Jazz Pharmaceuticals plc

Thank you for standing by. My name is Jeannie and I will be your conference operator today. At this time, I would like to welcome everyone to the Jazz Pharmaceuticals fourth quarter 2024 webcast. All lines have been placed on mute to prevent any background noise. After the speaker's remarks, there will be a question and answer session. If you would like to ask a question during this time, simply press star followed by the number one on your telephone keypad. If you would like to withdraw your question, press star 1 again. Thank you. I would now like to turn the call over to Jeff McDonald, Executive Director, Investor Relations. You may begin.

Thank you, Operator. Good afternoon, everyone. Today, Jazz Pharmaceuticals reported its fourth quarter and full year 2024 financial results. The slide presentation accompanying this webcast is available on the investor section of our website, as is the press release we issued earlier today. On the call are Bruce Cozadd, Chairman and Chief Executive Officer, Renee Gala, President and Chief Operating Officer, Rob Iannone, Executive Vice President, Global Head of R&D, and Phil Johnson, Chief Financial Officer. 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 We encourage you to review the statements contained in today's press release in our slide deck and the risks and uncertainties described under the caption risk factors in our annual report on Form 10-K for the fiscal year ended December 31st, 2023, our quarter report on Form 10-Q for the quarter ended September 30th, 2024, and our subsequent filings with the SEC including our annual report on form 10k for the fiscal year ended December 31st 2024 which identifies certain risk 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 these forward-looking statements as noted on slide three we will discuss non-gap financial measures on this webcast 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, Jeff. Good afternoon, everyone. Thank you for joining us today to discuss Jazz's fourth quarter and full year 2024 results. I'll start on slide five. I'm very pleased to report that 2024 was another record year for Jazz. Our strong commercial execution resulted in more than $4 billion in total annual revenue and fourth quarter revenue of nearly $1.1 billion, our highest ever. Importantly, we helped more patients who benefit from our highly differentiated therapies in areas with limited or no therapeutic options. These achievements reflect the tenacity and dedication of our talented employees around the world. On the R&D front, we achieved several important development and regulatory milestones in 2024, headlined by the accelerated approval of Zyhera in the U.S. for the treatment of second-line HER2-positive biliary tract cancer, or BTC, in November. In addition, we believe the positive results from the Phase III Zepzelka clinical trial in first-line maintenance for small cell lung cancer will support expansion into an earlier line of treatment potentially benefiting a broader patient population. We plan to further diversify our commercial and pipeline portfolios through strategic corporate development, which remains a key focus for JAS. As part of our ongoing search, we're evaluating neuroscience and oncology assets while also contemplating other rare and orphan diseases. In addition, durability of revenue, efficiency of commercial call points, and alignment with our expanded R&D capabilities are part of our considerations as we assess opportunities to maximize long-term shareholder value through corporate development. Turning to slide six, I'm pleased to confirm we achieved our 2024 guidance, delivering top line growth at the upper end of our range and $1.37 billion in adjusted net income on a non-GAAP basis. Phil will discuss our 2024 financial results and 2025 guidance in more detail later in the call. On the commercial front, our sleep, epilepsy, and oncology portfolios are each annualizing at over $1 billion based on fourth quarter net product sales. Zywave remains the number one branded treatment for narcolepsy based on revenue and the only FDA approved therapy to treat idiopathic hypersomnia or IH. We've been pleased with our execution across narcolepsy and IH as our team has navigated the entry of high sodium, fixed dose, branded oxovate, and authorized generic or AG competition since their introduction in 2023. Epidiolex net product revenues grew 15% in 2024 compared to 2023, and it is poised to reach blockbuster status this year. Oncology revenues grew 9% in 2024 to a record of more than $1.1 billion, even with changes to pediatric protocols, which temporarily impacted Riley's revenue in the second half of 2024. Renee will discuss our commercial performance in greater detail. Overall, our 2024 total revenue grew 6% compared to 2023, reflecting our strong execution of the commercial strategies we are implementing. We continue to advance promising opportunities in our pipeline. We look forward to the data readout from the Horizon GEA01 Phase 3 trial evaluating Xanidatamab in first-line gastroesophageal adenocarcinoma, or GEA. While we had previously provided an estimate of the second quarter of this year for top-line progression-free survival readout, based on our more mature projections of events accrued to date, we now expect data readout in the second half of this year. Rob will share additional color on this trial a bit later in the call. The first line BTC confirmatory trial, phase three breast cancer trial, and phase two pan tumor trial are all progressing well. In addition, we plan to submit a supplemental new drug application, or SMDA, for ZUP-Zelka as maintenance therapy in first line extensive stage small cell lung cancer in the first half of 2025. We remain focused on driving growth while maintaining a disciplined and strategic approach to capital allocation. Our financial strength and cash flow enable us to invest in our commercial portfolio, pipeline, and future corporate development opportunities. Before we move on, as previously shared, I'll be retiring from my role as CEO this year. It's been a privilege to lead Jazz through the growth and significant diversification that has transformed the business into the fully integrated biopharma company it is today. Importantly, we remain committed to reaching more patients by making strategic investments through corporate development, a focus that will continue during the CEO transition period. After a successor is appointed, I'll continue serving as chairman of the board of directors, providing ongoing leadership and strategic guidance. I'm confident Jazz's next leader will continue delivering for patients, employees, partners, and shareholders. I'll now turn the call over to Renee to discuss our commercial performance, after which Rob will cover our R&D pipeline. Phil will then provide a financial overview and review our 2025 guidance, and then we'll open the call for Q&A. Renee?