ALACHUA, Fla. and TAMPA, Fla., Oct. 15, 2025 (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 that it will report 2025 third quarter financial results on Wednesday, October 29, 2025, before the market opens. Axogen management will host an investment-community conference call and webcast at 8 a.m. ET following the release. Investors interested in participating in the con ...

Company Overview - Axogen, Inc. (NASDAQ: AXGN) is a leader in developing and marketing surgical solutions aimed at restoring peripheral nerve function [3] - The company focuses on the science, development, and commercialization of technologies for peripheral nerve regeneration and repair [3] - Axogen's mission is to help restore peripheral nerve function and improve the quality of life for patients with nerve damage through innovative and clinically proven solutions [3] Product Portfolio - Axogen's product offerings include: - **Avance Nerve Graft**: A processed human nerve allograft for bridging severed peripheral nerves [4] - **Axoguard Nerve Connector**: An extracellular matrix coaptation aid for tensionless repair of severed nerves [4] - **Axoguard Nerve Protector**: A product used to wrap and protect damaged nerves while minimizing soft tissue attachments [4] - **Axoguard HA+ Nerve Protector™**: A next-generation technology designed to enhance nerve gliding and provide protection for peripheral nerve injuries [4] - **Axoguard Nerve Cap**: A product to protect nerve ends and reduce the development of painful neuromas [4] - **Avive+ Soft Tissue Matrix™**: An amniotic membrane allograft used to protect and separate tissues during healing [4] - The product portfolio is available in multiple countries including the United States, Canada, Germany, the United Kingdom, Spain, and South Korea [4] Upcoming Investor Conferences - Axogen management is scheduled to participate in several investor conferences: - **Cantor Global Healthcare Conference**: Fireside chat on September 3, 2025 [1] - **Wells Fargo Healthcare Conference**: 1x1 investor meetings on September 4, 2025 [2] - **Morgan Stanley Annual Global Healthcare Conference**: 1x1 investor meetings on September 10, 2025 [2] - **Lake Street Best Ideas Growth (BIG 9) Conference**: 1x1 investor meetings on September 11, 2025 [2] - Webcast events will be accessible live and archived for 90 days on Axogen's investor page [2]

Core Insights - The FDA has extended the PDUFA goal date for Axogen's Biologics License Application for Avance Nerve Graft by three months to December 5, 2025 [1][2] - The extension is due to a Major Amendment designation, which allows additional time for the FDA to review substantial new manufacturing and facility data submitted by the company [2] - Feedback on product labeling is anticipated from the FDA in November 2025, aligning with standard PDUFA review procedures [3] Company Overview - Axogen, Inc. specializes in the science, development, and commercialization of technologies for peripheral nerve regeneration and repair [4] - The company aims to restore nerve function and improve the quality of life for patients with peripheral nerve injuries through innovative and clinically proven solutions [4] - Axogen's product portfolio includes several products designed for nerve repair, including Avance® Nerve Graft, Axoguard Nerve Connector®, and Axoguard Nerve Protector®, among others [4]

Core Viewpoint - Axogen, Inc. reported strong financial results for Q1 2025, highlighting robust revenue growth and progress towards long-term objectives, with a focus on enhancing sales productivity and commercial execution [3][5]. Financial Results - Q1 2025 revenue reached $48.6 million, marking a 17.4% increase compared to Q1 2024 [6]. - Gross margin for Q1 2025 was 71.9%, down from 78.8% in Q1 2024, attributed to increased product costs and inventory write-offs [6][7]. - The net loss for the quarter was $3.8 million, or $0.08 per share, an improvement from a net loss of $6.6 million, or $0.15 per share, in Q1 2024 [6][20]. - Adjusted net loss for the quarter was $0.9 million, or $0.02 per share, compared to $2.7 million, or $0.06 per share, in Q1 2024 [6][20]. - Adjusted EBITDA was $2.9 million for the quarter, up from $1.0 million in Q1 2024 [6][20]. Business Highlights - Revenue growth was broad-based across the product portfolio, with double-digit growth in all markets, including Extremities, Oral Maxillofacial & Head and Neck, and Breast [7]. - The FDA accepted the filing of the Biologics License Application (BLA) for Avance® Nerve Graft, with a goal date for approval set for September 5, 2025 [7]. - Regulatory milestones completed in Q1 2025 included a mid-cycle meeting with the FDA and clinical trial site inspections [7]. - Lindsey Hartley, CPA, was appointed as the new Chief Financial Officer effective May 12, 2025, succeeding Nir Naor [7]. 2025 Financial Guidance - The company maintains its full-year revenue growth guidance in the range of 15% to 17% and expects gross margin to be between 73% and 75% [5]. - The company anticipates being net cash flow positive for the full year [5].