Jazz Pharmaceuticals plc

Welcome to the Jazz Pharmaceuticals second quarter 2020 earnings conference call. Following an introduction from the company, we will open up the call to your questions. I will now turn the call over to Cathy Luttrell, head of investor relations at Jazz Pharmaceuticals.

Thank you, Chris, and thanks to those of you joining our investor call. Today we reported our second quarter 2020 financial results and updated our financial guidance for 2020. The press release and the slide presentation accompanying this call are available on the Investors section of our website. On the call today are Bruce Cozadd, CEO, Dan Swisher, President, Renee Gala, CFO, and Rob Iannone, Executive Vice President, R&D. Joining for the Q&A session are Kim Sutledge, Executive Vice President, General Manager of North America, Phil Jockelson, Sleep and Neuroscience Therapeutic Head, and Boardman, Hematology and Oncology Therapeutic Head. Sam Pearce, Senior Vice President Europe and International, Shawn Mendes, Senior Vice President Strategy and Finance, and Jed Black, our Senior Fellow Neuroscience. 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 statements contained in today's press release and our latest SEC disclosure documents 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 call, we discuss non-GAAP financial measures, reconciliations of GAAP to non-GAAP financial measures, Discussion of this 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. Good afternoon, everyone, and thank you for joining us. I'll start by providing an update on the significant progress made this quarter, demonstrating the strength and value of our underlying business. Renee will then provide a financial update. Dan will provide an overview of our commercial performance in neuroscience and oncology. and finally Rob will provide an update on our R&D programs. I'm proud of the strong financial and operational results we delivered in the second quarter. While COVID-19 brought continued challenges, our employees never lost focus and we have continued to advance our strategy, including two product launches in May and July. Our successes in the quarter align nicely with the important goals and milestones we set for the company at the start of the year. AIMED AT FURTHER TRANSFORMING OUR BUSINESS. DESPITE COVID-19, WE MADE SUBSTANTIAL PROGRESS ACROSS OUR REGULATORY, COMMERCIAL, AND R&D OPERATIONS, POSITIONING US TO DEMONSTRATE COMMERCIALIZATION EXCELLENCE AND AGILITY WITH THE EXECUTION OF UP TO FIVE PRODUCT LUNCHES IN 2020 AND 2021. WITH FDA APPROVAL OF ZYWAVE FOR THE TREATMENT OF CATAPLEXY AND EDS IN NARCLEPSY, WE CONTINUE TO DEMONSTRATE THE DURABILITY OF OUR OXYVATE FRANCHISE. We have been working for nearly a decade to develop this novel formulation, which has a 92% reduction in sodium compared to Zyrum. The Zywave label, unlike Zyrum, carries no sodium content warning and offers a significant benefit for narcolepsy patients who would otherwise shoulder the burden of lifelong exposure to high sodium intake. Zywave is the first treatment exclusively developed from concept Through Clinical Research to Production by Jazz and underscores the transformation of the company's research and development capabilities, Xyrem is an important scientific advance in the treatment of narcolepsy and reflects our deep commitment to improving the lives of people living with sleep disorders. We expect to launch ZyWave in the U.S. during the fourth quarter. In addition, we expect top line data from our phase three pivotal study of ZyWave in idiopathic hypersomnia or IH in the fourth quarter of this year and are targeting a U.S. launch of ZyWave in this new indication in late 2021 following a supplemental NDA submission and approval. Our oncology franchise is poised to generate substantial near and long-term value. We delivered a significant achievement for patients and shareholders with the U.S. approval and launch of Zepzelka. The first new treatment for relapsed small cell lung cancer in decades, adding another important and differentiated therapy to our oncology portfolio. Zepzelka received FDA approval in June, two months ahead of its PDUFA date and was launched last month. This was made possible through the tremendous efforts of our oncology team, quickly making this vital new treatment option available to patients and educating the medical community about Zepzelka's profile. Zepzelka is an important new growth driver in our expanding oncology business, and we are focused on fully realizing its significant value potential. The approval of Zywave and the launch of Zepzelka are the most recent examples of our proven development and commercialization capabilities, which, since 2014, have resulted in nine major product approvals and commercial launches, as well as a tripling of development pipeline projects. We continue to expand our portfolio of assets and remain focused on our purpose as an organization. We innovate to transform the lives of patients. At the same time, we continue to focus on maintaining operational efficiency, strong margins, and thoughtful capital allocation. We have driven significant and sustainable profitability and robust cash flow, with cash from operations of over $450 million in the first six months of the year. Together with our strong balance sheet and significant liquidity, this focus on efficiency and cash generation has allowed Jazz to make value enhancing investments while effectively managing expenses and continuing to evaluate internal and external opportunities to expand our portfolio and broaden our revenue base. Over the past year, we've continued to enhance our leadership team, adding a number of executives with a broad range of expertise and industry experience to strengthen our capabilities to innovate and execute on our corporate strategy. Most recently, we welcome Kim Sablich who joined us June 1st as Executive Vice President, General Manager of North America. Kim joins Jazz with a track record in leading successful commercialization teams, most recently at Myovant Sciences and previously at Glasso SmithKline and Merck. With this experienced executive leadership team, We are well positioned to grow our business and deliver significant value to our shareholders. This is an important year for the transformation of JAB. With five product launches on track through 2021 and multiple initiatives at key inflection points, the team is aligned and focused on execution as we strengthen our business. I'll now turn the call over to Renee for a financial update.