Jazz Pharmaceuticals Public Limited Company (NASDAQ:JAZZ) Q4 2015 Earnings Conference Call - Final Transcript

Feb 23, 2016 • 04:30 pm ET


Jazz Pharmaceuticals Public Limited Company (NASDAQ:JAZZ) Q4 2015 Earnings Conference Call - Final Transcript


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Bruce Cozadd

through CME symposia at the American Society of Hematology in December where the session focused on adult ALL.

As part of our preparation for potential defibrotide U.S. launch, we completed hiring and training our hematology/oncology sales force, increasing from 25 to 35 representatives, and adding to the depth of our experience in the transplant setting. The 10 new sales representatives entered near Erwinaze territories as of January 1.

The hematology/oncology sales force is prepared to sell both Erwinaze and defibrotide, following FDA approval of defibrotide in the U.S. We continue to observe strong Defitelio volume growth in the EU and are pleased to see better-than-expected usage of Defitelio in countries such as France and Italy where we do not currently have centralized reimbursement.

Our efforts in the EU are focused on providing medical education, an early identification of the warning signs of veno-occlusive disease, or VOD; VOD pathophysiology; appropriate diagnosis; and the importance of prompt treatment with Defitelio.

Our PDUFA date is March 31, and we are well-prepared for our planned launch of defibrotide in the U.S. after FDA approval of our NDA. Our initiatives were focused on increasing the timely recognition of VOD and educating health care providers on the importance of treatment with defibrotide.

In preparation for our planned U.S. launch, we had a strong presence at the American Society of Hematology Meeting in December with multiple abstract presentations; have medical science liaisons available to address defibrotide questions upon request; submitted the new technology add-on payment application for defibrotide to CMS; published pivotal data in blood last month; provided training to our hematology/oncology sales representatives; and had a strong presence at the American Society of Bone Marrow Transplant Meetings this past weekend.

Our reimbursement account managers, who will focus on ensuring that key hospital decision-makers such, as P&T committees, have an understanding of defibrotide's clinical value and understand the importance of rapid formulary approval to ensure patients have access to defibrotide in the EU. And importantly, they will also provide disease education to payers.

In summary, in 2016, we look forward to delivering on key financial, commercial and R&D goals that have the potential to drive significant value creation moving forward. In 2016 and beyond, we will continue to invest in our key products, Xyrem, Erwinaze and Defitelio and product candidate, JZP-110, as we pursue life cycle management and line extensions that have the potential to generate important new therapeutic options for patients and expand our business.

And we remain enthusiastic about opportunities to further enhance and diversify our portfolio through corporate development activities.

Matt, let me now turn the call over to you.

Matt Young

Thanks, Bruce, and good afternoon, everyone. We are pleased with our continued growth and strong performance in 2015 compared to 2014, as total revenues increased by 13% and adjusted net income and EPS attributable to Jazz increased by 15%. The growth in 2015 was driven primarily by higher sales of Xyrem.

Total net revenues of $1.32 billion for the full year 2015 and adjusted