AORT - NYSE

Greetings. And welcome to Artivion’s Second Quarter 2024 Financial Conference Call. At this time, all participants are on a listen-only mode. A question-and-answer session will follow the formal presentation. [Operator Instructions] As a reminder, this conference is being recorded. I would now like to turn the conference over to your host, Eileen Martin. Thank you. You may begin.

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 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 filing 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, Eileen, and good afternoon to everybody. We’re very pleased with our Q2 performance, which capped a strong first half of 2024 for Artivion, with which we made significant progress on our commercial, operational and financial goals. In the second quarter of 2024, we delivered constant currency revenue growth of 10% year-over-year, representing $98 million in revenue and adjusted EBITDA growth of 35% year-over-year, compared to the second quarter of 2023. More recently, we amended our credit facility and option purchase agreements with Endospan. The amended credit facility provides Endospan with additional funding subject to progress towards completion of the NEXUS PMA, while the amended option purchase agreement significantly improves our acquisition terms for Endospan, should we elect to exercise our option. From a financial perspective, our Q2 performance was led by On-X, which grew 15%, followed by stent grafts, which grew 13% and BioGlue that grew 12%, followed by tissue processing at 7%, each when compared to the second quarter of 2023, all on a constant currency basis. In the second quarter, we also continued to benefit from our regulatory approvals and commercial footprint expansion in key international markets, especially in Latin America and Asia-Pacific. As a whole, our results and regulatory achievements further validate our growth strategy and we remain laser-focused on expanding access to our differentiated product portfolio in existing and new markets. From a product category perspective, as I just mentioned, On-X revenues increased 15% 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 in an INR of 1.5 to 2.0. Based on feedback from the field, our recent market share gains, and the proven clinical benefits of the On-X aortic valve, we maintain our strong conviction that On-X is the best aortic valve on the market and will continue to take market share worldwide. Meanwhile, as I indicated earlier, our stent graft revenues grew 13% on a constant currency basis in the second quarter compared to the same period last year. Our stent graft portfolio remains a key component of our growth strategy, and we are encouraged by our strong results, which are driven by our differentiated product portfolio focused on the more complex segments of the stent graft market. Today, the products in our stent graft portfolio are primarily sold in Europe, where we leverage our existing direct infrastructure -- sales infrastructure and create significant cross-selling opportunities across our unique aortic products offering. Our pipeline consists largely of bringing these proven products to the U.S. and Japan markets, which represents a significant growth opportunity. We also saw strength in BioGlue during the second quarter, which grew 12% on a constant currency basis. As we have discussed previously, we expect to see some variability in the growth rates of BioGlue from quarter-to-quarter, driven by the significant amount of stocking distributor business in this product line. On an annual basis, we expect BioGlue to grow in the mid-single-digit range. Lastly, on tissue processing, our revenues grew 7% year-over-year on a constant currency basis in Q2, as we annualized the benefits from last year’s pricing initiatives. We continue to expect the tissue business to grow double digits for the full year of 2024, as we further leverage increased supply of our proprietary SynerGraft pulmonary valve and continue to benefit from our higher Ross procedure volumes. For those unfamiliar with the Ross procedure, it’s a double-valve procedure in which the patient’s native pulmonary valve is replaced by the patient’s defective aortic valve and then the patient’s pulmonary valve is then replaced by a donated pulmonary valve. The Ross procedure is considered the best option for young to middle-aged patients with a diseased aortic valve, as it provides the best option for these patients to have a normal life expectancy. The use of the Ross procedure has increased rapidly over the last couple of months and years, due to significant long-term data demonstrating these significant clinical benefits. Our SynerGraft pulmonary valve has no competitive alternative and is the market leader in allografts used in these procedures. Further, revenues in the second quarter were also driven by our continued progress and growth in Latin America and Asia-Pacific, primarily through new regulatory approvals and commercial footprint expansion. Latin America and Asia-Pacific delivered constant currency revenue growth of 25% and 15%, respectively, compared to the second quarter of last year. We continue to anticipate strong revenue growth for both regions for the full year, and over the coming years as we continue to leverage our industry-leading product portfolio in these regions. We are also excited about the progress of our partner, Endospan, as continuing to make on the U.S. IDE TRIOMPHE trial for the NEXUS aortic arch stent graft system. As of today, there have been 50 of the 60 primary endpoint patients enrolled in the chronic dissection arm. Given this current enrollment, patients are scheduled for procedures. We expect to complete this trial by the end of 2024. Assuming the trial endpoints are met, NEXUS remains on track for approval in the second half of 2026. As a reminder, aortic arch disease patients with aneurysms and dissections who receive treatment have previously had little choice, before NEXUS, but to undergo open chest surgery, which is an invasive and risky operation associated with lengthy hospitalizations and prolonged recuperation. NEXUS is a highly differentiated technology that transforms a complex surgical aortic arch repair into a minimally invasive endovascular procedure. In 2019, we secured exclusive right -- distribution rights for NEXUS in Europe and began leveraging our existing European direct sales organization to expand access to the technology and drive revenue growth. Based on our experience in Europe, we continue to see a significant global opportunity for NEXUS, which has been estimated on an annual global basis to be around $600 million. Also in 2019, we provided a credit facility to Endospan to support the NEXUS U.S. IDE trial in commercial operations. We also had entered into an option agreement to acquire Endospan until 90 days following the receipt of an FDA approval for NEXUS. Recently in July, we amended these two agreements, which has resulted in three major changes that Lance will cover shortly. We view our revised agreements with Endospan as an investment in the next frontier of aortic arch surgery. We also view it as a potential opportunity to meaningfully expand our total addressable market on significantly more favorable terms than we had before. We also continue to anticipate PMA approval for AMDS in 2025, which, as we have discussed, would open up an addressable market here in the U.S. for about $150 million with no competitive alternatives. In summary, we are very excited about our Q2 performance and look forward to sustaining our momentum throughout 2024 and beyond by driving continued growth in On-X, stent graft and our SynerGraft pulmonary valve business by further expanding our global footprint in Asia-Pacific and Latin America. With that, I’ll now turn the call over to Lance.

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 $98 million for the second quarter of 2024, up 10% compared to Q2 of 2023. Adjusted EBITDA increased approximately 35% from $13.8 million to $18.6 million in the second quarter of 2024. Adjusted EBITDA margin was 19% in the second quarter, a 350-basis-point improvement over the prior year, driven by a 320-basis-point reduction in general administrative and marketing expense as a percentage of sales. We continue to believe our sales and G&A infrastructure is very scalable, and the significant leverage we have produced in the first half of the year supports our belief. From a product line perspective, On-X revenues increased 15%, stent graft revenues grew 13%, BioGlue revenues grew 12%, and tissue processing revenues grew 7% in the second quarter of 2024. I would like to proactively note that other revenue declined approximately $1.3 million and 42% in the second quarter of 2024. We did not break this segment out by product, as it is relatively nominal to the business overall. However, I do want to provide some additional color on these results. The decline in Q2 was driven by the timing of PerClot orders from Baxter as they worked to manage down inventory levels. The order decline also had a modest negative impact to adjusted EBITDA in Q2. Though the underlying end-user sales of PerClot are continuing to ramp up, we expect these inventory dynamics to continue through the balance of 2024. Excluding this impact, our underlying business grew 11% in the second quarter of 2024 compared to Q2 of 2023. On a regional basis, revenues in Latin America increased 25%, Asia-Pacific increased 15%, EMEA increased 13%, and North America increased 5%, all compared to the second quarter of 2023. As anticipated, gross margins were 64.6 in Q2, a slight decrease from 65.1% compared to the second quarter of 2023. The decrease was due to normal fluctuations in geographic and product mix. Q2 margins were in line with the gross margins we saw in Q1 and in line with our full year expectations. General administrative and marketing expenses in the second quarter were $49.3 million, compared to $57.2 million in the second quarter of 2023. Non-GAAP general administrative and marketing expenses were $47.3 million in the second quarter, compared to $45.9 million in the second quarter of 2023, representing 320 basis points of leverage. R&D expenses for the second quarter were $7.5 million, compared to $7.4 million in the second quarter of 2023. 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 $8 million, as compared to $6.1 million in the prior year. Other income expense included foreign currency translation gains of approximately $900,000 this quarter. Free cash flow was $3.6 million in the second quarter of 2024. Importantly, we continue to expect free cash flow to be positive for the full year 2024. As of June 30, we had approximately $55 million in cash and $313.6 million in debt, net of $6.8 million of unamortized loan origination costs. It is important to note that this does not contemplate the impact of our recently closed amendment agreement to the Endospan, which I will speak to shortly. 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 Q2 was 4.1, down from 4.7 in prior year. At the midpoint of our EBITDA guidance range, we expect net debt leverage to be closer to 3.5 by the end of the year and to continue to decrease in 2025. In regard to the recently amended credit facility and option purchase agreements with Endospan, we are pleased with the combined results of these three major changes. First, Artivion will now provide additional loans to Endospan of up to $25 million in three tranches, which we expect to fund with free cash flow. Second, the upfront payment associated with the purchase option is reduced by $75 million and is now $135 million after offsetting the loans. And third, the $100 million minimum payout for the earn-out is eliminated. To reiterate Pat’s comments, we view the amended agreement as an investment in the future of aortic repair, while simultaneously providing Artivion with greater financial flexibility should we exercise our option to acquire Endospan. And now for our outlook for the remainder of 2024. Given our momentum in the first half of the year, we are raising fiscal year 2024 revenue guidance and now expect constant currency revenue growth of between 10% and 12% compared to the previous range of 9% to 12%. We expect reported revenues to be in the range of $388 million to $396 million, compared to our previous range of $386 million to $396 million. At current rates, we expect FX to have a negligible impact on full year revenue growth rates. With our continued topline revenue growth and general expense management through Q2, we are raising our fiscal year 2024 adjusted EBITDA guidance and now expect to be in the range of $69 million to $72 million for the full year 2024, representing a 28% to 34% growth over 2023 and 280 basis points of adjusted EBITDA margin expansion at the midpoint of our ranges. This compares to the previous guidance range of $68 million to $72 million, representing 26% to 34% growth over 2023. 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. With that, I will turn the call back to Pat for his closing comment.

Thanks, Lance. As you’ve heard, we’re very pleased with our second quarter results, which reflect the continued strength of our highly differentiated and highly defendable product portfolio. We are more excited than ever for our near-term and medium-term growth potential as we further expand our presence across markets with little existing competition and no anticipated new entrants by leveraging our existing global infrastructure and our ability to cross-sell into well-established account base. We are committed to delivering strong revenue growth and EBITDA growth through the balance of 2024 that expect to be driven by the following. First, strong growth in our stent graft business driven by our innovative portfolio. Second, market share increases for On-X. Third, continued expansion in Asia-Pacific and Latin America from our channel investment, as well as new regulatory approvals. Fourth, expense leverage driven by our global sales force and G&A infrastructure. And fifth, continued adjusted EBITDA margin expansion and positive free cash flow. Finally, I want to thank all the employees around the world for their continued dedication to our mission of being a leading partner to surgeons focused on aortic diseases. With that, Operator, please open the line for questions.

Thank you. [Operator Instructions] Our first question comes from Frank Takkinen with Lake Street Capital. Please proceed with your question.

Great. Thanks for taking the questions. Congrats on all the progress. I wanted to start with one on EBITDA. Obviously, the leverage profile continues to be impressive. Saw the updated guidance for the back half of the year. Help us understand in weighing investments into the business and EBITDA growth through the end of the year. I know in previous years, typically, you’ve had a little more EBITDA on the back half as a percentage of the full year versus the front half, and it’s about equal is what the guidance is implying for the back half. So is there may be some additional investment going on there or is that just in the interest of maybe a little bit of conservatism?

Yeah. There’s a little bit of spin timing between second and third quarter. Obviously, we had a really strong second quarter for EBITDA, and we do expect a very strong second half. I do think we’ll see Q3 growth probably be a little bit lighter than we saw in Q2 just due to timing. So it’s really not anything more than that. And as a reminder, we don’t have a ton of seasonality, but Q3 is typically our lowest revenue quarter, which does have a little bit of impact Q2 to Q3.

Got it. That’s helpful. And then maybe just for my second one, I’ll ask a follow-up on On-X. Maybe can you break out unit growth versus ASP and then talk about pricing in that line item? Obviously, you continue to take shares there. Still additional opportunity to raise price in the On-X portfolio?

Yeah. We don’t really break out the price volume. It’s not something we typically do. What I can tell you is, 15% growth of our mechanical valve segment is, we continue, I mean, in the last six years or seven years, we’ve grown this business on an average of around 15% over the last, I think, since we acquired the company. We still have a lot of opportunity internationally and we’re still taking share in the U.S., even from our high share position. We’re also increasing price. I mean, our recent post-approval data that came out shows an 85% reduction in major bleeding, which moves it a lot closer to a bioprosthetic valve. We’re also seeing, recent data that’s come out on mechanical versus bioprosthetic data that’s very compelling for people moving to the On-X valve in patients under 70. So we’re very bullish on what we have and we feel like we’ve got the best valve, and we’re going to keep taking share.

Got it. Thanks for taking the questions. Congrats again.

Thanks, Frank.

Our next question comes from Suraj Kalia with Oppenheimer. Please proceed with your question.

Hey, Pat, Lance, can you hear me all right?

Yeah. We can hear you fine, Suraj.

Congrats on all the progress. So, Pat, just keying off from the last comment you made to the previous question, can you I believe last quarter On-X was about 30% OUS share, 50% plus U.S.

Yeah.

Can you give us some color as to where we are exiting Q2?

Yeah. So, what I will tell you without getting into the granularity is we’re growing both markets double digits. As I just said, we’ve got -- your shared comments were pretty accurate, right? We’ve got about a 30% global and when you break that down, it’s, like, over 50% in the U.S. and 20%, 25% internationally. So we clearly have more opportunity internationally. But I think the big story on On-X is really all the dynamics that are going on. And, frankly, it’s our aortic valve portfolio in patients under 65. Our Ross, our pulmonary valve for the Ross, we have the only SynerGraft valve for that. It’s growing double digits consistently. On-X is growing consistently double digits with our new post-approval data. As you well know, you’re very well read on the data. It’s a dynamic market, but there’s kind of more and more negative data coming out on TAVR in patients under 65, on bioprosthetic in patients under 65. The difference in reoperation and mortality out to 15 years benefits mechanical valves and they’ve seen lots of reoperations in patients getting TAVR under 65. And I think that’s a real problem, right? I mean, there’s a difference in re-op and mortality at 15 years. These are 65-year-olds. That’s a big deal. So, again, I think we’ve got a great story with the On-X valve. We’re just going to keep telling our story.

Got it. I’m drawing the blank here, so please forgive me. On NEXUS, it reminds me, when you talk about chronic aortic dissection, right, and the need and the 600 million TAM, I get that. The enrollment of the trial, again, if memory serves me correctly, it’s like five, six patients per quarter. Is that by design? Is that due to patient selection? Just kind of help us understand, take a leap from here, from the trial enrollment, to if you’ll acquire NEXUS, Endospan, how NEXUS layout and whatnot. In commercial adoption, how should we think about the speed of adoption?

Yeah. So I would say there’s a lot in that. I think both of our messages, Lance and I commented on, we’re making an investment in the future of aortic technology. Patients today who have to have a chronic dissection repaired and we have technology for that. You’re looking at a seven-day to 10-day ICU stay. We have patients in Europe that are getting the NEXUS device that are standing out in front of the hospital the next day, right? So it’s a big deal. But like any new technology, there’s going to be an evolution, right? So what we’re talking about right now is a single branch into the innominate. That’s the U.S. IDE trial called TRIOMPHE. We’ve enrolled 50 out of 60. We should enroll that by the end of the year. I think that’ll have modest uptake when we launch it, but we’ll be looking to start a two-branch trial probably right after that. And we think that that technology can capture half the chronic dissections in the world. So it’s a big deal and we’re very interested in the space, which is why we recut the deal. The data’s been excellent, and the trial’s almost done. So, yeah, we’re very excited and look forward to having it report out.

Got it. Pat’s final question, I’ll hop back in queue. In terms of your sales reps, walk us through, how does the bell curve look for sales rep productivity? At this stage in Artivion’s evolution, are we at that point in terms of higher elasticity to sales rep commission structure? Just kind of put this thing together, how you’re seeing the direct force, the self-force, U.S. versus OUS. Gentlemen, thank you for taking my questions.

Yeah. Thanks, Suraj. So, to me, I think this is one of the real benefits that you’re seeing in how we can grow topline 10% and bottomline 35%. We’ve got an excellent sales force, if you talk about here in the U.S. as well as in Europe and some of the international markets. Most of our reps in the U.S. have 10 years with a company. They know their customers. They call on them for Ross procedures with SynerGraft. They call on them with On-X for aortic procedures. They call them with BioGlue. When we get AMDS approved, they will call on them for that and when we get our frozen elephant trunk approved, they’ll call on them for that. So, the cardiac surgery segment is a much different segment than many of the other kind of medtech spaces. You don’t have to scale your sales force kind of one-to-one with your revenue, and you see that in our leverage. So, we’re very excited about bringing our AMDS when it gets approved in late 2025, but we can just drop it in our existing reps’ bags and see a lot of that incremental profitability go right to the bottomline, which has been part of our story all along.

Our next question comes from Rick Wise with Stifel. Please proceed with your question.

Hi, Pat. Hi, Lance. This is John on for Rick today. Another strong quarter in this 2Q. Just wanted to sort of look ahead, think about the bigger picture. You’ve provided guidance or a rough structure at your 2022 Analyst Day on 2025-plus, but just thinking about the new approvals potentially coming through, the new potential products you’re adding to the portfolio and the areas where you’re innovating, just wanted to get your sense on the longer term, bigger picture looking ahead. Should we expect more of the same sort of double-digit growth 2025-plus?

Yeah. So, we’ve stayed away from kind of re-upping long-term guidance. We’re just now finishing, we gave some formal targets back in 2022 through 2024, so hadn’t quite finished those out yet, so we’re not sending out some new ones. But I think we feel good about saying, like, look, if you think about us looking further out with the portfolio we have now and then the things in our pipeline. We should be able to be a consistent double-digit grower for an extended period of time and then really we ought to be able to drive a lot of leverage off that. So, we ought to be able to grow the bottomline, really at least 2x the topline. I mean, if you look this year, our guidance is 3x the topline at the midpoint and we’re not committing to that forever going forward, but there’s a lot of leverage opportunity in the business. And our core business is very defendable. You’ve got PMA-based products in markets with not a lot of competition that are really unlikely to see new entrants and then we have this amazing pipeline. So, at a high level, we feel comfortable about double-digit growth and growing the bottomline at least 2x that.

Got it. No. I appreciate the color. And just as I look at the rest of the year, I realized last year, maybe in the second quarter, you guys put through a price increase. Just wanted to think about that in 2024, 2025. Is there another opportunity for Artivion to potentially take price or are you all done for a bit?

Yeah. And I’ve talked about this on previous calls. I mean, we look at the portfolio. We look at how differentiated our product line is, and in some cases, we have significant clinical outcomes where we’ve spent millions of dollars generating the data that nobody else has. And SynerGraft pulmonary valve is the perfect poster for that. We spent a million dollars developing the technology, patenting it, and getting the clinical data that now has 25-year results, which is the best valve operation for, I would say, a patient under 55 years old. For something like that, we’re going to charge a premium price for it because it warrants. I talked about On-X. We just invested millions of dollars in the post-approval trial and we came out with data that nobody else can match, and I think that that clinical data warrants a higher price. So we’re not going to go through kind of every line item on the portfolio, but you can get a sense of the things that are highly differentiated, backed by patents, backed by compelling clinical data. We will charge what we think is a fair price for those.

Yeah. Appreciate the color. Thanks for taking the questions.

[Operator Instructions] Our next question comes from Jeffrey Cohen with Ladenburg Thalmann. Please proceed with your question.

Oh! Hey, Pat and Lance. How are you?

Hey, Jeff.

Thanks for taking our questions in advance. Just a few from our end. I heard Lance call out on Baxter and the other revenue line. Are there any puts and takes there on PerClot or do you have any clarity or see-through into how things are going on their side?

Yeah. I mean, I guess, first of all, at a high level, I mean, it’s not really very meaningful to us, so, I mean, it’s tiny to Baxter. Just to put it in context, the only reason we brought it up is it just sticks out because the decline was so significant. And I mean, our visibility is not great to underlying sales, but our understanding is they’re continuing to ramp up. And this is just some basic managing the balance sheet on their side and just being good about inventory management is creating some fluctuation and with a very small line item, so it just jumps off the page. So, in general, we’re not going to talk about Baxter’s business. That’s their business. But again, I would just say, it’s not meaningful to us, so it’s really not meaningful to them.

Got it. Okay. And then, secondly, can you talk about BioGlue a little bit? It looked extremely strong for the second quarter coming into 1855 [ph]. So, any commentary there? Any outlook as far as the back half of the year or general commentary on its strength or specific geographies?

Yeah. I think that, we mentioned it -- Lance mentioned it in his comments, right? I mean, BioGlue grew like 1% in the first quarter and it grew 12% in the second quarter. Don’t plug 12% on your model because it’s a very kind of lumpy business. We have a lot of indirect. We sell in 110 countries around the world. So, you can, the phasing of every 90 days you get some bigger in some quarters, less in other quarters. But, on average, we think that that product line is going to grow kind of in the mid-single digits. So, obviously had a very good quarter this quarter and it’s obviously extremely profitable.

Got it. And then, lastly for us, could you talk a little bit about the aortic stent graft portfolio for the quarter? Areas of weakness or strength or any specific SKUs or items which are doing well or not as well?

Yeah. We don’t break. I mean, we made a move like a couple of years ago to kind of put these large buckets in place. I can tell you the area that we focus on, which is the highly differentiated, faster growing, higher margin stent graft segment, we’re growing double digits in every category. I’m not going to break out line items and give competitors roadmaps. So, we’re doing extremely well. Frankly, even in the non-differentiated, the more competitive stuff, we’re growing double digits. So, the whole portfolio is doing really well.

Perfect. That goes across. Thanks for taking our questions. Nice quarter.

Thanks, Jeff.

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

Yeah. Thanks for joining. Again, we’re excited about the quarter. Thanks for joining the call. We’ve obviously got a lot of great opportunity in front of us. As you heard both Lance and I talk, we’re executing well. We’re growing 10% topline and 35% on the bottomline. Again, this year, we did it last year. We just talked about our kind of, we’re not giving guidance, but we think we can grow double digits topline and twice that on the bottomline. We’ve got an exciting pipeline, a great channel, a great portfolio, highly differentiated and we’re very excited about building this aorta company and treating and taking care of more patients so our surgeons have what they need from a technology standpoint. So, thanks for joining.