ACADIA Pharmaceuticals Reports Second 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 second quarter and six months ended June 30, 2006. ACADIA reported a net loss of $11.9 million for the second quarter of 2006 compared to a net loss of $6.0 million for the second quarter of 2005. For the six months ended June 30, 2006, ACADIA reported a net loss of $21.3 million, compared to a net loss of $11.6 million for the comparable period of 2005. At June 30, 2006, ACADIA's cash, cash equivalents, investment securities, and restricted cash totaled $106.7 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. "The first half of 2006 was a successful period for ACADIA, highlighted by the achievement of key milestones in our proprietary Phase II programs and the strengthening of our balance sheet through our public offering," said Uli Hacksell, Ph.D., ACADIA's Chief Executive Officer. "We look forward to continuing this momentum through the remainder of the year as we focus on further advancing our proprietary clinical pipeline directed at novel treatments for central nervous system disorders." Revenues totaled $1.9 million for the second quarter of 2006 compared to $2.5 million for the second quarter of 2005. This decrease was primarily due to lower revenues and related research activities under ACADIA's collaborations with Allergan, Inc. Revenues from ACADIA's agreements with Sepracor and The Stanley Medical Research Institute (SMRI SMRI Stanley Medical Research Institute (Chevy Chase, MD) SMRI Structural Magnetic Resonance Imaging (neuroimaging) SMRI Society of Magnetic Resonance Imaging ) totaled $945,000 and $500,000, respectively, for the second quarter of 2006, and were comparable to revenues recognized under these agreements during the second quarter of 2005. Research and development expenses totaled $12.3 million for the second quarter of 2006, including $326,000 in stock-based compensation, compared to $6.8 million for the second quarter of 2005, including $206,000 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 and expansion of its research and development organization. Fees paid to external service providers, largely related to clinical development, totaled $5.7 million for the second quarter of 2006 compared to $2.1 million for the second quarter of 2005. General and administrative expenses totaled $2.3 million for the second quarter of 2006, including $360,000 in stock-based compensation, compared to $2.2 million for the second quarter of 2005, including $189,000 in stock-based compensation. Excluding stock-based compensation, the decrease in general and administrative expenses was primarily due to lower professional fees associated with Sarbanes-Oxley compliance efforts, partially offset by increased costs associated with expansion of ACADIA's administrative organization. For the second quarter of 2006, an aggregate of $686,000 of non-cash, stock-based compensation expense was recorded pursuant to Statement of Financial Accounting Standards No. 123(R) 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. Second Quarter 2006 and Recent Highlights Clinical Pipeline --ACADIA reported positive results in April 2006 from a proof-of-concept clinical study, which demonstrated that ACP-103 induced a statistically significant and dose-related increase in deep, or slow wave, sleep in healthy older volunteers. ACP-103 treatment also had a positive impact on measures for sleep maintenance, including decreases in the number of awakenings after sleep onset and in the time awake after sleep onset. --ACADIA continues to enroll patients in its multi-center, double-blind, placebo-controlled Phase II clinical trial Noun 1. phase II clinical trial - a clinical trial on more persons than in phase I; intended to evaluate the efficacy of a treatment for the condition it is intended to treat; possible side effects are monitored phase II designed to evaluate the ability of ACP-103 when used adjunctively with other antipsychotic drugs Antipsychotic Drugs Definition Antipsychotic drugs are a class of medicines used to treat psychosis and other mental and emotional conditions. Purpose to provide an improved therapy for patients with schizophrenia schizophrenia (skĭt'səfrē`nēə), group of severe mental disorders characterized by reality distortions resulting in unusual thought patterns and behaviors. . ACADIA met its previously announced objective by completing enrollment of the first 200 patients in this planned 400-patient clinical trial by mid-2006, and remains on track to report results from an interim analysis of this trial based on the first 200 patients by the end of 2006. --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 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 effects were observed within the tolerated dose range of ACP-104. Business and Financial --ACADIA completed a public offering in May 2006, raising net proceeds of $59.4 million through the sale of an aggregate of approximately 5.3 million shares of its common stock. --ACADIA appointed Roger G. Mills, M.D., as Executive Vice President, Development. Dr. Mills was previously Vice President, Development Pfizer Global R&D, where he was responsible for the management and direction of drug development activities at the Pfizer site in La Jolla La Jolla (lə hoi`yə), on the Pacific Ocean, S Calif., an uninc. district within the confines of San Diego; founded 1869. The beautiful ocean beaches, in particular La Jolla shores and Black's Beach, and sea-washed caves attract visitors and , California. Dr. Mills has extensive experience and a proven track record of leading successful drug development efforts in multiple therapeutic areas. --ACADIA was selected for addition to the NASDAQ Biotechnology Index The NASDAQ Biotechnology Index includes securities of NASDAQ-listed companies classified according to the Industry Classification Benchmark as either Biotechnology or Pharmaceuticals which also meet other eligibility criteria. (NBI NBI Niels Bohr Institute (Denmark) NBI National Bureau of Investigation NBI Nile Basin Initiative (Uganda) NBI National Bridge Inventory NBI Nation Brands Index (statistics) ) effective May 22, 2006. Conference Call and Webcast Information Uli Hacksell, Ph.D., Chief Executive Officer, and Thomas H. Aasen, Vice President and Chief Financial Officer, will review second quarter results and highlights via conference call and webcast later today at 5:00 p.m. Eastern Time. The conference call may be accessed by dialing 866-356-4279 for participants in the U.S. or Canada and 617-597-5394 for international callers (reference passcode 64732251). A telephone replay of the conference call may be accessed through August 22, 2006 by dialing 888-286-8010 for callers in the U.S. or Canada and 617-801-6888 for international callers (reference passcode 41993620). 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 August 22, 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 preclinical /pre·clin·i·cal/ (-klin´i-k'l) before a disease becomes clinically recognizable. pre·clin·i·cal adj. 1. and discovery assets directed at diseases with large unmet un·met adj. Not satisfied or fulfilled: unmet demands. medical needs, including schizophrenia, 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. , sleep maintenance insomnia insomnia, abnormal wakefulness or inability to sleep. The condition may result from illness or physical discomfort, or it may be caused by stimulants such as coffee or drugs. However, frequently some psychological factor, such as worry or tension, is the cause. , and neuropathic neuropathic /neu·ro·path·ic/ (-path´ik) pertaining to or characterized by neuropathy. neuropathic pertaining to disease of the nervous system. 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 Malmo, Sweden. Forward-Looking Statements forward-looking statement A projected financial statement based on management expectations. A forward-looking statement involves risks with regard to the accuracy of assumptions underlying the projections. 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. 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, collaborations with others, and 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. . 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 here·of adv. Of this. hereof Adverb Formal or law of or concerning this Adv. 1. hereof - of or concerning this; "the twigs hereof are physic" . 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 The whole, in contradistinction to a moiety or part only. When land is conveyed to Husband and Wife, they do not take by moieties, but both are seised of the entirety. by this cautionary statement and ACADIA undertakes no obligation to revise or update this press release to reflect events or circumstances CIRCUMSTANCES, evidence. The particulars which accompany a fact. 2. The facts proved are either possible or impossible, ordinary and probable, or extraordinary and improbable, recent or ancient; they may have happened near us, or afar off; they are public or after the date hereof.
ACADIA PHARMACEUTICALS INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(in thousands, except per share amounts)
(Unaudited)
Three Months Ended Six Months Ended
June 30, June 30,
------------------ -------------------
2006 2005 2006 2005
--------- -------- --------- ---------
Collaborative revenues $1,881 $2,515 $4,418 $4,840
Operating expenses
Research and development
(includes stock-based
compensation of $326, $206,
$885 and $417, respectively) 12,255 6,769 22,381 13,096
General and administrative
(includes stock-based
compensation of $360, $189,
$701 and $349, respectively) 2,296 2,240 4,581 4,038
Provision for loss from
litigation 194 -- 421 --
--------- -------- --------- ---------
Total operating expenses 14,745 9,009 27,383 17,134
--------- -------- --------- ---------
Loss from operations (12,864) (6,494) (22,965) (12,294)
Interest income (expense), net 997 456 1,579 668
--------- -------- --------- ---------
Loss before change in
accounting principle (11,867) (6,038) (21,386) (11,626)
Cumulative effect of change in
accounting principle -- -- 51 --
--------- -------- --------- ---------
Net loss $(11,867) $(6,038) $(21,335) $(11,626)
========= ======== ========= =========
Net loss per common share,
basic and diluted:
Before change in
accounting principle $(0.43) $(0.26) $(0.82) $(0.56)
Cumulative effect of
change in accounting
principle -- -- -- --
--------- -------- --------- ---------
Net loss per common
share, basic and
diluted $(0.43) $(0.26) $(0.82) $(0.56)
========= ======== ========= =========
Weighted average common shares
outstanding, basic and diluted 27,792 23,274 26,050 20,589
========= ======== ========= =========
ACADIA PHARMACEUTICALS INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(in thousands)
(Unaudited)
June 30, December 31,
2006 2005(1)
----------- -----------
Assets
Cash, cash equivalents, investment
securities and restricted cash $106,655 $55,521
Prepaid expenses, receivables and other
current assets 6,006 4,604
----------- -----------
Total current assets 112,661 60,125
Property and equipment, net 2,811 2,283
Other assets 96 98
----------- -----------
Total assets $115,568 $62,506
=========== ===========
Liabilities and Stockholders' Equity
Current liabilities 25,306 21,701
Long-term liabilities 1,716 1,434
Stockholders' equity 88,546 39,371
----------- -----------
Total liabilities and stockholders'
equity $115,568 $62,506
=========== ===========
(1) The condensed consolidated balance sheet at December 31, 2005
has been derived from the audited financial statements at that
date but does not include all of the information and footnotes
required by accounting principles generally accepted in the United
States for complete financial statements.
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