UroGen Pharma Ltd.

Good morning, ladies and gentlemen. Thank you for standing by. Welcome to the Eurogen Pharma first quarter 2024 earnings call. Please be advised that today's conference is being recorded. I would now like to hand the conference over to your first speaker today, Vincent Perrone, head of investor relations. You may begin.

Thank you, operator. Good morning, everyone, and welcome to Eurogen Pharma's first quarter 2024 financial results and business update conference call. Earlier this morning, we issued a press release providing an overview of our corporate highlights and financial results for the quarter ended March 31, 2024. The press release can be accessed on the investor's portion of our website. Joining me 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, our ongoing and planned clinical trials, commercial and clinical milestones, market and revenue opportunities, our commercialization strategy and expectation, as well as potential future commercialization activities for UGN 102, if approved. Anticipated data, including envisioned durability data, Regulatory filings and decisions, including UGN 102, potentially receiving priority review. UGN 102 being the primary growth driver, pre-urgent and for proof, future R&D efforts, our corporate goals, and 2024 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. You are cautioned not to place undue reliance on these forward-looking statements, and your agenda disclaims any obligations to update these statements. With that, I'll turn the call over to Liz. Liz?

Thank you, Vincent, and thank you, everyone, for joining us this morning. As we look ahead to 2024, we have several near-term catalysts, including the planned release of the 12-month duration of response data from the Envision study in June with our expected NDA submission this year. We have assembled a strong body of data that demonstrates a compelling clinical profile for UGM-102. The ATLAS and Envision trials both met their primary endpoints, and if approved, we believe UGM-102 will advance the standard of care in low-grade intermediate risk non-muscle invasive bladder cancer from repetitive surgery to a minimally invasive routine non-surgical option. Our research reflects overwhelming support from both urologists and patients with the intent to use by over 90% of surveyed urologists and over 90% of surveyed patients in the Envision study preferred UGM-102 to a TURBT. We are pleased to announce that we will host our virtual event to share the Envision durability data on June 13th. The database lock will occur later this week and we are very much looking forward to sharing the final results from Envision at that time. Earlier this year, we announced initiation of a rolling NDA submission, and we believe the upcoming Envision data will support completion of the NDA in Q3 of this year. Assuming priority review, we could launch as early as Q1 in 2025. The commercial opportunity is significant. We estimate that the overall market is approximately 10 times the size of the urothelial carcinoma market that John Mito currently addresses. We intend to seek a broad indication for UGM-102. Conservatively, we estimate the size of the market opportunity to be over $3 billion. This represents a substantial market opportunity for our company and a chance to meaningfully impact the treatment paradigms and improve patient outcomes. Our ongoing commercialization plan will include an incremental Salesforce expansion. Pricing analysis and market research are currently ongoing, but we expect pricing to be in the $16,000 to $19,000 range per dose. Given the response and feedback we have received, we believe patients will strongly welcome a minimally invasive non-surgical alternative to TURBT. While we don't expect to replace TURBT in all patients, UGN 102 will be the first and only medicine approved for patients with low-grade intermediate risk non-muscle invasive bladder cancer, and we believe will offer an advance in treatment if approved. Jeff will provide more details on our commercial strategy in a few minutes. In April, we announced FDA acceptance of the IND for UGN 103, an important next step in our lifecycle management strategy. 103 is our next generation formulation of UGN-102, which combines our proprietary RT gel technology with Med-Act's proprietary formulation of mitomycin. A key aspect of this program is the potential for extended patent coverage for our next generation urothelial cancer franchise. Med-Act has intellectual property protection into 2035, and URGEN's pending U.S. patent applications, if approved, could extend patent coverage until December of 2041. We are preparing to initiate clinical endpoint studies to support NDAs for UGM-103 and UGM-104, the latter being our next generation formulation of gel mito. We anticipate dosing patients in the planned phase three trial of UGM-103 by end of this year and UGM-104 shortly thereafter. As reported, Jomita revenues were $18.8 million for the quarter, an approximate 10% increase over Q1 2023. More importantly, patient enrollment forms, or PEPs, in Q1 were the highest ever, indicating demand continues to grow. As we have experienced in the past, seasonality in Q1 results in a delay in patients being treated due to resetting of insurance. We have seen conversions accelerate in March and April, providing support for continued growth of gel mito. We're very excited by a recent post hoc analysis from the Olympus trial that evaluated the long-term efficacy of gel mito in patients who experienced a complete response. Mark will elaborate on this momentarily, but at a high level, findings suggest that gel mito can offer extended disease-free periods, with some patients experiencing no recurrence for approximately 48 months. We recently released this data to the field and are optimistic about its impact with urologists. Lastly, our balance sheet remains a priority and our cash position strong with $164.5 million in cash, cash equivalents, and marketable securities as of March 31st. Our capital allocation strategy continues to prioritize the ramp up of UGM-102 supply and its commercial launch, alongside bolstering Gemido sales. Our latest financial projections, assumptions, and sales forecasts affirm our belief that our current balance sheet is robust enough to sustain our operations through anticipated break-even. So we do not need to raise additional capital with our current plans. Having said that, there is a plethora of opportunities to further study our medicines across new patient populations and position our company for longer-term sustained growth. We will remain diligent with capital deployment and opportunistically strengthen our balance sheet to accelerate and execute those potential growth opportunities. I will now turn the call over to Dr. Mark Schomburg, our Chief Medical Officer, for a clinical update. Mark?