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Portola Pharmaceuticals Inc (PTLA)
Q3 2013 Earnings Conference Call
November 05, 2013 / 4:30 p.m. E.T.
Alexandra Santos – Director, Corporate Communications and IR
Bill Lis – CEO
John Curnutte – EVP, R&D
Mardi Dier – CFO
Phil Nadeau – Cowen and Company
David Friedman – Morgan Stanley
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I would now like to turn the call over to Alexandra Santos, Director of Corporate Communications and Investor Relations at Portola Pharmaceuticals. Please go ahead.
Thank you, and welcome to Portola's third quarter 2013 financial results conference call. Joining me on the call today for the prepared remarks are Bill Lis, Chief Executive Officer; Dr. John Curnutte, Executive Vice President of Research & Development; and Mardi Dier, Chief Financial Officer.
We issued our third quarter press release earlier today, a copy of which can be found at www.portola.com in the Investor Relations section.
Before we begin I would like to remind you that various remarks we make on this call contain forward-looking statements subject to risks, uncertainties and other factors that could cause actual results to differ materially from those expressed or implied. The date of this conference call is November 5, 2013, and all forward-looking statements made on this call are based on beliefs of Portola as of this date only. Future events or simply the passage of time may cause these beliefs to change.
For a more detailed description of the risks that impact these forward-looking statements, please refer to our most recent Quarterly Report on Form 10-Q filed with the SEC. Please be aware that you should not place undue reliance on the forward-looking statements made today.
Finally, this conference call is the property of Portola Pharmaceuticals, Inc., and any taping, other duplication or rebroadcast without the express written consent of Portola Pharmaceuticals is prohibited.
With that I will turn the call over to Bill Lis, CEO.
Thank you, Alex, and good afternoon, everyone. Thank you for joining us today on our third quarter earnings call.
Since our initial public offering in May we've accomplished a number of milestones that advance our goal of building a company with multiple novel drugs that we can develop and commercialize. Our three 100%-owned clinical stage assets target areas of significant unmet medical need. We remain confident in our plan to advance our programs independently, because we have proven integrated capabilities and because all of our programs target large markets that only require hospital and specialty sales teams. Let me walk you through the highlights of our recent achievements.
Most recently we completed our first follow-on equity offering, successfully raising approximately $100 million in net proceeds to position us to independently fund our late-stage pipeline beyond betrixaban and regulatory milestones in 2014 and 2015. Consistent with our message from the IPO in May, we plan to use proceeds from the follow-on offering to advance andexanet alfa to a BLA filing and expand the scope of PRT2070 in our Phase 2 proof-of-concept study to include additional cancer types.
Betrixaban, our Phase 3 oral anticoagulant, blocks the clotting Factor Xa to prevent thrombosis. We're advancing betrixaban with the goal of being the first oral anticoagulant approved for the prevention of blood clots in acute medically ill patients.
This is a multibillion-dollar market and has an estimated 22 million acute medically ill patients that are at risk for pulmonary embolism, and an estimated 150,000 of these acute medically ill patients die of PE annually in the G7 countries. This is the unmet medical need. Currently there is no approved agent to treat these patients during the period when they are most at risk for experiencing an event.
During the third quarter the independent data monitoring committee for our Phase 3 APEX study held a second safety review and recommended that the study proceed, keeping us on track to report data as planned in 2015.
Andexanet alfa, our second late-stage development candidate, has the potential to be a first-in-class recombinant protein that is designed to reverse the anticoagulant activity of Factor Xa inhibitors in patients with major bleeding or those needing emergency surgery. This quarter we reported additional positive Phase 2 data demonstrating that we can extend the duration of andexanet's activity. This provides us with the potential to treat a broader range of patients, and John will review this in more detail.
Additionally, at the European Society of Cardiology Congress we presented data demonstrating that andexanet reduces blood loss in anticoagulated animals experiencing an active bleeding event by reversing Factor Xa inhibitor activity. Our Phase 3 and Phase 4 registration studies, scheduled to begin in 2014, are designed to confirm these findings.
In August we completed an end-of-Phase 2 meeting with the FDA regarding clinical and manufacturing paths forward for andexanet, and, based on our discussions that were positive with the agency we are pursuing an accelerated approval pathway.
Early in the quarter we entered into a clinical collaboration agreement with Daiichi Sankyo to study andexanet with their Factor Xa inhibitor, edoxaban. We now have collaboration agreements in place with all of the manufacturers of Factor Xa inhibitors, including BMS/Pfizer, J&J/Bayer and now Daiichi Sankyo. We believe this underscores andexanet's importance clinically and commercially.
In October we advanced our third proprietary program, PRT2070, into the clinic. This is an oral dual Syk-JAK inhibitor that's being evaluated in a Phase 1/2 proof-of-concept study for the treatment of patients with hematologic cancers, including genetically defined subtypes, which have been difficult to treat thus far.