Antares Pharma, Inc. (NYSE Amex: AIS) today reported financial and operating results for the first quarter ended March 31, 2011.
Quarter and Recent Highlights
- Total revenue and product revenue increased to $3.6 million and $1.4 million, respectively, in the first quarter of 2011 compared to $3.4 million and $1.3 million, respectively, in the first quarter of 2010.
- Revenue from royalties increased 87% to $0.7 million in the first quarter of 2011 from $0.4 million in the first quarter of 2010.
- Announced the acceptance for filing for review by the U.S. Food and Drug Administration (FDA) of the New Drug Application (NDA) for Anturol® Gel in patients with overactive bladder (OAB).
- Assigned a Prescription Drug User Fee Act (PDUFA) date of December 8, 2011 for Anturol®, which is the target date for the FDA to complete its review of the NDA.
- Initiated a clinical study of our Vibex™ MTX product, being developed for the treatment of rheumatoid arthritis.
- Ended the quarter with $13.1 million in cash.
Paul K. Wotton, Ph.D., President and Chief Executive Officer, stated, "In addition to a solid operational performance, the first quarter brought a number of important events including the FDA acceptance and granting of a filing fee waiver for our NDA filing for Anturol for OAB. We are pleased with our product sales and royalties from the success that Teva is having with TevTropin, and remain encouraged by the progress of the epinephrine auto injector product with Teva. We are also excited by the continued development of the novel Vibex MTX product. We have enrolled patients rapidly in our first clinical study with the Vibex MTX for rheumatoid arthritis, which we believe represents an important future product opportunity for Antares that can be positioned in the highly focused market segment of rheumatology."
First Quarter Financial Results
Total revenues were $3.6 million and $3.4 million for the three months ended March 31, 2011 and 2010, respectively. Product sales increased in the first quarter of 2011 to $1.4 million compared to $1.3 million in the prior year.
Licensing and development revenue in the first quarter of 2011 was $1.4 million compared to $1.6 million in the prior year. The revenue in the first quarter of 2011 was primarily a result of auto injector and pen injector development work for Teva and includes approximately $0.6 million of revenue, previously deferred, that was recognized as a result of an amendment to an agreement with Teva. The licensing and development revenue in the first quarter of 2010 was primarily due to auto injector development work for Teva, licensing revenue recognized under a license agreement with Ferring, and milestone payments received in connection with a license agreement with BioSante.
Revenue from royalties was $0.7 million and $0.4 million for the three months ended March 31, 2011 and 2010, respectively. The increase in royalties was primarily due to royalties received from Teva on sales of their hGH Tev-Tropin®.
Total gross profit increased in the first quarter of 2011 to $2.1 million compared to $2.0 million in 2010. The increase in the quarter was primarily due to the increase in royalties.
Total operating expenses were approximately $3.5 million and $3.6 million for the first quarters of 2011 and 2010, respectively. The decrease was primarily due to a decrease in research and development expenses following completion of the Phase III study of Anturol® for the treatment of OAB and the filing of our NDA in the fourth quarter of 2010.
Net loss was approximately $1.4 million and $1.6 million for the first quarters of 2011 and 2010, respectively, and net loss per share was $0.02 in both the first quarters of 2011 and 2010.
At March 31, 2011, Antares had approximately $13.1 million in cash and cash equivalents, compared to approximately $9.8 million at December 31, 2010. In the first quarter of 2011, approximately 3.4 million warrants and options were exercised resulting in proceeds of approximately $5.1 million.