Axogen Inc. reported robust second-quarter 2025 financial results and raised its full-year revenue growth target as the company approaches a critical regulatory milestone for its flagship peripheral nerve repair product. The company achieved Q2 sales of $56.7 million, representing 18.3% growth compared to the same period in 2024, according to CEO Michael D. Dale.
Regulatory Milestone Drives Optimism
The FDA accepted Axogen's Biologics License Application (BLA) for Avance Nerve Graft on November 1, 2024, and assigned a Prescription Drug User Fee Act goal date of September 5, 2025. During the second quarter, the company completed several critical regulatory milestones supporting the anticipated approval, including the late-cycle meeting with the FDA, pre-licensing inspection, and sponsor inspection under the FDA's Bioresearch Monitoring program.
Raised Financial Guidance
Based on the strong performance and regulatory progress, Axogen has increased its 2025 revenue guidance to at least 17% growth, representing $219 million for the full year. The company continues to expect gross margins in the range of 73% to 75%, though this range reflects one-time costs primarily related to the anticipated Avance Nerve Graft BLA approval, which is expected to negatively impact gross margin by approximately 1%.
Despite these temporary margin impacts, Axogen reiterated its expectation to achieve net cash flow positive status for the full year, demonstrating the underlying strength of its business model.
Comprehensive Product Portfolio
Axogen's product portfolio addresses various aspects of peripheral nerve repair and regeneration. The company's flagship product, Avance Nerve Graft, is a biologically active off-the-shelf processed human nerve allograft designed for bridging severed peripheral nerves without the complications associated with a second surgical site.
The portfolio also includes Axoguard Nerve Connector, a porcine submucosa extracellular matrix coaptation aid for tensionless repair of severed peripheral nerves, and Axoguard Nerve Protector, used to wrap and protect damaged peripheral nerves while minimizing soft tissue attachments. Additional products include Axoguard HA+ Nerve Protector, featuring a proprietary hyaluronate-alginate gel coating, Axoguard Nerve Cap for nerve end protection, and Avive+ Soft Tissue Matrix, a multi-layer amniotic membrane allograft.
Market Position and Clinical Impact
As the leading company focused specifically on peripheral nerve regeneration and repair, Axogen addresses a significant medical need. Physical damage to peripheral nerves or the inability to properly reconnect them can result in loss of muscle or organ function, loss of sensory feeling, or initiation of pain. The company's products are available in the United States, Canada, Germany, the United Kingdom, Spain, South Korea, and several other countries.
The anticipated BLA approval for Avance Nerve Graft represents a significant regulatory milestone that could expand the product's clinical applications and market access, supporting the company's optimistic revenue projections for 2025.
