Good afternoon. Thanks for joining us at the 24th Annual Needham Healthcare Conference. I'm Mike Matson, and I lead the MedTech and Diagnostics Equity Research Team at Needham & Company. I'm pleased to introduce Merit Medical's CFO, Raul Parra. Instead of a standard presentation, we are going to do a Q&A session. If you do have questions you would like to ask, you can submit them electronically through the Needham Conference website, or you can email them to me at mmatson@needhamco.com, and I'll do my best to fit them in. With that, we're going to go straight into the questions. Raul, just wanted to thank you for coming to the conference. I want to start with WRAPSODY, which is probably your favorite topic to discuss these days. Let's see, with WRAPSODY, it was approved by the FDA in December.
Can you just start out by giving us a quick overview of the product and where it's used for maybe people that aren't as familiar with it?
Yeah, look, I think, you know, first of all, thanks for having us, Mike. You know, excited to be here, and thanks for everybody listening. You know, look, I think, you know, WRAPSODY for us is our first PMA-approved product to use in dialysis, you know, AVG and AVF, you know, procedures. We're really excited about, you know, the launch of this product. The reception here in the U.S. has been great. As you pointed out, the data, you know, to support the WRAPSODY and FDA Breakthrough Device has been great. The six-month data came out, you know, earlier this year or last year, and you know, we were, that was well received. Now we just, you know, released the 12-month data at the SIR. Again, the data continues to be, you know, good and in our favor.
I think, you know, ultimately, I think, you know, we're getting not only is there good data behind it, you know, but the reception, you know, from doctors, you know, is a lot of positive feedback. Maybe one thing we haven't really talked about, quite frankly, is the delivery, you know, mechanism. You know, a lot of doctors are excited about the ease of placement with this product, and the delivery of the product is easier than other devices on the market. It allows for more accuracy. Not only do we have a solid, you know, product, but we also have a product that can be delivered, you know, easily and make, you know, the doctor's efforts a lot better.
Yeah. Okay. You know, just remind us again what the kind of market opportunity is, either, you know, in terms of procedures, patients, dollars, whatever you're able to kind of talk about here.
Yeah, I mean, we described, I guess, the market for us is really the dialysis access maintenance, you know, product. I think when we look at that, you know, we're looking at the, you know, Clarivate, you know, data for the current market. That's where we feel, we believe, provides a good data set for us to kind of look at it. You know, and they reported about 654,000 endovascular dialysis maintenance procedures in 2023. More importantly, within that report, they reported 95,000 stents units were implanted in dialysis access maintenance in 2023. We think, you know, for Merit, that's initially the addressable market that we're going to go after. In terms of, you know, kind of market growth, you know, they reported total stent, you know, somewhere in the low single digits.
Obviously, we're looking at not only at market growth, but also, you know, taking a market share. Again, we think it's a solid market. It's an area that we think we can compete well in and have been. You know, we'll see how it all shakes out.
Okay. You know, covered stents as a category have been around for a while, and there are a number of competitors out there. I think WRAPSODY has kind of proven itself to be different. It was designed differently, and the data has been really good. Maybe you could just talk a little bit more about, you know, the design and why it seems to have much better results than some of the other products that are out there.
Yeah, look, you know, I think we throw around the word stent a lot, right? If I had my marketing group in here, my clinicians, you know, they'd be poking me and prodding me with, you know, whatever they could throw at me, you know, or poke me with. You know, I think for us, as you know, this is an FDA Breakthrough Device. You know, part of that is really related to the impermeable endoprosthesis aspect of it. We think we have a layer that, you know, that works a lot better than stents. It's not just a covered stent, you know. We actually, you know, you know, call it, you know, we don't call it a stent. We call it, you know, the WRAPSODY Cell- Impermeable Endoprosthesis for a reason. We did get FDA Breakthrough on the Device.
Clearly, any technology that's out there, you know, or was out there, you know, was not on par with what the WRAPSODY is.
Okay. I think in terms, you know, from a reimbursement perspective, you're seeking both a transitional pass-through or TPT payment for outpatient use, as well as a new technology add-on payment or NTAP payment for inpatient use. Can you just give us an update there in terms of the process and timing of when you could potentially hear something there when the reimbursement might go into effect?
Yeah, look, we submitted for both NTAP and TPT, as you said, Mike. We submitted those all within the required time frames. You know, the next update from us will really come sometime in June when we find out, you know, for both, whether we got them or not. You know, if we did, you know, that would take effect sometime in the third quarter. You know, obviously, this is an FDA Breakthrough Device. You know, we have a high level of confidence. You know, at the end of the day, we've done everything we can in our control to submit, you know, our best foot forward. Now we've got to go through the process and see where it shakes out. Yeah, we're excited.
I think at the end of the day, regardless of what happens, we feel like we have a very competitive product that can do well with or without, you know, reimbursement. Obviously, clearly, we hope we get reimbursement.
Yeah. Okay. I mean, I know you have been kind of wary of disclosing the reimbursement or, sorry, the pricing. I'm not going to ask what the pricing is, but I guess, have you kind of priced it with the expectation that you're going to be getting these add-on payments? You know, does that sort of mean that it's kind of there's going to be a little bit of reimbursement headwinds in the first half of the year until, or I guess maybe even through like the third quarter until these sort of go into effect? At that point, maybe we could see sort of more of an inflection point where it starts to really take off once the, assuming you get these extra reimbursement payments in place.
Yeah. So, you know, in our WRAPSODY call, we did call out what our targeted, you know, reimbursement was. You know, ASP was around $5,800. You know, I think, you know, there's obviously the reimbursement, you know, aspect of it. Again, I think given the technology that we have, we have a high level of confidence in the pricing target that we're going after. I think the biggest hurdle for us really is kind of getting through all the value analysis committees, right? That just takes time. So far, we've been pretty successful at that. I think the second quarter is really kind of where that starts to pick up as far as kind of getting through those committees. You know, and hopefully by the end of the, you know, you know, sometime in June, we get some good news, right, for reimbursement.
As we look at, you know, kind of maybe stepping back and we look at our guidance, you know, we're shooting from some, you know, anywhere between $7 million and $9 million. You know, that $7 million and $9 million, as you can imagine, has all sorts of variables. I can say that we have a high level of confidence in the seven, regardless of kind of the outcome. As you look at and think about that guidance, it is definitely weighted towards the back half of the year. When you look at the back half of the year, it's definitely more weighted towards the fourth, you know, quarter than it is the third. There is just a process you have to go through, and it's time-consuming, and you just have to kind of get through it.
You know, so far, positive feedback from the salesforce and docs, and we have not had any issues with value analysis committees.
Okay. And then, you know, you mentioned those numbers earlier on. It was 95,000, you know, stent procedures out of the, I forget the exact number, 600,000, 700,000 total fistulas getting treated, AV fistulas getting treated, or AV access, maybe is a broader term. You know, it's only 95,000 out of that. I imagine it's because maybe stents aren't necessarily like a first-line treatment for these patients. Is there a potential for WRAPSODY to maybe expand that 95,000 to a greater portion of the total number of these procedures that are being done, and maybe even become like a first-line treatment? That's the first part of the question. I guess the second part would be, you know, what sort of would need to be done to achieve that?
Do you need, you know, more clinical data or guidelines or something else to change? Or do you think the doctors might just start doing it on their own if they have good results with the product?
Yeah, look, we know that, you know, obviously, when we talk, we talk on-label use, right? But, you know, the reality is that, you know, doctors use it, you know, the product off-label. I mean, we have a registry out there. We get to see where, how they use it. Look, I think, you know, you know, we're focused on the 95,000, you know, stents. I mean, I think if, you know, if we took those, I think everybody would be happy. You know, there would be no, no, you know, no disappointed people out there. You know, I think that's the primary focus right now. You know, obviously, the end goal would be kind of to change the standard of care, you know, for our product. Obviously, that expands the market opportunity for us.
I also highlight, you know, our RTG group, you know, who sells the WRAPSODY, you know, has a whole, you know, bag full of products that help in the dialysis access maintenance. You know, we think we have the broadest, you know, portfolio out there and one of the best, you know, setup portfolios. It was done in a thoughtful process, you know, with a direct salesforce that could be funded by these products. We've seen a positive uptick in the sale of those products and strong demand. Again, I think we have a strong belief that we, you know, we provide all the products that are needed within that procedure, you know, and obviously WRAPSODY is that, you know, takes hold. We'll be able to, you know, you know, take additional, you know, shares in other areas.
That is, you know, that is down the road. Right now, we are just primarily focused on the 95,000 stents.
Okay. And then, you know, with that, you know, dialysis business that you have that includes WRAPSODY and these other things you just mentioned. How, I do not know if you are willing to disclose or able to disclose the size of that salesforce, but I guess that would be my first question. The second question would be, even if you cannot just tell us the size, you know, is it safe to assume that you are, you know, adding people this year with WRAPSODY launch?
Yeah, look, we added, you know, and I won't disclose, you know, for competitive reasons, you know, the size of the salesforce, but we do feel like we have the right number of heads. We are going to add a few, you know, this year and have started to do that all within the budgets, you know, that we've outlaid in the forecast and then the guidance that we've given. Look, I think we're attacking all the major markets. You know, I think we've got the right, you know, amount of salespeople. We'll use kind of a pull method, you know, as opposed to kind of, you know, preloading any salespeople. We just think that's a much better, more efficient way to do it.
You know, clearly, again, I think in June, we'll have more information as to, you know, how fast we pick up the cadence on some of these things. You know, we're making good headway so far.
All right. I want to move on to the international business. You know, I'll start with China, which I know is another one of your favorite topics to talk about. I guess, you know, first, I have to ask about the tariff situation. I mean, I don't, I want to get into kind of the broader tariff impact on Merit later. Just specifically with regard to China, you know, they're putting tariffs, I guess, on U.S. products now coming into China. I don't know if that would include healthcare or medical devices. You know, just what have you heard there? Do you think your products will get tariffed when you're selling them into China? You know, what, if any, kind of impact do you expect that to have on that business?
Yeah, look, I think we are expecting the tariffs to be applied to medical devices. You know, I think there's no secret to that. I will say that I, you know, we do have global operations, right? So our major manufacturing site, you know, the largest manufacturing site at Merit is in Mexico. And then, you know, we have obviously international, you know, manufacturing also in Ireland, Singapore, Paris, and Venlo, you know, with obviously some operations in the U.S. These tariffs, you know, these counter tariffs really only apply to the, you know, the products that are coming out of the U.S. You know, I think, you know, this is an area that's been highly volatile, you know, with a lot of moving parts.
I mean, just today, I think the president announced that, you know, that China wanted to negotiate, right? Where yesterday he announced he was going to tack them on with 50% tariffs, right? I think it's a pretty variable kind of situation. I think, you know, for investors that are on here and, you know, you, Mike, Merit is going to do what it's always done in kind of a volatile or crisis-type environment, right? That's to focus on its business, focus on things that we can affect. You know, the tariff situation that's going to play out, we're not making any long-term decisions based on what's going on with the tariffs. I just think that's, you know, it's just not somewhere we want to waste our energy just given the dynamics of it. You know, 30 days ago, we were all worried about Mexico.
Now we're under the USMCA, you know, and, you know, essentially exempt, you know, from any tariff increases. I think there's a lot of variability to this. We're going to focus our efforts on making sure that we can deliver the CGI goals, work on things we can affect versus things that are outside of our control. We did that during COVID. We saw great results. We're, you know, we're pretty headstrong here, you know, thinking that we can just continue to do what we're doing. We'll deal with the tariffs on a kind of one-off situation and make sure that we disclose the impact so you guys can see how the management team is executing on the business outside of the tariff impact.
Yeah. Okay. You raised an important point there. You know, what you're saying effectively is that a lot of the products that you may be selling into the Chinese market aren't necessarily being manufactured within the U.S. They should avoid some of those, some or all of the tariffs if they were made at one of those other plants and shipped directly from those plants and not from the U.S., correct?
That's correct.
Okay.
Right. Obviously, there will be an impact because we do, you know, the U.S. sites are our second-largest manufacturing sites. I don't, you know, but we do have a balanced kind of, you know, manufacturing footprint. That will help with some of the, you know, some of the pain.
Okay. Got it. And then just the international business more broadly, are there new markets that you could enter? Are there other, you know, emerging markets that you're not in that maybe would be attractive for Merit?
You know, I mean, look, I think over the last, you know, couple of years, we've redirected investments, you know, to other APAC, you know, regions within, you know, outside of China, just given the, you know, the volume-based purchasing, you know, that was happening and just the uncertainty. You know, I think we'll continue to do that. I mean, when we look at our, you know, our 2025 international growth, you know, the midpoint of our, you know, constant currency growth rate is 7.5%. I think, you know, that's a pretty solid number. When you start to dig in, you know, within the regions, you know, EMEA is low double digits, you know, high teens growth in the rest of the world regions.
You know, about 1% growth in the APAC region, which is really related to kind of the China, you know, impact, you know, related to the volume-based, you know, purchasing headwinds that we continue to experience. I think from a volume-based purchasing, you know, China will do a little bit better than it did last year, you know, and hopefully, you know, as we get through 2026, you know, you know, we start to kind of, you know, climb our way out of it. Yeah, we have been investing in other areas. You know, the U.S. growth rate, I think, has been excellent. You know, you guys can, you know, see that. I think that's some of the redirected investments, you know, that we're making to areas that I think, you know, generally we see them as a little bit more stable.
That's not to say that we don't think China is a great market. You know, I think it's one of those markets that we think has a high level of potential. It's got aging population. We continue to, you know, register new products there. It's a, you know, we continue to focus on the peripheral intervention markets, which are, you know, more fragmented in an area we feel like we can better compete in. A lot of moving parts, but I think, you know, we've got a general, generally we're making the right investments, I think, in the right areas and not necessarily hyper-focused on China. You know, they've heard no more in the last two years than they ever have, you know, because, you know, given the growth rates that we were experiencing in China, they typically always got what they wanted.
That just has not been the case the last few years.
You're talking about your leadership in America.
Yeah.
Yeah. Okay. All right. Moving on to some of your products. You know, a question that I often get from investors is kind of just about, you know, where Merit fits kind of competitively. I mean, you are competing against some of the biggest companies in med tech, you know, Boston, Medtronic, Terumo, et cetera. You know, how are you guys sort of positioned in the market and how do you compete against these bigger companies effectively?
Look, we also have to remember that they're also our customers on the OEM side, right? Yes, we do compete in certain areas, but they're also our customers and, you know, in our OEM division. I think, you know, Merit has done an excellent job of just being light on its feet and going after markets that are underappreciated. I do truly feel like as these companies get bigger, they do leave things behind that just don't move the needle for them anymore. We're really good at, you know, finding those and picking those up and bringing those on and taking on that business. I think Merit has a, I think it's not just the products, right? I think it's our salesforce. We have a global salesforce. We have direct salesforce in all the major markets.
We have a global distribution footprint. Our customers can get, you know, products easy. We have a global manufacturing footprint that's vertically integrated. We're strong believers in high-quality products, you know, that make a difference in the doctor's hands. I think when you combine all those things, you know, we've been competing with these guys for a very long time. We continue to deliver high single-digit growth. You know, when you look at it, you know, over, you know, a 10-year period, I mean, we're doing really well. Quite frankly, the markets that we operate in, you know, grow anywhere from, you know, 3-4%. We continue to take market share in areas. Again, I think it's just, it's just a combination of everything that we do, Mike, you know, that allows us to continue to do that.
Okay. And then, you know, I just want to touch on a few products. I mean, there's so many different things to potentially talk about here, but I picked a few. You know, starting with kind of the SCOUT Radar Localization system. I know you acquired this a few years ago. Maybe you can just give a quick overview of, you know, for people that aren't as familiar, you know, what the product is and kind of, you know, just give us an update on, you know, where market penetration is in that market versus kind of the legacy wire approach and, you know, what you're seeing there in terms of adoption.
Yeah. I think the best way to kind of, you know, explain what it is, you know, it's for, you know, when you think of the current, you know, medical procedures, you know, you essentially, you know, put wires in the breast to localize the tumors, right? Find where they're at, and then you can go out and do your biopsies and figure out if it's, you know, benign or not. Our system is a wire, you know, free system. You place a device within the breast or, you know, near the tumor that allows the doctor to more accurately pinpoint where that mass is and then go do the work that they need to do, whether it's, you know, a biopsy or extraction, making sure that they get the right margin.
Think of our device as a tiny, actually, you know what, I have it right here, as a tiny little piece of, you know, grain of rice. For those of you that can see it, it's those little two black things that are sitting in there. Those are, you know, included in, you know, around the mass, you know, by a biopsy device or in it, you know, depending on what the doctor wants to do. As you can imagine, it's a much better process, you know, for patients, you know, because, you know, typically they insert wires into the breast and then they tape them up. Patient has to wait around. Sometimes they shift and they have to go back in, get them replaced. You know, with ours, it's a permanent implant if they want them to, or they can be taken out.
It's just a much more accurate, you know, process. And from a market penetration, we've done really well. I think that the, you know, the SCOUT system continues to do, you know, as well or better than expected. We have new devices that are, you know, that are coming out for it and a new monitoring system here over the next couple of years that we think will be better technology. And again, it's kind of the Merit way, right? We're not going to just wait, you know, to run this well dry. You know, we're bringing on new products to stay ahead of the curve and making sure that we're staying ahead of our competitors. So we're excited to see how those, you know, play out.
Over the next year or so, you'll start to see those, you know, devices, you know, kind of hit, or at least the monitoring system come out and, you know, hit the market. So we're excited about that.
Okay. And then, you know, I guess what are your competitors? Hologic a cquired Endomag, you know, just curious what you're seeing there. You know, how do you think, you know, SCOUT is kind of stacks up against Endomag's approach?
You know, we've been competing against Endomag for quite a long time, and we continue to win against them. Obviously, you know, now they have a higher backing, right? And we're paying attention to it. At the end of the day, you know, we're going to do what Merit does, and that's stay focused on our products, making sure that we're staying ahead with the technology. I think we'll be in a pretty good spot. Again, we continually win against them, you know, from an imaging standpoint. You know, their system does create a lot of artifact, you know, that sometimes doesn't allow, you know, for, you know, enough clarity, you know, to find out, you know, do what you want to do. Our device does not do that, but we consistently win against them.
Okay. Another product that you acquired was, or a company, I guess, was EndoGastric Solutions. They have the TIF procedure. Just wondering if you could give us an update there, kind of, you know, how it's done since you acquired it. I think you recently announced that there were some guideline changes for their procedures. How meaningful are those guideline changes? Is that something that's going to accelerate adoption of the product or procedure?
I think any news like along those lines, especially when it comes to reimbursement, I think is big news for us, right? I think, you know, when you think about the EGS group and our endoscopy group, last year they were two separate groups. As we brought the acquisition on, we kind of left them alone, let them finish out the year. In the meantime, they were doing training, cross-training on their products so that when 2025 came around, we would have a combined salesforce that would sell both portfolios, right? Again, we think they're complementary to each other, and I think it'll make the salesforce more efficient. Now, we understood that, you know, that, you know, as you bring, you know, two salesforces and combine them, that there's typically a little bit of disruption, right? We've accounted for that in our guidance.
You'll see the growth rate slow down a little bit. I think we've had some questions around that. It's strictly to give these guys some room to make sure that they have, you know, the confidence out there to go and execute on a combined sales bag. No, I think, you know, they were here yesterday doing some training, the EGS guys and the endoscopy guys, you know, so one combined salesforce, cross-training on each other's products. It went really well. Fred and I got to talk to them yesterday. A lot of excitement, you know, on what they can do. You know, we'll continue to monitor that. So far, it's fully integrated. We have one salesforce now. Things are moving in the right direction.
Okay. Got it. Just from in terms of clinical trials, you announced this MOTION Study for genicular artery embolization last year. I think it's, you know, it's a procedure to embolization procedure to treat knee pain. It seems like this could be a pretty big opportunity if it's successful. You know, when could we see results of that trial? You know, what's your take on the market opportunity there?
Yeah. Look, I think, you know, there's a pretty large market opportunity for it, you know, not only for knees, but, you know, shoulders, you know, anywhere kind of where you, you know, kind of, you know, any joint really. And, you know, I don't know about, you know, you, but, you know, both my shoulders are shot, you know, so, you know, any relief I can get there without actually going under the knife, you know, would be greatly appreciated. You know, I just think, you know, I think next year sometime, you know, we, you know, we'll be, you know, hopefully wrapping up the study, but I think it, you know, there is a pretty big potential. This is an area that doctors came to us and said, "Hey, we really want you guys, you know, involved in this.
We think your products are, you know, our best in class and could really, you know, help accelerate these procedures. You know, we're excited about it. It's just one of many things that we continue to be excited at here at Merit.
Okay. Just moving on to the Cook Medical acquisition, I think this was your most recent deal. Wondering if you could give us a quick update there in terms of how that operation's going.
No, that continues to, you know, to go well. You know, I think, you know, for us, you know, Cook was, you know, over that lead extraction, you know, team over at Cook was just, you know, quite frankly underappreciated. And I think, you know, they've had more interactions with the executive team and, you know, myself and Fred here than they ever did at Cook, right? I think they got to talk to the CEO once when they were there, and that's when they were told that they were sold to us. You know, we've met with them multiple times. We've listened to some of the needs that they want. You know, there was a specific product that had been, you know, that we brought over from Cook that had been off the market for, you know, well over a year.
We're going to, you know, the salesforce was adamant that they wanted it and needed it. We're going to have it in the market within four months, right? Again, that's what we do. We listen to our salesforce. We listen to the doctors. I think that, you know, they're getting the attention that they need. We have a, you know, obviously, you know, products that we can also feed into their bag. They're not just selling one, you know, one product. Now they have a bag of products. You know, they're excited about what they can do. Integration is going great. Obviously, the manufacturing component of the integration is going to take us a little bit longer, you know, just given the regulatory hurdles that we have to kind of overcome. That's just really timing-based.
It just takes time to get through these regulatory kind of, you know, paths. Everything continues to be on track, if not ahead of pace.
Okay. All right. You know, I want to address the tariff question kind of more broadly now. You know, we talked about China, but that's more of an issue of tariffs on your products, you know, as products going out the door as opposed to, you know, things coming in the door. You know, what, you know, how exposed are you? You have production in Mexico, but you mentioned some other places in Europe and things like that. You know, I'm sure you're not at a point where you're willing or able to quantify this, but maybe just help us think through, you know, how, and obviously it changes day to day, but, you know, how significant of an impact can this be?
Mexico, just as a follow-up, you mentioned USMCA, and, you know, we're hearing that from other companies as well at the conference that it does sound like that is going to be protective of tariffs if you're adhering to that. Just want to confirm that.
Yeah. Yeah. I'll just address that real quick because I think it's an important, you know, kind of fact pattern. I think, you know, Mexico is our largest manufacturing site, but we do, the majority of our products fall under the USMCA. There is a small immaterial kind of, you know, piece that doesn't, but the majority of those products do fall under the USMCA. For now, as of today, as of this minute, we're protected. Look, you know, Mike, I'll just maybe take a step back, right? Just at a high level. I just want to emphasize, you know, kind of, you know, the executive team's approach here at Merit. We do really well when we're focused and when there's a crisis out there.
You know, we kind of, you know, like to, you know, take pride and, you know, when there's a crisis that Merit usually kind of rises up to, you know, to do pretty, you know, pretty well in those situations. You know, our approach is that we are going to focus on the things that we can affect. You know, we're not doing any long-term planning based on, you know, what the current, you know, tariff situation is because it is so fluid. Just as an example, you know, 30 days ago, we were all concerned about Mexico, right? You know, that, you know, at least for now, that seems to be safe, you know, under the USMCA, you know, plan. I think, you know, we're going to continue to focus on making sure that we're delivering on the promises of Continued Growth Initiatives.
You know, we feel like we can better affect, you know, our performance that way. The tariff situation will play out. We'll call that out separately on our calls so that people understand how the management team is executing against its promises for CGI. You can weigh the tariffs, you know, as appropriate, you know, on your side. I just think it's a, it's too hard of a task and too dynamic of a task to chase the tariffs and try and come up with solutions when you're just going to be end up chasing your tail, right? Again, I like to give this example. I was at, you know, one of your competitors, you know, investors, you know, conference, you know, a month ago.
The day that I started the calls that, you know, the tariffs went into effect, as you can imagine, everybody was panicking about that and, you know, had a lot of questions about that. I got on the phone with Fred and said, "Hey, you know, we've kicked off some of our contingency plans for that. We should probably meet as an executive team. I'm traveling. I'm not back till Thursday. You're traveling. You're not back till Thursday either. Why don't we meet Friday?" You know, by the time Friday came around, there was already a solution. We didn't even get to talk about it, right? It is a very dynamic thing. I think, you know, again, our approach will be to focus on the things we can impact. We do really well when we do that. Clearly, there's going to be an impact.
I'm not going to, you know, kind of sugarcoat that. I think to the extent the management team can focus on its efficiency projects, you know, we'll see how the tariff thing kind of shakes out. It is a very dynamic situation and one that, you know, obviously is very frustrating, but we're not going to, you know, we're not going to lose sleep over it because I think, you know, the Merit team has a pretty good, you know, plan, a robust plan, you know, through 2026 for CGI. Our goal is to execute on that. You know, whatever happens with the tariffs, we'll deal with that on a separate basis.
Yeah. Okay. That all makes sense. Just moving on to kind of some of the line items in your P&L. In 2023 and 2024, you did see pretty significant gross margin improvement both years. I think your guidance for this year implies, you know, kind of flat, maybe slightly down gross margin. Just curious kind of what's changed there. Not to say you're not delivering, you know, operating margin improvement, but it's coming from a different place as opposed to gross margin, it seems like.
Yeah. I actually don't, you know, maybe that's, you know, kind of been, you know, maybe we weren't clear. But look, I think, you know, under CGI, most of our improvements for operating margin, if not all of them, come from gross margin. We had a great year last year. You know, this year, it's more of the same. Our, you know, most of our improvement is coming from gross margin, you know, especially when you look at the low end, you know, it's all gross margin on both, you know, the 2025 forecast and also the CGI program, you know, through 2026. On the high end, you're talking about gross margin improvement and some operating expense leverage. For us, you know, gross margin will continue to improve this year. You know, I think, you know, we are making some investments in OpEx.
I think we've been very clear, but I think we've got a very balanced approach to how we're doing it. We're still delivering operating margin expansion this year. As always, we always wait to see if the gross margin is coming in as expected. If it is, we'll make the investments, you know, we'll balance out the investments that we're making with the profitability we're delivering to, you know, to investors. Again, we've got a solid game plan this year, gross margin expansion, operating margin expansion, and I think a pretty solid growth, you know, for the year.
Okay. What about, you know, pricing? I know you've made more of a concerted effort there and I think developed maybe a team to focus on the pricing opportunity. Is that something that's going to, you know, again, putting aside the tariffs for now, but, you know, in a normal world, is that something that's still going to be, you know, beneficial to your top line and margins?
Yeah. Yeah. The way we look at it here, we made a significant investment under Foundations for Growth. And it was, you know, what we thought was a permanent investment that would, you know, allow us to have pricing be a net positive for Merit on a go-forward basis. And that's our intent, you know, Mike, is to make sure that, you know, those investments continue to pay off. We think we're much better at contract negotiations, you know, contract compliance. We're much better at the visibility that we get and execution from our salesforce on pricing targets. That is on purpose, right? We made those investments to make sure that this is what we were getting, you know, for the long term. We've been pretty happy with what's been happening there. Again, we see it as a net positive on a go-forward basis.
Okay. Somebody did email me a question. I'm going to ask it. I don't know if you're able to answer it or willing to answer it, but just, you know, with regard to Mexico, can you break out a portion or tell us the percent that isn't under USMCA that will be?
It's an immaterial amount that, I mean, it's not even worth worrying about. Yeah. I mean, you know, and I'm throwing out a percentage that, don't hold me to it, like 99% of our products are going to be under the USMCA, right? I can't say 100% because it's not all of it, but it's an immaterial amount for whoever asked that question.
Finally, just M&A, you know, you've been kind of ramped up your M&A efforts again. You know, should we expect to see more over the next 12 to 18 months? You know, does the tariffs come into play here at all in terms of like, you know, maybe you put things on hold until you know what's going to happen with tariffs, or is that just not something you consider?
Yeah. Again, I can't emphasize that we're not going to do any long-term planning based on the tariff situation today, right? I mean, I just think it's a decision.
It's not going to stop you from doing anything?
It's not going to stop us. You know, we've got a good strategy on M&A. I think you guys are seeing it play out. We're going into areas that we feel really comfortable with. It allows us to break up our sales bag and go deeper into certain areas. You know, you saw it with the EGS transaction. You saw it with, you know, with the Cook transaction for our, you know, cardiac interventions group. You know, you saw it with the AngioDynamics deal for, you know, setting up a, you know, an RTG group, you know, that could sell WRAPSODY. And we really like the way this is playing out. I mean, I think, you know, it allows us, our salesforce, to just be more focused and go deeper in the bag.
Okay. I think we're going to have to wrap up there. We're almost out of time. Thanks for all. Thanks for attending our conference. I hope you have some good meetings during the event.
Great. Thank you, everybody. Thanks for listening.