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.

ACADIAs top priority is to advance its Phase

III program with pimavanserin for Parkinsons

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 ACADIAs

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 ACADIAs 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, ACADIAs 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 ACADIAs 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 Parkinsons

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

ACADIAs product pipeline emanate from

discoveries made using its proprietary drug discovery platform and are

directed at indications with large unmet medical needs. ACADIAs

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 ACADIAs

drug discovery and development programs, including clinical trials and

the results therefrom, and the benefits to be derived from ACADIAs

product candidates, in each case including pimavanserin, as well as the

impact of the restructuring on ACADIAs

business and financials, the length of ACADIAs

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

ACADIAs 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
June

30,

Six Months Ended
June

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

 

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

 

 

ACADIA PHARMACEUTICALS INC.

CONDENSED CONSOLIDATED BALANCE SHEETS

(in thousands)

(Unaudited)

 

 

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

Total liabilities and stockholders equity

$

96,080

$

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.

 

ACADIA Pharmaceuticals Inc.
Lisa Barthelemy, Director, Investor

Relations
Thomas H. Aasen, Vice President and
Chief

Financial Officer
858-558-2871

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