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Antares Pharma, Inc. (NASDAQ: ATRS) today reported operating and financial results for the fourth quarter and full year ended December 31, 2013.
Received approval of OTREXUP (methotrexate) injection by the U.S. Food and Drug Administration (FDA). OTREXUP is the first FDA approved subcutaneous methotrexate for once weekly self-administration with an easy-to-use, single dose, disposable auto injector. OTREXUP was launched to rheumatologists in January 2014.
Entered into an exclusive promotion and marketing agreement with LEO Pharma for detailing OTREXUP (methotrexate) to dermatologists for symptomatic control of severe or disabling psoriasis in adults. LEO Pharma launched OTREXUP to dermatologists in March 2014. Received from LEO Pharma $10 million in milestone payments to date.
Announced positive results from a multicenter clinical study evaluating the pharmacokinetic profile of testosterone administered once-weekly by subcutaneous injection at doses of 50 mg and 100 mg using the VIBEX QuickShot device in testosterone deficient adult males.
Presented data from three OTREXUP (methotrexate) clinical studies at the annual American College of Rheumatology meeting. The clinical study data comparing the systemic availability of methotrexate (MTX) using OTREXUP compared with MTX taken orally was selected for a prestigious podium presentation.
Granted a new U.S. patent number 8,562,564 entitled “Prefilled Syringe Jet Injector”. This patent is designed to protect the use of medicament containing prefilled syringe based auto injectors such as those used in OTREXUP and QuickShot testosterone.
Reported total revenue of $4.7 million and $20.6 million for the three months and year ended December 31, 2013. Net loss per share was $0.04 and $0.16 for the same periods.
Ended the quarter with $69.1 million in cash and investments and no debt.
Paul K. Wotton, Ph.D., President and Chief Executive Officer, stated, “The October approval and subsequent first quarter launch of OTREXUP to rheumatologists and dermatologists capped an incredibly successful year for our Company and our shareholders.” He continued, “Our long-term vision of transforming Antares Pharma from a licensing Company to a self-marketing, revenue generating specialty pharmaceutical Company is now a reality. We are pleased to report that early feedback from rheumatologists on the OTREXUP launch is positive and we understand LEO Pharma is making good progress with dermatologists on the use of OTREXUP in psoriasis patients. We believe the coming year will bring continued success on the commercial front as well as on the development front as our QuickShot testosterone product enters the next phase of studies toward an expected 2015 filing of a New Drug Application, and we will expand our pipeline to create additional long-term shareholder value.”