- OTREXUP™ development program is on track with anticipated PDUFA date of October 14, 2013.
- Granted product specific U.S. patent 8,480,631 for OTREXUP™.
- Completed recruitment of a commercial team with significant rheumatology and product launch experience.
- Expanded intellectual property portfolio with 43 patents filed and 9 patents issued in the past 18 months, including recently issued QS Device U.S. patent 8,496,619.
- Continued to ship VIBEX™ auto injector devices to Teva for pre-launch quantities of Teva’s generic epinephrine auto injector product.
- Added Marvin Samson and Robert Roche Jr. to the Board of Directors, both experienced pharmaceutical executives with expertise in injectable manufacturing, delivery systems, commercialization and product launches.
- Total revenues increased 29% to $5.8 million and product revenues increased 41% to $4.5 million compared to the second quarter of 2012.
- Ended the quarter with $75.0 million in cash and investments and no debt.
Development revenues were $0.6 million in the three month period ended June 30, 2013 compared to $0.7 million in the prior year period. For the six months ended June 30, 2013, the Company’s development revenue was $1.4 million compared to $3.7 million in the first six months of 2012. The revenue in the first half of 2013 was primarily due to auto injector and pen injector development work for Teva. The revenue in the first half of 2012 was primarily due to a non-recurring FDA approval milestone payment of $2.5 million recognized in connection with our license agreement with Actavis (Watson), along with development revenue from Teva.Licensing revenues were $0.1 million in each of the three month periods ended June 30, 2013 and 2012. For the first half of 2013 licensing revenues were $0.1 million compared to $0.7 million in the first half of 2012. The licensing revenue in the second quarter and first six months of 2013 was primarily due to recognition of revenue deferred in prior years under agreements with Ferring. The licensing revenue in the first six months of 2012 was primarily due to an upfront license fee received in connection with our licensing agreement with Daewoong Pharmaceuticals for our 3% oxybutynin gel for South Korea signed in January of 2012, along with license revenue recognized in connection with our license agreement with Actavis. Royalty revenues were $0.7 million in the three month period ended June 30, 2013 compared to $0.5 million in the same period of the prior year. For the six month periods ended June 30, 2013 and 2012, royalty revenues were $1.8 million and $1.2 million, respectively. We receive royalties from Teva and Ferring related to needle-free injector device sales and/or hGH sales, from Actavis on sales of Gelnique, and from Meda Pharma on sales of Elestrin ®. The primary reason for the increase in royalty revenue in 2013 compared to 2012 were royalties received from Actavis on sales of Gelnique. Total gross profit was $2.4 million and $2.0 million in the second quarters of 2013 and 2012, respectively, and was $4.9 million for the first half of 2013 compared to $6.9 million for the first half of 2012. The decrease in the first half of 2013 compared to 2012 was mainly due to the non-recurring FDA approval milestone payment of $2.5 million from Actavis recognized as revenue in 2012.
Total operating expenses were approximately $7.5 million and $4.8 million for the three months ended June 30, 2013 and 2012, respectively, and were $13.4 million and $9.8 million for the six months ended June 30, 2013 and 2012, respectively. The increases were primarily due to an increase in OTREXUP™ commercialization and marketing activities in anticipation of a 2014 launch and increased development activity related to our Vibex™ QS T for testosterone replacement therapy, along with an increase in personnel to support our growing pharmaceutical business.Net loss per share was $0.04 and $0.03 for the second quarters of 2013 and 2012, respectively, and was $0.07 and $0.03 for the six month periods ended June 30, 2013 and 2012, respectively. At June 30, 2013, Antares had approximately $75.0 million in cash and investments, compared to approximately $85.2 million at December 31, 2012. Conference Call, Call Replay and Webcast Dr. Paul K. Wotton, President and Chief Executive Officer, and Robert F. Apple, EVP, Chief Financial Officer, and President of the Parenteral Products Division will provide a company update and review second quarter 2013 results via webcast and conference call on Wednesday, August 7, 2013, 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 1-877-941-8631 (US), or 1-480-629-9644 (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 August 21, 2013. To access the replay, callers should dial 1-800-406-7325 (US) or 1-303-590-3030 (International) and enter passcode 4632564. About Antares Pharma Antares Pharma focuses on self-administered parenteral pharmaceutical products and topical gel-based medicines. The Company is developing OTREXUP™, a combination product for the delivery of methotrexate using Medi-Jet™ technology for the treatment of rheumatoid arthritis, poly-articular-course juvenile rheumatoid arthritis and psoriasis, as well as VIBEX™ QS T for testosterone replacement therapy. The Company's technology platforms include VIBEX™ disposable Medi-Jet™, disposable multi-use pen injectors and Vision™ reusable needle-free injectors marketed as Tjet ® and Zomajet ® by Teva Pharmaceutical Industries, Ltd (Teva) and Ferring Pharmaceuticals (Ferring), respectively. Antares Pharma has a multi-product deal with Teva that includes Tev-Tropin ® human growth hormone (hGH), VIBEX™ epinephrine and several other products. Antares Pharma’s partnership with Ferring includes Zomacton ® hGH. In the U.S. Antares has received FDA approval for Gelnique 3%™, a treatment for overactive bladder that is marketed by Actavis. Elestrin ® (estradiol gel) is FDA approved for the treatment of moderate-to-severe vasomotor symptoms associated with menopause, and is marketed in the U.S. by Meda Pharma. Antares Pharma has two facilities in the U.S. The Parenteral Products Group located in Minneapolis, Minnesota directs the manufacturing and marketing of the Company’s reusable needle-free injection devices and related disposables, and develops its disposable pressure-assisted Medi-Jet and pen injector systems. The Company’s corporate office and Product Development and Commercial Groups are located in Ewing, New Jersey. 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. These statements are indicated by the words “may,” “will,” “plans,” “intends,” “believes,” “expects,” “anticipates,” “potential,” “could,” “would,” “should,” and similar expressions. 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 and difficulties or delays in the initiation, progress, or completion of product development. In addition, the OTREXUP™, QuickShot testosterone and the Vibex™ epinephrine products referred to in this press release have not yet been approved by the FDA, and the commercialization of OTREXUP™, QuickShot testosterone and Vibex™ epinephrine are dependent on the Company receiving FDA approval of these products. 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, 2012, 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||$||75,024||$||85,226|
|Equipment, molds, furniture and fixtures, net||5,291||3,583|
|Liabilities and Stockholders’ Equity|
|Accounts payable and accrued expenses||$||7,964||$||5,781|
|Total Liabilities and Stockholders’ Equity||$||89,590||$||95,527|
|ANTARES PHARMA, INC.|
|CONSOLIDATED CONDENSED STATEMENTS OF OPERATIONS|
|(amounts in thousands except share amounts)|
|For the Three Months Ended||For the Six Months Ended|
|June 30,||June 30,|
|Cost of revenue||3,481||2,531||5,508||4,521|
|Research and development||4,396||2,483||7,468||5,360|
|Sales and marketing||1,158||188||2,040||291|
|General and administrative||1,746||1,881||3,539||3,538|
|Total Operating Expenses||7,488||4,784||13,392||9,754|
|Other income and expenses||28||(16||)||22||6|
|Basic and diluted net loss per common share||$||(0.04||)||$||(0.03||)||$||(0.07||)||$||(0.03||)|
|Basic and diluted weighted average common shares outstanding||126,463||104,552||126,286||104,105|