Expert Financial Analysis and Reporting

Investment Thesis in Brief: In this report, I have put together an earnings forecast projecting EPS of (0.04) in 2019, $0.19 in 2020 and $0.33 in 2021. There are so many variables involved in my forecast that the error bars around these numbers are huge and they should be taken with a grain of salt. […]

Investment Thesis At Last, Three Major Product Approvals in 2018 It has been a torturous wait for Antares’ very promising pipeline to advance to commercialization, but the time has finally come. Antares and its partner Teva received approval for an AB rated generic to EpiPen on August 16, 2018 and Antares and its partner AMAG […]

Investment Summary At long last, the exciting new product potential of Antares is becoming a commercial reality. A very significant milestone for Antares was the approval gained by its distribution partner Teva in 2Q, 2016 for an AB rated generic to Imitrex (sumatriptan). This was the first of four AB rated generics that are known […]

Key Investment Issues In this report I focus on three very important product related issues that will likely drive the stock price performance of Antares in 2018. Roughly in order of importance they are: The launch trajectory of the Makena subcutaneous auto injector, Probable approval of the Teva’s AB rated generic to EpiPen, and The […]

Background on Xyosted NDA Resubmission Following Complete Response Letter The original PDUFA date for the Xyosted NDA was October 20, 2017, but Antares received a complete response letter (CRL) on October 11, 2017 which shocked management and investors. Just days earlier management had said that the FDA review was progressing smoothly and that they were […]

Management Comments on Type A Meeting Antares released the following comment on March 27, 2018 that deals with the Complete Response Letter on Xyosted that was received in October 2017 just before its PDUFA date and necessitated a Type A meeting with the FDA to discuss the CRL. It says. ”Antares Pharma today announced that […]

Overview of Report I listened to the presentation by CEO Bob Apple at the Raymond James conference on March 5th and go over his key remarks in this report I have been frustrated by the CRL for Xyosted and delays in approval for AB rated versions of EpiPen and Byetta which have had a sharply […]

Investment Thesis Finally, the FDA comes through with the approval for Makena SC. My Buy recommendation on Antares is based on an extensive and promising pipeline which I wrote about in my August 17, 2017 report This Small, Emerging Biotechnology Company Is Poised for Explosive Growth Based on Five Major New Product Introductions by 2020. […]

Regulatory Update Antares announced that it has scheduled a Type A meeting with FDA for Xyosted which is intended to resolve issues that have stalled the FDA regulatory review. Antares requested the meeting on December 21, 2017 in response to a Complete Response Letter on Xyosted. The meeting will take place on February 21, 2018. […]

Antares Pharma announced on December 21st that it had submitted a request to the FDA for a type A meeting in response to the CRL that it received in October on Xyosted. This action and timing is in line with what I have been expecting. See my note of November 9, 2017:  My Hypothesis on […]