Expert Financial Analysis and Reporting

Investment Thesis in Brief I want to emphasize at the very outset of this report that the key takeaway is that I believe that there is reasonable probability that analyst consensus estimates for Makena sales and projeciions for AMAG’s non-GAAP EPS for the period 2018 to 2020 could be substantially low. Management has issued no […]

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 […]

Investment Conclusions Along with most investors interested in Cryoport, I am expecting and awaiting a sharp upward inflection in sales as the CAR-T products gain traction in the market. Novartis’ Kymriah and Gilead’s Yescarta are both in early stages of their launches- Kymriah for pediatric r/r ALL and Yescarta for r/r DLBCL. In its conference […]

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 […]

Key Observations and Conclusions I believe there is a very strong possibility that AndexXa will be approved on its PDUFA date of May 4, 2018 even though the phase 3 trial that is the basis of the BLA leaves much to be desired. It is based on a single AndexXa arm which at this point […]

Cryoport reported 4Q results pretty much in line with my expectations. In my last report on November 6, 2017, I projected 4Q biopharma revenues (obviously the critical business segment) of $2.673 million and the Company reported $2.516 million. I guess you might call this a 157,000 shortfall (6% below projection), but well within the error […]

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 […]

Major New Uncertainty for AndexXa The fourth quarter conference call produced alarming information about the FDA review of AndexXa. This drug is an antidote for excessive bleeding that sometimes results from use of the Factor Xa anticoagulants Eliquis and Xarelto. Portola states that in the U.S. in 2017, there were approximately 150,000 hospital admissions that […]

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. […]

Introduction This report deals with comments made by President Trump in the State of the Union address in which he indicated that he wants to give terminally ill patients the right to receive experimental drugs, even though they might only be in phase 1 development. This could have positive implications for DCVax-L and DCVax Direct […]