ARTIVION, INC. Q4 FY2024 earnings call

• Cybersecurity Incident: Discovered in November 2024, it had a $4.5M negative impact on Q4 revenue. Manufacturing facilities and tissue processing were disrupted, but no meaningful full-year impact expected.
• Product Portfolio Growth: On-X saw 10% constant-currency revenue growth, stent grafts 8% in Q4, BioGlue 7% in constant currency, and tissue processing declined 8% in Q4.
• Regulatory Milestones: AMDS received HDE, with PMA submission pushed to mid-2026; Endospan NEXUS aortic stent graft system to present 30-day data at AATS in early May 2025.
• Global Expansion: Latin America and Asia-Pacific showed strong constant-currency revenue growth, with continued leverage of product portfolio in those regions.

On-X: Constant-currency revenue increased 10% year-over-year. Stent Grafts: Grew 8% on constant currency in Q4, with the portfolio focused on complex segments and pipeline to U.S. and Japanese markets. BioGlue: Grew 7% on constant currency, with commercialization in China expected in the second half of 2025. Tissue Processing: Declined 8% year-over-year on constant currency in Q4 due to the cyber incident. Geographic: Latin America and Asia-Pacific delivered constant-currency revenue growth of 26% and 11% respectively for the full-year, with strong growth anticipated in coming years.

• Full-year 2025 constant currency growth expected between 10% and 14%, resulting in reported revenue range of $420M to $435M.
• Adjusted EBITDA expected in range of $84M to $91M for 2025, representing 18% to 28% growth over 2024.
• AMDS HDE anticipated to have 1 to 2 percentage point positive impact on 2025 constant currency growth.
• Q1 2025 revenue forecasted at $94M to $96M, with expectation of revenue catch-up later in the year.

• Cybersecurity Incident: Impacted Q4 revenue and processing, but not expected to meaningfully affect full-year 2025 business. Operational inefficiencies from the incident were temporary and expected to be resolved.

Q: Could you give more detail on early AMDS commercial progress, including number of interested hospitals and physician feedback?

A: Received HDE in early December, trained U.S. commercial team in January, presented one-year PERSEVERE data, and have ~55 sales teams actively pursuing AMDS accounts with three steps (IRB, value analysis committee, surgeon training) in progress.

Q: How confident are you that lost revenue will return throughout the year, especially on tissue and On-X?

A: Demand for tissue and On-X products far exceeds supply, donations were normal during the cyber incident, and the clinical data (e.g., On-X mortality benefit in under-60 patients) supports strong future sales with expected catch-up in the year.

Q: Why was the AMDS PMA timeline delayed to mid-2026?

A: FDA required additional non-clinical benchtop testing due to new international standards, which added time to the submission and review process, but not expected to meaningfully impact revenue trajectory.

Q: How many implanting sites for AMDS are there in the U.S. and penetration with existing sales force?

A: ~1,000 centers do DeBakey type 1 dissections, focusing on top 600 centers which have 80% of the volume, with existing sales force covering these areas.

Q: What's the operational bottleneck in tissue processing due to the cybersecurity incident?

A: Manual processes were needed instead of usual system-based processes for tissues in process or received during the incident period, extending processing time.

Q: Can you comment on the cadence of Q1 EBITDA in light of revenue guidance?

A: Q1 is expected to have the lowest adjusted EBITDA of the year due to timing differences, but full-year guidance remains strong with expected revenue catch-up later in the year.

Q: What missionary work is needed to reverse the trajectory of mechanical valve decline?

A: Surgeons were impressed by the clinical data showing mechanical valve mortality benefit in under-60 patients, with plans to target referring cardiologists and accelerate adoption through mid-year initiatives.

Q: What's the conversation in the clinical community about AMDS from 30 days to one year?

A: The 30-day to one-year data from AMDS PERSEVERE trial showed sustained benefit with 50% lower mortality and zero DANE tears, receiving strong support from the clinical community.

Q: How much impact does FX have on OUS contribution?

A: FX is expected to have approximately a 2 percentage point negative impact on as-reported revenue in 2025, with a natural hedge from European manufacturing mitigating some EBITDA impact.

Q: When is the earliest decision on Endospan acquisition?

A: Endospan is expected to present 30-day data at AATS in May 2025, with PMA approval expected in the second half of 2026, and a decision on acquisition to be made 90 days post-approval, likely in Q1 2027.

Q: Why exchange convertible debt for shares instead of rolling it over?

A: To deleverage the balance sheet, reduce interest expense, and position for better financial health to execute on acquisition opportunities like Endospan.