Jazz Pharmaceuticals plc

Good day and thank you for standing by. Welcome to the second 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 during the session, you will need to press star 1 on your telephone. Please be advised that today's conference is being recorded. If you require any further assistance, please press star zero. I would now like to hand the conference over to your speaker today, Andrea Flynn. Please go ahead.

Thank you, and good afternoon, everyone. Today, Jazz Pharmaceuticals reported its second 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 Galla, Executive Vice President and Chief Financial Officer, Dan Swisher, President, and Rod Yannone, Executive Vice President, R&D, and Chief Medical Officer. Hill Jockelson, Neuroscience Therapeutic Head, will also join the team 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 on slide two 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 slide presentation available on the Investors section of our website. With that, 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. Looking back at the first half of the year, I'm proud of how our team has continued to deliver operational excellence. We accomplished milestones across commercial, R&D, and corporate development that collectively are driving our transformation to an innovative, high-growth global biopharma company. Our recent acquisition of GW Pharmaceuticals, combined with progress across our existing business, is foundational to what we expect will be a period of sustained growth for Jazz, underpinned by our ability to deliver on our expanding pipeline and our corporate development activities, as well as by leveraging our substantial commercial prowess and enhanced global footprint. We continue to be impressed with the superb cultural fit between legacy Jazz and GW teams and the successful completion of our integration will only further enhance our ability to innovate and execute. We are on track for another year of strong financial performance and sequential revenue growth. And for the first time, we expect to exceed $3 billion in annual revenue. I also want to emphasize the makeup of this revenue. Several years ago, we made revenue diversification a key corporate objective. With 41% of net product sales in the second quarter from products launched or acquired since 2019, we are well positioned to reach our goal of at least 65% of net product sales from these newer products in 2022. And these newer products are not only innovative therapies that address critical needs for patients with neurologic disorders and cancer, They are also durable assets with high growth potential. In short, Jazz has never been stronger. It's particularly striking that we've been able to consistently execute at such a high level while navigating the challenges created by the global pandemic. This was only possible thanks to the dedication and engagement of our teams across Jazz. We are taking the lessons we learned about remote work and collaboration over the past 18 months to redefine the future of work at Jazz. We believe that the combination of a purpose-focused culture that delivers innovative therapies to patients, the opportunity for rewarding professional experiences, and a workplace that adapts to meet employee expectations regarding flexibility, collaboration, diversity, and inclusion will make Jazz an even more attractive place to work for both our existing teams and top talent across our industry. I'm not going to address every bullet on slide five, as Dan, Rob, and Renee will provide greater detail, but I do want to note a few items that are key drivers of our future growth. We successfully closed the GW acquisition in early May, which has strengthened our position as a neuroscience leader with a global commercial and operational footprint. The acquisition is highly complementary to our existing business, further diversifying the commercial products we deliver to patients and adding the exciting GW cannabinoid platform to our R&D portfolio. We have also gained numerous talented colleagues and integration remains a key focus. I'm pleased with our progress today and we have successfully retained many GW employees who are in roles that are crucial to our continued success. The GW acquisition was transformative for our business and we are excited about the long-term value we believe it will deliver. We are very pleased with strong ZyWave adoption in the second quarter and that the benefits of a lower sodium oxibate are resonating with physicians and patients. It is our view that ZyWave as the only lower sodium oxibate product will be the oxibate therapy of choice even after other higher sodium oxibate products are available. We continue to expect that a majority of OxyVe patients, across all approved indications, will benefit from ZyWave in 2023. Looking ahead, we are preparing for the commercial launch of ZyWave in idiopathic hypersomnia, or IH, later this year pending FDA approval. This would be our fifth product launch since the beginning of 2020, achieving a key company objective while delivering a new treatment option to patients with IH. This hypersomnolence disorder has a profound effect on multiple aspects of daily life, and there currently are no approved therapies to treat IH. Turning to Zepzelka, we saw strong underlying growth in demand in second-line treatment as we moved toward our goal of establishing Zepzelka as standard of care in that setting. Zepzelka is providing an important therapeutic option for patients with small cell lung cancer, and we are advancing a robust development plan for this therapy, including initiating a phase three trial this year in combination with immunotherapy in first-line small cell lung cancer. And continuing with our oncology portfolio, on June 30th, we were pleased to announce FDA approval of Rylase, previously referred to as JZP458, under FDA's real-time oncology review. Rylase became commercially available on July 15th. This is a critical therapy for patients with acute lymphoblastic leukemia and lymphoblastic lymphoma who have developed hypersensitivity to E. coli-derived asparaginase, and we are excited to deliver a high-quality therapeutic option with reliable supply to these patients. Together with ZyWave, RyeLase showcases our growing R&D capabilities and demonstrates our ability to bring medicines from concept to commercialization. I'll now turn the call over to Dan for an overview of our commercial performance, after which Rob will provide an update on progress across our R&D programs. Rene will close our prepared remarks with a financial overview, and then we'll open the call to Q&A. Dan?