Jazz Pharmaceuticals plc

Good day, and thank you for standing by. Welcome to the Jazz Pharmaceuticals 2025 Third Quarter Earnings Conference Call. At this time, all participants are in a listen-only mode. After the speaker's presentation, there will be a question and answer session. To ask a question during the session, you will need to press star 1-1 on your telephone. You will then hear an automated message advising your hand is raised. To withdraw your question, please press star 11 again. We ask that all analysts please limit themselves to one question. Please be advised that today's conference is being recorded. I would now like to hand the conference over to your first speaker today, Jack Spinks, Executive Director, Investor Relations. Please go ahead.

Thank you, Operator, and good afternoon, everyone. Today, Jazz Pharmaceuticals reported its third quarter 2025 financial results. The slide presentation accompanying this webcast is available on the Investors section of our website. Investors should also refer to the press release and the quarterly report on Form 10-Q that we issued earlier today. Both are available on our website and filed with the SEC. On the call today are Rene Gala, President and Chief Executive Officer, Sam Pierce, Executive Vice President and Chief Commercial Officer, Robbie Annone, Executive Vice President, Global Head of R&D and Chief Medical Officer, and Phil Johnson, Executive Vice President and 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, regulatory and commercial milestones, which involve risks and uncertainties that could cause actual events, performance, and results differ materially from those contained in these forward-looking statements. We encourage you to review these risks and uncertainties described in today's press release and under the caption Risk Factors in our annual report on Form 10-K for the fiscal year ended December 31, 2024, and our subsequent filings with the SEC, including our quarterly report on Form 10-Q for the fiscal quarter ended September 30, 2025, 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. As noted on slide three, we will discuss non-GAAP 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 investor section of our website. I'll now turn the call over to Renee.

Thanks, Jack. Good afternoon, everyone, and thank you for joining us to discuss Jazz's third quarter 2025 results. I'm delighted to be speaking with you today as Jazz's CEO. The past three months have been energizing and productive. We delivered two FDA approvals that underscore Jazz's ability to bring highly differentiated therapies to patients with serious unmet needs. These milestones reflect the strength of our execution, dedication of our teams, and our continued momentum to drive sustainable growth and meaningful value for our patients and our shareholders. Beginning on slide five, the results of the quarter reflect that momentum. Starting with commercial, we achieved our highest ever revenue quarter, over $1.1 billion, driven by robust growth from ZyWave, Epidiolex, and the early successful launch of Medeso, the first and only drug treatment for recurrent H3K27M mutant diffused midline glioma, an ultra-rare and aggressive brain tumor. Approval of Medeso followed the acquisition of Chimerix earlier this year, reinforcing our ability to strengthen our portfolio through corporate development. We also secured FDA approval for Zepselca in combination with Etuzaluzumab as a first-line maintenance therapy for extensive stage small cell lung cancer. Both therapies are now included in NCCN guidelines, reflecting the meaningful advancements these therapies bring to patients. Moving on to our pipeline, we look forward to sharing the highly anticipated top-line results from the Phase III Xanidatamab Horizon Trial in gastroesophageal adenocarcinoma, or GEA, later this quarter. In addition, we strengthen our early-stage epilepsy pipeline through a global licensing agreement with Saniona. This agreement provides JAS with worldwide rights to develop and commercialize SAM 2355, a promising preclinical candidate designed to overcome the limitations of non-selective KD7 targeting compounds. On the financial front, we remain strongly positioned to invest in the key growth drivers of our business. We narrowed our 2025 revenue guidance to a range of 4.175 to $4.275 billion. reflecting increased confidence in our outlook at this point in the year. In addition, we were pleased to have reached settlement agreements across the entirety of the Xyrem antitrust litigation and the litigation with Avidel. With these matters behind us, we can focus squarely on executing our strategy, maximizing our impact for patients, and creating meaningful value for our shareholders. Finally, we're thrilled to welcome Dr. Ted Love to our board of directors. Ted's extensive leadership in the biopharmaceutical industry and track record of driving scientific innovation, commercial success, and shareholder value will complement the capabilities of our existing board and deepen our commitment to innovating for patients. In summary, we delivered a highly productive third quarter with record revenues, FDA approval and rapid launch of Medeso, completion of the Santa Yona licensing agreement, and in October, litigation settlements and first-line maintenance combination approval for Zepselka, all of which position us for a strong close of the year. I'll now turn the call over to Sam to discuss our commercial performance, after which Rob will cover our R&D pipeline, Phil will provide a financial update, and after that, we'll open the call to Q&A. Sam?