Jazz Pharmaceuticals plc

Good day, and welcome to the fourth quarter 2021 Jazz Pharmaceuticals earnings conference call. At this time, all participants are in 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 one on your touchtone telephone. If anyone should require assistance during the call, please press star then zero to reach an operator. As a reminder, this call may be recorded. I would like to turn the call over to Andrea Flynn, Head of Investor Relations. You may begin.

Thank you, and good afternoon, everyone. Today, Jazz Pharmaceuticals reported its fourth quarter and full year 2021 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 Rob Yannone, Executive Vice President, Global Head of R&D. Kim Sablich, Executive Vice President and General Manager, North America, 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 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. 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.

Thanks, Andrea. Good afternoon, everyone, and thank you for joining us today. I'll start on slide five. 2021 was a transformative year for Jazz. with strong performance and consistent execution. In the fourth quarter and throughout 2021, we made substantial progress across commercial, R&D, and corporate development, continuing our evolution to a diversified, innovative, global biopharmaceutical company. Beginning with our overall 2021 financial performance, for the first time, we exceeded $3 billion in annual revenue, delivering top-line performance at the upper end of our guidance range, and recorded nearly $1 billion of adjusted net income on a non-GAAP basis. Renee will discuss our financial results in more detail later in the call. Our exceptional top-line results were driven by strong commercial execution across our portfolio. We met our ambitious target of five key launches in 2020 and 2021. Two of those launches, Rileys, and ZyWave Indiopathic Hypersomnia, or IH, are therapies that Jazz advanced from concept to commercialization. Coupled with the addition of Epidiolex to our commercial portfolio through the GW Pharmaceuticals acquisition, we have significantly diversified our revenue and are on track to meet our goal of at least 65% of net product sales in 2022 coming from newly approved or acquired products. On the regulatory side, we secured FDA approval for Rylase for the treatment of ALL and ZyWave NIH in June and August 2021, respectively. We also received orphan drug exclusivity from FDA for ZyWave for narcolepsy in June, with FDA citing the clinical benefits of ZyWave as a lower sodium oxibate therapy compared to Zyrum. Subsequently, we received orphan drug exclusivity for ZyWave NIH. In addition, in January of this year, we submitted the SBLA for Rylase to support an updated dosing regimen in the U.S. In concert with delivering strong commercial results and achieving important regulatory milestones, we continue to advance our R&D pipeline, which now comprises 18 novel candidates being studied in 36 active clinical trials. On the neuroscience side, we initiated two important clinical programs in 2021, beginning Phase II trials for suvacaltamide or JZP385 in essential tremor and for JZP150 in post-traumatic stress disorder. We also initiated the third Phase III nabiximols clinical trial in multiple sclerosis-related spasticity. And as part of our ongoing growth in oncology, we have a robust development effort for Zepzelka, headlined by the initiation of a Phase III trial in collaboration with our partner, Roche, evaluating Zepzelka in combination with Ticentric as maintenance therapy in first-line extensive-stage small cell lung cancer. A noteworthy milestone in 2021 that contributed to our growth was the acquisition of GW Pharmaceuticals. The integration of GW has proceeded exceptionally well, and as I've noted in the past, there is a superb cultural fit between the Jazz and GW teams. The acquisition is proving to be highly complementary to our existing commercial portfolio and has added the industry-leading GW cannabinoid platform to our R&D pipeline. Just as important, we're thrilled that many talented and experienced members of the GW team are in leadership positions across our combined enterprise. These accomplishments, all of which were underpinned by strategic allocation of capital and strong cash flow, have set the stage for an exciting year ahead. We continue to be laser focused on executing our strategy to build a high-value portfolio of differentiated commercial and clinical stage therapies that deliver sustainable growth and enhanced value, At the JPMorgan Healthcare Conference this January, we introduced Vision 2025, which included commercial, pipeline, and operational components. On slide six, we've called out several upcoming value drivers that we believe will enable us to deliver on this vision. For commercial, we are focused on execution across our neuroscience and oncology portfolios, including maintaining the strong momentum of our ZyWave, ZebZelka, and Rylase launches, as well as continuing the growth of Epidiolex in the U.S. and global markets. With respect to our pipeline, we are advancing multiple mid- and late-stage programs and anticipate the first clinical data from our DeMiximals program in the first half of this year. And we will continue to focus on operational excellence, including advancing our goal of of achieving less than three and a half times net leverage by the end of 2022. Turning to slide seven, Vision 2025 will frame our business for the next several years as we strive to bring new and innovative therapies to patients in critical need. As I noted, there are three core components to our vision, commercial, pipeline, and operational excellence. First, commercial. After achieving over $3 billion in revenue in 2021, we're positioned to grow revenue to $5 billion in 2025. We expect to generate revenue from current products as well as realized contributions from pipeline candidates that we expect to advance to market and products that we may acquire through strategic corporate development transactions. The $5 billion also includes anticipated organic sales growth of existing products in our commercial portfolio, as well as indication and geographic expansion. Second, our pipeline. In 2021, our R&D organization advanced key programs addressing significant patient needs in neuroscience and oncology. With a solid foundation in place, we believe we will deliver at least five novel product approvals in areas of critical unmet need and significant market opportunity by the end of the decade. In addition to legacy compounds in our pipeline, we're excited about promising assets emerging from the GW cannabinoid platform, and we are continuing to evaluate and pursue novel neuroscience and oncology programs through potential corporate development opportunities. Finally, operational excellence. Our 2021 adjusted operating margin was 43%, and we plan to improve our adjusted operating margin by five percentage points from 2021 to 2025, delivering more of our top line through to the bottom line. Our track record of strong execution and accomplishments gives us confidence in our ability to achieve Vision 2025. And our 2022 guidance, which Renee will cover shortly, is in line with this vision. I'll now turn the call over to Dan for an overview of our commercial performance after which Rob will share an update on progress of our R&D programs. Renee will provide a financial overview, and then we'll open the call to Q&A. Dan?