What is the market's earnings forecast for Organogenesis next quarter?

What is Organogenesis's gross profit margin?

Did Organogenesis beat or miss consensus estimates last quarter?

What is the revenue and EPS growth rate for Organogenesis year over year?

What is Organogenesis's latest dividend and current dividend yield?

What factors drove the changes in Organogenesis's revenue and profit?

What guidance did Organogenesis's management provide for the next earnings period?

What were the key takeaways from Organogenesis’s earnings call?

- **Revenue Growth**: Q3 2025 revenue up 31% YoY to $150.5M, driven by Advanced Wound Care and Surgical/Sports Medicine products.
- **CMS Policy Impact**: 2026 fee schedule removes 200+ non-PMA products, favoring Organogenesis' PMA-approved Apligraf, Affinity, and NuShield. Reimbursement rates for PMA products to remain higher than 510(k)/361 devices.
- **ReNu Update**: Phase III trial missed statistical significance but showed numerical improvement in pain. FDA RMAT designation secured; BLA submission planned post-December 12 meeting.
- **2025 Guidance**: $500-525M net revenue (4-9% YoY growth), with EBITDA of $45.5-68.3M reflecting margin expansion from CMS policy and product mix.
- **Market Outlook**: ASPs to decline across market, but Apligraf's HOPD reimbursement rate increase and brand strength position company for share regain in 2026.


**【CEO Opening Remarks】**
- Q3 2025 revenue exceeded expectations, with Advanced Wound Care sales up 31% YoY and Surgical & Sports Medicine up 25% YoY, driven by strong execution and product differentiation.
- CMS finalized 2026 Medicare physician fee schedule, introducing per square centimeter payment for PMA products and removing over 200 non-PMA products from coverage. Company expects this to reduce market overuse and favor clinically differentiated products like Apligraf, Affinity, and NuShield.
- ReNu Phase III trial missed statistical significance but showed numerical improvement in pain reduction (−6.9 vs. −6.0) with favorable safety profile. FDA RMAT designation secured, with BLA submission planned post-December 12 FDA meeting.

**【CFO Financial Commentary】**
- Q3 net product revenue: $150.5M (31% YoY), driven by Advanced Wound Care ($141.5M, +31%) and Surgical & Sports Medicine ($9M, +25%).
- Gross margin: 76% (vs. 77% YoY), stable despite product mix shift.
- Operating expenses: $130.1M (+19% YoY), driven by R&D and SG&A investments.
- 2025 guidance updated: $500-525M net revenue (4-9% YoY growth), with Advanced Wound Care at $470-490M and Surgical/Sports at $30-35M.
- EBITDA guidance: $45.5-68.3M, reflecting margin expansion from CMS policy and product mix.

**【Q&A Highlights】**
- **Physician Behavior Change**: Early signs of administrative shifts (e.g., contract changes) but no immediate sales impact. Expect utilization to align with LCD-covered products post-1/1/26.
- **Market Margins**: ASPs across market will decline, but Apligraf's PMA status and higher reimbursement rates in HOPD position it for growth. Company expects to regain share lost to non-PMA products.
- **ReNu Timeline**: FDA meeting on December 12 to discuss combined Phase III data. Potential 2-month delay in BLA filing timeline, targeting late 2026/early 2027 approval.
- **Competitive Position**: Strong brand equity, clinical evidence, and covered products under LCDs (Apligraf, Affinity, NuShield) give competitive advantage in 2026+.


Organogenesis Holdings Inc. (ORGO) Q3 2025 Earnings Call Transcript

Advanced Wound Care

Surgical and Sports Medicine

ORGO

ORGO fundamentals

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