Antares Pharma, Inc. (NYSE Amex: AIS) today reported financial and operating results for the first quarter ended March 31, 2010.
Quarter and Recent Highlights
- Reported record quarterly product revenue and total revenue.
- Announced receipt of a $0.5 million sales-based milestone from Teva Pharmaceutical Industries, Ltd. related to achieving an undisclosed sales volume of Tev-Tropin® [somatropin (rDNA) for injection].
- Epinephrine has been identified as the second major product in development with Teva. Epinephrine is indicated in the emergency treatment of allergic reactions (anaphylaxis) to insect stings or bites, foods, drugs and other allergens as well as idiopathic or exercise-induced anaphylaxis.
- Completed enrollment in the double-blind portion of the Company's Phase 3 clinical trial of Anturol®, its transdermal oxybutynin ATD™ gel for the treatment of overactive bladder (OAB). Top line data from this pivotal trial continues to be expected in the third quarter of this year.
- Announced the formation of a strategic alliance with Uman Pharma to develop Vibex MTX™ (methotrexate) for use in the Company’s proprietary Vibex™ injection device for rheumatoid arthritis and related autoimmune conditions.
Paul K. Wotton, Ph.D., President and Chief Executive Officer, stated, “We are pleased with the strong results for the first quarter and expect our momentum to continue throughout 2010 as we execute against our strategic plan. Since launch, sales of our Tjet® needle-free injector system used with Tev-Tropin® have exceeded our expectations. Efforts with Teva regarding the commercial development of additional products continue to progress. We also look forward to announcing results for our ongoing study of Anturol in the third quarter of 2010."
First Quarter Results
Total revenue was $3.4 million and $2.4 million for the three months ended March 31, 2010 and the corresponding quarter in 2009, respectively, an increase of 42.2%. Product sales increased in the first quarter of 2010 to $1.3 million compared to $0.8 million in the prior year, an increase of 61.0%. The product sales increase in the quarter was due primarily to sales to Teva following the August 2009 launch of our Tjet® needle-free device with their hGH Tev-Tropin® and an increase in sales to Ferring. Other revenue, which includes licensing revenue, development revenue and royalties, was $2.0 million and $1.5 million in the 2010 and 2009 first quarter periods, respectively. The increase in the quarter was primarily due to auto-injector development work for epinephrine mentioned previously under a License, Development and Supply agreement with Teva and due to royalties received from Teva in connection with sales of their hGH Tev-Tropin®.
Total cost of revenue increased in the first quarter of 2010 to $1.3 million compared to $1.1 million in 2009. The increase was primarily due to higher product sales in 2010 compared to 2009.
Total operating expenses were approximately $3.6 million and $3.9 million for the three months ended March 31, 2010 and 2009, respectively. The decrease in operating expenses was primarily due to 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 first quarter to $0.02 in 2010 from $0.04 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 March 31, 2010, Antares had approximately $11.5 million in cash, compared to approximately $13.6 million at December 31, 2009. The net decrease in cash and cash equivalents was $2.0 million in the first quarter of 2010, compared to a net decrease of $2.9 million in the first quarter of 2009.
“We continued to invest substantially in our core programs, while simultaneously increasing our revenues and reducing cash burn,” said Robert Apple, Executive Vice President and Chief Financial Officer, “This has allowed us to maintain a strong balance sheet and continue to position Antares for significant long term growth.”
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, May 13, 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 1-877-941-0843 (US), or 1-480-629-9644 (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 27, 2010. To access the replay, callers should dial 1-800-406-7325 (US) or 1-303-590-3030 (International) and enter passcode #4293944.
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, Anturol® an oxybutynin ATDTM gel for the treatment of OAB (overactive bladder), is currently under evaluation in a pivotal Phase 3 trial. 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, including the phase 3 trial of Anturol, whether caused by competition, adverse events, investigative site initiation rates, patient enrollment rates, regulatory issues, or other factors; that clinical trials may not demonstrate that Anturol is both safe and effective for the treatment of patients with overactive bladder syndrome; that the safety and/or efficacy results of the phase 3 trial of Anturol may not support an application for marketing approval in the United States or any other country; 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 fund clinical trials. 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)|
|March 31,||December 31,|
|Cash and investments||$||11,546||$||13,559|
|Liabilities and Stockholders’ Equity|
|Accounts payable and accrued expenses||$||2,962||$||2,931|
|Total Liabilities and Stockholders’ Equity||$||17,131||$||19,143|
|ANTARES PHARMA, INC.|
|CONSOLIDATED CONDENSED STATEMENTS OF OPERATIONS|
|(amounts in thousands except share amounts)|
|For the Three Months Ended|
|Cost of revenue||1,315||1,089|
|Research and development||2,086||2,207|
|Sales, marketing and business development||330||335|
|General and administrative||1,218||1,312|
|Total Operating Expenses||3,634||3,854|
|Other expenses, net||(24||)||(197||)|
|Basic and diluted net loss per common share||$||(0.02||)||$||(0.04||)|
|Basic and diluted weighted average common shares outstanding||82,265||68,050|