Antares Pharma, Inc. (NYSE Amex: AIS) today reported financial and operating results for the fourth quarter and full year ended December 31, 2010 and outlined key objectives for 2011.
Recent Highlights
- Fiscal year 2010 total revenue increased by 54% to $12.8 million, the highest in the Company’s history, compared to $8.3 million in 2009.
- Dosed the first patient in a clinical study of our Vibex™ MTX product, being developed for the treatment of rheumatoid arthritis. The trial will evaluate several dose strengths delivered with our proprietary auto injector versus conventional needle and syringe administration by a healthcare professional.
- Filed a New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA) for Anturol® Gel for the treatment of overactive bladder (OAB). Subsequently, Antares announced the receipt from the FDA of a waiver for the $1.5 million NDA filing fee.
- Ended the year with $9.8 million in cash and equivalents. Subsequent to year-end, warrant and option exercises resulted in proceeds of approximately $5.1 million.
Paul K. Wotton, Ph.D., President and Chief Executive Officer, stated, “Our strategic plan put in place in 2009 to increase focus on our self-injectable technologies has led to the strong financial and operational results demonstrated in both the fourth quarter and the full year of 2010. We believe the solid foundation laid in 2010, including increasing product sales and royalties, continued development of the epinephrine product with Teva, the NDA filing for Anturol, and initiation of clinical testing of Vibex MTX, has left us well-positioned for a strong 2011.”
2011 Key Objectives
- Increase total revenues year-over-year;
- Report clinical data from ongoing trial of Vibex™ MTX;
- Obtain FDA approval for Anturol® and secure commercial partner;
- Continue advancement of epinephrine product with Teva;
Fourth Quarter and Year End 2010 Financial Results
Total revenue was $3.3 million and $12.8 million for the three months and year ended December 31, 2010, respectively, compared to $2.6 million and $8.3 million for the comparable periods in 2009, respectively. Product revenue increased in the fourth quarter to $1.6 million compared to $0.6 million in the prior year, and increased in the full year by 65% to $5.8 million compared to $3.5 million in 2009. The product revenue increase for the year was due primarily to a combination of the first full year of sales to Teva in connection with the launch of our Tjet needle-free device with their hGH Tev-Tropin® and an increase in sales to Ferring.
Licensing and development revenue decreased in the fourth quarter to $0.8 million compared to $1.7 million in the prior year, and increased in the full year to $5.0 million from $4.2 million in the prior year. Revenue for the quarter and full year periods of 2010 was primarily related to auto injector development work for the epinephrine product under our agreement with Teva along with revenue recognized under our agreement with Ferring. The decrease in the quarter was primarily due to timing of revenue recognized under the Teva agreement. The increase for the year was primarily due to revenue recognized under the Ferring agreement.
Revenue from royalties was $0.8 million and $2.1 million for the three months and year ended December 31, 2010, respectively, compared to $0.3 million and $0.6 million for the comparable period in 2009, respectively. The increase in royalties in the quarter and year-to-date periods was primarily due to royalties received from Teva on sales of their hGH Tev-Tropin®.
Total gross profit increased in the fourth quarter of 2010 to $2.4 million compared to $1.0 million in 2009, and increased for the year to $8.5 million in 2010 compared to $4.2 million in 2009. The increase in the quarter was primarily due to increases in product sales and royalties, which have higher gross margins than our other revenues. The increase for the year was due to increases in product sales and royalties as well as recognition of licensing fees under the license agreement with Ferring for which there were minimal direct costs.
Total operating expenses were approximately $3.6 million and $3.5 million for the fourth quarters of 2010 and 2009, respectively, and approximately $14.6 million and $13.9 million for the years ended December 31, 2010 and 2009, respectively. The increases in each period were primarily due to our Vibex™ MTX development program and other internally funded development projects. Fourth quarter research and development expenses were reduced by approximately $430,000 received from the qualifying therapeutic discovery grant program under section 48D of the internal revenue code. Research and development expenses in connection with the Phase III study of Anturol® for the treatment of overactive bladder was approximately $4.9 million in 2010 compared to $5.2 million in 2009.
Net loss was approximately $1.3 million and $2.4 million for the fourth quarters of 2010 and 2009, respectively, and $6.1 million and $10.3 million for the years ended December 31, 2010 and 2009, respectively.
Net loss per share decreased for the year to $0.07 in 2010 from $0.14 in 2009, primarily due to an increase in gross profit along with an increase in weighted average common shares outstanding. Net loss per share decreased to $0.02 for the fourth quarter of 2010 from $0.03 in 2009.
At December 31, 2010, Antares had approximately $9.8 million in cash and investments, compared to approximately $13.6 million at December 31, 2009. In the first quarter of 2011, approximately 3.2 million warrants with an exercise price of $1.50 were exercised resulting in proceeds of approximately $4.9 million and approximately 173,000 options were exercised resulting in proceeds of approximately $206,000, for total proceeds of approximately $5.1 million.
Conference Call, Call Replay and Webcast
Dr. Paul K. Wotton, President and Chief Executive Officer, and Robert F. Apple, Executive Vice President and Chief Financial Officer, will provide a company update and review 2010 results via webcast and conference call on Monday, March 14, 2011, at 4:30 p.m. 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 1-877-941-6010 (US), or 1-480-629-9772 (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 p.m. EDT on March 28, 2011. To access the replay, callers should dial 1-800-406-7325 (US) or 1-303-590-3030 (International) and enter passcode 4420705.
About Antares Pharma
Antares Pharma focuses on self-injection pharmaceutical products and topical gel-based medicines. The Company's subcutaneous and intramuscular injection technology platforms include Vibex™ disposable pressure-assisted auto injectors, Valeo™/Vision™ reusable needle-free injectors, and disposable multi-use pen injectors. In the injector area, Antares Pharma has a multi-product deal with Teva Pharmaceutical Industries, Ltd that includes Tev-Tropin® human growth hormone and a partnership with Ferring Pharmaceuticals. In the gel-based area, the Company's lead product candidate is Anturol®, an oxybutynin ATD™ gel that has completed Phase 3 studies for the treatment of OAB (overactive bladder). Antares also has a partnership with BioSante that includes LibiGel® (transdermal testosterone gel) in Phase 3 clinical development for the treatment of female sexual dysfunction (FSD), and Elestrin® (estradiol gel) indicated for the treatment of moderate-to-severe vasomotor symptoms associated with menopause, and currently marketed in the U.S. Antares Pharma has corporate headquarters in Ewing, New Jersey, with subsidiaries performing research, development and product commercialization activities in Minneapolis, Minnesota and Muttenz, 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. 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, changes in revenue growth, difficulties or delays in the initiation, progress, or completion of product development, clinical trials, difficulties or delays in the progress or completion of Anturol’s product development or in the success of the NDA and whether or not the Company’s application for marketing approval is accepted for review or at all by the FDA or any other regulatory authority. 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, 2010, 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.
TABLES FOLLOW
ANTARES PHARMA, INC. | ||||||
CONSOLIDATED CONDENSED BALANCE SHEETS | ||||||
(amounts in thousands) | ||||||
December 31, | ||||||
2010 | 2009 | |||||
Assets | ||||||
Cash and investments | $ | 9,848 | $ | 13,559 | ||
Accounts receivable | 1,246 | 1,542 | ||||
Patent rights | 803 | 742 | ||||
Goodwill | 1,095 | 1,095 | ||||
Other assets | 2,149 | 2,205 | ||||
Total Assets | $ | 15,141 | $ | 19,143 | ||
Liabilities and Stockholders’ Equity | ||||||
Accounts payable and accrued expenses | $ | 3,592 | $ | 2,931 | ||
Deferred revenue | 4,923 | 7,362 | ||||
Stockholder’s equity | 6,626 | 8,850 | ||||
Total Liabilities and Stockholders’ Equity | $ | 15,141 | $ | 19,143 | ||
ANTARES PHARMA, INC. | ||||||||||||||||
CONSOLIDATED CONDENSED STATEMENTS OF OPERATIONS | ||||||||||||||||
(amounts in thousands except share amounts) | ||||||||||||||||
For the Three Months | For the Year Ended | |||||||||||||||
Ended December 31, | December 31, | |||||||||||||||
2010 | 2009 | 2010 | 2009 | |||||||||||||
Product sales | $ | 1,642 | $ | 591 | $ | 5,774 | $ | 3,507 | ||||||||
Licensing and development revenue | 816 | 1,673 | 4,983 | 4,201 | ||||||||||||
Royalties | 824 | 318 | 2,062 | 603 | ||||||||||||
Total Revenue | 3,282 | 2,582 | 12,819 | 8,311 | ||||||||||||
Cost of revenue | 883 | 1,595 | 4,273 | 4,140 | ||||||||||||
Gross Profit | 2,399 | 987 | 8,546 | 4,171 | ||||||||||||
Research and development | 2,142 | 1,945 | 8,803 | 7,903 | ||||||||||||
Sales, marketing and business development | 258 | 325 | 1,035 | 1,051 | ||||||||||||
General and administrative | 1,224 | 1,196 | 4,734 | 4,911 | ||||||||||||
Total Operating Expenses | 3,624 | 3,466 | 14,572 | 13,865 | ||||||||||||
Operating loss | (1,225 | ) | (2,479 | ) | (6,026 | ) | (9,694 | ) | ||||||||
Other income and expenses | (73 | ) | 72 | (65 | ) | (597 | ) | |||||||||
Net loss | $ | (1,298 | ) | $ | (2,407 | ) | $ | (6,091 | ) | $ | (10,291 | ) | ||||
Basic and diluted net loss per common share | $ | (0.02 | ) | $ | (0.03 | ) | $ | (0.07 | ) | $ | (0.14 | ) | ||||
Basic and diluted weighted average common shares outstanding | 83,862 | 81,756 | 83,170 | 73,489 | ||||||||||||
Contacts:
Antares Pharma, Inc.
Robert F. Apple
Chief
Financial Officer
609-359-3020
or
Westwicke Partners, LLC
John
Woolford
443-213-0506
john.woolford@westwicke.com
or
Media
Contacts:
Tiberend Strategic Advisors, Inc.
212-827-0020
Tamara
Bright
tbright@tiberendstrategicadvisors.com
or
Farrell
Denby
fdenby@tiberendstrategicadvisors.com