On February 26, 2020 Portola Pharmaceuticals, Inc. (Nasdaq: PTLA) reported financial results for the fourth quarter and full year ended December 31, 2019 (Press release, Portola Pharmaceuticals, FEB 26, 2020, View Source [SID1234554804]).
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"2019 was a year of significant accomplishments for Portola with the launch of our Gen 2 formulation of Andexxa in the United States and the approval and launch of Ondexxya in Europe. In 2020 we have several catalysts that we expect to drive further adoption and growth worldwide," said Scott Garland, Portola’s president and chief executive officer. "This includes the presentation of new clinical data, enhanced education and support related to reimbursement, the initiation of our urgent surgery study, and continued execution of the Ondexxya launch in Europe. Combined with the robust growth in the Factor Xa inhibitor market and our other strategic initiatives, we are confident that Andexxa has significant long-term growth potential."
Quarter Ending December 31, 2019, and Full-Year 2019 Financial Results
Total global revenues for the fourth quarter of 2019 were $29.2 million compared with $15.3 million for the fourth quarter of 2018. This includes $28.4 million in net product revenues from sales of Andexxa/Ondexxya [coagulation factor Xa (recombinant), inactivated-zhzo], and $0.9 million in collaboration and license revenues. Total global revenues for the full year 2019 were $116.6 million compared with $40.1 million for the full year 2018. This includes $111.5 million in net product revenues from sales of Andexxa/Ondexxya, and $5.0 million in collaboration and license revenues.
Net loss attributable to Portola was $96.7 million, or $1.24 net loss per share for the fourth quarter of 2019, compared with a net loss of $88.5 million, or $1.34 net loss per share, for the same period in 2018. Net loss attributable to Portola was $290.7 million, or $4.06 net loss per share for the full year 2019, compared with a net loss of $350.2 million, or $5.31 net loss per share, for the full year 2018. This includes the effect of a $27.5 million charge taken in the fourth quarter of 2019 for Bevyxxa inventory and manufacturing related to the decision to discontinue the commercialization of Bevyxxa, and a $3.2 million impairment charge taken in the second quarter of 2019 related to the discontinuation of our SRX program.
Non-GAAP net loss for the fourth quarter of 2019 was $58.3 million, or a non-GAAP basic and diluted loss per share of $0.75. For the full year 2019, non-GAAP net loss was $198.2 million, or a non-GAAP basic and diluted loss per share of $2.77. Non-GAAP net loss and loss per share have been adjusted to exclude the Bevyxxa inventory and manufacturing charge and an impairment charge as well as stock-based compensation expenses. Please see the reconciliation of GAAP to non-GAAP financial measures at the end of this release for more details.
Total operating expenses for the fourth quarter of 2019 were $119.4 million compared with $102.5 million for the same period in 2018. Total operating expenses for the full year 2019 were $387.9 million, compared with $385.5 million for the full year 2018.
Non-GAAP total operating expenses, which excludes the Bevyxxa inventory and manufacturing charge and impairment charge as well as stock based compensation expenses, were $81.1 million for the fourth quarter of 2019, and $295.5 million for the full year 2019. Please see the reconciliation of GAAP to non-GAAP financial measures table at the end of this release for more details.
Research and development (R&D) expenses were $29.9 million for the fourth quarter of 2019 compared with $49.5 million for the fourth quarter of 2018. R&D expenses for the full year 2019 were $124.6 million, compared with $216.2 million for the full year 2018. The decrease in both periods is primarily due to the manufacturing costs for Andexxa Gen 2 being capitalized and no longer flowing through R&D.
Selling, general and administrative (SG&A) expenses for the fourth quarter 2019 were $60.0 million compared with $40.6 million for the fourth quarter of 2018. SG&A expenses for the full year 2019 were $218.9 million compared with $151.2 million for the full year 2018. The increase in both periods is due to commercial costs to support the launch of Andexxa, including the expansion of the field sales teams and support for the launch of Ondexxya in Europe.
Cost of sales (COS) for the fourth quarter of 2019 was $29.6 million compared to $12.4 million for the same period in 2018. COS for the full year 2019 was $44.4 million compared with $18.1 million for the full year 2018. The increase in both periods is due to a charge for Bevyxxa inventory and manufacturing as the Company winds down that program.
Please see the GAAP to non-GAAP reconciliation table at the end of this release for a detailed breakdown.
Cash, Cash Equivalents and Investments:
Cash, cash equivalents and investments at December 31, 2019, totaled $466.2 million, compared with $317.0 million as of December 31, 2018. During the fourth quarter, the Company drew down the remaining $62.5 million available under its $125.0 million loan agreement with HealthCare Royalty Partners (HCR) and investment funds manager Athyrium Capital Management, LP.
2020 Annual Financial Guidance
For the fiscal year 2020, Portola expects total R&D expenses to be between $105 million and $120 million, including stock-based compensation expenses of approximately $14 million. Portola expects total SG&A expenses to be between $235 million and $250 million, including stock-based compensation expenses of approximately $38 million.
Recent Achievements and Events
Completed an internal restructuring to align resources to drive Andexxa growth including the discontinuation of commercialization and partnering efforts for Bevyxxa. In addition, the Company has decided not to initiate the CELTIC-1 trial for the SYK/JAK inhibitor cerdulatinib until a partner is identified.
Initiated the single-arm urgent surgery study for Andexxa, ANNEXA-S.
Andexxa was highlighted as a first-line Factor Xa reversal option by the American College of Emergency Physicians in recommendations published in the Annals of Emergency Medicine, bringing the total number of guideline inclusions to 19.
Presented multiple abstracts related to cerdulatinib at the American Society of Hematology (ASH) (Free ASH Whitepaper) 2019 Annual Meeting in December. The data demonstrated good tolerability and clinical response in patients with relapsed/refractory peripheral T-cell lymphoma (PTCL) and cutaneous T-cell lymphoma (CTCL), including a 52% overall response rate in patients with angioimmunoblastic T-cell lymphoma (AITL), and a 76% overall response rate in patients with follicular lymphoma treated with cerdulatinib in combination with rituximab.
Appointed 20-year industry veteran Rajiv Patni, M.D., as executive vice president and chief medical officer, with responsibility for leading Clinical Development, Clinical Operations, Medical Affairs, Regulatory Affairs, Biometrics, Pharmacovigilance and Project Management.
Launched a partnership with the American Heart Association supporting its hospital-focused quality improvement initiative for enhanced awareness and understanding of best care practices for hemorrhagic stroke.
Planned Upcoming Milestones
Present and publish clinical, research and HEOR studies supporting the adoption of Andexxa at medical meetings and in peer-reviewed journals throughout the year, starting with the presentation of three abstracts at the American College of Cardiology 2020 Annual Meeting in March.
Secure reimbursement coverage in the United Kingdom (early 2H 2020), Germany (2H 2020) and other Wave 1 European countries.
Continue launch of Ondexxya into Wave 2 countries in Europe, which include the additional EU5 countries of France, Spain, and Italy.
Conference Call Details
Portola will host a conference call today, Wednesday, February 26, 2020, at 4:30 p.m. ET, during which time management will discuss the fourth quarter and full-year 2019 financial results, updates on the U.S. and European launches of Andexxa/Ondexxya, and its operations. The live call can be accessed by phone by calling (844) 452-6828 from the United States and Canada or 1 (765) 507-2588 internationally and using the passcode 6192918. 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.