Jazz Pharmaceuticals plc

Thank you for standing by. My name is Krista and I will be your conference operator today. At this time, I would like to welcome everyone to the Jazz Pharmaceuticals first quarter 2024 earnings 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'd like to ask a question during that time, simply press star followed by the number one on your telephone keypad. And if you'd like to withdraw that question, again, press star one. Thank you. I would now like to turn the conference over to Andrea Flynn, Vice President, Head of Investor Relations. Andrea, you may begin your conference.

Thank you, Operator, and good afternoon, everyone. Today, Jazz Pharmaceuticals reported its first quarter 2024 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 to our website. On the call today are Bruce Kozad, Chairman and Chief Executive Officer, Renee Galah, President and Chief Operating Officer, Rob Younone, Executive Vice President and Global Head of R&D, 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 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 the risks and uncertainties described in our SEC filings, which identify 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 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. to review our first quarter results. I want to begin by welcoming Phil Johnson, who joined Jazz in March as our Chief Financial Officer. We're very excited to have Phil on our executive team and look forward to his contributions to delivering value for patients and shareholders. Beginning on slide five, we made important progress during the first quarter, including year-over-year combined double-digit revenue growth from our key growth drivers, ZyWave, Epidiolex, and Rylase. along with meaningful advances in our pipeline. I'm also pleased to report that we are affirming our 2024 financial guidance. On the commercial front, we generated more than $900 million in total revenues across our growing and diversified portfolio of medicines. ZyWave revenues increased 14% year over year, reinforcing our confidence in its trajectory and durability. Epidiolex demand remains strong, and we continue to be confident in its blockbuster potential. Our oncology therapeutic area delivered another strong quarter with 13% year-over-year revenue growth. This continues the momentum we established last year when we surpassed $1 billion in annual oncology revenue for the first time. Moving to our R&D and pipeline efforts, 2024 is an important year for Jazz with multiple late-stage catalysts for therapies targeting substantial market opportunities. We achieved a significant milestone for Xanidatamab in March with the completion of our rolling VLA submission for the treatment of HER2-positive biliary tract cancer, or BTC, and we expect commercial launch in 2025 or earlier. If approved, Xanidatamab would be the first HER2-targeted treatment specifically for BTC in the U.S. We also expect important clinical data readouts in the near future for suvacaltamide in essential tremor, zanidatumab in gastroesophageal cancer, Epidiolex in Japan, and Zebselka in first-line small cell lung cancer. On the operational front, we are maintaining our focus on disciplined capital allocation. Our financial strength, including healthy operating cash flow, enables us to invest in the continued growth of our commercial portfolio and pipeline while also positioning us to execute on corporate development opportunities. Turning to slide six, we remain focused on advancing the three core tenets of Vision 2025. This includes advancing leading therapies in sleep disorders and epilepsy, along with a growing oncology portfolio, investing in R&D to expand our capabilities and pipeline, and making disciplined capital allocation decisions to enhance value for shareholders as we realize our ambition to be a high-growth, global biopharma leader. I'll now turn the call over to Renee to review our commercial performance, after which Rob will share an update on our R&D progress. Phil will provide a financial overview, and then we'll open the call to Q&A. Renee?