What happened
After it reported fourth-quarter results and solidified its cash position without issuing more shares, Portola Pharmaceuticals (PTLA) shares had gained 15.3% at noon EST on Friday.
So what
Portola Pharmaceuticals has struggled in its bid to go from promising clinical-stage upstart to commercial-stage darling. Despite Food and Drug Administration (FDA) approval for two distinct therapies, lackluster sales have dampened investors' enthusiasm.
Click here for the latest earnings call transcript for Portola Pharmaceuticals.
Image source: Getty Images.
In its fourth-quarter earnings report, the company unveiled some promising insights that could indicate its toughest days are behind it. Last year the company installed a new CEO who refocused resources away from Bevyxxa, a factor Xa anticoagulant targeting patients after hospitalization. Instead management redoubled efforts on Andexxa, a factor Xa reversal agent that can counter the anticoagulant effects of multibillion-dollar blockbusters Xarelto and Eliquis.
That decision appears to be paying off. Q4 Bevyxxa sales fell to just $35,000 from $552,000 in Q3, but Andexxa sales increased to $14 million in Q4 from $7.7 million in the prior quarter. The bump up in Andexxa revenue coincided with FDA approval of the company's generation-two manufacturing process, which should enable the company to significantly increase its distribution and to distribute to more emergency centers. For the full year, Portola's total revenue improved to $40.1 million from $22.5 million in 2017.
Revenue could head higher this year as Andexxa's penetration increases in the U.S., and if European regulators give Andexxa an OK. A key advisory committee in Europe has already backed Andexxa, and an official decision by EU decision makers is expected in May. If approved, it will be sold under the brand name Ondexxya.
The company also reported a royalty deal that bulks up its balance sheet. It inked a $125 million loan agreement with HealthCare Royalty Partners and Athyrium Capital Management. It finished 2018 with $317 million in cash, cash equivalents, and investments.
Now what
The company is spending oodles of money on R&D and in support of Andexxa, and as a result its net loss was a whopping $350 million in 2018. The company expects to spend at least $325 million on R&D and SG&A in 2019.
Nevertheless, Portola's cash infusion should help it expand Andexxa demand while also funding a registration study for its blood-cancer drug, cerdulatinib. Management met with the FDA to discuss midstage results for cerdulatinib, a Syk/JAK inhibitor, and based on those discussions, it plans to launch a phase 3 trial later this year.
Overall, Portola Pharmaceuticals isn't out of the woods yet, but it's making progress, and that's welcome news for shareholders.
