URGN

• A hypothetical 10% change in interest rates would not materially affect the fair value of the $108.0 million in cash, equivalents, and marketable securities.
• Inflation has not materially affected the business during the six months ended June 30, 2026 or 2025, though it could raise labor and clinical trial costs.
• A significant portion of operating expenses are incurred in New Israeli Shekels, exposing results to NIS appreciation or lagging devaluation versus inflation.
• A hypothetical 10% change in the NIS-to-dollar exchange rate during the six months ended June 30, 2026 would not materially affect operating expenses.
• The company does not currently hedge foreign currency exposure but may use forward and swap contracts in the future, with no assurance of full protection.

On April 2, 2024, we filed a lawsuit in the U.S. District Court for the District of Delaware against Teva Pharmaceuticals, Inc., Teva Pharmaceuticals USA, Inc. (together with Teva Pharmaceuticals, Inc., "Teva"), and Teva Pharmaceutical Industries, Ltd., alleging infringement of U.S. Patent Numbers 9,040,074 and 9,950,069 in response to Teva’s submission of an Abbreviated New Drug Application (“ANDA”) to the FDA seeking approval to manufacture, use, or sell a generic version of Jelmyto in the United States prior to the expiration of such patents. We sought a permanent injunction preventing U.S. market entry of Teva’s generic product prior to the expiration of such patents. By written stipulation dated June 11, 2024, Teva Pharmaceutical Industries, Ltd. was dismissed from the action. On June 2, 2026, we entered into a settlement and license agreement (the “Agreement”) with Teva, resolving this litigation. Under the Agreement, we have agreed to grant Teva a non-exclusive license to sell its generic version of Jelmyto beginning on September 15, 2030, if approved by the FDA, unless certain limited circumstances customarily included in these types of agreements occur. On June 3, 2026, the court granted the parties’ Stipulated Dismissal Order, dismissing and closing the civil action. As required by law, the parties submitted the Agreement to the U.S. Federal Trade Commission and U.S. Department of Justice for review. From time to time, we may be involved in various claims and legal proceedings relating to claims arising out of our operations. We are not currently a party to any material legal proceedings. Regardless of outcome, litigation can have an adverse impact on us because of defense and settlement costs, diversion of management resources and other factors.

• The company's success is highly dependent on the commercial success of its only two approved products, Jelmyto and Zusduri, which face risks of limited market adoption and physician acceptance.
• A new $200M senior secured loan with Pharmakon, carrying an 8.25% fixed interest rate, significantly increases indebtedness and imposes restrictive covenants that could limit future operations.
• The company relies on single-source suppliers for critical components, including a sole supplier for the mitomycin in its commercial products, creating substantial supply chain vulnerability.
• Newly emphasized risks include the potential adverse impact of international trade policies and tariffs on the company's global supply chain and manufacturing costs.
• Jelmyto faces imminent generic competition after its orphan drug exclusivity expires in April 2027, and a generic manufacturer has already filed an ANDA with a Paragraph IV certification.
• Operations in Israel expose the company to geopolitical instability, including the impact of recent regional conflicts on personnel, suppliers, and business continuity.