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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

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