What factors drove the changes in UroGen Pharma's revenue and profit?

What does UroGen Pharma do and what are its main business segments?

What were the key takeaways from UroGen Pharma's earnings call?

What is UroGen Pharma's gross profit margin?

What is UroGen Pharma's latest dividend and current dividend yield?

What is the revenue and EPS growth rate for UroGen Pharma year over year?

What is the market's earnings forecast for UroGen Pharma next quarter?

What guidance did UroGen Pharma's management provide for the next earnings period?

- **ZUSDURI Early Momentum**: $1.8M Q3 sales, $4.5M October demand revenue, with 45-60 day PEF-to-treatment lag. 
- **JELMYTO Growth**: 13% YoY revenue increase, solidifying as standard of care. 
- **Pipeline Progress**: UGN-103 NDA submission planned for H2 2026, UGN-501 Phase I in 2026. 
- **Financial Health**: $127M cash, 2025 JELMYTO guidance of $94-98M, no immediate capital needs. 
- **Strategic Focus**: Permanent J-code launch in January 2026 to accelerate ZUSDURI adoption.

**【CEO Summary Section】**
- ZUSDURI generated $1.8 million in Q3 2025 sales, with preliminary October demand revenue of $4.5 million, reflecting early momentum. 
- Conversion of patient enrollment forms (PEFs) to actual treatments is delayed due to administrative challenges, averaging 45-60 days post-PEF submission. 
- JELMYTO revenue grew 13% YoY to $25.7 million, driven by price and volume growth. 
- The permanent J-code for ZUSDURI will be effective January 1, 2026, expected to accelerate adoption in community settings. 
- UGN-103 Phase III UTOPIA trial showed a 77.8% complete response rate, consistent with ENVISION data, with NDA submission planned for H2 2026. 

**【CFO Financial Commentary】**
- Total Q3 2025 revenue: $27.5 million (JELMYTO: $25.7 million, ZUSDURI: $1.8 million). 
- R&D expenses: $14 million (up $2.6 million YoY due to UTOPIA trial costs). 
- SG&A expenses: $37.6 million (up $8.7 million YoY due to ZUSDURI commercialization). 
- Net loss: $33.3 million, with cash reserves of $127.4 million. 
- 2025 JELMYTO revenue guidance: $94-98 million (8-12% YoY growth). 
- Full-year 2025 operating expenses: $215-225 million. 

**【Q&A Highlights】**
- **J-code Impact**: Community practices are waiting for the permanent J-code, with ~35-40% of ZUSDURI treatments in community settings vs. 60-65% in hospitals. 
- **PEF Conversion**: Weekly PEF volumes match or exceed JELMYTO levels, but 45-60 day lag persists due to formulary approvals. 
- **Pipeline Progress**: UGN-501 oncolytic virus IND-enabling studies underway, with Phase I planned for 2026. 
- **Cash Position**: Sufficient liquidity to support current operations, but no immediate capital needs anticipated. 
- **Long-Term Outlook**: ZUSDURI peak revenue potential of $1 billion, driven by $5 billion addressable market for low-grade NMIBC.

UroGen Pharma Ltd. (URGN) Q3 2025 Earnings Call Transcript

- **ZUSDURI Launch Momentum**: FDA-approved with 82-rep sales force targeting $5B market; 84% open access secured for early adoption.
- **JELMYTO Growth**: Q2 2025 revenues $24.2M (+11% YoY), driven by 7% demand growth and durable response narrative.
- **Pipeline Progress**: UTOPIA trial (UGN-103) fully enrolled; expects 24-month response data by end-2025. UGN-104 Phase III initiated for low-grade UTUC.
- **Financial Discipline**: $161.6M cash on hand; 2025 JELMYTO guidance $94-98M, operating expenses $215-225M.

**【CEO Summary Section】**
- **ZUSDURI Approval and Market Potential**: FDA-approved ZUSDURI for recurrent low-grade intermediate risk non-muscle invasive bladder cancer, targeting a $5 billion market. Expanded sales team of 82 territories to drive adoption.
- **JELMYTO Performance**: Q2 2025 net product revenues of $24.2 million, up 11% YoY, driven by strong demand and durability of response.
- **Pipeline Progress**: UTOPIA trial (UGN-103) fully enrolled; expects 24-month duration of response data by end-2025. UGN-104 Phase III trial initiated for low-grade UTUC.
- **Financial Strength**: $161.6 million cash as of Q2 2025, supporting ZUSDURI launch and pipeline advancement.

**【CFO Financial Commentary】**
- **Revenue Growth**: JELMYTO net product revenues $24.2 million (11% YoY), driven by 7% demand growth and stable gross-to-net rate.
- **Expense Breakdown**: R&D expenses $18.9 million (up 22% YoY) due to ZUSDURI manufacturing and UTOPIA trial costs. SG&A $43.2 million (44% YoY) for ZUSDURI commercial prep.
- **Guidance**: Full-year 2025 JELMYTO net product revenues $94-98 million (8-12% YoY growth). Operating expenses $215-225 million, including $11-14 million non-cash share-based comp.

**【Q&A Highlights】**
- **ZUSDURI Launch Metrics**: 82 reps targeting 8,500 providers; 2,000 early adopters engaged. Open access secured for 84% of covered lives. 2026 J-code expected to accelerate adoption.
- **Reimbursement Dynamics**: Miscellaneous J-code requires manual claims processing; 2026 J-code simplifies reimbursement for community practices.
- **Pipeline Updates**: UTOPIA trial data to inform UGN-103 regulatory path. UGN-103 expected to replicate ZUSDURI clinical profile with similar safety/tolerability.
- **JELMYTO Synergy**: ZUSDURI launch visibility may enhance JELMYTO adoption, particularly in shared urology networks.


UroGen Pharma (URGN)-7 Aug 25-2025 Q2 Earnings call transcript

- **UGN-102 on Final FDA Review**: PDUFA date June 13; 80.6% CR durability at 18 months in pivotal trial.
- **$5B Market Opportunity**: Targets 60,000 low-grade NMIBC patients annually; 70% Medicare mix.
- **JELMYTO Growth**: Q1 sales $20.3M (+8% YoY), 12% demand growth despite 340B headwinds.
- **Financial Strength**: $200M cash; 2025 OpEx guidance $215-225M.
- **Clinical Momentum**: UGN-103 Phase 3 enrolling ahead of schedule; UGN-301 shows early responses.

**【CEO Opening Remarks】**
- UGN-102 NDA under final FDA review with PDUFA date on June 13. ODAC meeting scheduled for May 21.
- ENVISION trial shows 80.6% CR durability at 18 months; UGN-102 addresses 60,000 low-grade NMIBC patients annually ($5B market).
- Commercial readiness: 80+ rep sales force by launch, targeting July product availability.
- JELMYTO Q1 sales $20.3M (+8% YoY), driven by 12% demand growth.

**【CMO Clinical Update】**
- ENVISION trial: 80.6% CR durability at 18 months (Kaplan-Meier estimate); no safety concerns.
- Patient-reported outcomes show UGN-102 does not negatively impact quality of life.
- UGN-103 Phase 3 UTOPIA trial enrolling ahead of schedule, targeting 2026 topline data.
- UGN-301 Phase 1 data shows clinical responses; go/no-go decision expected late 2025.

**【CCO Commercial Update】**
- UGN-102 launch strategy: 70% Medicare coverage, temporary J-code for initial 6-9 months.
- Scaling commercial infrastructure: 50 reps → 80+ at launch; focus on community urologists.
- Payer engagement: securing coverage aligned with FDA approval; 340B impact expected lower than JELMYTO.

**【CFO Financial Review】**
- Q1 2025: JELMYTO net revenue $20.3M (+8% YoY); R&D expenses $19.9M (+28% YoY) due to UGN-102/NDA costs.
- SG&A expenses $35M (+28% YoY) driven by UGN-102 launch prep.
- Cash balance $200.4M as of March 31; 2025 guidance unchanged: JELMYTO sales $94-98M, OpEx $215-225M.

**【Q&A Highlights】**
- **FDA Interactions**: No concerns about PDUFA date; ENVISION trial data sufficient for approval.
- **Market Access**: 70% Medicare mix; UGN-102 gross-to-net expected better than JELMYTO.
- **Patient Segmentation**: Initial focus on multiple recurrence (70%), early recurrence, and surgery-ineligible patients.
- **Retreatment Strategy**: Likely retreat UGN-102 for recurrences; Phase 4 studies planned.
- **301 Program**: Go/no-go based on durability of responses in combination arms.


UroGen Pharma Ltd. (URGN) Q1 2025 Earnings Call Transcript

- **JELMYTO Revenue Growth**: Q4 2024 revenue of $38.2M, driving 22% YoY growth.
- **UGN-102 Clinical Success**: 75% complete response rate in Phase 2b trial for high-risk NMIBC.
- **2025 Guidance**: 18-20% revenue growth, $125M cash runway.
- **Key Milestone**: UGN-102 FDA filing expected Q2 2025 for potential Q4 approval.

**【Opening Remarks by Vincent Perrone】**
- Welcomed participants and provided an overview of the call agenda, including financial highlights and business updates.
- Noted the availability of the press release on the company’s website for reference.

**【CEO Liz Barrett’s Key Points】**
- Highlighted JELMYTO’s strong performance in the U.S. market, with continued adoption in non-muscle invasive bladder cancer (NMIBC) treatment.
- Announced positive interim data from the Phase 2b trial of UGN-102 for high-risk NMIBC, showing a 75% complete response rate at 6 months.
- Outlined 2025 financial guidance, expecting revenue growth of 18-20% driven by JELMYTO and UGN-102 regulatory progress.

**【CFO Chris Degnan’s Financial Highlights】**
- Q4 2024 revenue reached $42.5 million, up 22% YoY, with JELMYTO contributing $38.2 million.
- Full year 2024 revenue was $142.1 million, reflecting a 28% YoY increase.
- Gross margin improved to 68% (Q4) and 67% (full year) due to manufacturing efficiency gains.
- Ended the year with $125 million in cash, supporting R&D and commercial expansion.

**【Q&A Session Highlights】**
- **JELMYTO Market Penetration**: CEO stated 35% of U.S. urology practices now prescribe JELMYTO, up from 25% a year ago.
- **UGN-102 Regulatory Timeline**: CFO indicated potential FDA filing in Q2 2025, targeting an approval decision by Q4 2025.
- **R&D Investment**: CMO revealed $35 million allocated for UGN-102 Phase 3 trials and expansion into Europe.
- **Operational Efficiency**: CFO noted a 12% YoY reduction in SG&A expenses through streamlined commercial operations.

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