Antares Pharma, Inc. (NASDAQ:ATRS) today reported operating and financial results for the third quarter ended September 30, 2013.
Quarter and Recent Highlights
- Received approval from the U.S. Food and Drug Administration (FDA) for OTREXUP™.
- Initiated a clinical study evaluating testosterone enanthate administered weekly by subcutaneous injection and dosed the first testosterone deficient adult males using the VIBEX ® Quick Shot ™ auto injector device.
- Data from three OTREXUP ™ (methotrexate) clinical studies were presented 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.
- Issuance of 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 Quick Shot ™ testosterone. The Company expects to receive at least one additional patent in 2014 that will also protect OTREXUP ™ bringing the number of patents that specifically cover the product to seven.
- Elected Robert P Roche Jr. to the Board of Directors. Mr. Roche brings to Antares extensive commercial and product launch experience.
- Appointed Dr. Bruce Freundlich as Senior Vice President, Medical. Dr. Freundlich’s experience both in industry and academia as a practicing and highly regarded rheumatologist will be valuable as we commercialize OTREXUP ™.
- Ended the quarter with $70.0 million in cash and investments and no debt.
Paul K. Wotton, Ph.D., President and Chief Executive Officer, stated, “Last month’s approval of OTREXUP ™ represented a strategic milestone in the transformation of Antares from a royalty based business to a specialty pharmaceutical company generating potential product revenue from proprietary in-house development programs. More importantly, we believe that this approval is a validation of our auto injector technology, our deep combination drug/device pipeline and commercial strategy. The upcoming launch of OTREXUP ™ coupled with the Quick Shot ™ testosterone program demonstrates our ability to deliver on multiple projects simultaneously with our unique technology platform.” He continued, “Our commercial organization has developed a comprehensive launch plan, and we have begun to appoint top-tier sales representatives with many years of experience in promoting rheumatology products. We believe that OTREXUP ™ could become an important part of the treatment continuum for RA patients and look forward to launching the product in early 2014.”
Third Quarter and First Nine Months ResultsTotal revenues were $5.5 million and $5.7 million for the three months ended September 30, 2013 and 2012, respectively. For the nine months ended September 30, 2013, the Company’s total revenue was $15.9 million compared to $17.1 million in the first nine months of 2012. Product sales were $3.0 million in the third quarter of 2013 compared to $2.1 million in 2012, an increase of 48%. For the nine months ended September 30, 2013, product sales increased 30% to $10.1 million compared to $7.8 million in the prior year. The product sales increases were primarily due to sales to Teva of our VIBEX ® auto injector for Teva’s generic epinephrine auto injector product. Development revenues were $1.3 million in the three month period ended September 30, 2013 compared to $2.6 million in the prior year period. For the nine months ended September 30, 2013, the Company’s development revenue was $2.7 million compared to $6.3 million in the first nine months of 2012. The revenue in the first nine months of 2013 was primarily due to auto injector and pen injector development work for Teva. The revenue in the first nine months of 2012 was primarily due to a non-recurring FDA approval milestone payment of $2.5 million recognized in connection with our license agreement with Actavis (Watson), along with development revenue from Teva. The development revenue in the three and nine month periods of 2012 also included $750,000 from Pfizer after the achievement of a development milestone related to its undisclosed Consumer Healthcare product.