Expert Financial Analysis and Reporting

Key Points: Xyosted launch continues to impress. Projecting sales of $22 million in 2019 and over $50 million in 2019 AB rated generic to EpiPen royalties estimated at $6.2 million in 3Q. AB rated generic to Forteo could be launched this year. Potential is greater than AB rated generic to EpiPen. I predict that FDA […]

The FDA AdCom meeting voted 9 to 7 to withdraw Makena from the market. However, 6 of 7 practicing OB/GYNs on the panel voted to keep Makenna on the market and to do additional studies to properly define its role in the management of women with singleton pregnancies who previously have had a preterm birth. […]

Key Conclusions I believe that there is a 95% probability that Makena will remain on the market and only a 5% chance that it could be withdrawn. I think that results of PROLONG will be incorporated into the Makena label and the FDA may or may not ask for another trial. There is no approved […]

Opinion on Stock The recent sharp price decline has not been attributable to any change in perceived or actual fundamentals of Cryoport. (See the appendix of this report for a discussion on price behavior over the last month.) I have stated repeatedly that Cryoport has one of the best business models that I have seen […]

Introduction Aimmune is the first company for some time on which I have picked up coverage. My screening criteria is not rigid, but I generally look for a company with a unique late stage product that has great commercial potential and has a solid financial (cash) position. Aimmune Therapeutics with Palforzia for desensitization of patients […]

Key Points: Xyosted prescription trends remain impressive and based on audit data for the last 11 weeks, there has been an acceleration in the trend line. My model has slightly increased its 2019 sales estimate from $18.8 million as shown in my August 27 report to $19.4 million and for 2020 from $53.9 to $56.8 […]

Reason for This Further Discussion A number of subscribers have pointed out to me that my discussion of the survival tail could have been more clearly explained. Consequently, I have rewritten two sections as shown below that will hopefully be clearer. I have also summarized my analysis as follows: In the CheckMate trials in second […]

Key Points: NWBO is approaching unblinding of the critical phase 3 trial of DCVax-L in newly diagnosed glioblastoma (GBM). Management let the trial run longer in order to determine if there is a survival tail. This should prove critical to potential regulatory approval and commercialization. A meaningful survival tail has been key to the huge […]

Investment Thesis I have seen seven plus months of data on prescription trends for Xyosted as estimated by the prescription auditing service Symphony. My confidence is strong that Xyosted is experiencing a very solid launch and is on its way to becoming a major success. I have developed a model that uses the Symphony data […]

Investment Thesis is Almost Exclusively Driven by Prospects for Omecamtiv Mecarbil Omecamtiv Mecarbil is a Potential Mega- Blockbuster Omecamtiv mecarbil is one of the most exciting drugs in development in all of biopharma and is the primary driver of my investment thesis on Cytokinetics. If successful in the ongoing, phase 3 GALACTIC-HF trial, I believe […]