Artivion, Inc.

Good afternoon and welcome to the RTVN fourth quarter and year-end 2025 earnings call. At this time, all participants are in a listen-only mode. A brief question and answer session will follow the formal presentation. If anyone should require operator assistance during the conference, please press star zero on your telephone keypad. As a reminder, this conference is being recorded. I would now like to turn the conference over to Lane Morgan from the Gilmartin Group. Thank you. You may begin.

Thanks, operator. Good afternoon, and thank you for joining the call today. Joining me today from our TIVI management team are Pat Matkin, CEO, and Lance Berry, COO and CFO. Before we begin, I'd like to make the following statements to comply with the safe harbor requirements of the Private Securities Litigation Reform Act of 1995. Comments made on this call that look forward in time involve risks and uncertainties and are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. The forward-looking statements include statements made as to the company's or management's intentions, hopes, beliefs, expectations, or predictions of the future. These forward-looking statements are subject to a number of risks, uncertainties, estimates, and assumptions that may cause actual results to differ materially from these forward-looking statements. Additional information concerning certain risks and uncertainties that may impact these forward-looking statements is contained from time to time in the company's SEC filings and in the press release that was issued earlier today. You can also find a brief presentation with details highlighted on today's call on the investor relations section of the Attibian website. Lastly, I'd like to remind you to please refer to our press release published earlier today for information regarding our non-GAAP results, including a reconciliation of these results to our GAAP results. Unless otherwise stated, all of our comments today will be using our non-GAAP results. Additionally, all percentage changes discussed will be on a year-over-year basis, Revenue growth rates will be the adjusted constant currency rates and expenses as percent of sales will be based on adjusted revenues. Now, I'll turn it over to Artivion CEO, Pat Mackin.

Thanks, Elaine, and good afternoon, everybody. 2025 was a highly successful year for Artivion, during which our team made meaningful progress against our strategy design to drive long-term growth, profitable growth through our expanding and clinically differentiated product portfolio. I'm pleased to report that for the full year of 2025, total adjusted constant currency revenue growth was 13% and adjusted EBITDA growth was 26% year over year. This enabled us to deliver positive free cash flow for the year while also investing significantly in future growth and operational excellence. Our progress through the year culminated in a strong fourth quarter with performance driven by continued growth across our entire product portfolio led by StenCrafts and Onyx. As a reminder, during the fourth quarter of 2024, stent graft and preservation services businesses were negatively impacted by the cybersecurity incident. With that in mind, from a product category perspective, stent grafts grew 36% on a constant currency basis in the fourth quarter compared to the same period last year. Year-over-year growth was again driven in large part by AMDS in the U.S., continued strong growth in stent grafts internationally, as well as an easier year-over-year comp due to last year's cyber incident. We see our StentGraph portfolio as foundational component of our growth, and we are encouraged by the continued strong results across the portfolio. Looking ahead, we intend to replicate our proven strategy by bringing additional StentGraph products that are already generating revenue in Europe to the U.S. and Japan, which we believe will unlock further meaningful expansion of our StentGraph total addressable market. Also in Q4, our ONIX revenues grew 24% year-over-year on a constant currency basis. Growth was driven by our continued global market share gains and early traction in our new $100 million U.S. market opportunity unlocked by recently published data. As previously discussed, the clinical evidence supported by two leading journals demonstrated improved outcomes with mechanical versus bioprosthetic valves for younger patients. As a result, we maintain a strong conviction that Onix is the best aortic valve on the market for patients under the age of 65, and that we'll continue to take market share worldwide in that product line. In Q4, tissue processing revenue, which was the category most heavily impacted by last year's cybersecurity event, increased 6% year-over-year on a constant currency basis. Lastly, BioGlue was relatively flat on a constant currency basis compared to the same period last year. As we've discussed previously, we expect to see some variability in the growth rates of BioGlue quarter over quarter, driven by the significant amount of stocking distributor business in that product line. In addition to our strong financial performance, we continue to advance our clinical programs and pipeline. Recently, in January, we saw positive new clinical data from the AMDS-Persevere and Nexus-Triumph trials presented at the STS annual meeting in New Orleans. First, the two-year data for AMDS-Persevere trial demonstrates continued clinical benefits of AMDS after one year, including minimal additional mortality and morbidity, no additional unanticipated aortic reoperations, and the continued absence of vein tears. These data build on the positive findings from the 30-day and one-year readouts, further supporting the lifesaving nature of the AMDS technology, which represents our nearest term PMA opportunity. While the HDA enables us to sell AMDS in the U.S. ahead of the PMA approval, we remain focused on securing the PMA for AMDS. We are pleased to report that we recently filed the fourth and final module with the FDA, keeping us on track for FDA approval in mid-26. Second, our partner, Endospan, presented one-year data from the U.S. IDE trial for its Nexus aortic arch stent graft system. This trial is the first FDA IDE trial for the endovascular treatment of chronic dissections in the aortic arch and is focused on patients at high risk for open surgery. The data highlighted 94% of patient survival from lesion-related death and 91% of patients were free from stroke at one year post-treatment in this high-risk patient group. The data also showed 97% of patients were free from interventions due to endo leaks. In our discussions with physicians at STS, surgeons generally expressed that they believed that the one-year results were extremely promising. Based on these positive outcomes, we believe Nexus remains on track for approval in the second half of 2026. Lastly, on our pipeline, we continue to make progress on the Artisan trial for our R-Civo LSA product. We now have eight patients enrolled in our trial, which is a non-randomized clinical trial consisting of 132 patients in the U.S. and Europe at up to 30 centers for treatment of aortic dissection and aneurysm. The combined primary safety and efficacy endpoints assess the reduction in all-cause mortality, new permanent disabling stroke, new permanent paraplegia or paraparesis, unanticipated aortic reoperation in the treated segment, and less of clavian artery occlusion. We anticipate completing the full enrollment in mid-27. We're optimistic that the trial will be successful, supported by the positive clinical results from our current generation frozen elephant trunk, Aveda OpenNeo, We're outside the US. Following our one year follow up period, we're assuming that the trial meets its endpoints. We anticipate FDA approval for our Siebel LSA in 2029, unlocking an incremental 80 million in annual US market opportunity. In conclusion, 2025 was a standout year for Arctivion, and our strong financial, clinical and regulatory execution positioned us well for continued growth in 2026 and beyond. We remain confident in our ability to deliver sustainable double-digit revenue growth, drive EBITDA margin expansion, and grow adjusted EBITDA at twice the rate of constant currency revenue growth over the long term. With that, I'll now turn the call over to Lance.