Coloplast A/S (COLOB) Earnings Call Transcript & Summary

Hi, everyone. I hope the sound is okay, and my hair is not in the way of the mic. It's great to see so many of you today here at Coloplast. So I welcome you at our premises here in Humlebaek I'm Aleksandra. I have met many of you. I'm heading up the Investor Relations team. And I'm very happy again to just welcome you at Coloplast. The plenary session will be webcasted live, which means a warm welcome to those of you joining us virtually today as well. And I'll talk a little bit about the agenda for the day and also some of the practical things that you should be aware of during the day. So the plenary session would take around 1.5 hours. And you will hear from our CEO, Kristian Villumsen; our CFO; Anders Lonning-Skovgaard; and the Founder and President of Kerecis, Fertram Sigurjonsson. After the plenary session, for those of you that are here in the premise, we will have a lunch break of around 50 minutes, which will also give you an opportunity to see our products outside at the product stands and interact more with some of the Coloplast representatives. After the lunch break, we will be divided into 4 breakout sessions. You have a name tech and that name tech has a circle with some color on it. So this really represents the breakout session that you belong to. But don't worry about that, you will have the IR team guide you to the right room. With that, I think, with breakout sessions will finish around 6:00. And after that, I really hope to see many of you for light dinner, hopefully outside in the garden if the weather permits that. With that, I hand over to Kristian.

Thank you so much, Aleksandra. And good day to all of you. It's great to see so many of you in the room, many familiar faces. And also a warm welcome to those of you who found your way to the meeting online. I'm going to kick us off today with a strategy update, and I start very deliberately with an image of one of our user, one of our users called Stina. And I do that to remind all the listeners that Coloplast is a purpose-driven company, it always has been. I'm joined in this room today by about 30 of my colleagues. And we are, I can say, fired up about the mission of helping people with intimate health care needs to live better lives and also feel very privileged that we can do that type of work and also run a strong business. Now I'm going to talk about 3 things today. I'm going to talk about where the company is right now. I'm going to provide a strategic update with a focus on the work that we're doing around innovation and M&A and I'm going to talk about the company's outlook. The message is simple and optimistic. We're off to a good start this year. We are starting to reap the rewards of the investments that we've been making in innovation and M&A. And I'm optimistic about the outlook of the company, both when it comes to growth, margin and return on invested capital. With that, let me turn to the update of where the company is right now. This first half of the year, we delivered 8% organic growth, 9% reported revenue growth and an EBIT margin of 27%. The revenue growth, if I start from the core business, Ostomy Care and Continence Care delivered high single-digit growth, both of them. Ostomy is sitting around 7%, which I am satisfied with given that we have still relatively low contribution from China and also these first 6 months have relatively low contribution from the U.S. So it reflects strong growth in both Europe and EM. We are going to deliver another strong year in Ostomy Care. On the Continence Care side, growth is sitting at 8%. We're already seeing contribution from the Luja launch. Growth is across region -- across our regions, and I'm also confident that we're going to deliver another strong year on the Continence Care business. If we look to Advanced Wound Care, we continue to outgrow the market across all regions, so off to a good start, and projecting another strong year for our Advanced Wound Care business. And for one of the new members of the family, advanced -- or sorry, Voice and Respiratory Care, our President of the Business, Carolina is here in the room with us. We're off to a great year with double-digit growth after 6 months, strong growth in both laryngectomy and tracheostomy, and I'll talk more about all the opportunities that we think that we have in that business. The integration of Atos on Coloplast infrastructure is on track. The synergy extraction is on track. And if anything, we're a little ahead of the commercial plan. On the Interventional Urology side, we've had a slower start to the year. We were up against a higher baseline from last year, but we've also seen a slowdown in the women's health segment. And we are projecting mid-single-digit growth for the year for that business. And then if you look at the reported revenue growth, there is 4% from Kerecis in that number. Kerecis is the underlying growth and the business is sitting in the mid-30s, in line with the Coloplast plan. And in the reported EBIT margin guidance of 27%, there's about 100 basis points worth of headwind from Kerecis. This is probably a good time to say a few words about the LCD that I am assuming most of you, if not all of you, have been familiar with. It's been heavily talked about over the last few weeks. I'll reiterate what I said in the conference call that we welcome the process that has been undertaken. We believe that the biologics category should be about clinically relevant products. And we also still firmly believe that even though we're not in the draft policy and the draft list of products, we will be in the final policy in the final list of products. We participated fully in the process, been present at all the hearings and Fertram will tell you more about that later. But we have confidence because the study that we're basing this on has granted us access to 47 commercial payers and more than $100 million lives with commercial payers, and we think that, that is also sufficient for government payer. We're maintaining guidance for the year, 8% reported revenue growth of 10% to 11% and an EBIT margin of 27% to 28%. I have said on an earlier occasion that this is a comeback year, so this is the second year of 8% growth, but this is the year where we are starting to reap the rewards from the investments that we've made into innovation. This is a year where we start to reap the rewards of the investment that we've made into Atos Medical on both growth and margin. This is the year where we're starting to reap rewards on the investment in Kerecis on both growth and gross margin. And this is also a year that marks a return to growth in absolute profits. So I will be talking a lot about that this is a key year where we are starting to reap the rewards of investments that we've made in both innovation and M&A. And the key word for all of this is growth, profitable growth, of course, but growth. Coloplast has always been a growth company. We're almost 70 years old, and we have grown for all that time. We were founded more than 70 -- about 70 years ago, on a nurse's idea for the world's first adhesive ostomy bag. And part of the growth equation of the company has always been innovation. It's always been innovation. And you can only understand the performance of the company over time if you take a hard look at the products and the technologies that we bring to market. But we spent the first 25 years of the company's life as a manufacturer. So a quarter of a century, we were just another manufacturer of medical devices. And back in 1983, the company was listed on the Copenhagen Stock Exchange, and we did that to raise capital to invest in building health care standards in the markets in which we operate, partner with health care professionals and that decision, that evolution of the company marked the beginning of the chronic care model. So another point I am making here is that we have, over the years, consistently evolved our company. A company cannot be a static thing, it has to evolve. It has to evolve. And so from that decision of investing in building subsidiaries and partnering with clinicians, we work with that model for another quarter of a century. A lot to do with geographical expansion, building subsidiaries around the world. Until 2008, another 25 years later, where we made a big decision to basically start to build a channel to serve the people that use the products directly. Marked the beginning of an effort to try and build what we called a consumer health care company. This is when we built the care program, our patient support program, which is now all over the world. And we have built, we believe, a unique go-to-market model for the Chronic Care business, which is also part of the strength of that business. That strategic period also marked a margin transformation of the company. As you can see here in the middle of this chart, margins went up significantly. That was driven by moving up manufacturing from Denmark to Hungary, and it was driven by the establishment of a shared services center in Poland and also a very strong backbone IT infrastructure that allows the company to grow with good scalability. We continued on that journey until about 2017, we changed our margin guidance. Some of you who have history with the company will remember that we changed the margin guidance from 50 to 100 basis points annual improvement to a margin guidance of more than 30%. And we did that to basically allow us more degrees of freedom to invest in growth opportunities in the company and to invest more in innovation. And on the back of that decision, growth accelerated in the company from 7% to 8%, and we delivered 12 consecutive quarters of 8% growth basically until we ran into a global pandemic, which brings me into the current strategic period that we call Strive25. And Strive25, in many ways, is a continuation of things that have made the company successful historically around innovation and investment in commercial initiatives, but it's also an evolution of the company because, as you know, we have made 3 significant investments on the M&A side to build future growth platforms for the portfolio. Now, we also had setbacks, and you can see the setback very clearly in the chart here that the aftermath of COVID hurt the company. It hurt the company. So the input costs went up significantly. Energy costs went up significantly. Salaries went up significantly and margin took a hit. And of course, the financial performance of the company was also affected by the acquisitions that we've made. We've taken on more debt, and there's more invested capital in the company. But even though COVID affected us, and also, you could argue, still lingers around in China and consumer sentiment, I think that things are starting to look brighter now. The pandemic is behind us. Input prices are coming down, energy prices are coming down, salary inflation is coming down, and critically, some of the things that we've been investing in for future growth on the innovation side and on the M&A side are coming in. So let me talk a bit more about Strive, and how we thought about that? We set out to grow -- outgrow the market across business areas and geographies, a strong geographical focus on U.S. and China. U.S. is a core geography for all businesses that we're in, China mostly for Wound Care and Ostomy Care. It continued a history of investing in innovation here with a strong focus on the clinical performance program that we have talked about a lot. It's finally here. And these products are coming into the world. I'll talk more about that later. But we've also continued to invest in launching -- building and launching products into existing categories, what you might call a Coloplast classic. We've also, in this period, invested in growth and margin enablers. On the operations side of the company, we have opened up 2 new factories in Costa Rica. We've made a decision to build the largest site in the company's history in the northern part of Portugal, basically to optimize the manufacturing footprint. We're also driving a large-scale procurement program to address the external spend of the company to get us back to 30% EBIT margin. We've also done a ton of work on sustainability. I'm very happy with the progress that we're making around transitioning the company to green energy and the work that we're doing to reduce waste. And we fundamentally look as the sustainability theme as much more than, if you will, a right to play. We think it has the potential to become a long-term competitive advantage and also that it has real commercial potential. And you should expect that, that enterprise team is here to stay. We also continue to invest in our people. We're a growth company. You need a growing -- you need an organization that can handle the growth. So our strong focus is running an organization with a good level of engagement and building leaders that can drive the growth also for the future. And then, of course, uniquely to this period, we've engaged in M&A with a focus on building future growth platforms, also beyond the core of Ostomy Care and Continence Care with the acquisitions of Atos Medical, Kerecis and INTIBIA. I'm going to now talk a bit more about the highlights for each of these areas with a focus on growth, innovation and M&A. If I start with growth, I already said it, the core is strong. The core is strong. And a highlight for me personally is that we have got a breakthrough on Ostomy Care in the U.S. that is at a different level today than it has ever been. A few years back, we got on 2 GPOs, the 2 largest GPOs in the U.S., Vizient and Premier, that basically leveled the competitive playing field. We invested to expand our commercial footprint, and we've been gaining share. We've been gaining share in the hospital, in the home health channel and in the community. And you'll hear more from Manu Varma later today in the session on the U.S., but a real highlight for us. Emerging markets has been a strong growth region for the company for a very long time, a consistent double-digit grower. We have a leading commercial footprint in emerging markets. We have a very strong leadership bench with experienced organizations. And I'm really happy about the work that we have there, not least the way that we found a way of managing a portfolio of growth initiatives that we continue to deliver double-digit growth in EM. And one of the reasons that we can have confidence that that's going to continue is we're still growing in Europe. Europe for Coloplast is not a cash cow. It is a growth region. And Europe is still growing, and it will continue to grow. With the products that are coming into Europe now, we will raise the standard of care yet again, we will increase the patient value yet again, and we still have more work to do when it comes to driving penetration of treatment, particularly around continence care and bowel care. Europe is also a growth region. Innovation. It's a year of launches. The company is in the midst of rolling out the largest product roadmap in our history. And of course, at the top of that list, we've got 2 products from the clinical performance program, Heylo and Luja. Luja is an intermittent catheter with a micro-hole zone technology designed to empty the bladder in on free flow. This product works. It really works. It's in 13 markets. It's incredibly well received. It's ahead of forecast, and we're now launching the female version. And you should expect to see a full portfolio of catheters with micro-hole zone technology from the company. Heylo is a different thing. It's the world's first digital leakage notification system. It's a first of its kind, and therefore, it's also a different launch. It will require more discipline, more investment into training of clinicians, more close contact with consumers that we ensure that it actually becomes a standard of care and not a niche product. It deserves to become the standard of care. We have reimbursement now in the U.K. with a commercial launch, the 1st of July. You can hear more about that in the session that we have with the U.K. where, Johan Mastrell, our GM from the U.K. is also here. We're also continuing to launch products into existing categories and the SenSura Mio and Black, wonderful looking product is a great example of how we respond to the ask-for-consumer choice. And we also continue to make products that are about market development, and Peristeen Light is a good example of continuing to evolve the bowel care franchise that we haven't talked that much about historically. It's about DKK 1 billion turnover, a consistent double-digit grower, and a category that still needs a lot of development. With Peristeen Light, patients can now get initiated earlier, and you will see more things coming from a product offering point of view also on bowel care. On M&A, we made 3 significant decisions. This is all about building growth platforms, and of course, with decision like this, we've also taken on debt. That's more invested capital in the company. And we've also negatively affected EPS. But this is about long-term growth. And Atos Medical, you should expect that this is a consistent grower of 8% to 10% year-on-year right now at the top of that range, with EBITDA margins in the mid-30s. This is growth accretive, gross margin accretive and CapEx ratio lower than core. Kerecis is also a high-growth business, 30% CAGR for the first 3 years and an EBIT margin of 20% by '25, '26, again, this is a growth accretive gross margin accretive and with a favorable CapEx profile to the core. And then INTIBIA, which is an early-stage technology product that we are excited about what marked the entry of the company to overactive bladder, the pivotal trial is on track. All the implants have been done, and we expect to launch this device in '25, '26. What this adds up to are 4 growth platforms for the company. The first 2, you could say, are both in chronic care. So chronic care and voice and respiratory care are both Chronic Care businesses with a focus on winning patient in hospital and serving them later on in community. Whereas Advanced Wound Care and Interventional Urology are more focused on the hospital setting and where the customer more frequently is a clinician, different go-to-market models. What's common across all of these 4 is that the underlying market growth is sitting around 4% to 5% when you add it all up. These are all categories that are reimbursed, and I'll remind the group that reimbursement is both an opportunity and a threat if you work in health care. Sometimes you can open up new categories, like we've done with Heylo, sometimes there's a potential reform, but all of these are reimbursed categories. And for the company, 90%, 95% of the revenue is reimbursed revenue. They are also all niches. And I'd say our company is a story of success in niches, and the success in the niches is driven by, at the very core, strong technology. So let me just talk briefly about that before I round off. So if you look at the Chronic Care business in Ostomy Care and Continence Care, there is no way to understand how the company has been able to outgrow the market for so long without understanding the technologies. So for Ostomy Care, the adhesive platform that we run with on the Mio platform is more pliable, organic, elastic and it provides a better body fit. That's why it gets chosen. It's not something that any of our competitors has. It's a key source of differentiation. The entire supporting product portfolio we have around Ostomy Care is about bespoke body fit, this real technology, at the core. For the catheters, it's the same thing. It's triple action coating technology historically, so the coating platform that we run with. And now with Luja, increasingly, it's going to be the micro-hole zone technology. There's technology at the core. So the growth outlook for the Chronic Care business for me, has never been stronger if I look at the product offering, the product offering has never been stronger, and that's more coming. So there'll be growth coming from innovation, growth coming from share gain in the U.S. and growth coming from sustained double-digit growth in EM. Voice and Respiratory care, a similar yet different story. Here, we are also a category leader. The only thing is there's no other global company in the category of laryngectomy. So we are, in effect, test with evolving the category, building standards of care, ensuring that patients get on product. And the opportunity is to get the 2/3 of the patients who do not have access to technology today or not on product and even the third that do to get them on the right technology and the right amount of products, that's the growth opportunity. And for tracheostomy, our focus is on the patients who are discharged from the hospital with a tracheostomy. Nobody else has focused on that. And so we come to that category with a different mental set of lenses than the other players in that category who sell tubes and valves into the hospital. So we wish to serve the trache patients in community. We think that they deserve to also enjoy the technology benefit that you have from heat and moisture exchanges that provide -- that have really strong pulmonary benefits. On the Advanced Wound Care side, on the dressings, it really is 3D fit, dressings that conform to the wound bed, get better exudate management and better healing. And of course, you're going to hear a lot about the Kerecis' fish skin technology today. But the impetus for the acquisition was conviction on the technology and the level of differentiation in the technology that is borne through a unique advantage given to us by biology, not something that you can go out and design and replicate. Nature has made Kerecis more advantageous, we think, or at least more differentiated than the alternatives out there. Growth is going to come from continued growth in the U.S. and of course, for Kerecis, it's the aspiration to build a category leader. For Urology, again, it's a story of segments in men's health and women's health. And the key technology for future growth is going to be in tibia. All of this gives me optimism about the outlook for the company that we have strong positions in unique niches with technologies that are differentiated. And we're confirming our long-term guidance today of 8% to 10% growth and more than 30% EBIT margin beyond '24, '25. We are making our way into the next strategic period. And I can already share now that the next strategy is going to be all about how we unfold the potential of those 4 growth platforms. We'll all be invited to come here again about a year from now after the summer holiday of '25 and we will share a lot of wonderful findings about how we intend to deliver this. And with that, I'll hand over to Anders to give a financial update. Thank you.

Okay. So hi, everybody. My name is Anders, the CFO of Coloplast. I've been in the role for about 10 years. So as Kristian said, I'll just give you a short financial update and I'll also share a little bit on some of the moving parts we see into next financial year. As Kristian said, this strategic period has been impacted by COVID. It has also been impacted by the slower momentum in China due to consumer sentiment, but we are really happy that we are now back to a growth of around 8% that we also are forecasting for this financial year. One thing we also very satisfied with is that over the period, we have actually been able to increase the prices, and that is also because we have not seen any bigger health care reforms. On the margin side, we started out really strong in this strategic period, also because we did not spend as much money at least in the early days of COVID, but since then, our margin has been impacted by high input costs. So the gross margin took a hit, especially last year of around 2 percentage points. We have included the amortization related to the acquisitions, that's around 1 percentage point. And this year, we have included Kerecis, and that is diluting our group margins with 1 percentage point as well. So we have gotten impact from both input cost and the acquisitions on our margins throughout this strategic period. We have also, in this strategy, invested quite a bit into the business. We have invested quite a bit into innovation. We are launching new products across all our business areas. So we have launched new products within urology. That's the laser scope. We have launched new products within Wound Care. And as Kristian also mentioned, this is the year of launches within our Chronic business. We've also done quite a few investments into our commercial business, especially focusing on the U.S. So if you look across our market shares in the U.S. across all our businesses, it is lower than global averages. So we have invested into more salespeople within the Chronic, more salespeople within Wound Care, and also more salespeople within our Urology. So that's probably the biggest investment we have done in -- across the commercial organization. We also continued our investments within digital and consumer to drive our direct-to-consumer agenda. And we've also done quite a few investments into markets where we have gotten reimbursement within the catheter. So over the period, we have gotten reimbursement in Australia, Japan, Korea, and most recently, Poland within the catheter business. And we have invested quite a bit into these markets to drive future growth. And we're actually already now seeing quite a bit of contribution to our Continence Care growth from these markets. And then finally, we have also done selectively investments in emerging markets, opening up new subsidiaries and also investing into existing specifically in Latin America. And then on top of these organic investments, we have done the inorganic investments and spent around DKK 25 billion in the companies and technologies that Kristian also referred to earlier. And that has had an impact on our return on invested capital. It's down to around DKK 15 billion, but we are expecting from next year, as the earnings are growing to see our return on invested capital to grow again. But all of these investments into organic and inorganic activities that is really driving growth and earnings, not only into the next strategic period, but also beyond. One of the key initiatives we are focusing on that is to integrate the new -- or the acquisitions we have made. And right now, we have a lot of focus on integrating Atos into the Coloplast infrastructure. And here, we are really utilizing our shared services in Poland specifically in our finance area. We're also utilizing our one IT infrastructure. So we have a focus on having 1 ERP, 1 business intelligence, 1 quality management solution, 1 HR, et cetera, for the company. And here we are currently including the Atos, legal entities into that platform. And that's also why we would like to simplify the way we operate and have as few legal entities across the company as possible in order to optimize and simplify especially finance, et cetera. And then we're also working hard within global operations and integrating Atos into our distribution and the supplier network and combining our warehouses. So all in all, we are on track on reaping synergies of up to DKK 100 million. If we then move in and speak a little bit to what are the key moving parts into '24, '25, I just would like to share a few things. So on the growth side first, we are expecting that the chronic business will continue at the current levels, but also fueled by the new innovation that we are bringing into market. We're also expecting that our Advanced Wound Care business will continue to outgrow the market. And next year, Kerecis will also be part of the organic growth. And here, we expect Kerecis to contribute with around 1 percentage point. And this is, of course, under the assumption that we are going to be part of the final LCD policy when that is going to be announced. Innovation, as I said, it will contribute to Chronic, but it will also contribute to the other businesses as we have launched quite a lot of things over the last couple of years. I'm also assuming positive price under the assumption that we are not seeing any bigger health care reforms. I'm not expecting as much price -- positive price impact next year as the last couple of years, but I'm still assuming some price impact. And again, under the assumption, we are not having any health care reforms. I am, however, saying that long term, I am still expecting some health care reforms, so therefore, I'm also keeping this long-term health reform impact of up to minus 1%, but I just don't know when and where. Where we have challenges and they will probably also continue into next year, that's our urology business, specifically within women's health. Our women's health business is, as we have talked about after our Q2 release, impacted by competitive pressure, and we are not seeing that to improve at least not the short term. And then in China, we are still expecting challenges within our consumer business in China. But overall, we are actually also optimistic that into next year, we'll outgrow the market and take market shares across our businesses. We're also becoming more optimistic on the margin side. Input costs are coming down. This year, I'm expecting our raw material prices to increase something around mid-single digit, but we are seeing it coming down throughout the year. And I'm also expecting that the pressure into next year will be at a lower level. Electricity prices are also coming down. And when I was standing here 2 years ago, it almost hit the all-time high in Hungary. And now we're looking at electricity prices something around below EUR 100 per megawatt hour. So that is a significantly lower level also versus what we have hedged at this year. Freight cost, I'm also expecting some tailwind into next year. However, there is still some uncertainties also due to the whole Red Sea situation. And we're also expecting contribution from our Global Operations Plan 6 specifically on procurement. And then we will continue to be very prudent on cost across the organization and make sure that our costs will increase at a lower level than the top line growth also to secure scalability. Kerecis, I'm expecting that to continue to dilute something around 100 basis points. Wage inflation in Hungary is also something we have a lot of focus on. I am or we are becoming more optimistic that the level of regulation in '25 will be at a lower level than we have done this year. This year, we regulated the salaries in Hungary with around 10%. And then we will continue to ramp up in Costa Rica as well. But overall, we are optimistic both on the growth side, but also on the margin side when we move into next financial year. And speaking to some of the other key financial metrics. On the tax rate, we are confirming to sit around 23% into next year after we had some tailwind after we have integrated Atos. I'm also confirming a CapEx ratio in the level of 5% to sales. The way we're allocating CapEx, it's around 3% to new sites, automization within manufacturing and also investments into machines to produce existing products. Then we are allocating 1% to 1.5% into innovation, and then the rest sent to sustainability, digital and other things. Then we have the net working capital. That's one of the ratios. I'm not super satisfied with. We have seen an increase in our net working capital over the last couple of years, primarily due to higher inventories, but also some increases in accounts receivable in some of our geographies. So it is a key focus of us to reduce it down to around 25% this year and down to the 24% level in the next financial year so we will be back at the old levels. So all in all, we expect to deliver on the debt ratio of below 2x EBITDA into the coming financial year. And as Kristian said, we are confirming the long-term guidance, so organic growth in the level of 8% to 10% and come back to the 30% EBIT margin level beyond '25, '26. And finally, we're also confirming our cash return policy. So we will continue to pay out dividends, and we will also continue to do share buybacks. So we are also confirming that today. With that, I will hand over to Fertram, who will speak to Kerecis.

Thanks, Anders. So hello, everyone. So my name is Fertram Sigurjonsson. I'm the founder of Kerecis, and I'm going to tell you all about our fiscal and our business growth. So I'm an entrepreneur and inventor. So I've invented several products during my lifetime. I started my career in a company called Ossur, a prosthetic company. And there I became aware of that most of the Ossur's customers, the prosthetic users, they have been amputated. So basically, they have been amputated because of chronic wounds, because of failed wound healing. And there are a lot of people all around the world that get amputated every year, more than 150,000 in the U.S., probably around 500,000 all around the world. And becoming amputated is really bad news for people. The live expectancy of people that have been amputated is similar as having colon cancer. So I've been really interested in wound care ever since I started with my career in Medtech 25 years ago. So I have developed a commercialized several products in my carrier as employee in other companies. And at -- in 2007, we had the opportunity to actually start Kerecis. And at that time point, there were several new companies emerging in the wound care industry. There was a component of commercializing product from pig tissue. There was another company that was commercializing products made from human placenta actually from fetal sac, for women that give birth. They convert the fetal sac into a wound care product. And these products really start to take off. And they really created the biologics segment of the wound care industry. And now I'm from Iceland. Iceland is surrounded by the ocean. It's a lot of small fishing villages all around the coast. And actually, my routes are in 1 of these fishing villages, called Isafjordur in Northwest Iceland. It's 20 miles south of Arctic Circle, and it depends on fishing and fisheries. And when I was a young man, and I was in college studying chemistry and later engineering, actually I had some jobs in the fishing industry. So I did handle fish and fish skin. And then 10 years fast forward, when these companies were emerging in the U.S., establishing the biologics segment, I became interested in what coming with fish. I started looking at fish scales, but then I actually found out that the anatomy of fish skin and human skin is identical. And I'll talk a little bit about that later. But that was actually a very big moment. And then in 2007, the company started to take off. In 2010, it became formal. We got our first investment. We spent the first years actually doing clinical trials and getting through regulatory approvals. We didn't need to do -- we did need to do a human clinical trial, and we filed that at the FDA and the product got approved in 2014. In 2015, we spent getting a reimbursement product Medicare in the U.S. And 2016, we started selling the product with 1 person in the U.S. And the rest is really history. So now we are by far, the fastest-growing biologic company in the U.S. We are #5. There is no other company that is growing as fast as we are. We expect to climbed to the fourth seat next year. At the end of last year, or actually in September, Coloplast did acquire Kerecis. And in a way, that is a great news for Kerecis. It brings a great opportunity for us to make our platform global. And I will talk about that in more details later why that's such a great news, and why I'm so excited personally about that. But this is the product here. So this is basically fish skin that has been decellularized, and it's a byproduct from the food industry. So the fish skin test, they used to just be disposed of. This is similar to human skin. It has the same thickness and [indiscernible]. It used to be just thrown away, and actually, we make a valuable medical product of it. It can be sutured in place, it can be stapples in place or it can be left under wound dressing, elastic and flexible and allows for cellular ingrowth. But I'll talk more about the technology in a moment. So the market that we operate in, we do operate in that, first wound care market, which is DKK 54 million to DKK 56 billion market. And we are in the biologic segment of it, which is a 6% to 8% growing -- growth market, and it's DKK 5 billion to DKK 16 billion in size. It is mostly a U.S.-based market. It's almost exclusively in the U.S. That's where the biologics segment got created, and that's where the stronghold is still. We are competing market with several existing technologies. The products I mentioned before, the allografts made from human tissue, that's the human placenta and the fetal sacs, and then xenografts graph from pigs and cattle. And then we have created a new product group there with the fish skin. There is no other fish skin product in the market. It is clinically differentiated. There are some technological advantages that allow us to only use gentle processing that we change the structure of the fish skin. We are very mission-oriented. We have treated more than 40,000 patients with the product in the past years. We have more than 500 employees currently, much of them are in the U.S. We possess very strong IP. So there's no other company in the world that can make a product from intact fish skin currently. We also have strong R&D ongoing and we are working on generation 2 of the fish skin, generation 3. These new generations, they will bring overall -- bring about new patent protection, additional 20 years of patent protection. And I'll come a little bit into that strategy a little bit later. We have abundant supply. So fish has been caught in all parts around Iceland all year round. And currently, we're using less than 1% of all the fish skins that are available in Iceland. The logistic is simple. The product can be stored at room temperature for up to 3 years and it is sustainable. So all the fish skin stocks in Iceland. They are sustainably certified. So we have a quota system. Every year, there are scientists that decide how much fish can be caught and the quota goes up every year. And it is a byproduct for the circular economy product, the fish skin is used to be disposed of, but we take it and we convert it to a valuable medical product. So about our growth, we sold for DKK 772 million last year. And at the end of the first half of this year, we had sold for DKK 461 million. So this is a high-margin, low-volume product. We're only talking about tens of thousands of devices. This is not a high-volume business like a lot of the rest of the Coloplast business. Our EBIT margin this year, we're about -- this half year, we're about 10%, up from 6% last year and at a breakeven a year before. The business is mostly a U.S. business. So most of our revenue comes from the U.S. And we delevered from 2 main care settings, outpatient and inpatient. About 70% of revenue is inpatient and about 30% is outpatient, 20% is paid per Medicare and 10% is paid by commercial insurers. We operate 2 separate sales forces, one sales force for the inpatient and another sales force for the inpatient. And there, we have built a differentiated portfolio of products that we continue to grow steadily. So what's so special with the fish skin. So why is fish skin is so important? Why is this the best solution in the biologics market today? It is amazingly similar to human skin. It is actually identical. It has an epidermis, dermis, subcutaneous tissue. It has the same 3-dimensional structure as a human skin, same thickness, mechanical properties, same porosity and the same cell size. Also, the important thing here is that we derive the face from the cold waters of Iceland. The water is very cold, 0 to 2 degrees cold, and the fish lives in those circumstances. And there are viruses in fish like any other animals, but the viruses in the caught fish, they are designed to live at 0 to 2 degree Celsius. Our viruses in the human, they are designed for 37 degrees. So there is no risk of viral disease transfer risk from fish to humans. That allows us to process the fish skin gently. We don't use any house chemicals and we don't use any alcohol or detergents, and that allows us to preserve the similarity of the natural organization of the fish skin. The mechanical properties, the chemical composition, the molecular content, the protein, the elastin, the glycans, the soluble collagens, the insulouble collagens and most importantly, probably the fats. If however, our starting material would be pig tissue, viruses can jump from humans. So the regulatory authorities, they are very concerned about elicitation of diseases between species. So if our starting material would not be cold for a fish, but pig or pulp, then we would need to blast it with strong chemicals to make sure there wouldn't be any viruses in the product. I mean into that, you dissolve lot of the tissue, you dissolve the fats, you dissolve the lipids, you dissolve the glycans and you reduce and you change the chemical composition of the material. So actually, the heavily processed pigskin will be much more dissimilar than the human skin. But because of the gentle processing of the fish skin, we retain all the indigenous element of the fish skin, which makes it very similar to the human skin. And that has a very important role, and I'll come to that in a moment and I start talking about the clinical efficacy. So basically, we go down to the fish factory. It's a few hundred meters from our factory. We go and pick of a few thousand skins in the morning. We put it into our first clean room where we remove the scales and the mucus, then the material goes into the next clean room, then we remove the fish cells without destroying the material. So this is still just fish skin, but we have removed on the fish cells. And everywhere where the fish cells used to be, there are these small holes. So all these holes you see on the pictures, they used to be occupied by a cluster of fish cells, but we removed the fish cells. And then we package the product, we sterilize it. and it's sent to our warehouse in the U.S. and where it gets into the hands of the doctor. So there the doctor has a knife. He debrides the wound. So all wound care starts by debriding the wound. So the doctor cuts away all the dead tissue and it makes the wound red and bleeding, then it takes the fish skin, post the fish skin into the bleeding wound and post a cover dressing on top. Of course, we prefer the biotin wound dressing from Coloplast, but many other dressings can actually be used. And what happens then is that the cells -- the healthy cells from the wound perimeter, they will grow into the fish skin, and they will start to occupy these holes and build a new tissue, new human tissue. And over time, the fish skin will be converted to human tissue. So you will never remove the fish skin. It's left there in place permanently and the wound boundary and the wound bottom elevates 1 or 2 millimeters. But I'm going to show you one case here, clinical case. And Aleksandra told me to go very gently of you -- on you and show you not too much of a big wound, but wounds are bad. So there is a little bit of blood. But this wound care, this is a woman suffering from melanoma. So this would be more of the smaller wounds that we treat. Much of our wounds actually, by majority of wounds, it will be much bigger. And if you want to see those wounds, they're actually on the screen here in the break. These will be wounds with exposed bone, [indiscernible] flash. So this is a relatively small wound in the chin of this lady. So this lady has had the melanoma in her chin and the melanoma has been removed. But to make sure that there are no cancer cells, the wound has been made that bigger to make sure there are absolutely no cancer cells in the surrounding area of the melanoma. And about 70 -- 60% of our wounds are actually surgical wounds like this, either in the outpatient setting or the inpatient setting. So what the doctor has then done is that he actually -- has actually removed the skin here from the scalp and he actually has taken the flap and moved the flap into the wound. But then there is a new wound that is exposed here next to the hairline. And here, the doctor has 2 options. He can take skin from the shoulder or the hip and transfer it and put into the wound. The disadvantages of that is that the wound on her shoulder is much thicker than the face, so you would see it permanently always when you talk to this later, you would always see the different skin type in her face. But the alternative is to use a biologic. In this case, the doctor has chosen to use the fish skin. So because the fish skin in place, he lays it into view -- wound. He sutures it in place, then he puts the wound dressing on top of it. And on the fourth picture, you can actually see this -- how the granulation is coming through the fish skin. So the red dot that you can see, they are actually clusters of new cells that are growing into the fish skin and they've started to lay a new tissue. Then on the last picture, you can see the wound healed. There is a bit of a scar at the connecting edges between the wound, but that scar will be reduced over time. And the lady can also go to laser smoothening to get extra smoothened. And over time, it's gone to be rarely visible. So this is an example of how the fish skin is used. So I mentioned that it was important not to use harsh chemical processing and to retain the indigenous element of the fish skin, the lead pits that last in the glycans. And it is important because it creates very good clinical outcomes. And we have documented that in a body of our 40 clinical trials. Some of those clinical trials were created for regulatory purposes to make sure the FDA would approve the product. Other trials we do for market entry purposes to convince insurance companies to use our product, where we normally compare the fish skin other existing products on the market, standard of care products. And then the third type of trials are trials that are very comparing with other biologics. So where we're actually convincing the doctors to change to our product. Now, I would like to draw your attention to 2 studies there, the Study #2, which is the last study from 2023. So it's a 102-patient study that we did for market access purposes. Half of the patients are treated with fish skin and half are treated with another product, standard of care. And we had great outcomes of that, which will come into a little bit later. Then we are actually in the publication process of another study done by Dr. Dardari and team, and that's a 255-patient study. We're also comparing the fish skin against dental care in several European countries. And that's going to be a fundamental study for Kerecis. And it's actually both a market entry study, is also actually a convincing study for doctors to switch to our product because it covers very deep wounds. It covers wounds that touch bone and tendon, whereas normally studies in this industry, they are done on more shallower ones. But I'll come a little bit to that later. But the conclusion of all this body of evidence is that the treatment of fish skin results in reduction of treatment times, reduction in treatment costs and an improvement as to the outcomes that you could see in the picture before. But let's talk about the LCD policy and -- that Kristian touched upon. So all market access in the U.S. is depend on 3 fundaments: So it's about quoting, coverage and payment. And what we're talking about here is the coverage portion about what products are covered. What products will eventually be paid? And there are 2 types of coverage decisions. There are coverage decisions from Medicare. All Americans that are over age of 65, they are insured by Medicare or these are coverage decisions for private insurers. That will be for people that are under 65 and would have needed to get their own insurance. And remember again, about 20% of revenue is covered by Medicare and 10% of revenue is covered by private insurance. And let's dive into the LCD that was published -- the draft LCD that was published now in April. So the draft LCD introduces technical and clinical qualificator. The technical qualificator is easy. Our product fits directly into the technical qualificator. And the clinical qualificator establishes some requirements and clinical evidence. So the products that are to be covered, they need to be supported. They ran too much control study. And I think that's just great. Of course, products that cost thousands of dollars. Of course, they should be substantiated with clinical evidence run too much control studies. This is taxpayer money that goes into Medicare. And Medical should not be paying expensive products that don't have any clinical evidence behind them. So the tough policy has a list over all products that have been covered in the past. So there is one column with a list of products. And there's another column that contains the clinical evidence supporting these products. Then there is a third column where the personal wrote that chapter of the LCD, talks about if the clinical evidence is sufficient for the product to be paid or to be covered. And our product is indeed in the list, and there is clinical data in the second column. But the key thing there is that our Lantis 2023 study that I mentioned before is missing. And so the conclusion of the person that wrote the LCD is that we don't have enough clinical data to be covered. But why is our clinical evidence, why is the Lantis study not in the list? The reason behind that is actually very simple. The Lantis study had not been published when the person wrote this chapter. And that's why we had a commenting period. So when the Medicare contractors published this draft policy in April, they also announced a commenting period that ends tomorrow on Saturday on June 8. And during this commenting period, companies can submit additional data. And so what have we done during the commenting period? So we have performed the -- we have an external review contracted in all the clinical evidence. So we've got a consulting company to review all the clinical evidence in the draft policy and compared it to the Lantis 2023 study. And the outcome of that is favorable. The consultants concluded that we should be covered and that actually our clinical evidence is of higher quality than most of the products that are allowed under the policy. We did participate in all the public hearings and we talked about the clinical data there. And of course, we have submitted the clinical data to the medical contractors, including the Lantis 2023 study. Also, more than 100 of our customers, they have published the letters to the medical contractors requesting the product to be covered. And we've also engaged with the affiliations and industry organizations such as ADVAMED and the Wound Care Alliance and other organizations. Again, let's take a quick look at the Lantis study. It's 102 patients, half treated with fish skin and half treated with advanced wound care products. After 12 weeks, more than 80 -- there was 80% more wounds that have been closed with the fish skin and with standard of care product, 80% more wounds closed. And then the mean percentage wound area reduction at 12 weeks was 35% more the Kerecis product. So this is a substantial difference. It's, of course, very statistical significant. The p-value was 0.0163, and then 0.02, so it's far below the 0.1 requirement. So we have robust clinical data. And that's why I believe sincerely that we will be put on the policy as a covered product. I'm absolutely personally sure about that personally. So -- but let's continue to talk about the reimbursement because, obviously, it is a very important thing. So 70% of our sales are to the hospitals. And there is no product coverage there. There is quoting. The hospital will quote the disease of the patient, that is sent to the insurance company, could be medical or a proud insurance company. And then the hospital gets a bulk of money back. And the hospital, that's what they want to do with this one, they pay, rent, electricity, salaries for doctors, drugs, medical devices, biologics. They can do whatever they want with the money. So there is no reimbursement risk or reimbursement with Medicare or private insurers has nothing to do with Kerecis in the outpatient setting, which is about 70% of our sales. But let's then take a look at the other 30%. So there, we have a physician's office. That's about 20% of sales goes there. And to the hospital outpatient department, about 10% of our sales goes there. We talked about the LCD draft. The LCD draft covered 20% sales. But then let's -- and the LCD draft actually covers the Medicare portion, which is 20%. So it's a confidence that the physician offers 20% of revenue and that our medicare payment is 20% also. These are 2 totally separate matters. So 20% of our business in the physician office, 10% of our business is in the hospital outpatient departments, and 20% of our revenues is Medicare in these 2 segments and 10% is private insured of these 2 segments. And we have taken the Lantis study through the powered insurers that represent 10% of our revenue. And we have shown in the Lantis study. And 47 commercial insurers, they've actually accepted our data. We think the Lantis study is good enough to put our product on the list of covered products. And these 47 insurance companies, they represent 115 million American lives. So companies that insure 150 million Americans have accepted the Lantis 2023 study, and they are covering our product and they are paying for it. And these insurance companies are the most impactful and biggest insurance companies in the U.S. Companies like CareFirst, Anthem, Blue Cross Blue Shield, North Carolina Empire, Blue Cross South Carolina, Florida Blue and many others. They all thought that the Lantis study was good enough for them, and their 115 million patients. And of course, Medicare normally has a lower barrier than the commercial payer is going to accept those studies. But enough set on insurance, let's talk about strategy. So the Kerecis' short-term strategy has 3 main pillars. So it's about continuing to build our product portfolio. It's about building our national footprint, and it's about our digital offerings. And we have several digital offerings that we're offering to our customers. One of the offering is a portal where we help the private offices to find out if our product is paid or not. So basically, it's a portal with the type in data about the patient and the insurance of the patient, and then our system predicts if the product will be paid or not. So the alternative to do that is to actually send information to Medicare and interact with Medicare contractor. It takes several weeks, but in our software offering, you type an information about the patient and the system answers immediately that the patient is covered and not covered. And how do we do that? So we have thousands of data points on insurance for our customers. So we've interacted thousands of times and overseen this process thousands of times with the insurance companies. So we've built a big database of insurance information on how people are insured and how the insurance company reacts to that. That could be a private insurers like Blue-Cross or it could be medical contractor. So we have thousands of such data points in our systems. So we've implemented the artificial intelligence engines that evaluates our data and predicts if the insurance company is going to say yes or no or maybe. So instead of calling the insurance company, faxing data to the insurance company interacting with them over weeks, we can answer immediately, it's covered, not covered or maybe. And this is accelerating the private offices revenue cycle. This is providing care to the patient earlier. This is also accelerating the care-assisted revenue cycle. And also, this is connecting our IT systems into the IT systems, the business processes of the private offices, which represent again about 20% of our revenue. And so this is a very important thing for us. It is creating competitive advantage for us in the market space. It's creating differentiation, and we've filed several patents to protect this way of business processing. And none of our competitors is offering any services like that. But let's continue here and talk about our products. So when we started selling, we only had 1 product called Kerecis Omega 3. Then in 2021, we started differentiating the product for different care settings. We created specific brand names for the outpatient, the inpatient and special colors and special prices. So all of these brands, they have special prices. They have special reimbursement. They have an education material for our salespeople, their special education material for the doctors, the special webinars and a special marketing plan behind it. And we have 2 brands for the outpatient, so it's MariGen, which is for the hospital outpatient offices, and then the Shield for the physicians' offices. Then we also got GraftGuide, which is for the burn centers in the hospitals, the inpatient hospitals. Then we have SurgiClose and SurgiBind for the inpatient operating room segment. And this is run through our differentiated sales force. We have a dedicated sales force for outpatient and a separate sales force for inpatient. And our short-term strategy is built around continuing to differentiate our program. The small modifications of our product offering, particulars in the product. We are developing a new product where we put the particular material in considering and applied into tunnel tons and so on. And all our short-term plans with new products, they don't have any FDA risk. There is no need for new reimbursement codes, and there is no need for new FDA approval. Or if there is need for FDA approvals, these are very simple FDA approvals that are needed. And the Coloplast business case relating to Kerecis is all billed on this short-term process. So there is no FDA risk in the Coloplast business plan for Kerecis. There is no need for new reimbursement coverage for Kerecis business to meet the plants that Coloplast has announced on Kerecis. But let's talk about the mid- and long-term plans. So there, we have new platforms that we are developing. We are developing generation 2 of the fish skin that will come with new patent protection. Generation 3 of the fish skin that will have 20 more years of protection, all with new benefits for the patient, the new benefits and ease of use for the physician. And you will see these new products emerge over the next 5 or 10 years. Then we're also working on new indications that might need development or establishment of new markets and new sales teams. But those are mid- to long-term opportunities, and these are not included in the current Kerecis Coloplast business case. Let's talk about the commercial expansion. So our growth has been fueled by differentiating the product line and by establishing sales and hiring more salespeople. We started selling around the Watson DC area in 2016 with 1 person. Then we actually moved north to New York and Boston, then we moved down to Florida. And then 4 years ago, we started selling in Texas and a couple of years ago, we started selling on the West Coast in California, and up to Seattle. And this year, we are actually onboarding more than 30 -- we actually grow more sales force in more than 30%, with growing cells is actually very complicated task. And what we have actually identified now in the past months is that the productivity of our sales force has gone down a bit. And the productivity of the sales force has gone down because the new people that we hire are not as productive as the new people we hired several years ago and we've implemented several strategies to offset that and make sure that the sales team becomes productive as it was several years ago. And to establish new sales on the East Coast, where we have denser network of salespeople, that's about establish new sales territories, splitting sales territories establishing new areas and so on. On the west, it's more about the fund going into the hospital for the first time, introducing the product for the first time and really introducing Kerecis and the fish skin to the market. And when you're running a sales team of several hundred people, these things become very complicated. They become challenging. There're also a lot of fun, but you need totally different methods when you have salespeople -- when you have hundred of salespeople rather than a closed net team of 10 or 20 people. So the strategy that we've implemented that relate to hiring the right people and provide a more thorough clinical training. So when people are talking to the doctor, they are actually talking the right talk track. We also have a sales playbook where we teach the sales steps that people need to go through, and we have been optimizing the nurse curing and education on the sales playbook in the past months. We also have established a new department in the company where we have centralized the approval process. So when we are selling to a new hospital, it's about penetrating and actually going through, this was value analysis coming to the hospital. So there we need to submit clinical data about efficacy and profitability. Remember also that all the hospitals or most of the hospitals in U.S., they are for profit. So the product need to be profitable for them and it also needs to be efficacious. And the purpose of the value analysis commented to the hospital is to make sure that the product is both efficacious and profitable for the hospital. And when you have a lot of new people with new regional directors with new medical affairs people, this becomes a little bit of a complicated task, and that's why we have seen a little bit of slowdown in the efficacy of our sales force. And we have implemented a new centralized approval support function where we're actually supporting the steps that the salespeople need to take on these new accounts. We also have a lot of new -- a lot of accounts around the U.S. where we don't have a lot of sales in. We might have a hospital where only 2 or 3 sales -- 2 or 3 doctors are using our product. The other doctors are not using our product. So we've established [indiscernible] account sales team that works with the salespeople in the hospital to make sure that we are expanding horizontally within the hospital. And of course, that is a much cheaper thing to do rather than to chase new customers, onboard new customers. So we want to expand within these hospitals that we're already in. And we have some great success in doing that. We have several hospitals that are buying for millions of dollars annually. But we also have, as I said, big hospitals are not buying much, and that's why we implemented this enterprise account function. And again, building the national footprint. This is all what the Kerecis, Coloplast business case is about. So the business case that I discussed here, that Kristian and Anders have been talking about, is all about building the U.S. national footprint. But there is another business case here also, which is more the long term. And for me, as the inventor of the fish skin platform that's being made in my hometown in Isafjordur, it's extremely interesting. And that's the opportunity to take the fish skin and make it not only a global category leader in the U.S., but making it a true category leader globally to take the fish skin from Isafjordur and sell it around the world. And Coloplast has divisions and sales team all around the world to sell into more than 100 markets all around the world. And over the next 10 or 20 years, we have the opportunity to [ enter into ] these sales forces. And take the fish skin into these markets, open up new markets is quite complicated. You need to get reimbursement, you need to get the clinical adoption, you need to teach the doctors actually there's a new product category for them to use. But Coloplast has a perfect infrastructure to do that in markets all around the world. And this is really exciting. And it excites me as an inventor that my platform that has this great success in the U.S., that, that success could act be replicated to all around the world. And this is one that really drives me and makes me very excited. But -- so now I'm getting to the close of my presentation. So this is my second last slide here. And I wanted to talk briefly about the combination of our low-risk production process and the minimal processing. And that when you put these two things together, you get a very attractive financial profile. So our gross margin is more than 90%, the CapEx requirements are less than 3%. We have ample product capacity -- production capacity. We have abundant supply of raw materials. Fish skins are thrown away everywhere in Iceland. But we take them and we convert them into this valuable medical product. The material has a 3-year shelf life at room temperature. And we have 100% quality consistency. And we've never had an adverse reaction on our product, never. And imagine that having a 90% gross margin product, imagine the margin that we have to build up sales and marketing, to conduct new clinical trials, to develop new products; there is no other company in the market that has those kinds of margins. And also, should there be some kind of reforms and lowering of reimbursement, we are by far the best equipped company to react to any threats in the marketplace. There's no other company that has any margins close to our margins in this business that we are competing with now. So this is my last slide here. So Kerecis is uniquely positioned to support Coloplast's long-term value creation. So we are building to become a category leader. So we are #5 in the U.S. market space today. We are growing the fastest. We will be #4 next year. There is nobody else that is growing as fast as we are. We will become the category leader in the U.S. in the short term; in the next decades, the category leader globally. We have a clinically differentiated technology. People are buying our products all around the U.S. in the world's most competitive health care market. It's working, people are buying it. The commercial sales force expansion, we have a validated sales playbook. We have very good strategy in place to secure continued growth. We have top-tier gross margins. As I mentioned before, there is no other company that has [ end ] margin similar to us. No other company has as much money to use in sales and marketing, on clinical development, clinical trials, product development and to react to any reimbursement changes, no one. And then we have the mid- and long-term opportunities, as I mentioned before, the opportunity to take the fish skins and make it not only a category leader in the U.S., which we will do in the short term, but take the fish skins from Iceland, from my home town, and make it a true category leader, the standard of care all around the world for all people at threat of amputation and might lose their limbs. And when you put all this together, you can see a very strong financial performance and long-term value creation potential for the business. And our compounded annual growth rate estimate for the next 3 years is 30% or higher. And we expect that we will reach EBIT margin of 20% in financial year 2026. But I started here talking about the patient. So when I realized that people are amputated all around the world every day, that they lose their limbs, wound care isn't working, so the doctor resorts to chopping off the person's limb and making the person amputee because of the wound care did not work. We also have burn injuries, blast injuries, we have cancer, surgical dehiscence, all sorts of surgical problems. And we are really having an impact on this. We have the clinical evidence about that impact, and we have increased clinical adoption on our product in the U.S. But let's hear a patient talk about this, let's hear a patient story. So this gentleman is suffering from melanoma, just like the lady we saw on the picture. And let's see how the fish skins helped him, and let's hear how the fish skins have healed his wounds. [Presentation]

Good. Thank you, everyone. Thank you for the presentations. Now we'll go into the Q&A session. And I hope you're fine if we actually go 5 minutes above time. So the launch will start a little bit later. I'm sure there will be a lot of interest here in the room. So if you have a question, please raise your hand. Good. But I think you can start here, and then we'll just go throughout the room.

Veronika Dubajova from Citi. I have three questions on Kerecis. I hope that's okay. Sorry, Kristian, Anders, but we're -- you're going to be popular man today. The first thing I'd like to understand is your sort of statement and confidence that the only reason Lantis wasn't considered is the timing. Obviously, if you read through the draft LCD, the interim readout from the Lantis study was actually considered. So I'm kind of trying to understand your -- what you think the final study adds versus what the interim contained? And why you think looking at the final study will change the outcome if the interim was considered? And if you can comment around that around the 6 versus 4 applications that the LCD preferred versus the 5.9 in Lantis, that would be helpful. So that was my sort of first question. My second question is on the surgical side of things, really impressive video today, but just trying to understand how much clinical data and evidence you have there and how confident and comfortable you are with your positioning competitively in that segment. And then a longer-term question on the market. It obviously seems that there is a growing degree of scrutiny from the payers in the U.S. around use of skin substitutes. This is a category that hasn't really existed outside of the U.S. because of that data or lack of data. Just kind of how you're thinking about that sustainability of that high single-digit growth rate, not inpatient or outpatient, but just longer term for the category as a whole?

This is more of a memory test than a [ question ], but I mean it's easy -- the first question is easy to answer. So basically, the difference between -- so the interim study was much fewer patients. So basically, it means that the p value is not as good and the statistical difference is not as good as it is. And so that's easy. So we did 3 publications, first, second and third, the final because we wanted to have more data for the insurers. Some of the insurers, they actually accepted the second publication. So one of the Blue Crosses, for example, accepted second publication, so basically a number of patients. On your second question on the surgical data...

Hang on. A number of applications also.

Yes, exactly, number of applications. That's a good one. So when you start to use the Kerecis fish skin or any other product, you got some -- the healing process starts. Sometimes, it doesn't start. And then you can put a second one and third one and the fourth one. And there has been a problem in the industry that people are just putting on more and more and more skin substitutes and nothing happens. And it's a very good proposal actually in the LCD to limit it with 4 applications. So basically, you need to monitor the wound closure rate. So if there is nothing happening after 4 applications, you won't get more paid. But if you can document that the wound is actually closing, it didn't fully close after 4 applications, and you can document medical necessity for the fifth and sixth, you will be able under the new policy to actually show that they wound closed so much, so much so much, therefore, I need to get paid for the fifth and sixth. So I think that's just a good and prudent policy. It will be better if it would be limited to 6. But I think for protecting taxpayers money and [ protection ] issues, this is just a good rule. So in terms of the clinical study in the draft policy, so many of the studies that are actually sufficiently -- accepted as being sufficiently good for clinical documentation, they actually have more than 4 applications. So the LCD has no language or any requirements on that we needed to have a clinical trial that shows complete closure within 4 applications. And if that would have been the case, they would have listed our study there, they would have written out explicitly. They did read the [ Lantis ] 2023 study. It has a, what was it, 5.6 applications, and that's enough, and therefore, we're not including it. There was no such language. They just simply wrote the LCD before we published the third application. What was the third question?

Long-term growth in the market.

Exactly. So that's a great question. And I'm actually so excited about this new LCD because it put this clinical requirement on all the industry, and there are so many small companies that have been popping off without any clinical data. And there was this analysis company, I don't know if you heard about it, called Washington Analysis. So that company has nothing to do with Kerecis. We have not paid any studies there. But they specialize in analyzing government decisions and the impact of government decision on commercial companies. And they actually did analyze the new LCD, and they actually think that the Kerecis' market share is going to grow up to 22% because of this new LCD. And they also predict how the market will shrink, but I don't agree with that. We have salespeople all around the U.S. The companies that have products that are on the approved list, they also have salespeople all around the U.S. Companies that have -- hospitals have been using products [ that have ] been discontinued, they are just going to be so quickly visited by a salesperson by Kerecis, [ and bet ] on that, or one of our competitors and offered to use Kerecis. And so I don't believe that the market will shrink. And there is no language in the LCD on any [ caps ] or anything like that. Actually, you would need special laws on that and -- by the Congress. So I'm very positive on the continued growth of this segment.

Did that cover all of it?

And there was some question also on surgical, yes, exactly. I mean probably 1/3 of the data showed here is related to surgical operations. We have that on melanomas, we've that on Achilles' heel [ tendons ]. And so we have a -- it's not -- so we've been doing this for a shorter time. So the company started in the diabetic ones, then it moved to burns, [ collaborated with U.S. ] Department of Defense. And then in the past years in surgical. So we have a more [ emerging ] pool of data there.

Should we continue here with Hassan?

Hassan from Barclays. I also have three. A couple for you, Fertram. Firstly, on Biologics, are you seeing or do you expect any channel destocking or sales force turnover in line with some of your competitor commentary? And how we should think about timing around implementation? And then secondly, longer term, you have a pipeline of products in hernia repair, breast reconstruction. Can you talk about your thoughts on the market opportunity and potential timelines here? And then thirdly, for Anders, following up on your commentary around next year, can you expand on the levers that you have to pull to potentially achieve that 8% to 10% medium-term growth ambition next year and specifically, the expectations from new launches in growth terms, given China is still running at probably half the trend level, there should be some annualization in headwind -- of the headwinds from Women's Health and of course, now some potential uncertainty around Kerecis?

Okay. So your question on destocking and sales force turnover, I guess that would be in the situation that we would not be put on the policy. If we were not -- so very unlikely, extremely unlikely, unlikely, unlikely, unlikely event that we won't be put on the coverage -- list of products in the policy; we have a lot of opportunities. For example, in the dermatology clinic, so the people you saw here with skin cancer, they are not being treated in an LCD setting. So I would move from salespeople to penetrate the melanoma and the [ mole ] surgery operations in the dermatology [ chain better ]. I would probably also move some people over to my inpatient hospital team, into the [ operating room ] sales team or the burn sales team.

I think the question, Fertram, is also whether you're seeing any of this now.

No. No. Okay. Second question on the pipeline. So obviously, now we are part of Coloplast. And Coloplast has a very thorough strategy on its growth for the future. We are very focused now on building the national footprint in the U.S. So the success of this business case will be made in the U.S., where we are growing fast, we have a unique product, we are on the market, there is no FDA risk, there is no actual reimbursement risk either for the bulk of our business. And the Coloplast business case will be made with current products on current markets. Then we have the global opportunity to bring the product into other countries where Coloplast has a strong presence. Then we have the pipeline of products. So I can't really talk now about prioritization of where we launch our next products and in what therapeutic segments. It's a complicated decision. Would we go into a segment where we need to build up our new sales force? Would we partner with someone? And how do we do it? And we are not ready really to answer questions like that now.

For now, you should just think of it, Hassan, as there's optionality with the technology.

Exactly.

Yes. And let me take the third one, Hassan, you asked about the moving parts into next year. I already think I covered that in the presentation, but we expect our Chronic business to basically continue the current momentum, and we see good growth across Europe, emerging markets ex China. We see good growth also coming out of the U.S. And that is further fueled by innovation. And we're not disclosing specifically how much we expect from innovation, but we are expecting that innovation will contribute more next year than this year. We continue to see good growth within our Wound Care business and certainly above the market. We talked to Atos. Atos is sitting in the higher end of the 8% to 10% ambition. We also expect that to continue. And where we are seeing challenges currently, that is Urology. Women's Health, we have talked a lot about that also throughout this -- or after our Q2 release. We are not seeing that business to recover. So that will still be a headwind. And then finally, China consumer will still be a headwind also into next year. So those are the key moving parts as we see '24, '25.

It's Oliver Metzger from ODDO BHF. Three questions. The first one is also on Kerecis. So you mentioned the Generation 2, Generation 3 as next levels. And in the previous answer, you said, okay, it's about the expansion. For me, it sounds a little more profound. So how should we think conceptually what comes next? Is it like a real addition of the existing technologies like the fish skin with some other stuff on it that it just looks better? Second question about the international expansion. So out of the U.S., the market is not pretty well progressed. Is it a lot -- how do you think of it? Is this a step-by-step so you want to evolve the market to enter it? Or do you -- how should we think about that also other areas are -- also potentially up from when we can expect some revenues outside the U.S.? And the last one, Anders, is about the -- you mentioned a positive price impact, which you see still for this like year, next year. Does this positive price impact come from price increase on like-for-like base? Or does this comment also include that you bring better products and move into higher categories?

Okay. So on the generation question, so there's -- so we have about 7 years left of the patent protection for the fish skin platform. So in 5 years' time or so, we want to roll out Generation 2 of the fish skin platform. So basically, we'll take a new material platform fish skin, throw some added benefits to it and we relaunch all our portfolio with that new platform technology. And we'll get clinical adoption for that for the next 3 and 4 years.

And we are, of course, not telling you what it is.

No. And then when our first-generation patents start to expire, that technology will no longer be interesting because that will be yesterday's technology. It will be the old iPhone. Everybody wants to use the new iPhone. And that will be what our Kerecis fish skin will be at that time point. So this is separate from the new indications that we are developing and the launch time frame for that. And I cannot really go into any details on launch dates or what segments will be going into. But we have been examining and working on several. So it's an enormously interesting platform that we have. It can be used in so many different therapeutic areas. And outside the U.S., so we have our sales team in the [ DACH ] area, a small sales team, I think it's 6 people or 7 people. And it is very difficult to go into a new market. So this Biologics segment almost doesn't exist there. So it has existed in the U.S. for many years. Originally, it was fueled by tissue banks, so basically for companies that -- the people who are donating tissue when they die, and you could get access to [ cataract ] skin everywhere. That was used a lot in the U.S. It has been used a little bit in Europe, but it was never really a big business in Europe. And that is also the reason why the Biologics is not a big business in Europe either. And also in the U.S., you -- if you're a hospital in the U.S., you get one payment for the treatment of the patient in the hospital. And if you can get that hospital person out of the hospital sooner, you have less cost. So the hospitals in the U.S., they are more [ amenable ] to use a more expensive product that is likely to reduce the number of hospital stays than other health care system, where this is not measured accurately. So...

So can I just add one comment to that? So we are thinking about strategically the way that we think about that we're not in a hurry. But that's how the vast majority of the focus is going into, like Fertram said, succeeding in the U.S. And our point of view on what it takes to open a market in Europe, we really want to make sure that we have a body of evidence around the entry that we also establish the appropriate price point, and we get value for the technology.

Exactly. And I mentioned the [indiscernible], in my slide on studies, that's going to be important out of the European reimbursement authorities to potentially cover our product. But it's a long game. It's going to take decades to get to the same -- a decade or more to get to the same time point in Europe as well in the U.S. now.

And then the final question is on price. When we talk about price, it's like-for-like. So it does not include when we upgrade in certain markets from lower-priced products to higher-priced products. That's what we call mix.

Should we continue? Maybe Martin, I guess, from SEB.

I just have two questions in respect of time and my colleagues here. It's both for Fertram. First of all, I have a bit of a hard time to understand the logic that you're saying that the market will not shrink because as you say today, more applications than 4 are being used as there's been a tendency to use more and more and more. But with the Medicare cap of 4, we will most likely see that doctors and physicians will be a bit more careful using the products, which inevitably be -- sorry, which will create lower volumes over time and also with Kerecis being more effective or at least you don't need to put it on every single week. You might use it for a bit longer before you actually switch off the application. That's the first question, just understanding sort of the logic behind the volume and the market not swinging. And second of all is within the surgical space, which is 60% of your revenue. As far as I understand, a proportion of that, I would assume, is advanced [ surgery ], where today you don't have any clinical data to support it...

What is it?

That's what I'm hearing, at least, but maybe I'm wrong. But just that there's not at least the clinical data to support it in some areas, at least. Is there any potential risk -- legal risk in that area? That's the second question.

Yes. Okay. Well, thanks. So I think in terms of the market shrinking, so there are vendors out there that have expensive products that will go out of the market. So there might be [ substitutes ] of these products that are cheaper. So that's right, that might lead to some market shrinkage. But I don't believe that the volume, the units of devices sold will go down. And actually, the average number of units that we sell on a patient is below 4. So actually, when we sell in the outpatient segment, actually, our average number of devices is below -- under 4. So normally, when we are selling outpatient, we sell less than 4 applications per patient. And -- so the companies that are on the covered list and Kerecis, these are companies with thousands of salespeople, and they are covering all of the U.S. We are not covering all of the U.S., but our competitors are, the big companies. And if there is an account there that has been using a discontinued product, you can bet that the salespeople, they will jump there immediately and offer their products to those doctors. And these are good products that have clinical evidence. So these doctors will just switch to these products. So on the surgical thing, so of course, we have an [ IFU ] with a list of indications from -- approved by the FDA, and we are only selling on indications. There is not a -- there is, of course, no marketing or no practices going on where the product is being used or endorsed by Kerecis for off-label use. We have clinical documentation on a lot of surgical operations. And when we talk about the surgical space, there is also a lot of Wound Care in there. So it's -- so this might be wound -- so this might be [ topical ] closing of the wound. So we are doing some implantable use to support tissue where weakness exists, but there's also a lot of topical use in dehiscence, [ women's ] mastectomy. In fact, at suture line, women that go to Cesarean operation get infected, inflamed at suture line. That's where our product is being used. But the moment you start to do business in the U.S., you open yourself up for litigations. U.S. is a very litigious market, and there are a lot of creative lawyers there. And I guess, I don't know what would happen in the future. And it is a very litigious society. So I cannot really say that there won't be any such litigations.

But you could say, what you should take away is, we train hard that people sell according to the indications on the [ IFU ]. If you're at a bounce, you are out, of course. And then if there's any practice like that, we can't have that in the company.

Let's take one final question, and I mentioned Martin from SEB already. So let's go with that one.

Martin, SEB. Just on long-term guidance, once again, firstly, on the top line, and now we have -- you can see for '24, '25, you mentioned 2 headwinds with Urology and China. Do we have to remove all of these headwinds in order for you to deliver in the high end of your guidance of 8% to 10%? And on the similar -- on the margin side, Anders, most of the tailwinds that you mentioned for next year, that is something which is not in your own control. It's external factors. So how much buffer do you actually have your -- in your margin guidance if things are not externally going away that you hope and expect?

So if we talk to the growth first, Martin, so we are confirming the growth outlook of 8% to 10%. And it's clear if we are in the upper end, all cylinders needs to run at the same time. And on the margin side, yes, we are expecting that the pressure on input costs will come down into next year, but that we also have quite a bit to work with from a scalability point of view. And we are also working on that to make sure that, that will also contribute to our future margin improvement. Also, with the integration of Atos, we are taking out costs as part of the integration program. So there is a number of other things we're also able to work on in order to drive the margin uplift that we are committed to. So there is also a contribution from that.

Good. Thank you very much. So Fertram, Kristian and Anders will be available for more Q&A during the lunch break and also tonight at the barbecue. So please make sure to catch them there. And for now, I propose that we stop here. We'll meet outside for lunch, and then we continue with the breakout. Thank you very much.