Antares Pharma (NASDAQ: ATRS) reported Q1 EPS of ($0.03), in-line with the analyst estimate of ($0.03). Revenue for the quarter came in at $12 million versus the consensus estimate of $12.33 million.

“We are pleased with the continued growth in OTREXUP and Sumatriptan Injection, both products developed and supplied by Antares for commercial sale. With the potential for a late 2017 approval of QuickShot testosterone, we will leverage and look to expand our existing commercial organization and infrastructure to support the launch of QST into a large market opportunity which we believe may benefit from a new treatment option,” said Robert F. Apple, President and Chief Executive Officer of the Company. “The Company’s first quarter results reflect a continued focus on growing product revenue, producing prelaunch quantities of commercial devices and controlling operating expenses with appropriate reinvestment in our future while we await potential FDA approval of four partnered drug device combination products as well as our own QST product.”

• Reported first quarter 2017 revenue of $12.0 million, loss per share of $0.03 and cash and cash equivalents of $23.7 million at March 31, 2017.
• Announced that our New Drug Application had been accepted as filed by the U.S. Food and Drug Administration (FDA) for QuickShot® Testosterone (QST), a drug-device combination product for the delivery of testosterone enanthate using a subcutaneous auto injector. QST is intended to treat adult men with low testosterone associated with a diagnosed condition known as hypogonadism. The application is currently under active review by the FDA with an October 20, 2017 PDUFA date.
• Announced that data from the 52 week phase 3 study of the pharmacokinetics and safety of subcutaneous testosterone enanthate delivered through the QuickShot® auto injector was presented at a moderated poster session at the Endocrine Society Annual Meeting (ENDO 2017).
• AMAG Pharmaceuticals, Inc. announced the submission of a supplemental new drug application (sNDA) to the U.S. Food and Drug Administration (FDA) for the Makena® subcutaneous auto injector, a drug-device combination product utilizing Antares’ QuickShot® auto injector. AMAG anticipates a six month FDA review timeline for possible approval and launch in the fourth quarter of 2017.

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