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- **Revenue Surge**: Q3 2025 revenue up 23.5% YoY to $60.1 million, driven by Avance Nerve Graft adoption across all target markets.
- **BLA Milestone**: FDA extended BLA approval to December 5, 2025, with 12 years of exclusivity post-approval.
- **Coverage Expansion**: 64% of commercial payers now cover nerve repair, up from 55% last quarter.
- **Financial Strength**: Adjusted EBITDA $9.2 million (15.4% margin), cash balance $39.8 million.
- **Strategic Momentum**: Met hiring goals for breast and OMF, trained 62 breast surgeon pairs (75 target), and secured 10 new clinical publications.

**【CEO Summary Section】**
- **Revenue Growth**: Q3 2025 revenue reached $60.1 million, up 23.5% YoY, driven by Avance Nerve Graft adoption across extremities, oral maxillofacial (OMF), head and neck, and breast markets.
- **Case Stock Program Impact**: Discontinuation of the case stock sales program added $1.6 million to Q3 revenue as customers transitioned to direct sales. High potential accounts contributed 64% of growth, though case stock effects reduced this by 4%.
- **Strategic Initiatives**: Met hiring goals for breast (22 specialists) and OMF (4 market managers). Surgeon training on track: 62 breast surgeon pairs trained (75 target), 97 extremities surgeons trained (105 target).
- **Clinical & Regulatory Progress**: 10 new peer-reviewed publications, bringing total to 339. FDA extended BLA approval to December 5, 2025, with 12 years of exclusivity post-approval. Coverage expanded to 64% of commercial payers.

**【CFO Financial Commentary】**
- **Financial Performance**: Gross profit $46 million (76.6% margin), up from 74.9% YoY. Adjusted EBITDA $9.2 million (15.4% margin). Cash balance $39.8 million, up $3.9 million QoQ.
- **Guidance Update**: Raised 2025 revenue guidance to at least 19% growth ($222.8 million+). Gross margin expected 73-75%, with BLA-related costs impacting margin by ~1%.

**【Q&A Highlights】**
- **BLA Timeline**: FDA interactions positive; BLA approval expected by December 5, 2025. No immediate impact from government shutdown.
- **Coverage Expansion**: 1.1 million new covered lives in Q3, total 18.1 million year-to-date. Engaging 3 national payers to remove investigational labels.
- **Prostate Market**: Completed 100 clinical cases by year-end; outcomes to inform 2026 strategy. Level 1 studies planned for breast and other markets.
- **International Strategy**: Post-BLA, evaluate opportunities in Europe and Asia-Pacific.


Axogen, Inc. (AXGN) 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

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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

AXGN

AXGN fundamentals

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