SAN DIEGO—(BUSINESS WIRE)—Nov. 5, 2007—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 third quarter and nine monthsended September 30, 2007.
ACADIA reported a net loss of $16.0 million, or $0.43 per commonshare, for the third quarter of 2007 compared to a net loss of $11.3million, or $0.38 per common share, for the third quarter of 2006. Forthe nine months ended September 30, 2007, ACADIA reported a net lossof $39.4 million, or $1.14 per common share, compared to a net loss of$32.6 million, or $1.20 per common share, for the comparable period of2006.
At September 30, 2007, ACADIA's cash, cash equivalents, andinvestment securities totaled $141.0 million compared to $83.3 millionat December 31, 2006. The increase in cash was primarily due to $96.1million in net proceeds raised in a public offering of common stock,partially offset by cash used to fund ACADIA's operations.
"The third quarter of 2007 was highlighted by continued progresswith the ongoing trials in our advanced clinical programs, includingthe first pivotal trial in our Phase III program with pimavanserin forParkinson's disease psychosis and the Phase IIb trial with ACP-104 forschizophrenia," said Uli Hacksell, Ph.D., ACADIA's Chief ExecutiveOfficer. "Meanwhile, having completed our full analysis of the datafrom our Phase II schizophrenia co-therapy trial with pimavanserin, weare excited to present these data at the December meeting of theAmerican College of Neuropsychopharmacology. In addition, we willpresent these data and other information on our programs at ACADIA'sinaugural analyst/investor day, which we have scheduled immediatelyfollowing this prestigious medical meeting."
Revenues totaled $2.0 million for the third quarter of 2007compared to $1.9 million for the third quarter of 2006, and werecomprised of revenues earned from ACADIA's collaborations withSepracor Inc. and Allergan, Inc. as well as its agreements with otherparties.
Research and development expenses totaled $16.9 million for thethird quarter of 2007, including $805,000 in stock-based compensation,compared to $15.5 million for the third quarter of 2006, including$550,000 in stock-based compensation. The increase in research anddevelopment expenses was primarily due to increased costs associatedwith ongoing trials in ACADIA's advanced clinical programs, including$655,000 in increased fees paid to external service providers, whichtotaled $9.7 million for the third quarter of 2007, and increasedcosts associated with expansion of ACADIA's development organization.
General and administrative expenses totaled $2.9 million for thethird quarter of 2007, including $441,000 in stock-based compensation,compared to $3.0 million for the third quarter of 2006, including$421,000 in stock-based compensation.
The results for the comparable quarter and nine month periods of2006 included a gain of $4.0 million and $3.6 million, respectively,related to settlement of a civil action.
Third Quarter 2007 and Recent Highlights
- ACADIA, in collaboration with Herbert Y. Meltzer, M.D.,Professor of Psychiatry and Pharmacology and Director of thePsychosis Program at the Vanderbilt School of Medicine, ispreparing to present data from its Phase II schizophreniaco-therapy trial with pimavanserin at the 46th Annual Meetingof the American College of Neuropsychopharmacology to be heldin Boca Raton, Florida from December 9-13, 2007. Dr. Meltzer'spresentation will reflect data from the full analysis of thisPhase II schizophrenia co-therapy trial. This analysisconfirmed the robustness of the top-line results reported inMarch 2007 and provided additional data in support of thebenefits of pimavanserin co-therapy when combined with asub-maximal dose of risperidone.
- ACADIA announced today that it will host an analyst/investormeeting in New York City on Friday, December 14, 2007. Theevent will feature a presentation of data from ACADIA's PhaseII schizophrenia co-therapy trial with pimavanserin togetherwith presentations of ACADIA's Phase III program withpimavanserin for Parkinson's disease psychosis (PDP), itsPhase II program with ACP-104 for schizophrenia, and otherdiscovery and development activities.
- ACADIA continues to enroll patients in its Phase IIb clinicaltrial with ACP-104. This double-blind, placebo-controlledtrial is designed to evaluate the safety and efficacy ofACP-104 in approximately 250 patients with schizophrenia whoare experiencing an acute psychotic episode. ACADIA expects toreport top-line results from this trial during the thirdquarter of 2008.
- ACADIA continues to enroll patients in its first pivotal PhaseIII trial with pimavanserin as a treatment for PDP. Thedouble-blind, placebo-controlled trial is designed to evaluatethe safety and efficacy of pimavanserin in approximately 240patients with PDP. ACADIA expects to report top-line resultsfrom this trial during 2009.
- ACADIA announced in July that it earned a milestone paymentassociated with Allergan's initiation of an exploratoryclinical study with a small molecule drug candidate for thetreatment of glaucoma.
- ACADIA was selected to be one of the inaugural companies inthe new NASDAQ NeuroInsights Neurotech Index, which waslaunched on September 25, 2007.
Conference Call and Webcast Information
ACADIA management will review its third quarter results anddevelopment programs via conference call and webcast later today at5:00 p.m. Eastern Time. The conference call may be accessed by dialing866-203-2528 for participants in the U.S. or Canada and 617-213-8847for international callers (reference passcode 99836009). A telephonereplay of the conference call may be accessed through November 19,2007 by dialing 888-286-8010 for callers in the U.S. or Canada and617-801-6888 for international callers (reference passcode 54193185).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 November 19, 2007.
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 large unmetmedical needs, including schizophrenia, Parkinson's disease psychosis,sleep maintenance insomnia, and neuropathic pain. All of the drugcandidates in ACADIA's product pipeline emanate from discoveries madeusing its proprietary drug discovery platform. 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 ACADIA's plans to presentclinical data, the progress and timing of ACADIA's drug discovery anddevelopment programs, including clinical trials and the resultstherefrom, and the benefits to be derived from ACADIA's drugcandidates and preclinical programs, including pimavanserin andACP-104. These statements are only predictions based on currentinformation and expectations and involve a number of risks anduncertainties. 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, 2006 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 Ended Nine Months EndedSeptember 30, September 30,—————————- —————————-2007 2006 2007 2006————- ————- ————- ————-Collaborative revenues $ 1,957 $ 1,943 $ 5,972 $ 6,360Operating expensesResearch and development(includes stock-basedcompensation of $805, $550,$2,414 and $1,417,respectively) 16,909 15,501 40,664 36,611General and administrative(includes stock-basedcompensation of $441, $421,$1,188 and $1,141,respectively) 2,941 2,962 9,257 8,813Provision for loss from(settlement of) litigation —(3,981) —(3,560)————- ————- ————- ————-Total operatingexpenses 19,850 14,482 49,921 41,864————- ————- ————- ————-Loss from operations (17,893) (12,539) (43,949) (35,504)Interest income (expense), net 1,848 1,276 4,598 2,855————- ————- ————- ————-Loss before change inaccounting principle (16,045) (11,263) (39,351) (32,649)Cumulative effect of change inaccounting principle ———51————- ————- ————- ————-Net loss $(16,045) $(11,263) $(39,351) $(32,598)========= ========= ========= =========Net loss per common share,basic and dilutedBefore change inaccounting principle $ (0.43) $ (0.38) $ (1.14) $ (1.20)Cumulative effect ofchange in accountingprinciple ————————- ————- ————- ————-Net loss per commonshare, basic anddiluted $ (0.43) $ (0.38) $ (1.14) $ (1.20)========= ========= ========= =========Weighted average common sharesoutstanding, basic anddiluted 36,946 29,732 34,619 27,277========= ========= ========= =========
ACADIA PHARMACEUTICALS INC.CONDENSED CONSOLIDATED BALANCE SHEETS(in thousands)(Unaudited)September 30, December 31,2007 2006(1)——————- ——————AssetsCash, cash equivalents, and investmentsecurities $ 140,962 $ 83,255Prepaid expenses, receivables and othercurrent assets 3,989 2,528——————- ——————Total current assets 144,951 85,783Property and equipment, net 3,095 3,505Other assets 300 256——————- ——————Total assets $ 148,346 $ 89,544============= ============Liabilities and Stockholders' EquityCurrent liabilities 17,155 20,534Long-term liabilities 1,457 1,851Stockholders' equity 129,734 67,159——————- ——————Total liabilities and stockholders'equity $ 148,346 $ 89,544============= ============
(1) The condensed consolidated balance sheet at December 31, 2006 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 and Chief FinancialOfficer
(858) 558-2871
SOURCE: ACADIA Pharmaceuticals Inc.