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Antares Pharma Reports First Quarter 2011 Financial and Operating Results

Antares Pharma, Inc. (NYSE Amex: AIS) today reported financial and operating results for the first quarter ended March 31, 2011.

Quarter and Recent Highlights

  • Total revenue and product revenue increased to $3.6 million and $1.4 million, respectively, in the first quarter of 2011 compared to $3.4 million and $1.3 million, respectively, in the first quarter of 2010.
  • Revenue from royalties increased 87% to $0.7 million in the first quarter of 2011 from $0.4 million in the first quarter of 2010.
  • Announced the acceptance for filing for review by the U.S. Food and Drug Administration (FDA) of the New Drug Application (NDA) for Anturol® Gel in patients with overactive bladder (OAB).
  • Assigned a Prescription Drug User Fee Act (PDUFA) date of December 8, 2011 for Anturol®, which is the target date for the FDA to complete its review of the NDA.
  • Initiated a clinical study of our Vibex™ MTX product, being developed for the treatment of rheumatoid arthritis.
  • Ended the quarter with $13.1 million in cash.

Paul K. Wotton, Ph.D., President and Chief Executive Officer, stated, “In addition to a solid operational performance, the first quarter brought a number of important events including the FDA acceptance and granting of a filing fee waiver for our NDA filing for Anturol for OAB. We are pleased with our product sales and royalties from the success that Teva is having with TevTropin, and remain encouraged by the progress of the epinephrine auto injector product with Teva. We are also excited by the continued development of the novel Vibex MTX product. We have enrolled patients rapidly in our first clinical study with the Vibex MTX for rheumatoid arthritis, which we believe represents an important future product opportunity for Antares that can be positioned in the highly focused market segment of rheumatology.”

First Quarter Financial Results

Total revenues were $3.6 million and $3.4 million for the three months ended March 31, 2011 and 2010, respectively. Product sales increased in the first quarter of 2011 to $1.4 million compared to $1.3 million in the prior year.

Licensing and development revenue in the first quarter of 2011 was $1.4 million compared to $1.6 million in the prior year. The revenue in the first quarter of 2011 was primarily a result of auto injector and pen injector development work for Teva and includes approximately $0.6 million of revenue, previously deferred, that was recognized as a result of an amendment to an agreement with Teva. The licensing and development revenue in the first quarter of 2010 was primarily due to auto injector development work for Teva, licensing revenue recognized under a license agreement with Ferring, and milestone payments received in connection with a license agreement with BioSante.

Revenue from royalties was $0.7 million and $0.4 million for the three months ended March 31, 2011 and 2010, respectively. The increase in royalties was primarily due to royalties received from Teva on sales of their hGH Tev-Tropin®.

Total gross profit increased in the first quarter of 2011 to $2.1 million compared to $2.0 million in 2010. The increase in the quarter was primarily due to the increase in royalties.

Total operating expenses were approximately $3.5 million and $3.6 million for the first quarters of 2011 and 2010, respectively. The decrease was primarily due to a decrease in research and development expenses following completion of the Phase III study of Anturol® for the treatment of OAB and the filing of our NDA in the fourth quarter of 2010.

Net loss was approximately $1.4 million and $1.6 million for the first quarters of 2011 and 2010, respectively, and net loss per share was $0.02 in both the first quarters of 2011 and 2010.

At March 31, 2011, Antares had approximately $13.1 million in cash and cash equivalents, compared to approximately $9.8 million at December 31, 2010. In the first quarter of 2011, approximately 3.4 million warrants and options were exercised resulting in 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 first quarter 2011 results via webcast and conference call on Monday, May 9, 2011, at 8:30 a.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 1-877-941-2333 (US), or 1-480-629-9678 (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 May 23, 2011. To access the replay, callers should dial 1-800-406-7325 (US) or 1-303-590-3030 (International) and enter passcode 4437893.

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, disposable multi-use pen injectors and Vision™ reusable needle-free injectors distributed as Tjet® and Zomajet® by Teva Pharmaceutical Industries, Ltd (Teva) and Ferring Pharmaceuticals (Ferring), respectively. In the injector area, Antares Pharma has a multi-product deal with Teva that includes Tev-Tropin® human growth hormone (hGH) and a partnership with Ferring that includes Zomacton® hGH. In the gel-based area, the Company's lead product candidate is Anturol®, an oxybutynin ATD™ gel that is currently under review by the FDA 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. 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)
March 31,December 31,
20112010
Assets
Cash and cash equivalents $ 13,066 $ 9,848
Accounts receivable 1,607 1,246
Patent rights 839 803
Goodwill 1,095 1,095
Other assets 1,684 2,149
Total Assets $ 18,291 $ 15,141
Liabilities and Stockholders’ Equity
Accounts payable and accrued expenses $ 2,646 $ 3,592
Deferred revenue 4,855 4,923
Stockholder’s equity 10,790 6,626
Total Liabilities and Stockholders’ Equity $ 18,291 $ 15,141
ANTARES PHARMA, INC.
CONSOLIDATED CONDENSED STATEMENTS OF OPERATIONS
(amounts in thousands except share amounts)
For the Three Months Ended
March 31,
20112010
Product sales $ 1,405 $ 1,326
Licensing and development revenue 1,422 1,641
Royalties 742 397
Total Revenue 3,569 3,364
Cost of revenue 1,453 1,315
Gross Profit 2,116 2,049
Research and development 1,749 2,086
Sales, marketing and business development 289 330
General and administrative 1,490 1,218
Total Operating Expenses 3,528 3,634
Operating loss (1,412 ) (1,585 )
Other income and expenses 31 (24 )
Net loss $ (1,381 ) $ (1,609 )
Basic and diluted net loss per common share $ (0.02 ) $ (0.02 )
Basic and diluted weighted average common shares outstanding 85,720 82,265

Contacts:

Investor 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.
Tamara Bright, 212-827-0020
tbright@tiberendstrategicadvisors.com
or
Farrell Denby, 212-827-0020
fdenby@tiberendstrategicadvisors.com

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