Jazz Pharmaceuticals plc

welcome to the jazz pharmaceuticals plc first quarter 2021 earnings conference call following our introduction from the company we will open the call to questions i will now turn the call over to Andrea Flynn head of investor relations to jazz pharmaceuticals thank you please go ahead thank you and good afternoon everyone today we reported our first quarter 2021 financial results

The press release and slide presentation accompanying this webcast are available on the Investors section of our website. On the call today are Bruce Cozadd, Chairman and Chief Executive Officer, Renee Gala, Executive Vice President and Chief Financial Officer, Dan Swisher, President and Chief Operating Officer, and Rob Iannone, Executive Vice President, R&D, and Chief Medical Officer. Joining the Q&A are Kim Sablich, Executive Vice President, General Manager of North America, Phil Jackelson, Neuroscience Therapeutic Head, and Ann Borgman, Hematology and Oncology Therapeutic Head. On slides two and three, I'd like to remind you that today's webcast includes forward-looking statements, such as those related to our future financial and operating results and the transaction to acquire GW Pharmaceuticals, 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 on our latest SEC disclosure document, which identify certain factors that may cause the company's actual results to differ materially from those projected. We undertake no duty or obligation to update our forward-looking statements. On this webcast, we'll discuss non-GAAP financial measures. Reconciliations of GAAP to non-GAAP financial measures are included in today's press release and slide presentation. I'll now turn the call over to Bruce.

Thanks, Andrea. Good afternoon, everyone, and thank you for joining us today. I'll start on slide five. Following an incredibly productive 2020, we have continued this momentum into 2021 with sustained operational excellence across our commercial and R&D organizations, positioning us to achieve multiple milestones during the remainder of the year. Our transformation to an innovative high-growth biopharma company is well on its way. In February, we announced our planned acquisition of GW Pharmaceuticals, This acquisition positions Jazz as an industry leader in neuroscience with a global commercial and operational footprint. The addition of GW further diversifies our commercial portfolio and pipeline with therapies that are complementary to our existing business. Jazz and GW also share a common culture built around the same mission, innovating to transform the lives of patients. We look forward to building an even stronger company together with our GW colleagues and are excited about the greater impact we will continue to drive for patients, customers, and shareholders. Renee and her team have secured financing to support the acquisition and done a fantastic job in executing a very favorable debt structure. She'll provide more color around that as well as our plans to provide updated guidance for the combined Jazz GW enterprise Thank you for joining us. Thank you for joining us. I specifically call out all indications because we are preparing for potential FDA approval and commercial launch of ZyWave in idiopathic hypersomnia or IH later this year. This is an area of high unmet need with no FDA approved therapies and we are excited for this opportunity to bring a new treatment option to people with IH. Turning to Zepzelka, we are seeing continued growth In the second line setting in both platinum sensitive and platinum resistant patients as we move toward our target of Zepzelka becoming standard of care in the relapsed setting. Zepzelka is providing an important therapeutic option for patients with small cell lung cancer and we expect to see continued growth over the course of the year. As we exit the first quarter, Zywave and Zepzelka are making a significant contribution in to our revenue diversification targets with 23% of product sales in the quarter already coming from recently launched products. Another important therapy in our oncology portfolio is JCP458 for patients with acute lymphoblastic leukemia and lymphoblastic lymphoma who have developed hypersensitivity or silent inactivation to E. coli derived asparaginase. We initiated a regulatory submission for JCP458 under FDA real-time oncology review in December. We believe that JCP458 will enable us to provide a high-quality therapeutic option with reliable supply to these patients and are preparing for a mid-2021 launch upon FDA approval. It is important to note that in addition to successfully taking ZyWave through development to commercialization in narcolepsy. We have also advanced ZyWave in IH and JCP458 from concept to commercial readiness, demonstrating our team's maturing R&D capabilities. These capabilities are being leveraged across our robust pipeline, which will include several additional clinical stage development programs following the completion of the GW transaction. I'll now turn the call over to Dan for an overview of our commercial performance, after which Rob will provide an update on progress across our R&D programs. Renee will close our prepared remarks with a financial overview, and then we'll open the call to Q&A. Dan?