Artivion, Inc.

Good afternoon and welcome to the Artivian second quarter 2026 earnings call. At this time, all participants are in a listen-only mode. A brief question and answer session will follow the formal presentation. Should anyone 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 Brian Johnston from the Gilmartin Group. Thank you. You may begin.

Good afternoon and thank you for joining the call today. Joining me from our TIVIANS management team are Pat Mackin, 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 that are forward-looking statements within the meaning of the Federal Securities, Private Securities Litigation Reform Act of 1995. The forward-looking statements include statements made as 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 Artivian's 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 on the adjusted currency, constant currency rates, and expenses as percentage of sales will be based on adjusted revenues. With that, I'll turn the call over to Artivian CEO, Pat Mackin.

Hey, thanks, Brian, and good afternoon, everybody. Through the second quarter of 2026, we continue to execute on our strategy designed to drive long-term profitable growth through an expanding and clinically differentiated product portfolio. We delivered total constant currency revenue growth of 9% and adjusted EBITDA growth of 7% over prior year. Revenue growth was again driven primarily by ONIX and stent graphs, including AMVS. Before expanding further on product line performance, I want to take a moment to address two milestones that we were most focused on coming into this year and recently achieved In late June, we received U.S. FDA approval for the PMA for our AMDS hybrid prosthesis in line with our previously communicated expectations. The third quarter will be the first full quarter in which AMDS is sold in the U.S. under the full PMA. That is meaningful because PMA approval obviates the lengthy IRB review process and new accounts that previously had to work through. And we expect to accelerate new account conversion and set sales going forward. We are also pleased to complete the acquisition of Endospan in its Nexus AorticArch StentGraph system during the second quarter, again ahead of the timing we had anticipated. This acquisition completes our market-leading three-pronged AorticArch portfolio. We believe this technology, alongside AMDS and our CEVO, positions us at the forefront of this segment as the only company globally with a complete portfolio of AorticArch solutions. Importantly, Nexus is a platform technology, not just a single product. It supports three additional PMA programs in development that we expect will further extend and solidify our leadership in the aortic arch market over time. As it relates to Nexus, our message here is consistent with last quarter. Through 2026, our focus will be on building inventory, working through value analysis committees, and augmenting our U.S. sales team. We continue to expect a full U.S. commercial launch of the Nexus system in January of 2027. As a reminder, the device is approved to treat chronic aortic dissections, which represents about a $100 million market opportunity. With that, now let me turn to the second quarter results. From a product category perspective, StemCraft revenues grew 12% on a cost and currency basis in the second quarter compared to the same period last year. This is an acceleration from the 10% growth we reported in the first quarter and came against tougher year-over-year comparison, so we're encouraged to see this progress. Importantly, one of our key areas of focus coming out of the first quarter was on AMDS set sales. We were pleased to see improvement in set sales relative to the first quarter, with implant trends also remaining strong. As we said last quarter, we view implant reordering as the most critical indicator as strong reordering patterns reflect positive user experience and ultimately longer-term adoption and higher growth. Looking ahead, we expect USAMDS set sales to further accelerate following the recent AMDS PMA approval and as the barriers associated with the initial upfront 100,000 investment associated with the stocking continue to wane. Ultimately, we see our comprehensive StentGraph portfolio as a foundational component of our growth strategy. We are encouraged by our enduring fundamental strength and increasingly strong competitive advantages within this segment. Turning to ONIX, our second quarter ONIX revenues grew 18% year-over-year on a constant currency basis. This growth was again driven by global market share gains and the newer U.S. opportunity unlocked by data showing improved outcomes with mechanical versus bioprosthetic valves in younger patients. I also came against a much tougher year-over-year comparison than in prior quarters. The data supports our conviction that the onyx valve is the best aortic valve on the market for patients under the age of 65. Meanwhile, tissue processing came in slightly ahead of our expectations, generating approximately $26 million in revenue, representing an increase of 1% year-over-year on a constant currency basis against a challenging comp due to recovery from the 2024 cyber incident in Q2 of 2025. We had a strong finish to the quarter in terms of tissue releases, resulting in some volume we might otherwise have expected in the third quarter shifted into the second quarter. Overall, we remain on track with our expectations. I also want to briefly highlight the ROS procedure data that was recently published in JAK, the Journal of American College of Cardiology. The study reported a 12-year outcome of 455 adult ROS procedures that were performed at a single high-volume center. This study provides compelling long-term evidence regarding the performance of our proprietary Synagraph pulmonary valve. The results were outstanding. With survival compared to the age-matched general population, the autograft re-intervention rate was 1%, and the pulmonary homograft intervention rate was at less than 2%, and that's at 12 years. As a result, the overall re-intervention at 12 years was about 3.5%. Importantly, 95% of the pulmonary homographs implanted in this study were artesian cinegraph valves. These results further reinforced cinegraph's differentiated clinical profile and market leadership. We believe this level of long-term clinical evidence is unmatched in the pulmonary homograph market and strengthens physician confidence in the ROS procedure as well as our product. Collectively, these data reinforce our conviction that supply, not demand, continues to be the primary constraint in growth for this segment of our tissue business. Finally, BioGlue revenue declined modestly in the quarter on a cost and currency basis. As we discussed last quarter, this product line carries a meaningful amount of stocking distribution business, which creates normal quarter-to-quarter variability, and we continue to expect mid-single growth for BioGlue over the full year. Lastly, on our pipeline, we continue to make progress on the Artisan Clinical Trial for our Arcivo LSA product. We've now enrolled 30 patients in the trial, which is a non-randomized clinical trial up to 132 patients in the US and Europe at 30 centers. This is for the treatment of aortic dissection and aneurysm in the arch. We anticipate completing enrollment in mid-27. We are optimistic the trial will be successful. based on, in part, the positive clinical results from our current generation frozen elephant trunk, Aveda OpenNeo, outside the U.S. Following a one-year follow-up period and assuming the trial meets its endpoints, we anticipate FDA approval for our CEVO in 2029, unlocking an incremental $80 million of annual U.S. market opportunity. In conclusion, the second quarter was a quarter of meaningful progress against our long-term strategy. We delivered the AMDS PMA approval we had targeted for a mere year. We completed the Nexus acquisition ahead of schedule. Stencraft's revenue accelerated against a tougher comp. Honest continued to take share, and our preservation services business is growing, constrained generally by supply, not demand. The fundamentals that underpin our growth strategy remain exceptionally strong. A comprehensive, clinically differentiated portfolio a focused commercial organization, and a pipeline that stands to expand our total adjustable market over time. With that, I'll now turn the call over to Lance.