Post by tomsylver on Nov 7, 2018 22:50:16 GMT
Portola Pharmaceuticals Reports Third Quarter 2018 Financial Results and Provides Corporate Update
– Company Improves Financial Expectations for 2018 Operating Expenses –
– Conference Call Today at 4:30 p.m. ET –
“I am excited to join Portola at such a pivotal moment in the Company’s history. Having just completed my first month in role, I am very encouraged by the progress and momentum we’ve achieved since prioritizing Andexxa, including our preparations for the potential approval of Generation 2 supply in the United States and in Europe,” said Scott Garland, Portola’s president and chief executive officer. “The early feedback from our first full quarter of sales gives us confidence in the significant long-term potential for Andexxa, and we are now implementing our new focused strategy for Bevyxxa. I am also excited about the potential for cerdulatinib, which recently received Orphan Drug Designation. We have a number of critical milestones ahead that I expect we will achieve and we look forward to delivering our life-saving medications to more patients, and driving sustainable growth and value for shareholders.”
Third Quarter 2018 Financial Results
Total operating expenses for the third quarter of 2018 were $83.3 million, compared with $84.3 million for the same period in 2017. Total operating expenses for the third quarter of 2018 included $11.4 million in stock-based compensation expense, compared with $10.1 million for the same period in 2017.
Research and development expenses were $40.2 million for the third quarter of 2018, compared with $55.3 million for the third quarter of 2017. The decrease is driven primarily by the timing of manufacturing costs for Andexxa Generation 2 campaigns. Approximately $12 million, or 30 percent, of R&D expense for the quarter and $75 million, or 45 percent, for nine months year-to date of total R&D expense was related to Andexxa manufacturing.
Selling, general and administrative expenses for the third quarter of 2018 were $38.8 million, compared with $28.9 million for the same period in 2017, reflecting the investment in our field force and marketing for our product launches.
For the third quarter of 2018, Portola reported a net loss of $71.3 million, or $1.08 net loss per share, compared with a net loss of $82.9 million, or $1.41 net loss per share, for the same period in 2017.
Cash, cash equivalents and investments at September 30, 2018 totaled $380.9 million, compared with $534.2 million as of December 31, 2017.
2018 Annual Financial Guidance
For the fiscal year 2018, Portola is updating its guidance for GAAP operating expenses, which are now expected to be between $355 million and $365 million, a decrease from the prior guidance range of between $390 million and $430 million, both including stock-based compensation. The updated guidance reflects the Company’s narrowed focus on a group of key hospitals for the Bevyxxa launch, as well as additional cost savings for the year.
Recent Achievements and Events
• Submitted Prior Approval Supplement (PAS) to U.S. FDA for large-scale Generation 2 Andexxa manufacturing process; assigned a PDUFA
date of December 31, 2018.
• Transitioned commercial focus to the ongoing Andexxa U.S. launch under the Early Supply Program.
• Secured New Technology Add-on Payment (NTAP) for Andexxa, which became effective as of October 1, 2018.
• Implemented new strategy for Bevyxxa U.S. launch focused on establishing 10 Centers of Excellence to provide a model for driving broader adoption.
• Received Orphan Drug Designation from the U.S. Food and Drug Administration for cerdulatinib for the treatment of peripheral T-cell lymphoma.
• Eight abstracts presented at the European Society of Cardiology (ESC) meeting.
Upcoming Milestones
• Committee for Medicinal Products for Human Use (CHMP) opinion on andexanet alfa, with potential for European approval of andexanet alfa in the first half of 2019.
• End-of-Phase 2 meeting and determination of regulatory path forward for cerdulatinib in Q1 2019.
• New interim Phase 2a study results for cerdulatinib to be presented in an oral session at the 60th American Society of Hematology (ASH) Annual Meeting. Also accepted for presentation: outcomes-based research on the burden of hospital readmissions for venous
thromboembolism among patients with cancer (oral) and two poster presentations on andexanet alfa.
Conference Call Details
Portola will host a conference call today, Wednesday, November 7, 2018, at 4:30 p.m. ET, during which time management will discuss the third quarter 2018 financial results, updates on the U.S. launches of Andexxa and 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 3387315. The webcast can be accessed live on the Investor Relations section of the Company’s website at investors.portola.com. It will be archived for 30 days following the call.
(In thousands, except share and per share data)
Three Months Ended September 30, Nine Months Ended September 30,
2018 2017 2018 2017
Revenues:
Product revenue, net $ 7,176 $ — $ 10,047 $ —
Collaboration and license revenue 7,001 3,828 14,785 12,743
Total revenues 14,177 3,828 24,832 12,743
Operating expenses:
Cost of Sales 4,292 155 5,680 155
Research and development 40,237 55,273 166,744 135,210
Selling, general and administrative 38,792 28,856 110,547 64,206
Total operating expenses 83,321 84,284 282,971 199,571
Loss from operations (69,144) (80,456) (258,139) (186,828)
Interest and other income, net 3,924 663 9,123 952
Interest expense (5,957) (3,148) (12,642) (8,243)
Net loss (71,177) (82,941) (261,658) (194,119)
Net (income) loss attributable to noncontrolling interest (SRX Cardio) (126) 5 (17) (190)
Net loss attributable to Portola $ (71,303) $ (82,936) $ (261,675) $ (194,309)
Net loss per share attributable to Portola common stockholders:
Basic and diluted $ (1.08) $ (1.41) $ (3.97) $ (3.38)
Shares used to compute net loss per share attributable to Portola common
stockholders:
Basic and diluted 66,165,104 58,940,764 65,855,672 57,569,593
Unaudited Condensed Consolidated Balance Sheet Data
(In thousands)
September 30, 2018 December 31, 2017
(Unaudited)
Cash, cash equivalents and investments $ 380,865 $ 534,233
Prepaid research and development 963 734
Prepaid manufacturing 4,071 2,333
Trade and other receivables, net 7,150 3,750
Unbilled - collaboration and license revenue 9,872 —
Total current assets 403,692 477,923
Property and equipment, net 4,921 5,217
Intangible assets 7,423 7,851
Prepaid and other long-term assets 20,788 9,609
Total assets 447,705 571,676
Accounts payable 15,163 9,304
Accrued research and development 16,675 44,973
Accrued compensation and other liabilities 17,490 15,078
Deferred revenue (current portion and long-term) 7,443 29,967
Current portion of notes payable and long term debt 9,395 —
Total current liabilities 61,081 80,524
Notes payable, less current portion 49,074 50,565
Long term debt, less current portion 152,675 54,251
Long term obligation to collaborator, less current portion 7,204 8,000
Total liabilities 280,777 222,183
Total Portola stockholders’ equity 164,424 346,866
Noncontrolling interest (SRX Cardio) 2,504 2,627
Total stockholders’ equity 166,928 349,493
Total liabilities and stockholders’ equity 447,705 571,676
About Portola Pharmaceuticals, Inc.
Portola Pharmaceuticals is a commercial-stage biopharmaceutical company focused on the discovery, development and commercialization of novel
therapeutics that could significantly advance the fields of thrombosis and other hematologic diseases. The Company’s two FDA-approved medicines
are Andexxa® [coagulation factor Xa (recombinant), inactivated-zhzo], the first and only antidote for patients treated with rivaroxaban and apixaban
when reversal of anticoagulation is needed due to life-threatening or uncontrolled bleeding, and Bevyxxa® (betrixaban), the first and only oral, oncedaily
Factor Xa inhibitor for the prevention of VTE in adult patients hospitalized for an acute medical illness. The company also is advancing
cerdulatinib, a Syk/JAK inhibitor for the treatment of hematologic cancers.
Forward-Looking Statements
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, the statements under the caption
“Upcoming Milestones,” and those regarding 2018 financial guidance and potential regulatory approvals. Risks that contribute to the uncertain nature
of the forward-looking statements include: the risk that physicians, patients and payers may not see the benefits of utilizing Andexxa or Bevyxxa for
the indications which they are approved; our ability to continue to manufacture our products and to expand approved manufacturing facilities; the
possibility of unfavorable results from additional clinical trials involving Andexxa; the risk that the EMA may not approve Andexxa in the currently
anticipated timelines or at all, and that any marketing approvals or reimbursement limitations may have significant limitations on its use; the risk that
Portola may not obtain additional regulatory approvals necessary to expand approved indications for Andexxa; our expectation that we will incur
losses for the foreseeable future and will need additional funds to finance our operations; the accuracy of our estimates regarding expenses and capital
requirements; our ability to successfully build a hospital-based sales force and commercial infrastructure; our ability to obtain and maintain
intellectual property protection for our product candidates; and our ability to retain key scientific or management personnel. These and other risks and
uncertainties are described more fully in our most recent filings with the Securities and Exchange Commission, including our most recent quarterly
report on Form 10-Q. All forward-looking statements contained in this press release speak only as of the date on which they were made. We undertake
no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.
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Investor Contact: Media Contact:
Cara Miller Patrick Ryan
Portola Pharmaceuticals Pure Communications
ir@portola.com pryan@purecommunications.com