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Portola Pharmaceuticals Reports Second Quarter Financial Results and Provides Corporate Update
Conference Call Today at
“In the second quarter, we completed a successful IPO, raising approximately
- Completed a successful IPO, raising approximately
$126 millionin net proceeds.
Peter Strumphto the newly created position of vice president, technical and clinical operations. Mr. Strumph led the same functions previously at CV Therapeutics in support of the successful development and commercialization of Ranexa® (ranolazine) and Lexiscan® (regadenoson).
- Completed a series of discussions with the
U.S. Food and Drug Administration( FDA), including an end of Phase 2 meeting yesterday, regarding the clinical and manufacturing paths forward for andexanet alfa.
- Portola remains confident that it can develop andexanet alfa under an expedited approval pathway that will allow the Company to bring this important product to market as soon as possible to address a major unmet medical need. Final agreement is pending submission of the Phase 3 protocol, which Portola plans to submit later this year in anticipation of initiating these studies in the first half of 2014.
- Portola signed an agreement earlier this year with
Lonza Group Ltd.to develop a commercial-scale manufacturing process for andexanet alfa. The Company plans to implement changes at Lonzato initiate BLA-enabling studies with a manufacturing process that will allow it to launch andexanet alfa pursuant to an expedited approval. To improve the cost of goods further, additional process changes will be implemented later into the commercial process, either in the initial BLA or as a supplemental BLA.
- Presented positive data from a Phase 2 proof-of-concept study of andexanet alfa at the 2013
Congressof the International Society on Thrombosis and Haemostasis, demonstrating reversal of the anticoagulant activity of Bristol-Myers Squibb’s and Pfizer’s Factor Xa inhibitor Eliquis® (apixaban).
- 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. Portola retains all global development and commercialization rights for andexanet alfa.
- Presented positive data from a Phase 1 single ascending dose study of andexanet alfa at the Arteriosclerosis, Thrombosis and Vascular Biology 2013 Scientific Sessions.
- Complete a futility analysis in 2014 of the pivotal 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 (VTE) in high-risk, acute medically ill patients. Portola is on track to complete APEX enrollment in mid-2015.
- Report data from the ongoing Phase 2 study of andexanet alfa and the Factor Xa inhibitor XARELTO® (rivaroxaban) in the fourth quarter of 2013.
- Initiate a Phase 3 pivotal study in the first half of 2014.
- Report data from additional Phase 2 studies of andexanet alfa and other Factor Xa inhibitors, including edoxaban and betrixaban, and enoxaparin.
- Submit an Investigational New Drug (IND) application to the
FDAin 2013 for this novel, oral, dual Syk-JAK inhibitor program, which will target patients with genetically-defined hematologic cancers, including chronic lymphocytic leukemia and non-Hodgkin lymphoma.
- Initiate a Phase 1/2 clinical study of PRT2070 in 2013.
Second Quarter Financial Results
Collaboration revenues in the second quarter of 2013 were
Total operating expenses for the second quarter of 2013 were
Portola reported a net loss of
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 as a Factor Xa inhibitor, of andexanet alfa to reverse the anticoagulant activity in patients treated with a Factor Xa inhibitor, and of PRT2070 or PRT2607 as kinase inhibitors; the possibility of andexanet alfa being approved by the
*PRT4445 has a tentatively approved International Nonproprietary Name of andexanet alfa.
|PORTOLA PHARMACEUTICALS, INC.|
|Unaudited Condensed Statements of Operations Data|
(In thousands, except share and per share data)
|Three Months Ended||Six Months Ended|
|June 30,||June 30,|
|Collaboration and license revenue||$||2,601||$||66,865||$||5,709||$||69,346|
|Research and development||20,833||13,088||38,556||26,049|
|General and administrative||3,708||3,059||6,747||5,865|
|Total operating expenses||24,541||16,147||45,303||31,914|
|Income (loss) from operations||(21,940||)||50,718||(39,594||)||37,432|
|Interest and other income (expense), net||342||(956||)||(147||)||(796||)|
|Net income (loss)||$||(21,598||)||$||49,762||$||(39,741||)||$||36,636|
|Net income (loss) attributable to common stockholders:|
|Shares used to compute net income (loss) per share attributable to common stockholders:|
|Net income (loss) per share attributable to common stockholders:|
|PORTOLA PHARMACEUTICALS, INC.|
|Unaudited Condensed Balance Sheet Data|
|Cash, cash equivalents and investments||$||235,190||$||137,384|
|Receivables from collaborations||3,494||662|
|Total current assets||215,068||134,913|
|Property and equipment, net||2,516||2,861|
|Accrued and other liabilities||16,325||7,399|
|Total current liabilities||29,370||18,824|
|Total stockholders’ equity (deficit)||214,596||(191,569||)|