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Organogenesis (NasdaqCM:ORGO) Q3 2025 Earnings Call November 06, 2025 05:00 PM ET Speaker1Welcome, ladies and gentlemen, to the third quarter 2025 earnings conference call of Organogenesis Holdings. At this time, all participants have been placed in listen-only mode. Please note that this conference call is being recorded and that the recording will be available on the company's website for replay shortly. Before we begin, I would like to remind everyone that our remarks today may contain forward-looking st ...

Market Focus and Product Development - Organogenesis reported a significant focus on advanced wound care and surgical markets, addressing chronic and acute wounds with a comprehensive product portfolio[100] - The company plans to transition Dermagraft manufacturing to a new facility in Smithfield, Rhode Island, expected to begin in 2027, which will lead to substantial long-term cost savings[104] - A Phase 3 clinical trial for ReNu showed a statistically significant reduction in knee pain (p=0.0177) and maintenance of function (p<0.0001) at six months[107] - The second Phase 3 trial of ReNu did not achieve statistical significance for its primary endpoint, despite showing a numerical improvement in pain reduction[108] Financial Performance - Net product revenue increased by $35.3 million, or 31%, to $150.5 million for the three months ended September 30, 2025, compared to $115.2 million for the same period in 2024[131] - Advanced Wound Care net product revenue increased by $33.5 million, or 31%, to $141.5 million in Q3 2025, while it decreased by $21.0 million, or 6%, to $314.1 million for the nine months ended September 30, 2025[138] - Surgical & Sports Medicine net product revenue increased by $1.8 million, or 25%, to $9.0 million in Q3 2025, and by $3.6 million, or 17%, to $23.9 million for the nine months ended September 30, 2025[139] - Gross profit increased by $25.9 million, or 29%, to $114.2 million in Q3 2025, but decreased by $20.3 million, or 8%, to $250.4 million for the nine months ended September 30, 2025[141] - Adjusted EBITDA for Q3 2025 was $30.1 million, compared to $13.4 million in Q3 2024, reflecting a significant improvement in operational performance[134] - The company recorded a net income of $21.6 million for Q3 2025, compared to a net income of $12.3 million for the same period in 2024[131] - The total revenue for the nine months ended September 30, 2025, was $338.6 million, compared to $355.4 million for the same period in 2024, indicating a slight decline[131] Expenses and Investments - Selling, general and administrative expenses are expected to increase due to investments in market development and geographic expansion[123] - Research and development expenses include costs for clinical trials and enhancements to existing products, which are expensed as incurred[124] - Research and development expenses increased by $2.9 million, or 28%, to $13.2 million in Q3 2025 from $10.3 million in Q3 2024[143] - Selling, general and administrative expenses rose by $7.9 million, or 11%, to $79.7 million in Q3 2025 from $71.8 million in Q3 2024, primarily due to increased commissions and headcount-related expenses[144] - For the nine months ended September 30, 2025, selling, general and administrative expenses increased by $5.4 million, or 2%, to $226.1 million from $220.7 million in the same period of 2024[145] Cash Flow and Working Capital - As of September 30, 2025, the company had working capital of $205.1 million, including $63.7 million in cash and cash equivalents[150] - Net cash used in operating activities was $49.7 million for the nine months ended September 30, 2025, compared to net cash provided of $3.3 million in the same period of 2024[153] - During the nine months ended September 30, 2025, net cash used in investing activities was $9.5 million, up from $6.7 million in the same period of 2024[156] Tax and Compliance - Income tax benefit decreased by $6.1 million, or 94%, to $0.4 million in Q3 2025 from $6.5 million in Q3 2024, mainly due to changes in estimated effective tax rates[148] - Income tax benefit increased by $3.5 million, or 57%, to $9.8 million for the nine months ended September 30, 2025, compared to $6.2 million in the same period of 2024[149] - As of September 30, 2025, the company did not require a valuation allowance for its net U.S. deferred tax assets[128] - As of September 30, 2025, the company was in compliance with the covenants under the 2021 Credit Agreement, with no outstanding borrowings under the Term Loan Facility or the Revolving Facility[163] Market Risks and Accounting Standards - Medicare's proposed local coverage determinations could classify over 200 products as "non-covered," potentially impacting revenue from products like PuraPly and Novachor[111] - For calendar year 2026, CMS will pay approximately $127.28 per square centimeter for certain skin substitute products, which may affect product utilization and revenue[112] - There were no material changes to market risk disclosures for the nine months ended September 30, 2025[167] - Recently issued accounting standards were reviewed as disclosed in the financial statements[166] - No off-balance sheet arrangements were reported during the periods presented[165]

Exhibit 99.1 FOR IMMEDIATE RELEASE Organogenesis Holdings Inc. Reports Third Quarter 2025 Financial Results, Posts Record Revenue and Raises 2025 Guidance CANTON, Mass., (November 6, 2025) -- Organogenesis Holdings Inc. (Nasdaq: ORGO), a leading regenerative medicine company focused on the development, manufacture, and commercialization of product solutions for the Advanced Wound Care and Surgical & Sports Medicine markets, today reported financial results for the third quarter ended September 30, 2025. Thi ...

CANTON, Mass., Nov. 06, 2025 (GLOBE NEWSWIRE) -- Organogenesis Holdings Inc. (Nasdaq: ORGO), a leading regenerative medicine company focused on the development, manufacture, and commercialization of product solutions for the Advanced Wound Care and Surgical & Sports Medicine markets, today reported financial results for the third quarter ended September 30, 2025. Third Quarter 2025 Financial Results Summary: Net product revenue of $150.5 million for the third quarter of 2025, an increase of $35.3 million co ...

Core Insights - Organogenesis Holdings Inc. commends the Centers for Medicare & Medicaid Services (CMS) for its payment reform for skin substitutes and cellular and tissue-based products (CTPs) under the CY 2026 Physician Fee Schedule [1][2] Group 1: Payment Reform - The new payment methodology includes FDA classifications and a per centimeter square payment approach for both physician offices and hospital outpatient settings [2] - This reform is expected to enhance access to PMA products and address issues of abuse in the current payment system [2] Group 2: Company Positioning - Organogenesis believes it is well-positioned in the skin substitutes market for 2026 and beyond, leveraging over forty years of leadership in regenerative medicine [2] - The company has a diverse, evidence-based portfolio with technologies across all FDA categories, which supports its competitive stance in the market [2]

CANTON, Mass., Oct. 31, 2025 (GLOBE NEWSWIRE) -- Organogenesis Holdings Inc. (the “Company”) (Nasdaq: ORGO), a leading regenerative medicine company focused on the development, manufacture, and commercialization of product solutions for the Advanced Wound Care and Surgical & Sports Medicine markets, today announced that effective October 29, 2025, the Company’s Board of Directors granted inducement awards to Michael Catarina, the Company’s newly hired Chief Technology Officer, consisting of non-statutory st ...

LOS ANGELES--(BUSINESS WIRE)--Organogenesis Holdings Inc. Investigated for Securities Fraud Violations - Contact the DJS Law Group to Discuss Your Rights – ORGO. ...

Core Viewpoint - Pomerantz LLP is investigating potential securities fraud or unlawful business practices by Organogenesis Holdings Inc. following the failure of a key clinical trial for its product ReNu, which has led to a significant drop in the company's stock price [1][2]. Group 1: Company Performance - On September 25, 2025, Organogenesis announced that its second phase 3 trial for the cryopreserved amniotic suspension allograft ReNu did not meet its primary endpoint, failing to show a significant change in pain reduction [1]. - Following this announcement, Organogenesis's stock price decreased by $0.58 per share, or 12.39%, closing at $4.10 per share on September 26, 2025 [2]. Group 2: Legal Investigation - Pomerantz LLP is representing investors in investigating claims against Organogenesis and its officers/directors regarding possible securities fraud or other illegal business practices [1]. - The firm has a long history in corporate and securities class litigation, having recovered substantial damages for victims of securities fraud and corporate misconduct [3].

CANTON, Mass., Oct. 01, 2025 (GLOBE NEWSWIRE) -- Organogenesis Holdings Inc. (Nasdaq: ORGO), a leading regenerative medicine company focused on the development, manufacture, and commercialization of product solutions for the Advanced Wound Care and Surgical and Sports Medicine markets, today announced that third quarter of fiscal year 2025 financial results will be reported after the market closes on Thursday, November 6th. Management will host a conference call at 5:00 p.m. Eastern Time on November 6th to ...