Kuros Biosciences Aktie

Good morning, everyone. Welcome to Kuros Biosciences Capital Markets Day 2026. It's great to have a full room here in Zurich, and welcome to everybody online as well. I hope you enjoyed the little preview of our new U.S. headquarters in Alpharetta, Georgia. We're very proud to say that, that opened 2 weeks ago for the office staff, and we will be opening for manufacturing in August. It's a 50,000 square foot space. And currently, we occupy 35,000 square foot of that with room for growth. My name is Carly Dummer, Senior Director of Marketing for Kuros. I am very pleased to be here today to introduce you to your hosts and presenters for the morning. I'll share a little bit about the objectives that we have for this session and the agenda before I hand over to Chris.

Okay. So hopefully, you recognize most of these faces. Presenting to you today will be Chris Fair, our CEO; Joost de Bruijn, inventor of MagnetOs and Founder of Kuros. And our President, now our Executive Director and President of Innovation and Strategy; Daniel Geiger, our CFO; Joe Ross, SVP of Marketing. And last but by no means least, we are honored to be joined today by Mr. Andy Golberg. Mr. Golberg is a foot and ankle consultant surgeon practicing in the U.K. He is a leading authority in ankle replacement. And in 2011, he was awarded an OBE by the Queen for his dedication and commitment to medicine. So thank you, Mr. Golberg, for being here today.

So in terms of our meeting objectives, we know that you as investors really want to understand how we intend to achieve our profit and revenue targets. So we'll really focus on explaining to you today how we plan to make that happen. The team will walk you through our commercial plan and our business transformation initiatives, really with the aim of driving that compound enterprise value.

This wouldn't be a Kuros Biosciences presentation if we didn't share evidence and data. So you'll hear a little bit about our clinical strategy, some innovation initiatives. And very excitingly, Mr. Golberg will share with us his practice. You'll hopefully learn a little bit about the foot and ankle space, and he'll talk about how MagnetOs has had an impact for him. Following last year's meeting, we heard that you wanted to understand a little bit more about the surgeon impact, but also a patient perspective.

So we are also very pleased to share with you today a video from a patient called Alison, and she'll talk about the personal impact of MagnetOs to her. So in terms of the agenda specifics, we're going to have Chris kicking us off with our global commercial strategy. Where we're expanding into new markets and most recently, the trauma space. And he'll also share with you some of our customer engagement initiatives really designed to educate the surgeon community and to create a community and really make sure that we're understanding their needs and pivoting as we need to.

We will then have Joost talk through how we're really continuing to differentiate MagnetOs through our evidence generation and some really exciting initiatives that have been driven from our customer engagement events, really understanding their challenges and their needs and how we can really prove fusion potential with MagnetOs. Joe will then come up and talk through our product innovation pipeline. So you'll get to hear a little bit about upcoming products in the short, medium and long term. Then we'll have Mr. Andy Golberg, who will come and tell us about his experience. And as I said, you'll hopefully get to learn a little bit more about foot and ankle procedures.

We'll get that patient perspective and then rounding out with Daniel, who will talk through our business transformation initiatives. We will then have a Q&A. So for those of you online, please feel free to submit questions throughout the morning. For those in person, Daniel will lead the Q&A here at the end. And with that, I'll hand over to Chris.

Thank you, Carly. I don't think I need the microphone. Perfect. There's water. Good morning. I was told I have to stay within certain bounds because of a camera. So if I get out of the side of camera, I'm sorry, I like to dance around. But good morning. It's been such a journey here for Kuros and many faces in this room we've seen repeatedly over the years, and the story continues to get better. And we hope today is no different as we talk about what we've built to date, but more importantly, how we plan on building into the future.

We start every meeting within the organization to remind ourselves what we're based upon. We are our foundation. How do we see ourselves within the company? How do we act as servants to our patients and to our teammates and surgeons. And so these are our guiding principles and our mission as an organization.

So this slide is something we started putting out there, but last year, first-time profitability is not a small point to just overrun. It's a very big moment in time for any medical device company or any company in general. And so for a company our size, growing as fast as we are to achieve profitability with no debt. That is a massive achievement. We're quite proud of it.

So when we look at some of the 2025 and then understanding where we were to understand where we're going, you look at the consecutive top line growth and you look at the profitability, last year, we went to $146.1 million in revenue in U.S. dollars, 72% total growth and achieved over $19.8 million in cash. Again, a growing business like this continues to feed but also incrementally improve the bottom line. So qualitative and quality growth is extremely important to this business. We've achieved it earlier than we anticipated, and we'll continue to add on that as we move forward.

A slide I'd like to point to is not too long ago. So this is a slide highlighting different technologies. This is U.S. information specifically, talking about other biologics products within the marketplace that we compete with as well as don't compete with currently. So when we look at this, a year ago, we were in the #9, 10, 11 position. So in 1 year, we've moved to the #3 position in all biologics. If you just looked at products in fusion, which is the category today that we operate in, we've moved to #2. That is a huge jump in a single calendar year and is a testament to how surgeons have accepted our products.

When we start talking about the global commercial strategy, we've talked about -- we started in spine because the spine marketplace is a $4 billion-plus marketplace. But we also launched into the extremity space, specifically foot and ankle. And we'll talk about the procedure volumes here in just a second to support that and the reasons why. We started that with a small group of surgeons to make sure we had the right product for the right indications for the right applications. Do we need to have new part numbers? Do we -- is it effective enough? What cases would we focus on? If you're going to do something, you should do it right and take the time to understand it. And that's what we did in the first year.

This calendar year, what we're focused on is incrementally building the revenue stream as well as the clinical evidence. We launched the Level 1 trial Q4 of last year called the ASTRA, and we'll talk about that in a little bit. But we're making investments into the marketplace because it is fast growing. And because for us as a business, as an orthobiologics business, we wish to have a wide base servicing the musculoskeletal community. It started with spine. We walk into a foot and ankle, no pun intended. And then we go into trauma.

But trauma is also a big marketplace, a lot of different challenges with that, and we'll talk about that in a minute. And also oncology has a special place for us. And the reason being is the mechanism of action of our material is very unique. It allows us to be used in an oncology patient where other technologies are, quite frankly, not allowed to be used. It's harmful for the patient.

So this slide is a new slide for those of you who have been watching our decks. But what the story is being told here is where are we taking market share. So if we just look at the marketplaces where we center on between the advanced biologic phase, advanced biologic materials, there are peptides, cellular-based allografts, that's CBA, that's human tissue with cells, growth factors, synthetics and then ourselves.

And what you see from this is we are continuously taking market share. We're taking market share -- the peptides are essentially flat. Their growth has remained flat year-over-year. Cellular allografts have come down a great deal. A large part of that is the mounting clinical evidence that we have and the amount of evidence that those products have, which is 0. Hospitals are becoming more and more aware of the risk and also lack of reward in that category of products. And also from an expense perspective, a more cost-effective solution for the patient by going with us.

And we also see growth factors coming down. Growth factors would be the category of BMPs. So all in all, we are gaining market share within the category. We're gaining market share within the industry. And again, moving from a #9 to a #3 position. All of this combined shows you the impact that we're having in the health care community.

So we're asked often, how many surgeons are there? And these are U.S.-based surgeons, and we collect the data, and this is how we base our penetration rates. So we thought it would be a good idea to share with you how we look at the world from a surgeon base, what those numbers actually look like. So about 7,500 surgeons completing spinal fusion procedures in the U.S. The reality is about 4,500 of those surgeons are doing more than spinal fusion per week.

Those are the true spine surgeons that are busy in their practice. The others, every once in while, maybe it's a trauma patient that they might have walk in, they might do a laminectomy. But for the most part, we base it on the bottom number of 4,564 are true spine surgeons. And then when we look at the target procedures, we looked at anterior cervical fusion, posterior cervical fusion. And so we looked at all the typical fusion procedures where a product like ours could be used -- it's about 968,000 procedures. That's a lot of procedures. That's a lot of opportunity, and we're just getting started.

When we start looking at the foot and ankle marketplace, there's about [6,05977] foot and ankle surgeons, which are basically orthopedic surgeons as well as surgical podiatry surgeons in the United States doing fusions in the foot and ankle. But if you look at and say, who's really doing the work, there's about 1,800. From a procedure volume, over almost 600,000 foot and ankle procedures are being completed.

And then we start looking at the trauma. Over 19,500 physicians take trauma call. But there's really about 4,000 of those surgeons that are actively treating trauma patients on a regular basis. And so we start looking at the number of procedures, how many surgeons would we have to educate, look at penetration rates, but you're talking about over 636,000 procedures where products like ours could be applied. And we haven't even really touched this marketplace.

So when we ask our customers, whether they're spine or foot and ankle or otherwise, what's important to you when selecting a material like ours? First and foremost, Level 1 data. It's a really quick conversation because not many biologics businesses invest in Level 1 data. As you've heard the story before, we consistently invest. We continue to invest, not because it's a regulatory requirement, but we believe it's our responsibility to do so.

The educational events, learning from peers. The best way for a surgeon to hear about using of a product is from their peers. As much -- as charming as I can be and as great of a story as I can spin, it's much better to have a surgeon talk to a surgeon about their clinical usage. And so we ensure that the events that we put together allow for surgeons to teach surgeons, talk about their cases, talk about their failures, why did this work? Why did this not work? And that is where community is built, and that is what we have fostered, and we'll talk about that here in just a few minutes.

I think evident innovation and evidence generation. So as you go through and doing a study, a lot of ideas come through that. As you're using a product on your 20th or 21st time, a surgeon will say, gee, wouldn't it be great if this thing had this, not just in biologics, also in hardware and other areas. And so we want to make sure we're capturing that. And so we have the events to do that. I think from a user requirements, the product has to work, not just biologically, you have to be able to work within the surgeon's hands.

They have to be able to put it in the patient and have it stay where they're going to put it. That's a really bad feeling when you put -- you open up a box of a product, not a competitor product, of course. And if you put it into a patient and all of a sudden, it just gets washed away. That happens. And so it's -- from a surgeon's perspective, they want to make sure it goes where I want it to go all the time.

And the indications, regulatory approval, some products are approved for a certain indication. It may be approved for a single-level cervical fusion. But if they use it in the lumbar spine, they're using it off-label. And they run the regulatory risk. If there was any type of downstream lawsuit that could be used against the surgeon. Our product being regulatory cleared throughout the musculoskeletal system removes that risk from a legality perspective.

And then our sales force. We have a tremendous sales force that is educated. We train them on a consistent basis. It's an independent sales network, but we have employees of Kuros that spend their time working in the OR with surgeons as well as the sales force. We have a strong team of medical and scientific affairs people who have PhDs and our MDs working with physicians to ensure everybody is trained to the highest level throughout the organization. And these are all commitments for our customer.

So when we talk about expanding into new markets and we say, well, gee, those are big numbers for spine surgeons. Look at the growth. The growth-- although the total dollar number in foot and ankle is much smaller than in spine, there is a massive growth upswing occurring. And so we started the ASTRA Level 1 trial in Q4 of last year. I believe 15%, if not more, is already currently enrolled, and that's going to be a great study for us in supporting the foot and ankle marketplace.

We are building an extremity-based distribution network within the United States, much like we built in the spine, finding those folks who spend their time in the foot and ankle surgeons. Our foot and ankle focused education, foot and ankle meetings, foot and ankle materials, although the foundational material is the same and it operates in the body in the very same way, how you deliver the information is different. A spine surgeon and a foot and ankle surgeon -- they're both surgeons, but they have -- both have different experiences clinically, and we have to make sure we're putting the right product and the right information in front of them accordingly.

We've also hired specialists who solely focus on extremities, both from a clinical background, a sales background, so they can work with the physicians on how to use this product and translate that, not coming from a spine person, but coming from an extremities person. And then we talk about the orthopedic trauma, which we are in the very early days of. So if we go through time, we started in spine, but we went to foot and ankle. We started with a small group of surgeons, made sure we had the right product for the right indication, we launched the study.

That same methodology being used with trauma. We're currently working with a small group of surgeons now, identifying the right procedures, make sure we have the right product, and then we will eventually launch a study. This process is methodical on purpose. It ensures we're doing the right things at the right cadence and we're not moving too fast, chasing revenue when we're truly trying to chase the outcomes. If you chase the outcomes first, the revenue will occur. If you chase the revenue first, you're short change in the organization as well as the customers and the patient.

Again, massive growth opportunity within trauma. And so why is this such a great product for a foot and ankle? And certainly, we'll have a surgeon come up and talk to you shortly about his experience. Nonunion is a problem. And I know that we'll see a little bit evidence that shortly. But when you have a nonunion, your limitations on the patient continue to get worse. In spine fusion, you can revisit that fusion site. You have another level you can take to create stability. You don't have that option in foot and ankle. And so we also look at the marketplace.

There's not many biologics companies focused on this space specifically. And the reason being is spine is so big, they just spent their time over there. Our vision is building a global musculoskeletal biologic company. And in order to do that, we have to have a foundation in extremities, foot and ankle and trauma. So we're investing in the studies. The predictable handling and staying put, that is actually a really big advantage for us in the foot and ankle space. And obviously, having an osteoinductive graft used in the foot and ankle space will assist in the healing response. And again, Mr. Golberg will walk us through that.

Trauma. The thing about trauma is we don't know when somebody is going to fall off the ladder. We don't know when somebody is going to get in a car accident or train for an ironman and have a clavicle break. One of our colleagues had that happen actually. And so it's very unpredictable. So clinical studies become a challenge, but there are nonunions. And there are ways we can identify certain patient populations to prove our point to the trauma community.

That's where we are currently focused to identify which of those procedures makes the best use of our technology in a clinical study that we can control and have a predictable outcome. But again, nonunions in trauma is a big challenge.

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Carlos is a trauma surgeon in Northern New Jersey. Chief of trauma services there, so his thoughts on that--on his usage. I am also asked quite often, How do we work with our customers? How do they get educated? What does the training cycle look like? So a lot of times, there's an initial meeting. They may reach out to us. We may have a sales rep who knocks on their door to talk about the product. It may be in the OR. It may be at a general conference or meeting.

And so from there, we're assessing what their interest level is, but also what their understanding of different bone grafts because it's our -- we believe it's our purpose and our mission to really have a scientific foundational sale to the surgeons so they truly understand the mechanism, how it works. Many surgeons may come through fellowship and the biology of bone growth is probably a course they had many, many years ago, not something that's constantly reiterated, especially early in their practice.

So we set a foundation. So we have these what we call KICS events, Kuros Insight Exchange meetings. And this is where we bring a small group of users together to have people who are users, people who are not users. So the surgeons can talk to each other about how they use the product, why they don't use the product, what is the clinical evidence state. And for us, we just create the room in the community, and we let the physicians take the ownership of the message.

And that's been very, very impactful because we always learn something. By sitting in the room and watching them teach each other, we're always picking up something. And that may be for marketing materials. It might be for future product development. We also have meet the expert in journal clubs. Often, when you have fellowships and you have residents, our PhDs and our medical staff will go in and teach osteoimmunology to a group of fellows and a group of residents.

They are doing this on a weekly basis around the country at all times around the globe. We have a team also based in Europe. And so again, foundationally, this is who we are. We also work with scientific symposia, also other courses that we get invited to attend, have sponsored physicians to go up and talk about the public studies. This is, again, a much larger audience environment. And then lastly, we do what's called VIP visionaries.

People who have excelled with using the product, have great results, want to share those results with us as a company. But also we want to seek their opinion on things we're working on in the lab. And so we'll bring them to a headquarters, and we'll say, look, these are the secret projects that no one else gets to see. Do you think this is a good product for us to develop? How would you change it? Because it's always very important to ensure that our clinical community is engaged and involved in the development of technologies. We believe that's our way forward. And so for instance, we just held one in our home office in the Netherlands just recently, where we hosted 6 surgeons, had multiple conversations about things that are coming out in the pipeline, also learned tips and tricks on how our current technology works. So a very helpful way.

So when you look at the opportunities from an education, there's one for each size, and they each have a very specific purpose in training and educating our community. So this is kind of what we look like and how we market them. Again, they're able to get the latest updates on our products, our product development efforts, our clinical studies, where they're at. I would say we always get great feedback from the physicians saying that they -- how much they learned, and it's really the opposite. We learned such a great amount about our customers just by listening and haven't been putting them in a room.

Here's a few quotes from some of the surgeons that have attended this. It's not -- the one on the lower right-hand corner, it's not a sales pitch. It's space to learn, share and grow. And they're building friendships and partnerships. You have surgeons who have never met each other from different parts of the country or different parts of the world, sharing their clinical experiences and then also building friendships. So that's also building a community around Kuros.

So just a few highlights, 65 individual meetings with surgeons, 148 engaged journal clubs, we also sponsor fellowships for training and education and 5 different large conferences.

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So as I close this portion, and then I'll hand it over to Joost to talk about some of the innovation. The journey we're on, since I've been here, it's been almost 4 years, certainly a lot of accomplishments, a lot of financial accomplishments, a lot of operational product accomplishments, clinical accomplishments. But as you -- as we go through the rest of the day, what you'll gain is that we're just getting started.

The foundation has just been set. And we believe that 2026 is our transitional foundational year to accelerate even beyond where we've been. So we're very, very excited about the rest of today and laying out the future for you. I want to say thank you for taking the time to visit us here in person for those folks online. Hopefully, I stayed in the frame shot enough for you or I should stay out more. But again, a great schedule for you here today, and thank you for attending. So with that, Joost?

Great. Thanks a lot, Chris. So again, also welcome from me. Let's change gears a little bit. What I will do in my next 20, 30 minutes is show you what makes Kuros unique and what is really differentiating us and our technology from the competition. In order to do that, let's first look at the regulatory pathway. So what is required, and this is related to the U.S. to get a product on the market and get a product used clinically.

Here, we can see that at the bottom, human cell-based products, that is allograft, so there's donor bone or allograft with cells. Chris already mentioned that before. In order to get those products on the market, the evidence required is no animal or no human data is needed for that. So that relates to, again, CBAs, demineralized bone matrices, donor bone and also allografts. Then next to that, one level higher are the so-called Class II products, products like MagnetOs, other synthetics and also DBMs with carriers. They follow the so-called 510(k) pathway in order to get 510(k) clearance or FDA clearance. And the evidence required for those products is preclinical studies, animal studies. And in the spine, there, you need to do a posterolateral spine fusion model in a rabbit, very small animal.

If you have done those studies and show that your product is similar, equivalent to an already existing bone graft, you can go ahead and start selling and marketing your product. And then the highest level of requirement from an FDA perspective are the so-called Class III products. Those are growth factors like InFuse, BMP and also peptides. And the evidence required there because they are more actively active components in those products, they will require robust level 1 clinical studies.

Large cohorts of patients, often 100 to 200 patients with a control arm. So you have to compare the product to another product, the gold standard often, and that follows the so-called IDE trial. So again, for Class II products like MagnetOs, you would only need animal studies. However, we take it one step further. And you will not be surprised if you look at the number of Level 1 studies that are actually only required for the Class III products, growth factors and peptides, there is only a handful of Level 1 studies that have been performed.

You can see that on this slide, the bottom 3 are the peptides and the growth factors. Those are required in order to get regulatory approval. But the other 2 and the top one, MagnetOs, there, you do not require a Level 1 study. However, we do it because we believe in the product, and we want to show to surgeons that this product actually is working, not just in a rabbit, but it's also working in humans. It's a busy slide. I realize that. But what you can see in the difficulty of cases with the peptides and the growth factors, they have been regulated mainly for interbody fusion, which means putting the product in a cage and then try to get fusion. That is a less difficult way to get a fusion or obtain a fusion in the spine, whereas for MagnetOs, we have done studies in the posterolateral spine.

So that's the back of your spine, which is a more difficult area to get fusion. If you look at the success rate of these fusions at the bottom, product fusion line, you can see quite good fusion percentages with these growth factors and peptides compared to the control arm, which is patient-owned bone tissue. But at the top, let's focus to MagnetOs. There, after 1 year, we already saw 79% fusion with MagnetOs in a more difficult fusion area, posterolateral spine fusion compared to 47% of fusion with autograft.

This is significantly different and MagnetOs is significantly better in fusion compared to autograft. That's never been shown before. So first of all, we are only one of the very few synthetics that have done Level 1 studies. Secondly, when we did that study, we've even shown superiority of MagnetOs over autograft.

Then why is Level 1 so important? I already mentioned it several times. Well, there's different types of levels of studies, as you can see here, but it really matters for clinicians. It reduces bias because you do a large cohort of patients. You compare it to a control. Here, you compare it to autograft, the current gold standard in bone fusions. It supports stronger conclusions, and it actually builds surgeons confidence. So when we provide those studies and we perform those studies and show good efficacy, it really builds the confidence of these surgeons.

Next to the study that I presented before, in the posterolateral spine fusion area that's already been published by the way, that was called the MAXA trial. You may remember that name. We are also performing several other Level 1 studies. And here are 3 mentioned. They are well underway, the PROOF study, the PRECISE study and the ASTRA study. PROOF is posterolateral spine fusion, where we compare MagnetOs, in this case, Easypack. The samples are, by the way, outside for you. Those are here that want to see that product, and we compare them to DBM or DBM fibers, so allograft donor bone tissue.

PRECISE study, 100 patients included also posterolateral spine fusion, where we compare MagnetOs Flex Matrix, another iteration of our product to a cell-based allograft called Trinity Elite. And last but not least, as we went into or we mentioned that we're also going into foot and ankle areas, we are now in the process of the ASTRA trial. Chris also mentioned that, hindfoot & ankle fusion, where we compare MagnetOs Easypack Putty or MagnetOs Putty to autograft, again, the gold standard in foot and ankle. And you can see the enrollment. So we are actively enrolling patients in these studies.

Next to these, we already have published or investigators have published quite a lot of other studies, mainly Level 3 or 4 studies. Those are retrospective studies because the prospective study, as you can imagine, a Level 1 study takes a lot of time to be completed. Those studies have been -- are shown on this slide. On the left, we have data on the anterior or interbody fusion, which is, again, a less challenging way of getting fusion. You see very good success rates after 1 year of implantation or after 1 year of surgery. And on the right, we also have several posterolateral spine fusion studies.

One is the MAXA trial, as I mentioned, that has already been published with Dr. Kruyt, but also we have another study from Eskander, and I'll point to that a little bit later on in this presentation as well. So a lot of studies already been shown and being performed to show MagnetOs is indeed a very good bone graft to get spinal fusion.

Also, we are not stopping here. We are continuing doing our clinical studies. Here are just a group of studies. All -- most of them are Level 1, Level 2. Only one is a Level 4, which is the ACDF on the top left of the slide. You can see large numbers of patients where we compare the product also with BMP 2, the market leader currently, targeting 156 patients in this trial. We are doing also studies in the craniomaxillofacial area. So everywhere in the skeleton, we are doing trials with MagnetOs.

Scoliosis and also oncology. Chris mentioned that in oncology patients, you cannot use BMP or growth factors. And therefore, it's a very interesting opportunity for us to evaluate MagnetOs in this indication.

Now fusion, I talk a lot about fusion and fusion percentages, but that's just one criterion for surgeons to evaluate success. You have fusion rate, so the percentage of fusion after 1 year or 2 years or 6 months. Also fusion mass is important. You can imagine if you have got a very tiny fusion that may not be very robust, and you can get failure of the fusion afterwards. And speed to fusion is another variable, which is very important. And all these 3 actually also relate to the failure of the hardware. And hardware failure, actually, we're also going to evaluate. Those are the rods and the screws that you place anyway in the spinal fusion.

But first of all, let's look at fusion mass. So what does MagnetOs look like if you put that in a human or in a living animal. This is a study based on a preclinical study. So this is a sheep posterolateral spine fusion model where we implanted MagnetOs compared to autograft, the gold standard and 2 other competitor products. Here, the material was implanted for 3 months, and we looked at the volume of fusion.

And what you see on this slide is that when we implanted products, it was all 10cc, 10 milliliter of products were implanted. With MagnetOs Putty, after 12 weeks of implantation, you can see robust fusion on the top right of this slide. So in gray is the fusion mass, and you see robust fusion with MagnetOs. The mass is only slightly decreasing from 10cc that was initially placed to 9.6cc after 12 weeks.

Autograft, which is also known, is resorbing. Autograft is rapidly being resorbed by osteoclasts. And therefore, after 12 weeks in this model, the fusion mass went down from 10cc to 5.7 per cc. Whereas the other competitor products, NovaBone and Vitoss, you see the fusion mass has drastically reduced to about 3cc, also indicated by the gray levels on this slide.

As mentioned, also the speed of fusion is very important. And Dr. Eskander has done a study where he looked at fusion rates of MagnetOs that was implanted in patients that had high risk. 67% of these patients had 2 or more comorbidities, meaning that either heart disease, obesity, respiratory disease or diabetes, all indications or all diseases that can affect negatively fusion. And he looked at the fusion percentage of MagnetOs in the patients before 6 months of implantation and after 6 months of implantation. And you can see on this slide that there is no significant difference between the before 6 months and after 6 months.

And this means sort of take-home message here is fusion already was occurring before the 6 months of implantation side. So fusion starts very quickly at a very high level. And at later times, it just increases a little bit. But the speed to fusion, that's the result of this study is very fast in these patients with many comorbidities.

Another study done by Dr. Justin Davies, he also looked at MagnetOs in high-risk patients and now in interbody fusion. So again, in the anterior area where cages were filled with the MagnetOs. The graph on the right shows the patient comorbidities. So 65% of the patients had obesity were either current or former smokers, smoking negatively affect fusion, diabetic or had prior lumbar surgery. All these patients showed, and this was between 12 and 14 months after they've been operated, 94.4% fusion rate.

So tremendous success of Magnetos even in these patients that have many comorbidities and are usually difficult to fuse. But we are also taking it one step further and not just looking at fusion, but also we are now doing quite some studies where we look at biopsies, even biopsies from patients. And the reason for that is that the assessment of fusion is challenging. There are different ways to look at fusion. When a surgeon -- when a patient comes back to the surgeon, he can do an X-ray, he can do an MRI or a CT scan. And you can see on the graph here left, very simple. If you have a banana and you do an x-ray, an MRI or a CT scan, you can just see different things, and it all looks very difficult.

Then next to that, there's also many patient variables. Patients' bone quality can differ, and that can also be seen in the x-rays or the MRI. So we believe that histology, so taking samples out or taking biopsies and doing real histology will really tell you what is happening. Is it really a fusion? Is there material still? Or is it all bone formation? And histology matters, and that is why I put this slide in. This is based again on the preclinical study that we did before, sheep posterolateral spine fusion. So between the 2 spines or transfers processes, we placed either autograft, MagnetOs or the 2 competitor products. And by 3D CT scans, you can see in gray the fusion mass.

So it looks pretty good. Autograft looks very good. MagnetOs looks good. NovaBone, you can see some gray area. So surgeons can think, well, there's some fusion occurring and maybe that will continue and the same with Vitoss BA2X. However, when we performed histology on these samples, you can see that both autograft and MagnetOs indeed provide a great fusion between the 2 transfers processes. All the pink stuff that you can see here is bone. With MagnetOs, there's some black dots, which are still remnant MagnetOs, but there's a very good fusion. Whereas with NOvaBone and with Vitoss, you can see those 2 oval pieces of bone. Those are the transfer processes in between that, the implanted materials placed, but there is no signs of bone formation.

So what you see on the CT scan is not bone, it's remnant material. And these are just some examples, and we also present this to the surgeons where they realize, some of them, by the way, already realized, but that just looking at a CT scan or an MRI or an X-ray and you see density or opacity doesn't always mean that there's bone there. So again, as I said, we are taking this even one step further.

And here, I have got 2 case presentations, one from Dr. Todd Allen, and he did an implantation in a patient that had scoliosis, which is a bent spine, as you can see on the preoperative x-ray. And then he treated that patient by straightening the spine with metalware and then he implanted MagnetOs at one side of the spine and BMP at the other side of the spine. The patient then this was after about 22 months after surgery, came back to the surgeon and he had muscle spasms. You can see that here at the back of this patient, there was muscle spasms, most likely because of the hardware, because of the metal that was placed in the spine.

So he had to do a reoperation to remove the hardware, to remove the metal. And here, you can see what he found. So this is the site where MagnetOs had been placed, and this is a little movie and you can hear him ticking. This is after, again, 22 months of surgery. You can see him ticking and see that it's actually bone. So Magnetos was implanted and a 22-month robust bone was formed.

When he was doing this and when he was removing the hardware, he could also take a biopsy. So he can take a little piece of tissue out and process that for histology. And there, the results are shown on the left -- on the -- sorry, on the right. On the left, you can see the metalware that is implanted and the area where the MagnetOs was placed. MagnetOs biopsy was taken away from the existing bone. So really where MagnetOs was more in contact with muscle. And on the right, you can see the outcome.

Basically, what is pink is all bone. You can see some remnants with G. There's a remnant MagnetOs particles. Very few particles are still there, but robust bone formation and robust fusion. And this is just one example of showing not just doing the Level 1 trials or doing CT scans or x-rays, but actually doing histology and showing that MagnetOs works.

Another case study was done by Faheem Sandhu. This was a 65-year-old male that had quite a lot of comorbidities. He had severe back pain, was wheelchair dependent and he had to be operated. And you can see here that also rods and screws were placed and next to those rods and screws also 20cc of MagnetOs was implanted as a stand-alone.

This is what the results were after, I think, about a year of implantation, a patient came back to him he had severe pain, most likely again because of the hardware, hardware that was irritating the surrounding tissues. This is then what he did. He had to reoperate the patient to remove the hardware and then, of course, hope that the MagnetOs had provided solid fusion.

Normally, initially hardware provide fusion, rods and screws and then your bone graft has to take over. So he had to remove the hardware. And now also here, you can see. And you can hear where he placed the MagnetOs, solid bone formation. Also here, this is a higher magnification. I apologize, but we are still before lunch. So maybe a little bit bloody. But you see here the area where the screw was taken out, as you see on the bottom, that round area here. And on top of that, the more granular stuff is where MagnetOs was implanted.

He took a biopsy, and this is the outcome. So you see different magnifications here. The lighter areas is MagnetOs and the pink areas is bone. So MagnetOs is completely engulfed in bone tissue in this patient, and this is elderly patients with many comorbidities. So again, these are just some examples showing how we differentiate Kuros from the competition. We are doing Level 1 studies. Our competitors that have synthetic products don't do that because they don't have to do that. They can just get animal data, sheep posterolateral spine -- sorry, rabbit posterolateral spine fusion model and they start selling.

We are investing in Level 1 studies. Then we're also doing CT scans, x-rays to evaluate fusion, but now we've even taken it one step further by looking at histology. And currently, we have 7 of these case studies, and we are trying to get more in, of course, to really show and to really show to the surgeons as well that it's not just a material that is left over if they see that in CT scan, but actually it is real bone formed. And I think that was my last slide. So I would like to move over to Joe.

Thank you, Joost. Good morning. It's a true pleasure to be able to spend a few minutes to talk a little bit further about the product engine within Kuros. We will move to a break after my section, so I kind of win there. And I also promised I'm the last bald presenter.

So over the years, Kuros has been a true product engine based on the work that Joost began really 30 years ago in his career. We continue to do that. We invest very significantly in product development. Those product developments are informed by a lot of research on our side and then also a lot of voice of customer from surgeons from our salespeople from the market and ongoing. An example of that is this quote from Dr. Justin Davis. He's at the University of Kansas Medical Center in the middle of the United States. And he commented on the newly -- recently launched MagnetOs MIS delivery system.

He said Kuros Biosciences has nailed it with the MIS gun technology. I apologize for the American terminology. It maximizes grafting coverage in the disc space for my patients that need a minimally invasive TLIF and eliminates the need for traditional grafting funnels.

As you may have heard in previous conversations, Kuros has invested in, pursued and achieved very broad indications. Now these are U.S. indications, but it's very similar to the indications that we enjoy in Europe and around the world. So we have very broad indications across all MagnetOs formulations. You can see the new ones on the left for the MagnetOs MIS delivery system, where we have already clearance for posterolateral spine, intervertebral disc and pelvic and extremities. You might notice under Flex matrix that for pelvic and extremities, we are not yet FDA cleared. That is currently in process, and I would anticipate that this chart will change in the not-too-distant future.

But this really allows us to not just have the indications and market the indications, but we can educate and discuss these indications with surgeons where for our competition, if they are limited in their ability to have a conversation, they just can't educate, they can't have the conversation and they have to stay in their lane with regard to their indication. So this is a true competitive advantage for Kuros.

From a product development standpoint, we always start with an unmet clinical need that's been communicated to us. For this example, we will continue to talk about the MagnetOs MIS delivery system. And so we had surgeon customers come to us and say, "I need a way to deliver MagnetOs in my minimally invasive spine surgery procedures. We had no true great solution. So when we get feedback like that, we do research, we get voice of customer. We identify whether or not we think there's a market opportunity for us to develop a differentiated technology within Kuros.

The answer is yes. We activate that project. We develop prototypes. We test them internally. We then go out and we validate what we think is an advantageous product. We do a lot of cadaveric work with surgeons in laboratories. We get feedback from our internal team. We get feedback from our distributors. And if we think that we've landed on something that is really going to have a market advantage, we pursue a 510(k) clearance in the United States as well as EU clearance through MDD or MDR.

Once we have that and we launch the product, then we do another feedback loop and we revalidate whether or not what we thought going into 510(k) clearance was true in a post-commercial environment. So really, it's 3 very basic steps: identify the need, in this case, access, develop something, the MIS delivery system and then create it and provide it commercially.

So just briefly, what is minimally invasive spine surgery. So traditional open spine surgery and similar to some of the images that Joost shared intraoperatively, an open procedure starts with a long longitudinal incision down the spine. The soft tissues are stripped away from the bony elements, allowing the surgeon to visualize the bones of the spine. It provides really not just visualization, but good access for the application of bone grafts. And they don't need anything -- any special tools to really do that. They can use the basic putties or other formulations to lay it down.

However, for minimally invasive surgery on the right, it's usually 2 stab incisions left and right. Most of the soft tissues are left in place and the surgery is performed usually through some type of tubular access. So that limits visibility. It limits the opportunity to deliver the bone graft and you need some solution for that. Now the benefits are probably relatively obvious for minimally invasive surgery if performed properly, less blood loss, reduced muscle damage, reduced risk of infection, less postoperative pain, faster recovery and better cosmesis, which you would expect.

So this is the product that resulted from the development. So the MagnetOs MIS delivery system is the only MIS delivery system that is offered sterile, prefilled with the graft in the package. It contains no human tissue, and it's a graft solution that is backed by Level 1 clinical evidence. All of that while allowing the surgeon to achieve placement of the graft in about 1/3 of the time of traditional funnels. So we've had a really great response to this launch.

[Presentation]

That was, again you may have seen Dr. Brandon Lawrence from the University of Utah in Salt Lake City. So a couple of more examples. I won't go through this slide in detail. But the next example is the generation 2 of that same device. And during development of the product, we received feedback that said, I would really love to have an even more precise way to deliver MagnetOs when I'm doing my surgeries. So the unmet need is precision. The development focus was to identify ways to improve the placement and the accuracy and the outcome is going to be a generation 2 of this device.

The current device is on the left. And on the right, you can see that we've developed some very -- a couple of tips that will provide very precise placement of the MagnetOs graft. It's a rectangular one, an conical one for different applications. We feel that this solution will be very good for both spine and extremities. This formulation uses smaller MagnetOs granules. That allows -- that will allow MagnetOs to be placed in smaller defects, but also will improve the flow of the product through these smaller tips. And then on the delivery system itself, we've added some markings for the surgeon to have a more accurate understanding of exactly how much graft that they placed. So there's improvements not just with the tips, but with the delivery system itself.

And we expect that this to be available to physicians beginning in the first half of 2027. These are just some pictures and examples. So these are from like the voice-of-customer labs that we were doing. The X-ray photos that you can see, you can see the tip on the X-ray and it's adjacent to the back of an intervertebral cage, and they're using the tip to engage the cage and inject MagnetOs into the cage that has been implanted and expanded. So that was a voice-of-customer validation lab.

Next example is Flex Matrix. So we had a number of pieces of feedback that surgeons wanted different and larger sizes of Flex Matrix. This required a lot of feedback from our physician users because every surgeon will have a very slight variation of their own opinion. So it was a lot of voice-of-customer, a lot of research to kind of land on what we wanted to bring forward to market. So we had to determine the best options for sizing specific to posterolateral fusion, and we landed on 3 sizes. So picture on the left looks a lot like our other formulations, but the one on the far left is actually twice as thick as any other geometry of Flex Matrix that we currently offer, then we also have an extra long and we have an extra wide.

So at the end of the day, you have more sizes, more possibilities, more flexibility from a surgical standpoint. The picture on the left is just a particular technique that one surgeon likes to use and wrap MagnetOs around another form of bone graft. Not every surgeon does that. It's unique to him, which led him to give us the feedback that he wanted additional sizes. Those will be available beginning before the end of this year. So those are very close.

So what's next? So there's a lot on this slide, but this table represents a continuum of bone graft categories from left to right. So on the far left, regenerative bone grafts. On the right -- far right, polymethyl methacrylate, bone cement. And in between, there are variations of resorbable settable bone void fillers. Each of these categories has their own attributes. They have their own primary applications. You can see product examples on the bottom row. The MagnetOs, the entire MagnetOs family is in that left column. Kuros is interested in pursuing those middle 3 columns, the resorbable settable bone void fillers.

Those 3 columns are represented in these boxes. So these market opportunities are substantial. They're also growing quickly, and they're very high interest to us as we move forward. The first column, regenerative bone void filler, you can consider that an active project within Kuros. The middle column, antibiotic-eluting bone void filler. Imagine that as a recurrent research project within R&D. And then the last space, antibiotic beads or other type of dead space management, that's more ideation consideration for future R&D.

So the opportunity for these resorbable settable bone void fillers is very significant. Again, this is U.S. data. I apologize that so much of the data is U.S. focused. We are working to get more discrete data for the international markets. You can imagine the variability on what data is collected and what's available, but we are looking to get a more discrete global view. But even in the U.S., just in 2026, over 600,000 procedures are potentially available for these technologies in both lower extremities and upper extremities and the opportunity continues to grow over time.

So overall, in the near term, we expect to continue to develop and launch the technologies that I've mentioned. So the MagnetOs MIS delivery system Generation 2, we anticipate it will be just simply MagnetOs MIS Precision, the additional sizes for Flex Matrix and a resorbable settable bone void filler. Longer term, in the midterm, resorbable settable bone void filler with an antibiotic solution and then other organic developments that may include dead space management or osteopromotive platforms, including surface technologies that didn't really talk about in detail today, but they've been mentioned in previous meetings.

And then long term, we have a very active and ongoing strategic view of what we may intend to pursue both organically and inorganically to add to the portfolio going forward. And with that, everyone gets a break. Thank you.

[Break]

Okay. Welcome back. So you've heard the high-level strategy from the Kuros leadership team. Next up, we will invite Mr. Golberg, who is going to give us that deep dive into foot and ankle, talk through the procedures that he does and how MagnetOs has impacted his practice, and then we'll end this session with our patient video from Alison. Over to you, Mr. Golberg.

Thank you. Thank you very much for having me and for, and thank you to Kuros for inviting me. So my name is Andy Golberg, and I'm an orthopedic foot and ankle surgeon based in London. And today, we're going to go through everything from the unmet need right the way through to the clinical value proposition. And I think probably the best thing I can do, and apologies for walking around like Chris, but tell you a personal story that kind of exemplifies the unmet need and how I got into this space.

So about 30 years ago, I wasn't always going to be a foot and ankle surgeon. I was kind of -- I did a thesis looking at stem cells, trying to convert blood into cartilage and bone, very much like. So I was in that space, and I had a car crash. And so I was off work for way over 2 years. I messed up my back and ended up becoming a spinal patient. And I had 7 operations over those 2 years, and it culminated in a spinal fusion, a posterolateral fusion. So I'm actually not standing here necessarily just as a clinician, but also as a patient that's been in this situation.

And what was interesting is my spinal fusion didn't unite. So I got a nonunion of my spinal fusion. And 10 years after my surgery, I found a letter that I wrote to the surgeon, presumably high on Morphine in the day after the surgery. I was at home. I recovered. I was back in a bed in my home, and I've written this letter, which I only saw 10 years later because I became a consultant orthopedic surgeon at the Royal National Orthopedic Hospital, Europe's biggest orthopedic hospital. And I was a consultant. I've got my old notes. This is going back some time about 15 years ago, and we had old notes, proper notes, not electronic ones in those days. And I opened up the notes to find a letter from me in handwriting.

And it said, dear surgeon, I'm home and I've got this corset on and it's great and it's stopping me moving, but it's not stopping me rotating and twisting at night. Patients have great insights. Patients see a lot more. That's why it's all for me about the patient because patients see things that we don't necessarily see. And I wrote in this letter, I said, could it be that this rotation I'm doing tossing and turning uncomfortable every night is going to create motion at my spinal fusion and it's not going to knit. And that's all I wrote this letter and I sent off. I don't think he ever saw it. I think it was filed in the notes and sat there for 10 years until I found it. But it gave me the sort of insight that, a, nonunion of a bone is a real big problem, major problem. 4% of people that have a spinal problem keeping them off work for more than a year, ever get back to work.

So I was in a tiny little category, maybe never getting back to work. And when I eventually did get back to work, I had to decide what was I going to be? And although I did all my thesis on stem cells and knees, I decided I was going to do foot and ankle because I could sit down. That was my sort of logic. And at the time, foot and ankle surgery was in its infancy. It was a tiny specialty. There was a handful of people doing it. I figured I could kind of contribute to an area that was small and growing. Weirdly enough, over the last 20 years, it's grown faster than any other specialty. And foot and ankle surgery now is one of the hardest specialties to get into as a training doctor. It's growing at a pace that's far outreaching the growth in spine and growth in trauma.

And so I think foot and ankle is really a huge bulging opportunity. And it's particularly unique, okay? Because if you think of going to an engineer, there's 30 joints in the foot, 28 bones, 30 joints. And if you go to an engineer and said, design me something that is completely adaptable that you could stand on uneven surface on rocks and position yourself. But then when you push off, jump, hop or skip, it's completely rigid. The engineer would say to you, well, you could have mobile or you can have rigid, you can't have both. But someone whoever invented us has managed to create a structure that's exactly that. We can place our foot in any structure wherever we want, it's completely mobile. And yet when we want to push off, it becomes rigid, and that's because of clever design of the bones. They're often saddle shaped bones, muscles, tendons and all of the other things that pull together.

So what we know is it's an amazing structure, but also that if you fuse one of those joints, it doesn't limit your function because like the spine, there's lots of different spinal levels, you fuse one of them, you still can do and even with a nonunion, I can still do much of the things that I'd love to do. But the foot and ankle is very similar to the spine because you can fuse one of the areas and still have amazing function. So if people get arthritis and about 1 in 2 people over the age of 65 get arthritis in their lifetime, the 2 treatments, once you've tried everything else in pain killers to nonoperative measures, the 2 treatments are either to replace the joint, and we can now replace the ankle joint, and that's something that I do a lot of, or we fuse the joints.

And because you can still have excellent function because partly fusion is an important part of the foot and ankle, actually, it's a very common operation in the foot and ankle. But it's uniquely challenging, similar to the spine, okay, because of rotation, because of motion. It's, in fact, more challenging than the spine because it's an end organ. So if you think of the spine, there's lots of blood supply coming all the way around from everywhere, whereas the foot has an end organ structure. So it's got limited blood supply. So it's a particular challenge to get bones to knit when they haven't got as good a blood supply as anywhere else in the body.

And because you're having to move, you can't be non-weight bearing. You have to sort of put weight on it. So there's lots of motion that's required. So it's a challenging area to try and get to unite. And we, like all specialists, have these patients that are difficult, smokers, diabetics and revision surgery or people that have a metabolic issue like a low vitamin D. And in those patients, the nonunion rates can be as high as 40%. And so that is a major problem. And it's a major economic burden as well because GBP 1 in almost every GBP 125 of public spending in the National Health Service in the U.K. is spent on things like diabetic foot. It's a big problem.

And in terms of what's out there for us to treat that, well, we usually use autograft, and that involves telling the patient we're going to make a cut somewhere around their pelvis here, take a piece of their hip, which will leave a defect. Most patients complain a lot more of the pain they get here than they do for the surgery that we do on their foot. So autograft is not an ideal scenario. It carries donor-site morbidity. And it's only osteoconductive because it's effectively dead bone when you take it from one to the other. And so there's a lack of solutions to deal with our high-risk patients.

And as has already been said this morning, the market is increasingly growing. It's a big market, but growing at a rate much greater than many of the other specialties. And what's really important as a clinician is the evidence behind it. And that's what sort of drawn me to being an interest. I run a national -- it's called the NIHR, the National Institute of Health Research, a grant for a large study comparing fusion, which is an ankle fusion against ankle replacement. So that's a study that's publicly funded over $3 million. So I have a huge interest in this as an area. So when I saw a Level 1 equivalent study in the spine, clearly, that got me excited. And it's very rare for a company to present to you Level 1 data when you're looking at this as an area.

So I don't think spine and foot and ankle differ. I've already said to you that I think the notion of fusing 2 bones with a gap in between the irregular uneven surfaces are very similar in the spine. In terms of the mechanism of action, well, it's clearly the same no matter where in the body it is. What particularly excited me on this because I've got a very shallow mind is the notion that it was conceived through innovation, okay? So some calcium phosphate material was put into an autoclave and it changed the surface topography to make it -- have this -- what's now known as needle grip technology.

And that, for me, looked very much like kryptonite in the Superman film. So it kind of got me excited. But what was interesting is that changed the immune response and the way that the body responded to that material. And from a foot and ankle and spine perspective, we've already said that the patients are the same, the demand is the same. And for me, well, it's very clearly that it's a catastrophic of response for getting nonunion. But we don't have that data in the foot and ankle space yet. But what I was most excited about was the notion that we're going to get that data. And it's harder to do a Level 1 study. As I said, I'm doing a study of ankle fusion against ankle replacement that's comparing motion against fixations. That's a very different study.

But there's 200 operations that we do in foot and ankle, everything from Achilles problems to torn ligaments to arthritis to cartilage defects to instability. So it's very difficult to run a study when you've got 200 operations. That's partly the reason I like foot and ankle is that I don't have to do 10 hip replacements or 10 knee replacements on an operating list. I get to do lots of different things every day. But studies are now coming out and the ASTRA study and all the others that are there are going to generate the similar evidence in foot and ankle. And again, that for me is very exciting. But we're at early stage. This is sort of an early stage for us as clinicians and exciting to work with the company because there's 200 potential products on our procurement that we could use as bone graft substitutes.

I think it's 170 when we last looked. We counted 170. And it's very difficult as a clinician to be able to differentiate with the 2. So the one thing that we want to know is data. We want scientific meaningful data. And I think that's where it's been exciting working with Kuros. I'm going to give you some examples from my personal early experience. So this is why I was saying to you about arthritis of the ankle. -- it -- unlike hip and knee arthritis, it's not necessarily in your genes. It typically follows trauma. So if you break your ankle or sprain your ankle repeatedly, over a period of 10 to 20 years, your ankle tends to wear away and you end up with bone rubbing on bone. And that hurts, okay? And you can't go make a cup of tea.

Studies have shown that the effects on your quality of life when your bone is rubbing against bone is the same as end-stage heart failure and end-stage kidney failure. So it's a big problem. And so the typical treatment that we would use is to either replace that joint or convert it to a stiff but painless joint. So you're taking a stiff painful joint and making it a stiff painless one. And so in this case, the treatment that was decided was an ankle fusion which is to make a stiff painless joint. We have to join the 2 bones together, and we tend to do that with some screws or plates as shown. And then because it's a space where there's uneven space, there's like a big gap on either side, we want to fill those voids.

And so you would put in there some graft either again, autograft or you'd use something like a synthetic graft. And in this situation, I put in MagnetOs and was very assured that later on, what you could see as a gap there before is now filled in. What we're looking to do is to make all of this structure one structure. At that point, the metal work becomes obsolete. It's no longer needed. You could take it out if you wanted to. So there's a very example of a successful fusion augmented by a technology that as a surgeon, we want to get fusion at the end of it. from our study that we did, about 12% of patients didn't get union based on an x-ray at 1 year post surgery. So 12%. That's quite a big number given that in the U.K. alone, there's about 2,500 fusion procedures done a year. 10% of that is a large number that then need to have another operation.

I'll give you a second example now, and I think this is the great thing about foot and ankle. So this is a guy that came to see me with ankle instability. His ankle needed an operation to stabilize his ligaments. But when we did his scan, we found an incidental finding of a huge cyst sitting in the bone, his heal bone. And you can see it's a big hole that's sitting there, known as an intraosseous ganglion cyst. -- just like a ganglion you get on your wrist. And the bone around it was thin like an egg shell. So we discussed it in a multidisciplinary meeting, which is what we typically discuss, discussed it with the patient and said, we could just do your ligament repair, but you've got this huge cyst there.

It's probably okay to leave it. But if it did crush, you'd have a catastrophic failure. It would crush and you'd end up having a major proper operation. And we've got the opportunity of dealing with it at the same time, and he very much insisted that we would go away and fix this. So what we did, this forgive me if anyone, again, before lunch, this is the side of his foot, and this is his heel that you're seeing there. There's a cut. And what we've done is made a small window into the bone, taken out that window and then there's the cavity and you clear out the cyst, remove it all and then place into that cyst the MagnetOs, filling the hole and then you put the window back on. and that then looks like the end result, repaired his ligaments and finished.

And this is the radiograph taken just shortly afterwards showing that the defect is completely filled. And he's just recently, in fact, last week, I saw him in the clinic having had a CT scan showing that, that is now starting to look like it's turning into bone for me, a successful outcome in a patient that otherwise potentially could have a catastrophic result. I think this is interesting is that, as I said, there's 170 on the market of products that we could use. There's lots of commercial reasons and arguments that the procurement people in the hospital will use in order to justify why we should use a bone graft or a bone graft substitute. And so we have lots of reasons to do that. What -- the question is, how do you differentiate between one and the other. And this is where adoption of one over the other typically happens.

And I spent a lot of my life working on in the innovation space, watching how clinicians adopt new technologies. And typically, they can take 20 years for new technologies to change amongst clinicians because it's a very slow burn, it's word of mouth. Probably the best example of that is if anyone's ever had pins put through their legs, so known as the Ilizarov technique. This was started 30 years ago by a surgeon who had come from Russia, but was living in the States and developed a technique and slowly, it took 30 years to become mainstream.

If anyone's ever had club foot, Ponseti, the very quiet, quietly spoken surgeon didn't shout loudly about a technique that he used to avoid surgery in babies with club feet. And the Ponseti method took 27 years to become standard to stop operating on babies because he was quiet. So innovation is slow in health care. But there are ways in which you can speed up that innovation, okay? And that means clinicians supported by industry experts who potentially can actually help the clinicians with the tools that they're missing. And in this case, it's the clinical evidence.

And so as clinicians, we have networks. BOFAS stands for the British Orthopedic Foot and Ankle Society. When I started, there was less than 100 members. Now it's the biggest orthopedic meeting in the U.K. That's bigger than spines, bigger than knees and hips. It's 660 people at the last meeting. So it's a very big influential organization. EFAS in Europe is the European Foot and Ankle Society, again, a huge organization. In America, there's the American Academy of Foot and Ankle Surgeons. And those organizations will often use meetings where you have hundreds, if not thousands of delegates and surgeons standing up giving examples of their cases are hugely influential on other surgeons.

And the programs that we've heard about this morning, I think, are really exciting for us as clinicians because we like to go and talk about cases. We like to talk about with each other. What we don't like to do is necessarily go to a company's meeting. And so what was clever again about what Kuros has done is that they've provided just a platform for clinicians to share and discuss knowledge on issues, complex problems that we have as clinicians. And in particular, there's not a lot out there for the biology of how bones knit, both in terms of us knowing it as education, we don't get taught that as medical students or as junior doctors. And also when you're in practice, when you're -- as I said, you're using it and you're faced with 170 on the procurement, which ones you choose.

And clinicians are also very influential in their procurement decisions. The hospitals don't like to think so. But if a clinician says, I need to use this product, then it's far more likely that the procurement people are going to influence that introduction. So clinicians are probably the single most important variable in any procurement decision is the clinician. And clinicians are hugely and only influenced in outcomes. So they want to see outcomes. They want to see data, and then they will then naturally down the line, influence the people that are going to make the economic case.

So in summary, the problem is clearly real and growing. It's a big problem and foot and ankle is, I think, one of the most exciting areas to get into. And it was interesting watching Chris at the beginning talking about those spaces. I met -- Sir James Black, who is the inventor of beta-blockers and subsequently H2 antagonists, probably 2007, and I had dinner with him. And I was probably the last person to meet him because he died shortly afterwards, unfortunately, not after my dinner, but later that year.

And the reason it was interesting is that he was talking about how it would be almost impossible for him to have ever invented the things he did in industry now. He worked for ICI, which subsequently became Glaxo, but it would be almost impossible because people don't like taking risks. They don't like doing the early-stage innovation stuff. They want big commercial cases. And weirdly enough, when he made beta-blockers and he went back with his idea for H2 antagonists, the commercial guys in the company did the business case and said that his market was about $10 million. It was too small.

But because it was James Black, they'll put him in a room and let him just play with it, just let him keep quiet. And he told me this story. And he said, H2 antagonists outsold beta-blockers in their first year, even though the business case didn't support him. And then he left me with something that will stay with me for the rest of my life. He is -- and he's Scottish, a strong Scottish accent, which I can't do. He said, Andy, if you make something and it works, it will sell. And I think that was the message that I took away is that if something works, it will sell. So if a company focuses on the clinical evidence and focuses on the unmet need, it's irrelevant. Even if the market is small, it's going to grow and you're going to sell.

And I think that's -- again, the analogy here is that Kuros is spending a lot of effort on producing the requisite evidence, which is the foundation, if you like, for massive market growth. And there's no real dominant player in this market. All the players tend to be large players who have huge portfolios, but they've got very, very, very little knowledge in the biologics space. And I'm amazed when I'm working with probably the largest orthopedic company in the world by far, how the guys that I'm talking to can't even talk about biologics because their biologics is a different division, someone else that I have no relationship with gets involved.

And so -- and they don't even have any training themselves on their biologics. So being specialized in biologics and the ability to speak to clinicians, I think, is something that's potentially a game changer. We've got good evidence. We've talked about that. And for me, the early signals are consistent. In other words, if the outcomes weren't providing the outcomes that I'd like to see, then I wouldn't be standing here today. But because the early signals are consistent, I think it's very much along a trajectory that's going to lead to a positive outcome.

And the timing is right. We still don't have approvals for certain ideas. There are some things further down the line that are even more exciting that excite me of where this potentially can go. And so this is a quote that I said, but for me, it's really simple is the biological rationale was strong. The early clinical results were consistent for me to continue to use it. And I think -- I'd like to think I'm representative of how most clinicians evaluate new technologies in the same sort of way.

More importantly, we do it all because we're looking after patients. And so whilst I am historically an expert patient, I think the most important person that I can introduce now is a patient that's had treatment and her perspective, I think, is going to be very important.

[Presentation]

There you go, the last word to the patient. Thank you very much.

Thank you very much, Mr. Golberg. That was very insightful and really nice to see a patient perspective. Next up, we'll invite Daniel to the stage. Thanks, Daniel.

Thank you. So before we start, as you know, I'm the CFO. I will name out some numbers because my presentation will not be a lot about numbers. But I think one number which is really crucial and was a cornerstone for us is that we have grown almost 1,300%, right, since 2022. And the other number, which is astonishing is that we have only grown in fixed cost by about 400%, which basically allowed us in the end to now become cash flow break-even in H2 '24 and actually also allowed us to reach profitability end of 2025.

What that means is basically that we can fund our organic growth path with our own means. We have now basically spent in '26, almost $15 million to $16 million in CapEx. We spent about 6% in net working capital. And we spent another 4% to 5% in engineering, operations, regulatory affairs. So all of this obviously costs us money. But what is important is actually that you understand the volume growth we have seen, right? And the volume growth when I started here was hitting an organization which was super manual. It was actually labor intense. And the only way how we could deal with scale and volume was basically to further hire people, right? So what we initially did was really first to focus on are the right functions in the organization. So we started to build on Investor Relations, started to bring in treasury tax.

And since '25, we now started to focus more on the back end of the organization. And the business model transformation we have gone through, we divided into 3 dimensions: functional, structural digital. So if you look at the functional investments we did in '25, we actually heavily invested into IT because IT governance, IT security is obviously super important. But at the same time, we obviously wanted also to digitize our value chain. That was very important for us to basically first start with that initiative. We also implemented the enterprise risk management, just to understand where our risks are from a target operating model to actually achieve the vision which Chris and Joost already outlined.

What we then did, obviously was structural adaptation. So we worked on a dual production footprint that we are not just producing in the Netherlands, but also can expand to the U.S. and get closer to our home market. As you know, about 97% or 96% of our revenue is generated in the U.S. And the closer we get to the home market, the less transportation costs we'll have, the less sourcing costs we'll have, that helps us at the end of the day on the bottom line. What we also did, and we started with that already earlier on, thanks to the enterprise risk management, we anticipated actually that there might be tariffs coming. So we basically implemented a 3-layer approach. We first stockpiled which basically helped us to hedge against the tariffs up to September '25. Then we basically did further invest into additional structural impacts, which was the so-called first sale method.

The first sale method actually helped us to structure the supply chain instead of from the Netherlands to the U.S. directly, we basically went through Switzerland and then to the U.S. And this created the chain transaction. The first sale basically dictates the import price, helped us again to lower tariffs and basically hedge the company from that end. And then last but not least, and this is also the video I've seen, we have now opened up in Alpharetta, our new production site and also our new commercial headquarter.

The office people have started to already see what the benefits are also from a knowledge sharing perspective because there's a much higher daily interaction between the employees. But also in the long run, this production facility will also help us to have the production capacity available we need for 2028 and beyond. Up to 2027, we are more or less covered in the Netherlands that has been secured already earlier on where we doubled twice the production capacity in the Netherlands. But beyond that, the U.S. would then take over.

Last but not least, and as said, from a digital perspective, it's important that we can obviously increase productivity because we cannot just hire people. We also need to work on the workflows. We need to automate the workflows. We need to increase the efficiency, right? And what we looked at is from a purchase-to-pay perspective, how can we better automate this workflow and how can we also automate the whole supply chain and the whole production. And what we did there is basically implement so-called ERP enterprise resource planning system and also material resource planning system. And basically, we have that now live in the Netherlands. We'll now start to focus this MRP so-called also in the U.S.

And in '26, we have now started to focus more on the front end. So what we're going to do in the U.S. is basically that we will now further adapt the tax structure to the U.S. setup and basically see how we can further benefit from that new structure. And at the same time, obviously, we will also invest further into front-end automation, digitize the back end with the front end that we have full data visibility and can use business intelligence to basically further scale the business. So if you look at where we are today, we are almost there. We have now a global supply chain setup, which helps us in several ways.

So we are now obviously much more resilient -- we have a global scalable supply chain. It helps us to reduce the transportation cost from the Netherlands to the U.S. It will help us to lower the tariff because in the end, we produce local for local in essence. And it will also help us to further optimize the plant, source, make and deliver. And that's really crucial that we're going to see that over the next years. The way we do that is basically that in '26, we now have set the foundation stage, which basically means that we have now the ERP in place, we have the MRP in place. We have the U.S. site in place, and we have the Dutch new site in place. We also have just an opening of the new Dutch site last week or actually this week.

Then we're going to go into an emerging stage where the U.S. will ramp up. The Netherlands will continue to be a global supply hub, and we will continue to use the ERP to further enhance efficiencies. And then last but not least, in '28, we will then see this localized manufacturing footprint, which actually helps us to further save cost as well, obviously, to increase the EBITDA margin.

In terms of the MRP, just to give you some deep dive, the MRP in the end basically is a control center for us, right? So it helps us from raw material through the semi-finished product through the finished product to trace the SKU with bill of material and cost conversion to the end product. And that also helps us to understand cost deviation from a price perspective, from a volume perspective as well as from a mix perspective. And that, again, connecting the dots helps us basically to identify yield, understand what is the root cause, further optimize workflows and then actually reduce costs as a result of that.

And what that means from an operational benefit is we have more flexible production. We can adapt to market needs much faster. We also heard that just about 35,000 square feet are currently used. We will have further potential in the U.S. to further develop products there. And that's why we need to invest now in order to basically create this target addressable market in the future, which helps us to further grow and actually also increase our margin.

And from a financial benefit, as I said, basically helps us also to increase productivity, increase the bottom line to achieve that. The other deep dive is basically the front end, I said, we're going to digitize the front end now. That's the next project we are working on. And then we basically have a full end-to-end value chain digitization, which, in essence, means that we can then basically understand from the market what needs to be produced in the Netherlands or in the U.S. in order to basically then satisfy this demand. And it also helps us obviously to increase the cash collection cycle. We will have a much better capital allocation because currently on the balance sheet, we have a month forward coverage of about 4 to 6 months, which is obviously quite costly, as you can imagine.

And what this new setup will allow us in combination with the material resource planning is that we can much better allocate basically capital to net working capital, but also to CapEx in the foreseeable future. So to sum it up, we are now almost done with the foundational investments. So we have now up to '26 where basically all should be set in stone. The platform is then built in order to push through scale and then actually use the operational leverage to further increase the EBITDA margin. That's basically the game plan.

We obviously will increase scale through strategic alliance as with Medtronic national contracts, but also we will increase TAM as Joe presented through new product development, and we will also go into new indications to further increase the growth. And by doing that, we will actually see further reduction of the operational cost by increasing basically economies of scale and increasing the operating leverage. The way we can do that from a cost structure perspective is that we will further lower the sales and marketing costs, we will further lower the G&A cost and we'll keep the R&D cost at the level needed in order to provide that evidence we need to grow.

And last but not least, and we just reconfirm our guidance for '26. We are very confident that we're going to achieve that. As you have seen in Q1, we have grown by 51%. We'll give you an update on August 13, how things are going. We also confirm the adjusted EBITDA margin of 14%. As said, we invested about [ $45 million] and will invest in the second half of '26 into engineering, operations and regulatory affairs.

But there's a clear dedication from our side to continue to grow also in the long run and achieve the midterm target of $300 million to $330 million as well as achieving the bottom line target of above 20% adjusted EBITDA margin. And with that, I also close my section. Thank you very much.

Thank you, Daniel. I will now ask all of our hosts to come up to the front for our Q&A session. We will start with Q&A in the room, and then we'll move to online where Alex will be fielding questions. Over to you, Daniel. I'll let you pick the respondents.

Laura Pfeifer from Octavian. I have 2 questions that relate to your product pipeline where you have said today that you will develop and launch a bone void filler. I suppose that's a bone cement. So just wondering if you could give us more details about maybe the product formulation, time lines and the regulatory pathway here?

And then secondly, on the next stage for the bone void filler, you said you would also look into the antibiotic eluting bone void filler space. I guess this would involve a clinical study.

Just wondering here if you could give us an update on cost, like total cost and also time lines and also how this relates to your 2028 margin target, I think that you have just confirmed. I guess this is all included in the guidance. Just I think a little bit more color here would be appreciated.

Sure. Thank you. That's -- that was more than 2 questions. There's about 4 sub-questions, but we'll do the best to answer those. No, very exciting. So we're talking about entering a new marketplace for the company.

As we have said in the past, as we do product development, we want to make sure we're adding TAM to the business or extending our opportunities within the markets we serve. So going into creating a cement material puts us directly in competition for that $489 million segment, of which many of you are aware of companies such as BONESUPPORT. And so we have broken that down in 3 phases. As you saw, the marketplace as we see it, there are 3 primary buckets. The first and foremost being a settable bone void filler.

When we ask the physicians, and we've done a great deal of research and other clinicians about what's the most important attribute to such a product. It is not the addition of an antibiotic. And the reason being is antibiotics are available to every physician in the hospital. Most physicians will make their own secret sauce and mix it in the bin and then put the cement in. Really, the gap in the product portfolio and the product offering and the need we're looking to solve is a faster bone-growing bone settable cement.

That is a need that exists in the marketplace, and we feel very uniquely positioned to be able to do that. taking what we've learned from granule production, the purpose of surface topography and generating of bone is what we do, and we do that quite well. Putting that into a cement formulation is the R&D. And so what you can think is much like Intel on the inside for your computers, you can look at our granules on the inside of the cement being much more of an osteoinductive cement than osteoconductive cement, which is available today.

That is our unique position, and we believe it solves a big problem with the physician community. Again, entering a brand-new market, I'm not going to give you the actual launch date, but it is 0 to 2 years. So it is in the middle of active development. So what that means is from a regulatory perspective, it is certainly a 510(k) perspective. It's not a long-term clinical study. Relative to drug-eluting cements, certainly, that's in the center stage where we're going to see if it's a necessary need.

If we're able to do -- if we do go down that pathway, it certainly will be a clinical trial. From a cost perspective and from a margin perspective, we don't anticipate any large swings within the company's financials to go support that. We can do that with organic capital.

And the revenue, you are correct, is included of these future product developments as again, we normally have a 5-year product plan that we operate off of. I think I answered all of them. But I'm sure she's going to tell me if I didn't.

Any more questions in the room? All right. We'll go to Alex online.

Yes, sure. So we have, in the meantime, a few questions. First, given the clinical strength of your product, investors expected faster commercial scaling. What might be the reasons for that? Is it adoption, pricing, reimbursement or sales execution?

Faster commercial. So just to benchmark that, I'm not sure what industry they're coming from for the question, but this is the fastest-growing company in orthopedics, period. And so to go from 5,000 boxes to 50,000 boxes plus in a period of 3 or 4 years, that's pretty quick. Now could we have gone faster?

I mean, I think there's always that -- what's holding you back? I mean, honestly, infrastructure, the investments in infrastructure can slow down. If the car is only built for 40 miles an hour and you start driving it at 80 miles an hour, it's going to fall apart. We obviously didn't want the company to fall apart. We were metered in how we were going after markets. We also didn't want to spend cash in an inappropriate method.

As I've said before, we don't chase the revenue. We chase the clinical outcome first. Some folks may see that as slower on the revenue. We believe that's a better long-term strategic play for building a foundation. Also, we're talking about patients. We're talking about outcomes. We want to make sure we're providing the right benefits.

So I don't know if we could have grown faster, quite frankly, just because of the infrastructure and all the things I just previously mentioned. But the acceptance rate is also surgeons. And surgeons will move early adopters and folks who want to follow. So I think it's a mixture of all of these things. So hopefully, that answers the question. I don't know if it's specific enough, but I'll stop there.

I gave the example of many very successful innovations in health care taking 20 to 30 years. That's the time frame for most successful health care innovations to get to penetrants adoption, if you like. So actually, to echo Chris' point, this is very rapid. When you're faced as a clinician with 170 potential products that you could use, why pick one?

It's not going to be a very quick, easy point to get to thousands and thousands of clinicians unless that comes up organically. And actually, the speed, I think, of this is demonstrable evidence that the -- building the foundation, the clinical evidence is the route to growing this space. And at some stage, when adoption happens, the market exponentially rises. And we're kind of getting to that point of inflection, I think, at this stage.

And the final point that I'll add specific to entering these new markets like foot and ankle and trauma is that in order to do it the right way, you have to do it in a methodical manner. In that, you've got to build the team. You have to build the sales channel.

You have to build and provide the evidence, you have to educate in order to get to -- in foot and ankle and trauma where we've gotten to in spine and beyond. So all of those activities simply take time to do it the right way, and that's what we try to do.

So I have 2 questions, but I will combine them together. So -- and this is related to the share price of Kuros. So the recent development of the share price as we are showing a strong product performance and debt-free balance sheet, but the share price since the beginning of the year has been quite volatile or trending down.

What could be the reason behind it? Or what do you think might be the issue that the share price is not following actually the strong performance of the product?

Well, we very much see that as a sector play. So we see across the MedTech sector that there is decrease in share price since the beginning of the year. Also, if you look at our proxy, we always look at the U.S. MedTech ETF. We see that there's quite a devaluation going on.

The other topic in my view is also in our view is basically that there is a capital reallocation happening right now in the market more to AI and obviously, SpaceX just recently. We see that as well. But all we can say is from an operational perspective, we cannot see any reason why the share price is justified.

Yes. I mean it's a buying opportunity for sure. I mean I think that the folks who are covering us certainly believe what we're doing. We come out with solid positive results. We talk about building reputation within the clinical community, but also in the capital markets. The past 4 years or so, Daniel and I and Joost have gone out to the capital markets, said what we were going to go do. And each time we come back, we say we executed on that plus. And that has been a repeated behavior for the past 4 years.

Operationally, we're running on point. And so the share pullback, we don't take it personally. We'd like for it to stop, it would be great. But I think it's truly, as Daniel mentioned, the MedTech sector, we see some share buybacks from Boston Scientific, from Zimmer from other large medical device companies. Really, it's a matter of think people will come back to this sector. It's not as if patients have stopped falling off ladders or they no longer have degenerative disc disease. So we continue to operate and execute.

So the next question would also be to, let's say, concerning MagnetOs. So if there is any usage for the dental industry foreseen?

Yes. So certainly, the application of the material in growing bone, as was mentioned earlier, growing bone in the foot and ankle as well as the hip as well as the spine as well as in the dental infrastructure, bone operates the same way. Is there an opportunity there? Sure. We believe the technology works. And we also have a study in craniomaxillofacial as well. Is it a marketplace that we're going to go build a sales force after?

The answer is likely no. And the reason being is it's a cash-based business and the use of our efforts are better positioned to go execute in the marketplaces we've already defined. It doesn't mean at some point in time, we may find the appropriate partner down that road.

Maybe I can add to that. So we have done studies or studies have been done with MagnetOs in palate cleft surgeries. It's children with a palate cleft. MagnetOs is there working exceptionally well. You need tooth eruptions. The current market leader there is a material that is hardly resorbing and therefore, teeth cannot erupt. And the surgeons, the CMF surgeon is very happy with what Chris says, the market is just smaller. So we have to prioritize.

Maybe the last question before I hand over again to the audience. That's a new question here, interesting. How well is the company protect against cyber attacks?

Well, I said, I mean, we invested now the last 2 years heavily into IT, and we started actually with IT governance and IT security. And I would say, at this stage, we have all the right infrastructure in place in order to be protected. But I mean, in the end, it's still a human risk most obviously. So phishing attacks can always happen. So we train our people when they onboard the company. and we train them also on a regular basis when they are with us.

And yes, basically try to build that also into the enterprise risk management tool that we have all the mitigating controls in place. So I would say from that end, we are much better protected than 2 years ago. But -- they're always trying to find the gaps. So we will continue to build the structure to be protected.

So I'll just make a stop here and go back to the audience.

Yes. We have another question from Laura.

Maybe just coming back to your spinal fusion market share. I think you said you had around 6%, if I remember correctly. We also know that you have these Level 1 studies ongoing. I guess, at some point in time, they will read out the precise and. So I'm just wondering what are your expectations? Do you think you can generate superiority and then use that to further fuel the market share?

Or is non-inferiority sufficient? I'm just wondering what could it mean for your growth trajectory in the spinal fusion market.

Sure. So I will take that. Being able to demonstrate statistical superiority requires a certain level of statistical power in your predefined plan. Our first test is always non-inferiority for any trial that's consistent within medical device and biologics. That said, I feel that any prospective randomized controlled multicenter study in biologics in our market is incredibly powerful.

And the fact that we have published already, 2 in process, an additional one in foot and ankle, we are investing in clinical evidence at a rate greater than any of our competition. So I think pick any of those studies. I think each of them will be very powerful. I think to, I guess, pat ourselves on the back a little bit. Other biologics companies are not willing or brave enough to randomize their technology to the competition, much less MagnetOs.

And we are going -- we're very willing to go head-to-head with the advanced DBMs with the cellular allografts with autograft again. So I'm very proud of our investment in clinical research and just the bravery with which we're willing to push forward, Chris?

On the market side, I'll use cellular allograft as an example. It's about a $450 million market spend in the United States for a product that has 0 clinical publications. So literally, the Level 1 study with a head-to-head to our product will be the very first publication of any evidence of that entire category of product, of which we don't sell one.

So it will do several things, highlight the effectiveness of our product, highlight the ineffectiveness of that category and will drive that $450 million segment down quite a bit. It will also push into the hospital systems that are spending money on an ineffective product to take that same amount of capital, push it into products that are effective. So I think that study is a great example of not just serving the clinical need, but also the business need.

Thanks for the question. So thinking about your 2028 guidance, what would you expect from foot and ankle contribution compared to spine? What mix shift would you kind of expect from there?

So we haven't broken down the revenue as of yet between foot and ankle and spine. A large part of that reason is until the business becomes sizable enough to do that from a reporting structure, it doesn't make a whole lot of sense. I think that it's strategically very important.

Also, if you want to look globally of total dollars and revenue and you look at the market size, $4 billion in the U.S. is spent in spine and biologics, about $0.5 billion was spent in foot and ankle and about another, call it, $1 billion in trauma. And so you're looking at 20%, 25% is spent not because of much less procedures, but actually, it's the volume of material.

So the foot is yo big and the spine is yea big. And so there's more material that's being used. Procedure volumes are, I think it's about a 20% delta, 30% delta. So overall, we aren't splitting out the revenue just yet. I think that -- but the contribution margins in extremity actually are more favorable in spine. So also as we grow the extremity business, the contribution margins tend to be better there.

Yes. I think that's an important point, Chris is making. One of the strategies we have to further increase the margin is actually going into territories where we have lower commissions because that's a big part of our cost structure, right? And by obviously paying lower commissions, we can further boost the contribution margin that will help us to increase our bottom line.

Yes. And it's also the application of the product. We are already sitting in 6, how many hundreds of hospitals in the United States on the spine side. So our ability to go into that hospital system to expand our sale into extremities, whether it be trauma or foot and ankle is a much faster pickup versus starting fresh.

So the extremities business has a head start versus what the spine business had. So again, as we build that foundation, we build that base because we believe we can be the biologic entity servicing the entire musculoskeletal community, we're doing a much faster cadence on the extremity side.

And can you maybe give a ballpark range for those margin contributions? And then also just thinking about -- you already mentioned that once you're already present with your spine indications in the hospital, the barrier to entry, I would imagine, is lower. Are there any other barriers to entry that are different in extremities or in the like foot and ankle space that we should keep in mind?

So I'll deal with the barrier, I'll turn to margin over to Daniel. On the barriers to entry, they're very similar, right? So when we access a new marketplace, so we're going into foot and ankle as an example, we are just now expanding the sales and marketing efforts there. So traditionally, the sales agent that represents us in a hospital, they represent sales spine products, spine surgeons, spine products.

Rarely do they ever represent foot and ankle products. And so we're in that hospital system. We're cleared on the shelf. We now can go find a foot and ankle sales agent, educate them, train them, get them up to speed and the product is already on the shelf already at an agreed to price for the hospital. That's a much faster uptick.

Sometimes it can take a little bit longer going through a foot and ankle committee, but that's fewer than far between. The other part that is a challenge is large hospital buying groups or large hospital systems. So IDNs and hospital systems like HCA, which cover a great deal of hospital contracting, if you're not on contract, you won't be able to work within those hospital systems in the U.S.

We were fortunate enough to pick up rather large agreements in Q4 of last year at the very end of Q4 that we're starting to see benefit from and getting access to new hospitals that we didn't have before. That is part of our ongoing strategy and growing our breadth of how do we continue to be accepted, making sure we're in regional IDNs, national agreements. That's a very active part of our business.

Some of that, we just heard the other day, we got in a hospital system of about 25, 30 hospitals. That took 2 years. And so sometimes you just have to chip away. Again, something that wasn't mentioned earlier, MDR in Europe. This is another question. We received MDR approval for our technology, which will allow us to sell in the EU beyond 2027.

This is a process that was started 10 years ago. We are one of very few companies that have MDR approval. And so when we get closer to that point, it becomes a much more of a strategic advantage to be able to sell into Europe.

Yes. On the contribution side, the way we look at the cost structure is basically we have variable costs, which is obviously cost of goods sold, which is in the neighborhood of 8%, 9%, 10%, somewhere there. And then we obviously also measure what commissions we pay to the 1099, right? And going into extremity will certainly help us to improve that contribution margin by 5-plus percent. And that's also basically built into the EBITDA margin guidance.

If I could add 3 questions. So you mentioned M&A opportunities to grow inorganically. Can you help us understand the gaps you would like to fill and interesting opportunities in the market? So should I go one by one or...

Your choice.

Yes, I'll go one by one.

Okay. So in M&A -- where I'd say we are with inorganic strategy is we're very inquisitive. And so if we look at the landscape of all things that are biologic in nature, that a musculoskeletal surgeon will touch, essentially not going into hardcore metal implants, not going into hardcore instrumentation, we're not going to go into robots, but things that are soft and are biologic in nature, what are those areas?

And so that marketplace includes, again, as we've announced today, settable bone void fillers, right? It's a $500 million-plus marketplace growing. And so that's a marketplace we have announced today that we're going into. That's something that's interesting. That's something we feel organically we can go after. There are other spaces, and I'll list off a handful here. It could be anything from a dural adhesion barrier or sealant, which is operating with more neurosurgery and spine surgery. It could be analgesic delivery polymers. It could be all different kinds of marketplaces, things that a surgeon would use.

So we map those out and say, do we have a better chance of doing this ourselves? Do we have a better chance of partnering with somebody or licensing a technology or acquiring a company. And so we're very much through the mapping phase and now we're in the monitoring phase of looking at which technologies make sense. Are they technically advanced, what type of clinical work? We can look at technologies that are maybe not revenue producing, but we can provide our firepower relative to sales and marketing that we've been building, and it's so much less expensive. I think those are the areas where it's more of a tuck-in where we accentuate with the new marketplace that we're curious about.

I would just add that everything that Chris just described, we refer to internally as adjacent technologies, meaning it's the same surgeon customer, same surgery intraoperatively where other technologies might be used? And then just to finally add that we've messaged previously that we don't have a current intention to go into any biologic technologies that involve human tissue.

And probably just to add to the capital market, we will do that through non-dilutive financing.

The second question, you have several Level I studies ongoing. Maybe could you provide the key milestones investors should look at over the next 12 to 24 months? That would be helpful.

Well, I mean, for all of these studies, it comes down to the study design. The first key milestone that you want to kind of look forward to is completion of enrollment. So all of the three studies are currently being enrolled. So you'll want to listen to sort of the progress on enrollment to the target.

Once you get to completion of enrollment, then you're following patients. And each of the studies has very discrete follow-up criteria. It might be 6-month or 1-year X-rays or CT scans. There are differences between the ASTRA study, for instance, as compared to PROOF and PRECISE. I think that it's fair to say for all of the studies, the 1-year follow-up for those patients is going to be important. When the patients come to the -- back to their physicians, they get their 1-year follow-up, then you're in the data collection and analysis mode to get to the point where you can develop a manuscript and submit it for publication.

That can often take 3 to 6 months itself. So it's -- doing these studies is a time-consuming process, but it's enrollment, follow-up, data analysis, publication.

And unlike regulated trials with the FDA, we end up because we have no -- we're doing these studies not for the purpose of approval. We can shave off a great deal of time, effort and money by not having to go through the reporting structure, the reporting delays that are normally associated with a study this big and because there's no federal regulatory authority body attached to it.

And then third question, any changes in the competitive landscape you're observing that is notable and could impact the trajectory of MagnetOs?

I would say that nothing dramatic currently. However, given our success and the magnitude of our business, we do see competition in the market that is beginning to adopt a fair bit of our messaging and positioning themselves against MagnetOs. I don't feel that, that's a significant threat because they don't have the evidence.

And so every time one of these competitors comes forward and tries to imply to a surgeon that, well, they're similar to or just like MagnetOs, the answer is, okay, prove it. Show me the evidence. And they don't have any. They can't compare our Level I human clinical evidence to a rat study that they may have done as an example. So they can try, but they don't have the evidence to back it up.

And one of the nice things about being in biologics since they do have a clinical study on a unique technology in the pipeline, we see it. We know what the indications are. We know what the applications are. We know what their approval would likely look like. We can also map out a time line of when we think that would come to play. So there should be no surprises.

I think just I wanted to say that as well from a financing perspective, as you have seen, we are investing quite heavily right now into CapEx and net working capital and further expertise, as I mentioned. And you will see some low point in Q2 and Q3, but don't be too excited. We have a bridge loan in the bag. We will always be able to finance.

Just about the studies that you mentioned those three Level I studies. Did I get it more or less right that in the next 12 or even 18 months, there is not going to be a first readout?

Yes, that's correct. So they are being enrolled. And just what Joe said, the enrollment will take some time. When they're fully enrolled, there will be a primary endpoint between either 6 months or 1 year, mostly 1 year. So that will take some time. In the meantime, by the way, there will be output not from these studies, but from other retrospective studies, other investigator-led studies. But the big -- the important data of Level I studies will take some time.

I think proof will be fully enrolled by end of this year.

Just to maintain for these prospective studies to maintain academic integrity, you can't cheat and get sneak peeks. You have to wait for the full data sets to come together.

And then maybe on those hospital networks that you have made contracts with, you said first signs can be seen -- can you be a little bit more specific? What is the uptake? Or what are you expecting from these contracts?

So I can't give specifics, but I can walk you through a process. And so how a process would work with a large hospital group, it's actually a funny thing. They'll say, well, we won't let you into our hospitals because we don't have any surgeons asking for it. Well, the surgeons are asking for it, but you won't let them have access to it.

And so what you end up doing in the circular fashion is you end up getting local contracts with a handful of hospitals within the network on a one-off basis. And once you have enough of those, then you go up to the national level and say, gee, these 12 hospitals really like access and your entire 600 hospital system, we'd like to have a contract and access. And so that process can take from the start to actually getting a national agreement several years. And so once that occurs, now you have the ability to go after the remaining hospitals to see, okay, I'm already in the computer system. I've already agreed to a contracted price for that hospital.

Now I've got to go find those surgeons within that hospital system that might be interested in using the product that previously have been told no. So this one hospital system we approached or got a contract with in December. We are in the process, and we track that on a monthly basis. What is our penetration rate? What is -- what are we getting from new customer acquisition? What is the pull-through in the price. So it is working exactly as it should because you have limited competitors because most are on the outside. We're lucky to be on the inside.

And by the way, we got on the inside because of our clinical data and because of the efficaciousness and because of the surgeons that were willing to go to bat for us. That is how the process takes. And again, it can take 6 months, it can take 3 years. And so it's a long-term strategy to build your base. But we don't break it out by hospital system by penetration. What I can tell you is that our numbers of surgeons and hospitals continues to grow month-over-month, and we track penetration rate, not just by hospitals, but also by association of what's hospital systems.

[indiscernible] Can you talk a bit about the risks in the U.S. as most of your business is in the U.S. with Medicare, Medicaid, MFN, [ Nairoi ] protocols, Section 232 reimbursement cuts, especially Medicare and Medicaid and I guess you have had a big exposure to this segment. First question.

So in the U.S., we operate under a DRG health care system. So it's one payment for the entire surgery. So everything from the blade to the implants to the biologics to the sponges that are used, it's a capped fee that's sold -- that's paid to the hospital and then the hospital decides what they're paying for what.

Medicare and then obviously, the Blue Crosses and private health care is a percentage up on top of Medicare. The drug control pricing does not affect us. We are not a drug. We are a device. And so this discussion of 231, I believe, does not affect us one bit. Medicare and they set the pricing based on procedure volumes in coordination with hospitals and volumes of patients, et cetera.

Orthopedic care continues to get funded. There are -- tend to be cuts of 1% to 2% on different procedures, but then you see improvements in others. There's trying to keep the hospitals profitable. Orthopedic surgeons and orthopedic spine surgeons within the hospital system are very vital. And so the surgeries continue forward. So do we see a risk on the horizon of great magnitude to our procedures? No.

I think that having a wider amount of procedures we can be effect helps our case. So if one decision that Medicare happened to say, well, gee, we're going to focus on reducing reimbursement in the big toe versus spine. We don't have all of our business in the big toe, nothing against the big toe. So hopefully, that answers your question, but we see the risk is de minimis.

Sure. Just maybe related to that, you obviously work with mostly agents and distributors in the U.S. And I wonder if you have enough capacity to give the service in the U.S. as at least from my knowledge from larger joints, it's kind of mandatory for a sales rep to attend the operating theater and probably it's not in your segment, but I wonder if you have the capability to serve that via your own clinician or...

I don't know. So the question is if -- I'll ask -- I'll read back the question differently. Do we have the ability to have a direct sales force versus using a sales agent?

Not at this stage.

It's very expensive. We partner with sales agents in the United States for a couple of reasons. Number one, they're in the surgery with the hardware component of the surgery. And that tends to be the primary relationship between the physician and the sales agent. And so we partner with those folks. It's the reason why our relationship with Medtronic is so positive.

They have the #1 position, #1 sales force from a spine procedure out there. And as great as they are, they have a 23%, 24% market share. And so we partner with Medtronic where it makes sense for the company. And then if there's other areas where there might be a stronger sales force, we will partner with them. Our responsibility is to ensure we get to all the surgeons, not just the ones attached to one singular company. But -- so independent sales agents provide us the flexibility to pay-as-you-go versus direct sales forces, which tend to be very expensive. And in my experience, you have to have several product lines being able to carry your own sales force, but very much independent sales force.

Just to say from a clinician perspective, if you're using a for example, a joint replacement or something, and it's heavily instrumented. It's actually your scrub nurse, the people in the operating theater that you're actually helping by having the agent there. So the agents are there to help them know what to pick up next, what to put together and what to give to you as a surgeon.

When it comes to a biological, as I said, there's potentially 170 to choose from. Most surgeons are pretty capable of knowing what to do with the biologic to put it into the patient. So you don't actually need a rep with any expertise over the product. What you need is someone that's or sufficient materials or information to provide to you beforehand that gives you confidence that using that product over something else has benefits. So you don't actually need someone physically in the room with you for the biologic. But you do very much for a joint recon or for other parts because not necessarily for you as a surgeon, but for your scrub team to assist them with their part, which is very heavily instrumented.

I was just going to finally add that in the United States, we do and we have been committed to the independent agent model. To support that, we have a team of area directors that underneath them have a team of regional managers who directly manage those independent agents. And we add and remove agents on an ongoing basis at the local level.

But overall, the number of total independent agents with whom we work continues to increase. So I think that in direct answer to your question, do we have the capacity to support the growth from an agent perspective? The answer is yes, and we've got a team in place to manage that growth on the...

Yes. it's a pay-as-you-go. And so the independent agent model is fantastic for us. I'm a huge, huge proponent of it. Those are the sales agents that are listening, big fan. But there is no cap as far as how many we can add because they're not headcount. And so it's a variable cost. So yes, so there's no cap on how fast we can add them, and we supplement them with our own personnel from education, training, medical affairs, clinical affairs, any of our customer-facing entities. So...

Marketing...

And marketing. Sorry, Joe. He's right there. Another one. That's it. You've got your quota.

No, I was just coming back maybe to the trauma market, which you will enter, I think, in the not-too-distant future with a bone void filler. I guess that's the primary product you intend to position there. I'm just wondering if you could describe a little bit as we are not that familiar with the market, what are the other players doing? How fragmented is it? And also, how do you think about it in the long run? I mean, would it also make sense maybe to go into strategic alliance as you have done with Medtronic?

So a couple of things, and I'll ask Joe to pipe in as well or Mr. Golberg. I think predominantly, we're going after the trauma market initially with bone graft material, right? So there are certain patients that present that you do not need to have a settle bone void filler or cement-like product, where there's plates, there's screws and there's stability already being -- and there's not a massive defect, you're filling a crevice, that's fine.

You use existing product off the shelf. We're doing cases now. You saw from Carlos earlier in his presentation, some of the patients that he has been treating. Right now, where we are is gaining understanding of the right patient population, again, back to the methodology, understand the market you're in, ask your surgeons what they're missing, what features they'd like to see in a new product. So that kind of starts that basis just on the bone graft material.

On the settable bone void filler marketplace, what we have seen and heard to date from the physician community is that it's not so much about the antibiotic. It is much more about bone and bone replacement. So you're putting something in there to fill a defect but you eventually wish bone to replace it. The speed to which that happens, is it an osteoconductive or is it osteoinductive?

And so when looking at our technology and our prowess and knowledge, could we make a much faster bone-growing cement. That is the ask of the internal team, and I hand it over to Joost, but that's the rabbit we're chasing because we believe we can bring such a product to the marketplace, solve the true problem and then a surgeon can add gentamicin or vancomycin from the pharmacy in the hospital like they do already at a much lower cost.

Yes. No, just to say, if you're dealing with an infected case, so for example, in diabetic trauma, an infected case, you will often may have some indications from your microbiology colleagues of what antibiotics to use. And it won't necessarily be gentamicin or vancomycin. It may be something else, maybe a combination, [ ciccroplain ] or some other medication.

So often, it's not unusual for us to take advice from the microbiologists and then make that specific to the patient. So frankly, I don't think as a clinician, I would prefer to pay for a ready-made product where I'm paying a massive increment for the product because I'm paying for the regulatory pathway that they got to approve that product. When I can actually take a cheaper product, which is a bone substitute preferably one with osteoinductive capacity, but I can then tailor for that patient by giving the right antibiotics as advised by microbiology colleagues.

So it's personalized medicine, which is obviously in the future, but it's also cost effective because it's far cheaper for me to take the advice on the antibiotic, mix that with whatever bone substitute I'm going to use and place it onto that patient than it is for me to pay for a ready-made product, which has included all the costs of the regulatory pathway, the regulations, the approval of marketing and all the other things, which may be 3 or 4x the price.

So in terms of trauma, the good examples where there's big bone voids would be a tibial plateau, so a crush of the knee or pilon fracture, which is a crush of the distal tibia. But there's big bone voids, huge vacuous areas that we've got to fill. In those situations, you don't need antibiotics. And so you would use the same bone substitute, you're using as a bone filler, you're less likely to use antibiotics unless it's an open fracture where there's a hedgehog or something inside the wound.

So in closed fractures, which is probably more common than open fractures, where you're using it as a bone filler, you wouldn't need antibiotics. So yes, I think from my side, the ability to have a reliable bone substitute is more important than having had a regulatory approved drug device combination.

Any more questions in the room? Anything from Alex?

I think we have a follow-on question, which goes in the same direction also about here now about the antibiotic-eluting, settable bone filler. And can you share what the product would look like? So is it also a calcium phosphate or is it -- or what is it based on? And do you have anything to support that it also works? And what is reasonable to expect a clinical trial to resume? Or when is it going to start? And what would be the size of such a trial? And by when do we expect such a drug or product to be approved by the FDA?

That's a lot of questions. So I'm going to turn the technical expertise over to Joost, but relative to the initial technology, we've noticed -- we highlighted that we would have that available without antibiotic as a settable bone void filler focused on the bone growth capabilities, obviously, focusing on the granular, the microneedle structure that we already have.

And so that material is in development, will be released within the next 2 years, does not require a clinical trial. It doesn't mean we won't do one. Certainly, the animal work and some of the technology, I'll leave over to Joost.

Yes. So the animal work is on its way as we speak. The material itself is a calcium sulfate, like other injectable settable bone growth fillers with MagnetOs. And it's been mentioned before, MagnetOs will provide the osteoinductivity. Calcium sulfate is resorbing quickly. You could add your antibiotics to the calcium sulfate, which is what has been done also with competitor products.

But what Mr. Golberg rightly said, the question is, should we even do that because maybe some surgeons will just apply the antibiotics to this cement. That will be longer term, by the way, that product will be -- if we're developing that will be, I think, 3 to 5 years at least. But yes, so the product that currently we are developing without antibiotics is calcium sulfate with MagnetOs.

And as I mentioned in that -- previously, in that midterm column, which is where this resides, is currently in research. So to Joost's point, we're evaluating it internally. We're evaluating it in various formulations in different models, but it's not an active project with a time line. So it's impossible for us to speak or make an estimate on project approval because we're just still formulating exactly what we want to definitively pursue.

And that's for the antibiotic-eluting piece. The other one is active, in development, sub-2 years.

I have another question, and it's related to our Medtronic partnership. How is it going? And in the same way is also the question, is there a possibility for patients also to ask a surgeon to use MagnetOs or demand it?

Power to the patient. So I think that -- first off, the Medtronic relationship has been going great. I think the relationship that we signed, we started with a pilot program and then when we signed the relationship January of '24. '25. I forget what year it says. It's been great. We've been -- it's worked for both parties.

We've added numerous physicians and onboarded numerous physicians. We've been able to partner with them in certain territories and geographies in the U.S. And they've been able to fill a gap in their portfolio that exists that they don't have a product to service. When you look at their portfolio, and they have the BNP product, which is very effective, but at a higher cost than a Grafton product. They didn't really didn't have anything in the category in between. And so this really was a strategy for their end to fill a gap in their portfolio. The territories that we're working together with them in has been very successful. So all in all, great partnership.

And then the second question was patients. Yes, patient advocacy is great. Ask for it by name. Let's know how we can help.

Yes. I would add, I'm a large proponent of patient education. And if the patient often when they are going into these procedures, they're in pain, they're suffering, a surgeon is offering a solution. And often, they're not in a real position to like ask the details of exactly what's going to happen in my surgery.

Specifically, what else other than maybe the metal is going to go in and what's going to happen and what is it and how does it work? And so I like the idea of patients educated to a point where they can ask the question. Are you using a biologic? If so, what is it? And why do you have confidence in it? Maybe a patient is educated to the point where they say, I prefer to not have other human tissue implanted in my body. There are some religious groups that are very much against that. So we have an opportunity there. But on the marketing side, we do put content out in social media and through other channels in an effort that patients find us, become educated and just ask the surgeons their questions.

I'd just like to add that it's quite a long part of the consenting process is the use of biologics. So if you're going to use human tissue, you have to have their consent in writing before the case. And you can't -- for example, if you decide during the case, I need to use something, you can't then go and borrow something from another hospital because it's not allocated and pre-organized in that patient's name with that human tissue authority regulatory number on there.

So actually, technically, using human tissue is a big technical challenge for us. The other thing is it has to be available on the shelf. If the patient came in and said to me, I'd like to use MagnetOs and I'm in a hospital that doesn't have MagnetOs on the shelf, then I can't use MagnetOs because it's not there. So yes, it's irrelevant what the patient says if it's not available on the procurement side.

So an additional question would be probably to Daniel now. Is there any plan to also show the split of the sales in the different areas where we are active?

Yes. I mean, as Chris already said, I mean, once it's obviously reportable, then we will do it. So to answer your question.

And the last question online here is, is there any plan to go into animal health care?

Much like dental, the challenge there is the size of the market and the need. And so we can only do so many things. And so the size of that market is quite small. And so sadly, we won't be pursuing the veterinarian if somebody wish to partner with us, and we might go down that, but it's not a topic of focus for us.

The sales channel challenge is.

Yes, the sales channel there is very real. It's a problem, challenge, not a problem.

Okay. We have no more questions in the room. So I'll hand it over to you, Chris, for closing words.

First off, I want to thank you for the panel. Mr. Goldberg, thank you so much for your words, your guidance and certainly your clinical experience and how you use the product and also how you treat your patients. It's very enlightening for all of us, even those of us who have been in the community for quite some time, we always learn something new. So thank you very much for your participation.

It's an exciting day for us when we get to share a little bit deeper about how our business works and how we operate. It's also even more exciting to share when we're executing on all fronts, and then we're adding new business opportunities to the business. And so very excited with both the outcome and hopefully, the message we were able to deliver today.

So I thank you for your time. For those of you online, thank you for tuning in. Yes. Thank you very much.

Welcome to the Kuros Biosciences Full Year 2025 Financial Report. I will now hand over to Alex Muller from Investor Relations. Please go ahead.

Thank you, operator, and good afternoon or good morning, ladies and gentlemen. I welcome you to our presentation of Kuros full year results 2025. My name is Alex Muller, and I'm responsible for Investor Relations, and I'm joined today by Chris Fair, our CEO; and Daniel Geiger, our CFO, who will present the full year results.

[Operator Instructions] I would also like to remind you that the slides from today's presentation as well as our press release and annual report are all available on our website.

And with that, I would like to hand over to you, Chris.

Thank you very much. Good morning, good afternoon, and welcome to the 2025 year-end results of Kuros Biosciences, and a look forward to 2026 and beyond. As stated, I'm Chris Fair, CEO of Kuros, and I'm joined by Daniel Geiger, Chief Financial Officer.

Before we get started with the review of the results, I'd like to say thank you to the many, many people that make this possible. First, to my teammates across the globe, who continuously put forth great effort and care that has allowed this company to achieve such great success.

Secondly, to the surgeons and health care providers who have put their trust in our products so that their patients can begin their healing journey; and to the investment community and our Board of Directors, who entrusted myself and our management team to execute the plan before us, I thank you.

So with that, let's review the results. We are pleased to report that Kuros once again has overachieved guidance on revenue and provided a first-time profitability for the group organization, growing the business over 72% from year prior to $146.1 million in revenue and a $19.6 million adjusted EBITDA, resulting in a first-time net profit of $2.6 million.

Kuros certainly has continued our trend of growth in the top line revenue, but we have also executed in an operationally and financially responsible manner. We have $19.8 million in cash. We are debt-free, and we have a strong operating cash flow.

Our strategy to become a global and trusted leader in orthobiologics starts with having the right technology backed by clinical evidence. It also has a robust execution on the commercial channel and continuous improvement of our operations. When looking at 2025, I am happy to report we executed flawlessly in each of these areas.

We've launched new products such as the MIS Delivery System, which immediately expanded our customer base and a growing platform of revenue. We continue to expand out our commercial footprint across the globe and even at the end of the year with multiple health system approvals in the U.S. as well as being granted MDR approval in the EU. Neither of those are easy accomplishments.

We expanded our sales efforts into the foot and ankle segment, which resulted in our launching and enrolling patients into the ASTRA trial. We continue to lead the way in the marketplace in clinical evidence, presenting data and engaging the surgeon community on numerous events. In an industry first, we published human biopsy data that reinforces our clinical differentiation of MagnetOs. Just as important, we continued our investment in scaling the operation.

Initiating the building of our facility in the U.S. as well as improvements to existing infrastructure, with such explosive growth, activities ranging from the launch of the ERP to multiple operational initiatives, our company did not experience a single back order.

When looking at how we're building Kuros in the markets we serve, this $5.5 billion marketplace will continue to grow to over $8.2 billion by 2032. We're well positioned to capture market share. Markets like oncology, where we expect publications later this year; markets like trauma, where we intend to expand commercial efforts as well as initiate clinical studies. We are positioned to win and be the global leader in orthobiologics.

When we dive into some of the commercial statistics, it's clear we're executing on all fronts. We're adding sales agents. We're adding hospital accounts. We're adding surgeon customers. We doubled the percentage of spine surgeons who utilize MagnetOs in their practice from 7% to 14% in just 1 year.

We've expanded access to our channel with new nationwide hospital approvals. And the recent MDR approval will help pave the way for our commercial efforts in Europe for the years to come. Through the expanded adoption of our technology and our increased number of partnerships, we have absolutely strengthened our commercial foundation for the future.

At the core of our success is our continued investment into clinical evidence. Our 3 Level 1 trials that are highlighted here, ASTRA, PROOF and PRECISE; are all actively enrolling patients.

Now we invest in these studies not for regulatory approval, rather for supporting clinical proof and to provide comfort to our surgeon customers that the products that they have chosen to treat their patients with are backed by human clinical evidence, not solely animal data or marketing materials. And as we look to the future, it is our organic pipeline fueled by our attention to the voice of customer that will drive innovation and top line growth.

The launch of the MagnetOS MIS platform is a result of listening to our customers and our partners so that we can provide a best-in-class delivery system that helps to make surgeries become more efficient with a best-in-class biomaterial.

Our R&D hub in the Netherlands is pretty busy. Coupled with our expanding manufacturing center in the U.S., we will see new products that will access new markets and expand the total overall available market beyond what we serve today.

We have continued our investments into the infrastructure of Kuros, and Daniel will go through this in detail. But we have kept up with the commercial successes, and we continue to ensure we cannot just supply but also improve on our operational platforms. Our regulatory and quality teams have had numerous successes in 2025, culminating with the MDR approval, again, as a great competitive advantage in the EU.

In addition, our U.S. facility expansion is on track for producing products in the second half of 2026. While we do this, we optimize and expand the innovation hub in the Netherlands.

This dual source manufacturing derisks the overall business as well as provides financial advantages by providing products closer to the markets they serve. It also increases the capacity for growth, not just for MagnetOS, but to other future product platforms we will develop.

So with that, I will turn it over to Daniel. Daniel?

Thank you, Chris. Let me start with Slide 11. What this slide shows very clearly is that the revenue scale is now translating into operating leverage. We continue to grow strongly, and 2025 delivered the largest absolute revenue increase so far.

At the same time, fixed costs have grown significantly slower than revenue. This is an important inflection point. It tells us that the investments we made in systems, organization and infrastructure since 2023 are working and creating the respective profitability. The key message here is simple. We are not just growing the top line, the economics of the business are improving as we scale.

On Slide 12, I want to focus on two aspects: gross margin protection and commercial efficiency. Despite strong growth and external factors such as U.S. tariffs, we maintained solid gross margins in 2025. This reflects deliberate inventory planning and disciplined supply chain management. Overall, we therefore only incurred around USD 2 million of tariffs.

At the same time, sales and marketing expenses as a percentage of revenue are trending down. Please consider that these numbers include share-based payment charges. If you look at the cash impact only, the trend is even more improving. This shows that our commercial model is scaling efficiently. So the key takeaway from this slide is that growth is disciplined and sustainable and margin protection remains a clear priority of Kuros.

We continue to invest into R&D to support innovation and clinical evidence, which is essential for the differentiation of MagnetOs and Kuros overall, and specifically clinical data is a core USP. Importantly, while absolute spending has increased, both R&D and G&A are declining as a percentage of revenue.

However, given we are a scientific-based company, we will continue to invest into clinical data such as the ASTRA study along the building blocks we have always given to the market in the range of 7% to 9%.

With regards to G&A, our improved cost ratio reflects improved efficiency, digitalization and organizational maturity. From a CFO perspective, that's exactly what I want to see, investment for future growth combined with scalable cost base.

Slide 14 marks a key milestone of the company. In 2025, we achieved an adjusted EBITDA margin of 13.4% and delivered a first-time net profit ever. This improvement is driven by operating leverage, not by one-off effects. So this is clearly sustainable. Revenue growth is now outpacing the fixed cost base in a meaningful way.

It's important to understand that by switching the reporting currency from Swiss francs to U.S. dollar, the company is now economically protected for any FX movement against the U.S. dollar. Any translation impact, which is the major contributor of the financial result, will be offset by currency translation adjustments in OCI so that equity is restored.

Furthermore, on the tax side, we were able to implement Switzerland as a wholesaler and therefore, see now the first benefits coming through mainly on the tariff side. But we also expect to have in 2026, some benefits coming out of Switzerland on the tax side. Our adjusted effective tax rate came out at around 17%, which is in line with the guidance given.

To summarize, this picture confirms that the Kuros business model has reached a level where it can generate sustainable profitability.

We ended the year with strong liquidity and no debt. As in 2024, operating cash flow is supporting continued investment in working capital and capacity expansion. This means we are financing growth from a position of balance sheet strength without relying on external funding.

In terms of CapEx, we will invest substantial amounts into the U.S. as well as further optimize the innovation hub in the Netherlands. Overall, we will spend around USD 10 million to USD 12 million in the U.S. and around USD 2 million to USD 3 million in the Netherlands on top of another investment into IT applications of around USD 1 million. From a financial perspective, Kuros is well positioned to fund its organic growth path.

Let me now put it all together. Between 2023 and 2025, we deliberately invested ahead of growth to build an operating platform that allows Kuros to scale without losing control. Functionally, we strengthened leadership depth, quality systems, compliance and governance. This is a prerequisite for scaling a listed medtech company in a controlled fashion.

Structurally, we are moving to a dual production footprint with scalable capacity and higher supply chain resilience. This is about derisking growth and ensuring reliability as demand grows. Digitally, we now have an ERP and an MRP backbone in place. This supports planning discipline across inventory, production and working capital and reduces execution risks as volumes increase.

Importantly, we are about to integrate the front end and the back end of the organization. Commercial teams, R&D and clinical are fully supported by operations, finance, IT, legal and HR. 2026 will serve as a transition year to complete the business transformation, accelerate pipeline expansion and product launches, reinforce supply chain resilience and further digitize the platform to drive operating leverage and scale.

The conclusion is straightforward. In line with our guidance, the operating platform built between 2023 and 2025 and completed through 2026 is expected to support continued revenue growth and margin expansion through 2028.

With that, I now hand over back to our CEO, Chris, who will walk you through the 2026 guidance and how we see the path to 2028. Thank you.

Thanks, Daniel. Great work. As we bring the presentation portion to an end and open up for questions, it's my pleasure to provide guidance going into 2026 as well as midterm guidance into 2028.

In 2026, through our investments and as you've heard, increased market acceptance, we are providing top line guidance of at least 35% growth year-over-year and around 14% adjusted EBITDA margin. In addition, as we look to the midterm guidance, we anticipate that Kuros business will be between $300 million and $330 million in revenue with greater than a 20% adjusted EBITDA margin. That sounds like an exciting future for all of us.

So in summary, 2025 was another remarkable year for Kuros. We overachieved in every category imaginable, and we continue to set the pace in our marketplace. We delivered profitability for the first time to our investor community. We continued explosive growth in the top line, and we picked up wins in regulatory, international and operationally.

But we're not done, not buying a long shot. We have merely set the foundation for this business. With our increased focus on innovation, we will bring new products and new categories to Kuros. With our U.S. operational footprint active in the second half of 2026, we will see future lift to our financial effectiveness.

We continue to add experienced and talented people to this organization across the globe, setting the example of what a great team looks like. I'm very proud of what we've accomplished, but I'm even more excited of the future to come. We will accelerate into 2026 and beyond based on this position of strength and become the global leader in advanced orthobiologics.

So I thank you for your time and your support. And I will now turn it back over as we enter the Q&A portion.

[Operator Instructions] And our first question today comes from the line of Laura Pfeifer from Octavian.

Laura Pfeifer from Octavian here. I have three of them, please. So first, on your target to reach 300 million to 330 million in sales by '28, could you give us a little bit more granularity on how much of the growth you expect to come from Spine versus the newer segments such as extremities and oncology? And just to confirm, is this entirely organic?

Then secondly, on margins, it seems that the Q4 '25 stand-alone adjusted EBITDA margin was above 16%. I understand this is typically a seasonally strong quarter. But nevertheless, was there anything unusual supporting margins in this quarter?

And then related to that, should we think about your around 14% adjusted EBITDA margin guidance for '26 as more of a floor, given what I just said on Q4? And I guess here, the aim is really to get a better understanding of what are the key assumptions and investment areas behind that margin guidance.

And then maybe the third one is a rather quick question on tariffs and your U.S. production plans. You previously mentioned the tariff impact of around 6 million to 7 million for this year. Is this still the right number? And how should we think about the ramp-up of U.S. production and the share of local supply for the U.S. market then from H2 '26 onwards?

Now Laura, that was more than three questions. I'm just kidding. But I'll take the first one, and then I'll have Daniel drive the other ones and add commentary.

When we look at the guidance from a revenue perspective, we start with an organic pathway first. And surely, when we look at what we have in the pipeline with what we've already developed and we continue to launch into these new markets, we believe that the majority of this, if not all of it, will be all organic. We may find technologies along the way. But I can say right now from an organic path, we believe we will hit those targets.

The question as far as breaking down between Spine, extremities, oncology, et cetera, we have not done that in the past nor are we in a position to do that today. But I do -- we will obviously be a large portion of that being in the spine marketplace due to the size of the spine marketplace infusion will always be kind of our core marketplace. But the extremity business is growing rather rapidly, and we do see great opportunities there.

And so with that, Daniel can take on the tariffs and the EBITDA questions.

Yes. Let's first cover the tariffs. So basically, as said, in '25, we spent about 2 million or basically, we had about a P&L effect of 2 million. In '26, we still see it in the neighborhood of 6 million to 8 million.

I mean, currently, the situation is the following that as of the 24th of February, we are not paying any tariffs anymore through our customer agent, but we obviously accrue now for the 10%.

So forgive me if the picture right now is a little bit blurred to make exactly the estimate how this will play out, right? But overall, we believe definitely the 6 million to 8 million is a good number still. And then we'll see what the future will bring.

Is that good enough for you?

Yes, yes. But then maybe on the U.S. production to really know when we will have like a bigger share of U.S. supply.

Yes. So basically, the plan with the U.S. production, as you know, is to go live in H2 '26. It normally takes from start to finish about 3 months to 4 months to push it to the market. So we believe that in Q4, we should be able, if all goes well, to deliver the U.S. market from the U.S. And then we would obviously start to manage the tariff side concurrently. But that's the current plan that we would produce to market in Q4 out of the U.S.

All of it?

Well, all of it...

It's a transition time, right? So depending on -- not to give away our entire manufacturing strategy, but we're also derisking supply side in 2 different locations. And so it will be a feathering down, if you will, from one site to the next and then again, regionally supplying.

And then on the margin side, so your question was, was there anything special in H2?

No, I was referring to Q4 because I think when I do the math, it seems that you had an EBITDA margin and adjusted one-off, I think it was 16.5%, which is really high. I was just asking if there was anything special in that quarter that gave it a little bit of a margin boost.

Well, we have just, in general, seen a little bit a slowdown in the hiring than we planned initially. So we initially planned to hire roughly 190 to 200 people. We were a little bit below that, which contributed to that. And at the same time, we have seen some less spending for clinical studies. which was mainly a delay in terms of spending, which will be moved into the next quarter.

And on top of that, we now see clearly also the benefits kicking in from a digitalization perspective. So we were able to maintain, for example, in the finance department, the FTE level and even start to reduce that number as we have seen in the past. So we see now a combination of all of this.

But as said, in 2026, the target, and I think we positioned that also during the Capital Market Day, is that we continue to invest into product engineers, into quality people into IT engineers and in general, into operations to basically get ready for this transition to the U.S. And this basically will have some implications on the margin, of course.

But as I said, I mean, this is an investment into the future, which should then allow us to expand the margin in '27 and '28 to the at least 20% margin. But your question is right or your observation, I think the 14% we also consider more as a floor. That's right.

There are currently no further phone questions. I will now hand the call back to Alex for the webcast questions.

Yes. Thank you. So we have some incoming questions also here online. So I will just sum up a few that go together. So one -- obviously, one of the major questions is also concerning Medtronic. So how is the partnership going with Medtronic? And any chances in also giving some more details about revenues and the revenue split? And how the sales force from Medtronic has been integrated? And how -- yes, how the split of the different channels between Medtronic and Kuros is going on?

Sure. No. Thanks, Alex. The Medtronic relationship continues to be very positive, I think, both for them and for us. From a sales force integration perspective in the marketplaces where we have agreed to partner together, it's been a very -- it's been a great success for both parties. We also work with independent agents outside of the Medtronic relationship. And so with that, we continue to grow at about the same cadence inside the Medtronic relationships as well as in the non-Medtronic relationships.

In addition to that, we're growing our revenue base with in the extremities, which obviously is outside of Medtronic's call pattern. And so from all that perspective, I think we're doing a really nice job of managing the different sales agencies that we work with, including Medtronic.

We don't report out the data just as a habit. But again, I think that the rest assured that the relationship has been positive. And in the marketplaces where we work together, it's done extremely well for both Medtronic and for us. So again, at the end of the -- I guess, we're 1.5 years into the -- a little under 1.5 years into the agreement. So all things moving in the right direction.

Excellent. So the next question would be in terms of other segments like extremities. So what is the expectation in terms of the growth dynamics also for this year?

I think from a growth perspective, a lot of our focus now is -- if we think about what we did in 2025 was validation. In 2025, we spent the time making sure we had the right products for the right applications and the right procedures. We worked with a core group of physicians to ensure that, that was all working in the right direction, getting the right results. And that was all affirmed.

And we also wanted to make sure we knew which study we were going to do and take on. And again, in this space, in the foot and ankle, there's only been one other trial in orthobiologics in the past dozen years or so. And that trial was done for regulatory purposes. So the lack of data in this marketplace is astounding. And so we launched the ASTRA trial in support of this small group of physicians.

And so as we were doing that, going into 2026, we began to increase our efforts on the commercial front. We identified specialists with our organization, which we're bringing onboard now to work with our existing sales channel.

So again, leveraging our infrastructure that already exists servicing the spine community, we're able to add just a handful of people to provide the expertise and the knowledge in the extremity space to really make us even more effective in that market. And so we're adding sales agents in that marketplace. So we do see exponential growth.

Now mind you, the sales -- although the sales price per unit is about the same, the quantity of material used in a foot and ankle surgery is much less than, say, the quantity of material that's used in the spine surgery. It just makes sense if you look at your foot and then look at your back, one is bigger than the other. And so you're going to use more material in one and less in another.

But the procedures that are in foot and ankle are -- there's a high number of them. So the marketplace in foot and ankle is about $450 million compared to the spine marketplace. But we do anticipate a great deal of growth and bringing surgeons on board and expanding our foundation, our footprint in that marketplace.

Excellent. So from the next person, you have two questions. Firstly, could you please elaborate on the trauma target market? Will this see you competing directly in the [ cements ] market, which previously was seen as an adjacent market? And secondly, can you give us more detail on the IDN contract wins, specifically which regions and whether this gives you more leverage over Medtronic and the selling agents in terms of commission paid?

So I'll take the last one first and the first one last.

So on the IDN agreements, we actually received multiple national agreements towards the end of the year. And so that opened up access to almost double the amount of hospitals that we were currently servicing. They are national agreements. So they're not regional, they are national agreements.

And so with that, does it provide an advantage against Medtronic or it really provides an opportunity for all of the sales agents that we integrate and work with. And so whether it's a sales agent for Medtronic or whether it's an independent sales agent in another territory, this is a great benefit for them to get greater access to greater customers.

As far as leveraging that for commission reduction or things of that nature, we're focused on growing the revenue. I think that as time moves forward, as we fill the bag, it's going to be really evident that the sales agents that we partner with that partner with us to keep them working with us, I think that, that's going to be a big benefit. But again, we're focused on growing the revenue, the access to the customer. We're still a growth engine relative to that.

The second part of that question, which related to target markets in [ cements ] and bone support and trauma, the trauma marketplace for bone fusion is still actually pretty large, whether it's upper extremity, whether it's pelvic extremity that you're not using a cement base. you're still using a product that is to grow bone like MagnetOs.

And so that is not a competitive. And again, I know we talk about this quite a bit, competitive nature versus, say, a bone sport or any other type of cement like bone void filler. So there's a huge marketplace over $450 million available to us just in bone grafting material for trauma indications. It is -- we're getting clinical results back in currently.

And so those products in those -- in that study will be kicked off the second half of this year. And again, just for a bone fusion product using MagnetOS. Now whether we compete in the [ cement ] marketplace is yet to be seen. That would be -- if we were to go down that path, that would be a separate product line or a product development effort.

Great. So I have a next question, which goes a bit in the same direction. So can you give us a high-level idea of kind of new products you aim to introduce? When you expect them to launch? And by when they should start and materially contribute to top line?

Sure. Well, obviously, with a 300 million and 330 million target out there in the midterm, we're going to have to develop some new products and push them out into the marketplace as well. So we're very active, as I mentioned, in the Netherlands with our R&D hub there.

And so as far as giving a detailed product line or market, we're not at the point where we'd like to give that. We'd like to do that closer to launch. But needless to say, in the markets that we're going after, we are going to be leveraging not just our knowledge base that we have organically, but also the foundation sales force that we put in place. We will now have a sales force in Spine and a sales force in extremities and foot and ankle and trauma.

And so you can imagine all the other biomaterials that incorporate into those sales forces is what we're looking to bring forth. And again, having an organic understanding of how the body likes to respond to bone and bone-like products, you can start to dial in what technologies we might be developing in the future. But we will -- as time moves forward and we get closer to the timelines of launch, we'll be able to highlight those product launches.

Great. And then can you also elaborate on the market dynamics? And from which segments you are taking market share of? Is it bone graft space, allografts, synthetic, so give it the granularity where we are winning market shares and how it's developing.

Yes. So I think that the biggest market share shift we see is in cellular allograft. Cellular allografts have been in the U.S. marketplace for quite some time. However, to date, there is no publication of any Level 1 data that is -- has shown effectiveness of these products. More than likely, our study that is doing a head-to-head comparison, will be the first Level 1 study to publish any information on any cellular allograft.

And so from our perspective, when a surgeon sees the data that we're putting forth, and again, cellular allografts tend to be around a $400 million to $500 million marketplace; we're seeing a great deal of transition from those surgeons.

We're also seeing hospital systems wishing to remove that category because they also recognize they're spending a great deal of money on a product that has not only no clinical benefit published, but also there are still risks relative to disease transmission as has been reported before. So I think cellular allograft will be number one.

Any of the advanced biologics that we see out there, we do see some migration. We also see some migration from standard bone products such as DBM, although a less expensive alternative, we're showing such a great effectiveness that in some areas, they are willing to spend a little bit more money on a product that they know is going to work versus a product that may or may not work. So we're seeing a little bit of migration from there as well.

But I would say traditionally, and a large part of this is coming from cellular allografts, secondarily from other advanced biologics, certainly some other synthetics and -- yes.

Another is a block some more, let's say, about financials. So could you walk us through the key drivers behind the significant gross margin improvement? Do you expect this trend to continue? And what target gross margin level are you aiming for?

Gross margin remained at around 90%, which is our historical gross margin. So there's not really a change there. I mean what I can say is that with the tariffs now kicking in, obviously, we had some implications. So we always mentioned that it will be in the neighborhood of 1%, probably a little bit more. Obviously, in '26, we will now see how this plays out. I said, it's in the neighborhood of 6 million to 8 million. If you adjust for that, then we will remain at the 90%.

What we can see by shifting to the U.S. is that we see a little bit higher labor cost in the U.S. But labor overall from a production cost perspective, is just about 10% of all the material cost. And therefore, we don't believe that it will have a substantial impact on gross profit.

And at the same time, we believe that the inbound transportation cost from the Netherlands to the U.S. will obviously also be optimized. So we can see that there is some leveling off there. And therefore, we are quite confident to maintain the gross profit margin guidance also on a go-forward basis with 90%.

So -- and the next question is about, let's say, top line growth. So we are guiding for 35% growth in '26. So does that mean that possibly 30% in '27, 30% in '28 so that we can reach 333 million in sales in '28?

Yes. I think it's pretty much a standard math grid. Somebody wants to break out the Excel spreadsheet, they can go ahead and build that curve, to get us to the 300 million to 330 million. Again, these are big numbers that we're growing into. And so yes, I think that, yes, at least 35% growth for next year -- for this year.

So the next question would be about the operating leverage. So is with all this operating leverage that we have currently and the scaling effects kicking in, shouldn't the EPS, the earnings per share be a bit higher? Can this mostly be attributed to dilution from share-based compensation and therefore, also the increased shares outstanding?

Well, I mean, first, I want to say it's the first time we have a net profit. So I'm quite glad that we can now disclose earnings per share. So just to be clear.

And secondly, we will continue to offer LTIs to our employees also as a retention tool. That's important. But we have overall right now about 2.8 million of LTIs outstanding.

As you know, it's -- I think it's disclosure Note 21. I can't remember the page, but you can look it up there. It's about 2.8 million, as said. And yes, of course, this has a dilution effect on top of the 39 million shares. So if you do the math, it will give you the results we have presented now in the financial statements.

Excellent. So now the last question that I have online here, let's see. With 45 million in Q4 with you exit 2025 at a monthly run rate above 15 million in sales, assuming sequential growth through the quarter. If you assume no growth from this level and multiply by 12, assuming exited close to 16 million, you are already at 32% growth for '26. Why does your guide assume no sequential growth through the year?

Yes. Look, I think that when we -- historically, both Daniel and myself, we believe in providing guidance and information. Again, it's not too long ago where we didn't provide any guidance. And so we're very cautious to make sure that when we provide guidance or we provide information to the marketplace that we achieve it.

And I think that when we look at the marketplace and also recognize the fourth quarter is always heavily tilted, when we start looking at the market's percentage of revenue in the first half versus the second half, December is traditionally the largest month because we have such a large exposure in the international marketplace -- I'm sorry, to the domestic marketplace, all those things come into play.

And so it's very difficult to basically just take the last month of the year and straight line that as suggested and take that on a go-forward basis.

But when we look at all the challenges we have ongoing in the organization, but continue to grow at such a high percentage, especially compared to our peers, a marketplace that's growing at around 6% to 7%; we're putting forth saying that we will at least grow 35%. And so we're continuing to take market share going into this.

I think, again, that number puts you in and around that $200 million mark, give or take.

And so that's a significant business in the orthobiologics space, certainly the largest outside of BMP, largest product line in that space. Those are massive accomplishments. And so again, part of this is caution relative to how we have communicated to the marketplace. Part of this is also looking at -- it's still tremendous dollar growth within those markets. And we're also investing in infrastructure along the way.

So we feel confident in the guidance we're putting forth. And again, also leaning into how we have communicated to date quarter-over-quarter as well as how we have delivered quarter-over-quarter.

Okay. Thank you. Then there's a next question Well, that's beyond the guidance. But what do you think the potential is for EBITDA and the EBIT margin in 2030?

2030? I mean, look, we have given for the first time guidance for '26 and up to '28, and we feel comfortable with the plus 20. And after that, we'll see how we further progress. But right now, this is what we are willing to offer.

Thank you. There are no further questions online. So I hand over to the operator if there are any further questions by phone.

[Operator Instructions] We just got a question in one moment, please. And the question comes from the line of Laura Pfeifer from OCtavian.

Maybe just one quick follow-up question on the MagnetOs MIS launch. I think it happened in October. Just wondering if you could share a little bit more details on how that launch is progressing? What share of revenue does it already contribute? And maybe also, what is your expectation for the '26 contribution of MIS?

Thanks, Laura. Love repeat colors. The the MIS was a great launch for us. We launched that in the fourth quarter, and we are seeing great uptick. And I'll tell you a couple of things we -- it's validated but also learned.

We're finding that surgeons are using it not just in MIS procedures, but also in open procedures where they traditionally weren't using that delivery mechanism. And the reason being they had greater access into what I'll call the nooks and the cranies of the space, whether it's in the spine or other areas of the body of applying our material.

So I think that from an MIS perspective, it certainly has achieved the results, and we're seeing uptick in surgeons requesting the product. And so I think also from a spine perspective, we're getting access into spine procedures and open procedures where we didn't anticipate it.

And so all that is a positive thing because -- it also increases the ASP of those surgeries. As far as breaking out the revenue, we haven't done that to date. We haven't broken down product line contributions, and I don't want to start that habit today.

As far as going forward, we think that we're seeing certain procedures in foot and ankle who are desiring a similar mechanism, maybe even a smaller joint. And so we're looking at ways to optimize that technology to get into smaller crevices and smaller joints. And so we're also seeing even in trauma.

And so once we put the product out there, it certainly met the indications, but we're finding new nuances and new procedures that we can apply this to.

It also helps from a contract perspective as we look to add the product to existing contracts or open up new doors and new contracts because, quite frankly, there's not many other technologies out there that have such a delivery mechanism. So it certainly is a door opener for many surgeons who may not be using our product. So for all intents and purposes, the MIS delivery platform has been a home run for us.

There are no further phone questions. I will hand the call back to Alex.

Thank you. There is one last question here online. So of the surgeons that are using MagnetOs, do you have a feeling for how the product is growing in terms of the share of their procedures?

Yes. So we don't have the data to be able to put forth, but I'll tell you what traditionally happens with physicians when using a technology for the first time. normally, they'll have a subset of patients that are a challenge for their healing, as an example, or they don't want to use a specific product for an application. So it may be an advanced biologic that has challenges in posterior cervical. So they might give us a chance to work with them in posterior cervical.

They'll do a handful of patients and then wait and watch and look at the results. And so once those results come in, and that tends to be around the 3-month mark, 4-month mark, 5-month mark where the patients come back postoperatively and they're seeing the results. If they feel confident in those results, then they're expanded to other parts of their practice. And so that is a traditional pathway that we see physicians take.

What's interesting in the spine marketplace is that we are no longer in the early adopter part of the curve, we're in the meat of the curve. And so what we're seeing in that marketplace, we're seeing surgeons who have seen their partners have great results and they're adopting the technology into their practice.

They're not going through the same cycle, but our extremity physicians are doing the same behavior that the spine surgeons. So they will take a challenging fusion patient population, start there, see how that works, collect the results and then move on to their other fusion-based procedures.

Same thing happens in the trauma market. Right now, we're identifying the right procedures in the trauma marketplace to do this. And so that is the methodology of how a surgeon will walk through how they incorporate it into their practice. When we report the results, of 7% to 14%, again, just trying to get the actual data on procedures is a little bit of a challenge in the U.S. marketplace; but we're able to identify surgeons and how they're growing within the practice and what procedures.

So at least in one portion of their market and one portion of their procedure volume, they are using us on a continuous basis. And that's how we reported out that 7% to 14% jump. We may not have 100% of their practice, but we're certainly evolving into it.

Excellent. So since there are no further questions, I would like to hand over back to you, Chris, and -- for final remarks.

So again, thank you for all the questions. Thank you for listening to us today for this past hour. A tremendous 2025 all around. And I think that as you've listened today, the infrastructure that we as an organization have put in place is truly foundational. And so we've been able to grow this business, again, since I've been here for the past 3.5 years or so, 1,000% plus, whatever it is.

And again, the team that we have assembled, Daniel talked about the number of people, truly tremendous professionals across the board. We are so happy and excited for what the future holds. 2026 is off to a great start.

And again, between the pipeline, the operational infrastructure that we're putting in place, we're excited and great things to come. So thank you for your support, and thank you for your time. And with that, I guess we'll say goodbye.

Good afternoon, ladies and gentlemen. I welcome you to our presentation of Kuros Half Year Results 2025. My name is Alex Müller, I'm responsible for Investor Relations, and I'm joined by Chris Fair, our CEO; and Daniel Geiger, our CFO, who will present the half year results. The presentation will be followed by a Q&A session, and you can submit your questions either over the phone or via the webcast tool.

I would like to remind you that the slides from today's presentation as well as the press release and the half year report are all available on our website.

And with that, I would like to hand over to Chris to start with the presentation.

Thanks, Alex. Good afternoon, good morning. It is a great day here at Kuros as we review the first half results, and we are very excited of the progress that we have made. Next slide. Here are our standard disclaimers.

Next slide. Our results of the first half have continued to show our execution and our commitment to growing this organization, not just on the top line, but also on the bottom line as we reported our first time operating profit of $3.5 million. In addition to achieving over $63.5 million in revenue, we also achieved many different achievements. First and foremost, the MIS first cases and soft launch of that product for the next organic product development.

Our growth in the extremities business continues to take shape and continue to grow steam. Our global expansion, as we've outlined in the past, continues to take hold as we bring on more countries. In addition, we've expanded into our investor initiatives by having our first Capital Markets Day in the first half of this year. All of this could not be possible without growing our infrastructure, most notably our U.S. headquarters production facilities in the Netherlands and looking to growing our production capacity in the U.S. in 2026.

As we look at our revenue growth, not just in the direct revenue growth, but overall revenue growth, truly impressive when we start looking at the percentage of a 78% growth. We've done all of this while growing profitability and again, having our first operating profit of $3.5 million with a very stable cash on hand even while making all of these investments.

Next slide. When we start to look at the numbers and where we are growing and how we are achieving such results across the board, whether it's hospital penetration, surgeon usage, growth in both spine and extremities, we're seeing massive growth and recognition from our customer base. The Medtronic agreement that we kicked off in January in the first half of this year is beginning to show even more promise than we had hoped for. So when we look at our surgeon utilization in spine surgeons, when we start to look at the extremities, which is really just getting started, we have a tremendous growth profile and again, overachieving our internal targets.

Next slide, please. Talking about international, this continues to deliver for us as an organization. Previously, this was a small portion of our business. Our goal to continue to invest in the international marketplaces to eventually get this to represent about 10% of our revenue in the future, we need to continue to invest in markets like Brazil that we've talked about. But as you can see from the countries to the right, markets that we are considering such as Canada, Singapore, Japan and even new markets in Latin America will continue to drive revenue in the future and deliver high profit growth in these focused markets.

Next slide, please. Talking about the extremities business, we are well on plan. We talked about the extremities markets only about a year ago when we began to start setting out a plan, identifying the opportunity, looking at what partners we will take shape, what surgeons we wish to partner with as we begin to move forward. And here we are standing a year later with revenue, engagement from physicians, expert SAB from Mr. Goldberg from the U.K., Dr. Greg Berlet, Pete Mangone, Carlos Sagebien, all working towards growing the extremities opportunity for Kuros.

We will be participating in key societies such as AOFAS and ACFAS. But again, launching specific technology materials and meetings focused for the extremity physicians. There's literally no company out there that's going to invest as much in clinical evidence in the extremity business than Kuros. We're very excited and very happy how this has progressed, and we continue to see desire and uptick from the surgeons in the community.

Next slide, please. We talk about clinical evidence quite often. And one of the things that we wish to make sure that all of our shareholders and stakeholders understand are the different levels of evidence. There is evidence that we would call Level IV or Level V evidence. These are lower level evidence and the bar or hurdle is very low. They are not randomized studies. They are simply one-arm single-arm studies, maybe 25 patients, et cetera. It's not that, that data is not valuable, but you need to look at that in accumulation with all of the data being provided.

When we start to look at Kuros and the level of data we have provided to our clinical community, we clearly set the bar. We have Level I evidence. We have continuing studies in Level I evidence. We have Level II, Level III and Level IV. But more importantly, when you look at the investment on the bottom part of this slide, random controlled trials are Level I evidence. We have several. There's 4 investigator-led studies, which is what ILS refers to, where we are supporting but not driving the study. So less control, but still Level I data. These are normally head-to-head studies.

So we continue to invest a large part of our R&D investment into these studies because we believe that the physicians, more specifically the patients and the insurance carriers will need to see this data to make the right decision of what product to use for their fusions. So again, this is a little bit of education as to how we look at levels of evidence when we discuss Level I, Level II, Level III or Level IV evidence and also the types of biologic evidence that exists out there. We are the leader in clinical evidence as far as synthetics go, and we continue to grow our portfolio of studies.

Next slide, please. Before I hand it over to Daniel to walk through some of the financial and profitability, it's really important to understand that not -- achieving top line revenue must come with changes to internal infrastructure, whether it's production, but also in order to keep that continuing to grow, we have organic development. One of the key initiatives that we undertook internally was looking at how we develop products organically. And so we've changed how we've done that.

We've reoriented the R&D efforts as well as from a product development process. So our internal team and leaders, when they look at the MIS and the launch of being on time on budget and out in the marketplace with a product that the surgeons want exemplifies that process. So we have changed internally, and this will make us more efficient for future product development on an organic pathway.

So with that, I'll hand it over to Daniel to talk into more of the financials.

And also from my side, a warm welcome, ladies and gentlemen. What we have done over the last 2.5 years is really to transform the business model, and we have focused on driving the volume up, but at the same time, keeping the fixed cost as moderate as possible. And by doing that, we were able to now optimize several aspects of the business model.

We have done functional alignment across the front and back end, but we have also and are starting now to increment structural enhancement to diversify and scale the production footprint. And we just recently implemented an ERP system in order to digitize the value chain. And by doing that, we were able to increase the operating leverage to benefit from that. And for the first time in history of the group, we have now achieved an EBIT of $3.5 million.

Next slide. If we deep dive into the margins, important to note here is really and we stressed that already in Q4, we have started to stockpile in the U.S. And in order to do that, we were able to protect the company against tariffs. So what you see as a result is that the gross profit margin has been well over 90%, and we were able to fully protect in H1 the company. So no tariffs were affecting the results in H1, while we believe and estimate in H2 that there will be only an immaterial effect coming out of the tariffs. Important is also that our supply chain, and we will see that also later on is coming out of the Netherlands. So the EU tariffs would apply here.

But as said, we were able to stockpile and we'll see the further measures we have taken in order to protect the gross profit margin. On the sales and marketing side, you can see that we were able to invest into a new business segment, Extremities and at the same time, keep the cost ratio to revenue well below 60%. And by doing that, we can demonstrate that we are able to invest into growth opportunities, but at the same time, gradually increase the profitability.

Next slide. If you look at R&D and the ratio there, you can see that this is in the neighborhood of 7% to 9% and before we move to P&L, I quick want to hand over back to Chris to talk about the phase-to-phase studies we are currently conducting.

Again, looking at the R&D development costs and our investments, a good portion of our investments come into clinical evidence. When we talk about studies of head-to-head, and we've discussed those in the past and certainly at the Investor Day, there are certain studies that are investigator-led or ILS. Those studies are studies we may support financially, but have no control over the development and the collection of data. So it's truly independent clinical evidence where we don't have any hand in the study, data collection, et cetera.

And so that's important to recognize a good portion of our investment in R&D does come from that, but we have several active studies going down that path. It also helps from an innovation standpoint. We do anticipate to maintain that percentage on a go-forward basis because we do believe our organic pipeline will be full. Daniel?

Percentage in comparison to revenue is now also nicely coming down. So we will continue to optimize and transform, as I said, through functional development and expansion, structural adaptation and automation and digitization of the value chain. So we should see that ratio further coming down.

Next slide. This now all leads to the adjusted EBITDA, which you have seen in Q1 being around $11.6 million or $3.3 million and now gone up to $4.5 million or 12.9% margin. Important is that we adjust currently for share-based payment costs, and we had some very minor costs coming out of Fibrin PTH. But overall, this business segment is fully discontinued.

Next slide. On the funding side, important is that we can fund the organic growth path completely internally. So we are able now since the second half of '24 to generate enough cash flow to fund the organic growth path. And at the same time, we're also able to invest into net working capital, CapEx and benefit from LTI, which is, in essence, exercises our employees are basically doing and funding our company for that. Important is also that we have now identified in Atlanta, a new production site. I come to that again. And we can foresee for the moment that we would be able to fund that.

If that would not be the case and we would need additional funding, we have secured also a bridge loan, which has not been drawn at all at this point, but would be in the background in case we would need it. Important is, I said that we will continue to invest into net working capital where needed, and we have a tremendous amount of cash and cash equivalents as well as trade and other receivables available in order to do that.

Next slide. The most prominent topic in the recent weeks was obviously the tariffs. And important here is really to say again how the supply chain today works. So today, we produce in the Netherlands, important is that tariffs are determined by country of origin and therefore, the EU tariffs apply. As we said, in H1, we were able through stockpiling to protect the company from tariffs. In H2, we will see immaterial impact. And what we are doing in the long run or in the midterm is basically that we are now going live in H2 '26 with a new production facility in the U.S.

This has been started well before the tariffs came into play or in discussion and will basically also allow us to derisk and diversify the production footprint. In order to also redesign the supply chain, we have also done some adaptions, which helps us to make use of the tax loss carryforward in Switzerland, which amounts to roughly $50 million and will also help us to implement some tariff mechanisms.

Next slide. Last but not least here, the transformation roadmap. So the most important initiative we did in the functional expansion extension was certainly to change the reporting currency from Swiss francs to U.S. dollars. This has been done to reflect the primary market of the company, which is around 95% and also important driver for our cost base. And at the same time, we have also increased our visibility and have now introduced 2 new analysts. So I welcome Thomas from Baader and Christoph from Kepler.

In the structural adaptations, we have done the implementation of the wholesale principle, which goes live basically now in October. And as I said, we have implemented an ERP system and have also importantly introduced the manufacturing resource planning system, which basically allows us to now automate and digitize also the supply chain.

And with that, I hand back to Chris.

Thank you, Dan. Next slide, please. One of the key objectives for this year from an organic product development pathway was the MIS. And I thought I'd take a few seconds to talk about why that's important and truly what does it mean? Minimally invasive surgery is the fastest-growing section within spine. And what it means is taking a procedure that was traditionally done open, if you look at the image on the left-hand side of the slide, where it's a larger incision and greater retraction of the vessels in the muscles in order to get to the spine to where the places you would put screws, cages and ultimately bone graft like Kuros, the surgeon is able to do this procedure using tubes or smaller incisions.

Now we don't provide the tubes or the implants, the instruments to do that procedure. They're doing that with somebody else's technology and company. And there are technologies out there that have figured out how to put bone graft down a small tube. And so when we looked at the opportunity in the fastest-growing subsegment of spine opportunity, having a minimally invasive applicator for our technology was the goal and to ensure we have best-in-class both from a disposable standpoint, but utilizing proven technology in the MagnetOs material.

So if we go to the next slide, this is what it looks like. We're able to take our technology, go down through existing tubes and channels that the physician is already using. But we are the only bone graft delivery system that is sterile, prefilled that contains no human tissue and is supported by Level I evidence. This is very important because there are some technologies that may have one of these, but none of them have all of them.

And so as we begin to roll this out into the marketplace and our initial cases have shown that from a manual approach of doing this, this can speed up the delivery time threefold. We will see more and more physicians rotating to this type of format from competitor formats. So we're very excited about this technology. It's early days of the launch, but the early days have shown and certainly confirmed that our R&D and product development teams and marketing teams really nailed the product feature set as well as utilizing technology that the customer is already familiar with.

So next slide. Again, when we start looking at our competitive technologies, this highlights there are technologies out there. Again, if they are using human tissue, we have shown that, number one, we have clinical evidence; number two, the results with those technologies do not truly stand up in a clinical setting. And this technology is ready and available off the shelf, does not need to be frozen. And so from a user experience, it is also improved and also at a very competitive price.

Next slide. So with that, and we look in summary to what we have achieved, and I couldn't be happier with the organization with where we are. We are well on our way. Our commercial growth drivers, both in spine and extremity are on point. They continue to overachieve the targets that we have set before them. We are seeing market share gains, not just in the U.S., but certainly in the rest of the world, EU and looking at new registrations, certainly 20 new registrations in 2026 is the target. Our partnership with Medtronic has lived up to everything we thought it would be. They are excellent partners in our commercial growth, and we continue to see growth in the future with them.

When we look to our organic pipeline, we completed with the MIS, with the soft launch on time, on point. We have several others in the pipeline and more on that to come. We are looking to try to launch new products every 18 months, if not sooner, with the new redesigned development pathway that we put in place. Most importantly, the operational and financial execution cannot go unmentioned. The launching of a digitization process of our entire business on point and on budget in coordination with doubling capacity in our facilities in the Netherlands and then taking on currently the manufacturing process in the U.S. so that we're able to manufacture in the second half of next year.

We are doing all of this with a strong cash flow and maintaining strong cash on hand and doing it with our own financial means. That is a tremendous first half for any organization. We continue to be on our pathway here. We have shown at least 60% growth as we gave guidance for the first time at the end of last year, 6 months ago, and we continue to work towards the goal of $220 million to $250 million in sales in 2027. And again, very excited first half and great results.

Next slide. So with that, I'll turn it back over.[ id="-1" name="Operator" /> [Operator Instructions] The first question comes from the line of Laura Pfeifer from Octavian.

Laura Pfeifer from Octavian here. I have 3 of them. And I would like to ask them one by one, if that's okay with you. So maybe starting with the strong growth that you had in H1, 78% and the unchanged sales outlook for this year. You're expecting, I think, at least 60% growth, which implies a slowdown in the second half. Could you please comment on the dynamics you are expecting for Q3 and Q4? I mean I understand that Q3 maybe includes a summer break, but is there any reason to assume that your growth will significantly moderate over the next 2 quarters given the Medtronic Alliance that would kick in, the MIS launch that you do and also initial sales maybe from extremities. So this would be the first question.

Laura, great to hear from you, and thank you for the question. I think that, first and foremost, it says at least 60%. I think right now, when we look at our first half revenue and percentage of first half versus second half, if we look historically, we do believe that to be in line. We have not changed our guidance, and that's more of a procedural thing as we've just recently given guidance for the first time. But we do not see any change currently to our percentage from first half to second half that we've seen historically.

Okay. So this means that it will be a similar phasing as last year. Okay. Very clear. So the second question concerns your underlying margin development. I'm referring here to adjusted EBITDA. So I think you have shown a sequential improvement in Q2 over Q1 this year. And I'm wondering as this is probably linked to the higher sales volumes, are there any factors that could prevent a similar gradual improvement in the second half over H1? And maybe then the same question applies to the next year, too. So do you expect an improvement in margins next year?

Yes. So I mean, as we said in the past, right, this corridor of 10% to 12% has now been overachieved. That's correct, what you stated. And we always said that we continue to invest into growth initiatives and at the same time, invest into transformation initiatives to further optimize and automate the business model.

Having said that, we have seen some timing effects mainly in the R&D area where we expect in the second half to come in at a certain point in time. So this would, to a certain extent, impact the margin. But currently, what we can see is that we can definitely keep that level. Potentially, we will be able to gradually increase that. But this is, yes, something we need to be seen once we have the Q3 results.

Okay. And then maybe on next year, I guess there is scope for further improvement?

I mean there's always scope for further improvement, as you can imagine. But currently, we will stick to that gradual increase of the margin. We see definitely potential there. As you have seen, the operating leverage is now nicely kicking in. And we will continue to work on that and optimize it. But at the same time, we'll continue also to invest into further initiatives to further digitize the value chain. So the whole functional adaptation, but also the supply chain adaptation and the value chain automation will continue. So this will further need some investments. But as I said, our commitment is definitely there to increase that gradually to come up to a peer level.

Okay. And then my last question relates to the tariffs and your U.S. production plans. I think you were quite clear in saying that there will be no material tariff impact this year. And I'm aware that you're not yet providing guidance for next year. But nevertheless, could you still give us an indication directionally of how much the potential or if any, potential impact you would see for next year? What mitigating measures you see as we probably have to assume that at least H1 will not yet be supplied out of the U.S. factory.

And maybe if I can just squeeze in here also, I would be -- it would be helpful if you could quantify the total cost for the U.S. site, what you expect to spend there?

So in terms of CapEx, we will invest between $5 million and $7 million next year and about $2 million to $3 million this year. So that's for the CapEx we're going to invest there. In terms of tariffs, as I said, currently, there are a lot of moving targets. As you know, I mean, first of all, the situation is changing almost weekly now or daily, and that's definitely a challenge for us to estimate how big the impact will be, but we believe it's somewhere in the single million where we would see that impact currently in the lower single digit.

Okay. But just to make clear, so this is including any mitigating measures, price increases or whatever?

Yes. I mean this is mainly from cost side, how we estimate it so far. We will further look into that. And as I said, I mean, we're also doing adaptations to the supply chain, which will factor in as well. And once we have a clear indication how this will affect and assuming that we go live in H2 of next year, I believe that's the best estimate we currently have.

[ id="-1" name="Operator" /> [Operator Instructions] We will now take the next question from the line of Thomas Mayer from Baader-Helvea.

Thomas Mayer from Baader-Helvea. I just have one question actually, and it would be about a bit more of a forward-looking statement or forward-looking predictions about the development in the extremity segments. Can we assume that we'd see something similar as Medtronic for a partnership as the commercial rollout progresses?

Welcome, Thomas, and thanks for the question. It's interesting. When we look at our partnership with Medtronic and how that developed, it was after a period of time of the product being in the marketplace and getting initial clinical results. And at that point in time, we were on the radar screen of leadership of Medtronic, and that's how the partnership really bloomed. And so we had to be out there getting clinical evidence first.

Currently, our plan is to do this under the same vein of how we've built this business in the spine. It doesn't promise for a partnership down the road. But I think that the first thing first is we have to go collect -- go get clinical evidence, work with the right people, launch the right clinical studies. And if we do that the right way, then maybe the right partnership comes along. If the right partnership doesn't come along, then we're still well suited to go it alone. But -- so not to -- it's basically a nonanswer, but the steps we're taking are very similar to what we did on the spine business.

Yes, that makes sense. And maybe just a follow-on as well based on these different projects or expansions of indications. Do you have any more progress to maybe share about the other sort of indications with, say, trauma and oncology, for example, that we could get a quick look into?

So our product lines are able to be used, and this is very unique to our products compared to other products that may only have one clearance or one study that they can stand behind. Our products are widely used in all parts of the human anatomy, whether it's extremities or foot and ankle and upper extremities or spine. And our clearances support that across product portfolio. And so we're not limited as to where the product can be used as what clinical evidence we do have.

So new studies are not so much going for regulatory approval, but more for clinical evidence to engage clinicians to feel comfortable in using the product in the patient population. So when we look at all of the studies that we have ongoing, those are not there for regulatory purposes. They are there for increased marketability and market penetration purposes.

[ id="-1" name="Operator" /> There are no further questions on the phone. I would like to hand back over to Alexander Mueller. Apologies. There is one more question on the telephone. We will now take the question from Laura Pfeifer from Octavian.

I just have 2 follow-ups. So also on the foot and ankle market, can you please elaborate a little bit more in the early success you have seen so far? So how easy is it to gain these new accounts? And what market share is feasible over the next 2 to 3 years? I'm just wondering if you think it's -- your market share gains will rather mirror the spine market? Or are there other dynamics to consider that make this market may be quicker to penetrate?

Thanks, Laura. I think a couple of things on the extremity marketplace that we've learned in the first 6 months. First and foremost, there is a lack of evidence more so in the extremity space than in the spine space for biological products. There's only one Level I study that's been published and pushed out there in the past 10 years, specifically to foot and ankle. And so we feel that that's a massive opportunity. Our early discussions with clinicians certainly validates this, that there are a lot of companies who will apply their products to the marketplace but not invest into the marketplace to do the right evidence. And so our approach to this is being very -- has been welcomed greatly by the clinicians.

Secondly, because we've already registered in over 450-some-odd hospitals domestically and then also outside the U.S., partnered with great clinicians as well as partnership with distributor agents. We are seeing a little bit faster uptick because we're already in the hospital systems, whether on the spine approval. And that allows us to begin having the conversations with the extremity physicians. Clinical evidence-wise, as we've collected some of the evidence and anecdotally heard from the surgeons, they're finding the product very easy to use and easier to use than what they were previously using, but also at a cost savings.

There's a product line out there that is -- has the lion's share through the Stryker sales force, which was [ AUGMENT ]. And we are coming in at a lower expense, and you can use the analogy of BMP in the spine as AUGMENT kind of takes that price positioning within the foot and ankle space. And so we are showing up to the space with a product that has greater handling characteristics, greater flexibility, greater user formats at a lesser cost. So we're very excited.

Again, it's early days, 6 months to answer to the last part of your question. I think it's too early to talk about what market penetrations might look like in the next 2 to 3 years, but we're extremely encouraged with our -- and also confirms our -- what we saw as an opportunity to go into this $1.2-plus billion market opportunity.

That's helpful. And then maybe just quickly, could you also talk a little bit about your next product launches? I think at the end of your presentation, you mentioned that you have a full pipeline and are expecting to launch further products. I'm just wondering what this might include.

So for that, we'll have to tune in at a later time, but I'm encouraged with the -- as we launch more products, normally, it's going to serve a newer market or a marketplace we currently serve don't serve with our existing formats. And this is the case, the things that we have in development, I'm not ready or prepared to provide launch dates, but know that our pipeline and our R&D team is very busy.

[ id="-1" name="Operator" /> There are no further questions from the phone. I would like to hand back over to Alexandre Mueller for webcast questions.

Yes. Thank you. There are a few incoming questions here. So the first one, it's actually a sum of different people asking here about the Medtronic partnership that we have. So if you would have to grade the percentage impact of the Medtronic collaboration, where do we stand in H1? And what do you expect for H2 and beyond? And in that respect, also, when is the Medtronic partnership really going to flourish? And what is going to be the share of the revenue that we -- or what is the contribution of the revenues until '27?

So great question. I can answer some of that, but not all of that. The revenue from Medtronic so far to date continues to grow, and it's at the right partnership level that we had agreed in the early days. So we're extremely happy with the partnership. It's a very mutually beneficial arrangement where they get to represent our product and we get to utilize their sales force, we're mutually beneficial.

I think that reporting out revenue by different types of partners or sales agents is not something the company will engage in on a go-forward basis. The Medtronic revenue will continuously be a minority of our revenue base, certainly not the lion's share. And I think that the growth within the partnership is keeping up with our revenue outside of the partnership, which is also great to see. So as fast as we are growing with Medtronic, we're growing as fast, if not faster with non-Medtronic-based revenue. And this allows us to keep our independence, but also to utilize the partnership to our benefit.

Great. Then next question would be, if we're looking at the growth that we had in H1 with MagnetOs, can you give some more granularity in terms of where we are taking some market shares? Is it from synthetics, allografts or autografts? Or is there an idea from whom you are grabbing those market shares?

I think the majority of our market share shift domestically in the United States, I'll talk to that first, has to do with the cellular allograft marketplace. I think that from a comparison of a market that does not have any clinical evidence, we are seeing clinicians and hospitals recognize and realize that there's a product and a segment of the marketplace that has no evidence, but also, quite frankly, has shown to have some risk associated with disease transmission from human tissue. And currently, the FDA is looking into that as well.

So I think, number one, we are taking business from cellular allografts. In the field of advanced biologics and those would be any of the other Level I products, we are seeing advantages, most notably that our clinical evidence and the preponderance of it in combination with a much more favorable cost to the hospital system is driving hospitals to embrace our product portfolio as well as surgeons. So I think those 2 things we are taking out of the advanced marketplaces.

And I think as we look at a go-forward basis and the hospitals looking at their contracting needs, they are recognizing our product since it can be used standalone and not in combination with other products is a much more economical choice with better clinical benefits. Outside the U.S., we are seeing growth in every single market we enter. And again, a large part of this is we have a great deal built into the efficacy of the product, but also the user handling characteristics and quite frankly, the ability to ship product in stable temperature, in certain marketplaces, this is a huge benefit.

So our international team continues to bring on market and great partners. Our partners in the U.K. as an example, we brought them on not too long ago are really making an impact, not just in spine, but really leading the charge in extremities. So very excited about that.

Great. So the next question would be, what are the key risks that could prevent Kuros from achieving its forecasted growth targets?

Well, it's interesting. Key risks. And this is the world of turmoil that we're in from a macro scale. I think that every time we turn on the news, we see a new story popping up. And so we, as an organization, have to remain nimble. The best part of Kuros right now is that we have remained financially nimble because we do control our own destiny because we have cash on hand, a strong balance sheet, strong operating profit margin now, we are able to move quicker than most organizations.

And so that is a massive benefit to us who operate the company as well as to the shareholders who are engaged that they have the confidence to know that the company continues to execute on its plan, has the financial wherewithal to weather any storms that may happen externally and have the right team in place to be able to execute the plan in places of pivot.

Clearly, from a tariff perspective, we didn't anticipate tariffs, but we didn't anticipate the growth, and we also recognized there was a risk relative to having all of our infrastructure and manufacturing in one location. We started down that path before tariffs. And so being lucky, being good, I'll take them both, but that seems to have played out well for us. And I think as a leadership group, we're well positioned to look at these risks and identify the ones we need to act on immediately. And again, I keep coming back to our financial wherewithal, very strong balance sheet and currently, we're able to dictate our future path.

Great. Then a question about the pricing. So in terms of what is the price difference of the product looking at U.S. versus Europe and if there is any risk that the U.S. pricing or that the U.S. pricing could be at risk.

So when we look at pricing, and I think that's probably a question that goes to some of the pharmaceutical discussions. And so to clarify, we are not a pharmaceutical, we are a medical device. And so we're not subject to those pricing parameters has been publicized by our government. So first and -- and then second thing, our distribution channels are vastly different. Inside the U.S., we sell directly to the customer, and we receive the end dollar revenue. Outside the -- and we pay a sales commission.

Outside the United States, we pay -- we sell to a distributor. That is a cash -- a cost plus, and they end up getting end dollar revenue. So we don't see much risk relative to either of those business models are being disrupted. And again, we would not be subject to any of the pending discussions relative to pharmaceuticals that does not affect the medical device market.

Great. So next question would be about the penetration rate. So we have achieved about 8% in the U.S. spine surgeons market in H1. So what would be the midterm ambitions to achieve in terms of penetration?

Well, certainly, if not having the percentage number by 2027 to match up with that. When we start looking at growth in surgeon penetration, and it's not just surgeons who are aware of us. There's many surgeons aware of us, it's getting them to use our product. and using as part of their normal patient care. And so that number continues to go up. In my historic -- my memory, getting 2 market share points per year, which is above growth that's 2% above growth. That's a great penetration rate to continue to do year in and year out. And the key there is also not losing any.

And so as we get bigger, it is making sure our existing customers are continuing to see great results with the product. But I'm not prepared to kind of put a number on what mid-market will be. It obviously will be greater than 8%, and I hope that it continues to go in the right direction here from 8% to 10% to 12% to 20%. So we continue to do the right things for our clinicians, provide the right tools, entering new marketplace. So for instance, having an MIS tool is going to allow us to go sell to a spine surgeon that wasn't using our product before because they only do MIS surgery.

So now we have a tool that they can get exposed to and actually use our product. So that -- when we start looking at product development in new formats, that is really what we're trying to target and expand into. So...

Great. So the next question or questions would be around our U.S. operations. So in terms of when can we exactly start with the production in the U.S.? And what does it mean in terms of how many additional employees we have to hire? And is it difficult to hire qualified employees in the U.S. So can you give some insight into this?

Sure. So what we've been able to -- we're in early days of the plan. We have -- our operations team is really doing a fantastic job globally on this effort. So we have put out there the second half of the year, we will have production in the U.S. As time lines move and as we continue to get into production as anyone who's ever built a building, things can be a little bit flexible. So we're utilizing the second half of next year to be able to produce in the U.S.

The number of employees, we will be making an investment here in the state of Georgia in the United States for incremental employees and also an opportunity to cross-train with our counterparts in Europe from our manufacturing base there. So it truly is a global team effort. I'm not going to be putting out the number, but getting access to talent and manufacturing, certainly here in the state of Georgia, where I live. There are a great number of universities, whether it's Emory, Georgia Tech and others. And there's a great deal number of manufacturing companies in the biomedical space. And so getting talent to fill these positions should not be a challenge for us as we go forward.

Great. And then maybe the last question is about big topic everywhere about AI. So is AI impacting the Kuros business operations somehow in the short and the long term?

Daniel?

Yes. I mean what we are doing currently, as I explained, is that we digitize the value chain, right? And as part of that, we obviously will make use of robotics and also make use of AI in order to further optimize and get the operating leverage. So from that end, on the back end and on the front end, we are certainly evaluating that. And it's also important also to watch future trends and see whether there are opportunities out there also on the AI side to further monetize. But as I said, this is currently in the making, and we will see what additional prospects that will bring us.

Okay. Then just a new question arrived. Maybe the last one now. It's about the Chinese market. So how do you see or are there any plans to enter the Chinese market? And would you enter the market directly or through a collaboration?

So any market that we would consider entering in outside the U.S. and that we've identified, whether it be Japan or otherwise, we certainly would identify a partner that we would prefer to work with. So whether it's Japan or whether it's South Korea or whatever.

As it relates to China, and I mentioned this at the Investor Day, and this was brought up in discussion, it is not a market that we feel that it would be beneficial for Kuros to enter, just due to transfer price, regulatory hurdles and the ability to sell that product in that marketplace. It does not line up with the effort to the execution. We believe there's greater opportunities elsewhere.

Great. With that, we have answered all the questions from the webcast tool. So I hand over back to you, Chris, for the final remarks.

Thank you. Well, first off, I want to say what a great first half of the year, certainly overachieving what we expected to -- we set out to do for the first half. But it also continues to show at Kuros that we continue to communicate our plans, and we continue to deliver results and in a very clear and defined pathway. We also have a very clear and defined pathway for our future growth that we've communicated. So for us, in these days of turmoil and macro conditions that can change or shift from days to weeks to sometimes hours, we're very excited and happy that this business continues to grow in light of that in a very predictable fashion, in a very profitable fashion with a great opportunity and upside still ahead of us.

And so with that, I want to thank you for -- to the shareholders who are putting their faith in us, to our stakeholders and our employees, I want to say thank you for your dedication and your hard work. We certainly could not be here without you. And lastly, and really most importantly, to our physician friends and partners. Without you and trusting our product and our technology to be part of your patient care journey, we certainly couldn't achieve these results. And with that, I'm very humbly thankful for your participation in this journey with us.

So with that, I'd like to say thank you very much to all those involved to Daniel and the team and Alex to make this possible and all the work that goes into this. But again, a tremendous first half, and I look forward to reporting excellent results in the future. Thank you.