Good day, ladies and gentlemen, and welcome to Convatec's AGM trading update for the four months ending 30th of April, 2024. At this time, all participants are in listen-only mode. Later, we will conduct a Q&A session. If you wish to ask a question, we ask that you please use the Raise Hand function at the bottom of your Zoom screen. If you've dialed in, please select star nine to raise your hand and star six to unmute. Instructions will also follow at the time of the Q&A. Participants can also submit questions through the webcast page using the Ask a Question button. I would like to remind all participants that this call is being recorded. Questions will follow after the presentation. I will now hand over to Jonny Mason, CFO of Convatec, to start today's call. Good morning, everyone. Thank you for joining us today for this trading update ahead of our AGM later. I'm gonna say a few words to summarize the good sales performance, and then Karim and I will answer any questions that you have. For the first 4 months of 2024, our organic sales growth was 6.5%. This represented a continuation of the good sales growth from 2023 and was broad-based across four categories. In Advanced Wound Care, organic growth was mid-single digit, as expected. Growth was reduced from our normal high single-digit growth by the continuing market-wide anti-bribery and corruption campaign in China, also as expected. But we continued to gain market share in China, and we expect growth to accelerate there as the year progresses. The antimicrobials and foams portfolios continued to grow well, with good growth across North America, Europe, and GEM. The launch of ConvaFoam continued to progress with a strong win rate in clinical evaluations in the U.S.A.. We're on track to begin launching ConvaFoam in Europe later this year. In biologics, the growth in InnovaMatrix was strong, although the rate of growth was slower than last year as it lapsed the higher sales base. It contributed roughly two points to wound care growth, and I'll come back to talk about the draft proposed LCD position in a moment. In ostomy care, organic revenue growth was mid-single digit, as expected. The response to the Esteem Body launch in Italy in March has been strong, and we've begun launching in the U.S., Poland, and the Czech Republic as well. In continence care, organic growth was ahead of our expectations at high single digit. Our Home Services Group delivered outstanding customer service and continued to see strong new patient starts, supported by a further increase in reimbursement levels in the U.S.. Encouragingly, the performance outside of the U.S., although small, also contributed to growth, and we're pleased with the positive customer reaction to the launch of GentleCath Air for Women in France. In infusion care, organic growth was mid-single digit, as expected, with phasing of growth weighted to the second half. We continued to see strong underlying demand for our infusion sets, both within and outside of diabetes, and the diversification of products and customers is progressing well. Now moving to strategy, we made further progress in launching new and differentiated products across all four categories. In particular, in infusion care, new customer pump launches across diabetes and Parkinson's is building robust and more diversified demand for our innovative infusion sets. So overall, for the year- to- date, we delivered a strong start with wound, ostomy, and infusion care performing as expected, while continence care grew a bit faster than anticipated. And given this strong start, we now expect a more balanced growth between H1 and H2, and we are on track to deliver our full year guidance of 5% to 7% organic growth. Within that, the mix of categories may shift. The outlooks for ostomy care and infusion care are unchanged at mid-single digit and high single digit, respectively. Continence care is expected to grow faster, mid to high single digit, and wound care may grow a little slower, also mid to high single digit, allowing for the new uncertainty introduced by the draft LCDs. With sales on track, we are also on track to deliver the other financial targets of adjusted operating margin- At least 21% at constant currency and double-digit growth in EPS and free cash flow to equity. Now let me comment on the draft LCD proposals before moving on to Q&A. InnovaMatrix is an excellent product based on great technology. It delivers positive outcomes for patients, and we have seen strong support from healthcare professionals who appreciate and value having InnovaMatrix available to them as an innovative option. It is not on the list of covered products in the current draft proposed LCDs, and while it does meet the technical requirements outlined in the draft, being only two years since launch, the clinical evidence required by that current draft proposal has not yet been published. We are following the normal product development cycle under the 510(k) pathway. We have FDA clearance based on a predicate product, which is on the covered list, and we are currently carrying out four clinical studies in the U.S., which we expect to publish later this year. In the meantime, we are participating fully in the consultation process for the draft LCDs. It is worth noting that previous draft LCDs have been modified, delayed, or not implemented. So let's see how this consultation develops. We are confident in the qualities of the InnovaMatrix products and technology, and that it will be covered for reimbursement in diabetic foot ulcers and venous leg ulcers across all points of care, albeit the timing is currently uncertain. For now, InnovaMatrix is still covered for diabetic foot ulcers and venous leg ulcers. Remember that it is also cleared and covered for use for several other indications, such as pressure and vascular ulcers or post-Mohs surgery in skin cancer and through other points of care. There are good growth opportunities in these other areas. My final comment is that irrespective of any potential short-term disruption from the impact of the draft LCD, we remain confident of delivering our 2024 and our medium-term guidance. Our confidence is based on the broad-based global growth across attractive chronic care segments and the launching of several new and differentiated products across all of our four categories. Thank you very much, and Karim and I will now be happy to take any questions that you have. We will now begin the Q&A session with Karim Bitar, CEO, and Jonny Mason, CFO of Convatec. If you wish to ask a question, please use the Raise Hand function at the bottom of your Zoom screen. If you have dialed in, please select star nine to raise your hand and star six to unmute. Participants can also submit questions through the webcast page using the Ask a Question button. If you'd like to remind all participants that the call is being recorded. We will take our first question from Hassan Al-Wakeel at Barclays. Please unmute your line and ask your question. Hi. Good morning. Can you hear me? I can. Thank you. Perfect. Thank you for taking my questions. I have three, please. Firstly, can you talk about the growth guidance, and given the anticipated acceleration in infusion care and China wound in the second half, what, what exactly are you baking in for the impact on biologics? Are you seeing any disruption? And if you don't, what do you think the wound care business could achieve later this year? Secondly, in a worst-case scenario, can you talk about the potential impact on a full-year basis and what this could mean for the margin trajectory over the medium term? Does it delay the profile meaningfully, or do you see anything to mitigate the impact? And then finally, can you talk about the strength in continence, and I think you call out Europe after the U.S.. I'd love to hear about the traction that you've been having with GC Air and your conviction around growing share from what is a very low level in Europe. Thank you. Well, let me start, Hassan, on the H2 sales question and perhaps medium-term guidance, and then Karim will follow up with your third. We've had a good start to the year and are pointing now to a flatter profile of sales growth across the year. You're right that we still are confident in infusion care growing to high single digits this year. That is second-half weighted, as we said previously, and we've got visibility on orders. It's based on the several customer pump new product launches, which is building demand for our innovative infusion sets. And yes, we are starting to see that the bribery and corruption campaign is working towards its end in China. Access is starting to open up, although, you know, obviously it's had an impact on us in the early part of the year. So we do see growth in China, in wound care accelerating, in the second half. But look, we're being prudent, I think, in anticipating that these draft LCDs may lead to disruption, in wound care and in, in InnovaMatrix sales, specifically, as the year goes by. They may not. We haven't seen any disruption so far. If there isn't any disruption, then we'd be comfortable saying that wound care would be high single digit. But, you know, prudently, we're taking that down because we think there may well be some disruption. On your question of medium term, no, we don't anticipate that this is gonna impact our medium-term guidance, neither the sales growth nor the margin build trajectory. You know, when we bought InnovaMatrix or Triad Life Sciences, as it was called, we knew there was some uncertainty as regards reimbursement in the biologic sector. And therefore, that was built into our plans. And so our plans did include a certain prudence, and that's why we're comfortable in saying that the guidance, this latest new uncertainty won't impact the guidance that we're planning to deliver. Super. Good morning, everybody, and I'll just pick up the question around continence care. What I would just highlight is that the business in North America, particularly the U.S., continues to perform really well. As Johnny highlighted, the level of customer service that we're providing to both payers and to consumers is really outstanding. And as you know, we measure that in a very quantitative manner via Net Promoter Score, loyalty measures, and they really are world-class. We've introduced and rolled out that same capability now outside the United States in places like the U.K., and plan to further leverage that capability. And again, we're finding a way to replicate that level and quality of service. In regards to Hassan, specifically to GentleCath Air for Women, I would say that the pull that we're getting both from healthcare professionals and consumers is very strong and robust. What we're finding is that because we really have a third-generation intermittent catheter that's ready to use, and has no coating on it, right? And so, as you know, in the U.S., the FDA has awarded us a superiority claim in terms of comfort, because in essence, we really don't do any damage, to the urethra. You can imagine if you're using an intermittent catheter four to six times per day, that's really, really important. So the fact that it's ready to use, there is no sticky, gooey coating on it, and the fact that it really doesn't harm the urethra and has really been designed to frankly reduce the likelihood of getting a urinary tract infection seems to be very well received by consumers and healthcare providers. And so we're very excited about being able to launch it in other key European markets and also the U.S. later this year. So let's just say initial signs are encouraging. Perfect. Thank you. I'll jump back in the queue. Our next question is from Graham Doyle at UBS. Please unmute your line and ask your question. Morning, guys, again, hopefully you can hear me. Just with regards to, to InnovaMatrix, it'd be good to get a sense of what data you had when you bought the business. So what actually gave you confidence that the product works? That'd be a sort of first question. And the second question is just around the studies you talked about. Do you think the two prospective studies that you're running this year and will publish, do you think they'll be enough to justify reimbursement under the framework that we've seen at the moment? And then just a quick last one on Infusion Care and why it's so, why you're still expecting it to be H2-weighted. Is that related to any particular launches? Just be good to get a sense of that. Thank you. Sure. Maybe what I'll do is take the two questions really tied to InnovaMatrix, and then, Jonny, you can weigh in maybe on the IC business and why it's H2-weighted. Look, the reality is that we had analyzed and studied the biologics segment for a couple of years. And we were very thoughtful when we were making and pursuing the acquisition as to do we wanna be focused on an allograft, or do we wanna be focused on a xenograft? And we very clearly decided to focus on xenograft, and particularly porcine. So that was a very deliberate choice, having looked at the fish and the cows and human tissue, et cetera, et cetera. The rationale, really was that we wanted to focus on three criteria: quality of the offering; b, speed in terms of being able to cycle through and innovate; and then thirdly, anticipating that there would be downward pressure on the reimbursement front to make sure that we had, the lowest cost position. And so frankly, InnovaMatrix, ticked all three of those. Now, your specific question was, Graham, was what kind of data were we accessing? So when we do our assessments, we'll typically look at it in terms of what is the degree of technical risk, what is the degree of commercial risk, and then what is the ROI that we would anticipate from this acquisition? In the arena of technical risk, we went ahead and focused on clinical performance, and also in terms of the regulatory dossier, what we were dealing with. What we were dealing with at the time was that we ensured that we had actually received a clearance for the product by the 510(k) process. 80% to 90%, frankly, of Class II medical devices in the United States are cleared this way. This is a very normal way of doing it. So we knew that the likelihood of clearance, that risk had been taken out. The next thing we needed to focus on was from a clinical vantage point, how would clinicians respond to the utilization? Frankly, in dialoguing and engaging with a whole series of thought leaders around the United States, they had developed a whole series of case studies. We felt very encouraged by the feedback we were getting. As you know, we've been in the wound care business for, you know, several decades and are very familiar with that U.S. marketplace. So that clinical feedback we got from the case studies was very, very encouraging. Thirdly, we needed to go ahead and assess, well, what was gonna happen on the reimbursement front? And on the reimbursement front, what we typically will do is look at what's happening on the coding side, what's happening on the coverage side, and ultimately, what's the level of reimbursement you get. And we ensured that the coding had been put in place and that coverage was imminent, and that was exactly what the case was. So, that's kind of what we're dealing with at the time. Then as you can imagine, we looked at what was the investment we're gonna make relative to return, and the case was very compelling, and it's proven to be proven to be the case. In regards to the two prospective studies, what I would say is that we have one for diabetic foot ulcers, and one obviously for the whole pressure ulcers area, the venous leg ulcer area, excuse me, I stand corrected on that. And these two studies are ongoing, and we also have two real-world evidence studies ongoing. And you may note that here in December of 2023, the FDA actually has come up with draft guidance highlighting the importance and quality and caliber also of real-world evidence. So I think the bottom line is that we need to see what happens with the draft proposal LCD. Will it be modified? Will it be delayed? How will it be implemented? And I think that will create the basis for what level of clinical evidence is gonna be required. We've always planned on running and driving these clinical studies, and we've always planned on running randomized clinical trials in addition to these studies, to go ahead and also secure reimbursement coverage beyond Medicare, but also with private payers. So we're very much tracking where we wanted to be, and obviously, we're seeing some uncertainty and downward pressure now on the reimbursement front. I'll pass the baton on to Jonny, to maybe comment on infusion care and why we anticipate accelerated growth in the second half. Yeah. It's not based on any one particular thing, Graham, but the breadth of new product growth in the market. We've got infusion set demand growing with Beta Bionics, with their iLet pump, with Ipsomed, with AbbVie. That new Parkinson's application is growing very nicely, and they expect to launch it in the U.S. later this year as well. We've got Tandem, Mobi, and Medtronic 780G. So it's a broad base of increasing demand. And I guess why we are remaining confident that we will increase sales growth into the second half and hit high single digits for the year is that we have good visibility over the orders. You know, this is a B2B business. We talk to our customers regularly. As I say, it's across that spectrum of different things that we see demand growing. Great. Thanks a lot for the detailed answers, guys. Thank you. Our next question is from Kane Slutzkin at Deutsche Numis. Please unmute your line and ask your question. Thank you. Morning, guys. A quick one, sorry, to come back to the draft LCDs. But just, can you just give us a sense for the level of investment that has gone into that space for you—for yourselves, whether it be sort of sales and marketing? And, you know, in the event that these draft policies were implemented, you know, would there be a sort of case where you would pull back on some of that investment, i.e., you'd have some sort of fat to cut out, or would it be possible to redirect those resources to, I guess, other parts of the market, whether it's payment and coverage? And just what are the costs of some of these studies, or have you already borne those costs already? And then just finally, just on ostomy and continence. I know, Karim, you sort of, I think it was in March, where you, in the last results, where you mentioned sort of probably too early to call those two divisions sort of getting to sort of the mid or high single-digit growth. And it seems like you got there quite quickly on, on confidence. I guess, sort of, just sort of maybe a cheeky question is sort of, can we expect something similar on ostomy quicker than maybe you had alluded to in March? Thanks. Yeah. So look, let's start off with InnovaMatrix and the commercial infrastructure. We clearly have a commercial infrastructure focused on the physician office. So we're talking about general surgeons, typically podiatrists. But as you know, we also have a strong commercial presence in hospitals and then also in the outpatient wound clinics. I think the reality is that today, when you look at InnovaMatrix revenues, approximately 20% are actually outside of DFU and VLU. So I think that's an important thing to highlight. And B, I would just also highlight that all the other indications that Jonny mentioned. So things such as, say, pressure ulcers, vascular ulcers, the treatment of Mohs, right, which is a surgical method that's used to treat skin cancer. These are sort of all outside of the current draft proposed LCD. So I think there's a significant opportunity to grow above and beyond, DFU and VLU, and frankly, we're seeing rapid growth in that arena. So is there an opportunity to redeploy our commercial resources? I think the short answer is yes. Will we need the same size and scale, quote, unquote, "in a worst-case scenario, short term?" I think one needs to evaluate and assess that, right? And so that's what I would say there. In terms of the cost of the studies, look, we've always factored in that we would be investing, you know, in the tens of millions of dollars, right? So these are important investments. It's part of the business case. We fundamentally, as a company, are very committed to the whole concept of evidence-based medicine. Our view is that when you generate scientific evidence, clinical evidence, that really helps healthcare providers understand how do you use Convatec's solutions, right? And so whether that's in ostomy care, or continence care, or wound care, or infusion care, frankly, we've been ramping up our medical capabilities. And you may have seen recently at the European Wound Care Conference, where we highlighted the completion on Aquacel Ag Extra of a study where we were comparing ourselves to standard care. This was a non-inferiority study, and in fact, we demonstrated superiority, right? We were able to increase the ability to heal wounds, you know, during the course of 12 weeks by over 30%, right? The likelihood of being able to do that. That was a very meaningful achievement. So I think the point I'm trying to make is, yes, there's money to be spent. We've planned on doing this, but as you think about our vision of pioneering, trusted medical solutions, that you think about the FISBE strategy innovate, we've consistently contemplated making sure that the medical component of that is strong and robust, in addition to product development, process development, and regulatory. On OC and CC, you know, the question, Kane, you're posing is, you know, could those be high single digit? Look, I think I've answered the question before: Is it possible? I think the short answer is yes. Are we gonna strive to do that? The short answer is yes. But I think it's frankly premature at this point, to go ahead, and make that call. Let's continue to work hard in continence care to sustain the excellent service levels through the HSG group. Let's go ahead and make sure that GentleCath Air for Women is successful. Let's make sure that in the next 24 to 36 months, we roll out GentleCath Air for Men, right? That's something that we've spoken about briefly. And then in ostomy care, as you know, we have the Esteem Body, our one-piece convex, which is off to a good start. Let's make sure we succeed with that. And then we need to make sure that we also introduce, frankly, a comparable version of the Natura Body, the two-piece, with this, you know, tremendous base plate technology, where you basically avoid leakage. It's got the Leak Defense technology, and where now the pouch becomes truly discreet and has a whole series of benefits for patients. So, is it possible? Yes. I think it's premature to make that call. I'd like to see more data and more evidence of successfully launching the GC Air portfolio and the Body portfolio. And I think it will become a lot clearer to all of us during the course of the next 12 to 24 months if that's gonna be feasible. Kane, let me just build on- Yeah. Let me just build on Karim's first answer, numerically, as it were. Yeah. Given we're in build-up and there is a significant operating expense investment in the InnovaMatrix area, you know, the operating margin of that business is roughly in line with the rest of the group. So I don't think you should be expecting any disproportionate impact on profit over and above whatever sales impact you choose to model. And then secondly- Yeah just that, you know, the cost of the trials, as Karim said, these have always been planned, so that is already in our TNI investment numbers. All right. Thanks, guys. Our next question is from Anchal Verma at JP Morgan. Please unmute your line and ask your question. Hi, good morning. To start off again, apologies to stick on the LCD topic, just one more, please. In terms of kind of understanding when you would get the trial results from the real-world evidence study and the other two studies you are running, when can we expect these trial results to come out? And given the comments for the draft proposal are due in June, is it fair to assume potentially, this is- this will be helpful for the next cycle or the next round to try and get on the proposal based on these trials? And then on the reimbursement question as well, I think there was a wider term expectations for reimbursement pricing cuts. Is that still potentially looming in terms of a wider Medicare pricing reimbursement change? And then just the second question on margin phasing. Given top line is now expected to be more equal weighted, how should we think about the margins from H1 to H2? Yeah. Why don't I take the first two questions in regards to the LCD, the proposed draft LCD, and then maybe Jonny can comment on margin. Look, I think we've highlighted that these four studies we anticipate basically going ahead and publishing the results of these studies here in 2024. I think the whole draft proposal LCD, it's very dynamic, right?. and so I think that if you look at what's happened historically, you tend to have delays, you tend to have modifications, and then there's a whole aspect of how it actually gets implemented. And so, I think there's a fair amount of uncertainty. Obviously, the more clinical trial data and evidence we can generate, that certainly buttresses our position and strengthens our position. So frankly, independent of the LCD situation, we're very committed to going out and generating that evidence, publishing that evidence, and then sharing it with all the relevant authorities, is what I would say. Is there potentially further downward pressure on the reimbursement front? Look, I think that no one really knows at this point. I think it's a very dynamic situation. Obviously, CMS, the Centers for Medicare and Medicaid Services, has taken note of how much is being spent on these skin grafts. And so I think that it's uncertain. I think from our vantage point, we've always anticipated that there would be downward pressure on the reimbursement front, and clearly this draft proposal sort of moves in that direction. But on the other hand, I would say, based on the innate technological strength of InnovaMatrix, based on the fact that physicians are very keen to have this in their armamentarium, based on the tremendous results that they're seeing clinically, and based on the fact that patients are really appreciating it, and based on the fact that we're committed to ensuring that all the evidence is made available to the relevant authorities, I remain confident and optimistic about the prospects for InnovaMatrix. I'll pass the baton to Jonny in regards to margin. Yeah, look, you know, we're not talking about margin in detail today. This is just a trading update. But I think the general theme is that we are in an environment where inflation is abating. We've previously described how inflation last year was in the 5% to 7% zone, and we think this year more like 3% to 5%. It takes time for lower inflation to feed through into our P&Ls. Just like the other way around, it takes time. It did take time, when we were on the other side of the curve, for the higher inflation to feed through. You know, we do have certain hedges in place to stabilize the impact of any price changes on the P&L. And, and, and, you know, we're operating FIFO inventory accounting as well. So it takes time, and therefore, as inflation diminishes, you should expect the benefit of that to build through the year. You know, that's just a general comment, so more benefit from lower inflation in the second half than in the first. But we'll update you properly on margin at the half year. Perfect, thank you. Our next question is from Jack Reynolds-Clark at RBC. Please unmute your line and ask your question. Jack, please go ahead. It seems like Jack is having technical issues. We will now move on to our next questioner, which will be Veronika Dubajova at Citi. Please unmute your line and ask your question. Hi, guys. Hopefully you can hear me okay. It's Veronika here from Citi. Hi, we can hear you. Thank you, Veronika. Excellent. Very good. Thank you for taking my questions, please. I have three. The first one is actually on InnovaMatrix, and not related to the LCD, just to make it a little bit more fun. I would love to understand whether you're satisfied with the growth profile that InnovaMatrix has delivered year- to- date. If I look at the back half of last year, I think you called that a 4.5 percentage point contribution to the AWC growth from InnovaMatrix, then it has fallen down to 2 in the first four months of the year. I appreciate, obviously, the baseline has increased, but it does seem to me on my math like the growth has slowed down from something like 100% last year to 20% to 30% this year. So just curious, you know, to what extent this is in line with your expectations, and is there anything that's changing here in either the market dynamics or the commercial uptake potential that you see? So that's my first question. My second question is on the LCD, unfortunately. Just curious, Karim and Jonny, to get your thoughts on how you think the MAC will think about prospective single arm studies versus randomized clinical trials. My understanding from the document is that there's a very strong preference from the MAC for randomized clinical trials. And so I'm just curious whether you think the studies that you have will meet the threshold, and to the extent that they're not, are there any plans to commence an RCT over time? And then my final question is going to be on ostomy, and I'd love to understand how you feel about the traction that you're seeing in the U.S., but also in the U.K., and whether we're getting any closer to the point where the headwinds in the U.K. are starting to dissipate? Thank you so much. Should I take the first one, Karim, and then- Sure. Yeah. So, on the numbers, I haven't quite got the same numbers, Veronica, so let's, you know, offline, just check those. So I think we called out 3.5 points contribution to wound care last year. The general point is right, though, and we haven't got 20%; it's higher than that in the first quarter. But the general point is right, that roughly 100% growth last year will diminish this year as the base increases. You know, obviously, so for a similar dollar quantum of growth, and I think we've said, you know, prior to this new uncertainty, we were targeting roughly a similar dollar quantum of growth. That would be a lower percentage growth rate. Are we satisfied with the growth? Yes, we are. You know, we think we had a good start in InnovaMatrix, just like in the rest of wound care. Had it not been for this new uncertainty around draft proposed LCDs, we would've been reconfirming high single-digit growth for the year. But we, you know, we wanna be prudent, in case the drafts lead to some uncertainty in the market. Yeah, look, what I would say, Veronika, on the LCD draft proposal, I think obviously there's some challenges in terms of how it's been drafted, right? So, I don't wanna get into all the technicalities now, 'cause we're obviously engaging with all the various parties. But the first thing I would just say is, I think it's important to highlight that, you know, we launched in 2002, many of the other products have been on the market for decades, right? And so, I think it's very important to realize that the way the regulatory environment has been set up has been to frankly have a clearance process via a 510(k) process. And so a 510(k) allows you to get clearance, and therefore to market your product. The U.S. authorities, Health and Human Services, have always encouraged that there be innovation, and that's the way you encourage innovation, because then Medicare, in essence, encourages innovation. Then thereafter, typically producers that are serious and capable develop additional clinical evidence that then is utilized with private payers. Now, that's always been really the standard in the United States. It's quite interesting here that you have an LCD that tries to retrospectively change the rules of the game, not consistent and coherent with how the FDA has been approaching it for quite some time. I think that's important to kind of realize that this is a very atypical situation and approach. Having said that, I think your specific question was, "Hey, to what degree will the prospective study suffice?" I think the reality is that the prospective studies are important. I think real-world evidence is important. And I think, you know, randomized clinical trials are important, and they have different values and abilities to give you different indications. So we're very much tracking on publishing these prospective studies for diabetic foot ulcers, for venous leg ulcers this year. We're very much on track to publish our real-world evidence this year. And what I would say is we're very much on track to frankly go ahead and commence our randomized clinical trial studies this year. That's exactly what we've been planning for quite some time. I think it's important to realize that, if you're gonna go ahead and foster innovation from a regulatory environment, it's important to make sure that you afford parties the opportunity to develop and generate their evidence, to publish their evidence, and then share it. In terms of traction in Ostomy Care, I'd say our U.S. performance continues to improve. We're executing better. We have a strong support from the Home Services Group, and so that's really bodes very, very well. And we're very excited about the opportunity to frankly launch Esteem Body in the United States. We've obviously got some encouraging initial signs from Italy, and so that bodes well. I would say similarly with the U.K., we're in the midst of strengthening our commercial capabilities there, and we're also very excited about launching Esteem Body. So, I would say, look, let's stay tuned, but overall, I would say that the prospects for growth in Ostomy Care are robust as commercial execution improves, as we improve the quality of our current portfolio, and as we launch new products. So I'm cautiously optimistic that good things are gonna be happening in Ostomy Care. Thank you, Karim. Can I just ask, sorry to be annoying about the LCD and the trial question? I mean, do you have indication from the MAC that if you were to conduct a randomized clinical trial, and let's say that gets published, you know, one, 2 years from today, would they be open to revisit the coverage decision once that data is available? Or is your impression that this is sort of set in stone once we get there? Yeah, I don't think it's set in stone is the bottom line. I think that there's a strong regulatory and clinical incentive to encourage folks to generate the evidence and share the evidence. So I'll leave it at that. And you can imagine there's a lot of dialogue and engagement occurring with a variety of parties. Okay. Thank you, guys. Mm-hmm. Our next question is from Jack Reynolds-Clark at RBC. Please unmute your line and ask your question. Hi there. Thank you for taking the questions. Can you hear me? Yeah, we can hear you now. Thank you, Jack. Perfect. Perfect, lovely. Can I just push you a little bit on kind of what assumptions are baked into the wound care guidance? I mean, do you kind of assume some destocking, or kind of what kind of? Yeah, what assumptions are embedded in that? Thank you. the, well, so two different time perspectives. First of all, for the remainder of this year, it's, we've made a prudent assumption that a significant chunk of the of the sales of InnovaMatrix may be impacted by uncertainty in the market. And that is, irrespective of whether the LCD consultation process leads to alteration, delay, or implementation. You know, we don't know how it will play out. Certainly to date, we've seen no impact whatsoever. InnovaMatrix continues to grow nicely. It's early days, I accept, but it's continuing to sell well, as are the sales to the indications outside of the scope of the draft LCDs. So, you know, we've assumed that the sales we were anticipating for this year take a significant impact, just to be prudent, and that is what has led us to take the wound care indication of growth for this year down from high single digit to mid to high. So, you know, you can do your math and come up with the approximate quantum. But the only reason wound care indication has come down is because of that new uncertainty with LCDs. There's nothing else contributing to that reduction. Okay, and then- Sorry, Jack, I should have said, on the medium term, look, we had already got prudence in our plans for potential uncertainty in reimbursement around biologics, which we recognized right from when we made the acquisition. And so, you know, it's, it's because we have that prudence in our plans that this doesn't reduce our confidence in being able to hit the financial targets that we had set out in our medium-term guidance. Okay, that's, that's super clear. Thank you. And then just, just following up on the other indications, I guess, can you kind of talk about how, how fast that, that segment is growing? And, of course, you talked about reallocation of, of commercial resource there, potentially in a worst-case scenario, but kind of what levers do you have to kind of really accelerate your, your growth in those other, other segments? Yeah, Jack, what I would just highlight is that the clearance we had from the FDA covers a whole series of indications outside of diabetic foot ulcers and venous leg ulcers. So pressure ulcers, vascular ulcers, the treatment of, you know, skin cancer by Mohs surgery. So there's really a plethora, and it's a very large and significant opportunity. Frankly, if you did the simple math in terms of scale of the opportunity, it's at least comparable to DFU and VLU summed together, and probably one could argue, frankly, larger than that. Okay? Just to put things in perspective. So there's a large opportunity, outside. I think in terms of our ability to deploy resources at other points of care, so for example, let's say the dermatology area, where typically Mohs surgeries are carried out, because we're talking about skin cancer, that's something that we are capable of doing and frankly have been doing for some time. And that business has been growing rapidly, and if you sort of break it down by indication, it's one of the more rapidly growing segments for us, and frankly, the clinical performance we're being able to demonstrate is very, very robust. So, I think that bottom line, what we're really focused on is making sure that we engage with all the relevant parties, whether that be the MACs, whether that be healthcare providers and associations, whether that be patient associations. And again, I think it's really important to stress the fact that this is a draft proposal. It's a very dynamic situation, and one needs to see, will the draft proposal be delayed? Will it be modified? Will it be implemented? So clearly, there are degrees of freedom there that are important. Two, it's absolutely critical and important that we drive the whole aspect of the, you know, medical evidence, and that's exactly what we're doing, and we anticipate being able to publish a whole series of data and scientific and clinical information later this year. And then obviously, there is an opportunity above and beyond DFU and VLU, which we have been pursuing, and we'll go ahead and pursue vigorously. I hope that answers your question, Jack. That does, yeah. Thank you very much. Our next question is from Sam England at Berenberg. Please unmute your line and ask your question. Hi, guys. Thanks for taking the questions. I'll stay clear of the LCDs, 'cause there's been a lot already. So firstly, on Esteem Body, can you just give us a bit more color on the early success there in Italy? Is that being driven more by greater share of new patient starts or existing patients switching onto the product? And what sort of feedback are you getting from patients and healthcare professionals so far? And then just a quick one on wound. Is there any update on the nitric oxide platform in wound and any timelines around product launches there? Sure. Yeah, look, it's early days with Esteem Body. What I would say is that the whole concept of Leak Defense bodes really well. We've historically really been viewed as having the gold standard in terms of avoiding leakage, not causing skin irritation, not causing infections. And I think what we're finding is that patients, whether they be new patient starts or frankly, people are using our products and going ahead and upgrading. Frankly, it's a balance of the two, which is really positive for us, right? There is a high degree of interest in using it in both domains in a pretty balanced manner. And then there's this whole aspect of, you know, the 8-shaped pouch. You know, it's very, very discreet. It doesn't tend to go ahead and bloat and sag and bulk up. Frankly, based on its performance, we'll get feedback from consumers. We have one consumer who's been raving and ranting and basically highlighting how as a result of the bag not basically expanding and bloating, particularly when she sleeps next to her partner, guess what? She's now being able to sleep after 14 years of not being able to sleep, period. Right? Now, that may seem like a small element, but you can imagine that getting a good night's rest is hugely important, and that relates, frankly, to how we've designed our product. I don't wanna get too much into how exactly we were able to achieve that functional benefit, just from a competitive intelligence perspective. But clearly, it's a very well thought out design, in terms of avoiding leaks, being discreet, and maybe having the kind of experience that allows you to, you know, have a quote-unquote "normal life." In terms of the nitric oxide technology platform, that's moving along very nicely, both in Europe and the U.S. So we're very much tracking to go ahead and, you know, file the appropriate regulatory approvals during the course of 6 to 12 months, both in Europe and the U.S. And we're very committed to that technology platform, and as we've shared previously, we think that it's got some significant antimicrobial properties, which we've documented in randomized clinical trial studies and in diabetic foot ulcers, in fact. And B, we think that it may actually have the ability to accelerate the whole wound healing process. And so that bodes well in terms of clinical performance. So, I would say on track, and you know, would anticipate being able to introduce the nitric oxide technology platform in that 25 to 26 timeframe period. Great. Thanks very much. Mm-hmm. Our next question is from Lisa Clive at Bernstein. Please unmute your line and ask your question. Hi. Hi there. Can you hear me? We can. Yeah. Okay, great. Two questions. One, just on patch pumps. Any potential. Any update on the potential to get involved in that supply chain, or even potentially CGMs? And then second question on CombiVac. Are you still on track for a 2025 launch? And I assume, the lead time for that is around, collecting data. And obviously, you know, you've talked a lot about the importance of clinical data and, and clinical trials, et cetera. Is that, is that really what you're hoping to have, you know, in the back pocket for your sales reps when that product hits the market? Thanks. Yeah, Lisa, what I would say is, you know, the whole area of patch pumps and CGM, we're busy bunnies, and we're making progress, and I'm not gonna be able to say more than that. So I would just say, stay tuned. But clearly, an area that we're actively exploring. And then on CombiVac, again, we're very much tracking in terms of the development process and very focused on being able to introduce that new offering, both in the United States and in Europe, and potentially in the global emerging markets. And again, I think we're very much on track for a 2025/2026 launch. So, I think we're making good progress on both fronts, and I would just say stay tuned. Okay. Thanks very much. Mm-hmm. Our next question is from Christian Sheridan at Stifel. Please unmute your line and ask your question. Hi, guys. Thanks for taking the questions, please. Still on the LCDs, unfortunately. I suppose just to clarify some points of clarification here around the exposure to this issue. If you talk about the $74 million of sales you did last year, you said 20% was outside DFU field. Is that essentially 80% of your current business is exposed to these issues? Potential reimbursement, obviously. And then linked to that, any reasons why you can't get more into the hospital channels? Obviously, that's unaffected by DRG codes and the like. The second one is on just to come back on the medium-term guidance. I mean, it's. Are you saying sort of categorically that, say, say you are out, you no longer have this channel open to you, for, you know, let's say, 2 or 3 years, while you go away and do a randomized clinical trial, that scenario is still, you'll still be on track to hit your targets, in that scenario as well? And then finally, on just to set the scene around pricing of InnovaMatrix, maybe that typically is in this channel, versus some of the competition. And is pricing a potential discussion point, with the MACs, or is it just all around the clinical evidence? Thank you. Do you want me to take the first two, Karim? Yeah, that'd be great. So yeah, I think you've got the numbers right there, Christian. GBP 74 million of sales last year, about 20% of that was outside the scope of the draft LCDs, so the other 80% was in it. But, you know, note the comments we've made. The other 20% is growing faster. There is no reason why we can't get into the hospital channels. We've already started, although it's very small still. You know, there we have the opportunity to benefit from synergies with the rest of our wound care sales force, which is very well established, obviously, in the U.S.A., achieving 30% market shares in the antimicrobial sector, for example. So we, we'd expect that to grow faster. And as regards medium-term guidance, I think, look, you know, that's what we are saying, which is that there are a number of different ways that this current consultation might play out. You know, it might well be postponed or modified. You know, we're confident that we will have InnovaMatrix covered in all points of care. But we can't be sure of timing because, you know, that obviously will depend on how the consultation plays out. But you know, even so, that wouldn't be sufficient to knock us off being able to deliver on our medium-term guidance. Because in our plans, we had built in some, you know, contingency and uncertainty regarding reimbursement in biologics anyway. So yeah, we are. You know, despite this new uncertainty, we're still on for that medium-term guidance. Yeah, look, I appreciate on the last point in regards to price and clinical, right? I think they both are linked, right? I mean, ultimately, clinical performance and, you know, value for your money are important considerations, and obviously the MACs, you know, basically, are part of CMS. And so when you think about the Centers for Medicare and Medicaid Services, in essence, you know, really it is a public reimbursement entity or a payer. So, I think, look, I think it's very dynamic right now. I think clearly, you know, they've got a concern about the amount of spend and, you know, there's a whole plethora, frankly, of manufacturers that have tried to enter the total skin graft area, who maybe, are not as focused on, you know, evidence-based medicine, investing in clinical trials, being of a certain size and scale. And so, many of them, frankly, have not pursued, a 510(k) process, right? We spoke about that. We pursued that, worked with the FDA to get that clearance, particularly on the allograft or, you know, non-xenograft front. That's what we've seen happen. So look, I think, I think there's a desire on the regulator, to manage, both, the robustness of the clinical evidence, and, how much is being, invested in this area. I think on the other hand, the regulator also has a vested interest in making sure that healthcare professionals have the very best clinical choices to treat. And I think choice is absolutely important, and I think that as a company that is generating evidence, that is publishing evidence, and frankly, is able to add significant value to patient outcomes, I think that bodes well for us. And so, my level of confidence in terms of InnovaMatrix being a growth platform for the company, it certainly remains strong. Thanks. Could I have a quick follow-up, please, on the mention of a randomized RCT that you. I think you said was in the plan. Was that always in the plan? How progressed is that design of that trial, I guess? And then second, if I can, on continence care- Please. just quantify the U.S. reimbursement, the benefit that you've had on U.S. reimbursement for that upgrade to continence care. Thank you. Okay, maybe I'll take the first one on RCTs, and then Jonny can comment on continence care. Yeah, look, we've always planned on running our randomized clinical trials, right? I mean, you see that, for example, even with Aquacel AG Extra, we've run randomized clinical trials. You've seen us comment about randomized clinical trials tied to the nitric oxide technology. So, so we've always planned to do that, and we've always planned to basically start running those trials here. Or, when you go ahead and pursue a randomized clinical trial, frankly, it's very helpful to have prospective studies and real-world evidence to help you design those studies. You know, what is the scale? What are the criteria you wanna have? So you can imagine, we'll be leveraging the current four studies that we intend to publish by and are expected to publish by year-end with this year. And at the same time, make sure that those randomized clinical trials are well on their way. So always been planned. We're on track to go ahead and do that, and we'll be doing that. On continence care, it's a straightforward answer. CMS has granted an increase of 2.6% in this area. Now, remember, that applies to approximately half of our sales in the U.S. So, you know, a bit. It's around about 1% on top line for the category. Okay, thank you. That's helpful. I think, yeah, we're up for our time now. So I wonder if we might ask operator to hand us back. There are no further questions in the webinar, and I'll hand back to Karim Bitar for closing remarks. Super. Look, I just wanna say, you know, thank you to everybody. I really appreciate the active participation and engagement, and yeah, I think we're encouraged by our performance in the first four months. I think we got off to a strong start, and I think as Jonny highlighted, there's a sense of optimism and confidence in our ability to go ahead and grow the business 5% to 7% on the top line, to achieve the 21% plus EBIT margin this year. And then get into the mid-20s by 2026 or 2027, and then consistently make sure that we drive the EPS and free cash flow double digits. So again, big thank you to all of you, and look forward to reengaging with you here in the summer.