Axsome Therapeutics, Inc.

Hello and thank you for standing by. My name is Tiffany and I will be your conference operator today. At this time, I would like to welcome everyone to the Jazz Pharmaceuticals first quarter 2025 webcast conference call. 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 one again. We kindly ask that you limit yourself to one question for today's call. Thank you. I would now like to turn the call over to Executive Director of Investor Relations, Jeff MacDonald. Please go ahead.

Thank you, Operator, and good afternoon, everyone. Today, JASP Pharmaceuticals reported its first quarter 2025 financial results. The slide presentation accompanying this webcast is available on the investor section of our website. Investors should also refer to the press release we issued earlier today that is available on our website. On the call today are Bruce Kozad, Chairman and Chief Executive Officer, Renee Golov, President and Chief Operating Officer, Rob Yannone, Executive Vice President, Global Head of R&D and Chief Medical Officer, 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, regulatory and commercial 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 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, 2024, and our subsequent filings with the SEC, including our quarterly report on Form 10-Q for the financial quarter ended March 31, 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 Bruce.

Thanks, Jeff. Good afternoon, everyone. Thank you for joining us today to discuss Jazz's first quarter 2025 results. I'll start on slide five. JAS started the year with strong momentum following a productive 2024, and we're pleased with the meaningful progress we've made across the business in the first quarter of 2025. Our focus on execution and operational excellence resulted in solid commercial performance led by Epidiolex and ZyWave, and significant progress across our R&D pipeline. We submitted a supplemental new drug application, or SNDA, to expand Zepzelka into first-line maintenance in extensive stage small cell lung cancer and received a positive CHMP opinion recommending the marketing authorization for Zanidatamab and advanced HER2-positive biliary tract cancer, or BTC, in the European Union. In addition, the acquisition of Chimerix has further strengthened our presence in rare oncology. On the commercial front, we generated $898 million in total revenues across our portfolio. Our neuroscience portfolio had a strong start to the year, with ZyWave growing 9% year over year, remaining the number one branded treatment for narcolepsy as measured by revenue, and the only therapy approved to treat idiopathic hypersomnia, or IH. We saw strong epidiolex demand as revenues increased 10% year over year, and we remain confident in its blockbuster potential. While we experience near-term headwinds with certain oncology products, our oncology portfolio is poised for growth with three potential regulatory approvals in the coming months, including Dordaviprone, Zepzelka expansion into first-line maintenance therapy in the U.S., and Xanidatamab advanced BTC in Europe. Moving to R&D, we're advancing promising opportunities in our pipeline. The Horizon GEA01 Phase III trial evaluating Xanidatamab in first-line gastroesophageal adenocarcinoma, or GEA, remains on track to read out in the second half of this year. We continue to progress other key Xanidatamab clinical trials, including the Phase III Empower BC303 trial in breast cancer. We're looking forward to sharing important data on Zepzelka, Xanidatamab, and Dordavacrone at ASCO in June. We added Dordaviprone to our pipelines through the Chimerix acquisition, which closed in April, enhancing our presence in rare oncology and bringing a near-term commercial opportunity to help patients with limited treatment options. Given its patent protection into 2037 with possible extensions and the potential for expanded use in the frontline setting, we view Dordaviprone as a meaningful and durable revenue opportunity for Jazz. We are well positioned with respect to the impact of potential tariffs and have maintained financial flexibility supported by our strong balance sheet and cash flow. We remain confident in our top line revenue guidance and have updated our financial guidance to include the recent Chimerix acquisition and litigation settlement charges. I'll now turn the call over to Renee to discuss our commercial performance, after which Rob will cover our R&D pipeline. Bill will then provide a financial overview and discuss our updated guidance. And after that, we will open the call to Q&A. Renee?