On November 6, 2017 Portola Pharmaceuticals Inc. (Nasdaq:PTLA) will report financial results and provide a corporate update for the quarter ended September 30, 2017 (Press release, Portola Pharmaceuticals, NOV 6, 2017, View Source [SID1234521609]).
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“Following FDA approval of our first product, Bevyxxa, our team has been working diligently to bring this important new medicine to patients in need, and we are pleased to report good progress with the FDA on achieving product release,” said Bill Lis, chief executive officer of Portola. “We are also continuing to advance AndexXa, the first-ever Factor Xa inhibitor antidote. This treatment is highly anticipated by the medical community and we are continuing discussions with U.S. and European regulatory authorities on our filings for this novel therapy.”
Recent Achievements, Upcoming Events and Milestones
Betrixaban -– an oral, once-daily Factor Xa inhibitor
Bevyxxa (betrixaban) received U.S. Food and Drug Administration (FDA) approval 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
Committee for Medicinal Products for Human Use (CHMP) opinion anticipated by the end of 2017
Multiple abstracts accepted at the upcoming American Heart Association (AHA) and American Society of Hematology (ASH) (Free ASH Whitepaper) annual meetings
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
The FDA has set an action date of February 3, 2018 to respond to our Biologics License Application (BLA)
CHMP opinion anticipated in Q1 2018
Multiple abstracts accepted at the upcoming AHA and ASH (Free ASH Whitepaper) annual meetings
Corporate
Public offering successfully completed in September 2017, the net proceeds of which, including exercise of the underwriters’ over-allotment option, were $380.6 million.
Industry veteran John “Jack” Lawrence, M.D., appointed senior vice president and chief medical officer. Dr. Lawrence previously served as vice president and cardiovascular therapeutic area head for Bristol-Myers Squibb, including global responsibilities for apixaban.
Third Quarter 2017 Financial Results
Collaboration and license revenue earned under Portola’s collaboration and license agreements with Bristol-Myers Squibb Company, Pfizer, Bayer Pharma, Janssen Pharmaceuticals and Daiichi Sankyo was $3.8 million for the third quarter of 2017, compared with $9.3 million for the third quarter of 2016.
Total operating expenses for the third quarter of 2017 were $84.3 million, compared with $100.8 million for the same period in 2016. Total operating expenses for the third quarter of 2017 included $10.1 million in stock-based compensation expense, compared with $7.8 million for the same period in 2016.
Research and development expenses were $55.3 million for the third quarter of 2017, compared with $87.2 million for the third quarter of 2016. The decrease in R&D expenses was largely attributable to a $27.3 million one-time charge taken in the third quarter of 2016 resulting from the Company’s decision to suspend Line C manufacturing at CMC Biologics.
Selling, general and administrative expenses for the third quarter of 2017 were $28.9 million, compared with $13.6 million for the same period in 2016.
For the third quarter of 2017, Portola reported a net loss of $82.9 million, or $1.41 net loss per share, compared with a net loss of $92.9 million, or $1.64 net loss per share, for the same period in 2016.
Cash, cash equivalents and investments at September 30, 2017 totaled $597.8 million, compared with cash, cash equivalents and investments of $318.8 million as of December 31, 2016. The increase is due to the net proceeds of $380.6 million from the Company’s September 12, 2017 public offering.
If the FDA approves andexanet in Q1 2018, the Company will receive an additional $100 million from its royalty-based financing with Health Care Royalty Partners.
Conference Call Details
Portola will host a conference call today, Monday, November 6, 2017, at 4:30 p.m. Eastern Time, during which management will provide updates on the U.S. launch of Bevyxxa, third quarter 2017 financial results and other matters. The live call can be accessed by phone by calling (844) 452-6828 from the United States and Canada or (765) 507-2588 internationally and using the passcode 7269839. The webcast can be accessed live on the Investor Relations section of the Company’s website at View Source It will be archived for 30 days following the call.