Company maintains confidence in ReNu as innovative pain management therapy Second Phase 3 trial demonstrates numerical improvement in baseline pain reduction over the first Phase 3 trial despite not meeting the primary endpointStatistically significant maintenance of function (p<0.0001)Company will request pre-BLA meeting with FDA to discuss submission pathway CANTON, Mass., Sept. 25, 2025 (GLOBE NEWSWIRE) -- Organogenesis Holdings Inc. (Nasdaq: ORGO), a leading regenerative medicine company focused on the ...

Summary of Organogenesis Holdings Conference Call Company Overview - **Company**: Organogenesis Holdings (ORGO) - **Industry**: Biotechnology, specifically in wound care and surgical products - **Background**: Established in 1985 as a spin-off from MIT, with a focus on innovative wound care solutions. The company has evolved from a single product to a comprehensive portfolio addressing various wound care needs [1][2] Key Points Discussed Industry Changes and Regulatory Environment - **Physician Fee Schedule (PFS)**: A significant change in the reimbursement model is anticipated, which is viewed as a watershed moment for the industry. The proposed rule aims to standardize reimbursement across various care settings, enhancing patient access to products [4][5] - **Market Expansion**: The market volume has doubled from 2021 to 2024, indicating growth despite a tenfold increase in costs. This shift is expected to stabilize the market and reduce financial incentives based on product choice, focusing instead on clinical efficacy [6][7][8] Product Portfolio and Growth Areas - **Current Products**: The company highlighted the importance of PMA products, including the relaunch of Dermograph and the burn portfolio featuring Transite. These products are expected to gain value with the new reimbursement model [9][10] - **New Product Launches**: Two new dehydrated products were launched, which are gaining traction and are expected to contribute to stronger performance in the second half of the year [14][15] - **Surgical and Sports Medicine Growth**: The surgical segment grew by 16% in Q2 and 13% for the half-year, driven by the PuraPly brand and the introduction of Cygnus Matrix [16][17] Future Outlook and Strategic Initiatives - **Renew Product Update**: The second phase three trial has been completed, with top-line data expected soon. If successful, a BLA application will be filed by the end of the year, with commercialization anticipated in 2027 [20][21] - **Sales Strategy**: The company plans to build a direct sales force of 150 to 200 reps for the new product, focusing on the pain management market, particularly targeting the hyaluronic acid segment [22][23] Financial Health - **Balance Sheet**: The company reported a strong balance sheet with approximately $70 million in cash, positioning it well for future growth and profitability [25] Market Positioning - **Competitive Landscape**: The company aims to differentiate itself by offering a broad portfolio that addresses all stages of wound healing, utilizing both dehydrated and living technologies [26][27] Research and Development - **RCT Progress**: Ongoing research is expected to yield a publication by November 1, with plans to have PuraPly available on the LCD by January 1 [29] Additional Insights - **Hybrid Sales Model**: The introduction of hybrid representatives who can operate in both operating rooms and advanced wound care centers is seen as a valuable strategy to enhance customer relationships and sales [19] This summary encapsulates the key discussions and insights from the Organogenesis Holdings conference call, highlighting the company's strategic direction, product innovations, and market dynamics.

Financial Data and Key Metrics Changes - Net product revenue for Q2 was $100.8 million, down 23% year over year, within the guidance range of $100 million to $110 million [16] - Advanced Wound Care net product revenue was $92.7 million, down 25%, while Surgical and Sports Medicine products revenue increased by 16% to $8.1 million [16][20] - Gross profit for Q2 was $73.1 million, representing 73% of net product revenue, down from 78% the previous year [17] - Operating expenses decreased to $113.6 million from $144.1 million, a reduction of 21% year over year [17] - GAAP net loss for Q2 was $9.4 million, compared to a net loss of $17 million last year, showing improvement [18] Business Line Data and Key Metrics Changes - Advanced Wound Care products saw a revenue decline of 25%, attributed to customer demand disruptions and competitive pricing strategies [5][16] - Surgical and Sports Medicine products experienced a revenue increase of 16%, indicating strong performance in this segment [16] Market Data and Key Metrics Changes - The proposed Medicare payment reform for skin substitutes is expected to significantly impact the market, with a proposed rate of approximately $125 per square centimeter [30] - The current market for Aplograft is only 3% of units sold, indicating substantial growth potential with the new payment structure [31] Company Strategy and Development Direction - The company is focused on gathering clinical and real-world evidence to enhance its product portfolio and market penetration [10] - Expansion of biomanufacturing capabilities is underway, with a new facility in Smithfield, Rhode Island, aimed at supporting product reintroduction and new launches [11] - The RENEW program is on track for submission by the end of the year, targeting a significant market of over 30 million Americans suffering from knee osteoarthritis [12] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the proposed CMS payment reforms, viewing them as a transformational opportunity for the company and the industry [30] - The company anticipates aggressive pricing strategies from competitors in the latter half of 2025 but remains confident in its product momentum [33] - The guidance for 2025 has been updated, expecting net revenue between $480 million and $510 million, reflecting a year-over-year change of flat to a 6% increase [19][20] Other Important Information - The company has no outstanding debt obligations and reported cash and equivalents of $73.7 million as of June 30, 2025, down from $136.2 million at the end of 2024 [19] - Adjusted EBITDA loss for Q2 was $3.6 million, compared to adjusted EBITDA income of $15.6 million last year, indicating a significant shift in profitability [18] Q&A Session Summary Question: How does the CMS proposal for 2026 impact the company? - Management views the CMS proposal as a transformational event, providing a significant opportunity for their products and leveling the playing field in reimbursement [30][31] Question: Has the guidance reduction accounted for aggressive market behavior? - Management believes the guidance reduction reflects the current market conditions and anticipates strong performance from recently launched products in the second half of the year [34][35] Question: What is the timing for the reintroduction of Dermagraft? - Management indicated that Dermagraft is expected to be launched by 2027 [37] Question: How does RENEW position itself in the knee OA treatment landscape? - Management highlighted the strength of RENEW's data, indicating it will compete well against existing injectable options [41] Question: What drove the strength in the Surgical and Sports Medicine segment? - The segment's growth was attributed to strong performance and the implementation of hybrid sales strategies, with a 16% increase in Q2 [42]

PART I. FINANCIAL INFORMATION [Item 1. Unaudited Condensed Consolidated Financial Statements](index=4&type=section&id=Item%201.%20Unaudited%20Condensed%20Consolidated%20Financial%20Statements) This section presents the company's unaudited condensed consolidated financial statements and accompanying notes for the periods ended June 30, 2025, and December 31, 2024 [Condensed Consolidated Balance Sheets](index=4&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) | Metric | June 30, 2025 (in thousands) | December 31, 2024 (in thousands) | | :--- | :--- | :--- | | Total Assets | $461,128 | $497,886 | | Total Liabilities | $99,909 | $112,570 | | Redeemable Convertible Preferred Stock | $127,977 | $122,419 | | Total Stockholders' Equity | $233,242 | $262,897 | | Cash and cash equivalents | $73,076 | $135,571 | | Accounts receivable, net | $120,382 | $109,861 | | Inventories, net | $33,042 | $26,219 | | Total current assets | $260,223 | $285,941 | | Total current liabilities | $65,839 | $77,477 | - Total assets decreased by **$36.76 million** from December 31, 2024, to June 30, 2025, primarily driven by a significant reduction in cash and cash equivalents[11](index=11&type=chunk) - Cash and cash equivalents decreased by **$62.495 million**, from $135.571 million at December 31, 2024, to $73.076 million at June 30, 2025[11](index=11&type=chunk) [Condensed Consolidated Statements of Operations and Comprehensive Loss](index=5&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) | Metric (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 | | :--- | :--- | :--- | :--- | :--- | | Total Revenue | $101,005 | $130,234 | $187,698 | $240,210 | | 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 Attributable to Common Stockholders | $(12,202) | $(17,043) | $(33,793) | $(19,143) | | Basic and Diluted Net Loss Per Share | $(0.10) | $(0.13) | $(0.27) | $(0.14) | - Total revenue decreased by **22.4%** for the three months ended June 30, 2025, and by **21.8%** for the six months ended June 30, 2025, compared to the same periods in 2024[13](index=13&type=chunk) - Net loss attributable to common stockholders improved for the three months ended June 30, 2025, decreasing to **$(12,202) thousand** from $(17,043) thousand in 2024, but worsened for the six months ended June 30, 2025, increasing to **$(33,793) thousand** from $(19,143) thousand in 2024[13](index=13&type=chunk) [Condensed Consolidated Statements of Redeemable Convertible Preferred Stock and Stockholders' Equity](index=6&type=section&id=Condensed%20Consolidated%20Statements%20of%20Redeemable%20Convertible%20Preferred%20Stock%20and%20Stockholders'%20Equity) | Metric (in thousands) | December 31, 2024 | June 30, 2025 | | :--- | :--- | :--- | | Redeemable Convertible Preferred Stock | $122,419 | $127,977 | | Common Stock | $13 | $13 | | Additional Paid-in Capital | $302,994 | $301,574 | | Accumulated Deficit | $(40,110) | $(68,345) | | Total Stockholders' Equity | $262,897 | $233,242 | - Total stockholders' equity decreased by **$29.655 million** from December 31, 2024, to June 30, 2025, primarily due to the net loss incurred during the period and accretion of redeemable convertible preferred stock[16](index=16&type=chunk) - The accumulated deficit increased significantly from **$(40,110) thousand** at December 31, 2024, to **$(68,345) thousand** at June 30, 2025, reflecting the net losses[16](index=16&type=chunk) [Condensed Consolidated Statements of Cash Flows](index=7&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) | Cash Flow Activity (in thousands) | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :--- | :--- | :--- | | 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) | | Net change in cash, cash equivalents and restricted cash | $(62,416) | $(13,861) | | Cash, cash equivalents, and restricted cash, end of period | $73,735 | $90,477 | - Net cash used in operating activities increased substantially to **$(52,808) thousand** for the six months ended June 30, 2025, compared to $(5,424) thousand in the prior year, driven by net loss and changes in operating assets and liabilities[19](index=19&type=chunk)[137](index=137&type=chunk) - Cash, cash equivalents, and restricted cash at the end of the period decreased by **$62.416 million** to $73.735 million as of June 30, 2025[19](index=19&type=chunk) [Notes to Condensed Consolidated Financial Statements](index=8&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements) - The Company is a leading regenerative medicine and tissue innovations company focused on advanced wound care, and surgical and sports medicine markets[22](index=22&type=chunk) - New accounting policies for 2025 include performance-based share awards, assets held for sale, and government assistance, with performance-based share awards recognized when achievement of conditions is probable[24](index=24&type=chunk)[30](index=30&type=chunk) Revenue by Category | Revenue Category (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 | | :--- | :--- | :--- | :--- | :--- | | Advanced Wound Care | $92,696 | $123,237 | $172,623 | $227,101 | | Surgical & Sports Medicine | $8,083 | $6,997 | $14,849 | $13,109 | | Total Net Product Revenue | $100,779 | $130,234 | $187,472 | $240,210 | | Grant Income | $226 | $— | $226 | $— | - The Company received a **$5 million government grant** in Q2 2025 for its Smithfield Facility, with $2.5 million cash received and the remaining $2.5 million considered probable[38](index=38&type=chunk) - Accounts receivable, net, increased to **$120.382 million** at June 30, 2025, from $109.861 million at December 31, 2024, with the allowance for credit losses increasing to $11.153 million[39](index=39&type=chunk) - Inventories, net, increased to **$33.042 million** at June 30, 2025, from $26.219 million at December 31, 2024, with charges for excess and obsolescence of $6.093 million for the six months ended June 30, 2025[40](index=40&type=chunk) - Property and equipment, net, decreased to **$75.607 million** at June 30, 2025, from $89.128 million at December 31, 2024, partly due to a $8.313 million write-down of an asset held for sale in the six months ended June 30, 2025[41](index=41&type=chunk)[45](index=45&type=chunk) - Goodwill remained stable at **$28.772 million**, and intangible assets, net, decreased to $10.785 million at June 30, 2025, from $12.468 million at December 31, 2024[46](index=46&type=chunk) - Accrued expenses and other current liabilities decreased to **$26.348 million** at June 30, 2025, from $39.453 million at December 31, 2024, mainly due to decreases in personnel costs and accrued taxes[47](index=47&type=chunk) - The Company had **no outstanding borrowings** under its Term Loan Facility or Revolving Facility as of June 30, 2025, after prepaying the Term Loan Facility in November 2024[54](index=54&type=chunk) - Shareholders approved the issuance of Class A common stock upon conversion of Convertible Preferred Stock in excess of Ownership Limitations, allowing conversion into an aggregate of **36,051,283 shares** as of June 30, 2025[57](index=57&type=chunk) - Stock-based compensation expense for the six months ended June 30, 2025, was **$5.909 million**, an increase from $4.975 million in the prior year[64](index=64&type=chunk) - The Company granted **198,900 Performance Share Units (PSUs)** in the six months ended June 30, 2025, with the 2025 performance target deemed probable of being achieved[68](index=68&type=chunk) - The income tax benefit for the six months ended June 30, 2025, was **$9.382 million**, a significant increase from an expense of $(260) thousand in the prior year, due to a higher estimated effective tax rate and R&D tax credits[87](index=87&type=chunk)[132](index=132&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=26&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) This section provides management's perspective on the company's financial condition, results of operations, liquidity, and capital resources for the reported periods [Overview](index=26&type=section&id=Overview) - Organogenesis is a leading regenerative medicine and tissue innovations company, focusing on advanced wound care and surgical & sports medicine markets[92](index=92&type=chunk) - The company's products, including Apligraf, PuraPly AM, CYGNUS Dual, and NuShield, address chronic and acute wounds, and tendon/ligament injuries, supported by clinical data and FDA approvals[93](index=93&type=chunk)[94](index=94&type=chunk)[95](index=95&type=chunk) [Dermagraft](index=26&type=section&id=Dermagraft) - Manufacturing and sales of Dermagraft were suspended in Q4 2021 and Q2 2022, respectively[96](index=96&type=chunk) - The company plans to transition Dermagraft manufacturing to its new Smithfield, Rhode Island facility, with sales expected to resume by the end of 2027, aiming for substantial long-term cost savings[96](index=96&type=chunk) [Local Coverage Determinations and Centers for Medicare & Medicaid Services (CMS) Proposed Rule](index=26&type=section&id=Local%20Coverage%20Determinations%20and%20Centers%20for%20Medicare%20%26%20Medicaid%20Services%20(CMS)%20Proposed%20Rule) - New proposed Local Coverage Determinations (LCDs) for skin substitute grafts/CTPs for DFUs and VLUs, finalized in November 2024, have been **delayed until January 1, 2026**[97](index=97&type=chunk)[99](index=99&type=chunk) - If implemented in their current form, these LCDs would classify over 200 products, including PuraPly, Novachor, Dual, and Matrix, as **'non-covered'** for DFU and VLU indications, while Apligraf and Dermagraft would remain covered[99](index=99&type=chunk) - CMS proposed new rules in July 2025 for Medicare payments under the Physician Fee Schedule (PFS) and Hospital Outpatient Prospective Payment System (OPPS) for skin substitute products, effective January 1, 2026[100](index=100&type=chunk) - CMS proposes to align skin substitute categorization with FDA regulatory status (361 HCT/Ps, PMAs, 510(k)s) and use a single payment rate for 2026, with differentiated rates planned for future years[100](index=100&type=chunk) [License And Manufacturing Agreement](index=28&type=section&id=License%20And%20Manufacturing%20Agreement) - The company has a trademark license and manufacturing agreement with Vivex for Dual, Matrix, and VIA products[101](index=101&type=chunk) - The company pays a **low double-digit royalty** on Net Sales of Dual and VIA, and a **high single-digit royalty** on Net Sales of Matrix, with the initial term expiring December 31, 2026, and renewable for up to five additional one-year terms[101](index=101&type=chunk) [Components of Our Condensed Consolidated Results of Operations](index=28&type=section&id=Components%20of%20Our%20Condensed%20Consolidated%20Results%20of%20Operations) - Net product revenue is derived from Advanced Wound Care and Surgical & Sports Medicine products, sold through direct sales representatives and third-party agencies, respectively[103](index=103&type=chunk) - Grant income is recognized through 2027, offsetting expenses related to the Smithfield Facility[106](index=106&type=chunk) - Cost of goods sold includes personnel, testing, quality assurance, raw materials, manufacturing, and facility costs, affected by sales units and product mix[107](index=107&type=chunk) - Selling, general and administrative expenses are expected to increase due to investments in market development and sales force expansion[109](index=109&type=chunk) - Impairment and write-down expenses include adjustments for assets held for sale and write-downs of capitalized internal-use software costs[111](index=111&type=chunk) [Results of Operations](index=31&type=section&id=Results%20of%20Operations) | Metric (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 | | :--- | :--- | :--- | :--- | :--- | | 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) | [EBITDA and Adjusted EBITDA](index=31&type=section&id=EBITDA%20and%20Adjusted%20EBITDA) - Management uses Adjusted EBITDA as a non-GAAP financial measure to evaluate operating performance and trends, believing it provides useful information by excluding certain items[119](index=119&type=chunk) Reconciliation of Net Loss to EBITDA and Adjusted EBITDA | Metric (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 | | :--- | :--- | :--- | :--- | :--- | | Net Loss | $(9,392) | $(17,043) | $(28,235) | $(19,143) | | EBITDA | $(7,928) | $(9,720) | $(30,386) | $(9,576) | | Adjusted EBITDA | $(3,640) | $15,649 | $(16,164) | $18,200 | - **Adjusted EBITDA significantly decreased** to $(3,640) thousand for the three months ended June 30, 2025, from $15,649 thousand in the prior year, and to $(16,164) thousand for the six months ended June 30, 2025, from $18,200 thousand in the prior year[120](index=120&type=chunk) [Comparison of Three and Six Months Ended June 30, 2025 and 2024](index=32&type=section&id=Comparison%20of%20Three%20and%20Six%20Months%20Ended%20June%2030,%202025%20and%202024) Net Product Revenue by Category | Revenue Category (in thousands) | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Change ($) | Change (%) | | :--- | :--- | :--- | :--- | :--- | | Advanced Wound Care | $92,696 | $123,237 | $(30,541) | (25%) | | Surgical & Sports Medicine | $8,083 | $6,997 | $1,086 | 16% | | Net Product Revenue | $100,779 | $130,234 | $(29,455) | (23%) | - Advanced Wound Care net product revenue decreased by **25% and 24%** for the three and six months ended June 30, 2025, respectively, primarily due to increased ambiguity and disruption from delayed LCD implementation[121](index=121&type=chunk) - Surgical & Sports Medicine net product revenue increased by **16% and 13%** for the three and six months ended June 30, 2025, respectively, driven by increased customer buying patterns[123](index=123&type=chunk) - Cost of goods sold decreased by **5% and 11%** for the three and six months ended June 30, 2025, respectively, primarily due to decreased sales volume and a shift in product mix[124](index=124&type=chunk) - Gross profit decreased by **28% and 25%** for the three and six months ended June 30, 2025, respectively, with gross profit as a percentage of revenue also decreasing due to product mix shift[125](index=125&type=chunk) - Research and development expenses decreased by **33% and 26%** for the three and six months ended June 30, 2025, respectively, mainly due to reduced clinical research and trial expenses[126](index=126&type=chunk) - Selling, general and administrative expenses decreased by **4% and 2%** for the three and six months ended June 30, 2025, respectively, primarily due to lower commissions and royalty expense from decreased sales[127](index=127&type=chunk)[128](index=128&type=chunk) - The company recorded a **$1.7 million and $8.3 million write-down** for assets held for sale during the three and six months ended June 30, 2025, respectively[129](index=129&type=chunk) - Other income (expense), net, improved by **$1.4 million and $2.8 million** for the three and six months ended June 30, 2025, respectively, primarily due to interest income from interest-bearing sweep accounts[130](index=130&type=chunk) - Income tax expense shifted to a benefit of **$2.4 million and $9.4 million** for the three and six months ended June 30, 2025, respectively, driven by a higher estimated effective tax rate and R&D tax credits[131](index=131&type=chunk)[132](index=132&type=chunk) [Liquidity and Capital Resources](index=37&type=section&id=Liquidity%20and%20Capital%20Resources) - As of June 30, 2025, the company had working capital of **$189.1 million** and **$73.1 million** in cash and cash equivalents[133](index=133&type=chunk) - Management expects current cash, working capital, and net cash flows from product sales to fund operating expenses, capital expenditures, and debt service for at least 12 months[133](index=133&type=chunk) - Primary uses of cash include working capital, capital expenditures (e.g., Smithfield facility build-out), and debt service payments[134](index=134&type=chunk) - Net cash used in operating activities was **$(52.8) million** for the six months ended June 30, 2025, a significant increase from $(5.4) million in the prior year[136](index=136&type=chunk)[137](index=137&type=chunk) - Net cash used in investing activities was **$(7.3) million** for the six months ended June 30, 2025, primarily for capital expenditures[136](index=136&type=chunk)[139](index=139&type=chunk) - Net cash used in financing activities was **$(2.3) million** for the six months ended June 30, 2025, mainly for finance lease obligations and stock award payments[136](index=136&type=chunk)[140](index=140&type=chunk) - The company had **no outstanding borrowings** under its Term Loan Facility or Revolving Facility as of June 30, 2025, following prepayment of the Term Loan in November 2024[147](index=147&type=chunk) - An August 2025 amendment to the 2021 Credit Agreement waived the Consolidated Fixed Charge Coverage Ratio covenant for Q2 2025, but requires new financial covenants by September 30, 2025, or it will constitute an **event of default**[142](index=142&type=chunk) [Critical Accounting Policies and Significant Judgments and Estimates](index=40&type=section&id=Critical%20Accounting%20Policies%20and%20Significant%20Judgments%20and%20Estimates) - The preparation of financial statements requires management to make estimates, assumptions, and judgments that affect reported amounts, with significant uncertainty in income tax assets/liabilities and long-lived asset recoverability[148](index=148&type=chunk) [Off-Balance Sheet Arrangements](index=40&type=section&id=Off-Balance%20Sheet%20Arrangements) - The company did not have any off-balance sheet arrangements during the periods presented[149](index=149&type=chunk) [Recently Issued Accounting Pronouncements](index=40&type=section&id=Recently%20Issued%20Accounting%20Pronouncements) - The company has reviewed recently issued accounting standards as disclosed in Note 2, Summary of Significant Accounting Policies[150](index=150&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=40&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) This section states there were no material changes to the company's market risk disclosures during the six months ended June 30, 2025 - No material changes to market risk disclosures occurred during the six months ended June 30, 2025[151](index=151&type=chunk) [Item 4. Controls and Procedures](index=40&type=section&id=Item%204.%20Controls%20and%20Procedures) This section confirms the effectiveness of disclosure controls and procedures and reports no material changes in internal control over financial reporting [Evaluation of Disclosure Controls and Procedures](index=40&type=section&id=Evaluation%20of%20Disclosure%20Controls%20and%20Procedures) - Management concluded that disclosure controls and procedures were **effective** as of June 30, 2025[152](index=152&type=chunk) [Changes in Internal Control Over Financial Reporting](index=40&type=section&id=Changes%20in%20Internal%20Control%20Over%20Financial%20Reporting) - **No material changes** in internal controls over financial reporting occurred during the quarter ended June 30, 2025[153](index=153&type=chunk) PART II. OTHER INFORMATION [Item 1. Legal Proceedings](index=29&type=section&id=Item%201.%20Legal%20Proceedings) This section notes the dismissal of a False Claims Act complaint and confirms no other material legal proceedings are currently active - A False Claims Act complaint filed against the company was **dismissed without prejudice** on May 19, 2025, with consent from the United States and the State of Texas[154](index=154&type=chunk)[155](index=155&type=chunk) - The company is not a party to any other material legal proceedings and believes that the resolution of current claims would not have a material adverse effect on its financial position, operating results, or cash flows[156](index=156&type=chunk) [Item 1A. Risk Factors](index=30&type=section&id=Item%201A.%20Risk%20Factors) This section highlights new material risks related to proposed Medicare coverage policy changes and their potential adverse impact on the business - New proposed LCDs, if implemented, could classify over 200 of the company's products as **'non-covered'** for DFU and VLU treatments, potentially having a material adverse effect on utilization and revenue[158](index=158&type=chunk) - CMS proposed rules for Medicare payments under the PFS and OPPS, effective January 1, 2026, could materially impact product utilization, business, and revenue by changing payment structures and aligning categorization with FDA regulatory status[159](index=159&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=31&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) This section states there were no unregistered sales of equity securities or use of proceeds during the reporting period - No unregistered sales of equity securities or use of proceeds occurred[160](index=160&type=chunk) [Item 3. Defaults Upon Senior Securities](index=31&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) This section confirms that there were no defaults upon senior securities during the reporting period - No defaults upon senior securities occurred[161](index=161&type=chunk) [Item 4. Mine Safety Disclosures](index=31&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This section indicates that mine safety disclosures are not applicable to the company - Mine safety disclosures are not applicable[162](index=162&type=chunk) [Item 5. Other Information](index=31&type=section&id=Item%205.%20Other%20Information) This section reports no director or officer adopted or terminated a Rule 10b5-1 or non-Rule 10b5-1 trading arrangement during the quarter - No director or officer adopted or terminated a Rule 10b5-1 or non-Rule 10b5-1 trading arrangement during the three months ended June 30, 2025[163](index=163&type=chunk) [Item 6. Exhibits](index=32&type=section&id=Item%206.%20Exhibits) This section lists all exhibits filed with the Form 10-Q, including organizational documents, certifications, and XBRL-related documents - The report includes various exhibits such as Certificate of Incorporation, Bylaws, Certificate of Designations of Series A Convertible Preferred Stock, and certifications from principal executive and financial officers[164](index=164&type=chunk) SIGNATURES [SIGNATURES](index=46&type=section&id=SIGNATURES) This section contains the formal signatures confirming the submission of the Quarterly Report on Form 10-Q on August 7, 2025 - The report was signed by David Francisco, Chief Financial Officer (Principal Financial and Accounting Officer), on behalf of Organogenesis Holdings Inc. on August 7, 2025[168](index=168&type=chunk)

[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]