Antares Pharma (AIS) today reported financial and operating results for the first quarter ended March 31, 2012. Additionally, Antares has revealed that its new VIBEX QS1 injector will be for the treatment of Male Testosterone deficiency. This revelation has come 6 months sooner than expected as patent protection has been granted earlier than expected.
Quarter and Recent Highlights
- Increased total revenue 92% and product revenue 78% to $6.9 million and $2.5 million, respectively, in the first quarter of 2012 compared to $3.6 million and $1.4 million, respectively, in the first quarter of 2011.
- Ended the quarter with $33.2 million in cash and investments and no debt.
- Announced, along with partner Watson Pharma (WPI), the launch of Gelnique 3%™ for the treatment of overactive bladder (OAB). Watson will detail Gelnique 3% to physicians with their well-established commercial team focused on urology.
- Entered into a licensing agreement with Daewoong Pharmaceuticals Co. Ltd. for South Korean marketing rights for our topical oxybutynin gel 3% product receiving an upfront payment and potential regulatory and sales-based milestones as well as royalties on net sales of the product.
- Announced the settlement of the epinephrine auto-injector litigation between partners Teva (NASDAQ:TEVA) and Pfizer (NYSE:PFE), and executed a separate agreement under which Teva has agreed to provide us with device orders in 2013 and 2014 as well as a milestone payment upon FDA approval of the product.
- Continued to advance the Vibex™ MTX development program for the treatment of rheumatoid arthritis, and remain on track to file a New Drug Application (NDA) with the FDA in the first quarter of 2013.
Dr. Wotton, Antares CEO remarked,
On the product development front, we successfully initiated Vibex MTX studies during the first quarter under a previously agreed upon development strategy with the FDA. We remain on track for completion of these studies and anticipate a first quarter 2013 NDA filing. As these studies progress, we will continue to explore global partnership opportunities in order to enhance the commercial value of this proprietary product.
First Quarter Financial Results
Total revenues were $6.9 million and $3.6 million for the three months ended March 31, 2012 and 2011, respectively. Product sales increased in the first quarter of 2012 to $2.5 million compared to $1.4 million in the prior year, primarily due to sales of our oxybutynin gel 3% product to Watson in preparation for Watson's launch of Gelnique 3% in April 2012.
Development revenues were $3.0 million and $1.1 million for the three months ended March 31, 2012 and 2011, respectively. The development revenue in the first quarter of 2012 was primarily due to revenue recognized in connection with our license agreement with Watson, while the development revenue in the first quarter of 2011 was primarily due to auto injector and pen injector development work for Teva.
Licensing revenue was $0.6 million and $0.4 million for the three months ended March 31, 2012 and 2011, respectively. Licensing revenue in the first quarter of 2012 was primarily due to an upfront fee received in connection with our licensing agreement with Daewoong. Licensing revenue in the first quarter of 2011 was primarily related to Teva agreements.
Revenue from royalties was $0.8 million and $0.7 million for the three months ended March 31, 2012 and 2011, respectively. Royalties were primarily due to royalties received from Teva on sales of their hGH Tev-Tropin®.
Total gross profit increased in the first quarter of 2012 to $4.9 million compared to $2.1 million in 2011. The increase in the quarter was primarily due to a milestone payment from Watson received and deferred in December 2011 that was recognized as development revenue in the first quarter of 2012.
Total operating expenses were approximately $5.0 million and $3.5 million for the first quarters of 2012 and 2011, respectively. The increase was primarily due to an increase in research and development expenses associated with our Vibex™ MTX development program.
Net loss was approximately $0.1 million and $1.4 million for the first quarters of 2012 and 2011, respectively, and net loss per share was $0.00 and $0.02 in the first quarters of 2012 and 2011, respectively.
At March 31, 2012, Antares had approximately $33.2 million in cash and investments, compared to approximately $34.4 million at December 31, 2011.
Conference Call, Call Replay and Webcast
Dr. Paul K. Wotton, President and Chief Executive Officer, and Robert F. Apple, Executive Vice President, Chief Financial Officer, and President of the Parenteral Products Division will provide a company update and review first quarter 2012 results via webcast and conference call on Tuesday, May 8, 2012, at 8:30 a.m. Eastern Daylight Time (EDT). A replay of this conference call can now be heard here.
|ANTARES PHARMA, INC.|
|CONSOLIDATED CONDENSED BALANCE SHEETS|
|(amounts in thousands)|
|March 31,||December 31,|
|Cash and investments||$||33,200||$||34,396|
|Liabilities and Stockholders' Equity|
|Accounts payable and accrued expenses||$||4,664||$||4,364|
|Total Liabilities and Stockholders' Equity||$||40,727||$||41,963|
|ANTARES PHARMA, INC.|
|CONSOLIDATED CONDENSED STATEMENTS OF OPERATIONS|
|(amounts in thousands except share amounts)|
|For the Three Months Ended|
|Cost of revenue||1,991||1,453|
|Research and development||2,877||1,749|
|Sales, marketing and business development||436||289|
|General and administrative||1,658||1,490|
|Total Operating Expenses||4,971||3,528|
|Other income and expenses||23||31|
|Basic and diluted net loss per common share||$||(0.00||)||$||(0.02||)|
|Basic and diluted weighted average common shares outstanding||103,659||85,720|
Disclosure: I am long AIS.