Good afternoon, ladies and gentlemen. I welcome you to our presentation of Kuros Half-Year Results 2025. My name is Alexandre Müller, 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. 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 about 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 from the next organic product development. Our growth in the extremities business continues to take shape and continues 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 grow our production capacity in the U.S. in 2026. As we look at our revenue growth, not just in a 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. When we look at our surgeon utilization and 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 is 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. As you can see from the countries to the right, markets there 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.
Here we are standing a year later with revenue, engagement from physicians, expert SAB from Mr. Goldberg from the U.K., Dr. Greg Burlett, Pete Mangone, Carlos Sashbian, all working towards growing the extremities opportunity for Kuros . We will be participating in key societies such as AOFAS and ACFAS, launching specific technology, materials, and meetings focused for the extremity physicians. There is 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 four or level five evidence. These are lower-level evidence, and the bar or hurdle is very, 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 cumulation 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 one evidence. We have continuing studies in level one evidence. We have level two, level three, and level four. More importantly, when you look at the investment on the bottom part of this slide, random controlled trials are level one evidence.
We have several. There are four investigator-led studies, which is what ILS refers to, where we are supporting but not driving the study. There is less control, but still level one data. These are normally head-to-head studies. 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 insurance carriers, will need to see this data to make the right decision of what product to use for their fusions. This is a little bit of education as to how we look at levels of evidence when we discuss level one, level two, level three, or level four evidence, and also the types of biologic evidence that exist 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. We have changed how we've done that. We've reoriented the R&D efforts as well as from a product development process. Our internal team and leaders, when they look at the MIS and the launch of the being on time, on budget, and out in the marketplace with a product that the surgeons want, it exemplifies that process. We have changed internally, and this will make us more efficient for future product development on an organic pathway.
With that, I'll hand it over to Daniel to talk into more of the financials.
Not from my side, the warm welcome, ladies and gentlemen. What we have done over the last two and a half years is really to transform the business model. We have focused on driving the volume up, but at the same time, keeping the fixed cost as moderate as possible. 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 enhancements to diversify and scale the production footprint. We just recently implemented an ERP system in order to digitize the value chain. By doing that, we were able to increase the operating leverage to benefit from that. For the first time in the history of the group, we have now achieved an EBIT of CHF 3.5 million. Next slide.
If you 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. In order to do that, we were able to protect the company against tariffs. 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. 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'll see that also later on, is coming out of the Netherlands. The EU tariffs would apply here. As I 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%. 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%- 9%. Before we move to P&A, I quickly want to hand over back to Chris to talk about the face-to-face studies we are currently conducting.
Thanks, Daniel. 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 capital markets 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. It's truly independent clinical evidence where we don't have any hand in the study data collection, et cetera. That's important to recognize; a good portion of our investment in R&D does come from that. 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. 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. We should see that ratio further coming down. Next slide. This now all leads to the adjusted EBITDA, which we have seen in Q1 being around CHF 3.3 million or 11.6% and now gone up to CHF 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 fiber and PTH. 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. We are able now, since the second half of 2024, to generate enough cash flow to fund the organic growth path.
At the same time, we are 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. 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, as I said, that we will continue to invest into net working capital where needed.
We have a tremendous amount of cash and cash equivalent, as well as trade and all the receivables available in order to do that. Next slide. The most prominent topic in the recent weeks was obviously the tariffs. Important here is really to say, again, how the supply chain today works. 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 an immaterial impact. What we are doing in the long run or in the midterm is basically that we are now going live in H2 2026 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 de-risk and diversify the production footprint. In order to also redesign the supply chain, we have also done some adaptations, which help us to make use of the tax laws carried forward in Switzerland, which amounts to roughly CHF 50 million. It will also help us to implement some tariff mechanisms. Next slide. Last but not least, here is the transformation roadmap. The most important initiative we did in the functional expansion and extension was certainly to change the reporting currency from Swiss francs to US dollars. This has been done to reflect the primary market of the company, which is around 95%, and also an important driver for our cost base. At the same time, we have also increased our visibility and have now introduced two new analysts.
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. As I said, we have implemented an ERP system and have also, importantly, introduced a manufacturing resource planning system, which basically allows us to now automate and digitize the supply chain. With that, I hand...
Thank you, Daniel. Next slide, please. One of the key objectives for this year from an organic product development pathway was the MIS. I'll try to take a few seconds to talk about why that's important and truly what does that mean. Minimally invasive surgery is the fastest growing section within the spine. 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 and 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. 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.
There are technologies out there that have figured out how to put bone graft down a small tube. When we looked at the opportunity and the fastest growing subsegment of spine opportunity, having a minimally invasive applicator for our technology was the goal. To ensure we have best-in-class both from a disposable standpoint, but utilizing proven technology in the MagnetOs material. 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. We are the only bone graft delivery system that is sterile, pre-filled, that contains no human tissue, and is supported by level one evidence. This is very important because there are some technologies that may have one of these, but none of them have all of them.
As we begin to roll this out into the marketplace, 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. 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. Next slide. 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.
This technology is ready and available off the shelf. It does not need to be frozen. From a user experience, it is also improved and also at a very competitive price. Next slide. With that, 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. 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, six months ago. We continue to work towards the goal of $220 million- $250 million in sales in 2027. Again, very excited first half and great results. Next slide. With that, I'll turn it back over.
Thank you. To ask a question on the telephone, please press star one one on your telephone and wait for your name to be announced. To answer your question, please press star one and one again. Once again, that's star one and one if you wish to ask a question. We will now take the first question. The first question comes from the line of Laura Pfeiffer from Octavian. Please go ahead.
Yes. Hello. Good afternoon. Laura Pfeiffer from Octavian here. Thanks for taking my questions. I have three of them, and I would like to answer one by one, if that's okay with you. 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 understand that Q3 maybe includes a summer break, but is there any reason to assume that your growth will significantly moderate over the next two quarters, given the Medtronic alliance that should kick in, the MIS launch that you do, and also initial sales maybe from extremities? This would be the first question.
Good afternoon, 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. We do not see any change currently to our percentage from first half to second half that we've seen historically.
Okay. This means that it will be a similar phasing as last year. Very clear. The second question concerns your underlying margin development. I'm referring here to adjusted EBITDA. I think you have shown a sequential improvement in Q2 over Q1 this year. 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? Maybe the same question applies to next year too. Do you expect an improvement in margins next year?
Yeah. As we said in the post, this corridor of 10%- 12% has now been overachieved. That's correct, what you state. You know 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. This would, to a certain extent, impact the margin. Currently, what we can see is that we can definitely keep that level. Potentially, we will be able to gradually increase that. This is something we need to see once we have the Q3 results.
Okay. Thanks. 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. Currently, you know 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. We will continue to work on that and optimize it. At the same time, we will continue also to invest into further initiatives to further digitize the value chain. The whole functional adaptation, but also the supply chain adaptation and the value chain automation will continue. This will further need some investments. As I said, our commitment is definitely there to increase that gradually to come up to a peer level.
Okay. Thanks. 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. I'm aware that you're not yet providing guidance for next year. 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? Maybe if I can just squeeze in here also, it would be helpful if you could quantify the total cost for the U.S. site, what do you expect to spend there? Thanks.
In terms of CapEx, we will invest between $5 million and $7 million next year and about $2 million- $3 million this year. 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. The situation is changing almost weekly now or daily. That's definitely a challenge for us to estimate how big the impact will be. We believe it's somewhere in the single million where we would see that impact, currently in the lower single digit.
Okay. Just to make clear, this is including any mitigating measures, price increases, or whatever?
Yes. I mean, this is mainly from a cost side, how we estimate it so far. We will further look into that. As I said, we're also doing adaptations to the supply chain, which will factor in as well. Once we have a clear indication of 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.
Okay, thank you.
Thank you. As a reminder, please press star one and one to ask a question. We will now take the next question from the line of Thomas Meyer from Baader Helvea. Please go ahead.
Hi. Thank you for taking my question, Thomas Meyer 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 segment. Can we assume that we'd see something similar as Medtronic for a partnership as the commercial rollouts progress?
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. At that point in time, we were on the radar screen of leadership of Medtronic, and that's how the partnership really bloomed. 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. 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. If we do that the right way, then maybe the right partnership comes along.
If the right partnership doesn't come along, we're still well suited to go it alone. Basically, the steps we're taking are very similar to what we did on the spine business.
Thank you. Yeah, that makes sense. 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?
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. Our clearances support that across product portfolio. We're not limited as to where the product can be used as what clinical evidence we do have. 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 a patient population. 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.
All right. Sure. Okay. Thank you for the confirmation. Thank you. That's all for me.
Thank you. There are no further questions on the phone. I would like to hand back over to Alexandre Müller. Apologies, there is one more question on the telephone. We will now take the question from Laura Pfeiffer from Octavian. Please go ahead.
Yes. Hello. I just have two follow-ups. Also, on the foot and ankle market, can you please elaborate a little bit more on the early success you have seen so far? How easy is it to gain these new accounts, and what market share is feasible over the next two to three years? I'm just wondering if you think your market share gains will rather mirror the spine market, or are there other dynamics to consider that make this market maybe quicker to penetrate?
Thanks, Laura. I think a couple of things on the extremity marketplace that we've learned in the first six 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 one study that's been published and pushed out there in the past 10 years, specifically to foot and ankle. We feel that that's a massive opportunity. Our early discussions with clinicians certainly validate 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. Our approach to this is being very welcomed greatly by the clinicians.
Secondly, because we've already registered in over 450 somewhat hospitals domestically and then also outside the U.S., partnered with great clinicians as well as a partnership with distributor agents, we are seeing a little bit faster uptick because we're already in the hospital systems, whether it be on a spine approval. That allows us to begin having the conversations with the extremity physicians. Clinical evidence-wise, and 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. Also, at a cost savings, there's a product line out there that has a lion's share through the Stryker sales force, which was Augment. We are coming in at a lower expense.
You can use the analogy of BMP in the spine as Augment kind of takes that price positioning within the foot and ankle space. We are showing up to the space with a product that has greater handling characteristics, greater flexibility, greater user formats, at a lesser cost. We're very excited. Again, it's early days, six months. To answer the last part of your question, I think it's too early to talk about what market penetrations might look like in the next two to three years. We're extremely encouraged with our and also confirms what we saw as an opportunity to go into this $1.2+ billion market opportunity.
Okay. Thanks. That's helpful. Maybe just quickly, could you also talk a little bit about your next product launch? 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.
For that, we'll have to tune in at a later time. I'm encouraged with the, as we launch more products, normally it's going to serve a newer market or a marketplace we currently don't serve with our existing formats. 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.
Okay, thank you.
Thank you. There are no further questions on the phone. I would like to hand back over to Alexandre Müller for webcast questions.
Thank you. There are a few incoming questions here. The first one is actually a sum of different people asking about the Medtronic partnership that we have. 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? 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 2027?
Great question. I can answer some of that, but not all of that. The revenue for Medtronic so far to date continues to grow, and it's at the right partnership level that we had agreed in the early days. 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. I think that the growth within the partnership is keeping up with our revenue outside of the partnership, which is also great to see.
As fast as we are growing with Medtronic, we're growing as fast, if not faster, with non-Medtronic-based revenue. This allows us to keep our independence, but also to utilize the partnership to our benefit.
Great. The next question would be, if you'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? Is there an idea from whom you're 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're seeing clinicians and hospitals recognize and realize that there's a product in a segment of the marketplace that has no evidence, but also, quite frankly, has shown to have some risks associated with disease transmission from human tissue. Currently, the FDA is looking into that as well. 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 one 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. I think those two things we are taking out of the advanced marketplaces. I think as we look at a go-forward basis and 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. A large part of this is we have a great deal built into the efficacy of the product, but also the user handling characteristics.
Quite frankly, the ability to ship product in stable temperature in certain marketplaces, this is a huge benefit. Our international team continues to bring on markets and great partners. Our partners in the U.K. is an example that we brought them on not too long ago, really making an impact, not just in spine, but really leading the charge in extremities. Very excited about that.
Great. The next question would be, what are the key risks that could prevent Kuros from achieving its forecasted growth targets?
It's interesting. Key risks. You know, 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. 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.
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. 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. Being lucky, being good, I'll take them both. That seemed to have played out well for us. 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.
I keep coming back to our financial wherewithal, very strong balance sheet. Currently, we're able to dictate our future path.
Great. A question about the pricing. 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 could be at risk?
When we look at pricing, I think that that's probably a question that goes to some of the pharmaceutical discussions. To clarify, we are not a pharmaceutical. We are a medical device, and we're not subject to those pricing parameters as has been publicized by our government. First and foremost, 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 U.S., we pay a sales commission. Outside the United States, we sell to a distributor. That is a cost plus, and they end up getting end dollar revenue. We don't see much risk relative to either of those business models or being disrupted. Again, we would not be subject to any of the pending discussions relative to pharmaceuticals. That does not affect the medical device market.
Great. Next question would be about the penetration rate. We have achieved about 8% in the U.S. spine surgeons market in H1. What would be the midterm ambitions to achieve in terms of penetration?
If you know not having the percentage number by 2027 to match up with that, when we start looking at growth and surgeon penetration, it's not just surgeons who are aware of us. There are many surgeons aware of us. It's getting them to use our product and use it as part of their normal patient care. That number continues to go up. In my historic memory, getting two 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. The key there is also not losing any. As we get bigger, it's making sure our existing customers continue to see great results with the product. I'm not prepared to put a number on what mid-market will be. It obviously would be greater than 8%.
I hope that it continues to go in the right direction here from 8% to 10% to 12% to 20%. We continue to do the right things for our clinicians, provide the right tools, entering new marketplaces. 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. Now we have a tool that they can get exposed to and actually use our product. That is when we start looking at product development and new formats, that is really what we're trying to target and expand into.
Great. The next question or questions would be around our U.S. operations. 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.? Can you give some insight into this?
Sure. What we've been able to, you know, we're in early days of the plan. Our operations team is really doing a fantastic job globally on this effort. We have put out there the second half of the year, we will have production in the U.S. As timelines move and as we continue to get into production, as anyone who's ever built a building, things can be a little bit flexible. 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 and the United States for incremental employees and also an opportunity to cross-train with our counterparts in Europe from our manufacturing base there. 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, you know, whether it's Emory, Georgia Tech, and others. There's a great deal number of manufacturing companies in the biomedical space. Getting talent to fill these positions should not be a challenge for us as we go forward.
Great. Maybe the last question, it's about a big topic everywhere about AI. Is AI impacting the Kuros business operations somehow in the short or in the long term? Daniel?
Yeah. What we are doing currently, as I explained, is that we digitize the value chain, right? 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. From that end, on the back end and on the front end, we are certainly evaluating that. It's also important to watch future trends and see whether there are opportunities out there also on the AI sides to further monetize. As I said, this is currently in the making, and we will see what additional prospects that will bring us.
Okay. Just a new question here, maybe the last one now. It's about the Chinese market. How do you see or are there any plans to enter the Chinese market? Would you enter the market directly or through a collaboration?
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. Whether it's Japan or whether it's South Korea or whatever. As it relates to China, and I mentioned this at the capital markets 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. I hand over back to you, Chris, for the final remarks.
Thank you. First off, I want to say what a great first half of the year, certainly overachieving what we expected to have we set out to do for the first half. It also continues to show at Kuros that we continue to communicate our plans, and we continue to deliver results in a very clear and defined pathway. We also have a very clear and defined pathway for our future growth that we've communicated. 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.
With that, I want to thank you 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. 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. With that, I'm very humbly thankful for your participation in this journey with us. With that, I'd like to say thank you very much to all those involved, to Daniel and the team and Alexandre, to make this possible and all the work that goes into this. Again, a tremendous first half, and I look forward to reporting excellent results in the future. Thank you.