Core Insights - Organogenesis reported record fourth-quarter results for 2025, with net product revenue of $225.1 million, representing a 78% year-over-year increase and exceeding prior guidance [2][4][6] - The growth was primarily driven by an 83% year-over-year increase in advanced wound care product sales, which reached $217.2 million [3][6] - The company anticipates a revenue decline of 25% to 38% in 2026 due to near-term market disruptions related to recent CMS policy changes [4][6][16] Financial Performance - Fourth-quarter gross profit was $175.2 million, or 78% of net product revenue, an increase from 75% in the prior-year period [1] - Operating income for the quarter was $63.3 million, up from $10.2 million in the prior-year quarter, with non-GAAP operating income at $75.9 million [8] - Adjusted EBITDA was $84.2 million, or 37% of total revenue, compared to $18.2 million, or 14% of total revenue, in the prior-year quarter [11] Operating Expenses - Operating expenses in the fourth quarter were $162.3 million, a 39% increase from $116.4 million a year earlier [7] - Non-GAAP operating expenses, excluding cost of goods sold, were $112.4 million, up 32% from $85.4 million last year [7] Market Outlook - The company expects a significant revenue decline in Q1 2026, projecting a 50% decrease year-over-year, with a recovery anticipated in the second half of the year [6][20] - Management indicated that clinician confusion due to CMS comments is a major factor affecting near-term performance [16] Strategic Developments - Organogenesis is expanding its manufacturing and R&D center in Smithfield, Rhode Island, to support the scaling of its product portfolio [17] - The company initiated a rolling BLA submission for its ReNu product, which is seen as a potential transformational opportunity if approved by the FDA [18] Balance Sheet - As of the end of 2025, Organogenesis had $94.3 million in cash and no debt, compared to $136.2 million a year earlier [19] - The company has access to a revolving credit facility of up to $75 million to support operations [19]

Financial Data and Key Metrics Changes - The company reported record sales results for Q4 2025, with net product revenue of $225.1 million, up 78% year-over-year and up 50% sequentially, exceeding guidance expectations [14][5] - Gross profit for Q4 was $175.2 million, representing 78% of net product revenue, compared to 75% in the previous year [16] - Operating income for Q4 was $63.3 million, a significant increase of 519% year-over-year [18] - GAAP net income for Q4 was $43.7 million, up from $7.7 million in the previous year, marking a $36 million increase [18] - Adjusted EBITDA for Q4 was $84.2 million, or 37% of total revenue, compared to 14% of total revenue last year [20] Business Line Data and Key Metrics Changes - Advanced wound care products saw a revenue increase of 83% year-over-year, totaling $217.2 million in Q4 [15][5] - Sales of Surgical and Sports Medicine products declined by 2% year-over-year, amounting to $7.9 million in Q4 [15] Market Data and Key Metrics Changes - The company anticipates a total net revenue decline of 25%-38% year-over-year for the full year 2026 due to clinician confusion and market adjustments following CMS policy changes [21] - The first quarter of 2026 is expected to see revenue declines of approximately 50% year-over-year, primarily due to the impact of CMS's December 30th comments [22] Company Strategy and Development Direction - The company is focused on expanding its portfolio and capabilities, including a new manufacturing and R&D center in Rhode Island to support growth and product development [11] - The ReNu program is a key strategic initiative, with a rolling BLA submission expected to be completed in the first half of 2026, aiming to transform treatment for knee osteoarthritis [12] - The company aims to leverage its comprehensive portfolio across multiple FDA classifications to gain market share in the evolving healthcare landscape [21] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about future growth despite the challenges faced in early 2026, citing the potential for significant market share gains in the latter half of the year [10][25] - The company believes that the recent CMS policy changes represent a watershed moment for the industry, which could lead to long-term stability and growth [10] Other Important Information - The company had $94.3 million in cash equivalents as of December 31, 2025, down from $136.2 million the previous year, but remains well-capitalized with no outstanding debt [20] - Adjusted net income for Q4 was $52.9 million, significantly higher than $8.8 million in the previous year, reflecting strong operational performance [19] Q&A Session Summary Question: How much of the advanced wound care growth is due to inventory pull-forward? - Management indicated that there was not a significant amount of inventory pull-forward as products are primarily going to patients, and aggressive pricing tactics were not observed [27] Question: Can you bridge the gap between Q4 results and the forecasted decline for 2026? - Management noted that while Q1 will be challenging due to clinician confusion, they expect to gain market share throughout 2026, with competitive dynamics improving as the year progresses [28][29] Question: Are there signs of confidence in share gains moving forward? - Management observed early signs of changes in competitive dynamics and noted aggressive pricing pressure, indicating potential shifts in the market [30][31]

Financial Data and Key Metrics Changes - The company reported record sales results for Q4 2025, with net product revenue of $225.1 million, up 78% year-over-year and up 50% sequentially, exceeding the high end of guidance [14][5] - Gross profit for Q4 was $175.2 million, or 78% of net product revenue, compared to 75% last year, primarily due to a shift in product mix [16] - Operating income for Q4 was $63.3 million, an increase of 519% year-over-year, while GAAP net income was $43.7 million, up from $7.7 million last year [18][19] Business Line Data and Key Metrics Changes - Advanced wound care net product revenue for Q4 was $217.2 million, up 83% year-over-year, while Surgical and Sports Medicine products revenue was $7.9 million, down 2% year-over-year [15][5] - For the full year 2025, Surgical and Sports Medicine product sales increased by 12%, driven by strong growth in the PuraPly family of products [15] Market Data and Key Metrics Changes - The company anticipates a decline in total net revenue for 2026 in the range of 25%-38% year-over-year, primarily due to clinician confusion stemming from CMS's comments [21][22] - The first quarter of 2026 is expected to see revenue declines of approximately 50% year-over-year, with a recovery anticipated in the second half of the year [22] Company Strategy and Development Direction - The company is focused on expanding its portfolio and capabilities, including a new manufacturing and R&D center in Rhode Island to support growth and product expansion [11][12] - The ReNu program is a key strategic initiative, with a rolling BLA submission expected to be completed in the first half of 2026, representing a transformational opportunity for the company [12][24] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the future despite challenges in early 2026, believing that CMS's policy changes represent a significant opportunity for the industry [10][25] - The company is committed to working through clinician confusion and expects to gain market share in the latter half of 2026 [22][25] Other Important Information - The company had $94.3 million in cash equivalents as of December 31, 2025, with no outstanding debt obligations, indicating a strong capital position [20] - Adjusted EBITDA for Q4 was $84.2 million, or 37% of total revenue, compared to 14% of total revenue last year [20] Q&A Session Summary Question: How much of the advanced wound care growth is due to inventory pull-forward? - Management indicated that there was not a significant amount of inventory pull-forward, as products are primarily going to patients [27] Question: Can you bridge the gap between Q4 results and the forecasted decline for 2026? - Management noted that the decline is influenced by clinician confusion and pricing adjustments, but they expect to gain market share as competitive dynamics improve [28][29] Question: Are there signs of confidence in share gains moving through the year? - Management observed early signs of changes in competitive dynamics and noted aggressive pricing pressure, indicating potential market shifts [30][31]

Financial Data and Key Metrics Changes - The company reported record sales results for Q4 2025, with net product revenue of $225.1 million, up 78% year-over-year and up 50% sequentially, exceeding the high end of guidance [14][5] - Advanced wound care net product revenue was $217.2 million, reflecting an 83% increase year-over-year, while Surgical and Sports Medicine products saw a 2% decline to $7.9 million [14][5] - Gross profit for Q4 was $175.2 million, or 78% of net product revenue, compared to 75% in the previous year, primarily due to a shift in product mix [16] - Operating income surged to $63.3 million, a 519% increase from $10.2 million last year, with adjusted net income reaching $52.9 million compared to $8.8 million last year [18][19] Business Line Data and Key Metrics Changes - Advanced wound care products drove significant revenue growth, while Surgical and Sports Medicine products experienced a slight decline [14][5] - The PuraPly family of products contributed to a 12% increase in sales for the full year 2025 [15] Market Data and Key Metrics Changes - The company anticipates a decline in total net revenue for 2026 in the range of 25%-38% year-over-year due to clinician confusion stemming from recent CMS comments [21] - The first quarter of 2026 is expected to see revenue declines of approximately 50% year-over-year, with a recovery anticipated in the second half of the year [22] Company Strategy and Development Direction - The company is focused on expanding its portfolio and capabilities, including a new manufacturing and R&D center in Rhode Island to support growth and product development [11] - The ReNu program is positioned as a transformational opportunity, with a rolling BLA submission expected to be completed in the first half of 2026 [12] - The company aims to leverage its comprehensive portfolio across multiple FDA classifications to gain market share in the evolving reimbursement landscape [21] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about future growth despite challenges in early 2026, citing the potential for significant market share gains in the latter half of the year [10][26] - The company believes that the recent CMS policy changes represent a watershed moment for the industry, enhancing access to PMA products [10] Other Important Information - The company had $94.3 million in cash equivalents as of December 31, 2025, down from $136.2 million the previous year, but remains well-capitalized with no outstanding debt [20] Q&A Session Summary Question: How much of the advanced wound care growth is due to inventory pull-forward ahead of reimbursement changes? - Management indicated that there was not a significant amount of inventory pull-forward as products are primarily used on patients, and aggressive pricing tactics were not observed [28] Question: Can you bridge the gap between Q4 results and the forecasted decline for 2026? - Management noted that while Q1 will be challenging due to clinician confusion, they expect to gain market share and improve competitive dynamics throughout the year [29][30] Question: Are there signs of confidence in share gains moving forward? - Management observed early signs of changes in competitive dynamics and noted that aggressive pricing pressure is expected to be transitory [32][33]

Market Overview - Organogenesis focuses on regenerative medicine for advanced wound care and surgical markets, addressing a total addressable market of approximately $20 billion for chronic and acute wounds[39]. - The total addressable market for osteoarthritis is estimated at approximately $7 billion as of 2023[43]. - The company is experiencing a significant year-over-year decline in revenue in the first quarter of fiscal year 2026 due to changes in Medicare reimbursement policies[28]. - The company anticipates significant expansion to penetrate markets for existing and future products, which may strain management and operational resources[128]. - Governmental authorities are expected to continue initiatives aimed at lowering healthcare costs, which may restrict coverage and reimbursement for the company's products[219]. Product Portfolio - The company has a portfolio of products including Apligraf and Dermagraft, with Dermagraft's manufacturing currently suspended pending a transition to a new facility[23]. - Apligraf, launched in 1998, is the only PMA-approved bioengineered skin substitute for treating VLUs and DFUs, with over one million units shipped, demonstrating significant healing benefits[47]. - Dermagraft, acquired in 2014, had its manufacturing suspended in Q4 2021 and sales in Q2 2022, with plans to transition manufacturing to a new facility in 2027, expected to yield long-term cost savings[48]. - NuShield, launched in 2010, is a dehydrated placental allograft with a five-year shelf life, used as a protective barrier for chronic and acute wounds[49]. - PuraPly AM, launched in 2016, is an antimicrobial barrier skin substitute that received 510(k) clearance for managing various wound types, including diabetic ulcers and burns[50]. - Affinity and Novachor are unique placental allografts launched in 2014 and December 2021, respectively, and are among the few products containing viable amniotic cells[46]. Regulatory and Compliance - The FDA regulates the marketing of medical products, requiring either approval or clearance prior to marketing, with ongoing compliance necessary post-approval[79]. - The company has received RMAT designation for ReNu, indicating potential to address unmet medical needs in knee osteoarthritis[86]. - Coverage and reimbursement for products are primarily reliant on Medicare, Medicaid, and other third-party payers, with policies subject to change[94]. - Medicare coverage for skin substitute products is determined by local coverage determinations, which can affect coverage policy[96]. - The FDA may require additional regulatory approvals for products derived from human cells or tissues, which could significantly increase commercialization costs and delay product offerings[173]. - Compliance with the American Association of Tissue Banks (AATB) standards is necessary for accreditation, and noncompliance could lead to fines or penalties affecting business operations[184]. - The company must maintain compliance with extensive regulations governing product labeling, marketing, and sales, which are subject to ongoing review and scrutiny[191]. Financial Performance - The company recorded non-cash impairment and write-down charges of $11.2 million in 2025 and $18.8 million in 2024, adversely affecting operating results for those fiscal years[143]. - Federal net operating loss carry-forwards amount to approximately $19.6 million, while state net operating loss carry-forwards total approximately $16.3 million, expiring between 2027 and 2038[146]. - The company has federal and state research and development tax credits of approximately $3.3 million and $1.3 million, expiring in 2044 and 2038, respectively[146]. - The company anticipates that revenues in the fourth quarter are typically stronger due to increased hospital purchases coinciding with budget cycles[102]. - The company faces intense competition in the market, particularly in the placental-based and allograft tissue fields, due to lower barriers to entry[103]. Sales and Marketing Strategy - The company plans to expand its product portfolio and market presence in Advanced Wound Care and Surgical & Sports Medicine, leveraging its comprehensive product offerings and sales infrastructure[55]. - The company is focused on increasing sales outside the U.S., particularly in the European Union and the Middle East, as most current sales are domestic[58]. - Relationships with independent sales agencies are crucial for revenue generation, and any impairment or termination of these relationships could adversely affect profits[126]. - The company plans to invest significantly in sales and marketing to enhance capabilities, but there is no assurance that these efforts will lead to substantial sales increases[125]. Research and Development - The company has initiated a rolling Biologics License Application for ReNu, expecting to complete it in the first half of 2026[34]. - The R&D team focuses on improving patient outcomes and reducing costs, with activities conducted at facilities in Canton, MA, Birmingham, AL, and San Diego, CA[73]. - A robust pipeline of products is expected to launch in the coming years, enhancing the company's ability to address additional clinical applications[57]. - The company continues to invest in clinical studies and real-world evidence to support product efficacy and enhance market penetration[69]. Risks and Challenges - The company may face significant costs and delays in obtaining necessary regulatory approvals for its products, which could impede business objectives[162]. - There is a high failure rate for drugs and medical devices in clinical trials, which could adversely affect the company's financial condition and prospects[161]. - The company may incur additional impairment and write-down charges in the future, which could negatively impact operating results[144]. - The company faces risks associated with international sales, including compliance with trade regulations and potential penalties for violations[209]. - Cybersecurity threats pose significant risks to the company's information systems, and any breaches could lead to operational disruptions and financial losses[133].

Exhibit 99.1 FOR IMMEDIATE RELEASE Organogenesis Holdings Inc. Reports Fourth Quarter 2025 Financial Results, Posts Record Revenue CANTON, Mass., (February 26, 2026) -- Organogenesis Holdings Inc. (Nasdaq: ORGO), a leading regenerative medicine and tissue innovations company focused on empowering healing through the development, manufacturing, and sale of products for the advanced wound care, and surgical and sports medicine markets, today reported financial results for the fourth quarter and the year ended ...

Core Insights - Organogenesis Holdings Inc. reported record financial performance for 2025, with significant growth in net product revenue and net income, despite anticipated market challenges in 2026 due to regulatory changes [4][21]. Fourth Quarter 2025 Financial Results - Net product revenue reached $225.1 million, an increase of $98.4 million or 78% compared to Q4 2024 [6][7]. - Advanced Wound Care products generated $217.2 million, up 83% year-over-year, while Surgical & Sports Medicine products saw a slight decline of 2% to $7.9 million [6][7]. - Net income for Q4 2025 was $43.7 million, compared to $7.7 million in Q4 2024, marking an increase of $36.0 million [11]. - Adjusted EBITDA for Q4 2025 was $84.2 million, a significant increase of $66.0 million or 363% from the previous year [11][12]. Fiscal Year 2025 Financial Results - Total net product revenue for the year was $563.0 million, an increase of $81.0 million or 17% from 2024 [13][14]. - Advanced Wound Care products contributed $531.2 million, a 17% increase, while Surgical & Sports Medicine products increased by 12% to $31.8 million [13]. - Net income for the year was $37.0 million, compared to $0.9 million in 2024, an increase of $36.2 million [17]. - Adjusted EBITDA for the year was $98.1 million, up 97% from $49.8 million in 2024 [17][18]. Operating Expenses and Profitability - Operating expenses for Q4 2025 were $162.3 million, an increase of 39% from $116.4 million in Q4 2024 [9]. - Gross profit for Q4 2025 was $175.2 million, representing 78% of net product revenue, compared to 75% in Q4 2024 [8]. - Operating income for Q4 2025 was $63.3 million, a 519% increase from $10.2 million in Q4 2024 [10]. Cash Position and Outlook - As of December 31, 2025, the company had $94.3 million in cash and cash equivalents, down from $136.2 million in 2024 [19]. - For 2026, the company expects total net revenue to decline between 25% to 38% compared to 2025, with anticipated strong growth in the latter half of the year [21].

Core Viewpoint - Organogenesis Holdings Inc. will report its fourth quarter and fiscal year 2025 financial results on February 26, 2026, after market close [1] Group 1: Financial Reporting - The financial results will be discussed in a conference call scheduled for 5:00 p.m. Eastern Time on February 26, 2026 [2] - The conference call will include a corporate update and a question and answer session for participants [2] Group 2: Company Overview - Organogenesis Holdings Inc. is a leading company 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 - Pomerantz LLP is investigating potential securities fraud or unlawful business practices by Organogenesis Holdings Inc. and its officers or directors, following a significant stock price drop due to regulatory changes affecting the company [1][3]. Group 1: Company Overview - Organogenesis Holdings Inc. is a company listed on NASDAQ under the ticker ORGO [1]. - The company specializes in skin substitute grafts and cellular and tissue-based products [3]. Group 2: Regulatory Impact - On December 26, 2025, the Centers for Medicare & Medicaid Services announced the withdrawal of final Local Coverage Determinations (LCDs) related to Organogenesis's products, which were set to take effect in the following year [3]. - The withdrawal of these LCDs is expected to increase competition for Organogenesis, as over 300 other market participants will now be able to compete more freely in the market [3]. Group 3: Market Reaction - Following the announcement of the withdrawal of the LCDs, Organogenesis's stock price fell by $0.59 per share, representing a decline of 10.14%, closing at $5.28 per share on December 30, 2025 [3].

Core Insights - Organogenesis Holdings Inc. has initiated a rolling submission of a Biologics License Application (BLA) to the FDA for ReNu, a cryopreserved amniotic suspension allograft aimed at managing symptomatic knee arthritis, with final modules expected in the first half of 2026 [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 [4] Product Details - ReNu is designed for the management of symptomatic knee osteoarthritis and consists of amniotic fluid cells and micronized amniotic membrane, containing cellular, growth factor, and extracellular matrix components [3] - The product has been studied in three large randomized controlled trials (RCTs) involving over 1,300 patients and received FDA RMAT designation for Knee OA in 2021 [3] Market Context - Knee osteoarthritis (OA) affects an estimated 31.1 million Americans, projected to increase to 34.4 million by 2027, and is a leading cause of disability and poor quality of life [2]