I think, we're ready to start. My name is Nathan Treybeck. I'm one of the medical device analysts at Wells Fargo. Welcome to the first day of our healthcare conference. For our next session, I'm pleased to introduce management from Integer Holdings. Joining us from the company is Joe Dziedzic, President and CEO. Joe, thank you for joining us. Thank you, Nathan. Thanks for having us. So let's first touch on the macro environment and your guidance. You know, we've seen a number of med tech companies take down their full year guidance for the year this earnings season. Can you talk about what you are seeing in underlying volumes for your end markets, and would you call out any areas of strength or weakness? Yep. Well, I'll start with we didn't take down guidance. We raised guidance in second quarter, so it's better to be in that group than the other. You know, we guided to 9%-11% reported growth, 6%-8% organic growth for the year. First half, we delivered 9.3% reported growth, and on the medical segment of our business, which is 98% of our sales, 7.2% organic growth, so right in line with what we guided to for the year. We are expecting the second half sales to accelerate a little bit, but from an end market standpoint, we're continuing to see strength in the underlying markets, in particular, obviously, electrophysiology, where we're growing faster than the market, structural heart, where we're growing faster than the market. Our emerging customer PMAs, the pre-market approval customers, continue to do very well. We had predicted at the beginning of the year we'd be $100 million-$120 million of sales for that group of customers, and we're right on track to deliver that. A little more heavily weighted towards the second half than the first half, which was part of the full year guidance at the beginning of the year anyway, based upon our customers' product introduction and launch schedule. So, I wouldn't call out any meaningful changes from what we saw at the beginning of the year and from what we were hearing from customers. Okay. That's good to hear. So in terms of your guidance, and the second half acceleration to 8% from the 6% in the first half, can you talk about, like, the underlying drivers of this acceleration, and are there any specific end markets you would point to? Sure. So, and maybe I'll first start with the key drivers of the slight increase in the second half versus first half is we get more guidewire manufacturing capacity in our Irish facility. We took possession of an 80,000 square foot expansion in June. It's 70% more manufacturing capacity. We've had orders from customers of incremental demand we haven't been able to fulfill because we were fully at capacity. And so that incremental manufacturing capacity will give us more output in the third quarter and even more in the fourth quarter as we install and qualify more equipment for production. At the beginning of the year, we saw the emerging customer, emerging PMA customers with stronger second half ramp than first half based on the customers' schedules and plans, so that steps up in the second half, and then other product launches in structural heart and electrophysiology that contribute to it. And then on an organic basis, our non-medical business, which is only 2% of sales, was down 35% in the first half of 2024. That's because first half of 2023 had some supply chain recovery sales in it. And so, that was a drag in the first half on the total company-reported organic growth. That business will be more flattish in the second half, and so although it's only 2%, when you go from 35% to flattish, that does have an impact on the organic growth on a year-over-year basis as well. Okay. Just on your guidance philosophy, so, you know, Q2 was the second quarter in a row where you haven't raised the full year guidance. Can you talk about if there's anything that changed relative to your initial outlook going into the year? There really hasn't been. We did raise profit guidance. We did not raise top-line guidance. And maybe you're looking back to 2023, which I know a lot of investors do, where we did raise guidance regularly throughout the year. That was more a function of we knew we had demand, this is 2023, but we had supply chain constraints, and we weren't trying to predict when those supply chain constraints would lessen. And each quarter they did improve, which is great. Our direct labor turnover improved as well, and that enabled us to get more product out the door to customers, and that's why last year, in particular, every quarter, we did raise guidance. We feel that this year we gave 9%-11% reported or total sales growth, so call it 10% at midpoint. Last year was 16% growth. Stacking two years up, that's 26% over two years. We think that's pretty strong growth, and right on the trajectory that we want to be with 6%-8% organic growth this year, plus acquisitions. Okay. Can you talk about the visibility you have into your backlog? You know, have there been any adjustments by your customers to their demand that would suggest a stronger second half than you anticipated, like two months ago, you know, given all the guidance changes that we've seen from your customers in the quarter? Yeah, so we feel like we've got the best visibility into the industry that one can have. Our customers have given us almost $900 million worth of orders to ship. That's a specific SKU, a specific quantity, specific ship date. They're also telling us... Their manufacturing plants tell us a rolling twelve-month view of how they're planning to run their plants, which tells us what we need to do to be able to be prepared to supply and meet their needs. We feel like our customers are giving us the insight that they have because they're telling us how they're going to run their plants and what kind of volumes they're planning in their facilities. 80% of what we do, we ship to our customers' manufacturing plant. So we feel like we've got the best visibility that one can have because our customers are sharing their visibility, and then that's translating into how we're looking at our guidance, and so we feel like we're factoring in everything one can know. I wish our customers could perfectly predict what their sales were going to be and how the market was going to react to their new product introductions. And so there is variation, for sure, but with almost $900 million of orders on the books, we've got really good visibility. New product launches being maybe a variable that even our customers have to make an assumption, but they're in close communication with us on how they're progressing on that, to ensure that we can meet their needs. Okay. If I look at your growth just on a two-year stack basis, your organic growth guide implies similar growth this year as last year. Is there any reason why this cannot accelerate, given, you know, the contribution from your PMA portfolio and then the other high growth areas like PFA and other areas that you're getting into now? Sure. Well, 15% organic growth last year was kind of an outsized growth when, you know, we think our markets are growing in a normal time, 4-6%. We think last year, the markets probably grew closer to 9%. And so we think we, you know, we had above average growth in, on an organic basis, but the markets were very strong last year. So we think looking at our markets growing 4-6%, kind of over the long term, and growing 200 basis points better than that or faster than that, puts us at 6-8%. We're confident that our pipeline of development programs that we're getting designed into with customers will enable us to deliver at least two hundred basis points above those market growth rates, and then as we continue to shift the mix into the faster-growing markets, the weighted average growth rate over time will increase. Okay. Operating margin grew greater than your target of two times sales growth in the first half. Can you talk about why your guidance for the second half doesn't have operating margin growing at the same? Yep. Yeah, so first half, operating margin grew 23% year- over- year, and sales grew 9%, so stronger than the two times. If you look at the quarter splits last year, 2023, you'll see we had a meaningful step up in profit from first to second, and then we continued to increase that profitability in the third and the fourth quarter, and the margin rate in the second half of last year was almost 300 basis points higher than the first half of last year. I'd say, first off, comps get tougher as we would expect this year, margins to continue to improve throughout the year, but the second half just has a lot tougher comps than the first half did. The good news is, we're at 23% growth for the first half, and the full year guidance is 18%, which we still think 18% year-over-year improvement is at midpoint, sorry, 18% growth is the midpoint on operating profit, guidance for the year. We think that's really strong after twenty-six percent last year, and, you know, if you compound those two years, it's almost 50% over the two years. We're driving for more, of course, but we think that's a pretty strong year, 18% profit on midpoint of 10% sales, so almost one point eight. The high end of our guidance would be getting to profit growing twice as fast as sales, which is one of our strategic objectives. Okay. On your PMA launches, in terms of... Can you give us any more color on what these products are? I think you talked about they're in the neuromodulation space, mainly. A few of them are launching in the second half. Is there any color you can give on what these products are and, you know, what contribution you expect in the second half from PMA? Sure. So, I'll start with the emerging customer PMA. There are nine specific customers that are in various phases of product introduction or market launch. And we've been reporting their sales since 2019, showing how they've grown and how they're accelerating and getting traction. In 2018, they were $10 million, 2020, $20 million, 2022, $50 million, and then the guidance for 2024 is $100 million-$120 million. So they've continued to get traction in the marketplace, and we're excited for these customers and to help them. These are primarily single product customers that are bringing very novel therapies to the marketplace in various neuromodulation applications, sleep apnea being one. A lot of non-traditional stimulation, non-traditional spinal cord stim. You know, our business was primarily spinal cord stim seven years ago. Now, it's spinal cord stimulation is the minority piece of the markets that we serve in the emerging PMA customers. We've been working with these customers, most of them, for more than a decade, some of them even longer, and we're excited to be able to support their bringing these novel therapies to the market, that are really expanding the market that they're serving, because they're mostly treating patients who are not being treated today for indications that can't be adequately treated today. So it's been a good growth driver for us, and we would expect that to be able to continue. We have more than 25 customers in some stage of development or clinical or regulatory stage that we hope will ultimately make it to market introduction to continue the growth of this group of customers. Okay. On your recent M&A, can you just give us an update on InNeuroCo and Pulse Technologies? You know, I think on the last call or the call before that, you talked about the performance at these acquisitions has exceeded your deal models. Could we see M&A contribution above 300 basis points this year? Yeah, great. So first off, we're thrilled to have them be part of Integer. We've had an incredibly positive response from customers. We think that the culture fit and the technology fit that we saw is proving to be very true. The outperformance on the deal model is primarily on the profitability, because the operational synergies that the teams have found have been very real. We've benefited from some of the ways that they were running their operations. These are smaller and very entrepreneurial, innovative companies, and so we've learned some things from them. We think we've shared and brought some scalability to InNeuroCo and Pulse, and so the operational synergies have enabled the teams to outperform on the deal models. Top line's harder because the commercial synergies at this stage, given that they're with us less than a year, those are just discussions with customers. We've had very strong, positive customer reaction and the synergies that we've been able to share with customers and the opportunities giving us a good pipeline of things to work on, but given the deal cycles, we won't see that materialize into the top line for another year or two. But we're excited about the start that we've gotten on the commercial synergies and really happy with the operational synergies exceeding the deal model already. Okay. As far as the pricing environment this year, are there-- can you talk about which areas you're able to take price? And do you still expect the pricing action that you've taken or will take to just be neutral to earnings, or could there be upside from the pricing to your earnings? Sure. We, you know, historically were a price down business. Pre-pandemic, we did raise prices, but that was to pass through the inflation that we were incurring. And so, the structure of agreements we have in place look today are largely focused on incentivizing growth. We expect price neutral-ish to be our model going forward. We think that strikes the right balance holistically with our customers. And we'll continue to work on next generation pricing, and as we bring more innovation and more differentiation, and our customers are able to get more price for their products, we'll work with them to participate in that. Okay. You get this question a lot, but I figured we would just touch on it. So inventory, you know, I think most people could see that inventory in MedTech is higher, like, days sales outstanding versus pre-pandemic. Can you just share why you don't think this will be a headwind to growth? Maybe not this year, but just going forward. Yeah, it wouldn't be an investor meeting if we didn't talk about that. Yeah. So thanks for the question. I think we're batting a thousand today, which is good, but it's on everyone's minds. Yeah, I'll come back to what I said earlier. I think we have the best visibility that one can have. Our customers are sharing with us how they're running their manufacturing plants, because 80% of what we do, we ship to a customer's manufacturing plant. So they're telling us with almost $900 million of orders on hand, so specific SKUs, specific quantity, specific shipment date, plus their plants are giving us a rolling 12-month view of what they're planning to manufacture. So I think we're getting the best possible view of where the industry sales are, industry being our customers representing the industry, because they're sharing with us what they see, and I think that's the best one can do. We factor that into our guidance. Every time we do guidance, we weigh all that, and you know, I specifically ask our customers at the most senior levels about how they're positioned with in their inventory levels. And the feedback I keep getting is, "What my teams are sharing with you in terms of the specific orders and the demand and what they're telling you, how we're running our plants, is the best information we have." So we feel like we're getting the best available information that can be had, and we're not seeing or hearing of something significantly different or we would've built that into our guidance. But it's a fair question 'cause it's on everybody's mind. Okay. I mean, the other thing that's on everyone's mind is PFA, and we'll get to that. But before PFA, you know, the other areas that are really taking off in MedTech, and the bigger one, I think, for us is tricuspid. And I think you mentioned that you are participating here. I guess, how much of the tricuspid ramp this year, whether it's TriClip, Evoque, how much of that is baked into your guidance, and what are your expectations going forward? Sure. I'll start with, and we've baked in what our customers are sharing with us, a similar message on they give us as much insight as they possibly have, and particularly with new product launches, they're giving us a lot of insight because they want us to be prepared to ramp at whatever rate they're preparing to ramp with, and so we're side by side with our customers on that. You know, we really missed the aortic innovation 10-12 years ago. We didn't have the capability, and quite frankly, we weren't focused on the market because that was before our current strategy. We have really, for the last eight plus, eight, nine years, been very focused on mitral and tricuspid and working to get designed into our customers and their delivery systems in particular. We've had a very strong guidewire application in structural heart that has delivered very, very strong growth for us. And I think I shared on our most recent earnings call that our structural heart business, albeit smaller as a portion of our revenues and relative to some of our other segments or markets that we serve, but our business in structural heart is growing twice the rate of the industry growth rate, and so we feel like we're doing very well. We think we're well-positioned to support our customers as they bring these novel therapies to the marketplace. Can you talk about what it is you supply in structural heart? Is it, is it the delivery sheaths? Is it just guidewires? You know, if we think about tricuspid valves, is there anything that you do for the valves? Just, I think people would really want to understand the content that you deliver here. Sure. So it's absolutely guidewires, which we've been doing for a long time, design specific guidewires for that specific procedure. And then we've been getting designed into the delivery system itself in structural heart. That was something that we were not focused on back in, let's say, the 2015 timeframe. And quite frankly, we didn't have the breadth of capabilities that we've needed. So we very intentionally invested in organic capabilities to be able to provide the components and the subassemblies that would allow us to help with the delivery system itself, and get designed into that, and that's what we've been very successful at. Okay. So I think we'll shift to PFA if there are any other questions on guidance. Okay, so we've seen some estimates that PFA could be contributing as much as 50 basis points to your top line growth. I guess, is this a fair estimate, or is there potential for more contribution here? Sure. So we have not quantified the specific amount of PFA, and we've obviously got lots of questions on it, and I'll reinforce. Our message here is that in electrophysiology, we participate in the access, the diagnostics, as well as the ablation step itself. So on the access side, it's guide wires and steerable sheaths that we manufacture and supply to the industry broadly, as well as we're also on diagnostic catheters, and we have been for a very long time. We think we're the most vertically integrated provider into the space, and that's inclusive of competitors and customers because we manufacture components from raw material all the way to finished devices. On the ablation catheter itself, broadly speaking, for pulsed field ablation catheters, we have more content per device than we have historically on cryo or RF. And so we've looked at the analysis that we've seen a number of sell-siders publish, and we think that's a good framing, broadly speaking, of the size and potential impact on our business. And to the number you just quoted, that's not going to be a material singular driver for a $1.8 billion revenue company. But it's one of many of our growth drivers. We've talked a lot about our focus on structural heart, which we've talked about, electrophysiology, we talked about neuromodulation, we haven't talked about neurovascular. Those are the four targeted growth markets that we've been focused on since two thousand and eighteen, working to get designed into our customers' devices in those end markets. 80% of our development programs that we're working on today are in those faster-growing end markets. And so electrophysiology is one of, an important one, but one of four, markets that we're focused on, and pulsed field ablation is a contributor for the ablation catheter itself. But as it drives incremental procedure volume in electrophysiology, we benefit from providing the guide wires, the steerable sheaths, as well as the transseptal needle across the septum, for that procedure. So we benefit with more procedures holistically, and we benefit when it's pulsed field ablation as well. Can you speak of PFA in the context of, you know, cannibalizing your non-PFA ablation business? You know, a large part of the growth we're seeing right now in the EP market is really the ASP uplift from PFA. Mm-hmm. You talk about you don't really capture those economics, so the economics you capture from the increased content and more procedures. I guess, how much have you seen procedure growth increase, underlying procedure growth? Yeah. So I maybe I'll, I'll answer it this way, and I think I shared this on our last earnings call. Our electrophysiology portfolio of products, so this is, this is access diagnostics and, and ablation, is growing at about one and a half times the market rate over the last four quarters. Now, when I say that, you know, that, that includes half a year last year and the first half of this year, and we know the, the two devices that are approved in the U.S. were approved at year-end and beginning of this year, last year. But we're growing faster than the market, our portfolio of EP products. And so we, we feel like we're, we're outperforming in, in that space, and we expect that to continue for the foreseeable future. Have your expectations for PFA changed since, you know, your prior guidance or going into the year? We've heard Medtronic say that, you know, it's been stronger than they expected. So basically, what I'm trying to get at is, have you seen customer orders increase versus your initial budget? Yeah. I think if I answered that, I would be giving you more than I should, 'cause our customers are pretty sensitive to us talking about their expectations and their outlook for the future. Okay. As far as... You know, I, I'm assuming there was some PFA inventory build last year coming into the launches. You know, have you seen PFA inventory levels change, whether increase or decrease, and has that impacted growth? And just how to think on a, from a comps perspective, if you have PFA in your base in 2023, is there anything to consider for this year's growth from PFA? Yeah. Maybe the best way to answer that is, at the beginning of the year, we guided to 9%-11% growth, and we were at 9.3% for the first half, and we remain confident in our 9%-11% sales guidance. You did mention the transseptal needle. I believe Medtronic just acquired transseptal needle company. Is there any benefit you expect to see from that? Yeah, I probably shouldn't comment on anything specific to a customer. Okay. All right. Maybe if we could just move on to your outlook, maybe for twenty twenty-five. I understand you're not gonna guide, but kind of any early thoughts into the year? You know, qualitative commentary just around key catalysts or anything macro-specific we should be considering, and then just anything on the margin side, whether it's inflation or effects or pricing, anything high level that you would like to kind of let investors know? Sure. I'll start with, we're not providing or in a position to give 2025 guidance. We'll do that in normal course of business, probably February of next year when we finish 2024 and provide outlook for 2025. But, you know, broadly speaking, we remain confident that we can grow faster than the market on an organic basis. We still think over the long term, our markets are growing 4-6% organically, so 200 basis points faster than that would put us in that 6-8% range. We continue to target growing profit twice as fast as sales. I know this year we're at 1.8 times last year, 2023. I think we were 1.6 or 1.7 times. So we continue to work on the profitability to increase that and continue to expand margins. So that's probably the best thing to say about the future, but that's not specific to 2025. That's just looking forward. And as far as the guidewire capacity coming on in the back half of this year, you know, it's still gonna be in benefit next year. How are you thinking about guidewire, contribution to growth next year? Sure. I think the incremental capacity is gonna help us to deliver more guidewires to customers. Back in 2022, when we saw the significant increase in demand for guidewires, when it really began, that's when it began to exceed our capacity. We asked customers to place orders a year in advance, so in the middle of 2022, we asked customers to place orders for all of 2023. We did the same thing last year for all of 2024, and we have orders out into 2025 right now, and so we have good visibility to what customers want from a demand standpoint. We would expect to bring that order book down over time, and we'll adjust our lead times with customers so that they can order in a more historically normal, shorter lead time. And so we would expect our order book to come down because of that very identifiable reason, but we do expect that to give us an increase over and above kind of a normal growth rate next year with that incremental capacity. And so on top of the 4%-6% market growth, plus your 200 basis points above that, you know, you have expectations that you're gonna do consistent M&A, and that's part of your growth algorithm. Can you just remind investors how to think about M&A contribution to your top-line growth? Sure. We look at, for starters, 2.5-3.5 times debt leverage is one of our three financial objectives. We're very committed to maintaining that debt leverage. The feedback we get from investors is that's a comfortable zone to be in. We're at 3.2 right now at the end of the second quarter. If you look at the midpoint of our guidance for EBITDA and debt paydown, I think you get at year-end to something like 2.8, and the way we think about it is we have approximately $250 million-$300 million per year to spend on tuck-in acquisitions. We say tuck-in because $250 million-$300 million is gonna buy you tuck-ins. Our strategy is to buy companies that have some very specific criteria. We want customers that bring... Or I'm sorry, we want acquisitions that bring a differentiated capability in one of our four targeted growth markets, or we wanna compound an existing point of differentiation that we have. We wanna make sure that they have a pipeline and that they're in the development pipeline in one of, or as many of, the four targeted growth markets: electrophysiology, structural heart, neuromodulation, neurovascular. We ideally want them to be accretive to our sales growth rate and to our margin rate. You can't always get that. I'm just now defining the perfect acquisition. But if they aren't accretive at acquisition, we want a clear path to accretion, either through commercial synergies or through operational synergies, and we've been very successful with these tuck-in acquisitions over the past three-plus years. We've spent about $550 million in the last two and a half years on acquisitions. So we think we've got a good rhythm and a good cadence. and when we look at kind of the multiple, we think we'd have to pay and the margin rates, that would be at the EBITDA margin rates and the EBITDA that we would get, when that combined with our EBITDA growth and our cash flow growth, we think we've got $250 million-$300 million a year, and that gives us comfort and confidence that we can get 200-400 basis points a year of incremental sales from acquisitions. Now, we don't get to choose when sellers sell, and you know, usually, if you influence when a seller sells, you're probably paying a premium that you might not wanna pay. But we have a robust pipeline of opportunities. These are oftentimes founder-led, individual, privately run, owned businesses that we curate and build a relationship with over many years. Then timing's just kind of find when it's right for the acquisition or for the target company, when it's right for them. We love to do that without a formal deal process because we think that's how we get to a fair valuation for both of us and a path forward that we think is great for the acquisition and great for Integer and for our investors. We've seen a good amount of M&A among your customers. Does that in any way impact valuations or the appetite among your pipeline for the companies that you're looking to acquire? Yeah, so I. Our customers tend to buy, you know, finished product device companies, and we're looking at companies that are contract development manufacturers, designers, and outsourcers, and so the size of deals we're looking at, our customers aren't necessarily looking at. There are others who are looking at those opportunities. We think we're in a unique position to be able to diligence the acquisition opportunities. We think we're in a unique position to find opportunities, because a lot of times we're selling something to the acquisitions because we're providing them components that's going into the work that they're doing. Customers come to us with those acquisition opportunities. We get phone calls from acquisition targets who've seen what we've done with other acquisitions and like how they've played out. I mean, it's a, you know, it's a big industry, and there's a lot of smaller players, but it's a tight-knit group when you get to industry conferences, everybody tends to know everybody, and I think reputation matters, and I think we've got a positive reputation when it comes to how we integrate acquisitions, how we invest in them to support their growth, and we make them an integral part of our strategy. Because the reason we're acquiring them is 'cause we think they further our strategy. And so as long as we continue to remain disciplined and rigorous in acquiring companies that are great fits with our strategy, we think they'll be an integral part of us and that that'll just perpetuate the future acquisitions in the pipeline of the type of companies that we desire. Okay. If we think about your long-term outlook of the 4-6% market growth, plus the 200 basis points above that, you said this framework several years ago, and you know, there have been several industry developments like PFA and tricuspid therapies. Do you envision taking out this framework? Maybe you would be at a higher structural growth rate, given what's going on in the industry? Yeah, so we continuously monitor our weighted average market growth rate, and we've modeled out the development programs. We have 80% of our development programs, so this is the pipeline of programs, products we're being designed into. We've modeled out what that looks like over five years and how that shifts the mix of our sales by market. And without a doubt, over time, the weighted average market growth rate does go up. I wish it would go up faster and we'd get there faster, but with the size of business we have, it will take some time to move the overall weighted average market growth rate, but it does increase. And then when you have innovative products that can deliver sustained above average growth, then that helps as well. So we absolutely would expect the weighted average market growth rate to continue to increase on an underlying basis, and then with our mix of 80% of the development programs in faster growing end markets, we think that allows us to continue to stay above the market growth rate. Okay. With the last two minutes, maybe if we can just talk about margins. And, you know, if you could touch on kind of the path to getting back to your pre-COVID margins. You were at 31% gross margin, around 19% operating margin. I know you have a target of two times operating margin growth to revenue growth, but just generally, you know, how M&A folds into this, just generally, when do you think you could get back to those margin levels, or are they not kind of in the framework any longer? So we, we're confident we can get back to those margin rates, but we're not limiting ourselves to that. And our approach remains continue to drive operating profit, growing twice as fast as the sales growth rate. We think of that through two things: getting operating leverage off of overhead, fixed costs in the plant, SG&A and R&D. So we're working to limit overhead and SG&A and R&D to grow slower than sales. So that gives you operating leverage just inherently. And then to drive gross margin expansion, driving the variable costs. So, you know, when we measure our material scrap, material waste, and we measure our direct labor efficiency, we see meaningful opportunities to continue to deliver productivity. We are not at world-class levels of manufacturing, material scrap, and labor utilization, and we've got a Lean Six Sigma, Kaizen-based approach to drive those efficiencies in our operations. Supply chain has stabilized. Our direct labor turnover now in almost every site is at or below where we were pre-pandemic. In total, we're below where we were pre-pandemic, and so that's giving us the ability to focus on implementing lean manufacturing, Kaizen events to drive efficiencies, and we would expect to be able to continuously expand margins, get back to where we were in 2019 and beyond. Great. Well, I think that's all the time we have. Thank you, Joe. Thank you, Nathan. Appreciate it. Appreciate it. Thanks.