Artivion - Q1 2023

Transcript

Operator (participant)

Good day, ladies and gentlemen, welcome to the Artivion Q1 2023 Financial Conference Call. All lines have been placed on a listen-only mode. 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 Gilmartin Group. Sir, go ahead.

Brian Johnston (VP)

Thank you. Good afternoon, thank you for joining the call today. With me from Artivion's management team are Pat Mackin, CEO, and Ashley Lee, CFO. Before we begin, I'd like to remind you 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 Artivion CEO, Pat Mackin.

Pat Mackin (CEO)

Hey, thanks, Brian, and good afternoon, everyone. I'm pleased to report that the Q1 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 On-X platform, which grew 24%, followed by BioGlue at 8%, stent grafts at 8% and tissue processing at 7%, all compared to the Q1 of 2022 on a constant currency basis. Our Q1 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 addressable markets through our additional clinical pipeline.

To that end, we recently received an approval letter from the FDA for the PerClot PMA and expect approval for our recent PML inspection once our recent inspection is finalized, we'll even have even more confidence in our ability to deliver on our financial commitments for 2023. Given our Q1 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+ million in 2024. Our focus is clearly paying off.

As I mentioned earlier, On-X revenues grew 24% on a constant currency basis in the Q1 compared to the Q1 of last year. We saw double-digit constant currency year-over-year revenue growth in On-X across all geographies. We remain confident and will continue to take market share globally. We're the only mechanical heart valve that can be maintained at an INR of 1.5 to 2.0. Additionally, stent graft revenues grew 8% on a constant currency basis in the Q1 compared to the Q1 of 2022. Demand for our stent graft 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 stent graft 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 Q1 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 PerClot soon. Following this approval, we receive a $14.3 million milestone payment net of the amounts owed to our former partner, and we'll begin shipping products, revenue-generating product to Baxter.

For PROACT Mitral, 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 Mitral in 2023 is not factored into current forecasts and would represent further upside from our revenue 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 U.S. IDE 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 lumen 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 AMDS in 2025. Our partner Endospan is making progress on the U.S. IDE called TRIOMPHE for its NEXUS Aortic Stent Graft System. In that trial, there are approximately 44 patients enrolled and treated and a total number of 53 patients enrolled in approved 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 On-X aortic stent grafts, where 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.

D. Ashley Lee (EVP and CFO)

Thanks, Pat. Good afternoon, everyone. Total revenues were $83.2 million for the Q1 of 2023, up 8% on a GAAP basis and up 10% on a constant currency basis, both compared to Q1 of 2022. On a year-over-year basis in the Q1 of 2023, On-X 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 Q1 of 2022, On-X grew 24%, BioGlue and stent graft revenues both grew 8%, and tissue processing revenues increased 7%. On a regional basis, Q1 2023 revenues in Asia Pacific increased 17%, Latin America increased 36%, North America increased 10%, and Europe decreased 1%, all compared to the Q1 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 Q1 of 2022. Gross margins improved sequentially from the Q4 to 64.6% in Q1 compared to 65.7% for the Q1 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 Q1 were $50.4 million compared to $39 million in the Q1 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 Q1 of 2023 compared to $39.7 million in the Q1 of 2022. R&D expenses for the Q1 were $7.2 million compared to $10.1 million in the Q1 of 2022. The decrease in R&D spending primarily results from savings from the cessation of the PROACT Xa 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 GAAP net loss of approximately $13.5 million or $0.33 per fully diluted share in the Q1 of 2023.

Net loss for the Q1 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 $0.02 per share in the Q1. 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 Q1 of 2023 was $10.8 million compared to $10 million for the Q1 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. 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 PerClot, 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%-12%. We expect revenues to be in a range of $337 million-$348 million compared to our previous range of $331 million-$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 PerClot. Our strong Q1 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. 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. Finally, our Term Loan B contains no financial covenants that would place us in default unless we were to have more than seven and a half million dollars 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.

Pat Mackin (CEO)

Yeah. Thanks, Ashley. As you just heard, 2023 is off to an excellent start, and we expect that momentum to continue. Our strategy is working and 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, continued strong On-X performance together with potential for PROACT Mitral later this year. Two, stronger performance in our stent graft business due to recent staffing improvements at our German facility and other supply chain improvements. Three, continued strong performance in Asia Pacific and Latin America. Four, growth in BioGlue and PerClot due to recent regulatory approvals. Finally, these two U.S. clinical trials with AMDS PERSEVERE and Endospan NEXUS TRIOMPHE 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 Endospan 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 Q1 results and a continued dedication to our mission.

With that, operator, please open up the lines.

Operator (participant)

Thank you. The floor is now open for questions. If you do have a question, please press star one on your telephone keypad at this time. If your question has been answered, you can remove yourself from the queue by pressing one. Again, ladies and gentlemen, it's star one. Please hold while we pull for questions. Our first question comes from Rick Wise from Stifel. Go ahead, Rick.

Rick Wise (Managing Director)

Good afternoon. Hi, Pat. Hi, Ashley.

Pat Mackin (CEO)

Hey, Rick,

Rick Wise (Managing Director)

it's nice to see the quarter and great to hear the PerClot news. Just maybe my first question with a couple of parts to it on PerClot. Talk to us, you know, just 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. 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 gonna put it to use? Just maybe, you know, sort of two basic parts there. Thank you so much. Yes. Yeah.

Pat Mackin (CEO)

The first one, Rick, is, you know, the way this process works is they, part of the, part of the PMA is that they come in for a, you know, pre-approval inspection, and that was completed about one month ago. They have to write up their report and send it over to the, to the branch. That's basically what we're waiting on. Again, that could happen, you know, kind of any day now. As soon as that happens, you know, we should be, you know, get the green light and get the approval. You know, I'm hesitant to commit 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.

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. They're already starting to work on that given the approvable letter. We think in this quarter we'd be shipping product. Ashley, maybe you can comment on when we get the cash.

D. Ashley Lee (EVP and CFO)

Yeah. I mean, I think it's within a couple of weeks after we transfer all of the PMA documentation to Baxter. Again, assuming that we get the final approval from the FDA, which we expect, you know, we should get those funds later in the Q2. 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. You know, we'll continue to, you know, move forward and drive revenue growth and drive cash flow. 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.

Rick Wise (Managing Director)

Yeah. That sounds good. Maybe just turning to the 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 med tech 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. I'm just curious to, you know, from your perspective and from Artivion's vantage point portfolio, et cetera. How are those factors affecting you? You know, how did it benefit this quarter? 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.

Pat Mackin (CEO)

Yeah. I mean, it, you know, clearly a lot of the, 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. We grew every quarter in COVID except for one. 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. We never really felt a lot of that. I mean, there was definitely some noise in Europe this past quarter with striking. Again, how much that really impacts things, you know, it didn't really impact us that much.

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. We've been pretty lucky not to get sucked up into the staffing, but it does seem like it's getting better.

Rick Wise (Managing Director)

Good. Good. Ashley, it went by sort of quick, and I wanna 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 med tech as well. If you could just kindly say it again. What was the positive impact, I assume, of price in the Q1? What are you factoring into your guidance and your expectations?

Pat Mackin (CEO)

Let me-

Rick Wise (Managing Director)

Yeah.

Pat Mackin (CEO)

Let me take that. Let me take that one, Rick.

Rick Wise (Managing Director)

Okay.

Pat Mackin (CEO)

You know, we're not gonna get specific because of competition and things like that. 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. We are in those cases, you know, raising prices significantly, and you haven't even seen them in our numbers yet. Those are gonna be things that you're gonna see in Q2, Q3, and Q4. I'm just gonna leave it at that and not gonna get more specific.

Rick Wise (Managing Director)

Okay. I totally get it, but, good to hear. Thank you so much. I appreciate it. Thank you.

Pat Mackin (CEO)

Thanks, Rick.

Rick Wise (Managing Director)

Thanks, Rick.

Operator (participant)

Again, ladies and gentlemen, it's star one. Our next question comes from Suraj Kalia from Oppenheimer. Go ahead.

Speaker 7

Hi, Pat and Ashley. This is Seamus on for Suraj.

Pat Mackin (CEO)

Hey. How you doing?

Rick Wise (Managing Director)

How are you?

Speaker 7

Congrats. I'm good. I'm good. Thank you. Congrats on the quarter, and thanks for taking our questions. I guess to start off, kinda, you know, what are the kinda key sales and marketing changes in our rep commission territory assignments, that you'll do post, mitral approval?

Pat Mackin (CEO)

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 where the product is already on the shelf. It's a label change, right? If we were to get approval, it's just changing the label for the INR. From a launching standpoint, we've already got all of our, you know, commission plans and everything built out. You can see what On-X grew 24% in the Q1 without PROACT Mitral. 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, surgeon education and those things.

Our commercial teams are well set. Their comp plans are well set. 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. 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.

Speaker 7

Got it. Thank you. Kinda just one more. You know, PROACT Xa, I believe you said, supposed to be published, I believe, this weekend.

Pat Mackin (CEO)

Yeah, it's gonna be presented.

Speaker 7

You know-

Pat Mackin (CEO)

Product today is gonna be presented at AATS in Los Angeles on Saturday afternoon out there at the AATS meeting by Lars Svensson, who's the Chief of Cardiac and Vascular at Cleveland Clinic. That'll be presented on Saturday afternoon.

Speaker 7

Okay. 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?

Pat Mackin (CEO)

I do not have an update on the timing of that. Obviously, this is the presentation is the trigger for that. This is, you know, that's the first public data that's gonna be out there on it. From there, the publication will follow. You know, as soon as we have an update on that, we'll let people know.

Speaker 7

All right. Appreciate it. That's all from our end. Thank you.

Pat Mackin (CEO)

Sure.

Rick Wise (Managing Director)

Thanks, Seamus.

Operator (participant)

Our next question comes from Jeffrey Cohen from Ladenburg Thalmann. Go ahead.

Jeffrey Cohen (Managing Director of Equity Research)

Oh, hey, Pat and Ashley. How are you?

Pat Mackin (CEO)

Good.

Rick Wise (Managing Director)

Yeah.

Jeffrey Cohen (Managing Director of Equity Research)

A few questions from our end. 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 $5 million non-cash in the G&A line? 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 gonna be more gains on that front and as that relates to leverage?

Pat Mackin (CEO)

Yeah, I think I'll take the second one. I'll let Ashley take the G&A question.

Jeffrey Cohen (Managing Director of Equity Research)

Mm-hmm.

Pat Mackin (CEO)

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. You know, we've gone direct in a couple 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. You know, for example, when we get a product approval or multiple product approvals, then we'll potentially add a rep there. That's starting to kind of asymptote out now, and the number of people we're bringing on there is, you know, less this year than last year.

We are starting to actually get leverage out of both of those regions. They're actually, you know, growing much faster than the investment we're making in those regions. I think our channels are in pretty good shape, and we're going to start to see leverage as we push more product through those channels. It's what we've been talking about, you know, as we move into 2024 and seeing that EBITDA jump, that's one of the triggers for that, is actually pushing more product through our existing infrastructure. Then, Ashley, you can take the G&A question.

D. Ashley Lee (EVP and CFO)

Yeah. G&A reported was a little over $50 million, and you know, as I stated, Jeff, there was approximately $5 million included in that for contingent consideration changes related to the Osiris Acquisition. That is a balance that changes 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. So it's, you know, kind of difficult to precisely predict what that's gonna be on a quarterly basis. 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 the prior year. You know, there were some things that we did in the Q1 of this year that we have not been doing over the last couple of years. You know, we had sales meetings. We went to some really large major medical conferences in person, so you know, our, you know, G&X expenses were elevated in the Q1 compared to, you know, where they were in previous Q1s. Likely, they're probably a little higher than what they're gonna be for the remaining quarters of this year as well, because we're not gonna be, again, having sales meetings, you know, throughout the year to that magnitude.

Although we will be continuing to go to some medical conferences, probably not as heavy of a cadence as we had in the Q1.

Jeffrey Cohen (Managing Director of Equity Research)

Okay, I got it. I know there's a 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? Is Q1 a margin that you feel pretty comfortable with for the balance of the year?

D. Ashley Lee (EVP and CFO)

You know, I think margins are gonna be... You wanna take this one, Pat?

Pat Mackin (CEO)

No, go ahead.

D. Ashley Lee (EVP and CFO)

No. So margins, you know, we anticipate being, you know, relatively flattish throughout the year. You know, a lot of it's gonna 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 last year, and some of those layers of inventory are gonna be, you know, flowing through 2023. You've got that offsetting dynamic. You know, taking all of that as a whole, you know, we think margins are gonna be relatively flattish, you know, this year, especially compared to the prior year.

Jeffrey Cohen (Managing Director of Equity Research)

Okay. 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 of placements going on?

Pat Mackin (CEO)

We don't really pay much attention to that, to be honest with you. It's not really in our field.

Jeffrey Cohen (Managing Director of Equity Research)

Okay. Got it. Thanks for taking our questions. Appreciate it.

D. Ashley Lee (EVP and CFO)

Thanks, Jeff.

Operator (participant)

Thank you again. To ask a question on the phone, it's star one. Our next question comes from Frank Takkinen from Lake Street Capital. Go ahead, Frank.

Frank Takkinen (Senior Research Analyst)

Thanks for taking the questions. Congrats on all the progress. Wanted to start with one on On-X. 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?

Pat Mackin (CEO)

I mean, On-X has grown double digits for the last. You know, it's grown, I think our the CAGR over the last five years is 13%, 14%. This is a big jump. A lot of it's. I mean, we grew double digits in every single market. I think part of it is just the, you know, the data that keeps coming out on this valve is extremely strong. Our reps are well-trained. 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. I just think it's really taken hold kind of around the world, and you just continue to see, you know, strong performance on it.

Frank Takkinen (Senior Research Analyst)

Okay. Maybe one follow-up directly to that. I think obviously the stock price reflected pure panic when the data came out on PROACT Xa. I think maybe there was some assumptions around the demand profile of the device when that occurred. It occurs to me that that has not at all manifested in how the product is growing. Would you agree? Do you think this continue to be a 20% plus grower maybe now?

Pat Mackin (CEO)

Yeah. Well, we guided in our... You know, back in our March, last year, we guided 10%-15% growth for On-X over the planning period up to through 2024. You know, we've grown. Last year, we grew On-X 13%. Like I said, the CAGR has been right in that between 10% and 15%. Obviously, it was higher in the Q1. You know, there's a lot of international stuff there, I mean, we're not gonna like immediately jump to, you know, change the guidance on On-X. I think we're comfortable with, you know, it growing 10%-15%. To me, I mean, the PROACT Xa trial was a drug trial. We were changing the drug. The drug failed, right? It had nothing to do with the valve.

It was basically Eliquis can't protect the valve, and that data will be presented on Saturday. The On-X valve performs extremely well, with Coumadin and low INR, which we've shown in multiple studies. I think that's will give people 'cause it gives people confidence. In the end that, you know, the valve didn't have the problem, the drug had the problem.

Frank Takkinen (Senior Research Analyst)

Right. Good color. One last one for me. APAC and Latin America continue to outpace 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?

Pat Mackin (CEO)

Yeah. It's a pretty simple kind of algorithm. We get product approvals of our, you know, of our portfolio in new markets. I was in Australia in the Q1. You know, we now have our frozen elephant trunk approved there, the Neo. We've got our thoracoabdominal system approved there in a market we've never been in. We're waiting for approval of our AMDS in Taiwan, right? Just as these approvals come through, these are our existing products that are just getting paperwork to get the regulatory approvals. In some cases, when we get enough critical mass, we put feet on the street. 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.

You're now gonna start not only getting the good growth, but you're gonna start getting leverage around those regions. 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%-30% through 2020, you know, into 2024, and we've done that last year. We're doing it now. I think the, you know, the playbook is working.

Frank Takkinen (Senior Research Analyst)

Nice. Thanks for taking the questions. I'll stop there.

Pat Mackin (CEO)

Thanks, Ryan.

Operator (participant)

That appears to be the last question at this time. I would like to now turn it back to management for any closing remarks.

Pat Mackin (CEO)

Yeah. Like I said, we, you know, 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, but you heard in 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 Q1, and they are just now coming online. We expect, you know, the supply to improve and that to, you know, grow significantly. I talked about our pricing power with our proprietary devices, which we think we can get meaningful price increases from starting kinda now. You haven't even seen that in the gross margin. PerClot, we've got an approvable letter, you know, from the FDA.

We're just kinda waiting on the final inspection to get closed out. You know, we beat the Q1. We've raised our guidance on the top and bottom line, and we just need to execute, keep doing more of the same. We feel like we're set up for, you know, a very good 2023, and we expect to enroll two PMA trials this year, you know, in the second half of the year. You know, things are moving forward, and we're very bullish on what's in front of us. Thanks everybody for joining in on the call.

Operator (participant)

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.