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]

Core Viewpoint - Axogen, Inc. is set to report its first quarter financial results for 2025 on May 8, 2025, and will host a conference call for the investment community shortly after the release [1]. Company Overview - Axogen, Inc. is a leader in developing and marketing surgical solutions specifically for peripheral nerve injuries, focusing on restoring nerve function and improving patients' quality of life [3]. - The company offers a comprehensive portfolio of products for peripheral nerve repair, including Avance Nerve Graft®, Axoguard Nerve Connector®, Axoguard Nerve Protector®, Axoguard HA+ Nerve Protector™, Avive+ Soft Tissue Matrix™, and Axoguard Nerve Cap® [3]. - Axogen's products are utilized across various surgical specialties and applications, addressing both scheduled and emergent procedures related to peripheral nerve damage [3]. Product Applications - Scheduled procedures include nerve reconstruction for conditions caused by nerve defects, such as breast reconstruction post-mastectomy and oral and maxillofacial surgeries [3]. - Emergent procedures typically arise from traumatic injuries, requiring immediate or timely intervention by specialists [3]. - The company's products are available in multiple markets, including the United States, Canada, the United Kingdom, South Korea, and several European and international markets [3].

ALACHUA, Fla. and TAMPA, Fla., March 24, 2025 (GLOBE NEWSWIRE) -- Axogen, Inc. (NASDAQ: AXGN), a global leader in developing and marketing innovative surgical solutions for peripheral nerve injuries, today announced the appointment of Rick Ditto as Vice President, Global Health Economics, Reimbursement & Policy. Mr. Ditto will report to Michael Dale, President, and Chief Executive Officer, and will lead the development of the coverage and reimbursement-related strategies required to support Axogen’s mission ...

Financial Performance - Revenues for the year ended December 31, 2024 increased by $28,326, or 17.8%, to $187,338 compared to $159,012 for the year ended December 31, 2023, driven by a 9.0% increase in unit volume and a 5.5% impact from product mix changes [350]. - Gross profit for the year ended December 31, 2024 was $141,977, an increase of $20,108, or 16.5%, compared to $121,869 for the year ended December 31, 2023, with a gross margin of 75.8% [351]. - Net loss for 2024 decreased to $9.96 million compared to a net loss of $21.72 million in 2023, indicating improved financial performance [422]. - Total revenues for 2024 reached $187.34 million, a 17.8% increase from $159.01 million in 2023 [422]. - Gross profit for 2024 was $141.98 million, up from $121.87 million in 2023, reflecting a gross margin improvement [422]. Expenses and Costs - Total costs and expenses increased by $1,933, or 1.3%, to $145,264 for the year ended December 31, 2024, primarily due to $9,745 in compensation costs [352]. - Sales and marketing expenses increased by $881, or 1.1%, to $78,461 for the year ended December 31, 2024, attributed to $6,028 in compensation costs [353]. - Research and development expenses increased by $428, or 1.6%, to $27,767 for the year ended December 31, 2024, primarily due to product development and clinical expenses [354]. - General and administrative expenses increased by $624, or 1.6%, to $39,036 for the year ended December 31, 2024, mainly due to $921 in bad debt expense [355]. - Total other expense increased by $6,423, or 2528.7%, to $6,677 for the year ended December 31, 2024, primarily due to an increase in interest expense of $5,372 [356]. Cash Flow and Liquidity - Net cash provided by operating activities was $4,535 for the year ended December 31, 2024, compared to net cash used in operating activities of $5,716 for the year ended December 31, 2023 [369]. - Net cash used in investing activities was $10,297 for the year ended December 31, 2024, compared to net cash provided by investing activities of $19,253 for the year ended December 31, 2023 [371]. - Cash and cash equivalents at the end of 2024 were $27.55 million, down from $31.02 million in 2023 [420]. - As of December 31, 2024, the company had $50,000 outstanding in indebtedness under a credit facility, with $35,000 maturing on June 30, 2027, and $15,000 maturing on June 30, 2028 [376]. Inventory and Assets - The company’s total property and equipment, net, was $84,667,000 as of December 31, 2024, down from $88,730,000 in 2023 [492]. - The company's inventory as of December 31, 2024, was $33,183,000, an increase from $23,020,000 in 2023 [491]. - The provision for inventory write-down was $6,989,000 for the year ended December 31, 2024, compared to $1,939,000 in 2023 [491]. - Total current assets increased to $99.22 million in 2024 from $88.00 million in 2023, driven by higher inventory levels [420]. Shareholder Information - The company reported a weighted average of 44.26 million common shares outstanding in 2024, compared to 42.88 million in 2023 [422]. - The net loss attributable to common shareholders for the year ended December 31, 2024, was $9.964 million, compared to $21.716 million in 2023 and $28.948 million in 2022 [518]. - The weighted average common shares outstanding increased to 44,257,754 in 2024 from 42,878,543 in 2023 [518]. Research and Development - Research and development expenses for 2024 were $27.77 million, slightly up from $27.34 million in 2023, indicating continued investment in innovation [422]. - The company plans to continue focusing on the commercialization of its nerve regeneration technologies, including new product developments [430]. Debt and Interest - Long-term debt, net of debt discount and financing fees, increased to $47,496,000 in 2024 from $46,603,000 in 2023 [507]. - The interest rate for each tranche is 7.5% plus the greater of Adjusted SOFR or 2.0%, with a minimum interest rate of 9.5% [509]. - The Company recorded interest expense of $756,000 for the Revenue Participation Agreement for the years ended December 31, 2024, 2023, and 2022 [510]. Stock-Based Compensation - Total stock-based compensation expense for the year ended December 31, 2024, was $15.906 million, compared to $14.418 million in 2023 [521]. - The Company granted 1,010,671 Restricted Stock Units (RSUs) during the year ended December 31, 2024, with an average fair value of $8.79 per share [527]. - The total unrecognized compensation costs related to unvested PSU awards amounted to approximately $8,826,000, expected to be recognized over a weighted-average period of 1.7 years [535].

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]

Core Insights - Axogen, Inc. will hold its Analyst & Investor Day on March 4, 2025, from 9am to 12pm Eastern, featuring key executives discussing business strategies and financial objectives [1][2]. Company Overview - Axogen is a leader in developing and marketing surgical solutions for peripheral nerve injuries, focusing on restoring nerve function and quality of life for patients [4]. - The company offers a comprehensive portfolio of products for both scheduled non-trauma and emergent trauma procedures, addressing various nerve-related conditions [5]. Product Portfolio - Key products include: - Avance Nerve Graft: A processed human nerve allograft for bridging severed nerves [6]. - Axoguard Nerve Connector: An aid for tensionless repair of severed nerves [6]. - Axoguard Nerve Protector: A product to protect and reinforce damaged nerves [6]. - Axoguard HA+ Nerve Protector: A next-generation technology for nerve injury protection [6]. - Avive+ Soft Tissue Matrix: An amniotic membrane allograft for tissue protection during repair [6]. - Axoguard Nerve Cap: A product to protect nerve ends and reduce neuroma development [6]. - The product portfolio is available in multiple countries, including the United States, Canada, Germany, the United Kingdom, Spain, and South Korea [6]. Event Details - A live webcast of the Analyst & Investor Day will be available on Axogen's investor relations website, with a replay accessible for 90 days post-event [3].

Core Insights - Axogen, Inc. will hold its Analyst & Investor Day on March 4, 2025, from 9am to 12pm Eastern, featuring key executives discussing business strategies and financial objectives [1][2]. Company Overview - Axogen is a leader in developing and marketing surgical solutions for peripheral nerve injuries, focusing on restoring nerve function and quality of life for patients [4]. - The company offers a comprehensive portfolio of products for peripheral nerve repair, addressing both scheduled non-trauma procedures and emergent trauma procedures [5]. Product Portfolio - Key products include: - Avance® Nerve Graft: A processed human nerve allograft for bridging severed nerves [6]. - Axoguard Nerve Connector®: An aid for tensionless repair of severed nerves [6]. - Axoguard Nerve Protector®: A product to protect damaged nerves and reinforce reconstruction [6]. - Axoguard HA+ Nerve Protector™: A next-generation technology for nerve injury protection [6]. - Avive+ Soft Tissue Matrix™: An amniotic membrane allograft for tissue repair [6]. - Axoguard Nerve Cap®: A product to protect nerve ends and reduce painful neuroma development [6]. - The product portfolio is available in multiple countries, including the United States, Canada, Germany, the United Kingdom, Spain, and South Korea [6].

Core Insights - Axogen, Inc. reported strong financial results for Q4 and full-year 2024, with a focus on expanding its portfolio for peripheral nerve injuries [1][3][4] Financial Results - Q4 2024 revenue reached $49.4 million, marking a 15.1% increase from Q4 2023 [6] - Full-year 2024 revenue was $187.3 million, a 17.8% increase compared to $159.0 million in 2023 [7] - Gross margin for Q4 2024 was 76.1%, up from 74.6% in Q4 2023, while full-year gross margin was 75.8%, slightly down from 76.6% in 2023 [6][7] - Q4 2024 net income was $0.4 million, or $0.01 per share, compared to a net loss of $3.9 million, or $0.09 per share in Q4 2023 [6] - Full-year net loss for 2024 was $10.0 million, or $0.23 per share, an improvement from a net loss of $21.7 million, or $0.51 per share in 2023 [7] Operational Highlights - The company experienced broad-based revenue growth driven by improved commercial execution and new product adoption [7] - The FDA accepted the filing of the Biologics License Application for Avance Nerve Graft on November 1, 2024, with a PDUFA goal date set for September 5, 2025 [7] - An Investor Day is scheduled for March 4, 2025, to discuss strategic plans for 2025-2028 [7][8] Future Guidance - Axogen expects revenue growth in the range of 15% to 17% for 2025, with gross margin anticipated between 73% and 75% [9] - The company aims to achieve net cash flow positivity for the full year 2025 [9]