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    URGN
    Earnings call· Jun 2026(Q2 FY26)

    UroGen Pharma Q2 FY26 earnings call URGN

    Aug 5, 2026 Source

    Executive summary

    UroGen Pharma Q2 FY26 — ZUSDURI Revenue Surges 73% QoQ, Pipeline Advances

    UroGen Pharma reported a strong second quarter, driven by a 73% sequential increase in ZUSDURI net product revenue and expanding adoption in community practices. The company reaffirmed JELMYTO's full-year guidance and strengthened its intellectual property with a new patent extending to 2044. Pipeline progress includes UGN-103's NDA submission on track and UGN-501's Phase I initiation, with management confident in reaching profitability with existing capital despite increased investment.

    Highlights

    8

    • ZUSDURI net product revenue reached $50.4 million, representing 73% growth over Q1.

    • Activated accounts for ZUSDURI increased to 1,444, up from 972 in Q1, with unique prescribers rising to 452 from 256.

    • Repeat prescribers for ZUSDURI nearly doubled to 204, now representing approximately 45% of writers compared to 40% in Q1.

    • Community practice utilization for ZUSDURI expanded to 55% of total utilization, targeting the estimated 70% addressable market in this setting.

    • JELMYTO patent litigation with Teva was settled, providing greater visibility into its long-term commercial runway.

    • A new method of treatment patent covering ZUSDURI and UGN-103 was allowed, extending protection into July 2044.

    • UGN-103 NDA submission remains on track for Q3 2026, and UGN-501 Phase I trial is expected to initiate later this year following FDA IND clearance.

    • The company remains confident in reaching profitability with existing capital resources, despite increased investment in ZUSDURI and pipeline development.

    Concerns

    2

    • Operating expense guidance for the full year 2026 was increased to $260 million to $270 million due to accelerated investments.

    • Management noted potential for quarter-to-quarter variability in ZUSDURI growth, including summer seasonality, and does not expect acceleration in Q3.

    Guidance & targets

    9
    CategoryTargetConfidence
    JELMYTO net product revenue
    $97 million to $101 million
    medium materiality
    High
    Operating expense
    $260 million to $270 million
    high materiality
    High
    Noncash share-based compensation expense
    $20 million to $24 million
    low materiality
    High
    UGN-103 NDA submission
    On track
    high materiality
    High
    UGN-103 Phase III trial initiation
    Initiate later this year
    medium materiality
    High
    UGN-103 Phase III trial initiation
    On track for 2027
    medium materiality
    High
    UGN-104 Phase III enrollment completion
    Complete enrollment by the end of 2026
    medium materiality
    High
    UGN-501 Phase I trial initiation
    Initiate later this year
    medium materiality
    High
    ZUSDURI revenue guidance
    Not issuing for 2026
    high materiality
    High

    Segment performance

    2
    SegmentRevenueYoYQoQMargin
    ZUSDURI
    Strong growth driven by expanding adoption across hospital and community practices, increasing repeat utilization, and growing physician confidence. Reimbursement uncertainty is no longer a meaningful constraint.
    Activated accounts: 1,444 (up from 972 in Q1)Unique prescribers: 452 (up from 256 in Q1)Repeat prescribers: 204 (nearly doubled)Repeat prescribers as % of writers: 45% (vs 40% in Q1)Community practice utilization: 55% (vs 45% from hospitals)Addressable market in community practices: ~70%Open access: >95% of covered livesTime from patient enrollment to treatment initiation: improving, goal 2-3 weeks
    		$50.4 million—73%—
    JELMYTO
    Demonstrates a stable and predictable demand profile while continuing to add new users. On track to deliver within full year revenue guidance.
    		$22 million—up from $21.7 million in Q1—

    Operational metrics

    9
    Total revenue
    $72.5 millionvs $24.2 million in Q2 FY25
    Q2 FY26

    Increase driven by continued commercial launch of ZUSDURI.

    Research and development expenses
    $17.3 millionvs $18.9 million in Q2 FY25
    Q2 FY26

    Decrease primarily attributable to ZUSDURI manufacturing costs recognized as R&D in Q2 2025 prior to FDA approval.

    Selling, general and administrative expenses
    $48.4 millionvs $43.2 million in Q2 FY25
    Q2 FY26

    Increase primarily attributable to ZUSDURI commercial activities, including sales force expansion and higher brand marketing expenses.

    Noncash financing expense (prepaid forward obligation to RTW)
    $4.5 millionvs $4.6 million in Q2 FY25
    Q2 FY26

    Related to prepaid forward obligation to RTW investments.

    Interest expense on long-term debt
    $4.9 millionvs $4.1 million in Q2 FY25
    Q2 FY26

    Interest expense on the company's long-term debt.

    Net loss
    $14.4 millionvs $49.9 million in Q2 FY25
    Q2 FY26

    Reported net loss for the quarter.

    EPS (basic and diluted)
    -$0.28vs -$1.05 in Q2 FY25
    Q2 FY26

    Reported EPS for the quarter.

    Cash, cash equivalents and marketable securities
    $108 million
    as of June 30, 2026

    Cash balance at the end of the reporting period.

    ZUSDURI and UGN-103 patent protection
    July 2044
    until

    Notice of allowance received from U.S. Patent and Trademark Office for a new method of treatment patent covering both ZUSDURI and UGN-103.

    Industry KPIs

    3
    MetricValueDetails
    Launch access metrics>95%%
    Product franchise net sales$50.4MUSD
    Peak long term sales guidance$1B+USD

    Deals & partnerships

    1
    TevaSettlement and license agreement resolving JELMYTO patent litigation.

    The agreement resolved the JELMYTO patent litigation.

    Risks & headwinds

    2
    Potential summer seasonality for ZUSDURIQ3 FY26

    Not quantified

    Mitigation: Management expects continued linear growth but not acceleration in Q3.

    Competitive clinical trials impacting JELMYTO patient poolCurrent

    Not quantified

    Mitigation: JELMYTO continues to demonstrate a stable demand profile and add new users.

    What to watch in Q3 FY26

    5

    ZUSDURI revenue growth trajectory

    Q3 FY26
    Current$50.4M, 73% QoQ growth in Q2 FY26
    TargetContinued linear growth, avoiding significant deceleration due to seasonality.

    Why it matters

    ZUSDURI is the key growth driver; its sustained momentum is critical for the investment thesis.

    we do not expect to see that, particularly in Q3. We're hopeful, right, as we continue to grow throughout the year that we will see continued acceleration. But given what we've seen so far, we're comfortable with where we are, comfortable with our comments around linear growth in Q3.

    Q&A highlights

    8

    How does ZUSDURI demand and market opportunity compare between community practices and academic centers?

    Community practices represent about 70% of the addressable market, and adoption is still early but growing. Academic centers show faster uptake but see fewer patients. The biggest driver for accelerating growth will be integrating ZUSDURI into large group practices.

    “we know that most patients, whether it's around 70% of patients are actually seen in the community setting.”

    asked by Raghuram Selvaraju · answered by Elizabeth Barrett

    2 min read5 chapters

    Detailed Narrative

    01

    ZUSDURI Commercial Momentum

    ZUSDURI generated $50.4 million in net product revenue, marking a 73% sequential growth, driven by expanding adoption across hospital and community practices. Activated accounts increased to 1,444, and unique prescribers grew to 452, with repeat prescribers nearly doubling to 204, now representing 45% of writers. Community practices account for 55% of utilization, targeting the estimated 70% addressable market, and open access is available across over 95% of covered lives, with reimbursement no longer a significant constraint.

    02

    JELMYTO Performance & IP Strengthening

    JELMYTO maintained a stable demand profile, generating $22 million in revenue for the quarter, and is on track to meet its full-year guidance of $97 million to $101 million. The company strengthened its intellectual property by settling JELMYTO patent litigation with Teva, providing long-term commercial runway. Additionally, a new method of treatment patent for both ZUSDURI and UGN-103 was allowed, extending protection into July 2044, reinforcing the long-term commercial opportunity for the franchise.

    03

    Pipeline Advancement

    The pipeline continues to advance with UGN-103 on track for NDA submission in Q3 2026, supported by Phase III UTOPIA trial data showing 94.5% 6-month duration of response. A Phase III trial for UGN-103 in high-grade NMIBC and adjuvant setting is planned for later this year and 2027, respectively. UGN-104's Phase III enrollment is expected to complete by year-end, and UGN-501, a next-generation oncolytic virus, will initiate Phase I development later this year following FDA IND clearance, leveraging its differentiated biology for direct tumor cell destruction and immunomodulatory effects.

    04

    Financial Strategy & Investment

    Total revenue for the quarter was $72.5 million, significantly up from $24.2 million in Q2 2025. The company reported a net loss of $14.4 million, a substantial improvement from $49.9 million in the prior year. Operating expense guidance for FY26 was increased to $260 million to $270 million to accelerate investment in ZUSDURI commercial activities and pipeline development. Despite this, management remains confident that existing capital resources of $108 million will lead to profitability.

    05

    ZUSDURI Durability Data

    Updated durability data from the Phase III ENVISION trial for ZUSDURI showed that 64.5% of patients who achieved a complete response remained disease-free at 36 months by Kaplan-Meier estimate. The median duration of response has not yet been reached at a median follow-up of 35.5 months. These data highlight ZUSDURI's potential to interrupt the cycle of repeated recurrences and surgeries in low-grade intermediate risk NMIBC patients, with similar results now observed in routine clinical practice.

    AI-generated summary of the company’s earnings call. Not investment advice.