UroGen Pharma Ltd. (URGN) Earnings
UroGen Pharma Ltd. is expected to report next earnings on November 5, 2026 (in NaN days), with a consensus EPS estimate of $0.06. URGN has beaten EPS estimates in 6 of its last 12 reported quarters (average surprise -3.4% over the last four).
| Report date | EPS est | EPS actual | Surprise | Revenue | Rev. surprise |
|---|---|---|---|---|---|
| Aug 5, 2026 | $-0.27 | $-0.28 | -5.7% | $72M | +14.0% |
| May 6, 2026 | $-0.56 | $-0.47 | +16.1% | $51M | +13.7% |
| Nov 6, 2025 | $-0.72 | $-0.69 | +4.2% | $27M | -31.5% |
| Aug 7, 2025 | $-0.82 | $-1.05 | -28.0% | $24M | -27.9% |
| Mar 10, 2025 | $-0.69 | $-0.80 | -15.9% | $25M | +5.2% |
| Aug 13, 2024 | $-0.82 | $-0.91 | -11.0% | $22M | -8.8% |
| Mar 14, 2024 | $-0.67 | $-0.72 | -7.5% | $24M | +4.3% |
| Nov 14, 2023 | $-0.89 | $-0.68 | +23.6% | $21M | -7.6% |
| Aug 10, 2023 | $-1.13 | $-1.03 | +8.8% | $21M | +5.1% |
| May 11, 2023 | $-1.39 | $-1.30 | +6.5% | $17M | +0.1% |
| Mar 16, 2023 | $-1.12 | $-1.22 | -8.9% | $18M | -2.3% |
| Nov 10, 2022 | $-1.22 | $-1.13 | +7.4% | $16M | -20.1% |
Source: company filings + earnings calendar. For informational purposes only — not investment advice.
Earnings call summary
Q2 FY2026 · August 5, 2026
AI summary of management’s prepared remarks and analyst Q&A. For informational purposes only — not investment advice.
Management highlights
### Commercial Launch of Zesturi - As of June 30, 2026, Zesturi had 1,444 activated accounts (up from 972 at the end of Q1), 452 unique prescribers (up from 256 in Q1), and 204 repeat prescribers, which nearly doubled quarter-over-quarter. - Repeat prescribers now represent approximately 45% of all prescribers, up from ~40% in Q1, indicating growing physician confidence and real-world adoption. - 55% of Zesturi utilization is now in community urology practices, up from 45% in Q1, aligning with management's estimate that 70% of the addressable market resides in the community setting. - Reimbursement access is secured for more than 95% of covered lives, and the permanent J-code has eliminated meaningful reimbursement uncertainty as a barrier to adoption. - Operational efficiency has improved, with the company targeting a 2-3 week conversion cycle from patient enrollment to treatment initiation, matching current performance for Jalmito, by the end of 2026. ### Intellectual Property and Legal Updates - The company reached a settlement and license agreement with Teva that resolved Jalmito patent litigation, extending Jalmito's commercial runway and reinforcing the strength of the company's IP portfolio. - The U.S. Patent and Trademark Office issued a notice of allowance for a new method-of-treatment patent covering both Zesturi and UGM-103, which will provide IP protection through July 2044 once issued. ### Clinical Pipeline Progress - Updated Phase 3 InVision trial data with 35.5 months of median follow-up shows 64.5% of complete responders remained disease-free at 36 months, and median duration of response has not yet been reached, confirming durable efficacy without maintenance therapy. Real-world clinical practice data from the AUA annual meeting corroborates these trial results. - UGM-103, the next-generation candidate for recurrent low-grade intermediate-risk NMIBC, remains on track for NDA submission in Q3 2026. A Phase III trial for UGM-103 in high-grade NMIBC and the adjuvant setting for low-grade disease is planned to initiate in late 2026, on track for 2027. - UGN-104 Phase III development for low-grade upper tract urothelial cancer is progressing well, with enrollment expected to complete by the end of 2026. - The FDA cleared the IND for UGN-501, a next-generation oncolytic virus for high-grade NMIBC, and Phase I trial initiation is planned for late 2026.
Guidance
- Management maintained full-year 2026 net product revenue guidance for Gemido (Jalmito) at $97 million to $101 million, representing 3% to 7% year-over-year growth. - The company does not plan to issue full-year Zesturi revenue guidance while the launch remains in its early stages, and formal Zesturi guidance is not expected to be introduced until 2027. - Full-year 2026 operating expense guidance was revised upward to $260 million to $270 million (including $20 million to $24 million in non-cash share-based compensation). The upward revision reflects planned accelerated investment in Zesturi promotional education, patient awareness initiatives, startup activities for the UGM-103 high-grade trial, and UGN-501 development. - Management reaffirmed that the increased investment does not change its confidence that existing capital resources will be sufficient to reach and through profitability.
Segment performance
ureGen Pharma reports two core commercial product segments for Q2 2026: 1. Zesturi: Net product revenue of $50.4 million, representing 73% quarter-over-quarter growth from Q1 2026. This segment contributed 69.5% of total company revenue in the quarter. 2. Gemido (Jalmito): Net product revenue of $22 million, a slight increase from $21.7 million in Q1 2026. This segment contributed 30.5% of total company revenue in the quarter. Total company revenue for Q2 2026 was $72.5 million, up from $24.2 million in Q2 2025. R&D expenses were $17.3 million (down from $18.9 million year-over-year), SG&A expenses were $48.4 million (up from $43.2 million year-over-year), and the company reported a net loss of $14.4 million ($0.28 per share), improved from a $49.9 million ($1.05 per share) net loss in Q2 2025. Cash, cash equivalents, and marketable securities totaled $108 million as of June 30, 2026.
Risks & headwinds
- Forward-looking statements regarding launch trajectory, pipeline progress, and profitability are subject to inherent uncertainty, including potential changes in adoption trends, clinical trial results, regulatory decisions, and competitive market dynamics, as disclosed in the company's SEC filings. - Urologist adoption of new therapies is historically slower than in oncology, and Zesturi adoption in community practices (the largest addressable market opportunity) remains in very early stages, with significant operational work still required to drive broader uptake. - Zesturi may face quarter-to-quarter growth variability, including potential seasonality-related headwinds in Q3 2026 that could prevent the accelerated growth seen in Q2 2026 from continuing in the near term. - Ongoing competitor clinical trials are enrolling patients that would otherwise be candidates for Gemido, creating near-term demand pressure on the established commercial product. - Clinical development of new pipeline candidates carries inherent risk, including potential failure to meet safety or efficacy endpoints required for regulatory approval.
Analyst Q&A
Q: What is the market size difference between community practices and academic centers for Zesturi, when will Zesturi guidance be issued, and has Zesturi momentum driven spillover growth for Gemido? /
A: Approximately 70% of the target patient population is seen in community practices, making it the far larger long-term growth opportunity, while academic centers see faster early adoption but only a minority of patients. Zesturi adoption in communities remains very early, with significant runway for expansion. Management expects to issue formal Zesturi revenue guidance in 2026, after demand trends stabilize through the rest of 2026. No meaningful positive spillover (reverse halo effect) on Gemido uptake has been observed to date, partially because competitor clinical trials are enrolling patients that would otherwise be Gemido users.
Q: What drove Zesturi's faster-than-expected Q2 growth, and how should we expect growth to trend for the remainder of 2026? /
A: The faster Q2 growth came from consistent, broad-based improvement across all commercial adoption metrics, rather than one specific driver. Management expects continued quarter-over-quarter growth for the rest of the year, but anticipates some quarter-to-quarter variability, and does not expect the Q2 acceleration to continue into Q3 2026. A linear growth trajectory remains the appropriate baseline expectation from now until peak adoption.
Q: Has your long-term revenue outlook for Zesturi changed after the strong Q2 launch, and what will the transition from Zesturi to UGM-103 look like? /
A: Management has always projected $1 billion+ in peak Zesturi revenue alone at 20% market share, and now believes there is significant upside to this target given early positive adoption trends. The recently granted patent protection through 2044 provides flexibility for the product transition. The company will wait for UGM-103 approval and a permanent J-code before launching, with a period of overlap before phasing out Zesturi. UGM-103 offers manufacturing and supply benefits, so management will transition as quickly as possible without disrupting patient access or physician adoption.
Q: How is UGM-103 positioned in the high-grade NMIBC competitive landscape? /
A: UGM-103 will be tested as an adjuvant therapy for papillary high-grade NMIBC against the current standard of care, leveraging the company's RT-GL platform to extend drug dwell time compared to conventional aqueous chemotherapy. The high-grade NMIBC market is large (multi-billion dollar opportunity), representing the majority of total bladder cancer patients. Management believes UGM-103 will compete favorably with emerging therapies due to its favorable safety profile, ease of use, and strong efficacy profile, filling an unmet need for patients who want to avoid radical cystectomy.