Artivion Q1 2024 Earnings Call Transcript

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May 6, 2024

Key Takeaways

  • Artivion achieved 16% constant currency revenue growth in Q1, with revenues of $97.4 million and adjusted EBITDA up 60% year-over-year.
  • The company raised its 2024 revenue guidance to 9–12% constant currency growth and reiterated adjusted EBITDA guidance of $68–72 million, reflecting sustained momentum.
  • Five-year post-market data for the On X aortic valve showed an 87% reduction in major bleeding without increased thromboembolism, reinforcing its market-leading profile.
  • Late-breaking 30-day data from the AMDS PERSEVERE trial demonstrated positive aortic remodeling in over 80% of patients and prior IDE results showed a 72% reduction in mortality, supporting a PMA approval target in 2025.
  • Asia Pacific revenues declined 3% in Q1 due to distributor order timing impacting BioGlue sales, though full-year growth remains expected.
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Earnings Conference Call
Artivion Q1 2024
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Operator

Greetings. Welcome to Artivion first quarter 2024 financial conference call. At this time, all participants are in listen-only mode. A brief 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. As a reminder, this conference is being recorded. I will now turn the call over to Lane Martin of the Gilmartin Group. Thank you. You may begin.

Lane Martin
Company Representative at Gilmartin Group

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 statement to comply with the Safe Harbor requirements of the Private Securities Litigation Reform Act of 1995. The 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 from these forward-looking statements.

Lane Martin
Company Representative at Gilmartin Group

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 the 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.

Pat Mackin
Pat Mackin
CEO at Artivion

Hey, thanks, Lane, and good afternoon, everyone. Q1 was a strong quarter for Artivion as we maintained top-line growth momentum and executed on key operational priorities. I'm pleased to report that in the first quarter of 2024, we achieved constant currency revenue growth of 16% year over year, representing $97.4 million in revenue and adjusted EBITDA growth of 60% year over year compared to the first quarter of 2023. More recently, in April, new clinical data from our On-X Low INR post-market study and AMDS PERSEVERE trial were presented at the AATS annual meeting in Toronto. The five year results from our On-X Aortic Heart Valve Low INR post-approval study showed that the On-X Aortic Valve has an even more durable safety and efficacy profile for patients receiving low-dose warfarin than predicted by the results of the original PMA trial.

Pat Mackin
Pat Mackin
CEO at Artivion

Meanwhile, the late-breaking 30-day data from PERSEVERE demonstrates positive aortic remodeling in over 80% of patients after treatment with AMDS. These two milestones demonstrate the continued success in our clinical and regulatory programs, as well as the continued expansion of our market-leading aortic portfolio. Our investment in these two products and related clinical trials reinforce that we are committed to remaining the leader in aortic health. From a financial perspective, as anticipated, our strong Q1 performance was led by tissue processing, which grew 26%, followed by Stent Grafts at 19%, On-X at 11%, and BioGlue at 1% growth, each when compared to the first quarter of 2023, and all on a constant currency basis. In the first quarter, we also continued to benefit from our footprint expansion through regulatory approvals in key international markets.

Pat Mackin
Pat Mackin
CEO at Artivion

As a whole, our first quarter results and recent regulatory and clinical achievements further validate our growth strategy. From a product category perspective, as I just mentioned, tissue processing grew 26% year-over-year on a constant currency basis in Q1. We expect our tissue business will continue to grow double digits throughout the balance of 2024 as we further leverage our increased supply of our proprietary SynerGraft pulmonary valve and continue to benefit from higher Ross procedure volumes. Benefits from last year's tissue pricing initiative positively impacted Q1, but will begin to annualize in the second quarter of this year. As I also indicated earlier, our Stent Graft revenues grew 19% on a constant currency basis in the first quarter compared to the first quarter of last year.

Pat Mackin
Pat Mackin
CEO at Artivion

Our Stent Graft supply is now healthy and stable, which is producing strong growth across the stent graft portfolio. Lastly, I also previously mentioned On-X revenues increased 11% year-over-year on a constant currency basis as we continue to take market share globally with the only mechanical aortic valve that can be maintained at an INR of 1.5-2.0. Based on feedback from the field, these market share gains and proven clinical outcomes that were reinforced by the results of the post-market study recently presented at AATS, we will maintain our strong conviction that the On-X is the best aortic mechanical valve in the market and will continue to take market share worldwide. Revenues in the first quarter were also driven by continued progress in growth initiatives in APAC and Latin America, primarily through new regulatory approvals and commercial footprint expansion.

Pat Mackin
Pat Mackin
CEO at Artivion

Latin America delivered constant currency revenue growth of 22%, while APAC saw a 3% decline compared to the first quarter of last year. The decline in APAC this quarter was primarily driven by timing of distributor orders, which adversely impacted BioGlue revenue growth. Fluctuations in growth rates in APAC and Latin America are to be expected, as those regions have the highest percentages of stocking distributor sales. We still anticipate strong revenue growth for both regions for the full year and over the coming years, as we expect to leverage our industry-leading product portfolio in those regions. Let me turn now to the clinical data presented at AATS in April that I mentioned previously. We were very pleased to see positive results from the On-X Aortic Heart Valve low INR real-world post-market study presented at AATS in Toronto.

Pat Mackin
Pat Mackin
CEO at Artivion

The abstract reported long-term clinical outcomes of 229 study participants with a target INR of 1.8 out to five years. Results the results show a significantly lower composite primary endpoint for thromboembolism, valve thrombosis, and major bleeding, combined at 1.83%, compared to the predefined historic control of 5.39%. This was driven by an 87% reduction in major bleeding and no increase in thromboembolism. Notably, the data compares favorably to the results of the On-X aortic heart valve low INR trial, the one-year post-market study results presented last year, as well as the On-X aortic low INR IDE study that was first published in 2014.

Pat Mackin
Pat Mackin
CEO at Artivion

The fact the device performed as well or better in the real-world setting than it did in the original clinical trial, provides strong additional validation that the On-X Aortic Heart Valve is the best aortic mechanical heart valve on the market for patients, thus increasing our confidence in our ability to obtain even greater On-X Aortic Heart Valve market share globally. We believe the longevity of the On-X Aortic Heart Valve, combined with a significantly lower risk of bleeding over the other mechanical heart valves, make the On-X Aortic Heart Valve a compelling option for patients under the age of 65. Also at AATS, late-breaking 30-day data from our AMDS PERSEVERE trial demonstrated positive aortic remodeling in over 80% of patients, as well as no occurrence of DANE tears.

Pat Mackin
Pat Mackin
CEO at Artivion

These positive results follow the thirty-day IDE data from the same trial that was presented at STS in January 2024, which demonstrated a statistically significant 72% reduction of all-cause mortality and a 52% reduction in primary major adverse events when compared to the current standard of care Hemi-Arch procedure. We're excited to see the continued positive results of the PERSEVERE study, further reinforcing an unrivaled clinical benefit in the life-saving nature of AMDS. We continue to anticipate PMA approval for AMDS in 2025, which would open the U.S. addressable market opportunity of about $150 million with no competitive alternatives. In addition, our partner, Endospan, is continuing to make progress on its U.S. IDE trial, called TRIOMPHE, for its NEXUS Aortic Arch Stent system. As of today, there have been 44 of the 60 primary endpoint patients enrolled.

Pat Mackin
Pat Mackin
CEO at Artivion

Assuming the trial endpoints are met, NEXUS remains on track for approval in the back half of 2026. In summary, we're excited about our great progress early in 2024, and look forward to sustaining our momentum throughout 2024 and beyond by driving continued growth of our On-X portfolio, stent graft, SynerGraft pulmonary valve, and further expanding our footprint in APAC and Latin America. With that, I'll now turn the call over to Lance.

Lance Berry
Lance Berry
CFO at Artivion

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 $97.4 million for the first quarter of 2024, up 16% compared to Q1 of 2023. Non-GAAP adjusted EBITDA increased approximately 60%, from $10.8 million-$17.3 million in the first quarter of 2024. The combination of strong top-line constant currency growth and significant marketing and G&A expense leverage resulted in an adjusted EBITDA margin of 17.8%, a 480 basis point improvement over the prior year.

Lance Berry
Lance Berry
CFO at Artivion

From a product line perspective, tissue processing revenues increased 26%, Stent Graft revenues grew 19%, On-X revenues grew 11%, and BioGlue revenues grew 1% in the first quarter of 2024. As anticipated, growth in our tissue business was very strong this quarter, as we benefited from both the substantial price increase we implemented in Q2 of last year and improved supply from our yield improvement initiative. We expect the growth rate to come down in future quarters as we annualize the price increase, but we still anticipate double-digit growth for the full year. On a regional basis, revenues in Latin America increased 22%, North America increased 18%, EMEA increased 17%, and Asia decreased 3%, all compared to the first quarter of 2023.

Lance Berry
Lance Berry
CFO at Artivion

The decrease in Asia Pacific region was expected and driven primarily by timing of distributor orders, which also impacted BioGlue sales. As Pat discussed, you should expect to see some fluctuation in quarterly growth rates in the more distributor-based regions, and we still anticipate strong growth in Asia Pacific for the full year. As anticipated, gross margins were 64.6% in Q1, flat to the first quarter of 2023. General, administrative, and marketing expenses in the first quarter were $30.7 million, compared to $50.4 million in the first quarter of 2023. Non-GAAP general, administrative, and marketing expenses were $48.1 million in the first quarter, compared to $45.2 million in the first quarter of 2023, representing 500 basis points of leverage.

Lance Berry
Lance Berry
CFO at Artivion

R&D expenses for the first quarter were $6.9 million, compared to $7.2 million in the first quarter of 2023. We underspent in R&D in Q1, and we expect to catch up over the remainder of the year. We still anticipate full year R&D spend as a percentage of sales to be relatively flat to prior year. Interest expense net of interest income was $7.5 million, as compared to $6 million in the prior year. Other income expenses totaled $7.5 million dollars in net interest expense, $3.7 million for loss on extinguishment of debt, and foreign currency translation gains of approximately $1.4 million. On the bottom line, we reported GAAP net income of approximately $7.5 million, or $0.18 per diluted share in the first quarter of 2024.

Lance Berry
Lance Berry
CFO at Artivion

Non-GAAP net income was $2.6 million, or $0.06 per share for the first quarter. As expected, free cash flow was -$9.1 million in the first quarter of 2024. As a reminder, Q1 is our most cash-intensive quarter due to the payment of annual bonuses and due to normal activities such as sales meetings and industry conferences, which are heavier in the first quarter. Importantly, we continue to expect free cash flow to be positive for the full year, 2024. As of March 31st, we had approximately $51.1 million in cash and $313.3 million in debt, net of $7.1 million of unamortized loan origination costs. Importantly, this is inclusive of the impact of our recently closed comprehensive credit agreement in January.

Lance Berry
Lance Berry
CFO at Artivion

As a reminder, the initial $190 million term loan and $30 million from the revolving credit facility were drawn at close, along with the use of some cash on our balance sheet to retire the existing senior credit facilities and pay related transaction expenses in the first quarter. Overall, this credit agreement, coupled with strong financial performance, gives us flexibility with no near-term debt maturity overhang as we continue to evaluate the best options to address our convertible debt. Further, 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. Our net leverage at the end of Q1 was 4.5, down from 6.8 in prior year.

Lance Berry
Lance Berry
CFO at Artivion

At the midpoint of our EBITDA guidance, we expect net leverage to be closer to 3.5 by the end of the year and to continue to decrease in 2025. Now for our outlook for the remainder of 2024. Given our momentum in the first quarter of 2024, positive data from the recent AATS presentation supporting the long-term clinical benefits of On-X, improved stent graft supply, and robust demand for our SynerGraft pulmonary valves, we are raising the midpoint of our fiscal year 2024 revenue guidance and now expect constant currency revenue growth between 9% and 12% compared to the previous range of 8%-12%.

Lance Berry
Lance Berry
CFO at Artivion

We expect reported revenues to be in the range of $386 million-$396 million, compared to our previous range of $382 million-$396 million. At current rates, we expect FX to have a negligible impact on full-year revenue growth rates. With our continued top-line revenue growth and general expense management through Q1, we continue to expect Adjusted EBITDA to be in the range of $68 million-$72 million for the full year 2024, representing a 26%-34% growth over 2023 and 280 basis points of Adjusted EBITDA margin expansion at the midpoint of our ranges. The strong start to the year puts us on a good trajectory for achievement of this guidance.

Lance Berry
Lance Berry
CFO at Artivion

As a reminder, we expect gross margins to remain at levels similar to 2023 and continue to expect to drive significant leverage from our global sales force and G&A infrastructure. Additionally, R&D expense is expected to remain relatively flat as a percentage of sales. In summary, we feel great about the strong start to the year, and we are excited about the prospects of the business in 2024 and beyond. With that, I will turn the call back to Pat for his closing comment.

Pat Mackin
Pat Mackin
CEO at Artivion

Hey, thanks, Lance. So as you've heard, we're very pleased with our first quarter performance, kicking off 2024 with a very strong start. We continue to deliver strong top and bottom line growth, expand our markets, and advance our clinical pipeline. We expect future growth to be driven by, first, the continued strong growth in our Stent Graft business, driven by improved supply in our innovative portfolio. Second, continued market share gains of On-X, driven by the recent five year data from our real-world post-market trial, reinforcing the safety and efficacy of our On-X aortic low-dose warfarin. Third, growth of our proprietary SynerGraft pulmonary valve, driven by growth of the Ross procedure and our operational improvements. Four, continued growth in Asia Pacific and Latin America from our channel investments and new regulatory approvals. In conclusion, we remain confident in the near and long-term prospects of our business.

Pat Mackin
Pat Mackin
CEO at Artivion

We believe our first quarter results validate our expectation for a strong year ahead as we focus on continued revenue growth and free cash flow generation. I want to thank all of our employees around the globe for delivering a strong first quarter and their continued dedication to our mission of building a world-class aortic company. With that, operator, please open the line for questions.

Operator

Thank you. If you would like to ask a question, please press star one on your telephone keypad. A confirmation tone will indicate your line is in the question queue. You may press star two if you would like to remove your question from the queue, and for participants using speaker equipment, it may be necessary to pick up your handset before pressing the star keys. Our first question is from Mike Matson with Needham & Company. Please proceed.

Mike Matson
Mike Matson
Senior Equity Research Analyst and Managing Director at Needham & Company

Yeah, thanks. So I wanted to start with the Tissue business. So I know you talked a little bit about what drove the growth there, but maybe you could just elaborate on the supply and how you're able to increase that. And then the outlook, I know you're not giving guidance for 2025 yet, but I mean, is this the business in a position now where you could sustain double digits longer than this year, or is this more just kind of a unique year for tissue?

Pat Mackin
Pat Mackin
CEO at Artivion

Yeah, so I would say there's a couple things. Number one, you know, I've, I've talked previously about the growth of the Ross procedure. There's been a tremendous amount of new data that's been released on the Ross that shows at 25 years that you can actually have an aortic valve replacement, with your own native pulmonary valve and backfill your missing pulmonary valve with our valve. And your, your survival and morbidity matches that of the general population. So it's, it's a great operation, and it's growing extremely fast. So that's, that's the first. There was some data published at, presented at AATS, in Toronto last week about this procedure is growing extremely fast.

Pat Mackin
Pat Mackin
CEO at Artivion

Number two, you heard Lance talk about, you know, we had a big price increase last year that's kind of annualized, you know, at the end of the first quarter. But then we also do had talked previously about some of our operational improvements that we've undertaken here at the company, and so, you know, very nice increase in our yields. So I think the combination of those kind of three things, obviously, had a huge first quarter with the pricing kind of annualizing itself this year. It'll be basically supply benefiting the rest of the year.

Pat Mackin
Pat Mackin
CEO at Artivion

Then I think going forward, this procedure is not slowing down anytime soon. So, you know, I think there's a lot of opportunity for that. But as you know, there ultimately, there's a constraint on, you know, how many tissue valves you can get. So we're not gonna give 2025 guidance at this point, but, you know, feel very strong about double-digit growth this year.

Mike Matson
Mike Matson
Senior Equity Research Analyst and Managing Director at Needham & Company

Okay, I understand. And then if I take the EBITDA that you did this quarter and I just multiply by four, it gets you into the guidance range. It seems like the last two years we've seen EBITDA kind of ramp throughout the year as your revenue ramps. So, you know, just wondering why you're maintaining the guidance here. Is there maybe it's the R&D spending, timing, or something less?

Lance Berry
Lance Berry
CFO at Artivion

Yeah, I think there's a couple of things. First of all, it's just early in the year, that's one. Two, you know, we did have a good, a good start to, to the year, but part of that was definitely due to timing on the R&D spend, and, and we absolutely intend to spend that money this year. So those are the two big things. You know, just a little bit early to be to raise that number, which was, you know, pretty strong growth, and we'll see how it goes throughout the rest of the year.

Mike Matson
Mike Matson
Senior Equity Research Analyst and Managing Director at Needham & Company

Okay, great. Thanks.

Operator

Our next question is from Suraj Kalia with Oppenheimer & Co. Please proceed.

Suraj Kalia
Suraj Kalia
Managing Director and Senior Analyst at Oppenheimer & Co.

Good afternoon, Pat, Lance, can you hear me all right?

Pat Mackin
Pat Mackin
CEO at Artivion

Yeah. Hey, good afternoon, Suraj.

Suraj Kalia
Suraj Kalia
Managing Director and Senior Analyst at Oppenheimer & Co.

So, Pat, congrats again. You guys are on a roll. Pat, the obvious question, I know you've been talking about this for some time, but it seems like in the last two quarters, you know, you guys seem to be just shifting gears in terms of CAGR, now the leveragability, this quarter also surprised everyone. So, Pat, just talk to us. You know, I understand the supply issues and some of the other constraints that you were talking about, but is this something more fundamental we should be cognizant about? A more tenured sales force, rep commission changes, different marketing methods. Just, there seems to be a distinct shift in everything. Maybe if you could give us some additional color there.

Pat Mackin
Pat Mackin
CEO at Artivion

Yeah, sure. No, I think, I think it's, you know, it's one of the nice things about the company is we've got a, a portfolio of products, right? So we also have a, a portfolio of regions. And as you heard, we had strong double-digit growth across all of our, our entire portfolio, except for BioGlue, which, you know, we expect to grow kind of low single digits, and across all of our regions, except for APAC, because we had a timing thing. So it's, it's kind of a, you know, combination of, of we got highly differentiated products with really strong channels around the world, and you're seeing kind of them firing on all cylinders. And again, I just would remind you, you know, if you look at SynerGraft, nobody no other company has SynerGraft.

Pat Mackin
Pat Mackin
CEO at Artivion

The Ross procedure is growing very rapidly, and we are the market share leader, and we're taking advantage of that. You know, the On-X valve is the market-leading mechanical valve in the world, and we've just shown data that shows, you know, an almost 80% reduction, I mean, an 87% reduction in major bleeding. So we feel very strong that that is the only mechanical valve that should be used, and we're not gonna stop until we take it all. Number three, our stent graft portfolio. We have full supply. We have had no supplier problems, probably for, like, a year and a half. Very highly differentiated products.

Pat Mackin
Pat Mackin
CEO at Artivion

Our Neo device is growing rapidly. Our thoracoabdominal devices are growing rapidly. Nobody has an AMDS. Nobody has some of the technologies we have. So I think it's just the combination of all these portfolios under this aortic umbrella with powered by channels around the world. When you combine it all together, it's driving nice results. I think it's nothing more complicated than that.

Suraj Kalia
Suraj Kalia
Managing Director and Senior Analyst at Oppenheimer & Co.

So, Pat, would it be fair to summarize this as more of product attributes yielding a pull-through demand rather than any fundamental shift in your sales and marketing structure and messaging? Is that fair to put it that way?

Pat Mackin
Pat Mackin
CEO at Artivion

Yeah, I mean, I guess, I guess if you, if you think about it, we've, we've got great channels, but, you know, this is a dynamic market, right? So just since our last call, we've released the five-year post-approval data for, for On-X, and we've released more data on, on AMDS, right? So that AMDS PERSEVERE data was in the quarter. It was at the end of January. So, you know, we've got great sales forces, great products, but they're being backed up by very strong clinical data.

Pat Mackin
Pat Mackin
CEO at Artivion

Everything that's been coming out on the products has, has, has done nothing but reinforce, and same with the Ross. There was Ross data presented at AATS. It was one of the major focuses, and, you know, again, that's growing very rapidly. So it's truly the combination, Suraj, of proprietary product, strong channels, and really strong clinical data that just keeps coming out on all the products that we represent.

Suraj Kalia
Suraj Kalia
Managing Director and Senior Analyst at Oppenheimer & Co.

Got it. Pat, one for you, one for Lance, and I'll hop back into you. In terms of additional opportunities, especially as I think about NEXUS, Pat, love to get your updated thoughts. Lance, if I could quickly throw in there, I missed part of your commentary about the leverage, the SG&A in the quarter. Can you talk about the sustainability? And also, is my math right, that $23.5 seems to be the conversion price? How are we all thinking about the, you know, 2023 and beyond, what happens to the conversion? Gentlemen, congrats again. Thank you. Thank you for taking my questions.

Pat Mackin
Pat Mackin
CEO at Artivion

Hey, thanks, Suraj. Yeah, as far as Nexus goes, I mean, there's been data, you know, recent data was published at AATS, excuse me, at STS, on the TRIOMPHE trial. I think it was the first 20 out of the 60 in the pivotal arm showed very strong results. They've now enrolled 44 out of the 60. You know, that trial should enroll in the second half of this year. And it's, you know, the data looks very good. And again, I mean, and, you know, you guys have been around a long time, particularly you, Suraj, and you know how clinical trials go.

Pat Mackin
Pat Mackin
CEO at Artivion

But I think if you look at the data and the technology, that's a meaningful space to be able to treat a chronic dissection or an aneurysm of the arch with a catheter, you know, is a unique opportunity. And, you know, that's why we invested in the company, and that's why we have an option to acquire. We're obviously going to be watching this, as the trial enrolls and they get their data, but it looks promising. Lance, you want to take the other two?

Lance Berry
Lance Berry
CFO at Artivion

Yeah. So on SG&A leverage, you know, we think that's a big opportunity for us going forward. We had really good leverage last year. We have a good start in Q1. Now, 500 basis points is not something that we're committing to on a quarter-by-quarter basis, but you can really see when we have strong revenue growth, the leverage in the model. And I think that is a big opportunity for us going forward. On the convert, the $23.50 is when the convert is in the money, but we can't force conversion unless the stock gets to $30, I think, and some change. So, just to be clear on that, where that is.

Lance Berry
Lance Berry
CFO at Artivion

And then as far as how we're thinking about it, I mean, you know, we talked about this on the Q4 call, that, I mean, the spread between the interest, the cash interest we're paying on these converts versus the delayed draw term loan is pretty significant. And at the moment, we're just happy to pay the lower interest. And I think we'd probably all hope that interest rates would have maybe started to come down by now, but that's not the case. So we're just watching it, and, you know, we'll keep keeping our options open, on what to do on that.

Operator

Our next question is from Rick Wise with Stifel. Please proceed.

Analyst at STIFEL

Hey, Pat. Hey, Lance. This is John on for Rick this quarter. Really strong growth on the top line. I just wanted to maybe start off on the On-X data that recently read out at AATS. You know, as you highlighted, really strong. I just want to hear it maybe from more of a market perspective, how much share do you see as left to go for On-X to take in the mechanical space? And beyond that, what do you see as the opportunity for the valve to potentially reach the bioprosthetic market?

Pat Mackin
Pat Mackin
CEO at Artivion

Yeah, so on the pure mechanical market, you know, the global data we have, we've got about a 30% share globally. It's higher in the U.S. It's more like 50+ in the U.S. than it is outside the U.S. So we have a lot of room to go outside the U.S. I mean, I've heard comments from surgeons when we've talked to them about this data, about even competitive accounts, like, why would anybody use another valve? So, you know, our team's very fired up about going aggressively after this mechanical valve market.

Pat Mackin
Pat Mackin
CEO at Artivion

As far as the bioprosthetic segment, you know, in typically in patients under 65, there's certainly some signals there that this data can go after bioprosthetic, but I'm not going to get out over my skis here. This data just got released, and, you know, we're going to be exploring that. But, you know, for right now, we're going aggressively after the mechanical segment, when we still have a lot of room to go.

Analyst at STIFEL

Thanks, that's helpful. And if I could sneak in sort of a two-parter here, maybe the first for Pat, the second for Lance. Just on the aortic side of the business, growth was really strong this quarter. I think it came in at kind of mid-20s. I just want to get a sense from you what the key growth contributors are and how you're looking at growth for the aortic business for the rest of the year. And then second for Lance, just on the gross margin profile, tissue was particularly strong, near 60%. Just how are you thinking about tissue gross margin for the rest of the year and gross margin for the business as a whole? Thanks.

Pat Mackin
Pat Mackin
CEO at Artivion

Yeah. So just on the stent business, so the GAAP growth was 23%. We typically talk about constant currency was like 19%. You know, obviously very strong. And I mentioned it a little bit earlier. I mean, I think what's driving this, we've got strong channels kind of around the globe. But we've also got a very, you know, differentiating unique portfolio. For example, AMDS, we had the U.S. IDE trial PERSEVERE presented at the beginning of the quarter, you know, kind of the end of January, with phenomenal data. I mentioned it, a 72% reduction in mortality, a 52% reduction in major adverse events, no DANE tears. So clearly, the AMDS is proprietary, and nobody has it, and we just released great data.

Pat Mackin
Pat Mackin
CEO at Artivion

We've also got two very significant technologies in the branched Stent Graft area. The frozen elephant trunk in the arch, and then the branch thoraciabdominal, in the kind of the midsection of the aorta. And those are growing very rapidly. So again, it's the whole strategy, right? Is we're an aorta company. We can treat you from your aortic valve to your iliac with a bunch of different technologies, and the majority of them are very proprietary with a strong sales force. So I think that's, that's what's driving, the stent graft side. I think you had a question on margin for Lance?

Lance Berry
Lance Berry
CFO at Artivion

Yeah. So overall, we're, you know, qualitatively saying you expect gross margin to be relatively flat year-over-year. There's a lot of mix in our gross margin. I mean, we have, you know, four different product lines at different margins and in four different regions with different margins, and so there's a lot that goes into it. I will say, specifically on the SynerGraft pulmonary valve portion of our preservation services. Now, preservation services has historically been our lowest gross margin, but our pulmonary valves are actually north of company average. And so, you know, specifically with that, as that grows faster, you know, that's a tailwind, it's not a headwind. Now I don't want you to take those comments and say, Oh, that means mix should go up, because there's a lot of pieces. But that part growing faster isn't a negative for gross margin.

Mike Matson
Mike Matson
Senior Equity Research Analyst and Managing Director at Needham & Company

Thanks. That's helpful.

Operator

Our next question is from Frank Takkinen with Lake Street Capital Markets. Please proceed.

Frank Takkinen
Senior Research Analyst at Lake Street Capital Markets

Great. Thanks for taking the questions. Pat and Lance, congrats on the quarter. Was hoping to start with one on On-X as well. In light of all the data packs that have came out, consistently higher market share, how do you think about pricing opportunity? Have you taken any recent price increases, and do you think you have the ability to continue to take price?

Pat Mackin
Pat Mackin
CEO at Artivion

Yeah, it's a good question, Frank. I mean, it really is kind of, you know, evolving where, you know, it used to be mechanical valves and tissue valves, like, you know, two discrete buckets. But what's really kind of evolving from this data is that there's kind of a new category in between a mechanical valve and a tissue valve, which is On-X. So, I mean, we've really got... You know, the primary objective here is that we feel like this is the best mechanical valve out there. And I do think, you know, it should be the only mechanical valve being used. So, that does, I think, bring with it some pricing power, that we will exploit. I'm not gonna get into specifics on the call, but I do think there is an opportunity for that.

Frank Takkinen
Senior Research Analyst at Lake Street Capital Markets

Okay, that's helpful. And then maybe just one more from me, for Lance on the free cash flow commentary. Heard your comments about the -$9 million for the quarter. How should we think about free cash flow cadence for the remaining quarters of the year?

Lance Berry
Lance Berry
CFO at Artivion

Cash can kinda jump around quarter to quarter, so we're not really committing to positive for every single quarter. But definitely expect it to be positive for the full year, probably stronger in the back half. There's just some heavy cash outlay things that occur in the first half of the year, and the second half is just a little bit lighter on that. But definitely expect to be positive for the full year.

Frank Takkinen
Senior Research Analyst at Lake Street Capital Markets

Okay, that makes sense. Thanks for taking the questions.

Pat Mackin
Pat Mackin
CEO at Artivion

Thanks, Frank.

Operator

Our final question is from Jeffrey Cohen with Ladenburg Thalmann. Please proceed.

Jeffrey Cohen
Jeffrey Cohen
Managing Director and Director of Equity Research at Ladenburg Thalmann

Hi, Pat and Lance. Just a couple from our end. Could you talk about Neo a little bit as far as any macro reviews and any pricing that's been taken or planned to be taken? And is some of that uptake in the strong quarter from new users, new surgeons that are coming on board, or is it more in respect of higher utilization per surgeon or per facility?

Pat Mackin
Pat Mackin
CEO at Artivion

Yeah, so Neo, you know, we're not gonna break out, you know, specific products underneath the kind of aortic stent umbrella, if you will. But I will say that, you know, Neo is growing very rapidly. It's a combination of, you know, expansion, geographical expansion. We're selling Neo in Asia, we're selling Neo in Latin America, many markets in Europe. It's obviously not approved in the U.S. or Japan, but it's doing extremely well. And as I mentioned earlier, it's a proprietary technology. We have a very unique stent system on that device, which we feel has better outcomes than the other devices out there, and we're being very aggressive, kind of going after that business. So, you know, it's a product that's done well and continues to do well.

Jeffrey Cohen
Jeffrey Cohen
Managing Director and Director of Equity Research at Ladenburg Thalmann

Got it. Okay, and then secondly for us, Lance, can you talk a little bit about the SG&A and maybe cadence for 2024? It seemed like it was light in the first quarter, and how we should think about the leverage on your gross spend from Q2 to Q4.

Lance Berry
Lance Berry
CFO at Artivion

Yeah, I mean, honestly, like, on an as-adjusted basis. Now, it looked light on an as-reported basis, but that's because some of the contingent consideration fluctuations. But on an as-adjusted basis, you know, it was $48 million, which was fairly consistent with Q4. And, you know, I think something in that kind of range is really what we think about as we move throughout the year on an as-adjusted basis. So, we should drive some really good leverage year-over-year.

Jeffrey Cohen
Jeffrey Cohen
Managing Director and Director of Equity Research at Ladenburg Thalmann

Great. Finally, for us, any commentary on Tissue business with regard to... I know that pulmonary has been strong, but any commentary on cardiac versus vascular, generally speaking, on pricing or units out there for the quarter?

Pat Mackin
Pat Mackin
CEO at Artivion

Yeah, again, we're not, we're not gonna break out components underneath the, kind of the tissue. Obviously, we've, we've talked, you know, several quarters in a row about the price increases on cardiac and the volume increases. So cardiac's definitely driving it, but the, the whole segment's growing, so, but we're not gonna break out pieces.

Jeffrey Cohen
Jeffrey Cohen
Managing Director and Director of Equity Research at Ladenburg Thalmann

Perfect. Okay, I got it. That does it for us. Thanks for taking the questions.

Pat Mackin
Pat Mackin
CEO at Artivion

Thanks, Jeff.

Operator

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

Pat Mackin
Pat Mackin
CEO at Artivion

No, thanks for joining for our Q1 call. Again, we're very pleased with the first quarter and, you know, 16% top line growth, 60% bottom line growth. We're executing on the pipeline. We've got great products, great data, great sales forces, and plan on doing more of the same as the year keeps going. So appreciate your support and look forward to our next call with you.

Operator

Thank you. This will conclude today's conference. You may disconnect your lines at this time, and thank you for your participation.

Executives
Analysts
    • Frank Takkinen
      Senior Research Analyst at Lake Street Capital Markets
    • Jeffrey Cohen
      Managing Director and Director of Equity Research at Ladenburg Thalmann
    • Lane Martin
      Company Representative at Gilmartin Group
    • Mike Matson
      Senior Equity Research Analyst and Managing Director at Needham & Company
    • Suraj Kalia
      Managing Director and Senior Analyst at Oppenheimer & Co.
    • Analyst at STIFEL
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