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- **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

- **CMS Payment Reform Catalyst**: Proposed 2026 changes could elevate PMA products like Apligraf to 12-18% market share from 3%, offsetting 2025 pricing pressures.
- **ReNu Clinical Momentum**: Phase III data highlights efficacy in severe knee OA, positioning for BLA submission in Q4 2025.
- **Surgical Segment Outperformance**: 16% Q2 growth driven by new product launches and cross-selling strategies.
- **Financial Resilience**: Narrowed 2025 guidance to $480-510 million, reflecting Q2 execution and cautious H2 outlook with adjusted EBITDA of $31-62 million.


**【CEO Summary Section】**
- **Q2 Revenue Performance**: Total net product revenue of $100.8 million (-23% YoY), within guidance range, driven by 16% growth in Surgical & Sports Medicine products. Advanced Wound Care (AWC) revenue declined 25% to $92.7 million due to delayed LCD implementation and competitive pricing.
- **CMS Payment Reform**: Applauded CMS's proposed 2026 payment structure for skin substitutes, which tiers products by FDA classification. This could benefit PMA products like Apligraf and Dermagraft, currently underutilized (3% market share). Expected aggressive pricing in late 2025 but optimistic about new product launches.
- **Strategic Initiatives**: 
  - Reintroduction of Dermagraft and FortiShield at new Smithfield facility, targeting 2027 launch.
  - ReNu BLA submission on track for Q4 2025, with Phase III data release in September.
  - Submission of clinical data for PuraPly AM and Affinity to MACs by November 1, 2025.

**【CFO Financial Commentary】**
- **Q2 Financials**: 
  - Gross profit: $73.1 million (73% of revenue), down due to lower sales and expired inventory.
  - Operating expenses: $113.6 million (-21% YoY), driven by reduced R&D and SG&A.
  - Net loss: $9.4 million (-44% YoY), with adjusted EBITDA loss of $3.6 million.
- **2025 Guidance Update**: 
  - Total revenue: $480-510 million (flat to +6% YoY), with AWC at $450-475 million (-1% to +5%) and Surgical up 6-23%.
  - Gross margin: 74-76% (vs. 78-79% prior guidance).
  - Adjusted EBITDA: $31.1-61.9 million (vs. $43.6-83.2 million prior).
- **Cash Position**: $73.7 million as of Q2, down from $136.2 million at year-end.

**【Q&A Key Highlights】**
- **CMS 2026 Impact**: CEO expects PMA products to gain market share post-reform, with Apligraf's reimbursement rate set to align with clinical evidence. Anticipates aggressive pricing in Q4 2025 but confident in new product momentum.
- **Dermagraft Timeline**: Reintroduction expected in H2 2027, contingent on FDA approval.
- **ReNu Differentiation**: Phase III data shows efficacy in severe knee OA (KL4 patients), distinguishing it from HA and steroid competitors.
- **Surgical Growth Drivers**: Strong performance of in-licensed products and hybrid rep strategy boosting cross-selling.


Organogenesis (ORGO)-7 Aug 25-2025 Q2 Earnings call transcript

- **Q1 Revenue Stable**: $86.7M in line with guidance, reflecting LCD delay-induced demand volatility.\n- **Portfolio Expansion**: PuraPly AM access restored across all DFU/VLU indications, driving back-half recovery.\n- **ReNu Pipeline Momentum**: Phase III data expected in Q3, with BLA submission on track for end-2025.\n- **Manufacturing Growth**: New RI facility to boost capacity and reintroduce legacy products.\n- **Gross Margin Recovery**: 78-79% target for 2025, excluding one-time Q1 expiry costs.\n- **Cash Position Strong**: $110.5M cash on hand, supporting execution of growth initiatives.

**【CEO Summary Section】**
- Q1 2025 revenue was $86.7 million, down 21% YoY, in line with guidance due to LCD delay uncertainty.\n- PuraPly AM now available for all DFU/VLU indications, with full portfolio access restored.\n- ReNu Phase III study on track for BLA submission by end-2025, targeting symptomatic knee OA.\n- New manufacturing facility in RI to reintroduce Dermagraft and TransCyte, enhancing long-term growth.\n- 2025 revenue guidance reaffirmed at $480-535 million, with back-half stabilization expected.\n\n**【CFO Financial Commentary】**\n- Q1 GAAP net loss: $18.8 million (vs. $2.1M YoY). Non-GAAP adj. EBITDA loss: $12.5M (vs. $2.6M YoY).\n- Gross margin: 72.6% (vs. 73.9% YoY), impacted by lower revenue and expired inventory.\n- Operating expenses: $89.7M (+5% YoY), driven by $6.6M asset write-down.\n- Cash balance: $110.5M as of Q1, with $125M available under revolving credit.\n- 2025 guidance: GAAP net income $4.7-34M, adj. EBITDA $43.6-83.2M.\n\n**【Q&A Key Takeaways】**\n- Back-half recovery driven by formulary reinstatement and higher-margin product mix.\n- Gross margin expected to improve to 78-79% in 2025, excluding Q1 expiry impacts.\n- CMS delay to review coverage policies may expand LCD scope, benefiting PuraPly AM.\n- Competitive dynamics remain challenging, but portfolio flexibility mitigates risk.

Organogenesis (ORGO)-8 May 25-2025 Q1 Earnings call transcript

- **Q4 Revenue Beat**: $126.7M (+27% YoY) driven by delayed LCD implementation.
- **2025 Outlook**: Revenue $480M-$535M, adjusted EBITDA $43.6M-$83.2M, with Q1 2025 revenue $85M-$95M.
- **ReNu Milestone**: BLA submission end-2025, potential FDA approval Q1 2027.
- **Market Dynamics**: 55% of wound care market covered under LCD; PuraPly retains non-DFU/VLU usage.
- **Financial Strength**: $136.2M cash, no debt, 75.5% gross margin in Q4.

**【CEO Summary Section】**
- Q4 2024 revenue reached $126.7 million, up 27% YoY, driven by delayed LCD implementation and strong customer demand.
- 2025 guidance assumes LCD effective April 13, 2025, with Q1 2025 revenue expected between $85M-$95M.
- ReNu BLA submission targeted for end-2025, with potential FDA approval by Q1 2027.
- Focus on clinical data generation for ReNu and PuraPly to support reimbursement and market share growth.

**【CFO Financial Commentary】**
- Q4 2024 gross margin improved to 75.5% (vs. 72.1% YoY), driven by higher revenue and cost control.
- 2025 financial guidance: Net revenue $480M-$535M, adjusted EBITDA $43.6M-$83.2M.
- Operating expenses expected to increase 3%-6% YoY, driven by clinical trial and regulatory investments.
- Cash balance of $136.2M as of Q4 2024, no debt obligations post-debt repayment.

**【Q&A Key Takeaways】**
- Market disruption from delayed LCD implementation expected to persist through Q2 2025, with stabilization in Q3.
- 55% of wound care market (DFU/VLU) covered under LCD; PuraPly retains non-DFU/VLU usage opportunities.
- Salesforce retention stable, with attrition offset by new hires.
- PuraPly RCT interim analysis expected Q4 2025, with MAC reconsideration potential in Q1 2026.

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