Antares Pharma Reports First Quarter 2009 Financial and Operating Results.Total revenue increased to $2.0 million in Q1 2009 from $1.1 million in Q1 2008 EWING, N.J. -- Antares Pharma, Inc. (NYSE NYSE See: New York Stock Exchange Amex: AIS) today reported financial and operating results for the first quarter ended March 31, 2009. For the quarter ended March 31, 2009, the Company's reported total revenue increased to $2.0 million in the first quarter of 2009 from $1.1 million in the first quarter of 2008. Product revenue increased in the first quarter to $824,000 compared to $738,000 in the prior year due primarily to increases in device and disposable revenues from Ferring Pharmaceuticals Ferring Pharmaceuticals is a pharmaceutical company that specializes on the development and marketing of peptides for the use in human medicine. It was founded by Frederik Paulsen in Malmö, Sweden in 1950 initially as the Nordiska Hormon Laboratoriet, renamed Ferring . Other revenue increased to $1.2 million from $376,000, due primarily to development work related to the Company's transdermal gel and auto injector technologies. Total operating expenses Operating expenses The amount paid for asset maintenance or the cost of doing business, excluding depreciation. Earnings are distributed after operating expenses are deducted. were approximately $3.8 million and $4.1 million for the three months ended March 31, 2009 and 2008, respectively. The decrease was primarily due to efforts to reduce general overhead expenses. Overhead expense reductions were partially offset by increases in research and development expenses, which increased to approximately $2.2 million in 2009 from $2.0 million in 2008, primarily due to the 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 study of Anturol[TM] for the treatment of overactive bladder Overactive Bladder Definition Overactive bladder is the leakage of large amounts of urine at unexpected times, including during sleep. Description . The Company reported a net loss of $2.7 million, or $0.04 per share in the first quarter of 2009 as compared to a net loss of $3.5 million, or $0.05 per share for the same period in 2008. Net cash used in operations was approximately $2.3 million in the first three months of both 2009 and 2008. At March 31, 2009, Antares held approximately $10.2 million in cash and cash equivalents, compared to approximately $13.1 million at December 31, 2008. Paul K. Wotton, Ph.D., President and Chief Executive Officer, stated, "The first quarter's revenue exceeded our expectations due to an increase in pharmaceutical and device development revenue projects and in spite of the delayed timing of the TevTropin[R] hGH needle-free SNDA SNDA Supplemental New Drug Application SNDA Student National Dental Association SNDA Subordination, Non-Disturbance and Attornment SNDA Singapore Nutrition and Dietectics Association SNDA Southern Nevada Darts Association (Las Vegas, Nevada) approval. Together with Teva, we are awaiting 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. approval of our novel VISION[R] needle-free and reusable device, with TevTropin, which will potentially offer a significantly more convenient and patient-friendly delivery method for patients, namely children. Anturol, our topical gel for the treatment of an overactive bladder, is currently in Phase III trials and we are actively seeking a marketing partner for this promising opportunity. Through our partnership with BioSante, Elestrin[TM] (estradiol gel) was re-launched in the United States United States, officially United States of America, republic (2005 est. pop. 295,734,000), 3,539,227 sq mi (9,166,598 sq km), North America. The United States is the world's third largest country in population and the fourth largest country in area. by Azur Pharma in April. "As our products are patient focused, they typically improve safety and efficacy, reduce side effects Side effects Effects of a proposed project on other parts of the firm. and enable more efficient dosing. This was recently validated when our partner, Ferring Pharmaceuticals, was recognized by Frost & Sullivan with an award for its initiatives in providing needle-free injection for hGH, based on our unique VISION drug delivery system. Our advanced drug delivery systems are also well-positioned for "lifecycle extension" options, thereby offering a distinct value to patients, physicians and our shareholders. We believe that we will be able to secure additional revenue and partnering agreements based on the potential of these underlying technology platforms," concluded Wotton. Recent Corporate Highlights * Antares received two milestone payments--one from Teva Pharmaceutical Industries Teva Pharmaceutical Industries Ltd. (Hebrew: טבע תעשיות פרמצבטיות בע"מ), NASDAQ: TEVA is an international pharmaceutical company headquartered in Ltd. related to the filing of a Device Master File for a novel disposable pen injector; and the other from BioSante Pharmaceuticals, Inc. related to an agreement with AZUR Pharma for the marketing of Elestrin (estradiol gel) to treat moderate to severe hot flashes hot flashes Hot flush Gynecology A symptom afflicting 80-85% of middle-aged ♀, first occurring during the perimenopause, continuing with ↓ intensity for yrs, manifesting itself as transient waves of erythema and uncomfortable warmth beginning in the in menopausal women in the United States. Under this agreement with BioSante, Antares will receive royalties on all sales of Elestrin in the United States. * Our marketing partner, Ferring Pharmaceuticals, was awarded the 2008 Frost and Sullivan European Human Growth Hormone human growth hormone (HGH): see growth hormone. Competitive Strategy Leadership Award in recognition of Ferring's initiatives in providing needle-free injection for human growth hormone (hGH), which uses Antares proprietary and innovative VISION device. * An additional new, long-term patent has been issued covering Elestrin and its named inventors Antares Pharma and BioSante Pharmaceuticals Inc. Conference Call, Call Replay and Webcast Paul Wotton Paul Wotton (born August 17, 1977) is currently first choice captain of Plymouth Argyle Football Club. His first season for the club was also his first as a professional, under Neil Warnock in 1994/5. , President and Chief Executive Officer, and Robert Apple, Chief Financial Officer, will provide a company update and review first quarter 2009 results via webcast and conference call on Wednesday, May 13, 2009, at 8:30 AM Eastern Daylight Time (EDT EDT abbr. Eastern Daylight Time EDT Eastern Daylight Time EDT n abbr (US) (= Eastern Daylight Time) → hora de verano de Nueva York EDT ). A webcast of the call will be available from the investors/media section of the Company's web site at www.antarespharma.com. Alternatively, callers may participate in the conference call by 1-877-941-2930 (US), or 1-480-629-9726 (International). Participants should reference the Antares Pharma conference call. Webcast and telephone replays of the conference call will be available approximately two hours after the completion of the call through 12 PM (EDT) on May 27, 2009. To access the replay, callers should dial 800.406.7325 (US) or 303.590.3030 (International) and enter passcode 4066167. About Antares Pharma Antares Pharma is a product development company committed to improving pharmaceuticals through its patented drug delivery systems. Antares has multiple development partnerships with leading pharmaceutical companies. The Company's products are designed to improve safety and efficacy profiles by minimizing dosing and reducing side effects while enabling improved patient compliance. The Company's lead product candidate, Anturol[TM], an oxybutynin ATD ATD Anthropomorphic Test Dummy ATD Attention to Detail ATD Advanced Technology Demonstration AtD Achieving the Dream ATD Atmospheric Technology Division (US National Center for Atmospheric Research) ATD Assistant Technical Director [TM] gel for the treatment of OAB OAB Ordem dos Advogados do Brasil (Brazil) OAB Offline Address Book OAB Over-Active Bladder (urology) OAB Outlook Address Book (Microsoft) OAB Ocean Affairs Board (overactive bladder), is currently under evaluation in a pivotal Phase III trial. Antares has three validated drug delivery systems: the ATD(TM) Advanced Transdermal Gel Delivery system, injection technology platforms including both Vibex(TM) disposable pressure assisted auto injectors and Vision[R] reusable needle-free injectors; and Easy Tec(TM) oral disintegrating tablets (ODT See SCO Open Desktop. ODT - Open Desktop ). Two of the systems have generated FDA approved products. Antares Pharma leverages its multiple drug delivery systems to add value to existing drugs and to create new products. Antares Pharma has corporate headquarters in Ewing, New Jersey, with subsidiaries performing research, development, manufacturing and product commercialization activities in Minneapolis, Minnesota “Minneapolis” redirects here. For other uses, see Minneapolis (disambiguation). Minneapolis (pronounced IPA: /ˌmɪniˈæpəlɪs/) is the largest city in the U.S. and Basel, Switzerland. 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. Statement This press release contains forward-looking statements within the meaning of the safe harbor 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. Such forward-looking statements include statements related to the Company's future financial performance, and other statements which are other than statements of historical facts. In some cases, you can identify forward-looking statements by terminology such as "may," "will," "should," "expects," "intends," "plans," anticipates," "believes," "estimates," "predicts," "projects," "potential," "continue," and other similar terminology or the negative of these terms, but their absence does not mean that a particular statement is not forward-looking. Such forward-looking statements are not guarantees of future performance and are subject to risks and uncertainties that may cause actual results to differ materially from those anticipated by the forward-looking statements. These risks and uncertainties include, among others: that the Company may experience difficulties or delays in the initiation, progress, or completion of its clinical trials, including the phase 3 trial of Anturol, whether caused by competition, adverse events, investigative site initiation rates, patient enrolment rates, regulatory issues, or other factors; that clinical trials may not demonstrate that Anturol is both safe and effective for the treatment of patients with overactive bladder syndrome; that the safety and/or efficacy results of the phase 3 trial of Anturol may not support an application for marketing approval in the United States or any other country; that an application for marketing approval may not be accepted for review or at all by the FDA or any other regulatory authority Noun 1. regulatory authority - a governmental agency that regulates businesses in the public interest regulatory agency administrative body, administrative unit - a unit with administrative responsibilities ; and that the Company may lack the financial resources and access to capital to fund clinical trials. Additional information concerning these and other factors that may cause actual results to differ materially from those anticipated in the forward-looking statements is contained in the "Risk Factors" section of the Company'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, 2008, and in the Company's other periodic reports and filings with the Securities and Exchange Commission. The Company cautions investors not to place undue reliance on the forward-looking statements contained in this press release. All forward-looking statements are based on information currently available to the Company on the date hereof, and the Company undertakes no obligation to revise or update these forward-looking statements to reflect events or circumstances after the date of this press release, except as required by law. 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