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 first quarter
ended March 31, 2015.
ACADIA reported a net loss of $40.4 million, or $0.40 per common
share, for the first quarter of 2015 compared to a net loss of
$17.8 million, or $0.19 per common share, for the first quarter of
2014. The net loss for the first quarter of 2015 included $14.5
million in non-cash stock-based compensation expense, including
$9.0 million of non-cash stock-based compensation recognized in
connection with the retirement of ACADIA’s former Chief Executive
Officer. Non-cash stock-based compensation expense for the first
quarter of 2014 totaled $3.2 million. At March 31, 2015, ACADIA’s
cash, cash equivalents and investment securities totaled $297.9
million, compared to $322.5 million at December 31, 2014.
“We continue to make important progress in advancing NUPLAZID™
(pimavanserin) for Parkinson’s disease psychosis (PDP) toward
registration and in preparing for the planned commercial launch of
NUPLAZID in the United States,” said Steve Davis, ACADIA’s Interim
Chief Executive Officer. “We remain on track with completing the
preparation of manufacturing quality systems to support commercial
manufacturing and supply and, as previously indicated, we plan to
submit our NUPLAZID New Drug Application (NDA) to the U.S. Food and
Drug Administration (FDA) in the second half of 2015.”
“In addition, during the first quarter, we made significant
strides in our foundational medical education efforts, including
initiation of an important disease awareness campaign designed to
increase dialog in the medical community regarding the needs of
patients suffering from PDP. This initiative, together with a
further expansion of our sales management team and medical affairs
team, highlight the strong efforts we are putting behind addressing
the significant unmet need represented by PDP.”
Research and development expenses increased to $16.3 million for
the first quarter of 2015, including $2.4 million in stock-based
compensation expense, from $11.7 million for the comparable quarter
of 2014, including $1.0 million in stock-based compensation
expense. This increase was partly due to an increase of $3.1
million in personnel and related costs and stock-based compensation
expense associated with ACADIA’s expanded research and development
organization. Also contributing to the quarter-over-quarter
increase was an increase in external service costs of $1.5 million,
primarily related to ongoing work to complete the preparation of
manufacturing quality systems to support commercial manufacturing
and supply of NUPLAZID.
General and administrative expenses increased to $24.3 million
for the first quarter of 2015, including $12.2 million in
stock-based compensation expense, from $6.3 million for the
comparable quarter of 2014, including $2.2 million in stock-based
compensation expense. This increase was due to increases in
personnel and related costs and stock-based compensation expense of
$14.2 million and increases in external services costs of $3.8
million. Contributing to the increase in personnel costs and
stock-based compensation expense was $9.6 million in costs
recognized in connection with the retirement of ACADIA’s former
Chief Executive Officer, including $9.0 million of stock-based
compensation expense. Excluding these costs, the increases in
personnel costs and external services costs were largely related to
ACADIA’s commercial preparations for the planned launch of
NUPLAZID.
Conference Call and Webcast Information
ACADIA management will review its first 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 855-638-4820 for participants in the U.S. or
Canada and 443-877-4067 for international callers (reference
passcode 33769915). A telephone replay of the conference call may
be accessed through May 21, 2015 by dialing 855-859-2056 for
callers in the U.S. or Canada and 404-537-3406 for international
callers (reference passcode 33769915). 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 May
21, 2015.
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. 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) for
the treatment of PDP; the potential for pimavanserin to be the
first drug approved in the United States for PDP and the potential
timing of such approval, if approved at all; the activities planned
to be undertaken including preparation of manufacturing quality
systems; ACADIA’s ongoing pre-commercial activities and plans to
commercially launch NUPLAZID; 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, including planned trials for 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 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, 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 EndedMarch 31,
2015
2014 Collaborative
revenues $ 4 $ 30 Operating expenses Research and
development (includes stock-based compensation of $2,362 and
$1,006, respectively) 16,295 11,668 General and administrative
(includes stock-based compensation of $12,166 and $2,156,
respectively)
24,261
6,320 Total operating expenses
40,556 17,988 Loss
from operations (40,552 ) (17,958 ) Interest income, net
177 130 Net loss
$ (40,375 ) $
(17,828 ) Net loss per common share,
basic and diluted
$ (0.40 )
$ (0.19 ) Weighted average
common shares outstanding, basic and diluted
100,197 92,968
ACADIA PHARMACEUTICALS INC.
CONDENSED CONSOLIDATED BALANCE
SHEETS
(in thousands)
(Unaudited)
March 31,
2015
December 31,
2014(1)
Assets Cash, cash equivalents and investment securities $
297,893 $ 322,486 Prepaid expenses, receivables and other current
assets
2,006 2,132 Total
current assets 299,899 324,618 Other non-current assets
2,064 840 Total assets
$ 301,963 $
325,458 Liabilities and stockholders’ equity
Total liabilities $ 16,869 $ 15,969 Stockholders’ equity
285,094 309,489 Total liabilities
and stockholders’ equity
$ 301,963
$ 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.
ACADIA Pharmaceuticals Inc.Steve Davis, Interim Chief Executive
OfficerLisa Barthelemy, Director of Investor Relations(858)
558-2871
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