Earnings summaries and quarterly performance for Organogenesis Holdings.
Executive leadership at Organogenesis Holdings.
GS
Gary S. Gillheeney, Sr.
Detailed
Chief Executive Officer
CEO
AS
Antonio S. Montecalvo
Detailed
Vice President, Health Policy
BG
Brian Grow
Detailed
Chief Commercial Officer
DC
David C. Francisco
Detailed
Chief Financial Officer
LF
Lori Freedman
Detailed
Chief Administrative and Legal Officer
PB
Patrick Bilbo
Detailed
Chief Operating Officer
RC
Robert Cavorsi
Detailed
Vice President, Strategy
Board of directors at Organogenesis Holdings.
AS
Arthur S. Leibowitz
Detailed
Lead Independent Director
GL
Garrett Lustig
Detailed
Director
GQ
Gilberto Quintero
Detailed
Director
GH
Glenn H. Nussdorf
Detailed
Director
JG
Jon Giacomin
Detailed
Director
MJ
Michael J. Driscoll
Detailed
Director
MK
Michele Korfin
Detailed
Director
PD
Prathyusha Duraibabu
Detailed
Director
RA
Robert Ades
Detailed
Director
Research analysts who have asked questions during Organogenesis Holdings earnings calls.
Ryan Zimmerman
BTIG
4 questions for ORGO
Also covers: ALC, GEHC, GKOS +23 more
RO
Ross Osborn
Cantor Fitzgerald
3 questions for ORGO
Also covers: AXGN, CERS, CVRX +12 more
Aaron Wukmir
Lake Street Capital Markets
1 question for ORGO
Also covers: ELMD, LFVN, PIII +2 more
BO
Brooks O'Neil
Lake Street Capital Markets
1 question for ORGO
Also covers: ARAY, ATEC, BBNX +11 more
MP
Matthew Park
Cantor Fitzgerald
1 question for ORGO
Also covers: AXGN, BVS, CERS +5 more
Recent press releases and 8-K filings for ORGO.
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
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
Quarterly earnings call transcripts for Organogenesis Holdings.
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