UroGen Pharma Ltd. Ordinary Shares 2026 Q2 Earnings Call

Please go ahead. Thank you, good morning, everyone.

Welcome to UroGen Pharma's second quarter 2026 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 June 30th, 2026. The release can be accessed on the investors' portion of our website at investors.urogen.com. Joining me today are Liz Barrett, President and Chief Executive Officer, Dr. Mark Schoenberg, Chief Medical Officer, and Chris Degnan, Chief Financial Officer. On today's call, we will be making certain forward-looking statements.

These may include, among other things, statements regarding our ongoing commercialization activities related to ZUSDURI and JELMYTO, ongoing and planned clinical and non-clinical trials, commercial and clinical development milestones, market and revenue opportunities, our commercialization strategy and expectations, as well as anticipated data, regulatory filings and decisions, the importance of ZUSDURI's growth for UroGen's long-term strategy, the potential benefits of our products and product candidates and all future R&D efforts and milestones, our corporate goals, and 2026 financial guidance. 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, UroGen disclaims any obligation to update these statements. I'll now turn the call over to Liz Barrett, Chief Executive Officer.

Liz? Good morning, thank you all for joining us today.

I'm so pleased to share the results for another strong quarter, driven by continued momentum across the ZUSDURI launch and meaningful progress advancing our long-term growth strategy. ZUSDURI generated $50.4 million in net product revenue during the second quarter, representing a 73% growth over the first quarter. More importantly, the commercial trends underlying that growth continue to strengthen. We are seeing expanding adoption across both hospital and community practices, increasing repeat utilization, and growing physician confidence, all of which reinforces our confidence that we are building a meaningful commercial franchise. That progress reflects the compelling value proposition of ZUSDURI. As the first and only FDA-approved medicine for adults with recurrent, low-grade, intermediate-risk non-muscle invasive bladder cancer, ZUSDURI offers patients a treatment that provides unprecedented recurrence and treatment-free intervals.

ZUSDURI is a primary non-surgical option for a disease that historically had been managed through repeated surgical intervention under general anesthesia. We believe its unique clinical profile is changing how physicians think about treating these patients and increasingly establishing ZUSDURI as a foundational treatment in this setting. As with prior quarters, I'd like to provide an update on the operating metrics that we track most closely, as they continue to provide valuable insight into the trajectory of the launch. As of June 30th, 2026, we had 1,444 activated accounts, up from 972 at the end of the first quarter. Unique prescribers increased to 452 compared to 256 in Q1, while repeat prescribers nearly doubled to 204. Importantly, repeat prescribers now represent approximately 45% of writers, compared with around 40% in the first quarter. We continue to view repeat utilization as one of the strongest indicators of potential long-term success.

It demonstrates that physicians are gaining confidence through real-world experience and increasingly incorporating ZUSDURI into routine clinical practice. Equally encouraging, these trends remained consistent throughout the quarter, giving us confidence the launch is advancing and increasingly sustainable. We continue to see increased utilization within existing accounts, demonstrating that adoption is expanding across practices and within them. Patient enrollment forms are increasing, and new patient starts are tracking in line with that growth. Operationally, we continue to improve the time from patient enrollment to treatment initiation. As practices gain familiarity with ordering, reimbursement, and administration, workflows continue to become more efficient. Our goal is to achieve the two-to-three-week enrollment-to-treatment conversion cycle we see today with JELMYTO, and we expect continued progress toward that goal over the balance of the year. Another encouraging trend is expansion into community urology practices.

By the end of the quarter, approximately 55% of utilization was in community practices, compared to 45% from hospitals. This is important because we estimate approximately 70% of the addressable market resides in the community practices. As adoption continues to broaden, we believe the community setting will become an increasingly important driver of long-term growth, and we still see significant runway ahead. From an access perspective, we have open access across more than 95% of covered lives, and we see no material reimbursement barriers. The permanent J-code has performed exactly as anticipated by improving reimbursement confidence and enabling broader utilization. At this stage, reimbursement uncertainty is no longer a meaningful constraint to adoption. Looking ahead, we believe there remains a significant opportunity to build on this momentum through the remainder of 2026 and beyond.

Our priorities remain clear: expanding community adoption, increasing repeat utilization, continued improvement of patient conversion, and increasing awareness among both physicians and patients. We are beginning to invest more directly in patient awareness. Many patients with recurrent low-grade IR non-muscle invasive bladder cancer are not aware that a non-surgical treatment option exists, and we believe increasing that awareness represents an important opportunity to expand utilization in the mid to long term. Turning to JELMYTO, revenue was $22 million in the second quarter, compared to $21.7 million in the first quarter. JELMYTO continues to demonstrate a stable and predictable demand profile while also continuing to add new users. We believe we're on track to deliver within our full-year revenue guidance of $97 million-$101 million. During the quarter, we continued to strengthen the long-term foundation of our uro-oncology portfolio.

We reached a settlement and license agreement with Teva that resolved the JELMYTO patent litigation, providing greater visibility into the product's long-term commercial runway while reinforcing the strength of our RTGel intellectual property portfolio. In addition, we received a notice of allowance from the U.S. Patent and Trademark Office for a new method of treatment patent covering both ZUSDURI and UGN-103. This patent, once issued, is expected to provide protection into July of 2044, strengthening the intellectual property supporting the franchise and reinforcing the long-term commercial opportunity for both products. We continue to make meaningful progress across our pipeline. UGN-103 remains on track for NDA submission in the next few weeks. UGN-104 continues progress through phase III, and following FDA acceptance of our IND, we're excited to begin phase I development of UGN-501 this year.

Overall, the first half of 2026 has significantly strengthened our conviction in the long-term opportunity ahead. We are successfully scaling the ZUSDURI launch, advancing multiple pipeline programs, and building a company positioned for sustained growth. We believe this positions UroGen to deliver meaningful outcomes for patients while creating significant long-term value for shareholders. With that, I'll turn the call over to Mark for a clinical update.

Mark? Thank you, Liz, and good morning, everyone.

Let me begin with the most recent update from the phase III ENVISION trial. In May, we announced updated durability data from ENVISION with nearly three years of follow-up. Among patients who achieved a complete response at three months, the probability of remaining disease-free at 36 months was 64.5% by Kaplan-Meier estimate. Importantly, at a median follow-up of 35.5 months, the median duration of response has still not been reached. The most important takeaway is that the complete response obtained with ZUSDURI is highly durable through three years and was achieved without any maintenance therapy. In practical terms, by Kaplan-Meier estimate, most complete responders remain disease-free nearly three years after achieving a complete response. For a disease characterized by repeated recurrences and repeated surgeries, these data highlights ZUSDURI's potential to interrupt that cycle.