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 financial results for the fourth quarter and year
ended December 31, 2013.
ACADIA reported a net loss of $12.0 million, or $0.13 per common
share, for the fourth quarter of 2013, compared to a net loss of
$6.8 million, or $0.11 per common share, for the fourth quarter of
2012. The net losses for the fourth quarters of 2013 and 2012
included $2.2 million and $552,000, respectively, in non-cash,
stock-based compensation expense. For the year ended December 31,
2013, ACADIA reported a net loss of $37.9 million, or $0.44 per
common share, compared to a net loss of $20.8 million, or $0.38 per
common share, for 2012. The net losses for 2013 and 2012 included
$5.7 million and $1.9 million, respectively, in non-cash,
stock-based compensation expense.
At December 31, 2013, ACADIA’s cash, cash equivalents, and
investment securities totaled $185.8 million compared to $108.0
million at December 31, 2012. This increase was primarily due to
net proceeds from sales of equity securities, including $107.9
million raised in a public offering in May 2013, offset in part by
cash used to fund ACADIA’s operations.
“2013 was an extraordinary year for ACADIA, highlighted by the
establishment of an expedited path to an NDA filing for
pimavanserin, our strengthened balance sheet, and the publication
in The Lancet of our pivotal Phase III trial," said Uli Hacksell,
Ph.D., Chief Executive Officer of ACADIA. "Additionally, we closed
the year by initiating our Phase II trial in Alzheimer's disease
psychosis, which represents an integral part of our strategy to
broaden the pimavanserin franchise to address a range of major
neurological and psychiatric disorders. These achievements set the
stage for what we expect will be an exciting 2014. Importantly, we
have continued to advance our Phase III Parkinson's disease
psychosis program towards registration and remain on track for our
planned NDA submission near the end of this year. In parallel, we
are conducting pre-commercial activities to prepare for the planned
future launch of pimavanserin and we are planning additional
studies in our life cycle management program. We look forward to
building on this momentum as we pursue our ultimate goal of
bringing innovative medicines to market to improve the lives of
patients with neurological and related central nervous system
disorders."
Research and development expenses increased to $7.9 million for
the fourth quarter of 2013, including $791,000 in stock-based
compensation, from $4.9 million for the comparable quarter of 2012,
including $230,000 in stock-based compensation. This increase was
primarily due to increased external service costs incurred in our
pimavanserin program, as well as increased personnel and
stock-based compensation expenses.
General and administrative expenses increased to $4.3 million
for the fourth quarter of 2013, including $1.4 million in
stock-based compensation, from $2.3 million for the comparable
quarter of 2012, including $322,000 in stock-based compensation.
This increase was primarily due to increased stock-based
compensation expense and increased professional fees, including
costs related to ACADIA’s pre-commercial activities.
Revenues decreased to $37,000 for the fourth quarter of 2013
from $380,000 for the comparable quarter of 2012 primarily due to
the conclusion of our 2003 research collaboration with Allergan in
March 2013.
ACADIA anticipates that the level of cash used in its operations
will increase in 2014, relative to 2013, in order to fund ongoing
and planned development and pre-commercial activities for
pimavanserin. ACADIA currently expects that its cash, cash
equivalents, and investment securities will be greater than $120
million at December 31, 2014.
2013 Highlights
Pipeline
- Presented data from pivotal Phase III
-020 Study with pimavanserin in Parkinson’s disease psychosis at
the American Academy of Neurology Meeting in March 2013.
- Established an expedited path to an NDA
filing for pimavanserin in April 2013.
- Advanced novel glaucoma compound into
preclinical development through Allergan collaboration in May
2013.
- Presented data from Phase III
Parkinson’s disease psychosis program at the International Congress
of Parkinson’s Disease and Movement Disorders in June 2013.
- Published results from pivotal Phase
III -020 Study with pimavanserin in The Lancet in November
2013.
- Initiated Phase II trial with
pimavanserin in Alzheimer’s disease psychosis in November
2013.
Business and Other
- Completed a public offering of common
stock raising net proceeds of $107.9 million in May 2013.
- Added to NASDAQ Biotechnology Index and
Russell 2000 Index in May 2013 and June 2013, respectively.
- Appointed Terrence Moore as Executive
Vice President and Chief Commercial Officer in August 2013, and
strengthened ACADIA’s development, regulatory, medical affairs, and
commercial capabilities during 2013.
Conference Call and Webcast Information
ACADIA management will review its fourth 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 800-706-7741 for participants in the U.S. or
Canada and 617-614-3471 for international callers (reference
passcode 12002019). A telephone replay of the conference call may
be accessed through March 13, 2014 by dialing 888-286-8010 for
callers in the U.S. or Canada and 617-801-6888 for international
callers (reference passcode 39435923). 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 March
13, 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, which is in Phase III development as a potential
first-in-class treatment for Parkinson’s disease psychosis.
Pimavanserin is also in Phase II development for Alzheimer’s
disease psychosis and has successfully completed a Phase II trial
as a co-therapy for schizophrenia. ACADIA also has clinical-stage
programs for chronic pain and glaucoma in collaboration with
Allergan, Inc. and two advanced 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 ACADIA regularly posts copies of its 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
progress and timing 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 benefits
to be derived from ACADIA’s product candidates, in each case
including pimavanserin, the timing of an NDA submission for
pimavanserin and, if approved, any related launch therefor, the
strength of ACADIA’s balance sheet, strategic broadening of the
pimavanserin program, planned pre-commercial activities, ACADIA’s
growth potential, and ACADIA’s expected 2014 cash usage and
year-end balance. 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
December 31,
Years Ended
December 31,
2013
2012 2013 (1)
2012 (1) Collaborative
revenues $ 37 $ 380 $ 1,145 $ 4,907 Operating expenses
Research and development (includes stock-based compensation of
$791, $230, $2,208, and $680, respectively) 7,926 4,901 26,722
18,794 General and administrative (includes stock-based
compensation of $1,383, $322, $3,503, and $1,250, respectively)
4,276 2,298
12,720 6,999
Total operating expenses
12,202
7,199 39,442
25,793 Loss from operations (12,165 ) (6,819 )
(38,297 ) (20,886 ) Interest income, net
116
9 349
37 Net loss
$
(12,049 ) $
(6,810 ) $
(37,948 ) $
(20,849 ) Net loss per common share,
basic and diluted
$ (0.13 )
$ (0.11 ) $
(0.44 ) $ (0.38
) Weighted average common shares outstanding, basic
and diluted
90,947
60,618 85,715
55,116 (1) The condensed
consolidated statements of operations for the years ended December
31, 2013 and 2012 have been derived from the audited financial
statements but do 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.
CONDENSED CONSOLIDATED BALANCE
SHEETS
(in thousands)
(Unaudited)
December 31,
2013 (1)
December 31,
2012 (1)
Assets Cash, cash equivalents, and investment
securities $ 185,790 $ 107,967 Prepaid expenses, receivables and
other current assets
2,570
581 Total current assets 188,360 108,548 Other
non-current assets
758 42
Total assets
$ 189,118 $
108,590 Liabilities, redeemable common stock and
stockholders’ equity Total liabilities $ 6,987 $ 5,948
Redeemable common stock --- 17,658 Stockholders’ equity
182,131 84,984 Total liabilities,
redeemable common stock and stockholders’ equity
$
189,118 $ 108,590
(1)
The condensed consolidated balance sheets
at December 31, 2013 and 2012 have been derived from the audited
financial statements at such date but do 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.Thomas H. Aasen, Executive Vice
President,Chief Financial Officer and Chief Business OfficerLisa
Barthelemy, Director of Investor Relations(858) 558-2871
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