Portola Pharmaceuticals: AndexXa BLA Resubmitted; Reiterating Buy

Investment Thesis

Portola (PTLA) issued a press release on August 3, 2017, that reported it had just resubmitted the BLA for AndexXa, which is in line with prior management guidance. I anticipate a six-month review and US approval in 1Q, 2018. If so, it will represent the second approval of a potential blockbuster for Portola following the June 23, 2017, approval of Bevyxxa (betrixaban). In my opinion, these products have extraordinary commercial potential. I initiated coverage of Portola with a buy on May 4, 2017: see Portola Pharmaceuticals: Initiating Coverage with a Buy (PTLA, $40.05). In that report, I projected that in 2022 betrixaban would achieve worldwide sales of $1.3 billion and AndexXa $910 million. In the same report, I estimated a price target of $426 per share in 2021. 

My estimates for Bevyxxa are based only on the potential for use in its initial indication for acute medically ill patients; it is the only oral Factor Xa inhibitor approved for this indication. Some investors believe that my sales estimates are conservative because they give no potential for future approval and use in other key indications which have led to blockbuster sales for Eliquis, Xarelto, and Savaysa. These include:

  • reducing the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation,
  • treatment of deep vein thrombosis (DVT),
  • treatment pulmonary embolism (PE),
  • reduction in the risk of recurrence of DVT and of PE and
  • prophylaxis of DVT, which may lead to PE in patients undergoing knee or hip replacement surgery.

Because of the superior pharmacokinetics of Bevyexxa relative to the other oral Factor Xa inhibitors, some argue that it has the potential to gain meaningful share in these indications even though it is the fourth drug to come to market. They maintain that this means that my estimates could be quite conservative. I tend to agree with them.

In the press release, Portola estimated the addressable patient population for AndexXa in the US as 150,000 which is more than double the estimate I used in making the 2022 sales projection. Again, it appears that my sales estimate might be significantly low.

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Disclosure: None.

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