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- **Revenue Milestones**: Q3 2025 HIFU revenue up 49% YoY to €6.7M; U.S. procedures grow 15% YoY. 8 Focal One placements (167% YoY growth).
- **Clinical Validation**: HIFU non-inferior to radiation therapy in 10-year study; endometriosis Phase III RCT shows sustained symptom improvement.
- **Financial Strength**: Gross margin 43% (vs. 39.4% YoY); €11M EIB funding supports growth. 2025 guidance reaffirmed at €58-62M.
- **Strategic Wins**: 21/35 SUO programs adopt Focal One; WCET 2025 Industry Award for innovation. BPH U.S. trial underway.

**【CEO Summary Section】**
- **Record Revenue Growth**: Q3 2025 total revenue of €13.9M, with HIFU revenue up 49% YoY to €6.7M. U.S. Focal One procedures grew 15% YoY, returning to double-digit growth.
- **Clinical Adoption Expansion**: 8 Focal One placements (6 capital sales, 2 leases), up 167% YoY. Now integrated into 21/35 SUO-approved fellowship programs, training future urologists.
- **Reimbursement Progress**: Medicare Advantage coverage driving hospital economics; CMS rules reinforce HIFU's Medicare pathway.
- **Clinical Evidence Strength**: Peer-reviewed study shows HIFU non-inferior to radiation therapy for 10-year oncological outcomes. Endometriosis Phase III RCT shows sustained symptom improvement, with 85% sham patients opting for HIFU post-unblinding.
- **New Indications**: BPH U.S. clinical study IRB approved at Mount Sinai; European endometriosis limited launch underway. Focal One i awarded 2025 WCET Industry Award for innovation.

**【CFO Financial Commentary】**
- **Gross Margin Expansion**: 43% Q3 2025 vs. 39.4% YoY, driven by high-margin HIFU business. 9M 2025 gross margin 42.5% vs. 39.9% YoY.
- **Operational Efficiency**: Operating loss €4.9M (down €1M YoY). Cash €10.6M after EIB €11M tranche receipt. Tariff impact forecasted at €900K annually.
- **Balance Sheet Health**: Inventory optimized to €13.8M. New ultrasound scanner supplier to reduce costs in 2026.
- **Guidance Reaffirmed**: 2025 core HIFU revenue growth 26-34%, non-core ESWL/distribution down 25-30%.

**【Q&A Highlights】**
- **EIB Proceeds Usage**: Funds allocated to product development, clinical trials (e.g., BPH, endometriosis), and commercial growth. No short-term dilution to equity.
- **Procedure Coverage Mix**: Medicare, Medicare Advantage, and commercial payers. Medicare Advantage expansion driving growth.
- **Q4 Outlook**: Maintain 2025 guidance of €58-62M revenue. No quarterly guidance, but confident in achieving annual targets.

EDAP TMS S.A. (EDAP) Q3 2025 Earnings Call Transcript

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EDAP

EDAP fundamentals

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