Artivion, Inc. Q1 FY2024 Earnings Call

Thanks, operator. Good afternoon, and thank you for joining the call today. Joining me today from Artivion's management team are Pat Mackin, CEO; and Lance Berry, CFO. Before we begin, I'd like to make the following statements to comply with the safe harbor requirements of the Private Securities Litigation Reform Act of 1995. Comments made on this call that look forward in time involve risks and uncertainties and are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. The forward-looking statements include statements made as to the company's or management's intentions, hopes, beliefs, expectations or predictions of the future. These forward-looking statements are subject to a number of risks, uncertainties, estimates and assumptions that may cause actual results to differ materially from these forward-looking statements. Additional information concerning certain risks and uncertainties that may impact these forward-looking statements is contained from time to time in the company's SEC filings and in the press release that was issued earlier today. You can also find a brief presentation with the details highlighted on today's call on the Investor Relations section of the Artivion website. Now I'll turn it over to our Artivion CEO, Pat Mackin.

Thanks, Lynn, 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 5-year results from our On-X aortic heart valve low INR post-approval study show 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. Meanwhile, the late-breaking 30-day data from PERSEVERE demonstrates positive aortic remodeling in over 80% of patients after treatment with AMDS. These 2 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 2 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. 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 initiatives 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. 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 in an INR of 1.5 to 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. 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 percentage 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 are 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. The abstract reported long-term clinical outcomes of 229 study participants with a target INR of 1.8 out to 5 years. 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 1-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. The fact that 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 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 valve market share globally. We believe the longevity of the On-X aortic valve combined with the significantly lower risk of bleeding compared to other mechanical heart valves make the On-X aortic 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. These positive results follow a 30-day IDE data from the same trial that was presented at STS in January of 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 hemiarch procedure. We're excited to see the continued positive results of the PERSEVERE study, further reinforcing the 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. 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 momentum throughout 2024 and beyond by driving continued growth of our On-X portfolio, stent graft, and SynerGraft pulmonary valve while further expanding our footprint in APAC and Latin America.

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 to $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. 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 in 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. The decrease in the 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 and 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. 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 the prior year. Interest expense net of interest income was $7.5 million as compared to $6 million in the prior year. Other income and expenses totaled $7.5 million and net interest expense, $3.7 million for a 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. Non-GAAP net income was $2.6 million or $0.06 per share for the first quarter. As expected, free cash flow was negative $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 31, 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. 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 the prior year. 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. And 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 '24 revenue guidance and now expect constant currency revenue growth between 9% and 12% compared to the previous range of 8% to 12%. We expect reported revenues to be in the range of $386 million to $396 million compared to our previous range of $382 million to $396 million. At current rates, we expect foreign exchange 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 to $72 million for the full year of 2024 representing a 26% to 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. 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.

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 5-year data from our real-world post-market trial, reinforcing the safety and efficacy of our On-X aortic low-dose warfarin. Third, growth from our proprietary SynerGraft pulmonary valve, driven by growth of the Ross procedure and our operational improvements. Fourth, 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. 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.

Our first question is from Mike Matson with Needham & Company.

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 '25 yet, but I mean, is this 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?

There's a couple of things to mention. First, I've previously discussed the growth of the Ross procedure. New data has been released showing that after 25 years, patients can have an aortic valve replacement using their own native pulmonary valve, with a replacement for the missing pulmonary valve using our valve. The survival rates and morbidity levels are comparable to the general population. This procedure is seeing rapid growth. Recently, data was presented at AATS in Toronto indicating this growth trend. Second, we had a significant price increase last year that will reflect in our results at the end of the first quarter. We've also made operational improvements that have resulted in an increase in our yields. Combining these three factors, we experienced a strong first quarter with pricing stabilizing this year, and we expect to benefit from supply for the remainder of the year. Looking ahead, the growth of this procedure shows no signs of slowing down. There is considerable opportunity, although we have constraints on the number of tissue valves we can acquire. While we are not providing guidance for 2025 at this moment, we are confident in achieving double-digit growth this year.

Okay. I understand. If I take the EBITDA from this quarter and multiply it by 4, it falls within the guidance range. It seems that over the past few years, EBITDA tends to increase throughout the year alongside revenue. So I'm curious why you're sticking to the guidance. Is there possibly an issue with R&D spending and timing, Lance?

Yes, I believe there are a couple of factors to consider. First, it's still early in the year. Second, we had a good start, but that was partly due to the timing of our R&D expenditures, and we fully plan to utilize that budget this year. So, those are the two main points: it’s a bit premature to raise the numbers, which showed strong growth, and we will monitor how things develop throughout the remainder of the year.

Our next question is from Suraj Kalia with Oppenheimer & Company.

Pat, Lance, can you hear me? Pat, congratulations again. You are doing really well. Pat, the obvious question is, you've been discussing this for a while. It seems that in the last two quarters, you have shifted gears in terms of compound annual growth rate, and the leverageability this quarter surprised everyone. Can you talk to us about whether there is something more fundamental we should be aware of, such as a more experienced sales force, changes in commissions, or different marketing strategies? There appears to be a notable shift in everything. If you could provide some additional insight on that, it would be appreciated.

Yes, sure. One of the great aspects of the company is our diverse range of products, along with our presence in various regions. As noted, we experienced strong double-digit growth across our entire portfolio, with the exception of BioGlue, which we anticipate will grow at a low single-digit rate. We also saw growth across all regions except for APAC due to timing issues. We have highly differentiated products supported by robust distribution channels globally, and they are performing well. I want to emphasize that no other company offers SynerGraft. The Ross procedure is experiencing rapid growth, and we hold the leading market share, capitalizing on this trend. The On-X valve is the top mechanical valve worldwide, and we’ve recently reported data indicating an almost 87% reduction in major bleeding, which reinforces our belief that this is the only mechanical valve that should be utilized. We will keep pushing until we dominate the market. Additionally, our stent graft portfolio has seen full supply without problems for about 1.5 years, featuring highly differentiated products. The NEO device and our thoracic abdominal devices are growing quickly, and we possess unique technologies that others do not. All these elements combined under the aortic umbrella, supported by our global channels, are producing solid results. It's really as straightforward as that.

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?

Yes, we have excellent channels and it's important to recognize that this market is quite dynamic. Since our last call, we have released the five-year post-approval data for On-X as well as additional data on AMDS. The AMDS data was released at the end of January during the quarter. Our sales force and products are strong, and they are supported by robust clinical data. The information we've shared about our products has only strengthened our position, and the Ross data presented at AATS was a major highlight and is also growing rapidly. Ultimately, it is the combination of our proprietary products, strong channels, and the continuous flow of compelling clinical data across all our offerings that is driving our success.

Got it. Pat, one for you, one for Lance, and I'll hop back in queue. In terms of additional opportunities, especially as I think about Nexus. 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 you all thinking about '23 and beyond what happens to the conversion? Gentlemen, congrats again Thanks.

Yes, regarding NEXUS, recent data from the TRIOMPHE trial was released at STS. The initial results from the first 20 patients in the pivotal arm indicate strong outcomes. They have now enrolled 44 out of the 60 patients needed, and we expect full enrollment in the latter half of this year. The data looks very promising. Given your experience, especially yours Suraj, you understand how clinical trials develop. This technology represents a significant advancement for treating chronic dissections or aneurysms in the arch with a catheter, which is a unique opportunity. That’s why we chose to invest in the company and maintain an option to acquire. We will keep monitoring the trial's progress and the results as they come in, and they appear encouraging. Lance, would you like to take the next two questions?

We see significant potential for SG&A leverage moving forward. Last year, we achieved strong leverage, and we started Q1 well. While we are not committing to a specific number of 500 basis points each quarter, it's clear that with robust revenue growth, the leverage in our model becomes apparent. Regarding the convert, the effective price is 2,350, but conversion can only happen if the stock reaches around $30. It's important to clarify that point. Additionally, as we mentioned in the Q4 call, there is a notable difference in the interest we are paying on these convertibles compared to the delayed draw term loan. Currently, we are content with the lower interest rates we are paying. While we may have hoped interest rates would have begun to decline by now, that has not occurred, so we are monitoring the situation and considering our options for the future.

Our next question is from Rick Wise with Stifel.

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 as you highlighted, really strong. I just want to hear it maybe from 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?

We have a approximately 30% share in the global mechanical market, which is even higher in the U.S. at over 50%. This indicates significant potential for growth outside the U.S. We've heard from surgeons discussing this data and questioning why anyone would choose another valve. Our team is enthusiastic about aggressively pursuing the mechanical valve market. Regarding the bioprosthetic segment, there are indications that this data could be relevant for patients under 65, but I don't want to speculate too much right now as this information has just been released. For the time being, our focus is on actively targeting the mechanical segment where there is still considerable opportunity for expansion.

That's helpful. And if I could sneak in sort of a 2-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?

The stent business experienced a GAAP growth of 23%, with constant currency growth around 19%, which is quite strong. This growth is driven by robust global channels and a unique product portfolio. For instance, our AMDS had the U.S. IDE trial PERSEVERE presented early in the quarter, showcasing impressive data with a 72% reduction in mortality and a 52% reduction in major adverse events, with no device-related adverse events. The AMDS is proprietary and offers unique benefits. Additionally, we have two significant technologies in the branch stent graft segment, specifically the frozen elephant trunk and the branched thoracic abdominal devices, which are also experiencing rapid growth. Our overall strategy focuses on being an aorta company, capable of addressing needs from the aortic valve to the iliac with various proprietary technologies backed by a strong sales team. This is what is fueling our success in the stent graft market.

Yes. Overall, we expect gross margin to remain relatively flat year-over-year. There is significant variation in our gross margin due to the four different product lines operating in four different regions, each with its own margins. Specifically regarding the SynerGraft pulmonary valve segment of our preservation services, this area has historically had the lowest gross margin. However, our pulmonary valves perform above the company's average. As this segment grows at a faster rate, it serves as a positive factor rather than a negative one for gross margin. I want to clarify that these comments should not be interpreted to imply that the overall mix will improve, as there are many components involved. Yet, the growth in this specific segment is not detrimental to our gross margin.

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

Pat and Lance, congrats on the quarter. I 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?

Yes, that's a great question, Frank. The situation is evolving; it used to be that we categorized valves into mechanical and tissue as two distinct groups. However, the data shows that there’s now a new category emerging between mechanical and tissue valves, which is On-X. Our main goal is to position this as the best mechanical valve available, and I believe it should be the sole mechanical valve used. This gives us some pricing power that we intend to leverage. While I won't provide specific details on this call, I believe there is a significant opportunity.

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

Cash, it can kind of 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.

Our final question is from Jeffrey Cohen with Ladenburg Thalmann.

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

Yes. We won't provide specific details on the various products under the aortic stent category. However, I can say that Neo is experiencing rapid growth, driven by geographical expansion. We are selling Neo in Asia and Latin America, as well as in many European markets. While it is not approved in the U.S. or Japan, it is performing very well. As I mentioned earlier, this product features proprietary technology with a unique stent system that we believe results in better outcomes compared to other devices. We are actively pursuing this business, and the product is both successful and continues to thrive.

Got it. Okay. And then secondly, first, Lance, can you talk a little bit about the SG&A and maybe cadence for '24. It seemed like it was light in the first quarter and how we should think about the leverage on the overall spend from Q2 to Q4.

Yes. Honestly, on an adjusted basis, it appears similar to the reported basis, but that is due to fluctuations in contingent considerations. On an adjusted basis, we recorded $48 million, which aligns fairly well with Q4. We believe that amounts in this range will be our focus as we progress through the year on an adjusted basis, which we expect will drive strong year-over-year leverage.

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

Yes, we won't provide a detailed breakdown of the components within the tissue business. We've mentioned in previous quarters the price increases in cardiac and the increases in volume. Cardiac is certainly a key driver, but the entire segment is experiencing growth. However, we won’t disclose specific numbers.

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

No. Thanks for joining for our Q1 call again. We're very pleased with the first quarter and 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.

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