SAN DIEGO—(BUSINESS WIRE)—March 5, 2008—ACADIA Pharmaceuticals Inc. (Nasdaq:ACAD),a biopharmaceutical company utilizing innovative technology to fuel drug discoveryand clinical development of novel treatments for central nervous system disorders,today reported its unaudited financial results for the fourth quarter and yearended December 31, 2007.
ACADIA reported a net loss of $17.0 million, or $0.46 per common share, forthe fourth quarter of 2007 compared to a net loss of $12.5 million, or $0.42per common share, for the fourth quarter of 2006. For the year ended December31, 2007, ACADIA reported a net loss of $56.4 million, or $1.60 per common share,compared to a net loss of $45.0 million, or $1.61 per common share, for 2006.
At December 31, 2007, ACADIA's cash, cash equivalents, and investment securitiestotaled $126.9 million compared to $83.3 million at December 31, 2006. The increasein cash was primarily due to proceeds from sales of equity securities in 2007,including $96.1 million raised in a follow-on public offering, partially offsetby cash used to fund ACADIA's operations.
"2007 was an outstanding year for ACADIA, highlighted by the initiation ofour Phase III program with pimavanserin for Parkinson's disease psychosis, positiveresults from our Phase II schizophrenia co-therapy trial with pimavanserin,completion of enrollment in our Phase IIb schizophrenia trial with ACP-104,and the strengthening of our balance sheet through our successful financing,"said Uli Hacksell, Ph.D., ACADIA's Chief Executive Officer. "We expect to buildon this momentum during 2008 by continuing to advance our development pipelineand executing on our strategy to develop and commercialize pimavanserin togetherwith a strategic partner."
Revenues totaled $1.6 million for the fourth quarter of 2007 compared to $1.8million for the fourth quarter of 2006, and were comprised of revenues earnedfrom ACADIA's collaborations with Allergan, Inc. and Sepracor Inc. as well asits agreements with other parties.
Research and development expenses totaled $17.3 million for the fourth quarterof 2007, including $306,000 in stock-based compensation, compared to $12.8 millionfor the fourth quarter of 2006, including $449,000 in stock-based compensation.The increase in research and development expenses was primarily due to increasedclinical trial costs in ACADIA's advanced proprietary programs, including costsassociated with its Phase IIb schizophrenia trial with ACP-104 in which patientenrollment was completed in December. The increase in expenses was primarilyattributable to $4.1 million in increased fees paid to external service providers,which totaled $10.4 million for the fourth quarter of 2007.
General and administrative expenses totaled $3.0 million for the fourth quarterof 2007, including $387,000 in stock-based compensation, compared to $2.5 millionfor the fourth quarter of 2006, including $371,000 in stock-based compensation.The increase in general and administrative expenses was primarily due to increasedpersonnel and other administrative costs.
2007 and Recent Highlights
Pimavanserin as a Treatment for Parkinson's Disease Psychosis (PDP)- ACADIA continues to enroll patients in its first pivotal Phase III trialwith pimavanserin as a treatment for PDP. This double-blind, placebo-controlledtrial was initiated in June 2007 and is designed to evaluate the safety andefficacy of pimavanserin in approximately 240 patients with PDP.
- ACADIA has completed preparations for its second pivotal Phase III trialwith pimavanserin as a treatment for PDP and expects to initiate this trialduring March.
- ACADIA is currently conducting an open-label extension study pursuant towhich eligible patients who have completed either of the pivotal Phase IIItrials will have the opportunity to enroll if, in the opinion of the physician,the patient may benefit from continued treatment with pimavanserin.
- ACADIA also is continuing to conduct an open-label extension study in connectionwith its earlier Phase II PDP trial, pursuant to which 24 patients have beentreated with pimavanserin for at least one year, 12 of whom have been treatedfor two years.
Pimavanserin as a Co-Therapy for Schizophrenia
- Herbert Y. Meltzer, M.D., presented data from ACADIA's Phase II schizophreniaco-therapy trial with pimavanserin at the 46th Annual Meeting of the AmericanCollege of Neuropsychopharmacology in December 2007. The data confirmed thetop-line results ACADIA reported in March 2007 and demonstrated several advantagesof co-therapy with pimavanserin and a sub-maximal dose of risperidone, whichinclude an enhanced efficacy, a faster onset of antipsychotic action, andan improved side effect profile, including less weight gain.
- Murray Rosenthal, D.O., presented data from ACADIA's Phase II schizophreniaco-therapy trial at the 14th Biennial Winter Workshop on Schizophrenia andBipolar Disorders in February 2008. The presentation included new data fromthis trial showing that patients in the co-therapy arm combining pimavanserinwith a sub-maximal dose of risperidone (2 mg) had significantly less increasefrom baseline in serum glucose levels after treatment compared to patientsin the risperidone (6 mg) plus placebo arm.
- ACADIA presented data at the 37th Annual Meeting of the Society for Neurosciencein November 2007 showing that pimavanserin increases the potency of a numberof the most commonly used atypical antipsychotic agents in animal models predictiveof antipsychotic efficacy and reverses the adverse effects of these agentson cognitive function.
ACP-104 as a Stand-Alone Treatment for Schizophrenia
- ACADIA completed enrollment of 248 patients in its Phase IIb clinical trialwith ACP-104 in December 2007, significantly ahead of schedule. This double-blind,placebo-controlled trial was initiated in June 2007 and is designed to evaluatethe safety and efficacy of ACP-104 in patients with schizophrenia. The treatmentphase of this clinical trial has now been completed and ACADIA remains ontrack to report top-line results from this study during the second quarterof 2008.
- ACADIA presented data at the 37th Annual Meeting of the Society for Neuroscienceshowing that ACP-104, in addition to being active in animal models predictiveof antipsychotic activity, has a superior profile in animal models of cognitivefunction when compared to clozapine and other antipsychotic agents.
Other Development Programs
- ACADIA earned a milestone in one of its collaborative programs with Allerganfollowing Allergan's initiation of an exploratory clinical study with a smallmolecule drug candidate for the treatment of glaucoma.
- ACADIA nominated ACP-106, a proprietary, selective 5-HT2A inverse agonist,as a clinical candidate. ACP-106 and other compounds from its serotonin programmay enable ACADIA to more broadly pursue a range of CNS-related therapeuticindications.
Financing
- ACADIA completed a follow-on public offering in April 2007, raising netproceeds of $96.1 million.
Business and Other
- ACADIA reported today that it has extended the term of its March 2003 discoverycollaboration with Allergan through March 2009. Joint research efforts willcontinue in the area of pain and may be expanded to include additional effortsin ophthalmology.
- ACADIA appointed John J. Kaiser as Vice President, Strategic Marketingand Commercial Development in February 2008. Mr. Kaiser joins ACADIA fromEli Lilly & Co. where he held a variety of marketing and commercial managementpositions.
- ACADIA held its inaugural Analyst and Investor Day in December 2007 featuringpresentations on its advanced clinical programs as well as other discoveryand development activities.
- ACADIA was selected to be one of the inaugural companies in the NASDAQNeuroInsights Neurotech Index, which was launched in September 2007.
Conference Call and Webcast Information
ACADIA management will review its fourth quarter results and development programsvia conference call and webcast later today at 5:00 p.m. Eastern Time. The conferencecall may be accessed by dialing 866-713-8563 for participants in the U.S. orCanada and 617-597-5311 for international callers (reference passcode 19968971).A telephone replay of the conference call may be accessed through March 19,2008 by dialing 888-286-8010 for callers in the U.S. or Canada and 617-801-6888for international callers (reference passcode 33515453). The conference callalso will be webcast live on ACADIA's website, www.acadia-pharm.com, under theinvestors section and will be archived there until March 19, 2008.
About ACADIA Pharmaceuticals
ACADIA is a biopharmaceutical company utilizing innovative technology to fueldrug discovery and clinical development of novel treatments for central nervoussystem disorders. ACADIA currently has five mid-to-late stage clinical programsas well as a portfolio of preclinical and discovery assets directed at diseaseswith large unmet medical needs, including schizophrenia, Parkinson's diseasepsychosis, sleep maintenance insomnia, and neuropathic pain. All of the drugcandidates in ACADIA's product pipeline emanate from discoveries made usingits proprietary drug discovery platform. ACADIA's corporate headquarters islocated in San Diego, California and it maintains research and development operationsin both San Diego and Malmo, Sweden.
Forward-Looking Statements
Statements in this press release that are not strictly historical in natureare forward-looking statements. These statements include but are not limitedto statements related to the progress of and benefits to be derived from ACADIA'sdrug discovery and development programs, including pimavanserin, ACP-104 andACP-106, and from its collaborative efforts with Allergan; the timing or designof future clinical trials; the timing of announcements of results from clinicaltrials; and ACADIA's strategy to establish a strategic partnership to developand commercialize pimavanserin. These statements are only predictions basedon current information 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 discovery, development and commercialization, and collaborationswith others. For a discussion of these and other factors, please refer to ACADIA'sannual report on Form 10-K for the year ended December 31, 2006 as well as othersubsequent filings with the Securities and Exchange Commission. You are cautionednot to place undue reliance on these forward-looking statements, which speakonly as of the date hereof. This caution is made under the safe harbor provisionsof the 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 to reflectevents or circumstances after the date hereof.
ACADIA PHARMACEUTICALS INC.CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS(in thousands, except per share amounts)(Unaudited)Three Months Ended Years EndedDecember 31, December 31,—————————- —————————-2007 2006 2007 2006————- ————- ————- ————-Collaborative revenues $ 1,583 $ 1,773 $ 7,555 $ 8,133Operating expensesResearch and development(includes stock-basedcompensation of $306, $449,$2,721 and $1,866,respectively) 17,278 12,788 57,942 49,398General and administrative(includes stock-basedcompensation of $387, $371,$1,574 and $1,512,respectively) 3,010 2,536 12,267 11,349Provision for loss from(settlement of) litigation ———(3,560)————- ————- ————- ————-Total operatingexpenses 20,288 15,324 70,209 57,187————- ————- ————- ————-Loss from operations (18,705) (13,551) (62,654) (49,054)Interest income (expense), net 1,667 1,100 6,264 3,955————- ————- ————- ————-Loss before change inaccounting principle (17,038) (12,451) (56,390) (45,099)Cumulative effect of change inaccounting principle ———51————- ————- ————- ————-Net loss $(17,038) $(12,451) $(56,390) $(45,048)========= ========= ========= =========Net loss per common share,basic and diluted:Before change inaccounting principle $ (0.46) $ (0.42) $ (1.60) $ (1.61)Cumulative effect ofchange in accountingprinciple ————————- ————- ————- ————-Net loss per commonshare, basic anddiluted $ (0.46) $ (0.42) $ (1.60) $ (1.61)========= ========= ========= =========Weighted average common sharesoutstanding, basic anddiluted 36,989 29,869 35,211 27,923========= ========= ========= =========
ACADIA PHARMACEUTICALS INC.CONDENSED CONSOLIDATED BALANCE SHEETS(in thousands)(Unaudited)December 31, December 31,2007 2006(1)——————————————AssetsCash, cash equivalents, and investmentsecurities $ 126,858 $ 83,255Prepaid expenses, receivables andother current assets 4,395 2,528——————————————Total current assets 131,253 85,783Property and equipment, net 3,048 3,505Other assets 283 256——————————————Total assets $ 134,584 $ 89,544============== ==============Liabilities and Stockholders' EquityCurrent liabilities $ 19,287 $ 20,534Long-term liabilities 1,363 1,851Stockholders' equity 113,934 67,159——————————————Total liabilities andstockholders' equity $ 134,584 $ 89,544============== ==============
(1) The condensed consolidated balance sheet at December 31, 2006 has beenderived from the audited financial statements at that date but does not includeall of the information and footnotes required by accounting principles generallyaccepted in the United States for complete financial statements.
CONTACT: ACADIA Pharmaceuticals Inc.
Lisa Barthelemy, Director, Investor Relations
Thomas H. Aasen, Vice President and Chief Financial
Officer
858-558-2871
SOURCE: ACADIA Pharmaceuticals Inc.