ACADIA Pharmaceuticals Announces Second Quarter 2008 Financial Results and Strategic Restructuring
2008-08-05 07:00:00
ACADIA Pharmaceuticals Announces Second Quarter 2008 Financial Results and Strategic Restructuring
SAN DIEGO–(EMWNews)–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
ended June 30, 2008 and announced a strategic restructuring.
ACADIA will focus on developing a portfolio of its four most advanced
product candidates, consisting of two internal compounds as well as two
partnered compounds that are funded by Allergan. In connection with the
restructuring, ACADIA plans to reduce its total workforce by about 50
percent to 65 employees. This restructuring will impact employees at
both its San Diego and Malmö sites.
“Following a thorough strategic review of our
portfolio and business, we will focus resources on our most advanced
product candidates, with the primary emphasis on our Phase III program
with pimavanserin, and streamline our operations,”
said Uli Hacksell, Ph.D., Chief Executive Officer of ACADIA. “We
regret that this restructuring will result in a substantial reduction in
our workforce involving many dedicated and loyal employees. However,
through these actions we believe we have positioned ACADIA to achieve
key milestones in our advanced clinical programs while at the same time
extending our cash runway into the first half of 2010. We also have
added further strength and flexibility through a new Committed Equity
Financing Facility with Kingsbridge announced separately today.”
ACADIA’s top priority is to advance its Phase
III program with pimavanserin for Parkinson’s
disease psychosis, or PDP, toward registration. A key objective in this
program is the successful and timely execution of the first Phase III
pivotal trial. This trial remains on track and ACADIA anticipates
reporting top-line results during the third quarter of 2009. ACADIA is
also continuing to enroll patients in its second Phase III pivotal trial
for PDP. In addition, ACADIA will continue to evaluate and position
pimavanserin for potential broader market opportunities, including
neurological and neuropsychiatric indications that are underserved by
existing antipsychotics.
Through its collaborations with Allergan, ACADIA is also advancing a
Phase II program in chronic pain and a Phase I program in glaucoma. In
addition to its lead Phase III program with pimavanserin and the two
collaborative clinical programs, ACADIA intends to complete IND-enabling
studies to advance a fourth product candidate, ACP-106, into the clinic
in 2009.
“While we have significantly reduced our
spending on earlier-stage programs, we have maintained core discovery
capabilities to support our advanced clinical programs and
collaborations and to provide us with opportunities to introduce
additional clinical programs in the future,”
added Dr. Hacksell.
ACADIA estimates that it will record charges of between approximately
$2.0 to $2.5 million during the third quarter of 2008 in connection with
the restructuring. ACADIA anticipates that its internal operating
expenses will be reduced significantly following the restructuring and
that cash used in its operating activities during 2009 will be below its
2008 level.
Second Quarter Financial Results
ACADIA reported a net loss of $18.3 million, or $0.49 per common share,
for the second quarter of 2008 compared to a net loss of $10.8 million,
or $0.29 per common share, for the second quarter of 2007. For the six
months ended June 30, 2008, ACADIA reported a net loss of $34.7 million,
or $0.94 per common share, compared to a net loss of $23.3 million, or
$0.70 per common share, for the comparable period of 2007.
Revenues totaled $177,000 for the second quarter of 2008 compared to
$2.1 million for the second quarter of 2007. The decrease in revenues
was primarily due to completion of the terms of ACADIA’s
agreements with Sepracor Inc. and The Stanley Medical Research
Institute, as well as lower revenues from its collaborations with
Allergan.
Research and development expenses totaled $16.0 million for the second
quarter of 2008, including $380,000 in stock-based compensation,
compared to $11.5 million for the second quarter of 2007, including
$705,000 in stock-based compensation. The increase in research and
development expenses was primarily due to increased costs associated
with trials in ACADIA’s advanced clinical
programs, including $4.8 million in increased external costs, which
totaled $8.9 million for the second quarter of 2008.
General and administrative expenses totaled $3.2 million for the second
quarter of 2008, including $431,000 in stock-based compensation, and
were comparable to expenses for the second quarter of 2007.
At June 30, 2008, ACADIA’s cash, cash
equivalents, and investment securities totaled $89.6 million compared to
$126.9 million at December 31, 2007. Following its restructuring, ACADIA
anticipates that its existing cash resources will be sufficient to fund
its activities into the first half of 2010. The new Committed Equity
Financing Facility provides ACADIA with further financial strength and
flexibility through access to additional capital during the next three
years.
Conference Call and Webcast Information
ACADIA management will review its second quarter results and development
programs via conference call and webcast at 8:30 a.m. Eastern Time. The
conference call may be accessed by dialing 866-825-1709 for participants
in the U.S. or Canada and 617-213-8060 for international callers
(reference passcode 62862758). A telephone replay of the conference call
may be accessed through August 19, 2008 by dialing 888-286-8010 for
callers in the U.S. or Canada and 617-801-6888 for international callers
(reference passcode 47546867). 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,
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 is focused on developing a
portfolio of its four most advanced product candidates, including its
lead product candidate, pimavanserin in Phase III for Parkinson’s
disease psychosis, a compound in Phase II for chronic pain and a
compound in Phase I for glaucoma, both in collaboration with Allergan,
and ACP-106 in IND-track development. All of the drug candidates in
ACADIA’s product pipeline emanate from
discoveries made using its proprietary drug discovery platform and are
directed at indications with large unmet medical needs. 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 and timing of ACADIA’s
drug discovery and development programs, including clinical trials and
the results therefrom, and the benefits to be derived from ACADIA’s
product candidates, in each case including pimavanserin, as well as the
impact of the restructuring on ACADIA’s
business and financials, the length of ACADIA’s
cash runway and funds to be available under the Committed Equity
Financing Facility. 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.
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ACADIA PHARMACEUTICALS INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS |
||||||||||||||||
(in thousands, except per share amounts) |
||||||||||||||||
(Unaudited) |
||||||||||||||||
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||||||||||||||||
Three Months Ended 30, |
Six Months Ended 30, |
|||||||||||||||
2008 |
2007 |
2008 |
2007 |
|||||||||||||
|
||||||||||||||||
Collaborative revenues |
$ |
177 |
$ |
2,055 |
$ |
983 |
$ |
4,015 |
||||||||
|
||||||||||||||||
Operating expenses |
||||||||||||||||
Research and development (includes stock-based compensation of $380, $705, $795 and $1,609, respectively) |
16,036 |
11,495 |
31,207 |
23,756 |
||||||||||||
General and administrative (includes stock-based compensation of $431, $377, $852 and $747, respectively) |
|
3,184 |
|
|
3,163 |
|
|
6,454 |
|
|
6,316 |
|
||||
Total operating expenses |
|
19,220 |
|
|
14,658 |
|
|
37,661 |
|
|
30,072 |
|
||||
Loss from operations |
(19,043 |
) |
(12,603 |
) |
(36,678 |
) |
(26,057 |
) |
||||||||
Interest income (expense), net |
|
756 |
|
|
1,850 |
|
|
2,011 |
|
|
2,750 |
|
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Net loss |
$ |
(18,287 |
) |
$ |
(10,753 |
) |
$ |
(34,667 |
) |
$ |
(23,307 |
) |
||||
Net loss per common share, basic and diluted |
$ |
(0.49 |
) |
$ |
(0.29 |
) |
$ |
(0.94 |
) |
$ |
(0.70 |
) |
||||
Weighted average common shares outstanding, basic and diluted |
|
37,102 |
|
|
36,894 |
|
|
37,077 |
|
|
33,455 |
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ACADIA PHARMACEUTICALS INC.
CONDENSED CONSOLIDATED BALANCE SHEETS |
||||||
(in thousands) |
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(Unaudited) |
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June 30,
2008 |
December 31,
2007(1) |
|||||
Assets |
||||||
Cash, cash equivalents, and investment securities, available-for-sale |
$ |
89,621 |
$ |
126,858 |
||
Prepaid expenses, receivables and other current assets |
|
3,486 |
|
4,395 |
||
Total current assets |
93,107 |
131,253 |
||||
Property and equipment, net |
2,712 |
3,048 |
||||
Other assets |
|
261 |
|
283 |
||
Total assets |
$ |
96,080 |
$ |
134,584 |
||
Liabilities and Stockholders’ Equity |
||||||
Current liabilities |
13,889 |
19,287 |
||||
Long-term liabilities |
987 |
1,363 |
||||
Stockholders’ equity |
|
81,204 |
|
113,934 |
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Total liabilities and stockholders’ equity |
$ |
96,080 |
$ |
134,584 |
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(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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ACADIA Pharmaceuticals Inc. Relations Financial Officer |
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