
|
39
|
|
|
|
|
$
|
15
|
|
|
|
|
$
|
44
|
|
|
|
|
$
|
72
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating expenses
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development (includes stock-based compensation expense
of $3,938, $1,358, $9,139, and $3,452, respectively)
|
|
|
|
|
18,729
|
|
|
|
|
|
16,952
|
|
|
|
|
|
53,403
|
|
|
|
|
|
42,420
|
|
General and administrative (includes stock-based compensation
expense of $5,327, $2,544, $22,153, and $7,942, respectively)
|
|
|
|
|
20,308
|
|
|
|
|
|
8,057
|
|
|
|
|
|
65,688
|
|
|
|
|
|
22,328
|
|
Total operating expenses
|
|
|
|
|
39,037
|
|
|
|
|
|
25,009
|
|
|
|
|
|
119,091
|
|
|
|
|
|
64,748
|
|
Loss from operations
|
|
|
|
|
(38,998
|
)
|
|
|
|
|
(24,994
|
)
|
|
|
|
|
(119,047
|
)
|
|
|
|
|
(64,676
|
)
|
Interest income, net
|
|
|
|
|
92
|
|
|
|
|
|
208
|
|
|
|
|
|
388
|
|
|
|
|
|
567
|
|
Net loss
|
|
|
|
$
|
(38,906
|
)
|
|
|
|
$
|
(24,786
|
)
|
|
|
|
$
|
(118,659
|
)
|
|
|
|
$
|
(64,109
|
)
|
Net loss per common share, basic and diluted
|
|
|
|
$
|
(0.39
|
)
|
|
|
|
$
|
(0.25
|
)
|
|
|
|
$
|
(1.18
|
)
|
|
|
|
$
|
(0.66
|
)
|
Weighted average common shares outstanding, basic and diluted
|
|
|
|
|
100,756
|
|
|
|
|
|
99,497
|
|
|
|
|
|
100,436
|
|
|
|
|
|
97,210
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
ACADIA PHARMACEUTICALS INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(in thousands)
(Unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
September 30,
2015
|
|
|
|
|
|
|
|
|
December 31,
2014(1)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Assets
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash, cash equivalents, and investment securities
|
|
|
|
$
|
240,691
|
|
|
|
|
|
|
|
|
$
|
322,486
|
Prepaid expenses, receivables and other current assets
|
|
|
|
|
2,156
|
|
|
|
|
|
|
|
|
|
2,132
|
Total current assets
|
|
|
|
|
242,847
|
|
|
|
|
|
|
|
|
|
324,618
|
Other non-current assets
|
|
|
|
|
2,473
|
|
|
|
|
|
|
|
|
|
840
|
Total assets
|
|
|
|
$
|
245,320
|
|
|
|
|
|
|
|
|
$
|
325,458
|
Liabilities and stockholders’ equity
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total liabilities
|
|
|
|
$
|
17,974
|
|
|
|
|
|
|
|
|
$
|
15,969
|
Stockholders’ equity
|
|
|
|
|
227,346
|
|
|
|
|
|
|
|
|
|
309,489
|
Total liabilities and stockholders’ equity
|
|
|
|
$
|
245,320
|
|
|
|
|
|
|
|
|
$
|
325,458
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1)
|
|
|
The condensed consolidated balance sheet at December 31, 2014 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.
|
|
|
|
|
View source version on businesswire.com: http://www.businesswire.com/news/home/20151105006639/en/
Source: ACADIA Pharmaceuticals Inc.
ACADIA Pharmaceuticals Inc.
Lisa Barthelemy, Director of
Investor Relations
(858) 558-2871