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Expert Financial Analysis and Reporting

Tag archive for ‘Portola’

Portola: Tidbits from Presentation at JP Morgan Healthcare Conference (PTLA, Buy, $21.96)

Investment Thesis in Brief Andexxa is the only approved product for treating severe bleeds (sometimes life threatening) caused by the Factor Xa inhibitors, principally Xarelto and Eliquis. Current standard of care (SOC) treatments have scant clinical data and are not approved by the FDA. Impotantly, Andexxa inhibits 90% of Factor Xa activity in two minutes […]

Portola: Approval of Gen 2 Manufacturing Process for AndexXa is a Significant Positive (PTLA, Buy, $18.75)

Portola received approval for the Prior Approval Supplement (PAS) for the Gen 2 manufacturing process for AndexXa on the PDUFA date of December 31, 2018. Management had expressed confidence in approval but in dealing with the FDA, it is never over until it’s over. AndexXa was launched in June 2018 using the inefficient Gen 1 […]

Portola Pharmaceuticals: 2019 Is All About the Sales Trajectory of AndexXa (PTLA, $15.46, Buy)

The launch of AndexXa is still in an early stage and there is considerable uncertainty about the sales trajectory in 2019 and beyond. This report focuses on issues that largely will determine sales

Portola: Critical Upcoming Catalysts Have the Potential to Cause a Sharp Upward Move in the Stock (PTLA,  Buy, $29.19)

Investor focus is totally on Andexxa at this point in time as the disappointing 2Q, 2018 sales results for Bevyxxa have caused investors to write it off and cerdulatinib is barely a blip on their radar screen. In contrast to the negative view on Bevyxxa, I believe that it will become a very meaningful product […]

Portola: Reiteration of Buy Recommendation (PTLA, Buy, S27.46)

Introduction This is the latest in a series of updates on Portola and is prompted by information presented in the second quarter conference call. If this is your first encounter with the Company and you would like greater detail on the company’s technology, its products and clinical trial data, you may want to read my […]

Portola: Update and Reiteration of Buy Recommendation (PTLA, Buy, $39.31)

Investment Thesis in Brief This report is based on presentations by management at recent brokerage conferences. It is an update and not a comprehensive analysis of Portola. For more detailed analysis, you may want to refer to a series of reports on my website. I am reiterating my Buy recommendation on Portola. I have a […]

Portola: Approval of AndexXa is a Major Positive (PTLA, Buy, $41.19)

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, […]

Portola: Why I Think that AndexXa is Likely to be Approved (PTLA, Buy, $36.44)

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 […]

Portola: Uncertainty on AndexXa Approval Leads to 30% Decline in Stock Price (PTLA, Buy, $31.16)

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 […]

Portola Announces a Delay in PDUFA Date for AndexXa (PTLA, Buy, $54.86)

Portola announced after the close on December 22, 2017 that the FDA will extend its review of AndexXa (andexanet alfa) by 90 days. According to the Company, it just submitted additional data requested by the agency for the ongoing ANNEXA-4 study as part of the continuing review process.  This constitutes an amendment to the submission […]