UroGen Pharma Ltd.

Good morning, ladies and gentlemen, and thank you for standing by. Welcome to the Eurogen Farmer fourth quarter and full year 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. Please go ahead.

Thank you, operator. Good morning, everyone. and welcome to Eurogen Pharma's fourth quarter and full year 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 fourth quarter and year ended December 31st, 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 Gelmyo, our ongoing and planned clinical trials, commercial and clinical milestones, market and revenue opportunities, our commercialization strategy and expectations, as well as potential future commercialization activities for UGN 102, if approved. Anticipated data, regulatory filings and decisions, UGN 102 being the primary growth driver for Eurogen, if approved, future R&D efforts, our corporate goals, and 2025 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. You are cautioned not to place undue reliance on these forward-looking statements, and your agent disclaims any obligation to update these statements. I'll now turn the call over to Liz.

Thank you, Vincent, and thank you for joining us this morning. 2024 was a year of progress for URGEN as we continue to advance our mission of pioneering new therapies that meet the unique needs of patients with urothelial and specialty cancers. We achieved a major milestone by submitting a new drug application for UGM-102, our investigational product for intermediate risk, low-grade, non-muscle invasive bladder cancer, ahead of schedule. With FDA review underway in a PDUFA target date of June 13th, we are well-positioned to bring this innovative therapy to patients. At the same time, we continue to generate compelling clinical data that reinforces UGN 102's safety, efficacy, and paradigm-changing potential. Our commercial product, Gelmito, continues to grow, and we have made meaningful progress advancing our early-stage pipeline. Additionally, We strengthened our leadership team, ensuring we have the expertise Envision to drive URGEN's next phase of success. I will begin with an important clinical update on the pivotal Envision phase three trial that serves as a foundation for the UGM-102 NDA submission. Envision demonstrated a compelling complete response rate and unprecedented durability. As a reminder, the CR rate at three months stood at an impressive 79.6%, and the 12-month duration of response was an unprecedented 82.3% by Kappenmeier analysis. As the data continue to mature, we are highly encouraged by the disease-free status of many patients in follow-up. Today, we are reporting updated 18-month duration of response data from Envision, and note that these results remain consistent with our previous Kaplan-Meier estimates. With 101 patients now followed for at least 18 months following CR, or 21 months post-therapy start, the updated duration of response is 80.6% by Kaplan-Meier analysis. The median follow-up time for these patients has now extended to 18.7 months after three months CR, up from 13.8 months at the previous data cut, and the median duration of response is still not reached. We have provided these data to the FDA in our 120-day update, and they will be part of the submission. The durability of response is critical for a disease with historically high recurrence rates. By extending disease-free periods, UGM-102 has the potential to increase disease and treatment-free intervals. which are associated with morbidity and quality of life challenges in this population. We engaged with the FDA in a productive mid-cycle review meeting this past week. The agency confirmed they will be referring the NDA to ODAC. They previously indicated the meeting will take place in May, and we are awaiting official publication of the meeting date in the Federal Registry. We aligned with the agency that the advisory committee presentation and materials were focused on the recurrent patient population studied in the Envision trial. Therefore, we believe that UGM-102, if approved, will be indicated in the recurrent patient population. It's important to highlight that our data in this population is highly supportive, and this group represents the vast majority of the overall revenue opportunity. While these meetings are confidential and there's a limit to what we can share today, I want to take this opportunity to reaffirm our confidence in the strength of the data package we have submitted and in the potential of UGM-102 to address the significant unmet need for patients. We remain fully focused on preparing for our ODAC and look forward to the opportunity to present our compelling data to the advisory committee and engage with the broader medical community. if approved, UGM-102 will become the first medicine for this patient population, introducing a potentially paradigm-shifting solution for this disease. An approval of UGM-102 will be transformative for urogen, as it represents a significant market opportunity, a population nearly 10 times larger than the market for gel mito. This translates to a total addressable market of more than $5 billion. Importantly, our ability to identify and target physicians and their patients for UGM-102 will be easier. Unlike low-grade upper tracheothelial carcinoma, which is a dispersed rare disease, low-grade intermediate-risk non-multi-invasive bladder cancer is widespread and managed by nearly all urologists. UGM-102 is designed for seamless integration into outpatient practice workflows. The ease of use creates the opportunity for physicians to expand their practices and enhance patient care. Gelmito generated net product revenues of $90.4 million for the full year 2024, compared to $82.7 million for the prior year. The increase of $7.7 million year over year was primarily driven by increased underlying demand for Gelmito. partially offset by a decrease in creates X cells and an increase in 340B chargebacks. If we focus on actual underlying product demand, sales grew by approximately 12% year over year. Our commercial team recognizes this is a high-touch product, so we have been focused on increasing our reach and frequency with key accounts. This has resulted in consistent improvement across several key metrics, including overall volume, patient enrollment forms, and new patient starts, new script writers, and new sites of care. In Q4 2024, we saw our highest ever number of demand units. David Lim will provide more details in his update. We have also made great progress in advancing our long-term growth strategy with the recent acquisition of ICBB 1042 from Econobier. This next-generation investigational oncolytic virus represents an exciting opportunity in cancer care. With its unique mechanism, ICVB 1042 is designed to selectively target and destroy tumor cells without compromising its lytic activity. It's designed to enter a broad spectrum of tumor cells, allowing it to potentially treat a wide range of tumor types. This acquisition aligns with our vision and strategic focus to develop innovative therapies to address critical gaps in cancer care. For those interested, a replay of our investor webinar announcing the acquisition is available on our website. URGEN ended 2024 with a strong balance sheet, holding $241.7 million in cash, cash equivalents, and marketable securities. We remain well capitalized to execute our operating plan and advance the company to and through profitability with the anticipated launch of UGM-102 later this year. I will now turn the call over to Mark Schomburg, our Chief Medical Officer, for a clinical update. Mark?