On August 9, 2017 Portola Pharmaceuticals Inc. (Nasdaq:PTLA) reported financial results and provided a corporate update for the quarter ended June 30, 2017 (Press release, Portola Pharmaceuticals, AUG 9, 2017, View Source [SID1234520122]).
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"FDA approval of our first product, Bevyxxa, in the second quarter marked the ultimate milestone for Portola and the millions of patients who could benefit from this important new medicine," said Bill Lis, chief executive officer of Portola. "We resubmitted our BLA for AndexXa in the U.S. and are committed to working closely with the FDA toward approval, and with the EMA for approval of both products in 2018. Based on robust clinical data, both Bevyxxa and AndexXa are potentially life-saving medicines and are highly anticipated by the medical community."
Recent Achievements, Upcoming Events and Milestones
Bevyxxa (betrixaban) -– an oral, once-daily Factor Xa inhibitor approved by the U.S. Food and Drug Administration (FDA) under Priority Review on June 23, 2017
First and only anticoagulant for hospital and extended duration prophylaxis (35 to 42 days) of venous thromboembolism (VTE) in adult patients hospitalized for an acute medical illness who are at risk for thromboembolic complications due to moderate or severe restricted mobility and other risk factors for VTE
Anticipate U.S. launch between September and November 2017
Expect opinion from the Committee for Medicinal Products for Human Use (CHMP) by late 2017 or early 2018
AndexXa (andexanet alfa) – a Factor Xa inhibitor antidote in development for patients treated with a Factor Xa inhibitor when reversal of anticoagulation is needed due to life-threatening bleeding or when urgent surgery is required; designated a Breakthrough Therapy and an Orphan Drug by the FDA
Resubmitted Biologics License Application (BLA) to the FDA on August 3, 2017
Expect to receive an opinion from the CHMP by early 2018
Cerdulatinib – an oral, dual Syk/JAK inhibitor in development to treat relapsed and refractory hematologic cancers
Presented interim data at the International Congress of Malignant Lymphoma and the European Hematology Association (EHA) (Free EHA Whitepaper) from a Phase 2a study evaluating cerdulatnib in patients with relapsed/refractory B-cell malignancies that demonstrated evidence of clinical activity in patients with relapsed/refractory B-cell malignancies; also presented preliminary data suggesting activity in t-cell lymphoma
Second Quarter 2017 Financial Results
Collaboration and license revenue earned under Portola’s collaboration and license agreements with Bristol-Myers Squibb Company and Pfizer, Bayer Pharma, Janssen Pharmaceuticals and Daiichi Sankyo was $3.8 million for the second quarter of 2017 compared with $4.2 million for the second quarter of 2016.
Total operating expenses for the second quarter of 2017 were $69.6 million, compared with $61.9 million for the same period in 2016. Total operating expenses for the second quarter of 2017 included $13.3 million in stock-based compensation expense, compared with $7.6 million for the same period in 2016.
Research and development expenses were $49.3 million for the second quarter of 2017, compared with $44.8 million for the second quarter of 2016. The increase in R&D expenses was largely attributable to an increase in manufacturing costs to produce betrixaban active pharmaceutical ingredient and other program costs related to cerdulatinib.
Selling, general and administrative expenses for the second quarter of 2017 were $20.3 million, compared with $17.0 million for the same period in 2016.
For the second quarter of 2017, Portola reported a net loss of $69.7 million, or $1.22 net loss per share, compared with a net loss of $57.3 million, or $1.02 net loss per share, for the same period in 2016.
Cash, cash equivalents and investments at June 30, 2017 totaled $269.7 million, compared with cash, cash equivalents and investments of $318.8 million as of December 31, 2016.