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- **Revenue Growth**: HEPZATO volume up 150% YoY, CHOPAT trial data driving 76% ORR
- **Site Expansion**: 25 active sites → 60+ by 2026
- **Financial Strength**: $89M cash, 87% gross margin
- **Competitive Risk**: 109-patient Thomas Jefferson trial competition
- **Pipeline**: CRC trial interim data Q2 2027, breast cancer trial enrollment Q1 2026

**【Management Opening Remarks】**
- Gerard Michel highlighted Q3 2025 revenue growth of $19.3 million for HEPZATO, up 93% YoY, driven by 150% increase in treatment volume.
- Noted 25 REMS-certified treatment sites (up from 24 in Q2) and 11% pricing reduction due to NDRA participation.
- CHOPIN trial results showed 76.3% ORR, 54.7% 1-year PFS, and 23.1-month OS in combination therapy arm.

**【CEO Commentary】**
- Projected 2025 HEPZATO volume growth of nearly 150% vs 2024, with 40-60 sites targeted by end-2026.
- CHOPIN trial data expected to reduce physician hesitancy for extrahepatic mets patients.
- Faced 109-patient Thomas Jefferson single-center trial competition but maintained 4.8M quarterly cash flow.

**【CFO Financial Commentary】**
- Q3 2025: 
  - Revenue: $20.6M (HEPZATO + CHEMOSAT)
  - R&D: $8.0M (vs $3.9M prior year)
  - SG&A: $10.3M (vs $7.0M prior year)
  - Net Income: $0.8M (vs $1.9M prior year)
  - EBITDA: $5.3M (vs $1.0M prior year)
- Gross margin 87% (vs 85% prior year), targeting 85-87% in 2026.
- $89M cash balance with no debt.

**【Q&A Highlights】**
1. **Site Activation**: 
   - Q4 2025: 26-28 sites (current 25)
   - 2026: 40-60 sites via 9-region sales force expansion
2. **CHOPIN Impact**: 
   - 2026: Expected increased utilization as data disseminates
   - 2027+: Potential protocol adoption
3. **NDRA Participation**: 
   - ~50% of sites participate, 11% pricing impact
4. **R&D Allocation**: 
   - CRC trial interim data Q2 2027, primary readout Q2 2028
   - Breast cancer trial enrollment Q1 2026, readout 2029+

Delcath Systems, Inc. (DCTH) Q3 2025 Earnings Call Transcript

- **Revenue Growth**: Q2 2025 revenue of $24.2 million (+20% Q/Q), driven by U.S. HEPZATO sales.
- **Site Expansion**: 20 operational U.S. sites, targeting 25-28 by year-end (down from 30 prior guidance).
- **Financial Health**: $81 million cash, positive cash flow, and 86% gross margin.
- **NDRA Impact**: 10-15% Q3 revenue per kit reduction due to 340B discounts, but long-term market access benefits.
- **R&D Intensification**: Q2 R&D up 37% Q/Q, full-year spending up 140% vs. 2024.
- **Clinical Pipeline**: Metastatic colorectal and breast cancer trials begin dosing in Q3 2025, with interim data in 2027.

**【Management Opening Remarks】**
- Delcath reported Q2 2025 revenue of $24.2 million, a 20% increase from Q1 2025, driven by U.S. HEPZATO sales of $22.5 million and European CHEMOSAT sales of $1.7 million.
- The company achieved $7.3 million in positive cash flow from operations, net income of $2.7 million, and adjusted EBITDA of $9.8 million.
- Cash and investments totaled $81 million, with no debt outstanding.

**【CEO Summary Section】**
- 20 operational U.S. treating sites, with 10 additional centers in training and approval process.
- Projected 25-28 operational sites by end of 2025 (down from prior 30 target) due to complexities of activating large academic centers.
- Average treatments per center: ~2/month, expected to remain stable through 2025.
- Full-year revenue guidance adjusted to $93-96 million (down from prior $100 million+ range) due to slower site activations.
- Gross margin forecast remains 83-85%, with 175%+ HEPZATO treatment volume growth vs. 2024.
- Entered National Drug Rebate Agreement (NDRA), with 50% of HEPZATO kits sold at 340B discounted prices, leading to 10-15% Q3 revenue per kit reduction.
- Expanded U.S. sales force to 6 regions, each staffed with liver-directed therapy, oncology, and clinical specialists.
- Phase II trials for metastatic colorectal and breast cancer expected to begin dosing in Q3 2025, with interim data in 2027 and primary results in 2028-2029.

**【CFO Financial Commentary】**
- Q2 2025 revenue: $22.5 million (HEPZATO) + $1.7 million (CHEMOSAT) = $24.2 million (20% Q/Q growth).
- Gross margin: 86% (vs. 80% in Q2 2024).
- R&D expenses: $6.9 million (vs. $3.4 million in Q2 2024).
- SG&A expenses: $11.4 million (vs. $6.8 million in Q2 2024).
- Net income: $2.7 million (vs. -$13.7 million in Q2 2024).
- Adjusted EBITDA: $9.8 million (vs. -$0.8 million in Q2 2024).
- Cash flow: $7.3 million (vs. $2.2 million in Q1 2025).

**【Q&A Key Highlights】**
- **NDRA Impact**: 50% of HEPZATO kits sold at 340B prices, leading to 10-15% Q3 revenue per kit reduction. Long-term benefit from increased market access may offset short-term margin pressure.
- **Site Activation Challenges**: Perfusion service credentialing and workflow integration are key bottlenecks. 1-1.5 new sites/month expected through 2025.
- **R&D Spending**: Q2 R&D up 37% Q/Q, with further increases expected in Q3 (40%) and Q4 (25-30%). Full-year R&D up ~140% vs. 2024.
- **CHOPIN Trial**: ESMO 2025 presentation will include 1-year PFS, safety, and secondary efficacy data for CHEMOSAT + ipi/nivo vs. CHEMOSAT alone.
- **CHEMOSAT Growth**: Long-term benefit from colorectal and breast cancer trials may expand European oncologist engagement, but near-term impact limited.


Delcath Systems, Inc. (DCTH) Q2 2025 Earnings Call Transcript

- **Revenue Growth**: Q1 2025 revenue up 800% YoY to $19.8 million, driven by 19 U.S. centers.
- **Clinical Expansion**: 30-center target on track; Phase II trials for colorectal and breast cancer to start late 2025.
- **Financial Strength**: $59 million cash, 86% gross margin, and $7.6 million adjusted EBITDA.
- **Market Potential**: 7x larger addressable market for liver-dominant cancers vs. uveal melanoma.
- **Operational Efficiency**: ~2 treatments/month per center, stable despite new center additions.

**【CEO Business Overview】**
- Q1 2025 revenue reached $19.8 million, driven by $18 million from HEPZATO in the U.S. and $1.8 million from CHEMOSAT in Europe.
- 19 active treatment centers in the U.S., with 10 more centers in the pipeline, targeting 30 centers by year-end.
- Positive financial metrics: $2.2 million operating cash flow, $1.1 million net income, and $7.6 million adjusted EBITDA.
- Clinical expansion: Phase II trials for metastatic colorectal and breast cancer (HPS endpoints) expected to start late 2025, with data readouts in 2027-2029.
- Average treatments per center: ~2/month, stable due to new center ramp-up and conservative patient adoption.

**【CFO Financial Highlights】**
- Gross margin improved to 86% (vs. 71% YoY), reflecting scale and cost efficiency.
- R&D expenses: $5 million (vs. $3.7 million YoY) for clinical trial setup.
- SG&A expenses: $11.3 million (vs. $8.8 million YoY) for commercial expansion.
- Cash reserves: $59 million with no debt, supporting 2025 R&D and center activation.

**【Q&A Key Takeaways】**
- **Center Activation**: Q2 expects 2-3 new centers, maintaining 30-center target despite hospital delays.
- **European Strategy**: Focus on clinical data generation; U.K. reimbursement submission pending.
- **Trial Timeline**: Colorectal trial enrollment Q3/Q4 2025, breast cancer follow-up; 7,000+ addressable patients per indication.
- **Revenue Model**: ~$13 million breakeven threshold; no plans to license complementary therapies.
- **Patient Access**: HEPZATO KIT Access 360 reduces out-of-pocket costs, supporting adoption.


Delcath Systems, Inc. (DCTH) Q1 2025 Earnings Call Transcript

- **Revenue Milestone**: 2024 U.S. HEPZATO revenue of $32.3M, driven by 14 active centers and 137% European CHEMOSAT growth.
- **Financial Health**: $53.2M cash, $4.6M Q4 EBITDA, and $1M cash burn, signaling near-term cash flow breakeven.
- **Pipeline Momentum**: 2025 Phase 2 trials for CRC and breast cancer, with 6,000-10,000 addressable CRC patients annually.
- **Expansion Ambition**: Targeting 30 U.S. centers by year-end, supported by 6-region commercial team expansion.
- **R&D Investment**: $35-40M allocated for new indications, balancing growth with financial discipline.


**【CEO Summary Section】**
- **2024 Revenue Growth**: U.S. HEPZATO revenue reached $32.3 million, with Q4 contributing $13.7 million from 14 active centers. European CHEMOSAT sales grew 137% year-over-year.
- **Treatment Center Expansion**: 16 active U.S. centers as of early 2025, targeting 30 by year-end. New centers include Duke, Mayo Jacksonville, and MGH.
- **Financial Milestones**: $53.2 million in cash and investments, $4.6 million Q4 positive adjusted EBITDA, and $1 million cash burn in Q4.
- **Pipeline Progress**: Phase 2 trials for metastatic CRC and breast cancer expected to begin in 2025. Gross margin improved to 86% in Q4.

**【CFO Financial Commentary】**
- **Revenue Breakdown**: Q4 2024: $13.7M (HEPZATO) + $1.4M (CHEMOSAT); Full Year: $32.3M (HEPZATO) + $4.9M (CHEMOSAT).
- **Expense Management**: R&D down 24% YoY to $13.9M; SG&A up 34% YoY to $29.6M due to commercial expansion.
- **Profitability**: Net loss narrowed to $26.4M (vs. $47.7M in 2023); Non-GAAP adjusted EBITDA improved to -$2.5M (vs. -$30M in 2023).
- **Liquidity**: $53.2M cash on hand, no debt, and $41M from warrant exercises in 2024.

**【Q&A Key Highlights】**
- **Sales Force Expansion**: Transitioning from 4 to 6 regions, fully staffed by mid-2025. Expected SG&A increase of 30-40% YoY.
- **R&D Priorities**: $35-40M R&D spend in 2025 for CRC and breast cancer trials. No device modifications needed for new indications.
- **European Strategy**: Focus on clinical data generation in France, Italy, Spain. Modest revenue growth expected, prioritizing strategic value over scale.
- **Treatment Patterns**: Average 4.1 treatments per patient in U.S., consistent with FOCUS trial results. Referral network expansion targeting community oncologists.


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