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]

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 ...

Regentis Biomaterials Ltd. (NYSEAMERICAN:RGNT) is one of the best up and coming penny stocks to buy. On February 4, Regentis Biomaterials appointed Ori Gon as Chief Financial Officer and Chief Business Officer to lead the company’s financial strategy and commercial development. Gon joined the regenerative medicine firm as its lead product, GelrinC, nears commercial launch in Europe and progresses through a pivotal Phase III FDA trial in the US. With over 15 years of experience in medtech and capital mark ...

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 - Adia Nutrition Inc. is advancing its clinical research by submitting a second study for its product AdiaVita, aimed at alleviating lower back pain through non-invasive intravenous administration, which could transform pain management practices [1][4][7]. Clinical Study Details - The new clinical study will be a single-blind, placebo-controlled trial involving approximately 100 participants, assessing the efficacy of AdiaVita in reducing inflammation and promoting tissue repair in the lower back [3][4]. - The study will utilize a crossover design, allowing participants in the placebo group to receive AdiaVita after an initial three-month treatment period, facilitating within-subject comparisons [3]. Treatment Methodology - Unlike traditional treatments that require localized injections, this study focuses on systemic delivery via IV infusion, potentially offering a less invasive and more accessible treatment option for patients [4]. Financial Aspects - Participation in the study is structured as a patient-pay model, costing $5,000 per patient, with no additional fees for the crossover phase [5]. Ongoing Research Initiatives - This submission follows Adia Med's ongoing clinical research in Autism Spectrum Disorder (ASD), which is actively recruiting participants and aims to evaluate the combined effects of AdiaVita and glutathione therapy [6][8]. Company Vision and Growth - The CEO of Adia Nutrition expressed enthusiasm about the progress of the lower back pain study, highlighting the company's commitment to advancing patient-centered regenerative therapies that prioritize safety and accessibility [7]. - Adia Nutrition Inc. is expanding its services through Adia Med clinics, which specialize in various regenerative treatments, including stem cell therapies and advanced wound care solutions [10][11].

Core Viewpoint - Longeveron Inc. has appointed Stephen H. Willard as the new CEO, effective February 11, 2026, succeeding Than Powell, who served as interim CEO [1][2][5]. Company Overview - Longeveron Inc. is a clinical stage biotechnology company focused on developing regenerative medicines to address unmet medical needs, particularly in life-threatening conditions affecting children and the elderly [3][5]. - The company's lead investigational product is laromestrocel (LOMECEL-B®), an allogeneic mesenchymal stem cell therapy derived from the bone marrow of young, healthy adult donors [3]. Leadership Transition - Stephen H. Willard brings over 30 years of leadership experience in biotechnology and pharmaceuticals, having previously served as CEO for multiple firms [5]. - Than Powell will remain with the company to support the leadership transition and continue his work in business development activities [5]. Clinical Development - Longeveron is currently conducting a pivotal Phase 2b clinical trial for laromestrocel as a potential treatment for hypoplastic left heart syndrome (HLHS), with top-line results expected in the third quarter of 2026 [2][5]. - The company has received important FDA designations for its development programs, including Orphan Drug designation, Fast Track designation, and Rare Pediatric Disease designation for the HLHS program [3][6].

Company Overview - MedWell Ai, Inc has signed a Letter of Intent to establish a vertically integrated health, wellness, and longevity platform [1] - The new structure will consist of three core divisions: national pharma distribution and telemed platform, a portfolio of surgical and cosmetic centers, and an advanced biologics and product innovation group [2] Acquisitions and Financial Projections - The company plans to acquire and consolidate several entities, including Ageless Cosmetic Surgery Centers, Apollo BioWellness, and MedWell USA, which is currently generating revenues of $14 million in 2025 [3] - The consolidated company is projected to exceed $25 million in annual revenues for 2026, with conservative EBITDA margins of at least 20% [3] Strategic Goals and Management - The CEO of MedWell Ai emphasizes the goal of creating a comprehensive wellness ecosystem to enhance supply chain efficiency, quality control, and national expansion [5] - The company is also looking to bring in a seasoned management team to oversee the three verticals and is considering additional strategic acquisitions [5] Market Insights - The global regenerative medicine market was valued at approximately USD 35.5 billion in 2024 and is expected to grow to over USD 169 billion by 2034, with a CAGR of roughly 16% to 23% [7] - The broader global wellness economy reached USD 6.3 trillion in 2023 and is forecasted to reach USD 9.8 trillion by 2029 [7] - North America holds over 58% of the global market share in regenerative medicine, with the U.S. market projected to surpass USD 80 billion by 2033 [7]

Core Insights - Apollo Biowellness, Inc. has signed a Letter of Intent to establish a vertically integrated health, wellness, and longevity platform [1] - New MedWell Ai, Inc. will operate across three divisions: national pharma distribution and telemedicine, surgical and cosmetic centers, and advanced biologics [3] - The consolidated company is projected to exceed $25 million in annual revenues for 2026, based on trailing revenues of $14 million in 2025, with conservative EBITDA margins of at least 20% [4] Company Developments - The CEO of MedWell Ai, Steve Rubakh, emphasized the creation of a comprehensive wellness ecosystem aimed at reducing supply chain inefficiencies and enabling national expansion [5] - The company is also considering additional strategic acquisitions to enhance its position in the regenerative wellness sector [5] Market Overview - The global regenerative medicine market was valued at approximately $35.5 billion in 2024 and is expected to reach over $169 billion by 2034, growing at a CAGR of roughly 16% to 23% [8] - The broader global wellness economy reached $6.3 trillion in 2023 and is forecasted to grow to $9.8 trillion by 2029 [8] - North America is the leading market, accounting for over 58% of the global market share in 2024, with the U.S. market projected to surpass $80 billion by 2033 [8]