Antares Pharma, Inc. (NYSE Amex: AIS) today reported financial and operating results for the first quarter ended March 31, 2012.
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 our partner Watson, 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 our partner Teva and Pfizer, 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 our 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.
“We are very pleased with both our first quarter financial and operational results,” said Paul K. Wotton, Ph.D., President and Chief Executive Officer. “The recent announcement of the commercial availability of Gelnique 3% is further confirmation of the Company’s ability to move drug/device products through the FDA approval process and then oversee the timely completion of production quantities for distribution and launch.”
Dr. Wotton continued, “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 webcast of the call will be available from the investors/media section of the Company's web site at www.antarespharma.com. Alternatively, callers may participate in the conference call by dialing 1-877-941-8631 (US), or 1-480-629-9723 (International). Participants should reference the Antares Pharma conference call. Webcast and telephone replays of the conference call will be available approximately two hours after the completion of the call through 12 p.m. EDT on May 22, 2012. To access the replay, callers should dial 1-800-406-7325 (US) or 1-303-590-3030 (International) and enter passcode 4534582.
About Antares Pharma
Antares Pharma focuses on self-injection pharmaceutical products and topical gel-based medicines. The Company's subcutaneous and intramuscular injection technology platforms include Vibex™ disposable pressure-assisted auto injectors, disposable multi-use pen injectors and Vision™ reusable needle-free injectors marketed as Tjet® and Zomajet® by Teva Pharmaceutical Industries, Ltd (Teva) and Ferring Pharmaceuticals (Ferring), respectively. In the injector area, Antares Pharma has a multi-product deal with Teva that includes Tev-Tropin® human growth hormone (hGH) and a partnership with Ferring that includes Zomacton® hGH. In the gel-based area, the Company's FDA approved product is Gelnique 3%™ for the treatment of OAB (overactive bladder) which has been licensed to Watson Pharmaceuticals, Inc. for marketing in the U.S. and Canada. Antares’ portfolio includes Elestrin® (estradiol gel) indicated for the treatment of moderate-to-severe vasomotor symptoms associated with menopause, and marketed in the U.S. by Jazz Pharmaceuticals. Antares Pharma has two facilities in the U.S. The Parenteral Products Division located in Minneapolis, Minnesota directs the manufacturing and marketing of the Company’s reusable needle-free injection devices and related disposables, and develops its disposable pressure-assisted auto injector and pen injector systems. The Company’s corporate offices and Pharma Division are located in Ewing, New Jersey, where pharmaceutical products are developed utilizing both the Company’s transdermal systems and drug/device combination products.
Safe Harbor Statement
This press release contains forward-looking statements within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements include statements related to the Company’s future financial performance, and other statements which are other than statements of historical facts. Such forward-looking statements are not guarantees of future performance and are subject to risks and uncertainties that may cause actual results to differ materially from those anticipated by the forward-looking statements. These risks and uncertainties include, among others, changes in revenue growth, difficulties or delays in the initiation, progress, or completion of product development, clinical trials, or in the progress of Vibex MTX product development or in the success of the potential Vibex MTX NDA. Additional information concerning these and other factors that may cause actual results to differ materially from those anticipated in the forward-looking statements is contained in the "Risk Factors" section of the Company's Annual Report on Form 10-K for the year ended December 31, 2011, and in the Company's other periodic reports and filings with the Securities and Exchange Commission. The Company cautions investors not to place undue reliance on the forward-looking statements contained in this press release. All forward-looking statements are based on information currently available to the Company on the date hereof, and the Company undertakes no obligation to revise or update these forward-looking statements to reflect events or circumstances after the date of this press release, except as required by law.
|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|