Jazz Pharmaceuticals plc

Welcome to the JAD Pharmaceuticals plc first quarter 2020 earnings conference call. Following introduction from the company, we will open the call for questions. I will now turn the call over to Cathy Luttrell, head of investor relations at JAD Pharmaceuticals.

Thank you, Valerie, and thanks to those of you joining our investor call. Today we reported our first quarter 2020 financial results and updated our financial guidance for 2020. The press release and the slide presentation accompanying this call are available in the investors section of our website. On the call today are Bruce Cozadd, CEO, Dan Swisher, President, Renee Gala, CFO, Rob Iannone, Executive Vice President, R&D, and then joining for questions, Our Q&A session will include Mike Miller, Executive Vice President, U.S. Commercial, Phil Jockelson, Sleep and Neuroscience Therapeutic Head, Ann Borgman, Hematology and Oncology Therapeutic Head, Jed Black, our Sleep Neuroscience Fellow, and Shawn Mendes, Senior Vice President, Strategy and Finance. I'd like to remind you that today's call includes forward-looking statements such as those related to our future financial and operating results. and which involve risks and uncertainties that could cause actual events, performance and results to differ materially. We encourage you to review the statements contained in today's press release and our latest SEC disclosure docs which identify certain factors that may cause the company's actual results to differ materially from those projected. In particular, there is significant uncertainty about the duration and severity of the COVID-19 pandemic and its impact on Java's business and operations. The updated guidance reflects management's current expectations of the impact of these factors on our business. We undertake no duty or obligation to update our forward-looking statements. On this call, we discuss non-GAAP financial measures, Reconciliations of GAAP to non-GAAP financial measures discussed on the call are included in today's press release and slide presentation available on our website. I'll now turn the call over to Bruce.

Thank you, Kathy, and I'm not sure whether you mentioned audio-visual risk factors in your precursor, but we apologize in advance if you hear dogs barking or children playing in the background. Good afternoon everyone and thank you for joining us. I'll begin by sharing how proud I am of Jazz employees and their commitment to support continued delivery of our essential medicines to patients around the world during this unprecedented time. I would like to thank them for their dedication and ingenuity. In the first quarter, we generated total net revenues of $535 million and made significant progress toward our key 2020 objectives. We are actively preparing for the U.S. launches of Lurbanectin and JCP258 and are excited by the opportunity to bring these two important treatment options to patients later this year. Although we experienced limited financial impact of COVID-19 in the first quarter, given the global economic slowdown, the increasing unemployment rate, and the overall disruption to global healthcare systems, we have updated our financial guidance. including proactively reducing operating expenses to reflect the potential impact on our business for the remainder of 2020. We are excited about the opportunities ahead for Jazz and remain focused on diversifying our portfolio of essential medicines to provide innovative and life-changing options for patients through both our internal efforts and corporate development transactions. Building off the four transactions we entered into last year, We are focused on ensuring the continuity of patient care and our business operations. Our key priorities are maintaining sufficient supply of our medicines and ensuring patient access, including through comprehensive support of patients assistance programs for those impacted by changed economic circumstances. Protecting the safety and welfare of patients in our clinical studies, minimizing delays in enrollment, and maintaining the integrity of our clinical studies. Engaging with healthcare providers through digital platforms and other remote access activities Thank you so much for joining us. Now I'll review our sleep neuroscience portfolio. Xyrem delivered strong growth in the first quarter with bottle volume growth of 5% compared to the same period in 2019. The central pharmacy successfully navigated through the typical first quarter industry-wide payer churn. We observed an increase in the number of patients on therapy with the average number of active Xyrem patients at 15,025, up 3% compared to the same period last year. While the company observed a decline in daily new patient enrollments beginning in mid-March due to COVID-19, recent patient enrollment trends are strengthening, and we expect new patient diagnoses to start to increase as sleep centers reopen. Given the importance of managing narcolepsy, a serious and chronic disease, we believe that the demand for Zyramine 2020 will remain strong. Turning to JZP258. We submitted our NDA early in the first quarter and received priority review. At this time, we have not been notified by FDA of any delay to the July 21 PDUFA action date. Bringing JCP258 to patients as early as the fourth quarter following approval and REMS implementation is a top priority. JCP258 is a novel oxidative formulation with 92% less sodium than xyrib. Thank you for joining us. and Improving Cardiovascular Health. Following FDA approval, we will begin discussion with payers regarding the important value that JCP258 can provide to narcolepsy patients. Moving to CINOSI. In the first quarter, we were encouraged by the positive feedback received from patients and healthcare providers as well as a 41% growth in prescriptions versus fourth quarter 2019. Sanosi refill rates during the quarter were strong, indicating patient satisfaction and minimal out-of-pocket cost concerns. From launch through March 31, there have been more than 3,400 unique prescribers and more than 27,000 cumulative prescriptions representing our continued progress in expanding relationships with OSA physicians. We are pleased that more than 80% of commercially insured patients have access to coverage for Synosy. During the quarter, we experienced high coupon utilization, which is common with typical first quarter payer churn due to insurance plan changes and the resetting of patient deductibles. This resulted in high gross to net deduction. At this time, we believe Synosy gross to nets will trend lower For the remainder of the year. While we have implemented plans to mitigate the challenges of COVID-19, we anticipate our efforts to continue to reach new OSA treating physicians will be impacted by the extent and duration of the disruption. With the pandemic, many physician offices have closed and pulmonologists, one of our target physician audiences, have been focusing their attention on patients who present with respiratory complications of COVID-19. Our mitigation plans include remote salesforce engagement with healthcare providers to the extent possible, with a shift to virtual speaker programs, satellite disease awareness programs, and implementation of online sample and voucher programs. In Europe, we are actively preparing for the rolling launch of Synose, beginning in Germany this month with an initial focus on EDS and narcolepsy, and then expanding to EDS in OSA early next year. Recruitment of our German neuroscience sales force is largely complete and they are concluding product training in preparation for launch. To ensure we are supporting customers appropriately, we have plans to conduct a targeted virtual launch until we are able to progress to in-person interactions with healthcare providers. As we navigate through the COVID-19 pandemic, we anticipate there will be delays by some European regulatory authorities in their pricing and reimbursement reviews. We will monitor the impact and plan Salesforce recruitment appropriately. I'll now turn the call over to Dan to update you on key hematology and oncology activities. Then Rob will provide an update on our development programs and Renee will follow with an update on our financial performance.