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UroGen Pharma Ltd. (URGN)·Q3 2025 Earnings Summary

Executive Summary

  • Q3 2025 revenue was $27.482M, up sequentially, but below consensus; EPS was ($0.69), essentially in line with Street; EBITDA was more negative than consensus, driven by launch investments and the temporary reimbursement setup for ZUSDURI . Q3 2025 consensus: revenue $32.468M*, EPS ($0.683)*; actual: revenue $27.482M, EPS ($0.69) (miss on revenue, in line on EPS). Values retrieved from S&P Global.
  • ZUSDURI generated $1.8M in its first quarter on market, with October preliminary demand revenue of $4.5M indicating accelerating uptake heading into Q4; CMS assigned a permanent J-code (J9282) effective January 1, 2026, a key near-term catalyst for adoption .
  • JELMYTO delivered $25.7M, ~13% YoY underlying demand growth excluding prior-year CREATES Act sales; full-year JELMYTO guidance maintained at $94–$98M; operating expenses maintained at $215–$225M .
  • Management discontinued UGN-301 after Phase 1, refocusing R&D on UGN-103 (UTOPIA three-month CR 77.8%) and UGN-501 (oncolytic virus), with UGN-103 NDA targeted for 2H 2026 and potential approval in 2027 .

What Went Well and What Went Wrong

  • What Went Well

    • ZUSDURI launch momentum: “preliminary demand revenue for October is more than double the previous three months,” and PEFs “are currently on pace with JELMYTO after only four months on the market,” signaling growing physician adoption .
    • Market access progress: “open access for more than 95% of covered lives and approximately 296 million eligible patients,” reducing payer barriers ahead of permanent J-code activation .
    • Pipeline execution: UTOPIA CRR of 77.8% consistent with ENVISION; FDA agreed that UTOPIA can support UGN-103 NDA submission (2H 2026 target), preserving a clear regulatory path .

  • What Went Wrong

    • Revenue miss vs consensus due to slower-than-anticipated new patient starts and operational/logistical hurdles (miscellaneous J code), elongating PEF-to-dosing conversion to 45–60 days and delaying remittance timing .
    • Elevated SG&A ($37.6M) tied to launch build-out weighed on profitability; net loss widened YoY to ($33.3M) vs ($23.7M) .
    • ZUSDURI uptake skewed toward hospital settings (approx. 60–65%) with community physicians largely waiting for permanent J-code; near-term utilization limited by formulary and P&T approvals .

Financial Results

MetricQ1 2025Q2 2025Q3 2025
Revenue ($USD Millions)$20.254 $24.215 $27.482
Gross Profit ($USD Millions)$17.924 $20.665 $24.204
Operating Income ($USD Millions)($36.914) ($41.448) ($27.386)
Net Income - (IS) ($USD Millions)($43.843) ($49.940) ($33.347)
EBITDA ($USD Millions)($36.842)*($41.368)*($26.405)*
Diluted EPS ($USD)($0.92) ($1.05) ($0.69)

Values retrieved from S&P Global for cells marked with *.

Margin MetricQ1 2025Q2 2025Q3 2025
Gross Profit Margin %88.50%*85.34%*88.07%*
EBIT Margin %(182.26%)*(171.17%)*(99.65%)*
Net Income Margin %(216.47%)*(206.24%)*(121.34%)*

Values retrieved from S&P Global for cells marked with *.

Segment Revenue ($USD Millions)Q3 2024Q3 2025
JELMYTO$25.2 (incl. $2.6 CREATES Act) $25.7
ZUSDURIN/A$1.8
Total$25.2 $27.5
KPIs (Launch/Commercial)Q3 2025
Activated Sites of Care592
Unique ZUSDURI Prescribers54
Repeat ZUSDURI Prescribers16
October 2025 Preliminary Demand Revenue$4.5M
Share of Patients by Setting (Launch-to-date)~35–40% Community; ~60–65% Hospital

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
JELMYTO Net Product RevenueFY 2025$94–$98M $94–$98M Maintained
Operating ExpensesFY 2025$215–$225M (incl. $11–$14M SBC) $215–$225M (incl. $11–$14M SBC) Maintained

Earnings Call Themes & Trends

TopicPrevious Mentions (Q1 2025, Q2 2025)Current Period (Q3 2025)Trend
ZUSDURI launch readiness/adoptionQ1: NDA tracking; launch planning; $5B+ TAM . Q2: FDA approval June; launch commenced; sales force expansion .Adoption slower than anticipated; strong PEFs; October demand revenue $4.5M; hospitals leading initial use; conversion delays due to miscellaneous J code .Improving demand signals; operational hurdles easing into 2026.
Market access/J-codeQ1–Q2: Building payer coverage; commercial prep .Permanent J-code assigned (J9282), effective Jan 1, 2026; management expects acceleration in community adoption post-activation .Clear positive catalyst for reimbursement/process and adoption.
JELMYTO performanceQ1: $20.3M (+8% YoY) . Q2: $24.2M (+11% YoY) .$25.7M in Q3; ~13% YoY underlying demand growth .Durable growth; normalized gross-to-net.
R&D execution (UGN-103/104/501)Q1: UGN-103/104 trials advancing; UGN-501 acquired . Q2: UTOPIA enrollment complete; UGN-104 Phase 3 initiated .UTOPIA CRR 77.8%; FDA agrees UTOPIA supports NDA (2H 2026); IND-enabling for UGN-501 continues .On track; strengthened clinical validation.
Portfolio focus (UGN-301)Q1–Q2: Phase 1 dose escalation showed tolerability and signals .Program discontinued; focus shifts to UGN-103 and UGN-501; RTGel proof-of-concept validated .Strategic pruning to prioritize higher-return assets.
Operations/logisticsQ1–Q2: Launch build-out; training; distributor onboarding .45–60 day PEF-to-dosing lag; manual claims under misc J code; efforts to standardize workflows and reduce lag to 2–3 weeks over 2026 .Gradual improvement expected; foundational work underway.

Management Commentary

  • “Preliminary demand revenue for October is more than double the previous three months, demonstrating increased usage and adoption… PEFs continue to grow and are currently on pace with JELMYTO after only four months on the market.” — Liz Barrett, CEO .
  • “ZUSDURI is now broadly accessible… with open access to more than 95% of covered lives and approximately 296 million eligible patients.” — David Lin, CCO .
  • “We expect to see an acceleration in adoption once the permanent product-specific J code goes into effect on January 1st, 2026.” — Liz Barrett, CEO .
  • “Three-month complete response rate [UGN-103] was 77.8%… consistent with ENVISION, reinforcing the strength of our RTGel platform… FDA agreed UTOPIA can support an NDA.” — Mark Schoenberg, CMO .
  • “We have made the strategic decision to discontinue UGN-301… while confirming RTGel as a viable platform for localized delivery.” — Mark Schoenberg, CMO .

Q&A Highlights

  • Conversion and remittance timing: PEF-to-dosing averages 45–60 days; remittance takes longer under miscellaneous J code; both expected to improve gradually in H1 2026 with permanent J code and standardized workflows .
  • Pent-up community demand: Many community physicians intend to start with ZUSDURI once J9282 is effective; teams preparing sites in Q4 to enable faster activation post-Jan 1 .
  • Setting mix: Launch-to-date ~35–40% community and ~60–65% hospital; community share expected to rise in 2026 as reimbursement simplifies and experience builds .
  • Cash runway: ~$127.4M cash; management indicates cash to profitability under current plan while remaining opportunistic on future capital needs .
  • TURBT scheduling vs ZUSDURI: TURBT typically scheduled in 4–6 weeks; ZUSDURI can be nurse-administered, potentially improving practice economics and physician time allocation .

Estimates Context

MetricQ3 2025 ConsensusQ3 2025 ActualSurpriseQ4 2025 Consensus
Revenue ($USD Millions)$32.468*$27.482 Miss (~$5.0M)$41.450*
Primary EPS ($USD)($0.683)*($0.69) In line($0.489)*
EBITDA ($USD Millions)($23.57)*($26.405)*Miss (~$2.8M)($11.63)*
Target Price (USD)$35.25*$35.25*—$35.25*
Consensus Recommendation (Text)————

Values retrieved from S&P Global for cells marked with *.

Interpretation: Revenue and EBITDA missed consensus due to slower PEF-to-dosing conversion and administrative hurdles under the misc J code; EPS was essentially in line given operating investments and financing/interest expense profile. Management expects adoption to accelerate in 2026 with J9282, suggesting upward pressure on outer-quarter revenue estimates once operational lags compress .

Key Takeaways for Investors

  • Near-term setup: Expect continued sequential revenue progression into Q4 supported by October demand momentum, but community uptake likely inflects meaningfully after permanent J-code becomes effective on Jan 1, 2026 .
  • 2025 print: JELMYTO guidance ($94–$98M) and opex ($215–$225M) maintained; underlying JELMYTO demand remains solid with normalized gross-to-net, anchoring the base business .
  • Launch diagnostics: Strong PEF funnel and activated sites point to demand; focus on shortening PEF-to-dosing and speeding remittance should improve cash conversion and utilization metrics over H1 2026 .
  • Pipeline-driven optionality: UGN-103’s UTOPIA data and FDA alignment on NDA path provide medium-term catalyst potential (2026/2027); UGN-501 IND-enabling work sets longer-term oncology optionality .
  • Resource allocation: Discontinuation of UGN-301 concentrates capital on higher-probability assets, aligning with commercialization priorities and profitability trajectory .
  • Trading lens: Monitor December payer/process readiness, January J-code activation, and early Q1 conversion/commercial metrics; these should drive narrative shifts and estimate revisions as community adoption scales .
  • Risk checks: Reimbursement execution, hospital formulary timing, financing/interest expense, and macro utilization trends remain key sensitivities to watch through 2026 .