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Portola Pharmaceuticals Reports First Quarter 2018 Financial Results and Provides Corporate Update
-- Conference Call Today at
“We achieved several major manufacturing and regulatory milestones this past year, including last week’s U.S. approval of Andexxa®. We are now concentrating the Company’s efforts on the successful launch of Andexxa and Bevyxxa®, which both have the potential to impact public health and become standards of care in the field of thrombosis,” said
Recent Achievements, Upcoming Events and Milestones
Andexxa [coagulation factor Xa (recombinant), inactivated-zhzo]– antidote for the reversal of the Factor Xa inhibitors rivaroxaban and apixaban.
- Andexxa received Accelerated Approval from the
FDAon May 3, 2018for patients treated with rivaroxaban and apixaban, when reversal of anticoagulation is needed due to life-threatening or uncontrolled bleeding.
- Earned an additional
$100 millionmilestone payment from the Company’s royalty-based financing with Health Care Royalty Partnersbased on the FDAapproval of Andexxa in May 2018.
- Early Supply Program to launch in June with broader commercial launch anticipated in early 2019, upon
FDAapproval of the Generation 2 product.
- Presented interim data from the ongoing Phase 3b/4 ANNEXA-4 study in a late-breaking clinical trial presentation at the American College of Cardiology’s 67th Annual Scientific Session & Expo (ACC.18). Enrollment on track for completion this summer.
- Received a positive CHMP trend vote and working with regulatory authorities to address their accompanying request for additional data.
- Built significant Generation 2 product inventory to meet broad demand upon regulatory approval in the U.S. and
Bevyxxa (betrixaban) – oral, once-daily Factor Xa inhibitor approved for extended prophylaxis of venous thromboembolism (VTE) in acute medically ill patients with risk factors for VTE.
- Initiated U.S. commercial launch and continued to expand the field force and market access teams.
- Additional results from the APEX trial published in the
American Heart Journaland the American Journal of Medicinecontinue to highlight betrixaban’s effect on symptomatic VTE and VTE-related deaths.
- Eight abstracts accepted at the upcoming
International Society on Thrombosis and Haemostasis(ISTH) and European Society of Cardiology(ESC) meetings.
Cerdulatinib – an oral, dual-spleen tyrosine kinase (SYK) and janus kinase (JAK) inhibitor in development for the treatment of relapsed/refractory B-cell and other T-cell malignancies in patients who have failed multiple therapies.
- Completed enrollment in two of four cohorts of the ongoing Phase 2a study evaluating the safety and efficacy of cerdulatinib in patients with relapsed/refractory B-cell and T-cell malignancies who have failed multiple therapies.
- Interim results from the ongoing Phase 2a study accepted for presentation at the 2018
American Society of Clinical Oncology( ASCO) Annual Meeting.
- Received initial feedback from the
FDAon the potential regulatory pathway.
First Quarter 2018 Financial Results
Total revenue for the first quarter of 2018 was
Total operating expenses for the first quarter of 2018 were $91.9 million, compared with $45.7 million for the same period in 2017. Total operating expenses for the first quarter of 2018 included $11.0 million in stock-based compensation expense, compared with $9.0 million for the same period in 2017.
Research and development expenses were $60.1 million for the first quarter of 2018, compared with $30.6 million for the first quarter of 2017. The increase is due to the second Generation 2 commercial manufacturing campaign. Selling, general and administrative expenses for the first quarter of 2018 were $31.5 million, compared with $15.0 million for the same period in 2017. The increase is due to the build-out of the field force and marketing spend for the Bevyxxa launch.
For the first quarter of 2018, Portola reported a net loss of $84.2 million, or $1.28 net loss per share, compared with a net loss of $41.7 million, or $0.74 net loss per share, for the same period in 2017. Shares used to compute net loss per share attributable to common stockholders were 65.5 million for the first quarter of 2018 compared with 56.7 million for the same period in 2017.
Cash, cash equivalents and investments at March 31, 2018 totaled
Based on the FDA approval of Andexxa in
Conference Call Details
Portola will host a conference call today, Wednesday, May 9, 2018, at 4:30 p.m. ET, during which time management will provide first quarter 2018 financial results, updates on Andexxa, the U.S. launch of Bevyxxa and other matters. The live call can be accessed by phone by dialing (844) 452-6828 from the U.S. and Canada or 1 (765) 507-2588 internationally and using the passcode 7068059. The webcast can be accessed live on the Investor Relations section of the Company's website at http://investors.portola.com. It will be archived for 30 days following the call.
Statements contained in this press release regarding matters that are not historical facts are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Such statements include, but are not limited to, statements regarding the potential public health impact of Andexxa and Bevyxxa, the timing of the anticipated Early Supply Program launch of Andexxa, our plans to present cerdulatinib interim Phase 2a clinical trial results and our expected receipt of an additional
|Investor Contact:||Media Contact:|
|Cara Miller||Laurie Masonson|
|Portola Pharmaceuticals||Pure Communications|
|Unaudited Condensed Consolidated Statements of Operations|
|(In thousands, except share and per share data)|
|Three Months Ended March 31,|
|Product revenue, net||$||606||$||—|
|Collaboration and license revenue||6,038||5,128|
|Cost of Sales||336||—|
|Research and development||60,067||30,645|
|Selling, general and administrative||31,541||15,021|
|Total operating expenses||91,944||45,666|
|Loss from operations||(85,300||)||(40,538||)|
|Interest and other income, net||3,371||413|
|Net loss attributable to noncontrolling interest (SRX Cardio)||332||45|
|Net loss attributable to Portola||$||(84,178||)||$||(41,719||)|
|Net loss per share attributable to Portola common stockholders:|
|Basic and diluted||$||(1.28||)||$||(0.74||)|
|Shares used to compute net loss per share attributable to Portola common stockholders:|
|Basic and diluted||65,509,945||56,692,788|
|Unaudited Condensed Consolidated Balance Sheet Data|
|March 31, 2018||December 31, 2017|
|Cash, cash equivalents and investments||$||451,085||$||534,233|
|Prepaid research and development||3,449||734|
|Trade and other receivables, net||1,693||3,750|
|Unbilled - collaboration and license revenue||4,660||—|
|Total current assets||436,237||477,923|
|Property and equipment, net||5,393||5,217|
|Prepaid and other long-term assets||4,812||9,609|
|Accrued research and development||22,105||44,973|
|Accrued compensation and other liabilities||10,754||15,078|
|Deferred revenue (current portion and long-term)||9,273||29,967|
|Total current liabilities||57,508||80,524|
|Notes payable, long-term and Long-term debt||107,397||104,816|
|Long term obligation to Collaborator||8,000||8,000|
|Total Portola stockholders’ equity||307,992||346,866|
|Noncontrolling interest (SRX Cardio)||2,176||2,627|
|Total stockholders’ equity||310,168||349,493|
|Total liabilities and stockholders’ equity||496,666||571,676|
Source: Portola Pharmaceuticals, Inc.