UroGen Pharma Ltd. (URGN)

Key figures

The last twelve months reported, with the latest price and balance sheet.

Revenue, last twelve months

$188.7M

Revenue growth

100.3%

Net income, last twelve months

-$97.6M

Earnings per share

-$1.98

Gross margin

90.8%

Operating margin

-35.3%

Net margin

-51.7%

Free cash flow

-$159.1M

Market value

$1.7B

Cash

$79.1M

Debt

$200.0M

Shares outstanding

48.9M

Financial statements

Revenue, profit and cash flow by fiscal year, each year linked to its annual report.

By quarter

What the company said with its results

From the second quarter of 2026 results, filed 5 August 2026.

• Total revenue rose to $72.5 million. Total revenue was $72.5 million against $24.2 million a year earlier. Management attributed the increase to the continued commercial launch of ZUSDURI.
• ZUSDURI revenue up 73% sequentially. ZUSDURI net product revenue reached $50.4 million, 73% above the first quarter of 2026, which the prior release reported at $29.2 million.
• Net loss narrowed to $14.4 million. Net loss was $14.4 million, or $0.28 per basic and diluted share, against $49.9 million, or $1.05 per share, in the second quarter of 2025.
• Six-month revenue more than doubled. Six-month revenue was $123.4 million against $44.5 million in the first half of 2025. Six-month net loss was $37.9 million, or $0.75 per share.
• Repeat prescribers reached 45% of total. Repeat prescribers numbered 204, about 45% of total prescribers, up from 40% in the first quarter. The company reported 452 unique ZUSDURI prescribers and 1,444 activated sites of care at June 30.
• JELMYTO revenue declined year over year. JELMYTO net product revenue was $22.0 million, compared with $24.2 million in the second quarter of 2025. Management said the product continues to add new users.
• ZUSDURI durability data updated. Updated Phase 3 ENVISION data showed a 36-month duration of response of 64.5% among patients with complete response at three months. Median DOR was not reached at a median follow-up of 35.5 months.
• UGN-103 NDA on track for Q3. UGN-103 remains on track for NDA submission in the third quarter of 2026. Its six-month DOR in the Phase 3 UTOPIA trial was 94.5%.
• UTOPIA result compared with ZUSDURI. Management described the six-month UTOPIA results as generally consistent with the 91.9% six-month DOR observed with ZUSDURI in the ENVISION trial.
• UGN-501 IND accepted by FDA. The FDA accepted the IND for UGN-501, an investigational next-generation oncolytic virus for high-grade NMIBC. The Phase 1 trial is planned for the fourth quarter of 2026.
• UGN-104 enrollment on track. The Phase 3 UGN-104 trial in LG-UTUC is on track to complete enrollment by the end of 2026.
• R&D spend fell year over year. R&D expenses were $17.3 million, including $0.9 million of non-cash share-based compensation, against $18.9 million in the second quarter of 2025, when ZUSDURI manufacturing costs were expensed before approval.
• SG&A rose on ZUSDURI commercial spend. SG&A expenses were $48.4 million, including $4.4 million of non-cash share-based compensation, up from $43.2 million. The increase reflects the sales force expansion and higher brand marketing.
• Operating expense range raised. Full-year 2026 operating expense guidance rose to $260 million to $270 million from $240 million to $250 million. The non-cash share-based compensation range was kept at $20 million to $24 million.

Revenue by segment

As the company reports it in the segment note of its annual report.

By product, FY2025

Company events

The newest 8-K filings of 84 held.

Every filing

The newest filings with the SEC of 236 held.

Insider trades

Form 4 trades by officers, directors and 10% owners, last 12 months.

Planned insider sales

Form 144 notices, filed when the sell order goes to the broker.

Large holders

Schedule 13D and 13G filings by holders of more than 5% of the voting shares.

Short interest

Shares sold short and not yet bought back, on each FINRA settlement date.

Funds that hold it

From each fund's latest Form 13F.

212 funds held it at 30 Jun 2026: 99 added and 53 trimmed in the quarter. The largest:

Peers

Companies in the same industry.

• Eli Lilly & Co. (LLY): revenue $79.7B, market value $1.21T
• Johnson & Johnson (JNJ): revenue $99.3B, market value $652.9B
• AbbVie Inc. (ABBV): revenue $64.4B, market value $506.1B
• Merck & Co., Inc. (MRK): revenue $66.6B, market value $348.1B
• Novartis AG (NVS): revenue $54.5B, market value $297.8B
• AstraZeneca PLC (AZN): revenue $58.7B, market value $263.1B
• Abbott Laboratories (ABT): revenue $46.6B, market value $177.7B
• Novo Nordisk A/S (NVO): revenue $46.8B, market value $171.0B
• Pfizer Inc. (PFE): revenue $63.7B, market value $168.0B
• Vertex Pharmaceuticals Inc. (VRTX): revenue $12.6B, market value $134.2B

What the company does

UroGen is a biotechnology company that develops and sells treatments for urothelial and specialty cancers. It built RTGel, a reverse-thermal hydrogel that is liquid at lower temperatures and turns to gel at body temperature, and uses it to keep a drug in contact with urinary tract tissue for longer. Its two approved products, Jelmyto and Zusduri, both combine mitomycin with RTGel and are designed to ablate tumors without surgery. The company is organised under the laws of Israel and has its principal executive offices in Princeton, NJ. It had 291 employees as of 31 January 2026.

How RTGel works

RTGel is instilled as a liquid through a catheter or nephrostomy tube. It converts to a gel at body temperature, then gradually dissolves on contact with urine and releases the drug over several hours. The filing gives the average dwell time of standard water-based mitomycin in the upper urinary tract as approximately five minutes, against approximately six hours with RTGel. Only 0.5 mg of mitomycin dissolves in 1 mL of water, while up to 8 mg can be formulated with 1 mL of RTGel. The company says the technology may suit other body cavities, though its products so far target the bladder and upper urinary tract.

What it sells

Jelmyto (mitomycin) for pyelocalyceal solution was approved by the FDA on 15 April 2020 for adults with low-grade upper tract urothelial cancer ("low-grade UTUC"). The company estimates up to 7,000 new or recurrent cases a year in the United States. Before Jelmyto, patients were managed with endoscopic resection or removal of the kidney and upper urinary tract. UroGen began the US launch in June 2020.

Zusduri (mitomycin) for intravesical solution was approved by the FDA on 12 June 2025 for adults with recurrent low-grade intermediate risk non-muscle invasive bladder cancer ("low-grade intermediate risk NMIBC"). A trained healthcare professional delivers it into the bladder by catheter in an outpatient procedure. The drug is released for up to 24 hours, with a median of five hours. The company estimates the annual treatable US population at approximately 82,000 patients. The usual alternative is a surgical procedure called TURBT, often repeated for each recurrence. Promotion of Zusduri in the United States began in late June 2025.

The pipeline

UGN-103 and UGN-104 are mitomycin formulations that combine medac's 80 mg mitomycin formulation with RTGel. They are intended as follow-on versions of Zusduri and Jelmyto, under a licensing and supply agreement signed in January 2024. The Phase 3 UTOPIA trial of UGN-103 enrolled 99 patients, and the filing reports a three-month complete response rate of 77.8%. The company says it anticipates submitting an NDA for UGN-103 in the second half of 2026. A Phase 3 trial of UGN-104 in low-grade UTUC began in June 2025.

UGN-501 is an investigational oncolytic virus, acquired from IconOVir Bio in February 2025. IND-enabling studies are ongoing, and the company says it plans to start a Phase 1 study by the end of 2026. In November 2025 UroGen stopped developing UGN-301, an anti-CTLA-4 antibody, and gave Agenus notice that it was terminating the license.

How it reaches patients

UroGen sells in the United States through a customer-facing team of approximately 150 people. The team includes territory business managers, regional business directors, clinical nurse educators, field reimbursement managers, key account directors and medical science liaisons. Mixing pharmacies prepare and dispense the Jelmyto admixture after receiving a prescription. The FDA has authorised an in-use period of 96 hours after reconstitution.

Medicare has issued permanent product-specific J-codes for both products: effective 1 January 2021 for Jelmyto, and J9282 effective 1 January 2026 for Zusduri. The company reports open access to Zusduri for more than 95% of covered lives.

UroGen owns no manufacturing facilities. It relies on third-party contract manufacturers for raw materials, active ingredients and finished products, and has signed commercial supply agreements for Jelmyto and Zusduri. Outside the United States, the company says it intends, where appropriate, to work through commercialization partners.

Patents and competition

The company reports 54 granted patents worldwide and more than 13 pending applications. Orphan Drug exclusivity for Jelmyto runs until 15 April 2027, and the main US patents protecting it are set to expire in January 2031. The issued Zusduri patents are expected to expire in 2031.

The filing names AstraZeneca, Bristol Myers Squibb, GSK, ImmunityBio, Johnson & Johnson, Merck, Pfizer and Roche among companies developing drugs in urology and uro-oncology. It also lists surgical tumor resection as competition. For high-grade bladder cancer, the standard of care is TURBT followed by BCG immunotherapy.

Its people

Of the 291 employees, 251 are in the United States and 40 are in Israel. None is covered by a collective bargaining agreement. Liz Barrett is President and Chief Executive Officer, and Arie Belldegrun, M.D., is Chairman.

*From UroGen's annual report on Form 10-K for the year ended 31 December 2025. [The filing](https://www.sec.gov/Archives/edgar/data/1668243/000143774926006234/urgn20251231_10k.htm)*

From the company's 10-K.