AxoGen’s approach, which management referred to as the “Axogen algorithm,” is built around the Avance Nerve Graft, complemented by AxoGuard and Avive products intended to support healing and protect repairs. Dale described Avance as donated human tissue processed to be “immunologically benign” while remaining bioactive, retaining human laminin to support axon regeneration and Schwann cell infiltration.He framed peripheral nerve dysfunction as arising from injuries such as transection, crushing, or stretchin ...

ALACHUA, Fla. and TAMPA, Fla., Jan. 12, 2026 (GLOBE NEWSWIRE) -- Axogen, Inc. (NASDAQ: AXGN), a global leader in developing and marketing innovative surgical solutions for the restoration of peripheral nerve function, today announced preliminary unaudited fourth quarter and full-year 2025 key financials. Preliminary Fourth Quarter and Year-End Key Business Highlights Fourth quarter 2025 revenue is expected to be approximately $59.9 million, which represents a 21.3% increase over the fourth quarter of 2024, ...

Financial Data and Key Metrics Changes - Revenue for Q2 2025 was $56.7 million, reflecting an 18.3% increase compared to Q2 2024 and a 16.7% sequential increase over Q1 2025 [5][18] - Gross profit for the quarter was $42 million, up from $35.3 million in Q2 2024, representing a gross margin of 74.2%, an increase from 73.8% in the same period last year [18][19] - Net income for the quarter was $600,000 or $0.01 per share, compared to a net loss of $1.9 million or $0.04 per share in Q2 2024 [21] Business Line Data and Key Metrics Changes - Sales growth was driven by double-digit growth across all nerve repair target markets, including extremities, oral, maxillofacial, head and neck, and breast [5][6] - The advanced nerve graft remains the primary growth driver, complemented by other nerve repair products [6] - High potential accounts contributed approximately 70% of revenue growth in the first half of 2025, with 641 active high potential accounts, an increase of 19 accounts or 3% compared to 2024 [8][9] Market Data and Key Metrics Changes - Coverage for nerve repair using synthetic conduits or allografts has increased to over 55% among commercial payers, with an estimated 17 million additional lives covered year to date [13] - The company expects to achieve nearly complete commercial coverage over the strategic plan period, with significant progress noted in the healthcare climate in the U.S. [40][41] Company Strategy and Development Direction - The company is focused on executing its strategic plan, investing in innovation, optimizing resource allocation, and driving towards profitability [23] - The Biologics License Application (BLA) for the advanced nerve graft is on track for anticipated approval in September 2025, which will secure 12 years of market exclusivity [16][17] - The company aims to double its breast sales force by the end of 2025, targeting 22 representatives and two regional sales directors [10] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the ability to grow the business consistent with previously provided guidance, despite potential deceleration in the second half of the year due to BLA logistics [32] - The leadership team believes that the treatment penetration of nerve care is still low, indicating significant growth opportunities [28][29] - The company remains focused on maintaining operational efficiency and leveraging improvements post-BLA approval [56] Other Important Information - Operating expenses increased to $40.3 million, but as a percentage of revenue, they decreased by 3.5%, indicating improved operating leverage [20] - The company expects to be net cash flow positive for the year and to self-fund its strategic plan with growing cash from operations [22][23] Q&A Session Summary Question: Insights on business progress in the first half of the year - Management noted that growth is driven by effective sales management and strategies to increase adoption of nerve care [26][27] Question: Dynamics for the second half of the year - Management indicated a conservative approach until the BLA process is finalized, which may affect logistics and product supply [32] Question: Sales rep productivity and seasonal trends - Management expects historical seasonality to continue, with specific increases in procedures during favorable weather and year-end [36] Question: Coverage expansion and its drivers - Management highlighted the importance of updated evidence and clinician advocacy in driving coverage expansion [40][41] Question: BLA process and interactions with the FDA - Management described the interactions as professional and cooperative, with ongoing discussions about quality systems and labeling [46][82] Question: Manufacturing improvements post-BLA approval - Management outlined plans for continuous improvement processes and electronic systems to enhance operational efficiency [56] Question: Gross margin changes and future write-offs - Management indicated that while there may be future write-offs, they do not foresee significant issues at the moment [92]