Coloplast As Sp/Adr

Ladies and gentlemen, welcome to the Coloplast financial statement for the full year 2024-2025 and annual report 2024-2025 conference call. I am Sandra, the course call operator. I would like to remind you that all participants have been disanonymized and the conference has been recorded. The presentation will be followed by a Q&A session. You can register for questions at any time by pressing star and one on your telephone. For operator assistance, please press star and zero. The conference must not be recorded for publication or broadcast. At this time, it's my pleasure to hand over to Lars Rasmussen, Interim CEO. Please go ahead.

Thank you and good morning and welcome to our full year 24-25 conference call. I'm Lars Rasmussen, interim CEO of Coloplast and I'm joined by Anders Lonning-Skovgaard, our CFO and by our investor relations team. We will start with a short presentation by Anders and myself and then open up for questions. Please turn to slide number three. We delivered 7% organic growth and a reported EBIT margin before special items of 28% for this financial year. That is in line with our revised guidance, but below the 8-9% organic growth expectations that we set forth at the beginning of the year. The adjusted return on invested capital after tax and before special items was 15% on power last year. Chronic care, including voice and respiratory care and excluding China, delivered a solid year while we faced performance challenges in interventional neurology and advanced wound dressings. Both businesses were impacted by product recalls with significant negative impact on performance. We also saw increased volatility in the biologics markets, driven by the postponement of the final LCD policy, which led to a slowdown in the momentum for keresis in the second half of the year. In many ways, 24-25 did not become the year we had anticipated. It became a significantly more turbulent year and one that forced us to take decisive actions. In the year, we restructured our business in China. Performance during Stripe 25 was muted, and while we remain committed to serving the Chinese market, we have streamlined our organization to align with the new market reality and ensure a sustainable focus presence. Secondly, we initiated several profitability initiatives in wound care, among others the divestment of our skincare business in December 2024. These initiatives are aimed at simplifying our business operations and improving profitability. Thirdly, we took important steps toward optimizing our cost base in interventional urology. both to protect our profitability in the light of recent performance challenges, but also to ensure that we have the capacity to invest in new growth initiatives, including in tibia, our implantable tibial nerve stimulator, expected to launch in 26-27, assuming we obtain FDA approval. At a group level, we have also made significant changes, which I am confident will be vital for a strong strategy execution towards 2030. By structuring our business into two distinct units, chronic and acute care, we will, to an even larger extent, be able to honor the differences in market dynamics, customer needs, patients' pathways, and business models. And with a new and strengthened executive leadership team, we now have a balanced mix of commercial and technical expertise and a strong team to lead Coloplast into the next strategic period. Please turn to slide number four. Looking ahead, I believe the investments we have made in Stride25 combined with the structural changes that we made this year provides Coloplast with a strong foundation and key building blocks for the future value creation. Our addressable market for chronic care and acute care has a combined value of more than 120 billion Danish kroner and we have the strongest product portfolio that we have ever had. There is ample opportunity to go for and we are well positioned to capture it. With our new strategy, Impact4, we will utilize our solid foundation while setting a new direction for the company with a strong focus on customers and value creation. The Impact4 focuses on four priorities, growth through innovative offerings, unlock next level efficiency gains, embrace technology including AI to elevate our user experience and scale, and finally cultivate a winning and sustainable company. And these promises are supported by clear financial targets. The first is to deliver an organic revenue CAGR of 7% to 8% through 2930. Then to grow EBIT in line with or above revenue growth, and finally to achieve a return on invested capital above 20% by 2930. By putting customers at the center, we aim to deliver best-in-class products, services, and support, reinforcing our ambition to double our impact and reach 4 million people long-term. In the strategic period, we will also maintain a strong focus on sustainability, and we have set clear targets to reduce our environmental impact through emissions reductions and less material used in our products and packaging. Finally, we aim to positively impact society by improving reimbursement, ensuring access for users and healthcare professionals to the best products and services, as well as investing in initiatives that benefits people and communities. Now let's shift gears for a moment and look at today's results in more detail. Please turn to slide number five. In ostomy care, organic growth was 6% for the full year and growth in Danish kroner was 4%. Organic growth in Q4 was 7% and growth in Danish kroner was 1%. Our Sensure Mio portfolio continues to be the main growth driver, followed by Brava's range of supporting products. Our Sensure and Assure Alternative portfolios continue to contribute to growth in emerging markets. From a geographical perspective, growth in the quarter was broad-based across regions, with good growth in Europe. a high baseline in the U.S. due to the resolution of the supply disruptions in Q4 last year, and strong growth in emerging markets driven by increased tender activity. Sales in China declined, reflecting weaker consumer sentiment and competitive pressures. In continent care, organic growth was 8% for the full year and growth in Danish kroner was 5%. In Q4, organic growth was 9% and growth in Danish kroner was 3%. Lucia, our new intermittent catheter with micro-hole zone technology, was the main growth contributor in the quarter, especially the female version, driven by solid contribution from Europe and the U.S. From a geographical perspective, all regions contributed to growth. Growth in Europe was driven by France, the U.K., and Italy. In emerging markets, growth was led by Latam. Voice and respiratory care posted 9% organic growth for the full year, with growth in Danish kroner of 8%. In Q4, organic growth was 9% and growth in Danish kroner was 7%. The good performance in voice and respiratory care continues to be driven by broad-based contributions from both laryngectomy and tracheostomy, with high single-digit growth in laryngectomy and double-digit growth in tracheostomy. In wound and tissue repair, organic growth was 8% for the full year and growth in Danish corona was minus 3%, which reflects 8 percentage points negative impact from the skincare divestment. Organic growth in Q4 was 5% and growth in Danish corona was minus 11%, which includes 11% negative impact from the skincare divestment. The advanced wound dressings business in isolation declined 6% in the quarter as China detracted significantly from growth due to the product return in initiatives in Q3. From a product perspective, biotin superabsorber and biotin fiber continued to perform well. Revenue from Keresis amounted to around 1.3 billion Danish kroner in the full year of which 339 million Danish kroner was in Q4. The organic growth in the quarter was 20% and an improvement compared to Q3 as expected. The inpatient setting continued to deliver solid growth and was the main growth contributor. The outpatient setting saw an improved momentum in Q4. This was in line with our expectations that the impact from our LCD postponement and the resulting market shift to higher priced products would be most pronounced in Q3. In interventional urology, organic growth was 2% for the full year and growth in Danish kroner was flat. In Q4, organic growth was 2% and reported growth in Danish kroner was minus 2%. Growth in the quarter was driven by good momentum in the mental health business. Our flagship product within mental health, the Titan penile implant, continued to perform well with the patient funnel positively impacted by our patient support program targeted at prospective patients. The women's health business also contributed to growth in the quarter. Within kidney and bladder health, the thulium fiber laser drive continued to deliver a solid growth contribution, but the segment overall detracted from growth due to the impact from the product recall. We have begun to see early signs of recovery across key accounts, but expect some negative impacts to persist into Q1. With this, I'll now hand over to Anders, who will take you through the financials and outlook in more detail. Please turn to slide number six.

Thank you, Lars, and good morning, everyone. Reported revenue for the full year increased by 844 million Danish kroner, or 3%, compared to last year. Organic growth contributed 1.8 billion Danish kroner, or around 7%, to reported revenue. Divested businesses, mostly related to the skincare divestment in December 24, reduced reported revenue by 352 million Danish kroner, or around 1%. Fund exchange rates had a negative impact of 587 million Danish kroner on reported revenue or around 2%, mainly related to the depreciation of the US dollar and a basket of emerging markets currencies against the Danish kroner. Please turn to slide number 7. Gross profit for the full year amounted to 18.9 billion Danish kroner, corresponding to a gross margin of 68% on par with last year. The gross margin was positively impacted by a favorable development in the input cost, price increases, and country and product mix, partly offset by ramp-up costs at our manufacturing sites in Costa Rica and Portugal. The gross margin also included a small negative impact from currencies of around 20 basis points. Operating expenses for the full year amounted to around 11.3 billion Danish kroner, a 3% increase from last year. The distribution to sales ratio for the full year was 33% on par with last year. The increase in distribution cost was driven by continued commercial investments in carriers and higher sales activities across business areas. The admin to sales ratio for the full year was 5% on par with last year. The R&D to sales ratio for the full year was 3% on sales, also on par with last year. The special items expenses were extraordinarily high in 2024-25 and amounted to 469 million Danish kroner. The special items were related to profitability improvement initiatives, including the skincare divestment, management restructuring and the integration of Atos Medical. Overall, this resulted in an operating profit before special items of 7.7 billion Danish kroner in the full year and a 5% increase compared to last year. The EBIT margin before special items for the year was 28% compared to 27% last year. The EBIT margin included negative impact of around 110 basis points from the inclusion of kerosene, including PVA amortization costs, in line with the expectations, as well as around 30 basis points benefit from the divestment of the skincare business. Currencies had a small negative impact on the reported EBIT margin of around 30 basis points, related to the depreciation of the US dollar and a basket of emerging market currencies against the Danish kroner. In constant currencies, EBIT before special items grew 6% in full year 2024-2025. Financial items in the full year were a net expense of 1,044,000,000 Danish kroner compared to a net expense of 925,000,000 Danish kroner last year. The increase in net expenses was mostly due to a non-cash effect from currency exchange rate adjustments, which includes losses on balance sheet items driven by the depreciation of the US dollar against the Danish kroner. The ordinary tax expense for the full year was 1.4 billion Danish kroner, with an ordinary tax rate of 22% on par with last year. The total tax expense for the full year was 2.5 billion Danish kroner, impacted by the transfer of Kaos's intellectual property from Iceland to Denmark. As a result of the extraordinary tax expense, the effective tax rate amounted to 41%. As a result, net profit before special items for the full year was 4 billion Danish kroner compared to 5 billion Danish kroner last year. Diluted earnings per share before special items decreased by 21% to 17.76 Danish kroner. Adjusted for the extraordinary tax expenses related to Kels's IP transfer, the net profit before special items was 5.1 billion Danish kroner, a 123 million Danish kroner increase compared to last year. Adjusted diluted earnings per share before special items increased by 2% to 22.84 Danish kroner. Please turn to slide number 8. Operating cash flow for the full year was an inflow of 6.6 billion Danish kroner compared to an inflow of 2.8 billion Danish kroner last year. The positive development in cash flows was mostly driven by lower income tax paid as 23-24 included 2.5 billion Danish kroner, extraordinary impact from the transfer of Atos Medical intellectual property. Changes in working capital and adjustment of non-cash operating items also had a positive impact on the cash flows from operating activities. Cash flow from investing activities was an outflow of 1.25 million Danish kroner compared to an outflow of 1.1336 million Danish kroner and included positive impact from the divestment of skincare business of 192 million Danish kroner. Cabex for the full year amounted to around 5% of sales on par with last year and includes around 450 million Danish kroner related to the new manufacturing site in Portugal, expected to be operational in 2025-2026. As a result, the free cash flow for the full year was an inflow of 5.4 billion Danish kroner compared to an inflow of 1.4 billion Danish kroner last year. The adjusted free cash flow for the full year was 5.2 billion Danish kroner compared with 3.9 billion Danish kroner last year, or a 32% increase. The trading 12-month cash conversion was 82%, while the adjusted free cash flow to sales was 19% compared to 15% last year. Networking capital amounted to around 26% of sales compared to 25% last year, impacted by increased inventories and decreased trade payables. Now let's look at the guidance for 2025-2026 financial year. Please turn to slide number 9. For the 2025-2026 financial year, we expect organic revenue growth of around 7% and around 7% EBIT growth in constant currencies before special items. We also expect a return on invested capital of around 16% up around one percentage point from 15% adjusted last year. The organic revenue growth guidance of around 7% assumes continued good momentum in chronic care, including voice and respiratory care, and improvement in momentum in both wound and tissue repair and interventional urology. In chronic care, we expect good contribution from our recent product innovation, In continence care, we expect Lucia to continue driving the momentum in intermittent catheters. In ostomy care, we expect the recent line extensions such as Sensuo-Miyo black bags and the new two-piece Sensuo-Miyo offering to continue their good launch trajectory and support growth. In wound tissue repair, we expect an improved momentum driven by kerosis, which is expected to deliver growth of around 25%, partly offset by the negative impact from the product return in advanced wound dressings in China from Q1 to Q3. On kerosis, performance is subject to a higher degree of volatility due to the expected changes to the skin substitute's coverage and payments in the outpatient setting as of January 1, 2016. In international urology, we expect growth to improve to around mid single digit in 25-26, up from low single digit last year. We expect continued strong momentum in our men's health business, driven by the Titan penile implant and stable performance in our women's health business. In kidney and bladder health, we expect to see a recovery as the impact from the product recall relapse in December 25, after which we are up against an easier baseline. Reported revenue growth in Danish kroner is expected at 4-5% and assumes 2-3% negative impact from currencies, especially the US dollar and to a smaller extent the British pound and the Chinese one, as well as a 2-month negative impact from the skincare divestment. The EBIT growth in constant currencies of around 7% assumes stable inflation levels and continued ramp-up in Costa Rica and Portugal. The EBIT growth also assumes that Kerasys will deliver an EBIT margin uplift to around 20%, driven by scalability in non-sales functions and Salesforce efficiency improvements, enabled by a good top-line momentum and a high gross profit margin of around 90%. Furthermore, the EBIT growth guidance includes the initiation of impact for investments, including global technology investments and AI, investments towards a new bowel care opportunity in the US, and investments related to Intibia. In terms of phasing, we expect the organic revenue growth to be a second half awaited, with a soft start in Q1, where we will have the impact from the product recalls in both advanced wound dressings and interventional urology. Furthermore, we expect a soft start in ostomy care due to a high baseline in the U.S. and order facing in emerging markets. For 2025-2026, we expect around 50 million Danish kroner in special items from acquisition-related integration costs. The integration of Atos Medical is progressing according to plan, and we will be finalized during the year. The net financial expenses for 2025-2026 are expected at around minus 500 million Danish kroner, down from around 1 billion Danish kroner in 2024-2025, mostly driven by a more favorable outlook on net exchange rate adjustments based on spot rates as of October 31st, and to a smaller extent lower net interest expenses due to lower net interest in bearing debt and lower interest rates. The effective tax rate for 2025-2026 is expected to be around 22%. Net profit is expected to significantly increase year over year, as 2024-2025 has been impacted by extraordinary high special items, high financial items due to negative exchange rate adjustment and the extraordinary tax expense related to the transfer of Keras's intellectual property. The capex to sales ratio is expected at around 5% and includes investments to complete the new manufacturing site in Portugal, investments in new machines for existing and new products, and IT and sustainability investments. On networking capital, we expect a networking capital to sales ratio in 2025-2026 of around 25%, down from 26% in 2024-2025. Our guidance is based on the knowledge we have today and assumes immaterial impact from tariffs as we expect our products to remain exempted and no impact from healthcare reforms in the year. On October 31, 25, the Centers for Medicare and Medicaid Services in the U.S. issued a final rule on the Medicare physician fee schedule for calendar year 26, with a fixed payment of $127 per square centimeter for all products in the physician's private office in the outpatient setting. We consider both this rule as well as the final LCD policy as positive for the market and chaos in the long term and we will closely monitor market developments in relation to these initiatives. With this, I will hand it over to Lars for final remarks. Please turn to slide number 10.

Thank you, Anders. Holoplast is now entering an exciting phase as we begin to unfold the potential of our new Impact 4 strategy, and I look forward to continue leading this work until a new CEO takes office. As we move into Impact 4, we do so from a position of strength, with a strong product offering, clear structure, a strengthened leadership team, and an ambitious strategy towards 2030. I'd like to thank our customers, my colleagues, and our investors for your trust and support in 2024-25. Your engagement and partnership have been instrumental in advancing our mission, making a positive impact for patients, healthcare systems, and society. Coloplast is well-positioned to set the standard of care at scale, create lasting value for all stakeholders, and continue making life easier for people with intimate healthcare needs. Thank you very much. And operator, we are now ready to take questions.

Thank you. We will now begin the question and answer session. Anyone who wishes to ask a question may press star and one on the telephone. You will hear a tone to confirm that you have entered the queue. If you wish to remove yourself from the question queue, you may press star and two. In the interest of time, please limit yourself to two questions. Anyone who has a question may press star and one at this time. Our first question comes from Hassan Al-Waqil from Barclays. Please go ahead.

Good morning. Thank you for taking my questions. I'm going to try and sneak in three, please. Firstly, can you talk about the China Rostami business and the increased competition in the community channel and whether consumer sentiment is getting worse given the decline here and how you're thinking about business development in 26? Secondly... if you can expand on the drivers for the Kerasys margin ramp this year and the phasing of that improvement, given some of the volatility you've observed around reimbursement changes. And then finally, Lars, when we met recently, you talked about slower volume uptake in the UK for Halo. How is this trending and to what extent are you shelving potential launches elsewhere? And in hindsight, what went wrong? Thank you.

That was a good opening, Hassan. So the China... the China situation first. So it's more or less a flat growth that we are seeing. We actually see that we are quite competitive in the markets. So in that specific part of the market, we don't see that we are losing traction. But we... We have a consumer sentiment which is super important because it's out of pocket in the Chinese market, in the community market. We have a consumer sentiment which is negative and that basically reflects on how much consumers are willing to spend. We don't have an increased number of competitors. We still have a lot of competitors in the market, but their total market share is still super low. So we feel that our competitiveness is intact. But that the market sentiment basically is the reason why we don't grow in China. On the Caresis margin, yes, we expect to have a significantly better margin this year than we had in the year that we're coming out of. And it is basically due to scale. So now we... Now we start to be a little bit more of a mature business. It's not that we're not investing, but we do have more sales per head in the organization. We don't need to scale to the same extent all over the place when we are growing. And that is basically what is sitting in the increased margin for Caresis. And yes, there is volatility as we go into this year. And as you all know, Friday night, we received news on the LCD and the physician fee schedule changes. And I expect that we'll also talk to that a little bit later. But that means that there is some turbulence as we go into the year. But I'd like to say from the get-go, we consider the changes to be positive for us. But of course, it also means that we will have a bit of volatility as we go into the year. And then for Halo, What went wrong? Super good question. We are addressing the most pronounced problem that any Osprey patient has to understand how much of the adhesive that are still intact at this given point in time and how much of it have given up and we can show that by the mobile phone. We haven't found a way to sell this where we get the uptake that we expect to have. We give it still a chance to do that in what we consider to be the most advanced market in the world for ostomy care in Great Britain. And we are not going to go anywhere else until we have found a way to solve that in that market.

Thank you very much.

The next question comes from Jack Reynolds-Clark from RBC Capital Market. Please go ahead.

Hi there. Thank you for taking the questions. My first one was on the ATOS integration. You mentioned that you're expecting that to be completed next year. What's left to do on that, and when do you expect the benefits to start coming through meaningfully there? Then the next question was on tracheostomy. I think for the last couple of quarters, grade here has been a bit lower than it has been in the past. Is this a function of a higher base, or is there something else kind of going on here, and how should we think about this going forward?

Thanks. Hi, Jack. Let me take the first one. So we are finalizing the integration of Atos into our IT infrastructure and into our processes, our shared services, and all of that here during this financial year. and what we are, it's basically some of the bigger markets that are left, so it's the US, the UK, that we are currently focusing on. And then the integration will be finished, and we will also reap the synergies of around the 100 million that we have communicated when we acquired Atos some years ago. In terms of triglycemy, Yes, we have seen a little bit of a slowdown recently. It's also because we're up against a high baseline. So last year or the year before, we had a quite significant sales uptake due to forward integration. When that is said, the tracker ostomy business is developing very well, also compared to the acquisition case we did some years ago. And we actually expect that our tracker ostomy will support our growth within Atos quite significantly towards 2030. We are currently sitting with a market share of around 10%. and we actually feel we have an okay product platform and this will be one of the key focus areas towards the 2030 and also an area we will invest further in. So the Tracker Osteomy business is an area that we are very optimistic about going forward.

Fantastic, thank you very much.

The next question comes from Martin from SEB. Please go ahead.

Yes, Martin Parker, SEB 2, I don't know, two questions, I guess. Just on your guidance, I just want to get your confidence level because, you know, you started your thing a little back and loaded and that gave me some kind of deja vu for the last couple of years. how are you confident level this year of this actually will materialize? Do you think you have been more prudent this year than you have been in previous years? Are there buffer for potential hiccups which you have faced the last couple of years? And then second question is just on the ASP development. What kind of ASP development have you assumed in your guidance for this year? And maybe you can talk a little bit to that across your business areas.

Yes, Martin, let me take your two questions. On the guidance side, as we have communicated today, we expect organic growth to be around 7% for the year. We are, as I also said, seeing some headwinds here in Q1 due to the product recalls that we had last year. So the urology recall, we will lap that in December. And the recalls we have in China on the dressings part will still impact us in Q1, but also Q2, Q3. But overall, we are very confident that we are able to deliver on our organic growth guidance. Also back on back of a very challenging year last year, where we also had some challenges that we did not expect back to the product recalls. But also back to, as Lars said earlier, our Chinese momentum did not play out as we anticipated. So that's how we see it. And I would also highlight that the continent's business, the Atos business, is strong. And we also expect those to continue growing. as well as the chaos business throughout the year. So then your second question around, that was ASP? We are expecting a small positive on ASP development. We are not expecting any bigger health care reforms. So we are expecting small positive impact from ASP, especially within urology. We are also expecting some on the chronic side. And that is, again, primarily in emerging markets. And then we get the yearly impact. inflation adjustment in the UK. So those are some of the main reasons for us being positive on the ASP.

Thank you.

The next question comes from Martin Renaud from Nordea. Please go ahead.

Hi Larsen, Anders. Thank you for taking my questions. I'll build a bit on the other Martin's question here. We learned at the CMD that you held earlier in the year that you have quite normally two or three recalls during a year. And I just wonder how much you have baked into potential recalls in this year and how you have, if you have a financial buffer for that potential outcome. And then secondly, on Caresis, would be interesting to hear how you expect to re-accelerate 500 basis points, a few words on what is going to drive it in terms of product launches, new geographies, anything like that. Thank you.

So when you produce... products in the numbers of billions, then, of course, there can be from time to time recalls. What we saw from you already, primarily, is something which we see very, very rarely. And I would like to take this opportunity to remind everybody that the product returns that we have seen in China has nothing to do with products that doesn't work or complaint rates or anything like that. So the reason for that was actually reasons that we have never seen before and that we could not have done anything internally to avoid, I would say. So therefore, we do not have a buffer for very large recalls and it is something that we don't see. What we have seen of real events over the last couple of years has been the distribution center event that led to difficulties in delivering and then what we saw in IU. And it was completely unexpected and unexpected to a very large extent, internally driven, so we could have avoided them. And that's what we have tightened the system to make sure that we don't get into that situation. Having said that, you can't run a business and never have issues, but that we do have significant or not significant, but realistic buffers for. On Keresis, your question is how we are going to get the uptake on the epidermidine?

Sorry, no, not on organic growth.

Ah, okay. So as I started by saying, we actually consider this to be the changes to the physician fee schedule to be positive for us. And we also see that we have strong momentum. We are not in a situation where we have fully utilized the... our sales muscle so to speak so we are of course still hiring sales reps to go to the market but we see it as we get more access with what is happening now because there will be fewer there will be fewer companies to serve the same customer group as we had before. And that is definitely going to help us. We just need to see it played fully out before we start to become too positive. But we think that with where we are now, we can have an uptick because the turmoil that we saw in Q3 is not going to come back.

Thank you, Lars.

The next question comes from Aisha Noor from Morgan Stanley. Please go ahead.

Hi. Good morning. Thanks for taking my question. My first one is on the competitive bidding program in the U.S. for chronic care products. You mentioned in the press release that any changes would take effect in 2028 at the earliest, but your peers are flagging that this could even, you know, be a bit later, so 2029. Just curious what your internal assessments involve towards this timeline and whether you have any renewed thoughts on the potential magnitude of the sales impact for you. My second question is just a quick one on the wound recall impact in China. Could you help us quantify the negative impact that you are calling out in Q1, Q2, and Q3 for 2026? Thank you.

Yeah, let me take the competitive bidding question. So as you all are aware, this is something that is currently going on, and we expect some kind of an outcome as we understand it during this quarter. We, however, believe that if there will be an impact, and that is still highly uncertain, that it will not impact us until 28 at the earliest. So that's the information we are currently sitting with. In terms of the wound recall in China, as we have said a number of times now, we expect that to have an impact Q1, Q2, Q3, and my estimate per quarter is something around 25 million, based on the knowledge we have. Thank you very much. It's 25 million per quarter.

The next question comes from Anshul Verma from J.P. Morgan. Please go ahead.

Hi. Good morning. Thank you for taking my questions. The first question is just around gross margins. How should we think of gross margin development over FY26? Can you provide your assumptions around cost inflation, hungry wage inflation, and the other moving parts? And then the second one was just around if you could provide us an update on how the search for the new CEO is going or the expectations still for having announced a replacement by spring next year.

Thanks for your question. Let me take the first one. So our gross margin, my high-level assumptions are that we are looking into a year with pretty stable inflation levels. That also means that our raw material prices, utility costs, freight, et cetera, are pretty flattish compared to last year. But we will also have some headwinds still from high salary inflation in Hungary. We are still seeing a very intense labor market. And then we are investing in ramping up our facilities. Still some ramp up in Costa Rica, but next year we will really start to ramp up in Portugal. We are expecting Portugal to be in operation in Q4 of 2025-2026. So those are the main moving parts on our gross margin into 26.

And on the CEO search, in a sense, what I have said before, the search is going on. It's like a funnel, right? You start broad and then the field is narrowing down. And that's, of course, where we are now. We haven't... signed any contracts at this point in time but we have a number of qualified candidates and once we have a signature you will be the first to know and then of course it depends then on what kind of garden leave or other terms does that person have and that will then put a date on when a person can start And until then, it will be the team that you are meeting today that will be running the company together with the rest of the leaders in Coloplast.

Perfect. Thanks, Angelos. And maybe just a quick follow-up on margins, please. Are you able to provide or quantify the FX headwind to margins for S426? To EBIT margins, I mean.

So what we are saying is that on the top line, we are expecting a reported growth in the level of 4% to 5%, and that is also, again, driven by the U.S. dollar to a large extent. On the EBIT growth, we will see some headwind also coming from the U.S. dollar, also some on the British pound and the Hungarian hoof.

Thank you.

The next question comes from Veronica Dubajova from Citi. Please go ahead.

Hi, good morning, Lars and Anders. Thank you for taking my questions. I'll keep it to two, please. One, obviously, looking at the revenue growth and the EBIT growth guidance, and I appreciate, Anders, you don't want to talk about gross margin guidance, but it does seem to me that there is a fairly large amount of investments going into the business, obviously, year on year, especially stripping out Keras's, which is delivering a nice little tail into profitability. I was just hoping you could maybe talk about what are some of the areas of the business where where you are investing meaningfully with this high single-digit kind of OPEX growth guidance. That would be super helpful. And then I just want to circle back on the China competition answer because it wasn't clear to me, Lars, from your comments at the beginning. If I look at the press release, you are calling out competition in China for the first time. It wasn't in the prior releases. So just trying to understand what really has changed, what has prompted you to put it into the release, and I guess is that competition from local players or is it from other multinationals that are becoming more focused in the market? Thank you so much, Chris.

Thanks a lot, Veronica. Let me take the first one in terms of the investments. So now we are entering into the first year of our Impact4 strategy. And as we also said at the Capital Markets Day, we are going to invest into new initiatives, both to drive the top-line growth, but also to support our EBIT growth ambition. And what we will initiate this year is investments primarily into our U.S. chronic business. We see quite a few opportunities, also with the new opportunity within bowel care. We will also initiate investments in urology to support the launch of Intibia. We are expecting, when we get approval from the FDA, that we will launch Intibia into 26, 27. So we will also initiate investments here. And then we will initiate quite a bit of investments into technology and AI, both to support improvement in our user experience, but definitely also to support activities to automate and optimize back-office activities, especially order management, prescription management through AI. So those are some of the things that we will initiate basically to support our long-term growth and value creation agenda.

And for China, I think it's actually a very appropriate follow-up. Veronica, thank you for that. That gives me the opportunity to say that our community market share in ostomy care is very, very high in China. and we are not more than 60% and as we are not seeing growth like we used to it is primarily because we have a consumer sentiment that is not super positive. But of course, we also feel the pressure every single day that somebody would like to take away some of the market shares that we are having. We are seeing very able competitors in China. But having said that, the fact still is that we have a very, very, even though we have many local competitors, they have a very, very small market share. a very low single digit, I would say. And therefore, it is maybe just the way that we are writing it. It's not because we see an increased local competition, but of course, we feel local competition also in China. But it has not worsened. So that's not how you should read it.

Very clear. Thank you. The next question comes from Oliver Metzger from OdoBHF. Please go ahead.

Oliver Metzger Yes, good afternoon. Thanks for taking my questions. First question is also on crisis, and you mentioned this market shift towards a higher-priced product. Can you just elaborate a little bit more about the dynamics and how sustainable you regard this shift? The second question is about operating cost development, so follow up on Veronica. If I do the math and calculate a stable gross margin and also a stable EBIT margin and still the amount of operating leverage you should have, It would be great if you can dive deeper into respective costs. And, yeah, you mentioned the wrap-up in TBR, but I calculated a quite significant operating leverage, which is, according to your argumentation, eaten up. So it would be great to have a little bit more transparency regarding the cost positions and how the math works. Thank you.

So on your first one, Oliver, so the physician fee schedule changes to the payment as we are running right now with an average price of 110 US dollars per square centimeter. and the new fixed price is 127.3 USD per square centimeter from 1st of January 2026. That is of course positive on an average basis. There will also be fewer competitors we expect. That has not come out yet, but we expect before 1st of January that we will have a full list of who has coverage. And that dynamic altogether means that as the year progresses and as the stocks that have been built, they are being consumed, that we will be in a better position to compete than we are at this point in time because there are fewer competitors and what we compete with would have a higher average price. That's how we see it. That's also why we... think that this, at the end of the day, is a positive change, seen from our point of view.

And Oliver, to your second question around our cost development, I think I talked to the gross margin moving parts earlier. I also talked to where we are going to invest, back to Veronica's question. And you should, as I also said earlier, you should expect our inflation levels or the inflation levels, salary regulation, et cetera, to be pretty stable also compared to last year. So we are really... The leverage effect we have, we really invest that back into new initiatives, and I explained those initiatives earlier. So it's the U.S., it's in Tibia, and then also invest into technology, AI, to support long-term growth and long-term value creation.

Okay, thank you.

The next question comes from Julia Dormois from Jefferies. Please, go ahead.

Hi, good morning, Lars. Good morning, Anders. Thanks for taking my questions. The first one relates to continence. We should have the coding change taking effect in January of 26. So just curious what are your latest thoughts on this and how your ambition to make the most of that coding change and whether we should see any positive impact in 26 or is it more mid to long-term benefit we should observe? And the second question is trying to dissect a little more into the guidance for 26, particularly in chronic care. You have highlighted continued momentum in the business, but is it fair to assume that continence will continue to outperform ostomy, as it has in the recent past, and also considering the regulatory changes, the recent product launches and so on? So just curious whether ostomy should remain slightly subdued compared to continence into the next year. Thank you.

Thanks a lot, Julian. Let me start with the U.S. coding. Yes, it's going to have effect here from January, but we also are aware that there will be quite a lot of operational activities going on in moving the coding from the previous reimbursement codes and now to specific hydrophilic codes. So there will be quite a big operational activities in our U.S. business to get that fully implemented. And it is still for us too early to call out the impact, but over time we expect this to be positive. In terms to your second question around guidance on the chronic side, as you have seen also last year, we have a good momentum within the continent, driven by our intermittent catheters, driven by the Lugia launch, but we also see good momentum within our bowel care business. And we see that momentum also continue into 2025-2026, And remember, the ostomy franchise, as Lars also has mentioned a number of times now, are also impacted by low growth or flat-ish growth in China. So that is the main headwind, OC versus CC. But overall, we are expecting that the chronic business will continue with good momentum also into 2025-2026.

The next question comes from Sam England from Birnberg. Please go ahead.

Hi, thanks for taking the question. So the first one is just a follow-up on the investment and margins piece. Can you talk a bit about how the impact for investment evolves over the plan period to understand how margins might trend from here? Is it very much front-end weighted? Or are there areas like AI that are more sort of multi-year investments throughout the plan period? And then in voice and respiratory care, just wondering if you're expecting any more positive momentum on reimbursement during 2026, following the improved reimbursement that you saw in France for HMEs earlier this year. And then are you expecting any other new markets in voice and respiratory care to open reimbursement in 2026, like we saw with Poland this year? No.

Yeah, so thanks, Sam, to your first question around investments during the impact four period. The ones we have talked about today, that is front-loading some of the activities to support the growth and also value creation over the period. So we are, as I said, a couple of times now front-loading activities within the U.S. in TBI and technology AI to reap the benefits later in the strategic period. On voice and respiratory care, we expect the momentum we have seen in recent years to continue. We have seen some reimbursement openings in some of our smaller emerging markets, but also in France. But you should not expect any bigger ones, at least not short term. Great.

Thank you very much.

The next question comes from Graham Doyle from UBS. Please go ahead.

Morning, guys. Thanks for taking my questions. Just one for Anders and one for Lars. Anders, just in terms of the Q4, it looked like there was a fairly sizable step up in other operating income, which seems to be related to a transition services agreement, and it was kind of like 2%, 3% of EBIT. How sustainable is that, and when should we expect that to sort of run off? And then just a point on reimbursement for Lars here. When you look at the skin subs, is there not a danger if the ceiling reimbursement, i.e. what a doctor receives, is capped at $127? Why would there not be a race to the bottom to products for like $20, $30, $40 where you make this spread? So I'd just understand how you think doctors balance patient outcomes with, I suppose, financial incentives would be helpful. Thank you.

So thanks a lot Graham. Let me take the first one. Yes, we have a step up in other operating income throughout the year. And this is really related to our TSA or our services to the buyer of our skin business in the US. But actually the cost to do these services are sitting in the individual cost items. So when I net it up, In our P&L, it's actually a neutral effect. You should expect the other operating income also to continue into 2025-2026 and we expect to be done with the services towards the end of the year. But for the total EBIT, it's a neutral impact.

So on the Keresis, I think you know at least as much as I do about the dynamics, the financial dynamics of the skincare market in the U.S. The way I see this change is that for most people, they will get into a space where they have a significantly lower pay per square centimeter than they had before. And we come into a space where we have more. The vendors that are left in that space now, they can only be there when they have good quality clinical data. And the clinical data that you have to obtain to be in that market, you can only get those when you have a certain investment in the quality of those data. And I think that it's hard to see with the kind of investments that you have to do to both create these products, but also to document them, that it's going to be a substantial race to the bottom. On the contrary, I think that it's going to be a market that for some of the vendors will be hard to compete in. We just happen to be set up in a way where we have extremely strong clinical data. We also have a very competitive setup when it comes to the cost on this. So we are of course prepared to compete. But we... We just don't think that we are in a space where what you described there is there's a logic that that will just be the right or the first thing that happens. But we might be proven wrong on this, of course. But I really think that what happens, the steps that have been taken here, that gives a choice for the society to offer very, very strong products at a reasonable price. And those who would like to compete on that is in that space. That's how I see it.

I completely hear you. It was just something I thought about as we looked at how some of the higher price products are trending today. Thanks a lot for that.

Thanks. Okay. I think that we have to end with the next question because we are over time. But could we take one more?

The next question comes from Carsten Lundborg-Marsen from Danske Bank. Please go ahead.

Excellent. Thank you very much for squeezing me in. I was just hoping that you could talk a little bit about the scenarios for the LCD, because there is, of course, a sort of continuous rumor about it not being implemented and maybe being canceled. So what will actually happen with your organic revenue growth guidance for next financial year and if it should be in a situation where the LCD is not being implemented?

Carsten, let me take that one. Our assumption around chaos for the coming year is a growth of around 25%. And remember, around 70% of our business, that's the hospital business. And the hospital business, we have a very strong growth, quarter over quarter. And it's really the outpatient setting when we discuss the LCD and the price levels where we have some volatility. But we expect to deliver growth of around 25% for our kerosene business, 25%, 26%.

Okay, and then maybe a quick follow-up to this one in terms of the venous leg ulcers. I cannot completely remember your plans for submitting data and maybe potentially getting onto that list as well. Could you help me remember it?

Yeah, so we are in the process of doing clinical studies and we expect those to finish sometime next year. So that's the current assumption.

Thank you. Okay, so I actually changed my mind. That happens sometimes in life. So Jesper, if you're still online, you can ask your questions because you're the last one who's left. So that would be like almost personal if we leave you out here.

The next question comes from Jesper Ingersoll from DMP Carnegie. Please, go ahead.

Thanks for taking the time. Just maybe on the bowel care opportunity that you mentioned in regards to your increased investments into the next financial year, could you just elaborate a bit on that opportunity and what kind of contribution you expect to get from that? And then lastly, on Halo and the special items that you have specified, to my understanding, you don't do capitalization of your R&D. I'm just trying to understand what's specifically driving that and to some extent how big that cost is. Thanks.

Jesper, let me take your questions. When we had the CMD back in September and described our impact for ambition also for the U.S., we also talked to an opportunity we are seeing in the U.S. for our bowel care business. So the good news are that we are now getting a reimbursement for bowel care in the U.S., that's why we are now initiating investments into this specific area and and that's what we have been planning for during this year in terms of your second question the related to the halo yes we have evaluated the the value of halo also as a consequence of the current sales in the in the UK and our plans not to to launch in other markets, and therefore we have included a quite significant amount in our special items. And it's related to the IT investments we have done, so to develop the solution and to develop the app, and therefore we have reassessed basically the depreciation for the Halo solution, and that's what we have included in special items.

Thank you very much, guys, and looking forward to seeing many of you over the next period.