Group 1 - Axogen, Inc. is currently under a fraud investigation, providing an opportunity for investors to join the legal proceedings with the Schall Law Firm [1] - The investigation may impact the company's stock performance and investor sentiment [1] - The involvement of a law firm indicates potential legal ramifications for Axogen, Inc. and its management [1] Group 2 - The news highlights the importance of investor awareness regarding ongoing legal issues within companies [1] - It suggests that investors should consider the implications of such investigations on their investment strategies [1] - The situation may lead to increased scrutiny of Axogen, Inc.'s financial practices and disclosures [1]

Core Viewpoint - Pomerantz LLP is investigating potential securities fraud or unlawful business practices involving Axogen, Inc. and its officers or directors [1] Group 1: Company Developments - On August 25, 2025, Axogen announced that the FDA extended the PDUFA goal date for its Biologics License Application for Avance® Nerve Graft by three months to December 5, 2025 [3] - Following this announcement, Axogen's stock price decreased by $1.47 per share, or 9.04%, closing at $14.79 per share on the same day [3] Group 2: Legal Investigation - Pomerantz LLP is representing investors in investigating claims against Axogen for possible securities fraud or other unlawful business practices [1] - The firm has a long history in corporate, securities, and antitrust class litigation, having recovered numerous multimillion-dollar damages awards for victims of securities fraud [4]

Core Viewpoint - Pomerantz LLP is investigating potential securities fraud or unlawful business practices involving Axogen, Inc. and its officers or directors [1]. Group 1: Company Developments - On August 25, 2025, Axogen announced that the FDA extended the PDUFA goal date for its Biologics License Application for Avance® Nerve Graft by three months to December 5, 2025 [2]. - Following this announcement, Axogen's stock price decreased by $1.47 per share, representing a 9.04% decline, closing at $14.79 per share on the same day [2]. Group 2: Legal Context - Pomerantz LLP is recognized for its expertise in corporate, securities, and antitrust class litigation, having a history of recovering multimillion-dollar damages for victims of securities fraud and corporate misconduct [3].

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 Viewpoint - AxoGen (AXGN) shares have increased by 16.6% in the past four weeks, closing at $14.01, with a mean price target of $24.71 indicating a potential upside of 76.4% [1] Price Targets and Analyst Estimates - The mean estimate consists of seven short-term price targets with a standard deviation of $3.2, where the lowest estimate of $20.00 suggests a 42.8% increase, and the highest estimate of $30.00 indicates a 114.1% increase [2] - A low standard deviation signifies strong agreement among analysts regarding the stock's price movement, which can be a useful starting point for further research [9] Earnings Estimates and Analyst Optimism - Analysts show strong agreement in revising earnings per share (EPS) estimates higher, which correlates with potential stock price increases [11] - Over the last 30 days, two estimates have been revised upward, leading to a 27.1% increase in the Zacks Consensus Estimate for the current year [12] Zacks Rank and Investment Potential - AXGN holds a Zacks Rank 2 (Buy), placing it in the top 20% of over 4,000 ranked stocks based on earnings estimate factors, indicating strong potential for upside [13] - While consensus price targets may not be entirely reliable, the implied direction of price movement appears to be a good guide for potential investment [14]

Group 1 - Axogen (NASDAQ: AXGN) has experienced a continued selloff despite posting reasonably strong Q2 FY'25 numbers, indicating a wide distribution of potential outcomes for the company [1] Group 2 - The company operates within a framework that focuses on fundamental value drivers of business economics, aiming to identify high probability long-term compounders [2] - The research covers various investment securities and futures & options markets, indicating a broad approach to investment analysis [2] Group 3 - There is no indication of any stock, option, or similar derivative positions held by the analyst in the companies mentioned, suggesting an unbiased perspective [3] - The article expresses the author's own opinions without any compensation from the companies discussed, reinforcing the independence of the analysis [3] Group 4 - Seeking Alpha emphasizes that past performance does not guarantee future results, highlighting the inherent uncertainties in investment decisions [4] - The platform clarifies that it does not provide personalized investment advice, which is crucial for investors to consider [4]

[Forward-Looking Statements](index=4&type=section&id=Forward-Looking%20Statements) Axogen provides forward-looking statements on future results and business developments, subject to risks and uncertainties - Axogen, Inc. provides forward-looking statements regarding anticipated future results and business developments, based on management's current expectations and predictions. These statements are subject to risks and uncertainties that may cause actual results to differ materially[8](index=8&type=chunk)[9](index=9&type=chunk) - Key forward-looking statements include: continued growth in the nerve protection category, targeted strategy for nerve repair indication expansion, anticipated FDA approval of Avance® Nerve Graft by September 2025, and sufficient liquidity to fund operations for at least the next twelve months[10](index=10&type=chunk) [Part I - Financial Information](index=5&type=section&id=Part%20I%20-%20Financial%20Information) This part presents Axogen's unaudited condensed consolidated financial statements and management's discussion and analysis [Item 1. Financial Statements](index=5&type=section&id=Item%201.%20Financial%20Statements) This section presents Axogen, Inc.'s unaudited condensed consolidated financial statements, including the Balance Sheets, Statements of Operations, Statements of Cash Flows, and Statements of Changes in Shareholders' Equity, along with detailed notes explaining significant accounting policies, financial instrument valuations, and other financial commitments for the periods ended June 30, 2025 and 2024 [Condensed Consolidated Balance Sheets](index=5&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) This section provides a snapshot of Axogen's financial position, detailing assets, liabilities, and equity at specific dates Condensed Consolidated Balance Sheets | (in thousands) | June 30, 2025 | December 31, 2024 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $20,036 | $27,554 | | Investments | $9,886 | $5,928 | | Accounts receivable, net | $28,029 | $24,105 | | Inventory | $36,774 | $33,183 | | Total current assets | $103,419 | $99,217 | | Total assets | $205,453 | $203,728 | | **Liabilities and Shareholders' Equity** | | | | Accounts payable and accrued expenses | $22,770 | $28,641 | | Total current liabilities | $24,980 | $30,610 | | Total liabilities | $93,177 | $99,821 | | Total shareholders' equity | $112,276 | $103,907 | | Total liabilities and shareholders' equity | $205,453 | $203,728 | - Total assets increased by **$1,725 thousand** from December 31, 2024, to June 30, 2025, primarily driven by increases in investments, accounts receivable, and inventory, partially offset by a decrease in cash and cash equivalents[13](index=13&type=chunk) - Total liabilities decreased by **$6,644 thousand**, mainly due to a reduction in accounts payable and accrued expenses, while shareholders' equity increased by **$8,369 thousand**[13](index=13&type=chunk) [Condensed Consolidated Statements of Operations](index=7&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations) This section details Axogen's financial performance, including revenues, expenses, and net income or loss over specific periods Condensed Consolidated Statements of Operations | (in thousands, except per share amounts) | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :--- | :--- | :--- | :--- | :--- | | Revenues | $56,662 | $47,912 | $105,222 | $89,289 | | Cost of goods sold | $14,644 | $12,567 | $28,271 | $21,325 | | Gross profit | $42,018 | $35,345 | $76,951 | $67,964 | | Total costs and expenses | $40,346 | $35,773 | $76,940 | $72,952 | | Income (loss) from operations | $1,672 | $(428) | $11 | $(4,988) | | Net income (loss) | $579 | $(1,921) | $(3,255) | $(8,556) | | Net income (loss) per common share - basic | $0.01 | $(0.04) | $(0.07) | $(0.20) | | Net income (loss) per common share - diluted | $0.01 | $(0.04) | $(0.07) | $(0.20) | - For the three months ended June 30, 2025, revenues increased by **18.3% YoY** to **$56,662 thousand**, and the company reported a net income of **$579 thousand**, a significant improvement from a net loss of **$(1,921) thousand** in the prior year period[16](index=16&type=chunk) - For the six months ended June 30, 2025, revenues increased by **17.8% YoY** to **$105,222 thousand**, and the net loss decreased to **$(3,255) thousand** from **$(8,556) thousand** in the prior year period[16](index=16&type=chunk) [Condensed Consolidated Statements of Cash Flows](index=8&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) This section outlines Axogen's cash inflows and outflows from operating, investing, and financing activities Condensed Consolidated Statements of Cash Flows | (in thousands) | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :--- | :--- | :--- | | Net cash used in operating activities | $(5,449) | $(8,101) | | Net cash used in investing activities | $(5,608) | $(4,484) | | Net cash provided by financing activities | $3,539 | $748 | | Net decrease in cash and cash equivalents, and restricted cash | $(7,518) | $(11,837) | | Cash and cash equivalents, and restricted cash, end of period | $26,036 | $25,189 | - Net cash used in operating activities decreased by **$2,652 thousand (32.7%)** for the six months ended June 30, 2025, primarily due to a decrease in net loss[19](index=19&type=chunk)[114](index=114&type=chunk) - Net cash used in investing activities increased by **$1,124 thousand**, driven by higher purchases of investments, partially offset by proceeds from investment sales and decreased property and equipment purchases[19](index=19&type=chunk)[115](index=115&type=chunk) - Net cash provided by financing activities increased by **$2,791 thousand**, mainly due to increased proceeds from the exercise of stock options[19](index=19&type=chunk)[116](index=116&type=chunk) [Condensed Consolidated Statements of Changes in Shareholders' Equity](index=10&type=section&id=Condensed%20Consolidated%20Statements%20of%20Changes%20in%20Shareholders'%20Equity) This section details changes in Axogen's shareholders' equity, including net income/loss, stock compensation, and option exercises Condensed Consolidated Statements of Changes in Shareholders' Equity | (in thousands, except share amounts) | Balance at Dec 31, 2024 | Net Loss (6M 2025) | Stock-based Compensation (6M 2025) | Exercise of Stock Options (6M 2025) | Balance at Jun 30, 2025 | | :--- | :--- | :--- | :--- | :--- | :--- | | Common Stock (Amount) | $441 | — | — | $4 | $457 | | Additional Paid-in Capital | $394,726 | — | $8,077 | $3,543 | $406,334 | | Accumulated Deficit | $(291,260) | $(3,255) | — | — | $(294,515) | | Total Shareholders' Equity | $103,907 | $(3,255) | $8,077 | $3,547 | $112,276 | - Total shareholders' equity increased from **$103,907 thousand** at December 31, 2024, to **$112,276 thousand** at June 30, 2025, primarily driven by stock-based compensation and proceeds from stock option exercises, despite a net loss[22](index=22&type=chunk) [Notes to Unaudited Condensed Consolidated Financial Statements](index=11&type=section&id=Notes%20to%20Unaudited%20Condensed%20Consolidated%20Financial%20Statements) This section provides detailed explanations of Axogen's significant accounting policies, financial instrument valuations, and other commitments [1. Nature of Business](index=11&type=section&id=1.%20Nature%20of%20Business) This note describes Axogen's core business in peripheral nerve regeneration and repair, operating as a single segment - Axogen, Inc. specializes in the science, development, and commercialization of technologies for peripheral nerve regeneration and repair, with products including Avance Nerve Graft, Axoguard Nerve Connector, Axoguard Nerve Protector, Axoguard HA+ Nerve Protector™, Axoguard Nerve Cap, and Avive+ Soft Tissue Matrix™[24](index=24&type=chunk) - The Company operates as a single segment, with substantially all assets and revenues derived from sales to customers in the U.S.[24](index=24&type=chunk) [2. Summary of Significant Accounting Policies](index=11&type=section&id=2.%20Summary%20of%20Significant%20Accounting%20Policies) This note outlines Axogen's key accounting principles, including financial statement preparation and cash management - The unaudited condensed consolidated financial statements are prepared in accordance with Form 10-Q and Rule 10-01 of Regulation S-X, reflecting normal recurring adjustments, and should be read with the 2024 Annual Report on Form 10-K[26](index=26&type=chunk)[27](index=27&type=chunk) - Cash and cash equivalents include short-term, highly liquid investments, with **$19,536 thousand** not FDIC-insured or in excess of limits as of June 30, 2025[28](index=28&type=chunk) - Restricted cash of **$6,000 thousand** at June 30, 2025, and December 31, 2024, is held as collateral for a lease agreement[29](index=29&type=chunk)[30](index=30&type=chunk) - Recent accounting pronouncements, ASU 2024-03 and ASU 2023-09, will require enhanced disclosures for income statement expenses and income taxes, effective for annual periods beginning after December 15, 2026, and December 15, 2024, respectively[31](index=31&type=chunk)[32](index=32&type=chunk) [3. Inventory](index=12&type=section&id=3.%20Inventory) This note details Axogen's inventory composition and changes, including finished goods, work in process, and raw materials Inventory | (in thousands) | June 30, 2025 | December 31, 2024 | | :--- | :--- | :--- | | Finished goods | $31,266 | $27,054 | | Work in process | $1,485 | $1,325 | | Raw materials | $4,023 | $4,804 | | Total Inventory | $36,774 | $33,183 | - Total inventory increased by **$3,591 thousand** from December 31, 2024, to June 30, 2025, primarily due to an increase in finished goods[34](index=34&type=chunk) - The Company reserved **$3,679 thousand** for potential inventory losses as of June 30, 2025, up from **$1,630 thousand** at December 31, 2024[34](index=34&type=chunk) [4. Property and Equipment, Net](index=13&type=section&id=4.%20Property%20and%20Equipment%2C%20Net) This note presents Axogen's property and equipment, net of accumulated depreciation, and related depreciation expenses Property and Equipment, Net | (in thousands) | June 30, 2025 | December 31, 2024 | | :--- | :--- | :--- | | Property and equipment, at cost | $105,658 | $104,578 | | Less: accumulated depreciation | $(23,266) | $(19,911) | | Property and equipment, net | $82,392 | $84,667 | - Net property and equipment decreased by **$2,275 thousand** from December 31, 2024, to June 30, 2025, primarily due to accumulated depreciation exceeding new additions[35](index=35&type=chunk) - Depreciation expense for the six months ended June 30, 2025, was **$3,385 thousand**, an increase from **$3,177 thousand** in the prior year period[35](index=35&type=chunk) [5. Intangible Assets, Net](index=13&type=section&id=5.%20Intangible%20Assets%2C%20Net) This note details Axogen's intangible assets, including patents and trademarks, and associated amortization expenses Intangible Assets, Net | (in thousands) | June 30, 2025 Net Carrying Amount | December 31, 2024 Net Carrying Amount | | :--- | :--- | :--- | | Patents | $5,489 | $5,017 | | Trademarks | $626 | $562 | | Total intangible assets | $6,115 | $5,579 | - Net intangible assets increased by **$536 thousand** from December 31, 2024, to June 30, 2025, driven by an increase in patents and trademarks[36](index=36&type=chunk) - Amortization expense for the six months ended June 30, 2025, was **$133 thousand**, slightly down from **$138 thousand** in the prior year period[36](index=36&type=chunk) [6. Fair Value Measurements](index=14&type=section&id=6.%20Fair%20Value%20Measurements) This note describes Axogen's fair value measurements for financial instruments, including money market funds and debt derivatives Fair Value Measurements | (in thousands) | June 30, 2025 Total | December 31, 2024 Total | | :--- | :--- | :--- | | **Assets:** | | | | Money market funds | $10,869 | $19,399 | | U.S. Treasuries | $9,886 | $5,928 | | Total assets | $20,755 | $25,327 | | **Liabilities:** | | | | Debt derivative liabilities | $2,078 | $2,400 | - The fair value of debt derivative liabilities decreased from **$2,400 thousand** at December 31, 2024, to **$2,078 thousand** at June 30, 2025, reflecting a change in fair value included in net income (loss)[41](index=41&type=chunk) - Debt derivative liabilities are measured using a probability-weighted expected return model based on three potential settlement scenarios for the Credit Facility, with significant unobservable inputs including discount rates and probabilities of prepayment/held-to-maturity[42](index=42&type=chunk)[43](index=43&type=chunk)[45](index=45&type=chunk) [7. Leases](index=16&type=section&id=7.%20Leases) This note details Axogen's lease obligations, including operating lease costs, sublease income, and right-of-use assets Leases | (in thousands) | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :--- | :--- | :--- | | Operating lease costs | $1,830 | $1,826 | | Short-term lease costs | $262 | $375 | | Variable lease costs | $48 | $289 | | Sublease income | $(541) | — | | Total operating lease expense | $1,599 | $2,490 | - Total operating lease expense decreased by **$891 thousand** for the six months ended June 30, 2025, compared to the prior year, primarily due to **$541 thousand** in sublease income[47](index=47&type=chunk) - The Company has operating lease right-of-use assets of **$13,527 thousand** and long-term lease obligations of **$18,040 thousand** as of June 30, 2025, with a weighted average operating lease term of **8.4 years**[49](index=49&type=chunk)[50](index=50&type=chunk) [8. Long-Term Debt, Net of Debt Discount and Financing Fees](index=18&type=section&id=8.%20Long-Term%20Debt%2C%20Net%20of%20Debt%20Discount%20and%20Financing%20Fees) This note outlines Axogen's long-term debt, including Credit Facility details, interest rates, and derivative liabilities Long-Term Debt, Net of Debt Discount and Financing Fees | (in thousands) | June 30, 2025 | December 31, 2024 | | :--- | :--- | :--- | | Credit Facility - first tranche | $35,000 | $35,000 | | Credit Facility - second tranche | $15,000 | $15,000 | | Less: unamortized debt discount and deferred financing fees | $(2,062) | $(2,504) | | Long-term debt, net | $47,938 | $47,496 | - The Company has **$50,000 thousand** outstanding under its Credit Facility, with the first tranche maturing June 30, 2027, and the second tranche maturing June 30, 2028[55](index=55&type=chunk) - Interest is calculated at **7.5%** plus the greater of Adjusted SOFR or **2.0% (11.90% at June 30, 2025)**, plus quarterly royalty payments from a revenue participation agreement, totaling approximately **1.5% per year** of additional interest[56](index=56&type=chunk) - The fair value of debt derivative liabilities was **$2,078 thousand** at June 30, 2025, and **$2,400 thousand** at December 31, 2024, with changes reported in the Condensed Consolidated Statements of Operations[57](index=57&type=chunk) [9. Stock-Based Compensation](index=19&type=section&id=9.%20Stock-Based%20Compensation) This note details Axogen's stock-based compensation expense and the types of awards granted to employees and officers Stock-Based Compensation | (in thousands) | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :--- | :--- | :--- | :--- | :--- | | Stock-based compensation expense | $5,168 | $3,907 | $8,077 | $7,826 | - Total stock-based compensation expense increased to **$8,077 thousand** for the six months ended June 30, 2025, from **$7,826 thousand** in the prior year period[64](index=64&type=chunk) - Awards granted during the six months ended June 30, 2025, included Restricted Stock Units (RSUs) and Performance Stock Units (PSUs) to officers and employees, with vesting conditions tied to time, revenue CAGR, TSR, sales quota goals, and BLA approval milestones[63](index=63&type=chunk)[65](index=65&type=chunk) [10. Net Income (Loss) Per Common Share](index=20&type=section&id=10.%20Net%20Income%20%28Loss%29%20Per%20Common%20Share) This note presents Axogen's basic and diluted net income (loss) per common share calculations and anti-dilutive exclusions Net Income (Loss) Per Common Share | (in thousands, except per share amounts) | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :--- | :--- | :--- | :--- | :--- | | Net income (loss) | $579 | $(1,921) | $(3,255) | $(8,556) | | Weighted average shares outstanding - basic | 46,063,092 | 43,713,313 | 45,605,419 | 43,473,541 | | Net income (loss) per common share - basic | $0.01 | $(0.04) | $(0.07) | $(0.20) | | Net income (loss) per common share - diluted | $0.01 | $(0.04) | $(0.07) | $(0.20) | - Basic and diluted EPS improved to **$0.01** for the three months ended June 30, 2025, from **$(0.04)** in the prior year, and to **$(0.07)** for the six months ended June 30, 2025, from **$(0.20)** in the prior year[66](index=66&type=chunk) - Anti-dilutive shares, including stock options and restricted/performance stock units, were excluded from diluted EPS calculations for periods with net losses[66](index=66&type=chunk) [11. Income Taxes](index=20&type=section&id=11.%20Income%20Taxes) This note explains Axogen's income tax position, including the absence of expense/benefit due to net operating losses - The Company recorded no income tax expense or benefit for the three and six months ended June 30, 2025 and 2024, due to net operating losses with fully reserved benefits[67](index=67&type=chunk)[101](index=101&type=chunk)[108](index=108&type=chunk) - A full valuation allowance is maintained against deferred tax assets, and future utilization of net operating loss carryforwards may be limited by IRC Section 382[68](index=68&type=chunk) - The Company is evaluating the potential effects of the recently signed One Big Beautiful Bill Act (OBBBA) on its financial statements, which makes permanent key elements of the Tax Cuts and Jobs Act of 2017[70](index=70&type=chunk)[93](index=93&type=chunk) [12. Segments](index=21&type=section&id=12.%20Segments) This note clarifies that Axogen operates as a single operating and reportable segment for financial reporting - Axogen operates as a single operating and reportable segment, as the Chief Executive Officer (CODM) reviews only consolidated financial information for resource allocation and performance assessment[72](index=72&type=chunk) [13. Commitments and Contingencies](index=21&type=section&id=13.%20Commitments%20and%20Contingencies) This note details Axogen's contractual obligations, operational dependencies, potential grant repayments, and legal proceedings - The Company has service agreements, including with Solvita for tissue processing, and exclusive distribution and supply agreements with Evergen for Axoguard products, expiring in 2030 or 2031[73](index=73&type=chunk)[74](index=74&type=chunk)[75](index=75&type=chunk)[76](index=76&type=chunk) - Axogen is highly dependent on its processing facilities in Ohio and could be harmed by prolonged unavailability[79](index=79&type=chunk) - The Company is in discussions with grant authorities regarding unmet job creation milestones for economic development grants, potentially owing up to **$950 thousand**, though some waivers and extensions have been received[80](index=80&type=chunk) - There is an alternative interpretation of the make-whole payment calculation for the Credit Facility, which could result in significantly larger payments (e.g., approximately **$26,900 thousand** if prepaid on June 30, 2025, compared to the Company's estimate of approximately zero if held to maturity)[81](index=81&type=chunk)[82](index=82&type=chunk) - The Company is subject to various legal proceedings in the ordinary course of business, which management believes are adequately covered by insurance or indemnified, or not expected to have a material adverse effect[84](index=84&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=25&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) This section provides management's perspective on Axogen's financial condition and operational results for the three and six months ended June 30, 2025, compared to the prior year. It covers revenue growth drivers, changes in gross profit and expenses, and an analysis of liquidity and capital resources, highlighting key business achievements and future outlook [Overview](index=25&type=section&id=Overview) This section provides a high-level introduction to Axogen's mission and leadership in peripheral nerve repair - Axogen is a leading company focused on peripheral nerve regeneration and repair, providing innovative solutions to restore nerve function and quality of life for patients with peripheral nerve injuries[87](index=87&type=chunk) [Product Portfolio](index=25&type=section&id=Product%20Portfolio) This section describes Axogen's comprehensive product offerings for peripheral nerve repair and their market availability - The Company's comprehensive product portfolio for peripheral nerve repair includes Avance Nerve Graft, Axoguard Nerve Connector, Axoguard Nerve Protector, Axoguard HA+ Nerve Protector™, Axoguard Nerve Cap, and Avive+ Soft Tissue Matrix™[88](index=88&type=chunk)[91](index=91&type=chunk) - Products are available in the U.S., Canada, Germany, the UK, Spain, South Korea, and other countries, with substantially all revenues derived from U.S. sales[88](index=88&type=chunk) [Business Outlook](index=25&type=section&id=Business%20Outlook) This section outlines Axogen's strategic focus on market expansion and mitigation efforts against macroeconomic risks - Axogen's strategy focuses on deepening presence in high-potential accounts like Level 1 trauma centers and academic-affiliated hospitals by expanding nerve repair indications and driving adoption across surgical specialties[89](index=89&type=chunk) - The Company is assessing steps to mitigate potential adverse effects from the evolving macroeconomic environment, including financial market volatility and geopolitical tensions, which could impact net revenue[90](index=90&type=chunk)[92](index=92&type=chunk) [Summary of Operational and Business Highlights](index=26&type=section&id=Summary%20of%20Operational%20and%20Business%20Highlights) This section highlights key operational achievements, including revenue growth, expanded insurance coverage, and FDA approval milestones - Revenues for Q2 2025 increased by **18.3%** to **$56,662 thousand**, and gross profit increased by **18.9%** to **$42,018 thousand** compared to Q2 2024[96](index=96&type=chunk) - Expanded coverage and reimbursement for nerve repair products by an estimated **10 million new covered lives** in 2025, bringing total new lives covered to approximately **17 million** and private payer coverage to over **55%**[96](index=96&type=chunk) - The FDA accepted the BLA for Avance® Nerve Graft, with a Prescription Drug User Fee Act goal date of September 5, 2025. Regulatory milestones, including a late-cycle meeting, pre-licensing inspection, and sponsor inspection, were completed in Q2 2025[96](index=96&type=chunk) [Results of Operations - Three Months Ended June 30, 2025 and 2024](index=26&type=section&id=Results%20of%20Operations%20-%20Three%20Months%20Ended%20June%2030%2C%202025%20and%202024) This section analyzes Axogen's financial performance for the three months ended June 30, 2025, compared to the prior year Results of Operations - Three Months Ended June 30, 2025 and 2024 | (dollars in thousands) | 2025 Amount | 2025 % of Revenue | 2024 Amount | 2024 % of Revenue | | :--- | :--- | :--- | :--- | :--- | | Revenues | $56,662 | 100.0% | $47,912 | 100.0% | | Gross profit | $42,018 | 74.2% | $35,345 | 73.8% | | Income (loss) from operations | $1,672 | 3.0% | $(428) | (0.9)% | | Net income (loss) | $579 | 1.0% | $(1,921) | (4.0)% | - Revenues increased by **$8,750 thousand (18.3%)** due to a **12.2% increase in unit volume** and a combined **6.1% net impact** from changes in price and product mix[97](index=97&type=chunk) - Gross margin improved to **74.2%** from **73.8%**, driven by lower inventory write-offs and shipping costs (**0.9% increase**), partially offset by higher product costs (**0.5% decrease**)[98](index=98&type=chunk) - Total costs and expenses increased by **12.8%** to **$40,346 thousand**, primarily due to higher compensation costs (**$3,167 thousand**) and marketing program costs (**$912 thousand**)[99](index=99&type=chunk) - Other expense, net decreased by **$400 thousand (26.8%)**, mainly due to increases in other income and changes in fair value of debt derivative liabilities, and a decrease in interest expense[100](index=100&type=chunk) [Results of Operations - Six Months Ended June 30, 2025 and 2024](index=28&type=section&id=Results%20of%20Operations%20-%20Six%20Months%20Ended%20June%2030%2C%202025%20and%202024) This section analyzes Axogen's financial performance for the six months ended June 30, 2025, compared to the prior year Results of Operations - Six Months Ended June 30, 2025 and 2024 | (dollars in thousands) | 2025 Amount | 2025 % of Revenue | 2024 Amount | 2024 % of Revenue | | :--- | :--- | :--- | :--- | :--- | | Revenues | $105,222 | 100.0% | $89,289 | 100.0% | | Gross profit | $76,951 | 73.1% | $67,964 | 76.1% | | Income (loss) from operations | $11 | — | $(4,988) | (5.6)% | | Net loss | $(3,255) | (3.1)% | $(8,556) | (9.6)% | - Revenues increased by **$15,933 thousand (17.8%)** due to an **11.8% increase in unit volume** and a combined **5.5% net impact** from changes in price and product mix[104](index=104&type=chunk) - Gross margin decreased to **73.1%** from **76.1%**, primarily due to higher product costs (**2.8% decrease**) and increased inventory write-offs (**0.5% decrease**), partially offset by lower shipping costs (**0.4% increase**)[105](index=105&type=chunk) - Total costs and expenses increased by **5.5%** to **$76,940 thousand**, driven by sales and marketing (**13.5% increase**) but offset by decreases in research and development (**8.0% decrease**) and general and administrative (**1.2% decrease**) expenses[106](index=106&type=chunk) - Other expense, net decreased by **$302 thousand (8.5%)**, mainly due to decreases in interest expense and other expenses, partially offset by decreases in investment income and changes in fair value of debt derivative liabilities[107](index=107&type=chunk) [Critical Accounting Estimates](index=29&type=section&id=Critical%20Accounting%20Estimates) This section identifies Axogen's critical accounting policies requiring significant judgment and estimation, with no material changes - The Company's critical accounting policies include Inventories, Derivative Instruments, and Stock-based Compensation, which require substantial judgment and estimation. No material changes to these estimates occurred during the quarter[109](index=109&type=chunk) [Liquidity and Capital Resources](index=29&type=section&id=Liquidity%20and%20Capital%20Resources) This section analyzes Axogen's liquidity sources, capital structure, and future funding requirements - As of June 30, 2025, principal liquidity sources were cash and cash equivalents and investments totaling **$29,922 thousand**, a decrease of **$3,560 thousand** from December 31, 2024[110](index=110&type=chunk) - Current assets exceeded current liabilities by **$78,439 thousand**, with a current ratio of **4.1x**, and management believes existing liquidity and product sales will fund operations for at least the next twelve months[112](index=112&type=chunk) - The Company has **$50,000 thousand** outstanding under its Credit Facility, with quarterly interest and revenue participation payments due. A make-whole payment is required upon maturity or earlier repayment, calculated to achieve an **11.5% IRR** for the lender[117](index=117&type=chunk) - Future capital requirements depend on factors like customer base expansion, sales force growth, and regulatory approvals. Additional funding may be sought through equity or debt, with no assurance of availability on acceptable terms[118](index=118&type=chunk) [Contractual Obligations and Commitments](index=31&type=section&id=Contractual%20Obligations%20and%20Commitments) This section details Axogen's future contractual obligations, including debt principal, interest, and lease payments Contractual Obligations and Commitments | Contractual Obligations (in thousands) | 2025 Remaining | 2026-2027 | 2028-2029 | Thereafter | Total | | :--- | :--- | :--- | :--- | :--- | :--- | | Credit Facility principal | $— | $35,000 | $15,000 | $— | $50,000 | | Credit Facility interest | $2,975 | $9,816 | $892 | $— | $13,683 | | Credit Facility revenue participation payments | $232 | $1,512 | $231 | $— | $1,975 | | Operating and financing lease obligations | $2,089 | $7,404 | $6,306 | $15,386 | $31,185 | | Insurance financing agreements | $897 | $— | $— | $— | $897 | | Total | $6,193 | $53,732 | $22,429 | $15,386 | $97,740 | [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=31&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) This section discusses Axogen's exposure to market risks, primarily interest rate risk associated with its Credit Facility. It highlights that changes in the Adjusted SOFR rate could affect interest expense, with a 100 basis point increase potentially raising annual interest expense by approximately $500 thousand - Axogen has interest rate exposure from its **$50,000 thousand** Credit Facility, where interest is calculated as **7.5%** plus the greater of Adjusted SOFR or **2.0% (11.90% at June 30, 2025)**[124](index=124&type=chunk) - A **100 basis point increase** in interest rates would increase annual interest expense by approximately **$500 thousand**, which is not expected to materially affect results of operations[124](index=124&type=chunk) [Item 4. Controls and Procedures](index=31&type=section&id=Item%204.%20Controls%20and%20Procedures) This section confirms that Axogen's management, including its principal executive and financial officers, evaluated the effectiveness of its disclosure controls and procedures as of June 30, 2025, and concluded they were effective. No material changes in internal control over financial reporting occurred during the quarter - Management concluded that Axogen's disclosure controls and procedures were effective as of June 30, 2025, providing reasonable assurance of achieving desired objectives[125](index=125&type=chunk)[126](index=126&type=chunk) - There were no material changes in internal control over financial reporting during the three months ended June 30, 2025[127](index=127&type=chunk) [Part II - Other Information](index=32&type=section&id=Part%20II%20-%20Other%20Information) This part covers other required disclosures, including legal proceedings, risk factors, and equity security sales [Item 1. Legal Proceedings](index=32&type=section&id=Item%201.%20Legal%20Proceedings) This section refers to the legal proceedings disclosures in Note 13 - Commitments and Contingencies, indicating that Axogen is involved in various claims and lawsuits in the ordinary course of business, which management believes are not expected to have a material adverse effect - Axogen is subject to various claims, lawsuits, and proceedings in the ordinary course of business, as detailed in Note 13[128](index=128&type=chunk) - Management believes these matters are adequately covered by insurance or indemnified, or are not expected to result in a material adverse effect on the Company's financial condition, results of operations, or cash flows[84](index=84&type=chunk) [Item 1A. Risk Factors](index=32&type=section&id=Item%201A.%20Risk%20Factors) This section states that there have been no material changes to the risk factors previously disclosed in Axogen's 2024 Annual Report on Form 10-K. Investors are advised to carefully consider all disclosed risks, as they could materially harm the business and stock price - No material changes to the risk factors disclosed in the 2024 Annual Report on Form 10-K have occurred[129](index=129&type=chunk) - Investment in Axogen involves a high degree of risk, and potential investors should review all risk factors, as they could materially affect the business, financial condition, results of operations, and stock price[129](index=129&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=32&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) This section indicates that there were no unregistered sales of equity securities or use of proceeds to report during the period - No unregistered sales of equity securities and use of proceeds occurred[130](index=130&type=chunk) [Item 3. Defaults Upon Senior Securities](index=32&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) This section states that there were no defaults upon senior securities to report - No defaults upon senior securities occurred[131](index=131&type=chunk) [Item 4. Mine Safety Disclosures](index=32&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This section indicates that mine safety disclosures are not applicable to Axogen's operations - Mine safety disclosures are not applicable to the Company[132](index=132&type=chunk) [Item 5. Other Information](index=32&type=section&id=Item%205.%20Other%20Information) This section reports that no director or officer adopted or terminated a Rule 10b5-1 trading arrangement or a non-Rule 10b5-1 trading arrangement during the quarter ended June 30, 2025 - No director or officer adopted or terminated a Rule 10b5-1 or non-Rule 10b5-1 trading arrangement during the quarter ended June 30, 2025[133](index=133&type=chunk) [Item 6. Exhibits](index=33&type=section&id=Item%206.%20Exhibits) This section lists the exhibits filed with the Form 10-Q, including separation and employment agreements, certifications of principal executive and financial officers, and XBRL-related documents - Exhibits include Separation Agreement and Employment Agreement (both dated May 7, 2025), Certifications of Principal Executive and Financial Officers (pursuant to Sarbanes-Oxley Act), and various Inline XBRL Taxonomy documents[134](index=134&type=chunk)

分组1 - AxoGen reported quarterly earnings of $0.12 per share, exceeding the Zacks Consensus Estimate of $0.06 per share, and showing an increase from $0.05 per share a year ago, resulting in an earnings surprise of +100.00% [1] - The company achieved revenues of $56.66 million for the quarter ended June 2025, surpassing the Zacks Consensus Estimate by 7.11%, and up from $47.91 million year-over-year [2] - Over the last four quarters, AxoGen has surpassed consensus EPS estimates three times and topped consensus revenue estimates four times [2] 分组2 - The stock has underperformed, losing about 23.9% since the beginning of the year, while the S&P 500 has gained 7.6% [3] - The current consensus EPS estimate for the coming quarter is $0.07 on revenues of $55.93 million, and for the current fiscal year, it is $0.20 on revenues of $216.4 million [7] - The Zacks Industry Rank for Medical - Instruments is currently in the bottom 37% of over 250 Zacks industries, indicating potential underperformance compared to higher-ranked industries [8]