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Expert Financial Analysis and Reporting

Post archive for ‘Company Reports’

Portola: Reiterating Buy Prior to June 24th PDUFA Date for Betrixaban (PTLA, Buy, $39.35)

Portola has two drugs in late stage development that I believe are likely to be approved in 2017 or early 2018 in both the US and Europe. Betrixaban is an anticoagulant drug that is an oral factor Xa inhibitor. It has the same mechanism of action as two blockbuster drugs: Bristol-Myers Squibb/ Pfizer’s Eliquis ($3.3 […]

Alimera Sciences: Iluvien Sales Seem to Have Caught Traction; It Is Time to Buy! (ALIM, Buy, $1.35)

Key Points In 1Q, 2017 unit sales of Iluvien increased 34% in the US and foreign unit sales increased 32%.Management believes that these rates of growth could continue for the balance of 2017. Management also believes that it can reach breakeven or turn positive cash flow positive later in 2017. My model shows the Company […]

Windtree Therapeutics: Discussion of Licensing Deal with Lee’s Pharmaceutical and Two Imminent Key Clinical Events (WINT, Buy, $0.90)

Introduction This report discusses a new licensing deal with Lee’s Pharmaceutical and alerts investors to two upcoming catalysts for the stock. In July, the critical results from the phase 2b trial of Aerosurf will be published. Before then in June, results from the phase 2a trial in babies of the 26 to 28 weeks will […]

Windtree Therapeutics: Thinking About the Stock Price After Phase 2b Results for Aerosurf in RDS Are Released In July (WINT, $0.92)

Investment Thesis Windtree is facing the ultimate of binary events when it releases topline results in July for its critical phase 2b proof of concept trial of Aerosurf in premature babies with RDS syndrome. It is on track to run out of cash in July if it does not receive some type of cash infusion. […]

Cryoport: Observations on 1Q, 2017 Results (CYRX, Buy, $3.05)

Investment Section  Overview This report is a follow-up to my April 12, 2017 report “Cryoport: Initiating Coverage of this Highly Unique Health Care Company with a Buy (CYRX, Buy, $2.25)”. If you are unfamiliar with or need a refresher on Cryoport’s business, I would suggest that you read that report before continuing. By every measure […]

Cytokinetics: What Are the Implications for Tirasemtiv Following the Approval of Radicava (Edaravone) for ALS? (CYTK, Buy, $15.40)

Key Points: The surprising and unconventional approval of Radicava (edaravone) shows how desperate the FDA is to expedite the approval of drugs for ALS; this was the first such approval in 20 years. This urgency should extend to getting tirasemtiv on the market if results are generally positive; topline results from the phase 3 VITALITY-ALS […]

Portola Pharamceuticals: Initiating Coverage with a Buy (PTLA, $40.05)

Overview of Report I am initiating coverage of Portola Pharmaceuticals with a Buy and a 2021 price target of $426.This is an extensive initial report on Portola Pharmaceuticals that is organized into five parts: Investment Overview for Portola is a summary of the key investment issues. An investor only needs to read this section in […]

Thoughts on the Probable Launches of the First CAR-T Drugs; Cryoport is a Novel Way to Invest In This: Cryoport (CYRX, Buy, $2.36) and Kite (KITE, Underperform, $83.37)

Key Points: I continue to think that first ever CAR-T drug approval will be for Novartis’ CTL-019 in r/r pediatric ALL in September or October of 2017. Not long afterwards (weeks or a month or two), my best judgment is that CTL-019 and Kite’s Axi-Cel will be approved at the same time for the second […]

Antares: AMAG Submits Supplemental New Drug Application to FDA for Makena® Auto-Injector for Subcutaneous Use: (Antares (ATRS, Buy, $2.86)

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 […]

Cryoport: Initiating Coverage of this Highly Unique Health Care Company with a Buy (CYRX, Buy, $2.25)

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 […]