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DATE

Thursday, August 7, 2025, at 4:30 p.m. ET

CALL PARTICIPANTS

  • Chairman, President, and Chief Executive Officer — Pat Mackin
  • Chief Financial Officer — Lance Berry

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TAKEAWAYS

  • Total Revenue-- $113 million for 2025, representing over 14% constant currency growth year-over-year.
  • Adjusted EBITDA-- Adjusted EBITDA increased 33% from $18.6 million to $24.8 million in 2025, with adjusted EBITDA margin at 21.9% in 2025, up approximately 300 basis points.
  • Product Revenue Growth-- On-X revenues grew 24% year-over-year on a constant currency basis in Q2 2025, stent graft revenue grew 22% year over year on a constant currency basis in Q2 2025, BioGlue revenue grew 4% year over year on a constant currency basis in Q2 2025.
  • Gross Margin-- GAAP gross margin was 64.7% in Q2 2025; non-GAAP gross margin was 65.1% in Q2 2025, a 50 basis point non-GAAP increase in Q2 2025 primarily from the AMDS HDE launch and On-X growth in the U.S.
  • Operating Expenses-- Non-GAAP general and administrative costs were $53.4 million, or 47.2% of sales, down 100 basis points from the second quarter of 2024.
  • R&D Expenses-- $7.1 million, reflecting the timing of clinical expenses.
  • Interest Expense-- Net interest expense was $7.2 million for Q2 2025; other income included $4.5 million from foreign currency translation gains in Q2 2025.
  • Free Cash Flow-- $11.7 million generated, with expectations to remain positive for full year 2025.
  • Leverage and Liquidity-- $53.5 million cash at quarter end, $215.6 million debt; net leverage ratio improved to 2.2 at the end of the second quarter, down from 4.1 in the prior year, after retiring $100 million of convertible debt.
  • Updated Guidance-- Raised revenue midpoint to $435 million–$443 million (from $423 million–$435 million) for 2025; constant currency growth guidance raised to 12%-14% for full-year 2025, and adjusted EBITDA guidance lifted to $86 million–$91 million for full-year 2025 with adjusted EBITDA margin expansion forecast at about 200 basis points for the full year 2025.
  • AMDS U.S. Launch Progress-- Management cited "meaningful" sequential AMDS revenue growth and early clinical demand in Q2 2025 as the launch scales through the IRB and VAC processes, with a $150 million annual market opportunity for AMDS.
  • Clinical Pipeline Execution-- Announced July FDA IDE approval for the Arecibo LSA pivotal trial, which will enroll 132 patients across up to 30 sites.
  • Future Growth Catalysts-- Endospan NexSys remains on track for 2026 approval with 30-day TRIUMF trial data showing a protocol-defined 63% reduction in major adverse events compared to the comparators.

SUMMARY

Artivion (AORT 1.58%) management achieved double-digit topline and bottom-line growth, with constant currency revenue and adjusted EBITDA, in Q2 2025, retired nearly all 2025 convertible debt during the quarter, and raised both revenue and adjusted EBITDA guidance for full-year 2025. New FDA trial approvals in July 2025 expanded the pipeline, with AMDS U.S. launch gaining early traction through rapid customer adoption and cross-selling. Non-GAAP gross margin improved due to a favorable product mix in Q2 2025, while expense discipline contributed to EBITDA and free cash flow improvements. Clinical data and physician feedback fuel incremental progress in global expansion and new product opportunities.

  • Pat Mackin stated, We remain confident in our ability to deliver double-digit revenue growth at 2x the growth of EBITDA.
  • Lance Berry reported, We do not anticipate the need to raise additional capital to fund our debt obligations, our investments in our channels, or our pipeline in the foreseeable future.
  • FDA IDE approval for Arecibo LSA enables trial launch before year-end, initiating a direct entry to an additional surgical device market.
  • U.S. AMDS adoption benefits from a simplified training process resulting in immediate physician integration, boosting On-X usage by new accounts as described by management.
  • Endospan’s NexSys 30-day clinical data, presented at AATS in early May 2025, showed strong safety benefits and support the PMA approval timeline for 2026. The acquisition could unlock a $150 million annual addressable market, according to management comments.

INDUSTRY GLOSSARY

  • AMDS (Ascending Aortic Dissection Stent): An implantable aortic stent system, cleared under HDE, used in acute aortic dissection surgeries.
  • HDE (Humanitarian Device Exemption): FDA pathway allowing limited market introduction of devices intended to benefit patients with rare conditions.
  • IDE (Investigational Device Exemption): FDA approval for clinical studies of investigational devices to collect safety and efficacy data.
  • PMA (Premarket Approval): FDA authorization required for high-risk medical devices before wide-scale commercial distribution.
  • IRB (Institutional Review Board): Hospital-based committee approving and monitoring human research involving medical devices.
  • VAC (Value Analysis Committee): Hospital committee assessing new clinical products for value and suitability prior to adoption.
  • On-X Valve: Mechanical aortic heart valve that can be maintained at a lower International Normalized Ratio (INR), reducing bleeding risk.
  • Frozen Elephant Trunk: Hybrid surgical and endovascular technique/device for repairing extensive aortic arch disease.
  • Synagraf Pulmonary Valve: Cryopreserved human pulmonary valve tissue used in cardiac reconstructive surgery.

Full Conference Call Transcript

Pat Mackin: Thanks, Lane, and good afternoon, everybody. I'm pleased to report that our strong business momentum continued through the second quarter. We delivered total constant currency revenue growth of over 14% and adjusted EBITDA growth of 33% year over year. Further, we made continued early progress with our ongoing AMDS launch following FDA humanitarian device exemption approval or HDE approval. And we remain on track with each of our key clinical and pipeline initiatives aimed at expanding our addressable market. During the quarter, we also took steps to strengthen our balance sheet and meaningfully reduced our net leverage by retiring our convertible note due in 2025, which Lance will detail further.

Our Q2 performance was enabled by continued growth across our product portfolio with exceptional strength in U.S. On-X sales. From a product category standpoint, On-X revenue increased 24% year over year on a constant currency basis as we continue to take market share globally with the only mechanical aortic heart valve that can be maintained at a low INR of 1.5 to 2.0. Based on the proven clinical results of the On-X aortic valve and the growing body of evidence supporting the use of mechanical valves in younger patients, we maintain our strong conviction that the On-X is the best aortic valve on the market for patients under the age of 65 and will continue to take market share worldwide.

Our U.S. On-X performance was particularly strong, we benefited from continued growth in awareness and adoption of our On-X valves driven by positive new data and cross-selling opportunities for our initial AMDS launch. This cross-selling dynamic in particular has reinforced our conviction in our innovation-driven multipronged growth strategy and further strengthened our confidence in both our near and long-term outlook for growth and profitability. To that end, stent graft revenues grew 22% on a constant currency basis in the second quarter, compared to the same period last year, as the U.S. AMDS launch accelerated our growth rate.

Our stent graft portfolio remains a key component of our growth strategy and we are encouraged by our strong results driven by our differentiated portfolio of products focused on the more complex segments of the stent graft market. Today, products in our stent graft portfolio are sold primarily in Europe where we leverage our existing direct sales infrastructure to create significant cross-selling opportunities across our unique aortic product offerings. Our pipeline consists largely of bringing some of these proven products to the U.S. and Japan, representing a significant growth opportunity. The first of these products is AMDS. As mentioned, we're pleased with the ongoing U.S. launch of AMDS following our recent HDE approval in late 2024.

As a reminder, there are three steps that each center must complete before implanting an AMDS as part of the AMDS launch process. First, each hospital needs to receive a site-wide IRB approval except in the case of an emergency use. Second, we need to have AMDS approved by the Hospital Value Analysis Committee, or the VAC, and third, surgeons must be trained on this device. Reception to the launch has remained extremely encouraging, with more hospitals progressing through the IRB and VAC approval process. As expected, AMDS revenue grew meaningfully on a sequential basis in Q2 reflecting strong early demand and revenue from initial stocking orders. Meanwhile, feedback from physicians already using the device has been overwhelmingly positive.

Overall, we're encouraged by the early commercial traction of AMDS as we begin to tap into what we estimate to be a $150 million annual market opportunity with limited competitive alternatives. In addition, BioGlue grew 4% on a constant currency basis compared to the same period last year, and we continue to see growth with the product in all of our major markets. Lastly, tissue processing, which has been the category most heavily impacted by last year's cyber event, increased 3% year over year on a constant currency basis in Q2. As a reminder, a significant portion of our tissue revenues come from our Synagraf pulmonary valve, for which demand outstrips supply every quarter, therefore we hold no inventory.

Due to extended lead times for tissues that were in process or received during the period impacted by the cybersecurity event, there is a backlog of product that has not yet been released. Since last quarter, we've continued to make progress in reducing the backlog and remain on track to clear it by the end of the third quarter. Looking ahead, we are confident that our tissue business can be a mid-single-digit grower for the full year of 2025 and over the long term. I'll now turn to the pipeline. In July, we received investigational device exemption approval, or IDE approval, from the FDA to begin our U.S. pivotal trial for Arecibo LSA.

This is our third-generation frozen elephant trunk used to replace the entire aortic arch. The trial will evaluate the safety and effectiveness of Arecibo in the treatment of acute and chronic arch pathologies and will enroll 132 patients in up to 30 sites. We are optimistic that the trial will be successful, which is supported by the positive clinical results from our current generation frozen elephant trunk called the VITA Open Neo. We look forward to providing additional updates on future calls as we prepare to launch the trial by year-end. While the HDE enables us to commercially distribute AMDS in the U.S. prior to receipt of the PMA, we continue to focus on securing the PMA for AMDS.

Last quarter, we were pleased to have been informed by the FDA that it completed its review of our manufacturing and quality management system modules. Today, we've already filed three of the four modules, and this keeps us on track for an FDA approval in mid-2026. Lastly, on our pipeline, assuming we acquire Endospan, NexSys remains on track for approval in 2026. As I spoke about during the Q1 call, Endospan presented its late-breaking 30-day data from the NexSys U.S. IDE trial at AATS early May. This is the first FDA trial for an endovascular treatment of chronic dissections in the aortic arch focused on patients at high risk for open surgery.

The data indicated the trial would meet its protocol-defined primary endpoints of a 63% reduction in major adverse events relative to the comparators. In our conversations with physicians at AATS, surgeons were generally impressed with the 30-day result and were extremely positive. Surgeons were particularly pleased with the performance across stroke and renal endpoints, which was quite favorable compared to published data for alternative endovascular treatments. Overall, it was a great quarter. We accelerated our top-line growth rate for both On-X and stents to over 20%. We hit another significant milestone in our pipeline execution with our IDE approval. We significantly improved our capital structure by eliminating $100 million of convertible debt.

We're excited about our progress to date in 2025, and are 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. With that, I'll now turn the call over to Lance.

Lance Berry: Thanks, Pat, and good afternoon, everyone. Before I begin, 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. Additionally, all percentage changes discussed will be on a year-over-year basis and revenue growth rates will be in constant currency unless otherwise noted. Total revenues were $113 million for 2025, up over 14% compared to 2024. Meanwhile, adjusted EBITDA increased approximately 33% from $18.6 million to $24.8 million in 2025.

Adjusted EBITDA margin was 21.9% in 2025, an approximately 300 basis point improvement over the prior year, driven by improvements in gross margin, leverage in SG&A, and timing of R&D spend. From a product line perspective, On-X revenues increased 24%, stent graft grew 22%, BioGlue grew 4%, and tissue processing revenues grew 3% in 2025. On a regional basis, revenues in North America increased 18%, Asia Pacific increased 15%, EMEA increased 10%, and Latin America increased 7%, all compared to 2024. Our as-reported expenses include approximately $1.7 million in Q2 associated with the 2024 cybersecurity incident, which are excluded from adjusted EBITDA. While we have sought insurance reimbursement for some of these costs, the process will take some time.

We will exclude any insurance proceeds we receive from adjusted EBITDA as well. Gross margins were 64.7% in Q2 compared to 64.6% in 2024. Non-GAAP gross margins were 65.1% in Q2 2025, reflecting a 50 basis point increase from 2024 due primarily to favorable mix from AMDS HDE revenues in the U.S. and exceptional On-X growth, particularly in the U.S. General, administrative, and marketing expenses in the second quarter were $57.7 million compared to $49.3 million in 2024. Non-GAAP general and administrative expenses were $53.4 million, 47.2% of sales in the second quarter compared to $47.3 million or 48.2% of sales in 2024, reflecting a 100 basis point improvement while funding our AMDS HDE launch costs.

R&D expenses for the second quarter were $7.1 million compared to $7.5 million in 2024, reflecting timing of clinical expenses. Interest expense net of interest income was $7.2 million, as compared to $8 million in the prior year. Other income and expense this quarter included foreign currency translation gains of approximately $4.5 million. Free cash flow was $11.7 million in 2025. As Pat mentioned, during the quarter, we took action to significantly deleverage our balance sheet by retiring our convertible senior notes due 2025. As we announced in May, we successfully completed exchange agreements to convert approximately $99.54 million principal amount for an aggregate of 4.3 million shares of common stock.

Approximately $460,000 in aggregate principal amount remained outstanding as of June 30, and was settled with approximately 20,000 shares of common stock at maturity on July 1. Turning to cash and liquidity, we ended the quarter with approximately $53.5 million in cash and $215.6 million in debt, net of $4.9 million of unamortized loan origination costs. We do not anticipate the need to raise additional capital to fund our debt obligations, our investments in our channels, or our pipeline in the foreseeable future. At the end of the second quarter, our net leverage ratio was 2.2, down from 4.1 in the prior year. Now for our outlook for the remainder of 2025.

Given our momentum in the first half of the year, we are raising the midpoint of our full-year 2025 revenue guidance and now expect constant currency growth between 12-14% compared to the previous range of 11-14%. We expect reported revenues to be in the range of $435 million to $443 million compared to our previous range of $423 to $435 million, reflecting greater confidence in our overall growth outlook and an adjustment to our foreign currency assumptions for the second half of the year. This guidance range reflects our current estimate that the full-year 2025 currency impact will be approximately flat to 2024.

Given our strong top-line revenue growth and success with general expense management through the first half of the year, we are also raising the midpoint of our full-year adjusted EBITDA guidance. We now expect adjusted EBITDA to be in the range of $86 million to $91 million compared to $84 to $91 million for the full year 2025, representing a 21 to 28% growth over 2024 and approximately 200 basis points of adjusted EBITDA margin expansion at the midpoint of our ranges.

This guidance reflects a second-half revenue growth rate of 17% at the midpoint, 2.5 percentage points higher than Q2, driven primarily by the expected normalization of our remaining preservation services backlog in Q3 and the continued sequential growth of AMDS HDE revenues in the U.S. With that, I will turn the call back to Pat for his closing comments.

Pat Mackin: So to conclude, we're very pleased with our second quarter performance. We believe it reflects the strength of our highly differentiated and highly defendable product portfolio. We continue to deliver meaningful top and bottom-line growth, advance our robust pipeline, and enhance our balance sheet. We remain confident in our ability to deliver double-digit revenue growth at 2x the growth of EBITDA as we expand our presence across markets with limited competition and leverage our existing global infrastructure and cross-selling capabilities. More specifically, we expect future growth to be driven by the following key initiatives. First, the AMDS HDE launch. We're in the middle of commercializing AMDS in the U.S., starting to penetrate the $150 million annual market opportunity.

Second, On-X heart valve data. We are marketing the JAK, which is the Journal of American College of Cardiology clinical data showing a mortality benefit in patients 60 years of age compared to bioprosthetic or tissue valves. This is a new $100 million annual market opportunity that we will be pursuing with the only mechanical aortic heart valve that can be maintained at an INR of 1.5 to 2.0. Third, the NexSys PMA positive 30-day data from Endospan's TRIUMF trial. Endospan remains on track for PMA approval in 2026. This data presented in May, assuming if we exercise our option to acquire Endospan, brings us one step closer to being able to access the annual market opportunity of $150 million.

And fourth, the Arecibo LSA IDE Approval. We're preparing to launch the U.S. IDE trial for our third-generation frozen elephant trunk for the treatment of acute and chronic sections in the aorta. Finally, I want to thank all of our employees around the globe for their continued dedication to our mission of being a leading partner to surgeons focused on aortic disease. With that, operator, please open the line for questions.

Operator: At this time, we will conduct the question and answer session. If you would like to ask a question, please press star, then the number one, on your telephone keypad now, and you will be placed in the queue in the order received. Once again, to ask a question, press star, then the number one on your telephone keypad now. Your first question comes from Bill Plavonic with Canaccord Genuity. Your line is open.

Bill Plavonic: Great. Thanks. Thanks for taking my question. Good evening. Just really want to just focus in on the AMDS. I think last quarter, you had made the comment regarding 150 hospitals actively seeking IRB and VAC. Kind of where are you in that process? Have you added more accounts? Because I think 600 total. And are there other KPIs that you're looking at? And then just secondly, I think really interestingly, you talked about the cross-selling. I wonder if you could expand on that. What products are they picking up? What type of penetration rates are you seeing on those training sessions?

Anything to help us kind of give us some color on how that may impact the rest of the business? Thanks.

Lance Berry: So Bill, this is Lance. Maybe I'll address the metrics question and let Pat talk about how things are going. So you know, last quarter, we did give some nonfinancial metrics to try and give everyone some feel for how the launch is going early on, particularly given that revenue was pretty minimal. I think we try to be clear with people to not initially expect us to continue to give that every quarter, and we didn't give it this quarter. I will say that our pipeline is continuing to build, and those metrics had I given them would be larger than they were last quarter.

We'd probably leave it at that, and then I'll let Pat talk about how the launch is going.

Pat Mackin: Yeah. So, you know, and also just a correction, there's about a thousand accounts that you mentioned 600. I think on previous calls we've commented that about 80% of the 75% of the volume is in the top 600 centers. But there's about 1,000 accounts that do acute type As in the U.S. As far as your question about cross-selling, we're doing trainings every month where we bring, you know, up to 20 surgeons to these centers to learn. It's a one-day program to learn how to implant the AMDS. And we're obviously building relationships with those customers. Some are existing customers, some are customers we haven't—they may buy BioGlue but may not buy our On-X Valve.

And as they get to understand the AMDS technology, and then they understand the On-X technology and the new data, we've literally had customers leave the AMDS training and start using On-X when they get back to their hospital. So you know, we thought there'd be some cross-selling benefit. It was a little more profound than I thought it would be kind of as quickly as that. Great. Thanks. And then if I can ask one more, I will. It's just BioGlue in China. There wasn't really any commentary on that. Just wondering if you could give us an update there, and, thanks again for taking my questions. Yeah.

So when we talked about the launch of BioGlue, said it was really a second half 2025. Given the you know, all the kind of hoops you have to jump through with the provinces and the hospital contracts, etcetera. So we should start seeing BioGlue in the second half of this year. So we really haven't talked more about it than what we've previously put out.

Operator: Your next question comes from John McAulay with Stifel. Your line is open.

John McAulay: Congrats on the strong 2Q performance. Just wanted to start off on guidance. There's a few moving pieces just wanna make sure I have this right. There's currencies moving towards flat impact for the year. There was 2Q outperformance, but you're also feeling pretty strongly about 2Q '25. Could you just talk through how all those dynamics are impacting the updated guide?

Lance Berry: Yeah. I think, you know, high-level simple way to think about it is if you look at the second quarter, you know, we had given people an expectation of 13 constant currency growth for the second quarter. We came in at 14 and a half, so obviously, that was above that was above that. That was good underlying strength. Our currency assumption also turned out to be conservative for the second quarter. Which I'm sure people have seen that with the euro-dollar in particular has done. And so that drove some of the outperformance in Q2 on an as-reported, you know, top-line revenue number.

And then at this point, you know, I think we needed to just acknowledge that currencies moved in a pretty positive way. And go ahead and build a little bit of that into our guidance for the second half. So those are at a high level, the moving pieces. But you can see we also moved up our full-year expectation for constant currency revenue to 12 to 14%.

John McAulay: Got it. That's helpful. I wanted to follow-up on AMDS. I know Bill just asked about it, but we've recently done some checks in that space. And just wanted to get your sense on physician adoption and utilization. What we've heard is that once doctors get this in their hands, they're not really feeling a sense of caution that it's a new device. They're excited about it, and they're sort of immediately integrating it into their practices. Can you just talk about what you're seeing from that dynamic? Are physicians steadily ramping? Are they adopting immediately? Any thoughts there would be helpful. Thanks.

Pat Mackin: Yeah, so I think one of the—and we've kind of reiterated this on previous calls—I think one of the real advantages of AMDS is it's a simple, elegant solution to this problem. It solves a big clinical problem for patients, which is malperfusion. We were hearing case after case of patients coming in with malperfusion based bloods not flowing where it's supposed to go. With legs not showing up on MRIs, or CT scans, no blood flow, and then they put an AMDS in and the patient's got blood flow back to their legs. So it's an amazing device but it's super simple. We do a one-day training.

We want to make sure we're very clear about people how to size it. How to implant it, but after that, it's super simple, it's easy. And I think that's one of the real benefits is that every aortic surgeon in the U.S. or a surgeon that puts aortic valves in can use this device and it can be effective for them. So, unlike some technologies that are super complicated to use, this is not one of them. And I think that's gonna be one of the real benefits of the product going forward.

Operator: Thanks for taking the questions. Your next question comes from Frank Takkinen with Lake Street Capital. Your line is open.

Nelson Cox: Hey. This is Nelson on for Frank, and thanks for taking the questions, and congrats on all the progress here. Yeah. Obviously, we've talked in the past about AMDS and future launches kind of layering onto the existing Salesforce. Maybe just talk a bit more about that. I think the last I saw was the 55-person commercial team handling the ramps, and correct me if I'm wrong there. But understand it's still early innings, but any incremental targeted expansion that you're looking at kind of now? Or is that something you'd maybe take on with PMA approval?

Pat Mackin: Yes. So we've talked previously. I mean, we don't really see a huge difference with the PMA approval. I mean, other than not having to get an IRB, I think the point you bring up is a good one, right? So I mentioned earlier on the first question, there's about 1,000 centers that can do an AMDS. They do acute type A dissection surgery. We're pretty strong. Our team of 50 plus reps is pretty strong in the top 600 centers. We sell things in all 1,000, but it's not the last 400 aren't exactly a top focus for us. So that is something we're evaluating.

Maybe in the second phase of the launch, but we're not going to get into specifics on this call. We talk about that more when it happens down the road. Correct.

Nelson Cox: Makes sense. Thank you. And then on Arecibo, maybe just walk us through kind of the next steps there with IDE approval in hand and I heard you say you expect to start that trial kind of by year-end, but maybe just any additional color you can provide there on timelines or any—

Pat Mackin: Yeah. So we—yeah. We were super excited to get the approval. So we got FDA approval. Now it's just like any clinical trial in the medical device space. We've got to get contracts with the hospital. We have to get an IRB with the hospital for the trial. We've already got devices, sterile devices coming in. So it's really just how long it takes us to get through the contracting and the IRBs at the hospitals. And we expect to enroll our first patient before the end of the year.

Nelson Cox: Perfect. Alright. Thanks again, guys. Congrats.

Operator: Your next question comes from Suraj Kalia with Oppenheimer. Your line is open.

Jacob: Hey, Lance. This is Jacob on for Suraj. Thanks for taking the questions and congrats on the quarter. So just wanted to start off with your guide to adjusted EBITDA growing about twice as fast as the top line. Which suggests a shift in mix. Could you help break down what's driving that leverage? And I guess more specifically, what's the expected contribution from the AMDS launch on gross margin expansion? And how accretive do you see that being over time?

Lance Berry: Yes. So I think things are playing out the way we expected at the beginning of the year. We talked about, you know, the EBITDA margin kind of coming from both SG&A leverage, but also that we thought we could get about a point of gross margin expansion this year, primarily due to mix. And so far that's, you know, we're starting to see that play out. We had about 50 basis points of gross margin expansion this quarter early on in the launch. So we do think that can drive gross margin expansion going forward, which can be another enabler for EBITDA margin expansion.

This year, we are making sure that we invest every dollar we need to in this launch to make sure it gets off to a great start. So probably not quite as much drop through if you look in the outer years, I mean, this is an extremely high gross margin product that's being sold through the exact same Salesforce. So we expect it to be a significant contributor to EBITDA in the future.

Jacob: Yeah. I know. That's very helpful. And then just on-X, so it's been a consistent growth driver for you the past few years. How stable is that business looking ahead? And, really, on that note, can you provide any directional color on what's embedded in the guide for On-X and the stent graft portfolio?

Pat Mackin: Yeah, I'll take the first part. We've ever since we launched low INR for the On-X valve, which was when we acquired the company back in 2016, we've consistently grown that business double digits. I think the CAGR over the last seven or eight years is like 12 or 13%. You know, I talked about on the last call that we've got a bunch of things going in our favor. We've got the only indication for low INR. We've got the AMDS launch with the cross-selling opportunities I just mentioned earlier. We've got the five-year post-approval data that shows an 87% reduction in major bleeding.

And then there was a paper presented at STS in January showing if you get a mechanical valve under the age of 60, you have a mortality versus a tissue valve. So we haven't even started marketing that to cardiologists and the business is growing over 20%. So we're seeing a kind of an acceleration of On-X based on all those factors. And we're not gonna break out what we're truly thinking for in the back half. I mean, we have the segments we report against. But it's been obviously very robust.

Lance Berry: Yeah. And I think on the guidance thing, you know, we're not gonna get into the nitty-gritty on what's the change. But, you know, at the beginning of the year, we laid out kind of our standard set of parameters of how we think about their different product lines. Growing longer term with, you know, kind of BioGlue and tissue is a mid-single-digit growth rate businesses, and On-X is a low double-digit and stent grafts before taking into account AMDS in the U.S. is kind of a mid-teens business. And then, you know, U.S. AMDS adding incremental growth over that.

And then, you know, since then, we moved our midpoint up twice, you know, in both of the first and second quarter call. And I would I think I would just say, you know, definitely the On-X performance in the U.S. and the strength we're seeing in that business is definitely a big contributing factor to our ability to raise the midpoint.

Operator: Your next question comes from Mike Matson with Needham. Your line is open.

Joseph: Hey, guys. How are you doing today? This is Joseph on for Mike. Maybe to just start off, with On-X. I mean, you guys called out stocking orders for AMDS. I was curious if there were any kind of one-timers that affected On-X in the quarter.

Pat Mackin: As you said, there was cross-selling. You guys are seeing cross-selling opportunities with AMDS On-X. So just wondering, yeah, if there's any one-timers in that On-X or is, you know, is this all data and, you know, awareness-driven? Yeah. So the fastest-growing, the biggest and the fastest-growing market is in the U.S. And we don't do any bulk deals. We don't do any so kind of individual sales. It's all off consignment and use. Yeah. So the big chunk of that growth rate is coming off implants.

Joseph: Okay. Okay. Perfect. And then maybe just a quick one. The ARTISAN trial. Appreciate the color you guys have given so far. I'm just curious maybe a little bit more on the trial. What does follow-up time look like? Is there any idea on, you know, when data readouts could be? And I guess just given, you know, the complexity of the procedure, does it take a while to train surgeons who opt into this trial? Has training like that already, you know, happened with you with, you know, with Artivion, Inc.?

Pat Mackin: Yeah. So this is once again, it's a little bit like my comments on AMDS. I mean, one of our mantras at the company is to come up with simple, elegant solutions that improve outcomes. AMDS is kind of a poster of that. The Arecibo device, which is the trial called ARTISAN, it's the first frozen elephant trunk device that has a branched subclavian feature on it. That's going to make the procedure easier. So it's important to note all the surgeons in this trial already performed frozen elephant trunk operations. They use a competitive device. We think ours will be easier to use, faster, and provide better outcomes.

So don't think that is a, you know, there'll be some, there'll be some hands-on training because they have to be familiar with our delivery system. And the new device, but it's really not a huge training lift. So we expect this trial to ramp pretty quickly.

Joseph: Okay. Thanks very much, and congrats on the quarter. You guys are very strong.

Pat Mackin: Thanks.

Operator: Your next question comes from Destiny Hance with Ladenburg Thalmann. Your line is open.

Destiny Hance: Hey. Thank you for taking the questions. Just one for us. I'm sorry if I missed it, but curious. If you could talk about some pricing trends and if you're seeing any changes in pricing and power there.

Lance Berry: Yeah. So your question was just an overall question about pricing environment and what we're seeing. Is that correct?

Destiny Hance: Yes, please.

Lance Berry: Yeah. I mean, we've talked about this before. I mean, the nature of our devices is, you know, they're generally lifesaving. And not super high volume from an individual line item in the hospital. And, you know, because of that, we typically have not seen price pressure and have really had an ability to drive, you know, modest inflationary type price increases consistently over time. And, you know, that continues to be the case. Now I know in previous years, we've had some kind of exceptionally large price increases in individual products. We don't really have any of that going on at the moment. This is really more volume-driven. With just kind of normal inflationary price benefit.

Destiny Hance: Great. Thank you. I appreciate it.

Operator: Your next question comes from Dan Stauter with Citizens JMP. Your line is open.

Dan Stauter: Yeah. Hey. Great. Thanks for the questions. I just had a few quickly. So following up on the On-X growth, it's been talked a lot about, but just wanted to try to get a sense of how much of it was due to those cross-selling benefits. It seems like the business is still really strong beyond that, but could you give us any color on how much of the quarter's contribution was from new accounts that halo effect of AMDS and, you know, maybe if you have any metrics on higher utilization for On-X, that would be really helpful. Thank you.

Lance Berry: So we're not gonna get into the nitty-gritty on utilization, but I will say, definitely was a meaningful uptick from new accounts. Now is that due to cross-selling or due to the new data or a combination of both? Like, that's really hard to tease out. But it's not just increased utilization in our existing base. It is definitely also driven by new customers.

Dan Stauter: Okay. That's great. And then, just one follow-up. On free cash flow. Great improvement during the quarter. I just wanted to get a sense of how we should be thinking about it for the back half of '25, any cadence we should keep in mind and any more notable cash items that we should be thinking about for the rest of the year?

Lance Berry: Yeah. I will say, you know, timing of cash can make things fluctuate quarter to quarter. But, you know, what we've said consistently and we still say is that we expect to be positive for the full year. We did have a really good quarter this year. This quarter, which we needed to because some of that was catch up from Q1. I would say year to date, we're like we're in a pretty good spot to deliver on our objective of being free cash flow positive for the full year.

Dan Stauter: Great. Thanks for the questions, and great quarter.

Lance Berry: Thanks.

Operator: Mr. Mackin? There are no further questions at this time. Would you like to turn the floor back over to management for closing remarks?

Pat Mackin: Well, thanks for attending. Again, we're super excited about the quarter. We appreciate you all joining. We've got a lot of momentum. We're growing double digits. Going twice as fast on the bottom line. We're generating cash. We delevered. And we've got a lot of growth drivers we talked about in new clinical trials starting. So we're super excited and look forward to reporting out again next quarter.

Operator: This concludes today's call. Thank you for attending, and have a wonderful rest of your day.