SAN DIEGO—(BUSINESS WIRE)—Nov. 6, 2006—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, 2006.
ACADIA reported a net loss of $11.3 million for the third quarterof 2006 compared to a net loss of $12.3 million for the third quarterof 2005. For the nine months ended September 30, 2006, ACADIA reporteda net loss of $32.6 million, compared to a net loss of $23.9 millionfor the comparable period of 2005.
At September 30, 2006, ACADIA's cash, cash equivalents, andinvestment securities totaled $94.7 million compared to $55.5 millionat December 31, 2005. The increase in cash was primarily due to netproceeds from sales of equity securities, including $59.4 millionraised in a follow-on public offering during the second quarter of2006 and $10 million received from the sale of common stock toSepracor Inc. in January 2006, partially offset by cash used to fundACADIA's operations.
"During the third quarter, we accelerated patient enrollment inour large Phase II adjunctive therapy trial with ACP-103 in patientswith schizophrenia. I am pleased to announce that we completed patientenrollment early in the fourth quarter and we remain on track toprovide top-line results from this study in the first quarter of2007," said Uli Hacksell, Ph.D., ACADIA's Chief Executive Officer. "Wealso continue to make important progress in our preparations forupcoming studies in our other clinical programs, including the firstpivotal trial in our Phase III development program with ACP-103 forthe treatment of Parkinson's disease psychosis."
Revenues totaled $1.9 million for the third quarter of 2006compared to $3.7 million for the third quarter of 2005. This decreasewas primarily due to lower revenues under ACADIA's collaborations withAllergan, Inc. Revenues from ACADIA's agreements with Sepracor and TheStanley Medical Research Institute totaled $945,000 and $500,000,respectively, for the third quarter of 2006, and were comparable torevenues recognized under these agreements during the third quarter of2005.
Research and development expenses totaled $16.1 million for thethird quarter of 2006, including $561,000 in stock-based compensation,compared to $8.4 million for the third quarter of 2005, including$337,000 in stock-based compensation. The increase in research anddevelopment expenses was primarily due to increased clinicaldevelopment activity associated with ACADIA's proprietary PhaseII-stage programs. External service costs increased to $9.6 millionfor the third quarter of 2006 compared to $2.6 million for the thirdquarter of 2005 primarily due to accelerated patient enrollment andrelated costs for ACADIA's Phase II adjunctive therapy trial withACP-103 in patients with schizophrenia. The Company anticipates thatits external service costs will decrease during the fourth quarter of2006 relative to the third quarter due to completion of patientenrollment in this trial, which occurred early in the fourth quarter.
General and administrative expenses totaled $2.4 million for thethird quarter of 2006, including $410,000 in stock-based compensation,compared to $2.2 million for the third quarter of 2005, including$125,000 in stock-based compensation. Excluding stock-basedcompensation, the decrease in general and administrative expenses wasprimarily due to lower professional fees, partially offset byincreased costs associated with expansion of ACADIA's administrativeorganization.
In September 2006, ACADIA entered into an agreement to fullysettle its previously disclosed civil action, which settlementresulted in a gain of $4.0 million during the third quarter of 2006.During the third quarter of 2005, the Company recorded a provision forloss from litigation of $5.9 million related to this matter.
For the third quarter of 2006, an aggregate of $971,000 ofnon-cash, stock-based compensation expense was recorded pursuant toStatement of Financial Accounting Standards No. 123R and was includedin research and development and general and administrative expenses.Prior to January 1, 2006, ACADIA accounted for employee stock-basedcompensation using the intrinsic value method under AccountingPrinciples Board No. 25.
Third Quarter 2006 and Recent Highlights
- ACADIA announced in late-September 2006 that enrollment in itsPhase II adjunctive therapy trial with ACP-103 in patientswith schizophrenia was significantly ahead of schedule andthat it expected to complete enrollment in this trial early inthe fourth quarter. ACADIA reported today that it met thisobjective by completing enrollment of 423 patients in thisclinical trial during October 2006 and remains on track toreport top-line results from the study during the firstquarter of 2007.
- At the end of the third quarter, ACADIA held an end of PhaseII meeting with the U.S. Food and Drug Administration (FDA)regarding its ACP-103 program for Parkinson's diseasepsychosis (PDP). Following its interactions with the FDA,ACADIA is confirming its plans to initiate the first pivotaltrial in its Phase III development program for PDP during thefirst half of 2007. The primary endpoint of the trial will beantipsychotic efficacy as measured using the Scale for theAssessment of Positive Symptoms (SAPS). ACADIA anticipatesthat this trial will enroll an aggregate of about 240 patientsin three different study arms, which will include two doses ofACP-103 and one placebo arm. The treatment duration for eachpatient is expected to be six weeks.
- ACADIA reported encouraging results in July 2006 from threeinitial clinical studies of ACP-104 in patients withschizophrenia. The results of these studies demonstrated thatACP-104 is safe and well tolerated after repeated dosing of upto 600 mg per day, and that initial signals of antipsychoticeffects were observed within the tolerated dose range ofACP-104.
- ACADIA announced in October 2006 that it had agreed to provideinitial seed capital to help establish Abbey Pharmaceuticals,a startup biotechnology company focused on medications forsubstance abuse. The new company is led by Mark R. Brann,Ph.D., the founder and former President and Chief ScientificOfficer of ACADIA.
- ACADIA made presentations at the Society for NeuroscienceAnnual Meeting in October 2006 describing research completedin collaboration with Sepracor. In separate presentations,ACADIA scientists described studies aimed at furtherelucidating the molecular mechanisms by which novel muscarinicagonists selectively activate specific muscarinic receptorsubtypes.
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 dialing800-291-9234 for participants in the U.S. or Canada and 617-614-3923for international callers (reference passcode 62345370). A telephonereplay of the conference call may be accessed through November 20,2006 by dialing 888-286-8010 for callers in the U.S. or Canada and617-801-6888 for international callers (reference passcode 80393290).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 20, 2006.
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 Phase II-stage clinical programs as well as a portfolio ofpreclinical and discovery assets directed at diseases with large unmetmedical needs, including schizophrenia, Parkinson's disease, sleepmaintenance insomnia, and neuropathic pain. All of the drug candidatesin ACADIA's product pipeline emanate from discoveries made using itsproprietary drug discovery platform. ACADIA's corporate headquartersis located in San Diego, California and it maintains research anddevelopment 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 of and benefitsto be derived from ACADIA's drug discovery and development programs,the timing or design of future clinical trials, the timing ofannouncements of results from clinical trials, future plans with AbbeyPharmaceuticals, and expenditures for future periods. These statementsare only predictions based on current information and expectations andinvolve a number of risks and uncertainties. Actual events or resultsmay differ materially from those projected in any of such statementsdue to various factors, including the risks and uncertainties inherentin drug discovery, development and commercialization, andcollaborations with others. For a discussion of these and otherfactors, please refer to ACADIA's annual report on Form 10-K for theyear ended December 31, 2005 as well as other subsequent filings withthe Securities 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,—————————- —————————-2006 2005 2006 2005————- ————- ————- ————-Collaborative revenues $ 1,943 $ 3,673 $ 6,360 $ 8,513Operating expensesResearch and development(includes stock-basedcompensation of $561, $337,$1,447 and $754,respectively) 16,099 8,402 38,479 21,497General and administrative(includes stock-basedcompensation of $410, $125,$1,111 and $474,respectively) 2,364 2,223 6,945 6,261Provision for loss from(settlement of) litigation (3,981) 5,861 (3,560) 5,861————- ————- ————- ————-Total operating expenses 14,482 16,486 41,864 33,619————- ————- ————- ————-Loss from operations (12,539) (12,813) (35,504) (25,106)Interest income (expense), net 1,276 507 2,855 1,174————- ————- ————- ————-Loss before change inaccounting principle (11,263) (12,306) (32,649) (23,932)Cumulative effect of change inaccounting principle ——51 —————- ————- ————- ————-Net loss $(11,263) $(12,306) $(32,598) $(23,932)========= ========= ========= =========Net loss per common share,basic and diluted:Before change inaccounting principle $ (0.38) $ (0.53) $ (1.20) $ (1.11)Cumulative effect ofchange in accountingprinciple ————————- ————- ————- ————-Net loss per common share,basic and diluted $ (0.38) $ (0.53) $ (1.20) $ (1.11)========= ========= ========= =========Weighted average common sharesoutstanding, basic anddiluted 29,732 23,343 27,277 21,507========= ========= ========= =========
ACADIA PHARMACEUTICALS INC.CONDENSED CONSOLIDATED BALANCE SHEETS(in thousands)(Unaudited)September 30, December 31,2006 2005(1)———————————————-AssetsCash, cash equivalents, investmentsecurities and restricted cash $ 94,657 $ 55,521Prepaid expenses, receivables andother current assets 3,147 4,604———————————————-Total current assets 97,804 60,125Property and equipment, net 3,014 2,283Other assets 96 98———————————————-Total assets $ 100,914 $ 62,506================ ===============Liabilities and Stockholders' EquityCurrent liabilities 20,767 21,701Long-term liabilities 1,746 1,434Stockholders' equity 78,401 39,371———————————————-Total liabilities andstockholders' equity $ 100,914 $ 62,506================ ===============
(1) The condensed consolidated balance sheet at December 31, 2005 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 Financial
Officer
(858) 558-2871
SOURCE: ACADIA Pharmaceuticals Inc.