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Edited Transcript of LMAT earnings conference call or presentation 6-Feb-20 10:00pm GMT

Q4 2019 LeMaitre Vascular Inc Earnings Call

BURLINGTON Feb 13, 2020 (Thomson StreetEvents) -- Edited Transcript of LeMaitre Vascular Inc earnings conference call or presentation Thursday, February 6, 2020 at 10:00:00pm GMT

TEXT version of Transcript

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Corporate Participants

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* David B. Roberts

LeMaitre Vascular, Inc. - President & Director

* George W. LeMaitre

LeMaitre Vascular, Inc. - Chairman & CEO

* Joseph P. Pellegrino

LeMaitre Vascular, Inc. - CFO, Treasurer, Secretary & Director

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Conference Call Participants

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* Alex Silverman

AWM Investment Company Inc.

* Andrew Christopher Ranieri

Stifel, Nicolaus & Company, Incorporated, Research Division - Associate

* Frank James Takkinen

Lake Street Capital Markets, LLC, Research Division - Equity Research Analyst

* James Philip Sidoti

Sidoti & Company, LLC - Research Analyst

* John Young;Canaccord Genuity;Equity Research Associate

* Joseph P. Munda

First Analysis Securities Corporation, Research Division - VP

* Michael John Petusky

Barrington Research Associates, Inc., Research Division - MD & Senior Investment Analyst

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Presentation

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Operator [1]

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Welcome to the LeMaitre Vascular Fourth Quarter 2019 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. JJ Pellegrino, Chief Financial Officer of LeMaitre Vascular. Please go ahead, Sir.

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Joseph P. Pellegrino, LeMaitre Vascular, Inc. - CFO, Treasurer, Secretary & Director [2]

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Thank you, Liz. Good afternoon, and thank you for joining us on our Q4 2019 conference call. With me on today's call are our Chairman and 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, February 6, 2020, 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 numbers as well as adjusted operating income growth, operating income excluding certain onetime gains and charges and EBITDA. 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.

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George W. LeMaitre, LeMaitre Vascular, Inc. - Chairman & CEO [3]

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Thanks, JJ. In Q4, we posted record sales of $30.2 million, up 6%. Biologic patches, embolectomy catheters and valvulotomes led dollar growth. The recently acquired CardioCel patches ramped quickly, generating $1.4 million in Q4 sales. And the July 2019 Tru-Incise acquisition also had a strong Q4 with $500,000 in sales.

The Americas had a record quarter, up 6%, while Europe grew 4%, and Asia Pac was up 20%. Asia Pac's momentum was fueled by export growth of 53%, while our 3 direct markets of China, Japan and Australia all grew 10%. In Q4, we bought out our Singapore distributor and are now direct to hospital in that 6 million person city state. We're now direct to hospital in 23 countries and have 11 sales offices worldwide.

Biologics accounted for 37% of our sales in Q4. The biologics theme is not a new one if you've been on our earnings calls. Vascular surgeons seem to prefer biologic patches and implants versus synthetics. The recent CardioCel patch acquisition allows us to leverage our expertise in manufacturing and distributing biologics while gaining access to a new customer, the cardiac surgeon.

Separately, we're currently launching cardiac allografts in the U.S. and Canada, leveraging the 2016 RestoreFlow acquisition. We are also setting up to distribute RestoreFlow vascular allografts in Europe in H2 2020. This will be a first for us.

2019 was a bounce-back year. Organic growth improved to 6%, and the 4 acquisitions of 2018, 2019 performed better than expected. All 4 purchases were in familiar categories: embolectomy catheters, polyester grafts, valvulotomes and bovine patches.

We also improved our bottom line in 2019, with adjusted op income growth of 3% versus a 2% decline in 2018. Excluding the effects of the strong dollar, adjusted operating income grew 8% in 2019. As our guidance indicated, we expect this momentum will extend into 2020 with 10% sales growth and 17% op income growth.

A quick note on dividends. Our Board has just increased the payout for the 9th straight year this time by 12%. If we raise dividends in Q1 2021, I believe we gain entry into the Dividend Achievers Index, a 10-year version of the well-known 25-year Dividend Aristocrats Index. I highlight our history of growing dividends to underscore how we will continue to focus on op income and cash flow growth.

With that, I'll turn the call over to JJ.

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Joseph P. Pellegrino, LeMaitre Vascular, Inc. - CFO, Treasurer, Secretary & Director [4]

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Thanks, George.

Our Q4 2019 gross margin was 66%, down 1.7% versus the prior year period. The decline was driven largely by lower margins at our China subsidiary, higher polyester graft sales, the 2 recent acquisitions and the stronger dollar. As our guidance indicates, we expect the gross margin to remain flat in Q1 but improve thereafter. Q2 gross margin gains should be driven by manufacturing efficiencies while longer-term improvement should arrive as we begin selling Burlington-manufactured Omniflow and then Syntel products. Our Omniflow factory in Australia will be closed in Q2, and we will soon be manufacturing Syntel in Burlington.

In Q4 2019, our adjusted operating income was $4.9 million, down 12% from Q4 2018. The decrease was driven by a lower gross margin and an adjusted operating expense increase of 10%. In the full year 2019, operating income increased 3% or 8% excluding the effects of the strong dollar. Looking forward, our full year 2020 guidance implies an operating income increase of 17% to $24.7 million at the midpoint, an important sequential improvement from 2019.

This deserves some explanation. As you know, cost containment has been staple at LeMaitre over the years, and we will redouble our efforts in this area in 2020. Our guidance implies a 6% increase in expenses, down from 10% in 2019, as we find ways to avoid some costs and reduce others. In addition, with the large acquisitions of 2019 coming onstream for the full year, we anticipate that our record revenue growth of $12 million will also drive profit growth.

We ended Q4 with $32.7 million in cash, a decrease of $12.2 million during the quarter. The decrease was driven by acquisition-related payments of $16.4 million, capital expenditures of $1.4 million and dividends of $1.7 million. EBITDA in Q4 2016 was $6.5 million. And for the full year 2019, EBITDA was $26.4 million.

Our Q1 2020 sales guidance of $30.5 million to $31.7 million represents a year-over-year increase at the midpoint of 9%. We also expect Q1 2020 operating income of $3.8 million to $4.6 million, a decrease of 6% at the midpoint. Our full year 2020 sales guidance of $127.4 million to $130.8 million represents a year-over-year increase at the midpoint of 10%. We also expect full year operating income to be $23.6 million to $25.9 million, an increase of 17% at the midpoint.

As noted in our Q3 2019 10-Q, the transition from MDD to MDR in Europe requires more costly testing and data collection for most devices. All companies are undergoing this MDR transition. Separately, we had to refile our existing MDD approvals with the new notified body as our previous provider abandoned CE mark support. We expect this to largely resolve in H1 2020. In the interim, we have overstocked our Frankfurt warehouse to lessen any sales impact. We've tried to include any anticipated effects of MDD and MDR in our guidance.

With that, I'll turn it over to the operator for questions.

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Questions and Answers

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Operator [1]

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[Operator Instruction] Our first question comes from the line of Jason Mills with Canaccord Genuity.

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John Young;Canaccord Genuity;Equity Research Associate, [2]

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It's John Young on for Jason. Your 2020 guidance portends a more back-ended load year for both top and bottom line. Could you walk through in more detail the cadence of quarterly growth and operating margin leverage, coupled with corresponding drivers to the back-end-loaded guidance in terms of product launches, year-over-year comparisons or other drivers?

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Joseph P. Pellegrino, LeMaitre Vascular, Inc. - CFO, Treasurer, Secretary & Director [3]

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Sure. This is JJ. Maybe I'll start on that. There was a lot loaded in there. But I guess, I would say, on sales line, the reported sales growth by quarter is a fairly even cadence. It sort of feels not necessarily to vary on a reported sales basis by quarter. Although this quarter and looking back next year, this quarter might be an easier comp if we think about it that way in some ways. So I would say not necessarily on the sales line.

On the gross margin line, we're talking about Q1 being sort of static with where we are now but getting some nice manufacturing efficiencies potentially in Q2. And so maybe like a nice pickup there on the gross margin line and then sort of come back down to somewhere in between maybe where we are in there and sort of getting to that number that we guided for the year. So I think that's sort of how your gross margin feels as you go throughout the year.

And then in terms of operating expenses, I talked about cost cutting. And so we typically have a pretty highly loaded op expense line in Q1 because of our worldwide sales meetings and higher fringe and audit and tax work that's getting done around the turn of the year and all that kind of stuff. And that will naturally decrease a little bit throughout the year. But in addition, we're going to be doing some cost cutting pretty seriously, I think, as we go through the next quarters. And that should really help your OpEx line decrease over time. So if you're looking for the cadence of how that bottom line improves, you can sort of try and model out what I just told you.

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John Young;Canaccord Genuity;Equity Research Associate, [4]

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Great. And then my follow-up is that gross margin took another leg down in Q4 and guidance doesn't reflect much recovery in 2020. Could you give us your thoughts on medium to long-term trajectory of your gross margin? And any aspirations to maintain or improve gross margin specifically going forward? And how important is gross margin to you relative to other metrics, such as organic growth or operating margin leverage?

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Joseph P. Pellegrino, LeMaitre Vascular, Inc. - CFO, Treasurer, Secretary & Director [5]

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So gross margin is obviously a pretty important metric for us. It's a big part of the answer on the bottom line. You can see, as we've done 4 acquisitions over the last 12 months, that's had a pretty important impact on the bottom line, and that's because it's driven down our gross margin. That's typical for LeMaitre. We'll do the acquisitions. They'll hurt the margin for a while, we'll eventually incorporate or transition manufacturing into the Burlington facility, and we'll rebound on those margins. But we did our 4 deals in 12 months, and so that's clearly having an impact. So I would say, I've given you sort of a look through the year in terms of gross margin. I'm not going to guide you past that in terms of past 2020. I think that's a pretty good look for us.

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Operator [6]

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Our next question comes from Rick Wise with Stifel.

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Andrew Christopher Ranieri, Stifel, Nicolaus & Company, Incorporated, Research Division - Associate [7]

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It's Drew Ranieri on for Rick tonight. I guess, first, just wanted to touch on 2020 profitability from a different angle. I understand some of the 2020 headwinds. You've talked about them before on some of the recent calls. But just can you help us understand your commentary a bit more regarding the restrained 2020 OpEx spending? I mean should we read this as you -- as LeMaitre taking your foot off the gas to drive growth enhancing or growth sustaining investments, limiting R&D or sales force hires? Just help us think through where are these cost-cutting initiatives coming from basically.

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George W. LeMaitre, LeMaitre Vascular, Inc. - Chairman & CEO [8]

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Andrew, this is George. I'm going to go at this one a little bit differently, which is, actually, op expense is slated to grow 6% 2020 -- in 2020. It did grow 10% in 2019. And I feel like a lot of that had to do with that Q4 acquisition we did, the Admedus acquisition that you know. And I think 6% is not that much of a stretch. We will have to do cost cutting to get there, but it's not that bad. If you look back at our OpEx, the cadence, to use that word, is 10% in '19, 7% -- this is op expense growth, 10% in '19, 7% in '18 and 6% in the year before that, 2017. So to get us to 6% this year, yes, we're going to have to do cost cutting, but it's very doable for us. I think the bigger piece, as you look at -- when you look at our -- wow, these guys are doing a 17% op income growth.

I think the bigger piece, the secret piece to me that I sort of started figuring out as we're getting close to this call was we're loading on a record amount of dollar growth next year. We're putting on $12 million of dollar growth. And I don't want to make myself look silly later, but if you can't -- with that $12 million of dollar growth from these acquisitions and the organic growth, you can't make something happen on the bottom line, well then maybe you should be restraining op expense a little bit. But I think the picture for me is a little bit more about, wow, there's a lot of sales going on top of this company next year.

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Andrew Christopher Ranieri, Stifel, Nicolaus & Company, Incorporated, Research Division - Associate [9]

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Got it. But just to be a little bit more specific when you're talking about cost-cutting initiatives, is this just -- is it headcount? Or is it pulling back on R&D projects? Can you refine that just a little bit more?

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George W. LeMaitre, LeMaitre Vascular, Inc. - Chairman & CEO [10]

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No, like I said, it's still -- op expense is still growing 6%. So I don't want you to think this is some kind of draconian thing going on inside the company. It's going to -- op expenses are going to grow, but we're going to be a little bit better than what we were last year. And if you look at last year, with 10% op expense growth, I don't know the figure right now, but the amount that we got by buying that company in Q4 was substantial. Did anyone have that number, that's an interesting number? Because without that, probably op expense growth was 8% or something like that. So pulling back to 6% shouldn't be that big of a deal.

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Andrew Christopher Ranieri, Stifel, Nicolaus & Company, Incorporated, Research Division - Associate [11]

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Okay. And then just sticking with 2020 guidance for a second. Just backing into 2020 organic growth, it looks like it's decelerating from 6%, maybe down into the low single digit to maybe 5% range. Just first, is that math right? And maybe kind of what are your expectations for organic growth in 2020. And maybe just help us understand some dynamics there in deceleration, is that all MDR-driven?

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George W. LeMaitre, LeMaitre Vascular, Inc. - Chairman & CEO [12]

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Right. Okay. So good question. So the answer is yes, that number is right that you pulled out. So we expect 10% reported growth and 5% organic growth. A piece of this that you don't know or you couldn't know about is the OEM business inside our company is slowing down, and this is a business that it comes and it goes and it's slowing down right now. So I feel like that pulls about 1 point off of it next year. So if that were not the case, maybe you're sort of a 6% company. And furthermore, the MDR stuff pulls about -- we figured about EUR 800 out of sales, which is worth about 0.5 point. So you could if you wanted to, although we're not really that guy. We just -- we're going to grow 10% reported. There's going to be a lot of ins and outs and puts and takes inside of it. But you have a couple of things slowing you down there, the OEM as well as the CE mark stuff. And then to put the number in context, Drew, we're really excited about 2019 being a 6% growth versus a 3.8% growth in 2018. And so this 5% growth next year, with the takes from those 2 items I mentioned, it seems okay to us. Would we want it to be better? Of course, we would.

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Andrew Christopher Ranieri, Stifel, Nicolaus & Company, Incorporated, Research Division - Associate [13]

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Got it. And then just one last housekeeping question. Just can you talk about maybe what pricing was in the quarter? And any top line growth for Omniflow, XenoSure, RestoreFlow, anything that you can give there?

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George W. LeMaitre, LeMaitre Vascular, Inc. - Chairman & CEO [14]

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Sure, we can. I'm trying to think about how we approach that. So pricing, what was pricing in Q4, you mean?

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Andrew Christopher Ranieri, Stifel, Nicolaus & Company, Incorporated, Research Division - Associate [15]

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Right.

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George W. LeMaitre, LeMaitre Vascular, Inc. - Chairman & CEO [16]

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I think at a high level, we said it was -- Dave, you cited this pretty close.

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David B. Roberts, LeMaitre Vascular, Inc. - President & Director [17]

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Sure. So Drew, pricing was down in the quarter about 3%. It happened to be driven by a large disposables order in China. JJ mentioned China earlier of TRIVEX. Units were up 4.5% and then mix offset by 1.5%, also like price. So that was that. I think you asked about RestoreFlow. That was up 12% in Q4.

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Andrew Christopher Ranieri, Stifel, Nicolaus & Company, Incorporated, Research Division - Associate [18]

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Got it. And XenoSure and Omniflow?

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David B. Roberts, LeMaitre Vascular, Inc. - President & Director [19]

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I don't have Omniflow on my fingertips. XenoSure was flat.

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George W. LeMaitre, LeMaitre Vascular, Inc. - Chairman & CEO [20]

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2% organic growth for XenoSure for all of 2019.

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Joseph P. Pellegrino, LeMaitre Vascular, Inc. - CFO, Treasurer, Secretary & Director [21]

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Yes. The Omniflow was up mid-single digits.

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Operator [22]

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Our next question comes from Joe Munda with First Analysis.

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Joseph P. Munda, First Analysis Securities Corporation, Research Division - VP [23]

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So George, I was just wondering if you could give us a breakout of what the rep count looks like at the end of the year, given the guidance going forward? I think it would be helpful.

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George W. LeMaitre, LeMaitre Vascular, Inc. - Chairman & CEO [24]

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Sure. So you mean Q4 2019, like the December 31 we just finished?

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Joseph P. Munda, First Analysis Securities Corporation, Research Division - VP [25]

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Yes.

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George W. LeMaitre, LeMaitre Vascular, Inc. - Chairman & CEO [26]

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Okay. So 54 in the Americas, that's up 2 from Q3; 40 in Europe, that's down 1; 18 in Asia Pac, that's up 2; and worldwide, 112, being a total of up 3 from the end of the quarter, the previous quarter.

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Joseph P. Munda, First Analysis Securities Corporation, Research Division - VP [27]

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Okay. And then as we think out going forward, you're talking about OpEx spend slowing down going forward. Is that 112, is that the right way to think about going out through 2020? Or do you think you'll continue to pick up reps going forward? And then, I guess, with everything that's going on in China, how does that, I guess, craft your thinking both from the rep perspective as well as operationally with essentially China shutting down here essentially at the beginning of the year?

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George W. LeMaitre, LeMaitre Vascular, Inc. - Chairman & CEO [28]

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What if I handle the China question first and get on to the rep question after that. It's a good question. I'm sure a lot of people want to hear about that. So I know as much as I read in the Wall Street Journal about the coronavirus, and I'm sure most of the folks on this phone call are at that level. And it feels like you're saying that China is shutting down. To put a boundary on this for everyone, we had a $1.5 million business last year in China, and it grew 27% reported and 14% organic, kind of bouncing back from a big year 3 years ago and then it went down and went up. We sort of stopped thinking this is going to be a mega growth opportunity. So it's 1% of our sales. If we're a $129 million company next year, and it's $1.5 million, I would say, it's something you guys don't have to worry about. We don't think it's going to be great for us, but I feel like it's going to get, to a certain extent, buried for you guys at your level. So I hope that's a good one on China -- or sort of an explanation on China for you, Joe.

And then as far as the reps go, we just printed our goals for this year for 2020. And our goal is to sort of keep the reps around where they are right now. I think you saw us really go to some lengths to get the rep count up from about 90 to about 110 over the last 3 years. But I don't think we aspire to have a broader group of reps right this second.

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Operator [29]

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[Operator Instruction] Our next question comes from the line of Frank Takkinen with Lake Street Capital Markets.

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Frank James Takkinen, Lake Street Capital Markets, LLC, Research Division - Equity Research Analyst [30]

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Just a couple for you here. Just to completely be clear about the contribution from nonorganic next year, what are you guys kind of thinking about for Admedus next year? I think you mentioned 6% to 6.5% on your last call for 2020 contribution from that CardioCel and VascuCel.

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David B. Roberts, LeMaitre Vascular, Inc. - President & Director [31]

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Frank, it's Dave. Good question. Yes, we said $6 million to $6.5 million of revenue, that's what we projected in October call. But obviously, CardioCel came out of the gate a little bit quicker, so we're looking more at around -- a little over $7 million for 2020 at this point.

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Joseph P. Pellegrino, LeMaitre Vascular, Inc. - CFO, Treasurer, Secretary & Director [32]

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That's an annualized number. And if you're still on the incremental, it's more like $5.5 million, $5.6 million, FYI.

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Frank James Takkinen, Lake Street Capital Markets, LLC, Research Division - Equity Research Analyst [33]

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Okay. That makes sense. And I know there's been a lot of conversation around this in a couple of different areas. But could you just give us a broad overview of different moving pieces for the gross margin? I know you were dotting i's and crossing t's on a couple of products right at the end of the year to get fully integrated into [Burlington]. And then I know you have CardioCel and VascuCel for this year. But if you could just give us a broad overview on the different things you're doing to improve gross margins, that would be fantastic.

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Joseph P. Pellegrino, LeMaitre Vascular, Inc. - CFO, Treasurer, Secretary & Director [34]

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Yes. So there's a lot going on in the gross margin line these days. FX year-over-year actually hurt us 0.3% or so. And that China topic with a lower margin there and a little higher sales, that hurt us as well. And then mix-wise, we're selling more Dacron grafts these days. That's hurting us as well. And the CardioCel and the Tru-Incise, the 2 new acquisitions are coming up strong. And that's unfavorable to the margin as well. And then we had year-end cleanup costs around that sort of 66% number as well. So going forward, you don't have those year-end cleanup costs necessarily. I talked about those integrations that happen over time. I talked about in Q2 as a more immediate benefit coming off of the balance sheet onto the P&L vis-à-vis inventory that was made cheaper a while ago, and now we're getting the benefit of that. Price increases, those are good guides, too, obviously, to the gross margin. And so we feel like we'll probably get a pretty nice price hike this year, hopefully, going forward. In the past year, it was worth about 0.5% good guide to the gross margin, so maybe you can do that or a little bit better going forward in 2020.

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George W. LeMaitre, LeMaitre Vascular, Inc. - Chairman & CEO [35]

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J, maybe I'd chime in a little bit. Gross margin is sort of something that J does a little bit more than I do. But at a really high level, and we bought $15 million of revenue in the last 17 months or so, and the revenue we buy comes with a considerably discounted gross margin versus what we had before. And so unfortunately, this is something that we've learned to live with over time. We build the gross margin up, and then it gets beat back by these lower gross margin acquisitions that we wind up doing. In the very long run, we'll fix those gross margin issues, but it's a topic that never goes away at LeMaitre. And since we've been particularly active from an M&A perspective in the last 16 months, we're all feeling that right now, it's nothing we want to go through, and we know it doesn't look great, but it is what it is. When you buy these revenues, they mix with your good revenues and they drag you down.

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Operator [36]

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Our next question comes from Mike Petusky with Barrington Research.

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Michael John Petusky, Barrington Research Associates, Inc., Research Division - MD & Senior Investment Analyst [37]

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Just a few questions. I didn't catch it if you mentioned valvulotome growth for the quarter and for the year.

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George W. LeMaitre, LeMaitre Vascular, Inc. - Chairman & CEO [38]

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We did not mention that. I'm happy to get it if we can pull it up quickly.

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Joseph P. Pellegrino, LeMaitre Vascular, Inc. - CFO, Treasurer, Secretary & Director [39]

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Mike, in the quarter, about 9%. In the year, I don't have it. Maybe...

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George W. LeMaitre, LeMaitre Vascular, Inc. - Chairman & CEO [40]

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Organic, 3% for the year, I remember distinctly. And the difference there, Mike -- he's given you the quarter. But the difference is, of course, that we bought that valvulotome, the [EC-size] valvulotome and Tru-Incise Valvulotome midyear. And so that's your delta between 3% and roughly 9%. Reported number for the year, can we get that?

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Joseph P. Pellegrino, LeMaitre Vascular, Inc. - CFO, Treasurer, Secretary & Director [41]

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The reported for the year, see if I can pull this up. So it's like about 8% reported. So 9% reported in the quarter and about 8% for the year, Mike.

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Michael John Petusky, Barrington Research Associates, Inc., Research Division - MD & Senior Investment Analyst [42]

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Okay. All right, very good. So JJ, if I look at your guidance for the year, the tax rate assumption looks like sort of lower 20s, maybe 21%, 22%. Is that the right math there? Or what's your assumption on that?

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Joseph P. Pellegrino, LeMaitre Vascular, Inc. - CFO, Treasurer, Secretary & Director [43]

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Yes, yes, it's about 22%, yes.

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Michael John Petusky, Barrington Research Associates, Inc., Research Division - MD & Senior Investment Analyst [44]

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Okay. All right. And I guess, on -- just a couple on XenoSure real quick. On XenoSure, the new products, the Plus and the DuraSure, are you guys -- any traction or any anecdotal info we're sharing on that yet or not much?

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George W. LeMaitre, LeMaitre Vascular, Inc. - Chairman & CEO [45]

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Right. Mike, I would say, generally, not really just yet. It's a little bit early in the product cycle, but I would say, generally speaking, no, not really. Maybe I would pivot from talking about that to talking about the Asian approvals. So Australia has been going really well. We got that approved about 1.25 years ago, and that's showing terrific growth. We did get the Korean and Singapore approvals in 2019. Those still haven't really produced revenues, but we do have those now. And the Chinese clinical trial we've been talking about a lot, we enrolled past the 288 number. And then for safety's sake, we decided we wanted to enroll all the way up to 328. And so I think we're at about -- I don't know the exact numbers, I think we're at 295 right now.

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Joseph P. Pellegrino, LeMaitre Vascular, Inc. - CFO, Treasurer, Secretary & Director [46]

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288.

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George W. LeMaitre, LeMaitre Vascular, Inc. - Chairman & CEO [47]

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288. And we're trying to get to 328. And so we still have ways to go, but we are closing in on that. That thing will finish, and we have all kinds of incentives, et cetera, to get it done in the middle of this year.

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Michael John Petusky, Barrington Research Associates, Inc., Research Division - MD & Senior Investment Analyst [48]

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Okay. I certainly took your message on the coronavirus and the relative size of the China business. But I would assume that the coronavirus maybe slows down enrollment of everything over there. Or can you just talk about that?

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George W. LeMaitre, LeMaitre Vascular, Inc. - Chairman & CEO [49]

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I honestly don't know. I would assume it will, given the drone footage I've seen in these cities that have been emptied out, but that's all I know. So I assume it will slow down, but we'll see.

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Michael John Petusky, Barrington Research Associates, Inc., Research Division - MD & Senior Investment Analyst [50]

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Okay. Last question, on the 5% organic growth expectation for '20, any breakout between price and unit growth there?

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George W. LeMaitre, LeMaitre Vascular, Inc. - Chairman & CEO [51]

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Yes. I think we think price will be about 2%, and units will be about 3%.

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Operator [52]

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Our next question comes from Jim Sidoti with Sidoti & Company.

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James Philip Sidoti, Sidoti & Company, LLC - Research Analyst [53]

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Can you please repeat what the -- what you've generated from the acquisitions in the quarter? I think you said $500,000 from Cardial and what was CardioCel?

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George W. LeMaitre, LeMaitre Vascular, Inc. - Chairman & CEO [54]

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Yes. So CardioCel was $1.4 million, and the Tru-Incise was $515,000.

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James Philip Sidoti, Sidoti & Company, LLC - Research Analyst [55]

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And what 2 products do you plan to consolidate in 2020 to Burlington?

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George W. LeMaitre, LeMaitre Vascular, Inc. - Chairman & CEO [56]

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Right. So the Omniflow factory in Australia is being closed in May or June of this year. We had intended to close it in December, but we just didn't get it done. So that's one. And we'd be bringing the production of the Omniflow sheep graft back to Burlington. And then we bought the product line from Applied Medical, the Syntel Embolectomy Catheters. We made our last purchase for them in September and where -- we've got all the machines in Burlington, getting ready to start building those Syntel Embolectomy Catheters here. And probably by the end of H1, we'll be up and running with industrial strength production on these 3 different product lines inside of that acquisition.

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James Philip Sidoti, Sidoti & Company, LLC - Research Analyst [57]

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What impact do you think those 2 consolidations have on the gross margin in 2020? Is that something that's kind of neutral, when you work it out, it will be in your [goal] of by the second half of the year? Or is that going to be a headwind to gross margin for this year?

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Joseph P. Pellegrino, LeMaitre Vascular, Inc. - CFO, Treasurer, Secretary & Director [58]

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Yes, Jim, this is JJ. So I feel like the Omniflow piece will probably start to benefit a little bit in the second half of the year as we get away from expenses that were occurring over in Australia, still selling inventory made in Australia through the end of the year. So the cost of that won't change but there's some -- there are some costs probably in Australia that we might get away from as we close that. I think the Applied piece is a little bit longer-term topic as we sell out of the inventory that we had purchased from Applied. That will take through the end of the year. Maybe it's the beginning of the following year when we start to benefit from devices made here that are actually sold.

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James Philip Sidoti, Sidoti & Company, LLC - Research Analyst [59]

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So I know you don't want to give guidance too far ahead, but I think it's fair to say that you should see a bump to gross margin in the future as a result of these 2 consolidations.

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Joseph P. Pellegrino, LeMaitre Vascular, Inc. - CFO, Treasurer, Secretary & Director [60]

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I mean I wouldn't go forward like you're asking, but I would say, if you look backwards in history, that's been the story that's been rerun over and over at this company, which is you do an acquisition or 2, it screws up the margin for a while. You consolidate, you probably screw that up here for a while. And then you figure it out, and then it really improves the margin as you cut costs and get it to an even better place than it was before the acquisition. So I would say that's a totally normal answer for us. It's just that we're digesting 4 at a time right now.

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James Philip Sidoti, Sidoti & Company, LLC - Research Analyst [61]

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Okay. And then that was my follow-up question. You have done quite a few over the past 18 to 24 months. Are you going to keep Dave home for a little while and integrate these deals? Or is he still out there looking?

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David B. Roberts, LeMaitre Vascular, Inc. - President & Director [62]

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I'm actually right here in the room, but I am out looking, Jim. And I would say we have a very capable integration team. Yes, there's a lot to do there. But the acquisition team, we're open for business, and we're out hunting, and we've got our criteria. So yes, we're -- it's -- even though it seems like yesterday, it's been about 4 months since we did the last acquisition. So we're out looking.

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Operator [63]

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Our next question comes from Alex Silverman with AWM Investment.

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Alex Silverman, AWM Investment Company Inc. [64]

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JJ, I know that MDD, MDR is a huge pain for a lot of you -- for you guys and for a lot of competitors. What do you figure you guys are spending on this?

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Joseph P. Pellegrino, LeMaitre Vascular, Inc. - CFO, Treasurer, Secretary & Director [65]

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So I'm thinking in this year 2020, there's probably about an incremental $1 million, maybe a little bit more than it was going to be spent on that topic.

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Alex Silverman, AWM Investment Company Inc. [66]

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Okay. And how do you see the -- sort of the -- you said resolved in the first half?

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Joseph P. Pellegrino, LeMaitre Vascular, Inc. - CFO, Treasurer, Secretary & Director [67]

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Yes. I mean I think we're looking -- so there's 2 different topics. One is MDD to MDR, the change in the regulatory regime and what you have to do to prepare for that. And that's an expense topic for us. The question you just asked, how much more you're going to spend because there's more testing and more data collection, et cetera, involved in that. It's a separate, different topic, which is the reissuance of CE marks from a new notified body, related but different. And so we are expecting that reissuance over the next month or 2 or so. And so we think we've included any impacts from that in guidance. We made a ton of inventory back in the middle of last year, sort of July, August, September time frame, sent it over to Europe to sort of shield ourselves from, hopefully, any impact from this topic. But that's where we stand now. And so as I said in my guidance, I'm thinking over the next month, 2 or 3, we get that reissuance from our new notified body.

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Alex Silverman, AWM Investment Company Inc. [68]

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And last thing on that, we're hearing little manufacturers in different markets in Europe just walking away from -- walking away, given the expense and the difficulty of meeting the new standards. Are you guys seeing any benefit from that?

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George W. LeMaitre, LeMaitre Vascular, Inc. - Chairman & CEO [69]

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Yes, we are. This is George, Alex. Yes, we definitely are, particularly in some of these product lines like PTFE and Dacron, the polyester, the grafts that we make here. So more on the commodity side, we're definitely seeing that. It's going to happen a lot. This is -- the regulatory barriers are going up dramatically in Europe. And so people that own these CE marks, I would say, us, assuming we can get all of our issues fixed here, I think they stand to benefit a lot. A lot of them -- you say small companies. I would say, it's this -- the larger companies that have like a $4 million division that they think, oh, who cares, just I don't want to go through the pain to get this thing re-upped. And I think that will help LeMaitre Vascular, assuming LeMaitre fixes its own house on this topic.

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Operator [70]

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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.