SAN DIEGO—(BUSINESS WIRE)—May 5, 2008—ACADIA PharmaceuticalsInc. (Nasdaq:ACAD), a biopharmaceutical company utilizing innovativetechnology to fuel drug discovery and clinical development of noveltreatments for central nervous system (CNS) disorders, today reportedits unaudited financial results for the first quarter ended March 31,2008.
ACADIA reported a net loss of $16.4 million, or $0.44 per commonshare, for the first quarter of 2008 compared to a net loss of $12.6million, or $0.42 per common share, for the first quarter of 2007. Thenet losses for the first quarters of 2008 and 2007 included $836,000and $1.3 million, respectively, in non-cash, stock-based compensationexpense.
At March 31, 2008, ACADIA's cash, cash equivalents, and investmentsecurities totaled $106.5 million compared to $126.9 million atDecember 31, 2007. The decrease in cash was primarily attributable tocash used to fund ACADIA's operations, including an aggregate decreaseof $5.4 million in accounts payable and accrued expenses, largelyresulting from payments for clinical expenses incurred in 2007.
"The first quarter of 2008 was highlighted by continued progressin our most advanced clinical programs, including the initiation ofthe second Phase III pivotal trial in our program with pimavanserinfor Parkinson's disease psychosis and completion of the treatmentphase of our Phase IIb trial with ACP-104 for schizophrenia," said UliHacksell, Ph.D., ACADIA's Chief Executive Officer. "We look forward toreporting top-line results from our Phase IIb trial with ACP-104during the second quarter and continuing to advance our clinicalpipeline of novel treatments for patients suffering fromneuropsychiatric and related CNS disorders."
Revenues totaled $806,000 for the first quarter of 2008 comparedto $2.0 million for the first quarter of 2007. This decrease wasprimarily due to completion of ACADIA's agreements with Sepracor Inc.and The Stanley Medical Research Institute, partially offset byincreased revenues from smaller scale research and license agreementswith other parties.
Research and development expenses totaled $15.2 million for thefirst 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 anddevelopment expenses was primarily due to increased clinicaldevelopment costs associated with ACADIA's advanced clinical programs.The increase in expenses was primarily attributable to $3.0 million inincreased fees paid to external service providers, which totaled $7.8million for the first quarter of 2008.
General and administrative expenses totaled $3.3 million for thefirst 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 itsprogram with pimavanserin as a treatment for Parkinson'sdisease psychosis (PDP) in March 2008. ACADIA also iscontinuing to enroll patients in the first Phase III pivotaltrial in this program, which was initiated in June 2007. Eachof these Phase III trials is a double-blind,placebo-controlled study designed to evaluate the safety andefficacy of pimavanserin in approximately 240 patients withPDP.
- ACADIA is currently conducting an open-label safety extensionstudy pursuant to which eligible patients who have completedeither of the Phase III pivotal trials have the opportunity toenroll if, in the opinion of the physician, the patient maybenefit from continued treatment with pimavanserin. ACADIAalso is continuing to conduct an open-label extension study inconnection with its earlier Phase II PDP trial.
- ACADIA completed the treatment phase of its Phase IIb clinicaltrial with ACP-104 during the first quarter and remains ontrack to report top-line results from this study during thesecond quarter of 2008. This double-blind, placebo-controlledstudy is designed to evaluate the safety and efficacy ofACP-104 in 248 patients with schizophrenia.
- ACADIA presented data from its previously reported Phase IItrial with pimavanserin for PDP at the 60th American Academyof Neurology Annual Meeting in April 2008. ACADIA's abstracttitled "A Double-Blind Placebo-Controlled Dose-EscalationTrial of Pimavanserin in Parkinson's Disease and Psychosis"was chosen to be of special importance and interest to theattendees and was highlighted in the Movement DisordersScientific Topic Highlights session.
- Data from ACADIA's Phase II schizophrenia co-therapy trial waspresented at the 14th Biennial Winter Workshop onSchizophrenia and Bipolar Disorders in February 2008. Thepresentation included new data from this trial showing thatpatients in the co-therapy arm combining pimavanserin with asub-maximal dose of risperidone (2 mg) had significantly lessincrease from baseline in serum glucose levels after treatmentcompared to patients in the risperidone (6 mg) plus placeboarm.
- ACADIA extended the term of its March 2003 discovery alliancewith Allergan through March 2009. Joint research efforts willcontinue in the area of pain and may be expanded to includeadditional efforts in ophthalmology.
- ACADIA appointed John J. Kaiser as Vice President, StrategicMarketing and Commercial Development in February 2008. Mr.Kaiser joined ACADIA from Eli Lilly & Co. where he held avariety of marketing and commercial management positions.
Conference Call and Webcast Information
ACADIA management will review first quarter results and highlightsvia conference call and webcast later today at 5:00 p.m. Eastern Time.The conference call may be accessed by dialing 800-510-0219 forparticipants in the U.S. or Canada and 617-614-3451 for internationalcallers (reference passcode 76441895). A telephone replay of theconference call may be accessed through May 19, 2008 by dialing888-286-8010 for callers in the U.S. or Canada and 617-801-6888 forinternational callers (reference passcode 30376624). The conferencecall also will be webcast live on ACADIA's website,www.acadia-pharm.com, under the investors section and will be archivedthere until May 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 currently hasfive mid-to-late stage clinical programs as well as a portfolio ofpreclinical and discovery assets, directed at diseases with largeunmet medical needs, including schizophrenia, Parkinson's diseasepsychosis, sleep maintenance insomnia, and neuropathic pain. All ofthe drug candidates in ACADIA's product pipeline emanate fromdiscoveries made using its proprietary drug discovery platform.ACADIA's corporate headquarters is located in San Diego, Californiaand it maintains research and development operations in both San Diegoand 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 of ACADIA's drugdiscovery and development programs, the timing of reporting ofclinical results, and the benefits to be derived from ACADIA's drugcandidates and preclinical programs, in each case, includingpimavanserin and ACP-104. These statements are only predictions basedon current information and expectations and involve a number of risksand uncertainties. Actual events or results may differ materially fromthose 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, andthe fact that past results of clinical trials may not be indicative offurther trial results. For a discussion of these and other factors,please refer to ACADIA's annual report on Form 10-K for the year endedDecember 31, 2007 as well as other subsequent filings with theSecurities and Exchange Commission. You are cautioned not to placeundue reliance on these forward-looking statements, which speak onlyas of the date hereof. This caution is made under the safe harborprovisions of the Private Securities Litigation Reform Act of 1995.All forward-looking statements are qualified in their entirety by thiscautionary statement and ACADIA undertakes no obligation to revise orupdate this press release to reflect events or circumstances after thedate hereof.
ACADIA PHARMACEUTICALS INC.CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS(in thousands, except per share amounts)(Unaudited)Three Months EndedMarch 31,—————————-2008 2007————- ————-Collaborative revenues $ 806 $ 1,960Operating expensesResearch and development (includes stock-basedcompensation of $415 and $904 for the threemonths ended March 31, 2008 and 2007,respectively) 15,171 12,261General and administrative (includes stock-basedcompensation of $421 and $370 for the threemonths 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, basicand diluted 37,053 30,016========= =========
ACADIA PHARMACEUTICALS INC.CONDENSED CONSOLIDATED BALANCE SHEETS(in thousands)(Unaudited)March 31, December 31,2008 2007(1)————- ——————AssetsCash, cash equivalents and investmentsecurities $106,499 $126,858Prepaid expenses, receivables and other currentassets 3,671 4,395————- ——————Total current assets 110,170 131,253Property and equipment, net 2,919 3,048Other assets 236 283————- ——————Total assets $113,325 $134,584========= ============Liabilities and Stockholders' EquityCurrent liabilities 13,472 19,287Long-term liabilities 1,186 1,363Stockholders' equity 98,667 113,934————- ——————Total liabilities and stockholders' equity $113,325 $134,584========= ============
(1) The condensed consolidated balance sheet at December 31, 2007 hasbeen derived from the audited financial statements at that datebut does not include all of the information and footnotesrequired by accounting principles generally accepted in theUnited States for complete financial statements.
CONTACT: ACADIA Pharmaceuticals Inc.
Lisa Barthelemy, Director, Investor Relations
Thomas H. Aasen, Vice President andChief Financial Officer
858-558-2871
SOURCE: ACADIA Pharmaceuticals Inc.