SAN DIEGO--(BUSINESS WIRE)--Aug. 5, 2014--
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 Ended
June 30,
|
|
Six Months Ended
June 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.
Source: ACADIA Pharmaceuticals Inc.
ACADIA Pharmaceuticals Inc.
Steve Davis, Executive Vice
President,
Chief Financial Officer and Chief Business Officer
Lisa
Barthelemy, Director of Investor Relations
(858) 558-2871