Jazz Pharmaceuticals plc

Thank you, Operator, and good afternoon, everyone. Today, Jazz Pharmaceuticals reported its third 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, Rene Gauland, President and Chief Operating Officer, Rob Yannone, 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, 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 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 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. I'll start on slide five. We are pleased to report on our progress in the third quarter of 2024, which was headlined by delivering strong growth across our commercial portfolio and advancing our ZanyDataMap development program. Recently, we achieved an important clinical milestone with positive data from our Phase 3 trial evaluating Zepzelka in first-line maintenance for extensive-stage small-cell lung cancer. Diving into a bit more detail, I'll begin with our commercial execution for the third quarter. The durability of our neuroscience therapeutic area was underscored by both ZyWave and Epidiolex posting record quarterly sales and year-over-year double-digit growth. In addition, our oncology business reported 9% revenue growth year over year, including a strong quarter for Zepselka. In our neuroscience therapeutic area, ZyWave remains the oxidative choice as the number one branded treatment for narcolepsy and the only approved therapy for idiopathic hypersomnia, or IH. In IH, physicians and patients continue to provide positive feedback on the benefits of ZyWave as we build the market. And we expect this indication to drive growth for the brand. And in narcolepsy, we continue to see strong patient demand. Epidiolex growth remains strong as it nears blockbuster status. Patient demand in the U.S. is being driven by multiple commercial initiatives, and we've made steady progress in our ongoing ex-U.S. market expansion. Moving to our oncology therapeutic area, Zepzelka continues to perform well, and we now have an opportunity to move from second-line treatment to first-line maintenance therapy based on the positive results of the INFORTE trial. Rob will review the trial results and next steps later in the call. For Rylase, we are seeing high utilization in the pediatric population and are continuing to roll out programs to drive adoption in the adolescent and young adult markets. A recent update to Children's Oncology Group Pediatric Treatment Protocols for ALL has impacted the timing of asparaginase administration. We expect these new protocols will have a temporary negative impact on third quarter and fourth quarter RILAs revenue, after which we expect demand to normalize by early next year. Turning to our R&D and pipeline efforts, we are focused on rapidly advancing our ZanyDataMED program. The PDUFA date for Xanidatomab in second-line biliary tract cancer, or BTC, is coming up at the end of this month, and we are well-positioned for launch following approval. Our development program includes multiple ongoing trials in a number of HER2-positive tumors across lines of therapy. Xani is our most de-risked pipeline asset, and we are moving forward with a sense of urgency and purpose, in order to deliver this therapy to patients with HER2-positive tumors who are in need of new and effective treatment options. At the start of the call, I mentioned our recent data readout on Zepzelka. We're excited that patients will potentially have access to this therapy earlier in their treatment, where there is the potential to increase duration of response in a broader patient population, delaying disease progression and extending survival. Our commercial execution and focus on operational excellence have kept us in a strong financial position again this quarter. We continue to deliver top-line growth and generate significant cash flow from operations. We remain focused on investing in the products, pipeline programs, and corporate development opportunities that we believe have the highest potential to deliver sustainable growth and enhance value. As Phil will cover in more detail later in the call, we are affirming our total revenue and adjusted net income guidance provided on our second quarter 24 call, and have updated certain other elements of our guidance. 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?

Thanks, Bruce. I'll begin on slide seven. We're pleased with the performance of our sleep business this quarter. Total revenue, which includes ZyWave and XyRen net sales plus royalties from high-sodium oxibate authorized generics, or AGs, was approximately $505 million. In the third quarter, ZyWave net product sales grew 17% year-over-year to approximately $388 million, and we expect ZyWave to continue to be the oxibate of choice in both narcolepsy and IH. We are focused on enabling as many patients as possible to benefit from low-sodium ZyWave and saw an increase of approximately 400 net patients exiting the third quarter compared to the second quarter. In narcolepsy, we are seeing strong demand from both new and transition patients. Further, our ongoing focus on individualized dosing and educating patients and prescribers about the benefits of reducing sodium intake continues to drive growth, and I'm pleased to report we reported approximately 150 net narcolepsy patient adds compared to the prior quarter. Moving to IH, we remain excited about the growth potential of ZyWave in this indication. There were approximately 3,550 active IH patients on ZyWave exiting the third quarter. an increase of approximately 250 patients compared to the prior quarter, which is in line with the growth we've seen in recent quarters. Our expanded field force is continuing to focus on increasing the depth and breadth of IH prescribers, which is a primary driver of demand. We are also seeing positive impact from our field nurse educator program, which supports both narcolepsy and IH indications. This program enables new ZyWave patients to interact in person with trained healthcare professionals as they begin OxyBait therapy, providing education during the time when patients are titrating and optimizing their OxyBait therapy and are most likely to have questions related to their treatment. Moving to slide eight, an epidiolex. we achieved another strong quarter with net product sales of approximately $252 million in the third quarter, representing an 18% increase compared to the same quarter in 2023. Key drivers of increased demand in the US included the positive response to data on the benefits of Epidiolex beyond seizure control, such as language and communication, cognition, executive function, and emotional and social function, as well as synergies from treatment with Epidiolex plus Clobizam. Building on that body of evidence, which now includes data from more than 2,000 patient experiences, we presented data at the European Epilepsy Congress in September, that demonstrated improvements in seizure and non-seizure outcomes in patients receiving Epidiolex in combination with Clobizam. Importantly, our improved understanding of the real-world outcomes benefits of Epidiolex not only extends to patients, but to their families and caregivers as well. We're also continuing to see penetration in the adult patient setting, which is supported in part by data showing that many LGS patients may reach adulthood without a specific diagnosis, and by providing healthcare professionals with clear diagnostic tools for adult patients. Our virtual nurse navigator program, which we launched earlier this year, provides Epidiolex patients and their families with a resource to discuss medication-related topics, such as optimized dosing. While it's still early, we are seeing positive momentum with this program. Further opportunities for growth include focused data generation and geographic expansion beyond the more than 35 countries where Epidiolex is currently approved. Moving to slide nine and our oncology business, total oncology revenue for the quarter was approximately $285 million. representing 9% growth from the same period last year. Rylase not product sales were approximately $99 million, representing a 6% decrease from the third quarter of 2023. As Bruce noted earlier, over the summer, the Children's Oncology Group updated pediatric protocols for ALL that impact the timing of asparaginase administration. Importantly, the updated protocols do not change the recommended total number of doses of asparaginase, so we do not expect an impact to overall demand for Rylase. We anticipate the revenue impact of this timing shift to be primarily limited to the third and fourth quarter of this year and to normalize by early next year. We continue to see the most opportunity for growth in the adolescent and young adult or AYA market, and we are continuing to educate oncologists who treat these patients about the benefits of asparaginase therapy. This quarter, we initiated several new programs to drive AYA adoption and continue to see opportunity to build that market over time. Turning to slide 10 in Zephselka, We delivered another strong quarter with net product sales increasing 10% year over year to approximately $86 million. Zepselka remains the treatment of choice for second line small cell lung cancer patients, and healthcare providers continue to deliver positive feedback on the product's clinical benefit and ease of use. Last month, We were very pleased to announce positive data from the M-forte trial evaluating Zapfelka in a first-line maintenance regimen. Our team is preparing to submit an SNDA to include first-line maintenance therapy to the Zapfelka label. If approved, this change in practice to first-line maintenance would enable a larger number of small cell lung cancer patients to be eligible for Zapfelka treatment. With that, I will turn it over to Rob for an update on our pipeline and upcoming milestones. Rob?