UroGen Pharma Ltd. (URGN): Results of Operations and Financial Condition
UroGen Pharma Ltd. (URGN) filed an SEC Form 8-K — Results of Operations and Financial Condition. Exhibit 99.1 UroGen Reports $50.4 Million of ZUSDURI ® Revenue and Provides Second Quarter 2026 Financial Results and Highlights ● ZUSDURI ® generated $50.4 million in revenue in the second quarter of 2026, representing 73% quarter-over-quarter growth ● Once issued, new U.S. pate
How this was made
The 30-second read
Why it matters
Key trading inputs are the Q2 revenue prints for ZUSDURI and JELMYTO, the Notice of Allowance for a new US patent with expected protection into July 2044, and the reiterated timeline for UGN-103 NDA submission in Q3 2026 plus UGN-501 Phase 1 initiation in Q4 2026.
Market read
Traders can update models for ZUSDURI commercial trajectory and incorporate the next regulatory and clinical catalysts (UGN-103 NDA timing, UGN-501 Phase 1 start) alongside the IP extension narrative.
What to watch
The Teva settlement grants a future non-exclusive generic license starting September 15, 2030, which could cap long-term upside despite the July 2044 patent coverage narrative.
UroGen Reports $50.4 Million of ZUSDURI ® Revenue and Provides Second Quarter 2026 Financial Results and Highlights
Total revenue reached $72.5 million, driven by the ZUSDURI launch and 73% quarter-over-quarter ZUSDURI revenue growth. The company reported operating income of $111, but remained at a net loss of $14.4 million while increasing full-year operating expense guidance to fund commercial and pipeline investment.
Key metrics
as reported| Metric | Value | q/q | y/y |
|---|---|---|---|
| RevenueGAAP | $72.5 million | – | – |
| RevenueGAAP | $ 72,456 (U.S. dollars in thousands) | – | – |
| Cost of revenueGAAP | 6,572 (U.S. dollars in thousands) | – | – |
| Gross profitGAAP | 65,884 (U.S. dollars in thousands) | – | – |
| Research and development expensesGAAP | $17.3 million | – | – |
| Selling, general and administrative expensesGAAP | $48.4 million | – | – |
| Total operating expensesGAAP | 65,773 (U.S. dollars in thousands) | – | – |
| Operating income (loss)GAAP | 111 (U.S. dollars in thousands) | – | – |
| Financing on prepaid forward obligationGAAP | $4.5 million | – | – |
| Interest expense on long-term debtGAAP | $4.9 million | – | – |
| Interest and other income, netGAAP | 599 (U.S. dollars in thousands) | – | – |
| Loss before income taxesGAAP | $ (8,722) (U.S. dollars in thousands) | – | – |
| Net lossGAAP | $14.4 million | – | – |
| Net loss per basic and diluted shareGAAP | $0.28 per basic and diluted share | – | – |
| Six-month revenueGAAP | $ 123,415 (U.S. dollars in thousands) | – | – |
| Six-month cost of revenueGAAP | 10,711 (U.S. dollars in thousands) | – | – |
| Six-month gross profitGAAP | 112,704 (U.S. dollars in thousands) | – | – |
| Six-month research and development expensesGAAP | 32,933 (U.S. dollars in thousands) | – | – |
| Six-month selling, general and administrative expensesGAAP | 99,923 (U.S. dollars in thousands) | – | – |
| Six-month total operating expensesGAAP | 132,856 (U.S. dollars in thousands) | – | – |
| Six-month operating income (loss)GAAP | (20,152) (U.S. dollars in thousands) | – | – |
| Six-month financing on prepaid forward obligationGAAP | (9,051) (U.S. dollars in thousands) | – | – |
| Six-month interest expense on long-term debtGAAP | (9,072) (U.S. dollars in thousands) | – | – |
| Six-month interest and other income, netGAAP | 1,207 (U.S. dollars in thousands) | – | – |
| Six-month loss before income taxesGAAP | $ (37,068) (U.S. dollars in thousands) | – | – |
Segments
| Segment | Revenue | q/q | y/y |
|---|---|---|---|
| ZUSDURI (mitomycin) for intravesical solutionContinued increase in utilization, expanding adoption across community practices, and growing repeat use. | $50.4 million | 73% growth over the first quarter of 2026 | – |
| JELMYTO (mitomycin) for pyelocalyceal solution in LG-UTUCThe Company continues to add new users. | $22.0 million | – | – |
full-year 2026 outlook
- Revenue2026 net product revenue for JELMYTO to be in the range of $97 million to $101 million
- Operating expenses$260 million to $270 million
- NoteOperating expenses guidance includes non-cash share-based compensation expense of $20 million to $24 million.
- NoteThe Company is not providing full-year 2026 revenue guidance for ZUSDURI at this time.
- NoteUGN-103 NDA submission on track for the third quarter of 2026.
- NotePotential FDA approval for UGN-103 in 2027 and full launch anticipated following receipt of a unique J-Code.
- NoteThe Company expects to initiate a randomized controlled Phase 3 trial evaluating UGN-103 in high-risk NMIBC in the second half of 2026.
- NoteA trial evaluating UGN-103 as adjuvant therapy in newly diagnosed intermediate-risk NMIBC patients is expected in 2027.
- NoteThe Phase 3 clinical trial evaluating UGN-104 in LG-UTUC remains on track to complete enrollment by the end of 2026.
- NoteUGN-501 Phase 1 clinical trial in NMIBC is planned for the fourth quarter of 2026.
What drove it
- ZUSDURI generated net product revenue of $50.4 million and represented 73% growth over the first quarter of 2026.
- As of June 30, 2026, UroGen reported 1,444 activated sites of care and 452 unique ZUSDURI prescribers.
- UroGen reported 204 repeat ZUSDURI prescribers, representing approximately 45% of total prescribers, up from 40% in the first quarter of 2026.
- The revenue increase was driven by the continued commercial launch of ZUSDURI.
- R&D expense declined primarily because ZUSDURI manufacturing costs were recognized as R&D expense in the second quarter of 2025 before FDA approval.
- The company received a Notice of Allowance for a U.S. patent expected, once issued, to provide protection for ZUSDURI and UGN-103 into July 2044.
- UGN-103 achieved a 94.5% (95% CI: 86.1, 97.9) DOR at six months by Kaplan-Meier estimate in the ongoing Phase 3 UTOPIA trial.
Concerns
- SG&A expenses increased due to ZUSDURI commercial activities, including sales force expansion, higher brand marketing expense, and increased commercial operation costs.
- Interest expense increased primarily because of additional borrowings of $75.0 million in the first quarter of 2026 in connection with the Pharmakon refinancing of long-term debt, partially offset by a lower interest rate.
- The company reported a net loss of $14.4 million, or $0.28 per basic and diluted share.
- Full-year 2026 operating expense guidance was increased to $260 million to $270 million.
- JELMYTO net product revenue was $22.0 million, compared with $24.2 million reported for the second quarter of 2025.
What to watch
- Continued ZUSDURI utilization, site activation, prescriber additions, and repeat prescriber penetration.
- Delivery of JELMYTO full-year 2026 net product revenue within the $97 million to $101 million guidance range.
- UGN-103 NDA submission in the third quarter of 2026 and planned high-risk NMIBC Phase 3 trial initiation in the second half of 2026.
- UGN-104 Phase 3 enrollment completion by the end of 2026.
- UGN-501 Phase 1 trial initiation in the fourth quarter of 2026.
- Issuance of the allowed U.S. patent expected to provide protection into July 2044.
- Teva's non-exclusive license to sell a generic JELMYTO beginning on September 15, 2030, if approved by the FDA, subject to certain limited circumstances.
Balance sheet and cash flow
- Cash, cash equivalents and marketable securities totaled $108.0 million as of June 30, 2026.
- Cash and cash equivalents and marketable securities were $ 107,976 (U.S. dollars in thousands) as of June 30, 2026, compared with $ 120,456 (U.S. dollars in thousands) as of December 31, 2025.
- Total assets were $ 252,590 (U.S. dollars in thousands) as of June 30, 2026, compared with $ 200,455 (U.S. dollars in thousands) as of December 31, 2025.
- Total liabilities were $ 384,986 (U.S. dollars in thousands) as of June 30, 2026, compared with $ 305,929 (U.S. dollars in thousands) as of December 31, 2025.
- Total shareholders' deficit was $ (132,396) (U.S. dollars in thousands) as of June 30, 2026, compared with $ (105,474) (U.S. dollars in thousands) as of December 31, 2025.
Analysis
UroGen reported a substantial revenue step-up in the second quarter ended June 30, 2026. Total revenue was $72.5 million, compared with $24.2 million in the second quarter of 2025, with the company explicitly attributing the increase to the continued commercial launch of ZUSDURI. ZUSDURI produced $50.4 million of net product revenue and grew 73% over the first quarter of 2026. Commercial indicators included 1,444 activated sites of care, 452 unique prescribers, and 204 repeat prescribers, representing approximately 45% of total prescribers versus 40% in the first quarter of 2026.
The revenue expansion translated into $ 65,884 of gross profit and operating income of 111, each stated in U.S. dollars in thousands. This compares with gross profit of 20,665 and an operating loss of (41,448) in the second quarter of 2025. The company still reported a net loss of $14.4 million, or $0.28 per basic and diluted share. Financing on the prepaid forward obligation was $4.5 million and interest expense on long-term debt was $4.9 million, which management said rose principally due to additional borrowings of $75.0 million in the first quarter of 2026 tied to the Pharmakon refinancing.
Spending reflects an expanded commercial and development posture. R&D expenses declined to $17.3 million from $18.9 million, primarily because ZUSDURI manufacturing costs had been recorded as R&D expense in the second quarter of 2025 before FDA approval. SG&A rose to $48.4 million from $43.2 million, driven by sales force expansion, brand marketing, and broader commercial operations. UroGen raised full-year 2026 operating expense guidance to $260 million to $270 million, including $20 million to $24 million of non-cash share-based compensation, to support ZUSDURI promotional education and patient-awareness efforts and accelerated UGN-103 and UGN-501 activities.
JELMYTO generated $22.0 million in net product revenue, compared with $24.2 million in the second quarter of 2025. Management maintained its full-year 2026 JELMYTO revenue range of $97 million to $101 million and does not provide full-year ZUSDURI revenue guidance. The JELMYTO outlook and ZUSDURI launch execution are central near-term commercial markers, while the settlement with Teva allows a non-exclusive generic JELMYTO license beginning on September 15, 2030, if FDA approved, subject to specified circumstances.
Pipeline and intellectual-property milestones are also prominent. UGN-103 remains on track for NDA submission in the third quarter of 2026 after reporting a 94.5% six-month DOR in UTOPIA, and UroGen expects to begin a high-risk NMIBC Phase 3 trial in the second half of 2026. The company also plans UGN-501 Phase 1 initiation in the fourth quarter of 2026 and expects UGN-104 enrollment completion by the end of 2026. A Notice of Allowance for a patent expected, once issued, to protect ZUSDURI and UGN-103 into July 2044 supports the longer-term franchise strategy. Cash, cash equivalents and marketable securities totaled $108.0 million as of June 30, 2026.
Management, verbatim
The second quarter marked another important step in establishing ZUSDURI as a foundational therapy for adult patients with recurrent low-grade intermediate-risk non-muscle invasive bladder cancer.
Liz Barrett, President and Chief Executive Officer of UroGen
The continued increase in utilization, expanding adoption across community practices, and growing repeat use reinforce our confidence we are building a durable commercial franchise with blockbuster potential.
Liz Barrett, President and Chief Executive Officer of UroGen
Not in the filing
stated, not guessed- Gross margin was not reported.
- Non-GAAP revenue, earnings, operating income, net income, or EPS metrics were not reported.
- Prior-quarter total revenue, expenses, operating income, net loss, and EPS were not reported.
- Percentage year-over-year changes for total revenue, JELMYTO revenue, expenses, gross profit, operating income, and net loss were not reported.
- Operating cash flow and free cash flow were not reported.
- Debt balance was not reported.
- Share repurchases and dividends were not reported.
- Full-year 2026 ZUSDURI revenue guidance was not provided.
- Guidance for gross margin and tax rate was not provided.
- Prior outlook section was not provided, so no comparison with prior guidance is available.
- The supplied filing text is truncated within the income tax expense line of the consolidated statements; full statement-table income tax, net-loss, comprehensive-loss, and per-share line items for the six months ended June 30, 2026 and 2025 are unavailable.
AlphaAI analysis generated from the company’s SEC earnings filing (Form 8-K Item 2.02, or Form 6-K for a foreign private issuer). Every figure was cross-checked against the filing text; consensus estimates, price targets and share-price reactions are not shown because they are not in the filing. AI-generated research, not investment advice.
Background
This is an SEC Form 8-K (Item 2.02) with Exhibit 99.1 summarizing UroGen’s Q2 2026 financial results and pipeline/commercial updates.
Ticker impact
UroGen reported Q2 2026 ZUSDURI revenue of $50.4M, added patent allowance expected to extend protection into July 2044, and reiterated UGN-103 NDA timing for Q3 2026.
Near-term upside bias as traders price in durable franchise/IP extension and the upcoming NDA/Phase 1 milestones; volatility likely around biotech execution risk.
All cited items are primary disclosures in the 8-K exhibit: Q2 revenue, patent notice of allowance with stated expected coverage period, and explicit planned timing for NDA submission and trial initiation.
Market effects
Reinforces investor focus on bladder cancer intravesical therapies with durable response and IP life-cycle strategies.
Limited, primarily affects US small/mid-cap biotech sentiment.
Low; the catalysts are company-specific and US regulatory/patent related.
Counterpoint
Revenue growth and patent coverage may not translate into near-term earnings power if payer coverage, utilization durability, or competitive dynamics weaken.
Key entities
- companyUroGen Pharma Ltd.
Subject of the 8-K, reporting Q2 2026 results and providing updates on ZUSDURI, JELMYTO, and pipeline milestones.
- productZUSDURI
Mitomycin intravesical solution; reported $50.4M Q2 2026 revenue and durability data, plus patent allowance coverage into July 2044.
- pipeline_programUGN-103
Next-generation mitomycin-based therapy; on track for NDA submission in Q3 2026 and potential approval in 2027.
- pipeline_programUGN-501
Investigational oncolytic virus; FDA IND accepted with planned Phase 1 initiation in Q4 2026.
- counterpartyTeva Pharmaceuticals
Entered into a settlement and license agreement resolving JELMYTO generic patent litigation, with a non-exclusive license contingent on FDA approval.
