Jazz Pharmaceuticals plc

Good afternoon, ladies and gentlemen, and welcome to the 3rd Quarter 2021 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, you will need to press star 1 on your telephone. I would now like to turn the conference over to your host, Ms. Andrea Flynn, Head of Investor Relations. Ma'am, please go ahead.

Thank you, and good afternoon, everyone. Today, Jazz Pharmaceuticals reported its third quarter 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, R&D, and Chief Medical Officer. Kim Sablich, Executive Vice President and General Manager of North America, and Phil Jockelson, Neuroscience Therapeutic Head, will join 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 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 the slide deck 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. We remain laser-focused on executing our strategy across commercial, R&D, and corporate development. positioning Jazz to deliver sustained growth as we continue to build our high-value portfolio of commercial and clinical stage therapies. In the third quarter, we continued to make progress in our transition to a diversified, innovative biopharma company by focusing on our three primary pillars. First, growing sales of existing products in our commercial portfolio, including through indication and geographic expansion. The market-leading adoption of ZyWave in narcolepsy and top-tier launch of ZebZelka in small cell lung cancer highlight our commercial execution across both our neuroscience and oncology therapeutic areas. The recent approval and launch of ZyWave for idiopathic hypersomnia, or IH, showcases our ability to expand to new indications, in this case where there are no other FDA-approved therapies. Further, our progress in securing access and reimbursement for Epidiolex across major European markets demonstrates our team's capabilities beyond the US. Our acquisition of GW Pharmaceuticals epitomizes our second strategic pillar, acquiring differentiated commercial products and late-stage programs. This acquisition brought in a high-growth, durable commercial product in Epidiolex and expanded our R&D portfolio. Our third pillar is pursuing pipeline development of differentiated therapies. Excluding the acquisition of GW, since 2015, our team has increased our pipeline assets fourfold, resulting in 11 product approvals. Now, with the addition of the GW pipeline and cannabinoid platform, we are excited about a more robust pipeline that will further enhance that R&D productivity. Turning to several key highlights this quarter, In 2020, we established an aggressive target of completing five commercial launches in 2020 and 2021. I'm pleased to announce that earlier this month, we launched ZyWave for IH and adults, which completes that goal. This represents a major milestone for Jazz, underscoring our ability to advance therapies from concept to commercialization and successfully execute on launches and of differentiated products that address critical patient needs. The launch of ZyWave for IH provides a significant growth opportunity for our Oxibate franchise, which we view as a durable core component of Jazz's long-term value that has multiple Orange Book-listed patents that extend through 2033. We continue to expect that a majority of Oxibate patients across all approved indications will benefit from ZyWave in 2023, which accounts for branded and generic higher sodium oxidate therapies entering the market. With respect to the entry of authorized generic Xyrem, we plan to provide guidance for 2022 as usual on our fourth quarter earnings call. At that time, we anticipate providing more information on the Xyrem authorized generic launch. The integration of GW continues to move ahead And as I 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 added the exciting GW cannabinoid platform and science to our R&D pipeline. That said, we acknowledge there is work to be done. While we have continued to grow Epidiolex in the U.S., there have been challenges in the face of the COVID-19 pandemic. Dan will provide more detail about how our commercial team is addressing these challenges to support further Epidiolex growth in the U.S. We continue to strengthen the durability of Epidiolex and now have 20 Orange Book listed patents, with the majority extending through 2035. We are also generating additional IP, including a composition of matter-like patent that we expect will be issued later this year and listed in the Orange Book in the first quarter of 2022. This patent would expire in 2039. And I want to be very clear, we remain excited by the potential long-term value creation that the GW acquisition can deliver. And our confidence in Epidiolex's blockbuster potential and its importance as a component of our commercial portfolio has only increased since we brought it in-house. Turning to oncology, our Zepzelka team is executing a top-tier commercial launch. We are also advancing a robust clinical development plan, and Rob will provide more color on our R&D efforts for Zupselka and across our portfolio later in the call. On June 30th, we were pleased to announce approval of Rylase under FDA's real-time oncology review. While we're early in the launch, we believe that Rylase will become the standard of care for patients who need a non-E. coli-derived asparaginase. With respect to our financial performance, our third quarter delivered a 39% increase in total revenues compared to the same quarter last year. We continue to diversify our revenue with more than 50% of net product sales coming from products launched or acquired since 2019, in stark contrast to a year ago when the same metric was just 8%. These newer products are not only innovative medicines, that address critical needs for patients with neurologic disorders and cancer. There are also durable, long-lived therapies that support our strategy of building a diversified, high-growth commercial portfolio. Our strong cash flow and disciplined capital allocation is enabling us to invest in the growth of our business while staying on track to meet our deleveraging goal. With a strong foundation, exciting new opportunities, and continued execution against our plan, I remain highly confident in Jazz's future. 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 across our R&D programs. Renee will provide a financial overview, and then we'll open the call to Q&A. Dan, over to you.