SAN DIEGO—(BUSINESS WIRE)—March 6, 2007—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 fourth quarter and year endedDecember 31, 2006.
ACADIA reported a net loss of $12.5 million, or $0.42 per commonshare, for the fourth quarter of 2006 compared to a net loss of $10.2million, or $0.44 per common share, for the fourth quarter of 2005.The net loss for the fourth quarter of 2006 included $820,000 innon-cash, stock-based compensation expense compared to $80,000 innon-cash, stock-based compensation for the fourth quarter of 2005. Forthe year ended December 31, 2006, ACADIA reported a net loss of $45.0million, or $1.61 per common share, compared to a net loss of $34.1million, or $1.55 per common share, for 2005.
At December 31, 2006, ACADIA's cash, cash equivalents, andinvestment securities totaled $83.3 million compared to $55.5 millionat December 31, 2005. The increase in cash was primarily due toproceeds from sales of equity securities, including $59.4 millionraised in a follow-on public offering during the second quarter of2006 and $10 million received from the sale of common stock toSepracor Inc. in January 2006, partially offset by cash used to fundACADIA's operations.
"2006 was highlighted by major progress in all four of ourproprietary clinical programs and the strengthening of our balancesheet through the completion of our follow-on offering and Sepracor'ssecond equity investment," said Uli Hacksell, Ph.D., ACADIA's ChiefExecutive Officer. "ACADIA has now transitioned to a later-stagedevelopment company as we prepare to initiate the first pivotal trialin our Phase III program with ACP-103 for Parkinson's diseasepsychosis. We also look forward to other important milestones in 2007,including top-line results from our ACP-103 Phase II schizophreniaco-therapy trial, which we anticipate in March 2007, as well as theinitiation of more advanced Phase II trials in our two otherproprietary clinical programs."
Revenues totaled $1.8 million for the fourth quarter of 2006compared to $2.4 million for the fourth quarter of 2005. This decreasewas primarily due to lower revenues under ACADIA's collaborations withAllergan, Inc. Revenues from ACADIA's agreements with Sepracor and TheStanley Medical Research Institute totaled $945,000 and $500,000,respectively, for the fourth quarter of 2006 and were comparable torevenues recognized under these agreements during the fourth quarterof 2005.
Research and development expenses totaled $12.8 million for thefourth quarter of 2006, including $449,000 in stock-basedcompensation, compared to $9.7 million for the fourth quarter of 2005,including $(13,000) in stock-based compensation. The increase inresearch and development expenses was primarily due to increasedclinical development activity associated with ACADIA's proprietaryclinical programs, including its Phase II co-therapy trial withACP-103 for patients with schizophrenia. Excluding stock-basedcompensation, the increase in research and development expenses wasprimarily attributable to $1.8 million in increased fees paid toexternal service providers, which totaled $6.3 million for the fourthquarter of 2006, and increased costs associated with expansion ofACADIA's development organization.
General and administrative expenses totaled $2.5 million for thefourth quarter of 2006, including $371,000 in stock-basedcompensation, compared to $3.1 million for the fourth quarter of 2005,including $93,000 in stock-based compensation. The decrease in generaland administrative expenses was primarily due to lower professionalfees, partially offset by increased stock-based compensation.
For the fourth quarter of 2006, an aggregate of $820,000 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. During the fourth quarter of 2005, a total of $80,000 ofnon-cash, stock-based compensation expense was recorded using theintrinsic value method under Accounting Principles Board Opinion No.25.
2006 and Recent Highlights
Advancement of Proprietary Clinical Pipeline
ACP-103 as a Co-Therapy for Schizophrenia
- ACADIA completed enrollment of 423 patients in itsmulti-center, double-blind, placebo-controlled Phase IIco-therapy trial with ACP-103 in late-October 2006,significantly ahead of schedule. This trial is evaluating theability of ACP-103 when used as a co-therapy with otherantipsychotic drugs to provide an improved treatment forpatients with schizophrenia. The treatment phase of thisclinical trial has been completed and ACADIA remains on trackto report top-line results from the study during March 2007.
ACP-103 for the Treatment of Parkinson's Disease Psychosis
- ACADIA announced top-line results in March 2006 from amulti-center, double-blind, placebo-controlled Phase IIclinical trial, in which ACP-103 demonstrated antipsychoticeffects, was safe and well tolerated, and did not impairdisease-related motor function in patients with Parkinson'sdisease psychosis (PDP). In connection with this Phase IItrial, ACADIA is conducting an open-label extension study,pursuant to which 24 patients have been treated with ACP-103for at least one year, eight of whom have been treated forover 18 months.
- ACADIA held an end of Phase II meeting in late-September 2006with the U.S. Food and Drug Administration (FDA) regarding theACP-103 program for PDP. Following its interactions with theFDA, ACADIA is currently preparing to initiate the firstpivotal trial in its Phase III development program for PDPduring the first half of 2007.
ACP-104 for the Treatment of Schizophrenia
- ACADIA announced top-line 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. ACADIA is planning to initiate a multi-center,double-blind, placebo-controlled Phase IIb clinical trial withACP-104 in patients with schizophrenia during the first halfof 2007.
ACP-103 for the Treatment of Sleep Maintenance Insomnia
- ACADIA announced top-line 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. ACADIA is planning to initiate a Phase II clinicaltrial with ACP-103 in patients with sleep maintenance insomniaduring the first half of 2007.
Expansion of Pipeline
- ACADIA reported today that it has nominated ACP-106, a potentand selective 5-HT2A inverse agonist, as a clinical candidate.ACADIA believes that ACP-106 and other compounds in itsserotonin platform expand ACADIA's base of assets forpotential partnering, and will enable ACADIA, alone or incollaboration, to pursue more broadly a range of potentialtherapeutic indications, including PDP, schizophrenia, sleepmaintenance insomnia, and other central nervous systemdisturbances.
- ACADIA nominated ACP-105, a non-steroidal and selectiveandrogen receptor agonist as a clinical candidate during thefirst quarter of 2006. ACP-105 is part of a class of moleculesreferred to as selective androgen receptor modulators (SARMs)that may improve the standard of treatment for a variety ofdisorders, including muscle-wasting conditions andosteoporosis.
- ACADIA advanced its cannabinoid CB1 research into preclinicalprogram status during the second quarter of 2006. Blockade ofthe CB1 receptors may lead to novel treatments in obesity andsubstance abuse.
Business and Other Highlights
- ACADIA expanded and further strengthened its intellectualproperty portfolio for its serotonin platform by entering intoan agreement in November 2006 to license certain intellectualproperty rights from Ipsen.
- ACADIA completed a follow-on public offering during the secondquarter of 2006, raising net proceeds of $59.4 million.
- ACADIA strengthened its management team with the appointmentof Roger G. Mills, M.D., as Executive Vice President,Development during the second quarter of 2006, and theappointment of David C. Furlano, Ph.D., as Vice President,Regulatory Affairs during the first quarter of 2006.
- ACADIA was selected for addition to the NASDAQ BiotechnologyIndex (NBI) effective May 22, 2006.
- ACADIA extended the research term of its March 2003 discoverycollaboration with Allergan during the first quarter of 2006for two additional years through March 2008. Joint researchefforts are focused in the area of pain and support thecompanies' Phase II clinical program in neuropathic pain.
- During the first quarter of 2006, ACADIA received $10 millionfrom Sepracor's second purchase of ACADIA common stock inconnection with the companies' ongoing collaboration.
Conference Call and Webcast Information
ACADIA management will review its fourth quarter results anddevelopment programs via conference call and webcast later today at5:00 p.m. Eastern Time. The conference call may be accessed by dialing866-700-7173 for participants in the U.S. or Canada and 617-213-8838for international callers (reference passcode 55576242). A telephonereplay of the conference call may be accessed through March 20, 2007by dialing 888-286-8010 for callers in the U.S. or Canada and617-801-6888 for international callers (reference passcode 28337764).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 March 20, 2007.
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 clinical programs as well as a portfolio of preclinical anddiscovery assets directed at diseases with large unmet medical needs,including schizophrenia, Parkinson's disease psychosis, 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,including ACP-103, ACP-104, ACP-105 and ACP-106; the timing or designof future clinical trials; the timing of announcements of results fromclinical trials; and any future partnering events. These statementsare only predictions based on current information and expectations andinvolve a number of risks and uncertainties. Actual events or resultsmay differ materially from those projected in any of such statementsdue to various factors, including the risks and uncertainties inherentin drug discovery, development and commercialization, andcollaborations with others. For a discussion of these and otherfactors, please refer to ACADIA's annual report on Form 10-K for theyear ended December 31, 2005 as well as other subsequent filings withthe Securities and Exchange Commission. You are cautioned not to placeundue reliance on these forward-looking statements, which speak onlyas of the date hereof. This caution is made under the safe harborprovisions of the Private Securities Litigation Reform Act of 1995.All forward-looking statements are qualified in their entirety by thiscautionary statement and ACADIA undertakes no obligation to revise orupdate this press release to reflect events or circumstances after thedate hereof.
Additionally, certain of the information contained in this pressrelease reflects preliminary financial results, as the audit ofACADIA's financial statements for the year ended December 31, 2006 hasnot yet been completed. The 2006 audit and the evaluation of ACADIA'sinternal control over financial reporting under Section 404 of theSarbanes-Oxley Act of 2002 will be completed nearer the date thatACADIA files its Annual Report on Form 10-K for the year endedDecember 31, 2006 with the Securities and Exchange Commission.
ACADIA PHARMACEUTICALS INC.CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS(in thousands, except per share amounts)(Unaudited)Three Months Ended Years EndedDecember 31, December 31,—————————- —————————-2006 2005 2006 2005————- ————- ————- ————-Collaborative revenues $1,773 $2,443 $8,133 $10,956Operating expensesResearch and development(includes stock-basedcompensation of $449, $(13),$1,866 and $740,respectively) (1) 12,788 9,658 49,398 30,336General and administrative(includes stock-basedcompensation of $371, $93,$1,512 and $568,respectively) (1) 2,536 3,125 11,349 10,205Provision for loss from(settlement of) litigation —360 (3,560) 6,221————- ————- ————- ————-Total operating expenses 15,324 13,143 57,187 46,762————- ————- ————- ————-Loss from operations (13,551) (10,700) (49,054) (35,806)Interest income (expense), net 1,100 497 3,955 1,671————- ————- ————- ————-Loss before change inaccounting principle (12,451) (10,203) (45,099) (34,135)Cumulative effect of change inaccounting principle ——51 —————- ————- ————- ————-Net loss $(12,451) $(10,203) $(45,048) $(34,135)========= ========= ========= =========Net loss per common share,basic and diluted:Before change inaccounting principle $(0.42) $(0.44) $(1.61) $(1.55)Cumulative effect ofchange in accountingprinciple ————————- ————- ————- ————-Net loss per common share,basic and diluted $(0.42) $(0.44) $(1.61) $(1.55)========= ========= ========= =========Weighted average common sharesoutstanding, basic anddiluted 29,869 23,436 27,923 22,014========= ========= ========= =========(1) Certain costs for the three months and year ended December 31,2005 were reclassified to general and administrative expenses fromresearch and development expenses to conform to the presentation inthe corresponding periods of 2006.
ACADIA PHARMACEUTICALS INC.CONDENSED CONSOLIDATED BALANCE SHEETS(in thousands)(Unaudited)December December31, 31,2006 2005(1)————————AssetsCash, cash equivalents, and investment securities $83,255 $55,521Prepaid expenses, receivables and other currentassets 2,528 4,604————————Total current assets 85,783 60,125Property and equipment, net 3,505 2,283Other assets 256 98————————Total assets $89,544 $62,506======== ========Liabilities and Stockholders' EquityCurrent liabilities 20,534 21,701Long-term liabilities 1,851 1,434Stockholders' equity 67,159 39,371————————Total liabilities and stockholders' equity $89,544 $62,506======== ========(1) The condensed consolidated balance sheet at December 31, 2005 hasbeen derived from the audited financial statements at that date butdoes not include all of the information and footnotes required byaccounting principles generally accepted in the United States forcomplete financial statements.
CONTACT: ACADIA Pharmaceuticals Inc.
Lisa Barthelemy, Director, Investor Relations
Thomas H. Aasen, Vice President andChief Financial Officer
(858) 558-2871