LeMaitre Vascular Q3 2024 Earnings Call Transcript

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Provided by Quartr
October 31, 2024

Key Takeaways

  • LeMaitre reported 16% sales growth and 49% EPS growth in Q3, driven by grafts (+24%), patches (+13%) and carotid shunts (+18%), with APAC up 24%, EMEA up 22% and the Americas up 12%.
  • The sales organization grew to 149 reps (up from 146) with a year-end target of 155–160, complemented by a 17% increase in regional sales managers and new direct offices in Paris, Zurich and Shanghai plus planned distributor buyouts in Portugal and Czechia.
  • Regulatory momentum continued with 15 of 22 MDR CE Marks received and the key autograft approval expected in H1 2025, expanding international launch of their largest U.S. product into markets like Singapore, Australia and Canada.
  • Implementation of pricing floors across the U.S., Europe, Canada and Japan has lifted average annual price hikes to 9% since 2021 (versus 3% in 2015–2020), supporting a gross margin of 67.8% in Q3 (up 280 bps) and Q4 guidance of 68%.
  • CFO J.J. Pellegrino will retire in March 2025 after 19 years, with board election and an external search by Russell Reynolds underway to ensure a smooth leadership transition.
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Earnings Conference Call
LeMaitre Vascular Q3 2024
00:00 / 00:00

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Operator

Welcome to the LeMaitre Vascular Q3 2024 Financial Results Conference Call. As a reminder, today's call is being recorded. At this time, I would like to turn the call over to Mr. J.J. Pellegrino, Chief Financial Officer of LeMaitre Vascular. Please go ahead, sir.

J.J. Pellegrino
J.J. Pellegrino
CFO at LeMaitre Vascular

Thank you, Operator. Good afternoon, and thank you for joining us on our Q3 2024 Conference Call. With me on today's call is our CEO, George LeMaitre, and our President, Dave Roberts. Before we begin, I'll read our Safe Harbor Statement. Today, we will make some forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995, the accuracy of which is subject to risks and uncertainties. Wherever possible, we will try to identify those forward-looking statements by using words such as believe, expect, anticipate, pursue, forecast, and similar expressions. Our forward-looking statements are based on our estimates and assumptions as of today, October 31, 2024, and should not be relied upon as representing our estimates or views on any subsequent date.

J.J. Pellegrino
J.J. Pellegrino
CFO at LeMaitre Vascular

Please refer to the cautionary statement regarding forward-looking information and the risk factors in our most recent 10-K and subsequent SEC filings, including disclosure of the factors that could cause results to differ materially from those expressed or implied. During this call, we will discuss Non-GAAP financial measures, which include organic sales growth as well as operating income, operating expense, and EPS excluding special charges. A reconciliation of GAAP to Non-GAAP measures discussed in this call is contained in the associated press release and is available in the investor relations section of our website, www.lemaitre.com. I'll now turn the call over to George LeMaitre.

J.J. Pellegrino
J.J. Pellegrino
CFO at LeMaitre Vascular

Thanks, J.J. I believe this is our first ever Halloween earnings call, so I'll start my remarks appropriately. If a shareholder rang our doorbell tonight, we would have a few treats for their bag: 16% sales growth and 49% EPS growth. With that out of the way, I'll focus on five topics. Number one, our top line. Number two, the growth of our RSM team. Number three, our brick-and-mortar international sales offices. Number four, our latest go direct efforts, and finally, number five, our MDR CE mark progress. 16% sales growth in Q3 was led by grafts, patches, and carotid shunts, up 24%, 13%, and 18% respectively. APAC was our strongest region again, up 24% thanks to Thailand and Korea, our two newest direct markets. EMEA sales were up 22% in Q3, while the Americas were up 12%.

George LeMaitre
George LeMaitre
CEO at LeMaitre Vascular

Our 16% sales growth in Q3 was comprised of 10% pricing and 6% unit growth. We ended Q3 with 146 sales reps. As of today, we're at 149, and we're still targeting 155 to 160 for year-end. Of course, as we increase rep headcount, we need to build out our sales management team. We now have 28 RSMs, ASMs, and country managers, up 17% year-over-year. As for our brick-and-mortar sales offices, we continue to hire staff in our new Paris office, which contributed to 21% French sales growth in Q3, and we're set to lease our first ever Swiss office near the Zurich Airport. In China, we recently signed a lease which will bring together our Shanghai sales office and our Shanghai warehouse into a new, larger facility. While we continue to await XenoSure cardiac patch approval, our efforts in China are starting to bear fruit.

George LeMaitre
George LeMaitre
CEO at LeMaitre Vascular

Sales were up 62% in Q3. We've also begun to push forward with go direct projects in Portugal and Czechia, where we expect hospital sales to begin in 2025. These will be LeMaitre's first European go direct projects since 2016. Both countries utilize the CE mark and are members of the EU, making the transition less complex. Turning to regulatory, we've now received 15 of the 22 MDR CE marks we're currently seeking. The seven remaining MDRs should be received in 2025. One of these approvals is Artegraft, our largest U.S. product. We've now received Artegraft approval in New Zealand, South Africa, Thailand, and Malaysia, and we expect to receive approvals in Singapore, Australia, Canada, and Korea in 2025. Bringing this device to international markets was a key consideration at the time of the 2020 Artegraft acquisition. I'd also like to begin to thank J.J.

George LeMaitre
George LeMaitre
CEO at LeMaitre Vascular

for his 19 years at LeMaitre. As discussed in our August 8-K, he'll be hanging up his CFO cleats in March 2025 after a fantastic career. J.J. was elected to our board of directors in June 2024 for another three-year term. J.J. is also helping to select and train the next CFO. We retained Russell Reynolds for the search, and interviews are ongoing. In conclusion, 2024 is shaping up to be another year of healthy sales and profit growth. With that, I'll turn the call over to J.J.

J.J. Pellegrino
J.J. Pellegrino
CFO at LeMaitre Vascular

Thanks, George. In Q3, pricing and operational execution continued to drive our story. Our differentiated product portfolio enabled a 10% price increase, which helped improve both sales and the gross margin, while we continued to restrain operating expenses. In Q3, we posted a gross margin of 67.8%, up 280 basis points year-over-year. The increase was a result of higher ASPs, direct labor efficiencies, and improved RestoreFlow allograft yields. Higher ASPs were driven by our differentiated Artegraft, valvulotome, RestoreFlow, and shunt devices. We are guiding a Q4 gross margin of 68% as direct labor efficiencies continue. For the full year, we expect a gross margin of 68.3%, up 260 basis points year-over-year. Operating expenses in Q3 2024 were $24 million, an increase of 11% versus Q3 2023.

J.J. Pellegrino
J.J. Pellegrino
CFO at LeMaitre Vascular

Year to date, our worldwide headcount is up only 4% to 637, reflecting our shift from significant post-COVID rehiring to a more conservative hiring posture. As a result, Q3 2024 operating income increased 43% year-over-year to $13.1 million, an operating margin of 24%. For the full year, we also expect an operating margin of 24%, up significantly from 19% in 2023. We ended Q3 2024 with $124 million in cash and securities, an increase of $10.8 million in the quarter. On the August 1st earnings call, we fielded pricing floor questions. Over time, our executive team has become more responsible for pricing decisions, as reps have sometimes cut prices on their own. In 2020, we began installing pricing floors in key European sales managers' bonus plans. In 2021, we began printing USA price floors on our company-wide goal cards.

J.J. Pellegrino
J.J. Pellegrino
CFO at LeMaitre Vascular

In 2024, we began printing price floors for Europe, Canada, and Japan on these goal cards. As a result, from 2021 to 2024, our average annual price increase has been 9%. For comparison, from 2015 to 2020, our average annual price increase was 3%. We will continue to use this tool as an effective way to realize annual price increases. In general, this pricing strategy is consistent with our small niche market business plan. With regard to guidance, we are raising our Q4 sales and bottom line estimates, which are also reflected in our updated full-year outlook. For more details, please see today's press release, but a few Q4 highlights include sales growth of 14% on a reported basis and 14% organically, gross margin of 68%, operating income of $13.3 million, up 30%, and EPS of $0.49 per share, up 30%.

J.J. Pellegrino
J.J. Pellegrino
CFO at LeMaitre Vascular

Separately, we would like to welcome Ross Osborne from Cantor Fitzgerald, who initiated coverage on us earlier in October. With that, I'll turn it back over to the operator for questions.

Operator

Thank you. As a reminder, to ask a question, please star one one on your telephone and wait for your name to be announced. To withdraw your question, please star one one again. One moment for questions. Our first question comes from Suraj Kalia with Oppenheimer. You may proceed.

Suraj Kalia
Suraj Kalia
Managing Director at Oppenheimer

Hi, George. Can you hear me all right?

George LeMaitre
George LeMaitre
CEO at LeMaitre Vascular

Yes, Suraj. How are you doing?

Suraj Kalia
Suraj Kalia
Managing Director at Oppenheimer

I'm doing wonderful. Hope all is well. So, George, splitting out the different geographies by growth rate, right? U.S. was approximately 10%, EMEA was about 22%, APAC was 24%, and the composite growth rate was 16%. Fine. And 10% is ASP, 6% is units. Can you give us a little more granularity on all U.S. price increases versus unit increases? How does that split work out?

George LeMaitre
George LeMaitre
CEO at LeMaitre Vascular

I don't know if we're going to be able to do that for you live here, Suraj, and I apologize. We've looked at it globally, not by major geography buckets. So I think unless I get a yes from J.J. over here, who usually has more technical answers than me, I'm going to have to say we can pass on that question. Sounds like a reasonable question to ask. Maybe at the next meeting, we should be prepared for that.

Suraj Kalia
Suraj Kalia
Managing Director at Oppenheimer

Fair enough. I appreciate that. George, in terms of EMEA and APAC, as you ramp up your direct distribution, how should we think about inventory? Obviously, there are going to be fewer and fewer distributors, right? Is the logical way just to think about it that inventory currently is not a factor to be considered as we look forward to 2025?

George LeMaitre
George LeMaitre
CEO at LeMaitre Vascular

Yeah, certainly. I would say we have so much inventory because we focus on this no backorder promise to our hospital and distributor customers. But yes, in short, we've got plenty of inventory, and we're really only running effectively one shift worldwide right now. So if you really wanted to, you could triple the output at the factory. So inventory is not a problem for us.

Suraj Kalia
Suraj Kalia
Managing Director at Oppenheimer

Okay. Fair enough. And George, my final question. I'll hop back in queue and let others have a chance. Your gross margin growth has been pretty steady and attractive. Help us understand the puts and takes as we enter 2025, especially in terms of gross margins. What are the levers you obviously, the pricing floors are one, right? They will flow through in one form or the other. But just help us understand a little more additional color on how gross margins you'll see expanding in '25, and what are the different levers? Gentlemen, thank you for taking my questions.

J.J. Pellegrino
J.J. Pellegrino
CFO at LeMaitre Vascular

Suraj, this is J.J. Thanks for the question. So we don't give guidance, obviously, on the upcoming year, and we haven't done that yet. I would say at a high level, you can think of last year and the year before as the rehiring years. And so you saw OpEx grow pretty quickly. I think it was 20% last year and 16 or 17% the year before. And that slowed down this year nicely. And so we're looking at 11% in the recent Q3 and then maybe around 10%-ish for the full year. And so we've done a nice job bringing OpEx growth in line. So you can sort of think about that as you move forward.

J.J. Pellegrino
J.J. Pellegrino
CFO at LeMaitre Vascular

The gross margin line, you've seen that be in the 65% range in the rearview mirror and more recently over the last three or four quarters coming up into the 68% range. And we're not telling you anything about going forward. Hopefully, we can keep up the direct labor efficiencies that are driving that largely. And if you do that and you grow the top line nicely, then maybe you get a nice answer on the bottom line. We'll see where that goes.

Suraj Kalia
Suraj Kalia
Managing Director at Oppenheimer

Thank you.

Operator

Thank you. As a reminder.

J.J. Pellegrino
J.J. Pellegrino
CFO at LeMaitre Vascular

Thank you, George.

Operator

Thank you. And as a reminder to ask a question, please star one one on your telephone. Our next question comes from Rick Wise with Stifel. You may proceed.

Rick Wise
Rick Wise
Managing Director at Stifel

Good afternoon, George, and congrats, J.J., on an amazing run here. Just I guess I'll start off thinking about some of the key drivers, as you highlighted them, in no particular order. As we contemplate 2025, and I know you're not ready to give guidance, but what kind of band should we start to think about in terms of that unit and price growth driver and mix? I mean, J.J. highlighted what happened in what you did in 2020 and 2021 and 2022, etc. What's the next lever that's going to keep the price story going, for example?

J.J. Pellegrino
J.J. Pellegrino
CFO at LeMaitre Vascular

I mean, I'll take a high-level shot at it. Rick, the strategy itself, I think, is conducive to nice price hikes, generally speaking. So the niche product element to our story, where else are you going to get a valvulotome part of the story, is a nice piece of the ASP driver. The fact that we're sort of $200-$2,000-ish devices and not $30,000 devices is a nice part of the story that doesn't sort of break the bank, if you will, of the hospital systems. And then the fact that there's no direct reimbursement really for our devices. We live under DRG codes for procedures. I think that helps that as well. And then, as we said in the script, we've now sort of oddly, it took us this long.

J.J. Pellegrino
J.J. Pellegrino
CFO at LeMaitre Vascular

We were a little chagrined that it took us this long, but we were like, "Okay, we've got this tool now called the pricing floors." And so we think we can use that going forward to be more precise and more directed about the hikes that we get. It used to be you'd ask for an 8% hike, and you actually got a 4% hike or whatever the number was because reps were out there discounting. And maybe we can be a little more precise with that. I don't know, George, if you got other comments around that.

George LeMaitre
George LeMaitre
CEO at LeMaitre Vascular

No, that's pretty good. That's about what I would say, J.J.

Rick Wise
Rick Wise
Analyst at Stifel

Thank you, J.J. George, maybe expand on your sales expansion goals. I might have thought you would have been able to add more this quarter. I mean, it's an ambitious goal to add that number maybe by year-end. I don't know if it is. I'd be curious to hear your perspective. But how confident are you that you can get there? Do we expect similar kind of expansion numbers as we think about next year?

George LeMaitre
George LeMaitre
CEO at LeMaitre Vascular

So, I'll handle the back of the question first and say, "Yeah, you can." We're not guiding into next year, but we know we have a lot of people lined up currently to be hired. And if every last one of them got hired, we would be above that 160 number. So yeah, I would say you can expect further. I mean, I think we see ourselves more and more as a sales channel, and that's what sales channels do, is they acquire stuff and put stuff through themselves, and they have to keep growing the sales channel. That's a little bit why you see us focusing all this chatter on the brick-and-mortar offices and Czechia and Portugal, sort of Korea and Thailand, if you will, last year. So yes. And as to your question, can we get to 155? You know, I agree.

George LeMaitre
George LeMaitre
CEO at LeMaitre Vascular

It's a little bit slower than we had thought, but 155 is a very reasonable goal. We called out for you today that we're at 149 right this second, and I have someone else whispering in my ear, "Hey, we're about to bring on five more people in the month of November." So I feel comfortable we'll get there. I also keep telling my team, "We're not going to get thrown in jail if we don't get to the 155 or what is it, 155 quote guidance for sales reps." We've been talking about it a lot, but we feel like it's a goal. We should make it. But if we don't make it, I think you guys will be happy if we make our sales numbers and our EPS numbers first, and then this will be a secondary thing. So I'm not that worried, but I think we will make it.

Rick Wise
Rick Wise
Analyst at Stifel

Gotcha. I'll stop there. It's great to see another terrific quarter. Thank you.

George LeMaitre
George LeMaitre
CEO at LeMaitre Vascular

Thanks a lot, Rick.

Operator

Thank you. Our next question comes from Brett Fishman with KeyBanc. You may proceed.

Brett Fishman
Brett Fishman
Vice President and Senior Equity Research Analyst at KeyBanc

Hey, guys. Thanks for taking the questions. Just wanted to ask one on the R&D line, which came in lower relative to the past several quarters, and was curious if there was any type of transitory benefits that you may have seen there, or if you're starting to see more of a permanent reduction around some of the higher spending around the ERP implementations and regulatory costs that you've been absorbing for the last few years.

J.J. Pellegrino
J.J. Pellegrino
CFO at LeMaitre Vascular

Yeah, that's a good catch and a great question. Yeah, I think on the R&D line, the regulatory piece had a lighter quarter. And I think you guys know we've talked about this before. I think we've been spending $4-plus million a year or so for the last two-ish years, three-ish years. Maybe we're sort of $12 million or $13 million-ish into this spend for MDD, MDR, and it's sort of coming to some kind of conclusion-ish, if you will. And so maybe we're going to get some benefit to that going forward. We'll see. We certainly did in this quarter.

Brett Fishman
Brett Fishman
Vice President and Senior Equity Research Analyst at KeyBanc

All right. Super helpful. And then just one follow-up. Maybe I guess the question was kind of asked earlier, but if we take it on a global basis, the 6% volume growth for the total portfolio was pretty impressive. And was just wondering if there was any products that you could call out from purely a unit volume growth perspective that supported that level of performance this quarter? Thanks very much.

George LeMaitre
George LeMaitre
CEO at LeMaitre Vascular

Sure. Sure. Thanks a lot for the question, Brett. And that answer, I think, is pretty simple. The RFA, the Allograft product was up 26% in units, and the XenoSure product line was up 10% in units. And that kind of gets you to that 6.

Operator

Thank you. Our next question comes from Jason Wittes with ROTH. You may proceed.

Jason Wittes
Jason Wittes
Managing Director at ROTH

Hi, thank you. You guys mentioned some brick-and-mortar building over the U.S. Does that also include buying out of distributors, or is that purely de novo in your part in terms of the whole distribution, I guess, changes or investment?

George LeMaitre
George LeMaitre
CEO at LeMaitre Vascular

Hi, Jason. Yeah. You know, I think the way we worded it and ordered it might have been a little bit confusing. So to deconfuse everyone here, we are trying to do two distributor buyouts, one in Czechia and one in Portugal. That's new to you on this call. We sort of mentioned it the last call, but now it's real, and we have had discussions with those distributors. So you'll see us buy out Portugal and Czechia, and then somewhat separately, in these other markets like China and France and Switzerland, we've been direct for a very long time, and we're doing some in France, we did open up an office about three months ago or four months ago. In Switzerland, we're about to rent an office by the Zurich Airport, and in China, we're bringing our warehouse and our office together in a newly enlarged facility in Shanghai. So two of the first, two distributor buyouts, and then three brick-and-mortar changes that you're hearing about on this call.

Jason Wittes
Jason Wittes
Managing Director at ROTH

Okay. That's helpful. And then I know we're always asking about pricing because it's impressive. And I understand your positioning as a niche and sort of the only provider on a lot of these unique products. But based on what J.J. said, it sounds like you also feel that sort of the change in approach, limiting the sales force's ability to discount, is really what's behind this. And from that, it sounds like you also think there's a fair amount of sustainability in the kind of momentum we see, not necessarily the absolute numbers, but in terms of at least seeing some sort of impressive pricing. Is that the right way to think about it?

George LeMaitre
George LeMaitre
CEO at LeMaitre Vascular

Yes, I think it is. I think in the last six months, we've come to a realization that those price floors that we started three and a half years ago are real and they work. And I don't think we quite understood the full scope of that until we started studying it. Shame on us for not really figuring out what we were doing well a year and a half ago. But yes, I think you're onto it.

Jason Wittes
Jason Wittes
Managing Director at ROTH

Okay. That's good to hear. And then I guess related to that, if I can push you, you may not want to answer this, but if I think about your price increases, are they across the board? Or you mentioned sort of your three lead products, which are definitely leadership products for you for the market itself. Are those where most of the price increases happen, or is it really just something across the board?

George LeMaitre
George LeMaitre
CEO at LeMaitre Vascular

Jason, it's a good question, and no, it's not across the board. Roughly speaking, it's in about 50% of the categories, and it's places where we sort of have higher market share and where we have very distinct devices that are different from other products, as you might expect, so valvulotomes, shunts, some of the latex-free catheters, and then also these bovine and ovine grafts are sort of the picture of the products that are priceable, if you will. And then stuff like PTFE and Dacron grafts, where we're number three and number four in the market. The price is not set in Burlington, Massachusetts. It's set elsewhere.

Jason Wittes
Jason Wittes
Managing Director at ROTH

Okay. Great. And J.J., yes, congratulations on a great run. I agree with some other comments there. I just joined again, and I'll miss you. But all that said, I got to go trick-or-treating.

J.J. Pellegrino
J.J. Pellegrino
CFO at LeMaitre Vascular

Enjoy. Thanks very much.

Operator

Thank you. Our next question comes from Danny Stauder with Citizens JMP. You may proceed.

Danny Stauder
Danny Stauder
Director at Citizens JMP

Yeah. Great. Thanks. So I just wanted to start on the top line. So 16% growth in your hardest comp of the year. You talked about some of the drivers for your product categories and regions, but is there anything else you can point to or provide color on that's supporting this progress, the progress that you're seeing throughout this whole year? Are there any unexpected tailwinds in the market in terms of demand, or is this just really a blocking and tackling story broadly? Thanks.

George LeMaitre
George LeMaitre
CEO at LeMaitre Vascular

Okay. So underneath that graft category, Danny, thanks for the great question, underneath that graft category, where we're quoting you in the press release and also on this earnings call, grafts grew 24%. One subcategory of grafts that was particularly standing out was the Allograft piece of our business. It was up 47%. So we call that variously RFA and Allograft, and we build those products out in Chicago. So you've heard us talk about that like that. So I would say that's a big topic. And then also maybe sort of structurally over in Europe, I think we keep feeling, and we've been talking about this for almost 24 months on these calls now, so this is not new, but we keep feeling the exit of companies that are standing down and deciding not to file their MDRs and just said, "Hey, this product category is not large enough or not exciting enough.

George LeMaitre
George LeMaitre
CEO at LeMaitre Vascular

We're not going to follow through." So we keep feeling that over in Europe in certain categories, notably the shunts. And then I think there's also a couple of patch companies, some biologic patch companies that have retreated from the market and decided they didn't want to participate. So maybe allografts, RFA, big time this year, and then continuation of this exit from the market in Europe from some of these companies.

Danny Stauder
Danny Stauder
Director at Citizens JMP

No, that's great. And then just one-

J.J. Pellegrino
J.J. Pellegrino
CFO at LeMaitre Vascular

Yeah. Sorry. Sorry. I cut you off. I was just going to say you could toss in Korea and Thailand, geographically, doing really nicely and contributing to growth. Smaller, yes, I know, but stories that have been growing pretty nicely. And even we haven't talked about China that much over the last year and a half on these calls, and now the word's starting to come back in. So there's a little, again, small base here, but some nice answers coming out of China in terms of gaining some momentum. So nice geographic answers as well.

Dave Roberts
Dave Roberts
President at LeMaitre Vascular

Danny, this is Dave. I normally don't jump in on these topics, but you heard George talk about we've increased the number of sales managers in the company. We shuffled some of the upper management organization, and our sales managers, we now have 28. These are country managers, VPs, area sales managers, regional sales managers. They're up 17%. So I think the ratio of reps to managers is going down. The reps are probably being managed a little bit more tightly as well.

Danny Stauder
Danny Stauder
Director at Citizens JMP

Great. I appreciate the answer. Just one follow-up for me, more on the sales rep side. So do you have any plans to add more sales reps in Europe, just given some of the regulatory updates and progress there? I think when you updated your range last quarter, it was more North America focused, but how many of these are your mark for the EU, and do you feel you need to put more bodies out in the field with all the progress you've had there? Thank you.

George LeMaitre
George LeMaitre
CEO at LeMaitre Vascular

Yeah. That's a good insight. And yeah, it gives me a chance to say, yeah, I think we've morphed a little bit. I think maybe in May and June, we were thinking this is all about making this a big giant surge in the Americas. And I think our opinion has evolved, and I think we've added on. I think right now, if I think about my hiring board, I think there's about nine open European territories. And then, of course, you're hearing us talk about Czechia, where we'll need two reps, and Portland, excuse me, Portugal, where we're going to need one rep in Lisbon. So yes to that, and it's getting a little bit more European. It's not necessarily getting a little bit more APAC right now. We feel like we've got a lot of reps over there for the size of the business. But in the U.S. and Europe, we could certainly use more reps.

Danny Stauder
Danny Stauder
Director at Citizens JMP

Great. Thanks a lot. Great quarter.

George LeMaitre
George LeMaitre
CEO at LeMaitre Vascular

Thank you.

Operator

Thank you. Our next question comes from Michael Petusky with Barrington Research. You may proceed.

Michael Petusky
Michael Petusky
Research Analyst at Barrington Research

Hey. Good evening, guys. George, I'm wondering, I had a note that you guys would make a final submission for XenoSure, the cardiac indication in China in November. Is that still teed up to go here in the next 30 days?

George LeMaitre
George LeMaitre
CEO at LeMaitre Vascular

Yeah. That's a good question. That is done. The final submission is in, and now we just await. Our regulatory folks say, "Yeah, it'll be about six months," but you've heard that same story for six years on these phone calls. So if I were you, I wouldn't believe me on that.

Michael Petusky
Michael Petusky
Research Analyst at Barrington Research

Fair enough. So I'm curious in terms of, as J.J. transitions to the board here in the next six months or so, what are you guys looking for in terms of potential new CFO? I mean, is it important that he has public company experience, med tech, experience with M&A? What are some of the things you guys are looking for? Thanks.

George LeMaitre
George LeMaitre
CEO at LeMaitre Vascular

Okay. So are you asking me where the hole is in J.J.'s game here? I don't think you are.

Michael Petusky
Michael Petusky
Research Analyst at Barrington Research

I was not. all kidding.

George LeMaitre
George LeMaitre
CEO at LeMaitre Vascular

I'mI know that. I know. All kidding aside, we're blessed here a little bit at LeMaitre in that I think a lot of companies go at it with a CFO and a CEO, and we're blessed in that we have CEO, CFO, and mega VP of business development named Dave Roberts. So there's sort of a triad here rather than two people at most companies. So we don't have to chase down all the acquisition side of the portfolio. We can go at it a little bit more technically. We're still trying to figure out what split to make with the IR and things like that. We'll figure that out based on who shows up for these interviews and which ones we decide to pursue. So it's a good question.

George LeMaitre
George LeMaitre
CEO at LeMaitre Vascular

I think we're lucky that most companies, when they lose their CFO, they're losing one of the top two people. And here we are, we're losing one of the top three people. And it's a little bit helpful as we go into this. It's nerve-wracking, obviously, but we think we'll get through it.

Michael Petusky
Michael Petusky
Research Analyst at Barrington Research

Excellent. And then I guess a quick one for J.J., the subject here of the last question. J.J., in terms of the gross margin, I keep writing, "I think these gross margins are sustainable," but I'd much rather hear you say that than me write it. What are your thoughts?

J.J. Pellegrino
J.J. Pellegrino
CFO at LeMaitre Vascular

Mike, I'll tell you they're sustainable through Q4 because that's what we guided 68.0%. You got that out of me. Going forward, we'll see. Price is obviously a big driver for the gross margin going forward. To the extent that we can continue to benefit from that, that'll benefit the gross margin. On the other hand, RestoreFlow is growing like crazy, and that's got a lower gross margin than corporate. That drags you down a little bit. Then we've got the big piece around manufacturing efficiencies, and can we keep those up? Quality expense, can we keep that increase muted and have them get a little leverage on that over time as sales grow around it? So I mean, there's a lot of moving pieces, and we'll see where we go, but I think those are some of the bigger drivers for you.

Michael Petusky
Michael Petusky
Research Analyst at Barrington Research

Okay. All right. Great. And then let me ask the last one to the EVP, Dave. Dave, what are you seeing out there? I've seen some of what I would consider the companies in the public markets you guys get compared to. Merit has gotten more active in M&A and some others. I mean, what are you seeing out there in valuations and just anything you can talk about in terms of the assets that you at least may think are somewhat in play? Thanks.

George LeMaitre
George LeMaitre
CEO at LeMaitre Vascular

Yeah. Thanks, Mike. We do see some activity. You mentioned Merit. Also, of course, Boston Scientific acquired Silk Road Medical for six times sales not too long ago and Axonics for nine times sales. But I would say, no, those are higher figures, higher revenue multiples. Small cap med device is only trading about two times forward revenue. So that's down from the COVID days. Whereas larger companies, I think there's a benefit to scale. They're trading about five times. So we're out hunting, as always. And I would say at the margin, we're generally looking a little bit bigger, as I've said on previous calls, than we've looked in the past because obviously we're more profitable. We have a larger balance sheet. Things are going well for us. So yeah. So there are targets out there. We're at various stages of discussions, etc., with some of them. In the meantime, we feel good about our ability to reach for larger acquisitions.

Michael Petusky
Michael Petusky
Research Analyst at Barrington Research

Okay. Could I ask a part B to my last question? I guess it's maybe to J.J., but maybe to everybody. If you found that deal, that larger deal, I mean, would be one of the bigger or probably the biggest deal you've ever done, I mean, how leverage are you guys willing to get given where interest rates are and all the rest of it? I mean, how deep would you go on a transaction if you all felt like it was the right one? Thanks.

George LeMaitre
George LeMaitre
CEO at LeMaitre Vascular

I think we might need to keep our counsel on that one. It sounds like any answer we could give might scare people off either way, whatever we say. So I don't know. That may be a hypothetical there that we probably shouldn't step into unless one of you guys feels you want to go at this thing generically, I guess. I don't know.

J.J. Pellegrino
J.J. Pellegrino
CFO at LeMaitre Vascular

I mean, the easiest part of that is banks will lend you up to three and a half times combined, right? Now, beyond that, then you start to get into George's area here. What are you willing to be comfortable with? So maybe we just say that's certainly a comfort zone up to that. And then after that, depends on the circumstances.

Dave Roberts
Dave Roberts
President at LeMaitre Vascular

Right, so if our EBITDA is $60 million, three and a half turns of that, you're looking at $200 million or whatever, and then we have excess cash on the balance sheet as well, so Mike, I think even without getting into more complicated discussions, we're looking upwards of $300 million, just purely financeable without worrying about the EBITDA, the target, etc.

Michael Petusky
Michael Petusky
Research Analyst at Barrington Research

Gotcha. Are there deals out there like that, Dave?

Dave Roberts
Dave Roberts
President at LeMaitre Vascular

Yeah. I mean, look, there are deals as small as $5 million and deals which are hundreds of millions of dollars. And for me, always, just because I have a very long-term viewpoint on this company, I focus on the strategic fit first. And then if there are two targets which are equally meritorious strategically, then of course we'd rather do the larger deal, but that's just not how it works. I mean, but to answer your question, yes, there are larger deals out there.

Michael Petusky
Michael Petusky
Research Analyst at Barrington Research

All right. Very good. Thanks, guys. Another such a great quarter. Thanks.

George LeMaitre
George LeMaitre
CEO at LeMaitre Vascular

Thanks a lot, Mike.

Operator

Thank you. Our next question comes from Frank Takkinen with Lake Street Capital Markets. You may proceed.

Frank Takkinen
Senior Research Analyst at Lake Street Capital Markets

Great. Thanks for the questions. Congrats on the quarter. When you're explaining kind of price floor rollout, I think you're going by geography. Are there any geographies that you haven't rolled out that price floor strategy, or at this point, is it pretty much rolled out company-wide, worldwide?

George LeMaitre
George LeMaitre
CEO at LeMaitre Vascular

I think we've gotten to the bigger ones. Let's enumerate here. We have Australia. We have Japan. We have Canada. We have U.K. and Europe, and we have the USA. There might be a couple more to do, and then there might be a couple more to do elsewhere, but I think that's the larger chunk of our company. When we think about what do we do next year, we're always sort of testing which product lines should we apply to and which geographies. So if there's a place to go, we will go there with these floors.

Frank Takkinen
Senior Research Analyst at Lake Street Capital Markets

Fair. Okay. That makes sense, and then maybe just to clarify, and I may have missed it in the prepared remarks, but allograft, I think in previous calls you've said Ireland and Germany, 2025, 2026 respectively. Does that still remain the case and expectation?

George LeMaitre
George LeMaitre
CEO at LeMaitre Vascular

Actually, no. There's a little bit of a hiccup on both sides of that, and the very small hiccup in Germany, which is the more important one, which is the regulator was supposed to be in our building in Chicago October 15th or so and then called a week earlier and said, "Hey, I'm going to be sick a week from now," and so they still haven't rescheduled their audit of the factory out there, and so that one's held up only by a man's sickness schedule, and so I don't know what that means for the year. Maybe we leave that one alone as still a 2025 or a 2026.

George LeMaitre
George LeMaitre
CEO at LeMaitre Vascular

With Ireland, something different's cropped up, which is the state of Ireland or the country of Ireland has jumped in and said, "Hey, we're excited you want to do allografts." And we had previously intended just to do it as a paperwork exercise through Ireland, and now they're asking us to set up a facility there and to stock the product in Dublin and to give the state of Ireland and the healthcare system of Ireland right of first refusal on the devices, all of which got hairy and complicated pretty fast. So I would say we're taking a step back a little bit with Ireland, and we're thinking about what our next move should be. And we haven't really sorted it out ourselves yet. That's all breaking news as of, I don't know, 15 or 30 days ago. So we're still trying to figure out what to do.

George LeMaitre
George LeMaitre
CEO at LeMaitre Vascular

So little delay over there. We're still really excited about pursuing RFA approvals in Europe, but a little bit of a disappointment on those two devices or those two paths.

Frank Takkinen
Senior Research Analyst at Lake Street Capital Markets

Got it. Okay. I'll stop there. Thanks.

George LeMaitre
George LeMaitre
CEO at LeMaitre Vascular

Thanks a lot, Frank.

Operator

Thank you. Our next question comes from Jim Sidoti with Sidoti & Company. You may proceed.

Jim Sidoti
Jim Sidoti
Analyst at Sidoti & Company

Hi, good afternoon, and thanks for taking the questions. So of the seven MDR approvals that you're waiting for, are there one or two that you think will be more impactful, or do you think they're all about the same?

George LeMaitre
George LeMaitre
CEO at LeMaitre Vascular

No. In fact, I would say the only one that's really a game changer, and I'll explain why in a second, is this Artegraft device because it's a brand new one. We've never had an approval in Europe. With the other ones, Jim, the other six, we have current EU MDD CE marks, which are durable through 2027. So we don't have to worry about whether we're being stopped or not to sell those devices. The MDR is the way you're supposed to go, and once you get an MDR, it's then changeable, and you're not sort of in a straitjacket product-wise. But only one really counts. It's Artegraft.

Jim Sidoti
Jim Sidoti
Analyst at Sidoti & Company

Okay. And when do you expect that one?

George LeMaitre
George LeMaitre
CEO at LeMaitre Vascular

2025, and I think we're starting to say H1 2025.

Jim Sidoti
Jim Sidoti
Analyst at Sidoti & Company

Okay. All right. And Dave, you've been pretty disciplined the past couple of years. I mean, is there any reason why you need to do a deal with 16% top-line growth? Can you continue to be disciplined going forward?

Dave Roberts
Dave Roberts
President at LeMaitre Vascular

Yeah. I mean, Jim, it's a good question. We haven't done a deal since June of 2020. And I would say we're waiting for the right deal at the right price. We have bid on a few different deals, and for various reasons, it hasn't come together. And rather than chase deals up in price or whatever, as you mentioned, we have been disciplined. So in a funny way, I do think that even though I personally would like to do a deal, I feel like I'm slowing this down, waiting for the right deal. In the meantime, it allows the rest of the company to keep getting the house in order really, really nicely. And I think our ability to focus on pricing and these pricing floors is a great example of that. Our ability to consolidate factories like CardioCel and focus on gross margin and hire manufacturing engineers.

Dave Roberts
Dave Roberts
President at LeMaitre Vascular

A lot of good things are happening while we hunt for the next acquisition. So I think we will be disciplined, and we won't pull the trigger until we find something that we believe is really right.

Jim Sidoti
Jim Sidoti
Analyst at Sidoti & Company

All right, and just J.J., I just want to say whoever does replace you, they're going to have some big shoes to fill. You've been one of the, I think.

J.J. Pellegrino
J.J. Pellegrino
CFO at LeMaitre Vascular

There you go. Thanks. Appreciate that.

George LeMaitre
George LeMaitre
CEO at LeMaitre Vascular

There's probably five or six people on the call who will be happy to take that job if you guys want to take us.

George LeMaitre
George LeMaitre
CEO at LeMaitre Vascular

Thanks, Jim.

George LeMaitre
George LeMaitre
CEO at LeMaitre Vascular

Not me, though.

J.J. Pellegrino
J.J. Pellegrino
CFO at LeMaitre Vascular

I'm going to miss talking to you on these calls in between.

Jim Sidoti
Jim Sidoti
Analyst at Sidoti & Company

All right. Thank you, guys.

George LeMaitre
George LeMaitre
CEO at LeMaitre Vascular

Thanks a lot, Jim.

Operator

Thank you. Our next question comes from Ross Osborne with Cantor Fitzgerald. You may proceed.

Ross Osborne
Ross Osborne
Director at Cantor Fitzgerald

Hi guys. Congrats on the strong quarter, and thanks for taking our questions. So starting off, we'd be curious to hear how you are progressing in targeting cardiac surgeons. And as a follow-up to that, does it make sense to add cardiac-focused reps?

George LeMaitre
George LeMaitre
CEO at LeMaitre Vascular

Okay. So that's a great question. I think we're up to about 14% of our sales are now cardiac sales as opposed to vascular and still some interventional radiology and stuff like that. So 14%. We do not have any dedicated cardiac reps right now. I think the back part of your question is, are you considering cardiac reps, dedicated cardiac reps? It's certainly something we think about. We haven't gone forward with it yet. I still feel like I always say to Dave and J.J., the world's a big place, and filling out a peripheral vascular salesforce for the world, it's not 145 reps. It's a lot more than that. And so we have that imperative, and we've already got nine products for the vascular surgeons, and we only have two or three products, if you will, for the cardiac surgeons.

George LeMaitre
George LeMaitre
CEO at LeMaitre Vascular

So I think it's a more efficient call point, but it's certainly something we have to think about, particularly since, I would say, the targets that we see, the acquisition targets we see, something like 60% of them seem to be cardiac and 40% of them seem to be peripheral vascular. And so at some point here, the company's going to need two distinct sales channels. That's almost inevitable, in my opinion, but we shall see.

Ross Osborne
Ross Osborne
Director at Cantor Fitzgerald

Okay. Great. And sticking with your sales force, with headcount growing, would you walk through some of the low-hanging fruit and where you can leverage cross-selling?

George LeMaitre
George LeMaitre
CEO at LeMaitre Vascular

Sure. I would say the lowest hanging fruit is in the United States where still, because of that 2020 acquisition, we have really large sales per sales rep. I think in the US, it's something like $1.7 million per sales rep. And as a result, I would say the easiest thing to do is to, as a for instance, this isn't true, but if in Iowa, we only have one rep and they got $4 million worth of sales, let's say that were true, the low-hanging fruit is split Iowa up and have two reps there and have two of them with $2 million in sales. And I think that's where we keep going. We keep going after the really full sales reps who've got too much sales. They can't handle $3 million worth of sales.

Ross Osborne
Ross Osborne
Director at Cantor Fitzgerald

Got it. Thanks for taking our questions.

George LeMaitre
George LeMaitre
CEO at LeMaitre Vascular

Thank you very much. Welcome.

Operator

Thank you. Ladies and gentlemen, that concludes today's conference. I would like to thank you for your participation, and you may now disconnect. Have a great day.

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