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- **Revenue Surge**: Q3 2025 revenue up 16% to $113.4M, with 31% stent graft growth and 23% On-X valve expansion.
- **AMDS Success**: U.S. launch outperformed expectations, backed by new CMS DRG-209 reimbursement and late-breaking clinical data showing malperfusion benefits.
- **On-X Momentum**: 20%+ growth driven by JAK mortality data; cardiologist engagement to accelerate in 2026.
- **Pipeline Progress**: NEXUS 1-year data due in January 2026; Arcevo trial enrollment begins. Endospan acquisition option remains on track.
- **Financial Strength**: 39% EBITDA growth to $24.6M; 65.6% gross margin reflects high-margin product mix. 2025 guidance raised to 13-14% revenue growth.

**【CEO Summary Section】**
- **Revenue Growth**: Q3 2025 revenue increased 16% YoY to $113.4 million, driven by 31% growth in stent grafts (AMDS) and 23% growth in On-X valves. Adjusted EBITDA rose 39% to $24.6 million.
- **Product Highlights**: AMDS U.S. launch exceeded expectations, with strong clinical data and new CMS DRG-209 reimbursement. On-X valves benefit from JAK clinical trial showing mortality advantage in patients under 60.
- **Pipeline Progress**: NEXUS IDE trial 1-year data expected in January 2026; Arcevo LSA trial enrollment begins. Endospan acquisition option remains contingent on FDA approval.
- **Capacity Expansion**: Acquired two Austin facilities for On-X manufacturing, reducing long-term costs and ensuring capacity for growth.

**【CFO Financial Commentary】**
- **Financial Performance**: GAAP revenue $113.4M (+16% YoY), adjusted EBITDA $24.6M (+39% YoY). Gross margin 65.6% vs. 63.7% prior year, driven by high-margin AMDS and On-X sales.
- **Expense Management**: SG&A 47.3% of sales (-130bps YoY). R&D 7.1% of sales, supporting pipeline. Free cash flow $17.7M, with $12M one-time facility purchase impacting Q4 2025 cash flow.
- **Guidance Update**: Full-year 2025 revenue growth 13-14% (vs. prior 12-14%), adjusted EBITDA $88-91M (+24-28% YoY). 2026 outlook: double-digit revenue growth, EBITDA expansion at twice the rate.

**【Q&A Key Highlights】**
- **AMDS Reimbursement**: New DRG-209 reflects procedure complexity, enhancing provider economics and patient access. Q3 AMDS U.S. revenue contributed significantly to stent graft growth.
- **On-X Growth**: 20%+ YoY growth driven by JAK clinical data adoption and cross-selling with AMDS training. Cardiologist engagement expected to accelerate in 2026.
- **Pipeline Costs**: CVO trial may push R&D to 7-8% of sales in 2026. Endospan acquisition financing secured with $150M delayed draw term loan.
- **International Expansion**: AMDS Europe/Canada sales growing; Japan PMA filing planned post-U.S. PMA approval. BioGlue China launch expected to support mid-single-digit growth.

Artivion, Inc. (AORT) Q3 2025 Earnings Call Transcript

- **Revenue Acceleration**: Q2 2025 revenue +14% YoY, EBITDA +33%, driven by 24% On-X growth and AMDS launch.
- **Pipeline Breakthroughs**: IDE approval for Arcevo LSA trial (132 patients), NEXUS PMA on track for 2026 with 63% MACE reduction data.
- **Balance Sheet Strength**: Net leverage reduced to 2.2x, $11.7M free cash flow, and raised 2025 guidance to 12-14% revenue growth.
- **Strategic Cross-Selling**: AMDS training sessions directly leading to new On-X customers, reinforcing multipronged growth strategy.

**【CEO Summary Section】**
- **Revenue Growth**: Q2 2025 constant currency revenue up 14%, adjusted EBITDA up 33% YoY. On-X sales grew 24% YoY, driven by U.S. adoption and cross-selling with AMDS.
- **Product Performance**: AMDS U.S. launch generated strong early demand; stent grafts grew 22% YoY. Tissue processing backlog expected to clear by Q3, with mid-single-digit growth outlook.
- **Pipeline Progress**: IDE approval for Arcevo LSA (third-gen frozen elephant trunk) with 132-patient trial set to begin by year-end. NEXUS PMA on track for 2026 approval, supported by positive 30-day data from Endospan's TRIUMPH trial.
- **Balance Sheet**: Retired $99.5M convertible notes, reducing net leverage to 2.2x from 4.1x YoY. Free cash flow of $11.7M in Q2.

**【CFO Financial Commentary】**
- **Financial Highlights**: Q2 2025 revenues $113M (+14% YoY), adjusted EBITDA $24.8M (+33% YoY). Gross margin 65.1% (up 50bps YoY) due to AMDS and On-X mix. Free cash flow positive at $11.7M.
- **Guidance Update**: Full-year 2025 revenue guidance raised to 12-14% growth (prev. 11-14%), adjusted EBITDA $86-91M (+21-28% YoY). Q2 outperformance driven by currency tailwinds and AMDS/HDE revenue.
- **Expense Management**: SG&A as % of sales improved 100bps YoY to 47.2%, despite AMDS launch costs. R&D expenses stable at $7.1M.

**【Q&A Key Highlights】**
- **AMDS Adoption**: 1,000 U.S. centers capable of implanting AMDS; 600 top-volume centers targeted. Surgeons report immediate integration post-training, with cross-selling leading to new On-X customers.
- **On-X Growth**: 24% YoY growth driven by low INR indication, clinical data showing mortality benefit in <60yo patients, and AMDS cross-selling. No bulk deals; growth from implants.
- **Pipeline Momentum**: Arcevo LSA trial enrollment expected Q4 2025. NEXUS PMA on track for 2026, with Endospan's 30-day data showing 63% reduction in major adverse events.
- **BioGlue China**: Launch expected H2 2025, pending provincial approvals. Tissue processing backlog clearing by Q3, with mid-single-digit growth outlook.
- **Free Cash Flow**: Positive for full year; Q2 $11.7M reflects catch-up from Q1. Timing variability possible but confident in positive trend.

Artivion, Inc. (AORT) Q2 2025 Earnings Call Transcript

- **Q1 Growth Resilience**: 4% revenue growth despite tissue backlog, with stent grafts (+19%) and On-X (+11%) leading the charge.
- **AMDS Launch Momentum**: 150+ facilities in approval process, targeting 1-2% FY25 growth contribution.
- **On-X Market Expansion**: $100M new opportunity from mortality benefit data, supply chain fully restored.
- **NEXUS Pipeline Strength**: 63% MAE reduction in pivotal trial, on track for 2026 FDA approval.
- **FY25 Guidance Uptick**: Revenue growth raised to 11-14%, EBITDA +18-28%, driven by AMDS, On-X, and NEXUS.

**【CEO Opening Remarks】**
- Q1 2025 revenue grew 4% YoY (constant currency), driven by stent graft (+19%), On-X (+11%), and BioGlue (+9%) despite cybersecurity-related tissue backlog.
- AMDS HDE launch progress: 150+ facilities seeking IRB/VAC approvals, with 100% hit rate on targeted accounts.
- Tissue processing backlog reduced by 1/3 in Q1, expected to clear by Q3 2025.
- Key growth drivers: AMDS ($150M U.S. market), On-X mortality benefit data ($100M new market), and NEXUS PMA ($150M U.S. market).

**【CFO Financial Highlights】**
- Q1 2025 revenue: $99M (4% YoY growth), Adjusted EBITDA: $17.5M (1% YoY growth), margin: 17.7%.
- Product line performance: stent grafts ($19M, +19%), On-X ($11M, +11%), BioGlue ($9M, +9%).
- Regional growth: Latin America (+26%), EMEA (+14%), Asia Pacific (+8%), North America (-6%).
- Updated FY25 guidance: 11-14% constant currency revenue growth (up from 10-14%), Adjusted EBITDA: $84-91M (+18-28% YoY).
- Q2 2025 revenue outlook: $107.5-109.5M (13% YoY growth at midpoint).

**【Q&A Key Takeaways】**
- **AMDS Market Penetration**: 150+ facilities in process, potential for >100% of targeted accounts by year-end. AMDS to add 1-2% to FY25 growth rate.
- **On-X Supply Chain**: Back to normal levels post-cybersecurity incident, double-digit growth expected to continue.
- **NEXUS Clinical Data**: 63% reduction in MAEs vs. comparators, on track for FDA approval in H2 2026.
- **Cash Flow Management**: Free cash flow positive for FY25, Q1 elevated expenses due to AMDS launch and cybersecurity costs.
- **International Growth**: Latin America (+26%), Asia Pacific (+8%) driven by new regulatory approvals and pipeline expansion.

Artivion (AORT)-5 May 25-2025 Q1 Earnings call transcript

- **Strong 2024 Performance**: 10% constant currency revenue growth, 32% EBITDA expansion. Q4 revenue $97.3M, EBITDA $17.6M.
- **AMDS HDE Milestone**: U.S. sales enabled with 1-year data showing 50% mortality reduction. PMA delayed to mid-2026 due to FDA testing.
- **2025 Outlook**: 10-14% revenue growth, 18-28% EBITDA growth. AMDS to contribute 1-2% to growth.
- **Cyber Recovery**: Q1 revenue down $10M, fully recovered by year-end. Tissue and On-X backlogs resolved by Q2.
- **On-X Dominance**: Clinical data shows mechanical valves superior for <60-year-olds. 10%+ growth expected.

**【CEO Summary Section】**
- **Revenue Growth**: Total constant currency revenue up 10% (excluding PerClot) in 2024, driven by double-digit growth in On-X and stent grafts. Q4 revenue $97.3M (+3% YoY). Adjusted EBITDA $17.6M (+15% YoY), margin 18%.
- **Cybersecurity Impact**: Q4 revenue reduced by ~$4.5M due to cyber incident, but full year 2025 expected to recover. Tissue processing and stent graft delays in Q1 will be offset in later quarters.
- **AMDS Breakthrough**: Received HDE for AMDS in December, enabling U.S. sales ahead of PMA. 1-year PERSEVERE data shows 50% mortality reduction vs. control. PMA now expected mid-2026 due to additional FDA testing requirements.
- **Product Highlights**: On-X valve growth 10% YoY, driven by clinical data showing mortality benefit in <60-year-olds. BioGlue China approval pending, expected launch H2 2025. Tissue processing impacted by supply chain inefficiencies but demand remains strong.

**【CFO Financial Commentary】**
- **2024 Results**: Full year revenue $388.5M (+9.4% YoY). Adjusted EBITDA $73.4M (+32% YoY). Gross margin 63%, improved 200bps in G&A.
- **2025 Guidance**: Revenue $420-435M (+10-14% YoY). Adjusted EBITDA $84-91M (+18-28% YoY). AMDS expected to contribute 1-2% to growth, with minimal EBITDA impact in 2025 due to launch costs.
- **Financial Health**: Net leverage 3.8x at year-end. Convertible debt to convert to shares in July 2025, targeting <2x leverage by year-end.

**【Q&A Key Takeaways】**
- **AMDS Commercialization**: 55-person U.S. sales team actively pursuing ~55 hospitals. 1-year data shows 0 DANE tears vs. 70% in control group. Q1 sales minimal, expect sequential growth.
- **Cyber Recovery**: Tissue backlog to be cleared by year-end. On-X inventory replenished by Q2. Q1 revenue $94-96M, with $10M catch-up in later quarters.
- **On-X Momentum**: JACC study shows 72% mortality reduction in <60-year-olds. Strong surgeon support for mechanical valves post-clinical data.
- **Endospan Update**: NEXUS 30-day data to be presented at AATS in May. PMA submission expected H2 2026, with decision on Endospan acquisition by Q1 2027.


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