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Organogenesis Holdings (ORGO)

Earnings summaries and quarterly performance for Organogenesis Holdings.

Recent press releases and 8-K filings for ORGO.

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
Organogenesis Provides Update on Second Phase 3 ReNu Study
ORGO
Product Launch
New Projects/Investments
  • Organogenesis Holdings Inc. announced that its second Phase 3 randomized controlled trial of ReNu did not achieve statistical significance for its primary endpoint.
  • The primary endpoint, reduction in knee pain at six months, showed a numerical improvement of -0.5 favoring ReNu (p=0.0393), which was below the p=0.023 target threshold for statistical significance.
  • Despite this, the company noted a favorable safety profile and statistically significant maintenance of function (p<0.0001) for ReNu.
  • Organogenesis plans to request a pre-Biologics License Application (BLA) meeting with the FDA by the end of October 2025 to discuss the submission pathway, including potentially using combined efficacy analysis from both Phase 3 studies.
Sep 25, 2025, 9:00 PM
Organogenesis Holdings Discusses Physician Fee Schedule Impact, Product Portfolio, and Renew Product Development
ORGO
Guidance Update
Product Launch
New Projects/Investments
  • Organogenesis anticipates the proposed Physician Fee Schedule (PFS) changes, effective January 1, 2026, will be a significant positive for the industry, bringing consistent reimbursement across sites of care and recognizing PMA products as clinically differentiated.
  • The company is relaunching Dermograph and manufacturing Transite at its new Smithfield, Rhode Island facility. The surgical and sports medicine segment demonstrated strong growth, up 16% in Q2 2025 and 13% for the first half of 2025, driven by the PuraPly brand and new product launches.
  • For its Renew product, Organogenesis completed the second phase three trial and expects top-line data by the end of September 2025. If successful, a BLA application is anticipated by the end of 2025, with approval expected in 2026 and commercialization in 2027.
  • Organogenesis ended the first half of 2025 with over $70 million in cash and expects a stronger second half of 2025 with anticipated profit generation, despite some expected pricing pressure at the end of Q4 2025.
Sep 3, 2025, 7:24 PM