Shares of Portola Pharmaceuticals (PTLA) gained 5.6% during pre-market trading on Friday, after the company posted a loss of $1.04 per share, narrower than $1.09 per share expected by the Wall Street.
Revenue for the quarter soared 56% year-over-year to $15.3 million, smashing past average analysts’ projection of $10.43 million. The top line includes $14 million in net product revenues from Andexxa sales, $35,000 from Bevyxxa sales.
Portola is one of the biggest pharma gainers this year, rising over 60% in the year-to-date period, helped by positive results from the clinical trials of its bleeding reversal agent Andexxa.
Earlier today, the San Francisco, California-based firm said the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended that the European Commission (EC) grant Ondexxya (marketed as Andexxa in the US) a conditional approval.
The application will now be reviewed by the EC, which has the authority to approve medicines for use in the 28 countries of the European Union, Norway, Liechtenstein, and Iceland. A decision in this regard may be expected by May.
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CEO Scott Garland said, “With the full commercial launch of Andexxa now underway in the United States, the pending approval from the European Commission anticipated in early May, and the further extension of our cash runway, we look forward to continuing our positive momentum through 2019.”
R&D expenses fell 28% in Q4 to $49.5 million, primarily driven by the timing of manufacturing costs for Andexxa Gen 2 campaigns.
Looking into fiscal 2019, Portola expects R&D expenses to be between $125 million and $140 million. SG&A expenses are anticipated to be between $200 million and $215 million, including stock-based compensation expenses.