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- **U.S. Launch Success**: 15 implants completed in first 7 weeks post-FDA approval, exceeding internal expectations.
- **Reimbursement Breakthrough**: 100% prior authorization approval rate, 35 VAC approvals secured.
- **Financial Strength**: EUR 26 million capital raise provides 18-month cash runway.
- **Gross Margin Path**: 80%+ achievable with Genio 2.2 launch in 2027.
- **Patient Impact**: 50-54 year-old patients driving early adoption, no CCC contraindication.

**【CEO Summary Section】**
- **U.S. Launch Momentum**: 15 implants completed across 9 accounts by end of October 2025, generating EUR 231,000 in revenue.
- **Surgeon Training Progress**: 111 surgeons trained on Genio, with 125 targeted accounts activated out of 400 high-volume sites.
- **Reimbursement Milestones**: 35 VAC approvals and 21 prior authorization submissions approved at 100% success rate.
- **Commercial Expansion**: 26 million EUR raised through private placement and convertible bonds, providing cash runway into Q1 2027.

**【CFO Financial Commentary】**
- **Revenue Growth**: Q3 2025 revenue EUR 2 million (56% YoY growth), driven by U.S. launch and international expansion.
- **Financial Health**: Operating loss EUR 24.4 million (76% YoY increase) due to commercialization investments.
- **Gross Margin**: 60.5% (down 1.5% YoY) reflecting early-stage launch costs.
- **Q4 Guidance**: EUR 3.4-3.6 million revenue, with U.S. implants expected to accelerate post-VAC approvals.

**【Q&A Key Highlights】**
- **Implant Cadence**: 15 implants in September, ramping to 26 million EUR in Q4 2025.
- **Reimbursement Clarity**: CPT Code 64568 fully recognized by Medicare and 10 private payers.
- **Sales Force Scaling**: 85-person U.S. sales team targeting 400 high-volume implant sites by Q4 2026.
- **Gross Margin Outlook**: 80%+ achievable with Genio 2.2 launch in 2027.
- **Patient Demographics**: 50-54 year-old average age, no CCC contraindication in U.S. label.

Nyxoah SA (NYXH) Q3 2025 Earnings Call Transcript

Revenue

Sales and Services Revenue

Financing Services Revenue

Other Revenue

Cost of Revenue

Cost of Goods and Services

Cost of Financing Services

Other Cost

Gross Profit

Other Operating Income

Operating Expenses

Selling, General and Administrative Expenses

Selling and Marketing Expenses

General and Administrative Expenses

Research and Development Expenses

Loss on Bad Debts

Loss on Impairment of Other Assets

Loss on Disposal of Assets

Other Operating Expenses

Operating Income

Non-Operating Income (Loss)

Income (Loss) from Affiliates

Income (Loss) from Associates

Income (Loss) from Joint ventures

Gain (Loss) on Other Investment

Gain (Loss) on Change in Fair Value

Gain (Loss) on Foreign Currency Exchange

Other Non-Operating Income (Loss)

Net Interest Expense

Interest Expense

Interest Income

Pretax Income From Continuing Operations

Income Tax Expense

Current Income Tax

Deferred Income Tax

Income Tax Adjustments

Net Income from Continuing Operations

Income from Discontinued Operations

Other Items Before Net Income

Net Income

Net Income Attributable to Minority Interests

Net Income Attributable to Owners of the Company

Preferred Stock Dividends

Other Adjustments

Net Income Attributable to Common Stockholders

Other Comprehensive Income

Total Comprehensive Income

Total Comprehensive Income Attributable to Minority Interests

Total Comprehensive Income Attributable to Owners of the Company

Basic EPS

Basic EPS from Continuing Operations

Basic EPS from Discontinued Operations

Diluted EPS

Diluted EPS from Continuing Operations

Diluted EPS from Discontinued Operations

NYXH

NYXH fundamentals

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