On August 7, 2019 Portola Pharmaceuticals, Inc. (Nasdaq: PTLA) reported financial results for the three months ended June 30, 2019, and provided a corporate update (Press release, Portola Pharmaceuticals, AUG 7, 2019, View Source [SID1234538344]).

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"This is our fifth consecutive quarter of strong revenue growth reflecting our exceptional launch execution and continued demand for Andexxa. Support for this novel therapy continues to grow with CMS’ decision to increase our NTAP reimbursement and two recent updates from the Joint Commission which recommend specific reversal agents for Factor Xa inhibitors. In Europe, the team exceeded expectations on timing for the first sale of Ondexxya, and we are positioned well to continue our launch in key European countries," said Scott Garland, Portola’s president and chief executive officer. "We look forward to building upon our momentum backed by a rapidly growing Factor Xa inhibitor market and increasing global demand for Andexxa. Beyond Andexxa, we plan to initiate a registrational trial for cerdulatinib."

Quarter Ending June 30, 2019

Total revenues for the second quarter of 2019 were $28.4 million, compared with $4.0 million for the second quarter of 2018. This includes $27.1 million in net product revenues from sales of Andexxa [coagulation factor Xa (recombinant), inactivated-zhzo], $74 thousand in revenues from Bevyxxa (betrixaban) sales and $1.3 million in collaboration and license revenues.

Net loss attributable to Portola, according to generally accepted accounting principles in the U.S. (GAAP), was $66.2 million, or $0.97 net loss per share for the second quarter of 2019, compared with a net loss of $106.2 million, or $1.61 net loss per share, for the same period in 2018. This includes the effect of a $3.1 million impairment charge taken in the second quarter related to the discontinuation of our SRX program.

Cash, cash equivalents and investments at June 30, 2019, totaled $273.9 million, compared with $317.0 million as of December 31, 2018.

Total GAAP operating expenses for the second quarter of 2019 were $92.4 million, compared with $107.7 million for the same period in 2018. This decrease was driven primarily by manufacturing costs for Andexxa Gen 2 being capitalized and no longer flowing through R&D.

Stock-based compensation expense for the second quarter of 2019 was $12.3 million, compared with $13.2 million for the same period in 2018.

Cost of Sales (COS) for the second quarter of 2019 was $5.0 million, compared to $1.1 million for the same period in 2018. The increase was driven by the launch of Andexxa.

Research and development (R&D) expenses were $33.5 million for the second quarter of 2019, which includes the impairment charge, compared with $66.4 million for the second quarter of 2018. The decrease was driven primarily by the manufacturing costs for Andexxa Gen 2 being capitalized and no longer flowing through R&D and partially offset by the SRX program impairment charge.

Non-GAAP research and development expenses, which excludes the SRX program impairment charge, were $30.4 million for the second quarter of 2019. Please see the reconciliation of GAAP to non-GAAP financial measures table at the end of this release for more details.

Selling, general and administrative (SG&A) expenses for the second quarter of 2019 were $53.9 million, compared with $40.2 million for the same period in 2018. The increase was driven by the expansion of the Company’s field force, commercial activities to support the launch of Andexxa and launch preparations in Europe.
Recent Achievements and Events

Launched Ondexxya with first orders in Europe.
CMS increased maximum NTAP reimbursement for Andexxa from 50 to 65 percent effective on October 1, 2019.
Presented new Andexxa data from a subset of patients from the ANNEXA-4 study with spontaneous (non-traumatic) intracranial hemorrhage, which demonstrated excellent or good hemostasis achieved in 79% of evaluable patients.
Presented in vitro data demonstrating that four-factor prothrombin complex concentrate (4F-PCC) does not appear to have an effect on the inhibition of thrombin generation by apixaban or rivaroxaban unless the Factor Xa inhibitor concentration was less than 75 ng/mL. In contrast, data from the same thrombin generation assay demonstrated that Andexxa fully corrected the inhibition of thrombin generation by apixaban and rivaroxaban across a broad range of inhibitor concentrations.
Presented new interim results from the cerdulatinib Phase 2a study demonstrating favorable safety and efficacy profiles in patients with relapsed/refractory follicular lymphoma (FL) receiving cerdulatinib alone (45% objective response rate) or in combination with rituximab (62% objective response rate).
Planned Upcoming Milestones

Continue launch of Ondexxya in a select group of high-potential European countries where Factor Xa inhibitor use is among the highest.
Plan to initiate surgical study for Andexxa label expansion by year end or beginning of 2020.
Launch a cerdulatinib registrational study in peripheral T-cell lymphoma (PTCL) by the end of the year.
Present new data from additional subsets of the ANNEXA-4 study.
Conference Call Details
Portola will host a conference call today, Wednesday, August 7, 2019, at 4:30 p.m. ET, during which time management will discuss the second quarter 2019 financial results, updates on the U.S. launch of Andexxa, and other matters. 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 8046269. 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.