Welcome, and thank you for attending our presentation. As we discuss our 2024 earnings and outlook for the future for Kuros, what a fantastic year we've had. We are very excited to present to you our results. We will go through the results of the organization. I am also joined by my colleague and CFO, Daniel Geiger. We will walk through and take Q&A sessions at the very end. If we can start with the slides. Obviously, our disclaimer slide relative to our business. We can move forward from that. 2024 was an unbelievable year for the company. When we look at what we've accomplished, not just in the order of magnitude of revenue growth, but truly the accomplishments of our team on a global basis.
We were able to not just achieve exceptional sales results, which we'll review in greater detail, but also Level I published data for a biologic in a space that has no data for products like ourselves. The expanded regulatory clearances that we have in both spine and extremities, and in the extremities allowing us to enter new marketplaces, and also increase the global addressable market. The strategic agreement with Medtronic, which we signed very early this year in January, but we have had a relationship with in a small pivotal trial, really sets the stage for our growth going forward and is a major accomplishment for the organization. We now have a very clear focus on our commercial execution path. We have proven it. We have invested in scalable operational expansion.
We will talk a little bit more about our digitization of the business and what that means to our overall operational efficiency as we move forward. Again, setting the groundwork for increased revenue growth as well as operational opportunities. When we start looking at the revenue growth, it's not just in the U.S. We have made leaps and bounds of growth in the international marketplaces, which really, as we look at the opportunity for a product like ours and MagnetOs having a synthetic product into international marketplaces, is something that, from a competitive standpoint, you do not have the opportunity to do with products such as cellular allograft, which is traditionally not accepted in those marketplaces. We look at 136% top-line growth of MagnetOs sales. That is a tremendous, tremendous result.
It really comes as a team, everyone from the operational team, from the manufacturing standpoint, from the sales leadership, our partners in the independent distribution network, to our finance and quality, people who keep the machine running, a tremendous result for the entire organization. Also, when we look at the future, when we talk about what we've actually built over a short period of time, the EBITDA growth, we have a profitable business with no debt, with high growth in a med tech space. We have de-risked this business and set a foundation for growth for the future. Daniel will talk a little bit in greater detail relative to the intricacies of our financial metrics. Going into a $9 million EBITDA or 11.9% margin adjusted after the Fibrin-PTH write-off, that is a tremendous result.
There are very few organizations out there in our community that can boast such results. Again, very well financed through finance for our organic pathway. Next slide, please. When we look at our marketplace and we talk about our penetration, and again, most of our revenue does come domestically in the United States, we have shown in the last previous slides a 2.5% surge in utilization. That is now up to 7% of U.S. spine surgeons are currently using MagnetOs. That is a tremendous uptick in one year's period of time. It also highlights how much more we can grow within that marketplace. The relationship with Medtronic certainly provides that firepower to allow us to grow domestically. Also, when we start looking internationally, it spills over into that marketplace as well.
The increase of independent sales agents that are representing our products has increased year-over-year 65%, and our hospital penetration 85% year-over-year. By expanding with Medtronic and then our expansion efforts into extremities, which we'll talk about shortly, also is a growth engine for us for the future. Next slide, please. When we start looking at the globe in general, when we talk about where we started in 2024, we were selling in approximately 11 countries outside the United States. I'm happy to say that our team of international experts have grown that business to well over 20 countries. We are registered and we are growing. As you can see from the marketplaces there, from Saudi Arabia to Jordan and Kuwait, Lebanon, Brazil. Brazil is a marketplace we're very excited to enter this year.
We will be down at the Global Spine Congress in Brazil this year. I think that as we continue to grow this business, it becomes more and more important for us to be a global business. Our efforts here are ongoing. Next slide, please. As we've talked about before, as we continue to grow and build the foundation within the spine business, we are now ramping up our efforts in extremities. In extremities we look at two predominant areas. One is foot and ankle, and the other is in trauma. As we phase our approach and entrance into the extremities marketplace, we are leveraging our growth in spine.
As an example, if we're already present in a hospital system because we're on the shelf and being sold into spinal procedures, our time to spool up and create revenue for the extremities business is very small as compared to if you're going in cold and it takes about anywhere between four to six months to go through the registration process, to go through hospitals, to get your surgeons using again. We are building the extremities business in the same methodical pathway that we built the spine business. We identify in a Phase I approach where we identify key opinion leaders, we identify the clinical studies that are relevant, that are required for us to get customer and consumer confidence, and we start to execute on those. That is what it's occurring currently.
In the first half of this year, it's less focus on growing the revenue fast, but growing the evidence for our customer base. We will have revenue in the extremities business. It's already continuing to grow. Our focus is building on what we've learned in the spine business, extrapolating that over to the extremities business, and continuing to grow that. As we see that, and as we continue to grow the revenue, we're doing this in a very efficient manner. You can see that the sales and marketing impact as a percentage of revenue has come down drastically quarter- over- quarter or half- over- half. We continue to see that going forward. We are making investments into the extremity business. Essentially, you can think of it as building a business within the business. There's a great opportunity.
There's a billion dollar market opportunity between the foot and ankle and trauma businesses that we're excited to go after. We believe that our product is very well positioned. The early results and the early feedback from our physicians and KOLs that we've already associated with and the independent distributors is amazing. Next slide, please. Leading on the last comment on the G&A expenses as a percentage of revenue, you can see that the slope has come down quite a bit since 2021. We also have discontinued the operation of Fibrin-PTH . We wrapped up all of the costs associated with the Fibrin-PTH platform in 2024. Going forward, that is no longer a cost center for us. Also, one last moment.
The potential to receive the $21.3 milestone payments and up to $242 sales milestone payments from the legacy asset still remains within the system. Next slide. Daniel.
Yeah. From my side, a warm welcome to everybody, ladies and gentlemen. A fantastic year, as Chris already alluded to. We achieved our revenue target, which was 75–60% for H2. We landed roughly at 58%. Also, we doubled basically quarter four compared to last quarter four . Again, the revenue and what you can see now on this slide is also how the revenue is basically ramping up over two years. We have seen a volume growth as well as a revenue growth of more than 450%. At the same time, we have also seen an increase in contribution margin, which was to a certain extent driven by product mix price effects. At the same time, we were also able to negotiate volume discounts. Therefore, you see this curve and the steepness of the curve continuing.
At the same time, we were able to reduce the fixed cost. The fixed cost over the same period just rose about 100% compared to 450% on the revenue and the volumes. As a consequence of that, we obviously achieved a great operating leverage, which then led to the profitability in the company. When I say the company, it's also important to understand now that we are now basically one platform and basically have now allocated all the costs to the MedT ech segment. The MedT ech segment, and this is really with proudness, I say that we have now achieved, as we discussed at half year, an EBITDA in the high single digit. We also achieved a two-digit percentage margin. 11.9% is coming down from 12.5% at the end of H1 .
What you need to consider, and this is what Chris basically alluded to, is that we have built up and ramped up the extremities team, sales team, with now being ready to enter that market as well. Important to understand is also that not only were we positive from an adjusted EBITDA perspective, but if you factor out the impairment charge, which we have seen in the Checkmate asset, you will realize that overall, we now also reached a profitability level. If you adjust for the $5.1 million impairment we have seen with Checkmate, then we actually achieved in the MedT ech business profit of $1.3 million or $1.4 million rounded, basically. That, again, is a tremendous achievement and basically also a testament to the success and the trajectory we are on.
If you then look at the financial basis, which has progressed very well, you can see that we were able now to achieve and generate a cash flow break-even. More than that, we were able to generate operating cash flow of almost $4.7 million or $5 million rounded, which, again, if you look at it from a cash and cash equivalents perspective and factoring in CapEx, which we mentioned at half year that we will double capacity in 2024, again, well under $1 million. This CapEx does not only include production capacity CapEx, but also equipment and other CapEx items. We were able, together with the LTI exercise, to achieve almost $3.8 million of additional cash. This additional cash will also help us to now pursue the strategy of organic growth.
It will basically help the company to continue on a standalone basis without any need for funding. With that, I hand over back to Chris. Thank you.
Thank you, Daniel. Again, tremendous results in a very short period of time. If we can advance the slide, please. We talk about the future and we talk about our market share and our market opportunity and where we sit in this path. Again, a tremendous 2024 for the organization, 7% penetration of just spine surgeon. Our penetration in the extremities and non-spine marketplace opportunities, which is over $1.3 billion, remains. That is complete upside to the organization on top of what we're talking about with spine. I think when we look at the growing business, and by the way, demographically, these businesses continue to grow by 2031, achieving about $7.7 billion market opportunity. In 2024, we have set the framework in the launchpad for the organization going forward. Next slide, please. Let's talk about the extremity marketplace.
When we look at this business unit and the opportunity, we look at this in two predominant segments, which also correlates with how the physicians are organized and how hospitals view these patient populations. In the foot and ankle segment, this is just U.S. only. It is a $440 million market opportunity. It is broken down in different areas of forefoot, midfoot, hindfoot, and recon and trauma opportunities, as you can see there. As we look at our KOL development and as we look at the procedures as well as the clinical studies we wish to go put forth, not for regulatory clearance, but for our customer acquisition strategy, that is very important to us to look at how big the marketplace, the opportunity is, and what other players are in that space.
Secondarily, if you look at the U.S. trauma marketplace, again, in similar size at $475 million, that is a second half of 2025 strategy to start integrating into that marketplace. We have started development with our KOL strategy, started looking at the studies, but that is a secondary strategy. We are focused on the foot and ankle segment. We are seeing very early results, tremendous results and feedback from our clinicians, not just in the U.S., but also outside the United States. We are very, very pleased with the early indications. Our strategy here is to be thoughtful, purposeful relative to our approach to the marketplace, ensure we have the evidence to go attack this marketplace in the proper way, very similar to how we grew the spine business. Next slide.
When we look at how we've been successful over the past several years from a commercial standpoint, part of what we've done is, and this leads into our digitization process of connecting the back end to the front end of the business, really asking the right questions to our customers. When we ask our surgeons, "What is it? Why is it that you're using our product? What is it that would make you move from competitor A to our product?" First and foremost, physicians want data. When you look at our strategy as a company, the investment that we have made from an R&D perspective into prospective clinical data, there is not a biologics business out there that competes with us on this realm. We continuously invest into Level I human clinical data. We also continue to look at the criteria for these fusion models.
We are engaged in studies that are competing directly head-to-head with our competitors in a clinical setting, not just in an animal model, but in a clinical setting with human patients. This is what our physicians and our customers and our hospitals have asked for. When we go to a value analysis committee, the questions they're asking is, "Why are we using this product over that product?" When we can come in with clinical evidence in a Tier I journal and our competitors can't, that gives us an advantage. To that point, we have kicked off two Level I Kuros-initiated spine trials and head-to-head versus cellular allograft as well as demineralized bone matrices. We also have a Level I Kuros-initiated foot and ankle trial, which will be launched this year. We have four Level I investigator-initiated trials ongoing. Next slide, please.
As we look at our business and we break this into components of clinical, operational, product, market, and finance, you can see that this methodical approach of how we've attacked this business over this past several years, specifically in 2024, is paying dividends. We look at the Level I clinical trials, the operational capacity, doubling our capacity over the summer, not just once, but we're in the process of doing that again currently and doing it in a fiscally responsible manner. From a product perspective on an organic pathway, we will be launching into the MIS portfolio later this year. We will continue to do organic product development, hopefully getting to a cadence of two product launches per year. From a market standpoint, it's not just growing from spine into extremities. It's also geographic expansion.
As we mentioned earlier, geographic expansion, whether it be in Brazil, whether it be into Asia-Pacific markets or others, doing this in a thoughtful manner with the right partners is how we're going to continue to grow within the market. On the finance and M&A side, having a strong foundation of financial profitability with no debt gives us great leverage into looking at our existing business, how we can digitize that as we launch into an ERP system connecting the back to the front, but also looking at how we view things such as tariffs and the tax structure. We will talk a little bit more about that probably in the Q&A standpoint. We are very well positioned operationally, infrastructure for future growth. Again, as I mentioned before, with all these great opportunities, really setting a launchpad for us going forward. Next slide, please.
In summary, and very proud to provide this last slide, this is the first time in Kuros Biosciences history providing some level of guidance on a go-forward basis. We're very comfortable with the business that we anticipate at least 60% growth in 2025 and year-over-year growth. In 2027, being a company that's representing $220 million–$250 million in revenue, and that's in U.S. dollars. We did mention that we will be switching from a currency perspective into U.S. dollars on a go-forward basis. As we look at our growth opportunities with the foundation that we have set as an organization, our organic pathway is clear. We could be more opportunistic as we look at non-organic opportunities as a business. I'm sure we'll talk about that here in the Q&A standpoint. We're sufficiently financed from an organic path. The future is extremely bright for an organization.
We are very, very pleased with our results in 2024, and we hope that you are too. With that, I will hand it over.
Yes, hello. Good afternoon. My name is Laura Pfeiffer from Octavian. I will now open up and start the Q&A session. I have a list of questions. We will address this. At the end, we will open the floor for further questions from the audience. Maybe starting with a strong sales performance this year and then the outlook for 2025. You said you expect at least 60% growth this year, which implies at least CHF 120 million in sales. What are the key assumptions behind this growth target? What are the key risks? Also, how much sales growth is baked in from the extremities market?
Thank you, Laura. The sales growth opportunity for 2025 is with an agreement with Medtronic that we executed in early January. Our teams collectively with Medtronic and ours in Kuros have been working to find the mutually agreeable territories that we're going to work together. I think within a matter of days after the announcements, our teams were collectively looking at over 100 different opportunities. That pipeline is quite full at the moment. As we've mentioned before, the timeline to go from opportunity to impact tends to be in the four- to six-month range. As we continue to plan that out, onboard independent distributors, talk to physicians, work with the hospital systems to get them in the queue, the pipeline is full. We anticipate those results more towards the second half than the first half going forward.
As I've mentioned in prior calls, that's what we tend to see in the pipeline. Opportunities take about six months. I think the other part of our growth strategy is on the international expansion. We've been working at a feverish pace to expand into those marketplaces. We got several registrations and partners in the second half of last year that will start to pay dividends on a go-forward basis as well. I think from an extremity standpoint, as I mentioned during the presentation, we're focused on doing this the right way to ensure we have the clinical evidence. If you chase the revenue too soon and you don't get the clinical evidence, it's a very short-term result. We are interested in long-term growth. We are being very methodical about the customers we approach, the distributors we attach ourselves to, and the marketplaces we're going after.
What that means is from a revenue perspective, it will not rival the spine revenue in 2025, but we are setting up the future for success. I think that where I will judge the extremities business will be based on the execution of our clinical trial based on the partners we associate with. I think that that's a great opportunity. I think lastly, the assumption, the partnership with Medtronic and having such a great partner also allows us to leverage into the extremity marketplace a little bit faster. If we're in more hospitals, our access to the foot and ankle surgeons or the trauma surgeons becomes that much quicker.
Okay, thanks. Also in this context, can you comment on the growth momentum you have seen so far in Q1 and how we should think about the phasing? I mean, listening to your explanations, I guess it's rather a stronger H2 versus H1.
I think from a percentage standpoint, in the previous in 2024, we talked about somewhat of an in and around a 40–60 split, which is because of our domestic exposure. Q4 tends to be larger from a surgical volume just due to the way insurance works in the United States. I think as we continue to grow our business and continue to have such a large percentage attached to U.S. revenue, we're going to see a similar balance that we saw in 2024 and 2025. I think as our international business grows, that tends to get more equalized. I think you'll see a very similar split in the first half to second half that you saw in 2024 into 2025.
Okay, today you have provided this 2027 sales target of $220 million–$250 million. This suggests that you will continue to grow at an impressive rate of probably 30% or more beyond 2025. Maybe first to clarify, is this organic or does it include an inorganic component? In addition, can you give us an idea on the building blocks of this midterm target? How do you balance spine versus non-spine growth, maybe US versus ex-US? Also, how much will it depend on the clinical data that you still are gathering?
Answering the last question first, the clinical data I view as an accelerant to revenue. I believe since we already have regulatory clearances in the marketplaces to go after these spaces, it really is an accelerant. We will connect our marketing efforts to the clinical data as it comes available. As we look at the building blocks to achieving that revenue, not going to break down as we haven't done in the past, percentages attached to spine or extremities, etc. However, that blend of our effort, it will be done in a way that's fiscally responsible first and foremost, number one. Number two, partnering with the right physicians as well as independent agents. I think that the growth of the international markets, I think, is going to be impressive as we go forward.
I think what we're uncovering outside the U.S. is the true need for a product like ours in that there is no alternative. In many marketplaces, bone morphogenetic protein is not available or it's been removed from the country. Using patient bone or donor tissue is not available just because of how those systems operate. Having a high-performing biologic like ours, we're seeing an improved need in the international marketplace. I think that growth strategy is going to be driving a fair amount, more so than I think we have discussed in the past. Our domestic strategy, getting to the $220 million–$250 million number, is continuing to execute on our organic pathway. In that number, it does not take into consideration any non-organic opportunity.
Thank you. I think that's pretty clear. Maybe we speak a little bit about the alliance with Medtronic. Given that only today, around 7% of the U.S. surgeons use MagnetOs today, and considering Medtronic's commercial reach into hospitals, it seems to me that growth should benefit significantly. I guess here we agree. Can you please elaborate on first how the partnership is progressing now after your initial experience? Also, how significant is it in terms of revenue today and how quickly it can have an impact?
They are tremendous partners. Medtronic, during the pilot program, as well as in the early days of this five-year agreement, truly believe not just in our team, but also the technology and really the clinical foundation and the studies. What drew them to us was really the evidence and the work that we had put in. They are tremendous partners. Obviously, from a Medtronic standpoint, the global leader in spine, their reach is far and wide. We have been working diligently together to ensure we have a seamless approach to the marketplace. There is not a day that goes by where opportunities are not being presented to Kuros from the Medtronic team. We continue to work together. We are in the very early days of organizing that effort, but very proud to say that the teams are working in unison and harmony.
As far as breaking down the revenue, we haven't done that in the past, and we won't do that going forward as far as breaking down what percentage of revenue Medtronic sales, the sales agreement is bringing in. I would say that as we continue to grow, our goal is to continue to grow together and to have them more impactful in our revenue stream. If we're more impactful and we're able to grow into their 30% market share or 25% market share, I think that's a win for all parties. It's a win for Medtronic to be able to present our product to their customer base, but it's also a win for us and our shareholders and stakeholders as we continue to grow the business with the largest spine company in the world.
Okay. Now you have started to expand into the foot and ankle market. I think we heard that it is like a very diligent approach. Still, how quickly can you penetrate these new accounts? Do you think it will, once you have done the groundwork, it can quickly ramp up and you can go up to a quite significant share, or do you think it takes longer? Also, judging from Slide 11, I think you mentioned other markets that might also be eligible in the future. What is kind of your strategy here?
The strategy is to ensure we're able to meet the demands of our customers and our partners first and foremost. We want to set the expectations properly, make sure we meet and exceed them at all times. I think with the extremities business, we can grow that business faster than we did the spine business. The reason being is if we're already registered in, say, 400 hospitals domestically in the United States, we can approach those physicians immediately. The difference is we have a tremendous amount of spine data. We are being thoughtful to make sure that we have the right clinical data to present to that customer base. We've started with a small subset of physicians that we have identified and had discussions with. We are generating revenue.
We'll continue to grow that revenue base, and we're seeing growth within that segment month over month. Again, being thoughtful and responsive, once we have more clinical data and the right marketing materials, then we'll get to the second phase, which is penetration. Right now, we're in the ideation and origination part of customer acquisition, identifying the key opinion leaders, the right customers, the right partners, and then we'll expand that going forward as we get into the second phase, which will be in the second half of the year. We'll see a greater acceleration in the second half of the year in the extremity business as we build a foundation in the first half.
Okay. Just as an add-on, when will you have the clinical data available in foot and ankle?
We already have some data that's currently been pushed out there. It's not Level I evidence, but it is clinical data. We have been collecting case series from physicians, and we're starting those studies. The Level I trial will initiate later this year. We've already started the process of drafting the protocol and working with the PIs that will be involved in the study. From an enrollment standpoint, I don't have a schedule just yet, but we anticipate having that study ready to start enrolling patients in 2025. The data from that study will be forthcoming in several years, right? There's follow-up time on those patient populations. However, the early anecdotal information from the podium and non-Level I trial data we are getting on a regular basis, whether it be case presentations, journal clubs, surgeons presenting their early data, we are already feeding that grassroots approach.
Maybe just staying with the product pipeline, you also expect to launch the new Minimally Invasive MagnetOs formulation. I think you said in H2 2025. I thought previously that it was Q2, but maybe it has been pushed back a little bit. How significant could the impact of this new line extension be just on your spine growth?
I think it's not just in the spine. Actually, what we've found is there's actually great applications in extremities as well. I think that what it does, it allows us to work with physicians who are doing open procedures, say, in their hospital system, but maybe using a minimally invasive approach in their ASC. Maybe our product didn't have the right formulation or user interface that they could use that in their ASC. Now we'll be able to extend with our existing customer base into new opportunities. Also, there are physicians who only focus in, say, endoscopic spine. This type of product allows us to go into that fast-growing marketplace. I look at this line extension and opportunity as new surgeons for us to work with.
By the same token, if we may be approaching a physician who does not use us, who may be doing minimally invasive surgery, which is why he has never considered us, now we would be able to work with that surgeon in a minimally invasive platform and then pull that through over to the hospital situation. For us, it is an absolute door opener into talking about the science and the technology. It is a great market opportunity, but there is actually a great opportunity within the foot and ankle space as we look at the MIS opportunity in foot and ankle as a fast-growing marketplace. Fortunately, the surgeons and the KOLs that we have attached to ourselves are the leaders in that market as well. We are able to dial in the right product development pathway.
You are right, it's a June-July launch relative to minimally invasive.
Okay. I think you also mentioned that you have new surface technologies you're working on. I'm just wondering at what stage, I guess they're still at an early stage, but when could they be ready?
Right. In previous calls, we talked about things that we work on that are heavily into the R versus the D. We talked about how we can make an osteoinductive surface. Knowing what we know about our technology and how it works and Joost and our team, it's really tremendous what they've been able to achieve. We're still heavily into the research phase. We've gone through several animal models. We're back into the lab currently on slight modifications, but very promising research. We'll see where that leads us. We're talking about trying to develop the very first osteoinductive metal surface. It's not something you rush into doing. It's not an easy feat, but we're very, very positive on so far what we've seen. Again, heavily into the R phase.
Sure. Just on the ongoing head-to-head trials that you are running against DBX and against the cell-based allograft, can you remind us when the readouts are expected?
Those are actively enrolling. I give great kudos to our team for getting those multi-center sites up and running on a prospective study. Again, just to remind the audience that the level of evidence that is out there relative to products, say, in cellular allograft is very dismal, to say the least. This will be one of the first prospective studies done compared to cellular allografts. We are very, very proud of that fact. I believe that the readouts will be, again, we follow these patients out to two years. The official papers presented in Tier I journals, which is what our target will be, will be several years down the road, but we will have readouts along the way. I would anticipate that be a 2026-2027 target.
Okay. We won't see any kind of interim data. We just have to wait until you have the final data.
We're just enrolling.
Okay. Good. Maybe then turning to profitability. I think in 2024, you delivered an adjusted EBITDA margin of 11.9%. We heard that. Now in your guidance for 2025, you do not mention any EBITDA target, neither in absolute terms nor as a margin target range. How should we think about the profitability development this year? Is it fair to assume that it should improve gradually, or do you expect it to be rather stable? I think here it would be great if you could walk us through the building blocks and also the assumption for the cost base.
Sure. Yeah. What we said at the H1, and this still holds true, is that we are investing obviously into the infrastructure, into foundation, and also into the extremities market, right? We still see ourselves in a growth phase and want to continue to invest into growth. This will, to a certain extent, eat some of the EBITDA. As I said, last H1 already, we believe that 2025, we should at least be even or gradually increase. That is currently how we would see 2025. In terms of building blocks, they are the usual suspects. We have about 90% gross margin right now, which in essence will further improve potentially by 1% or 2%. We will see that. Important is really that we can get this economies of scale, as I mentioned before, that we can see this product-mixed price effects.
Currently, I would leave it at 90% to be on the safe side. In terms of sales and marketing, we are currently scratching at that 60% hurdle. Potentially, with increasing revenue, we will further bring that down. Somewhere in the 58%–60% range, I would see that. What we certainly want to continue to do is invest into R&D as a testament that we are a scientific-based company. We rather see it currently in the 8%–9% range in terms of investments into R&D. Last but not least, G&A is somewhere in the neighborhood. I mean, we have now arrived at 20%, which we have seen came down quite significantly, as Chris presented. We continue to invest, as Chris alluded to, into digitization of the value chain, right?
This is something which will hit our P&L because we cannot capitalize that. Again, with obviously the operating leverage kicking in, we would see that somewhere in the 15-16% range. As I said, our target is for sure to match the EBITDA margin we have achieved for 2024. Potentially, we try to come out a little bit better than that.
Sure. That's understood. With a gross margin of almost 90%, what level of sustainable profitability, also, I think in terms of EBITDA margin, do you see for Kuros in the medium term, let's say maybe 2027? Do you have a benchmark in mind that you could share with us?
Yeah. The way we build the budget is kind of driver-based. Top line is a key target for sure. As I said, 250 is basically what we're aiming for. As you probably know, our guidance practice, we try really to match the numbers. Therefore, we have considered that carefully when we built the budget. In terms of the cost side, we have a peer benchmark group and basically compare against that peer benchmark group. Currently, we see this gradually increasing, as I said. We hope that we can achieve an increase by one or two percentage points on an annual basis from 2026 going forward.
Okay. Okay. Now I didn't calculate it, but then I would probably be around 15%–16% by 2027. When I take 12% as a surplus.
Yeah. It seems like you're good and master here. That might be.
Okay. Good. Okay. In terms of CapEx and production capacity, where are you today? I think you said you doubled last year. What are your plans for the next couple of years, given your growth ambitions? Also, maybe you could discuss it a little bit in light of the discussion around the U.S. tariffs and your exposure to the U.S.
Yes. I start with the tariffs. We have a need to grow anyway, right? Which means we need to invest into production capacity. We have already started half a year ago or almost a year ago now to think about geographical diversification. As a result of that, we have considered or we are considering plans to expand to the U.S. Now in the light, obviously, of the tariffs, it is certainly something we will realize. We are currently thinking about a U.S. production footprint. In terms of tariffs, and I come to the CapEx expenditure in a minute. In terms of tariffs, what we also need to consider is that we have obviously a general warehouse in the U.S. We have a forward coverage sitting on the inventory or in the inventory.
Basically, this will hedge us to a certain extent if tariffs will come into play. Today, it's still hard to say whether this is going to happen or not, but we are still considering that obviously it will, as I said, further increase the stock levels to hedge there. What we're also doing, and this is also in relation to the tax loss carry forward, we have also sitting in Switzerland, we have started to now restructure, as Chris already alluded to, the tax structure of the overall group. We will now also have Switzerland acting as a wholesaler going forward. At the same time, we'll also implement a customs price mechanism, which will allow us to also bring down the transfer price when we import goods into the U.S. This will further protect us.
Last but not least, as discussed, we are considering to now invest into a production footprint in the U.S. In terms of CapEx expenditure, I think we said that number already in H1 as well. For 2025, it will be in the neighborhood of $2 million–$3 million. Again, this $2 million–$3 million will allow us again to double what we just doubled, right? It is a double of the double in essence. We will continue to further invest after 2025. As I said, the target is to basically have that then reflected as a diversification strategy for production capacity in the U.S. I am sure Chris also wants to mention something here. Sure. I think that what is important to talk about, we discussed the tariff issue. We had been having discussions of how to handle our explosive growth from an operational standpoint.
It made a great deal of sense from just a pure de-risking of the business to have multiple sites of manufacturing. Our U.S. expansion efforts will be focused on our growth and being able to service that growth. It just happens to coincide as being a risk mitigation strategy against whether it be tariffs or from a supply chain standpoint and being closer to the customer. As a business that's growing like ours, it certainly helps to have multiple sites of production. That's been our focus. We have been working on this premise for this is not a recent thing. This is a very it's an ongoing discussion. As soon as the doubling of the capacity over the summer was finished, we started to double that capacity. It seems like it's an ongoing thing.
I give a great deal of kudos and credit to our operational team and keeping up with the cadence and the pace because it's a bit frenetic and fast. Yeah, we've been working on this for quite some time.
Okay. Just to clarify, the $2 million–$3 million that you mentioned CapEx this year, is this then for the Netherlands or for U.S. already?
No, this is for the Netherlands. As I said, we are still basically planning out the U.S., but the U.S. will mainly kick in from a cash outflow perspective in 2026. There we have several scenarios we are looking at. Yeah, it will certainly be, again, probably in that range, even a little bit higher, but it will be an upfront investment in the U.S. We will get several grants out of Georgia. When you basically locate a production facility in the U.S., you normally get quite some benefits. We are factoring that in, and therefore it's kind of a moving target. CapEx will not be massive even if we transition to the U.S. to a certain extent.
Sure. Just very briefly on Checkmate, there was a small impairment related to a delay in the expected milestone. What are the earliest timelines now?
Yeah. I mean, last year, if my memory is right, we had about $4.4 million impairment, which resulted just purely out of a timing effect. We see that now again. We were or we are in close contact with CheckMate and Regeneron. It looks like that the earliest we would be able to see pre-commercial milestones would now be somewhere in the neighborhood of 2031, 2032.
Okay. Understood. Perhaps one last question from my side on the long-term strategy. You had $18 million of cash. You are profitable. You are well funded on your organic growth path. You mentioned that you might look also at inorganic opportunities. I'm just wondering if you have already started to do that. If yes, what kind of areas are you interested in?
Great question. Again, when we start talking about what we as an organization have achieved in getting to this stability and launchpad and growth, the non-organic strategy is very pertinent to us becoming a global leader in musculoskeletal biologic care. When we look at opportunities, to answer the first part of the question, yes, we are becoming more and more acquisitive about opportunities. I think that as we define the opportunities and as we expand into extremities, we're not just looking at biologically motivated technologies in the spine. We're looking at any musculoskeletal biologically motivated technologies. Those can range from a variety of different areas, whether it's implantable analgesics. Again, we're looking for things that are not going to be your traditional hardware-based businesses, but things that are biologically motivated, dural repair, things like that.
Those marketplaces are interesting to us, but we have certain preferences that we look for. First and foremost, we have built a reputation to our clinical community focused on clinical data and proof is in the science. That is first and foremost to us if we are going to consider taking on an acquisition. Again, sitting here, being profitable with cash in the balance sheet, with no debt, in a high-growing business, it's actually a fun place to be because it's rarefied air. There are not many other companies out here in this space like us. We can be very fortuitous relative to the opportunities we're looking for. Yes, we are becoming more inquisitive. I think we have the infrastructure now built up that we can sustain taking on an acquisition if it's the right one.
We are going to be very selective in what that might look like.
Great. Thank you very much for this interesting Q&A. I will now hand back to Alex for questions from the audience. Thank you.
Yeah. Thank you, Eric.
Thank you.
Laura, for your questions. I have a few incoming questions here, which I would like to read and then ask, obviously, to answer them. We presented also the potential in the extremities, but mainly in the lower extremities like foot and ankle. Where do you see the potential also in other extremities like hands? Is there some attractiveness in other markets as well?
The upper extremity certainly is a great opportunity for us. It's not broken out because it is actually categorized within the trauma, which we are focusing on in the second half. We are seeing some of our partners, say in the U.K., are running studies and looking at upper extremities. We tend to see more of the usage in those pathologies being more traumatic injuries than degenerative injuries, which is why it's lumped into that section. We're seeing great results, certainly in shoulder fractures and hand fractures, etc. That's a second-half focus when we start focusing on the trauma business. Purely from a nomenclature standpoint, we've broken it up foot and ankle and in trauma. When you start breaking down those segments, there are upper extremities and broken down by shoulder, by elbow, by toe, etc. It is an opportunity.
Again, our platform technology can approach anywhere where there is a musculoskeletal injury and need for bone healing.
Thank you. We have a next question. What are the reasons that revenues in Europe are only about 1% versus such a large stake in the U.S.? How do you see the potential for the further development outside of the U.S.?
On the revenue perspective, we should remind everyone that inside the U.S., we record revenue at the end dollar. We receive the end dollar what the product is sold for. Outside of the U.S., it's through a distributor channel. We sell it at a percentage above cost. The distributor will buy that from us and resell it at a higher price, and they retain the margin. There is a little bit of unbalancing relative to the revenue. A dollar in the U.S. might be represented at a percentage of a dollar outside the U.S. That's number one to it. We also really had started our organized pathway into outside international revenue about 12-18 months ago. We're still in the early days. That requires us getting into registrations, getting into marketplace, working with the clinicians and several different actors.
Also, the registration process is much more laborious than, say, in the United States. Tremendous opportunity for growth. It takes a great deal of dedication and organization to execution on a team perspective and very, very proud of our efforts there into seeing such high growth outside the United States. I do think it's going to continue to be that way. The market opportunity is there. I think when we look at markets like Asia-Pacific and we look at the data coming from the MAXA Trial, when we talk about compromised patients, whether it be smokers or diabetics, certain populations have a higher population of smokers and diabetics in the international marketplace. I think our penetration by using that data is certainly going to help us. No, I think I'm very bullish on what we're doing outside the US.
We continue to invest for resources there. The team is doing an excellent job.
Thank you, Chris. The next question is related to our reporting currency. Why are we switching or intend to switch from Swiss francs to U.S. dollar this year?
Daniel.
Yeah, I can take this one. In essence, it's pretty simple. I mean, USD is basically the language we talk internal when it comes to budget, when it comes to performance measurement. We basically, as you mentioned in your questions, generate the majority of our revenues in U.S. dollar. Therefore, we concluded that it would make most sense to basically now change the reporting currency. What's also important is that we have expanded now our institutional investor base over the last year successfully. Talking in U.S. dollars is certainly more international, will also be easier to explain to European, but also to U.S. investors. What you could also read or speculate out of that is that we would go to the U.S. That's currently not on the list. We are not planning a U.S. listing or an IPO.
We are very happy with the listing in Switzerland. We believe that Switzerland has a great MedTech industry. Therefore, in terms of the valuation we get here, there's currently no plan to go to the U.S., just that we are not starting to speculate there. It is really mainly the dollar language we want to have internally, but also externally, which led us to change the reporting currency.
Okay. Thank you very much. That's very clear. Let's go into the next question. Where do you see the potential of having Medtronic as a partner in the U.S. and not doing everything on our own?
I think when you have a market leader like Medtronic and you have an opportunity to collaborate with them in marketplaces that are mutually beneficial, you absolutely should. I mean, they are the market leader for a reason. Their representation, their reputation. I am very honored that we're working with them. In marketplaces, much like in any industry, you'll have pockets of who's strong where. We still leverage an independent sales network. We continue to grow our independent sales network outside of Medtronic. I think that from how we've organized our relationship through this agreement is very beneficial to Kuros because we get to pick and choose which marketplaces we wish to partner with Medtronic. If we felt like we had a better opportunity to do it on our own, we'll continue to do that as well.
The key part here is that we are in control of the revenue line, the contracting, and the relationship with the hospital and the customers. It is actually we get the best of both worlds. We are not isolated with just using Medtronic across the country.
Okay. Great. Thank you. We have just the last question. We just discussed about tariffs, but there is also an additional question in terms of the nomination of Robert Kennedy as U.S. Secretary of Health and Human Services and how this could impact Kuros.
Yeah. I don't believe there will be an impact, quite frankly. I think what we're seeing, we saw some disruption in the FDA from a registration. Initially, that was an impact relative to downsizing. It was not an impact of Kennedy by any stretch. I believe the focus of that administration with Kennedy is going to be more in the health of the population relative to other areas, not just in medtech. There is nothing that we look at in the pipeline from a risk standpoint of coming down and changing the pathway of revenue for us on a go-forward basis. I think submission times for FDA and 510(k)s and things of that nature, those will not be disrupted. We've seen we have 510(k) filings that are present. I'm here at the American Academy of Orthopaedic Surgeons talking to colleagues, and they're not seeing any impact.
We do not believe that there will be any risk attached to Kennedy. Again, his focus is more on the generic FDA relative to health and consumption rather than medtech sector.
Okay. Thank you very much, Chris. Actually, I hand back to you for the final words as we have no further questions.
Thank you very much. I just would like to say in summary, 2024 was an absolute amazing year on so many levels. I want to say thank you to the stakeholders, the shareholders, our teammates in the locations, whether it be in the U.S, whether it be in Bilthoven, whether it be in Schlieren. I'm extremely proud. The board is very, very pleased with our results. More importantly, how we have grown as an organization and how we have set ourselves up for success on a go-forward basis. The building blocks and the foundation for us to continue to accelerate not just the revenue growth, the expanding of our technology platforms, the expanding of our customers, but also the reach and being able to provide our product to markets that haven't had access to it as of yet.
Really, 2024 was so transformational for us as an organization. I wish to thank you, the investors, for listening to us, for staying with us, and hopefully continuing to grow with us as we move forward in growing this business into a $220 million–$250 million and beyond business. We are extremely excited about the future. Again, I am very, very pleased and honored to be here at the organization. With that, I say thank you and thank you for attending our call today.