SAN DIEGO, May 10 /PRNewswire-FirstCall/ —ACADIA Pharmaceuticals Inc.(Nasdaq: ACAD), a biopharmaceutical company utilizing innovative technology tofuel drug discovery and clinical development of novel treatments for centralnervous system disorders, today reported its unaudited financial results forthe first quarter ended March 31, 2006.
ACADIA reported a net loss of $9.5 million for the first quarter of 2006compared to a net loss of $5.6 million for the first quarter of 2005. The netloss for the first quarter of 2006 and 2005 included $900,000 and $371,000,respectively, in non-cash, stock-based compensation expense.
At March 31, 2006, ACADIA's cash, cash equivalents, investment securities,and restricted cash totaled $56.2 million compared to $55.5 million atDecember 31, 2005. The increase in cash was primarily due to Sepracor Inc.'spurchase of shares of ACADIA common stock for $10 million in January 2006,offset by cash used to fund ACADIA's operations. Following the end of thefirst quarter, ACADIA raised an additional $55.6 million in net proceeds fromthe sale of approximately 4.9 million shares of its common stock in a publicoffering, which closed on May 3, 2006.
"The beginning of 2006 has been an important period for ACADIA highlightedby positive clinical trial results in two of our proprietary Phase II-stageprograms, Sepracor's second $10 million equity investment, and the completionof our recent public offering," said Uli Hacksell, Ph.D., ACADIA's ChiefExecutive Officer. "We are now well positioned to further advance ourproprietary clinical pipeline directed at novel treatments for central nervoussystem disorders and other areas of unmet medical need."
Revenues totaled $2.5 million for the first quarter of 2006 compared to$2.3 million for the first quarter of 2005. This increase was primarily dueto increased revenues earned under ACADIA's collaborations with Allergan, Inc.and Sepracor. Revenues from ACADIA's collaborations with Allergan totaled$1.1 million for the first quarter of 2006 compared to $1.0 million for thefirst quarter of 2005, while revenues from the Sepracor collaboration totaled$931,000 for the first quarter of 2006 compared to $820,000 for the firstquarter of 2005.
Research and development expenses totaled $10.1 million for the firstquarter of 2006, including $559,000 in stock-based compensation, compared to$6.3 million for the first quarter of 2005, including $211,000 in stock-basedcompensation. This increase was primarily due to increased clinicaldevelopment costs associated with ACADIA's proprietary Phase II-stage programsand expansion of its research and development organization. Fees paid toexternal service providers, largely related to clinical development, totaled$4.2 million for the first quarter of 2006 compared to $1.3 million for thefirst quarter of 2005.
General and administrative expenses totaled $2.3 million for the firstquarter of 2006, including $341,000 in stock-based compensation, compared to$1.8 million for the first quarter of 2005, including $160,000 in stock-basedcompensation. This increase was primarily due to increased professional feesand increased costs associated with expansion of its administrativeorganization.
Effective January 1, 2006, ACADIA adopted the fair value recognitionprovisions of Statement of Financial Accounting Standards No. 123(R),Share-Based Payment, using the modified prospective transition method. Underthis transition method, results for the prior periods have not been restated.For the first quarter of 2006, an aggregate of $900,000 of stock-basedcompensation expense was included in research and development and general andadministrative expenses. Prior to January 1, 2006, ACADIA accounted foremployee stock-based compensation using the intrinsic value method underAccounting Principles Board No. 25. For the first quarter of 2005, anaggregate of $371,000 of stock-based compensation expense was included inresearch and development and general and administrative expenses.
ACADIA has indicated that it expects to use between $38 million and$42 million of its cash resources to fund its operations for the year endedDecember 31, 2006.
First Quarter 2006 and Recent Highlights
- ACADIA announced positive results in March 2006 from a multi-centerPhase II trial, in which ACP-103 demonstrated antipsychotic effects,was safe and well tolerated, and did not worsen disease-related motoricfunction in patients with Parkinson's disease suffering fromtreatment-induced psychosis. Many of the eligible patients from thistrial have enrolled in an open-label extension study, including somepatients who have been treated with ACP-103 for over one year.
- ACADIA announced positive results in April 2006 from a proof-of-conceptclinical study, which demonstrated that ACP-103 induced a statisticallysignificant and dose-related increase in deep, or slow wave, sleep inhealthy older volunteers.
- ACADIA nominated ACP-105, a non-steroidal and selective androgenreceptor agonist (SARM), as a development candidate. SARMs may improvethe standard of treatment for a variety of disorders includingmuscle-wasting conditions and osteoporosis.
- ACADIA advanced its cannabinoid CB1 research into preclinical programstatus. Blockade of the CB1 receptors may lead to novel treatments inobesity and substance abuse.
- In January 2006, Sepracor made the second of two $10 million purchasesof ACADIA common stock in connection with the companies' ongoingcollaboration.
- ACADIA extended the research term of its March 2003 discoverycollaboration with Allergan for two years through March 2008. Jointresearch efforts are focused in the area of pain and support thecompanies' Phase II clinical program in neuropathic pain.
- ACADIA completed a public offering on May 3, 2006, raising net proceedsof $55.6 million through the sale of approximately 4.9 million sharesof its common stock.
Conference Call and Webcast Information
Uli Hacksell, Ph.D., Chief Executive Officer, and Thomas H. Aasen, VicePresident and Chief Financial Officer, will review first quarter results andhighlights via conference call and webcast later today at 5:00 p.m. EasternTime. The conference call may be accessed by dialing 866-713-8395 forparticipants in the U.S. or Canada and 617-597-5309 for international callers(reference passcode 76699715). A telephone replay of the conference call maybe accessed through May 24, 2006 by dialing 888-286-8010 for callers in theU.S. or Canada and 617-801-6888 for international callers (reference passcode24798056). The conference call also will be webcast live on ACADIA's website,www.acadia-pharm.com, under the investors section and will be archived thereuntil May 24, 2006.
About ACADIA Pharmaceuticals
ACADIA is a biopharmaceutical company utilizing innovative technology tofuel drug discovery and clinical development of novel treatments for centralnervous system disorders. ACADIA currently has five Phase II-stage clinicalprograms as well as a portfolio of preclinical and discovery assets directedat diseases with large unmet medical needs, including schizophrenia,Parkinson's disease, sleep maintenance insomnia, and neuropathic pain. All ofthe drug candidates 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 maintains research anddevelopment operations in both San Diego and Malmo, Sweden.
Forward-Looking Statements
Statements in this press release that are not strictly historical innature are forward-looking statements. These statements include but are notlimited to statements related to the 2006 cash burn, the progress of ACADIA'sdrug discovery and development programs, the potential of ACADIA'scollaborations, and the benefits to be derived from ACADIA's technology,approach and drug candidates, in each case, including ACP-103, ACP-104, andACP-105. These statements are only predictions based on current informationand expectations and involve a number of risks and uncertainties. Actualevents or results may differ materially from those projected in any of suchstatements due to various factors, including the risks and uncertaintiesinherent in drug discovery, development and commercialization, collaborationswith others, and litigation. For a discussion of these and other factors,please refer to ACADIA's annual report on Form 10-K for the year endedDecember 31, 2005 as well as other subsequent filings with the Securities andExchange Commission. You are cautioned not to place undue reliance on theseforward-looking statements, which speak only as of the date hereof. Thiscaution is made under the safe harbor provisions of the Private SecuritiesLitigation Reform Act of 1995. All forward-looking statements are qualifiedin their entirety by this cautionary statement and ACADIA undertakes noobligation to revise or update this press release to reflect events orcircumstances after the date hereof.
Contacts:
ACADIA Pharmaceuticals Inc.
Lisa Barthelemy, Director, Investor Relations
Thomas H. Aasen, Vice President and Chief Financial Officer
(858) 558-2871
ACADIA PHARMACEUTICALS INC.CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS(in thousands, except per share amounts)(Unaudited)Three Months EndedMarch 31,2006 2005Collaborative revenues $2,537 $2,325Operating expensesResearch and development (includes stock-basedcompensation of $559 and $211 for the threemonths ended March 31, 2006 and 2005,respectively) 10,126 6,327General and administrative (includesstock-based compensation of $341 and $160 forthe three months ended March 31, 2006 and 2005,respectively) 2,284 1,798Provision for loss from litigation 227 —Total operating expenses 12,637 8,125Loss from operations (10,100) (5,800)Interest income (expense), net 582 211Loss before change inaccounting principle $(9,518) $(5,589)Cumulative effect of change in accountingprinciple 51 —Net loss $(9,467) $(5,589)Net loss per common share, basic and diluted:Before change in accounting principle $(0.39) $(0.31)Cumulative effect of change inaccounting principle ——Net loss per common share, basicand diluted $(0.39) $(0.31)Weighted average common shares outstanding,basic and diluted 24,308 17,903ACADIA PHARMACEUTICALS INC.CONDENSED CONSOLIDATED BALANCE SHEETS(in thousands)(Unaudited)March 31, December 31,2006 2005(1)AssetsCash, cash equivalents, investment securitiesand restricted cash $56,204 $55,521Prepaid expenses, receivables and othercurrent assets 4,917 4,604Total current assets 61,121 60,125Property and equipment, net 2,299 2,283Other assets 98 98Total assets $63,518 $62,506Liabilities and Stockholders' EquityCurrent liabilities 21,743 21,701Long-term liabilities 1,916 1,434Stockholders' equity 39,859 39,371Total liabilities andstockholders' equity $63,518 $62,506(1) The condensed consolidated balance sheet at December 31, 2005 has beenderived from the audited financial statements at that date but doesnot include all of the information and footnotes required byaccounting principles generally accepted in the United States forcomplete financial statements.