Jazz Pharmaceuticals Public Limited Company (NASDAQ:JAZZ) Q4 2015 Earnings Conference Call - Final Transcript
Feb 23, 2016 • 04:30 pm ET
number of fronts. We've implemented our approved REMS for Xyrem, realigned our European team to focus exclusively in hematology and oncology, launched our Phase III program for JZP-110 and completed our NDA submission for defibrotide.
With our guidance today, you can see that we plan to grow our top and bottom line nicely again in 2016 while advancing our development pipeline in meaningful ways. Our PDUFA date on our defibrotide NDA is next month, and this year, we plan to start a clinical trial of defibrotide in prevention of VOD in high-risk patients, complete enrollment in our study of Xyrem in pediatric patients and complete enrollment in, and see top line data from, our JZP-110 program.
And we are well positioned to broaden our business through corporate development, with a strong balance sheet, significant cash and overall market valuations that are more conducive to transactions that we generate strong returns. Current market conditions are also allowing us to repurchase stock under our existing $300 million stock repurchase program at extremely attractive prices.
In short, we're well positioned to deliver results in 2016 that we believe will generate increased shareholder value. I'll now update you on key commercial, legal, regulatory and clinical development activities during the fourth quarter, highlight some key events that we expect in 2016 and then turn the call over to Matt to review our financial results for the quarter and full year and provide 2016 financial guidance.
Let me start my comments with our SLEEP therapeutic area and our lead product, Xyrem. In 2015, we continued to see strong underlying organic demand for Xyrem. In the fourth quarter, the average number of active Xyrem patients grew to a record 12,550. During the fourth quarter of 2015, Xyrem bottle growth was negatively impacted by the operational disruptions to central pharmacy, resulting in approximately 1% growth compared to the strong fourth quarter of 2014.
Volume growth during the first half of 2015, prior to the REMS implementation in late August, was approximately 10% compared with the same period of 2014, while our full year 2015 volume growth was 6%. By the end of 2015, our operational metrics at the central pharmacy had returned to normal, and we expect high single-digit volume growth this year.
As expected, in the increasingly complex managed care environment for the Specialty Pharmaceuticals category, we observed further increases in the rate of Xyrem prior authorizations and reauthorizations during 2015 and are seeing further increases in reauthorizations in early 2016. These prior auths and reauths lead to an increased workload for physician offices and the central pharmacy.
However, we are pleased that high reimbursement approval rates for patients remain steady. We believe that the central pharmacy is prepared to handle the increased prior authorizations and reauthorizations, including typical first quarter payer churn, as a result of significant improvements in central pharmacy processes and increased staffing put in place during the second half of 2015.
Turning now to key Xyrem growth opportunities. We believe that we have