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spk01: Greetings and welcome to the Arcadian First Quarter 2022 Financial Conference Call. At this time, all participants are in a 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 Brian Johnson from the Gilmartin Group. Thank you. You may begin.
spk02: Thanks, operator. Good afternoon and thank you for joining the call today. Joining me today from Artivian's management team are Pat Mackin, CEO, and Ashley, 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 that 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. Now, I'll turn it over to Artivian CEO, Pat Mackin. Hey, thanks, Brian.
spk05: I'm pleased to report after an exceptional performance in the fourth quarter of last year, we followed up with a very strong first quarter this year. Constant currency revenue growth was 11.2% compared to Q1 of 2021, despite substantial COVID headwinds in the first half of the quarter. This is our second consecutive quarter of double-digit constant currency revenue growth. Our growth in Q1 was driven by our aortic stent grafts, onyx mechanical valves, and tissue processing. More specifically, on a constant currency basis comparing Q1 of 22 to Q1 of 21, stent graphs grew 34%, and onyx and tissue processing both grew 11%. As many of you know, we held an analyst and investor day on March 23rd in New York City. If you're not able to attend, I would encourage you to listen to the webcast replay. We provided a detailed overview of our goals and our strategy for the next three years, We also had KOL share their experience using our products and had members of our leadership team provide you with a review of our products and pipeline. It was an excellent event and a great way to understand why we were so excited about the future of the company. We announced three key growth initiatives that we will focus on over the next three years to drive double-digit constant currency revenue growth. They are as follows. First, we will continue to drive growth in onyx and aortic stent grafts. Second, we will generate further upside from our investments in our channels and our new regulatory approvals in Asia Pacific and Latin America. And third, in 2022, we will drive further growth through our PMA approvals in the U.S. for per-clot and the ONIX Proact Mitral low INR indication. This quarter, we made solid progress in each of these initiatives, so let me take a few minutes to review them. Starting with our stent graph offerings. Revenue in the first quarter increased 34% on a constant currency basis compared to the first quarter of last year, building on our performance in Q4 where we posted 33% year-over-year growth in stent grafts. We had particular strength in our Aveda OpenNeo frozen elephant trunk product as well as AMDS. For ONIX, we posted 11% constant currency revenue growth in the first quarter of 22 compared to the first quarter of last year. And the fourth quarter of 2021 where we posted 13% year-over-year growth compared to the fourth quarter of 2020. We anticipate demand for these products will continue to build as adoption improves and hospital staffing shortage abates. We believe that we are at only the beginning to see the full potential of our portfolio in an environment not significantly hampered by the effects of the pandemic. Moving on to our next initiative, international expansion in Asia Pacific and Latin America, through new regulatory approvals and commercial footprint expansion. I'm pleased to report that we are executing very well on the strategy as demonstrated by first quarter constant currency revenue growth of 39 percent in Asia Pacific and 93 percent in Latin America. We continue to expect these regions to be important contributors to our growth over the coming years as we continue to execute on this strategy. Regarding our third initiative, we continue to make progress on achieving regulatory approvals for onyx mitral and perclaw. First is our application in the U.S. for a lower INR label for the onyx mitral valve, which we believe will be a significant clinical benefit for patients. We are in active dialogue with the FDA, continue to expect to receive PMA approval for the lower INR label for the onyx mitral valve, just like our lower INR label for the onyx aortic valve sometime in 2022. If approved, we believe we will take significant market share in the U.S. with the onyx mitral valve just as we've done and continue to do so with the onyx aortic valve. For per-clot, we continue to work closely with the FDA and expect to receive approval during the second half of 2022. If approved, we will receive a $25 million milestone payment due to us under the divestiture agreement we have with Baxter, and we'll begin to supply per-clot to Baxter and generate revenue for approximately two years thereafter. In addition to our progress on each of these three initiatives, we also continue to make strides on our midterm pipeline, with key products currently in U.S. clinical trials and others about to start later this year. These three products are PROACT-10A, Nexus, and AMDS. We continue to make significant enrollment progress in PROACT-10A, which is our prospective randomized clinical trial to determine if patients with the onyx aortic valves can be maintained safely and effectively on Eliquis versus Warfarin. We currently have enrolled 698 patients so far in the study, and feedback from surgeons and patients participating in the trial remain very positive. We anticipate completing the enrollment in this trial around the end of the third quarter of 2022, and assuming the trial meets its endpoints, we believe we can achieve FDA approval for this new indication by early 2025. If approved by the FDA, we believe the onyx aortic valve using Eliquis rather than warfarin should become the market-leading aortic valve in the market for patients under the age of 70, given the significant benefits to patients of using Eliquis rather than Warfarin. As for AMDS, we recently received FDA approval to begin our pivotal clinical trial called Persevere. The Persevere trial is a non-randomized clinical trial at up to 25 sites in the U.S., in which we expect to enroll around 100 patients. These patients will experience acute type A aortic dissections. The combined primary efficacy and safety endpoints of the trial are as follows. Reduction in all-cause mortality, new disabilitating stroke, myocardial infarction, and new onset renal failure requiring dialysis, as well as the expansion of the true lumen of the aorta. We anticipate enrolling the first patient this month and completing full enrollment by the end of the year. Following a one-year follow-up period, we anticipate we would receive FDA approval for AMDS in early 2025. In addition to the progress we've made on Project 10A and AMDS, we are also pleased to report that our partner, Endospan, is making progress on its USID trial for nexus known as Triumph. There are approximately 19 patients that have currently been treated, as well as up to 24 who have been approved for treatment. Endospan is currently estimating the completion of the trial in September of 2023. and likely leading to a PME approval in Q2 of 2025. If each of these three trials proceed as we anticipate and we get FDA approval for ProAct-10A, AMDS, and NEXUS in 2025, this would increase our adjustable market opportunity by an estimate of $1.3 billion. With that, I'll now turn the call over to Ashley.
spk04: Thanks, Pat, and good afternoon, everyone. Total revenues were $77.2 million for the first quarter, up 8.6% on a gap basis, and up 11.2% on a constant currency basis, both compared to Q1 of 2021. Revenues benefited from strength in aortic stent grafts, onyx, and cardiac tissues. On a year-over-year basis, in the first quarter of 2022, aortic stent graft revenues increased 26%, reflecting increased procedure volumes and revenues from our new product launches. Onyx revenues increased 10%, and tissue processing revenues increased 11%, reflecting improving procedure volumes relative to the first quarter of 2021. BioBlue revenues decreased 12%, reflecting lower procedure volume in the U.S. in the first half of the quarter due primarily to hospital staffing shortages. On a constant currency basis compared to the first quarter of 2021, aortic stent graft revenues increased 34%, Onyx and tissue processing revenues both increased 11%, and body glue revenues decreased 11%. On a regional basis, first quarter 2022 revenues in EMEA increased 5%, Asia Pacific increased 38%, Latin America increased 88%, and North America increased 4%, all compared to the first quarter of 2021. On a constant currency basis, revenues in Europe increased 12%, Asia Pacific increased 39 percent, Latin America increased 93 percent, and North America increased 4 percent, all compared to the first quarter of 2021. Gross margins were 65.7 percent in Q1 compared to 67.3 percent for the first quarter of 2021. The decrease was driven primarily by product mix within our aortic stent graft, lime, and bio-glue being a smaller portion of our revenues. G&A expenses in the first quarter were $39 million compared to $38.6 million in the first quarter of 2021. Excluding non-recurring acquisition related and business development benefit of $1.6 million in 2022, which primarily consists of a non-cash $1.8 million benefit related to fair value adjustments for OSIRIS contingent consideration, and rebranding charges of $883,000, and then excluding non-recurring acquisition and business development charges of $1.5 million in 2021. G&A expenses were $39.7 million for the first quarter of 22 compared to $37.2 million in the first quarter of 21. On the bottom line, we reported GAAP net loss of $3.4 million, or 8 cents per fully diluted chair, in the first quarter. Non-GAAP net income was $1.1 million, or 3 cents per share, in the first quarter. As of March 31, 2022, we had approximately $51 million in cash, $317 million in debt, and a full $30 million available under our revolving credit facility. Adjusted EBITDA for the first quarter of 22 was $10 million, compared to $11.4 million for the first quarter of 21. Please refer to our press release for additional information about our non-GAAP results, including a reconciliation of those results to our GAAP results. And now for our 2022 outlook. We continue to expect constant currency revenue growth of between 9 and 11% for the full year of 22 compared to 21. In our last call, we stated that we faced a $6 million currency headwind in 22 versus 21. Since that time, the dollar has continued to strengthen, resulting in additional FX headwinds of approximately $2 million. Considering this, we anticipate full-year revenues will now be in a range of $317 to $323 million for the full year. Though we want to be clear that we will not be issuing quarterly guidance going forward, we felt it would be best to provide a little bit more information on what we see for the second quarter. Given our assumption of a Euro-USD FX rate of 1.08 for the second quarter, our prior year Q2 2021 adjusted revenue is $73.6 million, which accounts for an anticipated $2.4 million currency headwind. As we have previously communicated, since our notified body for BioBlue exited the market in 2019, we received an extension for our CE mark until December 31, 2021. Due to COVID-related travel restrictions, our new notified body was unable to complete the recertification process by that time and will now not be able to recertify BioGlue until Q3 of this year. As we have previously indicated, we have been seeking derogations in certain EU countries pending recertification but that process, too, has been delayed by factors beyond our control. As a result, BioBlue revenues in the second quarter could be adversely affected by up to $3 million. If revenues are affected by $3 million, constant currency growth in the second quarter will be in the range of 4% to 6%. If not for this temporary delay in BioBlue recertification, 2Q constant currency revenue growth would be in a range of 8% to 10%. Despite the delays in Q2 and a similar $3 million potential headwind in Q3, we still expect full-year constant currency revenue growth in the range of between 9% and 11%. If we receive additional derogations, the impact to Q2 and Q3 could be significantly less. Our guidance assumes no other significant impact from COVID during the remainder of this year in a return to a more normal operating environment, meaning limited deferred surgeries and staff shortages and more in-person selling. We believe that we can comfortably continue to invest in our commercial channels in Asia Pacific and Latin America, our R&D pipeline, and service our debt without having to raise any additional capital. With that, I'll turn it back over to Pat for his closing comments.
spk05: Hey, thanks, Ashley. So to summarize, our goal is to become a world leader in aero repair through innovation. We firmly believe we have the necessary pieces in place to deliver on these growth initiatives of what we laid out on our investor day. We've made key acquisitions in the past few years and have provided us with products in a pipeline to deliver solid revenue growth for years to come. Our direct sales channel is broad and expanding. We've invested in manufacturing and have significantly increased our manufacturing capacity. In the next three years, we expect to grow double digits and become a $400 million business. We also anticipate 200 basis point increase in our gross margin. We expect to generate $75 to $80 million in adjusted EBITDA while reducing our net leverage to less than three times. Our first quarter, we had our first successful quarter that moves us much closer to delivering on these metrics. We saw 34% constant currency growth in our aortic stent graft portfolio and 11% growth in our onyx and tissue processing portfolios. Second, we posted 93% constant currency growth in Latin America and 39% growth in Asia Pacific. And we're continuing to invest in these regions. Third, in 2022, expect to receive PM approvals for per clot as well as onyx, proact, mitral, low INR. And we have a robust midterm pipeline of three U.S. clinical trials either enrolling or about to start enrolling. These trials, PROACT 10A, Nexus Triumph, and AMBIUS Persevere, should expand our total adjustable market by $1.3 billion in late 24, early 25. In closing, our business momentum is strong. We believe that we have the strategy, the products, and the team in place to continue that trend for the foreseeable future. Thank you for your time and continued interest in Artivion. Operator, please open the line for questions.
spk01: Thank you. We'll now be conducting a question and answer session. If you would like to ask a question, please press star 1 on your telephone keypad. A confirmation tone will indicate your line is in the question queue. You may press star 2 if you'd like to move your question from the queue. For participants using speaker equipment, it may be necessary to pick up your handset before pressing the star keys. One moment, please, while we pull for your questions. Our first question comes from the line of Rick Wise with Staple. Please proceed with your question.
spk03: Good afternoon, Pat, and great to see the solid progress in the quarter. Maybe to start off with, just to start somewhere, start off with the ONIX performance, another solid quarter from ONIX. As you know, we did some doc due diligence work and I, for one, came away impressed that the ducts really feel like this is an important product. They're going to use it more. They're focused on the lower INR. And the engineering, the valve engineering, is competitively differentiated. So just reflecting all that, what are next steps in getting the message out on Onyx? And maybe just as part of that discussion, how do the – How does the Proact mitral opportunity play into that or complement what you're already doing on the aortic side?
spk05: Yeah, thanks, Rick. And, you know, so I think the thing that's been interesting about Onyx is that this has been, you know, we acquired that company, you know, almost six years ago. And with the Proact aortic, which is the first ever low INR approval by the FDA in the mechanical valve segment, you know, we've taken like 30 points of market share against some big competitors. And our sales force at that time when we launched that product had been selling, you know, tissue valves, aortic and pulmonary tissue valves, and they had not had experience in the mechanical segment. And so they've got six years of experience not only selling the aortic low INR, but also building relationships with all the cardiac surgeons in the U.S. as well as in Europe and Asia. who implant heart valves, whether it's an aortic or a mitral. They're the same group. So I think that the proxy of using the ProAct aortic as a surrogate for what we're going to do with the ProAct mitral is a good one because we've got a highly trained sales force. The mitral valves are on the shelves of lots of hospitals. Once we get this label change, customers are used to a lower INR for a valve like the Onyx aortic. So the transition, I think, will be easier. I also think that it's, as we talked about in our investor day, the mitral position is a low-pressure valve situation which requires a higher INR, so any reduction from the standard of care is even more meaningful for the patient and their lifestyle. And then I think the third is, obviously, we're almost at 700 patients enrolled in PROACT 10A, and obviously we are not marketing that from a commercial standpoint, But we've got 60 centers involved in that trial, so I think the combination of the ONIX PROACT-A ORDIC continued adoption, the pending ONIX MITRAL approval, and we plan on completing enrollment in the PROACT-10A trial here in the next quarter or so. I think the three of those really kind of highlight the brand of ONIX and the technology around that brand. and that we do things differently with that brand. Because of the technology, we can run at low INRs, and we're also testing it in a massive clinical trial to see if we can prove that you can use Eliquis going forward with a real game-changing technology. So I think, you know, Onyx is just continuing to roll, and we had another great quarter, and, you know, look for more of the same. Look forward to the Mitral approval later this year.
spk03: Great. And can you... talk on the other side, darker side of the world, on the Bioglu delayed research. I'd be curious to hear what steps you can take to, if there are any, to help accelerate this and resolve it. I appreciate you being very clear and it's great to understand it, but I'd be curious to hear, I mean, is there anything that you can do as a company to push this forward and maybe help us understand what our next steps.
spk05: Yeah, thanks, Rick. So, I mean, this is very frustrating, and this has got nothing to do with the product's safety, performance. There's still great demand for the product. This is, frankly, a regulatory administrative issue that was triggered by our previous notified body for BioGlue decided once these new MDR regulations came out, that they thought it was too big of a burden and they didn't want to do it, so they just got out, which meant we had to find a new notified body well in advance of when MDR goes into full effect, which is in May of 2024, which left us having to go find a new notified body, and we've done that. And in the process of doing the recertification, which was supposed to happen, you know, they have to do a site visit. They were supposed to come to our facility here in Atlanta last fall, which would have put us in plenty of time to get the approval by the end of the year. They literally delayed it because of COVID travel restrictions. So now they're not coming until June. We've gone through this derogation process, which nobody's ever done before because nobody's ever needed to do it. And it's taken a lot longer. We've been successful in some places. We have some other big countries that are in the wings. I think one of the things that we wanted to be transparent about the situation, the numbers that I actually talked about are kind of the worst case for BioGlue. We have a couple of big countries in the works right now that could come through, but they're going through government agencies, so I have really very little control. We're also going for a European-wide derogation, which again has not happened frequently because no one's ever been in this situation before. There are other companies that are dealing with this. So this is a transient issue. It's got really nothing to do with the business. This product has got almost 3 million units implanted around the world. It's approved in Japan. It's approved in the U.S., We have no safety issues with the product. We're shipping and selling everywhere else. It's got nothing to do with manufacturing. It's, frankly, an administrative regulatory thing that people couldn't travel to inspect our site because of COVID. And, you know, we offered to fly them on a private jet, and they didn't want to do that. So, I mean, we're doing everything we can. And we've been working at this for a while, but, you know, it is what it is. And as soon as we get our inspection done in June and, you know, we're kind of at the mercy of how long it takes the notified body, so we expect probably in Q3 sometime we'll be back and, you know, be back in business. So, That's kind of the full picture on that situation.
spk03: I appreciate it. Thanks so much. Thanks, Rick.
spk01: Thank you. Thank you. Once again, as a reminder, if you would like to ask a question, please press star 1 on your telephone keypad. Our next question comes from the line of Suraj Kalia with Oppenheimer. Please proceed with your question.
spk00: Hey, Pat, Ashley, can you hear me all right?
spk04: Yeah, hey, Suraj.
spk00: Perfect. Hey, Pat, congrats on a great quarter. So, Pat, if memory serves me right, this is the first quarter where international sales were greater than domestic sales. Please correct me if I'm wrong. And I'm curious, you know, there are FX headwinds, right? You referenced that at your analyst day about a month or so ago, you know, at 1.13 for the euro. Obviously, Latin America doubled almost in the quarter. Just walk us through what are the drivers and more importantly, how sustainable do you see these?
spk05: Yeah, thanks, Raj. So I think it's a couple of things. One of the things that's interesting about this business, as we've talked before, I mean, we're very different than a lot of companies of our size in that many companies of our size have mostly U.S., you know, a couple of products mostly in the U.S. We have, you know, many different products, and we're in 100 countries. So we're very diversified for our products, and we're very diversified for our channels. What happened this quarter is As you well know, the first half of Q1, U.S. staffing in hospitals was a real issue. I know you're hearing this from all your calls, right? So we were seeing real issues with hospital staffing. It wasn't patients clogging up the ICUs with COVID. It was really the hospital staffs getting infected and not being able to work. So what happened was the U.S., we saw kind of a shortfall in BioGlue in vascular tissue in the first quarter really out of the U.S., and that was the difference between us even growing 15%. Simultaneously, we saw recoveries from COVID in Latin America and Asia Pacific, but we've been talking about this investment in Asia Pacific and Latin America for a while now, and it's a pretty simple kind of process. We get new approvals for all the products we have in our portfolio, and then we hire salespeople, and they go to work. And we've said at the analyst that we're expecting 25 to 30% growth in Asia Pacific and Latin America for the next three years. And we obviously had a big quarter in both right out of the box. And then our European business, as you know, has got all of our new Stencraft technology. So they're doing extremely well with NEO, with our branched local endominal inside, with AMDS. I guess it's just kind of multiple different pieces depending on the geographies, but clearly we expected to see faster growth outside the U.S. We didn't expect to see the U.S. being off like they were, but we also didn't know Omicron was going to be as, you know, Berlin from a staffing standpoint was not going to have such a big impact in the first half of the quarter.
spk00: Right. Okay. Fair enough. Hey, Pat, a multi-layered question. So on Onyx, right, How should we think about U.S. versus OUS contribution in the quarter? When is, for PROACT 10A, when is, remind us the DSMB was going to meet in May. Forgive me, there are many calls going on. Maybe you referenced this already as to when you'll expect the DSMB to meet this month. And also, Pat, if I could just throw in, you know, the Mitral, Onyx Mitral PMA approval status. Gentlemen, congrats, and thank you for taking my questions.
spk05: Okay, yeah, I'll go through these one at a time. I think similar to on the first one about ONIX USOUS, again, the US staffing issues caused ONIX to be lighter than normal. Still, we did okay with it, but we had way better growth outside the US because we didn't have the staffing issues. So that was not normal, but it's not a surprise given what happened in the first half of the quarter here in the US. Proact 10A, the DSMB, I mean, they meet every six months. I believe it's the end of May. You know, we don't put out press releases on this kind of stuff, but I think it's going to be the end of May, end of this month. And then Proact Mitral, we're expecting approval, you know, probably in the second half of this year. We're working with the FDA, you know, in real time on both of those PMAs, Proact Mitral as well as Perclot. So You know, we're excited about the opportunity to have the sister valve to the PROACT aortic, and our team's kind of raring to go, so we're just waiting for the approval, and again, I think it's probably going to be more of the second half for the PROACT mitral.
spk00: Thank you. Thanks, Raj.
spk01: Thank you. Mr. Mackin, there are no further questions at this time. I'd like to turn the floor back over to management for any closing remarks.
spk05: Well, thanks for joining, and we appreciate your time. As I said, at the investor day, we laid out kind of a clear plan for the next three years, and you can kind of measure our progress. And we told you we were going to grow our focus products, onyx and stents and stent crafts in the high teens to 20. We grew 34. We told you we were going to grow onyx 10% to mid-teens. We grew 11. We told you we were going to grow the overall business 9 to 11 this year. We grew 11. We told you that Asia Pacific and Latin America should grow 25 to 30. They grew 39 and 93, respectively, Asia Pacific and Latin America. We said we'd get two PMAs approved, and we're tracking towards both Perclot and Proact Mitral in the second half of this year. And our midterm pipeline of Proact 10A, the Nexus Triumph, and the AMDS Persevere, we expect to enroll Proact 10A, we expect to enroll Persevere, and we expect to have big improvement in the nexus enrollment. So we pretty much checked all the boxes even in the face of challenges like Omicron here in the U.S. So we appreciate your support and look forward to getting back with you next quarter. Thank you.
spk01: Thank you. This concludes today's teleconference. You may disconnect your lines at this time. Thank you for your participation and have a wonderful day.
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