UroGen outlines $1B ZUSDURI peak revenue ambition as adoption set to accelerate with permanent J-code in 2026

Earnings Call Insights: UroGen Pharma Ltd. (URGN) Q3 2025

MANAGEMENT VIEW

*
CEO Elizabeth Barrett highlighted the progress of the ZUSDURI launch and noted, "The preliminary demand revenue for October is more than double the previous 3 months, demonstrating increased usage and adoption." She stated that patient enrollment forms (PEFs) in Q3 were on track with expectations, but conversions to dosed patients are delayed due to logistical and reimbursement challenges. Barrett emphasized that "ZUSDURI addresses an estimated $5 billion annual market, and we are well positioned to take advantage of this significant opportunity," reiterating confidence in the long-term potential for ZUSDURI to become standard of care and deliver over $1 billion in peak revenue.

*
Barrett also reported JELMYTO net product revenue of $25.7 million for the quarter, citing a 13% increase in underlying demand revenue over the same period in 2024, and announced continued pipeline advancement with plans to submit an NDA for UGN-103 in the second half of 2026.

*
Chief Medical Officer Mark Schoenberg discussed ZUSDURI’s clinical profile, stating that "80% of patients achieving a complete response at 3 months and 80% of those patients remaining disease-free at 12 months and remarkably, 72% at 24 months." He announced the discontinuation of the UGN-301 program, citing insufficient clinical rationale for advancement, and redirected focus to UGN-103 and UGN-501.

*
Chief Commercial Officer David Lin provided a commercial update, noting ZUSDURI sales of $1.8 million in Q3 and a preliminary demand revenue estimate of $4.5 million for October. Lin highlighted the onboarding of 30 new sales representatives, bringing the total to 82, and detailed that approximately 600 sites are now activated for ZUSDURI ordering and administration. Lin stressed the importance of the upcoming permanent J-code, stating, "Once the permanent J-code becomes effective, we expect to see acceleration in adoption, primarily in the community setting."

*
CFO Christopher Degnan reported total revenues of $27.5 million for Q3, with $25.7 million from JELMYTO and $1.8 million from ZUSDURI. Degnan also provided guidance, stating, "We continue to expect 2025 JELMYTO net product revenues to be in the range of $94 million to $98 million."

OUTLOOK

* The company reiterated its expectation of 2025 JELMYTO net product revenues in the range of $94 million to $98 million, implying year-over-year growth of approximately 8% to 12% over 2024, excluding CREATES Act sales. Guidance on full year 2025 operating expenses remains unchanged at $215 million to $225 million, including noncash share-based compensation expense of $11 million to $14 million. Management expects an acceleration of ZUSDURI adoption once the permanent J-code is implemented in January 2026 and maintains the target of over $1 billion in ZUSDURI peak revenue.

FINANCIAL RESULTS

* Total revenues in Q3 were $27.5 million, with $25.7 million in JELMYTO sales and $1.8 million in ZUSDURI sales. R&D expenses for the quarter were $14 million. Selling, general and administrative expenses were $37.6 million, primarily driven by ZUSDURI commercial activities. Net loss for Q3 was $33.3 million or $0.69 per share. Cash, cash equivalents, and marketable securities totaled $127.4 million as of quarter end. There was an increase in R&D and SG&A expenses compared to the prior year, driven by the ZUSDURI launch and pipeline development.

Q&A

*
Tara Bancroft, TD Cowen: Asked for specifics on timing from PEF to revenue and outlook for Q4. David Lin explained that the 45- to 60-day lag is mainly due to benefit investigations and site setup, and remittance times are longer with the miscellaneous J-code. Lin expects gradual improvement into 2026 as the permanent J-code becomes active.

*
Paul Jeng, Guggenheim: Asked about pent-up demand and physician feedback waiting for the J-code. Lin stated that many community physicians are waiting for the permanent J-code, and Barrett added that most practices are holding off prescribing until the J-code is available, but patient identification is strong.

*
Kelsey Goodwin, Piper Sandler: Sought color on patient enrollment forms and revenue estimate methodology. Lin noted steady growth in PEFs, sometimes surpassing JELMYTO, and Barrett clarified that the $4.5 million October figure reflects actual sales, not implied demand.

*
Raghuram Selvaraju, H.C. Wainwright: Inquired about the quantitative impact of the J-code and UGN-103 regulatory pathway. Lin anticipates adoption acceleration with the permanent J-code and expects lag times to drop below 30 days over time. Schoenberg stated that the FDA will likely require about 12 months of durability data for UGN-103 submission.

*
Kyuwon Choi, Goldman Sachs: Asked about convergence of patient start times to JELMYTO levels and cash needs. Lin expects timelines to converge during 2026, and Degnan reported $127 million in cash is sufficient for core priorities and a path to profitability.

*
Leland Gershell, Oppenheimer: Queried on community vs. hospital uptake and physician overlap. Lin noted that 35%-40% of ZUSDURI patients are community-based and initial prescribers are often JELMYTO users, with expectations for increased community uptake in 2026.

*
Aydin Huseynov, Ladenburg: Asked about TURBT scheduling and economics. Lin stated TURBT typically takes 4-6 weeks to schedule, and ZUSDURI economics are favorable for urologists. Schoenberg addressed UGN-501 competitive positioning, noting its unique replication and immune response features.

SENTIMENT ANALYSIS

*
Analysts expressed cautious optimism, focusing on operational headwinds, reimbursement delays, and demand signals, with questions recurring around the impact and timing of the permanent J-code and the pace of patient conversion. The tone was slightly positive but remained probing regarding timing and financial sustainability.

*
Management maintained a confident and constructive tone in both prepared remarks and Q&A. Barrett repeatedly stated confidence in ZUSDURI’s long-term prospects and the company’s ability to achieve strategic goals. The tone was more assertive and forward-looking compared to the prior quarter, emphasizing operational progress and future milestones.

*
Compared to the previous quarter, both management and analyst sentiment shifted from early launch curiosity to implementation focus, with more detailed operational discussion and growing emphasis on reimbursement and execution challenges.

QUARTER-OVER-QUARTER COMPARISON

*
The current quarter saw a significant increase in ZUSDURI sales momentum, with October preliminary demand revenue more than double the previous three months. Management explicitly stated a $1 billion peak revenue target for the product and provided detailed metrics on sales force expansion and site activation.

*
Compared to the previous quarter, there was a strategic shift with the discontinuation of UGN-301 and renewed focus on UGN-103 and UGN-501. Analyst questions evolved from launch logistics and initial demand to concrete revenue timing and operational execution.

*
Guidance for JELMYTO revenue and operating expenses remained unchanged, while management tone became more confident about ZUSDURI’s adoption trajectory as operational hurdles get addressed.

RISKS AND CONCERNS

*
Management identified logistical and operational challenges, especially delays in converting PEFs to dosed patients due to reimbursement complexities with the miscellaneous J-code.

*
The delay is expected to improve gradually as processes mature and the permanent J-code becomes effective, which should simplify reimbursement and accelerate adoption, particularly in community settings.

*
Analysts raised concerns about timing of revenue recognition, operational execution, and the pace of commercial expansion.

FINAL TAKEAWAY

UroGen management reiterated confidence in the long-term growth trajectory driven by ZUSDURI, underlined by strong physician interest, expanding site readiness, and the strategic importance of the upcoming permanent J-code. The company remains focused on operational execution and expects meaningful acceleration in adoption and revenue as reimbursement barriers are addressed, positioning ZUSDURI to become the standard of care and reach over $1 billion in peak sales.

Read the full Earnings Call Transcript [https://seekingalpha.com/symbol/urgn/earnings/transcripts]

MORE ON UROGEN PHARMA

* UroGen Pharma Ltd. (URGN) Q3 2025 Earnings Call Transcript [https://seekingalpha.com/article/4839946-urogen-pharma-ltd-urgn-q3-2025-earnings-call-transcript]
* UroGen: Expect Rough Patch Before Strong Recovery In 2026 [https://seekingalpha.com/article/4836758-urogen-expect-rough-patch-before-strong-recovery-in-2026]
* UroGen Pharma: Targeting Profits In 2027 [https://seekingalpha.com/article/4814605-urogen-pharma-targeting-profits-in-2027]
* UroGen Pharma Q3 2025 Earnings Preview [https://seekingalpha.com/news/4516180-urogen-pharma-q3-2025-earnings-preview]
* Summit draws Neutral view on risk/reward setup as Piper initiates biotech cancer names [https://seekingalpha.com/news/4487168-summit-stock-gets-neutral-view-piper-sandler]