Portola Pharmaceuticals Inc. (PTLA)
2Q 2013 Results - Earnings Call Transcript
August 15, 2013 08:30 AM ET
Alexandra Santos - Director of Corporate Communications and IR
Bill Lis - Chief Executive Officer
Mardi Dier - Chief Financial Officer
John Curnutte - EVP of Research and development
Jason Kantor - Credit Suisse
John Sonnier - William Blair
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 second quarter 2013 financial results conference call. Joining me on the call today for the prepared remarks are Bill Lis, Chief Executive Officer and Mardi Dier, Chief Financial Officer. John Curnutte, Executive Vice President of Research and development will join Bill and Mardi for Q&A.
Before we begin, I would like to remind you that various remarks we will make on this call contains forward-looking statements subject to risk, uncertainties and other factors that could cause actual results to differ materially from those expressed or implied. For a more detail description of the risk that impacted forward-looking statements, please refer to the information under the heading forward-looking statements and our press release today and other information regarding risks in the Portolo quarterly report on Form 10-Q, filed with the SEC on August 14, 2013.
Please be aware that you should not place undue reliance of forward-looking statements made today. The date of this conference call is August 15, 2013 and all forward-looking statements made on this call are made based on the belief of Portola as of this date only. Future events or simply a passage of time may cause these beliefs to change.
Finally, this conference call is the property of Portola Pharmaceuticals Inc. and any taping or other duplication or re-broadcast without the express written consent of Portola Pharmaceuticals is prohibited. We issued our second quarter press release earlier today, a copy of which can be found at www.portola.com in the Investor Relations section.
With that I will turn the call over to Bill Lis, CEO, Portola.
Thank you, Alexandra and good morning everyone. Thank you for joining us today on our inaugural earnings call. I’ll begin with the corporate overview of recent accomplishment for our clinical development programs, Mardi will then provide a review of second quarter financial results and then I conclude with the important upcoming milestones of the company.
In May, we completed a successful IPO in which we raised approximately $126 million in net proceeds, we plan to use these proceeds to develop our two late-stage thrombosis programs, betrixaban and andexanet alfa or PRT4445 and move our third product candidate PRT2070 into the clinic this year.
PRT2070 is a novel oral, dual Syk-JAK kinase inhibitor for the treatment of genetically-defined hematologic cancers. Our lead compound betrixaban is an oral small molecule anticoagulant that directly inhibits the activity of Factor Xa, and important and validated target in blood coagulation pathway.
We are developing this novel once daily Factor Xa inhibitor for hospitals and post-discharge prevention of venous thromboembolism or VTE in high-risk acute medically ill patients. We are currently evaluating the betrixaban in global pivotal Phase 3 study called APEX. The study is enrolling approximately 6,850 patients and more than 400 study sites throughout the world. And we remain on track to complete enrollment in mid 2015.
Currently there is no anticoagulant proof for extended-duration [VTE] prophylaxis in this population therefore if APEX succeeds betrixaban could potentially be the first Factor Xa inhibitor to the market and there is significant unmet need. Importantly, we have worldwide rights to develop and commercialize the betrixaban event.
Our second lead development candidate andexanet alfa, is a recombinant protein designed to reverse the anticoagulant activity in patients treated with Factor Xa inhibitor who suffered uncontrolled bleeding episode or require emergency surgery, andexanet alfa is the first antidote to demonstrate reversal effect of Xa inhibitor activity in the clinic.
During the second quarter we achieved significant milestones in this program, in May, we successfully completed first of the series of Phase 2 concept studies of andexanet alfa demonstrating reversal of the anticoagulant activity of Bristol-Myers Squibb and Pfizer Factor Xa inhibitor Eliquis. These findings which were presented at the 2013 Congress of the International Society on Thrombosis and Haemostasis showed for the first time in the clinic that an antidote can reverse the anticoagulant effect of the Factor Xa inhibitor.
Our Phase 2 with andexanet alfa and XARELTO was ongoing and we anticipate announcing these results later this year. Importantly, we entered into a clinical collaboration agreement with agreement with Daiichi Sankyo to study andexanet alfa with edoxaban. With this agreement we now have collaboration agreements in place with all the manufacture of Factor Xa inhibitors this includes BMS [Bristol-Myers Squibb’s], Pfizer, J&J, Bayer, and Daiichi Sankyo to evaluate andexanet alfa in reversing the anticoagulant activity of Eliquis, XARELTO, edoxaban respectively.
It is important to note that we retain full worldwide commercialization rights for this investigation of Factor Xa inhibitor antidote.
We've now completed a series of discussions with the FDA including just yesterday and end the Phase 2 meeting regarding the clinical and manufacturing path forward for andexanet alfa. We conducted these meetings yesterday with our academic leaders for the program and with our collaborators from J&J, Bayer and BMS Pfizer.