Urogen Pharma Q4 Earnings Call Highlights

Key Points

• Zusduri launch is gaining momentum after the permanent J-code (effective Jan. 1), with management reporting $15.8M in Zusduri revenue in 2025, acceleration in new/repeat prescribers and patient starts, 838 activated sites, and >95% of covered lives with open access.
• UGN-103 is on a fast track—Phase 3 UTOPIA showed a 77.8% complete response rate at three months, and UroGen expects to file an NDA in the second half of 2026 with potential approval in 2027 and a planned launch after securing a permanent J-code.
• Financials and balance-sheet moves: 2025 revenue was $109.8M (Jelmyto $94.0M) with a net loss of $153.5M and $120.5M in cash/marketable securities, and UroGen completed a refinancing with a up-to-$250M senior secured term loan (initial $200M funded) at a fixed 8.25% to extend runway and lower cost of capital.

Urogen Pharma NASDAQ: URGN executives used the company’s fiscal 2025 earnings call to highlight early commercial momentum for newly launched Zusduri, continued growth from its established product Jelmyto, and a strengthened balance sheet following a refinancing with Pharmakon Advisors. Management also outlined upcoming clinical and regulatory milestones across its next-generation pipeline, including plans for an NDA submission for UGN-103 in the second half of 2026.

Zusduri launch: J-code seen as key catalyst for uptake

Chief Executive Officer Liz Barrett said the company’s “top priority” is the commercial launch of Zusduri in recurrent low-grade intermediate-risk non-muscle invasive bladder cancer (NMIBC). Barrett pointed to an “encouraged” early 2026 trajectory following the permanent J-code becoming effective on Jan. 1, which she described as removing a key barrier to adoption by enabling more predictable patient access.

Zusduri revenue in 2025 totaled $15.8 million, which Barrett said reflected “early launch dynamics” while the company worked through reimbursement and operational steps. Chief Commercial Officer David Lin added that Zusduri generated $1.8 million in net product revenue in the third quarter and $14.0 million in the fourth quarter.

Since the permanent J-code took effect, management said it has seen acceleration across several launch indicators, including new and repeat prescribers, patient enrollment forms, and new patient starts. Lin said the company was not seeing “material friction points” in reimbursement, logistics, or treatment delivery, and noted growing engagement from community-based urologists, who had been more cautious during the miscellaneous J-code period.

As of Dec. 31, 2025, UroGen reported 838 activated sites of care, with 102 unique prescribers and 32 repeat prescribers. Lin said over 95% of covered lives had open access to Zusduri by year-end.

Physician and patient feedback, plus how usage is developing

Chief Medical Officer Dr. Mark Schoenberg reviewed clinical outcomes from the ENVISION trial that supported Zusduri’s approval, citing an approximately 80% complete response rate at three months. Among those who achieved a complete response, he said the probability of remaining event-free was approximately 80% at 12 months and approximately 72% at 24 months by Kaplan-Meier estimate. He emphasized Zusduri’s six-dose outpatient regimen and that it does not require surgery or maintenance therapy.

Schoenberg also shared anecdotal feedback from early adopters and patient conversations, stressing it was not from formal study outcomes. He said physicians described Zusduri as integrating smoothly into practice, with simple administration and predictable workflows after initial experience. From the patient perspective, he said some individuals who have had multiple TURBT procedures valued a non-surgical outpatient option.

On current use patterns, Lin said physicians were using Zusduri in patients as expected, including those who recur early, those with frequent recurrences, and those physicians feel “just shouldn’t go through another surgery.” In response to questions about channel mix, Lin said Zusduri utilization in 2025 was about 60% in hospital-type settings, but by late February 2026 had shifted to approximately a 50/50 split between hospital and community settings, which he attributed to improved reimbursement clarity with the permanent J-code.

UGN-103, UGN-104, and UGN-501: timeline and expansion plans

Management spent significant time discussing UGN-103, described as a next-generation mitomycin-based formulation designed to streamline manufacturing and reconstitution relative to Zusduri. Schoenberg said the ongoing Phase 3 UTOPIA trial showed a 77.8% complete response rate at three months, and the company has aligned with the FDA that the data can support an NDA submission in recurrent low-grade intermediate-risk NMIBC in the second half of 2026, with potential approval in 2027.

The company also described plans to evaluate UGN-103 beyond the initial setting, including in high-grade NMIBC and as an adjuvant therapy. Schoenberg said UroGen anticipates Type C meetings with the FDA in the second or third quarter to align on development plans for these potential programs, and expects both studies to be randomized, controlled, and event-driven. Subject to regulatory alignment, the company intends to initiate the high-grade NMIBC study in the second half of 2026.

Barrett addressed commercialization strategy for UGN-103, saying the company would not introduce it until after obtaining a permanent J-code. In response to an analyst question, she said approval in 2027 could support a launch “likely” in early 2028. She also said the company would aim to transition to UGN-103 as quickly as possible to minimize confusion, with only a limited period where UGN-103 and Zusduri would overlap.

For UGN-104, described as a next-generation program for low-grade upper tract urothelial cancer, Schoenberg said the Phase 3 program continues and enrollment is expected to complete by the end of 2026.

UroGen also discussed UGN-501, an investigational next-generation oncolytic virus in development for high-risk NMIBC. Schoenberg said IND-enabling studies are underway, and the company’s goal is to submit an IND and initiate a Phase 1 clinical trial in 2026. He added that the planned Phase 1 study initially uses an aqueous-based preparation preceded by an activating agent (DDM). The company is studying whether longer dwell time could improve efficacy and potentially reduce the need for additional interventions prior to virus administration, though he characterized this as theoretical and under investigation.

Financial results, refinancing, and 2026 guidance

Chief Financial Officer Chris Stegman reported 2025 revenue of $109.8 million, up from $90.4 million in 2024, driven by the Zusduri launch and increased Jelmyto sales. Jelmyto generated net product revenue of $94.0 million in 2025.

R&D expense was $67.1 million in 2025 versus $57.1 million in 2024, which Stegman said was primarily driven by higher manufacturing costs for Zusduri (recognized as R&D prior to FDA approval), Phase 3 costs for UGN-103 and UGN-104, and the acquisition of UGN-501, partially offset by lower clinical trial and regulatory expenses related to Zusduri.

SG&A expenses increased to $155.1 million from $121.2 million, driven primarily by Zusduri commercial activities, including sales force expansion and higher commercial operating costs. UroGen reported a net loss of $153.5 million, or $3.19 per basic and diluted share, compared with a net loss of $126.9 million, or $2.96 per share, in 2024. Cash, equivalents, and marketable securities totaled $120.5 million as of Dec. 31, 2025.

Stegman also detailed a refinancing with Pharmakon Advisors: a second amended and restated senior secured term loan facility of up to $250 million across two tranches. The initial $200 million tranche was funded at closing and used to refinance the prior $125 million term loan and provide additional non-dilutive capital. A second $50 million tranche may be drawn through June 30, 2027, subject to customary conditions. The loan carries a fixed interest rate of 8.25%, with repayment via four equal quarterly principal payments beginning in the first quarter of 2030.

For 2026, the company provided guidance for Jelmyto net product revenue and total operating expenses, but not for Zusduri sales given the early launch stage. Jelmyto net product revenue is expected to be $97 million to $101 million, and 2026 operating expenses are expected to be $240 million to $250 million, including $20 million to $24 million of non-cash share-based compensation.

Management commentary on outlook and timing for Zusduri guidance

When asked about when the company might provide formal Zusduri guidance, Stegman said UroGen may consider providing it after achieving better visibility into steady-state demand, which he suggested could be “at least two quarters” after the permanent J-code. Barrett added that internal indicators in February were tracking ahead of Jelmyto’s launch metrics, including patient enrollment forms, new patient starts, and doses, while reiterating the company was not providing specific figures.

Barrett said the company is investing in Zusduri “like UGN-103 doesn’t exist,” emphasizing that the commercial infrastructure built now will serve as a foundation for UGN-103 later. Stegman tied the path to profitability to Zusduri uptake and said the refinancing reduced the cost of capital and extended the repayment timeline, while providing added flexibility without changing prior commentary on the path to profitability.

About Urogen Pharma NASDAQ: URGN

UroGen Pharma is a clinical-stage biopharmaceutical company focused on developing and commercializing novel treatments for uro-oncology and uro-genital diseases. Founded in 2010 and headquartered in Ra'anana, Israel, with offices in New York, UroGen applies its proprietary RTGel® reverse thermal gel delivery platform to create sustained-release formulations designed for in-office use by urologists.

The company's lead product, Jelmyto® (mitomycin gel), received U.S. Food and Drug Administration approval in 2020 for the treatment of adults with low-grade upper tract urothelial cancer.

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