- **EscharEx Peak Sales Estimate**: Updated to $831M, driven by HEOR benefits and 50% premium pricing strategy.
- **NexoBrid Growth**: 38% YoY revenue growth, 6x manufacturing capacity expansion on track for 2025. BARDA contract resumption expected post-shutdown.
- **Financial Resilience**: $60M cash position supports strategic initiatives, 9M gross margin 19.7%.

**【CEO Summary Section】**
- **EscharEx VLU Trial Progress**: Enrollment in the Phase III trial for venous leg ulcers (VLU) is on track with 216 patients across 40 U.S. and EU sites. The trial aims to assess complete debridement and wound closure, with a prespecified interim analysis at 65% enrollment. Medicare's reduced reimbursement for skin substitutes highlights EscharEx's potential in the enzymatic debridement market ($370M annually). Updated U.S. peak sales estimate is $831M, driven by HEOR benefits and a 50% premium over legacy product pricing.
- **NexoBrid Manufacturing Expansion**: New facility increases production capacity by 6x, with full operational readiness by year-end 2025. Vericel reports 38% YoY revenue growth, and NexoBrid is approved in 45 countries. BARDA contract progress paused due to U.S. government shutdown, but expected resumption post-shutdown.
- **Financial Strength**: $30M equity financing strengthens balance sheet, supporting strategic initiatives.

**【CFO Financial Commentary】**
- **Q3 2025 Results**: Revenue $5.4M (23% YoY), gross profit $0.9M (16.5% margin). R&D expenses $3.5M (+40% YoY) due to EscharEx trial. Operating loss $6.5M, net loss $2.7M. 9M 2025 cash position $60M, up from $44M at year-end 2024.
- **Key Metrics**: Adjusted EBITDA loss $5.4M (Q3) and $13.9M (9M). Gross margin improvement to 19.7% for 9M, driven by favorable revenue mix.

**【Q&A Highlights】**
- **EscharEx Pricing Strategy**: Conservative $831M peak sales estimate reflects 15-50% premium over legacy product. DFU trial expected H2 2026. CPT code progress and HEOR benefits key to adoption.
- **BARDA Contract Update**: Vericel awaits contract award post-shutdown. NexoBrid's temporary CPT code supports 60+ burn centers, with permanent code sought for 2027. Manufacturing expansion to meet global demand.

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