3/2/2026

speaker
Operator

Good day and thank you for standing by. Welcome to EuroGen Pharma's fourth quarter 2025 earnings call. At this time, all participants are in a listen-only mode. After the speaker's presentation, there will be a question and answer session. To ask a question during this session, you'll need to press star 1 1 on your telephone. You will then hear an automated message advising your hand is raised. To withdraw your question, please press star 1 1 again. Please be advised that today's conference is being recorded. I'd now like to hand the conference over to Vincent Perrone, Senior Director of Investor Relations. Please go ahead.

speaker
Vincent Perrone
Senior Director of Investor Relations

Thank you. Good morning, everyone, and welcome to Eurogen Pharma's full year 2025 financial results and business update conference call. Earlier this morning, we issued two press releases, the first providing an overview of the refinancing of our debt facility with Pharmacon Advisors, and the second providing an overview of our recent corporate highlights and financial results for the fourth quarter and year ended December 31st, 2025. Both releases can be accessed on the investors portion of our website at investors.eurogen.com. Joining me 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. On today's call, we will be making certain forward-looking statements. These may include statements regarding our ongoing commercialization activities related to Gelmido and Zesturi, our ongoing and planned clinical trials and non-clinical studies, the commercial and clinical development milestones, market and revenue opportunities, our commercialization and long-term growth strategy and expectations, as well as anticipated data, regulatory filings and decisions, the potential benefits of our products and product candidates, future R&D efforts and milestones, our corporate goals, and 2026 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 agenda disclaims any obligation to update these statements. I'll now turn the call over to Ms. Barrett, Chief Executive Officer.

speaker
Liz Barrett
President and Chief Executive Officer

Thanks, Vincent. Good morning, and thank you for joining us today. Our top priority is the commercial launch of Zysturi in recurrent, low-grade, intermediate-risk, non-muscle-invasive bladder cancer, a pivotal step in advancing our long-term growth strategy. As we outlined in our earnings release this morning, we are encouraged by the early 2026 trajectory following the permanent J code becoming effective January 1st. The story revenue in 2025 was $15.8 million, reflecting early launch dynamics as we worked through typical reimbursement and operational steps necessary to build the foundation for broader adoption. With the permanent J-code now in place, a key barrier to adoption has been removed, facilitating more predictable patient access. Since that milestone, as expected, we have seen a clear acceleration across key launch indicators, including the number of new and repeat prescribers, patient enrollment forms, and new patient starts. Overall, we are pleased with how the launch is unfolding in early 2026, and we are on track with the assumptions we've made around its trajectory. Zesturi addresses a large and underserved market, and based on our assumptions regarding market penetration, pricing, and physician adoption, we believe Zesturi has the potential to achieve greater than $1 billion in peak revenue. Importantly, Zesturi provides the first and only medication approved by the FDA, that can provide patients with a primary office-based therapy that can result in extended recurrence and treatment-free living. Turning to the rest of the business, Jalmito generated net product revenue of $94 million for the full year 2025, reflecting continued underlying demand growth. We are also advancing our pipeline in a disciplined manner. UGN-103, our next-generation formulation of Zisteri, demonstrated compelling complete response results in the Phase III utopia trial, consistent with the envisioned study. We remain on track to submit an NDA and recurrent low-grade intermediate-risk non-Muslim-based bladder cancer in the second half of 2026, with potential FDA approval in 2027. With a clear regulatory pathway established for UGN103 and low-grade IR non-Muslim-based bladder cancer, we are evaluating its potential in additional bladder cancer settings, including as an adjuvant in intermediate and high-risk non-Muslim-based bladder cancer as part of our broader lifecycle strategy. UGN104, our next-generation formulation of Gelmito, continues to progress through Phase III with enrollment expected to complete by the end of 2026. Finally, following the refinancing of our term loan with Pharmacon, we have further strengthened our balance sheet and enhanced our financial flexibility. Together with our existing cash on hand, this refinancing provides additional non-dilutive capital that supports our operating plan and allows us to continue executing our strategy in a disciplined manner. Importantly, our fortified balance sheet enables us to fully support the ongoing sistery launch, advance our next generation pipeline, and thoughtfully pursue lifecycle management opportunities over time. We believe this approach positions us well to allocate capital responsibly and create long-term value for patients and shareholders. I will now turn the call over to Mark for a clinical update. Mark?

Disclaimer

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