Executive Summary

Q2 delivered a clean top-line beat and bottom-line miss: revenue was $24.22M vs. S&P Global consensus $23.13M, while EPS was ($1.05) vs. ($0.83) consensus; the miss was driven by higher SG&A tied to the ZUSDURI launch and elevated R&D, including UGN‑103 costs . Revenue Consensus and EPS Consensus from S&P Global marked with “*” below. Values retrieved from S&P Global.
FDA approval and launch of ZUSDURI (UGN‑102) transforms UroGen into a multi‑product uro‑oncology company; management emphasized strong physician interest but reiterated that reimbursement frictions (miscellaneous J‑code) will constrain near‑term velocity until a permanent J‑code expected January 1, 2026 .
JELMYTO net product sales grew 11% YoY to $24.2M, supported by 7% underlying demand growth and price favorability; FY25 JELMYTO sales guidance ($94–$98M) and OpEx guidance ($215–$225M) were maintained, framing a disciplined but investment‑heavy launch year .
Balance sheet remains solid to fund the launch and pipeline: cash, cash equivalents and marketable securities were $161.6M at quarter‑end; management highlighted ~84% payer coverage for ZUSDURI already, a positive early‑launch signal .
Near‑term stock catalysts: traction metrics post‑launch (sites activated, first paid claims), progress on payer coverage/formularies, and clarity on ZUSDURI adoption ramp vs. J‑code timing; medium‑term catalysts include initial UGN‑103 readouts and continued durability updates for ZUSDURI .

What Went Well and What Went Wrong

What Went Well
- ZUSDURI FDA approval and commercial launch; CEO: “truly transformative milestone…marking our evolution into a multi‑product uro‑oncology company” .
- JELMYTO performance: $24.2M in Q2 (+11% YoY), with 7% demand growth; gross‑to‑net has stabilized, supporting revenue quality .
- Early launch infrastructure strong: sales force expanded to 82 territories, ~84% payer coverage already, and an initial focus on ~2,000 likely early adopters to overcome miscellaneous J‑code frictions .
What Went Wrong
- Profitability pressure intensified: net loss widened to ($49.9M) vs. ($33.4M) YoY; EPS ($1.05) missed consensus as SG&A stepped up for the ZUSDURI launch and R&D rose with UGN‑103 manufacturing and trial costs .
- Reimbursement friction near‑term: management declined to provide early script/paid‑claim metrics and underscored that the biggest hurdle is reimbursement until a permanent J‑code arrives in Jan‑26, delaying broader community uptake .
- Higher financing/interest burden: interest expense rose to $4.1M (term loan) and prepaid forward obligation expense was $4.6M; OpEx remains elevated with ~$15M in non‑recurring costs during Q2 (ODAC/launch/manufacturing) .

Financial Results

Metric	Q4 2024	Q1 2025	Q2 2025 (Actual)	Q2 2025 (Consensus)*
Revenue ($M)	$24.565	$20.254	$24.215	$23.135*
Gross Profit ($M)	$22.094	$17.924	$20.665	—
Gross Margin (%)	89.9% (calc. from )	88.6% (calc. from )	85.3% (calc. from )	—
EBITDA ($M)	—	—	($41.368)*	—
EBITDA Margin (%)	—	—	(170.8%)*	—
Net Loss ($M)	($37.512)	($43.843)	($49.940)	—
EPS (basic & diluted)	($0.80)	($0.92)	($1.05)	($0.83)*

Values marked with “*” are from S&P Global and lack document citations. Values retrieved from S&P Global.

Segment/product KPIs and operating items:

KPI / Operating Item	Q4 2024	Q1 2025	Q2 2025
JELMYTO Net Product Revenue ($M)	$24.565	$20.3	$24.2 (↑11% YoY; demand +7%)
R&D Expense ($M)	$14.894	$19.871	$18.914
SG&A Expense ($M)	$34.858	$34.967	$43.199
Cash, Cash Equivalents & Marketable Securities ($M)	$241.7	$200.4	$161.6

Notes:

YoY JELMYTO growth and demand details per press release .
Management highlighted ~$15M of non‑recurring costs in Q2 related to acquisition, ODAC, launch meeting, and pre‑approval manufacturing expensed as R&D before approval .

Guidance Changes

Metric	Period	Previous Guidance	Current Guidance	Change
JELMYTO Net Product Revenue	FY 2025	$94–$98M	$94–$98M	Maintained
Operating Expenses (incl. SBC)	FY 2025	$215–$225M (SBC $11–$14M)	$215–$225M (SBC $11–$14M)	Maintained

Earnings Call Themes & Trends

Topic	Q4 2024 (Q‑2)	Q1 2025 (Q‑1)	Q2 2025 (Current)	Trend
ZUSDURI (UGN‑102) approval/launch	Anticipated approval (PDUFA 6/13/25); pricing research ~$18–19k/dose; analog to JELMYTO early ramp; misc. J‑code before Jan‑26	Pre‑launch readiness; expand reps to >80; payer engagement; hospital outpatient initial focus	FDA approval; launch underway; 82 territories; focus on ~2,000 early adopters; ~84% coverage; no hard KPIs yet; reimbursement is the gating item	Positive setup; adoption gated by reimbursement until Jan‑26
JELMYTO performance	FY24 demand +12%; Q4 demand +15%	Q1 sales $20.3M; demand +12%; GtN stabilizing	Q2 sales $24.2M; +11% YoY; demand +7%	Steady growth; leverage from expanded field force
Reimbursement/J‑code dynamics	Expect misc. J‑code → slower cycle times; permanent J‑code by Jan‑26	Same framing; education & white‑glove support	Reiterated friction; focus on hospital outpatient initially; permanent J‑code expected 1/1/26	Improving payer coverage; operational friction persists near‑term
Pipeline (UGN‑103/104/301)	UGN‑103/104 progressing; 301 Phase 1 combos; 1042 IND‑enabling	Env. data updated (UGN‑102); 301 durable responses; UGN‑103 enrollment ahead of plan	UGN‑103 fully enrolled (UTOPIA); planning initial CR data by YE25; UGN‑104 Phase 3 initiated; 301 dose‑escalation complete	Advancing per plan
Clinical durability data	ENVISION 18‑mo DOR 80.6%	AUA podium: 18‑mo DOR 80.6%	ENVISION 24‑mo DOR 72.2% among 3‑mo CRs (median not reached)	Further de‑risking durability

Management Commentary

CEO (Liz Barrett): “The recent FDA approval of ZUSDURI…represents a truly transformative milestone…marking our evolution into a multi‑product uro‑oncology company” .
CCO (David Lin): “We have completed the expansion of our sales force…from 50 to 82…With this footprint…reach the 8,500 HCPs who treat ≈90% of the addressable patients…~84% of covered lives with open access” .
CMO (Mark Schoenberg): “ZUSDURI…offers a convenient office‑based outpatient alternative to repeated surgeries…24‑month duration of response is 72.2%…median DOR not reached” .
CFO (Chris Degnan): “Non‑recurring costs totaled ≈$15M in Q2…ODAC, national launch meeting, manufacturing prior to FDA approval” .

Q&A Highlights

Early launch metrics: Management declined to provide scripts/paid‑claims this early; emphasized strong physician interest and site activations, with reimbursement as the main hurdle until permanent J‑code; expect acceleration post‑Jan‑26 .
Payer/access and process: “White‑glove” education/support; initial focus on ~2,000 early adopters; hospital outpatient sites facilitate early use; permanent J‑code expected 1/1/26, which should halve reimbursement cycle times .
Market sizing and peak sales: CFO reiterated ZUSDURI peak sales potential >$1B; broader engagement across the 8.5k HCP universe planned by mid‑2026 .
Pipeline and durability: UGN‑103 UTOPIA fully enrolled; study mirrors ENVISION to streamline regulatory path; additional life‑cycle studies under consideration .

Estimates Context

Results vs. S&P Global consensus (Q2 2025):

Revenue: $24.215M vs. $23.135M consensus* → beat .
EPS: ($1.05) vs. ($0.83) consensus* → miss .
Values marked with “*” are from S&P Global and lack document citations. Values retrieved from S&P Global.

Forward consensus snapshot (S&P Global) to frame revisions risk:

Revenue ($M): Q3’25 $32.47*, Q4’25 $41.45*, Q1’26 $43.62*
EPS: Q3’25 ($0.683), Q4’25 ($0.489), Q1’26 ($0.507)*
Values marked with “*” are from S&P Global and lack document citations. Values retrieved from S&P Global.

Given management’s launch posture (no KPIs yet; reimbursement gating until permanent J‑code), near‑term revenue estimate dispersion could widen; OpEx trajectory (maintained guidance) suggests limited near‑term EPS relief absent faster‑than‑expected adoption .

Key Takeaways for Investors

ZUSDURI approval is the structural catalyst; adoption should be measured against reimbursement milestones (P&T decisions, first paid claims, permanent J‑code by 1/1/26) rather than early script counts .
JELMYTO continues to perform, providing a base while ZUSDURI scales; dual‑product leverage from the expanded field force should support steady JELMYTO demand .
Expect near‑term EPS pressure: SG&A is elevated to support launch; non‑recurring costs in Q2 were significant (~$15M) and should moderate modestly in 2H25 per CFO .
Estimate revisions risk: revenue beats can continue if access execution stays ahead of consensus, but EPS may lag until OpEx normalizes and ZUSDURI contributes materially; track coverage wins and site activations closely .
Pipeline momentum de‑risks medium‑term: UGN‑103 fully enrolled; initial CR data by YE25; UGN‑104 Phase 3 initiated; continued durability updates (24‑mo DOR 72.2%) reinforce pharmacologic alternative to TURBT .
Trading setup: upside on tangible proof points (first paid claims cadence, payer/formulary breadth, hospital outpatient activation) and any early indication of adoption beyond initial 2,000 targets; downside if reimbursement timelines slip or OpEx runs above plan .
Balance sheet can fund the plan ($161.6M cash/equivalents/marketable secs at 6/30); watch capital needs vs. drawdown optionality on remaining debt tranches .

Appendix: Source Highlights

Q2 2025 press release/8‑K (financials, guidance, business update): .
ZUSDURI FDA approval/launch positioning and payer coverage: .
JELMYTO Q2 performance (11% YoY; demand +7%): .
ENVISION 24‑month DOR 72.2% update: .
UGN‑103 UTOPIA enrollment completion: .
Prior periods for trend (Q1 2025, Q4 2024): .

UroGen Pharma Ltd. (URGN)·Q2 2025 Earnings Summary