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 Insights - Axogen, Inc. has raised its full-year revenue guidance to at least 17% growth, equating to approximately $219 million [5] - The company reported strong second-quarter results, with revenue of $56.7 million, an 18.3% increase compared to the same quarter in 2024 [6][7] - The CEO expressed confidence in the company's strategic plan and market development objectives, emphasizing the goal of making peripheral nerve function restoration a standard of care [3] Financial Performance - Second-quarter revenue was $56.7 million, reflecting an 18.3% increase year-over-year and a 16.7% increase from the first quarter of 2025 [6][7] - Gross margin for the second quarter was 74.2%, up from 73.8% in the same quarter of 2024 [6] - Net income for the quarter was $0.6 million, or $0.01 per share, compared to a net loss of $1.9 million, or $0.04 per share, in the second quarter of 2024 [6][7] - Adjusted net income for the quarter was $5.7 million, or $0.12 per share, compared to $2.0 million, or $0.05 per share, for the same period in 2024 [6][7] Business Highlights - The company achieved broad-based revenue growth across all markets, including Extremities, Oral Maxillofacial & Head and Neck, and Breast [7] - Coverage and reimbursement for nerve repair using synthetic conduits or allografts expanded by an estimated 10 million new covered lives in 2025, totaling approximately 17 million new lives covered [7] - The FDA accepted the filing of the Biologics License Application for Avance® Nerve Graft, with a goal date for approval set for September 5, 2025 [7] Cash Position - As of June 30, 2025, the balance of cash and cash equivalents, restricted cash, and investments was $35.9 million, down from $39.5 million at the end of 2024 [6] - The company expects to be net cash flow positive for the full year [5]

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].

Core Insights - Axogen, Inc. has appointed Lindsey Hartley, CPA, as the new Chief Financial Officer, effective May 12, 2025, succeeding Nir Naor, who will remain in an advisory role until July 1, 2025 [1][2] Company Overview - Axogen, Inc. is a leader in developing and marketing surgical solutions for peripheral nerve injuries, focusing on restoring health and improving quality of life through innovative technologies [3][4] - The company offers a range of products including Avance Nerve Graft, Axoguard Nerve Connector, and Axoguard Nerve Protector, which are designed to aid in the repair and protection of peripheral nerves [4][5] Leadership Transition - Michael Dale, President and CEO of Axogen, expressed gratitude for Nir Naor's contributions, highlighting improvements in operating expense and cash flow management during his tenure [2] - Lindsey Hartley brings over 19 years of financial leadership experience, having previously served as Vice President, Corporate Controller at Axogen, where she improved financial reporting processes and reduced month-end close time by 40% [2][3] Strategic Focus - Lindsey Hartley aims to emphasize financial discipline and strategic growth initiatives to support Axogen's mission of restoring nerve function and transforming patients' lives [3]