SAN DIEGO—(BUSINESS WIRE)—Aug. 5, 2008—ACADIA PharmaceuticalsInc. (Nasdaq: ACAD), a biopharmaceutical company utilizing innovativetechnology to fuel drug discovery and clinical development of noveltreatments for central nervous system disorders, today reported itsunaudited financial results for the second quarter ended June 30, 2008and announced a strategic restructuring.
ACADIA will focus on developing a portfolio of its four mostadvanced product candidates, consisting of two internal compounds aswell as two partnered compounds that are funded by Allergan. Inconnection with the restructuring, ACADIA plans to reduce its totalworkforce by about 50 percent to 65 employees. This restructuring willimpact employees at both its San Diego and Malmo sites.
"Following a thorough strategic review of our portfolio andbusiness, we will focus resources on our most advanced productcandidates, with the primary emphasis on our Phase III program withpimavanserin, and streamline our operations," said Uli Hacksell,Ph.D., Chief Executive Officer of ACADIA. "We regret that thisrestructuring will result in a substantial reduction in our workforceinvolving many dedicated and loyal employees. However, through theseactions we believe we have positioned ACADIA to achieve key milestonesin our advanced clinical programs while at the same time extending ourcash runway into the first half of 2010. We also have added furtherstrength and flexibility through a new Committed Equity FinancingFacility with Kingsbridge announced separately today."
ACADIA's top priority is to advance its Phase III program withpimavanserin for Parkinson's disease psychosis, or PDP, towardregistration. A key objective in this program is the successful andtimely execution of the first Phase III pivotal trial. This trialremains on track and ACADIA anticipates reporting top-line resultsduring the third quarter of 2009. ACADIA is also continuing to enrollpatients in its second Phase III pivotal trial for PDP. In addition,ACADIA will continue to evaluate and position pimavanserin forpotential broader market opportunities, including neurological andneuropsychiatric indications that are underserved by existingantipsychotics.
Through its collaborations with Allergan, ACADIA is also advancinga Phase II program in chronic pain and a Phase I program in glaucoma.In addition to its lead Phase III program with pimavanserin and thetwo collaborative clinical programs, ACADIA intends to completeIND-enabling studies to advance a fourth product candidate, ACP-106,into the clinic in 2009.
"While we have significantly reduced our spending on earlier-stageprograms, we have maintained core discovery capabilities to supportour advanced clinical programs and collaborations and to provide uswith opportunities to introduce additional clinical programs in thefuture," added Dr. Hacksell.
ACADIA estimates that it will record charges of betweenapproximately $2.0 to $2.5 million during the third quarter of 2008 inconnection with the restructuring. ACADIA anticipates that itsinternal operating expenses will be reduced significantly followingthe restructuring and that cash used in its operating activitiesduring 2009 will be below its 2008 level.
Second Quarter Financial Results
ACADIA reported a net loss of $18.3 million, or $0.49 per commonshare, for the second quarter of 2008 compared to a net loss of $10.8million, 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 of2007.
Revenues totaled $177,000 for the second quarter of 2008 comparedto $2.1 million for the second quarter of 2007. The decrease inrevenues was primarily due to completion of the terms of ACADIA'sagreements with Sepracor Inc. and The Stanley Medical ResearchInstitute, as well as lower revenues from its collaborations withAllergan.
Research and development expenses totaled $16.0 million for thesecond quarter of 2008, including $380,000 in stock-basedcompensation, compared to $11.5 million for the second quarter of2007, including $705,000 in stock-based compensation. The increase inresearch and development expenses was primarily due to increased costsassociated with trials in ACADIA's advanced clinical programs,including $4.8 million in increased external costs, which totaled $8.9million for the second quarter of 2008.
General and administrative expenses totaled $3.2 million for thesecond quarter of 2008, including $431,000 in stock-basedcompensation, and were comparable to expenses for the second quarterof 2007.
At June 30, 2008, ACADIA's cash, cash equivalents, and investmentsecurities totaled $89.6 million compared to $126.9 million atDecember 31, 2007. Following its restructuring, ACADIA anticipatesthat its existing cash resources will be sufficient to fund itsactivities into the first half of 2010. The new Committed EquityFinancing Facility provides ACADIA with further financial strength andflexibility through access to additional capital during the next threeyears.
Conference Call and Webcast Information
ACADIA management will review its second quarter results anddevelopment programs via conference call and webcast at 8:30 a.m.Eastern Time. The conference call may be accessed by dialing866-825-1709 for participants in the U.S. or Canada and 617-213-8060for international callers (reference passcode 62862758). A telephonereplay of the conference call may be accessed through August 19, 2008by dialing 888-286-8010 for callers in the U.S. or Canada and617-801-6888 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 archivedthere until August 19, 2008.
About ACADIA Pharmaceuticals
ACADIA is a biopharmaceutical company utilizing innovativetechnology to fuel drug discovery and clinical development of noveltreatments for central nervous system disorders. ACADIA is focused ondeveloping a portfolio of its four most advanced product candidates,including its lead product candidate, pimavanserin in Phase III forParkinson's disease psychosis, a compound in Phase II for chronic painand a compound in Phase I for glaucoma, both in collaboration withAllergan, and ACP-106 in IND-track development. All of the drugcandidates in ACADIA's product pipeline emanate from discoveries madeusing its proprietary drug discovery platform and are directed atindications with large unmet medical needs. ACADIA's corporateheadquarters is located in San Diego, California and it maintainsresearch and development operations in both San Diego and Malmo,Sweden.
Forward-Looking Statements
Statements in this press release that are not strictly historicalin nature are forward-looking statements. These statements include butare not limited to statements related to the progress and timing ofACADIA's drug discovery and development programs, including clinicaltrials and the results therefrom, and the benefits to be derived fromACADIA's product candidates, in each case including pimavanserin, aswell as the impact of the restructuring on ACADIA's business andfinancials, the length of ACADIA's cash runway and funds to beavailable under the Committed Equity Financing Facility. Thesestatements are only predictions based on current information andexpectations and involve a number of risks and uncertainties. Actualevents or results may differ materially from those projected in any ofsuch statements due to various factors, including the risks anduncertainties inherent in drug discovery, development andcommercialization, and collaborations with others, and the fact thatpast results of clinical trials may not be indicative of further trialresults. For a discussion of these and other factors, please refer toACADIA's annual report on Form 10-K for the year ended December 31,2007 as well as other subsequent filings with the Securities andExchange Commission. You are cautioned not to place undue reliance onthese forward-looking statements, which speak only as of the datehereof. This caution is made under the safe harbor provisions of thePrivate Securities Litigation Reform Act of 1995. All forward-lookingstatements are qualified in their entirety by this cautionarystatement and ACADIA undertakes no obligation to revise or update thispress release to reflect events or circumstances after the datehereof.
ACADIA PHARMACEUTICALS INC.CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS(in thousands, except per share amounts)(Unaudited)Three Months Ended Six Months EndedJune 30, June 30,—————————- —————————-2008 2007 2008 2007————- ————- ————- ————-Collaborative revenues $ 177 $ 2,055 $ 983 $ 4,015Operating expensesResearch and development(includes stock-basedcompensation of $380, $705,$795 and $1,609,respectively) 16,036 11,495 31,207 23,756General and administrative(includes stock-basedcompensation of $431, $377,$852 and $747, respectively) 3,184 3,163 6,454 6,316————- ————- ————- ————-Total operatingexpenses 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 sharesoutstanding, basic anddiluted 37,102 36,894 37,077 33,455========= ========= ========= =========
ACADIA PHARMACEUTICALS INC.CONDENSED CONSOLIDATED BALANCE SHEETS(in thousands)(Unaudited)June 30, December 31,2008 2007(1)——————————AssetsCash, cash equivalents, and investmentsecurities, available-for-sale $89,621 $126,858Prepaid expenses, receivables and other currentassets 3,486 4,395——————————Total current assets 93,107 131,253Property and equipment, net 2,712 3,048Other assets 261 283——————————Total assets $96,080 $134,584======== ============Liabilities and Stockholders' EquityCurrent liabilities 13,889 19,287Long-term liabilities 987 1,363Stockholders' equity 81,204 113,934——————————Total liabilities and stockholders' equity $96,080 $134,584======== ============(1) The condensed consolidated balance sheet at December 31, 2007 hasbeen derived from the audited financial statements at that date butdoes not include all of the information and footnotes required byaccounting principles generally accepted in the United States forcomplete financial statements.
CONTACT: ACADIA Pharmaceuticals Inc.
Lisa Barthelemy, Director, Investor Relations
Thomas H. Aasen, Vice President and
Chief Financial Officer
858-558-2871
SOURCE: ACADIA Pharmaceuticals Inc.