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Core Insights - AxoGen, Inc. specializes in developing and marketing surgical solutions for peripheral nerve injuries, operating in the healthcare sector with a focus on nerve repair and protection [1] - The company faces competition from AtriCure, Tactile Systems Technology, BioLife Solutions, AnaptysBio, and Assembly Biosciences [1] Financial Performance - AxoGen's Return on Invested Capital (ROIC) is 2.07%, which is significantly lower than its Weighted Average Cost of Capital (WACC) of 8.72%, indicating inefficient capital utilization [2][5] - AtriCure has a negative ROIC of -6.47% and a WACC of 11.01%, resulting in a ROIC to WACC ratio of -0.59, suggesting struggles in generating returns above its cost of capital [3] - BioLife Solutions and AnaptysBio also report negative ROICs of -4.85% and -28.56%, respectively, with WACCs of 12.57% and 9.10% [3] - Assembly Biosciences shows the highest inefficiency with a ROIC of -127.67% and a WACC of 6.45%, leading to a ROIC to WACC ratio of -19.80 [4][5]

Financial Performance - Revenues for the quarter ended September 30, 2025, were $60,082, an increase of $11,438 or 23.5% compared to $48,644 for the same quarter in 2024[106] - Gross profit for the quarter ended September 30, 2025, was $45,993, reflecting an increase of $9,555 or 26.2% from $36,438 in the prior year, with a gross margin of 76.6%[110] - Net income for the quarter ended September 30, 2025, was $708, compared to a net loss of $1,858 in the same quarter of 2024[107] - Revenues for the nine months ended September 30, 2025 increased by $27,371, or 19.8%, to $165,304 compared to $137,933 for the same period in 2024[115] - Gross profit for the nine months ended September 30, 2025 increased by $18,542, or 17.8%, to $122,944, with a gross margin of 74.4% compared to 75.7% in 2024[117] - Net loss for the nine months ended September 30, 2025 was $2,547, a significant improvement from a net loss of $10,414 in 2024[120] Costs and Expenses - Total costs and expenses for the quarter ended September 30, 2025, were $44,081, a 19.9% increase from $36,754 in the same quarter of 2024[111] - Sales and marketing expenses increased by 35.7% to $25,680 for the quarter ended September 30, 2025, compared to $18,924 in 2024[111] - Total costs and expenses for the nine months ended September 30, 2025 were $121,021, an increase of 10.3% from $109,706 in 2024, driven primarily by higher sales and marketing costs[118] - Research and development costs for the quarter ended September 30, 2025, were $7,565, representing an 8.1% increase from $6,996 in the same quarter of 2024[111] - Research and development costs decreased by 2.6% to $20,509 for the nine months ended September 30, 2025, primarily due to lower product development expenses[119] Cash Flow and Liquidity - Cash and cash equivalents and investments increased by $2,309 to $35,791 as of September 30, 2025, primarily due to proceeds from stock options and the release of restricted cash[123] - Net cash used in operating activities decreased by $1,974, or 47.0%, to $2,226 for the nine months ended September 30, 2025, reflecting a decrease in net loss[126] - Net cash provided by financing activities increased by $4,613 to $5,933 for the nine months ended September 30, 2025, primarily due to increased proceeds from the exercise of stock options[128] - The current ratio improved to 4.1x as of September 30, 2025, compared to 3.2x at December 31, 2024, indicating stronger liquidity[124] Business Developments - The company expanded coverage for nerve repair, increasing the total number of new lives covered in 2025 to approximately 18.1 million, with coverage among commercial payers exceeding 64%[106] - The FDA accepted the filing of the Biologics License Application for Avance Nerve Graft, with a new PDUFA goal date of December 5, 2025, following a major amendment submission[106] - The company discontinued its case stock sales program for Avance Nerve Graft, positively impacting revenue by approximately $1.6 million, or about 3%[109] - The company discontinued its case stock sales program for Avance Nerve Graft, positively impacting revenue by approximately $1.6 million, or about 1%[116] Debt and Interest - As of September 30, 2025, the outstanding principal amount of loans under the Credit Facility was $50,000[137] - Interest on loans under the Credit Facility is calculated at 7.5% plus the greater of Adjusted SOFR or 2.0%, with a minimum interest rate of 9.5%[137] - At September 30, 2025, the Adjusted SOFR was 11.89%[137] - A 100 basis points increase in interest rates would increase annual interest expense by approximately $500[137] - Changes in the Adjusted SOFR rate may affect interest expense associated with the Credit Facility[137]

AxoGen (AXGN) came out with quarterly earnings of $0.12 per share, beating the Zacks Consensus Estimate of $0.09 per share. This compares to earnings of $0.07 per share a year ago. These figures are adjusted for non-recurring items.This quarterly report represents an earnings surprise of +33.33%. A quarter ago, it was expected that this regenerative medicine company would post earnings of $0.06 per share when it actually produced earnings of $0.12, delivering a surprise of +100%.Over the last four quarters, ...

AxoGen (NasdaqCM:AXGN) Q3 2025 Earnings Call October 29, 2025 08:00 AM ET Company ParticipantsMichael Dale - CEO and DirectorLindsey Hartley - CFOCaitlin Roberts - Director of MedTech Equity ResearchJens Kemp - CMORick Ditto - VP of Global Health Economics, Reimbursement, and PolicyConference Call ParticipantsRoss Osborn - Director and Lead Research AnalystDavid Turkaly - Research AnalystMichael Sarcone - AnalystAnthony Petrone - Managing Director, Senior Medical Devices, Diagnostics, and Therapeutics Equit ...

AxoGen (NasdaqCM:AXGN) Q3 2025 Earnings Call October 29, 2025 08:00 AM ET Company ParticipantsMichael Dale - CEO and DirectorLindsey Hartley - CFOCaitlin Roberts - Director of MedTech Equity ResearchJens Kemp - CMORick Ditto - VP of Global Health Economics, Reimbursement, and PolicyConference Call ParticipantsRoss Osborn - Director and Lead Research AnalystDavid Turkaly - Research AnalystMichael Sarcone - AnalystAnthony Petrone - Managing Director, Senior Medical Devices, Diagnostics, and Therapeutics Equit ...

Financial Data and Key Metrics Changes - Revenue for Q3 2025 was $60.1 million, reflecting a 23.5% increase compared to Q3 2024 and a 6% sequential increase over Q2 2025 [5][18] - Gross profit for the quarter was $46 million, up from $36.4 million in Q3 2024, resulting in a gross margin of 76.6%, an increase from 74.9% in the same period last year [19] - Net income for the quarter was $0.7 million or $0.01 per share, compared to a net loss of $1.9 million or $0.04 per share in Q3 2024 [22] - Adjusted net income was $6.1 million or $0.12 per share, compared to $3.1 million or $0.07 per share in Q3 2024 [23] Business Line Data and Key Metrics Changes - Strong revenue growth was noted across all nerve repair target markets, including extremities, oromaxillofacial, head and neck, and breast [5][6] - The Avance Nerve Graft was identified as the primary growth driver, with significant adoption in various procedures [6] - Active breast ReSensation programs increased by 7% year-over-year, with 281 surgeons performing procedures in Q3 2025, a 20% increase from Q3 2024 [11] Market Data and Key Metrics Changes - Approximately 64% of revenue growth was driven by high-potential accounts, slightly below the target of 66% [7] - Coverage for nerve repair using synthetic conduits or allografts expanded to an estimated 18.1 million additional lives year-to-date, with commercial payer coverage exceeding 64% [15] Company Strategy and Development Direction - The company aims to optimize business models based on experience and maintain growth consistent with strategic plan guidance [5] - Continued focus on expanding presence in high-potential accounts to drive consistent customer creation and algorithm adoption [7] - The company is on track to complete a level one study protocol for implant-based neurotization and advance clinical research initiatives [12] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the ability to complete the Biologics License Application (BLA) for Avance Nerve Graft by December 5, 2025, which is expected to secure market exclusivity [17] - The company anticipates that the BLA approval will enhance market development efforts and support coverage expansion [77] Other Important Information - The company raised its revenue growth guidance for 2025 to at least 19%, expecting revenue of at least $222.8 million [24] - Operating expenses increased to $44.1 million, but as a percentage of revenue, they decreased, indicating improved operating leverage [21] Q&A Session Summary Question: Insights on Q4 revenue expectations and case stock sales program impact - Management indicated that the $1.6 million revenue increase in Q3 was related to the transition from the case stock program and advised excluding this from Q4 models [28] Question: Comments on BLA labeling expectations - Management confirmed that discussions regarding labeling are ongoing, but no definitive insights were available [33] Question: Coverage expansion trajectory before BLA approval - The increase in commercially covered lives was attributed to refined data tracking, with ongoing engagement with national payers expected [38] Question: Future steps for targeting the prostate market - The company plans to evaluate outcomes from initial clinical trials before determining future investments in the prostate market [58] Question: Impact of BLA on market development efforts - Management noted that BLA approval would positively support market development but cautioned against expecting immediate widespread adoption [77]

Q3 2025 Financial Results October 29, 2025 1 Disclaimer Forward-looking Statements About Non-GAAP Financial Measures To supplement our condensed consolidated financial statements, we use the non-GAAP financial measures of EBITDA, which measures earnings before interest, income taxes, depreciation and amortization, EBITDA margin, Adjusted EBITDA, which further excludes non-cash stock compensation expense, and Adjusted EBITDA margin. We also use the non-GAAP financial measures of Adjusted Net Income (Loss) an ...

Financial Performance - Third quarter revenue was $60.1 million, a 23.5% increase compared to the third quarter of 2024, and a 6.0% increase over the second quarter of 2025[5] - Gross margin for the third quarter was 76.6%, up from 74.9% for the third quarter of 2024[5] - Net income for the quarter was $0.7 million, or $0.01 per share, compared to a net loss of $1.9 million, or $0.04 per share for the third quarter of 2024[5] - Adjusted EBITDA was $9.2 million for the quarter, compared to $6.5 million for the third quarter of 2024[5] - Adjusted net income for the quarter was $6.1 million, or $0.12 per share, compared to $3.1 million, or $0.07 per share, for the third quarter of 2024[5] - Revenues for the three months ended September 30, 2025, were $60,082 thousand, a 23.5% increase from $48,644 thousand in the same period of 2024[20] - Gross profit for the three months ended September 30, 2025, was $45,993 thousand, compared to $36,438 thousand for the same period in 2024, reflecting a gross margin improvement[20] - Net income for the three months ended September 30, 2025, was $708 thousand, a significant recovery from a net loss of $1,858 thousand in the same period of 2024[22] - Adjusted EBITDA for the nine months ended September 30, 2025, was $21,374 thousand, up from $13,115 thousand for the same period in 2024, indicating a strong operational performance[22] Cash Flow and Guidance - The company raised its full year revenue guidance to at least 19% growth, or $222.8 million[7] - The company expects to be net cash flow positive for the full year[7] - The company reported a net cash used in operating activities of $2,226 thousand for the nine months ended September 30, 2025, an improvement compared to $4,200 thousand for the same period in 2024[26] - Cash and cash equivalents, restricted cash, and investments increased by $3.9 million during the third quarter of 2025, totaling $39.8 million as of September 30, 2025[5] - Cash and cash equivalents, and restricted cash at the end of the period were $27,902 thousand, down from $33,554 thousand at the beginning of the period[26] Expenses and Investments - Total costs and expenses for the three months ended September 30, 2025, were $44,081 thousand, compared to $36,754 thousand in the same period of 2024, reflecting increased investment in sales and marketing[20] - The company incurred $25,680 thousand in sales and marketing expenses for the three months ended September 30, 2025, up from $18,924 thousand in the same period of 2024[20] Operational Metrics - The number of covered lives increased by 1.1 million, bringing the total to approximately 18.1 million in 2025[12] - The weighted average common shares outstanding — diluted for the three months ended September 30, 2025, was 49,088,436, compared to 43,882,110 for the same period in 2024[22] - The adjusted net income per common share — diluted for the three months ended September 30, 2025, was $0.12, compared to $0.07 for the same period in 2024[22] Regulatory Updates - The FDA has extended the PDUFA goal date for the Avance Nerve Graft BLA to December 5, 2025[12]

Raises Full Year Revenue Guidance to at Least 19% Growth or $222.8 millionALACHUA, Fla. and TAMPA, Fla., Oct. 29, 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 reported financial results and business highlights for the third quarter ended September 30, 2025. Third Quarter Financial Results Third quarter revenue was $60.1 million, a 23.5% increase compared to the third qua ...