Good morning or evening, everybody, welcome to this video webcast on the Medartis 2022 full-year results. We appreciate you taking the time to dial in on this Tuesday despite your busy schedules and the recent market turmoil caused by the collapse of the SVB. Thank you for your participation. I'm joined today as usual by our CEO, Christoph Brönnimann, and our CFO, Dirk Kirsten. Usual, we will use the presentation slide deck, which was published this morning on our website together with our press release, as well as the annual and sustainability report. Particular, I would like to draw your attention to the disclaimer on page two regarding forward-looking statements. On slide three, you can see today's agenda. The end of the presentation, we will conclude or wrap up with the Q&A session.
To improve the user experience, we have changed the setup a little bit and are now using a video platform. We would therefore like you to ask you to turn on your camera and microphone when you ask a question. Of course, you can also submit your questions in written. With this, I would like to hand over to Christoph for his opening remarks and the key highlights of the year 2022. Please go ahead, Christoph.
Good morning, everyone, and welcome to the full-year 2022 presentation of Medartis, including the outlook for 2023. Following two years of the pandemic, we have hoped to return into a more stable business environment. However, the economical and business environment have changed significantly. In this volatile environment, we have reached a top line of CHF 182.8 million in total net revenue. We have strengthened our market position, and we delivered again share gain in most of the markets across all of our business segments. We have posted double-digit growth in EMEA, in the U.S., and also in the LatAm region. Our revenue growth amounted to 17.8% in constant exchange rates versus prior year, which is in line with our mid-year guidance. The organic growth, excluding the NSI manufacturing business, amounted to 14.6 percentage points.
The underlying margin was 12.8 percentage points. One-off effects like China and NSI integration, however, lowered the reported EBITDA margin by 3.9 percentage points. Running OpEx and dilution of NSI customer manufacturing business put temporary pressure on our underlying margin. We have made strong progress in the execution of our strategy. We're very pleased to announce that we have increased our stake in KeriMedical from 25% to 47%. Late last year, we have signed a global distribution agreement with the Australian-based Field Orthopaedics. On the next slide, we have gained market share all of the product categories with low double-digit increases, especially in the upper extremities and lower extremity.
We have grown in the mid-teens to high teens. The CMF business has grown in the lower teens as we are still in the conversion from a MODUS 1 to our MODUS 2 systems. I am particularly pleased with our performance in EMEA and Latin America. The Asia Pacific region struggled with the low activity levels still coming out of the COVID, which was effective most of the year. Despite the double-digit organic growth, it is a year of change in our U.S. organization. We have seen an acceleration of growth from 9.8 percentage points in the 1st half to 15.5% in the 2nd half. This acceleration momentum has continued into the beginning of Q1 of 2023. The U.S. team concluded the NSI integration in the 4th quarter. We have established global responsibilities for production, quality, and R&D.
Late last year, we also have made the decision to consolidate our U.S. operation locations in Warsaw, Indiana, which as a result, we're going to close the Exton facility by the end of March 2023. Please let me move on to innovation. One of our core competence and key priorities in the past years has been to strengthen our innovation pipeline and to bring more differentiating technologies to the market that improve the patient outcome. I'm very pleased to report that we have made great progress in this dimension as well. We have introduced the versatile 3.5 straight plate system, which complements the lower extremity trauma system. We have also concluded the clinical cases and the market acceptance test for the first NSI technologies, LapiPrep, and also StealthFix, which are now being able to be launched starting at the end of this month.
The KeriMedical portfolio, and especially the TOUCH prosthesis, has become one of the growth drivers in those markets where we distribute the TOUCH for our hand portfolio. We still believe in the high potential of the treatment of rheumatoid arthritis through a TOUCH, and we also have still strong beliefs in the potential of the entire KeriMedical portfolio. I'm very pleased about the first FDA approval for KeriFlex for the U.S., which is the silicone finger joint that is about to be launched in the U.S. as we speak. On the next page, we have signed, comment a bit on the global partnership with Field Orthopaedics. Field Orthopaedics has a nailing portfolio which is called the NX Nail System that addresses the growing need of surgeons for an efficient, less invasive treatment of mid-hand and finger fractures.
It is the most comprehensive nailing system on the market, and it perfectly complements our hand plating systems. It provides the surgeon now an option to choose either nailing or a plating option for the treatment of those fractures. It mainly provides an opportunity for growth in the extremities market in the U.S., once regulatory approval is granted, we are also considering the portfolio to be launched in other markets as well. Sales start was in the late last quarter of the last year. On the next slide, please. We have now grown as a Medartis company from 684 to 866 employees. Through the acquisition of NSI, 97 employees and colleagues have joined the company.
In addition, roughly 80 new employees have been hired during the course of last year, mainly in the markets in EMEA, also in the U.S. commercial organization, as well as in the headquarter functions. On the next slide, I'm pleased to announce the appointment of Mario Della Casa as the Chief Operating Officer. As we introduce and expand our operations activities into the U.S. now with the NSI acquisition, we have made the decision to create the new function of Chief Operating Officer. Mario Della Casa joins us with a wealth of industry experience in medical devices, but also automotive industry, and it makes him well equipped to lead the acceleration of our digital processes in manufacturing, planning, and also logistics. A very warm welcome to Mario Della Casa.
With those comments, I would like to hand it over to our CFO, Dirk Kirsten, for the operation and financial review. Dirk.
Thank you, Christoph. Good morning, everybody. As Christoph already mentioned, three out of four regions have grown double digits in 2022. EMEA 17.3% at CER, LatAm 27.7% at CER. The U.S. 12.8% organically. If you include the former NSI business, it's even 28.7%. Only APAC grew lower with 3.5%. In total, the group achieved full-year growth of 17.8% at CER, which converts into 14.4% in reported CHF. Our reported sales reached CHF 182.8 million. When going into the different regions, let me give you a little bit more flavor. In EMEA, the DACH region grew more than 10%. Growth in France, the U.K., and in Poland was above 20%.
In Spain, our youngest country, we even doubled our size, and with that reach an absolute size, which is after three years in the business, bigger than in Poland, our direct business in Japan, and it's same size as Mexico. These results were driven mainly by commercial execution, further share gains in our hand and wrist systems, and a strong update of new products launched in 2022, 2021 and 2021. Examples, therefore, are implants for the treatment of clavicle, the ankle joint, as well as the versatile CCS screw extensions. In Germany, Austria, and the U.K., where Medartis has exclusive distribution rights, KeriMedical sales also contributed remarkably to our growth. For our CMF business line MODUS, the migration from its first generation to MODUS 2 is progressing continuously.
In the APAC region, sales for the full-year increased 3.5% at CER in 2022. Our direct lower extremities business in Japan reported strong growth, while the indirect business in upper extremities or CMF were flattish or even lower than in previous periods. This example is a strong proof for us that our own marketing efforts, as well as our strengthening of training and education, supported also by independent IBRA, are besides innovation, the most decisive factor to drive above average growth and win market share. In Australia and New Zealand, sales were adversely impacted as post-COVID restrictions were still existent, hospitals are not allowed elective procedures to accelerate again. We've seen some signs of recovery since Q1 2023, we believe our continued investments into sales, marketing, education, will bring us back the strong momentum which we had also seen before the pandemic.
As mentioned before, we decided to withdraw from the Chinese market in 2022, which was following the decision of the Chinese government to introduce centralized procurement and with that, the need to cut prices down to a level which would not have allowed us to make any profit in the foreseeable future. In LatAm, Medartis reached 27.7% growth at CER during 2022. While this number must be partially seen against a low comparison base in 2021, it however reflects the strong success which our direct organizations in Brazil and Mexico have been proud of. During COVID, both teams had focused on training and education and sales excellence. After the pandemic, a continuous conversion of customers from competitors could be realized and will continue in the future. By broader category, the distal radius, hand and CCS screw product lines were the top performers.
Medartis further accelerated CMF sales in Brazil. For the near future, a number of products which have been already launched in other regions are expected to achieve regulatory approval also in Brazil. This makes us confident to continue strong growth across the entire region, also increasingly from its distributor markets. With that one, let me comment on the U.S.. Here, we report full-year growth of 12.8% for our own Medartis business, which is 15.5% in the second half. While this growth is behind our own expectations, though a couple of positive developments can be pointed out. First, our new leadership team in the U.S. has successfully taken over and systematically segmented and prioritized its channel building activities. Second, all launches of the new NSI products were prepared accordingly to the original timetable, and various full launches are just happening right now.
Third, and also important, we have combined our teams and decided to build one single Medartis organization in Warsaw, Indiana. The new Medartis U.S. headquarters are not only a sales subsidiary, but instead a fully fledged organization with U.S. dedicated R&D, with own manufacturing, product management and marketing, as well as training and education, and also customer services. As in Australia, we've seen increased year-on-year growth in early 2023, and aim to achieve growth above group average for the next couple of years. This will be also supported by our most recent distribution agreement or partnership with Field Orthopaedics Products and the launch of KeriFlex, a silicone finger joint which received FDA approval last October. Accelerating U.S. growth by starting to achieve cost ratio improvements and that is the number one top priority for group management in 2023.
We are committed to show gradual improvements quarter by quarter and year by year. Turning towards the P&L. Page 14 summarizes the gross margin development in 2022, starting from 83.4% at CER in 2021. The gross margin for our core business decreased only 40 basis points and stood at 83.0% in 2022. Our high production efficiency was almost unchanged. An unfavorable country and distributor mix and the increase of more distribution sales explain the year-on-year impact on our core gross margin. The main factor for the decrease, which you see here on this slide, of the reported gross margin was the acquired NSI, what we call the third-party manufacturing business, which sales has much lower margins than the Medartis core business.
We expect this business to fade out over the next coming years. We will use the free capacities to systematically build the manufacturing for our own global product portfolio in the new plant in Warsaw. On page 15, you can see our OpEx development year-over-year. The OpEx ratio increased from 78.4% at CER in 2021 towards 82.8% as reported in 2022. After excluding CHF 7.2 million of one-off costs for M&A transaction, for the U.S. restructuring for only one side and also for China, the underlying OpEx ratio was 78.9% in 2023. Note that this increase of only 50 basis points include the full consolidation of former NSI with functions like R&D, operations, QA, regulatory and so on. All other regions increased their costs more than CHF 10 million.
Also in 2022, Medartis has continued to invest into sales, marketing, training and education in almost all countries. At the same time, almost no cost increase in central headquarter functions was recorded. Headquarter costs decreased year on year by about 5% as percentage of sales. Seeking for more efficiency for all of our processes will be continued systematically also in the future. During 2023, the group intends to upgrade its company-wide ERP system to new generation, and this will further improve our process management, and with that, realize also material economies of scales in the years to come. Page 16 summarize the aforementioned factors. The 2021 full-year EBITDA margin of 17.2% as reported or 15.5% at CER came down towards 8.9% in 2022 or 12.8% excluding one-offs.
The underlying decrease of 2.7 percentage points results from a combination of the gross margin dilution from former NSI third-party manufacturing and the explained OpEx ratio increases. As mentioned in H1 2022 reporting, we will continuously drive up the EBITDA margin over the next two to three years. To conclude the P&L, page 17 shows the development of net profit. Medartis reports a net loss of CHF 5.8 million or a small net profit of CHF 1.5 million, excluding the above-mentioned one-offs. The key reason for that decrease was the lower operating profit. The combined financial result and income tax result was slightly positive for 2022, but had almost no major impact on net earnings as reported. With that, let me come to the cash flow development on page 18.
Starting with high cash levels of over CHF 80 million in January 2022. Our operative business decreased cash towards CHF 61.7 million. In addition, the acquisition of NSI, the small increase of our holding in KeriMedical and Ethics Movements brought reported cash down to a level of CHF 20.6 million Swiss francs towards the end of the year. This balance, as well as the newly negotiated committee line, committed loans with various banks, provides sufficient liquidity also going forward. Opportunistic financing of the newly announced increase in KeriMedical doesn't exclude a small capital increase of maximum CHF 20 million-CHF 30 million, subject to investor appetite and market development. With this, let me hand back to our CEO, Christoph Brönnimann.
Dirk, thank you. Let's move on with the strategy and the business update. Our strategy remains unchanged. We are passionately dedicated to developing and bringing to market differentiated technologies that improve patient care in the extremities and in CMF. We continue to focus our investments in new product and solutions, expansion of our sales organizations, and new market opportunities. In the extremities market, we still believed we're playing in an attractive market, which is mainly driven by demographics. Our priorities for 2023 are the following. We want to deliver innovation that we have developed and with NSI acquired. I think we have been focusing on broadening the strength of our pipeline through own and internal developments and through acquisition. We start the phase where we bring those technologies to the market, which I'm enormously excited about.
We also continue to broaden our digital offerings in the CMX space by new launches and expanding our indications. The second priority is profitable growth. We have launched many technologies following the pandemic, the COVID pandemic, and before the MDD, MDR switch. We have still sufficient potential to continue to grow in those segments and in those technologies like foot and ankle, also clavicle, that we want to harvest on. Our main priority remains to continue to develop and expand our sales distribution channel, mainly in the U.S.. The third priority is protection of our gross margin. It's not only the business environment and inflation that has changed or the economical outlook, we need to accelerate, continue the optimization and efficiency gains in our manufacturing and production cost base.
On the next slide, gives you an overview now what I meant with the NSI and also the internal development technologies that are now becoming available for global launch. On the left-hand side, you see an overview of LapiPrep and StealthFix, which are the first NSI technologies that are being ready now for launch. Launch is starting by the end of March. Especially LapiPrep and StealthFix now give us an opportunity to go into the market of instrument-aided, controlled correction of the hallux valgus. It's a market which we believe is around CHF 300 million, growing at 5%. It's also a market that is shifting from the so-called freehand procedure towards the instrumented and guided procedures. We will be able to play in the market, and it's fully compatible.
The LapiPrep is fully compatible with our Medartis portfolio, either with the CCS screws or with the TMT plating system, or could even be used with the StealthFix. The feedback that we have received from our surgeons is not only the controlled correction, the easiness of the compression, but also the flexibility of the fixation method once the osteotomy is cut. CalcShift will be launched later this year in the second half, and it will be helping us to expand our indications for the controlled corrections from the hallux valgus into the midfoot and into the hindfoot. We will go into the market of instrumented aided corrections of hallux valgus and all the flat foot indications. On the global level, we're going to continue to launch our and expand our CCS portfolio.
We increase the indications in the midfinger and in the midhand finger fractures. Very excited about the launch of KeriFlex as the silicon prosthesis now in the U.S. We also have an extension of the forearm in the distal ulna plate. The APTUS Foot system will ideally complement our trauma system for the foot, and it will allow and support the expansion into indications in the corrections of flat foot. In the CMX space, we're going to go into the CMX ankle and also orthognathic, so that ankle corrections and orthognathic corrections now will be covered by the digital planning all the way with all the services towards a patient-specific implant.
On the next page, we have this morning announced that we have acquired an additional 18% of the KeriMedical, which brings our holding from 25 to 30% and now to 47% in total. This is a strong sign of the execution of our strategy to enter not only the joint replacement, but also to bring the KeriMedical portfolio into the U.S. We now have clarity, especially when it comes to U.S., to jointly develop the reference centers, the training centers, and leverage our KOLs in the space of hand surgery to expand our product offering from plates and screws into the KeriMedical portfolio, mainly in the U.S. It also allows for a better collaboration in R&D, regulatory marketing, and professional education. Next page, please.
On our second priority, we have a significant potential to grow in all our segments in all our markets. Our number one priority is to continue to gain share in the distal radius, where we have the most comprehensive portfolio, comprehensive clinical studies, and a very well-educated sales force. We are gonna continue to focus on building our competence in the distal radius to drive market share gains in all of our markets. The second priority, we have our foot and ankle business that we have started to build. With all the technologies that we are going to bring to the market, you can understand that we're building now a comprehensive portfolio addressing forefoot, midfoot, hindfoot corrections, in addition to the trauma indications that we already have.
The NSI technologies will be launched in the U.S. first. Over time, we will also bring those technologies to the global markets as well. KeriMedical has become a growth drivers in our hand segment, especially in Germany, U.K., and Austria, especially through the TOUCH prosthesis. We believe that the TOUCH prosthesis has the potential to change the way of treatment of wrist arthrosis from a trapeziectomy towards a complete joint replacement with the TOUCH prosthesis. Encouraged by that success, we're looking forward now to take the KeriMedical portfolio also into the U.S., starting with KeriFlex as we speak. Let me comment on the U.S.. We have been focusing on changing and expanding our sales channel. I think bringing those technologies into the market, we need two things.
First and foremost, that's our number 1 priority, continue to expand the sales force, but also to strengthen the sales force. The second priority is on gaining and expanding our market access. Our U.S. team has been very active in both dimensions. Last year, we continued to expand. We're now well on track with the current sales rep and the expansion of the independent agents. In the top right chart, you can see we're right now about 230 reps. We have also focused on the strength of our channels. Meaning, that we increase the exclusivity, that we have changed and addressed underperformance and changed some of the distributors, mainly those who had joint replacement in the bag. We wanna drive towards fully dedicated, exclusive independent agents carrying the entire Medartis portfolio.
Certainly, we have expanded in the upper and lower extremity, but going forward and in light of the NSI technologies, we must continue to expand and accelerate the sales channels, especially in the lower extremities. We have intensified our efforts in contracting and in pricing and have expanded and invested in the team, gained significant market access in the Central South and the Central North and Southeast region, and we're working on continue to expand the market access across the United States in national contracts. This has also become more and more of a value driver for us in negotiations with distributorships, gaining more and distributorships in our sales channel.
We have established the IBRA U.S. chapter, we're going to continue to expand in the number of courses, focusing mainly on young surgeons getting closer to the upper extremity and lower extremity fellowship centers. With all those activities, we are very confident that we're gonna be delivering and expect in 2025 in the U.S., $80 million of revenue approximately. On the next slide, protecting our gross margin. We are very well on the way in our manufacturing site here in Basel. We're now going to focus the streamlining of the operation activities in the U.S. that came in with NSI. We're consolidating the operational sites and consolidate in Warsaw, Indiana, closing the ex-Exton facility, which will also give us addition efficiencies in the back office and in our commercial capabilities.
We have initiated a product transfer and a manufacturing transfer project that we can start producing semi-finished Medartis plates and screws in Warsaw earliest beginning of 2024. Therefore, we have already initiated the know-how transfer and the design transfer for those products. As you can imagine, the many different departments, regulatory, quality that are being affected. For such a know-how and knowledge transfer. We also improve and continue to work on the improvement of the OpEx sales ratio, especially in our U.S. organization when it comes to the non-product production areas, which is an enormous important lever also for us to become more profitable as a group. On the next slide. Let me conclude with the outlook for 2023.
In the outlook of 2023, bearing any unforeseen circumstances, of course, we're guiding towards an organic sales gross growth of 15%-18%. Continue to recover in the elective procedure and the hospital capacities is an assumption that we also go after in 2023. Our underlying EBITDA margin is expected to grow back into 13%-15%, which is in line what we had communicated after the NSI acquisition, where we benefit from operational leverage. With those remarks, I would conclude the presentation part and probably open it up for Q&A.
Thank you, Christoph. Thank you, Dirk. Excellent questions. Excellent presentation. Let's move on to the presentation. Christoph, Dirk, are you ready? We have been waiting all day for this, so we have a few questions coming in, mainly from the telephone line. Just as a reminder, if you'd like to ask a question through the video chat, so there's on the left-hand side of your webcast, there's a little icon which is intuitively called Video Q&A. You can also ask your questions anonymously by pushing on the Text Q&A button or in the traditional way, via telephone. Let me quickly look in. I will then suggest that we go to the telephone line first. Operator, can we have the first question, please?
Daniel Jelovcan of Stifel.
Good morning, Daniel.
Daniel.
Please unmute your line.
Sorry. Do you hear me? Hello.
Yes, we can. Please go ahead.
Good morning. Sorry, I was on mute. Just two questions. The NX Nail fixation system. You mentioned it's already launched late in Q4. Can you indicate about the rollout in most important markets outside U.S.? I guess the biggest market is in the U.S., though, and if you can maybe give us a global, let's say, opportunity for you in this probably attractive business. And the second one.
Okay.
On the U.S. strategy, I think you plan to hire 20% more sales in the U.S. this year. Where do you get them from? Are they mostly third-party sales or direct sales reps? I guess also because there's a certain payoff time when you hire a new rep that probably it's diluting the margin in the beginning. That's probably also a reason for the kind of slight margin improvement on an underlying base. I guess the dilution is coming from the U.S. this year. Thanks.
Good. Daniel, we couldn't hear you really well. Try to repeat the questions. The first was, and please correct me if I interpreted it incorrectly. The first question was on the NX Nail. Christoph, how we wanna roll it out, what is the market opportunity, and what is the potential outside the U.S.? If you could elaborate on that first, and then I'll give you the second question.
Okay. Let me comment on the NX Nail. The NX Nail is a new technology or a new way of treating finger fractures that has mainly come up in the U.S. It's much less used in Europe. There is some interest around it. It also has some disadvantages. In the U.S. market, we have seen that the market has started to slide a little bit towards using nailing system. A little bit means it's around about 10% of those finger fractures that are treated with a nail. The plate and screw still is and remains the gold standard for the treatment of those fractures. However, there is some group of surgeons that are tending towards using an intramedullary nailing, and that was the opportunity that we saw.
As there is the NX Nail available on the market, they have asked and searched for more distribution capabilities. For us, it was a strategic decision to add the portfolio that complements the hand and plate portfolio in the U.S..
Good. Thank you, Christoph. The next question would be related to the sales force expansion. We have shown on slide 24 that the indirect and direct sales rep will have grown in 2022 to a level of just short of 230, and that will continue to 270 next year. The question is: Is there a time delay in training and making these sales rep for our agents mainly productive, and will that dilute the margins in the medium term or short term?
I think as you can see from a numbers perspective of total reps, we're following about the plan. The plan is also based on the onboarding equipment of distributors with the new sets, but also providing the required training for our products and the indications. From that perspective, we're on track. We will continue to expand as we had planned. I think it's not only, it's not only about the number of reps, but it's also about the strength, the dedication, and the share of voice, the share of time that we gain from those reps. We are equally paying attention to select the right distributors. The right distributor for us means distributors who are dedicated to the extremities, that do not carry a joint replacement product line in the back in addition, first of all.
We put more and more emphasis now as we become more competitive in our portfolio to get exclusivity, so that we're the only manufacturer with plates and screws in our portfolio in the product lines of those distributors. I think those are the two dimensions that we pay enormous focus on in the future, in the future expansion.
Okay. Excellent, Christoph. Daniel, was your question fully answered, or would you like to add another one?
No, that's great. Thanks.
Good. Otherwise you rejoin the queue.
Next question, please.
Yeah. Otherwise, you rejoin the queue afterwards.
Thanks.
Next question, please.
Chris Gretler from Credit Suisse, please go ahead.
Thank you. Good morning, Medartis team. Maybe two questions. Now first is, just on this sales force, actually, kind of. Could you discuss the productivity? Because if I calculate that, you know, it's basically kind of, you know, shy of CHF 200,000, you know, per, you know, direct or indirect sales rep. You know, which is fairly low for this industry, you know. Maybe could you discuss that and what, you know, is the opportunity and how you drive basically sales per rep, here?
Okay. Another question. Good morning, Chris Gretler. Thank you very much for the question. On the productivity, our goal is to reach an average of about CHF 500,000-CHF 750,000 per rep. That's what we consider a good size territory. Now, as we expand and onboard new reps, you will always have a mix of new reps which are significantly lower sales compared to the more mature reps. Our biggest reps, they're probably running at about CHF 2 million- plus. In an average across the entire organization, we strive towards getting in the range of CHF 500,000-CHF 750,000.
Okay. Maybe, you know, the other thing is, just on CapEx, you know. Could you maybe discuss, you know, the capital requirement, you know, for this year and maybe next year now in terms of, you know, instrumentation that, you know, you're planning to put out in order to support, the growth, particularly on the U.S.?
Christoph, I take the question. Dirk here. Last year we've put a lot of new sets into the U.S., which was also given the fact that we wanted to ramp up this business. We had a new team. We're also reviewing customer relationships, we really didn't take out any sets. Even the opposite. We were very generous and put in a lot of sets. We've also selectively increased the number of sets to all the other countries, especially those countries which will grow very quickly. With respect to this year, we will be a little bit more modest. Means on the one hand, what I call the installed basis for the U.S. is much higher than it was a year ago. We also expect that there's some set turn, some revenue to come on these sets.
The other thing is also that we believe that the level of sets which are in the country is now at a level where we feel comfortable and from which we can grow. That being said, our CapEx for sets will be certainly lower than it was last year. We will also be a little bit more cautious on the inventory build-up, which last year we were in a special situation also with the NSI transfer, semi-finished products, other things. You should expect a CapEx number which is clearly below this year, 2022.
Maybe to add on your comment on the NSI launches, of course. Those are new technologies that we're going to get into the market. I think we will also be cautious in terms of do we have the right reps? Do we convert the surgeons? How many sets do we need in order to support? We're certainly not gonna go and flood the market with NSI technology sets, but we want to make sure that we get the sales turns and the set turns that we target at an early start of the launch.
Okay. Thank you, Dirk and Christoph. The next question comes from the video line. Sandra Dietschy from Bank Octavian. Can you please go ahead?
Yes. Good morning, gentlemen. My first question is on the U.S. sales target. You said you are targeting roughly $80 million of sales by 2025. What's the split between sales from products from NSI products versus the underlying business there? The second question is also related to NSI. On the third-party sales, what should we expect to phase out over. Is it kind of the next two to three years, or how long do you expect to still sell the third-party sales? If I may, I also have a third question on the salesforce expansion in the U.S.. You are now focusing on the independent sales agents, and there are obviously two different types. The ones that are dedicated to either upper or lower, and the ones that are doing both.
Can you share what's the split today and how this will develop going forward? Is it to onboard more dedicated ones, or how should we think about that? Thank you.
Okay. Fabian, you may repeat the first two questions. They're difficult to hear as he turned down the volume.
Let me start with the last one on the salesforce expansion in that direction, then Sandra, if you might. We had a technical issue here at the beginning, so it was very.
I can take the second.
Okay. Let me start with the expansion of the salesforce. As I mentioned, our ambition actually is to move to independent agencies that have both. That have reps that serve upper extremity and reps that serve the lower extremity field. I think at the end, we will have dedicated reps, upper extremity and lower extremities. The portfolio becomes too wide to cover all the indications. We wanna get that specialty, that training, that knowledge, that competence into our salesforce on the upper as well as in the lower extremities. We have a combination. There are some distributors that have both. There are other distributors that have only upper extremity and/or lower leg extremity. Right now, from a total salesforce perspective, our dedicated lower extremity is still on a smaller level. It's around 20%.
That is certainly the competence that we need to accelerate to build, especially as we come now with the NSI technologies. Dirk, you have the second question.
Sandra, my understanding of the second question, though I couldn't hear you very well, was how about the third-party manufactured products? How big are they, and what is our plan going forward for the next two years? How big will that be? Did I understand your question correctly?
Yes. If it's rather a phasing out or if we should expect...
Yeah.
Kind of a dedicated stop of these sales.
As you know, we've taken over this business as a part of the transaction with NSI. We've also committed to maintain and to continue that business because there are contractual agreements with third parties, and also we have, at this point of time, spare capacity in Warsaw on our production. We're not guiding for it, which means that when Christoph has guided you with respect to top line, always take the, what we call the organic growth that includes the Medartis business, but it does not include what we call the third-party manufacturing. You would start from a basis which is around CHF 82.8 million, and then deduct the approximately CHF 5 million, which we got from NSI for the third-party manufacturing, and that is the basis for growth. We call that organic growth. Number one.
How big the number is, within that context, not really relevant. It does matter when in terms of gross margin and then also the overall profitability is affected by that one. I would assume that it's gonna be a single-digit number for this year, and it's gonna fade out for the next two, three years. Of course, I can't tell you what the demand behavior and the order level in the time to come will be also from the third parties. Does it make sense?
Yeah, just to clarify. The third-party sales is even though you have acquired it, I think it was March last year, is not considered to be organic in... Your guidance is excluding the third party.
Our guidance is on Medartis products only. That includes the new technology.
Including the new NSI products.
Which we got from NSI, so the products which Christoph has referred to, but we consider them to be our products. The third-party manufacturing, which is the heritage business of what we got on top of everything, is not part of our guidance. We do it as it comes in, but it doesn't really matter for our own business development.
Okay. Super duper clear.
And Sandra-
The first question.
Sandra, apologize.
Yeah, sorry.
Could you repeat the first one? I apologize.
Yes. The first question was on this $80 million sales target in the U.S. You mentioned you target to reach by 2025 approximately. How much of this $80 million is coming from new NSI products, and how much is what I would call the underlying business? If you could kind of give a split here.
Well, those $80 million, we don't break down, we don't guide for individual product lines. We had for multiple times, we had already talked about reaching those $80 million, that included the expansion of our lower extremities portfolio. The lower extremity portfolio is now fully consolidated into those $80 million. It includes the plates and screws, also includes the NSI technologies, mainly the three that we have mentioned today that we start launching. Those are the ones that will have the key impact. From that perspective, the $80 million, the growth that you can imagine or that you can calculate, which is gonna add up about a 25% CAGR year-over-year to reach those $80 million. That will be driven by our existing portfolio, plus all the new products that we are about to launch this year.
Okay. The target of the CHF 150 million sales by 2028 from NSI products, that target is still in place?
Well, we still confirm and believe in the high potential of those products. Exactly. Now, the difficulty is a bit to range up is, as I said, building the sales channel. I think if we look back, we have been building very fast in 2021, but we have also realized last year, not all of that expansion has been sustainable. This is also why we changed some of the underperformance, also why we changed from some distributors to others, mainly focusing on purely extremity dedicated. I think, if I take a lesson learned from the 2021 expansion, certainly the one more quality rather than speed. I think the basis that we have on the distributors that we have gained is a very solid one.
Many of the new ones I have visited last year and also started to visit this year. I feel much more comfortable that we have the right partners in there, which is a good base then to sell to accelerate and to continue to expand.
Thank you.
You're welcome.
Good. I'll have a look at the list again. We don't have any further questions for video Q&A. Operator, do we have somebody in the telephone line?
No, sir. We don't have any questions over the phone.
Okay. Let me remind you can push the star one on your touch-tone telephone to pose a question. If you go on the left-hand side and click Video Q&A, you can, as Sandra did just before, ask a question through the video interface. Wait a few more seconds. There's one question just coming in from the email interface, that person would like to know, could we break out the cost of NSI on the OpEx level? We indicated obviously that the margin were dilutive because of additional cost of these 97 people. Can you break out how much these costs, excluding the acquisition and restructuring costs were?
I can take that question. Very happy to do so. There is one slide in the presentation where we've drawn a very fine line, which is the increase of OpEx. Within that, you can also see that approximately half of the increase is coming from NSI. What you have to know is that as of September, we run the company as one company, so we're not making any difference anymore, whether it's former NSI, whether it's former Axomed, it's actually one business, and we run it together. I wouldn't overemphasize or over-focus on this specific NSI number. It's our U.S. business, and Christoph has said that we're trying to improve our OpEx ratio for the entire business significantly also during this next year to come.
What you can see from the, from the chart is that approximately half of the business or half of the OpEx is coming from former NSI, but no guidance on this number going forward.
Yep. Perfect. Dirk, there's another question through email. The person would like to know on slide 21, where you show off all the innovations, the product introduction in 2023, which of the NSI products is the product with the biggest sales potential?
I think that the product with the biggest sales potential is clearly the LapiPrep. The LapiPrep, the instrumentation for the controlled correction of the hallux valgus. I think it's not per se sold as an implant. I think it is combined with the implants. It can be used with the screws and plates. It can be used together with StealthFix. For us, it's the system that we have developed, instrumentation and also fixation opportunity for the instrument-aided correction of the hallux valgus.
How the U.S. labor market looks like at the moment. Is it difficult to find sales rep and also to hire agents that have an exclusivity or a focus on the products that are relevant for Medartis?
If I take that question, the labor market per se has certainly changed also in the U.S. We have made the experience that also in the sales force, that reps rather take a job and position in the elective joint replacement where they work from nine to five, probably, rather than in a trauma indication where they need to work 24/7. Having said that, on the other side, we also see many changes in the industry. Acquisitions, we also see consolidations. We're now hearing about layoff rounds and restructurings in the bigger. That will open up and has already opened up opportunities to recruit dedicated extremity, independent agency. Rather less of an issue and impact on the distributors, much more impact on individual labor market.
Good. Perfect. There are more questions from the video line. Bank Octavian, ZKB, would like to ask a question. Please, operator, can we have them, put through, please?
There are no questions on the phone.
Doesn't seem to work. Sandra Dietschy was in before. Let's still wait for a few seconds before we move on. Okay. The operator just told me there are no further questions on the line. If that's the line, I mean, we can definitely also take the questions up afterwards bilaterally. Thank you for your active participation. For that, then I would... Yeah, no, Sandra Dietschy is coming in. Can we have her put through, please? Sandra, can you hear us?
Yes, now it's working again. Just a follow-up question on the KeriMedical. Is it still the plan to get the FDA approval by 2024 for the TOUCH? Is that kind of the timeframe we should think of? What are the thoughts regarding the remaining 53% stake of this company?
Thank you for the question, Sandra. Yes, the regulatory approval for the TOUCH prosthesis is still expected mid next year, end of 2Q, maybe going into the 3Q. I think we're fairly stable as the TOUCH has been granted the fast track approval process by the FDA. There's no change in our expectation. Going forward, as you can imagine, having started with 25% and now increasing our share to 47%, there will be certainly be an interest on our side to increase, to further increase our stake, but it always takes two, and more than those 18% have not been available as of now.
Good. Perfect.
Thank you.
There was another question through email. Can you elaborate of the phasing of your sales guidance between H 1 and H 2? Is the growth more pronounced in the first half, in the first six months of the year than in the second half? Dirk, you wanna take that question maybe?
I can do so. There's certainly a higher proportion expected for H2. This is on the one hand based on the momentum. Christoph has alluded to the increasing momentum of the U.S.. He's also referred to the increasing momentum, which we also see from Australia. That should happen when the year continues to come through. The other thing is also the introduction of the new products, the launches, both the former NSI products, but also our own pipeline, which is being launched currently. That would also give a stronger bias towards the second half of the year.
Good. Perfect. Thank you for your engagement. Excellent question and your interest in Medartis. With this last question, we're going to close this out for today. Before we terminate this webcast and the closing remarks from our CEO, Christoph Brönnimann, let me draw your attention to our IR calendar on slide 30. We hope to meet as many of you, obviously, during one of the roadshow activities or at one of the listed conferences. To access our annual report, which was released this morning, just simply press on the button on slide 29. With that, I would pass the word back to Christoph for his closing remarks.
Thank you, Fabian. First of all, I would like to thank you all for your interest and engagement and the questions that you asked. When we put those presentations together, I was really inspired and really impressed again as when we talked about the broadening and the strengthening of our pipeline, to reach, change the strategy to go beyond the plates and screws, also in the joint replacement and also more and more in digital services. Now a couple of years later, seeing those technologies being available for launch, getting introduced into the market alongside with the KeriMedical, but also now looking forward to the NSI products to be launched, starting as we speak, actually, at the end of this month.
Also seeing the progress that we have made in the strength of the sales channel in the U.S.. I'm very excited about the 2023. I'm very optimistic that we're gonna bring a lot of new technologies into the market that really have an impact on our patients. In that sense, I'm really looking forward to 2023. Thank you again for the time that you have taken, for the engagement, and hope to see you soon. Thank you very much, and have a great day.