SAN DIEGO—(BUSINESS WIRE)—Aug. 8, 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 second quarter and six monthsended June 30, 2006.
ACADIA reported a net loss of $11.9 million for the second quarterof 2006 compared to a net loss of $6.0 million for the second quarterof 2005. For the six months ended June 30, 2006, ACADIA reported a netloss of $21.3 million, compared to a net loss of $11.6 million for thecomparable period of 2005.
At June 30, 2006, ACADIA's cash, cash equivalents, investmentsecurities, and restricted cash totaled $106.7 million compared to$55.5 million at December 31, 2005. The increase in cash was primarilydue to net proceeds from sales of equity securities, including $59.4million raised in a follow-on public offering during the secondquarter of 2006 and $10 million received from the sale of common stockto Sepracor Inc. in January 2006, partially offset by cash used tofund ACADIA's operations.
"The first half of 2006 was a successful period for ACADIA,highlighted by the achievement of key milestones in our proprietaryPhase II programs and the strengthening of our balance sheet throughour public offering," said Uli Hacksell, Ph.D., ACADIA's ChiefExecutive Officer. "We look forward to continuing this momentumthrough the remainder of the year as we focus on further advancing ourproprietary clinical pipeline directed at novel treatments for centralnervous system disorders."
Revenues totaled $1.9 million for the second quarter of 2006compared to $2.5 million for the second quarter of 2005. This decreasewas primarily due to lower revenues and related research activitiesunder ACADIA's collaborations with Allergan, Inc. Revenues fromACADIA's agreements with Sepracor and The Stanley Medical ResearchInstitute (SMRI) totaled $945,000 and $500,000, respectively, for thesecond quarter of 2006, and were comparable to revenues recognizedunder these agreements during the second quarter of 2005.
Research and development expenses totaled $12.3 million for thesecond quarter of 2006, including $326,000 in stock-basedcompensation, compared to $6.8 million for the second quarter of 2005,including $206,000 in stock-based compensation. The increase inresearch and development expenses was primarily due to increasedclinical development activity associated with ACADIA's proprietaryPhase II-stage programs and expansion of its research and developmentorganization. Fees paid to external service providers, largely relatedto clinical development, totaled $5.7 million for the second quarterof 2006 compared to $2.1 million for the second quarter of 2005.
General and administrative expenses totaled $2.3 million for thesecond quarter of 2006, including $360,000 in stock-basedcompensation, compared to $2.2 million for the second quarter of 2005,including $189,000 in stock-based compensation. Excluding stock-basedcompensation, the decrease in general and administrative expenses wasprimarily due to lower professional fees associated withSarbanes-Oxley compliance efforts, partially offset by increased costsassociated with expansion of ACADIA's administrative organization.
For the second quarter of 2006, an aggregate of $686,000 ofnon-cash, stock-based compensation expense was recorded pursuant toStatement of Financial Accounting Standards No. 123(R) and wasincluded in research and development and general and administrativeexpenses. Prior to January 1, 2006, ACADIA accounted for employeestock-based compensation using the intrinsic value method underAccounting Principles Board No. 25.
Second Quarter 2006 and Recent Highlights
Clinical Pipeline
- ACADIA reported positive results in April 2006 from aproof-of-concept clinical study, which demonstrated thatACP-103 induced a statistically significant and dose-relatedincrease in deep, or slow wave, sleep in healthy oldervolunteers. ACP-103 treatment also had a positive impact onmeasures for sleep maintenance, including decreases in thenumber of awakenings after sleep onset and in the time awakeafter sleep onset.
- ACADIA continues to enroll patients in its multi-center,double-blind, placebo-controlled Phase II clinical trialdesigned to evaluate the ability of ACP-103 when usedadjunctively with other antipsychotic drugs to provide animproved therapy for patients with schizophrenia. ACADIA metits previously announced objective by completing enrollment ofthe first 200 patients in this planned 400-patient clinicaltrial by mid-2006, and remains on track to report results froman interim analysis of this trial based on the first 200patients by the end of 2006.
- 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.
Business and Financial
- ACADIA completed a public offering in May 2006, raising netproceeds of $59.4 million through the sale of an aggregate ofapproximately 5.3 million shares of its common stock.
- ACADIA appointed Roger G. Mills, M.D., as Executive VicePresident, Development. Dr. Mills was previously VicePresident, Development Pfizer Global R&D, where he wasresponsible for the management and direction of drugdevelopment activities at the Pfizer site in La Jolla,California. Dr. Mills has extensive experience and a proventrack record of leading successful drug development efforts inmultiple therapeutic areas.
- ACADIA was selected for addition to the NASDAQ BiotechnologyIndex (NBI) effective May 22, 2006.
Conference Call and Webcast Information
Uli Hacksell, Ph.D., Chief Executive Officer, and Thomas H. Aasen,Vice President and Chief Financial Officer, will review second quarterresults and highlights via conference call and webcast later today at5:00 p.m. Eastern Time. The conference call may be accessed by dialing866-356-4279 for participants in the U.S. or Canada and 617-597-5394for international callers (reference passcode 64732251). A telephonereplay of the conference call may be accessed through August 22, 2006by dialing 888-286-8010 for callers in the U.S. or Canada and617-801-6888 for international callers (reference passcode 41993620).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 22, 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.These statements 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, collaborations with others, and litigation. For adiscussion of these and other factors, please refer to ACADIA's annualreport on Form 10-K for the year ended December 31, 2005 as well asother subsequent filings with the Securities and Exchange Commission.You are cautioned not to place undue reliance on these forward-lookingstatements, which speak only as of the date hereof. This caution ismade under the safe harbor provisions of the Private SecuritiesLitigation Reform Act of 1995. All forward-looking statements arequalified in their entirety by this cautionary statement and ACADIAundertakes no obligation to revise or update this press release toreflect 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 Six Months EndedJune 30, June 30,——————————————————-2006 2005 2006 2005————- ————————- ————-Collaborative revenues $1,881 $2,515 $4,418 $4,840Operating expensesResearch and development(includes stock-basedcompensation of $326, $206,$885 and $417, respectively) 12,255 6,769 22,381 13,096General and administrative(includes stock-basedcompensation of $360, $189,$701 and $349, respectively) 2,296 2,240 4,581 4,038Provision for loss fromlitigation 194 —421 —————- ————————- ————-Total operating expenses 14,745 9,009 27,383 17,134————- ————————- ————-Loss from operations (12,864) (6,494) (22,965) (12,294)Interest income (expense), net 997 456 1,579 668————- ————————- ————-Loss before change inaccounting principle (11,867) (6,038) (21,386) (11,626)Cumulative effect of change inaccounting principle ——51 —————- ————————- ————-Net loss $(11,867) $(6,038) $(21,335) $(11,626)========= ======== ========= =========Net loss per common share,basic and diluted:Before change inaccounting principle $(0.43) $(0.26) $(0.82) $(0.56)Cumulative effect ofchange in accountingprinciple ————————- ————————- ————-Net loss per commonshare, basic anddiluted $(0.43) $(0.26) $(0.82) $(0.56)========= ======== ========= =========Weighted average common sharesoutstanding, basic and diluted 27,792 23,274 26,050 20,589========= ======== ========= =========ACADIA PHARMACEUTICALS INC.CONDENSED CONSOLIDATED BALANCE SHEETS(in thousands)(Unaudited)June 30, December 31,2006 2005(1)—————- —————-AssetsCash, cash equivalents, investmentsecurities and restricted cash $106,655 $55,521Prepaid expenses, receivables and othercurrent assets 6,006 4,604—————- —————-Total current assets 112,661 60,125Property and equipment, net 2,811 2,283Other assets 96 98—————- —————-Total assets $115,568 $62,506=========== ===========Liabilities and Stockholders' EquityCurrent liabilities 25,306 21,701Long-term liabilities 1,716 1,434Stockholders' equity 88,546 39,371—————- —————-Total liabilities and stockholders'equity $115,568 $62,506=========== ===========(1) The condensed consolidated balance sheet at December 31, 2005has been derived from the audited financial statements at thatdate but does not include all of the information and footnotesrequired by accounting principles generally accepted in the UnitedStates for complete financial statements.
CONTACT: ACADIA Pharmaceuticals Inc.
Lisa Barthelemy, Director, Investor Relations
Thomas H. Aasen, Vice President andChief Financial Officer
858-558-2871