Bonesupport Holding AB (publ) (BONEX) Earnings Call Transcript & Summary

Thank you so much, operator, and welcome, everyone, for this beautiful day where Hakan and I are sitting here with a big smile on our face. And what we want to do is to take you through a brief presentation on the news that we have released early this morning, and then open up the line for questions and answers. We have a presentation that the operator will manage. So if we go to Slide 2, as usual, there are some disclaimers regarding what we will share with you today, and let's immediately jump to Slide #3, please. So what we released this morning is that CERAMENT G has received market authorization. We received the e-mail notification from FDA sometime after midnight early this morning, and we woke up to this very good news. It is the first ever antibiotic elution bone graft that has been authorized for the U.S. market. As a matter of fact, it is the first-ever combination product, a combination of device and drug, that has ever been approved through the De Novo process. We have understood from the documentation sent to us on the approval notice why potentially the final notification was somewhat delayed, and it very much relates to the fact that this is the first ever of its kind, so a new category has been set up and developed specifically for this product. And needless to say, CERAMENT G is now the only product in that category. The product CERAMENT G has received market authorization grant order for bone infections, and it's a broad and wide covering approval, so the bone infection does not take into account different etiologies. It means that CERAMENT G is approved for bone infections regardless of how that bone infection has started. And when I say regardless, I mean the indication and not the term of pathology related to different bacteria because, of course, there are certain bacteria that are resistant to gentamicin, and here, other treatment modalities will have to be taken into consideration. The product is also specifically to be used in extremities by adult patients, so it doesn't have the pediatric indication. And as I mentioned before, there are no real relevant clinical restrictions. The material that has been sent in to FDA to receive the market optimization is extensive, and we will look at some of the details later on in the presentation. If we go to Slide 4, please. So when we have spoken about the U.S. bone graft market before, and what is also available in public reports, is that the market is about 360,000 surgical procedures per year. This represents a market value of USD 350 million. And this consists of all the different treatment options that currently are available. And as you know, autograft, meaning when a bone tissue is taken from the patient and transplanted into the injury, is part of the procedures, but it's not part of the value because there is no way to put a price tag on autograft. So the value today is made up of all the commercially available product, while the procedures are all the procedures. And that means that about 70,000 procedures doesn't have a value. We see a clear tendency that the market is moving away from autograft and more into synthetic product, and this is also why there is exceptionally strong value growth in this market segment. So in terms of procedures, it's 50,000 procedures a year where bone grafting is done and the patients present themselves at the clinic with a bone infection. We've also added in this slide, you could see 90,000 procedures where the patient does not have a bone infection, but the surgeons is suspecting that an infection could develop over the next couple of days. Or this is maybe a high-risk patient, many of them, as we know, come from open fractures in trauma. So if we look then to the right side of the values, CERAMENT G has now a grant order, and it's a full widespread grant order for bone infection. So it is applicable to all of the USD 98 million or almost USD 100 million of market value. The market value for preventing infections with local antibiotics is USD 112 million, and the rest of the market is about USD 150 million. One could react and say that there is a big discrepancy between procedure and value for the non-infected but no local antibiotic is used, and that is correct. And the biggest discrepancy here is on the autografts, which doesn't have a value. If there is an infection, it's very unlikely to use an autograft. If you're preventing an infection, autograft is also much less used, but autograft has a big presence in the blue part of this pie chart. Let's move on to Slide 5, please. So if we look at the, let's say, total markets for local antibiotic treatment, it is about SEK 200 million. The SEK 100 million, SEK 98 million that CERAMENT G has received market authorization for, and then there's the USD 112 million where we are considering to pursue also in the future to extend the label also into preventative care and treatment. So -- but if you look at Slide 5, you can see what different treatment modalities are used today, both when a surgeon is addressing an existing infection and when a surgeon is trying to prevent and use local antibiotics to avoid that an infection might occur. Sorry for the gory picture there to the left, where you see a picture actually from a surgery where PMMA beads are removed from the wound. PMMA beads represents close to 40% of the treatment choices for the situations where infections are either managed, treated or prevented. And as you know, with PMMA beads, it's something that is implanted and later on has to be removed. And this procedure is repeated a couple of times until the infection is completely eradicated, and then focus is on healing the actual bone injury. Operator, if you please could take me to Slide 8, so we jump through Slide 4. So if we look at the material -- this is a business slide, so I will just highlight and to give even further insight to why it took quite a while to get De Novo approval. We have submitted extensive data both on the treatment group as well as the control group, the comparison, so slightly above 400 patients in total. And those [ support ] have, together with our advisers and together with our partners, collected, processed, concluded and submitted more than, well, close to 17,000 data ports. So in a way, you can say that what we have submitted is actually as extensive as if we would have done a PMA application. We have supplemented both the treatment group and the control group with extensive amount of x-rays that have been interpreted by experts, and this has been part of supplementary packages that we sent in September of last year. Some of you might remember that we were asked by FDA in February, end of February 2021, to bring additional people into control group, additional patients into control group. And this was quite extensive work, which was submitted by my great team in end of September. And with this data, FDA could proceed until what we have today, which is a market approval. Also, I would like you to look at the graph on Slide 8 at the top right corner. So what we had to do, because this is the first-ever combination product of device and drug in De Novo, we had to submit extensive documentation, pre-clinical and clinical data regarding the elution profile of CERAMENT G. This relates to the pharmacogenetics and the pharmacology of gentamicin and distribution volumes. And as you know, the very strong results of CERAMENT G comes from the fact that it's a one-stage procedure where you treat and address the bone and skeleton injury and you have a very high dose of gentamicin, in this case, eluted over more than 30 days. The scale on this graph is logarithmical. So you can see that in the very first days, the concentration that you have locally is more than 1,000-fold of the minimal inhibitory concentration. And this now, without any systemic side effect, which we also had a demand from FDA to show extensively with clinical data. So if we go to Slide 9 and actually share with you, for the first time ever, what is the outcome of and what is the result of the data that we have submitted. The treatment group had eventually 163 patients and the control group eventually landed at 270 patients. The control group consists of patients that have been treated with the most common treatment modality in the U.S. today, which is PMMA beads. The data for PMMA beads comes from publicized clinical study and also from a meta analysis of some 7 different published clinical data, and that's how we could eventually build our control group significantly above what we had in the first application submission. The treatment results is based on the Oxford data, which is one of the bone infection centers in the world that has the most extensive clinical documentation, not only on CERAMENT, but in total, we would say. So here, we can see the results that the patients treated with CERAMENT G had a recurrence rate of infection of 4.3% after 2 years. And at the mean over 4 years, this number was 5.5%. And when it says mean 4 years, that means that some patients were followed up significantly longer, up to 6, 7 years and -- but the average of those core patients was 4 years. And the PMMA control group had infection rate between 13.2% and 13.3%. So CERAMENT G shows clearly superior clinical outcome versus PMMA. This is -- it was as strong in the clinical -- this is strong in the clinical setting and has led to strong statistical significance. What I'd like to show you now is also -- now is also the clinical data we thought we have submitted. I also would like to take you through some of the marketing intelligence that we have because we have conducted a quite extensive market research, and I'd like to share some of those details with you to back up some of the statements that we have made this morning that we believe that this product is very much longed for in the U.S. market. If you can go to Slide 10, please. We conducted this market research in 2020 at almost 180 interviews with decision-makers, either physicians or value analysis managers in the purchasing departments of the hospital. And the questions that were asked is how is bone infections treated today, and how satisfied are the surgeons and the administrators with the current treatment options that are available? If we go to Slide 11, please. So the question I received a couple of times this morning is, is this product really new? Does it bring something of value? And is it really something that the surgeons are looking for? We found out from this research that 94% of the surgeons dealing with bone infections believe that there have to be improvements made. So that means basically, in short, that 94% are dissatisfied with the treatment options that are available today. It was also concluded, as you see on the bottom right, that both the surgeons and the health care system believe that bone infection is a difficult and challenging condition, that it has a high rate of recurrence. And when the surgeons were asked how their patients perceive having a bone infection, of course, 62% responded that it was a challenging indication for their patients. So if we go to the next slide, 12, please. We saw the reinfection rates with CERAMENT G. They were between 4.3% and 5.5%. We saw that with PMMA beads, from these extensive clinical studies, many of them done at some of the best infection centers in the world, was 13.2% and 13.3%. The surgeons that we have in the market research claimed that they had reinfection rate of 24%, so meaning that is even a better reflection of the reality. We know that when we start a clinical study and we follow a strict protocol, sometimes the results are improved just by the fact that you did it in a clinical study. So the surgeons in the U.S. said that about 24% of the cases have reinfection. When we look at need analysis for Europe, that number is rather between 10% and 15%. I think again, this shows the market potential in the U.S. And when the surgeons were asked how they feel about multi-stage procedure, 92% expressed dissatisfaction with a multi-stage procedure and a clear preference for a single-stage procedure, which CERAMENT G is the only one that can offer it. Go to Slide 13, please. And this is the final slide just on the market research. But again, it gives a bit of flavor to what is it that the U.S. orthopedic surgeons are looking for. 88% said that it's most important is to have sustained local antibiotic over a period of time, that the drug dilution is consistent, which, of course, none of the off-label current treatments for local antibiotics have proven a predictable drug elution, and also high scoring for bone remodeling capabilities. And of course, when we finished this market research in 2020 and saw the result in the very end of 2020, it was a strong encouragement for us at BONESUPPORT and our teams to continue to work on these projects despite the setbacks and sometime challenges that we had with FDA in the beginning of COVID. So if we go to Slide 14, now we're coming more down to the tactical part. So what's going to happen? Well, we have communicated to the market this morning that we are aiming to launch somewhere between September and October. We keep it a bit open because we now have to go through the entire grant order and see what modifications we might have to do to labels or our claims and the promotional material. Then we'll start producing labels, material for the salespeople, do final training, then we have to produce, partner, ship it over to the U.S. and then we start shipping to customers. The selling we'll go start a bit earlier, that we will start to inform the most prominent surgeons in this field. As you know, we have received a very generous, I would say, NTAP for the product. So it's not only covered by the DRG for all the CMS patients, there will also be an extra payment of USD 4,920. We also know that many of the private insurance companies use the CMS guidelines as guiding principles that they later also adopt. So if we go to Slide 15, please. Here, you see some further details on the reimbursement. I think we have covered that. But what I also would like to add is, as we expected and we had discussions also early on with FDA, this is the first-ever combination of device and drug, and that's why FDA is very keen on [ loans for doing ] a post-market surveillance study. This was clearly expected from our side. We know that it takes place for all the PMA applications, for example. And given how few De Novo approvals there has been, we were anticipating that this demand will come. We are looking at collecting real-world patient data to include about 160 patients. This will be done over the next 4 to 5 years. So patients with bone infections in the U.S. and -- sorry, not in the U.S., we will actually later on determine where the center will be. That will be done in the dialogue with FDA. But there will be 160 patients included over 4 to 5 years, and the cost of this will be about SEK 25 million, plus minus SEK 5 million, that will be spread over the period of 4 to 5 years. Slide 16, please. Coming to the end of this presentation, the only thing actually to add here is that the launch, as I mentioned, will take place at the very end of quarter 3, beginning of quarter 4. And once my very hardworking team have had a bit of a break, we're going to start now also to analyze the available data in terms of label broadening where we anticipate to -- we're able to submit something to FDA between quarter 2 and quarter 3 next year. We had a slightly, slightly earlier timing in previous presentations, but since we are now 3 months delayed from the original date, I think it's fair to say that between quarter 3 and quarter -- quarter 2 and quarter 3 next year is when this will be submitted. And we will look at different indications, but highest priority, of course, is trauma, as you know. So if you go to the final slide, Slide 17. Well, to just conclude what we have said today, so CERAMENT G, last slide, early this morning has received market optimization. This is clearly a milestone for us as a company, but I would say even more so it's a milestone for the patients in the U.S. We know that there is about 150,000 amputations per year in the U.S. of lower extremities, leg. And the second most common reason for going into an amputation is trauma; trauma, open fractures, bone infections. So hopefully, by bringing CERAMENT G to the market, that will make a big difference. We have seen the clinical studies. We have seen the market research, implying that there is indeed a large unmet clinical need in the market. And very happy to announce that CERAMENT G has indeed shown clear superiority to what is currently the U.S. market standard. We will be launching hopefully somewhere early October or late September, and we're aiming at a list price somewhere between $5,200 to $5,800. This is not yet fully determined, but it will be in that range. And I'm happy also to say that we have already the 375 salespeople that today are selling CERAMENT BVF, very eager and hungry to get CERAMENT G into their portfolio and start the next chapter for BONESUPPORT in the U.S. That concludes my presentation, and let's now open up for questions.

[Operator Instructions] Our first question comes from the line of Kristofer Liljeberg.

Congratulations, of course. A big day for you. Three questions. The clinical benefit you show there in percent. Is that something that you would be able to include in the label? Also, I didn't fully understand what you mean with your planning there to broaden the label, if you could explain that a bit more? And then when it comes to access to U.S. clinics, with the setup you have today, it's supposed to say how large proportion of U.S. clinics that you currently do business with or at least have access to. And would you say that there's a need here to add more resources when it comes to sales capability, both with external partners and internally to really being able to catch this great opportunity in the U.S.?

Yes. Kristofer. Yes, we're super happy to have received this approval, and let me try to answer your question. So first of all, on the label, FDA does not allow that we put any numbers in terms of how superior the product has come out in the, say, the clinical study. So the label is quite neutral and quite clinical use, stating what the product should be used for and how it should be used, and what warning signs there could be for patient safety. So when we speak about a broadened label. So today, the purpose of the product is to supplement the surgical treatment of a bone infection. So bone infection is our indication. But as you saw on the pie chart, we also would like to use CERAMENT G to prevent infection in, for example, trauma. Now that FDA has granted approval, they have gone through a massive amount of documentation showing the work mechanism and how gentamicin is reabsorbed and spread [ with a ] locally and how it eliminates the bacteria. So all the data will be the same, but we will have to find additional data on the indication in trauma. And here, I think we will be very much helped by the [indiscernible] in the Hungary papers that are specifically on trauma. So the work mechanism and the product as such has gone through the scrutiny of FDA with a positive verdict. So we believe that extending the label into other indications such as trauma, maybe ortho-oncology and so on, is probably more like a 510(k) process rather than a new De Novo, but that has to be investigated. So it's a potential positive in terms of the timing and complexity. And finally --

Okay. So on trauma, so what -- sorry, so on trauma, you see an easier path to getting U.S. approval there following the failure of the launch Phase III trial this -- at last quarter?

Yes. Well, easy, I've learned that nothing with FDA is easy. But now that we have the approvals, there is the chance possible of a 510(k) application rather than a full new De Novo. And that takes off a lot of burden, of course.

Yes. And in Europe, do you have an approximately figure, how much of CERAMENT G and the usage or sales that goes to prevention versus treating existing bone infection?

A majority of the sales we have in Europe, I would say, close to 60% of the sales we have in Europe for these products is for treating, and then the remaining part is for prevention.

Great.

So the big part is the bone infections in Europe, and then -- but we do believe on -- in longer term, that prevention is going to grow faster. And your final question was on market access. Well, the beauty with the setup we have in the U.S. is that it's highly scalable. So I have actually -- I have great distributors that we have qualified over the last 3 years, and I said it's about 370 salespeople that are selling CERAMENT today. We think that can increase to 500 salespeople because CERAMENT G is such a unique and special and expensive product. And since they're paid on commission, I think it will be a lucrative way to get all hands on deck.

Okay. And the payment you will do, is that the same percentage for -- in terms as for the standard version in the U.S.?

Yes, it will be -- yes, they are paid 30% on the standard CERAMENT, and they will be paid 30% on the much more expensive CERAMENT G. Correct.

Our next question comes from the line of Hans Bostrom, Trinity Delta.

I'd like to extend my congratulations as well. I'd like to understand, of the 360,000 procedures you mentioned, how large a share of those would be immediately addressable relating to the treatment indication of infection? And secondly, also just like to tally the $360 million that you mentioned, which would suggest $100 -- or $1,000 per procedure. Is this -- I mean are you -- will you be charging a premium to the average price at the moment? Or how should we view that? And will this market therefore expand considerably in size?

Yes. Yes. Of course. So the 360,000 procedures that are being done annually, 50,000 of those are on patients that have an existing infection, and that's where the approval has been given. These 50,000 procedures represents USD 100 million today, and the current treatment options that are being used average just south of $2,000. So if you would take these 50,000 procedures and say all of it would be CERAMENT, well, the market opportunity is a bit north of USD 200 million. So the answer is, yes, we do believe that the market value is going to significantly grow now that the first product that is approved in the U.S. market has a substantially higher price than the previous versions, but also a significantly higher payment through the NTAP system.

Great. And I just would be curious, would you expect any competitive response to this? I mean there is a -- obviously, a very large competitor in the trauma market in the U.S. which presumably is also active in this market. I mean what type of -- I mean do you see any interaction with existing incumbent providers in that they would be responding relating to your entry in the market in any way?

I'm sure there will be something. What I don't know -- I have to somehow emphasize that the bone graft market in the U.S. is underdeveloped and a bit tired. The regular CERAMENT has come as a fresh innovation and quickly gained very strong market share in a short period of time. The big competitors have tried to innovate in this space, but I would say there's nothing material that have come to the market other than CERAMENT. And when we now come in additional with CERAMENT containing local antibiotics, I think we're already a few miles ahead of competitors. For sure, I mean we live in a competitive world. But for someone to take a product to the market, similar target, will have to go through the same pathway that we have done. And it will take a lot of years, a lot of clinical documentation. So I think even the big companies will think twice before they try to challenge us in our turf. And then, of course, we have the patents that are protecting us. So I think this is our space to rule now for a while forward.

Great. Best of luck.

[Operator Instructions] Our next question comes from the line of Sten Westerberg from Analysguiden.

Can you hear me?

Yes.

Yes, we can hear you.

And let me join the choir of congratulations to this event. Now, could you explain a little bit more about this preventive market in the United States which you have not received approval for? But I guess there is an extensive use of off-label products in this market area. For example, have you included the countings of fixations and that kind of product in this 90,000 procedures?

Yes. Sten. Maybe, operator, you could help me, let's go back to Slide 4, so that the participants can see that slide while we're talking. So Slide 4, please. So this is only on bone grafts. It -- if we look at the European market, we know that sometimes the surgeon will use plates or screws and nails that they will also coat with CERAMENT. There's some early sign anecdotal stories, but also case studies showing that this could be very effective to creating osteo integration, meaning having the bone grow close, let's say, to the plate, sometimes grow into the plates, and also to prevent the infection. That is not at all calculated in the data you see here. So we are talking only about bone graft when CERAMENT is used to fill the void between 2 ends of a bone that the doctor would like to grow together. So what you talked about is an additional market which we're looking at for the future. The first step there is to provide clinical evidence and then also broaden the label to include a coating of [ macro ] hardware, but we're not there yet. That's a project in our pipeline.

One additional question. I do see some reports asking for single-step procedures for PMMAs as well. Could you comment this practice? Is it that all in use in the U.S.?

Yes, I know that there are discussions on PMMA, which is bone cement, as a one-stage procedure. None of the big centers are recommending this. I would say, even opposite. If we look at the French CRIOAc centers, they clearly state that when PMMA is used, it needs to be removed afterwards. I think the only possible application area where it could potentially be tolerated, if the right clinical studies are made and the right regulatory hurdles are passed, is in joint replacement potentially, which is one of our smallest area. But otherwise, I don't see any merit for it, actually. The only -- if you want to have a one-stage procedure, and you want to build bone and you want to prevent or treat an infection, then CERAMENT G or CERAMENT V are the options you have.

Our next question comes from the line of Erik Cassel from ABG.

Congratulations, Emil and Hakan. Very impressive feat you managed. So my first question, the 50,000 cases that are addressable with this approval, but how many additional cases would be reasonable to assume through sort of off-label use?

I don't dare to speculate in that. I think within a year, we will know what the doctor decides to do. We will only promote CERAMENT for what it is approved for, meaning, bone infection. But I think we should -- we should bear in mind, we should look at reality. Reality is such that an orthopedic surgeon comes to the office, to the clinic. Let's say, in the morning, they have 2 patients with bone infection. Now that CERAMENT G is approved and it's very convenient to use, I think there's a high likelihood that, that surgeon will prefer to use an approved FDA product rather than the off-label mixing. I think the advantages are more than obvious. In the afternoon, if the same doctor has a trauma patient with a high risk of infection, well, I think we can ask ourselves, what is that physician going to do? Are they going to then go back to use off-label? Or are they going to use the same product that they successfully used that morning for bone infections? I think that's the consideration that many doctors will have. And to what degree that will take place over the next year or so, I think we will have to find out. I don't dare to speculate in it. But what we can see in Europe, where there are more local antibiotics approved over CERAMENT G, and V has been on the market longer, the preventative market is growing very fast. So if you look at the U.S. proportions, it's actually slightly underdeveloped. But of course, if you don't have the product and it's not approved, I guess that it doesn't reach its full potential. A regulatory approval, of course, is one of the keys to get there. And that's the next of our priorities now, too, to work on, also to get, for example, trauma as an extended label.

Okay. And then I assume you can be a bit more aggressive on pricing, given that you have the fairly strong NTAP. But considering that the sort of off-label use won't be covered by the NTAP and you -- most likely will be quite a bit of repricing, do you think that, that will hold back off-label use to some extent?

If we look at the market research, cost and price was not the major concerns of the orthopedic surgeons. They have many other vectors and parameters that were much higher in their priority order. We don't have any such indications. I think the price has been well chosen. The final price is, as I said, not set yet. That's why we gave a range. But we should remember also that CERAMENT G has gone through tremendous clinical documentation, which we will use in our promotion to the physicians. And when an orthopedic surgeon has a procedure and the patient comes back after a few days with a bone infection, the reimbursement for that clinic that we work in for that doctor drops dramatically. It's almost to the extent that a failure by an orthopedic surgeon, a failure which presents itself that the patient has developed the infection, will lead to a loss-making on the patient when they come back because they get administered DRG for the follow-up business and they have to treat that bone infection. So I think the doctor will have quite a high acceptance for choosing a slightly premium product if it gives enough security to avoid that the patient comes back. And by that, I say, of course, the well-being of the patient goes first. But once that is covered, I think there's also a strong financial aspiration by the doctor in which product they choose.

Okay, Emil. Good answer. And can you just remind us, is the standard DRG for this somewhere in the range between $20,000 to $25,000?

Yes. So there's -- I think applicable now with bone infection is from 50 to 60 different DRGs. As we got a broad label, there could be infection in the bones in the hand. It could be infection in the collar bone or in the leg or in the arm. But if you take the most common, the most common indication like a tibia, an open tibia fracture that had led to an infection, then the DRG is around that level that you mentioned. And then, of course, the more difficult it is, the higher the DRG moves up. But what you could say now is if you have even a rather small procedure, let's say there's an infection in the bone in the hand which would have a very low DRG normally, the doctor can now choose to use CERAMENT G because they get an NTAP also on this indication code. So if you say that CERAMENT G would potentially be cost prohibitive to fix a finger, or this is an infection in the bone and the finger and the NTAP kicks in, all of a sudden, it's all of a sudden a good cost reimbursement benefit again for the doctor.

Okay. Yes, that makes sense. And just on the list price, I know you won't get into the specifics. But could you tell us which part of the range you're sort of leaning towards, because this is a fairly wide range at the moment?

The upper part of the range.

Good to hear. And then just the last question before I jump back in the queue. I mean considering the data used in the submission for bone infection and that has led to an approval, I know trauma is a bit more challenging of an indication, but do you feel that the data you have on hand for trauma is sort of sufficient to meet this part the FDA has set? Or are you a bit less certain about trauma?

Well, let me start with what I have at hand. I actually believe that over the last 3 to 4 years and also before that, we have built one of the strongest regulatory teams in the industry. So if anyone can do it, it's these guys here. They have now -- they deserve a break. It has been intensive with FDA all the way to the end, and after that, we will start looking into some of those studies I mentioned before. We don't know. I cannot really say until we have seen the patient granular detail behind those studies. But I promise we will come back once we've made that determination and give a clear outlook, both on timing and success rate.

Okay. And congratulations. Well done.

Thank you so much, Erik. Appreciate it.

We have a follow-up from Kristofer Liljeberg from Carnegie.

Yes, very quick. When it comes to manufacturing of CERAMENT G, do you have any sort of limitation? And how easy is it for you to scale up?

So we don't have any limitations at hand. We don't see that. But to produce the products, it takes about 3 months to go through the different sterilizations and receive all the different parts from different manufacturers. So there's a complexity with it, of course, and the quality controls are meticulous. So this is -- and we couldn't start producing actually. We didn't want to do that before we got the approval. We know and you heard from some of our suppliers that yes, it's a tougher environment, shipping costs going up, components, there's lack of supply. But we haven't seen anything so far, which it doesn't mean that we couldn't have disruption, but I cannot foresee that. So in 3 months from now, if we get started next week, we should have the first U.S. designated products and then we have the chance to ship them over to the U.S.

We have no more questions at this time, so I hand the word back to the speakers for concluding remarks.

So, well, I would like to say it has been a long journey. It was very intense time to time. This autumn, we had several discussions with FDA when we submitted our supplementary information. Then we waited for almost 4 months and we thought we were going to get a final approval. And then the last 10 days, the dialogue again intensified, focused on more practical questions regarding the product and label and detail. And we are now extremely happy, of course, after this long journey to finally be able to deliver also and offer our breakthrough technology and our blockbuster product from Europe into the U.S. market as the first-ever approved device-drug combination and as the first-ever approved synthetic bone graft with antibiotics. So a new chapter has started for BONESUPPORT, and we're, of course, very happy. So thank you, everyone, for making the time today. We look forward to speaking to you all soon. Thank you.