UroGen Pharma Ltd.

Good day, and thank you for standing by. And welcome to the Eurogen Pharma Q4 2022 earnings call. At this time, all participants are in a listen-only mode. After the speaker's presentation, there'll be a question and answer session. To ask a question during the session, you'll need to press star 11 on your telephone. You will then hear an automated message advising your hand has been raised. To withdraw your question, please press star 11 again. Please be advised that today's conference is being recorded. I would now like to hand the conference over to your speaker today, Vincent Perrone, Head of Investor Relations. You may begin.

Thank you, operator. Good morning, everyone, and welcome to Eurogen Pharma's fourth quarter and year-end 2022 financial results and business update conference call. Earlier this morning, we issued a press release providing an overview of our recent corporate highlights and preliminary financial results for the quarter ended December 31, 2022. The press release can be accessed on the investors portion of our website at investors.eurogen.com. Joining me on the call today are Liz Barrett, President and Chief Executive Officer, Dr. Mark Schoenberg, Chief Medical Officer, Jeff Boba, Chief Commercial Officer, and Don Kim, Chief Financial Officer. During today's call, we will be making certain forward-looking statements. These may include statements regarding our ongoing commercialization activities related to gel mito, anticipated seasonality for gel mito in 2023, our ongoing and planned clinical trials, commercial and clinical milestones in the year ahead, the potential of UGN-102 to transform the treatment paradigm as the first nonsurgical treatment for low-grade, intermediate-risk, non-muscle-invasive bladder cancer, market opportunities, potential future commercialization activities for UGN-102, if approved, Data presentations, regulatory filings, future research and development efforts, our corporate goals, our optimism regarding multiple avenues available to us to further strengthen our balance sheet, and 2023 financial guidance, among other things. These forward-looking statements are based on current information, assumptions, and expectations that are subject to change. A description of potential risks can be found in our earnings press release and latest SEC disclosure document. Your caution not to place undue reliance on these forward-looking statements and your agenda's claims any obligation to update these statements. I will now turn the call over to Liz. Liz?

Thank you, Vincent, and thank you, everyone, for joining us today. Looking back on 2022, I'm proud of our progress and more enthusiastic than ever about the future of URGEN. We returned to growth in Q4, delivering our strongest quarter ever for Gelmido, ending the year with $64.4 million in net product revenues. representing a 34% increase from full year 2021. This bodes well for UGM-102 as we continue to think of gel mito as proof of concept and the gateway for the much larger market of bladder cancer. That belief is substantiated by the incredible momentum we experience in our UGM-102 clinical trial. In just 20 months, we've enrolled over 500 patients between both the ATLAS and the Envision Phase III trials. In fact, we completed enrollment of Envision, our pivotal study for UGM-102, for the treatment of low-grade intermediate-risk non-Muslim-based bladder cancer in less than a year. We firmly believe that this has the potential to transform the way urologists treat patients, and based on how quickly we enrolled the trial, that we have a base of urologists who are eager to elevate their practice. We are planning to provide top-line data from both of our phase three studies of UGM-102 mid-year. We will provide an update on complete response and durability in ATLAS while also providing the primary endpoint of complete response rate in the Envision study. Assuming positive results, these studies will form the basis of our FDA submission in 2024 once durability has matured. UGM-102 is designed to address a much larger patient population, and administration is much simpler without the need for fluoroscopy. Therefore, if approved, we anticipate UGM-102 will prove to be our main growth driver in the future. At the end of last year, we shared long-term follow-up data from the Jelmito Olympus Pivotal Trial and the Phase IIb Optima II study of UGM-102. In each of these, we observed a greater than two-year median duration of response. Along with a recently completed small home installation study, we are optimistic about the upcoming data from Atlas and Envision, will further establish the potentially transformative nature of our products. Before turning the call over to my colleagues, I would like to quickly address our balance sheet. We've now come to better understand the adoption curve of Jalmaito and expect revenue growth in 2023 to reflect growth of 20 to 30% over 2022 and revenues of 76 to $86 million. While we ended the year strong with $100 million in cash, We continue to reduce cash spend and focus on our core assets. Especially given the market potential for UGM 102, we're optimistic that we will be in a position to explore multiple avenues to further strengthen our balance sheet when necessary. Overall, I am very enthusiastic about the progress we've made in 2022 and the road ahead as we plan for an FDA submission of UGM 102 in 2024. We believe Gelmito and UGN 102 together represent a billion-dollar revenue opportunity for URGEN and remain focused on solid execution to turn that belief into a reality. With that, I'll pass the call over to Mark to further update you on our clinical development program. Mark?