SAN DIEGO, Aug 11, 2004 /PRNewswire via COMTEX/ —ACADIA Pharmaceuticals Inc.(Nasdaq: ACAD), a biopharmaceutical company utilizing innovative science tofuel drug discovery and clinical development of novel treatments for centralnervous system disorders, today reported financial results for the secondquarter and six months ended June 30, 2004.
ACADIA reported a net loss of $5.9 million for the second quarter endedJune 30, 2004, compared to a net loss of $3.0 million for the second quarterof 2003. For the six months ended June 30, 2004, ACADIA reported a net lossof $12.4 million, compared to a net loss of $6.4 million for the comparableperiod of 2003. At June 30, 2004, ACADIA's cash, cash equivalents, andinvestment securities totaled $48.8 million, compared to $27.2 million atDecember 31, 2003.
Second Quarter and Six Month Financial Results
Revenues totaled $1.0 million and $1.9 million for the second quarter andsix months ended June 30, 2004, respectively, compared to $2.3 million and$4.1 million for the comparable periods of 2003. Revenues consisted largelyof collaborative revenues earned under the company's agreements with Allerganand, for the 2003 periods, also included revenues from the company's agreementwith Amgen, the research term of which was completed in late 2003.
Research and development expenses totaled $5.4 million and $11.2 millionfor the second quarter and six months ended June 30, 2004, respectively,compared to $4.3 million and $8.5 million for the comparable periods of 2003.The increase in research and development expenses largely reflected increasedclinical development costs associated with ACADIA's proprietary drugcandidates as well as increased costs associated with expansion of thecompany's internal research and development activities.
General and administrative expenses totaled $880,000 and $1.8 million forthe second quarter and six months ended June 30, 2004, respectively, comparedto $644,000 and $1.4 million for the comparable periods of 2003. The increasein general and administrative expenses was due primarily to increasedprofessional fees and other costs associated with ACADIA's transition tobecoming a publicly traded company.
Non-cash, stock-based compensation expenses increased to $614,000 and$1.3 million for the second quarter and six months ended June 30, 2004,respectively, compared to $218,000 and $443,000 for the comparable periods of2003.
"The second quarter of 2004 was a productive period for ACADIA as weaggressively advanced our proprietary clinical development programs, broadenedour portfolio of discovery assets, and completed our initial public offering,"said Uli Hacksell, Ph.D., ACADIA's Chief Executive Officer. "We are nowpositioned to deliver on our key objective to complete Phase II studies ineach of our three proprietary clinical programs through 2005, while continuingto build a broad portfolio of innovative therapies to treat central nervoussystem disorders and other areas of unmet medical need."
Second Quarter and Recent Highlights* ACADIA presented results of a Phase Ib/IIa clinical trial of ACP-103in patients with Parkinson's disease during the second quarter of2004. ACP-103 was safe and well tolerated with no adverse eventsreported, and did not worsen the pre-existing motor deficits of thesepatients. In a subgroup of patients who entered the trial withtreatment-induced dyskinesias, these symptoms were reduced followingACP-103 administration. This finding is consistent with thepreviously demonstrated antidyskinetic activity of ACP-103 in a monkeymodel of Parkinson's disease. Following these encouraging initialfindings, ACADIA is preparing to begin a clinical pharmacology studyto further explore the antidyskinetic activity of ACP-103.* ACADIA is currently conducting a multi-center Phase II clinical trialwith ACP-103, designed to evaluate the efficacy and safety of thisdrug candidate in Parkinson's disease patients who suffer fromtreatment-induced psychosis. During the second quarter of 2004,ACADIA began the clinical phase of this trial and ACADIA has nowopened all trial sites and continues to enroll patients. Results fromthis trial are expected during the first half of 2005.* ACADIA is advancing with its Phase II program using ACP-103 as anadjunctive therapy for schizophrenia. This Phase II program consistsof an ongoing clinical pharmacology study and two clinical trialsdesigned to evaluate the ability of ACP-103 to reduce motordisturbances and to improve the efficacy of current antipsychoticagents. ACADIA expects to begin the clinical trials shortly andreport results during 2005.* ACADIA recently published research linking the mechanism of its drugcandidate ACP-104, the major metabolite of clozapine, to the uniqueability of clozapine to improve cognition in patients withschizophrenia.* ACADIA entered into a three-year development agreement withThe Stanley Medical Research Institute, which will provide ACADIA withup to $5 million in funding to support the further development ofACP-104. ACADIA expects to initiate clinical trials shortly in itsPhase II program for ACP-104.* ACADIA closed the initial public offering of shares of its commonstock on June 2, 2004, resulting in net proceeds to ACADIA of$31.0 million.
Conference Call and Webcast Information
Uli Hacksell, Ph.D., Chief Executive Officer, and Thomas H. Aasen, VicePresident and Chief Financial Officer, will review second quarter results viaconference call and webcast later today at 4:30 p.m. EDT. The conference callmay be accessed by dialing 800-901-5231 for participants from the UnitedStates or Canada and 617-786-2961 for international callers (referenceparticipant passcode 69887488). The conference call also will be webcast liveon ACADIA's website at http://www.acadia-pharm.com, under the investorrelations section, and will be archived there until August 25, 2004.
About ACADIA Pharmaceuticals
ACADIA Pharmaceuticals is a biopharmaceutical company utilizing innovativescience to fuel drug discovery and clinical development of novel treatmentsfor central nervous system disorders. ACADIA currently has five drug programsin clinical and preclinical development directed at large unmet medical needsand major commercial markets, including Parkinson's disease, schizophrenia,chronic pain, and glaucoma. Using its proprietary drug discovery platform,ACADIA has discovered all of the drug candidates in its product pipeline.ACADIA's corporate headquarters and biological research facilities are locatedin San Diego, California and its chemistry research facilities are located inCopenhagen, 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+1-858-558-2871ACADIA PHARMACEUTICALS INC.CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS(in thousands, except per share amounts)(Unaudited)Three Months Ended Six Months EndedJune 30, June 30,2004 2003 2004 2003Collaborative researchrevenues $1,016 $2,281 $1,940 $4,131Operating expensesResearch and development 5,407 4,323 11,156 8,454General and administrative 880 644 1,791 1,390Stock-based compensation 614 218 1,310 443Total operating expenses 6,901 5,185 14,257 10,287Loss from operations (5,885) (2,904) (12,317) (6,156)Interest income (expense) (1) (72) (51) (231)Net loss $(5,886) $(2,976) $(12,368) $(6,387)Participation ofpreferred stock (3,110) (2,594) (8,587) (5,567)Net loss available tocommon stockholders (2,776) (382) (3,781) (820)Net loss per common share,basic and diluted $(0.42) $(0.26) $(0.94) $(0.56)Weighted average commonshares outstanding,basic and diluted 6,552 1,459 4,024 1,458Net loss available toparticipating preferredstockholders $(3,110) $(2,594) $(8,587) $(5,567)Net loss per participatingpreferred share,basic and diluted $(0.31) $(0.27) $(0.87) $(0.71)Weighted averageparticipating preferredshares outstanding,basic and diluted 9,901 9,716 9,901 7,853ACADIA's preferred stock was reclassified or converted into9,900,913 shares of common stock upon the completion of theinitial public offering on June 2, 2004.ACADIA PHARMACEUTICALS INC.CONDENSED CONSOLIDATED BALANCE SHEETS(in thousands)(Unaudited)June 30, December 31,2004 2003AssetsCash, cash equivalents andinvestment securities, available-for-sale $48,793 $27,214Prepaid expenses and other current assets 1,465 1,058Total current assets 50,258 28,272Property and equipment, net 2,761 3,117Other assets 285 304Total assets $53,304 $31,693Liabilities and Stockholders' Equity (Deficit)Current liabilities $9,566 $8,226Long-term liabilities 946 1,624Convertible preferred stock —74,514Stockholders' equity (deficit) 42,792 (52,671)Total liabilities andstockholders' equity (deficit) $53,304 $31,693
Thomas H. Aasen, Vice President and Chief Financial Officer ofACADIA Pharmaceuticals Inc., +1-858-558-2871
http://www.acadia-pharm.com