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]

Group 1 - U.S. stocks experienced mixed performance, with the Dow Jones index declining over 200 points on Monday [1] - Keurig Dr Pepper Inc. shares fell sharply by 7.8% to $32.38 following the announcement of its acquisition of JDE Peet's [1] - Valneva SE shares dropped 21% to $9.19 after the FDA suspended the license for IXCHIQ [3] Group 2 - DeFi Development Corp. saw its shares dip 18% to $16.51 after announcing a $125 million offering of 4.2 million shares at $12.50 per share [3] - Venu Holding Corporation's shares fell 13.3% to $15.56 after announcing an offering of 1.7 million shares [3] - Axogen, Inc. shares declined 10.2% to $14.60 due to an FDA Major Amendment designation delaying the Avance Nerve Graft decision to December 5, 2025 [3]

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 - Tissium has achieved a significant breakthrough in the field of tissue repair with the FDA approval of its Coaptium Connect nerve repair system and Tissium Light platform, marking the first approval of a medical device based on a new polymer platform since 2007 [1][3] About Coaptium Connect - Coaptium Connect is a non-invasive, suture-free peripheral nerve repair system that utilizes Tissium Light technology, eliminating the need for traditional microsuturing and reducing the risk of scarring and additional trauma [3][5] - The system employs bioabsorbable materials that naturally degrade in the body, minimizing postoperative complications as no secondary surgery is required for removal [5] - The system simplifies the surgical process for nerve repair, making it suitable for clinical applications and improving surgical efficiency [7] Clinical Data - A clinical study involving 12 patients with finger nerve injuries demonstrated a 100% surgical success rate, with all patients regaining full flexion and extension of the injured fingers after 12 months, achieving a motor function recovery score of 98.2±1.3% and reporting no pain [8] Executive Commentary - Tissium's co-founder and Chief Innovation Officer highlighted the product's demonstration of the polymer platform's versatility and potential, with plans for commercialization in the U.S. and development of other solutions for various surgical applications [9] Market Overview - The global incidence of peripheral nerve injuries has surpassed 2 million cases annually, with traditional suturing methods facing challenges such as high nerve mismatch rates and suboptimal functional recovery [10] - The global peripheral nerve repair market is projected to grow from approximately $242 million in 2024 to $574 million by 2031, with a compound annual growth rate (CAGR) of 13.4% from 2025 to 2031 [10] - North America is the largest market, expected to account for about 73% of the market share in 2024, driven by advanced medical infrastructure and R&D investments [10] Similar Products - Axogen's Avance Nerve Graft is a human decellularized nerve allograft used for bridging severed nerves, requiring surgical implantation and potentially involving suturing [13] - Polyganics' Neurocap is a bioabsorbable nerve conduit designed to protect severed nerve ends and prevent neuroma formation, made from synthetic polyester materials [14] - Integra LifeSciences' NeuraGen Nerve Guide is a collagen-based nerve conduit for guiding nerve regeneration, suitable for longer nerve defects and requiring surgical implantation [15] About Tissium - Tissium is a medical innovation technology company based in Paris, focused on developing and commercializing products derived from its unique synthetic, bioformable, and programmable polymer platform [16] - The company has raised over €170 million (approximately $197 million) since its founding in 2013 and currently offers seven products across three areas: non-invasive nerve repair, non-invasive hernia repair, and cardiovascular sealing [16]

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]

Financial Data and Key Metrics Changes - Full year 2024 revenue was $187.3 million, a 17.8% increase compared to 2023 [11] - Fourth quarter revenue increased to $49.4 million, up 15.1% compared to the prior year [12] - Gross profit for the fourth quarter was $37.6 million, representing a gross margin of 76.1%, up from 74.6% in the same period last year [31] - Net income for the fourth quarter was $0.4 million or $0.01 per share, compared to a net loss of $3.9 million or $0.09 per share in the fourth quarter of 2023 [33] - Adjusted fourth quarter EBITDA was $6.7 million compared to an adjusted EBITDA of $0.6 million in the prior year [33] Business Line Data and Key Metrics Changes - The extremities business, which includes traumatic and chronic nerve injuries, represents more than half of the company's business [20] - The breast neurotization market, driven by the Resensation technique, is the fastest-growing business for the company [22] - The oral, maxillofacial, and head and neck business represents a large market opportunity with high procedural concentration in about 900 hospitals [24] Market Data and Key Metrics Changes - The total addressable market (TAM) for peripheral nerve repair is estimated at $5 billion, which is significantly higher than previous estimates [17] - The company aims for a compound annual growth rate (CAGR) of 15% to 20% over the planning period [18] Company Strategy and Development Direction - The company has established three near-term priorities: complete the submission of the BLA application, meet revenue guidance, and develop a new strategic plan [7][8] - The strategic plan focuses on expanding into markets with elective procedures, advancing the Axogen algorithm towards standard of care, and establishing leadership in the breast neurotization market [19][22] - The company plans to invest in innovation programs and operational efficiencies to improve gross margins [27][28] Management's Comments on Operating Environment and Future Outlook - Management expressed increased confidence entering 2025 due to successful completion of key commitments and the new strategic plan [6][9] - The company expects to maintain positive cash flows and self-fund its growth initiatives [35] - Management is optimistic about the BLA approval process and does not foresee delays [73] Other Important Information - The company anticipates full-year 2025 revenue growth in the range of 15% to 17% compared to the prior year [34] - The company expects to incur approximately $2 million in one-time costs related to the BLA approval, impacting gross margin by about 1 percentage point [34] Q&A Session Summary Question: What is the difference in the $5 billion U.S. TAM estimate compared to previous estimates? - Management evaluated various factors and is comfortable with the new TAM estimate, which includes new opportunities like prostatectomy [41][42] Question: Can the company balance top-line growth with margin expansion? - Management believes it can balance both top-line growth and margin expansion through practical investments tied to clinical applications [46][48] Question: What are the key assumptions for the 15% to 17% sales guidance for 2025? - The guidance is based on existing momentum and investments that are expected to bear fruit throughout the year [60] Question: What is the comfort level with existing data for the breast reconstruction business? - Management is confident in the benefit-risk proposition of the Resensation technique but acknowledges the need for more data to support standard of care [109] Question: How will the company increase its sales and marketing efforts this year? - The company plans to double its sales force in the breast segment and expand market development and professional education staff [76][80]

Financial Data and Key Metrics Changes - Full year 2024 revenue was $187.3 million, a 17.8% increase compared to 2023 [10] - Fourth quarter revenue increased to $49.4 million, up 15.1% compared to the prior year [11] - Gross profit for the fourth quarter was $37.6 million, representing a gross margin of 76.1%, up from 74.6% in the same period last year [30] - Net income for the fourth quarter was $0.4 million or $0.01 per share, compared to a net loss of $3.9 million or $0.09 per share in the fourth quarter of 2023 [32] - Adjusted EBITDA for the fourth quarter was $6.7 million compared to $0.6 million in the prior year [32] Business Line Data and Key Metrics Changes - The extremities business, which includes traumatic and chronic nerve injuries, represents more than half of the company's business [18] - The breast neurotization market, driven by the Resensation technique, is the fastest-growing business for the company [21] - The oral, maxillofacial, and head and neck business represents a large market opportunity with high procedural concentration in about 900 hospitals [23] Market Data and Key Metrics Changes - The total addressable market (TAM) for peripheral nerve repair is estimated at $5 billion, which is significantly higher than previous estimates [16] - The company aims for a compound annual growth rate (CAGR) of 15% to 20% over the planning period [17] Company Strategy and Development Direction - The company has established three near-term priorities: complete the submission of the BLA application, meet revenue guidance, and develop a new strategic plan [6][7] - The strategic plan focuses on expanding into markets with elective procedures, advancing the Axogen algorithm towards standard of care, and increasing investments in breast commercial infrastructure [18][21] - The company plans to drive operational efficiencies in manufacturing to optimize gross margin [26] Management's Comments on Operating Environment and Future Outlook - Management expressed increased confidence entering 2025 due to successful completion of key commitments and strategic planning [5][8] - The company expects to maintain positive cash flows and self-fund its growth initiatives [34] - Management is optimistic about the BLA approval process and does not foresee delays [72] Other Important Information - The company anticipates full year 2025 revenue growth in the range of 15% to 17% compared to the prior year [33] - The anticipated BLA approval is expected in September 2025, which will provide market exclusivity for Avance Nerve Graft [14] Q&A Session Summary Question: What is the difference in the $5 billion U.S. TAM estimate? - Management evaluated various factors and is comfortable with the new TAM estimate, which includes new opportunities like prostatectomy [40][42] Question: Can the company balance top-line growth with margin expansion? - Management believes it can balance both top-line growth and margin expansion through practical and executable plans [45][47] Question: What are the key assumptions for the 15% to 17% sales guidance? - The guidance is based on existing momentum and investments that will take time to bear fruit [59] Question: What is the comfort level with existing data for the breast reconstruction business? - Management is confident in the benefit-risk proposition of the Resensation technique but acknowledges the need for more data to support adoption [106][108] Question: How will the sales and marketing strategy change this year? - The company plans to double its sales force in the breast segment and expand market development staff [76][78] Question: What is the company's capacity to meet future demands? - Management is comfortable with current capacity and does not foresee constraints during the planning period [112]