Jazz Pharmaceuticals plc

Good day, ladies and gentlemen, and thank you for standing by. Welcome to the Jazz Pharmaceuticals first quarter 2022 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 then 1 on your telephone keypad. As a reminder, this conference call is being recorded. If you require any further assistance, please press star then 0. At this time, I would like to turn the conference over to Ms. Andrea Flynn. Ma'am, you may begin.

Thank you, and good afternoon, everyone. Today, Jazz Pharmaceuticals reported its first 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 Cozad, Chairman and Chief Executive Officer, Renee Galoff, Executive Vice President and Chief Financial Officer, Dan Swisher, President, and Rob Yannone, Executive Vice President, Global Head of R&D. Kim Fablich, Executive Vice President and General Manager, North America, and Phil Jockelson, Neuroscience Therapeutic Head, will join the team for Q&A. On slide two, 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 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 documents. 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. 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 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. Following our strong performance and execution in 2021, we began 2022 with substantial momentum. Since the beginning of the year, we've demonstrated considerable progress across commercial, R&D, and corporate development while delivering solid year-over-year top and bottom line growth in the first quarter. Importantly, we continue to substantially diversify our business with an eye toward optimizing our product portfolio and improving our adjusted operating margin. I'm excited by the progress we are making in transforming our business. Despite typical first quarter payer churn and impact from the Omicron variant, our year-to-date performance has been strong. That coupled with our continued focus on strategic capital allocation has has enabled us to increase our guidance ranges for both the top and bottom line. On the commercial front, we're very encouraged by the positive direction of the launch of ZyWave in idiopathic hypersomnia, or IH, underscored by the growing number of patients on therapy, the effectiveness of ongoing outreach to educate prescribers and patients about the benefits of ZyWave, and the high level of engagement and receptivity in the market. We're seeing strong demand for Rylase, and in January of this year, we submitted an SBLA to support Monday, Wednesday, Friday intramuscular dosing, followed in April by a separate SBLA for IV administration. Dan will provide a more complete overview of our performance across our commercial portfolio later in the call. Turning to our pipeline, we've made substantial advances this year. Starting with oncology, we enrolled the first patient in a Phase II basket trial for zebzelka, evaluating its safety and efficacy across several solid tumors. And for the first time, we presented preclinical data on JCP815, our next-generation pan-RAF kinase inhibitor, at the AACR annual meeting in April. Moving to neuroscience, data from the first of three ongoing Phase III clinical trials of the bixomols in multiple sclerosis-related spasticity is expected this quarter, as is the initiation of our Phase III trial of Epidiolex in epilepsy with myoclonic atonic seizures, or EMOS. We've also added two promising compounds to our pipeline since the beginning of the year. This afternoon, we announced a licensing agreement with Sumitomo Pharma for DSP0187, which we are now referring to as JCP441, JCP-441 is a potent, highly selective orexin-2 receptor agonist that has the potential to advance the treatment of narcolepsy and other sleep disorders and further solidifies our sleep leadership position. This follows our licensing agreement last month with Werewolf Therapeutics for WTX-613, which we now refer to as JCP-898. JCP-898 is a differentiated conditionally activated interferon alpha-indakine molecule that has the potential to minimize the toxicity associated with systemic interferon alpha therapy, thereby expanding its clinical utility in treating cancer. Both of these transactions expand our pipeline in core therapeutic areas and are consistent with our strategy. While expanding our pipeline and diversifying our revenue remain key imperatives, We also regularly review our commercial and pipeline portfolios to prioritize the medicines and R&D programs that are most likely to deliver value to patients and shareholders. As a result, in the first quarter, we entered into an agreement to divest Sanosi to Axome Therapeutics. We believe Axome is well positioned to deliver continued access to this important medication. These transactions demonstrate our discipline, strategic allocation of capital, and commitment to drive long-term value as we transform our business. Our execution in the first quarter drove significant growth and has positioned us to raise our guidance for the year on both the top and bottom line, with improved operating margin at the midpoint. We continue to see growth opportunities for our key commercial products and remain focused on operating efficiency and enhancing and expanding our pipeline. In short, we're really pleased with where the business is, and more importantly, where it's going. Moving to slide six, in January, we announced Vision 2025, which includes three components central to driving sustainable growth and enhanced value, commercial, pipeline, and operational excellence. After achieving over $3 billion in revenue in 2021, we're positioned to grow revenue to $5 billion in 2025. Our R&D organization continues to advance key programs addressing significant patient needs in neuroscience and oncology, including recent Phase II trial initiations for subacaltimide and JCP-150. And we anticipate delivering at least five novel product approvals by the end of the decade. 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. Collectively, our continued execution in the first quarter provides additional evidence of our ability to achieve Vision 2025. I'll now turn the call over to Dan for an overview of our first quarter commercial performance, after which Rob will share an update on progress of our R&D programs. Renee will provide a financial overview and discuss the year's corporate development transactions, and then we'll open the call to Q&A. Dan? Thanks, Bruce.