Artivion, Inc. Q1 FY2026 earnings call

• Acquisition of Endospan: PMA approval of NEXUS aortic arch stent graft system for chronic aortic dissections, plan to supplement label to include aortic aneurysms, expected to close in 2026 and launch NEXUS in Jan 2027. - AMDS: U.S. AMDS starter set sales fell short of expectations in Q1, but implant and reorder patterns in accounts using AMDS are positive. Anticipate PMA approval of AMDS in coming months. - On-X: Continues to take market share, with data showing improved outcomes for younger patients. - Tissue processing: Revenues increased as tissue volumes normalized post-cybersecurity event. - Pipeline: ARTISON clinical trial for next-generation frozen elephant trunk has 26 patients enrolled, anticipate completing full enrollment in mid-2027, and FDA approval of C-Branch LSA in 2029.

Stent graft revenues grew 10% on a constant currency basis in Q1 2026. On-X revenue was up 17% year over year on a constant currency basis. Tissue processing revenues increased 23% year over year on a constant currency basis. BioGlue was relatively flat on a constant currency basis. Revenue contribution: Stent grafts, On-X, tissue processing, and BioGlue each contributed differently to total revenue.

• Adjusted constant currency growth for full year 2026 is expected to be between 7% and 11%, with reported revenue range of $480 million to $496 million. - Excluding Endospan acquisition, adjusted EBITDA for 2026 is expected to be in range of $100 million to $107 million. - If Endospan acquisition closes, incremental $8 million expense expected, reducing adjusted EBITDA to $92 million to $99 million. - Anticipate first meaningful revenue contribution from NEXUS in Jan 2027, and combined results to be EBITDA neutral for 2027 as NEXUS revenue ramps.

• International market softness, particularly in the Middle East, impacting stent graft revenues. - Supply chain challenges affecting some stent graft products. - Barriers to AMDS starter set sales such as upfront $100 thousand cost and IRB requirements. - Uncertainty around timing and impact of actions to mitigate issues affecting revenue.

Q: Understand better on guidance reset, especially AMDS PMA and NEXUS commercial infrastructure.

A: Pat and Lance discussed factors impacting guidance, AMDS PMA expected midyear, and steps to build NEXUS commercial infrastructure like going through value analysis committees, building inventory, and hiring clinical specialists.

Q: Color on reordering versus new accounts for AMDS.

A: Implant sales of AMDS were ahead of plan, but barriers exist for upfront $100 thousand purchase, working on programs to overcome barriers.

Q: Details on NEXUS growth trajectory and $8 million incremental cost.

A: Surgeons adopt NEXUS rapidly due to unmet need, $8 million incremental cost has components like launch prep, R&D/clinical, and run-rate expenses, expected to be EBITDA neutral in 2027 as NEXUS revenue ramps.

Q: Quantify AMDS accounts deferring for PMA approval, core stent business growth.

A: Multiple accounts deferring for PMA approval, details not given on counts, and core stent business growth affected by international slowdown.

Q: Updates on commercial organization and tissue business.

A: Limited sales force additions planned, tissue business expected to average about $24 million per quarter within normal fluctuations.

Q: AMDS consignment and international stent graft issues.

A: Not planning to shift to consignment for AMDS, international stent graft issues like Middle East and supply chain about half and half impact.

Q: AMDS reordering behavior and margin.

A: Reorders increase as usage spreads within accounts, no meaningful difference in gross margin between reorders and initial orders.

Q: On-X usage split and NEXUS go-forward plans.

A: On-X growth in focus segment of 50-65 year olds, NEXUS plans to bring Duo and Tre to U.S. with clinical trial, off-the-shelf version, and logistics aligned to elective case scheduling.

Q: Supply chain challenges for stent grafts.

A: Supply chain challenges related to supplier network, ring-fenced, working to solve but will take time, impacting specific products in stent graft portfolio.