[Management View]
UroGen Pharma Ltd. reported cash reserves of over $127 million, which management believes will support operations through profitability if current plans are maintained. The launch of Zasturi has shown steady growth in patient enrollment forms month-over-month, with approximately 35%-40% of patients treated in community settings and 60%-65% in institutional settings. The implementation of a permanent J code is expected to reduce reimbursement lag time from 45-60 days to under 30 days gradually. Management anticipates time from enrollment to patient dosing for Zasturi to reach equivalence with Jelmyto during 2026. UGN-103 is targeted for regulatory submission in 2026, with FDA approval expected in 2027, requiring approximately 12-month longitudinal follow-up data. UGN-501 is in IND-enabling activities, with Phase I initiation anticipated in 2026.

[Outlook]
Management expects the proportion of community physicians treating patients to steadily increase over the course of 2026 as the permanent J code takes effect. Market access for Zasturi is being proactively supported by early operational readiness at care sites, intended to accelerate adoption once reimbursement mechanisms streamline. UGN-501 is highlighted for its unique viral engineering advantages relevant to high-grade non-muscle invasive bladder cancer.

[Financial Performance]
UroGen Pharma Ltd. reported a positive trend in patient enrollment forms and revenue growth, with October revenue showing similar trends to Q3. The company remains confident in its cash position and operational plans to transition to profitability.

[Q&A Highlights]
Question 1: In terms of patient enrollment forms, could you provide some color on how those are tracking month over month from a growth perspective? And is the $4.5 million figure the actual sales estimate for October or the implied demand?
Answer: We are seeing very steady growth in enrollment forms month over month, with early signs indicating an average per week increase. October revenue is not implied demand but actual sales, showing similar trends to Q3.

Question 2: What do you expect the granular quantitative impact of the J code to be once it comes online, particularly in terms of reducing lag time from patient enrollment to dosing? And what additional longitudinal clinical data will the FDA require for UGN-103 approval?
Answer: The J code will gradually reduce lag time from 45-60 days to under 30 days, with improvements over time as practices become more standardized. For UGN-103, the FDA is expected to require around 12 months of follow-up data, with submission targeted for 2026 and approval in 2027.

Question 3: Do you think you can get the time between enrollment form to revenue recognition down to where Jelmyto currently is in 2026? Will you need additional capital in 2026 to transition to profitability?
Answer: We anticipate that over the course of 2026, the time to new patient starts will converge with Jelmyto. We believe our current cash position is sufficient to transition to profitability based on our operational plan.

Question 4: Could you comment on the ratio of community uptake versus institutional settings for Zasturi? And what is the overlap in historical Jelmyto users and their interest in Zasturi?
Answer: Approximately 35%-40% of patients are treated in community settings and 60%-65% in institutional settings. Many initial Zasturi prescribers have prior Jelmyto experience, with new physician adoption rising and generating a "reverse halo" effect boosting Jelmyto demand.

Question 5: How long does it usually take to schedule a TURBT surgery, and do urologists have more financial incentives to run another TURBT surgery or administer Zasturi?
Answer: Scheduling a TURBT surgery typically requires 4-6 weeks. Administering Zasturi offers financial and workflow advantages, allowing urologists to attend to other matters while a nurse administers the treatment.

Question 6: Can you help us understand the competitive landscape for UGN-501 and its parallels with CGM College?
Answer: UGN-501 is analogous to CGM College in terms of asset type and mechanism of action, developed for high-grade non-muscle invasive bladder cancer. It has specific replication advantages in potency, speed, and ability to affect primary tumor cell lysis and adjunctive anti-tumor immune response.

[Sentiment Analysis]
Analysts and management expressed optimism about the steady growth in patient enrollment forms and the positive impact of the permanent J code on reimbursement lag time. The tone was confident regarding the company's cash position and strategic plans for pipeline development.

[Quarterly Comparison]
| Metric | Q3 2025 | Q2 2025 | YoY Change |
|-------------------------|---------|---------|------------|
| Cash Reserves | $127M | $120M | +5.83% |
| Patient Enrollment Forms| Steady | Steady | N/A |
| Revenue | $4.5M | $4.2M | +7.14% |

[Risks and Concerns]
Management cautioned that the improvement in reimbursement lag time with the permanent J code will be gradual and not immediate. There is also a need for approximately 12-month longitudinal follow-up data for UGN-103 FDA approval, which may pose a regulatory risk.

[Final Takeaway]
UroGen Pharma Ltd. is making significant progress with the launch of Zasturi and pipeline development, supported by strong cash reserves and strategic plans. The implementation of a permanent J code is expected to enhance reimbursement processes, while the company's focus on community physician adoption and pipeline advancement positions it well for future growth. Investors should monitor the gradual improvement in reimbursement lag time and the regulatory submission process for UGN-103.