Expert Financial Analysis and Reporting

AMAG announced on April17, 2017 that it had submitted a sNDA for the Makena Auto-Injector. This was in line with guidance.  AMAG anticipates a six-month FDA review timeline with the potential for approval and launch in the fourth quarter of 2017. AMAG developed the Makena auto-injector using an auto-injector developed by Antares. AMAG revealed that it will […]

Introduction I am recommending purchase of Cryoport, which has developed a first mover, business model for providing cold chain logistics for high value life science products requiring cryogenic temperatures during shipment. This is report is divided into four sections: Investment Thesis: The first 11 pages of this report summarize the reasons why I am recommending […]

Investment Overview and Thesis A Long Buy Recommendation of Mine I first recommended Repligen in an initiation report in December 2012. At the time and on many occasions since, I have described its business model as being one of the very best I have seen. On a macro-basis its business sail is driven by the […]

Introduction I was just going though the most recently published slide deck of Cytokinetics and found some slides that I thought were an interesting way of conveying information on corporate collaborations, the clinical status of CK-107, tirasemtiv and the serious unmet medical need for treatment of patients hospitalized with heart failure. None of these are […]

Key Points: Novartis will almost certainly gain approval for CTL-019 in r/r pediatric ALL early in 4Q, 2017. This would represent the first ever approval for a CAR-T product. Kite says that it will receive approval for Axi-Cel ((axicabtagene ciloleucel)) in r/r DLBCL and launch in the US in 2017 and will have first mover […]

Acronyms Used in this Report SOC: The standard of care in newly diagnosed glioblastoma patients is surgical resection followed by treatment with radiation and the chemotherapy drug temozolomide PFS: Progression free survival is the time from which the surgery is performed until the tumor begins to regrow mPFS: The median time at which half of […]

Key Points: Antares has an impressive portfolio of seven new products that could lead to explosive growth over the next four years. I am projecting that revenues of five partnered products could increase from $17.0 million in 2016 to $142.0 million in 2021 (a nearly five fold increase) and that revenues from two wholly owned […]

The Investment Thesis Is Based on Three Drugs in Late Stage Development In partnership with Amgen, Cytokinetics has advanced omecamtiv mecarbil into phase 3 development for congestive heart failure; topline data is projected for January 2021. Without a partner, Cytokinetics has progressed tirasemtiv into a late phase 3 ALS trial; topline data is projected for […]

Key Points: Cytokinetics is likely to report results from the phase 3 VITALITY-ALS trial in early December 2017. I believe that this trial has a good chance of hitting the primary endpoint of sustained vital capacity (SVC) and gaining approval. The economic consequences for CYTK shareholders are enormous. In this report, I estimate a 2025 […]

Key Points: Amgen and Cytokinetics have begun enrolling the phase 3 GALACTIC-HF trial of omecamtiv mecarbil in congestive heart failure (CHF). Topline data is not expected until January 2021. However, in the event of strong efficacy, the trial could potentially be halted at an interim look in 2020. Between now and then there will be […]