Axogen Inc. reported preliminary unaudited results for the fourth quarter and full year ended December 31 2025, showing revenue of $49.4 million for Q4 and $187.3 million for the year, up 21.3 % and 20.2 % year‑over‑year respectively. The growth was driven by robust demand for its Avance nerve allograft, which now enjoys FDA approval as a biologic, and by increased adoption of the Resensation procedure across the peripheral nerve repair market.
Gross margin for Q4 2025 was 76.1 %, a slight improvement over the 75.8 % margin reported for the full year 2024. The margin expansion reflects a favorable product mix shift toward higher‑margin Avance sales and effective cost control, offsetting a $1.9 million one‑time charge related to the BLA approval. Net loss narrowed to $10.0 million, or $0.23 per share, compared with a $21.7 million loss ($0.51 per share) in 2023, underscoring stronger profitability as the company scales its commercial operations.
Management highlighted that the December 3 2025 BLA approval removes a major regulatory hurdle, potentially granting 12 years of market exclusivity and positioning Avance as the only implantable biologic for peripheral nerve repair. CEO Michael Dale noted that the milestone “validates our strategic plan and market development strategies,” and that commercial availability is expected in early Q2 2026. The approval is expected to improve insurance coverage and broaden the addressable market, reinforcing Axogen’s competitive advantage.
Guidance for 2026 remains unchanged, with management reaffirming confidence in continued revenue growth driven by expanding market share and the launch of Avance. The company emphasized ongoing investments in product development and commercial expansion, while maintaining disciplined cost management to support margin targets. Analysts view the earnings beat and regulatory milestone as positive signals of execution strength and future upside potential.
The results and BLA approval together suggest a solid trajectory for Axogen, with the company positioned to capture a larger share of the multi‑billion‑dollar peripheral nerve repair market while maintaining healthy margins and improving profitability.
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