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Organogenesis Holdings (ORGO)

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Earnings summaries and quarterly performance for Organogenesis Holdings.

Recent press releases and 8-K filings for ORGO.

OrganTech Defines Stem Cell Set for Functional Hair Follicle Regeneration
ORGO
New Projects/Investments
  • OrganTech's research team has defined a minimal stem cell set required for functional hair follicle regeneration in vitro, establishing a cellular framework for next-generation regenerative strategies for alopecia.
  • This breakthrough enables the generation of fully functional hair follicles under defined in vitro conditions, offering a novel approach to reconstruct hair follicle units at the organ level.
  • The global hair restoration market is projected to exceed $15 billion within the coming decade, highlighting a significant commercial opportunity for OrganTech's technology.
  • OrganTech has filed international patent applications covering its organ germ–based regenerative technologies and is advancing a staged clinical translation strategy targeting alopecia.
6 days ago
Organogenesis Holdings Announces Q4 2025 Results and 2026 Outlook
ORGO
Earnings
Guidance Update
New Projects/Investments
  • Organogenesis Holdings reported record Q4 2025 net product revenue of $225.1 million, an increase of 78% year-over-year, driven by 83% growth in Advanced Wound Care products.
  • Adjusted EBITDA for Q4 2025 was $84.2 million, or 37% of total revenue, significantly up from $18.2 million or 14% last year.
  • For the full year 2026, the company expects total net revenue to decline in the range of 25%-38% year-over-year, primarily due to clinician confusion stemming from CMS comments on December 30th.
  • The company anticipates significant challenges in the first half of 2026, with Q1 revenue expected to decline approximately 50% year-over-year, but projects strong sequential growth in the second half, leading to positive adjusted EBITDA in Q4 2026.
  • Strategic initiatives include advancing the ReNu program with a rolling BLA submission expected to be completed in the first half of 2026, and investing in a new manufacturing and R&D center.
Feb 26, 2026, 10:00 PM
Organogenesis Holdings Reports Record Q4 2025 Revenue Amidst Challenging 2026 Outlook
ORGO
Earnings
Guidance Update
New Projects/Investments
  • Organogenesis Holdings reported record net product revenue of $225.1 million in Q4 2025, marking a 78% year-over-year increase, primarily driven by 83% growth in advanced wound care products.
  • The company achieved GAAP net income of $43.7 million and Adjusted EBITDA of $84.2 million (37% of total revenue) for Q4 2025.
  • For the full year 2026, Organogenesis projects a total net revenue decline in the range of 25%-38% year-over-year, with Q1 2026 revenue expected to decrease by approximately 50% due to significant clinical confusion surrounding recent CMS comments on discarded products.
  • Despite anticipated near-term challenges, the company expects strong sequential revenue growth in the second half of 2026, leading to positive adjusted EBITDA in Q4 2026, and aims to gain market share.
  • Organogenesis is advancing its ReNu program, having initiated a rolling BLA submission in late 2025, with completion expected in the first half of 2026, targeting the knee osteoarthritis market.
Feb 26, 2026, 10:00 PM
Organogenesis Holdings Reports Record Q4 2025 Revenue, Forecasts 2026 Decline Amidst CMS Policy Confusion
ORGO
Earnings
Guidance Update
New Projects/Investments
  • Organogenesis Holdings reported record net product revenue of $225.1 million in Q4 2025, an increase of 78% year-over-year, with Advanced Wound Care net product revenue up 83%. The company achieved a gross profit of $175.2 million (78% of net product revenue) and adjusted EBITDA of $84.2 million (37% of total revenue) in Q4 2025.
  • For the full year 2026, the company forecasts a total net revenue decline of 25%-38% year-over-year, with a projected 50% year-over-year decline in Q1 2026, primarily due to near-term challenges and clinician confusion surrounding CMS comments on December 30th.
  • Despite the challenging start to 2026, Organogenesis expects substantial market share gains and meaningful improvement in the second half of 2026, leading to positive adjusted EBITDA in Q4 2026. The company is also advancing its ReNu program with a rolling BLA submission expected to complete in H1 2026 and investing in a new manufacturing and R&D center in Smithfield, Rhode Island.
Feb 26, 2026, 10:00 PM
Organogenesis Holdings Inc. Reports Q4 and Full-Year 2025 Financial Results, Provides 2026 Outlook
ORGO
Earnings
Guidance Update
Demand Weakening
  • Organogenesis Holdings Inc. (ORGO) reported record net product revenue of $225.1 million for the fourth quarter of 2025, a 78% increase from Q4 2024, and $563.0 million for the full fiscal year 2025, up 17% year-over-year.
  • Net income for Q4 2025 was $43.7 million, an increase of $36.0 million from Q4 2024, while full-year 2025 net income was $37.0 million, an increase of $36.2 million from FY 2024.
  • The company ended fiscal year 2025 with $94.3 million in cash, cash equivalents, and restricted cash and no outstanding debt obligations as of December 31, 2025.
  • For fiscal year 2026, Organogenesis expects total net revenue between $350.0 million and $420.0 million, representing a projected decline of 25% to 38% compared to total net revenue of $564.2 million for FY 2025.
  • Management anticipates a significant year-over-year revenue decline in the first quarter of 2026, followed by strong quarter-over-quarter growth in the second, third, and fourth quarters of 2026, with a return to normalized growth expected in 2027.
Feb 26, 2026, 9:09 PM
Organogenesis Initiates Biologics License Application for ReNu®
ORGO
Product Launch
New Projects/Investments
  • Organogenesis Holdings Inc. (ORGO) has initiated a rolling submission of a Biologics License Application (BLA) to the FDA for ReNu®, a cryopreserved, amniotic suspension allograft developed for the management of symptomatic knee arthritis.
  • The company plans to complete the BLA submission with the final modules in the first half of 2026.
  • If approved, ReNu® would be the first non-surgical biologic therapy to address knee osteoarthritis pain for all patients, including those classified as most severe.
  • ReNu® has been studied in three large randomized controlled trials involving over 1,300 patients and received FDA RMAT designation for Knee OA in 2021.
Dec 23, 2025, 9:05 PM
Organogenesis Announces Plan to File BLA for ReNu for Knee Osteoarthritis
ORGO
Product Launch
New Projects/Investments
  • Organogenesis Holdings Inc. announced the successful completion of a Type-B meeting with the FDA, confirming the initiation of a rolling Biologics License Application (BLA) for ReNu.
  • The company plans to submit the BLA for ReNu, a treatment for symptomatic knee osteoarthritis, before the end of December 2025.
  • The FDA deemed ReNu's clinical development program, which includes two large Phase 3 randomized controlled trials and Regenerative Medicine Advanced Therapy (RMAT) designation, appropriate for BLA submission.
  • ReNu targets knee osteoarthritis, a condition affecting an estimated 31.1 million Americans and projected to grow to 34.4 million by 2027.
Dec 15, 2025, 9:25 PM
Organogenesis Holdings Reports Strong Q3 2025 Results and Raises Full-Year Guidance
ORGO
Earnings
Guidance Update
Revenue Acceleration/Inflection
  • Organogenesis Holdings reported Q3 2025 net product revenue of $150.5 million, marking a 31% year-over-year increase, with GAAP net income of $21.6 million and adjusted EBITDA of $30.1 million.
  • The company updated its full-year 2025 net revenue guidance to between $500 million and $525 million and its adjusted EBITDA guidance to between $45.5 million and $68.3 million, both representing an increase from previous ranges.
  • CMS finalized the Medicare physician fee schedule for calendar year 2026, which includes skin substitute classifications based on FDA regulatory status and a per square centimeter payment methodology, a development Organogenesis views as a significant positive for the wound care market.
  • The second phase three trial for the Renew program did not achieve statistical significance for its primary endpoint, but the company has a meeting scheduled with the FDA on December 12th to discuss a Biologic License Application (BLA) submission, with potential approval timelines possibly delayed by about two months.
Nov 6, 2025, 10:00 PM
Organogenesis Holdings Inc. Reports Record Q3 2025 Financial Results and Raises 2025 Guidance
ORGO
Earnings
Guidance Update
Revenue Acceleration/Inflection
  • Organogenesis Holdings Inc. reported record net product revenue of $150.5 million for the third quarter ended September 30, 2025, marking a 31% increase from $115.2 million in the third quarter of 2024. This growth was primarily driven by a 31% increase in Advanced Wound Care products and a 25% increase in Surgical & Sports Medicine products.
  • For the third quarter of 2025, the company achieved net income of $21.6 million and Adjusted EBITDA of $30.1 million, representing increases of $9.2 million and $16.7 million, respectively, compared to the third quarter of 2024.
  • The company raised its fiscal year 2025 guidance, now projecting net product revenue between $500.0 million and $525.0 million, which would be an increase of 4% to 9% year-over-year compared to 2024.
  • Updated fiscal year 2025 guidance also includes expected net income between $8.6 million and $25.4 million, and Adjusted EBITDA between $45.5 million and $68.3 million.
Nov 6, 2025, 9:23 PM
Nickolas Asset Management Acquires OGO and Medal Technologies
ORGO
M&A
New Projects/Investments
Hiring
  • Nickolas Asset Management (NAM), in partnership with the Reinhart Family of Companies and Configure Brands, has acquired OGO and Medal Technologies in North Baltimore, Ohio.
  • The acquisition includes a 32,500 sq. ft. production facility which will expand manufacturing capacity and produce proprietary product lines for OGO, Medal Technologies, and Configure's 50 Strong brand.
  • This strategic move is expected to double revenue at the facility and NAM plans to double the facility's size, machine count, and number of jobs.
  • NAM, which operates as a buy-to-hold investor, intends to expand into high-growth categories such as RV, off-grid living, and emergency preparedness.
Oct 6, 2025, 4:13 PM