UroGen Pharma Ltd.

Good morning, ladies and gentlemen. Thank you for standing by and welcome to the Eurogen Pharma third 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 speaker today, Vincent Perrone, head of investor relations. You may now begin.

Thank you, operator. Good morning, everyone, and welcome to Eurogen Pharma's third quarter 2024 financial results and business update conference call. Earlier this morning, we issued a press release providing an overview of our recent corporate highlights and financial results for the quarter ended September 30, 2024. 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, David Lin, Chief Commercial Officer, and Chris Degnan, 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 Gelmido, our ongoing and planned clinical trials, commercial and clinical milestones, market and revenue opportunities, our commercialization strategy and expectations, as well as future commercialization activities for UGN 102 if approved, anticipated data, regulatory filings and decisions, UGN 102 being the growth driver for Eurogen if approved, 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 documents. Your caution not to place undue reliance on these forward-looking statements, and Eurogen disclaims any obligation to update these statements. I'll now turn the call over to Liz Barron.

Thank you, Vincent, and thank you for joining us this morning. As we continue to innovate and pioneer new treatment paradigms in urothelial cancers, I'm excited to highlight the progress we've made with UGN-102, our groundbreaking therapy for low-grade intermediate-risk non-muscle-invasive bladder cancer. Ahead of schedule, we successfully submitted the new drug application for UGN-102 in August, And in October, we were pleased to announce the FDA's acceptance of the NDA with a PDUFA target date of June 13th, 2025. This milestone represents more than a regulatory achievement. It is a testament to the dedication of our team and a pivotal step toward our goal of changing how low-grade intermediate-risk non-Muslim-based bladder cancer is treated. Our regulatory and clinical teams are committed to working closely with the FDA during the review process as we move toward a potential approval. Meanwhile, we are initiating our pre-commercial activities to position ourselves for a robust launch with the ability to deliver UGN 102 to patients at the earliest opportunity. David will provide more details on this shortly. If approved, UGN 102 will become the first FDA-approved medicine for this patient population. introducing a novel solution that can significantly reduce recurrent rates while extending the time between treatments. UGM-102 aligns with our commitment to enhancing patient outcomes and reshaping treatment paradigms in urologic oncology. The market opportunity for UGM-102 has the potential to be transformative for our company. With more than 80,000 addressable patients annually in the U.S., This market is approximately 10 times larger than the market gel mito currently serves and represents an estimated total addressable market of over $5 billion. In contrast to the gel mito market opportunity in low-grade upper tracheothelial carcinoma, which is a rare disease, which is dispersed and episodic, low-grade intermediate risk non-loss invasive bladder cancer is widespread and regularly managed by nearly all urologists. UGN 102 is straightforward to administer and integrates seamlessly into existing outpatient practice workflows without the need for special equipment. Delmido delivered $25.2 million in net product revenue for the third quarter, representing a 21% year-over-year increase. The revenue reflected strong underlying patient demand, but also included $2.6 million from CREATE-ACT cells, in Q3 of 2024 compared to 1.1 million in the same period in 2023. Recognizing the high-touch nature of this product, we strategically focused on increasing our reach and frequency with key accounts in the quarter, which we believe is contributing to improved demand growth in the third quarter compared to the first half of this year. In fact, new patient enrollments in Q3 increased over 30% versus prior year, representing an all-time high since launch. Similarly, we continue to drive a healthy increase in new prescribers, up over 30% versus a year ago. We are seeing signs of continued momentum in early Q4 and expect to be able to deliver low double-digit revenue growth for Gemido for the full year 2024. despite the gross-to-net headwinds that we've experienced in recent quarters. Looking ahead at the core of URGEN's lifecycle management strategy is ensuring the long-term success and growth of our uro-oncology franchise. In September, we announced receipt of a notice of allowance from the U.S. Patent and Trademark Office for a patent covering key technology used in the development of UGN-103 and UGN-104. our next-generation therapies for UGM-102 and gel mito, respectively. Upon issuance, the patent will extend through December of 2041 and cover the innovative combination of our proprietary RT gel technology with a unique mitomycin formulation licensed from Med-Act. This is a critical step in strengthening our intellectual property portfolio and providing lifecycle management that extends our franchise for the long term. Dosing in the phase three utopia trial for UGM-103 commenced in early October, demonstrated continued momentum in our clinical development. Mark will provide further details on this exciting progress. In October, we appointed Chris Degnan as chief financial officer. Chris has extensive CFO experience with publicly traded biotech companies. most recently at Galera Therapeutics and Verica Pharmaceuticals. He has also held senior positions at Endo International and worked at AstraZeneca for more than 10 years. He has broad expertise in financial strategy, investor relations, SEC reporting, accounting, and compliance. I want to take this opportunity to formally welcome Craig Urgen. He is joining us on the call today and will provide financial results for the quarter shortly. Chris's appointment is part of the broader initiative to enhance our leadership team as we prepare to commercialize UGN 102 and take Urogen to the next stage of growth. We also welcome David Lin as our new chief commercial officer in June. I will now turn the call over to Mark Schomburg, our chief medical officer, for a clinical update.