Antares Pharma, Inc. (NYSE Amex: AIS) today reported financial and operating results for the fourth quarter and year ended December 31, 2009 and outlined key objectives for 2010.
- Fiscal year 2009 reported total revenue increased by 47% to $8.3 million, the highest in the Company’s history, compared to $5.7 million in 2008.
- Strengthened its balance sheet with approximately $13.6 million in cash as of December 31, 2009 through increased revenues, cost containment efforts, and capital raises.
- Announced the signing of a license and asset purchase agreement with Ferring International Center S.A. relating to Antares’ proprietary transdermal gel delivery technology, while retaining all rights to products in clinical development.
- Announced successful results of a Phase 2 trial for Nestorone, a novel contraceptive advanced transdermal delivery (ATD™) gel together with the Population Council.
- Announced the completion of patient enrollment in a Phase 3 pivotal trial of Anturol® for the treatment of overactive bladder (OAB).
- Enhanced the senior management team with the addition of Pavan Handa as Senior Vice President of Business Development.
2010 Key Objectives
- Increase revenues year-over-year.
- Advance device products in development with Teva.
- Complete Phase III pivotal trial and file New Drug Application (NDA) for Anturol®.
- Further development of internal drug/device combination products.
- Continue development progress of partnered products including LibiGel® and Nestorone.
Paul K. Wotton, Ph.D., President and Chief Executive Officer, stated, “We are pleased with the considerable progress achieved in both 2009 and our fourth quarter. Over the past year, we have increased our focus on our self-injectable technologies, highlighted by the launch of the Tjet® needle-free injector system for the administration of Tev-Tropin® [somatropin (rDNA) for injection] brand human growth hormone by our partner, Teva Pharmaceutical Industries Ltd, in addition to Teva’s continued commitment to the commercial development of additional products. The results of this focus on injectable products, when combined with the significant operational changes we have made, are now being reflected in our reported financial results. Additionally, we continued the advancement of our Phase III gel product, Anturol®, as evidenced by the completion of enrollment. Our 2009 research and development spend was focused almost entirely on moving forward Anturol® and our products with Teva. Our 2010 key objectives reflect continued focus on product revenue growth as well as development of near term product opportunities.”
Fourth Quarter and Year End 2009 Financial Results
Total revenue was $2.6 million and $8.3 million for the three months and year ended December 31, 2009, respectively, compared to $1.8 million and $5.7 million for the three months and year ended December 31, 2008, respectively. Product revenue decreased in the fourth quarter to $591,000 compared to $670,000 in the prior year, and increased in the full year by 4.7% to $3.5 million compared to $3.3 million in 2008. The product revenue increase for the year was due primarily to a combination of first year sales to Teva in connection with Teva’s launch of our Tjet® needle-free device with their hGH Tev-Tropin® and a decrease in sales to Ferring. Ferring sales decreased from quarter to quarter and the decrease year over year was driven mainly by Ferring inventory management practices. Ferring’s 2009 hGH sales were the highest to date, therefore it is expected that product sales to Ferring will normalize in 2010. Other revenue, which includes licensing revenue, development revenue and royalties, was $2.0 million and $4.8 million in the 2009 fourth quarter and full year periods, respectively, compared to $1.1 million and $2.3 million in the same respective periods of 2008. The increases in the quarter and year-to-date periods were primarily due to auto-injector development work under a License, Development and Supply agreement with Teva.
Total cost of revenue increased in the fourth quarter of 2009 to $1.6 million compared to $437,000 in 2008, and increased for the year to $4.1 million in 2009 compared to $2.0 million in 2008. The increases were primarily due to development costs related to a License, Development and Supply Agreement with Teva for a product utilizing our auto-injector technology.
Total operating expenses were approximately $3.5 million and $3.9 million for the three months ended December 31, 2009 and 2008, respectively, and approximately $13.9 million and $15.8 million for the years ended December 31, 2009 and 2008, respectively. A significant portion of the decreases were due to a reduction in personnel in 2009 compared to 2008. An increase in research and development expenses for a Phase III study of Anturol® for the treatment of overactive bladder to $5.2 million in 2009 compared to $3.8 million in 2008 was offset by reductions in other research and development projects costs. Net loss was approximately $2.4 million and $2.7 million for the quarters ended December 31, 2009 and 2008, respectively, and $10.3 million and $12.7 million for the years ended December 31, 2009 and 2008, respectively.
Net loss per share decreased for the year to $0.14 in 2009 from $0.19 in 2008, primarily due to a decrease in operating expenses along with an increase in weighted average common shares outstanding. Net loss per share decreased to $0.03 for the fourth quarter of 2009 from $0.04 in 2008.
At December 31, 2009, Antares had approximately $13.6 million in cash and investments, compared to approximately $13.1 million at December 31, 2008. In addition, Antares paid off its credit facility, which had a principal balance of $4.9 million as of December 31, 2008.
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 2009 results via webcast and conference call on Tuesday, March 23, 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 1-877-941-2333 (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 April 6, 2010. To access the replay, callers should dial 1-800-406-7325 (US) or 1-303-590-3030 (International) and enter passcode 4255654.
About Antares Pharma
Antares Pharma is an emerging pharma company that focuses on self-injection pharmaceutical products and technologies and topical gel-based products. The Company's subcutaneous injection technology platforms include Vibex™ disposable pressure-assisted auto injectors, Valeo™/Vision™ 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 ATD™ 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) 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)|
|Cash and investments||$||13,559||$||13,096|
|Liabilities and Stockholders’ Equity|
|Accounts payable and accrued expenses||$||2,931||$||3,486|
|Total Liabilities and Stockholders’ Equity||$||19,143||$||19,911|
|ANTARES PHARMA, INC.|
|CONSOLIDATED CONDENSED STATEMENTS OF OPERATIONS|
|(amounts in thousands except share amounts)|
|For the Three Months||For the Year Ended|
|Ended December 31,||December 31,|
|Cost of revenue||1,595||437||4,140||2,020|
|Research and development||1,945||1,956||7,903||7,866|
|Sales, marketing and business development||325||272||1,051||1,625|
|General and administrative||1,196||1,706||4,911||6,348|
|Total Operating Expenses||3,466||3,934||13,865||15,839|
|Other income and expenses||72||(140||)||(597||)||(492||)|
|Basic and diluted net loss per common share||$||(0.03||)||$||(0.04||)||$||(0.14||)||$||(0.19||)|
|Basic and diluted weighted average common shares outstanding|