SAN DIEGO, Nov 10, 2004 /PRNewswire-FirstCall via COMTEX/ —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 financial results for the thirdquarter and nine months ended September 30, 2004.
ACADIA reported a net loss of $6.2 million for the third quarter endedSeptember 30, 2004, compared to a net loss of $3.4 million for the thirdquarter of 2003. For the nine months ended September 30, 2004, ACADIAreported a net loss of $18.6 million, compared to a net loss of $9.8 millionfor the comparable period of 2003.
At September 30, 2004, ACADIA's cash, cash equivalents and investmentsecurities totaled $43.2 million, compared to $27.2 million at December 31,2003.
Third Quarter Financial Results
Revenues totaled $1.6 million for the third quarter ended September 30,2004, compared to $1.7 million for the third quarter of 2003. Revenuesconsisted primarily of research and milestone payments earned under thecompany's collaborative agreements with Allergan, Inc.
Research and development expenses increased to $5.9 million for the thirdquarter ended September 30, 2004 from $4.0 million for the third quarter of2003. The increase in research and development expenses largely reflectedincreased costs associated with ACADIA's three proprietary clinicaldevelopment programs, ACP-103 for treatment-induced dysfunction in Parkinson'sdisease, ACP-103 as an adjunctive therapy for schizophrenia, and ACP-104 forthe treatment of schizophrenia.
General and administrative expenses increased to $1.3 million for thethird quarter ended September 30, 2004 from $642,000 for the comparablequarter of 2003. The increase in general and administrative expenses was dueprimarily to increased insurance costs, professional fees, and personnelexpenses associated with ACADIA operating as a publicly traded company.
Non-cash, stock-based compensation expenses totaled $670,000 for the thirdquarter ended September 30, 2004, compared to $359,000 for the third quarterof 2003.
"The third quarter of 2004 marked another exciting period for ACADIA as wecontinued to make important progress in our three proprietary clinicalprograms and successfully advanced to the clinic our neuropathic pain programin collaboration with Allergan," said Uli Hacksell, Ph.D., ACADIA's ChiefExecutive Officer. "With four clinical programs and a portfolio ofpreclinical and discovery assets, we continue to execute on our strategy ofbuilding a broad pipeline of innovative therapies to treat central nervoussystem disorders and other areas of unmet medical need."
Third Quarter and Recent Highlights
* ACADIA announced results of a clinical study that assessed the abilityof ACP-103 to reduce side effects associated with currentantipsychotic drug treatments. These side effects included akathesia,an extremely distressful motor disturbance, and hyprolactinemia, acondition of elevated prolactin secretion that can adversely affectmenstrual and sexual function. Results of this study showed thatACP-103 reduced both the akathesia and hyprolactinemia caused byhaloperidol treatment.
* ACADIA initiated a clinical trial during the third quarter to evaluatethe ability of ACP-103 to treat levodopa-induced dyskinesias, oruncontrollable movements of the limbs, in patients with Parkinson'sdisease. This double-blind, placebo-controlled study is beingconducted at the National Institute of Neurological Disorders andStroke, an institute of the National Institutes of Health, and isexpected to enroll up to twenty patients. This clinical trial followsencouraging results obtained from a Phase Ib/IIaclinical trial with ACP-103 in patients with Parkinson's disease.
* ACADIA announced that Allergan filed an Investigational New Drug (IND)application with the FDA covering a small molecule drug candidate forthe treatment of neuropathic pain, which was discovered and is beingdeveloped under one of the companies' collaborations. ACADIA earned amilestone payment upon the filing of the IND application and isentitled to receive additional milestone and royalty payments onproducts successfully developed and commercialized under thecollaboration.
* ACADIA continues to advance its three proprietary Phase II programs:ACP-103 for treatment-induced dysfunction in Parkinson's disease;ACP-103 as an adjunctive therapy for schizophrenia; and ACP-104 as atreatment for schizophrenia. ACADIA anticipates reporting resultsfrom Phase II studies in each of these programs during 2005.
* ACADIA presented research on novel small molecules that targetreceptors implicated in the therapy of pain and inflammation at theSociety of Neuroscience's Annual Meeting held in San Diego in lateOctober. In separate presentations, ACADIA scientists describedstudies of compounds selectively acting on MrG, ER-beta and PAR-2receptors. In addition, ACADIA scientists presented studies ofcompounds that relieve neuropathic pain in animals by selectivelytargeting NPFF2 receptors.
Conference Call and Webcast Information
Uli Hacksell, Ph.D., Chief Executive Officer, and Thomas H. Aasen, VicePresident and Chief Financial Officer, will review third quarter results andhighlights via conference call and webcast later today at 4:30 p.m. EST. Theconference call may be accessed by dialing 800-901-5247 for participants fromthe United States or Canada and 617-786-4501 for international callers(reference participant passcode 92945056). The conference call also will bewebcast live on ACADIA's website, www.acadia-pharm.com, under the investorrelations section and will be archived there until November 24, 2004.
About ACADIA Pharmaceuticals
ACADIA Pharmaceuticals is a biopharmaceutical company utilizing innovativetechnology to fuel drug discovery and clinical development of novel treatmentsfor central nervous system disorders. ACADIA currently has five drug programsin clinical and preclinical development as well as a portfolio of drugdiscovery assets directed at large unmet medical needs, including Parkinson'sdisease, schizophrenia, neuropathic pain, and glaucoma. Using its proprietarydrug discovery platform, ACADIA has discovered all of the drug candidates inits product pipeline. ACADIA's corporate headquarters and biology researchfacilities are located in San Diego, California and its chemistry researchfacilities are located near Copenhagen, Denmark.
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 progress and timing of our drugdevelopment programs and related trials and the efficacy of our drugcandidates. These statements are only predictions based on currentinformation and expectations and involve a number of risks and uncertainties.Actual events or results may differ materially from those projected in any ofsuch statements due to various factors, including the risks and uncertaintiesinherent in drug development and commercialization. For a discussion of theseand other factors, please refer to the company's registration statement onForm S-1 as well as other subsequent filings with the Securities and ExchangeCommission.
Contact:
ACADIA Pharmaceuticals Inc.
Thomas H. Aasen, Vice President and Chief Financial Officer
+1-858-558-2871
ACADIA PHARMACEUTICALS INC.CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS(in thousands, except per share amounts)(Unaudited)Three Months Ended Nine Months EndedSeptember 30, September 30,2004 2003 2004 2003Collaborative researchrevenues $1,581 $1,675 $3,521 $5,806Operating expensesResearch anddevelopment 5,923 3,989 17,079 12,444General andadministrative 1,311 642 3,103 2,032Stock-basedcompensation 670 359 1,979 802Total operatingexpenses 7,904 4,990 22,161 15,278Loss fromoperations (6,323) (3,315) (18,640) (9,472)Interest income(expense) 108 (61) 58 (292)Net loss $(6,215) $(3,376) $(18,582) $(9,764)Participation ofpreferred stock —(2,943) (8,587) (8,509)Net loss availableto commonstockholders (6,215) (433) (9,995) (1,255)Net loss per commonshare, basic anddiluted $(0.37) $(0.30) $(1.22) $(0.86)Weighted average commonshares outstanding,basic and diluted 16,629 1,459 8,225 1,458Net loss availableto participatingpreferredstockholders $—$(2,943) $(8,587) $(8,509)Net loss perparticipatingpreferred share,basic and diluted $—$(0.30) $(0.87) $(1.00)Weighted averageparticipatingpreferred sharesoutstanding, basicand diluted —9,901 9,901 8,536
ACADIA's preferred stock was reclassified or converted into9,900,913 shares of common stock upon the closing of its initial publicoffering on June 2, 2004.
ACADIA PHARMACEUTICALS INC.CONDENSED CONSOLIDATED BALANCE SHEETS(in thousands)(Unaudited)September 30, December 31,2004 2003(unaudited)AssetsCash, cash equivalentsand investmentsecurities,available-for-sale $43,158 $27,214Prepaid expenses andother current assets 1,748 1,058Total current assets 44,906 28,272Property and equipment,net 2,549 3,117Other assets 295 304Total assets $47,750 $31,693Liabilities andStockholders' Equity(Deficit)Current liabilities 9,364 8,226Long-term liabilities 1,027 1,624Convertible preferredstock —74,514Stockholders' equity(deficit) 37,359 (52,671)Total liabilities andstockholders' equity(deficit) $47,750 $31,693