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."
Fourth Quarter and Year End 2013 Financial Results
Total revenue was $4.7 million and $20.6 million for the three months and year ended December 31, 2013, respectively, compared to $5.5 million and $22.6 million for the comparable periods in 2012. Product revenue decreased in the fourth quarter to $0.9 million compared to $1.4 million in the prior year, and increased in the full year by 20% to $11.0 million compared to $9.1 million in 2012. The decrease in product revenues in the fourth quarter was primarily due to a decrease in sales of our oxybutynin gel 3% product (Gelnique 3%) to Actavis, as Actavis assumed all manufacturing of Gelnique 3% in the first quarter of 2013, as contracted. The product revenue increase for the full year was primarily due to $6.2 million of initial sales to Teva of our Vibex auto injector for Teva's generic epinephrine auto injector product.
Development revenue was $1.5 million and $4.1 million for the three months and year ended December 31, 2013, respectively, compared to $1.1 million and $7.4 million during the same periods of 2012. The decrease for the full year was due to a reduction in development revenue earned under the Actavis license agreement. The remaining development revenue in each year was generated primarily from auto injector and pen injector development work for Teva.
Licensing revenue was $0.6 million and $0.8 million for the three months and year ended December 31, 2013, respectively, compared to $1.3 million and $2.1 million during the same periods of 2012. During the fourth quarter of 2013, we received a milestone payment of $5.0 million upon execution of the LEO Pharma license which is being amortized into revenue over approximately a three year period. Revenue for the fourth quarter of 2012 was primarily related to a non-recurring payment received from a pharmaceutical partner and licensing revenue for the full year of 2012 also included an upfront fee received in connection with our licensing agreement with Daewoong Pharmaceuticals for our 3% oxybutynin gel for South Korea, along with revenue recognized in connection with our license agreement with Actavis.
Revenue from royalties was $1.7 million and $4.7 million for the three months and year ended December 31, 2013, respectively, compared to $1.7 million and $3.9 million for the comparable periods in 2012. We received royalties from Teva and Ferring related to needle-free injector device sales and/or hGH sales and from Meda Pharmaceuticals on sales of Elestrin. We also received royalty payments from Actavis on sales of Gelnique 3%, which began in the third quarter of 2012 and was the primary reason for the increase in royalties in the year-to-date period.
Total gross profit increased in the fourth quarter of 2013 to $4.1 million compared to $3.8 million in 2012, and decreased for the year to $11.4 million in 2013 compared to $13.1 million in 2012. The decrease for the full year was primarily attributable to decreases in development and licensing revenue.
Total operating expenses were approximately $10.0 million and $8.8 million for the fourth quarters of 2013 and 2012, respectively, and approximately $32.3 million and $24.5 million for the years ended December 31, 2013 and 2012, respectively. The increases in 2013 were primarily due to expenses related to sales and marketing activities in connection with preparation for the commercial launch of OTREXUP. Also contributing to the increase in operating expenses was an overall increase in personnel as the Company added employees in 2013 in preparation for the launch of OTREXUP.
Net loss was approximately $5.6 million and $5.0 million for the fourth quarters of 2013 and 2012, respectively, and $20.5 million and $11.4 million for the years ended December 31, 2013 and 2012.
Net loss per share increased for the year to $0.16 in 2013 from $0.10 in 2012, primarily due to an increase in operating expenses in connection with OTREXUP pre-commercialization activities. Net loss per share was $0.04 for the fourth quarters of both 2013 and 2012.
At December 31, 2013, cash and investments totalled approximately $69.1 million compared to approximately $85.2 million at December 31, 2012.