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 second quarter
and six months ended June 30, 2009.
ACADIA reported a net loss of $12.7 million, or $0.34 per common share,
for the second quarter of 2009 compared to a net loss of $18.3 million,
or $0.49 per common share, for the second quarter of 2008. For the six
months ended June 30, 2009, ACADIA reported a net loss of $27.7 million,
or $0.75 per common share, compared to a net loss of $34.7 million, or
$0.94 per common share, for the comparable period of 2008.
At June 30, 2009, ACADIA’s cash, cash equivalents, and investment
securities totaled $66.2 million compared to $60.1 million at December
31, 2008. The increase in cash was primarily due to an upfront cash
payment of $30 million received in May 2009 pursuant to ACADIA’s
collaboration with Biovail, partially offset by cash used to fund
operations.
“The second quarter of 2009 was highlighted by the formation of our
collaboration with Biovail and continued progress in our Phase III
program with pimavanserin, most notably the completion of enrollment in
our first pivotal Phase III trial in patients with Parkinson’s disease
psychosis,” said Uli Hacksell, Ph.D., ACADIA’s Chief Executive Officer.
“We remain on track to report top-line results from this Phase III trial
during the third quarter, as we continue to advance our pipeline of
novel treatments for patients suffering from CNS disorders.”
Revenues totaled $1.8 million for the second quarter of 2009 compared to
$177,000 for the second quarter of 2008. The increase in revenues was
primarily due to $1.4 million in initial revenues recognized under
ACADIA’s collaboration with Biovail, which commenced in May 2009, as
well as increased revenues from other agreements.
Research and development expenses totaled $12.0 million for the second
quarter of 2009, including $283,000 in stock-based compensation,
compared to $16.0 million for the second quarter of 2008, including
$380,000 in stock-based compensation. The decrease in research and
development expenses was primarily due to $3.5 million in decreased
personnel and other costs associated with ACADIA’s research and
development organization, following a restructuring in August 2008, and
lower external service costs. External service costs totaled $8.4
million for the second quarter of 2009 and were primarily comprised of
development costs for pimavanserin.
General and administrative expenses totaled $2.7 million for the second
quarter of 2009, including $333,000 in stock-based compensation,
compared to $3.2 million for the second quarter of 2008, including
$431,000 in stock-based compensation. The decrease in general and
administrative expenses was primarily due to decreased personnel and
other administrative costs following the restructuring, offset in part
by increased external service costs.
Net interest income decreased to $93,000 for the second quarter of 2009
from $756,000 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 continues to anticipate that its cash, cash equivalents and
investment securities will be greater than $40 million at December 31,
2009, and that the Company’s existing cash resources and payments from
its collaborations will be sufficient to fund its operations at least
into the first half of 2011.
Second Quarter 2009 Highlights
-
ACADIA completed enrollment in the first pivotal Phase III trial of
pimavanserin in patients with Parkinson’s disease psychosis (PDP) in
May 2009. ACADIA expects to report top-line results from this trial in
the third quarter of 2009.
-
ACADIA continues to enroll patients in the second pivotal Phase III
trial of pimavanserin in patients with PDP. ACADIA also continues 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, the 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 extended the term of its discovery alliance with Allergan for
one additional year through March 2010. Joint research efforts are
focused in ophthalmic indications.
Conference Call and Webcast Information
ACADIA management will review its second quarter results and development
programs via conference call and webcast today at 5:00 p.m. Eastern
Time. The conference call may be accessed by dialing 866-831-6234 for
participants in the U.S. or Canada and 617-213-8854 for international
callers (reference passcode 31522932). A telephone replay of the
conference call may be accessed through August 19, 2009 by dialing
888-286-8010 for callers in the U.S. or Canada and 617-801-6888 for
international callers (reference passcode 97036682). 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 August 19,
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 cash position
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.
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ACADIA PHARMACEUTICALS INC.
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CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
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(in thousands, except per share amounts)
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|
(Unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
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Three Months Ended June 30,
|
|
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Six Months Ended June 30,
|
|
|
|
|
|
2009
|
|
|
|
2008
|
|
|
|
|
2009
|
|
|
|
2008
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Collaborative revenues
|
|
|
$
|
1,820
|
|
|
$
|
177
|
|
|
|
$
|
2,194
|
|
|
$
|
983
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating expenses
|
|
|
|
|
|
|
|
|
|
|
|
Research and development (includes stock-based compensation of $283,
$380, $504 and $795, respectively)
|
|
|
|
11,979
|
|
|
|
16,036
|
|
|
|
|
24,533
|
|
|
|
31,207
|
|
|
General and administrative (includes stock-based compensation of
$333, $431, $687 and $852, respectively)
|
|
|
|
2,662
|
|
|
|
3,184
|
|
|
|
|
5,649
|
|
|
|
6,454
|
|
|
Total operating expenses
|
|
|
|
14,641
|
|
|
|
19,220
|
|
|
|
|
30,182
|
|
|
|
37,661
|
|
|
Loss from operations
|
|
|
|
(12,821
|
)
|
|
|
(19,043
|
)
|
|
|
|
(27,988
|
)
|
|
|
(36,678
|
)
|
|
Interest income (expense), net
|
|
|
|
93
|
|
|
|
756
|
|
|
|
|
260
|
|
|
|
2,011
|
|
|
Net loss
|
|
|
$
|
(12,728
|
)
|
|
$
|
(18,287
|
)
|
|
|
$
|
(27,728
|
)
|
|
$
|
(34,667
|
)
|
|
Net loss per common share, basic and diluted
|
|
|
$
|
(0.34
|
)
|
|
$
|
(0.49
|
)
|
|
|
$
|
(0.75
|
)
|
|
$
|
(0.94
|
)
|
|
Weighted average common shares outstanding, basic and diluted
|
|
|
|
37,220
|
|
|
|
37,102
|
|
|
|
|
37,200
|
|
|
|
37,077
|
|
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ACADIA PHARMACEUTICALS INC.
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CONDENSED CONSOLIDATED BALANCE SHEETS
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(in thousands)
|
|
(Unaudited)
|
|
|
|
|
|
|
June 30,
2009
|
|
|
December 31,
2008(1)
|
|
|
|
|
|
|
|
|
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Assets
|
|
|
|
|
|
|
|
Cash, cash equivalents, and investment securities
|
|
|
$
|
66,152
|
|
|
$
|
60,083
|
|
Prepaid expenses, receivables and other current assets
|
|
|
|
2,062
|
|
|
|
2,299
|
|
Total current assets
|
|
|
|
68,214
|
|
|
|
62,382
|
|
Property and equipment, net
|
|
|
|
1,657
|
|
|
|
2,103
|
|
Other assets
|
|
|
|
192
|
|
|
|
192
|
|
Total assets
|
|
|
$
|
70,063
|
|
|
$
|
64,677
|
|
Liabilities and Stockholders’ Equity
|
|
|
|
|
|
|
|
Current liabilities
|
|
|
|
20,936
|
|
|
|
11,051
|
|
Long-term liabilities
|
|
|
|
22,714
|
|
|
|
634
|
|
Stockholders’ equity
|
|
|
|
26,413
|
|
|
|
52,992
|
|
Total liabilities and stockholders’ equity
|
|
|
$
|
70,063
|
|
|
$
|
64,677
|
|
|
|
|
|
|
|
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(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.
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ACADIA Pharmaceuticals Inc.
Lisa Barthelemy, Director, Investor
Relations
Thomas H. Aasen, Vice President and Chief
Financial Officer
(858) 558-2871