Good day and thank you for standing by. Welcome to the Merit Medical Systems Third Quarter 2022 Earnings Conference Call. [Operator Instructions] Please be aware that today’s conference is being recorded. I would now like to hand the conference over to your speaker today Fred Lampropoulos. Please go ahead.

Thank you and welcome, everyone, to Merit Medical System’s third quarter of fiscal year 2022 earnings conference call. I’m joined on the call today by Raul Parra, our Chief Financial Officer and Treasurer; and Brian Lloyd, our Chief Legal Officer and Corporate Secretary. Brian, would you mind taking us through the Safe Harbor provisions, please?

Thank you, Fred. I would like to remind everyone that this presentation contains forward-looking statements that receive Safe Harbor protection under federal securities laws. Although we believe these forward-looking statements are based upon reasonable assumptions, they are subject to unknown risks and uncertainties. The realization of any of these risks or uncertainties, as well as extraordinary events or transactions impacting our company, could cause actual results to differ materially from those currently anticipated. In addition, any forward-looking statements represent our views only as of today, October 26, 2022 and should not be relied upon as representing our views as of any other date. We specifically disclaim any obligation to update such statements, except as required by applicable law. Please refer to the section entitled Cautionary Statement Regarding Forward-Looking Statements in today’s presentation for important information regarding such statements. Please also refer to our most recent filings with the SEC for a discussion of factors that could cause actual results to differ from these forward-looking statements. Our financial statements are prepared in accordance with accounting principles which are generally accepted in the United States. However, we believe certain non-GAAP financial measures provide investors with useful information regarding the underlying business trends and performance of our ongoing operations and can be useful for period-over-period comparisons of such operations. This presentation also contains certain non-GAAP financial measures. A reconciliation of non-GAAP financial measures to the most directly comparable U.S. GAAP measures is included in today’s press release and presentation furnished to the SEC under Form 8-K. Please refer to the section of our presentation entitled Non-GAAP Financial Measures for important information regarding non-GAAP financial measures discussed on this call. Readers should consider non-GAAP financial measures in addition to, not as a substitute for, financial reporting measures prepared in accordance with GAAP. Please note that these calculations may not be comparable with similarly titled measures of other companies. Both today’s press release and our presentation are available on the Investors page of our website. I will now turn the call back to Fred.

Thank you, Brian. And let me start with a brief agenda of what we will cover during our prepared remarks. I will start with an overview of our better-than-expected revenue results for the third quarter. After my opening remarks, Raul will provide you with a more in-depth review of our quarterly financial results and the formal financial guidance for 2022 that we updated in today’s press release, as well as a summary of our balance sheet and financial condition. We will then open the call for your questions. Beginning with a review of our second quarter revenue performance, we reported total GAAP revenues of $287 million in the third quarter, up 7.5% year-over-year. Our total GAAP revenue growth was driven by a 8.6% growth in U.S. sales and 6.1% growth in international sales. Our total revenue increased 10.5% year-over-year in the third quarter on an organic constant currency basis, excluding the headwind to our GAAP revenue growth related to changes in exchange rates compared to the prior year period. We delivered constant currency revenue results that exceeded the growth expectations that we discussed in our second quarter earnings call. Specifically, we shared our expectation for constant currency revenue growth in the range of a 4% to 6% year-over-year in quarter 3. The better than expected constant currency revenue results were driven by solid execution from our team, stronger than anticipated demand in the U.S. and more favorable than anticipated international sales trends, particularly in EMEA and the APAC reasons. Now, let me provide you with a more detailed review of our revenue results in the third quarter, beginning with a sales performance in each of our primary reportable product categories. Unless otherwise stated, all growth rates are approximated and are on a year-over-year and constant currency basis. We’ve included reconciliations…

Thank you, Fred. Given Fred’s detailed discussion of our revenue results, I will begin with a review of our financial performance across the rest of the P&L. For the avoidance of doubt unless otherwise noted, my commentary will focus on the company’s non-GAAP results during the third quarter of fiscal year 2022. We have included reconciliations from our GAAP reporting results to the related non-GAAP items in our press release and presentation available on our website. Gross profit increased approximately 6% year-over-year in third quarter. Our gross margin for the third quarter was 48.4% compared to 49.1% in the prior year period. The 66 basis point decrease in gross margins year-over-year was primarily due to unfavorable manufacturing variances specifically purchase price variances. As expected, we experienced higher freight costs compared to the prior year period. We continue to prioritize meeting customer demand and mandating back orders which has led to a higher mix of air shipments and delayed the transition back to a more cost effective ocean alternative. As expected, our third quarter results reflect the inflationary headwinds we are seeing in freight, logistics, labor and increasingly in raw materials. Similar to what we experienced in Q2 while our guidance assumed higher raw material costs and freight logistics expense year-over-year our third quarter results included incremental headwinds from higher than expected raw materials, and freight and logistics expenses, each of which represented headwinds to our non-GAAP gross margins of roughly 30 basis points on a year-over-year basis. Third quarter operating expenses increased 1% compared to the third quarter of 2021. The year-over-year increase in operating expense was driven by a 2% increase in SG&A expense and a 3% decrease in R&D expense. Compared to the prior period. Our operating expense performance in Q3 was better than expected and reflects continued…

Well, thank you Raul. A lot of numbers and a lot of work done there. So I appreciate very much. In closing our third quarter growth and profitability performance exceeded our expectations. But we believe as a direct result of our team has continued strong execution and relentless focus on our strategic initiatives. We now know how hard they are working and how that they are delivering these strong results despite the continued challenging operating environment around the world. We’d like to thank all of our team members around the world that made our performance over the first nine months of 2022 possible. Importantly, we’re not resting on our prior success, we remain committed to continued progress. We’re confident in our 2022 guidance which now calls for the total revenue growth on a constant currency basis of 9% year-over-year. We also continue to expect to report improving non-GAAP operating margins and strong free cash flow in 2022. Now that wraps up are prepared remarks. And we’ll turn the time back over now to our administrator for questions. And then following that Raul and I will be available for the next couple of hours to visit and get into more detail if necessary. We will now turn it over to the administrator, thank you very much.

[Operator Instructions] All right, our first question comes from the line of Jayson Bedford from Raymond James. Your line is open.

Good afternoon, and congratulations on the quarter, you guys are doing a nice job. So I guess just a few for me. First, fourth quarter guidance specifically on the implied organic growth there, I guess the question is, and I can appreciate it’s dynamic market out there. But was there anything one time-ish in the third quarter result that kind of propped up the organic growth in the quarter?

Jason, the answer is no.

Maybe for Raul or Fred some of the gross margin dynamics, you stress kind of the ocean versus air in terms of freight? When does that dynamic slip? I’m guessing some time in ‘23. But any kind of framing on that will be great.

Yes, we won’t get ahead of ourselves to talk about 2023 Jason, but I think what we’re looking for is reliability. I think things are definitely opening up and there’s more capacity. It’s just not reliable enough for our customers needs, quite frankly. And so, to the extent we continue to see the demand that we’re seeing. We’ll continue to kind of use the current air versus ocean mix that we have. So I guess it’s dependent a little bit on that reliability of the carriers, and the demand from our customers.

Yes. And I would just say that’s correct. And I think you saw that international result. And that was a result of making decisions to meet customer needs. It’s as simple as that.

And maybe just the last one from a product related. Can you comment on Rhapsody in Europe, and then just a reminder as to where we stand in terms of U.S. timing for that product? Thanks.

Sure. Rhapsody is in terms of timing, we’re about halfway through, pretty close to halfway through the trial. Again, there was a number of we have the whole COVID thing and then, but it has been accelerating in terms of that enrollment. So I’m going to still say its two and a half years out for that approval. We still continue to be very pleased and we’ve also seen a lot of interests that continued to build a business over in Europe, as well as Brazil.

Thank you. One moment for our next question. Our next question comes line of Larry Biegelsen from Wells Fargo. Your line is open.

Good afternoon. Thanks for taking the question. And I’ll echo my congratulations on a really nice quarter here, Fred and Raul. Fred. I just wanted to start maybe on 2022 year-to-date OpEx is relatively flat R&D spending it’s actually down a little bit. So how are you holding up x flat in an inflationary environment?

Yes, it’s good question, Larry. I’m going to Raul, and I were talking about this, and I think he has a better explanation that I would have, I’ll let him pick this up. And then I’ll come back and comment if I need anything for further. Raul?

Yes , I mean, I think we’ve a lot of the right investments this year, Larry in certain things like trade shows, and travel some of that some of the expenses up and you’ll, you’ll see it in the SG&A line. I think on the R&D line, quite frankly, there is there’s cost initiatives and things that that are ongoing from that standpoint, including R&D and clinical, I think on the clinical side things have been a little bit slower than we anticipated on the enrollment. So that helps. And also, just as we shift and move on priorities within R&D, that tends to push expenses out one way or the other. So, again, I think it’s just prudent expense management on our side, making sure that we understood that we’re still in a choppy environment on the way to kind of normalized recovery. So just being patient with our expenditures, and then some of it’s just kind of outside of our scope.

And let me just add to that you’ve heard me say this many, many times, our vertical integration, allows us to control our production and to adapt to the conditions. And that continues to be a very big deal for us, Merritt. Just doesn’t really well, I mean, we made those investments a long time and over the years, but it’s made a difference. Raul?

I think, lastly to I just want to make sure that I point out our executive team and our employees, we’re all really committed to achieving the 18%, non-GAAP operating margin as we head into 2023. So, I think there’s a broad commitment from the executive team and the employees on making sure that we’re frugal in our expenses.

That’s helpful. How do you, if I think about 2023, you guys, could have flat sales essentially and still meet your foundations for growth 5% CAGR because you’ve done so well since you gave those goals in 2020. Fred, how do you want people to think about the momentum you have here? I mean the guidance implies about 9% organic growth in 2022, the momentum and how do you want people to just think about the growth algorithm for Merit going forward. Thanks for taking the question.

You’re welcome. Thanks, Larry. Larry, we want them to think about February of 2023 when we will go through our entire program. That’s what we want people, we want to finish the year, we want to stick to the goals that we’ve set, and then 2023 and around February-ish, we will go through and we will lay out our plan from there.

Thank you. One moment for our next question. Our next question from the line of Mike Matson from Needham. Your line is open.

Yes, thanks for taking my questions. I want to ask one on currency. I understand the you’re pretty clear with the impact on your top line, but I just wanted to maybe talk about the impact on the expense side or the P&L. Has it had a material impact on your earnings? How well hedged are you and as we head into 2023 is there a risk of any surprises there in terms of hedges rolling off or anything like that?

Yes. So we obviously have a hedging program in place that that buffers, some of the impact that we’re seeing. We also have natural hedges in place, as you know we have operations in Europe. And then also some level of expenses in the APAC region that help also with our hedging. So I say, generally, we don’t disclose the impact to the rest of the P&L. I would say that we might have some geography mixes within gross margin and OpEx because of the effects. But our hedging program is really designed to minimize the impact on EPS. And so I think that’s why you’re seeing a kind of a minimal impact on the earnings side.

And just as we head into 2023 and when there’s no reason to expect that to change at all, that you should be able to continue to offset most of the impact from EPS.

I think we’re going to be like most people, right from an FX standpoint, I think most people as things lapse, you’re probably looking at the first half of the year, next year, the people are going to be challenged with FX, but again, for us, I think it’s kind of business as usual.

Well, and I think Raul to your point, we have what we think is a successful program, and we’ll stick with that program.

And then just one on China. So I think you said you saw mid teens growth there. But you did call out some impacts some of the VVP program. So I don’t know, if you’re willing to quantify like how much better your growth would have been without VVP and then just what’s the longer term outlook there in terms of VVP do you expect continue headwinds from that over the next few years as they expand into more product categories?

Yes. Mike, volume based purchasing tenders are happening, but they are contemplating in our guidance. So we’ve taken that. We don’t stop and talk specifically about this, that or the other, but we have contemplated those and those are part of our guidance that we’ve provided, and will be part of our discussion in February.

Thank you. One moment for next question. Our next question comes from the line of William Plovanic from Canaccord. Your line is open.

Great, thanks. Good evening. A question on guidance for this year. If I’m doing my math right, and please correct me if I’m not, you’re basically saying revenue is going to be flat sequentially in Q4 and EPS will be about flat sequentially when we get to the low end to guidance. What are you contemplating in that low end guidance? Fourth quarter is typically a much bigger quarter for everything. So I’m just trying to understand what gets us to the low end versus the high end?

Sure, for sure. Look, I think, first of all, we had a great Q3. I think our Q4 growth really reflects kind of the continued improvement in the operating environment, as we’ve talked about over the last year and a half. So, again, a chop, kind of a recovery a choppy recovery to normal is kind of how we see things. So we expect Q4 total revenue growth of approximately 6% to 8% year-over-year on a constant currency basis. The midpoint of our fourth quarter constant currency sales growth, expectations assumes roughly approximately 5%, constant currency growth year-over-year in the U.S. markets, and approximately 10%, constant currency growth year-over-year our O-U.S. markets. So, again, I think those are pretty, pretty solid growth numbers when you look at it on a year-over-year basis.

And then how does FX the hedging impact your gross margins? Obviously, you’re taking a hit to revenue. Help us understand because the question really lies is, okay, so you haven’t your gross margins have actually come down a little, it doesn’t seem like you get to benefit from it depending on where you put your FX into the P&L and I’m just trying to understand, okay, as rates kind of the dollar peak strengthening and search weakening again, how does that flow through into next year in terms of gross margin as we’re looking at it?

Yes, again, I guess we’re not going to get into the details of that, as you know Bill, I mean, these things are pretty complex especially companies from company to company. I would just generally say that we have operations in Ireland so as the Euro drops obviously, that helps us, but also as revenue drops, that hurts us. So there’s a lot of offsets and hedging that goes in place, along with intercompany balances that also kind of feed into that from a hedging standpoint. So, I’d say it’s pretty complicated stuff, but which is why we don’t get into all the details of what it does to the rest of the P&L. I’ll just end with saying that that our hedging program is made to really minimize the impact on EPS. Right. So that’s the ultimate test for us is how is our EPS moving one way or the other. And so far, I think it’s done a pretty good job of keeping us within our original.

Last question, if I may. Just on China. I mean, you guys have a significant exposure to China. I think it’s 13% of your sales or something like that. It’s pretty big piece of your business. Help us understand obviously, in this day and age, there’s just a lot more protectionism coming in. And how are you protected from a top line and bottom line perspective in terms of that business?

Well, I mean look, I think if you look at our growth for one, I mean we had outstanding growth in almost every region. So I would say that we’re not overly dependent on China. I mean our APAC growth was pretty stellar. So I would say that generally, China is a big part of our business, but and we continue to invest there we continue to register products. But I think there’s other areas that we’re investing also that can help minimize the impact from that standpoint.

Thank you. One moment for next question. Our next question will come the line of Jason Bednar from Piper Sandler. Your line is open.

Congrats on the solid quarter. You got so down here on producing. So bigger picture question on pricing dynamics. It sounds like some of the initiatives from the company are having some real positive effects and a few intertwine questions here. But could you give us a sense as to where you’re having the most success taking price in this environment on a product level or country level basis? And then how sticky do you think this price increase trend can be as we look forward to ‘23?

Yes, let me just say that pricing is part of one of the pillars of our foundations for growth. And I think that is, generally the area I don’t I’m not going to address specifically, but it is one of those issues that we identified a long time ago. And it’s helping a lot. So I’ll just leave it at that. And it helps to offset, of course, the inflationary pressures, and it’s part of the reason we delivered the financial results in the third quarter. So it’s an important part of our overall program. And again, we’ll talk about maybe these factors sometime in February.

So one more from us. So I have in my notes that you wreck sitting in some product line transfers from your Texas facility down to Mexico. And we’re wondering if you could update us here on the progress you’ve made with that initiative as a complete, and what’s the right way to think about the cost savings from this --

Yes, I’m going to let Raul pick that one up.

Yes, it’s obviously one of our foundations for growth targets. We don’t give detailed kind of status of where things stand, I would say it’s in progress. It is a multiyear effort as you can imagine, moving them any product lines that are registered all over the world just takes time, and which is why we don’t call out the specific details, but I would say the work is ongoing, and they’re still want to jump there.

And part of our another pillar and our foundation for growth. These are the things that we identified and we talked about when we came out with our program, in terms of footprint, and consolidations. It’s an important part of our overall program of improving the operations of the company.

One moment for our next question. Our next question comes from the line of Jim Sidoti from Sidoti. Your line is open.

Hi, good afternoon. Thanks for taking the question.

Welcome Jim.

So you increase your revenue guidance, despite a increase in the currency headwind. So are you doing that because you’re seeing share gains, are you getting better traction with the new products? Or the price increase is starting to take effect?

That was a good answer.

I mean, I don’t want to be a wise guy. But I think the performance is always as you know, Jim, a function of a lot of factors.

Yes, I mean, I’ll take a minute to maybe thank our sales force for the efforts and the execution on their part, not just one region. I mean, it’s across multiple regions, and then also our operations group for being able to deliver the product. I think it’s a challenging environment right now procuring raw materials and getting people to show up to work. And they’re doing a magnificent job, not only on execution on the sales side, but then being able to also deliver the product. So we’re pretty excited about the efforts on their part, and want to just thank them, I think publicly.

Well done. It sounds like the supply chain issues with the endovascular business are behind you at this point. Do you see any of the other supply chain issues starting to improve? Or do you think they’re still going to be affected going into next year?

Jim, that’s a great question. We continue to see kind of modest disruption. I think it’s hard to predict that that’s what I would say. I think things are generally getting better. But we have a hard time predicting whether things are going to be stable or not. And it’s just one that’s the problem that we see. It’s a little plastic part that you wouldn’t have thought of and it’s just, its random things, and it’s still difficult. But again, I think we’re doing a pretty good job. Obviously, you can see the sales numbers. We are executing a very high level, and that’s not possible without our operations through delivering the product. So I think it’s going to I don’t know how long it’ll stick around. But what we want to be able to see before we are comfortable with it, is just getting a little bit forecasting those raw material purchases a little bit better and not getting surprises is what we’re looking for.

And you highlighted a few of the new products that benefited during the quarter. And then you mentioned that you’re about 50% enrolled on Rhapsody. When Rhapsody gets approved, do you think that’ll be a contributor on the same order of magnitude as new products you have now? Or do you think that’ll be something that’ll be a much larger contributor?

Well, I’m not going to go into that number, Jim, in terms of matching it up on something that we have a belief in earnest that we’ll wait to see how this develops. And, again, it’ll be maybe part of our discussion down the road. But I think what really is important is that merits ability to work through the supply chain, meet the demands of customers and continue are the same thing that Merit has been known for so long. And that’s coming out with a new products whether it be breakthrough designations, or the new scout BX delivery system, the mini reflector, the resolve, pneumothorax tray, all of those things all add up, and I think part of Merit’s heritage.

And then the last one for me if we do hit, if it is a recessionary environment next year, are there any product lines that you’re concerned about in particular? Or do you think you’ll be able to file to that?

It’s a good question, Jim. And it’s one that I’m happy to answer. And that is, generally speaking over the years, our business does not suffer from as you might have other consumer types and other product lines, and businesses, people still get sick, people still need to be treated. And so recessions are not a big factor at Merit. It’s just as simple as that. I think history would go back and look at it, you’ll find that Merit has done quite well during these economic pullbacks.

One moment for our next question. Our next question will come from the line of Michael Petuski from Barrington Research. Your line is open.

So I guess, Fred first of all, impressive Q3. When you sort of think about all the macro issues that are out there, whether it’s labor retention, inflation, shipping challenges, currency headwinds, as the previous question, possible recession, flu, COVID, possibly coming back heavy in the winter. I mean what are the two or three things if you get narrowed down to two or three things that you really are, are sort of like, this concerns me or this is going to be a challenge or we’re really going to have to be bringing our A game to this particular area, this particular headwind? I mean, how do you sort of I can’t remember a time when there’s been more to think about on a macro level than right now. Thanks.

I think when you were talking about Raul said war, I mean, that’s another factor. What’s that going to do? And what goes on all these places. I think maybe the better way to answer the best way to answer that question is, if we look over the 35, years of Merit’s history whether it be financial meltdowns, whether it be threats here and there, whether it be wars, whether it be terrorism, I mean, when you really kind of look at all of this COVID we can’t forget all those other things that happened. What it did to slow down 9/11 war in Iraq, war and Afghanistan, I mean, all of these things. We’ve been hit by all of these things over the years. So Mike, I guess, to answer the best way to answer your question is the ones we’ve already been hit with we know how to deal with those generally, it’s always the one that you don’t see coming. But even with that, as COVID came through, Merit adapted, our workforce adapted our sales force adapted to meet customer needs. We found products that we can build, like the swabs that were temporary, but it helped the business to keep 200 people employed. We helped people, we helped the nation. So I think that a success of a business and I’m going to speak military for 30 seconds, you adapt to the conditions. That’s the key to it and its one American strong suits. It always has been. So taken up whatever it has been.

It is a lot of it too we talked a lot of a lot about all the issues that are out there, Mike, I think you could lose focus very quick if you just focus on those issues right there. But the reality is a lot of that’s outside of our control. And so really being focused on what we can control and execute on is what we’ve been doing really the last few years. And I think it’s helped us tremendously, obviously.

And I think that’s a terrific answer. We’ll work on the things that we can and will adapt to the things that we can’t.

Fair enough. So then sort of pivot off that question. I suspect that some other companies, maybe haven’t managed through all of this quite as cleanly as you guys have, and I’m not minimizing. I know, it’s been a Herculean effort on your part. But there are probably some other companies out there, that maybe are looking to divest product lines or that sort of thing. And really what I’m getting around to is you’re generating a lot of cash balance sheets, de-levered in great shape. I mean, I would assume valuations for assets are coming down as far as the type of assets you guys look at. I mean what are you seeing and what are your thoughts?

Well, I think you’re right, I think those things are out there. But I want to make sure that I emphasize again, that Merit’s goal is to finish that third year of foundations for growth, while keeping their eyes open. We understand that we do and are in a position to look at things. So but they have to fit, and we’re very patient in the business I think is doing fine. It’s just the discipline, and the focus. And I think that’s what’s helped us to be able to deliver these kinds of results. So we know they’re out there. We’ve talked about them. There are opportunities. But again, they have to be consistent with the long term goals that we’ve set out in our foundations for growth, Mike. So I mean, that may sound like a canned answer. It kind of is because we have a camp program. We are focused, laser focused on what we want to accomplish and what we promised.

I suspect a lot of investors are giving us standing out for that answer. Hey, last quick question on just this idea that flu could be heavy this winter, and maybe COVID comes back. Are you hearing anything from your contacts in hospital systems, about concerns about staffing of hospitals or anything that would sort of really curtail surgical volumes? Thanks.

Yes. Not specifically into surgical but staffing. We have a member of our board that runs a hospital system. And staffing is a problem for everybody. Until we get the participation rate higher and things like this. It’s a challenge for everybody Mike. It’s not going away. So what we’re not hearing are things that we were hearing before, like, elective procedures and that sort of stuff. I’m not hearing that language, just staffing in general, is a problem, but not in terms of procedural rights at this point.

Thank you. And that will conclude Q&A. I’ll turn it over to Fred for any closing remarks.

Well, ladies and gentlemen, thank you very much for your time. It’s a busy day. And just one closing note. It’s snowing like crazy out here. Come out and see us. We’d love to host you here in Salt Lake City. Thank you again for the time and we’ll look forward to talking to you again soon. Best wishes. And good night from Salt Lake.

This concludes today’s conference call. Thank you for participating. You may now disconnect. Everyone good day.