Jazz Pharmaceuticals plc

Good afternoon. My name is Krista and I'll be your conference operator today. At this time, I would like to welcome everyone to the Jazz Pharmaceuticals third quarter 2023 earnings 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 that time, simply press star followed by the number one on your telephone keypad. And if you would like to withdraw your 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. You may begin.

Thank you, Operator, and good afternoon, everyone. Today, Jazz Pharmaceuticals reported its third quarter 2023 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, Rene Galla, President and Chief Operating Officer, and Rob Younone, 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 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. Turning to slide three on this webcast, we'll 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 investor 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 third quarter of 2023, we delivered strong commercial results advanced multiple late-stage programs within our pipeline, and maintain our focus on driving operational excellence. Our results for the quarter exemplify the successful execution that has led to an exciting transformation and diversification of our business across our commercial portfolio and R&D pipeline, and we remain well-positioned to achieve Vision 2025. As we highlighted in today's press release, we have updated our 2023 guidance. raising our full-year total revenue and oncology revenue guidance at the midpoints. And as our pipeline continues to advance, we are increasing our R&D guidance, primarily driven by investments in Xanidatamab development across multiple HER2-expressing cancers that we believe will allow us to deliver an important new therapeutic option with the potential to raise the standard of care for patients and create long-term value for JAS. It's important to note that our disciplined approach to capital allocation has allowed us to invest in R&D, as well as key commercial franchises, while remaining on track to deliver on our full-year gap net income and non-gap adjusted net income guidance. With regard to our commercial business, we are seeing strong momentum across all three key growth drivers, ZyWave, Epidiolex, and Rylase. Combined, revenue from these products grew 24% in the third quarter compared to the same period last year. We remain confident in the durability of our Oxibate franchise and the growth of Zywave in both narcolepsy and idiopathic hypersomnia, or IH, even as high-sodium branded and authorized generic competition has entered the narcolepsy market. Zywave is annualizing at $1.3 billion in revenue, remains the Oxibate of choice, and is the only approved treatment for IH. Underlying demand continues to drive Epidiolex growth. We remain confident in its potential to reach blockbuster status and contribute more than a billion dollars in revenue to our Vision 2025 revenue target. Outside the U.S., we expect additional launches and indication expansions through 2024. In oncology, Rylase has continued to grow in the U.S., supported by strong demand from pediatric patients and our increasing emphasis on the adolescent and young adult market. In addition, we recently received marketing authorization for the product in Europe under the trade name Enrylase. The performance of these products, together with Zepselca revenues, is fueling the ongoing diversification of our commercial business. More than half of net product revenue this quarter came from Epidiolex and our oncology products combined. and ZyWave represented more than two-thirds of our Oxibate revenue. This marks a significant shift from just a few years ago when ZyREM represented three-quarters of total revenue. This diversified revenue stream is a direct result of our outstanding commercial execution along with successful corporate development and internal R&D efforts. Moving to our pipeline, we now expect up to five late-stage readouts through the end of 2024. Rob will cover our R&D progress in more detail later in the call, but I want to highlight that we view Xanidatamab as the most de-risked and highest priority program in our pipeline. We plan to initiate a rolling biologics license application, or BLA, submission this year for accelerated approval of Xanidatamab for second-line treatment of biliary tract cancers, or BTC. This is an important step in delivering Xanidatamab to patients with BTC and other HER2-expressing cancers with limited treatment options. Given the strength of clinical data to date and its promise in multiple indications, we believe Zannie has the potential to deliver more than $2 billion in peak revenues. On the operational front, our commercial execution, along with attention to operational excellence, has put us in strong financial position. We continue to generate significant cash flow from operations, which combined with our strong balance sheet gives us the capacity to invest in the products, pipeline programs, and corporate development opportunities with the highest potential to deliver sustainable growth and enhance value. Turning to slide six, we are very pleased with our progress in the third quarter and believe it has advanced us toward achieving all three components of Vision 2025 as we continue our transformation into 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. I'll provide a financial overview, and then we'll open the call to Q&A. Renee?