Highlights

  • Second quarter 2026 revenue was $72.5 million, compared with $24.2 million a year earlier, and the net loss was $14.4 million.
  • Zusduri net product sales were $50,429 thousand and Jelmyto net product sales were $22,028 thousand for the quarter.
  • Cash, cash equivalents and marketable securities were $108.0 million at June 30, 2026, and the accumulated deficit was $997.6 million.
  • Management said it expects 2026 operating expenses of $260 million to $270 million, including non-cash share-based compensation expense.

UroGen Pharma Ltd. (NASDAQ: URGN) shares were trading at USD 33.71 on October 27, 2026, down 0.97%, with a relative volume at time of 2.82. The biotechnology company settled its Jelmyto patent litigation with Teva on June 2, 2026, announced a Notice of Allowance for a new U.S. patent in July 2026, and filed its quarterly report for the period ended June 30, 2026 on August 5, 2026.

UroGen is incorporated in Israel and has principal executive offices in Princeton, New Jersey. It develops and commercializes treatments for urothelial and specialty cancers using its RTGel reverse-thermal hydrogel technology. Its approved products are Jelmyto (mitomycin) for pyelocalyceal solution, for low-grade upper tract urothelial cancer, and Zusduri (mitomycin) for intravesical solution, for recurrent low-grade intermediate risk non-muscle invasive bladder cancer. Its fiscal year ends December 31.

Second Quarter 2026 Results

The Form 10-Q reports unaudited results. Revenue was $72.5 million for the three months ended June 30, 2026, compared with $24.2 million for the same period of 2025. The company said the increase of $48.3 million primarily reflects the volume of sales of Zusduri, which was launched late in the second quarter of 2025.

Jelmyto net product sales were $22,028 thousand, compared with $24,215 thousand a year earlier. Research and development expenses were $17.3 million, compared with $18.9 million. Selling and marketing expenses were $32.9 million, compared with $27.9 million, which the company attributed primarily to Zusduri commercial activities, including sales force expansion. General and administrative expenses were $15.5 million.

Operating income was $111 thousand, compared with an operating loss of $41,448 thousand a year earlier. After financing on the prepaid forward obligation of $4.5 million, interest expense on long-term debt of $4.9 million and income tax expense of $5,629 thousand, the net loss was $14,351 thousand, or $0.28 per share, compared with $49,940 thousand, or $1.05 per share.

Balance Sheet, Debt and Cash Flow

UroGen held $108.0 million in cash and cash equivalents and marketable securities as of June 30, 2026. It reported an accumulated deficit of $997.6 million and negative cash flows from operations since inception. Net cash used in operating activities was $78.3 million for the six months ended June 30, 2026, compared with $81.8 million a year earlier.

On February 26, 2026, the company entered into a loan agreement with Pharmakon for a senior secured term loan facility of up to $250.0 million. The first tranche of $200.0 million was advanced at closing and refinanced a facility with $125.0 million of outstanding principal. The loans accrue interest at a fixed rate of 8.25%.

The filing states that the company's ability to continue as a going concern is expected to be affected by product sales, the rate of Zusduri adoption and its ability to raise additional capital. It also states that the company believes its cash is sufficient to fund operations beyond one year from the issuance of the financial statements, and that additional equity financing would dilute shareholders.

Products, Pipeline and Outlook

On the call, management reported 1,444 activated accounts as of June 30, 2026, compared with 972 at the end of the first quarter, and 452 unique prescribers, compared with 256.

The Teva settlement grants a non-exclusive license to sell a generic version of Jelmyto beginning on September 15, 2030, if approved by the FDA. The company expects to complete enrollment in the Phase 3 trial of UGN-104 by the end of 2026 and plans to start a Phase 1 trial of UGN-501 by the end of 2026.

Management said it expects 2026 operating expenses of $260 million to $270 million, including approximately $20 million to $24 million of non-cash share-based compensation expense. It said it continues to expect Jelmyto net product revenue of $97 million to $101 million and is not issuing full-year Zusduri guidance.