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UroGen Pharma Ltd. (URGN)·Q4 2024 Earnings Summary

Executive Summary

  • Q4 delivered steady top-line with JELMYTO net product revenue of $24.6M (+4.4% YoY), while underlying demand rose 15% YoY; GAAP net loss widened to $37.5M as OpEx stepped up ahead of the UGN-102 launch .
  • Management showcased updated 18‑month ENVISION DOR of 80.6% (KM) in UGN‑102’s CR cohort and confirmed the FDA will convene an ODAC focused on the recurrent patient population; UGN‑102 pricing framework indicated at $18–$19k per dose .
  • 2025 outlook introduced: JELMYTO revenue guide $94–$98M and OpEx $215–$225M (incl. $11–$14M SBC) as the company scales for potential UGN‑102 approval (PDUFA June 13, 2025) .
  • Stock narrative catalysts: ODAC in spring (May indicated on call), PDUFA decision June 13, reimbursement ramp (misc. J‑code initially; permanent J‑code expected Jan 2026), and execution on commercial scale‑up from 52 to ~83 reps .

What Went Well and What Went Wrong

  • What Went Well

    • UGN‑102 durability strengthened: ENVISION 18‑month DOR 80.6% (CR cohort), consistent with prior 12‑month 82%+ KM estimate; median DOR not yet reached . Quote (CEO): “The updated duration of response is 80.6%... The median duration of response is still not reached.”
    • JELMYTO demand momentum: Q4 underlying demand revenue +15% YoY; 2024 saw +33% new prescribers and +13% new patient starts, underpinning $90.4M FY revenue (+9% YoY) .
    • Balance sheet strength: $241.7M cash, cash equivalents and marketable securities at year‑end, supporting launch readiness and pipeline execution .

  • What Went Wrong

    • Profitability pressure: Net loss widened to $37.5M in Q4 (vs. $26.0M LY) on higher SG&A supporting UGN‑102 launch readiness; SG&A rose to $34.9M (+42% YoY) .
    • Financing headwinds persist: Non‑cash RTW prepaid forward expense $6.1M in Q4 and Pharmakon interest $3.9M weighed on results .
    • JELMYTO revenue mix headwind: CREATES Act sales fell to $0.2M in Q4 vs. $2.4M LY, partially offsetting demand growth .

Financial Results

MetricQ2 2024Q3 2024Q4 2024
Revenue ($USD Millions)$21.8 $25.204 $24.565
JELMYTO Net Product Revenue ($USD Millions)$21.8 $25.2 $24.6
Gross Profit ($USD Millions)NA$22.751 $22.094
Gross Margin %NA90.3% (22.751/25.204) 90.0% (22.094/24.565)
R&D Expense ($USD Millions)$15.4 $11.355 $14.894
SG&A Expense ($USD Millions)$30.1 (18.9+11.2) $28.941 $34.858
Net Loss ($USD Millions)$(33.4) $(23.673) $(37.512)
Diluted EPS ($)$(0.91) $(0.55) $(0.80)
Cash & Equivalents ($USD Millions)$241.3 $254.217 $241.707

Notes: Gross margin is computed from cited revenue and gross profit. Q2 SG&A shown as Selling + G&A combined from disclosed components .

KPI details and mix

KPIQ3 2024Q4 2024FY 2024
Underlying Demand Revenue YoY (JELMYTO)Not disclosed (Q3 included non-patient purchases) +15% YoY +12% YoY (demand revenue)
CREATES Act Sales ($M)$2.6 $0.2 $3.0
New Prescribers YoY——+33%
New Patient Starts YoY——+13%
“Demand units” YoY (Q4)—+15% YoY (highest ever) —

Actual vs. consensus (S&P Global)

MetricQ4 2024 ActualQ4 2024 ConsensusDelta
Revenue ($USD Millions)$24.565 NA (S&P Global consensus unavailable at time of analysis)—
EPS (GAAP, $)$(0.80) NA (S&P Global consensus unavailable at time of analysis)—

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
JELMYTO Net Product RevenueFY 2025N/A$94–$98M New
Operating Expenses (incl. SBC)FY 2025N/A$215–$225M; SBC $11–$14M included New

Additional outlook/context (not formal guidance):

  • UGN‑102 pricing framework: $18,000–$19,000 per dose under evaluation with payers .
  • Reimbursement: misc. J‑code initially (expected ~50–60 days to reimbursement), goal for permanent J‑code by Jan 2026; initial uptake skewed to hospital/institutional settings before broader community adoption .

Earnings Call Themes & Trends

TopicPrevious Mentions (Q2 2024, Q3 2024)Current Period (Q4 2024)Trend
UGN‑102 durability/efficacyQ2: 12‑mo DOR 82.3% (KM); highest reported; CR 79.6% at 3 months . Q3: NDA accepted; ODAC anticipated .18‑mo DOR 80.6% (KM), median DOR not reached; data in FDA 120‑day update .Data strengthening and maturing positively.
ODAC and label scopeQ2: Priority review hoped; ODAC not yet confirmed . Q3: ODAC expected; timing likely 2–3 months pre‑PDUFA .Mid‑cycle review confirmed ODAC; focus on recurrent population; management comfortable impact on projections .ODAC confirmed; indication likely recurrent initially.
Pricing & Access (UGN‑102)Q2: Commercial planning underway; scale-up contemplated . Q3: Misc. J‑code then permanent J‑code Jan 2026 .Pricing $18–$19k per dose under consideration; misc. J‑code implies ~50–60 days reimbursement; heavier hospital uptake early .Added specificity; operational ramp detailed.
Field force scalingQ2: Modest increase contemplated (10–15 reps) . Q3: Plan to >80 reps at launch .Expanding from 52 to ~83 reps by launch; broader support org described .Acceleration of commercial build.
JELMYTO demand vs. gross‑to‑net headwindsQ2: 340B and wastage pressures; demand growth muted in net sales . Q3: FY24 revenue below low end; demand improving .Underlying demand +15% YoY in Q4; CREATES Act sales decline a mix headwind .Demand momentum continues; mix/gross‑to‑net remains a watch item.
Next‑gen lifecycle (UGN‑103/104)Q2: UTOPIA to start; NDA for 103 targeted 2026, launch 2027 . Q3: First patient dosed UGN‑103; 104 planned .UGN‑103 enrollment ongoing; UGN‑104 Phase 3 start 1H25 .Execution on timelines; steady progress.
Immuno‑oncology (UGN‑301)Q2: Phase 1 mono and combo cohorts progressing . Q3: Updates planned at SUO; litigation/IP questions addressed .Dose escalation completed; responses observed; durability follow‑up ongoing; data later in 2025 .Early signal‑finding continues.
New oncolytic virus (ICVB‑1042)——Acquisition announced; IND‑enabling in 2025; potential RTGel delivery; initial focus bladder cancer .

Management Commentary

  • Strategic positioning: “We engaged with the FDA in a productive mid‑cycle review… The agency confirmed they will be referring the NDA to ODAC… [and] indicated… focus on the recurrent patient population.”
  • Commercial readiness and pricing: “We are significantly expanding our sales force from 52 reps today to approximately 83 at our anticipated launch.” “We continue to think of pricing in the $18,000 to $19,000 per dose… we continue to do research with payers.”
  • Cash runway: “At the close of 2024, cash, cash equivalents and marketable securities totaled $241.7 million… we are well equipped to drive our company towards profitability with the anticipated launch of UGN‑102 later this year.”
  • Lifecycle/competitive strategy: On UGN‑103: “After [103] approval… we would… take UGN‑102 off the market and shift… to UGN‑103… raising the bar for any generic entrant.”

Q&A Highlights

  • ODAC scope and off‑label use: Label expected for recurrent population only; off‑label use in select newly diagnosed/surgery‑ineligible patients would be payer‑dependent; management reiterated this does not change their >$1B revenue view for UGN‑102 over time .
  • Pricing and reimbursement mechanics: Pricing targeted at $18–$19k per dose; misc. J‑code initially with ~50–60 day reimbursement cycle; expect initial adoption more in hospitals/institutions before permanent J‑code in Jan 2026 broadens community uptake .
  • Launch build analogs: Uptake curve shape modeled similar to JELMYTO’s early pattern but with larger absolute numbers due to bigger patient pool .
  • UGN‑103 timeline: Enrollment completion expected in 2025, top‑line 2026, approval 2027 (company plan) .
  • Lifecycle transition: Plan to sunset UGN‑102 post‑UGN‑103 approval to maximize IP/exclusivity dynamics and reduce generic interchangeability risk .

Estimates Context

  • S&P Global consensus for Q4 2024 revenue and EPS was unavailable at the time of analysis; we will update beat/miss framing upon availability. Actuals: revenue $24.565M and GAAP EPS $(0.80) .

Key Takeaways for Investors

  • UGN‑102 data de‑risking continues: 18‑month DOR of 80.6% with median not reached strengthens the clinical durability narrative heading into ODAC and PDUFA; ODAC will focus on recurrent patients, aligning label expectations with the core revenue opportunity .
  • Near‑term catalysts: ODAC (spring) and PDUFA (June 13) are the primary stock drivers; pricing clarity and early access dynamics (misc. J‑code) will shape launch cadence in 2H25 .
  • Commercial scale‑up on track: Sales force expanding to ~83, with comprehensive reimbursement and practice‑integration support—a key lesson from JELMYTO—targeting smoother uptake in a much broader market .
  • JELMYTO provides a durable base: Underlying demand is growing (Q4 +15% YoY) while CREATES Act sales decline creates mix pressure; 2025 guide ($94–$98M) suggests continued moderate growth .
  • OpEx will rise into launch: 2025 OpEx guide ($215–$225M) reflects investment in the 102 launch and late‑stage programs (UGN‑103/104); balance sheet ($241.7M cash) supports execution into commercial inflection .
  • Lifecycle strategy extends runway: Intent to transition from 102 to next‑gen 103 post‑approval may mitigate generic substitution risks; 104 and 301 plus ICVB‑1042 broaden optionality .
  • Trading frame: Outcome risk around ODAC/PDUFA dominates near‑term; a constructive panel readout and line‑of‑sight on pricing/access could reset expectations positively, while delays or narrowing beyond recurrent setting would be a downside risk .

Appendix: Segment and Balance Sheet Snapshots

Segment (JELMYTO) revenue and mix

MetricQ3 2024Q4 2024
JELMYTO Net Product Revenue ($M)$25.2 $24.6
Underlying Demand Revenue YoY—+15%
CREATES Act Sales ($M)$2.6 $0.2

Selected balance sheet (year‑end)

MetricDec 31, 2023Dec 31, 2024
Cash & Marketable Securities ($000s)$141,470 $241,707
Total Assets ($000s)$178,311 $285,711
Total Liabilities ($000s)$243,523 $294,514
Shareholders’ Deficit ($000s)$(65,212) $(8,803)