Jazz Pharmaceuticals plc

Ladies and gentlemen, thank you for standing by and welcome to the second quarter 2022 Jazz Pharmaceuticals earnings call. At this time, all participants are in a listen-only mode. After the speaker's presentation, there will be a question. To ask a question during the session, you need to press star 1-1 on your telephone. I would now like to turn the caller over to your host, Andrea Flynn, Vice President, Head of Investor Relations. You may begin.

Thank you, and good afternoon, everyone. Today, Jazz Pharmaceuticals reported its second quarter 2022 financial results. The slide presentation accompanying this webcast is available on the Investors section of our website. Investors may also refer to the press release we issued earlier today, which is also posted on our website. On the call today are Bruce Kozad, Chairman and Chief Executive Officer, Renee Galah, Executive Vice President and Chief Financial Officer, Dan Swisher, President, and Rob Unone, Executive Vice President, Global Head of R&D. Kim Sablich, Executive Vice President and General Manager, North America, will join the team for Q&A. On slide two, I'll remind you that today's webcast includes forward-looking statements, such as those related to our future financial and operating results, including expectations related to Vision 2025 and our guidance for 2022, growth potential, and anticipated development and commercialization milestones and goals, which involve risks and uncertainties that could cause actual events, performance, and results to differ materially from those contained in these forward-looking statements. We encourage you to review the statements contained in today's press release, in our slide deck, and in our latest SEC disclosure document, which identifies certain factors that may cause the company's actual events, performance, and results to differ materially from those contained in the forward-looking statements made on today's webcast. We undertake no duty or obligation to update our forward-looking statements. Turning to slide three 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 in the slide presentation available on the Investors section of our website. I'll now turn the call over to Bruce.

Thank you, Andrea. Good afternoon, everyone, and thank you for joining us today. I'll start on slide five. We entered 2022 with substantial momentum, and our team has continued to make notable advances across our business through the first half of the year, while delivering solid year-over-year top and bottom line growth in the first and second quarters. Our productive second quarter reflects meaningful progress towards achieving Vision 2025, which we introduced at the beginning of the year. We're pleased with our results in the first half of the year and are confident that we are on track to achieve our full year 2022 guidance. Starting with our commercial business, our Oxibate franchise is performing well, and we remain confident in the durability of ZyWave. which we believe will be the oxidate therapy of choice in the market, even following the entry of higher sodium authorized generics and potentially branded competition. We are pleased to see continued ZyWave adoption in narcolepsy and are equally excited about the positive momentum of the launch of ZyWave in idiopathic hypersomnia, or IH. There are a growing number of IH patients on ZyWave therapy and a high level of engagement and receptivity in the market, all of which is underpinned by strong reimbursement. Turning to Epidiolex, we continue to expand our prescriber base and are generating real-world evidence and data to further substantiate Epidiolex's broad effect across seizure types. Our team has done an excellent job of launching the product XUS, and we remain confident we can achieve blockbuster status for Epidiolex. Zulca remains the treatment of choice in second-line small-cell lung cancer. and our robust development effort is aimed at identifying additional patient populations who may benefit from therapy. Rylase has continued its strong launch, and we are pleased to be able to deliver the only therapy available to patients in the U.S. who experience a hypersensitivity reaction to E. coli-derived asparaginase. Dan will provide a detailed overview of our performance across our commercial portfolio later in the call. Our R&D team has remained very productive in the first half of 2022, advancing multiple clinical programs. In addition, we were pleased that FDA cleared the IND application for JCP815, allowing this program to enter clinical development. As we highlighted on our last earnings call, we completed in-licensing deals to add two new early-stage molecules to our pipeline in the second quarter, including JCP441 a potent, highly selective orexin-2 agonist that has the potential to advance the treatment of narcolepsy and other sleep disorders, and JCP-898, a differentiated, conditionally activated interferon-alpha-inducine molecule with the potential to minimize the toxicity associated with systemic interferon-alpha therapy, thereby expanding its clinical utility in treating cancer. These transactions demonstrate our commitment to expanding our pipeline and diversifying our revenue. Consistent with these objectives, we are prioritizing the medicines and R&D programs most likely to deliver value to patients and shareholders. I'm also pleased to share that we've achieved our deleveraging target two quarters ahead of our stated timeline, finishing the second quarter with a non-GAAP net leverage ratio of 3.2. The current macro environment is creating attractive options for corporate development, and our strong balance sheet provides us with flexibility to be active in identifying additional opportunities. Turning to slide six, Vision 2025 provides us with a clear roadmap as we transform our business and includes three components central to driving sustainable growth and enhanced value, commercial, pipeline, and operational excellence. Starting with commercial, After achieving over $3 billion in revenue in 2021, we're positioned to grow revenue to $5 billion in 2025 through a combination of existing products, as well as potential new therapies emerging from our pipeline and through corporate development. Our R&D organization continues to advance key programs addressing significant patient needs in neuroscience and oncology, and we anticipate delivering at least five novel product approvals by the end of the decade. through a combination of existing pipeline programs and corporate development. And on operational excellence, our 2021 adjusted operating margin was 43%, and we plan to improve that by five percentage points from 2021 to 2025, delivering more of our top line through to the bottom line. I'll now turn the call over to Dan for an overview of our second quarter commercial performance, after which Rob will share an update on the progress of our R&D programs. Renee will provide a financial overview, and then we'll open the call to Q&A.