EWING, N.J., Feb. 28, 2019 (GLOBE NEWSWIRE) -- Antares Pharma, Inc. (NASDAQ: ATRS) today reported unaudited consolidated financial results and operational highlights for the fourth quarter and full year ended December 31, 2018. The Company reported total revenue of $18.8 million for the fourth quarter of 2018 and $63.6 million for the year ended December 31, 2018. Net income per share was $0.04 for the fourth quarter of 2018 and a net loss per share of $0.04 for the year ended December 31, 2018, both of which were positively impacted by a $12.5 million gain recognized in connection with the previously disclosed sale of our needle free product line to Ferring Pharmaceuticals.

“Antares achieved several significant and transformational milestones last year which drove record revenue. We obtained three product approvals utilizing our device platform for our own product and our partners Teva and AMAG, and we announced a new rescue pen development collaboration with Pfizer. This is the fifth consecutive year of solid revenue growth driven by our expanding and diversified portfolio of proprietary and partnered products,” said Robert F. Apple, President and Chief Executive Officer of the Company. “Looking at 2019, our focus remains on the successful launch of XYOSTED, our once-weekly subcutaneous auto injector product for testosterone deficiency and the continued growth of our diverse commercial business. On the development front, we remain actively involved with Teva on the teriparatide ANDA and have begun manufacturing devices for a potential launch of this product in the second half of 2019, pending FDA approval. We believe Antares has made significant progress both internally and through partnerships toward achieving our goal of being recognized as a leading combination drug device company.”

Fourth Quarter 2018 and Recent Highlights

• Reported quarterly revenue of $18.8 million and annual revenue of $63.6 million for the fourth quarter and year ended December 31, 2018. Reported cash and cash equivalents of $27.9 million at December 31, 2018.
• Announced U.S. Food and Drug Administration (“FDA”) approval of XYOSTED^™ (testosterone enanthate) injection for testosterone replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone. XYOSTED^™ was made commercially available in late November 2018 with the sales team commencing detailing to target physicians in mid-December 2018.
• Announced that our partner Teva Pharmaceutical Industries, Ltd.’s (“Teva”) commercially launched their generic EpiPen^® in limited quantities. The product was approved by the FDA and deemed therapeutically equivalent and fully substitutable at the pharmacy to the EpiPen^®.
• Recorded the remaining gain on the 2017 sale of our needle free product line to Ferring Pharmaceuticals of $12.5 million in the fourth quarter of 2018.
• Appointed Peter S. Greenleaf to the Antares Board of Directors. Mr. Greenleaf has over 20 years of pharmaceutical experience and currently serves as the Chief Executive Officer of Cerecor Inc. (NASDAQ: CERC). He is also Chairman of the Board at BioDelivery Sciences (NASDAQ: BDSI).

Fourth Quarter and Year End 2018 Financial Results

Total revenue represents revenue generated from product sales, licensing and development revenue and royalties. Total revenue was $18.8 million for the three months ended December 31, 2018, compared to $14.0 million for the comparable period in 2017, a 34% increase. For the year ended December 31, 2018, total revenue was $63.6 million, compared to $54.5 million for the year ended December 31, 2017, a 17% increase.

Product sales represent sales of our proprietary products and devices or device components to our partners. Product sales were $14.2 million for the three months ended December 31, 2018, compared to $11.0 million for the comparable period in 2017, a 30% increase and were $47.9 million for the year ended December 31, 2018 compared to $41.7 million in the same period of 2017, a 15% increase. The increase in product revenue for the three month period was primarily attributable to sales of Makena^® auto injectors to AMAG, sumatriptan injection and XYOSTED^™ offset by a decrease in orders by Ferring for needle free devices. The increase in product sales for the year was primarily driven by sales of Makena^® auto injectors to AMAG offset by decreases in pre-launch generic epinephrine auto injector devices, sumatriptan, and OTREXUP^®.

Licensing and development revenue includes license fees received from partners for the right to use our intellectual property and amounts earned in joint development arrangements with partners under which we perform development activities or develop new products on their behalf. Licensing and development revenue was $1.1 million and $2.2 million for the three months ended December 31, 2018 and 2017, respectively, and $6.8 million and $11.2 million for the year ended December 31, 2018 and 2017, respectively. The decrease in licensing and development revenue for both the three month period and year was primarily the result of a reduction in development activities with AMAG for the Makena^®subcutaneous auto injector product, which was approved by the FDA in February 2018 and is now a marketed product.

Royalties are recognized based on in-market sales of products sold by our partners. Royalties were $3.5 million for the three months ended December 31, 2018 compared to $0.8 million for the same period in 2017, and were $8.9 million for the year ended December 31, 2018 compared to $1.6 million for 2017. The significant increase in royalties for both the three month period and year was attributable to the launch of AMAG’s Makena^® auto injector product.

Total operating expenses were $14.9 million for the three months ended December 31, 2018 compared to $11.0 million in the comparable period of 2017. Total operating expenses for the year ended December 31, 2018 were $49.1 million as compared to $43.5 million for the same period in 2017. The increase in operating expenses for the three and twelve month periods of 2018 was primarily due to increased compensation expense, sales, marketing and administrative expenses associated with the approval and launch of XYOSTED^™.

Net income was $6.1 million for the fourth quarter of 2018, compared to a loss of $3.7 million in the same period in 2017, and a net loss of $6.5 million for the twelve months ended December 31, 2018 compared to $16.7 million in the same period of 2017. In the fourth quarter of 2018, we recognized a $12.5 million gain in connection with the sale of our needle free product line to Ferring Pharmaceuticals, resulting in net income per share of $0.04 for the fourth quarter of 2018, compared to net loss per share of $0.02 for the same period in 2017. Net loss per share was $0.04 for the year ended December 31, 2018 compared to $0.11 for 2017.

At December 31, 2018, cash, cash equivalents and investments were $27.9 million compared to $31.6 million at December 31, 2017. During the fourth quarter of 2018, we generated $7.5 million in gross proceeds from the sale of common stock at an average price of $3.53 through the previously established at-the-market equity offering program, or ATM.

2019 Financial Guidance

The Company reaffirms total revenue guidance of $95.0 million to $105.0 million for 2019.

About Antares Pharma

Antares Pharma, Inc. is a combination drug device company focused on the development and commercialization of self-administered parenteral pharmaceutical products using advanced drug delivery auto injector technology. The Company has a portfolio of proprietary and partnered commercial products with several product candidates in advanced stages of development, as well as significant strategic alliances with industry leading pharmaceutical companies including Teva Pharmaceutical Industries, Ltd. (Teva), AMAG Pharmaceuticals, Inc. and Pfizer Inc. (Pfizer). Antares Pharma’s proprietary products include XYOSTED^™ (testosterone enanthate) injection, OTREXUP^® (methotrexate) injection for subcutaneous use and Sumatriptan Injection USP, which is distributed by Teva.