Antares Pharma, Inc. (NYSE Amex: AIS) today reported financial and operating results for the fourth quarter and year ended December 31, 2008 and outlined key objectives for 2009. For the quarter ended December 31, 2008, the Company reported a net loss of $2.7 million, or $0.04 per share, compared to a net loss of $3.2 million, or $0.05 per share for the same period in 2007. For the year ended December 31, 2008, the Company reported a net loss of $12.7 million, or $0.19 per share, compared to a net loss of $8.6 million, or $0.14 per share, for 2007. At December 31, 2008, Antares had approximately $13.1 million in cash.
Paul K. Wotton, Ph.D., President and Chief Executive Officer, stated, “Antares has continued to make strong progress across all fronts, namely in our solid relationship with Teva Pharmaceuticals where we have 5 products under contract for development and we eagerly await the approval of a supplemental NDA for TevTropin® hGH in our needle-free device. Additionally, enrollment progresses in our 600 patient three-arm Anturol™ Phase III trial where we will seek to partner the product in 2009, and finally, there is the potential to secure additional agreements with partners for our FDA-approved technologies, which we believe offer clear advantages over existing products for patients with respect to side effects, dosing and convenience. Furthermore, the potential to earn revenue and milestone payments through these agreements and incremental opportunities helps us navigate through these difficult economic times.”
Fourth Quarter and Recent Corporate Highlights
- Filed a Device Master File for a novel disposable pen injector with FDA, triggering a milestone payment from Teva Pharmaceuticals;
- Received a milestone payment from BioSante Pharmaceuticals, Inc. related to an agreement with AZUR Pharma for the marketing of Elestrin;
- Announced the initiation of a Phase II trial for a novel contraceptive advanced transdermal delivery (ATD™) gel together with the Population Council;
- Received additional regulatory approvals in Europe and Australia through our license partner, Ferring Pharmaceuticals, for needle-free injection devices for Ferring’s human growth hormone (hGH), Zomacton;
- Appointed Paul K. Wotton, Ph.D., as President and Chief Executive Officer;
- Obtain FDA Approval and launch of TEVA’s needle-free hGH;
- Continued advancement of products in development with TEVA;
- Secure additional partners, including one for Anturol;
- Complete patient enrollment in Phase III study for Anturol™.
Fourth Quarter and Year End 2008 Financial Results
Product revenue increased in the fourth quarter by 9.5% to $670,000 compared to $612,000 in the prior year, and increased in the full year by 4.3% to $3.3 million compared to $3.2 million in 2007. The product revenue increase was due primarily to increases in device and disposable revenues from Ferring Pharmaceuticals. Other revenue, which includes licensing revenue, development revenue and royalties, was $1.1 million and $2.3 million in the 2008 fourth quarter and full year periods, respectively, compared to $1.4 million and $4.6 million in the same respective periods of 2007. Development revenue and royalties increased in the 2008 fourth quarter and full year periods compared to 2007, while licensing revenue decreased primarily due to $875,000 and $2.6 million received in the fourth quarter and full year periods of 2007 related to an existing license agreement with BioSante Pharmaceuticals, Inc. Total revenue was $1.8 million and $5.7 million for the three months and year ended December 31, 2008, respectively, compared to $2.0 million and $7.9 million for the three months and year ended December 31, 2007, respectively.
Total cost of revenue decreased in the fourth quarter of 2008 to $437,000 compared to $1.9 million in 2007, and decreased for the year to $2.0 million in 2008 compared to $3.4 million in 2007. The decrease was due to recognition in 2007 of an impairment charge of $1.4 million consisting primarily of the write off of a prepaid license discount related to a license agreement with Eli Lilly. The effect of the impairment charge on the 2007 full year gross profit was minimized by the increased license revenue related to payments received from BioSante. Total operating expenses were approximately $3.9 million and $3.4 million for the three months ended December 31, 2008 and 2007, respectively, and approximately $15.8 million and $13.1 million for the years ended December 31, 2008 and 2007, respectively. The increases were due primarily to $2.5 million in research and development for a Phase III study of Anturol™ for the treatment of overactive bladder. Net loss was approximately $2.7 million and $3.2 million for the quarters ended December 31, 2008 and 2007, respectively, and $12.7 million and $8.6 million for the years ended December 31, 2008 and 2007, respectively.
Net loss per share increased for the year to $0.19 in 2008 from $0.14 in 2007, primarily due to a decrease in licensing and development revenue and increase in research and development expenses, and was partially offset by the elimination of the one-time impairment charge as described above. Net loss per share decreased to $0.04 for the fourth quarter of 2008 from $0.05 in 2007.
At December 31, 2008, Antares had approximately $13.1 million in cash and investments, compared to approximately $26.1 million at December 31, 2007.
Conference Call, Call Replay and Webcast
Paul Wotton, President and Chief Executive Officer, and Robert Apple, Chief Financial Officer, will provide a company update and review 2008 results via webcast and conference call on Wednesday, March 25, 2009, at 8:30 AM 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 800.762.8795 (domestic) or 480.248.5081 (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 PM (EDT) on April 8, 2009. To access the replay, callers should dial 800.406.7325 (domestic) or 303.590.3030 (international) and enter passcode 4023588.
About Antares Pharma
Antares Pharma is a product development company committed to improving pharmaceuticals through its patented drug delivery systems. Antares has multiple development partnerships with leading pharmaceutical companies. The Company’s products are designed to improve safety and efficacy profiles by minimizing dosing and reducing side effects while enabling improved patient compliance. 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 III trial. Antares has three validated drug delivery systems: the ATDTM Advanced Transdermal Gel Delivery system, injection technology platforms including both VibexTM disposable pressure assisted auto injectors and Vision® reusable needle-free injectors; and Easy TecTM oral disintegrating tablets (ODT). Two of the systems have generated FDA approved products. Antares Pharma leverages its multiple drug delivery systems to add value to existing drugs and to create new products. Antares Pharma has corporate headquarters in Ewing, New Jersey, with subsidiaries performing research, development, manufacturing and product commercialization activities in Minneapolis, Minnesota and Basel, 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: that the Company may experience difficulties or delays in the initiation, progress, or completion of its 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 priority 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 future 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, 2008, 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||$||13,096||$||26,060|
|Liabilities and Stockholders’ Equity|
|Accounts payable and accrued expenses||$||3,486||$||2,348|
|Total Liabilities and Stockholders’ Equity||$||19,911||$||30,217|
ANTARES PHARMA, INC.
CONSOLIDATED CONDENSED STATEMENTS OF OPERATIONS
(amounts in thousands except share amounts)
For the Three Months
Ended December 31,
For the Year Ended
|Impairment of prepaid license discount and related charges|
|Other cost of revenue||437||416||2,020||2,003|
|Total cost of revenue||437||1,855||2,020||3,442|
|Research and development||1,956||1,365||7,866||5,362|
|Sales, marketing and business development||272||455||1,625||1,641|
|General and administrative||1,706||1,595||6,348||6,058|
|Total Operating Expenses||3,934||3,415||15,839||13,061|
|Other income and expenses||(140||)||52||(492||)||67|
|Basic and diluted net loss per common share||$||(0.04||)||$||(0.05||)||$||(0.19||)||$||(0.14||)|
|Basic and diluted weighted average common shares outstanding|
Robert F. Apple, 609-359-3020
In-Site Communications, Inc.
Lisa M. Wilson, 917-543-9932