ACADIA Pharmaceuticals Inc. (Nasdaq: ACAD), a biopharmaceutical company
utilizing innovative technology to fuel drug discovery and clinical
development of novel treatments for central nervous system disorders,
today reported its unaudited financial results for the first quarter
ended March 31, 2009.
ACADIA reported a net loss of $15.0 million, or $0.40 per common share,
for the first quarter of 2009 compared to a net loss of $16.4 million,
or $0.44 per common share, for the first quarter of 2008. The net losses
for the first quarters of 2009 and 2008 included $575,000 and $836,000,
respectively, in non-cash, stock-based compensation expense.
At March 31, 2009, ACADIA’s cash, cash equivalents, and investment
securities totaled $46.4 million compared to $60.1 million at December
31, 2008. Following the end of the first quarter, ACADIA received an
upfront cash payment of $30 million under the terms of its collaboration
with Biovail Laboratories International SRL, which was established in
early May 2009.
“The beginning of 2009 has been a highly productive period for ACADIA,
highlighted by the formation of two important new collaborations with
Biovail and Meiji Seika, and the completion of enrollment in our first
pivotal Phase III trial with pimavanserin in patients with Parkinson’s
disease psychosis,” said Uli Hacksell, Ph.D., ACADIA’s Chief Executive
Officer. “We believe that ACADIA is well positioned to continue to
advance our promising portfolio of product candidates that provide us
with multiple product and commercial opportunities.”
Revenues totaled $374,000 for the first quarter of 2009 compared to
$806,000 for the first quarter of 2008. This decrease was primarily due
to lower revenues from ACADIA’s collaborations with Allergan and its
agreements with other parties.
Research and development expenses totaled $12.6 million for the first
quarter of 2009, including $221,000 in stock-based compensation,
compared to $15.2 million for the first quarter of 2008, including
$415,000 in stock-based compensation. The decrease in research and
development expenses was primarily due to approximately $3.9 million in
decreased personnel and other costs associated with the research and
development organization following ACADIA’s restructuring in August
2008, offset in part by $1.3 million in increased external service
costs. External service costs totaled $9.1 million for the first quarter
of 2009 and were primarily comprised of development costs for
pimavanserin.
General and administrative expenses totaled $3.0 million for the first
quarter of 2009, including $354,000 in stock-based compensation,
compared to $3.3 million for the first quarter of 2008, including
$421,000 in stock-based compensation. The decrease in general and
administrative expenses was primarily due to decreased personnel and
other administrative costs resulting from ACADIA’s restructuring, offset
in part by increased external expenses.
Net interest income decreased to $167,000 for the first quarter of 2009
from $1.3 million in the comparable quarter of 2008 due to decreased
yields on ACADIA's investment security portfolio and lower average
levels of cash and investment securities.
ACADIA anticipates that its cash, cash equivalents and investment
securities will be greater than $40 million at December 31, 2009, and
that its existing cash resources and payments from its collaborations
will be sufficient to fund its operations at least into the first half
of 2011.
First Quarter 2009 and Recent Highlights
-
ACADIA announced completion of enrollment in the first pivotal Phase
III trial of pimavanserin in patients with Parkinson’s disease
psychosis (PDP) in early May 2009. Top-line results from this trial
are expected to be reported by the end of the third quarter of 2009.
-
ACADIA is continuing to enroll patients in the second pivotal Phase
III trial of pimavanserin in patients with PDP. ACADIA also is
continuing to conduct an open-label safety extension study pursuant to
which eligible patients who have completed either of the two pivotal
Phase III trials have the opportunity to enroll if, in the opinion of
the physician, a patient may benefit from continued treatment with
pimavanserin.
-
ACADIA established a collaboration with Biovail Laboratories
International SRL to co-develop and commercialize pimavanserin for
neurological and psychiatric indications, including PDP and
Alzheimer’s disease psychosis (ADP), in the United States and Canada.
-
ACADIA established a collaboration with Meiji Seika Kaisha, Ltd. to
develop and commercialize a novel class of pro-cognitive drugs to
treat patients with schizophrenia and related disorders in Japan and
several other Asian countries.
-
ACADIA extended the term of its March 2003 discovery alliance with
Allergan for one additional year through March 2010. Joint research
efforts will be focused in ophthalmic indications.
-
ACADIA was awarded a grant from the Michael J. Fox Foundation for the
development of novel estrogen receptor beta (ER-beta) agonists for the
treatment of Parkinson’s disease.
Conference Call and Webcast Information
ACADIA management will review its first quarter results and development
programs via conference call and webcast at 5:00 p.m. Eastern Time. The
conference call may be accessed by dialing 866-825-3209 for participants
in the U.S. or Canada and 617-213-8061 for international callers
(reference passcode 62919191). A telephone replay of the conference call
may be accessed through May 25, 2009 by dialing 888-286-8010 for callers
in the U.S. or Canada and 617-801-6888 for international callers
(reference passcode 93775458). 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 25,
2009.
About ACADIA Pharmaceuticals
ACADIA is a biopharmaceutical company utilizing innovative technology to
fuel drug discovery and clinical development of novel treatments for
central nervous system disorders. ACADIA is currently developing a
portfolio consisting of its five most advanced product candidates
including pimavanserin, which is in Phase III development for
Parkinson’s disease psychosis in collaboration with Biovail. In addition
to pimavanserin, ACADIA has a product candidate in Phase II for chronic
pain and a product candidate in Phase I for glaucoma, both in
collaboration with Allergan, as well as two programs in IND-track
development. All of the product candidates in ACADIA’s pipeline emanate
from discoveries made using its proprietary drug discovery platform.
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 email 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 (collectively referred to as its
pipeline) either alone or with a partner, including clinical trials and
the results therefrom, and the benefits to be derived from ACADIA’s
product candidates, in each case including pimavanserin, potential
payments under its collaboration agreements, its future financial
performance and the length of its cash runway. 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 and commercialization, and collaborations with
others, and the fact that past results of clinical trials may not be
indicative of further 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, 2008 as well as other 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.
|
ACADIA PHARMACEUTICALS INC.
|
|
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
|
|
(in thousands, except per share amounts)
|
|
(Unaudited)
|
|
|
|
|
|
|
|
|
Three Months Ended March 31,
|
|
|
|
|
|
|
|
2009
|
|
|
|
|
2008
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Collaborative revenues
|
|
|
|
|
$
|
374
|
|
|
|
$
|
806
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating expenses
|
|
|
|
|
|
|
|
|
|
Research and development (includes stock-based compensation of $221
and $415 for the three months ended March 31, 2009 and 2008,
respectively)
|
|
|
|
|
|
12,554
|
|
|
|
|
15,171
|
|
|
General and administrative (includes stock-based compensation of
$354 and $421 for the three months ended March 31, 2009 and 2008,
respectively)
|
|
|
|
|
|
2,988
|
|
|
|
|
3,270
|
|
|
Total operating expenses
|
|
|
|
|
|
15,542
|
|
|
|
|
18,441
|
|
|
Loss from operations
|
|
|
|
|
|
(15,168
|
)
|
|
|
|
(17,635
|
)
|
|
Interest income (expense), net
|
|
|
|
|
|
167
|
|
|
|
|
1,255
|
|
|
Net loss
|
|
|
|
|
$
|
(15,001
|
)
|
|
|
$
|
(16,380
|
)
|
|
Net loss per common share, basic and diluted
|
|
|
|
|
$
|
(0.40
|
)
|
|
|
$
|
(0.44
|
)
|
|
Weighted average common shares outstanding, basic and diluted
|
|
|
|
|
|
37,179
|
|
|
|
|
37,053
|
|
|
ACADIA PHARMACEUTICALS INC.
|
|
CONDENSED CONSOLIDATED BALANCE SHEETS
|
|
(in thousands)
|
|
(Unaudited)
|
|
|
|
|
|
|
|
|
March 31,
2009
|
|
|
December 31,
2008(1)
|
|
|
|
|
|
|
|
|
|
|
|
Assets
|
|
|
|
|
|
|
|
|
|
Cash, cash equivalents and investment securities
|
|
|
|
|
$
|
46,384
|
|
|
$
|
60,083
|
|
Prepaid expenses, receivables and other current assets
|
|
|
|
|
|
1,903
|
|
|
|
2,299
|
|
Total current assets
|
|
|
|
|
|
48,287
|
|
|
|
62,382
|
|
Property and equipment, net
|
|
|
|
|
|
1,846
|
|
|
|
2,103
|
|
Other assets
|
|
|
|
|
|
238
|
|
|
|
192
|
|
Total assets
|
|
|
|
|
$
|
50,371
|
|
|
$
|
64,677
|
|
Liabilities and Stockholders’ Equity
|
|
|
|
|
|
|
|
|
|
Current liabilities
|
|
|
|
|
|
11,436
|
|
|
|
11,051
|
|
Long-term liabilities
|
|
|
|
|
|
549
|
|
|
|
634
|
|
Stockholders’ equity
|
|
|
|
|
|
38,386
|
|
|
|
52,992
|
|
Total liabilities and stockholders’ equity
|
|
|
|
|
$
|
50,371
|
|
|
$
|
64,677
|
|
|
|
(1) The condensed consolidated balance sheet at December 31, 2008
has been derived from the audited financial statements at that
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.
Lisa Barthelemy, Director, Investor
Relations
Thomas H. Aasen, Vice President and Chief
Financial Officer
(858) 558-2871