SAN DIEGO, Nov 10, 2005 /PRNewswire-FirstCall via COMTEX News Network/ —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 third quarter and nine months ended September 30, 2005.
ACADIA reported a net loss of $12.3 million for the third quarter of 2005,compared to a net loss of $6.2 million for the third quarter of 2004. The netloss for the third quarter of 2005 included a provision of $5.9 million forloss from litigation related to a previously disclosed civil action. For thenine months ended September 30, 2005, ACADIA reported a net loss of$23.9 million, compared to a net loss of $18.6 million for the comparableperiod of 2004.
At September 30, 2005, ACADIA's cash, cash equivalents, and investmentsecurities totaled $62.7 million, compared to $35.9 million atDecember 31, 2004. The increase in cash was primarily due to net proceedsfrom sales of equity securities, including $34.0 million raised in a privateplacement in April 2005 and $10.0 million received from Sepracor's purchase ofcommon stock in January 2005 in connection with a collaboration agreement,partially offset by cash used to fund ACADIA's operations.
"During the third quarter of 2005, we made important advances in each ofour three proprietary Phase II clinical programs and earned a milestone in ourcollaborative neuropathic pain program following Allergan's start of aninitial exploratory Phase II clinical study," said Uli Hacksell, Ph.D.,ACADIA's Chief Executive Officer. "We intend to build on this momentum as weadvance our pipeline of innovative drugs to treat central nervous systemdisorders and other areas of unmet medical need."
Revenues increased to $3.7 million for the third quarter of 2005, comparedto $1.6 million for the third quarter of 2004. This increase was primarilydue to $985,000 in revenues recognized under ACADIA's collaboration withSepracor, which commenced in January 2005, increased revenues from ACADIA'scollaborations with Allergan, and $500,000 in revenues earned pursuant toACADIA's development agreement with the Stanley Medical Research Institute.Revenues from ACADIA's collaborations with Allergan increased to $2.1 millionfor the third quarter of 2005 from $1.5 million for the comparable period of2004.
Research and development expenses increased to $8.1 million for the thirdquarter of 2005 from $5.9 million for the third quarter of 2004. Thisincrease largely reflected increased clinical development costs associatedwith ACADIA's proprietary Phase II clinical programs and increased personneland other costs associated with expansion of ACADIA's research and developmentorganization.
General and administrative expenses increased to $2.1 million for thethird quarter of 2005 from $1.3 million for the comparable quarter of 2004.This increase was primarily due to increased professional fees, includingincreased costs associated with operating as a public company and costsrelated to litigation, as well as increased personnel costs.
Although ACADIA strongly disagrees with and has appealed the previouslydisclosed civil verdict, ACADIA recorded a provision for loss from litigationof $5.9 million during the third quarter of 2005. This provision representedthe total amount of damages and related fees and costs awarded pursuant to thejury verdict, net of $2.5 million in remaining proceeds, which may be receivedunder ACADIA's employment practices liability insurance policy.
ACADIA anticipates that its cash and investment securities will totalapproximately $52 million to $55 million at December 31, 2005 and that itscurrent cash resources, plus anticipated payments from existing agreementswith its collaborators, will be sufficient to fund ACADIA's estimated cashrequirements through at least mid-2007.
Third Quarter 2005 and Recent Highlights
* ACADIA continued to advance its Phase II program with ACP-103 as anadjunctive therapy for schizophrenia:
—ACADIA expects to report results during the fourth quarter of 2005from a double-blind, placebo-controlled Phase II study designed toevaluate the ability of ACP-103 to treat side effects associated withtreatment with haloperidol in patients with schizophrenia;
—ACADIA began enrolling patients in a multi-center, double-blind,placebo-controlled Phase II trial designed to evaluate the ability ofACP-103 when used adjunctively with other antipsychotic drugs toprovide an improved therapy for schizophrenia patients. This trialis designed to enroll up to 400 patients with schizophrenia and toinclude a formal interim analysis after 200 patients have completedthe 42-day treatment schedule. ACADIA expects to report results fromthe interim analysis in 2006.
* ACADIA has completed enrollment in its multi-center, double-blind,placebo-controlled Phase II clinical trial designed to evaluate theefficacy and tolerability of ACP-103 in Parkinson's disease patientssuffering from treatment-induced psychosis. ACADIA expects to reportcomplete results from the trial during the first quarter of 2006.
* ACADIA announced today in a separate news release, initial results froman ongoing single-dose clinical trial of ACP-104 in patients withschizophrenia.
* ACADIA published research in the Journal of Pharmacology andExperimental Therapeutics showing that ACP-104, the major metabolite ofclozapine, is a partial agonist at dopamine D2 and D3 receptors, whereasclozapine and most other antipsychotics block these receptors. ACADIAbelieves that these partial agonist properties of ACP-104 may lead toless motoric side effects than seen with most other antipsychotic drugs.
* ACADIA earned a milestone resulting from Allergan's start of an initialsingle-dose exploratory Phase II clinical trial in the companies'collaborative program directed at novel treatments for neuropathic pain.* ACADIA elected Michael T. Borer to its board of directors. Mr. Borer
served as Chief Executive Officer and President of Xcel Pharmaceuticals,Inc. until the sale of that company to Valeant PharmaceuticalsInternational in early 2005.
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 andthe status of ACADIA's development programs via conference call and webcastlater today at 5:00 p.m. Eastern Time. The conference call may be accessed bydialing 800-573-4754 for participants in the U.S. or Canada and 617-224-4325for international callers (reference participant passcode 26957802). Atelephone replay of the conference call may be accessed throughNovember 24, 2005 by dialing 888-286-8010 for callers in the U.S. or Canadaand 617-801-6888 for international callers (reference passcode 48989379).The conference call also will be webcast live on ACADIA's website,www.acadia-pharm.com, under the investors section and will be archived thereuntil November 24, 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. 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 developmentoperations in both San Diego and Malmo, Sweden.
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 drug discoveryand development programs and related trials, the safety, efficacy andpotential benefits of our drug candidates, the potential of our collaborationsand any payments we may receive thereunder, and our future results. Thesestatements are only predictions based on current information and expectationsand involve a number of risks and uncertainties. Actual events or results maydiffer materially from those projected in any of such statements due tovarious factors, including the risks and uncertainties inherent in drugdiscovery, development and commercialization, collaborations with others andlitigation. For a discussion of these and other factors, please refer toACADIA's annual report on Form 10-K for the year ended December 31, 2004 filedwith the United States Securities and Exchange Commission as well as othersubsequent filings with the Securities and Exchange Commission. You arecautioned not to place undue reliance on these forward-looking statements,which speak only as of the date hereof. This caution is made under the safeharbor provisions 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 or updatethis press release to reflect events or circumstances after the date hereof.
Contacts:
ACADIA Pharmaceuticals Inc.
Lisa Barthelemy, Director, Investor Relations
Thomas H. Aasen, Vice President and Chief Financial Officer
(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 30,2005 2004 2005 2004Collaborative revenues $3,674 $1,581 $8,513 $3,521Operating expensesResearch and development 8,065 5,923 20,743 17,079General and administrative 2,098 1,311 5,787 3,103Provision for loss fromlitigation 5,861 —5,861 —Stock-based compensation 462 670 1,228 1,979Total operating expenses 16,486 7,904 33,619 22,161Loss from operations (12,812) (6,323) (25,106) (18,640)Interest income (expense) 506 108 1,174 58Net loss (12,306) (6,215) (23,932) (18,582)Participation of preferredstock ———(8,587)Net loss available to commonstockholders (12,306) (6,215) (23,932) (9,995)Net loss per common share,basic and diluted $(0.53) $(0.37) $(1.11) $(1.22)Weighted average common sharesoutstanding, basic and diluted 23,343 16,629 21,507 8,225Net loss available toparticipating preferredstockholders $—$—$—$(8,587)Net loss per participatingpreferred share, basicand diluted $—$—$—$(0.87)Weighted average participatingpreferred shares outstanding,basic and diluted ———9,901ACADIA's preferred stock was reclassified or converted into 9,900,913shares of common stock upon the closing of its initial public offering onJune 2, 2004.ACADIA PHARMACEUTICALS INC.CONDENSED CONSOLIDATED BALANCE SHEETS(in thousands)(Unaudited)September 30, December 31,2005 2004 (1)AssetsCash, cash equivalents and investmentsecurities, available-for-sale $62,731 $35,927Prepaid expenses, receivables and othercurrent assets(2) 5,269 1,891Total current assets 68,000 37,818Property and equipment, net 2,249 2,547Other assets 22 —Total assets $70,271 $40,365Liabilities and Stockholders' EquityCurrent liabilities(3) $19,689 $8,641Long-term liabilities 1,385 1,044Stockholders' equity 49,197 30,680Total liabilities and stockholders'equity $70,271 $40,365(1) The condensed consolidated balance sheet at December 31, 2004 has beenderived from the audited financial statements at that date but doesnot include all of the information and footnotes required byaccounting principles generally accepted in the United States forcomplete financial statements.(2) Prepaid expenses, receivables and other current assets atSeptember 30, 2005 includes a receivable of $2.5 million for insuranceproceeds related to litigation.(3) Current liabilities at September 30, 2005 includes accrued loss fromlitigation of $8.4 million.