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Portola Pharmaceuticals Reports Third Quarter Financial Results and Provides Corporate Update
"Throughout this year, we demonstrated our continued ability to execute on our strategic plan and reconfirm our long-term commitment to building an enduring growth company," said
- Completed a follow-on equity financing on
October 22, 2013, raising approximately $100 millionin net proceeds for the Company. With the follow-on offering, the Company now plans to advance andexanet alfa to a BLA filing and expand the scope of the PRT2070 Phase 2 proof-of-concept study to include additional cancer types.
Mark Gossettas senior vice president of commercial to build, lead and develop the commercial organization. He has more than 25 years of experience commercializing important medicines, including the multi-billion dollar anticoagulant Lovenox® (enoxaparin).
- Continued to enroll patients in the global Phase 3 APEX study (Acute Medically Ill VTE Prevention with Extended Duration Betrixaban), which is evaluating betrixaban for hospital and post-discharge prevention of venous thromboembolism in high-risk, acute medically ill patients. The independent data monitoring committee for this study held its second meeting in August and recommended that the Company proceed with the study as planned.
Andexanet alfa (PRT4445*)
- Announced new findings from a Phase 2 proof-of-concept study of andexanet alfa administered as a bolus plus continuous infusion for up to two hours. Results showed a rapid and near complete reversal of the anticoagulation effect of the Factor Xa inhibitor Eliquis®, which was sustained for the duration of the infusion.
- Presented data at the 2013
European Society of Cardiology Congressdemonstrating that andexanet alfa reduced blood loss in anticoagulated animals experiencing an active bleed by reversing Factor Xa inhibitor activity.
- Completed an end-of-phase 2 meeting with the
Food and Drug Administrationregarding the clinical and manufacturing paths forward for andexanet, and based on those discussions, the Company plans to pursue an Accelerated Approval pathway.
- Entered into a collaboration agreement with
Daiichi Sankyofor a Phase 2 program to evaluate andexanet alfa in reversing the anticoagulant activity of the investigational Factor Xa inhibitor edoxaban.
- Initiated and began enrollment in a Phase 1/2 proof-of-concept clinical study of the oral dual Syk-JAK inhibitor PRT2070 in patients with non-Hodgkin's lymphoma or chronic lymphocytic leukemia, including those patients who have progressive or relapsed disease, genetically-defined subtypes or acquired mutations.
Planned Upcoming Milestones
- Complete a futility analysis in 2014 of the Phase 3 APEX Study. Portola remains on track to complete APEX enrollment and report data in mid-2015.
- Report data from two Phase 2 studies of andexanet alfa and the Factor Xa inhibitors XARELTO® (rivaroxaban) and Lovenox® (enoxaparin) over the next two quarters.
- Initiate a pivotal Phase 3 study and Phase 4 confirmatory study in 2014, while concurrently working on manufacturing transfer and process development changes at
- Report proof-of-activity data from the Phase 1/2 clinical study in 2014.
Third Quarter Financial Results
Collaboration revenue for the third quarter of 2013 was
Total operating expenses for the third quarter of 2013 were
Net loss for the third quarter of 2013 was
Conference Call Details
To access the live conference call today,
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 efficacy and use of betrixaban, andexanet alfa and PRT2070; development of a commercial manufacturing process for andexanet alfa; and the statements in the section titled "Upcoming Milestones." Risks that contribute to the uncertain nature of the forward-looking statements include: the accuracy of Portola's estimates regarding its ability to initiate and/or complete its clinical trials; the success of Portola's clinical trials and the demonstrated efficacy of Portola's product candidates thereunder; the accuracy of Portola's estimates regarding its expenses and capital requirements; regulatory developments in
*PRT4445 has a proposed International Nonproprietary Name (pINN) of andexanet alfa.
|PORTOLA PHARMACEUTICALS, INC.|
|Unaudited Condensed Statements of Operations Data|
|(In thousands, except share and per share data)|
|Three Months Ended
|Nine Months Ended |
|Collaboration and license revenue||$ 2,766||$ 738||$ 8,474||$ 70,084|
|Research and development||18,088||9,954||56,642||36,004|
|General and administrative||3,907||2,879||10,654||8,744|
|Total operating expenses||21,995||12,833||67,297||44,748|
|Income (loss) from operations||(19,229)||(12,095)||(58,822)||25,336|
|Interest and other income (expense), net||679||607||532||(188)|
|Net income (loss)||$ (18,550)||$ (11,488)||$ (58,290)||$ 25,148|
|Net income (loss) attributable to common stockholders:|
|Basic||$ (18,550)||$ (11,488)||$ (58,290)||$ 322|
|Diluted||$ (18,550)||$ (11,488)||$ (58,290)||$ 462|
|Shares used to compute net income (loss) per share attributable to common stockholders:|
|Net income (loss) per share attributable to common stockholders:|
|Basic||$ (0.53)||$ (8.38)||$ (3.39)||$ 0.24|
|Diluted||$ (0.53)||$ (8.38)||$ (3.39)||$ 0.23|
|PORTOLA PHARMACEUTICALS, INC.|
|Unaudited Condensed Balance Sheet Data|
|December 31, |
|Cash, cash equivalents and investments||$ 218,928||$ 137,384|
|Receivables from collaborations||227||662|
|Total current assets||178,672||134,913|
|Property and equipment, net||2,428||2,861|
|Accrued and other liabilities||15,960||7,399|
|Deferred revenue – current portion||3,930||4,042|
|Total current liabilities||23,270||18,824|
|Deferred revenue – noncurrent portion||3,337||--|
|Total stockholders' equity (deficit)||197,949||(191,569)|