Axogen Reports Q4 2025 Results, FDA Approval Drives 2026 Growth Outlook

Axogen reported fourth quarter 2025 revenue of $59.9 million, a 21.3% increase compared to the fourth quarter 2024 revenue, and full-year 2025 revenue of $225.2 million, a 20.2% increase compared to 2024 revenue of $187.3 million. The company swung to a net loss of $13.2 million, or $0.28 per share, in the fourth quarter of 2025, compared to net income of $0.5 million, or $0.01 per share for the fourth quarter of 2024.

Fourth quarter 2025 gross margin was 74.1%, down from 76.1% for the fourth quarter of 2024, and down from 76.6% in the third quarter of 2025. Gross margin reflects one-time costs of approximately $1.9 million, or 3% for the fourth quarter of 2025, related to the FDA Biologics License Application approval of Avance, of which 67% are non-cash and relate to the vesting of certain stock compensation awards containing FDA BLA approval of Avance milestones. Full-year 2025 gross margin was 74.3%, compared to 75.8% in 2024.

On December 3, 2025, the FDA approved the BLA for Avance (acellular nerve allograft-arwx), granting 12 years of market exclusivity and establishing it as the standard of care in nerve repair. This milestone enhances reimbursement dynamics and procedural adoption. Effective January 1, 2026, CMS created a new Level 3 Nerve Procedure Code, increasing Avance facility reimbursement 40% year-over-year to $8,965 for hospital outpatient and 35% to $6,157 for ASC-based procedures.

Fourth quarter and full-year 2025 revenue growth was broad-based, including double-digit growth in all markets, which includes Extremities, Oral Maxillofacial & Head and Neck, and Breast. The company expanded coverage and reimbursement for peripheral nerve repair using synthetic conduits and allografts, increasing the total number of newly covered lives in 2025 to approximately 19.8 million and raising commercial payer coverage to more than 65%.

On January 23, 2026, Axogen closed an upsized public offering with the sale of 4.6 million shares of common stock, yielding net proceeds of $133.3 million. From these net proceeds, $69.7 million were used to fully repay and terminate the Oberland loan facility on January 28, 2026. Remaining funds will be available for working capital, capital expenditures, and other general corporate purposes. As of December 31, 2025, cash and cash equivalents, restricted cash, and investments was $45.5 million, as compared to $39.5 million as of December 31, 2024, an increase of $6.0 million.

The company guided 2026 full-year revenue growth of at least 18%, or $265.7 million minimum, with gross margin targeting 74–76% despite near-term product cost pressures from biologic manufacturing. The company expects to be free cash flow positive for the full-year 2026, with operating leverage improvements excluding stock-based compensation. Strategic priorities included expanding commercial infrastructure, with 10–12 sales reps added in 2025 and plans to grow the team further in 2026, including scaling the Breast team to 30 and Extremities to 130 in 2026.

Adjusted net income for the fourth quarter of 2025 and 2024 were both $3.5 million, or $0.07 per share. Adjusted EBITDA was $6.5 million for the fourth quarter 2025, compared to $6.7 million for the fourth quarter of 2024. Adjusted net income was $14.4 million for the full-year 2025, or $0.29 per share, compared to $5.9 million for the full-year, or $0.13 per share for 2024. Adjusted EBITDA was $27.9 million for the full-year 2025, compared to $19.8 million for 2024.

Additionally, Axogen advanced clinical trials in prostate procedures, completing over 100 surgeries across 10 sites, signaling progress in diversifying its market footprint. Innovation focused on nerve repair algorithms, with clinical trials in breast and prostate expected to advance in 2026.