Antares Pharma, Inc. (NYSE Amex: AIS) today reported financial and operating results for the second quarter ended June 30, 2010.
Quarter and Recent Highlights
- Second quarter 2010 total revenue increased 78% to $3.1 million from $1.7 million in the same quarter in 2009. For the six months ended June 30, 2010, the Company’s total revenue increased 57% to $6.4 million from $4.1 million in the first six months of 2009.
- Announced positive results from its Phase 3 study of Anturol® Gel in patients with overactive bladder (OAB). The study met its primary endpoint of a statistically significant reduction in urinary incontinence episodes for both doses studied.
- Received a milestone payment from Ferring International Center S.A. related to achieving a development-based milestone under a license and asset purchase agreement regarding certain intellectual property relating to transdermal gel delivery technology.
- Continued to progress other key device development programs including the epinephrine auto injector and Vibex MTX™ (methotrexate).
Paul K. Wotton, Ph.D., President and Chief Executive Officer, stated, “We are pleased with our strong accomplishments in 2010, highlighted by the recent positive results announced for Anturol® in its Phase 3 study for the treatment of overactive bladder. Based on increasing sales of Tev-Tropin®, which utilizes our Tjet® injector system, continuing efforts with Teva regarding the commercial development of additional products, and our anticipated filing of a New Drug Application for Anturol® with the U.S. Food and Administration by the end of 2010, we expect our strong momentum to continue through the remainder of the year and well beyond."
Second Quarter and First Half Results
Total revenue was $3.1 million and $1.7 million for the three months ended June 30, 2010 and the corresponding quarter in 2009, respectively, an increase of 78%. For the six months ended June 30, 2010, the Company’s total revenue increased to $6.4 million, or 57%, from $4.1 million in the first six months of 2009. Product sales were $1.2 million in the second quarter of 2010 compared to $1.2 million in 2009. For the six months ended June 30, 2010, product sales increased 24% to $2.5 million compared to $2.0 million in the prior year. The increase in product sales in the first half was primarily due to increased sales to Ferring. Product sales to Teva in the first half of 2010 nearly matched product sales in the first half of 2009 which included initial stocking quantities in anticipation of the launch of the Tjet® needle-free injector system with their brand of hGH Tev-Tropin®. Licensing and development revenue was $1.5 million and $0.4 million in the 2010 and 2009 second quarter periods, respectively, and was $3.2 million and $1.9 million in the six month periods ended June 30, 2010 and 2009, respectively. The increases in the quarter and six month periods were primarily due to auto injector development work for an epinephrine product under a License, Development and Supply agreement with Teva, a milestone payment received from Teva triggered by achievement of a certain sales level of their hGH Tev-Tropin® and revenue recognized under an Exclusive License Agreement with Ferring. Revenue from royalties was $0.4 million and $0.1 million in the 2010 and 2009 second quarter periods, respectively, and was $0.8 million and $0.2 million in the 2010 and 2009 six month periods, respectively. The increases were due to royalties received from Teva in connection with sales of their hGH Tev-Tropin®.
Total gross profit increased in the second quarter of 2010 to $2.1 million compared to $1.0 million in 2009, and increased to $4.1 million for the first half of 2010 compared to $2.3 million for the first half of 2009. The increases in the quarter and first half periods were mainly due to a milestone payment and royalties received from Teva related to sales of their hGH Tev-Tropin® and revenue recognized under an Exclusive License Agreement with Ferring. The increase in the first half was also due to an increase in product sales.
Total operating expenses were approximately $3.6 million and $3.1 million for the three months ended June 30, 2010 and 2009, respectively, and were $7.2 million and $7.0 million for the six months ended June 30, 2010 and 2009, respectively. The increases in operating expenses were primarily a result of increases in spending for product development projects. These increases were partially offset by cost savings from the sale of a substantial portion of the operations in Switzerland to Ferring International Center S.A. at the end of 2009.
Net loss per share decreased for the second quarter to $0.02 in 2010 from $0.03 in 2009, and decreased for the six month period to $0.04 in 2010 from $0.07 in 2009, primarily due to an increase in revenue and gross profit resulting in a reduced net loss, along with an increase in weighted average common shares outstanding.
At June 30, 2010, Antares had approximately $11.4 million in cash, compared to approximately $13.6 million at December 31, 2009. The net decrease in cash and cash equivalents was approximately $2.1 million in the first half of 2010, compared to a net decrease of $6.1 million in the first half of 2009. Cash decreased by only $0.1 million in the second quarter of 2010 from the first quarter of 2010 due to receipt of milestone payments and exercises of stock options and warrants.
“Our balance sheet remains strong, as we continued to invest substantially in our core programs, while simultaneously increasing our revenues and reducing cash burn. At this time, we expect that our cash position is sufficient to last for more than 12 months without taking into effect any potential business development deal around any of our technologies or development programs, including Anturol®,” said Robert Apple, EVP, Chief Financial Officer and President of the Parenteral Products Division.
Conference Call, Call Replay and Webcast
Dr. Paul K. Wotton, President and Chief Executive Officer, and Robert F. Apple, Executive Vice President and Chief Financial Officer, will provide a company update and review first quarter 2010 results via webcast and conference call on Thursday, August 12, 2010, at 4:30 p.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 1-800-762-8779 (US), or 1-480-629-9771 (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 August 26, 2010. To access the replay, callers should dial 1-800-406-7325 (US) or 1-303-590-3030 (International) and enter passcode 4333008.
About Antares Pharma
Antares Pharma focuses on self-injection delivery technologies and topical gel-based pharmaceutical products. The Company's subcutaneous and intramuscular injection technology platforms include VIBEXTM disposable pressure-assisted auto injectors, ValeoTM/VisionTM reusable needle-free injectors, and disposable multi-use pen injectors. In the injector area, Antares Pharma has a multi-product deal with Teva Pharmaceutical Industries, Ltd that includes Tev-Tropin® human growth hormone and a partnership with Ferring Pharmaceuticals. In the gel-based area, the Company's lead product candidate is Anturol® an oxybutynin ATDTM gel for the treatment of OAB (overactive bladder). Antares also has a partnership with BioSante that includes LibiGel® (transdermal testosterone gel) in Phase 3 clinical development for the treatment of female sexual dysfunction (FSD), and Elestrin® (estradiol gel) indicated for the treatment of moderate-to-severe vasomotor symptoms associated with menopause, and currently marketed in the U.S. Antares Pharma has corporate headquarters in Ewing, New Jersey, with subsidiaries performing research, development and product commercialization activities in Minneapolis, Minnesota and Muttenz, Switzerland.
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. In some cases, you can identify forward-looking statements by terminology such as "may," "will," "should," "expects," "intends," "plans," "anticipates," "believes," "estimates," "predicts," "projects," "potential," "continue," and other similar terminology or the negative of these terms, but their absence does not mean that a particular statement is not forward-looking. 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, statements about future product revenue growth, difficulties or delays in the initiation, progress, or completion of its product development, clinical trials, difficulties or delays in the progress or completion of Anturol’s product development or in the preparation of the NDA, whether caused by competition, adverse events, investigative site initiation rates, patient enrollment rates, regulatory issues, or other factors; that an application for marketing approval may not be accepted for review or at all by the FDA or any other regulatory authority; and that the Company may lack the financial resources and access to capital to continue to fund the development of Anturol®. 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, 2009, 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)
|June 30,||December 31,|
|Cash and investments||$||11,443||$||13,559|
|Liabilities and Stockholders’ Equity|
|Accounts payable and accrued expenses||$||2,159||$||2,931|
|Total Liabilities and Stockholders’ Equity|
|ANTARES PHARMA, INC.|
|CONSOLIDATED CONDENSED STATEMENTS OF OPERATIONS|
|(amounts in thousands except share amounts)|
|For the Three Months Ended||For the Six Months Ended|
|June 30,||June 30,|
|Licensing and development revenue||1,541||430||3,182||1,874|
|Cost of revenue||996||700||2,311||1,788|
|Research and development||2,243||1,745||4,329||3,952|
|Sales, marketing and business development||241||217||572||552|
|General and administrative||1,122||1,141||2,339||2,453|
|Total Operating Expenses||3,606||3,103||7,240||6,957|
|Other expenses, net||(1||)||(191||)||(25||)||(389||)|
|Basic and diluted net loss per common share||$||(0.02||)||$||(0.03||)||$||(0.04||)||$||(0.07||)|
|Basic and diluted weighted average common shares outstanding|