[Executive Summary & Business Outlook](index=1&type=section&id=1.%20Executive%20Summary%20%26%20Business%20Outlook) Organogenesis Holdings Inc. is a regenerative medicine company reporting Q2 2025 financial results, with the CEO expressing confidence in strategic outlook and future policy changes [Company Overview](index=1&type=section&id=1.1%20Company%20Overview) Organogenesis Holdings Inc. is a regenerative medicine company specializing in product solutions for Advanced Wound Care and Surgical & Sports Medicine markets - Organogenesis Holdings Inc. is a leading regenerative medicine company focused on developing, manufacturing, and commercializing product solutions for Advanced Wound Care and Surgical & Sports Medicine markets[1](index=1&type=chunk) [CEO Commentary and Strategic Outlook](index=1&type=section&id=1.2%20CEO%20Commentary%20and%20Strategic%20Outlook) The CEO expressed satisfaction with Q2 performance and the company's ability to navigate a disrupted environment. He anticipates 2026 policy changes to bring industry stability and opportunities, reinforcing confidence in the company's comprehensive portfolio and the transformational potential of ReNu for knee OA, with Phase 3 data expected in September - CEO Gary S. Gillheeney, Sr. is pleased with the team's Q2 performance and focus on helping customers navigate a disrupted environment[3](index=3&type=chunk) - Policy changes expected in 2026 are anticipated to be a 'watershed moment' for the industry, bringing stability and creating opportunities[3](index=3&type=chunk) - The company remains confident in the transformational potential of ReNu for knee OA and expects to share top-line data from its second Phase 3 study in September[3](index=3&type=chunk) [Second Quarter 2025 Financial Highlights](index=1&type=section&id=1.3%20Second%20Quarter%202025%20Financial%20Highlights) Organogenesis reported a decrease in net product revenue and a net loss for Q2 2025, though the net loss improved compared to Q2 2024. Adjusted net income and Adjusted EBITDA, however, saw significant declines | Metric | Q2 2025 (Millions) | Q2 2024 (Millions) | Change (Millions) | Change (%) | | :-------------------------- | :----------------- | :----------------- | :---------------- | :--------- | | Net product revenue | $100.8 | $130.2 | $(29.5) | (23%) | | Net loss | $(9.4) | $(17.0) | $7.6 | 45% | | Adjusted net loss | $(7.5) | $0.2 | $(7.7) | - | | Adjusted EBITDA loss | $(3.6) | $15.6 | $(19.3) | - | - Net product revenue from Advanced Wound Care products decreased by **25%** to **$92.7 million**[4](index=4&type=chunk) - Net product revenue from Surgical & Sports Medicine products increased by **16%** to **$8.1 million**[4](index=4&type=chunk) [Second Quarter 2025 Financial Results](index=2&type=section&id=2.%20Second%20Quarter%202025%20Financial%20Results) This section provides a detailed breakdown of Organogenesis's financial performance for the second quarter of 2025, covering revenue, expenses, and profitability metrics [Net Product Revenue](index=2&type=section&id=2.1%20Net%20Product%20Revenue) Net product revenue for Q2 2025 decreased by 23% year-over-year, primarily due to a significant decline in Advanced Wound Care products, partially offset by growth in Surgical & Sports Medicine products | Product Category | Q2 2025 (Thousands) | Q2 2024 (Thousands) | Change (Thousands) | Change (%) | | :------------------------- | :------------------ | :------------------ | :----------------- | :--------- | | Advanced Wound Care | $92,696 | $123,237 | $(30,541) | (25%) | | Surgical & Sports Medicine | $8,083 | $6,997 | $1,086 | 16% | | **Total Net Product Revenue** | **$100,779** | **$130,234** | **$(29,455)** | **(23%)** | - The decrease in net product revenue was primarily driven by a **$30.5 million**, or **25%**, decrease in Advanced Wound Care products[5](index=5&type=chunk) - The decrease was partially offset by a **$1.1 million**, or **16%**, increase in Surgical & Sports Medicine products[5](index=5&type=chunk) [Gross Profit and Operating Expenses](index=2&type=section&id=2.2%20Gross%20Profit%20and%20Operating%20Expenses) Gross profit decreased by 28% in Q2 2025, with the gross margin declining to 73%. Total operating expenses decreased by 21%, driven by reductions in R&D and impairment expenses, while SG&A saw a smaller decrease | Metric | Q2 2025 (Thousands) | Q2 2024 (Thousands) | Change (Thousands) | Change (%) | | :---------------------- | :------------------ | :------------------ | :----------------- | :--------- | | Gross Profit | $73,100 | $101,000 | $(27,900) | (28%) | | Gross Profit Margin | 73% | 78% | -5% pts | - | | Total Operating Expenses| $113,581 | $144,126 | $(30,545) | (21%) | | Cost of Goods Sold | $27,630 | $29,198 | $(1,568) | (5%) | | R&D Expense | $10,395 | $15,587 | $(5,192) | (33%) | | SG&A Expenses | $73,810 | $76,540 | $(2,730) | (4%) | | Impairment & Write-down | $1,746 | $22,801 | $(21,055) | (92%) | - The company recorded **$0.2 million** in grant income during Q2 2025[6](index=6&type=chunk) [Profitability (GAAP & Non-GAAP)](index=2&type=section&id=2.3%20Profitability%20(GAAP%20%26%20Non-GAAP)) Organogenesis reported an improved GAAP net loss for Q2 2025 compared to the prior year, with a smaller operating loss. However, adjusted net income shifted to a loss, and Adjusted EBITDA turned negative, indicating a decline in underlying operational profitability | Metric | Q2 2025 (Thousands) | Q2 2024 (Thousands) | Change (Thousands) | Change (%) | | :-------------------------- | :------------------ | :------------------ | :----------------- | :--------- | | Operating Loss | $(12,576) | $(13,892) | $1,316 | 9% |\n| Total Other Income (Expense)| $742 | $(648) | $1,390 | - | | Net Loss | $(9,392) | $(17,043) | $7,651 | 45% | | Net Loss Per Share (Basic & Diluted) | $(0.10) | $(0.13) | $0.03 | 23% | | Adjusted Net Loss | $(7,503) | $211 | $(7,714) | - | | Adjusted EBITDA Loss | $(3,640) | $15,649 | $(19,289) | - | | Non-GAAP Operating Loss | $(9,989) | $9,743 | $(19,732) | - | [Cash and Debt Position](index=3&type=section&id=2.4%20Cash%20and%20Debt%20Position) As of June 30, 2025, the company's cash, cash equivalents, and restricted cash significantly decreased compared to December 31, 2024, while maintaining no outstanding debt obligations | Metric | June 30, 2025 (Millions) | December 31, 2024 (Millions) | Change (Millions) | | :-------------------------------------- | :----------------------- | :--------------------------- | :---------------- | | Cash, cash equivalents, restricted cash | $73.7 | $136.2 | $(62.5) | | Outstanding Debt Obligations | $0 | $0 | $0 | [First Half 2025 Financial Results](index=3&type=section&id=3.%20First%20Half%202025%20Financial%20Results) This section presents Organogenesis's financial performance for the first half of 2025, including revenue, cost structures, and profitability across GAAP and non-GAAP measures [Net Product Revenue](index=3&type=section&id=3.1%20Net%20Product%20Revenue) For the first half of 2025, net product revenue decreased by 22% year-over-year, primarily driven by a substantial decline in Advanced Wound Care products, partially offset by growth in Surgical & Sports Medicine products | Product Category | H1 2025 (Thousands) | H1 2024 (Thousands) | Change (Thousands) | Change (%) | | :------------------------- | :------------------ | :------------------ | :----------------- | :--------- | | Advanced Wound Care | $172,623 | $227,101 | $(54,478) | (24%) | | Surgical & Sports Medicine | $14,849 | $13,109 | $1,740 | 13% | | **Total Net Product Revenue** | **$187,472** | **$240,210** | **$(52,738)** | **(22%)** | - The decrease in net product revenue was driven by a **$54.5 million**, or **24%**, decrease in Advanced Wound Care products[12](index=12&type=chunk) - This was partially offset by a **$1.7 million**, or **13%**, increase in Surgical & Sports Medicine products[12](index=12&type=chunk) [Gross Profit and Operating Expenses](index=3&type=section&id=3.2%20Gross%20Profit%20and%20Operating%20Expenses) Gross profit for the first half of 2025 decreased by 25%, with the gross margin falling to 73%. Total operating expenses decreased by 12%, mainly due to lower R&D and impairment expenses, while SG&A saw a modest reduction | Metric | H1 2025 (Thousands) | H1 2024 (Thousands) | Change (Thousands) | Change (%) | | :---------------------- | :------------------ | :------------------ | :----------------- | :--------- | | Gross Profit | $136,100 | $182,300 | $(46,200) | (25%) | | Gross Profit Margin | 73% | 76% | -3% pts | - | | Total Operating Expenses| $227,020 | $257,954 | $(30,934) | (12%) | | Cost of Goods Sold | $51,353 | $57,894 | $(6,541) | (11%) | | R&D Expense | $21,035 | $28,397 | $(7,362) | (26%) | | SG&A Expenses | $146,319 | $148,862 | $(2,543) | (2%) | | Impairment & Write-down | $8,313 | $22,799 | $(14,486) | (64%) | [Profitability (GAAP & Non-GAAP)](index=3&type=section&id=3.3%20Profitability%20(GAAP%20%26%20Non-GAAP)) For the first half of 2025, Organogenesis experienced an increased GAAP net loss and operating loss compared to the prior year. Adjusted net loss and Adjusted EBITDA also worsened significantly, reflecting a challenging first half for profitability | Metric | H1 2025 (Thousands) | H1 2024 (Thousands) | Change (Thousands) | Change (%) | | :-------------------------- | :------------------ | :------------------ | :----------------- | :--------- | | Operating Loss | $(39,322) | $(17,744) | $(21,578) | (122%) | | Total Other Income (Expense)| $1,705 | $(1,139) | $2,844 | - | | Net Loss | $(28,235) | $(19,143) | $(9,092) | (47%) | | Net Loss Per Share (Basic & Diluted) | $(0.27) | $(0.14) | $(0.13) | (93%) | | Adjusted Net Loss | $(20,938) | $(1,232) | $(19,706) | (1600%) | | Adjusted EBITDA Loss | $(16,164) | $18,200 | $(34,364) | - | | Non-GAAP Operating Loss | $(29,326) | $6,792 | $(36,118) | - | [Cash and Debt Position](index=4&type=section&id=3.4%20Cash%20and%20Debt%20Position) As of June 30, 2025, the company's cash, cash equivalents, and restricted cash significantly decreased compared to the end of 2024, with no outstanding debt obligations | Metric | June 30, 2025 (Millions) | December 31, 2024 (Millions) | Change (Millions) | | :-------------------------------------- | :----------------------- | :--------------------------- | :---------------- | | Cash, cash equivalents, restricted cash | $73.7 | $136.2 | $(62.5) | | Outstanding Debt Obligations | $0 | $0 | $0 | [Fiscal Year 2025 Guidance](index=4&type=section&id=4.%20Fiscal%20Year%202025%20Guidance) The company updated its fiscal year 2025 guidance, projecting revenue and profitability ranges for the full year [Revenue Guidance](index=4&type=section&id=4.1%20Revenue%20Guidance) Organogenesis updated its fiscal year 2025 revenue guidance, projecting overall net product revenue to be roughly flat to an increase of 6% year-over-year, with Advanced Wound Care products showing slight growth and Surgical & Sports Medicine products expecting stronger growth | Metric | FY 2025 Guidance Range (Millions) | FY 2024 (Millions) | YoY Change Range (%) | | :-------------------------------------- | :-------------------------------- | :----------------- | :------------------- | | Net product revenue | $480.0 - $510.0 | $482.0 | Flat to 6% | | Advanced Wound Care product revenue | $450.0 - $475.0 | $453.6 | -1% to 5% | | Surgical & Sports Medicine product revenue | $30.0 - $35.0 | $28.4 | 6% to 23% | [Profitability Guidance](index=4&type=section&id=4.2%20Profitability%20Guidance) The company updated its profitability guidance for fiscal year 2025, expecting a range from a net loss to a net income, and projecting positive adjusted net income, EBITDA, and Adjusted EBITDA | Metric | FY 2025 Guidance Range (Millions) | | :------------------ | :-------------------------------- | | Net income (loss) | $(6.4) - $16.4 | | Adjusted net income | $5.5 - $28.3 | | EBITDA | $6.2 - $37.0 | | Adjusted EBITDA | $31.1 - $61.9 | [Unaudited Consolidated Financial Statements](index=5&type=section&id=5.%20Unaudited%20Consolidated%20Financial%20Statements) This section provides the unaudited consolidated financial statements, including balance sheets, statements of operations, and cash flow data for the reported periods [Consolidated Balance Sheets](index=5&type=section&id=5.1%20Consolidated%20Balance%20Sheets) The balance sheet shows a decrease in total assets and total liabilities from December 31, 2024, to June 30, 2025, primarily driven by a reduction in cash and cash equivalents | Metric (Thousands) | June 30, 2025 | December 31, 2024 | | :----------------------------- | :------------ | :---------------- | | Cash and cash equivalents | $73,076 | $135,571 | | Total current assets | $260,223 | $285,941 | | Total assets | $461,128 | $497,886 | | Total current liabilities | $65,839 | $77,477 | | Total liabilities | $99,909 | $112,570 | | Total stockholders' equity | $233,242 | $262,897 | - Accounts receivable, net, increased from **$109.9 million** to **$120.4 million**[22](index=22&type=chunk) - Inventories, net, increased from **$26.2 million** to **$33.0 million**[22](index=22&type=chunk) [Consolidated Statements of Operations and Comprehensive Loss](index=6&type=section&id=5.2%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) The consolidated statements of operations show a decrease in total revenue for both the three and six months ended June 30, 2025, leading to increased operating and net losses compared to the prior year periods | Metric (Thousands) | Q2 2025 | Q2 2024 | H1 2025 | H1 2024 | | :----------------------------- | :------------ | :------------ | :------------ | :------------ | | Net product revenue | $100,779 | $130,234 | $187,472 | $240,210 | | Total revenue | $101,005 | $130,234 | $187,698 | $240,210 | | Total operating expenses | $113,581 | $144,126 | $227,020 | $257,954 | | Loss from operations | $(12,576) | $(13,892) | $(39,322) | $(17,744) | | Net loss and comprehensive loss| $(9,392) | $(17,043) | $(28,235) | $(19,143) | | Net loss per share (Basic & Diluted) | $(0.10) | $(0.13) | $(0.27) | $(0.14) | - Grant income of **$0.2 million** was recorded in Q2 and H1 2025, which was not present in the prior year[24](index=24&type=chunk) - Impairment and write-down expenses were significantly lower in Q2 2025 (**$1.7 million**) compared to Q2 2024 (**$22.8 million**)[24](index=24&type=chunk) [Consolidated Statement of Cash Flows](index=7&type=section&id=5.3%20Consolidated%20Statement%20of%20Cash%20Flows) The consolidated statement of cash flows indicates a significant increase in net cash used in operating activities for the first half of 2025 compared to the prior year, primarily driven by changes in working capital, leading to a substantial decrease in cash, cash equivalents, and restricted cash | Metric (Thousands) | H1 2025 | H1 2024 | | :----------------------------------------------- | :------------ | :------------ | | Net loss | $(28,235) | $(19,143) | | Net cash used in operating activities | $(52,808) | $(5,424) | | Net cash used in investing activities | $(7,264) | $(4,102) | | Net cash used in financing activities | $(2,344) | $(4,335) | | Change in cash, cash equivalents and restricted cash | $(62,416) | $(13,861) | | Cash, cash equivalents, and restricted cash, end of period | $73,735 | $90,477 | - Significant changes in operating assets and liabilities include a **$13.6 million** increase in accounts receivable (use of cash) and a **$15.9 million** increase in inventories (use of cash) in H1 2025[26](index=26&type=chunk) - Purchases of property and equipment increased to **$7.3 million** in H1 2025 from **$4.1 million** in H1 2024[26](index=26&type=chunk) [Non-GAAP Financial Measures Reconciliation](index=8&type=section&id=6.%20Non-GAAP%20Financial%20Measures%20Reconciliation) This section reconciles GAAP financial measures to non-GAAP metrics such as Adjusted EBITDA, Adjusted Net Income, and Non-GAAP Operating Income for both historical and projected periods [Adjusted EBITDA Reconciliation](index=8&type=section&id=6.1%20Adjusted%20EBITDA%20Reconciliation) Adjusted EBITDA, a key non-GAAP metric used by management, showed a significant shift from income in Q2 and H1 2024 to a loss in Q2 and H1 2025, reflecting a decline in operational performance excluding certain non-cash and infrequent items - Adjusted EBITDA excludes interest, income tax, depreciation, amortization of intangibles, stock-based compensation, and other infrequent adjustments[28](index=28&type=chunk) | Metric (Thousands) | Q2 2025 | Q2 2024 | H1 2025 | H1 2024 | | :-------------------------- | :-------- | :-------- | :--------- | :--------- | | Net loss | $(9,392) | $(17,043) | $(28,235) | $(19,143) | | EBITDA | $(7,928) | $(9,720) | $(30,386) | $(9,576) | | Stock-based compensation | $2,542 | $2,568 | $5,909 | $4,975 | | Write-down for asset held for sale | $1,746 | — | $8,313 | — | | Impairment of property | — | $18,842 | — | $18,842 | | Write-down of software costs| — | $3,959 | — | $3,959 | | **Adjusted EBITDA** | **$(3,640)** | **$15,649** | **$(16,164)** | **$18,200** | [Adjusted Net Income (Loss) Reconciliation](index=8&type=section&id=6.2%20Adjusted%20Net%20Income%20(Loss)%20Reconciliation) Adjusted net income (loss) for Q2 and H1 2025 significantly declined compared to the prior year, moving from a positive adjusted net income in Q2 2024 to a substantial adjusted net loss in Q2 2025, after accounting for amortization of intangibles and other specific adjustments - Adjusted net income (loss) is defined as GAAP net loss plus amortization of intangible assets and other infrequent adjustments, less the estimated tax on these adjustments[30](index=30&type=chunk) | Metric (Thousands) | Q2 2025 | Q2 2024 | H1 2025 | H1 2024 | | :-------------------------- | :-------- | :-------- | :--------- | :--------- | | Net loss | $(9,392) | $(17,043) | $(28,235) | $(19,143) | | Amortization of intangibles | $841 | $834 | $1,683 | $1,735 | | Write-down for asset held for sale | $1,746 | — | $8,313 | — | | Impairment of property | — | $18,842 | — | $18,842 | | Write-down of software costs| — | $3,959 | — | $3,959 | | Tax on above | $(698) | $(6,381) | $(2,699) | $(6,625) | | **Adjusted net income (loss)** | **$(7,503)** | **$211** | **$(20,938)** | **$(1,232)** | [Non-GAAP Operating Income (Loss) Reconciliation](index=9&type=section&id=6.3%20Non-GAAP%20Operating%20Income%20(Loss)%20Reconciliation) Non-GAAP operating income (loss) for Q2 and H1 2025 shifted from income in the prior year to a loss, indicating a deterioration in core operating performance when excluding amortization of intangibles and other specific non-operating adjustments - Non-GAAP operating income (loss) is defined as GAAP loss from operations plus amortization of intangible assets and other infrequent adjustments[33](index=33&type=chunk) | Metric (Thousands) | Q2 2025 | Q2 2024 | H1 2025 | H1 2024 | | :-------------------------- | :-------- | :-------- | :--------- | :--------- | | Loss from operations | $(12,576) | $(13,892) | $(39,322) | $(17,744) | | Amortization of intangibles | $841 | $834 | $1,683 | $1,735 | | Write-down for asset held for sale | $1,746 | — | $8,313 | — | | Impairment of property | — | $18,842 | — | $18,842 | | Write-down of software costs| — | $3,959 | — | $3,959 | | **Non-GAAP operating income (loss)** | **$(9,989)** | **$9,743** | **$(29,326)** | **$6,792** | [Projected Non-GAAP Reconciliations](index=9&type=section&id=6.4%20Projected%20Non-GAAP%20Reconciliations) The company provided projected reconciliations for its fiscal year 2025 guidance, showing expected ranges for EBITDA, Adjusted EBITDA, and Adjusted Net Income, which are used by management to evaluate operating results | Metric (Thousands) | FY 2025L | FY 2025H | | :-------------------------- | :-------- | :-------- | | Net income (loss) | $(6,400) | $16,400 | | EBITDA | $6,200 | $37,000 | | Adjusted EBITDA | $31,100 | $61,900 | | Adjusted net income | $5,500 | $28,300 | - Projected Adjusted EBITDA includes adjustments for stock-based compensation, write-down for asset held for sale, and FDA fees[36](index=36&type=chunk) - Projected Adjusted Net Income includes adjustments for amortization of intangible assets, write-down for asset held for sale, FDA fees, and related tax impacts[37](index=37&type=chunk) [Corporate Information](index=11&type=section&id=7.%20Corporate%20Information) This section provides essential corporate information, including forward-looking statements, a company overview, and investor and media contact details [Forward-Looking Statements](index=11&type=section&id=7.1%20Forward-Looking%20Statements) This section outlines the forward-looking nature of statements in the release, cautioning readers about inherent risks and uncertainties that could cause actual results to differ materially from projections, including regulatory changes, competition, technological shifts, and product commercialization challenges - Forward-looking statements relate to expectations or forecasts of future events, including expected revenue, net income, adjusted net income, EBITDA, and Adjusted EBITDA for fiscal 2025[38](index=38&type=chunk) - Key risk factors include the impact of changes to coverage and reimbursement levels (e.g., proposed LCDs and CMS rules for 2026), significant competition, rapid technological change, and the ability to convince physicians of product safety and efficacy[38](index=38&type=chunk) - Other risks include the ability to raise funds, potential future losses, regulatory changes, supply chain issues, and the commercialization status of products like ReNu and Dermagraft[38](index=38&type=chunk) [About Organogenesis Holdings Inc.](index=12&type=section&id=7.2%20About%20Organogenesis%20Inc.) Organogenesis Holdings Inc. is a regenerative medicine company offering a broad portfolio of innovative products for advanced wound care and surgical & sports medicine markets, aiming to address patient needs across the continuum of care - Organogenesis Holdings Inc. is a leading regenerative medicine company[39](index=39&type=chunk) - The company focuses on developing, manufacturing, and commercializing solutions for advanced wound care and surgical and sports medicine markets[39](index=39&type=chunk) - It offers a comprehensive portfolio of innovative regenerative products[39](index=39&type=chunk) [Investor and Media Contacts](index=12&type=section&id=7.3%20Investor%20and%20Media%20Contacts) Contact information is provided for investor inquiries through ICR Healthcare and for press and media inquiries directly with Organogenesis - Investor inquiries should be directed to Mike Piccinino, CFA at ICR Healthcare (OrganoIR@icrinc.com)[40](index=40&type=chunk) - Press and media inquiries should be directed to Organogenesis (communications@organo.com)[40](index=40&type=chunk)

Core Viewpoint - Organogenesis Holdings Inc. reported a significant decline in net product revenue for the second quarter of 2025, primarily due to a decrease in Advanced Wound Care products, while Surgical & Sports Medicine products showed growth. The company anticipates policy changes in 2026 that could stabilize the industry and create new opportunities for patient care [3][4][5]. Financial Results Summary Second Quarter 2025 - Net product revenue was $100.8 million, down from $130.2 million in Q2 2024, representing a decrease of 23% [5][9]. - Advanced Wound Care revenue decreased by 25% to $92.7 million, while Surgical & Sports Medicine revenue increased by 16% to $8.1 million [4][5]. - The net loss for Q2 2025 was $9.4 million, an improvement from a net loss of $17.0 million in Q2 2024 [9][10]. - Adjusted net loss was $7.5 million, compared to an adjusted net income of $0.2 million in Q2 2024 [5][9]. - Adjusted EBITDA loss was $3.6 million, down from an adjusted EBITDA income of $15.6 million in Q2 2024 [5][9]. First Half 2025 - Net product revenue for the first half of 2025 was $187.5 million, a decrease of 22% from $240.2 million in the same period of 2024 [11][12]. - Advanced Wound Care revenue for the first half decreased by 24% to $172.6 million, while Surgical & Sports Medicine revenue increased by 13% to $14.8 million [11][12]. - The net loss for the first half was $28.2 million, compared to a net loss of $19.1 million in the first half of 2024 [15][16]. - Adjusted net loss for the first half was $20.9 million, compared to an adjusted net loss of $1.2 million in the same period of 2024 [15][16]. - Adjusted EBITDA loss was $16.2 million, a significant decline from adjusted EBITDA income of $18.2 million in the first half of 2024 [16]. Operating Expenses - Operating expenses for Q2 2025 were $113.6 million, down 21% from $144.1 million in Q2 2024 [7][8]. - R&D expenses decreased by 33% to $10.4 million in Q2 2025 [7]. - Selling, general, and administrative expenses were $73.8 million, a decrease of 4% from $76.5 million in Q2 2024 [7]. Cash Position - As of June 30, 2025, the company had $73.7 million in cash and cash equivalents, down from $136.2 million at the end of 2024 [10][17]. Fiscal Year 2025 Guidance - The company expects net product revenue for 2025 to be between $480.0 million and $510.0 million, with Advanced Wound Care revenue projected between $450.0 million and $475.0 million [19]. - Surgical & Sports Medicine revenue is expected to be between $30.0 million and $35.0 million [19]. - The company anticipates a net income (loss) between $(6.4) million and $16.4 million for the year [19].

Core Viewpoint - Organogenesis Holdings Inc. will report its second quarter fiscal year 2025 financial results on August 7, 2025, after market close [1] Group 1: Financial Results Announcement - The financial results for the second quarter of fiscal year 2025 will be disclosed after the market closes on August 7, 2025 [1] - A conference call will be held at 5:00 p.m. Eastern Time on the same day to discuss the results and provide a corporate update [2] Group 2: Company Overview - Organogenesis Holdings Inc. specializes in regenerative medicine, focusing on advanced wound care and surgical and sports medicine markets [3] - The company offers a comprehensive portfolio of innovative regenerative products to meet patient needs across the continuum of care [3]

Core Viewpoint - Organogenesis Holdings Inc. supports the Centers for Medicare & Medicaid Services' (CMS) proposed new payment methodology for skin substitutes, emphasizing the need for payment rates to reflect clinical value and relative cost [1][2]. Company Overview - Organogenesis Holdings Inc. is a leading regenerative medicine company focused on developing, manufacturing, and commercializing solutions for advanced wound care and surgical and sports medicine markets [3][5]. - The company offers a comprehensive portfolio of innovative regenerative products to meet patient needs across the continuum of care [3][5]. Industry Context - The proposed payment structure by CMS aims to establish a per centimeter square payment methodology based on FDA classification for skin substitutes, which is expected to reduce Medicare spending and ensure consistent payment across care settings [2]. - The new payment approach is anticipated to enhance access to innovative wound healing technologies, which have been shown to reduce life-threatening amputations and complications [2]. Future Outlook - With over forty years of leadership in regenerative medicine, the company is well-positioned for growth in the evolving wound care market [2]. - The company remains committed to collaborating with CMS and other stakeholders to refine proposed policies that promote long-term stability and expand access to PMA products [2].

Core Viewpoint - The article does not provide any specific insights or analysis related to a company or industry, focusing instead on the author's qualifications and disclosures [1][2][3]. Group 1 - The author holds multiple degrees in engineering, computer science, business management, and computer applications from various institutions [1]. - The author collaborates with another professional but emphasizes independent analysis and adherence to guidelines [1]. - There is a clear statement of no current stock or derivative positions in any mentioned companies, indicating a lack of conflict of interest [2]. Group 2 - The article includes disclaimers about past performance not guaranteeing future results and clarifies that no investment advice is being provided [3]. - It highlights that the views expressed may not reflect those of the platform as a whole, indicating a diversity of opinions among contributors [3]. - The article notes that the analysts may not be licensed or certified, which could impact the credibility of the analysis [3].

Company Performance - Organogenesis reported a quarterly loss of $0.13 per share, missing the Zacks Consensus Estimate of $0.04, and compared to a loss of $0.02 per share a year ago, representing an earnings surprise of -425% [1] - The company posted revenues of $86.69 million for the quarter ended March 2025, missing the Zacks Consensus Estimate by 4.06%, and down from $109.98 million year-over-year [2] - Over the last four quarters, Organogenesis has surpassed consensus EPS estimates two times and topped consensus revenue estimates three times [2] Stock Performance - Organogenesis shares have increased approximately 61.9% since the beginning of the year, contrasting with the S&P 500's decline of -4.3% [3] - The current consensus EPS estimate for the upcoming quarter is $0.04 on revenues of $143.96 million, and for the current fiscal year, it is $0.16 on revenues of $508.6 million [7] Industry Outlook - The Medical - Drugs industry, to which Organogenesis belongs, is currently ranked in the top 26% of over 250 Zacks industries, indicating a favorable outlook [8] - Empirical research shows a strong correlation between near-term stock movements and trends in earnings estimate revisions, suggesting that industry performance can significantly impact stock performance [5][8]

Financial Data and Key Metrics Changes - Net revenue for Q1 2025 was $86.7 million, down 21% year-over-year [16] - Advanced Wound Care net revenue was $79.9 million, down 23% [17] - Surgical and Sports Medicine products net revenue was $6.8 million, up 11% [17] - Gross profit was $63 million, or 72.6% of net revenue, compared to 73.9% last year [17] - Operating loss for Q1 was $26.7 million, compared to an operating loss of $3.9 million last year [17] - GAAP net loss for Q1 was $18.8 million, compared to a net loss of $2.1 million last year [18] - Adjusted EBITDA loss for Q1 was $12.5 million, compared to adjusted EBITDA of $2.6 million last year [19] Business Line Data and Key Metrics Changes - Advanced Wound Care products experienced a significant decline in revenue, while Surgical and Sports Medicine products showed growth [17] - The company faced challenges due to the delayed implementation of the LCD, impacting customer demand and ordering patterns [5][6] Market Data and Key Metrics Changes - The market environment remains uncertain due to the delayed LCD, which has affected customer behavior and buying patterns [5][6] - The company is optimistic about the long-term opportunity as changes in coverage policies are expected to be implemented in 2026, potentially increasing patient access [10] Company Strategy and Development Direction - The company is focused on gathering robust clinical and real-world evidence to support its product portfolio and drive market penetration [11] - The RENEW program is on track, with expectations for a BLA submission by the end of 2025, targeting a large pain management market [12] - The company is expanding its manufacturing capabilities with a new biomanufacturing facility, which will support the introduction of new products [15] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company's ability to navigate the challenging market and reaffirmed financial guidance for 2025 [9][19] - The company anticipates a stabilization of market dynamics in the second half of 2025, despite ongoing uncertainties [26][58] Other Important Information - The company has $110.5 million in cash and cash equivalents as of March 31, 2025, with no outstanding debt [19] - The 2025 revenue guidance remains between $480 million and $535 million, with expectations for a gradual improvement in business trends [20] Q&A Session Summary Question: Inquiry about the cadence throughout the year and guidance confidence - Management expressed confidence in the guidance, highlighting optionality in the portfolio and the availability of PuraPly across all indications [24][25] Question: Clarification on gross margin expectations - Management indicated that gross margins are expected to improve in the second half of the year due to a mix shift in the product portfolio and reduced expirations [28][30] Question: Comparison of Q1 performance to Q4 and market dynamics - Management noted that confusion regarding the LCD led to a contraction in the market, which was not present in Q4 [36][37] Question: Future changes in the LCD and CMS involvement - Management believes that CMS is reviewing coverage policies and that the delay allows for more data collection, which could positively impact product approvals [41][42] Question: Guidance reiteration despite LCD delays - Management explained that the broader product portfolio and higher-margin products provide flexibility to maintain guidance despite the LCD delay [50][54]

Financial Data and Key Metrics Changes - The company reported net revenue for Q1 2025 of $86.7 million, a decrease of 21% year-over-year [15] - Advanced Wound Care net revenue was $79.9 million, down 23%, while Surgical and Sports Medicine products revenue increased by 11% to $6.8 million [16] - Gross profit for Q1 was $63 million, representing 72.6% of net revenue, compared to 73.9% in the previous year [16] - Operating loss for Q1 was $26.7 million, significantly higher than the operating loss of $3.9 million in the prior year [17] - GAAP net loss for Q1 was $18.8 million, compared to a net loss of $2.1 million last year [17] - Adjusted EBITDA loss for Q1 was $12.5 million, compared to adjusted EBITDA of $2.6 million in the previous year [18] Business Line Data and Key Metrics Changes - Advanced Wound Care experienced a revenue decline of 23%, while Surgical and Sports Medicine products saw an increase of 11% [16] - The company expects net revenue from Advanced Wound Care products for 2025 to be between $450 million and $500 million, indicating a year-over-year change of a decline of 1% to an increase of 10% [19] - Surgical and Sports Medicine products are projected to generate revenue between $30 million and $35 million, representing a year-over-year increase of 6% to 23% [19] Market Data and Key Metrics Changes - The company noted disruptions in customer demand and ordering patterns due to uncertainty surrounding the effective date of the final LCD for skin substitute grafts [5] - The delay in the LCD implementation until January 1, 2026, is expected to provide an opportunity for the company to serve more patients and positively impact the wound care market [10] Company Strategy and Development Direction - The company is focused on gathering robust clinical and real-world evidence to enhance its product portfolio and market penetration [11] - The RENEW program is on track, with expectations to complete the second Phase III study by the end of Q2 2025 and submit a BLA by the end of the year [12] - The company is expanding its manufacturing capabilities with a new biomanufacturing facility in Smithfield, Rhode Island, which will support the reintroduction of key products [14] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the long-term opportunities for the company, particularly with the expected changes in coverage policies in 2026 [10] - The company anticipates a challenging environment in the first half of 2025, followed by significant improvement in business trends starting in Q3 [19] - Management emphasized the importance of educating customers to stabilize buying behaviors and return to previous purchasing patterns [53] Other Important Information - The company reaffirmed its financial guidance for 2025, expecting net revenue between $480 million and $535 million, with a year-over-year change of roughly flat to an increase of 11% [19] - The company has $110.5 million in cash and cash equivalents as of March 31, 2025, with no outstanding debt obligations [18] Q&A Session Summary Question: Inquiry about the cadence throughout the year and guidance confidence - Management expressed confidence in the guidance, highlighting the optionality in the portfolio and the execution capabilities despite market uncertainties [22][23] Question: Clarification on gross margin expectations - Management indicated that gross margins should improve in the second half of the year due to a mix shift in the product portfolio and reduced expiries [26][27] Question: Comparison of Q1 performance to Q4 and market dynamics - Management noted that confusion regarding the LCD led to a contraction in the market, which was not present in Q4 [34] Question: Discussion on the delay of the LCD and its implications - Management explained that the delay allows for more data collection and could expand the number of products eligible for coverage, which is seen as positive [40][41] Question: Further clarification on guidance and expected inflection points - Management reiterated that the full portfolio is now available, which supports revenue stabilization and growth despite the LCD delay [48][49]

[PART I. FINANCIAL INFORMATION](index=4&type=section&id=PART%20I.%20FINANCIAL%20INFORMATION) [Unaudited Condensed Consolidated Financial Statements](index=4&type=section&id=Item%201.%20Unaudited%20Condensed%20Consolidated%20Financial%20Statements) The company reported a significant Q1 2025 net revenue decrease and increased net loss, with total assets declining and a notable asset write-down [Condensed Consolidated Balance Sheets](index=4&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) As of March 31, 2025, total assets decreased to **$467.4 million**, driven by reduced cash, while liabilities and equity also declined Condensed Consolidated Balance Sheet Highlights (in thousands) | Account | March 31, 2025 | December 31, 2024 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $109,965 | $135,571 | | Accounts receivable, net | $103,320 | $109,861 | | Asset held for sale | $7,033 | $— | | Total current assets | $268,160 | $285,941 | | Total assets | $467,394 | $497,886 | | **Liabilities & Equity** | | | | Total current liabilities | $65,053 | $77,477 | | Total liabilities | $99,325 | $112,570 | | Total stockholders' equity | $242,902 | $262,897 | [Condensed Consolidated Statements of Operations and Comprehensive Loss](index=5&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) Net revenue decreased **21.2%** to **$86.7 million** in Q1 2025, leading to a significantly increased operating loss and net loss per share Q1 2025 vs Q1 2024 Statement of Operations (in thousands, except per share data) | Metric | Q1 2025 | Q1 2024 | | :--- | :--- | :--- | | Net revenue | $86,693 | $109,976 | | Gross profit | $62,970 | $81,280 | | Total operating expenses | $89,716 | $85,132 | | Loss from operations | $(26,746) | $(3,852) | | Net loss | $(18,843) | $(2,100) | | Net loss per share (basic and diluted) | $(0.17) | $(0.02) | - A write-down of **$6,567 thousand** for an asset held for sale was a significant operating expense in Q1 2025, contributing to the increased operating loss[14](index=14&type=chunk) [Condensed Consolidated Statements of Cash Flows](index=7&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Net cash used in operating activities significantly increased to **$19.9 million** in Q1 2025, alongside increased cash usage in investing and financing activities Cash Flow Summary (in thousands) | Activity | Q1 2025 | Q1 2024 | | :--- | :--- | :--- | | Net cash used in operating activities | $(19,935) | $(10,162) | | Net cash used in investing activities | $(3,626) | $(2,222) | | Net cash used in financing activities | $(2,056) | $(2,608) | | **Change in cash, cash equivalents and restricted cash** | **$(25,617)** | **$(14,992)** | [Notes to Condensed Consolidated Financial Statements](index=8&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements) The notes detail key accounting policies, including a significant decline in Advanced Wound Care revenue, an asset write-down, PSU introduction, and no outstanding debt Revenue by Product Category (in thousands) | Product Category | Q1 2025 | Q1 2024 | | :--- | :--- | :--- | | Advanced Wound Care | $79,927 | $103,864 | | Surgical & Sports Medicine | $6,766 | $6,112 | | **Total net revenue** | **$86,693** | **$109,976** | - In Q1 2025, the company listed a property for sale and recognized a **$6,567 thousand** write-down to adjust its carrying value to estimated fair market value[43](index=43&type=chunk) - The company introduced Performance Share Units (PSUs) in Q1 2025, granting **602,727 units** to executives, which vest based on performance goals[65](index=65&type=chunk)[66](index=66&type=chunk) - As of March 31, 2025, the company had no outstanding borrowings under its Term Loan Facility or its **$125 million** Revolving Facility[55](index=55&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=22&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management attributes the **21%** revenue decline to customer disruption from delayed Medicare LCDs, leading to increased net loss despite stable liquidity - The implementation of new Local Coverage Determinations (LCDs) by Medicare Administrative Contractors (MACs) has been delayed to **January 1, 2026**. If implemented as finalized, these LCDs would render several of the company's products, including PuraPly and Novachor, non-covered for DFU and VLU indications, which could materially impact revenue[95](index=95&type=chunk)[96](index=96&type=chunk) - Manufacturing of Dermagraft remains suspended, with plans to transition to a new facility in Smithfield, Rhode Island, expected to begin in **2027**. Delays could adversely affect future revenue[94](index=94&type=chunk) Reconciliation of Net Loss to Adjusted EBITDA (Non-GAAP, in thousands) | Metric | Q1 2025 | Q1 2024 | | :--- | :--- | :--- | | Net loss | $(18,843) | $(2,100) | | EBITDA | $(22,458) | $144 | | Stock-based compensation expense | $3,367 | $2,407 | | Write-down for asset held for sale | $6,567 | $— | | **Adjusted EBITDA** | **$(12,524)** | **$2,551** | [Results of Operations](index=27&type=section&id=MD%26A_Results_of_Operations) Net revenue declined **21%** in Q1 2025, primarily due to a **23%** drop in Advanced Wound Care, while R&D expenses decreased and SG&A remained flat Revenue Comparison: Q1 2025 vs Q1 2024 (in thousands) | Category | Q1 2025 | Q1 2024 | Change ($) | Change (%) | | :--- | :--- | :--- | :--- | :--- | | Advanced Wound Care | $79,927 | $103,864 | $(23,937) | (23%) | | Surgical & Sports Medicine | $6,766 | $6,112 | $654 | 11% | | **Net revenue** | **$86,693** | **$109,976** | **$(23,283)** | **(21%)** | - The decrease in Advanced Wound Care revenue was primarily attributed to increased ambiguity and disruption in customer behavior following the delayed implementation of the LCDs[115](index=115&type=chunk) - R&D expenses decreased by **$2.2 million (17%)** due to a reduction in expenses for clinical research and trials[120](index=120&type=chunk) [Liquidity and Capital Resources](index=30&type=section&id=MD%26A_Liquidity_and_Capital_Resources) As of March 31, 2025, the company maintained strong liquidity with **$110.0 million** in cash and **$125.0 million** available credit, having prepaid its Term Loan Facility - As of March 31, 2025, the company had **$110.0 million** in cash and cash equivalents and **$125.0 million** available for borrowing under its Revolving Facility[125](index=125&type=chunk) - The company prepaid its Term Loan Facility in November 2024 and had no outstanding borrowings under the Term Loan or Revolving Facility as of March 31, 2025[134](index=134&type=chunk)[139](index=139&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=34&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) The company states that there were no material changes to its market risk disclosures during the three months ended March 31, 2025, as compared to the disclosures in its 2024 Annual Report on Form 10-K - There were no material changes to market risk disclosures during the first quarter of 2025[144](index=144&type=chunk) [Controls and Procedures](index=34&type=section&id=Item%204.%20Controls%20and%20Procedures) Management, including the principal executive and financial officers, evaluated the company's disclosure controls and procedures and concluded they were effective as of March 31, 2025. There were no material changes in internal control over financial reporting during the quarter - Management concluded that as of March 31, 2025, the company's disclosure controls and procedures are effective[145](index=145&type=chunk) - No material changes to internal controls over financial reporting occurred during the quarter ended March 31, 2025[146](index=146&type=chunk) [PART II. OTHER INFORMATION](index=34&type=section&id=PART%20II.%20OTHER%20INFORMATION) [Legal Proceedings](index=34&type=section&id=Item%201.%20Legal%20Proceedings) The company is contesting a complaint filed by a terminated employee under the U.S. False Claims Act and the Texas State Medicaid Fraud Prevention Act. The U.S. and the State of Texas have declined to intervene. The company believes the claims are without merit and intends to defend itself vigorously - The company was served with a complaint alleging claims under the U.S. False Claims Act and Texas State Medicaid Fraud Prevention Act by a terminated employee[147](index=147&type=chunk) - The United States and the State of Texas declined to intervene in the case in September 2024. The company believes the claims are without merit[147](index=147&type=chunk) [Risk Factors](index=34&type=section&id=Item%201A.%20Risk%20Factors) The primary risk factor highlighted is the new Local Coverage Determinations (LCDs) finalized by seven Medicare Administrative Contractors (MACs). Although implementation has been delayed to January 1, 2026, if they take effect as written, they would classify several of the company's key products as 'non-covered' for diabetic foot ulcers (DFUs) and venous leg ulcers (VLUs). This could have a material adverse effect on the company's business and revenue - New LCDs finalized by seven MACs, if implemented, would classify products like PuraPly, PuraPly AM, PuraPly XT, Novachor, TransCyte, Dual, and Matrix as 'non-covered' for DFUs and VLUs[96](index=96&type=chunk)[151](index=151&type=chunk) - The implementation of these new LCDs has been delayed until **January 1, 2026**, but uncertainty remains about further delays, revisions, or rescission[151](index=151&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=36&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) The company reported no unregistered sales of equity securities during the period - None[152](index=152&type=chunk) [Other Information](index=36&type=section&id=Item%205.%20Other%20Information) In March 2025, two company officers, Gary S. Gillheeney, Sr. and Antonio S. Montecalvo, adopted Rule 10b5-1 trading plans to sell shares of the company's Class A common stock, subject to certain conditions - On March 12, 2025, Gary S. Gillheeney, Sr. adopted a Rule 10b5-1 trading plan to sell up to **827,688 shares**[156](index=156&type=chunk) - On March 13, 2025, Antonio S. Montecalvo adopted a Rule 10b5-1 trading plan to sell up to **200,000 shares** (**40,708 common stock** and **159,292** from options)[157](index=157&type=chunk) [Exhibits](index=37&type=section&id=Item%206.%20Exhibits) This section lists the exhibits filed with the Form 10-Q, including corporate governance documents, a lease amendment, a form of performance share award agreement, and officer certifications

[First Quarter 2025 Financial Results](index=1&type=section&id=First%20Quarter%202025%20Financial%20Results) [Q1 2025 Performance Summary](index=1&type=section&id=Q1%202025%20Performance%20Summary) Organogenesis reported a 21% year-over-year decrease in net revenue to $86.7 million for Q1 2025, driven by a 23% decline in the Advanced Wound Care segment, while the Surgical & Sports Medicine segment grew by 11% The company experienced a significant increase in net loss to $18.8 million, compared to a $2.1 million loss in Q1 2024, and an Adjusted EBITDA loss of $12.5 million Management expressed confidence in their commercial strategy despite market challenges and noted progress in the ReNu development plan, with a BLA submission expected by year-end 2025 Q1 2025 Key Financial Metrics vs. Q1 2024 | Metric | Q1 2025 | Q1 2024 | Change | | :--- | :--- | :--- | :--- | | **Net Revenue** | **$86.7M** | **$110.0M** | **-$23.3M (-21%)** | | - Advanced Wound Care | $79.9M | $103.9M | -23% | | - Surgical & Sports Medicine | $6.8M | $6.1M | +11% | | **Net Loss** | **$18.8M** | **$2.1M** | **+$16.7M** | | **Adjusted Net Loss** | **$13.4M** | **$1.4M** | **+$12.0M** | | **Adjusted EBITDA** | **($12.5M)** | **$2.6M** | **-$15.1M** | - CEO Gary S. Gillheeney, Sr. stated the company managed anticipated disruption well and is confident in its ability to execute its commercial strategy for the remainder of the year, leveraging strong brand equity and customer relationships[3](index=3&type=chunk) - The development of ReNu is progressing, with all patients expected to complete the second phase 3 study by the end of Q2 2025 The company remains on track to submit the Biologics License Application (BLA) by the end of 2025[3](index=3&type=chunk) [Detailed Financial Analysis (Q1 2025)](index=2&type=section&id=Detailed%20Financial%20Analysis%20%28Q1%202025%29) In Q1 2025, gross profit fell 23% to $63.0 million with a gross margin of 73%, down from 74% in Q1 2024 Operating expenses increased by 5% to $89.7 million, largely due to a $6.6 million write-down expense for an asset held for sale This led to an operating loss of $26.7 million, a significant increase from the $3.9 million loss in the prior-year period The company ended the quarter with $110.5 million in cash and no debt - Gross profit decreased by **$18.3 million** to **$63.0 million** in Q1 2025, with the gross margin slightly contracting to **73%** from 74% in Q1 2024[6](index=6&type=chunk) - Operating expenses rose **5%** to **$89.7 million**, primarily driven by a new **$6.6 million** write-down expense R&D expenses decreased by 17%, while SG&A expenses remained relatively flat[7](index=7&type=chunk) - The company's cash, cash equivalents, and restricted cash position decreased from **$136.2 million** at the end of 2024 to **$110.5 million** as of March 31, 2025, with no outstanding debt[11](index=11&type=chunk) Q1 2025 vs Q1 2024 Profit and Loss Details | Metric | Q1 2025 | Q1 2024 | Change | | :--- | :--- | :--- | :--- | | **Operating Loss** | **($26.7M)** | **($3.9M)** | **+$22.9M** | | **Net Loss** | **($18.8M)** | **($2.1M)** | **+$16.7M** | | **Net Loss per Share** | **($0.17)** | **($0.02)** | **($0.15)** | [Fiscal Year 2025 Guidance](index=3&type=section&id=Fiscal%20Year%202025%20Guidance) [Full Year 2025 Outlook](index=3&type=section&id=Full%20Year%202025%20Outlook) Organogenesis reaffirmed its full-year 2025 revenue guidance of $480.0 million to $535.0 million, representing a change of flat to 11% growth year-over-year The company updated its profitability guidance, now expecting net income between $4.7 million and $34.0 million, and Adjusted EBITDA between $43.6 million and $83.2 million Fiscal Year 2025 Guidance | Metric | Low End | High End | YoY Change vs. 2024 | | :--- | :--- | :--- | :--- | | **Net Revenue** | **$480.0M** | **$535.0M** | **~0% to +11%** | | - Advanced Wound Care | $450.0M | $500.0M | -1% to +10% | | - Surgical & Sports Medicine | $30.0M | $35.0M | +6% to +23% | | **Net Income** | **$4.7M** | **$34.0M** | N/A | | **Adjusted Net Income** | **$15.3M** | **$44.6M** | N/A | | **EBITDA** | **$20.0M** | **$59.6M** | N/A | | **Adjusted EBITDA** | **$43.6M** | **$83.2M** | N/A | [Consolidated Financial Statements](index=4&type=section&id=Consolidated%20Financial%20Statements) [Consolidated Balance Sheets](index=4&type=section&id=UNAUDITED%20CONSOLIDATED%20BALANCE%20SHEETS) As of March 31, 2025, Organogenesis reported total assets of $467.4 million, a decrease from $497.9 million at year-end 2024 The decline was primarily driven by a reduction in cash and cash equivalents Total liabilities also decreased to $99.3 million from $112.6 million, mainly due to lower accounts payable and accrued expenses Total stockholders' equity stood at $242.9 million Balance Sheet Summary (in thousands) | Account | March 31, 2025 | December 31, 2024 | | :--- | :--- | :--- | | **Total Current Assets** | **$268,160** | **$285,941** | | Cash and cash equivalents | $109,965 | $135,571 | | Accounts receivable, net | $103,320 | $109,861 | | **Total Assets** | **$467,394** | **$497,886** | | **Total Current Liabilities** | **$65,053** | **$77,477** | | **Total Liabilities** | **$99,325** | **$112,570** | | **Total Stockholders' Equity** | **$242,902** | **$262,897** | [Consolidated Statements of Operations](index=5&type=section&id=UNAUDITED%20CONSOLIDATED%20STATEMENTS%20OF%20OPERATIONS%20AND%20COMPREHENSIVE%20LOSS) For the three months ended March 31, 2025, the company's net revenue was $86.7 million, down from $110.0 million in the prior-year period Gross profit was $63.0 million A loss from operations of $26.7 million was recorded, significantly higher than the $3.9 million loss in Q1 2024 The net loss for the quarter was $18.8 million, or ($0.17) per share, compared to a net loss of $2.1 million, or ($0.02) per share, in Q1 2024 Q1 Statement of Operations (in thousands, except per share data) | Metric | Q1 2025 | Q1 2024 | | :--- | :--- | :--- | | Net revenue | $86,693 | $109,976 | | Gross profit | $62,970 | $81,280 | | Total operating expenses | $89,716 | $85,132 | | Loss from operations | $(26,746) | $(3,852) | | Net loss | $(18,843) | $(2,100) | | Net loss per share (Basic & Diluted) | $(0.17) | $(0.02) | [Consolidated Statement of Cash Flows](index=6&type=section&id=UNAUDITED%20CONSOLIDATED%20STATEMENT%20OF%20CASH%20FLOWS) In Q1 2025, net cash used in operating activities was $19.9 million, an increase from $10.2 million in Q1 2024 Net cash used in investing activities was $3.6 million for property and equipment purchases Net cash used in financing activities was $2.1 million This resulted in a total decrease in cash, cash equivalents, and restricted cash of $25.6 million for the quarter Q1 Cash Flow Summary (in thousands) | Cash Flow Activity | Q1 2025 | Q1 2024 | | :--- | :--- | :--- | | Net cash used in operating activities | $(19,935) | $(10,162) | | Net cash used in investing activities | $(3,626) | $(2,222) | | Net cash used in financing activities | $(2,056) | $(2,608) | | **Change in cash, cash equivalents and restricted cash** | **$(25,617)** | **$(14,992)** | | **Cash, cash equivalents, and restricted cash, end of period** | **$110,534** | **$89,346** | [Non-GAAP Financial Measures and Reconciliations](index=7&type=section&id=Non-GAAP%20Financial%20Measures%20and%20Reconciliations) [Reconciliation of GAAP Net Loss to Non-GAAP Adjusted EBITDA](index=7&type=section&id=Reconciliation%20of%20GAAP%20Net%20Loss%20to%20Non-GAAP%20Adjusted%20EBITDA) For Q1 2025, the company reported an Adjusted EBITDA loss of $12.5 million, a significant decrease from an Adjusted EBITDA income of $2.6 million in Q1 2024 The reconciliation from a GAAP net loss of $18.8 million includes adjustments for interest, taxes, D&A, stock-based compensation, and a $6.6 million write-down for an asset held for sale Q1 Adjusted EBITDA Reconciliation (in thousands) | Line Item | Q1 2025 | Q1 2024 | | :--- | :--- | :--- | | Net loss | $(18,843) | $(2,100) | | Interest (income) expense, net | $(961) | $514 | | Income tax benefit | $(6,940) | $(2,243) | | Depreciation and amortization | $3,444 | $3,072 | | Amortization of intangible assets | $842 | $901 | | **EBITDA** | **$(22,458)** | **$144** | | Stock-based compensation expense | $3,367 | $2,407 | | Write-down to fair value for asset held for sale | $6,567 | $— | | **Adjusted EBITDA** | **$(12,524)** | **$2,551** | [Reconciliation of GAAP Net Loss to Non-GAAP Adjusted Net Loss](index=8&type=section&id=Reconciliation%20of%20GAAP%20Net%20Loss%20to%20Non-GAAP%20Adjusted%20Net%20Loss) The company's adjusted net loss for Q1 2025 was $13.4 million, compared to an adjusted net loss of $1.4 million in Q1 2024 The adjustment from the GAAP net loss of $18.8 million primarily accounts for the amortization of intangible assets and the write-down of an asset held for sale, net of tax effects Q1 Adjusted Net Loss Reconciliation (in thousands) | Line Item | Q1 2025 | Q1 2024 | | :--- | :--- | :--- | | Net loss | $(18,843) | $(2,100) | | Amortization of intangible assets | $842 | $901 | | Write-down to fair value for asset held for sale | $6,567 | $— | | Tax on above | $(2,000) | $(241) | | **Adjusted net loss** | **$(13,434)** | **$(1,440)** | [Reconciliation of GAAP Loss from Operations to Non-GAAP Operating Loss](index=8&type=section&id=Reconciliation%20of%20GAAP%20Loss%20from%20Operations%20to%20Non-GAAP%20Operating%20Loss) Non-GAAP operating loss for Q1 2025 was $19.3 million, an increase from a $3.0 million loss in the prior-year quarter This figure is derived from the GAAP operating loss of $26.7 million by adding back the amortization of intangible assets and the write-down for an asset held for sale Q1 Non-GAAP Operating Loss Reconciliation (in thousands) | Line Item | Q1 2025 | Q1 2024 | | :--- | :--- | :--- | | Loss from operations | $(26,746) | $(3,852) | | Amortization of intangible assets | $842 | $901 | | Write-down to fair value for asset held for sale | $6,567 | $— | | **Non-GAAP operating loss** | **$(19,337)** | **$(2,951)** | [Projected Non-GAAP Reconciliations for Fiscal Year 2025](index=8&type=section&id=Projected%20Non-GAAP%20Reconciliations%20for%20Fiscal%20Year%202025) For the full fiscal year 2025, the company provided reconciliations for its guidance Projected GAAP net income of $4.7 million to $34.0 million is expected to reconcile to an Adjusted EBITDA of $43.6 million to $83.2 million Similarly, projected adjusted net income is expected to be between $15.3 million and $44.6 million FY2025 Projected GAAP Net Income to Adjusted EBITDA (in thousands) | Line Item | 2025 Low | 2025 High | | :--- | :--- | :--- | | Net income | $4,700 | $34,000 | | Adjustments (Interest, Tax, D&A, etc.) | $15,300 | $25,600 | | **EBITDA** | **$20,000** | **$59,600** | | Additional Adjustments (Stock Comp, Write-down, FDA fee) | $23,600 | $23,600 | | **Adjusted EBITDA** | **$43,600** | **$83,200** | FY2025 Projected GAAP Net Income to Adjusted Net Income (in thousands) | Line Item | 2025 Low | 2025 High | | :--- | :--- | :--- | | Net income | $4,700 | $34,000 | | Adjustments (Amortization, Write-down, FDA fee) | $14,500 | $14,500 | | Tax on above | $(3,900) | $(3,900) | | **Adjusted net income** | **$15,300** | **$44,600** | [Other Information](index=10&type=section&id=Other%20Information) [Forward-Looking Statements](index=10&type=section&id=Forward-Looking%20Statements) This report contains forward-looking statements regarding the company's expected financial performance for fiscal 2025 and strategic plans These statements are subject to numerous risks and uncertainties, including changes in product reimbursement levels, competition, technological changes, the ability to raise funds, and regulatory approvals, which could cause actual results to differ materially from expectations - Forward-looking statements include guidance on revenue, net income, and EBITDA for fiscal 2025[26](index=26&type=chunk) - Key risks include uncertainty in coverage and reimbursement (including proposed LCDs effective as soon as Jan 1, 2026), significant competition, rapid technological change, and the ability to obtain regulatory approval for products like ReNu[26](index=26&type=chunk) [About Organogenesis Holdings Inc.](index=11&type=section&id=About%20Organogenesis%20Holdings%20Inc.) Organogenesis Holdings Inc. is a leading regenerative medicine company that develops, manufactures, and commercializes solutions for the advanced wound care and surgical and sports medicine markets, offering a comprehensive portfolio of innovative products - The company focuses on regenerative medicine solutions for advanced wound care and surgical/sports medicine markets[27](index=27&type=chunk)