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spk01: Good day, ladies and gentlemen, and welcome to the Artivion First Core 2023 Financial Conference Call. All lines have been placed on a listen-only mode, and the floor will be open for questions and comments following the presentation. If you should require assistance throughout the conference, please press star zero on your telephone keypad to reach a live operator. At this time, it is my pleasure to turn the floor over to your host, Brian Johnston, VP of Guildmark Group. Sir, go ahead.
spk02: Thank you. Good afternoon, and thank you for joining the call today. With me from our Tibian's management team are Pat Mackin, CEO, and Ashley Lee, CFO. Before we begin, I'd like to remind you that the following statements 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 invoke 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 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. With that, I'll turn it over to Artivian CEO, Pat Mackin.
spk07: Hey, thanks, Brian, and good afternoon, everyone. I'm pleased to report that the first quarter of 2023, our business performed well, enabling us to deliver constant currency revenue growth of 10% year over year. Our strong performance was led by our ONIX platform, which grew 24%, followed by BioGlu at 8%, StentGraphs at 8%, and Tissue Processing at 7%, all compared to the first quarter of 2022 on a constant currency basis. Our first quarter success demonstrates that our strategy is working. Under this strategy, we're driving increased revenue within existing markets, as well as in new geographies through expansion of our commercial footprint and by expanding our adjustable markets through our additional clinical pipeline. To that end, we recently received an approval letter from the FDA for the per-clot PMA and expect approval for our recent female inspection once our recent inspection is finalized. leave us even more confidence in our ability to deliver on our financial commitments for 2023. Given our first quarter performance, we likewise are even more confident in our ability to deliver strong bottom line growth in 2023 and beyond. As you'll recall from our investor day in March of 2022, we've committed to delivering annual double-digit constant currency revenue growth through 2024 and are focused on driving further operating leverage across our business to deliver adjusted EBITDA, of $75-plus million in 2024. Our focus is clearly paying off. As I mentioned earlier, ONIX revenues grew 24% on a constant currency basis in the first quarter compared to the first quarter of last year. We saw double-digit constant currency year-over-year revenue grow within ONIX across all geographies. We remain confident that we'll continue to take market share globally with the only mechanical heartfelt that can be maintained in an INR of 1.5 to 2.0, Additionally, Stencraft revenues grew 8% on a constant currency basis in the first quarter compared to the first quarter of 22. Demand for a Stencraft portfolio remains high, and we expect it to grow even higher. As you may recall, to meet this demand, we hired additional staff in Germany last year who are now contributing to our increased Stencraft production and whose productivity we expect to improve throughout the year. As a result, we anticipate in 2023 and beyond being able to better meet the strong demand of our stent grafts and accelerate the growth in revenues of these products. We're also executing extremely well on our initiative to grow product sales in APAC and Latin America through new regulatory approvals and commercial footprint expansion. In APAC and Latin America, we delivered first quarter constant currency revenue growth of 18% and 34% respectively compared to the prior year period. We continue to expect these regions to be important growth drivers over the coming years. As I mentioned earlier, we expect FDA approval for PERCLAW soon. Following this approval, we will receive a $14.3 million milestone payment, none of the amounts owed to our former partner, and we'll begin shipping revenue-generating product to Baxter. As for Project Mitril, we're in dialogue with the FDA and look forward to potential approval in the second half of this year. As we mentioned in our last call, approval for ProAct Michelin 2023 is not factored into current forecasts and would represent further upside from our rather than growth outlook for 2023. In addition to our progress in each of these three initiatives, we continue to make progress on the AMDS trial. We've now enrolled 51 patients in the Persevere trial, which is our USID clinical trial for PMA approval. in up to 30 U.S. centers and approximately 100 patients who have experienced an acute type A dissection. The combined primary efficacy and safety endpoints of the trial are reduction in all-cause mortality, new disability and stroke, myocardial infarction, and new onset of renal failure requiring dialysis, and the re-expansion of the true limit of the aorta. We anticipate completing full enrollment in Persevere in the second half of this year. Following a one-year follow-up period and assuming the trial meets its endpoints, we anticipate we should receive FDA approval for AMGS in 2025. In addition, our partner, Endospan, is making progress on the USID called TRIOV for its Nexus Aortic Stent Graph System. In that trial, there were approximately 44 patients enrolled and treated, and a total number of 53 patients enrolled and approved for treatment. Endospan estimates enrollment completion later this year and PMA approval in 2025. Again, assuming the endpoints are met. To reiterate, if these PMA trials proceed as anticipated, we expect FDA approval for AMDS and Nexus in 2025. At that time, assuming we exercise our option for Endospan, these products would increase our adjustable market opportunity by an estimated $900 million. Looking ahead, we intend to build on our strong growth in 2023, but continue to drive growth in the onyx aortic stent grafts We have a clear differentiation in pricing power. We also expect to benefit further from our investments in commercial channels and new regulatory approvals in Asia Pacific and Latin America. With that, I'll now turn the call over to Ashley.
spk09: Thanks, Pat, and good afternoon, everyone. Total revenues were $83.2 million for the first quarter of 2023, up 8% on a gap basis and up 10% on a constant currency basis, both compared to Q1 of 2022. On a year-over-year basis in the first quarter of 2023, Onyx revenues increased 23%, BioGlue increased 7%, tissue processing revenues increased 6%, and aortic stent grafts grew 3%. On a constant currency basis compared to the first quarter of 2022, Onyx grew 24%, BioGlue and stent graft revenues both grew 8%, and tissue processing revenues increased 7%. On a regional basis, first quarter 2023 revenues in Asia Pacific increased 17%, Latin America increased 36%, North America increased 10%, and Europe decreased 1%, all compared to the first quarter of 2022. On a constant currency basis, revenues in Asia Pacific increased 18%, Latin America increased 34%, North America increased 10%, and Europe increased 5%, all compared to the first quarter of 2022. Gross margins improved sequentially from the fourth quarter to 64.6% in Q1, compared to 65.7% for the first quarter of 2022. The decrease compared to Q1 of 2022 was driven by inflationary impacts on materials and labor, as well as geographic and product line mix. G&A expenses in the first quarter were $50.4 million compared to $39 million in the first quarter of 2022. Excluding non-recurring acquisition-related business development expenses and benefits and other non-recurring charges, G&A expenses were $45.2 million for the first quarter of 2023 compared to $39.7 million in the first quarter of 2022. R&D expenses for the first quarter were $7.2 million compared to $10.1 million in the first quarter of 2022. The decrease in R&D spending primarily results from savings from the cessation of the PRO Act 10A trial. Other income and expenses include $6 million in net interest expense and foreign currency translation gains of approximately $1 million. On the bottom line, we reported gap net loss of approximately $13.5 million or 33 cents per fully diluted share in the first quarter of 2023. Net loss for the first quarter of 2023 includes a pre-tax charge of $4.8 million related to contingent consideration for the acquisition of AMDS and the impact of valuation allowances on our deferred tax assets. Non-GAAP net income was $769,000 or two cents per share in the first quarter. Non-GAAP income includes foreign currency gains and excludes business development and other non-recurring charges. As of March 31, 2023, we had approximately $30.8 million in cash, $314 million in debt, and the full $30 million available to us under our revolving credit facility. Non-GAAP adjusted EBITDA for the first quarter of 2023 was $10.8 million compared to $10 million for the first quarter of 2022. Please refer to our press release for additional information about our non-GAAP results, including a reconciliation of these results to our GAAP results. And now for our outlook for the remainder of 2023. Given our momentum in Q1, our price increase initiatives, anticipated improvement in supply of stent grafts, and anticipated FDA approval for per clot, we are raising our revenue guidance and now expect constant currency revenue growth of between 9% and 12% for the full year of 2023 compared to the previous range of 8% to 12%. We expect revenues to be in a range of $337 to $348 million compared to our previous range of $331 to $343 million. We continue to expect revenue growth will accelerate more meaningfully in the second half of the year compared to the first as recent hires in Germany become fully productive. as we continue to pursue price increases for products where we have clear clinical differentiation and with the approval of per cloud. With our strong first quarter performance, continued top-line revenue growth, general expense management, and a decrease in R&D spending, we are also raising our adjusted EBITDA guidance from a minimum of $50 million to a minimum of $52 million for 2023. This will put us on track to meet our 2024 adjusted EBITDA commitments we made in March of last year at our Investor Day. 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. We expect we will be able to comfortably service our debt and continue to invest in growth. And finally, our term loan B contains no financial covenants that would place us in default unless we were to have more than $7.5 million drawn on our revolving credit facility at the end of any calendar quarter, which we do not. As of now, we have the full $30 million available under our credit facility and do not foresee the need to draw on it. As a reminder, our convertible notes do not contain any financial covenants. Overall, we are laser focused on continuing to deliver strong top and bottom line growth to afford even greater flexibility as we consider our future obligations and efforts to deliver meaningful shareholder value. I will turn the call back over to Pat for his closing comments.
spk07: Thanks, Ashley. So as you just heard, 2023 is off to an excellent start. We expect that momentum to continue. Our strategy is working in generating what we expect to be meaningful EBITDA growth this year. We also took guidance up this quarter and believe that we will deliver on our financial commitments for the following reasons. First, continue strong ONIX performance, together with potential for Proact Mitral later this year. Two, stronger performance in our StentCraft business due to recent staffing improvements at our German facility and other supply chain improvements. Three, continue strong performance in Asia Pacific and Latin America. Four, growth in BioGU and PERCLAW to do recent regulatory approvals. And then finally, These two U.S. clinical trials with AMD's Persevere and Endospin Nexus Triumph are currently enrolling and should enroll this year. Combined, we expect our total addressable market will increase by $900 million in 2025, assuming we exercise the Endospin option. Through the remainder of the year and through 2024, we continue to expect to grow double digits on a compounded annual growth basis and to generate greater than $75 million in adjusted EBITDA in 2024. which will end up reducing our net leverage to less than three times, despite the headwinds we face from inflation and its impact on gross margins. In conclusion, we continue to advance our goal of being the market leader in aortic repair, and we expect 2023 to be a standout year for the company. I want to thank all of our employees around the globe for delivering on our exceptional first quarter results and a continued dedication to our mission. With that, operator, please open up the lines.
spk01: Thank you. The floor is now open for questions. If you do have a question, please press star 1 on your telephone keypad at this time. If your question has been answered, you can remove yourself from the queue by pressing 1. Again, ladies and gentlemen, it's star 1. Please hold while we poll for questions. And our first question comes from Rick Wise from Stifel. Go ahead, Rick.
spk05: Good afternoon. Hi, Pat. Hi, Ashley. Hey, Rick. Nice to see the quarter and great to hear the per clot news. Just maybe my first question with a couple of parts to it on per clot. Talk to us, if you could just flesh out some of the comments in the press release. Once the inspection is finalized, help us understand what's involved in that and when it's likely to occur. And just, you know, and then sort of going on beyond that, When would you expect to start shipping? When does that 14.3 million, I think was the number, come in the door? How are you going to put it to use? Just maybe sort of two basic parts there. Thank you so much.
spk07: Yes. So the first one, Rick, is the way this process works is part of the PMA is that they come in for a pre-approval inspection. And that was completed about a month ago. And they have to write up their report and send it over to the, to the branch. So that's basically what we're waiting on. And again, that could happen, you know, kind of any day now. And as soon as that happens, you know, we, we should be, you know, get the green light and get the approval. So, you know, I, I, I'm hesitant to commit what, what regulators are going to do, but I think we're kind of at the end of line, we've received the approvable letter and we're just waiting for this kind of inspection paperwork to clear. And then once that's done, we should be able to ship product to Baxter, you know, within, you know, probably they've got to do some paperwork on their side, and they're already starting to work on that given the approvable letter. So we think in this quarter we'd be shipping product. And then, Ashley, maybe you can comment on when we get the cash.
spk09: Yeah. I mean, I think it's within a couple of weeks after we transfer all of the PMA documentation to Baxter. So again, assuming that we get the final approval from the FDA, which we expect, you know, we should get those funds later in the second quarter. And then, you know, in regards, you know, what we plan to do with it, you know, it'll certainly help to strengthen the balance sheet and, you know, we'll continue to, you know, move forward and, and drive revenue growth and drive cash flow. And in the event that we don't find, you know, good alternative uses, we'll, you know, consider paying down debt at some point in the future.
spk05: Yeah, that sounds good. Maybe just turning to sort of a larger picture, you've been clear we've heard a lot this quarter, Pat, I'm sure you've listened or heard about some of them from other MedTech companies, larger and smaller. that the environment's improving, that volumes are recovering, that the macro is getting less of a headwind, supply chain, blah, blah, blah, blah, blah. I'm just curious, from your perspective and from Artibian's vantage point, portfolio, et cetera, how are those factors affecting you? You know, how did it benefit this quarter? And how do we think about that kind of dynamic, macro dynamic, improving macro dynamic, giving you confidence about the rest of the year? Just if you could put all that in context for us.
spk07: Yeah, I mean, you know, clearly a lot of the, you know, we never really experienced and we've talked about this previously, we never really experienced a lot of staffing impact for us because of the nature of our procedures. You know, we grew every quarter in COVID except for one. So, you know, the staffing stuff is annoying. It may move a case a day or two. It causes inefficiencies. It causes a lot of stress on our commercial team. But we never really felt a lot of that. I mean, there was definitely some noise in Europe this past quarter with striking. And again, how much that really impacts things. You know, it didn't really impact us that much. So, you know, again, I don't think we really, because of the portfolio we have, I don't think we really were subject. At the end of the day, if there's a staffing issue, they somehow find a way to get the cardiac stuff done, partly because of the urgent need of the patients, as well as the, you know, in most cases, the profitability of the procedure. So, we've been pretty lucky not to get sucked up into the staffing, but it does seem like it's getting better.
spk05: Good, good. And, Ashley, it went by sort of quick, and I want to make sure I understood what you were saying and make sure I understand what you're referring to. You talked about price, your pricing moving higher. I'm hearing a lot of that in MedTech as well. If you could just kindly say it again, and how, what was the positive impact, I assume, of price in the first quarter? what are you factoring into your guidance and your expectations?
spk07: Let me, let me, let me take that. Let me take that. Let me take that one, Rick. So, you know, we're not going to get specific. We're not going to get specific because it can competition and things like that. So just suffice it to say that, you know, we have some technologies in our portfolio that are very proprietary that nobody else has. We also have a very high demand on those technologies. So we are we, in those cases, you know, raising prices significantly. And you haven't even seen them in our numbers yet. So those are going to be things that you're going to see in Q2, 3, and 4. So I'm just going to leave it at that and not going to get more specific.
spk05: Okay. I totally get it, but good to hear. Thank you so much. I appreciate it. Thank you. Thanks, Rick. Thanks, Rick.
spk01: Again, ladies and gentlemen, that's star one. Our next question comes from Siraj Khalia from Oppenheimer. Go ahead.
spk06: Hi, Pat and Ashley. This is Seamus on for Siraj. Hey, how are you? Congrats. I'm good. I'm good. Thank you. Congrats on the quarter, and thanks for taking our questions. So I guess to start off, kind of, you know, what are the kind of key sales and marketing changes in our rep commission territory assignments? that you'll do post Mitral approval?
spk07: Yeah, you know, we haven't even, I mean, the great thing about the Mitral, it's kind of unique in this situation. It's one of the few product launches I've been involved with. The product is already on the shelf. It's a label change, right? It's just a, you're changing, if we were to get approval, it's just changing the label for the INR. So from a launching standpoint, We've already got all of our, you know, commission plans and everything built out. You can see what Onyx grew 24% in the first quarter without Proact Mitral. So, you know, again, we don't really anticipate having to make any changes other than the launch plans and the marketing plans and those kind of things, surge in education and those things. Our commercial teams are well set. Their comp plans are well set. And the product, in many cases, is already on the shelf. All we have to do is, you know, get the label changed and then market from there. So, it's a different launch than what you normally think of as, you know, rolling out a new product off the assembly line versus it's literally on the shelf already.
spk06: Got it. Thank you. And kind of just one more, you know, PROACT XA, I believe you said, is supposed to be published, I believe, this weekend.
spk07: Yeah, the project today is going to be presented at AATS in Los Angeles on Saturday afternoon out there at the AATS meeting by Lars Henschen, who's the chief of cardiac and vascular at Cleveland Clinic. So that will be presented on Saturday afternoon.
spk06: Okay, and I guess on a follow-up on that, you know, publication details, and I know you previously talked about a journal for it. Any idea on timing on that, or we're still too far out?
spk07: I do not have an update on the timing of that. Obviously, the presentation is the trigger for that. So that's the first public data that's going to be out there on it. So from there, the publication will follow. But as soon as we have an update on that, we'll let people know.
spk06: All right. Appreciate it. That's all from our end. Thank you. Sure. Thanks, James.
spk01: And our next question comes from Jeffrey Cohen from Landberg Thalmann. Go ahead.
spk08: Oh, hey, Pat and Ashley. How are you? Good. So a few questions from Aaron. Nice top line for the quarter. Congratulations. Could you talk about the G&A line a little bit as far as some of those extra, those $5 million non-cash in the G&A line? And then maybe from a larger perspective, talk a little bit about the commercial organization. Does it seem like you're ahead of or catching up with the growth on the top line as far as your increased trajectory? Does it feel like you're prepped for the coming year or two or there's going to be more gains on that front as that relates to leverage?
spk07: Yeah, I think I'll take the second one and then I'll let Ashley take the G&A question. You know, as far as the channel goes, I mean, our channels, if you look around the world, our channels are pretty well set in the U.S. We're not adding at this point. Europe is pretty well set. We're not adding. We've gone direct in a couple of countries where we may have added a handful of people. The real expansion has been primarily in Asia. And we're basically titrating that investment with the growth. So, you know, for example, when we get a product approval or multiple product approvals, then we'll potentially add a rep there. But that's starting to kind of asthmatoid out now. And the number of people we're bringing on there is, you know, less this year than last year. So we are starting to actually get leverage out of both of those regions. So they're actually, you know, growing much faster than the investment we're making in those regions. So I think our channels are actually in pretty good shape. And we're going to start to see leverage as we push more product through those channels. That's what we've been talking about, you know, as we move into 24 and seeing that EBITDA jump. That's one of the triggers for that is actually pushing more product through our existing infrastructure. So maybe, and then Ashley, you can take the G&A question.
spk09: Yeah, so G&A reported was a little over $50 million, and as I stated, Jeff, there was approximately $5 million included in that for contingent consideration changes related to the OSIRIS acquisition. And that is a balance that changes constantly. every quarter, and there are multiple factors that go into determining what the adjustment is. There are discount rates. There are, you know, probabilities of success. There's time. And so it's, you know, kind of difficult to precisely predict what that's going to be on a quarterly basis. But this quarter, you know, it happened to be, you know, close to $5 million. If you look at the remainder of the G&A, about $45 million, it was higher than than the prior year. But there were some things that we did in the first quarter of this year that we have not been doing over the last couple of years. We had sales meetings. We went to some really large major medical conferences in person. So our G&A expenses were elevated in the first quarter compared to where they were in previous first quarters. And likely they're probably a little higher than what they're going to be for the remaining quarters of this year as well, because we're not going to be, again, having sales meetings, you know, throughout the year to that magnitude. And although we will be continuing to go to some medical conferences, probably not as heavy of a cadence as we had in the first quarter.
spk08: Okay, I got it. And then I know this previous question on pricing, but I'm more curious on the margin front. How does it feel out there as far as your costs, as far as labor, transportation, logistics, et cetera? And is Q1 a margin that you feel pretty comfortable with for the balance of the year?
spk09: You know, I think margins are going to be – you want to take this one, Pat? No, go ahead. So margins, you know, we anticipate being, you know, relatively flat-ish throughout the year. You know, a lot of it's going to depend on, you know, how successful we are in securing these price increases that Pat talked about a little bit earlier. You know, another thing that dynamic that comes into play is, you know, inflation was really high in the second half of 2020. of last year, and some of those layers of inventory are going to be, you know, flowing through 2023. So you've got that offsetting dynamic. But, you know, taking all of that as a whole, you know, we think margins are going to be relatively flattish, you know, this year, especially compared to the prior year.
spk08: Okay. And then just one quick one, if I may. Have you seen any or heard of any robotic placements going on of any equipment or robotic testing emplacements going on?
spk07: We don't really pay much attention to that, to be honest with you. It's not really in our field.
spk08: Okay. Got it. Thanks for taking our questions. Appreciate it. Thanks, Jeff.
spk01: Thank you again. To ask a question on the phone, it's Star 1. Our next question comes from Frank Tuckin from Lake Street Capital. Go ahead, Frank.
spk03: Hey, thanks for taking the questions, and congrats on all the progress. I wanted to start with one on Onyx. Looks like growth continues to be really solid there. Could you just take us a little deeper into what the primary growth drivers are there? Is it related to more competitive wins? Does the market just feel better out there, and you're getting a little rebound from a choppy market over the last few years, or is it something completely different?
spk07: I mean, Onyx has grown double digits for the last, you know, I think the CAGR over the last five years is 13%, 14%. So this is a big jump. A lot of this, I mean, we grew double digits in every single market. I think part of it is just the data that keeps coming out on this valve is extremely strong. Our reps are well-trained. And I think it's just, you know, it's become the valve of choice. I mean, it's the market-leading mechanical valve in the U.S. We're the only valve that has a low INR. So I just think it's really taken hold kind of around the world, and you just continue to see strong performance on it.
spk04: Okay, maybe one follow-up directly to that.
spk03: I think, obviously, the stock price reflected pure panic when the data came out on PROACT 10A, and I think maybe there was some assumptions around the demand profile of the device when that occurred at It occurs to me that that has not at all manifested in how the product is growing. Would you agree? And do you think this continue to be a 20% plus grower maybe now?
spk07: Yeah, well, we guided in our, you know, back in March last year, we guided 10% to 15% growth for Onyx over the planning period up through 2024. And, you know, we've grown. Last year we grew Onyx 13%. Like I said, the CAGR has been rated at between 10% and 15%. Obviously, it was higher in the first quarter. You know, there's a lot of international stuff there. So, I mean, we're not going to, like, immediately jump to, you know, change the guidance on Onyx. I think we're comfortable with, you know, it growing 10% to 15%. But to me, I mean, the Project 10A trial was a drug trial. We were changing the drug. The drug failed, right? So it had nothing to do with the valve. It was basically eloquence can't protect the valve, and that data will be presented on Saturday. But the onyx valve performs extremely well with cumin in their low INR, which we've shown in multiple studies, and I think that gives people confidence. But in the end, the valve didn't have the problem. The drug had the problem.
spk03: Right. Good call. One last one from me. APAC and Latin America continue to outpaced growth of the rest of the organization looks good. Can you just maybe run through what you're looking at for 2023 as the key catalysts or regulatory approvals or investments that need to be made in that geography to maintain that growth profile?
spk07: Yeah, so it's a pretty simple kind of algorithm. We get product approvals of our portfolio in new markets. So if I was in Australia in the first quarter, we now have our frozen elephant trunk approved there, the Neo. We've got our thoracal abdominal system approved there in a market we've never been in. We're waiting for approval of our AMDS in Taiwan, right? So just as these approvals come through, these are our existing products that are just getting paperwork to get the regulatory approvals. And in some cases, when we get enough critical mass, we put feet on the street. And as I mentioned earlier, you know, we've overinvested the growth rate or around the growth rate previously, but we're now backing that down. So you're now going to start not only getting the good growth, but you're going to start getting leverage around those regions. But it's a simple equation. It's, you know, get product approvals and add reps, and it works, right? We've said we think that those regions can grow 25 to 30%. through 2020 or, you know, into 2024. And we've done that last year. We're doing it now. So I think the, you know, the playbook is working.
spk04: Nice. Thanks for taking the questions. I'll stop there. Thanks, Ryan.
spk01: And that appears to be the last question at this time. I would like to now turn it back to management for any closing remarks.
spk07: Yeah, like I said, we're pleased with the quarter, and we feel like we've got momentum coming out of Q1. You heard in my comments, I just mentioned a few things. You heard my comments. We've hired a big chunk of people in our manufacturing facility in Germany in the fourth quarter. They were trained in the first quarter, and they are just now coming online. So we expect the supply to improve and that to grow significantly. I talked about our pricing power with some of our proprietary devices, which we think we can get meaningful price increases from starting kind of now. So you haven't even seen that in the gross margin. Per clot, we've got an approvable letter from the FDA. We're just kind of waiting on the final inspection to get closed out. We beat the first quarter. We've raised our guidance on the top and bottom line. And we just need to execute, keep doing more of the same. And we feel like we're set up for, you know, a very good 23, and we expect to enroll two PMA trials this year, you know, in the second half of the year. So, you know, things are moving forward, and we're very bullish on what's in front of us. So thanks, everybody, for joining in on the call.
spk01: Thank you. This does conclude today's conference. We thank you for your participation. You may disconnect your lines at this time, and have a wonderful day.
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