UroGen Pharma Ltd.: Q3 FY2026 earnings call

What management said about Q3 FY2026, from the documents filed with the SEC on 4 November 2026: press release. Guidance figures: 1 lowered, 1 new, 2 kept. The quarter’s numbers.

Read the filing

Key takeaways

• Total revenue rose to $89.0 million: Total revenue was $89.0 million, against $27.5 million in the third quarter of 2025. The company attributes the increase to the continued ZUSDURI launch. Source
• Net loss narrowed to $1.5 million: Net loss was $1.5 million, or $0.03 per share, compared with $33.3 million, or $0.69 per share, in the third quarter of 2025. Source
• ZUSDURI revenue up 35% in quarter: ZUSDURI net product revenue was $68.0 million, 35% above the second quarter of 2026, which was $50.4 million as reported in the prior release. Source
• JELMYTO revenue fell year on year: JELMYTO net product revenue was $21.0 million, compared with $25.7 million reported for the third quarter of 2025. Source
• Trial enrollment hit JELMYTO starts: Ongoing competitive clinical trial enrollment affected JELMYTO patient starts in low-grade upper tract urothelial cancer. Source
• UGN-103 NDA accepted for review: The FDA accepted for review the NDA for UGN-103, a next-generation mitomycin-based formulation, in October 2026. Source
• Cash and securities at $90.5 million: Cash, cash equivalents and marketable securities totaled $90.5 million at September 30, 2026, down from $108.0 million at June 30, 2026. Source

“We delivered another strong quarter of execution, with ZUSDURI continuing to scale as growing repeat utilization, expanding community adoption, and broader physician engagement reinforce our confidence in the long-term commercial opportunity,”

Liz Barrett, President and Chief Executive Officer of UroGen

Guidance

What changed from last quarter

• Guidance lowered: Full-year 2026 JELMYTO net product revenue guidance was lowered from $97 million to $101 million to about $90 million. Source
• New: The FDA accepted the UGN-103 new drug application for review in October 2026, after the second-quarter release said submission was planned for the third quarter. Source
• New: A strategic collaboration, licensing option and equity investment agreement with IntraGel Therapeutics was entered into in August 2026. Source
• New: The U.S. method-of-treatment patent has been issued and listed in the Orange Book for ZUSDURI, after the second-quarter release reported a Notice of Allowance. Source
• New: The FDA cleared the investigational new drug application for UGN-501 in July 2026, and the first patient began Phase 1 treatment. Source
• New: The high-grade NMIBC Phase 3 trial is now named LONGVIEW-HR and is planned to start in Q4 2026, replacing the prior second-half 2026 timing for a high-risk trial. Source

Results and growth drivers

• Total revenue rose to $89.0 million: Total revenue was $89.0 million, against $27.5 million in the third quarter of 2025. The company attributes the increase to the continued ZUSDURI launch. Source
• Net loss narrowed to $1.5 million: Net loss was $1.5 million, or $0.03 per share, compared with $33.3 million, or $0.69 per share, in the third quarter of 2025. Source
• Operating income positive this quarter: Operating income was $8.3 million, against an operating loss of $27.4 million in the third quarter of 2025, according to the statement of operations. Source
• Nine-month revenue reached $212.4 million: Revenue for the nine months ended September 30, 2026 was $212.4 million, against $72.0 million for the same period of 2025. Source

ZUSDURI adoption and prescribers

• ZUSDURI revenue up 35% in quarter: ZUSDURI net product revenue was $68.0 million, 35% above the second quarter of 2026, which was $50.4 million as reported in the prior release. Source
• Activated sites reached 1,538: Activated sites of care rose to 1,538 as of September 30, 2026, from 1,444 as of June 30, 2026. Source
• Unique prescribers reached 662: Unique ZUSDURI prescribers were 662 as of September 30, 2026, up from 452 as of June 30, 2026. Source
• Repeat prescribers near half of total: Repeat prescribers were 331, about 50% of total prescribers, up from 45% at June 30, 2026. Source
• Trends read as deeper physician engagement: Management attributes the trends to growth in breadth and depth of adoption, with repeat use reinforcing physician confidence and routine practice integration. Source

“Looking ahead, our planned expansion into high-grade NMIBC with UGN-103, advancement of UGN-501 into the clinic, and strategic collaboration with IntraGel provide multiple opportunities for future growth.”

Liz Barrett, President and Chief Executive Officer of UroGen

JELMYTO revenue and gross-to-net

• JELMYTO revenue fell year on year: JELMYTO net product revenue was $21.0 million, compared with $25.7 million reported for the third quarter of 2025. Source
• One-time CMS adjustment reduced revenue: A one-time unfavorable gross-to-net adjustment of about $1.5 million was recorded, relating to a CMS invoice for the discarded drug program and a prior-year true-up. Source
• Trial enrollment hit JELMYTO starts: Ongoing competitive clinical trial enrollment affected JELMYTO patient starts in low-grade upper tract urothelial cancer. Source

Pipeline and regulatory milestones

• UGN-103 NDA accepted for review: The FDA accepted for review the NDA for UGN-103, a next-generation mitomycin-based formulation, in October 2026. Source
• UTOPIA results consistent with ENVISION: UTOPIA three-month complete response rate, six-month duration of response and safety were consistent with those in the pivotal ENVISION trial of ZUSDURI. Source
• UGN-501 first patient dosed in Phase 1: The first patient began treatment in the Phase 1 trial of UGN-501, which initially uses an aqueous solution to evaluate intravesical administration. Source

“Together, we believe these achievements position UroGen to build a sustainable growth company and create meaningful long-term shareholder value.”

Liz Barrett, President and Chief Executive Officer of UroGen

Operating costs and expense drivers

• R&D expense rose to $26.0 million: R&D expenses were $26.0 million, including $0.9 million of non-cash share-based compensation, against $14.0 million a year earlier. Source
• R&D growth from UGN programs: R&D increase is attributed to UGN-103 and UGN-104 clinical costs, the PDUFA fee for the UGN-103 NDA, and increased UGN-501 development costs. Source
• SG&A rose on ZUSDURI commercial spend: SG&A expenses were $47.2 million, including $5.3 million of non-cash share-based compensation, against $37.6 million a year earlier. Source

Capital, cash and balance sheet

• Cash and securities at $90.5 million: Cash, cash equivalents and marketable securities totaled $90.5 million at September 30, 2026, down from $108.0 million at June 30, 2026. Source
• Shareholders' deficit of $125.2 million: Total liabilities were $397.1 million and total assets were $271.9 million at September 30, 2026, leaving a shareholders' deficit of $125.2 million. Source
• Prepaid forward financing expense steady: Non-cash financing expense on the RTW prepaid forward obligation was $4.5 million, against $4.6 million a year earlier. Source
• Debt interest rose after Pharmakon refinancing: Interest on long-term debt was $4.8 million, up from $3.4 million, reflecting $75.0 million of additional borrowings in Q1 2026, partly offset by a lower interest rate. Source

Strategy, collaborations and IP

• IntraGel collaboration signed in August: The IntraGel agreement gives UroGen an exclusive option on up to three oncology products using the SRGel platform, and an option to acquire cisplatin rights. Source
• Up to $7 million in IntraGel equity: UroGen agreed to invest up to $7 million in IntraGel equity securities, of which $4 million was invested in the third quarter of 2026. Source
• Patent issued covering ZUSDURI into 2044: A U.S. method-of-treatment patent for recurrent LG-IR-NMIBC is issued and listed in the Orange Book for ZUSDURI, expected to provide coverage into July 2044. Source

Coming up, as management said on 4 November 2026

• 12-month DOR data to FDA during review: UroGen plans to submit 12-month duration of response data from the UTOPIA trial to the FDA during the UGN-103 NDA review. Source
• UGN-103 PDUFA date set: The PDUFA target action date for UGN-103 is June 14, 2027. Source
• LONGVIEW-HR starts in Q4 2026: The Phase 3 LONGVIEW-HR trial of adjuvant UGN-103 versus intravesical gemcitabine is planned to start in the fourth quarter of 2026. Source
• Adjuvant intermediate-risk trial in 2027: A non-registrational trial of UGN-103 as adjuvant therapy in newly diagnosed intermediate-risk NMIBC is planned for 2027. Source
• UGN-104 enrollment completion expected: The Phase 3 UGN-104 trial in LG-UTUC is expected to complete enrollment by the end of 2026 or in early 2027. Source
• UGN-501 RTGel formulation later: After the aqueous-solution Phase 1, future UGN-501 development is expected to explore delivery using RTGel technology. Source

Figures management reported

Risks management discussed

• Demand: Ongoing competitive clinical trial enrollment in the United States has affected JELMYTO patient starts in low-grade upper tract urothelial cancer. Source
• Regulatory: A one-time gross-to-net adjustment relates to a CMS discard drug provision true-up, which reduced JELMYTO revenue this quarter. Source

Earlier plans management reported on

• Not stated: Management updated the JELMYTO full-year 2026 revenue guidance to about $90 million from the prior range. Source
• Not stated: Management continues to expect 2026 operating expenses of $260 million to $270 million, toward the upper end of the range. Source
• Not stated: The earlier plan was to submit the UGN-103 NDA in the third quarter of 2026; the FDA accepted the NDA in October 2026. Source
• Not stated: The earlier plan was a Phase 1 start in the fourth quarter of 2026; the first patient began treatment in November 2026. Source

Other quarters

• Q2 FY2026 earnings call
• Q1 FY2026 earnings call
• Q4 FY2025 earnings call
• Q3 FY2025 results

Summarised with AI from the documents the company filed with the SEC. Every point is checked against the filing before it is shown: management’s own words word for word, figures against the line or table row they come from. A point that fails the check is left out. Source opens the filing at that line.