ACADIA Pharmaceuticals Reports Third Quarter 2006 Financial Results.SAN DIEGO San Diego (săn dēā`gō), city (1990 pop. 1,110,549), seat of San Diego co., S Calif., on San Diego Bay; inc. 1850. San Diego includes the unincorporated communities of La Jolla and Spring Valley. Coronado is across the bay. -- ACADIA Acadia (əkā`dēə), Fr. Acadie, region and former French colony, E Canada, encompassing modern Nova Scotia but also New Brunswick, Prince Edward Island, and coastal areas of E Maine. After an abortive 1604 settlement of St. Pharmaceuticals Inc. (Nasdaq:ACAD ACAD Academy ACAD Academic ACAD AutoCAD (design/drafting development software by Autodesk) ACAD Acadia National Park (US National Park Service) ACAD Atherosclerotic Coronary Artery Disease ), a biopharmaceutical company utilizing innovative technology to fuel drug discovery and clinical development of novel treatments for central nervous system disorders Nervous system disorders A satisfactory classification of diseases of the nervous system should include not only the type of reaction (congenital malformation, infection, trauma, neoplasm, vascular diseases, and degenerative, metabolic, toxic, or deficiency , today reported its unaudited financial results for the third quarter and nine months ended September 30, 2006. ACADIA reported a net loss of $11.3 million for the third quarter of 2006 compared to a net loss of $12.3 million for the third quarter of 2005. For the nine months ended September 30, 2006, ACADIA reported a net loss of $32.6 million, compared to a net loss of $23.9 million for the comparable period of 2005. At September 30, 2006, ACADIA's cash, cash equivalents, and investment securities totaled $94.7 million compared to $55.5 million at December 31, 2005. The increase in cash was primarily due to net proceeds Net Proceeds The amount received after all costs are deducted from the sale of a piece of property or security. Notes: In the case of an investor selling a security, net proceeds represent the proceeds from the sale minus any trading costs (i.e. commissions). from sales of equity securities, including $59.4 million raised in a follow-on public offering during the second quarter of 2006 and $10 million received from the sale of common stock to Sepracor Inc. in January 2006, partially offset by cash used to fund ACADIA's operations. "During the third quarter, we accelerated patient enrollment in our large Phase II adjunctive therapy adjunctive therapy Medtalk A therapeutic maneuver(s) with an ancillary role in treating a disease by ↓ M&M, but not part of the immediate therapy required to stabilize the Pt. Cf Adjuvant therapy. trial with ACP-103 in patients with schizophrenia. I am pleased to announce that we completed patient enrollment early in the fourth quarter and we remain on track to provide top-line results from this study in the first quarter of 2007," said Uli Hacksell, Ph.D., ACADIA's Chief Executive Officer. "We also continue to make important progress in our preparations for upcoming studies in our other clinical programs, including the first pivotal trial in our Phase III Noun 1. phase III - a large clinical trial of a treatment or drug that in phase I and phase II has been shown to be efficacious with tolerable side effects; after successful conclusion of these clinical trials it will receive formal approval from the FDA development program with ACP-103 for the treatment of Parkinson's disease Parkinson's disease or Parkinsonism, degenerative brain disorder first described by the English surgeon James Parkinson in 1817. When there is no known cause, the disease usually appears after age 40 and is referred to as Parkinson's disease. psychosis psychosis (sīkō`sĭs), in psychiatry, a broad category of mental disorder encompassing the most serious emotional disturbances, often rendering the individual incapable of staying in contact with reality. ." Revenues totaled $1.9 million for the third quarter of 2006 compared to $3.7 million for the third quarter of 2005. This decrease was primarily due to lower revenues under ACADIA's collaborations with Allergan, Inc. Revenues from ACADIA's agreements with Sepracor and The Stanley Medical Research Institute totaled $945,000 and $500,000, respectively, for the third quarter of 2006, and were comparable to revenues recognized under these agreements during the third quarter of 2005. Research and development expenses totaled $16.1 million for the third quarter of 2006, including $561,000 in stock-based compensation, compared to $8.4 million for the third quarter of 2005, including $337,000 in stock-based compensation. The increase in research and development expenses was primarily due to increased clinical development activity associated with ACADIA's proprietary Phase II-stage programs. External service costs increased to $9.6 million for the third quarter of 2006 compared to $2.6 million for the third quarter of 2005 primarily due to accelerated patient enrollment and related costs for ACADIA's Phase II adjunctive therapy trial with ACP-103 in patients with schizophrenia. The Company anticipates that its external service costs will decrease during the fourth quarter of 2006 relative to the third quarter due to completion of patient enrollment in this trial, which occurred early in the fourth quarter. General and administrative expenses totaled $2.4 million for the third quarter of 2006, including $410,000 in stock-based compensation, compared to $2.2 million for the third quarter of 2005, including $125,000 in stock-based compensation. Excluding stock-based compensation, the decrease in general and administrative expenses was primarily due to lower professional fees, partially offset by increased costs associated with expansion of ACADIA's administrative organization. In September 2006, ACADIA entered into an agreement to fully settle its previously disclosed civil action, which settlement resulted in a gain of $4.0 million during the third quarter of 2006. During the third quarter of 2005, the Company recorded a provision for loss from litigation An action brought in court to enforce a particular right. The act or process of bringing a lawsuit in and of itself; a judicial contest; any dispute. When a person begins a civil lawsuit, the person enters into a process called litigation. of $5.9 million related to this matter. For the third quarter of 2006, an aggregate of $971,000 of non-cash, stock-based compensation expense was recorded pursuant to Statement of Financial Accounting Standards No. 123R and was included in research and development and general and administrative expenses. Prior to January 1, 2006, ACADIA accounted for employee stock-based compensation using the intrinsic value Intrinsic Value 1. The value of a company or an asset based on an underlying perception of the value. 2. For call options, this is the difference between the underlying stock's price and the strike price. method under Accounting Principles Board The Accounting Principles Board (APB) is the former authoritative body of the American Institute of Certified Public Accountants (AICPA). It was created by the American Institute of Certified Public Accountants in 1959 and issued pronouncements on accounting principles until 1973, No. 25. Third Quarter 2006 and Recent Highlights * ACADIA announced in late-September 2006 that enrollment in its Phase II adjunctive therapy trial with ACP-103 in patients with schizophrenia was significantly ahead of schedule and that it expected to complete enrollment in this trial early in the fourth quarter. ACADIA reported today that it met this objective by completing enrollment of 423 patients in this clinical trial during October 2006 and remains on track to report top-line results from the study during the first quarter of 2007. * At the end of the third quarter, ACADIA held an end of Phase II meeting with the U.S. Food and Drug Administration (FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. ) regarding its ACP-103 program for Parkinson's disease psychosis (PDP (1) (Plasma Display Panel) See plasma display. (2) (Policy Decision Point) See COPS and XACML. (3) (Programmed Data P ). Following its interactions with the FDA, ACADIA is confirming its plans to initiate the first pivotal trial in its Phase III development program for PDP during the first half of 2007. The primary endpoint of the trial will be antipsychotic antipsychotic /an·ti·psy·chot·ic/ (-si-kot´ik) effective in the treatment of psychotic disorders; also, an agent that so acts. Antipsychotics are a chemically diverse but pharmacologically similar class of drugs; besides psychotic efficacy as measured using the Scale for the Assessment of Positive Symptoms Positive symptoms Symptoms of schizophrenia that are characterized by the production or presence of behaviors that are grossly abnormal or excessive, including hallucinations and thought-process disorder. (SAPS). ACADIA anticipates that this trial will enroll an aggregate of about 240 patients in three different study arms, which will include two doses of ACP-103 and one placebo arm. The treatment duration for each patient is expected to be six weeks. * ACADIA reported encouraging results in July 2006 from three initial clinical studies of ACP-104 in patients with schizophrenia. The results of these studies demonstrated that ACP-104 is safe and well tolerated after repeated dosing of up to 600 mg per day, and that initial signals of antipsychotic effects were observed within the tolerated dose range of ACP-104. * ACADIA announced in October 2006 that it had agreed to provide initial seed capital to help establish Abbey Pharmaceuticals, a startup biotechnology company focused on medications for substance abuse. The new company is led by Mark R. Brann, Ph.D., the founder and former President and Chief Scientific Officer of ACADIA. * ACADIA made presentations at the Society for Neuroscience For other uses, see SFN (disambiguation). The Society for Neuroscience (SfN) is a professional society for basic scientists and physicians around the world whose research is focused on the study of the brain and nervous system. Annual Meeting in October 2006 describing research completed in collaboration with Sepracor. In separate presentations, ACADIA scientists described studies aimed at further elucidating the molecular mechanisms by which novel muscarinic agonists selectively activate specific muscarinic muscarinic /mus·ca·rin·ic/ (mus?kah-rin´ik) denoting the cholinergic effects of muscarine on postganglionic parasympathetic neural impulses. receptor subtypes. Conference Call and Webcast Information ACADIA management will review its third quarter results and development programs via conference call and webcast later today at 5:00 p.m. Eastern Time. The conference call may be accessed by dialing 800-291-9234 for participants in the U.S. or Canada and 617-614-3923 for international callers (reference passcode 62345370). A telephone replay of the conference call may be accessed through November 20, 2006 by dialing 888-286-8010 for callers in the U.S. or Canada and 617-801-6888 for international callers (reference passcode 80393290). The conference call also will be webcast live on ACADIA's website, www.acadia-pharm.com, under the investors section and will be archived there until November 20, 2006. About ACADIA Pharmaceuticals ACADIA is a biopharmaceutical company utilizing innovative technology to fuel drug discovery and clinical development of novel treatments for central nervous system disorders. ACADIA currently has five Phase II-stage clinical programs as well as a portfolio of preclinical and discovery assets directed at diseases with large unmet medical needs, including schizophrenia, Parkinson's disease, sleep maintenance insomnia, and neuropathic pain. All of the drug candidates in ACADIA's product pipeline emanate em·a·nate intr. & tr.v. em·a·nat·ed, em·a·nat·ing, em·a·nates To come or send forth, as from a source: light that emanated from a lamp; a stove that emanated a steady heat. from discoveries made using its proprietary drug discovery platform. ACADIA's corporate headquarters is located in San Diego, California “San Diego” redirects here. For other uses, see San Diego (disambiguation). San Diego is a coastal Southern California city located in the southwestern corner of the continental United States. As of 2006, the city has a population of 1,256,951. and it maintains research and development operations in both San Diego and MalmE, Sweden. Forward-Looking Statements Statements in this press release that are not strictly historical in nature are forward-looking statements. These statements include but are not limited to statements related to the progress of and benefits to be derived from ACADIA's drug discovery and development programs, the timing or design of future clinical trials, the timing of announcements of results from clinical trials, future plans with Abbey Pharmaceuticals, and expenditures for future periods. These statements are only predictions based on current information and expectations and involve a number of risks and uncertainties. Actual events or results may differ materially from those projected in any of such statements due to various factors, including the risks and uncertainties inherent in drug discovery, development and commercialization, and collaborations with others. For a discussion of these and other factors, please refer to ACADIA's annual report on Form 10-K Form 10-K A report required by the SEC from exchange-listed companies that provides for annual disclosure of certain financial information. Form 10-K See 10-K. for the year ended December 31, 2005 as well as other subsequent filings with the Securities and Exchange Commission. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. This caution is made under the safe harbor Safe Harbor 1. A legal provision to reduce or eliminate liability as long as good faith is demonstrated. 2. A form of shark repellent implemented by a target company acquiring a business that is so poorly regulated that the target itself is less attractive. provisions of the Private Securities Litigation Reform Act The Private Securities Litigation Reform Act of 1995 (PSLRA) implemented several significant substantive changes affecting certain cases brought under the federal securities laws, including changes related to pleading, discovery, liability, class representation and awards fees and of 1995. All forward-looking statements are qualified in their entirety by this cautionary statement and ACADIA undertakes no obligation to revise or update this press release to reflect events or circumstances after the date hereof. [TABLE OMITTED] [TABLE OMITTED] [TABLE OMITTED] |
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