Jazz Pharmaceuticals plc

Good day, and thank you for standing by. Welcome to the Q3 2022 Jazz Pharmaceuticals 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 11 on your telephone, and you will then hear an automated message advising your hand is raised. Please be advised that today's conference is being recorded. I would now like to hand the conference over to your speaker today, Andrea Flynn, Vice President of Investor Relations. Please go ahead.

Thank you, Operator, and good afternoon, everyone. Today, Jazz Pharmaceuticals reported its third quarter 2022 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, Executive Vice President and Chief Financial Officer, Dan Swisher, President and Chief Operating Officer, and Rob Yannone, Executive Vice President, Global Head of R&D. Kim Sablich, Executive Vice President and General Manager, U.S., will join the team for Q&A. On slide 2, I'll remind you that today's webcast includes forward-looking statements, such as those related to our future financial and operating results, including expectations related to Vision 2025 and our guidance for 2022, growth potential and anticipated development programs and pipeline, regulatory activities and commercialization milestones, goals and expected timing, and statements with respect to our licensing agreement for Zana Data Map that is subject to closing conditions, 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 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 press release. 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. Reconciliations of GAAP to non-GAAP financial measures are included in today's press release and in the slide presentation available on the investor section of our website. I'll now turn the call over to Bruce.

Thank you, Andrea. Good afternoon, everyone, and thanks for joining us today. I'll start on slide five. In the third quarter, strong operational performance across all areas of our business enabled us to deliver significant year-over-year top and bottom line growth for the quarter, building on a productive first half of the year. I'm pleased to report that based on our performance through the first three quarters of 2022, we are raising the midpoint of our full-year revenue guidance, reflecting increases in the guidance midpoints of both our neurology and oncology net sales projections. Renee will discuss these and other updates to our guidance later in the call. Our commercial business continues to execute well. In our neuroscience franchise, we are seeing compelling adoption of ZyWave in both narcolepsy and idiopathic hypersomnia, or IH. And we're pleased to have achieved another important milestone. Exiting October 2022, there are now more narcolepsy patients taking ZyWave than ZyREM. Looking ahead, we remain confident in the durability of ZyWave as a core component of our commercial portfolio. For Epidiolex, we are seeing growth driven by underlying demand, and recently we completed the pricing and reimbursement process in France, paving the way for commercial launch in this key European market. We believe Epidiolex can become a cornerstone of treatment for refractory seizures and remain confident in Epidiolex's potential to achieve blockbuster status. Moving to oncology, Zepzelka is established as the treatment of choice in second-line small cell lung cancer. Our ongoing clinical development efforts are focused on expanding within that indication as well as looking to address additional patient populations who may benefit from therapy. Rylase had another strong quarter as momentum with prescribers has continued. Rylase remains the only therapy available to patients in the U.S. who experience a hypersensitivity reaction to E. coli-derived asparaginase. Dan will provide a detailed overview of our performance across the commercial portfolio later in the call. Our pipeline efforts were productive again this quarter, with multiple clinical trial starts. We enrolled the first patient in our phase one trial, evaluating JCP815, our pan-RAF inhibitor, for the treatment of solid tumors that contain mutations in the MAPK pathway. We initiated a Phase II trial for subacaltimide in Parkinson's disease tremor, which complements our ongoing Phase IIb trial in essential tremor. And for Epidiolex, we initiated our Phase III trial evaluating Epidiolex in patients with epilepsy with myoclonic atonic seizures, or EMOS, as well as enrolled the first patient in our pivotal trial in Japan. And just last month, we announced a licensing agreement to further expand our late-stage pipeline as part of our agreement with ZymWorks to acquire development and commercialization rights to ZanyDatamab, a novel HER2-targeted bispecific antibody in the U.S., Europe, Japan, and other markets. Rob will provide additional comments on our pipeline programs in progress, including ZanyDatamab, later in the call. Turning to slide six. Vision 2025 includes three components central to driving sustainable growth and enhanced value as we transform our company, commercial, pipeline, and operational excellence. Starting with commercial, we're positioned to grow revenue to $5 billion in 2025 through a combination of existing products, potential new therapies emerging from our pipeline, and corporate development. Our R&D organization is advancing key programs addressing significant patient needs in neuroscience and oncology, and we anticipate delivering at least five novel product approvals by the end of the decade through a combination of existing pipeline programs and corporate development. The Zany Data Map transaction is an example of a corporate development initiative that could contribute to both our commercial and pipeline objectives. And on operational excellence, our 2021 adjusted operating margin was 43%, and we plan to improve that by five percentage points from 2021 to 2025, delivering more of our top line through to the bottom line. With Vision 2025 as our roadmap, we continue to transform our business and operating model to ensure we have the appropriate structure in place to scale. while continuing to invest in our business in order to meet our goals. We believe our accomplishments in the third quarter position us for a strong ending to the year, entering 2023 with considerable momentum across the business and well positioned to achieve vision 2025. I'll now turn the call over to Dan to review our third quarter commercial performance, after which Rob will share an update on the progress of our R&D programs, Renee will provide a financial overview, including a corporate development update, and then we'll open the call up for Q&A. Dan?