Jazz Pharmaceuticals plc

Hello, and welcome to the Jazz Pharmaceuticals four-year and fourth quarter 2020 financial results earnings conference call. Following an introduction from the company, we will open the call for questions. I will now turn the call over to Andrea Flynn, Head of Investor Relations at Jazz Pharmaceuticals. You may begin.

Thank you, and thanks everyone joining the call. Today, we reported our fourth quarter and full year 2020 financial results and provided our financial guidance for 2021. The press release and the slide presentation accompanying this call are available on the Investors section of our website. On the call today are Bruce Cozadd, CEO, Renee Gala, CFO, Dan Swisher, President, and Rob Iannone, Executive Vice President, R&D, and Chief Medical Officer. Joining the Q&A are Kim Sablich, Executive Vice President, General Manager of North America, Phil Jockelson, Neuroscience Therapeutic Head, Ann Borgman, Hematology and Oncology Therapeutic Head, Sam Pearce, Senior Vice President Europe and International, and Shawn Mendes, Senior Vice President Strategy and Finance. I'd like to remind you that today's call includes forward-looking statements, such as those related to our future financial and operating results, and which involve risks and uncertainties that could cause actual events, performance, and results to differ materially. We encourage you to review statements contained in today's press release and our latest SEC disclosure documents, which identify certain factors that may cause the company's actual results to differ materially from those projected. We undertake no duty or obligation to update our forward-looking statements. On this call, we discuss non-GAAP financial measures. Reconciliations of GAAP to non-GAAP financial measures discussed on this call are included in today's press release and slide presentation available on our website. This communication is not intended to constitute an offer to buy or sell or the solicitation of an offer to buy any securities or solicitation of any vote or approval. GW intends to file a proxy statement with the FCC regarding the proposed transaction that will be mailed to GW shareholders. You should review materials filed with the FCC carefully, as they will include important information regarding the proposed transaction, including information about Jazz and GW, the respective directors, executive officers, and certain other members of management and employees who may be deemed to be participants in the solicitation of proxies from GW pharmaceutical security holders in connection with the proposed transaction. Please also review slides two through five of today's presentation for other important information, including where you can find more information on the proposed transaction and on the directors and executive officers of Jazz and GW. With that, I'll now turn the call over to Bruce.

Thanks, Andrea. Good afternoon, everyone, and thank you for joining us today. 2020 was an exceptionally productive year for Jazz. Driven by the expertise, commitment, and capabilities of our organization, and defined by operational excellence across commercial and R&D. We enter 2021 in a position of strength. We plan to execute on significant milestones that we expect will further enhance the growth and durability of our business and to accelerate our transformation as an innovative biopharma company. I'm very proud that from this position of strength and readiness, we announced earlier this month that we signed a definitive agreement for the acquisition of GW Pharmaceuticals, We're excited about the potential to add Epilepsys, a third high-growth commercial franchise, to our business, with Epidiolex, a potential near-term blockbuster, as well as GW's robust neuroscience pipeline. The combined company would be a leader in neuroscience with a global commercial and operational footprint, and we expect this transaction to deliver substantial shareholder value. We are excited to be joining two companies with a shared culture built around the same mission. Innovating to Transform the Lives of Patients In 2020, we demonstrated the resilience of our business and our agility, innovation, and execution capabilities across the company despite the pandemic. We launched important new treatment options for patients, including Zepzelka and Zywave in the U.S., and Synosi in Europe, delivered robust revenue growth, and generated significant value for shareholders. successfully advanced early and late stage clinical trials and added multiple new innovative products and targets to our expanding pipeline. Our R&D organization initiated regulatory submissions to FDA for JCP458 in acute lymphoblastic leukemia under the real-time oncology review in December and completed the rolling SNDA submission for JCP258 in idiopathic hypersomnia this month. which positions us for two more potential product launches in 2021. Last year we also continued the expansion of our innovative oncology and neuroscience pipeline through internal and external collaborations with a focus on highly differentiated products that are durable and can be effectively commercialized, positioning us to transform patient lives and continue to deliver long-term growth. Highlights of our successful execution on key 2020 objectives include the successful launch of Zebsulka in the U.S. in July 2020, just six months after we acquired U.S. licensing rights, the launch of ZyWave in November 2020 for the treatment of cataplexy and excessive daytime sleepiness in narcolepsy. I couldn't be more pleased with our early progress on this launch. The initiation of the European rolling launch for Synosy in May 2020 and The initiation of a new drug submission for Zebzelka in Canada in December. The announcement of compelling top-line results in the JCP258 Phase III study in idiopathic hypersomnia in October 2020, followed by the completion of the rolling supplemental NDA submission to FDA in February 2021, positioning us for a potential launch in the fourth quarter of this year. The initiation of the BLA submission to FDA for JCP458 in ALL in December 2020 with a potential launch in mid-2021 and deployment of capital through multiple corporate development deals to grow and diversify revenues with innovative new early to late stage product candidates such as JCP150 and post-traumatic stress syndrome and Zepzelka for the treatment of small cell lung cancer. As we think about our key objectives for 2021, we are excited about the potential GW transaction and maintaining the significant momentum of GW's Epidiolex and ours iWave and Zepzelco launches. We also remain on track to execute and deliver on two more important product approvals and launches in 2021 with JCP458 in ALL and JCP258 in idiopathic hypersomnia. Thank you for joining us today. I'll now turn the call over to Dan to give an overview of our commercial performance, after which Rob will provide an update on progress across our R&D programs before Renee closes out with a financial overview. Over to you, Dan.