What happened
After the company reported its fourth-quarter financials and disclosed that the Food and Drug Administration has requested additional information on AndexXa, a drug that the agency has already once rejected, shares of Portola Pharmaceuticals (PTLA +0.00%) tumbled 25.4% today.
So what
Portola Pharmaceuticals' two most advanced drugs are Bevyxxa, an anticoagulant that won FDA approval last year and launched in January 2018, and AndexXa, an anticoagulant reversal agent under FDA review for approval.
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The recent launch of Bevyxxa means that Portola Pharmaceuticals' fourth-quarter financials don't offer much insight. Absent any product sales in the quarter, the company reported $9.8 million in collaboration and licensing revenue and a loss of $91.8 million.
On the earnings conference call, however, management did provide some color on its business and, unfortunately, not all of it was encouraging.
The good news is that Portola Pharmaceuticals has secured insurance coverage for Bevyxxa for about 98 million lives and management thinks sales could begin to meaningfully ramp up later this year.
The bad news, though, is that AndexXa's launch timeline could be in jeopardy. During its conference call, management revealed that a request by EU regulators for additional data on AndexXa by will push their decision on the drug back toward the end of this year. Furthermore, it was disclosed that the FDA is also requesting more information on AndexXa. It isn't saying that request will delay the FDA's decision beyond the scheduled May 4 date, but it's possible.
Now what
Bevyxxa and AndexXa have the potential to be billion-dollar blockbusters, but there are questions that investors need answers to. Specifically, will Bevyxxa live up to expectations, and will AndexXa's approval be delayed?
We'll find out the answer to the Bevyxxa question over the next few quarters, so investors will want to watch sales trends to confirm that prescription volume is climbing as quickly as expected. As for AndexXa, management hopes to provide more insight into the FDA's request when it presents data at the American College of Cardiology meeting on March 12. Hopefully, it will be able to confirm AndexXa's FDA decision date then.
