The FDA approved Portola Pharmaceuticals' (NASDAQ:PTLA) first commercial drug, Bevyxxa, in June, but changes to its manufacturing process resulted in the filing of a prior approval supplement (PAS) and, as a result, a delay in Bevyxxa's launch. The FDA had planned to make a decision on Bevyxxa's PAS at the end of November. However, on Nov. 22, it pushed its decision date to Jan. 30. Apparently, it didn't need as much time as it thought. It signed off on the PAS yesterday, clearing the way for Portola Pharmaceuticals to begin selling Bevyxxa in January.
Reshaping an important market
Bevyxxa is a factor Xa anticoagulant approved to prevent venous thromboembolism (VTE) in acutely ill medical patients who are being discharged from hospitals following a serious medical event, such as heart failure, stroke, and infection.
Currently, doctors prescribe Lovenox to these patients for between six and 14 days to reduce the risk of VTE, yet clots are still common. An estimated 24 million acutely ill medical patients are hospitalized every year in the G7 countries, and sadly, VTEs cause 100,000 deaths per year in this patient population in the U.S. alone, despite Lovenox's use.
Bevyxxa inhibits factor Xa, a key clotting factor, and in trials, dosing Bevyxxa for 35 days to 42 days resulted in fewer cases of VTE than were observed in a control group of patients given Lovenox. Since factor Xa's drugs, including Xarelto and Eliquis, are already widely prescribed in other indications, persuading doctors to prescribe Bevyxxa shouldn't be very hard.
Bevyxxa could quickly displace Lovenox in much the same way that Xarelto and Eliquis are displacing warfarin, an anticoagulant that's dominated markets like atrial fibrillation for decades. Xarelto and Eliquis are both multibillion-dollar drugs, and Lovenox's peaks sales were near $3 billion before losing patent protection, so Bevyxxa has a good shot at becoming a top seller.
Portola Pharmaceuticals' already hired, trained and deployed 56 sales representatives who have been laying the groundwork with decision makers so that Bevyxxa can hit the ground running. Management said on its third-quarter conference call that it plans to increase the number of sales representatives to 72 after the FDA approves the PAS, so it's likely that hiring will begin soon.
Bevyxxa's launch could provide an important source of revenue in 2018, but it's not the only important drug that management might launch next year. Investors could get even more good news if the FDA approves AndexXa, Portola Pharmaceuticals' factor Xa reversal agent. The FDA is scheduled to make a decision on AndexXa on Feb. 3, and if it gets the green light, it will become the only FDA-approved drug that can be used to halt the anticoagulant activity among this class of drugs. Between 1% and 3% of patients on oral factor Xa inhibitors experience a major bleeding event, and another 1% of patients require emergency surgery, so AndexXa's addressable market is about 90,000 people in the U.S. alone. The size of that market suggests this company could have two blockbuster drug launches in 2018, assuming AndexXa's review goes off without a hitch.
Exactly how much money these drugs bring in for Portola Pharmaceuticals in 2018 will depend on how payer negotiations go, but given Bevyxxa could reduce rehospitalization and AndexXa could reduce complications associated with unexpected bleeds or emergency surgery, I think payers will embrace them. If I'm right, then Portola Pharmaceuticals could make a big leap toward profitability next year, making it an intriguing stock for investors to buy.