Good day, ladies and gentlemen, and welcome to the Artivion Second Quarter 2025 Earnings Call. Our host for today's call is Lanie Morgan, Investor Relations, Gilmartin Group. [Operator Instructions].I would now like to turn the call over to your host. Laine, you may begin.

Thanks, operator. Good afternoon, and thank you for joining the call today. Joining me today from Artivion's management team are Pat Mackin, CEO; and Lance Berry, 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 those forward-looking statements -- 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 Artivion website. Now I'll turn it over to Artivion's CEO, Pat Mackin.

Thanks, Laine, and good afternoon, everybody. I'm pleased to report that our strong business momentum continued through the second quarter as 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 in the market for patients under the age of 65, and we'll continue to take market share worldwide. Our U.S. On-X performance was particularly strong as we benefited from our continued growth in awareness and adoption of our On- X valves, driven by positive new data and cross-selling opportunities from our initial AMDS launch. This cross-selling dynamic, in particular, has reinforced our conviction in our innovation-driven multipronged growth strategy and further strengthen our confidence in both our near- and long-term outlooks for growth and profitability. To that end, stent graft…

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 the second quarter of 2025, up over 14% compared to Q2 of 2024. Meanwhile, adjusted EBITDA increased approximately 33% from $18.6 million to $24.8 million in the second quarter of 2025. Adjusted EBITDA margin was 21.9% in the second quarter of 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 the second quarter of 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 the second quarter of 2024. Our as-reported expenses included 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 the second quarter of 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 and administrative and marketing…

Thanks, Lance. So to conclude, we're very pleased with our second quarter performance, which we believe 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. and 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 under 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 NEXUS PMA positive 30-day data from Endospan's TRIUMPH trial. Endospan remains on track for PMA approval in the second half of 2026. This data presented in May would, assuming if we exercise our option to acquire Endospan, bring us one step closer to being able to access the annual market opportunity of $150 million. And fourth, the Arcevo 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 dissections 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 Instructions] Your first question comes from Bill Plovanic with Canaccord Genuity.

Great. Thanks for taking my question. 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 back. Kind of where are you in that process? Have you added more accounts because I think there's 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?

Bill, this is Lance. Maybe I'll address the metrics question and let Pat talk about how things are going. So 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 necessarily 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 this quarter than they were last quarter, but probably leave it at that. And then I'll let Pat talk about how the launch is going.

Yes. So -- and also just a correction, there's about 1,000 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 A in the U.S. As far as your question about cross-selling, we're doing trainings every month where we bring up to 20 surgeons to these centers to learn. It's a 1-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 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. 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.

Yes. So when we talked about the launch of BioGlue, we said it was really a second half 2025, given all the kind of hoops you have to jump through with the provinces and the hospital contracts, et cetera. 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.

Your next question comes from John McAuley with Stifel.

Congrats on the strong 2Q performance. Just wanted to start off on guidance. There's a few moving pieces. I just want to 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 guidance?

Yes. I think high-level simple way to think about it is if you look at the second quarter, we had given people a midpoint expectation of 13% constant currency growth for second quarter. We came in at 14.5%. So obviously, 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 what the euro and dollar in particular, has done. And so that drove some of the outperformance in Q2 on an as-reported top line revenue number. And then at this point, I think we needed to just acknowledge that currency moved in a pretty positive way and go ahead and build a little bit of that into our guidance for the second half. So that -- 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%.

Got it. That's helpful. And 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.

Yes. 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 blood is 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 got blood flow back to their legs. So it's an amazing device, but it's super simple. We do a 1-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 and 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 going to be one of the real benefits of the product going forward.

Your next question comes from Frank Takkinen with Lake Street Capital. This is Nelson on for Frank.

Congrats on all the progress here. Obviously, we've talked in the past about AMDS and future launches kind of layering on to the existing sales force. Maybe just talk a bit more about that. I think the last I saw was the 55-person commercial team handling the ramp. correct me if I'm wrong there, but I 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?

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 -- but 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 do AMDS implant 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.

Makes sense. And then on Arcevo, 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 time lines or anything.

Yes. So 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.

Your next question comes from Suraj Kalia with Oppenheimer.

This is Jacob on for Suraj. Congrats on the quarter. So I 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?

Yes. So I think things are playing out the way we expected at the beginning of the year. We talked about the EBITDA margin kind of coming from both SG&A leverage, but also that we thought we could get about 1 point of gross margin expansion this year, primarily due to mix. And so far, that's -- we're starting to see that play out. We had about 50 basis points of gross margin expansion this quarter and we're early on in the launch. So we do think that, 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 it's probably not quite as much drop-through. But 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 sales force. So we expect it to be a significant contributor to EBITDA in the future.

Yes. No, that's very helpful. And then just on On-X. So it's been a consistent growth driver for you in 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?

Yes, 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 7 or 8 years is like 12% or 13%. 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 5-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 benefit 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 going to break out what we're thinking for in the back half. I mean we have the segments we report against, but it's been obviously very robust.

Yes. And I think on the guidance thing, we're not going to get into the nitty-gritty on what's the change. But at the beginning of the year, we laid out kind of our standard set of parameters of how we think about the different product lines, growing longer term with kind of BioGlue and tissue as 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 U.S. AMDS adding incremental growth over that. And then since then, we've moved our midpoint up twice in both of the first and second quarter call. And I think I would just say, 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.

Your next question comes from Mike Matson with Needham.

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 was any kind of one-timers that affected On-X in the quarter. As you said, there was cross-selling -- you guys are seeing cross- selling opportunities with AMDS and On-X. So just wondering, yes, if there's any one-timers in the On-X -- or is this all data and awareness driven?

Yes. So the fastest growing -- the biggest market and the fastest-growing market is in the U.S. And we don't do any bulk deals. We don't do any kind of individual sales that's all off consignment and use. So the big chunk of that growth rate is coming off implants.

Okay. Okay. Perfect. And then maybe just a quick one on the ARTIZEN trial. I 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 when data readouts could be? And I guess, just given the complexity of the procedure, does it take a while to train surgeons who opt into this trial? Has training like that already happened with you with Artivion?

Yes. So this is -- once again, it's a little bit like my comments on AMDS. I mean one of our mantras of the company is to come up with simple, elegant solutions that improve outcomes. ADS is kind of a poster of that. The Arcevo device, which is the trial called ARTIZEN, it's the first frozen elephant trunk device that has a branch 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 perform frozen elephant trunk operations. They use a competitive device. We think ours will be easier to use faster and provide better outcomes. So we don't think that is a -- there'll be some -- some be hands-on training because they have to get 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.

Your next question comes from Destiny Hance with Ladenburg Thalmann.

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.

Yes. So Destiny, your question was just an overall question about pricing environment and what we're seeing. Is that correct?

Yes, please.

Yes. I mean we talked about this before. I mean the nature of our devices is they're generally life-saving and not super high volume from an individual line item in the hospital. And because of that, we typically have not seen price pressure and have really had an ability to drive modest inflationary type price increases consistently over time, and 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.

Your next question comes from Dan Stouter with Citizens JMP.

I just had a few quickly. So following up on the On-X growth. It's been talked a lot about, but I 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 and that halo effect with AMDS? And maybe if you have any metrics on higher utilization for On-X, that would be really helpful.

Yes. So we're not going to get into the nitty-gritty on utilization, but I will say definitely, there 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, that's really hard to tease out. But it's not just increased utilization in our existing customer base. It is definitely also driven by new customers.

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?

Yes. I will say timing of cash can make things fluctuate quarter-to-quarter. But 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 feel like we're in a pretty good spot to deliver on our objective of being free cash flow positive for the full year.

Mr. Mackin, there are no further questions at this time. I would like to turn the floor back over to management for closing remarks.

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. We're growing twice as fast on the bottom line. We're generating cash. We've 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 that again next quarter.

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