Organogenesis (NasdaqCM:ORGO) Q4 2025 Earnings call February 26, 2026 05:00 PM ET Company ParticipantsDave Francisco - CFOGary S. Gillheeney, Senior - President, CEO, and Chair of the BoardNone - Company RepresentativeOperatorWelcome, ladies and gentlemen, to the Fourth Quarter and Full Year 2025 Earnings Conference Call for Organogenesis Holdings, Inc 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 a ...

Organogenesis (NasdaqCM:ORGO) Q4 2025 Earnings call February 26, 2026 05:00 PM ET Company ParticipantsDave Francisco - CFOGary S. Gillheeney, Senior - President, CEO, and Chair of the BoardNone - Company RepresentativeOperatorWelcome, ladies and gentlemen, to the fourth quarter and full year 2025 earnings conference call for Organogenesis Holdings, Inc. 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 ...

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]

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the Fiscal Year Ended December 31, 2025 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Commission File Number: 001-37906 ORGANOGENESIS HOLDINGS INC. (Exact Name of Registrant as Specified in Its Charter) (State or Other Jurisdiction of (I.R.S. Employer Incorporatio ...

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 ...

CANTON, Mass., Feb. 26, 2026 (GLOBE NEWSWIRE) -- 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 December 31, 2025. Fourth Quarter 2025 Financial Results Summary: Net product revenue of $225.1 million for the fourth ...

CANTON, Mass., Feb. 19, 2026 (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 fourth quarter and fiscal year 2025 financial results will be reported after the market closes on Thursday, February 26th. Management will host a conference call at 5:00 p.m. Eastern Time on February 26th ...

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]

Core Insights - Organogenesis Holdings Inc. has successfully completed a Type-B meeting with the FDA, confirming the initiation of a rolling Biologics License Application (BLA) for its product ReNu, expected to be submitted by the end of December 2025 [2][3] 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 [5] - The company offers a comprehensive portfolio of innovative regenerative products to address patient needs across the continuum of care [5] Product Details - ReNu is a cryopreserved amniotic suspension allograft designed for managing symptomatic knee osteoarthritis, consisting of amniotic fluid cells and micronized amniotic membrane [4] - The product has been studied in three large randomized controlled trials (RCTs) involving over 1,300 patients and received FDA Regenerative Medicine Advanced Therapy (RMAT) designation for knee osteoarthritis in 2021 [4] Market Context - Knee osteoarthritis (OA) affects an estimated 31.1 million Americans, projected to increase to 34.4 million by 2027, making it one of the most common causes of disability and poor quality of life [3]