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 (CNS)
disorders, today reported its unaudited financial results for the first
quarter ended March 31, 2008.
ACADIA reported a net loss of $16.4 million, or $0.44 per common share,
for the first quarter of 2008 compared to a net loss of $12.6 million,
or $0.42 per common share, for the first quarter of 2007. The net losses
for the first quarters of 2008 and 2007 included $836,000 and $1.3
million, respectively, in non-cash, stock-based compensation expense.
At March 31, 2008, ACADIA’s cash, cash
equivalents, and investment securities totaled $106.5 million compared
to $126.9 million at December 31, 2007. The decrease in cash was
primarily attributable to cash used to fund ACADIA’s
operations, including an aggregate decrease of $5.4 million in accounts
payable and accrued expenses, largely resulting from payments for
clinical expenses incurred in 2007.
“The first quarter of 2008 was highlighted by
continued progress in our most advanced clinical programs, including the
initiation of the second Phase III pivotal trial in our program with
pimavanserin for Parkinson’s disease psychosis
and completion of the treatment phase of our Phase IIb trial with
ACP-104 for schizophrenia,” said Uli
Hacksell, Ph.D., ACADIA’s Chief Executive
Officer. “We look forward to reporting
top-line results from our Phase IIb trial with ACP-104 during the second
quarter and continuing to advance our clinical pipeline of novel
treatments for patients suffering from neuropsychiatric and related CNS
disorders.”
Revenues totaled $806,000 for the first quarter of 2008 compared to $2.0
million for the first quarter of 2007. This decrease was primarily due
to completion of ACADIA’s agreements with
Sepracor Inc. and The Stanley Medical Research Institute, partially
offset by increased revenues from smaller scale research and license
agreements with other parties.
Research and development expenses totaled $15.2 million for the first
quarter of 2008, including $415,000 in stock-based compensation,
compared to $12.3 million for the first quarter of 2007, including
$904,000 in stock-based compensation. The increase in research and
development expenses was primarily due to increased clinical development
costs associated with ACADIA’s advanced
clinical programs. The increase in expenses was primarily attributable
to $3.0 million in increased fees paid to external service providers,
which totaled $7.8 million for the first quarter of 2008.
General and administrative expenses totaled $3.3 million for the first
quarter of 2008, including $421,000 in stock-based compensation,
compared to $3.2 million for the first quarter of 2007, including
$370,000 in stock-based compensation.
First Quarter 2008 and Recent Highlights
ACADIA initiated the second Phase III pivotal trial in its program
with pimavanserin as a treatment for Parkinson’s
disease psychosis (PDP) in March 2008. ACADIA also is continuing to
enroll patients in the first Phase III pivotal trial in this program,
which was initiated in June 2007. Each of these Phase III trials is a
double-blind, placebo-controlled study designed to evaluate the safety
and efficacy of pimavanserin in approximately 240 patients with PDP.
ACADIA is currently conducting an open-label safety extension study
pursuant to which eligible patients who have completed either of the
Phase III pivotal trials have the opportunity to enroll if, in the
opinion of the physician, the patient may benefit from continued
treatment with pimavanserin. ACADIA also is continuing to conduct an
open-label extension study in connection with its earlier Phase II PDP
trial.
ACADIA completed the treatment phase of its Phase IIb clinical trial
with ACP-104 during the first quarter and remains on track to report
top-line results from this study during the second quarter of 2008.
This double-blind, placebo-controlled study is designed to evaluate
the safety and efficacy of ACP-104 in 248 patients with schizophrenia.
ACADIA presented data from its previously reported Phase II trial with
pimavanserin for PDP at the 60th American
Academy of Neurology Annual Meeting in April 2008. ACADIA’s
abstract titled “A Double-Blind
Placebo-Controlled Dose-Escalation Trial of Pimavanserin in Parkinson’s
Disease and Psychosis” was chosen to be of
special importance and interest to the attendees and was highlighted
in the Movement Disorders Scientific Topic Highlights session.
Data from ACADIA’s Phase II schizophrenia
co-therapy trial was presented at the 14th
Biennial Winter Workshop on Schizophrenia and Bipolar Disorders in
February 2008. The presentation included new data from this trial
showing that patients in the co-therapy arm combining pimavanserin
with a sub-maximal dose of risperidone (2 mg) had significantly less
increase from baseline in serum glucose levels after treatment
compared to patients in the risperidone (6 mg) plus placebo arm.
ACADIA extended the term of its March 2003 discovery alliance with
Allergan through March 2009. Joint research efforts will continue in
the area of pain and may be expanded to include additional efforts in
ophthalmology.
ACADIA appointed John J. Kaiser as Vice President, Strategic Marketing
and Commercial Development in February 2008. Mr. Kaiser joined ACADIA
from Eli Lilly & Co. where he held a variety of marketing and
commercial management positions.
Conference Call and Webcast Information
ACADIA management will review first quarter results and highlights via
conference call and webcast later today at 5:00 p.m. Eastern Time. The
conference call may be accessed by dialing 800-510-0219 for participants
in the U.S. or Canada and 617-614-3451 for international callers
(reference passcode 76441895). A telephone replay of the conference call
may be accessed through May 19, 2008 by dialing 888-286-8010 for callers
in the U.S. or Canada and 617-801-6888 for international callers
(reference passcode 30376624). 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 19,
2008.
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 currently has five mid-to-late
stage clinical programs as well as a portfolio of preclinical and
discovery assets, directed at diseases with large unmet medical needs,
including schizophrenia, Parkinson’s disease
psychosis, sleep maintenance insomnia, and neuropathic pain. All of the
drug candidates in ACADIA’s product pipeline
emanate from discoveries made using its proprietary drug discovery
platform. ACADIA’s corporate headquarters is
located in San Diego, California and it maintains research and
development operations in both San Diego and Malmö,
Sweden.
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 of ACADIA’s
drug discovery and development programs, the timing of reporting of
clinical results, and the benefits to be derived from ACADIA’s
drug candidates and preclinical programs, in each case, including
pimavanserin and ACP-104. 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, 2007 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,
2008
2007
Collaborative revenues
$
806
$
1,960
Operating expenses
Research and development (includes stock-based compensation of $415
and $904 for the three months ended March 31, 2008 and 2007,
respectively)
15,171
12,261
General and administrative (includes stock-based compensation of
$421 and $370 for the three months ended March 31, 2008 and 2007,
respectively)
3,270
3,152
Total operating expenses
18,441
15,413
Loss from operations
(17,635
)
(13,453
)
Interest income (expense), net
1,255
899
Net loss
$
(16,380
)
$
(12,554
)
Net loss per common share, basic and diluted
$
(0.44
)
$
(0.42
)
Weighted average common shares outstanding, basic and diluted
37,053
30,016
ACADIA PHARMACEUTICALS INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(in thousands)
(Unaudited)
March 31,
2008
December 31,
2007(1)
Assets
Cash, cash equivalents and investment securities
$
106,499
$
126,858
Prepaid expenses, receivables and other current assets
3,671
4,395
Total current assets
110,170
131,253
Property and equipment, net
2,919
3,048
Other assets
236
283
Total assets
$
113,325
$
134,584
Liabilities and Stockholders’ Equity
Current liabilities
13,472
19,287
Long-term liabilities
1,186
1,363
Stockholders’ equity
98,667
113,934
Total liabilities and stockholders’ equity
$
113,325
$
134,584
(1)
The condensed consolidated balance sheet at December 31, 2007 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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