Financial Data and Key Metrics Changes - Revenue for the first quarter increased to $48.6 million, representing a 17.4% growth compared to the same period last year, driven by a 14% increase in unit volume and a 3% increase in price [22][24] - Gross profit for the quarter was $34.9 million, with a gross margin of approximately 71.9%, down from 78.8% year-over-year [22][23] - The company reported a net loss of $3.8 million or $0.08 per share, compared to a net loss of $6.6 million or $0.15 per share in the first quarter of the previous year [25] Business Line Data and Key Metrics Changes - The extremities market experienced double-digit growth, with continued adoption of the nerve protection portfolio [12] - In the breast segment, there was a 16% increase in the number of surgeons performing breast resensation procedures, totaling 254 surgeons [15] - The oral, maxillofacial, and head and neck markets showed strong growth from the adoption of the nerve algorithm in mandible reconstruction procedures [15] Market Data and Key Metrics Changes - The company is targeting to generate approximately 66% of its growth in 2025 from high potential accounts, with an average account productivity increase of 24% in the first quarter [10][11] - There were 566 active high potential accounts at the end of the first quarter, representing a 5% increase compared to the same period last year [11] Company Strategy and Development Direction - The company is focused on making nerve care a standard of care for all patients, leveraging clinical evidence and societal support [8][19] - Plans to expand commercial infrastructure include adding sales representatives and conducting professional education programs [12][13] - The biologics license application (BLA) for the advanced nerve graft is on track, with expectations for approval in September [20][21] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the growth strategy, highlighting broad-based growth across the portfolio and the importance of high potential accounts [8][9] - The company anticipates improvements in gross margin following BLA approval and the implementation of process improvements [23][26] Other Important Information - A leadership transition was announced, with Nir Naor stepping down as CFO and Lindsay Hartley appointed as the new CFO [5][6] - The company is maintaining its full-year 2025 revenue growth guidance in the range of 15% to 17% [26] Q&A Session Summary Question: Insights on Avance and BLA approval process - Management does not expect major changes to ordering or shipment for Avance post-approval, and reimbursement pathways will remain unchanged [34] Question: Gross margin concerns - The one-time inventory write-offs were significant, and management expects gross margin to improve throughout the year, particularly after BLA approval [36][37] Question: Sales team expansion - The company plans to have approximately 20 net new sales representatives by the end of the year, with hiring running slightly behind schedule [46] Question: High potential accounts initiative - There are approximately 780 high potential accounts, with 566 active accounts, and management sees opportunities to expand within existing and new accounts [52][53] Question: Clinical studies and evidence generation - Management is committed to generating level one evidence to support clinical adoption and reimbursement, with plans for additional studies [62] Question: BLA process and major checkpoints - The next major milestone is the late cycle meeting with the FDA, and management is confident in the progress made so far [98]

Financial Data and Key Metrics Changes - Revenue for Q1 2025 reached $48.6 million, representing a 17.4% increase compared to Q1 2024, driven by a 14% increase in unit volume and a 3% increase in price [21][22] - Gross profit for the quarter was $34.9 million, with a gross margin of approximately 71.9%, down from 78.8% in the same period last year [22][24] - The company reported a net loss of $3.8 million or $0.08 per share, compared to a net loss of $6.6 million or $0.15 per share in Q1 2024 [25] Business Line Data and Key Metrics Changes - The extremities market experienced double-digit growth, with continued adoption of the nerve protection portfolio [10] - In the breast segment, there was a 16% increase in the number of surgeons performing breast resensation procedures, with 254 active surgeons in Q1 2025 [12][13] - The oral, maxillofacial, and head and neck markets saw strong growth from the adoption of the nerve algorithm in mandible reconstruction procedures [13] Market Data and Key Metrics Changes - The company reported an increase in average account productivity of 24% in high potential accounts, exceeding the target of 21% [9] - There were 566 active high potential accounts at the end of Q1 2025, representing a 5% increase compared to Q1 2024 [9] - The prostate clinical and market development plan is on track, with three clinical pilot sites confirmed and discussions ongoing with additional sites [15][16] Company Strategy and Development Direction - The company aims to make nerve care a standard of care for all patients, focusing on high potential hospital providers and physicians [6][8] - Plans for 2025 include expanding the commercial infrastructure and increasing the number of sales representatives in high potential territories [10][11] - The company is advancing its therapeutic reconstruction program and exploring next-generation applications for its protection technologies [18][19] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the BLA process for the advanced nerve graft, expecting approval in September 2025 [20] - The company anticipates improvements in gross margin following BLA approval, with ongoing process and quality system enhancements [23][26] - Management remains optimistic about achieving full-year revenue growth guidance in the range of 15% to 17% for 2025 [26][27] Other Important Information - A leadership transition was announced, with Lindsay Hartley succeeding Nir Naor as Chief Financial Officer [4][5] - The company is maintaining its focus on generating clinical evidence to support its technologies and improve surgeon confidence [17][18] Q&A Session Summary Question: Insights on Avance and BLA approval process - Management does not expect major changes to ordering or shipment for Avance post-approval, and reimbursement pathways will remain unchanged [36] Question: Impact of one-time inventory write-offs on gross margin - Significant one-time inventory write-offs impacted Q1 gross margin, but improvements are expected throughout the year [38][39] Question: Status of high potential accounts - There are approximately 780 high potential accounts, with 566 active in Q1 2025; opportunities exist to expand within existing accounts and establish new relationships [56][57] Question: Update on sales team expansion - The company plans to have approximately 20 net new sales representatives by the end of the year, with ongoing recruitment efforts [50][72] Question: BLA process and major checkpoints - The next major milestone is the late cycle meeting with the FDA, where the company will review progress and address any outstanding questions [100]

THIS EXECUTIVE EMPLOYMENT AGREEMENT (the "Agreement"), effective as of May 12, 2025 (the "Effective Date"), is made by and between AXOGEN CORPORATION, a Delaware corporation ("AXOGEN"), and Lindsey Hartley ("Employee") (collectively, the "Parties"). RECITALS: WHEREAS, AXOGEN and the Employee desire to enter into this Agreement to state the terms and conditions of the Agreement in its entirety on the Effective Date on the terms and conditions set forth in this Agreement. NOW, THEREFORE, in consideration of t ...

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]