Antares Pharma, Inc. (AMEX: AIS) today reported financial and operating results for the third quarter 2008. For the quarter ended September 30, 2008, the Company reported a net loss of $3.2 million, or $0.05 per share, compared to a net loss of $2.6 million, or $0.04 per share for the same period in 2007. For the nine months ended September 30, 2008 the Company reported a net loss of $9.9 million, or $0.15 per share, compared to a net loss of $5.3 million, or $0.09 per share for the same period in 2007. In the first nine months of 2008 the Company used cash of approximately $8.1 million in operating activities principally due to the Company’s Phase 3 pivotal trial for Anturol™. At September 30, 2008 Antares held approximately $15.8 million in cash and cash equivalents.
“The third quarter was a good quarter for Antares; our revenue base from product sales increased, we signed an additional agreement for our ATD gel technology and we achieved additional approvals for our needle-free injection devices. We continue to expect that the sNDA filed for human growth hormone with our needle-free injector could be approved in the fourth quarter of 2008 which will mean additional product revenues in 2009,” said Paul K. Wotton, Ph.D., Chief Executive Officer of Antares.
Third Quarter 2008 Financial Results
Product revenue increased in the third quarter of 2008 to $996,000 compared to $904,000 in the prior year. Total revenue increased to $1.4 million for the third quarter of 2008, compared to $1.2 million in 2007. The increase in revenues was primarily due to an increase in product sales to the Company’s major European customer, Ferring. Total revenue was $3.9 million for the nine months ended September 30, 2008 compared to $5.9 million for the nine months ended September 30, 2007. The decrease in the first nine months of 2008 compared to 2007 was primarily due to a one-time $1.75 million milestone payment received in the first quarter of 2007 related to an existing license agreement with BioSante Pharmaceuticals, Inc. Product revenue for the nine months ended September 30, 2008 was $2.7 million compared to $2.6 million for the nine months ended September 30, 2007.
Total operating expenses were approximately $3.8 million and $3.4 million for the three months ended September 30, 2008 and 2007, respectively, and were approximately $11.9 million and $9.6 million for the nine months ended September 30, 2008 and 2007, respectively. Operating expenses increased primarily due to the pivotal Phase 3 trial of ANTUROL for the treatment of overactive bladder syndrome (OAB), which we initiated during the second half of 2007. Net loss was approximately $3.2 million and $2.6 million for the quarters ended September 30, 2008 and 2007, respectively, and was approximately $9.9 million and $5.3 million for the nine-month periods ended September 30, 2008 and 2007, respectively. Net cash used in operations increased from $4.0 million for the nine months ended September 30, 2007 to $8.1 million for the comparable period in 2008 as a result of our increased investment in our Anturol clinical study.
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 3 trial. Antares has three validated drug delivery systems: the ATDTM Advanced Transdermal Gel Delivery system; subcutaneous injection technology platforms including VibexTM disposable pressure assisted auto injectors, ValeoTM/Vision® reusable needle-free injectors and disposable multi-use pen injectors and Easy TecTM oral disintegrating tablets (ODT). Two of the systems have generated FDA approved 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 sNDA filing for human growth hormone being approved in the fourth quarter of 2008 with additional product revenues in 2009, 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, 2007, 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||$||15,828||$||26,060|
|Liabilities and Stockholders’ Equity|
|Accounts payable and accrued expenses||$||3,529||$||2,348|
|Total Liabilities and Stockholders’ Equity||$||22,275||$||30,217|
ANTARES PHARMA, INC.
CONSOLIDATED CONDENSED STATEMENTS OF OPERATIONS
(amounts in thousands except share amounts)
|For the Three Months Ended September 30,||For the Nine Months Ended September 30,|
|Cost of revenue||596||552||1,583||1,587|
|Research and development||2,153||1,652||5,911||3,998|
|Sales, marketing and business development||347||369||1,352||1,186|
|General and administrative||1,319||1,347||4,642||4,462|
|Total Operating Expenses||3,819||3,368||11,905||9,646|
|Other income and expenses||(162||)||78||(352||)||15|
|Basic and diluted net loss per common share||$||(0.05||)||$||(0.04||)||$||(0.15||)||$||(0.09||)|
|Basic and diluted weighted average common shares outstanding|