Artivion (NYSE:AORT) executives highlighted what they described as a “highly successful” 2025, driven by broad-based growth across the company’s product portfolio and improved profitability, while also providing 2026 guidance and updates on key clinical and regulatory milestones.
2025 results and Q4 performance
CEO Pat Mackin said the company delivered 13% total adjusted constant-currency revenue growth for the full year 2025 and 26% adjusted EBITDA growth, which enabled positive free cash flow while continuing to invest in growth initiatives and operations.
For full-year 2025, Berry reported total adjusted revenue of $443.6 million, up 13% from 2024, and adjusted EBITDA margin of 20.2%, up 190 basis points year-over-year.
Product category trends and the lingering cyber incident comparison
Management emphasized that year-over-year comparisons were affected by a cybersecurity incident in the fourth quarter of 2024 that negatively impacted stent graft and tissue processing revenue. Berry said the incident reduced Q4 2024 revenue by about $4.5 million, including roughly $2.0 million in stent grafts and $2.5 million in tissue processing.
In Q4 2025, Artivion’s product category performance (constant currency) was led by:
- Stent grafts: up 36% reported for Q4, with Mackin citing AMDS growth in the U.S., strong international performance, and an easier comparison due to the prior-year cyber incident. Berry added that excluding the prior-year cyber impact, Q4 stent graft revenue increased 28%.
- On-X: up 24% in Q4, which management attributed to global market share gains and what Mackin called early traction in a $100 million U.S. market opportunity supported by recently published clinical data comparing mechanical and bioprosthetic valves in younger patients.
- Tissue processing: up 6% in Q4, which management noted was the category most heavily impacted by the prior-year cybersecurity event; excluding the cyber impact, Berry said Q4 tissue processing revenue declined 4%.
- BioGlue: relatively flat in Q4; Mackin said quarter-to-quarter variability can occur due to stocking distributor activity.
Berry also said tissue processing revenue for the full year declined 3% compared to 2024, coming in below expectations due primarily to lingering effects of the cybersecurity incident in Q1.
Italian “payback” adjustment and other profitability drivers
Berry discussed the impact of Italian government “payback” legislation, which requires medical device suppliers to public Italian hospitals to repay a portion of revenue when regional healthcare spending exceeds specified budgets. He said a settlement proposal for fiscal years 2015 through 2018 became effective in Q3 2025 and had minimal impact on Artivion.
In Q4 2025, the company recorded a $2.3 million adjustment to revenue for estimated payback obligations for fiscal years 2019 through 2025, which was excluded from adjusted revenue. Berry said the quarterly impact after 2025 is expected to be immaterial compared with the cumulative adjustment recorded for 2019–2025, and the company does not expect to adjust for the payback moving forward unless estimates change significantly.
In the Q&A, management clarified that the Italian payback impact was outside the U.S., specifically in the EMEA line, and was reported in an “other” revenue line item rather than in the company’s “big four” product categories.
Gross margin was 63% in both Q4 2025 and Q4 2024. Berry noted Q4 2024 gross margin was negatively impacted by an idle plant charge tied to the cybersecurity incident, while Q4 2025 gross margin was negatively impacted by roughly 1 percentage point from the Italian payback adjustment and by certain manufacturing inefficiencies the company does not expect to repeat in 2026.
On operating expenses, Berry reported non-GAAP general, administrative, and marketing expenses of $53.5 million in Q4 (45.2% of sales), down from 48.8% of sales in Q4 2024, reflecting a 360 basis point improvement. He attributed roughly 200 basis points to leveraging existing infrastructure and about 160 basis points to stock-based compensation. R&D expense rose to $9.1 million in Q4 (7.7% of sales), up from $7.4 million (7.6% of sales) in the year-ago quarter, driven by the start of the ARTISAN clinical trial.
Pipeline and regulatory updates: AMDS, NEXUS, and ARCEVO LSA
Mackin said Artivion presented positive clinical data in January from the AMDS PERSEVERE trial and from partner Endospan’s NEXUS TRIOMPHE trial at the STS annual meeting.
For AMDS, Mackin said two-year PERSEVERE data showed continued clinical benefit after one year, including minimal additional mortality and morbidity, no additional unanticipated aortic reoperations, and continued absence of de novo tears. He described AMDS as the company’s nearest-term PMA opportunity and said Artivion filed the fourth and final module with the FDA, keeping it on track for FDA approval in mid-2026. In response to an analyst question, Mackin said the main difference between the current HDE pathway and PMA approval is the requirement under HDE for hospitals to obtain local IRB approval, and he characterized PMA as primarily reducing administrative burden rather than changing the overall commercial opportunity.
For NEXUS, Mackin highlighted one-year U.S. IDE data presented by Endospan, including 94% survival from lesion-related death and 91% of patients free from stroke at one year in a high-risk group, with 97% free from reinterventions due to endoleaks. Mackin said the company believes NEXUS remains on track for approval in the second half of 2026. He described NEXUS as a platform technology aimed at a “nascent” market with one approved product already in the U.S. market and reiterated the company’s view of a $150 million annual U.S. opportunity. Management emphasized that NEXUS would likely be used in fewer centers than AMDS and would require more intensive training because it is an endovascular arch procedure for highly specialized physicians.
On the ARCEVO LSA program, Mackin said the ARTISAN trial has enrolled eight patients to date. The non-randomized trial is planned for 132 patients in the U.S. and Europe across up to 30 centers. Mackin said the company anticipates completing enrollment in mid-2027 and, assuming endpoints are met, expects FDA approval in 2029, which management believes could unlock an incremental $80 million in annual U.S. market opportunity.
Cash flow, balance sheet, and 2026 outlook
Berry said free cash flow was approximately $1 million in 2025, above expectations, despite investments including one-time cash payments of about $20 million related to the purchase of two Austin facilities in Q4 (with one building closing accelerated from Q1 2026 into Q4 2025). As of Dec. 31, 2025, Artivion had about $64.9 million in cash and $215.1 million in debt (net of unamortized loan origination costs). The net leverage ratio was 1.8 at quarter-end, down from 3.8 a year earlier.
For 2026, Berry guided to constant-currency revenue growth of 10% to 14%, representing reported revenue of $486 million to $504 million, with foreign exchange expected to have an insignificant impact. The outlook excludes any impact from a potential acquisition of Endospan. By segment, management expects:
- Tissue revenue: relatively flat year-over-year
- BioGlue: mid-single-digit growth
- On-X: mid-teens growth
- Stent grafts: low-twenties growth
Berry said Q1 2026 growth is expected to be stronger than the rest of the year due to easier comparisons tied to lingering cybersecurity impacts in Q1 2025, with tougher comparisons later in the year as On-X and AMDS anniversary the prior-year growth rates.
Adjusted EBITDA is projected at $105 million to $110 million in 2026, representing 18% to 22% growth over 2025, along with about 150 basis points of margin expansion at the midpoint. Berry said the company expects about 50 basis points of gross margin improvement driven by mix benefits from U.S. AMDS and U.S. On-X growth, and about 200 basis points of leverage from SG&A partially offset by an expected 100 basis point increase in R&D as a percentage of sales (from roughly 7% in 2025 to about 8% in 2026) due to a full year of ARTISAN trial expense.
Berry also said free cash flow is expected to be slightly positive in 2026, with capital expenditures projected at approximately $50 million, up from $39 million in 2025. He attributed the elevated CapEx primarily to investments supporting On-X growth, as well as increased investment in internal IT systems, and said CapEx is expected to moderate in later years.
About Artivion (NYSE:AORT)
Artivion, Inc (NYSE: AORT) is a global medical technology company that develops, manufactures and markets implantable tissue products and surgical devices for cardiac and vascular surgery. The company’s portfolio includes biologic implants derived from human and animal tissue, such as allografts and xenografts, as well as synthetic scaffolds and surgical adhesives. These products are designed to repair, reinforce or replace damaged cardiovascular and thoracic tissues during procedures such as aortic repair, heart valve surgery and vascular reconstruction.
Originally founded in 1984 under the name CryoLife, the company rebranded as Artivion in early 2022 to reflect its broader mission in cardiovascular innovation.
