SAN DIEGO, March 3, 2005 /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 its unaudited financial results forthe fourth quarter and year ended December 31, 2004.
ACADIA reported a net loss of $7.3 million for the fourth quarter of 2004,compared to a net loss of $4.3 million for the fourth quarter of 2003. Forthe year ended December 31, 2004, ACADIA reported a net loss of $25.9 millioncompared to a net loss of $14.1 million for 2003.
At December 31, 2004, ACADIA's cash, cash equivalents and investmentsecurities totaled $35.9 million compared to $27.2 million at December 31,2003. The year-end cash balance did not include $10 million in proceeds fromthe sale of 1,077,029 shares of ACADIA's common stock in January of this year,in connection with a new collaboration agreement with Sepracor Inc. Sepracorhas also agreed to purchase an additional $10 million in ACADIA common stockin January 2006, subject to specified closing conditions.
Financial Results
Revenues totaled $1.1 million for the fourth quarter of 2004, compared to$1.6 million for the fourth quarter of 2003. The decrease in revenues wasprimarily due to lower revenues recognized under ACADIA's collaborations withAllergan, Inc. as well as a decline in other research revenues. Revenuesdecreased to $4.6 million for the year ended December 31, 2004, from$7.4 million for 2003, primarily due to lower revenues following thecompletion in late-2003 of our research collaboration with Amgen Inc.
Research and development expenses increased to $6.4 million for the fourthquarter of 2004, from $4.5 million for the fourth quarter of 2003. Theincrease in research and development expenses was primarily due to$1.3 million in increased fees paid to external service providers, andincreased costs associated with ACADIA's internal research and developmentactivities, including increased personnel and supply costs. Research anddevelopment expenses increased to $23.5 million for the year endedDecember 31, 2004, from $16.9 million for 2003, primarily due to $3.5 millionin increased fees paid to external service providers and increased costsassociated with ACADIA's internal research and development activities. Theincrease in fees paid to external service providers largely reflectedincreased costs associated with ACADIA's three proprietary clinicaldevelopment programs.
General and administrative expenses increased to $1.8 million for thefourth quarter of 2004, from $759,000 for the fourth quarter of 2003. Theincrease in general and administrative expenses was primarily due to increasedprofessional services and personnel costs associated with operating as apublicly traded company, as well as increased costs related to businessdevelopment activities. General and administrative expenses increased to$4.9 million for the year ended December 31, 2004, from $2.8 million for 2003,primarily due to increased professional services and personnel expensesassociated with operating as a publicly traded company.
Non-cash, stock-based compensation totaled $376,000 for the fourth quarterof 2004, compared to $591,000 for the fourth quarter of 2003. Stock-basedcompensation totaled $2.4 million for the year ended December 31, 2004,compared to $1.4 million for 2003.
"2004 was a productive year for ACADIA, highlighted by the advancement ofour clinical development pipeline and the completion of our initial publicoffering," said Uli Hacksell, Ph.D., ACADIA's Chief Executive Officer. "Weare pleased to begin the new year with the formation of an important newcollaboration with Sepracor and we believe that 2005 holds the potential to bea transforming year for ACADIA as we execute on our strategy of building abroad pipeline of innovative therapies to treat central nervous systemdisorders and other areas of unmet medical need."
2004 and Recent HighlightsRecent Collaboration to Accelerate Preclinical Pipeline* ACADIA formed a collaboration with Sepracor in January 2005 for thedevelopment of new drug candidates targeted toward the treatment ofcentral nervous system, or CNS, disorders. This collaboration willexplore potential clinical candidates resulting from ACADIA'spreclinical muscarinic program, and also includes an option to selecta preclinical compound from ACADIA's 5-HT2A program for use incombination with LUNESTA, Sepracor's insomnia drug, for sleep-relatedindications.Strengthening of ACADIA's Business Development and R&D Organization* ACADIA has appointed Brian Lundstrom to the position of Senior VicePresident, Business Development. Mr. Lundstrom previously held theposition of Vice President, Business Development at GenzymeCorporation.* ACADIA has appointed Daniel P. van Kammen, M.D., Ph.D. to the positionof Vice President, Clinical Development. Dr. van Kammen waspreviously Head of CNS, Clinical Discovery and Human Pharmacology atAventis, where he was co-responsible for Aventis' schizophreniastrategy.* ACADIA has appointed Douglas W. Bonhaus, Ph.D. to the position of VicePresident, Biosciences. Dr. Bonhaus was previously Department Headand Senior Scientist at Roche.Continued Advancement of Clinical Pipeline* ACP-103 for treatment-induced psychosis in Parkinson's disease:—ACADIA reported favorable results from a Phase Ib/IIa clinicaltrial of ACP-103 in patients with Parkinson's disease in the secondquarter of 2004.—ACADIA is conducting a multi-center, double-blind, placebo-controlled Phase II trial designed to evaluate the efficacy andtolerability of ACP-103 in up to 60 Parkinson's disease patientswho suffer from treatment-induced psychosis. ACADIA is planning toreport results from this trial at two points during the study. Bymid-2005, ACADIA intends to report on potential trends in patientresponses to ACP-103 seen in the first 30 patients enrolled in thestudy. This initial examination will be limited to trends relativeto the trial's endpoints of efficacy. ACADIA is continuing toenroll patients in this trial and expects to report results from acomplete statistical analysis of all clinical endpoints on all60 patients in late-2005 or early-2006.—ACADIA also reported that it has an ongoing study involving theextended use of ACP-103 in Parkinson's patients with psychosis whohave completed the aforementioned Phase II trial and may, in theopinion of the treating physician, benefit from continued treatmentwith ACP-103. During the fourth quarter of 2004 and in early-2005,several sites began enrolling patients in this open-label extensionstudy, which is designed to determine the safety of ACP-103 duringlong-term administration.* ACP-103 as an adjunctive therapy for schizophrenia:—ACADIA announced results of the first clinical study in thisprogram during the third quarter of 2004. This clinicalpharmacology study showed that ACP-103 reduced side effectsassociated with haloperidol treatment.—ACADIA has an ongoing double-blind, placebo-controlled Phase IItrial designed to evaluate the ability of ACP-103 to reduce motordisturbances associated with chronic haloperidol treatment inpatients with schizophrenia. ACADIA expects to report results fromthis study during the second half of 2005.—ACADIA is preparing to conduct a multi-center, double-blind,placebo-controlled Phase II trial designed to evaluate the abilityof ACP-103 when used adjunctively with other antipsychotic drugs toprovide an improved therapy for patients with schizophrenia. Theprotocol for this clinical trial was expanded during the secondhalf of 2004 to explore the use of ACP-103 in adjunctive therapywith risperidone, in addition to its original design aimed atdemonstrating the beneficial effect of adjunctive therapy usingACP-103 with haloperidol. ACADIA anticipates that it will startthe clinical phase of this study during the second quarter of 2005.* ACP-104 as a therapy for schizophrenia:—ACADIA published research linking the mechanism of ACP-104, themajor metabolite of clozapine, to the unique ability of clozapineto improve cognition in patients with schizophrenia, during thethird quarter of 2004.—ACADIA's Phase II program for ACP-104 includes multiple clinicalstudies. The initial trials are single-dose and multiple-doseescalation clinical trials in patients with schizophrenia. Thesestudies, which are ongoing, are focused primarily on safety andtolerability, pharmacokinetics, and preliminary indications of theefficacy of ACP-104 in patients with schizophrenia. ACADIA expectsto report results from these studies during the second half of2005. Following these studies, ACADIA is planning to beginadditional studies to further evaluate the ability of ACP-104 totreat schizophrenia and cognitive impairment.* Collaborative neuropathic pain program:—ACADIA announced in the fourth quarter of 2004 that Allergan filedan Investigational New Drug application with the FDA covering asmall molecule drug candidate for the treatment of neuropathicpain, which was discovered under one of the companies'collaborations. This program is currently in Phase I clinicaltrials.Conference Call and Webcast Information
Uli Hacksell, Ph.D., Chief Executive Officer, and Thomas H. Aasen, VicePresident and Chief Financial Officer, will review fourth quarter results andhighlights via conference call and webcast later today at 4:30 p.m. EasternTime. The conference call may be accessed by dialing 800-295-3991 forparticipants from the United States or Canada and 617-614-3924 forinternational callers (reference participant passcode 39550576). Theconference call also will be webcast live on ACADIA's website,www.acadia-pharm.com, under the investors section and will be archived thereuntil March 17, 2005.
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 four drug programsin clinical development as well as a portfolio of preclinical and discoveryassets directed at large unmet medical needs, including schizophrenia,Parkinson's disease, 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, the safety and efficacy of our drugcandidates, the potential of our collaborations and any payments we mayreceive thereunder, and our future results. These statements are onlypredictions based on current information and expectations and involve a numberof risks and uncertainties. Actual events or results may differ materiallyfrom those projected in any of such statements due to various factors,including the risks and uncertainties inherent in drug development andcommercialization. For a discussion of these and other factors, please referto ACADIA's registration statement on Form S-1 as well as other subsequentfilings with the Securities and Exchange Commission. You are cautioned not toplace undue reliance on these forward-looking statements, which speak only asof the date hereof. This caution is made under the safe harbor provisions ofthe Private Securities Litigation Reform Act of 1995. All forward-lookingstatements are qualified in their entirety by this cautionary statement andACADIA undertakes no obligation to revise or update this press release toreflect events or circumstances after the date hereof. Additionally, theinformation contained in this press release reflects preliminary financialresults, as ACADIA's 2004 audit has not yet been completed. The 2004 auditwill be completed near the date that ACADIA files its Annual Report on Form10-K with the Securities and Exchange Commission.
ACADIA PHARMACEUTICALS INC.SELECTED CONSOLIDATED FINANCIAL DATA(in thousands)(Unaudited)Three Months Ended Years EndedDecember 31, December 31,2004 2003 2004 2003Consolidated Statementsof Operations Data:Collaborative researchrevenues $1,083 $1,573 $4,604 $7,378Operating expensesResearch and development 6,375 4,491 23,454 16,935General and administrative 1,788 759 4,889 2,791Stock-based compensation 376 591 2,356 1,392Total operating expenses 8,539 5,841 30,699 21,118Loss from operations (7,456) (4,268) (26,095) (13,740)Interest income (expense) 121 (61) 178 (352)Net loss $(7,335) $(4,329) $(25,917) $(14,092)December 31,2004 2003Consolidated Balance Sheets Data:AssetsCash, cash equivalents andinvestment securities, available-for-sale $35,927 $27,214Prepaid expenses and other current assets 1,891 1,058Total current assets 37,818 28,272Property and equipment, net 2,547 3,117Other assets —304Total assets $40,365 $31,693Liabilities and Stockholders' Equity (Deficit)Current liabilities 8,641 8,226Long-term liabilities 1,044 1,624Convertible preferred stock —74,514Stockholders' equity (deficit) 30,680 (52,671)Total liabilities and stockholders'equity (deficit) $40,365 $31,693
SOURCE ACADIA Pharmaceuticals Inc.
Lisa Barthelemy, Director, Investor Relations, or
Thomas H. Aasen, Vice President anChief Financial Officer,
both of ACADIA Pharmaceuticals Inc., +1-858-558-2871
http://www.prnewswire.com