Artivion, Inc.

Good afternoon and welcome to Artivian's fourth quarter and year-end 2025 earnings conference call. At this time, all participants are on a listen-only mode. A 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. I would now like to turn the conference over to your host, Mr. Brian Johnson, from the Gilmartin Group. Thank you. You may begin.

Thank you. Good afternoon, and thank you for joining the call today. Joining me from our TBIANS management team are Pat Mackin, CEO, and Lance Ferry, 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 Artivian website. Lastly, I would 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 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 percentage of sales will be based on adjusted revenues. With that, I'll turn the call to Artinian CEO, Pat Mackin.

Thanks, Brian, and good afternoon, everybody. Through the first quarter of 2026, we continued to execute our strategy designed to drive long-term profitable growth through an expanding and clinically differentiated product portfolio. In the quarter, we delivered constant currency revenue growth of 12% and adjusted EBITDA growth of 26% year-over-year. Revenue growth was driven primarily by onyx and stent grafts, including AMDS. We also benefited from growth within preservation services as tissue processing volumes normalized following the 2024 cybersecurity event. Before expanding further on product line performance, I'd like to take a moment to address today's exciting news regarding the exercise of our option to acquire Endospan. This is following the PMA approval of its Nexus aortic arch stent graft system for chronic aortic dissections, which they achieved in early April. The MEXIS system is a branched endovascular stem graft system that is purpose-built for minimally invasive treatment of aortic arch disease, where patients often have no choice other than open-heart surgery. The clinical data is compelling. Data from the chronic aortic arch dissection cohort of the TRIUMPH trial demonstrated 93% of patients survived from lesion-related death, 90% freedom from disabling stroke, and at one year post-treatment. Also, 95% were free from intervention due to endoleaks, excluding type 2 endoleaks at one year, which is a very high-risk population. As a reminder, the total annual U.S. addressable market opportunity associated with both cohorts is estimated to be around $150 million, with dissections representing about $100 million of that. We plan to pursue supplementing the label to include aortic aneurysms through formal regulatory processes expeditiously post-acquisition. Importantly, our anticipated acquisition of Endospan and its Nexus system will complete our market-leading three-pronged aortic arch portfolio. This technology, if acquired alongside AMDS and our SIBO LSA, will position us at the forefront of this segment as the only company globally with a complete portfolio of aortic arch solutions. And importantly, Nexus is the platform technology, not just a single product. It's supported by additional three PMA programs in development that we expect to further extend and solidify our leadership in the aortic arch market over time. We are pleased to have had the financing already in place for this acquisition, and subject to satisfactory and customary closing conditions, we expect to close in the second quarter of 2026. As Lance will discuss in greater detail, we expect a full U.S. commercial launch of Nexus in January of 2027, following efforts to scale inventory production, complete value-announced committee processes, and augment our U.S. sales team. With that, let me turn back to our Q126 results. From a product category perspective, StantCraft revenues grew 10% on a constant currency basis in the first quarter compared to the same period last year. Year-over-year constant currency growth fell below our expectations due to lower-than-expected AMDS set sales in the U.S., as well as softer than expected performance internationally, particularly in the Middle East. Year-over-year growth also reflects a tougher crop in Europe following a strong Q1 2025 performance as we recovered from the 2024 cybersecurity event. While U.S. AMBS sales associated with initial stocking fell short of our expectations in Q1, we've been very encouraged by implanting reorder patterns within the accounts already using AMBS. We view this as a much more critical item than the immediate impact of sales from starter sets. As strong reordering patterns reflect positive user experience and ultimately our long-term adoption of these in our growth uses. Looking ahead, we expect U.S. AMDS set sales to accelerate as more accounts are already through the VAC process. They finalize the procurement as we benefit from steps being taken now to ease the initial upfront $100,000 cost burden associated with stocking. We also anticipate PMA of approval of AMDS in the coming months, which will obviate the need for entirely new accounts which won't have to go through the IRB process, some of which have deferred the PMA approval because of this increasingly imminent date. Ultimately, we see our comprehensive StenCraft portfolio as a foundational component to our growth strategy. We are encouraged by our enduring fundamental strength and increasingly strong competitive advantage within the segment. Looking ahead, we intend to replicate our proven strategy by bringing additional StenCraft 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. Meanwhile, our Q1 ONIX revenue was 17% year-over-year growth on a cost and currency basis. This growth was driven by further global market share gains and continued early traction in our new $100 million U.S. market opportunity, unlocked by recently published data, which demonstrate improved outcomes with mechanical valves versus bioprosthetic valves for younger patients. We maintain our conviction that Onyx is the best aortic valve in the market for patients under the age of 65, and we will continue to take market share worldwide in that product line. Tissue processing revenues increased 23% year-over-year on a constant currency basis in the first quarter, as demand for our products remained strong and tissue volumes normalized year-over-year following the cybersecurity incident in late 24. Key win results were slightly ahead of our expectations of roughly $24 million per quarter for that business. Lastly, BioGlue is relatively flat on a constant currency basis compared to the same period last year. While this performance was slightly lower than our mid-single-digit growth expectation contemplated in our previously communicated four-year revenue guidance, it falls within the range of normal quarter-to-quarter growth variability due to significant amount of stock and distributor business in that product line. Lastly, on our pipeline, we continue to make great progress on the ARTISAN clinical trial for our SIBO LSA product. We now have 26 patients enrolled in the trial, which is a non-randomized clinical trial consisting of 132 patients in the US and Europe, and up to 30 centers for treatment for aortic dissection and aneurysm in the arch. We anticipate completing full enrollment in mid-27. We are optimistic that the trial will be successful, supported by our clinical results from our current generation frozen elephant trunk, Avita OpenNeo, which is available outside the U.S., following our one-year follow-up period. And assuming the trial meets its endpoints, we anticipate FDA approval for our C1 LSA in 2029, unlocking an incremental $80 million annual U.S. market opportunity. In conclusion, while Q1 results fall short of our constant currency expectation, and reflected some moving pieces that Lance will walk you through in detail. It was a quarter of meaningful progress against our long-term strategy. The fundamentals that underpin our growth strategy remain intact. A comprehensive, clinically differentiated portfolio, a focused commercial organization, and a pipeline that stands to exceed the total addressable market, expand our total addressable market continuously over time. The reordering behavior we are seeing within AMDS accounts reinforces our conviction in the long-term adoption story. We have a clear line of sight in the near-term drivers that will accelerate new account conversion. Honest continues to take share from both mechanical and bioprosthetic valves as the leading aortic valve on the market for patients under the age of 65. And with the addition of Nexus, we now have what we believe is the most comprehensive aortic arch portfolio in the world, a position we have built deliberately and intend to extend. With that, I'll now turn the call over to Lance.