Merit Medical Systems, Inc.

Welcome to the Merit Medical Systems fourth quarter 2025 earnings conference call. At this time, all participants have been placed in listen-only mode. Please note that this conference call is being recorded and that the recording will be available on the company's website for replay shortly. I would now like to turn the call over to Martha Aronson, Merit Medical Systems President and Chief Executive Officer.

Thank you, Operator, and welcome, everyone. I am 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 please take us through the safe harbor statements, please?

Thank you, Martha. 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 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 the expectations and projections expressed or implied by our forward-looking statements. In addition, any forward-looking statements represent our views only as of today, February 24, 2026, 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 press release and presentation for important information regarding such statements. For discussion of factors that could cause actual results to differ from these forward-looking statements, please also refer to our most recent findings with the SEC, which are available on our website. 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 sections of our press release and 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 Martha.

Thank you, Brian. Let me start with a brief agenda of what we plan to cover during our prepared remarks. I will begin with a brief summary of the fourth quarter and full year 2025 financial results. Then Raul will provide a more in-depth review of the quarterly and full-year financial results, as well as financial guidance for 2026, which we introduced in today's press release. I'll then provide some closing comments before opening the call for your questions. Beginning with a review of our fourth quarter results, we reported total revenue of $393.9 million, up 11% year-over-year on a gap basis, and up 10% year over year on a constant currency basis. The constant currency revenue growth delivered in the fourth quarter exceeded the high end of the range of the growth expectations that we outlined on the Q3 2025 earnings call. Our constant currency growth in Q4 was driven by 6.6% organic constant currency growth in Q4, which modestly exceeded the high end of the range assumed in our guidance and contributions from our acquisitions, which also exceeded the high end of our expectations. With respect to the profitability performance in the fourth quarter, we delivered financial results that significantly exceeded expectations. Our non-GAAP operating margin increased 138 basis points year over year to 21%. The team delivered 12% growth in non-GAAP EPS, which exceeded the high end of expectations. and we generated $74 million of free cash flow, an increase of 13% year over year, and a quarterly record for the company. The fourth quarter results reflect continued strong momentum in the business this year. I want to thank our 7,500 employees around the world for their commitment to achieving our annual goals in the midst of a meaningful leadership change during the second half of the year. For the full year 2025, The team delivered total constant currency revenue growth of 11%, a non-GAAP operating margin of 20.3%, representing a 131 basis point increase year over year, and more than $215 million of free cash flow. These are impressive financial results on their own to be sure, but more importantly, each of these exceeded the high end of the original guidance range for 2025 provided on the fourth quarter 2024 call last February, despite the continued challenges related to the dynamic and uncertain global macro environment. Specifically, the high end of the original 2025 guidance called for constant currency revenue growth of 10%, non-GAAP operating margin of 19.7%, and free cash flow of $150 million. This outstanding performance is a direct result of the team's strong execution and commitment to achieving the company's multi-year financial targets. We introduced financial guidance for 2026 in today's press release, which calls for solid constant currency growth, year-over-year non-gap operating margin expansion, and strong free cash flow generation. The organization is aligned around our priorities for 2026. specifically to drive strong execution around the globe and to successfully complete our continued growth initiatives program, which includes our previously disclosed financial targets for the three-year period ending December 31st, 2026. With that, I'll turn the call over to Raul for an in-depth review of our quarterly financial results and our financial guidance for 2026. Raul?

Thank you, Martha. I will start with a detailed review of our revenue results in the fourth quarter, beginning with the sales performance in each of our primary reportable product categories. Note, unless otherwise stated, all growth rates are approximated and presented on both year-over-year and constant currency basis. Fourth quarter total revenue growth of 10% was driven primarily by 9% growth in our cardiovascular segment and, to a lesser extent, by 15% growth in our endoscopy segment. Cardiovascular segment sales exceeded the high end of the expectations we outlined on our third quarter call, and endoscopy sales came in at the midpoint of our expectations. Q4 total revenue results included approximately 10.8 million of inorganic revenue from our acquisitions of lead management products from Cook Medical, BioLife Delaware LLC, and C2 CryoBaloo device from Pentax of America. Excluding sales of acquired products, our total revenue growth on an organic constant currency basis was 6.6%, slightly better than the high end of our expectations in the fourth quarter. Turning to a review of our fourth quarter revenue results by product category, cardiac intervention product sales increased 21%, representing the largest driver of cardiovascular segment growth in the period. CI sales increased 12%, excluding the contributions from the sale of acquired products. This performance was well above the high-end organic growth expectations we assumed for Q4. Organic growth in our CI business was driven primarily by strong sales in our EP, CRM, and geography and access products, which together represented more than 60% of our total CI organic growth year over year. Demand for our prelude SNAP in our Ventrax delivery system were the largest contributors to EP, CRM, organic growth in Q4. High teens growth in sales of wires fueled our geography product sales results and demand for our Prelude radial sheath and our Prelude wave hydrophilic sheath introducer with SnapFix technology were the largest drivers of our access products organic growth in Q4. Peripheral intervention products sales increased 13% and represented the largest driver of organic cardiovascular segment growth in the period. PI sales exceeded the high end of our growth expectations in Q4. Growth in our PI business was driven primarily by strong sales in our radar localization and delivery systems categories, which together increased more than 25% year-over-year, representing 45% of our total PI growth year-over-year. Importantly, fourth quarter PI growth was driven primarily by broad-based strengths across multiple categories, including EMBOA therapy, drainage, angiography, and access products, which together represent more than half of our total PI business, and posted 10% growth in Q4. Rounding out the Q4 performance across the rest of our cardio segment, sales of our custom procedural solutions products increased 4% above the high end of our expectations, driven primarily by high teens growth in kit sales, offset partially by high single-digit declines in sales of critical care products. CPS growth in Q4 was impacted in part due to the planned divestiture of our dual cap line which I'll discuss in further detail shortly. Finally, sales of our OEM products decreased 15%, significantly lower than the low single-digit growth assumed in our guidance. The largest contributor to the softer-than-expected OEM performance in Q4 was sales to OEM customers outside the U.S., which continued to see demand trends impacted by macroenvironment. Sales to OEM customers in the U.S. decreased in the high single digits year-over-year compared to low single-digit growth we had expected. We attribute the softer than expected U.S. OEM performance substantially to customer inventory destocking. While we were disappointed with where OEM sales landed in Q4, our OEM business increased 2% year-over-year on a constant currency basis in 2025. This performance is slightly better than what our original guidance assumed coming into 2025. Our OEM business remains healthy despite the quarter-to-quarter fluctuations in growth rates. And we continue to believe the appropriate normalized growth profile for our OEM business is in the mid to high single digits annually. Turning to a brief summary of our sales performance on a geographic basis. Our fourth quarter sales in the U.S. increased 12% year over year and 8% on our organic constant currency basis. International sales increased 6% year over year and 4% on our organic constant currency basis. Q4 U.S. and international sales results were both at the high end of our organic growth expectations. Turning to a review of our P&L performance, for the avoidance of doubt, unless otherwise noted, my commentary will focus on the company's non-GAAP results during the fourth quarter of 2025. And all growth rates are approximated and presented on a year-over-year basis. We have included reconciliations from our GAAP-reported results to the most directly comparable non-GAAP item in our press release and presentation available on our website. Gross profit increased approximately 13% in the fourth quarter. Our gross margin was 54.5%, up 103 basis points year over year, and represents the highest quarterly gross margin in the company's history. The year over year improvement in gross margin was primarily driven by mix, by product, and by geography, as well as improvements in pricing compared to the prior year period. As expected, Tasks were a material headwind to the year-over-year improvement in gross margin in Q4, representing a 112 basis point incremental impact year-over-year. Operating expense increased by 10%. The increase in operating expenses was driven primarily by a 10% increase in SG&A expense and an 8% increase in R&D expense compared to the prior year period. Total operating income in the fourth quarter increased $13 million, or 19% from prior year period, to $82.7 million. Our operating margin was 21% compared to 19.6% in the prior year period, an increase of 138 basis points year over year. Fourth quarter other expense net was $1.3 million compared to $1.1 million for the comparable period last year. The change in other expense net was driven primarily by lower interest income associated with lower average cash balances, offset partially by lower interest expense compared to the prior year period. Fourth quarter net income was $62.5 million or $1.04 per share compared to $56.3 million or $0.93 per share in the prior period. Fourth quarter net income and EPS exceeded the high end of our guidance range by $1.8 million and $0.03 respectively. We generated $74 million of free cash flow in the fourth quarter of 2025, up 13% year over year. For the full year of 2025 period, We delivered constant currency revenue growth of 11%, driven primarily by 7% organic growth and contributions from acquisitions of $62 million. We delivered non-GAAP operating profit growth of 19% year-over-year and non-GAAP net income and EPS growth of 13% and 11%, respectively, year-over-year. we generated nearly 216 million of free cash flow in 2025, up 16% year-over-year and well ahead of our guidance, which called for free cash flow generation of more than 150 million for the year. This strong free cash flow performance was driven primarily by the year-over-year increase in non-GAAP net income, along with improving use of cash for working capital. Notably, we delivered this free cash flow performance while continuing to invest in capital expenditures, both maintenance capex and growth-related capex, specifically $30 million invested in our new distribution center in Utah. Turning to a review of our balance sheet and financial condition, as of December 31, 2025, we had cash and cash equivalents of $446.4 million, total debt obligations of $747.5 million, and available borrowing capacity of approximately $697 million. compared to cash and cash equivalents of 376.7 million, total debt obligations of 747.5 million, and available learning capacity of approximately 697 million as of December 31st, 2024. Our net leverage ratio as of December 31st was 1.6 times on an adjusted basis. Turning to a review of our fiscal year 2026 financial guidance, which we introduced in today's press release. Our 2026 guidance assumes the following. Total gap net revenue growth in the range of 6% to 8% year over year and 5% to 7% year over year on a constant currency basis, excluding an expected 80 basis point tailwind to gap growth from changes in foreign currency exchange rates. Among other factors to consider when evaluating a projected constant currency revenue growth range for 2026 are the following items. Our total constant currency range of 5% to 7% assumes 6% to 7% growth in the US and 5% to 6% growth outside the US. Second, our total net revenue guidance for fiscal year 2026 assumes inorganic revenue contributions from the BioLife and C2 acquisitions in the range of $13 to $15 million in 2026. Excluding this inorganic revenue, our 2026 guidance reflects total net revenue growth on a constant currency organic basis in the range of approximately 4.5% to 6% year-over-year. Third, our total net revenue guidance for fiscal year 2026 assumes a U.S. revenue from the sales of Rhapsody CIE of approximately $7 million, compared to $3 million in fiscal year 2025. Fourth, our total net revenue guidance for fiscal year 2026 reflects the decision to divest our dual-cap product line, We sold the dual cap product line for 28 million effective February 17th. The dual cap product line was part of our critical care offering reported in our test and procedural solutions revenue category. Product sales and royalty revenue for dual cap total approximately 20 million in 2025 and represent an estimated year over year headwind of approximately 140 basis points to our total constant currency revenue growth in 2026. These products are non-core to our business And we believe that divestiture will create additional manufacturing capacity and free up sales and marketing resource to invest in higher margin, higher growth products. With respect to profitability guidance for 2026, we expect non-GAAP diluted earnings per share in the range of $4.01 to $4.15, up 5% to 8% year over year. Our 2026 non-GAAP diluted EPS growth is expected to be driven primarily by solid constant currency growth and non-GAAP operating margin expansion in the range of 36 to 76 basis points year over year, offset partially by the projected incremental impact of tariffs, trade policies, and related actions implemented by the U.S. and other countries of approximately $0.07 and the estimated incremental dilution from our convertible debt facility of approximately $0.01. For avoidance of doubt, Our 2026 non-GAAP EPS guidance assumes a 12-month tariff impact of approximately $15 million or $0.19 per share compared to $9 million or $0.12 per share realized during the last eight months of 2025. The expected 12-month tariff impact assumed in our 2026 non-GAAP EPS range is based on tariff policies in place prior to the recent decision of the U.S. Supreme Court on February 20th and does not include any impact for new and or additional tariffs or retaliatory actions or changes to tariff policy, which could change the anticipated impact to our non-GAAP EPS in 2026. The ultimate impact of the U.S. Supreme Court decision and subsequent new and or additional tariffs or retaliatory actions or changes to tariffs on our business will depend on the timing, amount, scope, and nature of such tariffs, among other factors, most of which are currently unknown. For modeling purposes, our fiscal year 2026 financial guidance assumes non-GAAP operating margins in the range of approximately 20.6% to 21% compared to 20.3% in 2025. Non-GAAP interest and other expense net of approximately 8 million compared to 7.7 million in 2025. Non-GAAP tax rate of approximately 23% and diluted shares outstanding of approximately 62.2 million. Our weighted average share count assumes an incremental solution of approximately 500,000 shares related to our convertible debt facility. This represents an approximate impact of 4 cents to our non-GAAP EPS in 2026 compared to a 3 cent impact in 2025. Finally, we expect to generate free cash flow of at least $200 million in 2026, inclusive of the expectation that we will invest approximately $90 million in capital expenditures this year. We would also like to provide additional transparency related to our growth and profitability expectations for the first quarter of 2026. Specifically, we expect our total revenue in the range of $375 to $380 million for the first quarter, representing growth of 6% to 7% year-over-year on a GAAP basis and approximately 3% to 5% on a constant currency basis. The midpoint of our fiscal quarter constant currency sales growth expectations assumes U.S. sales increase 6% in international sales increased 2% year over year. Note, our first quarter constant currency sales growth expectations include inorganic revenue in the range of approximately 6 to 7 million. Excluding inorganic contributions, our first quarter total revenue is expected to increase in the range of approximately 2 to 3% on an organic constant currency basis. With respect to our profitability expectations for the first quarter of 2026, we expect... Non-GAAP operating margins in the range of approximately 16.7% to 18.5% compared to 19.3% last year. And non-GAAP EPS in the range of 77 cents to 87 cents compared to 86 cents last year. I'll now turn the call back to Martha for closing remarks. Martha?

Thanks, Rahul. On our third quarter earnings call, I provided a summary of the areas of focus since taking over as CEO on October 3rd, 2025. as well as where I intended to spend my time over the balance of my, quote, first hundred days. So I thought it would be helpful to provide an update on my progress since that call. As discussed, my listening tour has been a top priority for me during my first four months on the job, and I expect it to continue for several more. I have now visited the majority of our global sites and have enjoyed meeting the teams at these various locations, touring manufacturing facilities, spending time with our global R&D team, reviewing the business of local management, and holding town halls at each location. I've particularly enjoyed meeting with Merit employees around the world and have been inspired by their enthusiasm and commitment to Merit's mission to understand, to innovate, and to deliver. And a few weeks ago, I had the opportunity to meet many of the rest of the members of our global commercial team as Merit's first ever global sales meeting was held here in Salt Lake City. Many of our colleagues were able to tour our fantastic facility and meet the operators who work so hard to produce our high-quality products. Throughout the week, as I engaged with this team, my belief in the merit way that guides our entire organization was enhanced even further. I've spent considerable time learning about our products and understanding our processes, and I remain quite optimistic about our future based on all that I've learned in recent months. My listening tour has provided me with valuable feedback from across the MERIT organization. I've also had the opportunity to solicit feedback from constituents outside our organization. I've attended several key medical meetings, as well as one of our physician advisory board meetings. I've also had the opportunity to engage with the investment community, and I've spent more time with our board of directors. All of these activities are centered around gathering as much feedback as possible and learning as much as I can. A tall task to be sure, but one that I remain extremely excited about. While the majority of my time as CEO has been filled with listening and learning, I have made several changes which I believe will enhance the company's foundation for success going forward. Upon arrival in October, I established a new executive leadership team as well as a global operating committee. As discussed on our last earnings call, Merit is transitioning from a founder-led to a founder-inspired organization. I'm impressed with how our leaders across the globe are working more closely together across geographies and across functions. Next, we've solidified our platform structure by pairing up leaders from R&D with marketing and then surrounding them with the critical functions to develop a cohesive global business strategy and product pipeline roadmap. I just completed our first round of reviews of these platforms and I'm excited about the progress of these teams. As the new executive leadership team and I have been analyzing the business, it became clear that we had an opportunity to streamline our internal planning and reporting processes with the goal of aligning how we think about, evaluate, and plan each of our underlying businesses. Pursuant to this internal transition, we intend to streamline how we talk about the business externally as well. We believe this will allow us to not only align how we talk about the business both internally and externally, but will also help the investment community and our shareholders better understand the underlying growth drivers of our business today and going forward. As I have dug into the business, I've developed even more appreciation for what Fred and the team have built since they developed Merit's first syringe to inject dye for angiography in 1987. Merit has grown to a $1.5 billion revenue company as of 2025, and this revenue is globally diversified with roughly 40% of our revenue coming from customers outside the United States. Today, we report our revenue in two segments, cardiovascular and endoscopy. And within each segment, we sell a large number of products that address multiple markets procedure categories, sites of care, and physician customers all around the world. As I learned about the business and have engaged with various stakeholders on my listening tour, the same question keeps popping up. What drives growth in this business? Well, the simple answer is that Merit is really fortunate in that we have a very broad portfolio of products that contribute to our strong track record of growth, as seen by a 10% revenue CAGR over the last three years. This 10% CAGR has been driven by our portfolio products that fall into two primary groups. The first group is what we call foundational products, which are the products that are used primarily for access or enabling in vascular and other procedures. Merit's foundational products comprise about two-thirds of our total revenue and had a 6% compound annual growth rate over the last three years. The second group is what we call our therapeutic products, which are devices and systems that treat disease in a number of very large markets that together represent significant growth potential. Merit's therapeutic products comprise about one-third of our total revenue and had a 19% compound annual growth rate over the last three years. On an organic basis, they had an 11% CAGR over that time period. We will be talking more about each of these product groups going forward, But in the interim, it's important to appreciate two key themes. First, that we have several platforms where we combine both foundational products and therapeutic products, making Merit a full-line supplier to several of our customer groups. And second, the track record of growth Merit has delivered has been fueled by the powerful combination of strong internally developed product innovation and strategic M&A to enhance our competitive position in key markets. With respect to internally developed product innovation, I think it's important to understand that Merit has a track record of consistent development and introduction of new products that represent important contributors to our growth each year. As an example, approximately 10% of the 2025 revenue growth in our two largest product categories, cardiac intervention and peripheral intervention, came from new products introduced in 2025. As I referenced earlier, as we move into 2026, we remain laser-focused on achieving our continued growth initiative commitments. Specifically, for the three-year period ending December 31, 2026, we are targeting an organic, constant currency revenue CAGR of 5% to 7%, a non-GAAP operating margin in the range of 20% to 22%, and cumulative free cash flow generation of more than $400 million. As our 2026 financial guidance indicates, we believe we are tracking nicely towards these CGI financial targets. During 2026, we will spend time developing our strategy for the period of 2027 through 2030. We will build this out based on the framework of key platforms where we offer our foundational and therapeutic products. We will prioritize our research and development efforts through the lens of our customers. We will actively engage in potential M&A transactions in a very disciplined manner while structuring our product portfolio to not only align with our financial goals, but also support our commitment to providing patients with life-saving solutions that positively contribute to the healthcare communities we serve all around the world. We are looking critically at all parts of the business and where it makes strategic sense, we will take steps to optimize our offering like we did with the divestiture of the dual cap product line earlier this month. We will also work to ensure that our infrastructure remains solid while continuing to identify opportunities to enhance our operational efficiency and productivity. We believe the successful execution of our strategy will enable us to profitably scale the business around the world and drive compelling shareholder returns while we help patients in the years to come. I want to conclude my prepared remarks by again thanking our teammates all around the world. I'm honored to be part of Merit Medical, and I'm excited to work on continuing to help so many patients around the world with our products and therapies. Operator, we would now like to open up the line for questions.

Thank you. If you would like to ask a question, please signal by pressing star 11 on your telephone keypad. If you're using a speakerphone, please make sure your mute function is turned off to allow your signal to reach our equipment. We do ask that you please limit yourself to one question and one follow-up. If you would like to ask additional questions, we invite you to add yourself again to the queue by pressing star 11. One moment for our first question. Our first question comes in the line of Jason Bednar from Piper Sandler.

Hey, afternoon, everyone. Thanks for taking the questions, and congrats on another good quarter here.

Just to start, I'm probably going to sound like a broken record, but the growth margin progress has just been really impressive here. It's almost unheard of to have the kind of improvement you've seen. I think it's expanded like 400 basis points here in a two-year period. you've done it in spite of tariffs. I know you'll tell us not to extrapolate. So maybe I'll just ask the question where additional gross margin drivers exist for the company at this point. Are there core opportunities or does it need to come through actions like more M&A or more in like the therapeutic M&A or divestitures like what we're seeing with dual cap?

Yeah, look, I mean, I think it continues to be more of the same, right? And Jason, you know, with I'm just going to repeat what you said. I'm going to sound like a broken record, too, right? Look, I think, you know, first of all, just kind of, you know, just going to congratulate our sales force and our operations group, you know, for what they've done, I think, which is in a really tough environment. And to overcome the tariffs in the way they did, I think, you know, applause to them. Just, you know, it's just impressive to be able to do, you know, what we've done here in the last, you know, few years. And again, just, you know, thank you. You know, I know they're listening, so I just want to thank them. But it's really just more of the same, right? So, you know, continue to be focused on mix, whether that's, you know, new R&D projects, you know, or acquisitions, you know, pushing the geography, you know, kind of, you know, areas too. I think you saw the divestiture of dual cap. That was a low margin product. You know, just making sure that we continue our skew rationalization process. And just, you know, really throw the kitchen sink at the gross margin. I know you guys are getting sick of hearing that, but that's really what it takes to drive the gross margin in this environment. And it's focused on pricing, focused on cost discipline, you know, moving things to lower cost areas, mix, you know, our R&D department just focusing on launching the right products at the right price in our manufacturing department. being able to manufacture those at the lowest cost possible while keeping our quality where it needs to be.

So it's just more of the same for us.

Okay. All right. That's helpful. And I'll follow up with one on Rhapsody here.

We're a few months into the commercial launch in the outpatient setting. The real genesis of the question is going to be, is the business where you thought it would be? So what's going well? What could go better? And then why is 7 million the right starting point for revenue expectations this year? And really, is that guide a reflection of what you're seeing today? Is it a conservative swipe at the outlook? Just trying to think about how to think about that guide in the context of what you're seeing real time here with Rhapsody.

Yeah, Jason, thanks for the question. Let me make a couple comments, if I could, about Rhapsody. I mean, first, I do think it is fair to say, right, our original 2025, Rhapsody revenue expectations missed the mark, that that's fair to say. So as we really thought about our guidance for 2026, I mean, I think as you said, you know, we're only, you know, we're only about four months into our newer strategy for the non-hospital locations, but we really tried to take a similar approach as we thought about our guidance for Rhapsody in a similar way to how we provide guidance for the whole company, right? So We have a high level of confidence in hitting this $7 million revenue number. I think, as you said, what are we seeing out there? We still feel very strongly that this is a fantastic option for the clinicians who really think about, I want to treat patients with the best clinical data and Rhapsody has that and it's a very high performing product. So we're thrilled with that and we believe this market does definitely support a third player. And I think our team is really energized and they're working really hard each and every day out there. At the same time, we know we've entered a competitive space and we know competitors don't stand still when they see an outstanding product come to market. I'd say that's kind of how we're looking at things right now for Rhapsody.

All right. Helpful. Thank you.

Thank you. One moment for our next question. Our next question comes from the line of Mike Mattson from Needham.

Hi, Martha Rowe. Thank you very much. This is Joseph on from Mike. Maybe just Wanted to dive a little deeper into guidance. I guess maybe just on free cash flow. I understand you have the divestiture, but it looks like 2026 guiding down versus 2025. Is this, you know, more conservatism? You know, does this have to do with more of the divestiture or increased capex spend? Just wondering, you're thinking around the guidance there.

Yeah, no, thank you. Thank you for the question. I'm going to take the time to take a small victory lap, right? I mean, you know, when we launched CGI, as you know, our target was a minimum of $400 million in free cash flow. You know, we're obviously, you know, ahead of that. So super proud of the team for, you know, for continuing focus on that. I will say a couple of things. Super happy with the performance in Q4. You know, $216 million of free cash flow for the year is just a really impressive number, I think. So I think we'll continue to focus on free cash flow. You know, $200 million, it's a minimum of $200 million. We do have the building that's going up across the street, and we've got a couple of things that we want to do. But generally speaking, I think, you know, there is a lot of timing-based items that happen with free cash flow. It is a little bit of a conservative, you know, nature to it just because, you know, there are certain timing things that we can't control that are, quite frankly, just hard to predict. But I can say that, you know, we always kind of take a minimum approach. So our expectation is that we'll hit at least, you know, $200 million in free cash flow, which will set us up really nice for our CGI goals.

Okay. Of course. Yeah, that makes sense. And, you know, 2025, very strong year. Maybe just one on the M&A target list. I guess just what are the areas there that Merit's strategically looking at? Is this, you know, looking more at innovative technology or therapeutic products that have that higher growth potential? You know, is it more tuck-ins to leverage your, you know, your current growth drivers, maybe Rhapsody? Yeah, maybe just broadly, you know, what areas are you looking at? Is it, you know, EP, dialysis, endoscopy? Any help there would be great. Thank you very much and congrats on the quarter.

Yeah, thanks, Joseph. So, I think as you've heard us start to talk about, right, we're really organizing the, you know, the company and the organization around these platforms, right? And so, we have a number of platforms. where we've really put a cross-functional team and cross-geographic team together that's really, frankly, thinking about all aspects of the business, including, right, what would be helpful from an acquisition standpoint. So we're really looking to those teams to come with sort of, I'll call it their wish list, if you will. And so we want to try to be very strategic about how we think about some of those opportunities and where they'll make the most sense. So we definitely have sort of strategic criteria we think about as well as financial criteria when we're thinking about M&A. It will include, you know, both foundational products and therapeutic products because in some cases the gap, if you will, or, you know, an area where we feel like we could fill a rep's bag out even more fully could be either on the therapeutic side or the foundational side. So that's really the way we're thinking about that as we continue to think about the growth drivers of the business going forward. But we very much intend to continue both internal development as well as inorganic M&A to drive growth.

Thank you. Thank you very much.

Our next question comes from the line of Larry Beagleson from Wells Fargo.

Hey, guys. Thanks for taking the question. Could we just spend a minute on OEM? Was Q4 all inventory destocking in both the U.S. and OUS? And why would that happen in both geographies at the same time? And I just want to make sure the mid to high signal digits kind of underlying growth. that you said on the call, is that what's baked into 2026?

Yeah, Larry, you know, great question, right? So just to, you know, maybe clarity, the U.S. component of OEM is really what we were talking about from a customer inventory destocking. I think when you look, you know, outside of the U.S., it's really kind of the macro environment, and it's really kind of centered around you know, China and some of the impacts we're seeing there just related to the macro environment. So hopefully that, you know, clarifies that. I think, again, I've been pretty consistent, I think, in our messaging. OEM, you know, tends to be choppy. I think when we look at that business, we think it's a great business. It's a great addition to, you know, to merit. It really delivers a lot of volume growth, you know, through since we're essentially selling, you know, capacity. Our OEM business, you know, remains healthy despite the quarter-to-quarter fluctuations and, you know, in growth rates. But we continue to believe the appropriate normalized growth profile of our OEM business is in the mid to high single digits. And I've been pretty consistent in that messaging. So, you know, I think they're doing great.

Sorry, but it was two percent.

Yeah, that's one year. What did they do the year before, Larry? I think they did pretty good. Okay. Right? Okay. Yeah. Yeah.

Got it. And for my follow-up, Raul, let's focus on the Q1 guidance. Why only 2% to 3% organic? How much is the impact greater from the divestiture in Q1 and the lower operating margin? Look, the math I'm getting at the midpoint, it's about 170 basis points down year over year. Could you bridge us on how much is tariffs? I understand tariffs didn't occur a year ago. but you just grew operating margin 140 basis points by my math in Q4 where it didn't have, you know, a tariff impact. So it would be helpful to understand kind of the Q1 guidance for organic growth and the operating margin a little bit more. Thanks for taking the question.

Yeah, no problem. You know, I'll just start, right? I mean, I think, you know, I appreciate the focus on Q1 and I'll give you some color around that, Larry, but I will highlight that I think we've put a pretty strong year together from a guidance perspective. I think it's right in line with our CGI goals. And so I just want to highlight that, right, because I don't want to lose the focus on the quarterly discussion. But I think we've put a great year together and well on our way for our CGI goals. When it comes to Q1, I think you do have to think about a dual cap. Obviously, excluding that, you'd be up to 3% to 4%. There is some primary drivers of slower organic growth in Q1 that I'll highlight. And we talked about the first one, OEM. You know, we do expect, you know, 2026 growth to be in the, you know, in the mid to high single digits consistent with our normalized annual growth profile for OEM. But, you know, Q1 revenue will be down year over year due to some continued OUS softness and a little bit of that inventory destocking that we talked about. And also, you know, want to talk about China. Softer in Q1 given really the weighting of full year expected VBP impact. And then we're also dealing with a few little supply chain related challenges that we expect to resolve as we move through 2026. As you know, I've been pretty frank about the, you know, supply chain issues that although they're a lot less than they have been, you know, post-COVID, we are still dealing with them. You know, there's, you know, vendor consolidations and things like that that are happening. And so as they come, we deal with them. But our manufacturing industry Our operations group does a really good job of getting this out of them as quickly as they can. So those would be the kind of the three primary drivers for that softer Q1 that you guys would expect. But I would urge everybody to kind of focus on the full year numbers that we put together because I think it's a really solid plan.

All right. Thank you.

Yep. Thank you. One moment for our next question. Our next question comes from the line of Jason Bedford from Raymond James and Associates.

Good afternoon and congrats on the progress here. So I guess maybe just to piggyback on the last line of questioning, can you comment on growth in China in 25 and then your assumption in 26?

We're not going to call out the China growth in 2026. Sorry, I'm still stuck on Larry here, Jason. But I think China was down year over year. I would say that we continue to see volume-based purchasing kind of impact the business. Generally, you know, the metric that I use, and I think you guys have heard me say this, you know, a lot before, you know, volume continued to be, you know, up year over year, which is, you know, I think a good sign for us. We'll continue to deal with volume-based purchasing in 2026. You know, the goal is obviously to kind of, you know, hopefully it gets better every year, you know, and so we'll see if that kind of shakes out according to plan. But I would say, you know, 2025 China, you know, I think was down as a, you know, basically in line with our expectations.

Okay. Okay. And then as my second question or follow-up, you mentioned freeing up capacity from the dual cap sale. Just wondering, you kind of framed the revenue impact. What does this sale do to margins in 26? And then is there an associated EPS impact? Thanks.

There is a minimal EPS impact. I won't call it out. It's not worth mentioning. It's not material enough to worry about. I mean, really, we'll talk about gross margin and operating margin. It is a 140 basis point headwind to growth that everybody should consider as they look at the revenue guidance. And it's specifically with the U.S., That's about 240 basis point, you know, headwind to growth, you know, for the U.S. So it was very U.S. centric. But again, it's still driving operating expansion in 26 despite, you know, we are still driving operating margin expansion, you know, despite, you know, the divestiture and despite tariffs.

Again, we've got a $15 million impact baked into our guidance. Okay. Thank you. Yep.

Thank you. One moment for our next question. Our next question comes from the line of David Rescott from Baird.

Great. Thanks for taking the questions. Appreciate the comments on, you know, the near-term Rhapsody, right? I think, you know, you're four months or so, I guess two or three, three or four months or so into this. You know, post-reimbursement landscape rollout. And, you know, I heard some of the commentary just around how you're thinking about the contribution for this year. But maybe could you help us understand more of the longer term, you know, vision here? Obviously, reimbursement plays a role, but when you think about just a longer-term story on what Rhapsody can be, is there any reason to think that longer-term this isn't a product that captures 20, 30-plus percent of the market?

Thanks, David. Appreciate the question. Look, again, I think it's fair to say we're in early innings here, if you will, as you said, with kind of a new strategy. We're pleased with where we are so far. I think, you know, as we've talked about, this is really the initial PMA product for this company. We do think about Rhapsody, I would say, as more of a platform than just a one-off product. So we do, you know, and I think you've heard me say, we will spend time during this year, during 2026, doing strategic planning work. And we're really going to think, you know, spend a lot of time thinking about, you know, where are some of our bigger future opportunities? Where do we want to continue to drive growth as we go forward? So we'll continue to think about that. We're not ready to, you know, to share any more specifics on that at this point. But that is definitely how we're thinking about that opportunity as we move forward.

Maybe, you know, maybe I'll give you a little more color on just kind of, you know, maybe the assumptions, right? So, you know, just a little color, David, to help you out. You know, obviously, we don't want to get ahead of ourselves, you know, past 2026, but, you know, and we do not provide specific assumptions, including unit price, you know, and site of care, et cetera. But I'll remind you that market data providers, including Clarivate, which we have referenced on prior earnings calls, reported 100,000 stents and implanted in approximately 77,000 procedures in 2023, or roughly 1.2 stents per procedure. An estimated 60 to 70,000 of the total 77,000 procedures occur in the non-hospital setting each year. Clarivate, now this is Clarivate's number, reported an average selling price for coverage stents in the non-hospital setting of approximately 2,400. We will not comment on our pricing in either site of care specifically. But we want you guys, investors, are free, you know, to model potential scenarios for each of these inputs and depending on a range of potential ASPs. It is fair, I think, to assume the $7 million estimate implies market penetration in the low to mid single digits in the first full year of commercialization under the new strategy that we have for the US Rhapsody. So hopefully, you know, that gives you a little bit of color. Again, I think we've referenced Clarivate, you know, several times, so, you know, that's how we're kind of thinking about it.

Okay, that's helpful. And then maybe just on the, you know, the margin contribution, you know, from the product, obviously it's a smaller number relative to the broader portfolio, but any just, you know, insight or can you level set us on, maybe how you're thinking about the product from a contribution perspective on the margin front, not only in the – or implied in the guide, but also just, you know, as you think about this product in the portfolio longer term. Thank you.

Well, look, I think, you know, thank you. Probably not going to answer it the way you want, but I'll just say this. I think – I just want to point out, right, our total constant currency growth expectations for 2026 – are 5% to 7%, right? I think it's compelling. And nearly all of this growth is expected to be driven by our globally diversified business, right? So we've got a broad product portfolio, not to take away anything from Rhapsody, but specifically sales of U.S. Rhapsody are expected to contribute somewhere around 25 basis points to this constant currency growth range. So we are excited about the product. We're excited about what it can do. Martha covered it nicely. I can't add anything there.

But I just want to kind of focus everybody on the entire portfolio. Thank you.

One moment for our next question. Our next question comes from the line of Michael Petuschki from Barrington Research.

Hey, good evening. Thanks for the question. Well, I'm just curious, the incremental growth or the growth in PI from 24 to 25 in terms of just the three months, roughly about 20 million, how much of that was related to that scout system?

Well, I mean, I think, you know, I won't, you know, kind of, you know, comment on it specifically, but it was a primary, you know, growth driver, you know, I think when you think about the, you know, radar localization and the delivery system itself, you know, or the delivery systems, you know, category, together they increase, you know, more than 25% year over year. So, I mean, they represented, you know, between radar localization and our delivery systems, Mike, you know, they represented almost 45% of our total PI growth year over year.

Okay, so it was roughly half then of the $20 million was attributable to Scout. Is that correct?

Well, it's two different product categories, right, just to be clear.

Right, right, right.

Yeah, yeah.

Okay, okay, all right.

And, Mike, just Martha here, if I could just add, I mean, I think we shared on the last call, you know, Scout hit a really significant milestone, too, in terms of the number of procedures it's been used in. So, again, we're very pleased with how that business is doing, and it's one of those that just makes an enormous difference in patients' lives.

What explains that level of growth? I mean, were there just big contract wins? Like, what happened there?

Well, I don't know that it's been... that huge of a number, right? I mean, it's certainly a very nice growth number, but I think we've got a really, really top-notch sales organization out there. They've got excellent relationships with the key physicians who do this work. And I think like other things, people see the clinical value in the product and what it can do. So I think you combine all those things, We had a little bit of a, you know, a slowdown in supply, I think. I can't remember the exact timing, but we picked that back up. So that can lead to a little lumpiness, too. But, again, just overall, you know, the team all pulling together from the operations side to the clinical side, you know, to the sales side.

Okay, great. And just one more. I don't think I missed this, but maybe I did. Did you guys give sort of – by region sort of performance? Usually you guys give like EMEA and APAC and sort of make some commentary, obviously, around China. I don't feel like I've heard that tonight, or did I miss it?

Yeah, I mean, I think we can say, right, so at least for the fourth quarter, you know, U.S. sales increased about 12% year over year. They were up roughly 8% on an organic constant currency basis. When you look at the international side of the business, it increased about 6% year over year, up 4% on an organic constant currency basis. I would highlight that both were at the high end of our organic growth expectations. You know, APAC, you know, roughly up, you know, 3% constant currency. EMEA up, you know, 12% constant currency. Rest of the world, 4.5%, you know, constant currency.

Okay. And you said earlier, sorry, this is the last one for real. You said earlier that China was down in line with your expectations. Can you remind me what your expectations were? I don't recall at the beginning of the year what you guys said as your expectations for China.

I think it came in right around where we thought it would be, right about 2%. Down?

Down 2%. Okay.

All right. Great. Thank you so much. And congrats on the free cash.

Yeah. Thank you. Our next question comes from the line of John Young from Canaccord.

Well, Martha and I will congrats on the quarter. I want to ask on Rhapsody. I know you're giving, you know, somewhat limited information, but try to get a little bit more here. Martha, I know you said you just held a national sales meeting. I would love to hear what you're hearing from the sales force so far in selling the product with a new strategy. Are you focusing the sales force on opening new accounts versus going deep in accounts? And can you remind me too, is there any stocking revenue as they go and open these accounts? Thanks.

Yeah. So first of all, I would tell you we have an extremely energized group. I guess I would call it small yet mighty. I think if you compare to perhaps, you know, some of the competitors in this area. So as I said, really inspiring for me, frankly, to spend some time with this group and see how motivated they are. You know, heard a lot of really moving patient stories from about when a physician would use Rhapsody and the difference that they would see pretty immediately with it. So I think, again, you know, that was super exciting. The team has very detailed plans around, you know, their targeting and, you know, where they're going. You know, we're pursuing, I mean, as we talked about, if you look at the market, right, it's primarily, predominantly, probably 85%, 90% non-hospital setting versus the hospital. At the same time, as you know, since we had the NTAP, You know, there's slightly higher pricing on the hospital side, and we had a lot of that work in process, you know, last year. So that certainly continues, albeit oftentimes, as you probably know, with challenges to get through VAC committees and that kind of thing. So that can take a long time, and you can get just pushed quarter to quarter in getting your slot on a VAC committee meeting. So, simultaneously then, of course, they're pursuing the non-hospital, you know, sites of service as well. So, I think the answer is, you know, they're going everywhere, as I said, as much as our small and mighty team can. So, I think that's how we, you know, spent some time better understanding that and came to our guidance for this year in the U.S. So that's kind of how we're thinking about it. Again, you know, I just have to remind everybody, I know Raul just did, but have to remind everybody, you know, that Rhapsody is a great product, a critical product for us, and one of many, many, many in a $1.5 billion portfolio.

I appreciate that, Martha. And also, just to follow up on that, it sounds like you've been doing a lot of work on R&D with that platform approach that you're talking about. Just any color on the pipeline for 2026 for investors and longer term, given where you are today over ASCII so far, do you expect Merit to pursue additional PMAs?

Yeah. So, as I said, we're going to do a lot of work this year around our strategic plan and our long-term product and platform roadmaps, if you will. So, yes, I think the answer is I don't see any reason for us not to continue to pursue PMA-type products. Again, as we think about it, we want to figure out how do we best leverage PMA the technical talent that we have in this organization, which is extraordinary. So we want to think about that. And then, as I said, we also want to layer that on top of each one of our various platforms and think about the customer groups that we're serving and figure out, again, how can we best help them? How can we make their procedures more efficient? How can we help bring cost down of a procedure? How do we fill a bag where there's a gap in a sales rep's bag? Those are all the questions we're really going to be asking ourselves as we do this work and think about the longer-term strategy.

Thanks again. Thank you. One moment for our next question. Our next question comes from the line of Travis Steed from Bank of America Securities.

This is Aidan on for Travis. Just my first one, a point of clarification. So does the organic growth guide not back out the divestiture, or is that included in there?

No, I mean, we gave you our guidance, and we didn't make an adjustment. I think other companies might do that. We gave you the number. We gave you the impact. I think, obviously, you should consider it as you look at our revenue growth numbers. Okay, great. Thank you. Just to maybe repeat it, right? 140 basis points. you know, to constant currency growth. And then, you know, 240 basis points for the U.S.

Got it. Thank you. Yep. And then, you know, in January, you talked about your exposure to TAVR, EP renal, and maybe that's less appreciated in terms of the exposure you have to these higher growth procedures. Kind of, as you think ahead at a high level, Are there any other procedures you think you have the opportunity to deepen your penetration to or expand into that you weren't in before? Thank you.

Yeah, I mean, I think you've already, you've hit on some of the current bigger ones, right? And, you know, I mean, I think this is really, as we think about strategy going forward, right, it's really, you're asking, I think, the question, you know, would we enter into, I'll call it a whole new platform, potentially calling on a whole new customer group, right? The answer is, would we consider it? Yes. But I'd say right now, the primary focus is really focusing in on the platforms that we currently have. And again, as you all know, the cost of a distribution organization is not inexpensive. And so we have a lot of really talented reps out there around the world. And as I said, what we want to make sure we're doing is helping make sure that you have a full bag wherever possible and some of the latest and best technology wherever possible. So that's really our areas of focus for now rather than I'd say adding on a whole new platform.

Thank you.

One moment for our next question. Our next question comes from the line of Jim Sidoti from Sidoti and Company.

Hi, good afternoon. Thanks for taking the questions. Another question on R&D, because I noticed it's up about a million year over year, two million sequentially. You know, I would expect R&D to be at least flat because of the end of the work on Rhapsody's PMA. Where are those dollars going right now?

Yeah, I mean, I think the better way to look at it and, you know, is obviously as a percentage of revenue. I mean, that'll continue to be about 6%. You know, Jim, especially as you guys think about 2026, right? So just, you know, kind of focus you there. You know, as far as 2025 or Q4, you know, we did have some higher clinical spend, but we also had some one-time events, you know, higher regulatory submission spend and some product development expense, you know, that we'll call out. But I think as you look at 2026, you should think about it as a percentage of revenue, and it should be about 6%, you know, in that ballpark.

And then I also noticed the MDR expenses, I mean, really have ticked down. Is that project completed at this point?

Yeah, you know, we're getting closer and closer every year, right? I mean, I think, you know, as you guys know, that's been, you know, pretty frustrating, right? I mean, you know, to re-register products that we've been selling in there for a lot of years. You know, my guess is, you know, as soon as we're done with it, you know, they'll change the rules and make it easier. You know, that's usually how it works. But, you know, I think those are winding down. Our regulatory group and, you know, our R&D and operations group have done a great job of staying ahead of it and getting, you know, making sure our products stay registered, you know, outside the U.S. You know, so applaud them for keeping their head down and getting that done.

Thank you.

Thanks, Jim.

Thank you. One moment for our next question. Our next question comes from the line of Robbie Marcus from JP Morgan.

Oh, great. Thanks for taking the question. Maybe I could, Raul, if you don't mind, circle back to Larry's question on first quarter. And I guess I'll follow up with the question of, you know, you kind of highlighted what's driving some of the first quarter softness. What's driving... the second through fourth quarter acceleration, and how should we think about the cadence of improvement and drivers of improvement throughout the year?

You know, I think, Robbie, I think that's a great question, right? I mean, I think, you know, as far as the detail quarter by quarter, I don't think that I'll get into that. You know, I obviously gave you guys modeling considerations for Q1, so you guys can have that. I will point you maybe just at a higher level, just the seasonality, you know, in our business, you know, Q1 and Q2, And Q3 are typically from a revenue standpoint, you know, lower, you know, growth and revenue quarters with the second and the fourth being our strongest quarters. You know, again, I think we have a great plan for the year. And, you know, as we progress throughout the year, we'll give you additional color as we head into the next quarter. But, you know, for now, we're just talking about Q1.

And maybe, again, just to follow up on Larry's question, you know, the margin considerations in first quarter? It feels like it's implying down, and what's the components of that? Thanks.

Well, you've got to remember, right, the tariffs didn't start until April. So there is a component to that that you should consider. I think it's about 80 basis points or $3 million of gross margin impact as we apply the tariffs. So I think when you look at that, You know, there's obviously, you know, that makes up kind of the majority of it, you know, kind of 80 basis points. I think if you look at it, you know, also, you're really seeing the impact of a larger expense base, you know, as we progress, you know, throughout the year on a smaller revenue quarter because, as I mentioned, the seasonality in our business. And also, just to highlight, right, I mean, I think there's some good things going on. I mean, we had our first ever global sales meeting. you know, one of a number of items that are kind of, you know, that increase the expense, you know, in Q1, you know, that's taking that operating margin down. But again, just, you know, focus everybody on the year, you know, year-over-year results that we're shooting for.

Thank you.

Thank you. One moment for our next question. Our next question goes to the line of Sam Iber from BTIG.

Hi. Good afternoon. Thanks for taking the questions here. Just one on my end, and I don't mean to beat a dead horse here on capital allocation, but at 1.6 times leverage, it feels like you guys have the capacity to do something maybe bigger than you've done in your past. I guess what's the appetite for that? Obviously, you know the prior commentary on strategic and financial guardrails, but we'd love to get any more color you can provide. Thanks.

Yeah, Sam, thanks for the question. And, you know, here's the way I guess we're thinking about it, right? I mean, I think the answer is, you know, there is an appetite for some things that could be slightly larger from some of the things that, you know, this company's done in the past. Again, it's got to make good sense. We are going to be disciplined about it, but, you know, we do want to continue to be a growth company. You know, we believe we've still got lots of opportunity to be out helping patients, and so if we're going to continue to, you know, have the kind of growth that we'd like to have, I think you can also do some math, right, that says, you know, if we're going to be acquisitive, it might make sense to do some things that are slightly larger. So, I do not mean a transformative deal by any means, but I think, you know, tuck-in or slightly larger than tuck-in, depending on how you define these things, would be reasonable for you to think about.

Thank you. At this time, I would now like to turn the conference back over to Martha Aronson for closing remarks.

Thanks very much. Again, I just want to thank all of our hardworking employees all around the world and thank our shareholders and our investors for your interest in Merit Medical. So have a great day.

This concludes our conference call for today. Thank you for your participation. You may now disconnect.