Expert Financial Analysis and Reporting

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 […]

Investment Thesis The investment thesis for AMAG in 2018 and 2019is overwhelmingly dependent on how successful the Company will be in switching patients from the intra-muscular (IM) dosage of Makena to the new subcutaneous (subcu) formulation. The subcu was launched on March 26 and the first patient was injected on March 28. The subcu has […]

Investment Opinion Based on assumptions made in this report, I estimate that AndexXa could be valued by investors at $114 to $ 200 per Portola share by 2023. This makes Portola a very attractive investment opportunity without taking into account any contribution from Bevyxxa which was recently launched in the US and potential pipeline contributions, […]

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 […]