Urogen Pharma Q1 Earnings Call Highlights

Key Points

• ZUSDURI launch accelerated after a permanent J‑code in January, generating $29.2 million in Q1 revenue (>100% quarter‑over‑quarter) with prescriber adoption rising to 256 unique and 103 repeat prescribers and conversion times improving to ~30–35 days toward a target of two to three weeks.
• Clinical and pipeline momentum: Phase III ENVISION showed ~80% complete response at three months and ~72% 24‑month event‑free probability among responders, and UroGen plans an NDA for next‑generation UGN‑103 in H2 2026 (potential approval in 2027) while advancing UGN‑104 and preparing an IND for UGN‑501 in Q2 2026.
• Financials and guidance: total revenue was $51.0 million in Q1 driven by ZUSDURI and JELMYTO, net loss narrowed to $23.6 million, SG&A rose due to commercialization and refinancing costs, and management maintained JELMYTO guidance of $97–101 million and full‑year operating expense guidance of $240–250 million while providing no formal ZUSDURI sales forecast for 2026.

Urogen Pharma NASDAQ: URGN reported first-quarter 2026 results that management said showed accelerating early momentum from the commercial launch of ZUSDURI, driven in part by the implementation of a permanent J-code in January. The company posted $29.2 million in ZUSDURI revenue for the quarter, which Chief Executive Officer Liz Barrett said represented “more than 100% quarter-over-quarter growth.”

“As expected, the implementation of the permanent J-code in January marked a major inflection point,” Barrett said, adding that early launch momentum is now translating into “expanded utilization and meaningful growth.”

Leadership change and commercial launch progress

Barrett opened the call by noting a leadership change tied to the ZUSDURI launch. She said the board and management decided “a few months ago” that she would assume direct oversight of the commercial organization, which resulted in the departure of David Lynn. Barrett said the change has improved agility and decision-making as the company executes on the launch.

Barrett emphasized ZUSDURI’s positioning as “the first and only FDA-approved medicine for adults with recurrent low-grade intermediate-risk non-muscle invasive bladder cancer,” describing it as a non-surgical, primary chemoablative approach in a setting historically treated with repeated surgical intervention.

In detailing launch indicators, Barrett said prescriber adoption continued to build during the quarter:

• 256 unique prescribers by quarter-end, up from 102 at year-end
• 103 repeat prescribers, up from 32

Barrett said repeat prescribers are “the most important” indicator the company tracks because they reflect healthcare provider confidence and integration into routine practice. She added that the growth was consistent throughout the quarter and “not limited to the immediate period” after the J-code went into effect, which she said supports expectations for continued growth through the rest of the year.

The company also discussed patient enrollment forms (PEFs) as an early measure of demand. Barrett said PEF volume grew sequentially in the quarter and that PEFs, new patient starts, and doses “all significantly outpaced JELMYTO in Q1.”

Access, reimbursement, and community practice adoption

Management highlighted improving conversion timing and expanding community uptake. Barrett said the cycle time from PEF to treatment initiation was approximately 45–60 days in the fourth quarter, reflecting onboarding and workflow integration, and that the company saw improvement in the first quarter with expectations to move toward the “two to three week range” seen with JELMYTO over time.

Chief Financial Officer Chris Degnan later provided more specific conversion figures, stating that the average time to conversion in the first quarter was “30–35 days,” and that the company expects steady-state conversion to resemble JELMYTO at roughly two to three weeks from PEF to new patient start.

Barrett said the site-of-care mix is shifting toward community practices, which management views as critical given where most patients are treated. She said the mix moved from about 60% hospital and 40% community in the fourth quarter to a more balanced split “closer to 50/50” by the end of the first quarter. Degnan said the company had “exceeded 50% mix in the community setting in Q1” and expects a continued shift throughout the year.

On reimbursement, Barrett said UroGen has “open access across more than 95% of covered lives,” and that reimbursement confidence improved significantly with the permanent J-code. In response to analyst questions, she also addressed pricing and treatment duration, noting ZUSDURI’s six-dose regimen and the absence of maintenance therapy as key differentiators compared to longer-duration regimens.

Clinical update and upcoming AUA meeting

Chief Medical Officer Mark Schoenberg said UroGen expects a “significant presence” at the American Urological Association annual meeting May 15–18 in Washington, D.C., calling it an important opportunity to engage urologists and discuss the clinical value of ZUSDURI and JELMYTO.

Schoenberg reviewed data from the Phase III ENVISION trial that supported ZUSDURI’s approval. He said ZUSDURI showed a complete response rate of approximately 80% at three months, with Kaplan-Meier estimates indicating a 24-month probability of remaining event-free of approximately 72% among complete responders. He added that median duration of response has not been reached at a median follow-up of 23.7 months after a three-month complete response. Schoenberg said the findings were recently published in The Journal of Urology and will be featured in a podium presentation at AUA.

He also emphasized ZUSDURI’s administration as a finite six-dose outpatient regimen without surgery or maintenance therapy, contrasting it with therapies in development that are often evaluated in the adjuvant setting following TURBT and can involve induction and maintenance over extended periods.

Pipeline updates: UGN-103, UGN-104, and UGN-501

Schoenberg outlined several pipeline programs, led by UGN-103, a next-generation mitomycin-based intravesical therapy for recurrent low-grade intermediate-risk NMIBC. He said UGN-103 is intended to improve manufacturing and reconstitution versus the current formulation and has intellectual property coverage into December 2041.

UroGen plans to submit an NDA for UGN-103 in the second half of 2026 based on Phase III UTOPIA trial results, which Schoenberg said showed a 77.8% complete response rate at three months. He said the company is aligned with the FDA that the filing can be submitted with six-month durability data, with plans to update the NDA as 12-month durability data become available. Six-month durability data are expected mid-year, he said, and UroGen expects that if UGN-103 is approved in 2027, a permanent J-code could become effective “as early as the beginning of 2028.”

Schoenberg added that UroGen is pursuing expansion opportunities for UGN-103 in high-grade NMIBC and in the adjuvant setting for intermediate-risk disease. He said the company plans Type C meetings with the FDA in the second quarter of 2026 to align on development plans, with the goal of initiating a Phase III trial in high-grade disease before year-end and an adjuvant intermediate-risk study thereafter.

Separately, Schoenberg said UGN-104, a next-generation program for low-grade upper tract urothelial cancer, is progressing in a Phase III trial with enrollment expected to complete by the end of 2026.

He also discussed UGN-501, an investigational oncolytic virus therapy designed for local administration. Schoenberg said UroGen plans to submit an IND in the second quarter of 2026 and initiate a Phase I clinical trial in NMIBC by year-end. The first Phase I evaluation will use aqueous intravesical administration, while the company also plans to explore delivery using its RTGel technology to potentially extend dwell time.

Financial results and 2026 guidance

Degnan reported total revenue of $51.0 million for the quarter ended March 31, 2026, compared with $20.3 million in the prior-year period, driven primarily by ZUSDURI’s launch and contributions from JELMYTO growth. JELMYTO revenue was $21.7 million in the first quarter, which Barrett characterized as stable and predictable, and she said the company remains on track to meet its 2026 JELMYTO sales guidance.

R&D expense was $15.6 million, down from $19.9 million a year earlier. Degnan attributed the decrease primarily to the prior-year acquisition of UGN-501 and to ZUSDURI manufacturing costs that were recognized as R&D before FDA approval.

SG&A expense rose to $51.5 million from $35.0 million, which Degnan said was primarily due to ZUSDURI commercial activities, including sales force expansion and marketing, as well as higher advisory costs tied to the company’s Pharmakon debt refinancing. Degnan said the first quarter is expected to be the high point of SG&A expense for the year due to phasing and one-time refinancing costs.

UroGen reported a net loss of $23.6 million, or $0.47 per share, compared with a net loss of $43.8 million, or $0.92 per share, in the first quarter of 2025. Cash, cash equivalents, and marketable securities totaled $140.3 million as of March 31, 2026.

For guidance, Degnan said the company’s outlook is unchanged from the year-end call. UroGen expects full-year 2026 JELMYTO net product revenue of $97 million to $101 million and full-year operating expenses of $240 million to $250 million, including $20 million to $24 million of non-cash share-based compensation. Degnan said the company is not providing formal ZUSDURI sales guidance for 2026 because the product remains in the early stages of launch.

On the Q&A, management said ZUSDURI demand indicators continued to rise into the early part of the second quarter. Degnan said the company was not seeing a distinct acceleration, but rather “continued demand growth,” while Barrett cautioned that quarter-over-quarter growth rates may not match the step-change seen from the J-code dynamics between the fourth and first quarters.

Barrett also said that while early ZUSDURI use skewed toward patients with multiple prior TURBTs, physicians are increasingly adopting the therapy more broadly within the recurrent setting. She noted anecdotal feedback of patients requesting the treatment and argued that avoiding surgery and maintenance therapy could remain a key differentiator as the treatment landscape evolves.

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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