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Portola Pharmaceuticals Reports Fourth Quarter and Year-End 2015 Financial Results and Provides Corporate Update
“During the fourth quarter of 2015, we executed on several milestones that we expect will make 2016 a year of unprecedented progress. We plan to commercially launch andexanet alfa and report pivotal Phase 3 results from our APEX study that, if positive, will support the global approval of betrixaban,” said
Recent Achievements, Upcoming Events and Milestones
Betrixaban – an
- Plan to report topline results from the 7,514-patient pivotal Phase 3 APEX (Acute Medically Ill VTE Prevention with Extended Duration Betrixaban) Study in early April.
- Plan to submit a New Drug Application to the
FDAin the second half of 2016, subject to positive APEX data.
Andexanet alfa – an
FDAaccepted the Biologics License Application (BLA) for filing February 16, 2016. The BLA was granted a priority review under an Accelerated Approval pathway, and assigned a PDUFA date of August 17, 2016. We plan to launch andexanet alfa commercially in the U.S. in the second half of 2016, subject to FDAapproval.
- The full data set from the ANNEXA-R study with rivaroxaban was presented in a Late-Breaking Clinical Trial Session at the American Heart Association’s Scientific Sessions 2015 and simultaneously published in the
New England Journal of Medicine.
- Licensed development and commercial rights in
Japanto Bristol-Myers Squibb Companyand Pfizer Inc.Separately, entered into a clinical collaboration agreement with Bayer HealthCareto include its Factor Xa inhibitor rivaroxaban in the development program in Japan.
- Continue to enroll patients in ANNEXA-4, a Phase 4 confirmatory study of patients receiving apixaban, rivaroxaban, edoxaban or enoxaparin who present to the hospital with an acute major bleed.
- Plan to present data from the Phase 2 proof-of-concept andexanet study with betrixaban in healthy volunteers at a medical conference in 2016 The study was designed to evaluate safety and define the dose of andexanet required to reverse the anticoagulant effect of betrixaban.
- Plan to complete
FDApre-approval inspection of the initial (Generation 1 2,500 liter scale at CMC Biologics). Generation 1 validation batch runs at the 6 x 2,000 liter scale are ongoing.
- Completed two Generation 2 engineering batches manufactured by
Lonzaat the 10,000 liter scale, with target yields achieved. Expect commercial validation batches to begin in the second half of 2016.
Cerdulatinib – an oral, dual Syk/JAK kinase inhibitor in development to treat resistant or relapsed hematologic cancer patients.
- Presented three abstracts at the 2015 ASH Annual Meeting on cerdulatinib’s preclinical activity in chronic lymphocytic leukemia; clinical and pharmacodynamic results of a Phase 1/2 study with relapsed/refractory B cell malignancies; and pharmacokinetic modeling of cerdulatinib plasma concentrations in patients with relapsed/refractory B cell malignancies.
- Continue to dose-escalate for clinical activity and tolerability in the ongoing Phase 1/2 study in patients with relapsed/refractory B-cell malignancies. Plan to initiate enrollment in expansion cohorts this year.
$162.7 millionin net proceeds from an underwritten public offering of common stock in December 2015.
Fourth Quarter and Year-End Financial Results
Collaboration revenue earned under Portola's collaborations with
Total operating expenses for the fourth quarter of 2015 were
For the fourth quarter of 2015, Portola reported a net loss of
Cash, cash equivalents and investments at
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Portola Forward-looking Statement
Statements contained in this press release regarding matters that are not historical facts are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Such statements include, but are not limited to, statements regarding: the timing and ability to achieve the milestones and events described under the section "Recent Achievements, Upcoming Events and Milestones," our goal of becoming a fully commercialized biopharmaceutical company, the projected timing of our product launches, the occurrence and timing of planned filings with the
|Unaudited Condensed Statements of Operations|
|(In thousands, except share and per share data)|
|Three Months Ended||Twelve Months Ended|
|December 31,||December 31,|
|Collaboration and license revenue||$||4,414||$||2,412||$||12,070||$||9,625|
|Research and development||59,814||34,722||200,376||123,639|
|Selling, general and administrative||10,881||6,950||38,869||23,552|
|Total operating expenses||70,695||41,672||239,245||147,191|
|Loss from operations||(66,281||)||(39,260||)||(227,175||)||(137,566||)|
|Interest and other income (expense),net||(190||)||5||305||441|
|Net loss attributable to common stockholders||$||(66,471||)||$||(39,255||)||$||(226,870||)||$||(137,125||)|
|Income tax benefit||365||-||365||-|
|Net loss attributable to Noncontrolling interest (VIE)||-||-||-||-|
|Net loss attributable to Portola||$||(66,106||)||$||(39,255||)||$||(226,505||)||$||(137,125||)|
|Shares used to compute net loss per share attributable to common stockholders:|
|Basic and diluted||53,623,313||48,153,468||51,981,463||42,997,463|
|Net loss per share attributable to common stockholders:|
|Basic and diluted||$||(1.23||)||$||(0.82||)||$||(4.36||)||$||(3.19||)|
|Unaudited Condensed Balance Sheet Data|
|December 31,||December 31,|
|Cash, cash equivalents and investments||$||460,161||$||392,303|
|Prepaid research and development||16,976||1,686|
|Total current assets||465,577||315,077|
|Property and equipment, net||6,243||2,776|
|Accrued research and development||24,195||12,545|
|Accrued compensation and other liabilities||8,285||4,933|
|Deferred revenue (current portion and long-term)||27,016||36,585|
|Total current liabilities||51,146||41,131|
|Total Portola stockholders’ equity||427,396||347,802|
|Noncontrolling interest (VIE)||2,927||-|
|Total liabilities and stockholders equity||502,924||416,495|
Investor Contact: Ana Kapor
Portola Pharmaceuticalsir@portola.com Media Contact: Julie Normart W2O Groupjnormart@w2ogroup.com