Antares Pharma, Inc. (Amex:AIS) today reported financial and operating results for the fourth quarter and year ended December 31, 2007 and outlined key objectives for 2008. Total revenues increased to $7.9 million for 2007, an increase of 84% over 2006. Net cash used in operations for 2007 was $5.4 million, compared to $6.1 million in 2006. At December 31, 2007, Antares had approximately $26.1 million in cash, cash equivalents and short-term investments. For the year ended December 31, 2007, the Company reported a net loss applicable to common shares of $8.6 million, or $0.14 per share, compared to a net loss applicable to common shares of $8.2 million, or $0.16 per share, for 2006.
“2007 was a productive year for Antares as we continued to make good progress with the development and commercial efforts of our drug delivery systems and products,” said Jack E. Stover, President and Chief Executive Officer. “We are pleased with our total revenue growth resulting from both solid product growth and licensing revenues. Following on the approval of Elestrin, we continued to advance our ATD™ gel system by initiating the pivotal trial of ANTUROL™ for the treatment of overactive bladder syndrome (OAB). We have also staked new territory by executing our first EasyTec™ ODT (oral disintegrating tablet) life cycle extension development and license agreement with a (as yet, unannounced) global pharmaceutical company. Having recently executed a fourth commercial agreement with Teva Pharmaceuticals clearly demonstrates our specialized expertise in the parenteral medicines sector, while securing further potential revenue growth. As we look forward we expect to complete patient enrollment in the ANTUROL trial in 2008. A key objective in 2008 is to seek agreement with the regulatory agencies in Europe for our estradiol ATD gel (Elestrin™), ANTUROL™ and our testosterone ATD gel for female sexual dysfunction (FSD) (LibiGel®).”
Fourth Quarter and Recent Corporate Highlights
Advanced our ATDTM (Advanced Transdermal Delivery) gel system development with the initiation of the pivotal trial of ANTUROL 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
|--||Further expanded and validated our commercial partnering strategy with the execution of a fourth agreement with Teva Pharmaceuticals under which Antares will develop and supply a new disposable pen injector for use with two patient-administered products|
|--||Announced, jointly with the Population Council, positive results from a Phase I dose-ranging pharmacokinetic trial of a novel contraceptive gel containing the progestin, Nestorone and the bio-identical estrogen, estradiol, utilizing our ATD gel system|
Announced receipt of an additional milestone payment of $875,000 from BioSante Pharmaceuticals Inc. for ElestrinTM, a low dose transdermal estradiol therapy delivered in our proprietary ATD gel system. Elestrin is used for the treatment of vasometer symptoms in menopausal women
|--||Clarified European regulatory pathway for our low dose testosterone ATD gel for FSD (LibiGel(R)). In February 2008, the European Medicines Agency ("EMEA") provided positive guidance that the current Phase III placebo-controlled studies being carried out in the US should be sufficient for a decision regarding 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|
|--||Advance and expand the development efforts for the Company's advanced drug delivery systems and products:|
|--||Complete enrollment in pivotal trial of ANTUROL for overactive bladder|
|--||In partnership with the Population Council, initiate Phase II trial of Nestorone and estradiol utilizing the Antares ATD gel system.|
|--||Initiate second Phase 1 trial of AP-1126, the Company's proprietary CNS gel.|
|--||Reach agreement with the regulatory authorities in Europe for Elestrin, ANTUROL and LibiGel|
|--||Execute commercial strategy to drive revenue generation and partnering opportunities:|
|--||Launch hGH in U.S. with partner in the second half of the year|
|--||Support Teva launch of disposable auto-injector|
|--||Expand licensed territories|
Fourth Quarter and Year End 2007 Financial Results
Total revenue for 2007 was $7.9 million, a year-over-year increase of 84% compared to $4.3 million for 2006. Total revenue was $2.0 million for the fourth quarter of 2007, consistent with the fourth quarter of 2006. In 2007 the Company received a total of $2.6 million under a license agreement with BioSante Pharmaceuticals, Inc., of which $875,000 was received in the fourth quarter. The Company also received $875,000 under this agreement in the fourth quarter of 2006. Product revenue increased in the full year by 46% to $3.2 million compared to $2.2 million in 2006 and decreased in the fourth quarter by 15% to $612,000 compared to $720,000 in the prior year. The product revenue increase was due primarily to an increase in product sales to our major European customer.
Total cost of revenue increased in the fourth quarter of 2007 due to recognition of an impairment charge of $1.4 million consisting primarily of the write off of prepaid license discount related to a license agreement with Eli Lilly. The impairment charge also impacted the gross margin which decreased to 56% for 2007 from 64% for 2006. The effect of the impairment charge on the 2007 full year gross profit was partially offset by the increased license revenue related to payments received from BioSante. Total operating expenses were approximately $13.1 million and $11.0 million for the years ended December 31, 2007, and 2006 and approximately $3.4 million and $2.9 million for the three months ended December 31, 2007 and 2006, respectively. The increases were due primarily to an increase in research and development expenses related to the initiation of the pivotal study of ANTUROLTM (oxybutynin gel) for the treatment of overactive bladder. Net loss was approximately $8.6 million and $8.2 million for the years ended December 31, 2007 and 2006, and $3.2 million and $1.4 million for the quarters ended December 31, 2007 and 2006, respectively.
Net loss per common share decreased for the year to $0.14 in 2007 from $0.16 in 2006, primarily due to an increase in weighted average common shares outstanding resulting from the private placement of common stock in the third quarter of 2007 and increased to $0.05 for the fourth quarter of 2007 from $0.03 in 2006.
At December 31, 2007, Antares had approximately $26.1 million in cash, cash equivalents and short-term investments, compared to approximately $7.7 million at December 31, 2006. In the fourth quarter the Company drew down an additional $2.5 million under its credit facility.
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 2007 results via webcast and conference call on Wednesday, March 26, 2008, at 8:00 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. Alternatively, callers may participate in the conference call by dialing 800.762.8779 (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 April 9, 2008. To access the replay, callers should dial 800.406.7325 (domestic) or 303.590.3030 (international). The passcode is 3853688.
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 systems: the ATDTM Advanced Transdermal Gel Delivery system, subcutaneous injection technology platforms including both VibexTM disposable pressure assisted auto injectors and ValeoTM/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. 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’ reports on Form 10-Q and 10-K 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||$||26,060||$||7,659|
|Liabilities and Stockholders’ Equity|
|Accounts payable and accrued expenses||$||2,348||$||1,884|
|Total Liabilities and Stockholders’ Equity||$||30,217||$||11,534|
ANTARES PHARMA, INC.
CONSOLIDATED CONDENSED STATEMENTS OF OPERATIONS
(amounts in thousands except share amounts)
|For the Three Months Ended December 31,||For the Year Ended December 31,|
|Impairment of prepaid license discount and related charges|
|Other cost of revenue||416||484||2,003||1,556|
|Total cost of revenue||1,855||484||3,442||1,556|
|Research and development||1,365||1,126||5,362||3,778|
|Sales, marketing and business development||455||362||1,641||1,350|
|General and administrative||1,595||1,432||6,058||5,861|
|Total Operating Expenses||3,415||2,920||13,061||10,989|
|Other income and expenses||52||(26||)||67||177|
|Net loss applicable to common shares||$||(3,242||)||$||(1,414||)||$||(8,579||)||$||(8,199||)|
|Basic and diluted net loss per common share||$||(0.05||)||$||(0.03||)||$||(0.14||)||$||(0.16||)|
|Basic and diluted weighted average common shares outstanding|