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

February 15, 2024

Nasdaq Stockholm SE Health Care Biotechnology earnings 49 min

Earnings Call Speaker Segments

Emil Billbäck

executive
#1

Yes. So good morning, everyone, and thank you, operator. Welcome to the Bonesupport's Quarter 4 2023 Result Call. My name is Emil Billback, and sitting next to me is Hakan Johansson, our CFO. We're broadcasting from the U.S. West Coast, where we are participating in the largest American Orthopedic Congress. So we will use the next 25 minutes to guide you through the presentation of the fourth quarter results, and then we will open up the line for question and answers. So we go to the next slide. Before we will start this presentation, we would like to draw your attention to any disclaimers covering forward potential looking statements that we might do today. So let's go to Slide 3 and get started. So I would like to begin this presentation with some condensed highlights from the report that we released an hour ago. The overall quarter 4 sales were SEK 173 million, which corresponds to a reported growth of 67% year-over-year. In constant exchange rate, the growth rate was 60%. The operating results before incentive provisions was SEK 11 million, which is a profit improvement versus the same period last year of SEK 21 million. Reported EBIT was a negative SEK 8 million, negatively influenced by a few distinct topics, which will be covered in the finance section. The main highlight of the period was, of course, the ongoing launch of CERAMENT G in the U.S. but I also want to draw your attention to the following topic. In the quarter, we received MDR certification for CERAMENT V and CERAMENT BVF, bringing us to full MDR certification for all our products and our quality management system. We submitted the market authorization request for a label extension with CERAMENT G in the U.S. for the indication open fracture trauma. And at our Capital Markets Day in November, we announced our ambition to enter the spinal fusion segment with CERAMENT. Lastly, CERAMENT G was granted an untapped outpatient reimbursement through CMS transitional pass-through payment program, the TPT. I will cover these topics more in detail during the presentation, but let's first look at the sales development, and let's go to Slide 4 of our deck. So this is one of our standard charts for the quarterly report and investor presentations and obviously, one of our favorite charts. It shows the last 12 months sales in Swedish currency every quarter since quarter 4, 2016, split by region and product category. The sales numbers are really taking off. If you look at what looks as a big disruption to top line in 2018, following the change in U.S. commercial structure and strategy, it now rather looks like a small dent on a successful journey. The strong acceleration in both geographic segments over the last 24 months becomes very visible in this slide. In the U.S., the performance has been boosted, of course, by the continued launch of CERAMENT G. In Europe, we see improved market dynamics and strong capturing of market shares by CERAMENT from more traditional treatment methods. In total, the antibiotic eluting CERAMENT globally is grown with 220% versus quarter 4, 2022 and 25% sequentially over quarter 3, 2023. Let's go a bit into the details, and we will start with North America. So sales was, as you have seen, SEK 132 million in the quarter, which corresponds to a reported growth of 79% year-over-year. At constant exchange rates, growth would have been 70%. The U.S. pandemic surgical backlog has been quite decisively addressed during 2023 by the health care systems through stretched hours in the operating theater and increased recruitment by the hospital. This has created favorable market dynamics during 2023 for hip and knee surgeries, but also for corrective post-trauma surgeries and for foot and ankle surgeries. The Swedish krona experienced exceptional volatility in the quarter, impacting both reported sales and expenses. Large impact was seen on the recalculation of operating assets and operating liabilities and Hakan will cover this later in detail. Sales are taking off well in the U.S. with the largest driver being CERAMENT G in the U.S. Sales reached SEK 76 million in the quarter, which is up SEK 13 million or 21% sequentially. We have now several surgeons that have used the product and developed experience and also collect the data in a structured way. These surgeons are forming our growing base of ambassadors, and we're facilitating peer-to-peer group discussions within the hospital and at hospitals in the region. We see good continuous progress with hospital systems, adding approvals at the same pace as in previous quarters. We saw one of the strongest quarters when it comes to onboarding of new surgeons, surgery centers and orthopedic departments. This is driven by the hospital system approvals that were accomplished in quarter 2 and quarter 3. Now being a breakthrough device and a disruptive standard -- a disruptive product to standard of care, a surgeon will not be allowed to use and apply CERAMENT G until they and the operating staff have been properly trained. A large share of the salespeople's focus in the U.S. is now to ensure that these new customers get properly onboarded, trained in application technique and instructed on building procedures. In December, we submitted the label extension request to FDA for the CERAMENT G in prophylactic use. The data for the submission is compliant out of existing published peer-reviewed clinical studies. And these show strong results with CERAMENT G at index surgeries of open fracture trauma cases. A 400-patient demographically matched cohort control group have been used. The infection incidence for the control group was reported to be a mean 14.5%. In comparison, new clinical publications for CERAMENT G used at open fracture trauma, infection rates have been reported to be between 1% and 3.7%. During quarter 4 in 2023, CMS approved CERAMENT G for outpatient reimbursement through CMS transitional pass-through payment with its own reimbursement code. This payment is intended to reimburse hospital outpatient departments and ambulatory surgical centers for the incremental device cost that they otherwise might have of CERAMENT G. The purpose of this reimbursement program is to promote new technology and provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions. The PPT is untapped and valid for 3 years. So I think the TPT could be said to really be a strong testament and recognition of the strong differentiation health economic benefits and improved patient outcome shown in multiple clinical studies for CERAMENT G. I would like to draw your attention that since 2016, there are only 20 medical devices that have ever received the untapped TPT reimbursement. So that's on the U.S. Let's also go a bit more in detail on Europe on the next slide. So for the quarter, we saw sales of SEK 41 million, corresponding to a reported growth of 38% year-over-year and 32% at constant exchange rates. Europe has been delaying the ability to address the large surgical backlog due to shortage of staff and structural disruptions. Towards the latter half of 2023, we saw improved market dynamics from increased surgical capacity and also a stronger focus on the health care systems to address the pandemic induced backlog. Reliable market data in this era is not readily available, but several sources imply market growth rates of around 6%. Now within this type strong dynamic, CERAMENT is capturing significant market shares, mainly on autograft and traditional bone cement, which is obvious by our growth rate. While we got a bit disrupted by the pandemic in setting up our hybrid structure in Spain and Italy, we are now seeing these underpinned markets take off nicely with strong growth rates above 70% in the quarter. With the medical device regulatory certification for CERAMENT BVF and CERAMENT V, we have now full CE certification for our entire portfolio and our quality management system. This is a strong achievement as the transition from the EU medical device directive, the former regulatory landscape to the EU MDR, which is the new landscape, poses a challenge to the companies within the med tech industry with significantly higher demand for clinical evidence. Data from mid-2023 indicates that less than 30% of submitted MDR applications have so far reached certification and that there is still a large number of devices for which the MDR application having been submitted. Thus, I'm very pleased that the solid documentation, the growing pool of clinical evidence and the skilled organization at Bonesupport has brought us to the other side of this process. The level of marketing and market and marketing activities is very high. We participated in several of the regional and national orthopedic conventions in order to meet surgeons that still have not yet heard about CERAMENT. At the 2 largest meeting that both took place during quarter 4, the European Bone and Joint Infection Society and the German Orthopedic Trauma Meeting, the DKOU, we held satellite symposia and these symposias were facilitated by faculties consisting of distinguished orthopedic surgeon with a program featuring a blend of clinical evidence presentations, patient cases and panel discussions. In total, over 250 orthopedic surgeons attended our symposia, generating many new potential users. So that is a short wrap-up of the business in the region. And we'll now hand over to Hakan for more of a deep dive into the figures. And over to you, Håkan.

Håkan Johansson

executive
#2

Thank you, Emil. So net sales improved from EUR 103.2 million to SEK 172.7 million, equaling a growth of 67% or 60% in constant exchange rate. Emil has already spoken about the strong performance in the 2 segments and the major drivers behind the sales acceleration. Let me comment on the currency. Changes in currencies measured in year-to-date averages into 2023 versus 2022 had a positive impact of, in total, SEK 7.7 million, of which 6 million relates to the stronger U.S. dollar. Currency movements and conversion to Swedish impact expenses as you will see in later slides, but also through realized impact from in and outgoing payments and from conversion of assets and liabilities in foreign currencies to say. Let's move to the next slide. The contribution from the segment in North America improved with SEK 34.7 million and was reported to a regional contribution of SEK 52 million. The improved contribution relates to increased sales after effect from increased costs. Sales and marketing expenses during the quarter amounted to SEK 73.2 million compared with SEK 52.1 million previous year, of which sales commissions to distributors and fees amounted to SEK 4 million compared with SEK 24.3 million in the same period last year. The increase of SEK 1.4 million, excluding the sales commissions and fees, was driven by currency effects of SEK 1.3 million. The contribution was also charged by R&D costs related to clinical studies of SEK 0.5 million in the quarter compared to SEK 1.7 million previous year, where previous years included EUR 1.3 million related to ongoing projects. From the lower graph showing net sales as bars and gross margin as the orange marker, it can be noted that the gross margin is remaining strong and reported to 95%. In Europe and Rest of the World, a contribution of SEK 5.7 million was reported to be compared with SEK 3 million previous year. The improved contribution relates to the increased sales of from increased costs. Sales and marketing expenses increased with EUR 6.5 million and was driven by field vacancies, increase in sales percentages and high level of market activities to capture the momentum we now see in euro, but also by currency effects of EUR 1.4 million. From the lower graph and the orange market, you can see the gross margin remaining stable compared with the previous quarter this year with a minor impact from product and market mix. Next slide, please. Selling expenses increased with SEK 12.8 million versus last year, of which EUR 2.7 million relates to currency effects. In Europe, we have filled vacancies and increased our total euro commercial organization to 1 people. The cost increase in the quarter relates to a ramp-up in activity level of congresses, medical education and, of course, the continued launch program for CERAMENT G in the U.S. As presented at our Capital Markets Day in November last year, R&D initiatives are now accelerating due to the execution of strategic initiatives, such as future expansion into spinal fusion and the planned marketing authorization submission for CERAMENT G in the U.S. In the quarter, we had the FDA submission fee for the CERAMENT G trauma label extension and the cost for NDRC certification for CERAMENT BVF and CERAMENT V totaling a bit more than EUR 2.5 million. And underlying administration expense, excluding the effects from the long-term incentive programs, remaining on a stable level. The quarter included a temporary impact in consultancy spend and provisions for short-term incentives, the later following the strong business performance during the year. Next slide, please. The adjusted operating profit was reported to SEK 10.9 million compared with a loss of SEK 10.1 million for the same period previous year. the SEK 21 million improvement following a strong sales performance and despite substantial negative impact from currencies with a net negative impact of SEK 11 million. The difference between adjusted EBIT and reported EBIT, operating loss, our expense provisions regarding long-term incentive programs amounting to an expense of SEK 18.9 million this year compared with SEK 9.2 million previous year, as you could see on the previous slide. The reason behind this is highest long-term incentive programs. Of the total cost of SEK 8.9 million in the period, only SEK 1 million is cash flow impacting in the future. For the second consecutive quarter, a positive cash flow from operations was reported. The [indiscernible] period involving a high buildup in both semifinished and finished products, ensuring full flexibility the flexibility of products to future market needs. And with this, I hand back to Emil.

Emil Billbäck

executive
#3

So thank you, Hakan. Let me then start with a short recap of the key messages from our Capital Markets Day in November and also announced a change in timing for one of the coated milestones. So one of the key messages from the Capital Markets Day was the ambition to enter the spinal fusion segment with CERAMENT. We will be entering this segment in the future with a strong value proposition, matching an existing market need. So one of five spinal procedures actually failed to fuse due to insufficient bone remodeling. And in about 40% of the procedures, off-label antibiotics are used, yet in 2% to 6% of the procedures in infection develops both surgery. There's plenty of solid data confirming the strong bone remodeling capabilities of CERAMENT. Most of it is in extremities, but there are also compelling evidence supporting these capabilities in spinal fusion. In autumn last year, a preclinical spinal infusion was -- study was presented, showing positive results for CERAMENT BVS. We have decided that there are strong data points for us to submit the application for the interbody fusion indication, while we continue to generate more data related to certain application techniques. And just as a reminder, the regulatory clearance in the U.S. for spinal posterolateral fusion, called PLF, for our CERAMENT BVF is already in place. the application that we are referring to here is the supplementary spinal interbody fusion procedure. The application is already completed and the submission will take place during quarter 1, 2024. This will, however, not change our timing for potential market entry, which is slotted at the earliest for the end of 2025. As a second step, our ambition is to introduce antibiotic eluting CERAMENT to the spinal fusion indication, but we will return on the future timing for this. Another highlight of our Capital Markets Day is that we will be submitting a marketing authorization for CERAMENT V in the U.S., and that will take place in the first quarter of 2025. We also gave a guidance where we emphasize that sales growth in 2024 will be above 40% in constant currency. So let me, with that, go to the last on this presentation and do a quick wrap up. Now we are, of course, pleased to present such a strong quarterly results. That is more than confirming the high and strong traction that we see of CERAMENT in the market, reflecting how surgeons are experiencing improved patient outcome with this therapy. We have today reported a top line growth of 67% for quarter 4 2023. We reported on continued success of CERAMENT G in the U.S., regulatory filing for the extended label. And finally, the untapped incremental reimbursement in the ambulatory surgical centers under Medicare. And that concludes our presentation. And let me then open up the floor for questions that you might have.

Operator

operator
#4

[Operator Instructions] The next question comes from Mattias Vadsten from SEB.

Mattias Vadsten

analyst
#5

Mattias Vadsten from SEB. The first, I think, we'll take them one by one. The first one, the decision to submit the application in Q1 now to act for CERAMENT BVF fusion, previous communication in Q4. Could you talk a little bit more about this? And then I think I did hear it correctly, that it doesn't sense market entry timing. That confuses a little bit. So yes, that's the first question.

Emil Billbäck

executive
#6

Thank you, Mattias. We will start by that. So we have carefully reviewed the data that we have available on CERAMENT BVF. What we felt we were missing was a small animal study that articulated some of the parameters, which we felt was required for such a submission. And during late autumn, bone remodeling. Now given that this is a fairly crowded segment, the spinal fusion. Our strategy here is that we will submit the data that we have. And then let the questions from FDA potentially guide us in what we should continue to reply to their questions or if we should generate any additional data. Timing-wise, that would be more or less the same as the original timing. The spinal fusion, small animal study that came during autumn, shows good results, both in the micro CT and in palpation of Newton force for the spinal fusion. So we felt that we have a good package and we'd like to submit that to FDA to also initiate the dialogue. So your question is, well, if we do that 6 months earlier than planned, then why aren't we launching potentially earlier. Well, that's also because we if this submission is accepted and approved and will lead to the interbody fusion. That's all fine. But we also feel that we will not go to market before we have extensive application technique data. So you could almost see it as the studies that have been built into our applications are very much on the mechanism of action and the bone building capabilities on microbiology perspective, but it doesn't take [indiscernible] fact that the clinicians to start also to see how the product is applied in various different shapes and forms before we go to market with it. So that's why we remain with the original timing. So we have enough time to collect the evidence that signifies when we go to market, we pride ourselves in having strong evidence looking at the product from all different angles.

Mattias Vadsten

analyst
#7

Then I think in the previous call in conjunction with Q3, you highlighted the 2 system approvals, hospital system approvals. That at the time were around about 1,000 hospitals, 1 out of 5 board at least 1 board of 72. And I'm just wondering what's the case here now in terms of a number of hospitals and what share that both at least 1 board. And then maybe to this question, if you could update if there is anything new on vision and what that could imply? That's the next one.

Emil Billbäck

executive
#8

Yes. Thank you, Mattias. Yes. So in the beginning of the launch of SEMA, we disclosed the number of hospital systems where we had approval, but we felt that also led to quite a lot of conversations on how many hospitals are in the different systems and what is the penetration rate. And eventually, we felt that maybe that's not where we want to drive the absolute focus, but rather show and display what sales we have on CERAMENT G. So the pace of getting hospital system approvals in quarter 4 was the same as in previous quarters. So the delta between quarter 2 and quarter 3, you can apply that on quarter 4, if you wanted the pace remain unchanged. The biggest difference, rather, is that the approvals have gone a bit better and a bit faster than we anticipated. So we have spent a fair bit of quarter 4 to bring on board those hospitals that have received approvals to work with the product from their central organization. So we have been very active in the market. And in quarter 4, we had actually a record high recruitment of new surgeons and new clinics starting to use not only LNG but also CERAMENT BVF. So the quarter has been very much focused on training, education, application techniques. You also asked a bit about Vizient. What about Vizient? No news on Vizient, ongoing discussions. But as we have discussed a couple of times that several of the big hospitals under Vizient are very determined to use the most updated and modern therapies, and they will do that regardless of what the somewhat weaker central organization might think about that.

Mattias Vadsten

analyst
#9

I appreciate that and the good answer. Then my next one actually relates to EMEA, which looks to accelerate growth in the fourth quarter compared to what we've seen earlier in the year. So the market, I guess, it's improving a bit, but it looks like you get some leverage on the extra sales that you've put out facing customers. So if you could give some flavor here, how we should look at it because yes, it looks strong in EMEA. I must say.

Emil Billbäck

executive
#10

No, I agree. Absolutely. It is a very strong result. And it's easy maybe to lose track of percentage points back and forth when the business has grown with almost 40%. But at that growth, we're definitely taking strong market shares on more or less all markets. But the dynamics have improved, Mattias. We see that. Europe specifically was slow in getting extra staff in and stretching also their surgical titer hours, and I think we should expect that the market dynamics in Europe will continue to be favorable. I mean there will be quarters up, but there will be big quarters down, and we -- we've seen that they're also more prone to disruption when surgeons go on strike. But governments have noticed the large surgical backlog and are putting a higher focus on it. So we are definitely on top of that wave, with a positive market dynamics also going into 2024.

Operator

operator
#11

[Operator Instructions] The next question comes from Erik Cassel from Danske Bank.

Erik Cassel

analyst
#12

First, I just want to touch upon the profitability issues that the market seems to be seeing. I mean you touched upon the NRI several times. But when I sort of tried to do a math on that, I get a clean EBIT of nearly SEK 26 million, when sort of looking at underlying profitability adjusting for nuisincentive costs and FX, I mean, is that the sort of ballpark figure correct where you see underlying earnings as well? Or has something more structurally changed?

Emil Billbäck

executive
#13

I'm glad how you phrased the question, Erik, because it also shows that you've been able to capture all the disclosures that we have in the board trying to indicate what -- how is the underlying business going? And what is the impact of those external factors. So I can always say, Erik, that you're in the right ballpark.

Erik Cassel

analyst
#14

Okay. Perfect. Then I have a question on the sort of mix of the growth as of now. You've been on market now for quite some time. I mean is it possible to now give some sort of flavor on how much is coming from more use of the early adopters using it for more cases versus still mostly new surgeons trying out the product?

Emil Billbäck

executive
#15

Yes, absolutely. And you -- I assume you refer them to CERAMENT G in the U.S.

Erik Cassel

analyst
#16

Yes, exactly.

Emil Billbäck

executive
#17

Yes. Yes. So the dynamic here is quite interesting. What we have referred to in earlier quarterly calls is this go stop goal we clearly see that. So we have had a lot of surgeons starting to use the product in quarter 3 and quarter 4. But we also have a few surgeons where the hospital administration is okay, we need to look further into this product as it has both a bit of a price difference versus standard of care, but it is a new technology, and they're figuring out how to build it, how to deal with it administratively. The surgeons that have used the product, and we've traced it back now to quarter 1, we can very positively say that they are seeing the results that had been shown in clinical studies. And this is very rewarding. So right now, we are one of the biggest orthopedic conventions in the world and in the U.S. And we have sessions where surgeons can come forward and present case studies. And those that have done the structural way, they see that their patient outcome mirrors what has been done in the big clinical studies. And this, of course, leads to an increased use among those surgeons also and more ambassadorship where they talk to other surgeons that still haven't discovered SLNG. We should remember that we're still in the very early phase of this launch. So if you look at sales, in the quarter, majority of that sales is coming from customers that came on board during the year because they have much bigger volume use. And then there are quite a few also new surgeons, actually a record amount of new surgeons, but they are using it maybe in 1 week and then they wait 3 weeks before they use it the next time also in terms of evaluating with the operating staff, how they would go was a desired results and did also the patients in the first checkup, perform as anticipated. So we must always remember ourselves that introducing these breakthrough devices in orthopedics unless it's a generic, which is absolutely not. It takes time, and it's a long journey.

Erik Cassel

analyst
#18

All right. Then I think I'll limit myself to just one more. I was just a bit curious on what more can be said about the cannibalization of BVF in the U.S. And sort of how do you expect that to trend? Because previously, you sort of expected to BVF in Europe. I'm just wondering if you see any sort of change to that statement?

Emil Billbäck

executive
#19

No change in the statement, really. There will be cannibalization on CERAMENT BVF. And I think mid long term, the ratio between CERAMENT G and CERAMENT PBF is going to be the same as in Europe, but not because CERAMENT BVF will decline, but due to the exceptional growth rate in that ratio will eventually be reached also there.

Operator

operator
#20

The next question comes from Sten Gustafsson from ABG Sundal Collier.

Unknown Analyst

analyst
#21

Just to follow up on the previous question regarding FX impact on nonrecurring items, in the other operating income and expenses, is it fair to assume that all of that is related to revaluation effects, which are noncash or at least a majority?

Håkan Johansson

executive
#22

Thank you, Stan. So on that line, a vast majority with exception of a few hundred thousand, everything relates to either realized FX impacts from in and outgoing payments or the conversion of assets and liabilities to Swedish.

Unknown Analyst

analyst
#23

All right. Yes. That's good. When it comes to the overall OpEx spending in '24, how should we think about R&D costs. I mean you mentioned there were some fees to FDA and MDR in Q4, but we also perhaps should expect that there will be some additional clinical trials coming, et cetera. So I see the R&D line develop throughout the year?

Håkan Johansson

executive
#24

Well, thank you, Stan. And again, I think that the way to think here is that, of course, all the ambitions expressed at the Capital Markets Day in November, will also mean an impact in R&D spend going forward. The animal studies that we need to do to support the submissions we have in the plan, et cetera, will mean that the existing run rate will move up during the year. So I think that what we see in the fourth quarter with the step-up that we see in expense levels, et cetera, that can be expected also to continue going into 2024.

Unknown Analyst

analyst
#25

And regarding the sales coming level, it seems like it's coming down a bit in percentage of sales, at least compared to my estimates, but is the level right now is that a good proxy for the year? Or are there any sort of one-offs in there that we should be mindful about?

Håkan Johansson

executive
#26

I think that the latest quarter, it's only a minor movements in the total percentage. And again, just to remind use and everyone else that the commission and fees is not only the sales commission. It's the sales commission, it's freight cost is GPO fees and a few others related charges. And we believe that it's a good indication of the level we can expect also going forward.

Unknown Analyst

analyst
#27

Okay. Excellent. My final question relates to the TPT approval you got there. Will this approval have any impact on pricing? And how do you see pricing on CERAMENT G in general for 2024?

Emil Billbäck

executive
#28

So the TPT will not have any effect on our pricing. We're not making any changes to the pricing. We believe the value proposition is well balanced and well accepted. So we don't see any need for it. If anything, possible in the future, there might be price increases, but not as we have in the near term.

Unknown Analyst

analyst
#29

That's good to know. Excellent. Congratulations on another good strong quarter.

Operator

operator
#30

There are no more questions at this time. So I hand the conference back to the speakers for any written questions or closing comments.

Emil Billbäck

executive
#31

So back to us here. We have 2 written questions that I would like to address. We have one from Christopher Liber where he says, can you explain the drivers for the sequentially higher selling expenses in quarter 4 and what the number of hospital approvals was in the quarter. So I have already commented on the hospital approval. It -- it is almost a completely straight line in terms of hospital approvals, mirroring what we've seen in quarter 2 and quarter 3. And Håkan, would you like to comment on the sequentially higher selling expenses.

Håkan Johansson

executive
#32

Yes, I can. So again, first, I think that to keep in mind is that from a seasonality point of view, we have Q2 and Q4, that is all is more active in terms of marked activities, congresses, et cetera. So there is a service in that seasonality, which means that Q4 is coming in higher than and discuss sequencing to Q3. And then in this year, we also have the FX that is impacting and accelerating that pattern even more.

Emil Billbäck

executive
#33

Very good. And then we have 1 question from Dr. Maximilian Kern. First of all, really good top line performance in the fourth quarter. Can you give us some hints regarding the current momentum into next quarter? And in contrast, your guidance of more than 40% growth. So as I mentioned, the momentum in Europe and the market dynamics is very strong. We have seen during the '23 an increased capacity in the U.S. hospital systems, which has led to strong momentum in knee and hip surgeries. I know it is more in foot and ankle where we are more represented. It's difficult to say how long the strong momentum in the U.S. will continue. It started before Europe. And I really couldn't have a good view on it. But in terms of Europe, we do expect that the catch-up of the backlog will continue. Now all that said, in terms of market dynamics, it seems almost -- regardless of market dynamics, if we look at the key markets where we are present, we are growing at a factor of significantly higher than what the market is doing. So we are obviously taking market share on every single one, the different markets that we are on. And probably, that's where we are focusing, but we can also enjoy, of course, that all those patients that have not had the elective surgery is finally now getting good care. So those were the questions we had. Thanks, everyone, for calling this early morning in San Francisco and afternoon.

Operator

operator
#34

There is another question on the phone line. One moment.

Emil Billbäck

executive
#35

Great. We have one more question. That's great. We'll do that.

Operator

operator
#36

The next question comes from Mattias Vadsten from SEB.

Mattias Vadsten

analyst
#37

Yes. Sorry, maybe 1 or 2 more. In terms of the one-off costs, if you could take the investment to increase manufacturing capacity was mentioned, please for MDR supplications and the FDA filing. So if we could just take those one by one and how much they were, in the quarter?

Håkan Johansson

executive
#38

Sure. And again, listen, as we have presented also in the quarterly report, the expenses that relates to MDR and the submission is SEK 1.7 million related to the extended submission. SEK 1.3 million relates to MDR certification. And the minor, you could say, investment in increase in production capacity is SEK 1.2 million.

Emil Billbäck

executive
#39

Yes. So some of these costs are mandatory fees when you send in the submission. The production capacity increase is simply because we believe that our sales growth is very strong and will continue very strong. So we're making some modifications to accommodate that. So these are costs that will occur at some quarters, but each of them are carefully measured against preparing us for the future. Well, that's -- yes, that's all talks now. Håkan and I are off for the first morning coffee. And we wish you all a good time until we speak again. Thank you for taking the time to listen to us, and please keep following our exciting journey. Bye-bye.

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