Antares Pharma, Inc. (Amex:AIS) today reported financial and operating results for the first quarter of 2008. For the quarter ended March 31, 2008, the Company reported a net loss of $3.5 million, or $0.05 per share, compared to a net loss of $430,000, or $0.01 per share, for the same period in 2007. In the first quarter of 2008 the Company used cash of approximately $2.3 million in operating activities principally due to the company’s ongoing pivotal clinical trial for Anturol™. At March 31, 2008, Antares held approximately $23.1 million in cash, cash equivalents and short-term investments.
“I am pleased to report on a productive start to the year for Antares as we continued to make progress with the development and commercial efforts for our advanced drug delivery systems, based on our three proprietary technology platforms, two of which have now produced FDA approved products,” said Jack E. Stover, President and Chief Executive Officer. “Our product revenue increased 18% and our gross margin increased to 59%. We strengthened our intellectual property portfolio with a second patent extension on our Advanced Transdermal Delivery (ATD™) Gel System and confidently advanced development of this system with our on-going pivotal trial of Anturol™ in patients with overactive bladder syndrome.”
Recent Corporate Highlights
- Further validated and advanced the ATD Gel platform with announcement by the Company’s partner, Jazz Pharmaceuticals, Inc., that it plans to initiate a Phase III clinical trial for a Central Nervous System (CNS) product candidate they call JZP-7 which utilizes Antares’ ATD™ (Advanced Transdermal Delivery) system to deliver ropinirole. The product candidate is designed to provide an effective, once-daily treatment for moderate to severe restless legs syndrome (RLS)
- Strengthened intellectual property portfolio with receipt from the United States Patent and Trademark Office of a second patent extension until August 2021 covering the Company’s proprietary Advanced Transdermal Delivery (ATD™) Gel System
- Continued to advance the pivotal Phase III trial of Anturol ATDTM gel for the treatment of overactive bladder syndrome (OAB). This trial is being conducted under an agreement reached with the U.S. Food and Drug Administration under its Special Protocol Assessment (SPA) process
- Clarified European regulatory pathway for the Company’s low dose testosterone gel for the treatment of Female Sexual Dysfunction, (called LibiGel® in the U.S.). In February 2008, the European Medicines Agency ("EMEA") confirmed that the current Phase III placebo-controlled studies being carried out in the U.S. by our partner, BioSante Pharmaceuticals, would support a potential European registration
- Strengthened the Company’s senior management team with the appointment of Kaushik J. Dave, PhD, R.Ph, MBA, as Vice President of Clinical and Regulatory Affairs
First Quarter 2008 Financial Results
Product revenue increased in the first quarter by 18% to $738,000 compared to $626,000 in the prior year, due primarily to increases in product sales to customers in Europe and Japan. Total revenue was $1.1 million for the first quarter of 2008, compared to $2.8 million for the first quarter of 2007. In the first quarter of 2007 the Company received $1,750,000 under a license agreement with BioSante Pharmaceuticals, Inc., and in the fourth quarter of 2007 received an additional $875,000 under this same agreement.
Excluding the payment of $1,750,000 received in the first quarter of 2007, gross margins increased in the first quarter of 2008 to 59% compared to 57% in the prior year period. Total operating expenses were approximately $4.1 million and $2.8 million for the three months ended March 31, 2008 and 2007, respectively. Operating expenses increased primarily due to the continuation of the pivotal trial of Anturol™ for the treatment of overactive bladder syndrome (OAB), initiated in the fourth quarter of 2007. Net loss was approximately $3.5 million and $430,000 for the quarters ended March 31, 2008 and 2007, respectively. Net loss per common share increased to $(0.05) for the first quarter of 2008 from $(0.01) in 2007, primarily due to the larger net loss in 2008.
In the first quarter of 2008 the Company also began investing in production tooling and equipment in connection with previously announced commercial device production for anticipated new products, resulting in spending of approximately $648,000, compared to approximately $6,000 of spending for capital purchases in the first quarter of 2007.
Conference Call, Call Replay and Webcast
Jack E. Stover, President and Chief Executive Officer, and other members of Antares’ senior management will provide a company update and review 2008 first quarter results via webcast and conference call on Thursday, May 15, 2008, at 8:30 a.m. ET. The webcast of this call will be available from the investors/media section of the Company's web site, www.antarespharma.com and will be archived for 14 days. Alternatively, callers may participate in the conference call by dialing 800.762.8932 (domestic) or 480.629.9031 (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 Friday, May 23, 2008. To access the replay, callers should dial 800.406.7325 (domestic) or 303.590.3030 (international). The passcode is 3876024.
About Antares Pharma
Antares Pharma is a specialized pharma product development company committed to improving pharmaceuticals through its patented drug delivery systems. Antares has three validated drug delivery platforms: the ATD(TM) Advanced Transdermal Delivery system; subcutaneous injection technology platforms including both Vibex(TM) disposable mini-needle injection device and Valeo(TM)/Vision(R) reusable needle-free injection devices; and Easy Tec(TM) oral fast-melt technology. Two of the platforms have generated FDA approved products. Antares Pharma leverages its multiple drug delivery platforms to add value to existing drugs and to create new pharmaceutical products and injectable devices. The Company's products are engineered to improve safety and efficacy profiles by minimizing dosing and reducing side effects while enabling improved patient compliance. 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
In addition to historical facts or statements or current conditions, this press release contains forward-looking statements within the meaning of the “Safe Harbor” provisions of The Private Securities Litigation Reform Act of 1995, including statements regarding the timing of product sales, market estimates, market potential and growth prospects, technology platforms and working capital needs. Forward-looking statements provide Antares’ current expectation or forecasts of future events. Antares’ results could differ materially from those reflected in these forward-looking statements due to decisions of regulatory authorities, Antares’ ability to execute on its development plans, capital needs and general financial, economic, regulatory and political conditions affecting the pharmaceutical industry generally. For a discussion of these and other risks and uncertainties that may effect the forward-looking statements, please see the risk factors in Antares’ quarterly reports and other filings made with the Securities and Exchange Commission. Given these risks and uncertainties, any or all of these forward-looking statements may prove to be incorrect. Antares undertakes no obligation to update publicly any forward-looking statement.
|ANTARES PHARMA, INC.|
|CONSOLIDATED CONDENSED BALANCE SHEETS|
|(amounts in thousands)|
|Cash and investments||$||23,136||$||26,060|
|Liabilities and Stockholders’ Equity|
|Accounts payable and accrued expenses||$||3,339||$||2,348|
|Total Liabilities and Stockholders’ Equity||$||28,256||$||30,217|
|ANTARES PHARMA, INC.|
|CONSOLIDATED CONDENSED STATEMENTS OF OPERATIONS|
|(amounts in thousands except share amounts)|
For the Three Months Ended
|Cost of revenue||452||468|
|Research and development||1,966||823|
|Sales, marketing and business development||431||386|
|General and administrative||1,687||1,631|
|Total Operating Expenses||4,084||2,840|
|Other income and expenses||(76||)||34|
|Basic and diluted net loss per common share||$||(0.05||)||$||(0.01||)|
|Basic and diluted weighted average common shares outstanding||65,629||53,413|