UroGen Pharma Ltd. — Third Quarter 2026 Earnings Summary

Financial Performance:

• Total revenue for the quarter ended September 30, 2026, was $89.0 million, compared to $27.5 million in the same period of 2025.
• ZUSDURI generated $68.0 million in net product revenue, representing 35% quarter-over-quarter growth.
• JELMYTO generated $21.0 million in net product revenue, a decrease from $25.7 million in the third quarter of 2025.
• Net loss for the quarter was $1.5 million ($0.03 per share), compared to a net loss of $33.3 million ($0.69 per share) in the third quarter of 2025.
• Research and Development (R&D) expenses were $26.0 million, up from $14.0 million in the prior year period.
• Selling, General and Administrative (SG&A) expenses were $47.2 million, up from $37.6 million in the prior year period.
• Cash, cash equivalents, and marketable securities totaled $90.5 million as of September 30, 2026.
• Interest expense on long-term debt was $4.8 million, compared to $3.4 million in the third quarter of 2025.
• Non-cash financing expense related to the prepaid forward obligation was $4.5 million, compared to $4.6 million in the prior year period.

Guidance and Future Outlook:

• Full-year 2026 net product revenue guidance for JELMYTO has been updated to approximately $90 million, revised down from a previous range of $97 million to $101 million.
• Full-year 2026 operating expenses are expected to remain in the range of $260 million to $270 million, anticipated toward the upper end of the range.
• Non-cash share-based compensation expense for 2026 is expected to be between $20 million and $24 million.
• The PDUFA goal date for the UGN-103 NDA is set for June 14, 2027.
• UroGen plans to initiate the Phase 3 LONGVIEW-HR trial in the fourth quarter of 2026.
• A non-registrational trial for UGN-103 in newly diagnosed intermediate-risk NMIBC is planned for 2027.
• Enrollment for the Phase 3 UGN-104 trial in LG-UTUC is expected to complete by the end of 2026 or early 2027.

Business Segments and Product Lines:

• ZUSDURI:
  • Activated sites of care increased to 1,538 as of September 30, 2026, from 1,444 as of June 30, 2026.
  • Unique prescribers increased to 662 as of September 30, 2026, from 452 as of June 30, 2026.
  • Repeat prescribers increased to 331 as of September 30, 2026, from 204 as of June 20, 2026, representing approximately 50% of total prescribers (up from 45%).
  • A new U.S. method-of-treatment patent covering non-surgical treatment of recurrent LG-IR-NMIBC was issued and listed in the FDA's Orange Book, providing coverage into July 2044.
• JELMYTO:
  • Q3 2026 results included a one-time unfavorable gross-to-net adjustment of approximately $1.5 million related to a CMS invoice for the discarded drug program.
  • Patient starts were affected by ongoing competitive clinical trial enrollment activity in LG-UTUC.
• UGN-103:
  • The FDA accepted the NDA for UGN-103 in low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC).
  • Clinical data from the Phase 3 UTOPIA trial showed three-month complete response rates, six-month duration of response, and safety results consistent with the ENVISION trial of ZUSDURI.
  • UroGen plans to submit 12-month duration of response data from the UTOPIA trial during the NDA review.
• UGN-501:
  • The FDA cleared the IND application for UGN-501 in July 2026.
  • The first patient was dosed in the Phase 1 trial in November 2026 to evaluate safety, tolerability, and feasibility.
• Strategic Collaboration with IntraGel:
  • Entered into an agreement in August 2026 providing an exclusive option to develop up to three future oncology products using IntraGel's SRGel platform.
  • Includes an exclusive option to acquire worldwide rights to IntraGel's Phase 2-ready cisplatin therapy for head and neck cancer.
  • UroGen agreed to invest up to $7 million in IntraGel equity, with $4 million invested in the third quarter of 2026.

Market and Competitive Landscape:

• JELMYTO revenue was impacted by competitive clinical trial enrollment activity affecting patient starts in LG-UTUC.
• ZUSDURI adoption trends reflect growth in both breadth (new prescribers/sites) and depth (repeat utilization) of commercial integration.
• The company aims to expand UGN-103 into high-grade NMIBC and newly diagnosed intermediate-risk NMIBC populations.

Risks and Challenges:

• JELMYTO revenue guidance was reduced due to a one-time unfavorable gross-to-net adjustment and competitive trial enrollment activity.
• There is no guarantee that the UGN-103 NDA will be approved on the expected timeframe or at all.
• The PDUFA date of June 14, 2027, may be delayed due to factors outside UroGen's control.
• Risks include potential safety complications, difficulties in clinical trial enrollment, and the ability to protect intellectual property.
• Future revenue depends on market acceptance, payor coverage, and the successful development of product candidates incorporating RTGel technology.

Management Commentary and Tone:

• CEO Liz Barrett described the quarter as "another strong quarter of execution" with ZUSDURI continuing to scale.
• Management expressed confidence in the long-term commercial opportunity driven by repeat utilization and expanding community adoption.
• The company highlighted the FDA acceptance of the UGN-103 NDA and the new patent issuance as reinforcing long-term revenue potential.
• Management views the expansion into high-grade NMIBC, advancement of UGN-501, and the IntraGel collaboration as multiple opportunities for future growth.

Other Key Points:

• UroGen refinanced long-term debt in the first quarter of 2026 with Pharmakon Advisors, LP, borrowing an additional $75.0 million, which contributed to higher interest expense despite a lower interest rate.
• The company reported a total shareholders' deficit of $125.2 million as of September 30, 2026.
• Total assets increased to $271.9 million as of September 30, 2026, compared to $200.5 million as of December 31, 2025.
• Total liabilities increased to $397.1 million as of September 30, 2026, compared to $305.9 million as of December 31, 2025.