LeMaitre Vascular, a global provider of medical devices for vascular surgery, has reported significant growth in its Q2 2024 earnings call. The company announced a 12% increase in organic sales and a substantial 44% growth in earnings per share (EPS). Growth was broad-based across product lines and regions, with the Asia-Pacific (APAC) region leading with a 20% increase. The Americas and AMEA regions also saw healthy growth rates. LeMaitre Vascular is expanding its salesforce and has raised its full-year 2024 sales and EPS guidance. The company also discussed regulatory progress, with 14 out of 22 MDR CE Marks received, and shared optimism about salesforce expansion and regulatory developments in Europe and APAC.
Key Takeaways
- LeMaitre Vascular achieved 12% organic sales growth and 44% EPS growth in Q2 2024.
- Sales growth was broad-based, with record numbers in several product lines.
- APAC region sales grew by 20%, AMEA by 13%, and the Americas by 10%.
- The company plans to expand its salesforce to between 155 and 160 representatives by year-end.
- 14 out of 22 MDR CE Marks have been received, with the rest expected in 2025.
- Gross margin increased to 68.9%, and operating margin reached 26%.
- Full-year 2024 sales guidance was raised by $3.8 million, and EPS guidance by $0.07 per share.
- The company ended Q2 2024 with $113 million in cash and securities.
Company Outlook
- LeMaitre Vascular raised its full-year 2024 sales and EPS guidance, reflecting confidence in continued growth.
- The company is actively seeking acquisitions, particularly in the open vascular surgery field and adjacent markets like cardiac surgery and endovascular.
- Artegraft, the company's largest American product, is expected to receive European approval in June 2025, earlier than anticipated.
Bearish Highlights
- There may be a slight step down in gross margin in Q3 due to manufacturing efficiencies and higher costs.
- The company has not closed a significant acquisition recently due to valuation and divestiture complexities.
Bullish Highlights
- The company's salesforce expansion and regulatory barriers in Europe are contributing to price increases.
- Positive procedural trends in the US and Europe indicate full hospitals and increased credit card swipes, a proxy for healthcare activity.
Misses
- The lack of recent significant acquisitions was noted, with ongoing dialogues and considerations of various factors delaying deals.
Q&A Highlights
- J.J. Pellegrino discussed the company's growth strategy, focusing on maintaining good top-line growth while controlling operating expenses.
- The company is setting prices for 2025 and remains optimistic about their salesforce expansion and regulatory developments.
LeMaitre Vascular, with its ticker symbol LMAT, has shown resilience and strategic growth in a competitive market. The company's focus on expanding its salesforce and obtaining regulatory approvals in key regions is poised to bolster its market presence. With a strong financial position and a clear vision for the future, LeMaitre Vascular continues to navigate the dynamic landscape of the medical device industry.
InvestingPro Insights
LeMaitre Vascular's recent earnings call has highlighted its robust financial health and strategic growth initiatives. To provide a deeper understanding of the company's financial status and market potential, here are some insights based on real-time data from InvestingPro:
InvestingPro Data:
- The company's market capitalization stands at $1.91 billion, reflecting its significant presence in the medical device industry.
- With a P/E ratio of 50.76 and an adjusted P/E ratio for the last twelve months as of Q1 2024 at 56.09, the company is trading at a high earnings multiple, which may indicate investor confidence in its future growth.
- Revenue growth for the last twelve months as of Q1 2024 was a healthy 18.16%, demonstrating the company's ability to increase sales effectively.
InvestingPro Tips:
- LeMaitre Vascular has shown a commitment to returning value to shareholders, raising its dividend for 13 consecutive years, which may appeal to income-focused investors.
- Analyst optimism is apparent, as 6 analysts have revised their earnings estimates upwards for the upcoming period, suggesting potential positive performance ahead.
These insights, along with additional tips available on InvestingPro, can offer a comprehensive view of LeMaitre Vascular's financial landscape. For those interested in exploring further, there are 18 additional InvestingPro Tips available, providing a wealth of information for making informed investment decisions. Visit https://www.investing.com/pro/LMAT to discover more about LeMaitre Vascular's financial metrics and market potential.
Full transcript - LeMaitre Vascular Inc (LMAT) Q2 2024:
Operator: Welcome to the LeMaitre Vascular Q2 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 for LeMaitre Vascular. Please go ahead, sir.
J.J. Pellegrino: Good afternoon, and thank you for joining us on our Q2 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, August 1st, 2024, and should not be relied upon as representing our estimates or views on any subsequent date. 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 is 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 Lame.
George LeMaitre: Thanks, J.J. Q2 is an excellent quarter, featuring 12% organic sales growth and 44% EPS growth. I'll focus my remarks on our top line salesforce and the MDR CE Marks. Our 12% organic growth in Q2 was broad based with 7 of our 12 product lines posting records. RestoreFlow allograft were up 30%, bovine patches 12% and shunts 22%. APAC was our strongest region again, up 20% thanks to Thailand and Korea, our recently converted direct markets. AMEA sales were up 13% in Q2, while the Americas were up 10%. Two of our larger subsidiaries continued to excel in Q2. Canada was up 33% and the UK was up 27%. Both benefited from exceptional RestoreFlow growth. We added seven reps in Q2, ending the quarter with 144, and we're now targeting 155 to 160 at year end. This mid-year expansion is largely about North America, where the territories remain too large. As for our International sales offices, we continue to hire staff into the new Paris office, and we've begun scouting for an office in Zurich. We also continue to evaluate go-direct opportunities in Europe, including Portugal, Czechia, Poland, and Greece. Turning to regulatory. Since our last call, we've received 11 more MDR CE Marks bringing our total to 14 of the 22 approvals we're seeking. These eight remaining CE Marks should be received in 2025. Some analysts believe that only 70% of all MDD cleared devices industry-wide will eventually receive MDR CE Marks. Europe's regulatory barriers have been raised and it's allowing us to capture share. As an example, we now have approximately 90% of the European shunt market due to Bard's CE driven exit. One of the CE Marks, which we expect to receive in 2025 is Artegraft, our largest American product. We have also submitted Artegraft’s applications in Thailand, Malaysia, and Singapore, and we plan to make filings by year end in Australia, Canada, and Korea. Bringing this device to international markets was a key consideration at the time of the 2020 Artegraft acquisition. With respect to RestoreFlow, we now believe our Irish and German approvals will be received in 2025 and 2026 respectively. RestoreFlow needs to be to be approved by each individual country as there is no pan-European approval. We currently have approvals in just three countries, the US, the UK, and Canada, with a combined sales CAGR has been 23% since the 2016 RestoreFlow acquisition. I'd like to welcome back analyst, Jason Wittes of ROTH Capital, who reinitiated coverage in May of this year. In 2014, Jason initiated LeMaitre coverage while at another firm with an $11 target and three headlines, owning a niche disciplined acquisitions and international expansion. To conclude my remarks, 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: Thanks, George. In Q2 2024, we continue to execute the LeMaitre playbook, a targeted call point, niche markets, and a focus on the bottom line. We posted a gross margin of 68.9%, up 490 basis points year over year. The increase was driven by productivity improvements and higher ASPs. Productivity improvements were driven by higher direct labor utilization, lower times to build and lower quality costs. ASP increased 10% in Q2, driven by our highly differentiated Artegraft, valvulotomes and shunt devices as well as our supply constrained RestoreFlow. Our gross margin was 68.1% in Q4, 68.6% in Q1, and now 68.9% in Q2. Operating expenses in Q2 2024 were $24.1 million, an increase of just 6% versus Q2 2023. This compares favorably to last year's 20% operating expense increase, reflecting our shift from significant post-COVID rehiring to a more restrained hiring posture. As a result, Q2 2024 operating income increased 52% year over year to $14.4 million an operating margin of 26%. Our operating income was $10.1 million in Q4, $11.9 million in Q1, and now $14.4 million in Q2. We ended Q2 2024 with $113 million in cash and securities, an increase of $4.8 million in the quarter. The increase was driven by cash from operations of $9.6 million and was partially offset by dividends of $3.6 million. With regard to guidance, sales growth in the back half of 2024 should accelerate into the mid-teens, while operating expenses increased moderately as we continue to build out the sales channel and invest in new regulatory approvals. As a result, we have increased our full year 2024 sales guidance by $3.8 million and our full year EPS guidance by $0.07 per share. Our guidance implies an operating margin of 23% for 2024 and 19% versus 19% in 2023. For more details, please see today's press release. What a few Q3 highlights include: sales growth of 14%; organically gross margin of 68%; operating income of $12 million, up 31%; and EPS of $0.44 per share, up 32%. With that, I'll turn it back over to the operator for questions.
Operator: [Operator Instructions] And our first question will be coming from Rick Wise of Stifel. Your line is open, Rick.
Rick Wise: Great to see this excellent quarter. Let me start off there's -- lot to chew on here. I think let me start off with the sales force expansion. I mean, this is a meaningful step up and you're raising the bar again. Just a couple of questions surrounding it and I'll let you take it away. Just help us understand your thinking behind raising that bar for the rest of the year. And you were particularly emphatic about North America and the territories being too large, implying, I assume the opportunity to split them and help drive increase sales. Just talk us through some of those factors in your thinking.
George LeMaitre: It's George, and I got at a little bit of this last time and as you're pointing out correctly, I feel like there's an expanded feeling of that at this call where we really have opened up a bunch of new territories. It's the same thing, which is -- the years go by and you get this 10%, 12%, 14% organic growth, and I feel like we never really not recovered because it's a good thing, but we never really got the sizes down following the Artegraft acquisition in 2020. So, we're still playing around with these $2 million territories in the U.S. and they're just too big geographically and financially. So about 12 months ago, we teed ourself up for all this by having a sort of a reorg in the sales force where we got four area sales managers. We had never had those before watching over what was then 10% or 11% regional managers. And before that it was just a VP of sales and then nine regional managers. So, I think we're better equipped structurally to handle it now. And so, yes, we've launched a bunch of these things and we'll see when they come on board. Interestingly enough, the hiring is you read in the newspaper, it's easier to hire these days. We're not exactly finding that. It's still hard to hire for us in the sales.
J.J. Pellegrino: Rick, this is J.J. from a financial perspective as well. I mean, it's a nice time to fit them into the P&L and you can see op income going to $12 million in Q1 and $14.4 million in Q2, up 52% for both quarters year over year. And so, it's just a nice time to slot those investments also into the P&L story that we have going on.
Rick Wise: And turning to operating margins J.J. you were very clear in reminding us, and you're basically assuming you hit your targets approaching like a 400-basis point step up year over year ‘24 versus ‘23 in operating margins. A couple things, I guess two questions related to that. One, help us think about the sustainable drivers there. Obviously, volume mix, price you talked about the gross margin productivity, but how do we start thinking about ‘25, ‘26 and beyond in terms of where -- gosh, you could -- what kind of operating margin potential is left? And how do we think about it and is it just doing what you're doing and just help us think through that?
J.J. Pellegrino: And that's a tough one obviously because you're looking way out there and we don't give guidance that far out. But I would say if you remember from way back when we used to say 10% 20% a lot, we're going to grow the top line 10% and the bottom line 20%. And if you do that, you get leverage on the bottom line in terms of an op margin story. Now, I'm not saying we're 10%, 20% anymore and we've certainly been beating that recently and who knows where we're going to go beyond this year because we haven't talked about that. But I would say if you keep having nice top line growth numbers and keep a lid on OpEx, you're probably going to get a good answer there. That said, I mean if you have a 30% op margin number that you're thinking of way out there, I'd be like, no, I don't think that's who we want to be, really. Maybe we could -- if you said to us, do that tomorrow and do it for a year and a half, we could certainly do that by pulling back on expenses. But if we want to keep investing in the medium-term and long-term of the business, which we do, obviously, then you're going to sort of stay range bound to some extent. So, I would say, without totally answering your question, that's sort of the bench post for you.
Operator: Our next question will come from Suraj Kalia of Oppenheimer & Co. Your line is open.
Unidentified Analyst: This is [Seamus] on for Suraj. Thank you for taking our questions. Just looking at the gross margin guidance for 3Q and for the full year. Just kind of wondering put up a very nice quarter there, about 69%. It looks like a little step down in 3Q and I think the full year was lowered a little bit, but you guys raised -- revenue guidance, increased EPS guidance, just looking to understand the puts and takes there if you could.
J.J. Pellegrino: If you look at our Q3 guidance of 68%, then you can sort of impute a little step up in Q4 to 68%, two or three or four or something like that. And so that's the cadence for you. I think the Q3 step down is a number of things. One is our manufacturing team has been doing an awesome job and they've been really pulling through a lot of efficiencies, and I'm sort of trying to outguess that and say maybe that doesn't continue sort of steadily throughout the rest of the year. So maybe that's thing one. Thing two is, we know we have some higher cost coming at us on the RestoreFlow side, so we take that into account and maybe some E&O topics outside the U.S. coming up for the back half of the year. So, I'll take that into account. And then seasonally, oddly, generally speaking, Q3 is lower in the year, then sort of the other quarters in the year. So, it would make sense that you would step down in Q3 maybe and then move back up in Q4. I don't know if that totally answers and gets at what you were asking.
Unidentified Analyst: And just kind of two are more from my end and I'll just kind of throw them together. Any latest updates on M&A? I know I think you said last quarter you were talking about two different companies, just kind of wondering what the -- any updates that you can give there? And then secondly, you guys have seen sorry -- we've seen you take a lot of price so to speak in terms of this past year kind of as we start to firm up our models for ‘25 where is there still up where you can take price? What do you think kind of -- what numbers are you looking at? Any color there would be helpful.
Dave Roberts: [Seamus], I'll take the acquisitions question then maybe I'll turn it over to George on price, but on acquisitions, I mean obviously, there's nothing too specific that I can share with you. The acquisitions department is healthy, is busy. We just added another person to the department. And we continue to seek out the same targets with the same criteria. Of course, what's nice is that our cash balance is growing. Our EBITDA is growing. So, the size of deal we can look at is increasing, and I'd say everything else equal, we would prefer to do a larger deal. There are various active targets at various stages and when I can disclose more, I will sometimes you think things are moving along and they don't. But we continue to be active and I do expect at some point, I don't know exactly when we will be able to announce something, but I don't know if it'll be this year or next year, whenever, but what we're not sitting our thumbs.
J.J. Pellegrino: And [Seamus], on pricing. I would say concretely for 2025, you won't -- we're not going to try to set our prices until November or December. So, there's that a little bit. If you wanted to get some insight into how we price. I think we've updated our slideshow on the internet, on our website and it shows the last four years of pricing, I think they were 8, 8, 12, and 8 or something like that. And also, it puts it up against the CPI. So, to see what kind of price, so you could look at that and you could make your own inferences about where you think we're going. A couple of the things I would say is that the two items really help us with doing more price hike, which is when we expand the sales force, a lot of the responsibility that we put in the hands of a sales rep is to go get that price hike. When you see us expanding the sales force, that's our army to get price hikes of course. And then also in Europe where, the CE mark, the transition of the MDR is putting up a lot of barriers, and I think they're making it significantly easier to pass along price increases as long as you stay in your segment because a lot of the other companies are electing not to stay in the segment. It's to just not file for the MDR CE mark. So, barriers to entry help us, salesforce expansion helps us. And then, the record's fairly clear over the last four years. If you could surmise what you think we might do next year.
Operator: Our next question comes from Jason Wittes of ROTH. Your line is open.
Jason Wittes: A solid quarter here. And I guess also thanks for the mention at the beginning, I guess if $11 was my target. You guys have done great on execution since I last looked at you guys, so congrats on that as well. That said, so a couple questions. One, I apologize from the -- if this was mentioned already, but can you break out what price and volume was in the quarter for revenues?
J.J. Pellegrino: Sure. So organic growth was 12 and 10 was price and 2 was units.
Jason Wittes: That's helpful. And then you mentioned shunts are benefiting from bar dropping out. I'm wondering, if there are other large product lines that are also seeing competition drop out, especially in the biologic front over in Europe?
George LeMaitre: Yes, interesting. You mentioned biologics that the first place I would go to, which is we've seen patches, biologic patches by Abbott, and then I think BioIntegral, a Canadian company, drop out of the European markets. That's helped us a lot with XenoSure over in Europe as well as CardioCel over in Europe.
Jason Wittes: Are these, I mean, is this driving the upside to the year or is this the sales force addition that you've recently added?
George LeMaitre: I would say over last….
Jason Wittes: For everything?
George LeMaitre: Yes, I think over the last two or three years we felt the dropping out of competition allowing us to do pricing and giving us better unit share. And then I think the European rep surge, if you will, came a little bit earlier than the American rep surge, so I feel like they picked up a bunch of reps. I can do the numbers. Here, we had 47 reps a year ago. Now we have 52 over in Europe. And so, they've had a bit of a surge in Europe, and that's helping us as well.
Jason Wittes: And then just I don't know if you also break out on gross margins between biologics and I guess non-biologic for implants. If there's a breakout there that we could track, meaning what's the gross name?
George LeMaitre: So, we don't do that. We just give one number. I think sometimes we answer are they above corporate or below corporate. And if you ask what -- which particular brand are you interested in?
Jason Wittes: I'm just the bovine patches and the allografts, I imagine they're a little bit different, but you've had a nice rise in gross margin. I always thought part of that was due to the fact that you've improved your yields dramatically on the biologic front. I thought that was a major driver. I don't know if that's the case right now.
J.J. Pellegrino: Jason, this is J.J. So, generally, when we say RestoreFlows done well and Dacron has done well, that's going to hurt the margin. And generally, when we say, XenoSure is doing well and Artegraft doing well, that's generally going to help the margin. That's helpful directionally for you.
Jason Wittes: I’ll jump back in queue.
J.J. Pellegrino: Thanks Jason.
George LeMaitre: Hit a little quiet pocket here. So, I know there's a couple other questioners out there. I don't really know how to get to them. Would the operator want to introduce the next questioner?
Operator: Certainly. The next question is coming from Danny Stauder of Citizens JMP. He’s on the stage.
Danny Stauder: So, I guess just first real-quick on the sales rep adds. I know, you upped your full year target, but could you just give any color on your plans or your expected cadence for adding these new reps? And with that, how long does it typically take for these new reps to ramp up to the corporate average or even above the corporate average typically?
George LeMaitre: Danny, I've handled this question a number of ways in a number over the years, and I always give an unsatisfactory answer, but I'll try it again. I'll try something different here, maybe. The cadence for hiring is we put a lot of approvals out there and our guess that we're trying to do for you guys right now is that will 155 or 160 reps by the end of this year. And I think what happens after that, I don't know, but it feels like we'll get to that. So, there's the timing of that. And then the second question you're asking is, when do they get up to snuff? And I would say we've done a couple studies around here lately, and oddly the good ones get up to snuff right away, and the ones that aren't going to make it don't get up to snuff. And so, it's not really that much about time. I think in the old days, the answer we would give to everyone, the generic answer was about nine months until really get going and understand everything. But in terms of, if you really look and study quota for all these reps that come on board, it happens pretty quickly for a good guy, a good woman who's doing a good job at the sales position.
Danny Stauder: And then just one more for me. Asia-Pacific really strong again, you talked about some of the drivers there, but as we look out for the rest of the year or I guess in the back half and into 2025, how much of a runway is there for this outsize growth?
Dave Roberts: I think the runway there, I don't, and it never guide past the year that we're in. So, we're in 2024 for these six months, I think there's terrific runway and space for the APAC. We're on fire over there, we're starting all these new entities and I said on the last call, it's this just simply an old-fashioned virgin territory play, where we didn't exist in Asia except for Japan until about 10 years ago. So, I feel really excited about what's going on over there. And they also have half of the approvals have not -- we have not got into the half of the approvals that we need over there, whereas in Western Europe and North America, you largely have all the approvals that you need right now. And in Asia that's not true. You're 50%-ish.
Operator: Our next question will be coming from Michael Sarcone of Jefferies. Your line is open.
Michael Sarcone: You talked about adding reps particularly in North America and some of these territories getting up to $2 million. Sometimes, we do see potential for disruption. When you do split sales territories, I guess, how confident are you that you can split some of these territories and not cause any disruption and basically how do you plan to mitigate the risks there?
George LeMaitre: It's true, sometimes there is a kerfuffle when you break up a territory, the person doesn't want it to happen, the person does want it to happen. So yes, that's true. Although, I would say, we've been doing this for years and years and years in Europe and the U.S. and so how we do it, I think is, I think we do it the right way, which is we announce it early, we're very open about it, and we pay double commissions for the back of the year after the person gets hired in the new territory. So, the person who's running the, who was previously running the territory is getting full commissions the whole time. And then when the new person comes on, let's say in October, they're getting commissions on that on the split, the smaller territory that's been split off and so is the sort of legacy rep there. So, we try to do it like that and we always tell the reps that we believe the way it'll be set up, your W2 will go up next year. So, we have a new plan every year and it takes into account what their base quota was with the new smaller territory.
Michael Sarcone: And just one on 2Q, really strong gross margin expansion there. I know J.J. mentioned, on the manufacturing side, your team has been doing great work. I was just curious, if you could help parse out, how much of that year over year expansion was related to these solid productivity improvements versus the price taking?
J.J. Pellegrino: Yes, Mike, so about half of that was the ASP, so 9%, 10% ASP increase sort of equates to 2.3%, 2.4%, good guy on the gross margin, which is nice. And then the rest of it basically sort of manufacturing improvements around ES manufacturing team being more efficient, being more utilized, reducing their times to build, but also our quality costs have been flat now for a little while and it's, I think it's a nice story within the Company that we don't really see too much outside of it, but it's popping through now in the gross margin line and helping about 0.3% or so year-over-year, just keeping that sort of constant.
George LeMaitre: Thanks, J.J., and if I could just squeeze in one more. Just on pricing averaging about 9% for the first half of this year. Do you feel like that's sustainable through the back half and is that what's baked into the guidance?
J.J. Pellegrino: We have I think 14% organic in Q3 and implied 14% organic in Q4. We try not to split out what of that is going to be units and what is going to be pricing. But it seems like you got a couple quarters that you can run with and figure it out.
George LeMaitre: Mike, as I was trying to say in my script portion these differentiated devices in these categories with lower rivalry, where you have big market share really allow you to sort of take advantage of some of that to some extent. And it's sort of a nice tailwind there. And then on the RestoreFlow side, there's a supply constraint issue. And so if we can make them, we can generally tell them they're really in high demand in the marketplace and that helps as well. So, some nice dynamics as tailwinds for pricing.
Operator: Our next question will be coming from Michael Petusky of Barrington Research. Your line is open.
Michael Petusky: So, George, I'm just curious with the positive comments around APAC. Anything new in China worth talking about? Or is that just not a market that, that is worth the time and energy when you've got everything else going on over there?
George LeMaitre: So, we've been up and down on this one. We were all excited about it for five years, and then I think we tried to make it sort of a four-letter word on these conference calls for the last five years. And I feel like two good things are happening here. One is the small organic business that we do have of about five different products approved. It's hard to get approvals over there. That business is really doing well right now. It's small. I think it's about a $1.3 or $1.4 million run rate business right now. But I think I mentioned this on the last call. We had a 93% growth rate in Q1, and then in this quarter Q2 we had a 35% growth rate. And I don't see that slowing down. I mean, it's a big country as and we have four sales reps right now. So, to say that we've only scratched the surface would be the understatement of the universe. So that's one thing. Second thing that's probably more exciting is this crazy eight-year clinical trial that we're involved in. Again, we don't bring it up much. Maybe we're doing it now on a response to a question, but it's just been this long thing. And it does feel like if you can believe me now, which you -- I've been a liar for the last seven years, so if you can believe me now, we're making our final submission in November, and we believe we'll have the approval for XenoSure in next year. So, let's see. But that is the call.
Michael Petusky: Cardiac.
George LeMaitre: What's that? For the Cardiac. Excuse me, for the cardiac XenoSure, and also, we have peripheral XenoSure, but we're sort of thinking maybe we'll wait till we get the cardiac approval and then do that as a submission change to the submission. So, it feels really good right now on those two fronts, but it is quite small for a -- what our guidance is 218 million for this business this year. And it's a $1.4 million business. So, I guess it's pretty small.
Michael Petusky: What's the turnaround on regulatory body over there on a trial where you've submitted the data in like November? I mean, is it six months? Is it 12 months? What's the turnaround for a potential approval?
George LeMaitre: And when I say this submission, this is the quote, final submission. We've had two or three other final submissions, which came back making data requests and things like that. So, the word out of my regulatory group is, okay, this is the last final questions that they want. And then in six or 12 months, you're going to get your approval. So, supposedly it's Q2 to Q4 next year we get XenoSure in China, but we'll see. I don't, we've lost faith in the timing on this topic a long time ago.
Michael Petusky: Don't bet my house…
George LeMaitre: No, I bet your house on organic growth and other markets not.
Michael Petusky: Absolutely. Just real, quick and you guys talk faster sometimes than I can take notes. On Artegraft, you may have mentioned it at in the prepared remarks, but have there been any additional regulatory approvals OUS on Artegraft, in the last 90 days or what's there going forward?
George LeMaitre: That's the big good question. I'm glad you're asking that. Maybe we glossed over it quickly, which is, so, we're applying in seven different places all Europe as a whole, let's call it. And then in the prepared remarks, we're talking about Thailand, Malaysia, Singapore have already been approved -- excuse me, have been applied for, and then Australia, Canada and Korea will go in by the end of this year. One positive thing that happened in the last, I don't know, three or six months here has been that we had previously thinking, been thinking that Artegraft was a late 2025 approval, and we're now thinking it's more like a June approval of 2025 -- excuse me, in Europe. Sorry about that. Thanks Dave. In Europe, the CE mark. We feel really good about that. And so that's -- it's been drawn forward a little bit and usually you don't hear us do that. That's the biggie because, this is our largest American product. I think sales are approximately $33 million this year annualized for Artegraft. We talked on the last call that maybe there's an $8 million market over Europe, and then maybe we were just sort of, this is very high-level stuff, but maybe there's another $8 million market over an APAC or something like that. This is the big one that we want to get approved and things are going well in the approval process in Europe.
Michael Petusky: If I could just sneak one last one in for Dave. In terms of M&A, obviously this is probably the longest period of time that at least since I've been around that I can remember you guys not doing anything like super meaningful in terms of external growth opportunities. What are the hangups? I mean, is it just a lot of valuation? Are you not seeing the assets that really strategically make sense? Like what are you coming, I guess, coming up against in terms of just this sort of gap in closing a meaningful deal? Last few things.
Dave Roberts: Thanks Mike. I mean the target pool where, if we stick very close to our call point, which is open vascular surgery, they are on 25 targets with more than 5 million or 10 million of revenue. And so, we obviously know who they all are. We have ongoing dialogue. Those targets product lines are owned by about 18 companies. And some of those companies have never done divestiture. So, we've been very close to those targets, et cetera. But we've also expanded a little bit. We've looked in an adjacent field, cardiac surgery. I think, some cardiac surgery products are, would work better inside LeMaitre than others because some are crossover used by vascular surgeons and others aren't. But there's a strategic question there about, do you want to get in a cardiac surgery and how much and which products? And then also on the other side, another immediately adjacent market is endovascular. And while some of the products, there are dozens of products that are endovascular, some are more used by our physician specialty, the vascular surgeon than others. But what you run up against there is much more competitive markets. A lot of bigger players in that space. And then also endovascular products get used by other specialties like interventional cardiologists and radiologists. So strategically, we're factoring all of those things in. The good news is, I think, as I mentioned on previous calls, we've been active with letters of intent over the last couple, few years. Sometimes, it's valuation. Sometimes, there's a divestiture from a large company and they want to sell us a bundle of products and we want some, but we don't want others. So, we might bid just for what we want, but they don't want to sell the garage without the house, et cetera. So, I think that's some of what we're up against. But I would say, we're not discouraged at all. I mean, to state it positively, we're waiting for our pitch. And I've done this long enough that I know doing an acquisition that isn't strategically on is very painful. It takes a long time to unwind that. And you're much better off just waiting for the right strategic target and at the right price. And so, in the meanwhile, we're just building our cash. And I'd say, if I could just add one more idea it's been a nice opportunity for the Company, if you will really get the house in order with respect to regulatory and quality and salesforce optimization and all that. So, you see the Company performing well while we're building the bank account. At some point, you'll get news from lame, but that I hope answers your question
Operator: Our next question will be coming from a Frank Takkinen of Lake Street Capital Markets. Your line is open.
Frank Takkinen: Congrats on all the progress. Maybe I'll start with kind of following up with what you were alluding to right at the end of that last question, Dave. Maybe is the sales force and kind of double down in a way, expanded hiring goals for the year, a function of the bright acquisition not showing up and in turn saying we have the right product portfolio right now, let's maybe double down a little bit more on the sales force and get prepared in that way instead of kind of going the wrong -- going down the wrong avenue with the wrong acquisition.
Dave Roberts: For sure. I mean, look, we you can grow two ways in this life. You can go grow organically or inorganically. And what I focus on a lot for the Company is the inorganic growth. And sometimes that's only so much within your control. On the organic side there are buttons you can push. And clearly for us adding sales reps is a critical growth driver. Expanding the channel, not just filling in reps in the United States and other markets where we're already direct, but investing in new countries like Korea and Thailand. And as George mentioned on this call, there could be others in Europe maybe next year. And so, that's really important. Getting the regulatory approvals in new markets, that's really important. Getting and supporting price increases, that's really important. So, there are a bunch of things we can do to accelerate organic growth. And I would say at a high level, it feels like that's been working. So, while my -- me and my team, while we've been off hunting for the next deal, I would say the organic growth team and the organic operations team here is doing a really excellent job pushing the business forward and we're getting stronger in all departments. So, the day when we do an acquisition, I think our ability to integrate is just that much more strengthened. So, I guess, that's how I'd answer that question.
Frank Takkinen: And maybe a little bit bigger picture question on Salesforce (NYSE:CRM) productivity. I think, you alluded to it on this call, the U.S. reps over 2 million. I think in previous calls you kind of said EMEA reps in the just over 1 million range. And then APAC reps a little below 1 million, I think around 700,000. Where can those international reps really mature from a utilization standpoint?
J.J. Pellegrino: That's a good question. Frank, thanks for remembering the figures from the last phone call. So, we actually have answers to that already, which is in Germany and the UK, you have reps pushing 1.1 million, 1.4 million euros or pounds in those respective markets. So, there's no reason they can't get larger size and can control more revenues than what they are right now. So, it does happen overseas and I think, I have one example over in I think the Nagoya rep is something like $800,000 in revenue. So, it does happen over there. It is taking longer. And of course, pricing is lower in all those places, it takes more units to get there.
Frank Takkinen: Then last one, maybe just housekeeping item, 144 reps plus seven, mostly U.S. Can you give us that breakout U.S., EMEA and APAC?
J.J. Pellegrino: Right now, we have 67 North American reps, 52 European reps, and 25 Asia-Pac reps, and that should get you to 144.
Operator: [Operator Instructions] Our next question will come from Brett Fishbin of KeyBanc Capital Markets. Your line is open.
Unidentified Analyst: This is actually Liv on for Brett. If I could just start a little bit more broadly, could you share what you've been seeing in regards to procedural trends in the U.S. and Europe? We've got into some mixed commentary so far and we'd just love to get your take.
J.J. Pellegrino: Interestingly enough, it's your data that we'd go to for a lot of this with those credit card swipes. And so, beyond what we see for our sales units and dollar growth, we then go back to the KeyBanc Capital Markets data, and we try to figure out what's going on. I think you'd corroborate this, which is, it's been a very healthy six months of staffing inside the hospitals, which we get from the Bureau of Labor Statistics and then also credit card swipes, general credit card swipes in the hospitals are up and it's indicating full hospitals. So ironically, you're asking that question to me, but I'd flash it right back at you.
Unidentified Analyst: I'm glad we can be abused to you guys, could you also update us on where you're at with the new ERP implementation and what that timeline looks like?
George LeMaitre: Yes, so we implemented in the U.S. on February 1st and then spent the next two months putting out fires and keeping the business functioning. And we've sort of started to settle down on that topic and we've started looking towards Europe. And so, we recently signed an agreement to start our implementation in the UK as our first European geography. And we'll create a template of sort of what Europe needs from an ERP perspective, and then, we'll roll that out to the other geographies in Europe, maybe Germany next, and then Italy and France, et cetera. So, it's ongoing.
Operator: Thank you. Ladies and gentlemen, that concludes today's conference. I would like to thank you for your participation. You may now disconnect. Thank you and have a great day.
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