Antares Pharma, Inc. (AMEX:AIS) today reported financial and operating results for the second quarter 2008. For the quarter ended June 30, 2008, the Company reported a net loss of $3.3 million, or $0.05 per share, compared to a net loss of $2.3 million, or $0.04 per share for the same period in 2007. For the six months ended June 30, 2008 the Company reported a net loss of $6.8 million, or $0.10 per share, compared to a net loss of $2.7 million, or $0.05 per share for the same period in 2007. Year to date the Company has used cash of approximately $5.2 million in operating activities principally due to the Company’s ongoing Phase 3 pivotal trial for Anturol™. At June 30, 2008 Antares held approximately $20.2 million in cash, cash equivalents and short-term investments.
“During the second quarter we continued to make solid progress executing on our business plan with the advancement of our Phase 3 pivotal trial for Anturol as well as the advancement of our key partnership with Teva Pharmaceuticals, with the expectation that the sNDA filed for human growth hormone with our needle free injector may be approved in the fourth quarter of 2008,” said Jack E. Stover, Chief Executive Officer of Antares.
Recent Corporate Highlights
- Continued to advance our partnership with Teva Pharmaceuticals (presently four separate agreements for five products) by the filing of a Supplemental New Drug Application (sNDA) for our Needle-Free injector with Human Growth Hormone (hGH); potential approval in Q4 2008
- Further strengthened intellectual property portfolio with receipt from the United States Patent & Trademark Office of a Notice of Allowance for the patent application “Permeation Enhancing Compositions for Anticholinergic Agents” related to Anturol for the treatment of overactive bladder (OAB)
- Strengthened the Company’s senior management team with the appointment of Paul Wotton, PH.D. as President and Chief Operating Officer
- Advanced patient enrollment in the Phase 3 pivotal, randomized, double-blinded, parallel, placebo controlled multi-center study of Anturol designed to evaluate efficacy in patients with urge incontinence episodes
Second Quarter 2008 Financial Results
Product revenue decreased in the second quarter of 2008 to $945,000 compared to $1.07 million in the prior year. Total revenue decreased to $1.39 million for the second quarter of 2008, compared to $1.81 million in 2007. The decrease in revenues was primarily due to decreases in development revenue from agreements related to use of the Company’s proprietary ATD gel technology and oral fast-melting tablet technology.
Total operating expenses were approximately $4.0 million for the three months ended June 30, 2008, compared to $3.4 million for the same period a year ago. Operating expenses, largely research and development expenses, increased primarily due to the ramp-up of 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 $3.3 million and $2.3 million for the quarters ended June 30, 2008 and 2007, respectively. Net cash used in operations increased from $2.4 million for the six months ended June 30, 2007 to $5.2 million for the comparable period in 2008 as a result of our increased research and development investment primarily in our Anturol clinical study. Net loss per common share was $(0.05) for the second quarter of 2008 compared to $(0.04) in the second quarter of 2007. Net loss per common share was $(0.10) for the first six months of 2008 compared to $(0.05) in the first six months of 2007. Overall, the cash position remained strong at $20.2 million at June 30, 2008.
About Antares Pharma, Inc.
Antares Pharma is a specialized pharma product development company committed to improving pharmaceuticals through its patented drug delivery systems. Antares has three validated 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. The Company’s products are engineered 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. The Anturol™ trial is being conducted under an agreement reached with the U.S. Food and Drug Administration under its special protocol assessment, or SPA process.
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 relating to the Company’s projected timeline for potential approval of a sNDA for the Company’s Needle-Free injector with hGH, the advancement and timing of the Phase 3 trial of Anturol, 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)|
|June 30,||December 31,|
|Cash and investments||$||20,174||$||26,060|
|Liabilities and Stockholders’ Equity|
|Accounts payable and accrued expenses||$||4,165||$||2,348|
|Total Liabilities and Stockholders’ Equity||$||26,406||$||30,217|
|ANTARES PHARMA, INC.|
|CONSOLIDATED CONDENSED STATEMENTS OF OPERATIONS|
|(amounts in thousands except per share amounts)|
|For the Three Months Ended|
For the Six Months Ended
|Cost of revenue||535||567||987||1,035|
|Research and development||1,791||1,522||3,758||2,345|
|Sales, marketing and business development||575||430||1,005||816|
|General and administrative||1,635||1,485||3,323||3,116|
|Total Operating Expenses||4,001||3,437||8,086||6,277|
|Other income and expenses||(115||)||(99||)||(190||)||(65||)|
|Basic and diluted net loss per common share||$||(0.05||)||$||(0.04||)||$||(0.10||)||$||(0.05||)|
|Basic and diluted weighted average common shares outstanding|