Jazz Pharmaceuticals plc

Good afternoon, and thank you for attending the Jazz Pharmaceuticals second quarter 2023 financial results call. My name is Alyssa, and I will be your moderator for today's call. All lines will be muted during the presentation portion of the call with an opportunity for questions and answers at the end. I would now like to pass the call over to the Jazz Pharmaceuticals team. You may proceed.

Thank you, operator, and good afternoon, everyone. Today, Jazz Pharmaceuticals reported its second quarter 2023 financial results. The slide presentation accompanying this webcast is available on the investor's section of our website. Investors may also refer to the press release we issued earlier today, which is also posted to 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 Chief Operating Officer, and Rob Hunone, Executive Vice President, Global Head of R&D. Kim Sablich, Executive Vice President and General Manager, United States, will join the team for Q&A. On slide two, 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, 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 will discuss non-GAAP financial measures, descriptions of these non-GAAP financial measures, and reconciliations of GAAP to non-GAAP financial measures. are included in today's press release and the slide presentation available on the investors section of our website. 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. In the second quarter of 2023, we once again delivered strong commercial results, advanced our efforts to unlock the tremendous potential of our pipeline, and built on our record of driving operational excellence. In particular, our results in the second quarter highlight the durability and growth potential of our commercial portfolio, the capabilities and productivity of our R&D efforts, and our focus on operational excellence. We are pleased to report strong execution across our commercial portfolio with all three key growth drivers of our commercial business, SideWave, Epidiolex, and Rylase, achieving year-over-year double-digit growth. Zywave grew by 39% in the second quarter compared to the same period last year and is annualizing at well over a billion dollars in revenue. Zywave continues to be the OxyBait of choice and the only approved therapy for idiopathic hypersomnia. We expect our OxyBait franchise to contribute $2 billion of the $5 billion in total revenue component of Vision 2025 and are well positioned to reach this target. As a reminder, our 2023 neuroscience revenue guidance, which we are raising at the midpoint today, and Vision 2025, both account for the availability of high sodium oxibate authorized generics, or AGs, and branded fixed dose high sodium oxibate. Epidiolex growth remains strong, and we are confident in its potential to reach blockbuster status. We achieved double digit net sales growth in 2Q23 compared to the same period last year as we continue to drive prescriber growth across our global markets. Our launch in Europe is gaining momentum with additional international launches and indication expansions expected this year. In oncology, Rylase has continued to grow in the U.S., underpinned by strong demand and our increasing emphasis on the adolescent and young adult market. Moving to our pipeline, Given the level of productivity in our R&D organization, I'm going to call out just a few items. Rob will cover our R&D progress in more detail later in the call. Our pipeline continues to advance towards meaningful catalysts with the potential for as many as four late-stage data readouts through 2024, the first being JCP150 late this year, followed by Suvacaltamide and Xanidatamab and GEA next year, and top-line PFS for Zepzelka in combination with Ticentric in first-line extensive-stage small-cell lung cancer at the end of 2024 or early 2025. In addition to its strong commercial performance in the U.S., we are extremely pleased that we recently received a positive CHMP opinion on our marketing authorization application for JCP458, marketed as RILAs in the U.S., and expect European Commission approval later this year. Since we added Zany Datamab to our pipeline last year, it has continued to impress, and we're excited by its broad applicability, which we believe represents 2 billion plus in peak sales potential. Positive, pivotal data from our Phase IIb trial in biliary tract cancers, or BTC, were featured in an oral session at this year's ASCO conference and concurrently published in the Lancet Oncology These data were also selected for the best of ASCO meeting. Top-line data readout from the ongoing Phase III gastroesophageal adenocarcinoma, or GEA, trial is expected in 2024. I'm also pleased to report that we recently received IND clearance for JCP898, an engineered interferon alpha cytokine prodrug that is activated specifically within the tumor microenvironment where it can stimulate interferon alpha receptors on cancer-fighting immune effector cells. With this milestone achieved, we remain on track to initiate a phase one trial of JCP-898 later this year. On the operational side, we generated continued top and bottom line growth in the second quarter. Our commercial execution, coupled with our focus on operational excellence, has put us in a strong financial position. enabling us to execute a focused capital allocation strategy to invest in the products, pipeline programs, and corporate development opportunities with the highest potential to deliver sustainable growth and enhanced value. Given our financial strength and our current stock price, we have resumed share repurchases under our existing program, which Rene will expand upon shortly. Based on our performance in the first half of 2023, and expectations for the remainder of the year, we are raising our full year financial guidance for 2023. And longer term, we believe we are well positioned to achieve Vision 2025. Renee will provide additional commentary on our financials and guidance later in the call. Turning to slide six, we are excited about the progress we've achieved in the second quarter and believe it has substantially advanced us in all three areas of Vision 2025. and we are well-positioned to achieve these important milestones in our transformation to a high-growth global biopharma leader. I'll now turn the call over to Dan to review our commercial performance, after which Rob will share an update on our R&D progress, Renee will provide a financial overview, and then we'll open the call to Q&A. Dan?