Artivion, Inc. Q4 FY2025 earnings call

Key Points

• 2025 was a successful year with total adjusted constant currency revenue growth of 13% and adjusted EBITDA growth of 26%.
• Fourth quarter performance was strong, driven by growth across all product portfolios, led by stent grafts and On-X.
• Stent grafts grew 36% in Q4 constant currency, with plans to bring more European products to U.S. and Japan.
• On-X revenues grew 24% in Q4, driven by global market share gains and new U.S. market opportunity from clinical data.
• Tissue processing revenue increased 6% in Q4 but declined 3% full year due to cybersecurity incident.
• Clinical progress: Positive data from AMDS PERSEVERE and NEXUS TRIUMPH trials, and progress on ARTISAN trial for Arecibo LSA.

For the fourth quarter of 2025, stent grafts grew 36% on a constant currency basis. On-X revenues grew 24% year over year on a constant currency basis. Tissue processing revenue increased 6% year over year on a constant currency basis in Q4, while full-year tissue processing growth declined 3% compared to 2024. BioGlue was relatively flat on a constant currency basis. Total adjusted constant currency revenue growth for 2025 was 13%, and adjusted EBITDA growth was 26%.

2026 Guidance

• Expected constant currency growth between 10% to 14%, resulting in reported revenue range of $486 million to $504 million.
• Adjusted EBITDA expected to be in the range of $105 million to $110 million, representing 18% to 22% growth over 2025.
• Gross margins expected to improve by approximately 50 basis points.
• R&D spend expected to increase to ~8% of sales in 2026.
• CapEx expected to be approximately $50 million in 2026, up from $39 million in 2025.

Risks

• Impact of Italian government payback legislation, although quarterly impact is expected to be immaterial moving forward.
• Lingering effects of the 2024 cybersecurity incident on tissue processing revenue.
• Uncertainties in clinical trial execution and regulatory approvals for new products.

Q: About the Italian clawback, was it in OUS and did it impact revenue line items?

A: Yes, it was in OUS (EMEA line) and did not impact the big four line items.

Q: Progress on AMDS PMA and market penetration?

A: AMDS was launched in the U.S., with 2025 being a year of opening accounts, and 2026 expected to continue opening new accounts and increasing implants.

Q: Pricing for AMDS and NEXUS, and stress testing guidance?

A: These are cutting-edge therapies with favorable reimbursement, and upside depends on successful market penetration of On-X and AMDS.

Q: CapEx and its purpose?

A: CapEx is primarily for capacity expansion to support On-X growth and IT system improvements, expected to moderate in subsequent years.