Antares Pharma, Inc. (NYSE Amex: AIS) today reported financial and operating results for the third quarter ended September 30, 2010.
Quarter and Recent Highlights
- Record third quarter 2010 product revenue increased 79% to $1.7 million from $0.9 million in the same quarter in 2009.
- Announced positive results from a pivotal 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.
- 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, “The quality revenues and strong results of the third quarter demonstrate that since our product focused strategic plan was put into place eighteen months ago, we have not only stabilized the Company, but have also entered into a new growth phase. Increased product revenue and continued advancement of our pipeline programs, including the epinephrine auto injector, Vibex MTX and Anturol, provide a solid foundation for robust future growth."
Third Quarter and Nine Month Results
Total revenue was $3.1 million and $1.7 million for the three months ended September 30, 2010 and the corresponding quarter in 2009, respectively, an increase of 89%. For the nine months ended September 30, 2010, the Company’s total revenue increased to $9.5 million, or 66%, from $5.7 million in the first nine months of 2009.
Product sales increased 79% to $1.7 million in the third quarter of 2010 compared to $0.9 million in 2009. For the nine months ended September 30, 2010, product sales increased 42% to $4.1 million compared to $2.9 million in the prior year. The increases in product sales in the quarter and nine-month periods were primarily due to increased sales of our ZomaJet and TJet devices and disposables to Ferring Pharmaceuticals and Teva Pharmaceuticals.
Licensing and development revenue was $1.0 million and $0.7 million in the 2010 and 2009 third quarter periods, respectively, and was $4.2 million and $2.5 million in the nine month periods ended September 30, 2010 and 2009, respectively. The increases in the quarter and nine month periods were primarily due to auto injector development work for an epinephrine product under a license, development and supply agreement with Teva along with revenue recognized under an exclusive license agreement with Ferring. The 2010 nine-month period also included a milestone payment received from Teva triggered by achievement of a certain sales level of their hGH Tev-Tropin®.
Revenue from royalties was $0.5 million and $0.1 million in the 2010 and 2009 third quarter periods, respectively, and was $1.2 million and $0.3 million in the 2010 and 2009 nine-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 third quarter of 2010 to $2.0 million compared to $0.9 million in 2009, and increased to $6.1 million for the nine months ended September 30, 2010 compared to $3.2 million for the nine-month period of 2009. The increases in the quarter and nine-month periods were mainly the result of increases in product sales, royalties received from Teva related to sales of their hGH Tev-Tropin® and revenue recognized under an exclusive license agreement with Ferring.
Total operating expenses were approximately $3.7 million and $3.4 million for the three months ended September 30, 2010 and 2009, respectively, and were $10.9 million and $10.4 million for the nine months ended September 30, 2010 and 2009, respectively. The increases in operating expenses were primarily a result of increases in spending for product development projects such as Vibex MTX™. 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 third quarter to $0.02 in 2010 from $0.04 in 2009, and decreased for the nine month period to $0.06 in 2010 from $0.11 in 2009, primarily due to an increase in revenue and gross profit, along with an increase in weighted average common shares outstanding.
At September 30, 2010, Antares had approximately $10.2 million in cash, compared to approximately $13.6 million at December 31, 2009.
“Continued revenue growth and ongoing cost containment limited our cash burn and maintained our balance sheet strength. With reduced R&D expenditures following completion of the Anturol studies along with strong product sales and increasing royalties, we expect our current cash to carry us into 2012,” said Robert Apple, EVP, CFO 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 third quarter 2010 results via webcast and conference call on Wednesday, November 10, 2010, at 4:30 p.m. Eastern Standard Time (EST). 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 1-877-941-2927 (US), or 1-480-629-9724 (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. EST on November 24, 2010. To access the replay, callers should dial 1-800-406-7325 (US) or 1-303-590-3030 (International) and enter passcode 4379936.
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 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 that has completed Phase 3 studies 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 cash position. 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, difficulties or delays in the progress or completion of Anturol’s product development or in the preparation of the NDA and whether or not the Company’s application for marketing approval is accepted for review or at all by the FDA or any other regulatory authority. 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)|
|September 30,||December 31,|
|Cash and investments||$||10,227||$||13,559|
|Liabilities and Stockholders’ Equity|
|Accounts payable and accrued expenses||$||2,827||$||2,931|
|Total Liabilities and Stockholders’ Equity||$||14,667||$||19,143|
|ANTARES PHARMA, INC.|
|CONSOLIDATED CONDENSED STATEMENTS OF OPERATIONS|
|(amounts in thousands except share amounts)|
|For the Three Months||For the Nine Months Ended|
|Ended September 30,||September 30,|
|Licensing and development revenue||985||655||4,167||2,528|
|Cost of revenue||1,079||757||3,390||2,544|
|Research and development||2,333||2,005||6,661||5,957|
|Sales, marketing and business development||205||174||777||726|
|General and administrative||1,170||1,262||3,510||3,716|
|Total Operating Expenses||3,708||3,441||10,948||10,399|
|Other income (expenses), net||34||(281||)||8||(670||)|
|Basic and diluted net loss per common share||$||(0.02||)||$||(0.04||)||$||(0.06||)||$||(0.11||)|
|Basic and diluted weighted average common shares outstanding|