All right. Good morning. My name's Bill Plovanic. I'm a Senior Med Tech Analyst here at Canaccord Genuity. Welcome to our 46th Annual Global Growth Conference. With us up next, we have Artivion, and for Artivion, we have Lance Berry, CFO and COO. The format is going to be a short overview presentation by Lance, and then we'll sit down and we'll have our fireside chat. With that, hand it over to Lance. Thanks, Bill. Good morning, everyone. Quick overview on Artivion. We are an aorta-focused medical device company. We did a little over $400 million in 2025, have guidance closer to $500 million for 2026, and roughly $90 million of EBITDA. We basically do two things. We have aortic valve replacements. We have allografts, and we have mechanical valves. Then we have a series of products to treat dissections and aneurysms of the aorta. Then we also have a product that's an adjunct to the procedure, a surgical sealant called BioGlue. That's basically what we do. On aortic valves, we're focused on younger patients, which we define as patients under the age of 65. As far as financial objectives, what our goal is in any given year is we're trying to produce double-digit revenue growth and to grow EBITDA twice as fast as revenue. Kind of the formula for that is you see the left-hand side of the pie chart is the more legacy parts of the business, preservation services, and surgical sealants. Those are low to mid single-digit growth businesses. They're very highly differentiated products, but just in very mature markets. They don't grow very fast, but the growth is very durable, and they're very profitable. On the right-hand side, we have our higher growth, higher margin segments, mechanical heart valves, which the brand is On-X, and then our portfolio of stent grafts, which is really where all of our future growth is going to be driven and where all of our pipeline is focused. We have a really good opportunity to expand EBITDA margins, and we have three ways to do that. First, we have this excellent pipeline of products that we're bringing to the U.S. market, and each of those products have significantly higher gross margins than our current corporate average, so we have an opportunity to expand gross margin through mix. We have a global sales force that's fully built out. Our reps don't need to cover each case, which is a little bit unusual for a med tech company. Frequently, reps are in the surgery. We do not have that, and so that gives us an opportunity to leverage the sales force. Then, like most companies our size, we have a global G&A infrastructure that's built out that we can leverage. Those things together allow us to take what is double-digit growth and grow EBITDA significantly faster. Highlights of why would you invest in this company. We have really category-defining, highly differentiated products that are very defendable. They are all PMA, FDA-approval products, which is a very high barrier to entry from additional competitors. We have significant leverage opportunity. We are very focused on a concentrated call point with a focused sales organization. We have this core business that, although slower growth, is very profitable. Then we have this high margin, high growth opportunity with this excellent pipeline. You add that all together, and you can get this sustainable revenue growth with a meaningful leverage opportunity. Lastly, just a couple of highlights on things that happened this quarter. We reported earnings last Thursday. We did 9% growth, which is a little below our target. We are expecting that to improve going forward. We did have some really good progress in the stent grafts business, which grew a little bit faster than we did in Q1, despite a much more difficult comparable. Then we had high -teens growth in our On-X line, which is fantastic. Then on the non-financial side, we had some pretty big milestones that occurred in the quarter. First, one of our high-growth devices, AMDS, we have been marketing under a humanitarian device exemption, and we got full PMA approval of that right at the end of Q2. Also, we completed an acquisition of the company Endospan. Their product is NEXUS, which got PMA approval in early Q2. We also had some amazing data presented related to our SynerGraft pulmonary valve, which is in our preservation services business. We continue to enroll in our next-generation product, Arcevo. The trial is called ARTIZEN, and we are at 30 patients enrolled there. We reiterated guidance for the year. Overall, a really good Q2, a lot of good progress, both financially and non-financially, and have more confidence in our full-year guidance. That is a high-level overview. Excellent. We will shift to the fireside chat portion. All right. For Artivion, the transformational vision that the company laid out several years ago, which was build Artivion into a market leader in the aortic arch repair, I mean, this is coming into focus. This is an interesting name. Every time I bring up the name Artivion, usually people are like, "Who?" Then you say, "Oh, it is CryoLife," and they are like, "Oh, yeah, I remember CryoLife," which I think now it is like 25% of your revenues or something like that from the original business. Right. The business has been transformed in the past decade significantly. You have the recent PMAs. You talked about AMDS and NEXUS. Before I get deeper into this, the questions I am usually hit with first are going to be on guidance revenues margin. I am going to start there and work my way down. You had a nice Q2 beat. We saw strong stent growth. On-X was good despite tough comps. Now you have the AMDS PMA approval in hand. Guidance was unchanged. I think the biggest pushback this year is you started out, you had to pull guidance back after Q1, and now here we go where it was like, okay, feels like we are back on track. Just what happened through the year? What changed between Q1 and Q2? I know it did not change guidance, but all of a sudden it feels like, oh, wait a minute, this is not as bad as it felt. Yeah. So, for those of you that were not following, we did have a pretty challenging Q1. We had some negative surprises, and we did lower our guidance on our Q1 call. Then we had honestly, a really solid Q2. We made some real progress. I mentioned some non-financial progress, but financially it was really good. Stent grafts, we had a slightly better growth rate despite a much more difficult comp. Then On-X was high -teens, which was ahead of expectations, again, despite a difficult comp. So we made some really good progress. We felt good about the guidance. We did not feel good about lowering it, but we felt good about the guidance that we gave on the Q1 call. Qualitatively, obviously, we feel better about that guidance now than we did then. I think just given the challenges we saw in Q1, we felt like some caution was appropriate. Let us get further in the year before we think about changing this guidance. Okay. The EBITDA, as you mentioned, it is revenue double- digits, EBITDA twice as fast as revenue basically. The EBITDA was down slightly year-over-year despite the strong sales, because you are making these investments in NEXUS. You got R&D. You are spending a little money there. How do we think about what is the right framework to balance growth investments versus long-term goal of EBITDA leverage? Now that we are kind of getting back on track, does that still hold? Yeah. I think 2026 has some noise in it from the acquisition. There are some things we need to spend some money on, some of which will not repeat. Honestly, we had our own R&D programs going, but the Endospan team had R&D programs going as well that we are really excited about, and we wanted to keep going. So our R&D investment for the remainder of 2026 is hotter than normal. But we felt that was appropriate. As we move into 2027, we will be able to manage that back into our normal. We, any given year, want to invest 7%-8% of sales in R&D. We do not think there will be a need to go beyond that in 2027, even though we are in 2026. Then obviously we have two great new products with AMDS and NEXUS. We want to maximize those opportunities, which will require some investment. But AMDS is kind of in the system at this point. NEXUS, it will require some investment, but it is not like a start-from-scratch thing, right. So we will have a small increase in sales force. We will have some training, but it is a very high ASP product. It does not take a lot of volume to cover those investments. I want to ask you, go to the R&D. It is interesting. So you said 7%-8% R&D, but you are really only doing R&D on one of the business segments because the rest of them do not require a lot of R&D. So it is really more of like a 20-ish percent or something— Yeah. —on that one piece. I think it's a great thing about our business model is that we have a large portion of our revenue that's very differentiated, very protected, but doesn't require ongoing R&D to keep it going and allows us to concentrate all of our investment into essentially one product line. As you point out, for that product line, we're investing 20%+, and that's what is allowing us to shoot for a cadence of a new PMA in that product line every two years. You had mentioned that the NEXUS acquisition isn't a product, it's a platform. Help us understand that. Yeah. It's a fantastic product. We've been selling the product in Europe for a number of years through a distribution agreement prior to the acquisition. We think it's fantastic. The product that is first approved in the U.S. is a single-branch device. In Europe, we are selling the next generation, which is a two and three-branch device. That'll be the first thing we're focused on is getting that to the stage where we can get an IDE trial going in the U.S. and try and get PMA approval for that. But then they have derivatives coming off of that that will actually get us into adjacent segments of the arch that are pretty substantial, multi-hundred million dollar type opportunities. That is a little further down the line. The near-term focus is just going to be getting this two and three branch on the U.S., but really closing that Endospan acquisition pretty much has solidified our pipeline, I would say, for 5+ years. You talked about the full launch for NEXUS is going to be January next year, and it is manufacturing scale up. You have been selling it in Europe. Why do you not have enough product on the shelf today to sell it in the U.S. on approval if they are already making it for Europe? Well, believe me, I wish we were swimming in inventory to go launch the product. I think you have to remember this was essentially a startup company. They sold us the product almost at cost. They did not make much money through us through a distribution agreement. They had a pre-negotiated deal to basically be acquired upon PMA approval. So they weren't going to invest in inventory for something that was going to happen after they sold the company. I think it was very reasonable. We tried to work with them to make sure that they did some minor things to increase capacity and to be ready to go, which allowed us to hit the ground running the day after we closed. But there are a number of SKUs in the system, and we have to build that inventory up. Also, we want to make sure that we are really healthy. The last thing you want to do is launch a product and then not being able to meet demand. On free cash flow, it is kind of all over the map, given the Endospan deal and everything going on. 2026 ends up being a little messy because of that. How do we think about free cash flow in 2027 and beyond? Yeah. We think we have the opportunity for some significant free cash flow in future years. I think maybe a marker I will throw out to think about is in 2026, we were roughly free cash flow neutral. But that was including $20 million of investment in purchasing two of our existing buildings where we manufacture our On-X product, and then a third building for expansion. That is an unusual non-recurring thing. We are, in general, not a very capital-intensive business. So if you would have pulled that out, we would have produced $20 million of free cash flow in 2026. I think that is kind of a good way to think about as a starting point as we go forward that we are going to try and be in those levels and build off of that. Do you mean in 2025? I apologize. 2025, yes. Gotcha. 2025— For the transcript— —would've been $20 million. Thank you. —I don't want you to be predicting free cash flow. No, free cash flow this year definitely is messy because of the things we discussed with that acquisition. Right. Okay. Yeah. Let's talk about AMDS, because I think that's been kind of what some of the challenges were as you shifted from the HDE to the PMA. Why did it matter? The questions I'm getting is, one, why did it matter? And two, if that was one of the reasons you've kind of reset guidance, you haven't really talked about the other issue was the $100,000 upfront, how you've addressed that. Let's hit those two topics. Okay. First of all, getting PMA approval was assumed in the guidance. We had a high level of confidence that that was going to occur. That was expected. If you think about what does the move from HDE to PMA do, it does a couple of things. First of all, under the HDE, each hospital has to put in place an IRB, an investigational review board. It's just a requirement of the HDE. That's hoops that the surgeon that's championing this product has to jump through. They have to do all the administrative things to get approval for that and get that put in place. That's just extra work for the surgeon. And in some cases, the hospital, the HDE doesn't require this, but the institution itself requires ongoing patient-by-patient administrative work to be done under the IRB. With the PMA approval, those things all go away. That's some friction in the system to both get to the point where they make the initial stocking investment that goes away, but then also it's less burden to actually use the device and implant it going forward. Directionally positive in both cases. Also, we were somewhat limited on how we could market the device under the HDE. The PMA frees us up a little bit more around that. For example, we've had multiple papers published at major industry events post the actual IDE trial with additional information around benefits to patients with malperfusion, remodeling of the device. We have an international study that was done that has data out to five years, so we have longer-term data. We didn't have the ability to market those things. Now, we're free and clear to do that. That will be helpful as well. What it does not do is it does not change the fact that someone in the finance arm of the hospital needs to approve an investment of $100,000. Realistically, that person probably does not care if we have a PMA or not. We still have to work that issue. I think that was one of the things that we ran into in the first quarter as being a bigger hurdle than we understood. In Q2, now that we are aware, we were able to go attack that. You could see in the numbers, we made progress on that. That is still a battle we have to fight, but I think our reps are much more equipped to go have the conversation, tools in their toolkit to help the finance person understand, like you are leaving profit on the table by not using this device because it has increased reimbursement versus the alternative, and help them understand why this is a good financial investment for the hospital. Still more work to do there. We are going to have to grind that out. I think we are in a better position than we were at the end of Q1, and I think the PMA directionally is helpful, particularly at the surgeon level. If you have the PMA and it was an impediment to getting new accounts on board with having an HDE and you clear the HDE and now you are PMA, you get rid of the bottleneck with the surgeons, all this, you probably had a big backlog. Why would not that be like a rat through a snake? Why would not we just see this kind of pop through in the next quarter or two where all of a sudden you get a bunch of new accounts which at $100,000 stocking could be some big quarters out of this product? Good question. I would say we definitely had some accounts where the surgeon was saying, "Look, I am not willing to champion this through the process with all this extra work I am going to have to do when you are telling me the PMA is right around the corner." Okay, so we get the PMA. That starts the process, it does not end the process. Okay, so that is one. That is why it is not the rat going through the snake. I think it will make it easier to go through the process, but it is not going to create this bolus of things that are going to come through. I do also think it will help with implants. I think anecdotally, we have had some feedback from surgeons that they were really a little more narrow in their focus on patient selection under the HDE as opposed to the PMA. Then again, some of them had some administrative friction under the IRB that is now removed that I think will also see a positive impact on implants. Do not expect a big avalanche of new accounts to come through just because we got the PMA. The label was broader than the original HDE label, the final label. I think it is more just without the full stamp of approval of a PMA, that they were being more cautious on basically the most needy of patients, that type. It is a humanitarian exemption, it is not a full approval. The other question we get is we have seen the On-X valve business, which has been kind of losing share for years. It has been growth, but all of a sudden it is new life breathed into it. We have seen these teen growth rates out of it, and we are all trying to figure out what is the durability of that teen growth rate. I know it was a data-driven thing, but how much has that even been pushed into the market yet? What can we expect out of that? Yeah, good question. This has been a solid double-digit growth business for us for years and years. Then last year, based on some data that we didn't produce, that was independent of us, two different very large 100,000 + patient studies, that was very favorable for mechanical valves versus the alternatives. We saw our growth rate jump to 20%+, right. Which has been fantastic and it's slowed down some, but we were high -teens this quarter, which was on tougher comps, which is excellent. I think we took that data and we did our own quantitative market research and said, "Okay, what does this mean for a market opportunity if the physicians were to adopt, b asically the mindset that this clinical data would say they should adopt for treating their patients?" We sized that as roughly a $100 million U.S. market expansion opportunity. Realistically, we're in the early adopter phase of basically taking that data and turning it into patient treatment. We still have a long ways to go. Now, it takes time for data to disseminate. You still have basic change management at a surgeon level that you have to go through. You're asking them to change their mindset on a way they've been advising patients for decades, r ight. So there's a lot of work to do there, but the data is incredibly compelling. We're working hard to make sure that every cardiac surgeon in the U.S. that does aortic valve replacement is aware of the data, understands the data. It's been great, and we think we have years of opportunity to grow above that kind of low double- digit that we grew previously. On the aortic arch business, you have these differentiated PMA products you're launching. The TAMs are pretty small, usually, for the incremental add $150 million, $250 million. Not typically what you see in a PMA. How do I think about the competitive landscape in those different sub-segments? Who's your number one competitor kind of in the aortic arch today? As you launch this, what type of competitive response do you expect from them? Yeah, I think it's one of the interesting things about the business model is we have these differentiated products in these modest-sized segments that require PMAs to get a product to market. Really, it probably doesn't make sense from a VC investment standpoint to invest in those, and probably from a very large company also probably doesn't. The markets aren't big enough. But they're meaningful to us, and we can fund them just within our normal business model, r ight. We're not raising money to do these things. We're not having a major downturn in profitability to fund it. We can fund these in 7%-8% of sales. Then once we get them approved, it's a very high barrier to additional competition. In general, in the U.S., these products in the arch are going to have zero or one competitor, r ight. So AMDS has zero competitors. It's a greenfield opportunity. It's just an adjunct to the existing procedure. There may never be another competitor for that. For NEXUS, it just approved one competitor on the market, Gore, that has a device that has been approved there for a short period of time, but it was a device that was designed actually for a different part of the arch. It's kind of been moved over to the part where NEXUS is. We think we have some feature function benefit differentiation versus Gore. You will have one competitor that we think we have some incremental leapfrogs to. If they want to get a new device, that's probably a multi-year development IDE clinical trial, about a year regulatory process, so d ifficult to respond. The next device in line, our Arcevo device, is an IDE clinical trial right now. There's one competitor on the market, Terumo. We think, again, we have a leapfrog to their device. We have basically a stent graft for the left subclavian artery, which is the most difficult part of the surgery. We think you could save as much as 20 -minutes on the surgery, and these are patients that are on a heart-lung machine, so that really matters. Again, it'll be difficult for them to have a competitive response to that. It'll be very expensive and time-consuming for them to do that. It's one of the best things about this business is the high barriers to additional competition. With the Endospan acquisition, you had to take on incremental debt, so you re-levered up after de-leveraging. How do we think about the de-leveraging going forward? Are you going to need more capital to get there to pay this down? How much room do you have to make it without having to do that? How should we think about it? We don't see any need to raise additional capital. At this point, M&A is not part of our core strategy to hit those financial objectives that I laid out at the beginning. Endospan was really, in some ways, the last step in this transformation that we've been doing for multiple years. All the exciting things in our space are currently in our pipeline, not in other people's pipeline. M&A is not really a necessary component for us to hit our objectives. Really, we can grow our EBITDA, and we can get our leverage to come down. We expect a free cash flow significantly going forward. I really see no need to raise additional capital. Yeah, I think the incremental products, as you mentioned, are—w e didn't talk about it here, but I think they're like 90%+ gross margin products. Yeah. Way higher than our current corporate average, so expected to be very profitable. This business is not very capital or inventory intensive, so it's helpful. See if there's any questions from the audience. Anything you'd like to leave us with? Glad to be here. I think Artivion is a fantastic company. I've only been here about two years. I didn't do the transformation. I came in pretty much when it was over. But I think it's really compelling from both a strategic standpoint with high barriers to competition, really differentiated products, and has a really great business model with an opportunity for leverage. If you're not familiar with it, I would encourage you to take a look. Excellent. Thank you so much.
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