Bonesupport Holding AB

STO:BONEX

Earnings Call Transcript 2021-Q3

[Operator]

Welcome to the BONESUPPORT Q3 2021 report. [Operator Instructions] Today, I'm pleased to present the CEO, Emil Billback; and the CFO, Hakan Johansson. Speakers, please begin.

[Emil Billbäck, Chief Executive Officer]

Thank you very much, operator. Welcome everyone and good morning. We're here to go through the BONESUPPORT quarter 3, 2021 results call. My name is Emil Billback. I am the CEO of the company and next to me is Hakan Johansson, our CFO. So in regular order, we will use the next 20 to 25 minutes to guide you through the presentation of the third quarter results and then we will open the line for question and answer session. Next slide, please. And before starting with this presentation, I would like to draw your attention and ask you to read through the disclaimers that might be covering any forward-looking statements that we might do today.Next slide, Slide 3, please. I would like to begin this presentation with some condensed highlights from the report that we released this morning. Overall, quarter 3 sales were SEK 55 million, which was a reported growth of 14% year-over-year. Currency movements versus last year have been quite significant, and growth in constant exchange rate was 26%. This is a strong growth rate, given the impact on the market conditions we have seen from the resurgence of the pandemic. EBIT was at a negative SEK 13 million, which is a strong improvement over last year.From the business operations perspective, we have seen an uneven return of orthopedic surgeries influenced by regional pandemic surges and also staff shortages. In the quarter, we also reported that an unfortunately high dropout rate in the follow-up period, fueled by the pandemic waves made the FORTIFY study inconclusive. At the end of the quarter, we submitted additional data in a supplementary De Novo application for bone infections as a response to the areas requested by FDA earlier this year. This submission is an incremental addition to the original application that was made in 2020. All in all, we have seen diverse and varying market conditions in the quarter, but with continued strong growth with CERAMENT.Let me go into the next slide and discuss a bit more in detail how the pandemic has impacted the market's dynamics. Slide 4, please. So while society is opening up and while restrictions are gradually being lifted, the situation for many of the hospitals and clinics has been constrained in the quarter. Several large hospitals have been forced to, again, reduce the number of surgical procedures as COVID hospitalization reached levels in the middle of quarter 3 that have not been seen since January and February earlier this year.As CERAMENT sales are tightly correlated to the number of surgeries conducted, our sales have, in turn, been determined by the pandemic impact. And while some regions have seen a gradual ramp-up of surgeries, and also strong sales of CERAMENT, the situation has been very much the opposite in other regions. On top of this, there has been a shortage of hospital staff, which has added challenges to keeping procedural capacity up. The example from Sweden at the bottom right side of the slide shows reduced surgery productivity in 2020 and in year-to-date, July of this year, 2021 in total, with a bit more than 20% reduction in productivity versus the previous baseline.The backlog is now close to 130,000 procedures, and it would take almost 7 years to recover this if and when the surgical productivity was to increase by 5% above the historical baseline. To the bottom left, we see how the discrepancy of increasing patient flow and limited capacity is driving an even higher number of patients on waiting lists for elective care than the all-time high main number that we shared with you when we presented our quarter 2 report in July, and these are the U.K. numbers for elective care. So hence, the U.K. government has provided extra funding to the NHS and similar support is being discussed and debated in several other countries.Slide 5, please. So I would like now to guide you through the development of our quarterly sales performance. We have gone through the details of this slide at many previous occasions, so let's just focus on the trending, should we? On the European side, so the red and the orange bars, we see a very strong growth trending in 2019, which is then halted by the pandemic. We see a gradual, but rather slow, return of surgeries in the last 2 quarters as the vaccination rate is picking up.Nevertheless, despite the pandemic, quarter 3 was our best quarter ever as we continue to take market shares even during the pandemic influenced market conditions. Our U.S. sales is now more than double the sales that we had in quarter 2, 2018 when we cancelled the contract with Zimmer Biomet. And on top of that, the sales we have now is with a very strong growth momentum. So let's with that transition into the different geographic segments.Let's got to Slide 6 and start with North America. In the quarter we delivered sales of SEK 33 million which represents a reported growth of 16% year-over-year and a growth of 34% at constant exchange rate. As I alluded to earlier in the presentation there was a major impact from the surging pandemic. and especially in populist southern states such as Texas, Florida, Georgia and the Carolinas. 34% sales growth of CERAMENT in this market conditions is a very strong testament to the appreciation of CERAMENT and the power of a strong commercial platform. Based on public records and the financial reporting from our U.S. competitors, we estimate a year-over-year flat market development in Q3 of 2021.After the period end, we launched a subchondral bold lesion application kit, which open up new attractive indications and increases our addressable market with some 20,000 procedures yearly in the U.S. I will come back a little bit more to the details of this new application on the next slide. But first, also to mention that, of course, our key priority or remaining priority is to pursue the CERAMENT G registration in the U.S. In late September, we sent a supplementary De Novo bone infection submission to the FDA. The submission addresses the request that was made by FDA earlier this year and the supplementary data builds on the foundation of the previous application. We have had 2 interactive meetings with FDA to discuss the material and answer questions on the new submitted data. And so far, everything is progressing to plan. All our attention in this period has been directed on succeeding with the bone infection De Novo pathway. After securing the approval for bone infection, the way forward is to extend the label for CERAMENT G into adjacent indications will focus on trauma.Before we go into the bone lesion indication, I would like to bring your attention to the fact that we have initiated work on a large U.S. cost benefit model for the use of CERAMENT G in bone infection. This study will utilize the CMS cost data, and it will be a very valuable tool in the upcoming reimbursement processes for especially private payers like insurance company. Here, I would like to clarify that the data that this study is supposed to generate is not intended to supplement the FDA registration approval process, but it will be a very important market penetration tool post a potential registration approval.So let's now go to Slide 17 -- sorry, Slide 7, of course. So if we then look at this new indication and treatment area, I think we all know that CERAMENT is very well-proven and has a strong set of evidence in both open and minimal invasive surgery. But one area that has been previously out of bounds for the orthopedic surgeon using CERAMENT has been where the cortical bone is intact. Now, the cortical bone is the hard and dense outer layer of the bone, where this has been intact, but there has been an injury on the inside of it and an injury in the so-called subchondral area.As you can see on the picture to the right, the subchondral area is this spongious area just adjacent to the joint cartilage. So on the picture, you could see the area shaded slightly with yellow. Our innovation consists of a set of guiding tubes and infusion needles that allows targeted delivery and controlled minimally invasive access through the cortical bone. The previous application tips and cannulas on CERAMENT were flexible to reach specific areas in trauma and filling open bone voids. And we are now adding to that portfolio a set of steel, needles and guiding tubes to also go beyond the cortical bone when it's intact.The market size in the U.S. for these procedures is about 20,000. So 20,000 procedures a year. And the injuries in this area is very common among athletes and for sports practitioners. And here, of course, a quick recovery is of high priority. Historically, these procedures have either been just left alone or the injury has been filled with bone cement, which has been too hard actually to give the patient back full mobility. CERAMENT, on the other hand, has properties that makes it ideal for treatment of this condition. CERAMENT, as you know, has same characteristics as native bone. The application kit was launched in October 1, and it's sold through the existing sales infrastructure in the U.S. To close off the segment North America, let's take a look at the time lines also of bringing CERAMENT G for the indication bone infection to the U.S. market.So next slide, please. So the review of the supplementary data is ongoing now by FDA and a successful outcome of that review could bring a potential market approval in quarter 1 of 2022. We expect then a launch to take place in quarter 2 of next year. As I mentioned before, the dialogue and the revenue process is progressing to plan, so no surprises. There have been a few questions on the material that we have answered. And so far, the review is continuing. It's quite an extensive material that we have submitted, and we look forward to hearing more back from FDA shortly. Other milestones, the NTAP submission for 2022 was sent in good order in early October. And as you remember, we did that also a year ago and got the NTAP awarded, and it has to be redone every year until you have your final FDA approval. So let's then go to Slide 9. And instead, we take a look at the segment Europe & Rest of the World. Sales landed at SEK 22 million, which is growth of 12%, 16% in constant exchange rates. And what we've seen in the region is a partial return on surgery has been very regionalized. The rate of surgeries has been influenced by COVID hospitalization, but also quite a lot by staff capacity. The brave health care practitioners, so nurses and physicians, have worked under very difficult conditions for the last 18 months and the staff shortages are to some extent related to exhaustion of this resource. There has also been occasions where the union has demanded extra vacation for nurses and surgery staff, which of course, has limited the ability to move back to higher capacity.Among our new markets where we have recently started up business Australia, South Africa and Middle East, we have seen quite an intensive impact from the pandemic. And Australia has, during the quarter, almost had a complete lockdown due to rising incidence rates. So postponing a bit our marketing and market penetration efforts. Looking also at some of the operational highlights. We are pleased to see that despite some resurgence in certain regions, there is a return of congresses and physical meetings. And that means that our sales force now can start to move again in the recruitment of new accounts and to promote the CERAMENT concept.We also see that several health care systems are in the deliberation of potentially delivering additional funds to the health care systems to cope with a procedure backlog that the pandemic has caused. And as you saw in my earlier slide, the backlog is greater than it has ever been in many of the regions where we sell our product.So that concludes the operational part, I would say, also sharing some of the recent highlights as well as strong growth numbers. And with that, I hand over to Hakan, who will give you a bit more on the financial overview and details.

[Håkan Johansson, Chief Financial Officer]

Thank you, Emil. So let us go to Slide 11. Net sales improved from SEK 48.1 to SEK 54.9 million, equaling a growth of 14%. The organic growth in the segment North America measured in fixed currencies was SEK 9.3 million or 34%, and the organic growth in Europe & Rest of the World was SEK 3.2 million or 16%. Changes in currencies had a negative impact in comparison with the third quarter last year or in total SEK 5.7 million, of which SEK 4.9 million relates to the weaker U.S. dollar.Next slide, please. The contribution from the segment North America improved with SEK 2.9 million and was reported to a profit of SEK 1.3 million. The improved contribution relates to increased sales, after effect from increased costs. Sales and marketing expenses during the quarter amounted to SEK 25.5 million compared with SEK 18.6 million previous year, of which sales commissions to distributors increased with SEK 0.8 million to SEK 10 million. The increase in sales and marketing expenses relates to the reversal of cost reductions reported previous year because of COVID-19. The contribution was also charged by R&D costs related to studies, decreasing from SEK 4.8 million last year to SEK 3.8 million this reported quarter.From the lower graph, showing net sales as bars and gross margin as the orange marker, it can be noted that the gross margin remained stable and in line with previous quarters this year. In Europe & Rest of the World, a contribution of SEK 2.4 million was reported to be compared with SEK 1.4 million previous year. The increased contribution was explained by increased sales. Sales and marketing costs increased marginally by SEK 0.4 million compared to the corresponding quarter previous year and amounted to SEK 16.8 million. In Europe & Rest of the World a declined gross margin was reported following the market mix during the reported quarter.Next slide, please. In summary, we reported a 40% growth despite continued impact from the pandemic, reaching an all-time high of almost SEK 55 million. Gross margin remained stable and in line with previous quarters. The high gross margin in the same period last year related to corrections made related to the preceding quarters last year. The operating profit was reported to a negative SEK 13.3 million, an improvement with close to SEK 6 million compared with a loss of SEK 19 million for the same period previous year. The lower loss included effects regarding long term incentive programs, a positive effect of SEK 2.4 million this year compared with a cost of SEK 4.7 million previous year, a difference of SEK 7 million. The effect during the period is mainly due to a reversal of accruals previously made for Social Security charges as the result of the recent share price development. Cash at period end is reported SEK 84 million less compared with the second quarter this year. The cash flow includes the effect of the share swap agreement that was entered during the period, in line with the mandate from the Annual General Meeting earlier this year to secure the commitments in the group incentive program, LTI 2021. The total of 786,000 shares was hedged at a total accrual of SEK 62 million.Next slide, please. Selling expenses increased with SEK 3.5 million following a gradual ramp-up in sales and marketing activity as the third quarter previous year included cost reductions because of the pandemic. R&D reported in line with previous year. The reduction compared with second quarter this year followed normal seasonality as a reported quarter included the holiday season. Administrative expenses were impacted by the effects from the incentive programs, as previously explained. Administrative expenses, if we exclude these effects, amounted to SEK 7.8 million compared to SEK 6.9 million previous year and increase mainly relates to cost reductions made previous year following the pandemic. And with this, I hand back over to you, Emil.

[Emil Billbäck, Chief Executive Officer]

Thank you, Hakan. So let me then sum up some of the key findings from the presentation today and give also an outlook on the journey ahead. We should then be on Slide 16. So BONESUPPORT was one of the absolutely fastest companies out within the orthopedic industry to transition to digital communications, webinars and accreditation over virtual surgery education at the pandemic outbreak. So our agility and decisiveness have led also to good lead generation even during the pandemic, especially in the U.S.We have a stronger commercial setup than ever before with better geographical opinion leader and GPO contract presence. We are ready to continue the rollout of our market penetration programs in a post-pandemic marketplace.We expanded and solidified customer base and well progressed distribution model in the U.S., we are eager to move to the next level with an impactful and broad potential launch of CERAMENT G in quarter 2 next year. FORTIFY and the high dropout rate was a huge disappointment to us. But even without this specific data, we have more high quality, published, peer-reviewed clinical evidence than any other bone graft on the market, and we are confident to succeed in transforming an outdated standard of care.At a year-to-date growth rate of 31% in constant currencies, we are taking significant market shares in a pandemic influenced market. We are close to, but not fully live up to our growth objectives that we set in 2018. However, the corporate target of an annual growth of 40% once the pandemic recedes remains.With that, we conclude our presentation and have delivered the quarter 3 financial results as well as some highlights on the operational part of the business. And I would like to open up the line for questions.

[Operator]

[Operator Instructions] We have a question from Erik Cassel from ABG Sundal Collier.

[Erik Cassel, Analyst]

So first off, obviously, strong numbers in North America. Could you perhaps provide any color on -- if this mostly is related to new hospitals and surgeons starting to use CERAMENT or if you're largely seeing increased usage from the sort of same existing customers you had last year?

[Emil Billbäck, Chief Executive Officer]

Yes, thank you, Erik. Yes, we're very pleased with the sales performance in the U.S., and we can conclude that while the pandemic has had resurgence in both Europe and the U.S., U.S. is somehow faster and more flexible to work around those hospitals and zones that have been shut down and that's also been seen in the volumes. If you look at the split of customers in quarter 3, it is actually matching the split as we had before the pandemic, possibly with a slightly higher overweight on existing customers. So it's clear that during the pandemic, it has been difficult for us to recruit new customers, even though I think we have succeeded better than most companies in the orthopedic industry due to our quick transition into more digital mediums.

[Erik Cassel, Analyst]

And then sort of on current trading. My assessment is that we had a pretty good run rate of electives at the end of the quarter. But could you comment anything on how the current environment in Q4 looks now that we're one more month in?

[Emil Billbäck, Chief Executive Officer]

Yes. So the predictability in the current market conditions, I must say, is very difficult. And I have also gone through the quarterly reports from some of the other orthopedic bigger companies to see how are they viewing the near-term future. And I think we all somehow stand in the consensus line with the statement that it's difficult to predict.When we came to the end of quarter 2 of this year, we saw a strong boost of elective surgeries, only to see that dropped significantly after less than 3 weeks. So this infection has a variability to it. And with the Delta and later on Delta plus that seems to have a high infection incidence. As people are letting down the guard a little bit from restrictions, it seems like outbreaks and surges can come even faster than both what we can assume and what the collective group of scientists in this specific area can predict on.So I think I have to answer, by not fully answering your questions, unfortunately, Erik. But it's such a high unpredictability right now, so I can tell you that I hope that the elective surgeries are going to continue on the trend that we have seen in quarter 3, but I've learned to take nothing for granted.

[Erik Cassel, Analyst]

It's highly unpredictable, so fully understandable. But then as a follow-up, are you seeing any improved access for sales people now or are there still some hesitation from customers in that sense?

[Emil Billbäck, Chief Executive Officer]

The -- yes, the market access is opening up. The -- it's getting better and better to meet existing customers and also to initiate new customers. But it's not on the same -- it's by far not on the same level as pre-pandemic. If I would take a bold stance, I would say that maybe our market access is around 85% of what it was before the pandemic broke out.

[Erik Cassel, Analyst]

And then perhaps -- perhaps a long shot, but probably the most important question as well. Can you say anything about your conversations with the FDA so far for the trauma indication? And if you can't, when do you expect to be able to give us an update on the progress?

[Emil Billbäck, Chief Executive Officer]

So the last 3 weeks has been quite intense in terms of dialogue with FDA. But the team that is reviewing the De Novo for bone infection is slightly different than a potential team for trauma. So we have concentrated all our efforts and energy on the team -- and the ongoing conversation on De Novo application for bone infection. And here, as I stated, the discussion is good.There has been a great exchange of e-mails, but also 2 interactive meetings. And we want to get a little bit further with this process before we have the next conversation with FDA on what a potential route to market on trauma could look like. But, internally, with BONESUPPORT, we have a strong determination to eventually pursue trauma. We are not dropping that case, we will definitely go after it.

[Erik Cassel, Analyst]

But have you had any time internally to look at the data you have in EU to sort of assess if that's likely enough for the De Novo extension?

[Emil Billbäck, Chief Executive Officer]

We have, but I would not like to give a statement on that until we have matched our findings with the findings of the authority in charge. So I will request to be able to come back to that.

[Erik Cassel, Analyst]

And then lastly, the CMS cost data that you talked about, what sort of time line could we expect here? I guess it's fair to assume that it won't be in place for the potential also bone infection in Q2 next year, at least.

[Emil Billbäck, Chief Executive Officer]

I have a great team at BONESUPPORT, both in this area, on the regulatory field, on the R&D side, on the clinical side. And the target is to have this data available shortly after we have a potential launch of CERAMENT G in the U.S. So the whole narrative around this big initiative is to bring further augmentation for a quick and solid market penetration that also appeals to the financial potential benefit for private payers and society. So they should come in -- with not too far apart the launch and the release of this paper.

[Operator]

The next question comes from Carl Mellerby from SEB.

[Carl Mellerby, Equity Research Analyst]

Just a short follow-up on this cost-effectiveness study in the U.S. Could you comment on the costs related to that? Is that material? And then secondly, also on the De Novo for CERAMENT G in bone infections, what kind of potential do you see in off-label use in other indications if we were to get an approval here in Q1 next year? And then lastly, on R&D, considering that you're no longer pursuing the PMA pathway for the trauma indication CERAMENT G, what kind of delta in terms of costs are you expecting from this heading into full year 2022, any kind of guidance would be helpful.

[Emil Billbäck, Chief Executive Officer]

All right. Let's start with the first one. So the analysis of the CMS data that we're doing, it's a big investigation. It's a big study to basically replicate some of the European data that you've seen also from England, where we look at osteomyelitis, cost on society, cost on payer. And given how the U.S. payer system is constructed, we know already by our submission to NTAP that there was a very favorable attitude towards CERAMENT G. We know that FDA has designated CERAMENT G as a breakthrough device. And we are now adding this important data to also show those private payers in the U.S. that treating these difficult conditions -- bone infections with a one stage procedure, with a product containing antibiotic will be not only very beneficial for the patient, but also financially for the one holding the wallet. The cost for such a big study is anywhere between EUR 100,000 and EUR 300,000. So it depends a little bit on the details that we produce and the number of patients that are included. So the cost that -- for this study is somewhere in between that range.The second question was on potentially getting an approval for CERAMENT G on bone infection, how much can we expect to see in off-label use? It's a good question. I ask myself that question. It's equally difficult to answer. I can conclude that if we look at the U.S. market today, depending on different indications and conditions, of course, the U.S. surgeons are so convinced about adding local antibiotics that between 60% and 80% of them are doing it off-label. Because simply, there is no other approved means of getting local antibiotics in the site of the injury.There's a few publications that have been done to look at the behavior of orthopedic surgeons in the U.S. and the most common is PMMA beads drenched in antibiotic. This is off-label. It's not approved by FDA. The second most common alternative is to sprinkle antibiotic powder directly into the wound. This is off-label. And whenever there is off-label circumstances, of course, there's a risk -- there's a risk for the nursing staff to mix antibiotic in the open. There is a new risk for the patient and there's a liability topic. So the question I've asked myself is, if you have an orthopedic surgeon that in the morning, he or she, is treating bone infections. And then in the whole afternoon, they have trauma patients. And in the morning, they have been very successful using a specific Swedish bone graft substitute containing antibiotic. What is that person going to use in the afternoon? I think there's a high likelihood that the -- given the orthopedic surgeons rely very much on their own clinical practice and experience that what they use in the morning, that is working, is also what they will use in the afternoon. Regardless of if that product is approved or not for a certain indication. That at least the behavior they show today with 60% to 80% off-label use. But what that would translate into in sales dollars is, that I cannot talk so much about. It's clear that BONESUPPORT always stays on the right side of the fence, so we would not promote a product outside of the indications where it's approved. But we also know that orthopedic surgeons rely very much on their own judgment. So quite likely, yes, Carl, there would be off-label use, the extent to which I can only guess.

[Carl Mellerby, Equity Research Analyst]

And then just on the last one on the R&D expenses there.

[Emil Billbäck, Chief Executive Officer]

Yes. So, of course, what has happened is that there's been a lot of dramatic things at BONESUPPORT, but also in our environment with the pandemic. The world look very different now than it has done before. Clear is that the cost for doing a PMA application is not going to materialize. The -- some final wrap up cost for FORTIFY is not going to be there. And as we come into next year, there, of course, not going to be any FORTIFY expenses.I have communicated to the market already the approximate cost of filing a De Novo instead for specifically a trauma or other indications. So there will be some reduced costs. There will be other costs that will come. I think it's fair to assess that the R&D costs for next year are going to be less than they are in this year. And exactly that amount, we don't give a guidance on. We can just point in a certain direction.

[Operator]

Our next question comes from [indiscernible] from Carnegie.

[Unknown Analyst]

This is [ Arbit ] calling in from Kristofer today. So first off, on the strong growth in North America, could you just detail, are there any sort of more temporary restocking effects baked into this? Or would you say that most customers are moving towards a more normalized purchasing pattern?

[Emil Billbäck, Chief Executive Officer]

Yes. I think, [ Arbit ] that's a good question, actually, and maybe I should have mentioned that. So we track every month how much of the orders that go into the shelf, meaning if they buy a product and put it -- if they're buying like 3 products and they put it on the shelf next to the surgery room or if the product goes immediately into surgery, because it then assigned a certain code, which has to do with reimbursement. And what we have seen in the quarter is a low level of shelf orders, so there's no buffering, there's no loading, but a steep increase in case orders. Meaning, products that are being immediately used.And given that we have concluded that the market in quarter 3 has been rather flat, at least when we look at the reports and public records from big companies, we are concluding that we are gaining significant market shares in all of the states currently.

[Unknown Analyst]

And then on Europe then, just recognizing the surging in -- surge in infections in many of your key focus markets. And, yes, pretty bad trends in many of the direct markets as well. Could you just give us a bit more of a granular view here of how sales have developed in the last couple of months on a sort of by country basis?

[Emil Billbäck, Chief Executive Officer]

Yes. I'll try to do a good job here. So I think there's a very good public record on how many patients are hospitalized with COVID in the different countries. This is produced by the European Medical Agency. And our sales mirrors this in reverse, should you say, in opposite. So what we saw in the U.K., for example, in end of quarter 2 and beginning of quarter 3 was a low level of hospitalization for COVID, and our sales was hitting all-time high month after month after month.As then quarter 3 progressed, the Delta and Delta plus variants increased in the U.K., hospital beds were taken into account for COVID instead of orthopedic surgeries and our sales fell back slightly. The population in Germany have quite a steady group of anti-vaxx or people that are refusing to get vaccinated. And infection has surged mainly among these. Of people that have been in hospitalized due to COVID in Germany, close to 85% has been unvaccinated citizens.And what happens is when a surge takes place then, let's say, in the south of Germany, in Baden-Wuerttemberg or Bayern, we try to move the sales resources to areas where the COVID is not so present. But this has proven a bit difficult. I think our salespeople have been very brave and very flexible, but it's difficult to ship people around.So we can see actually week-by-week. We have seen a great pickup in Netherlands, where we just one year ago went direct. And now I think everyone saw on the news a couple of days ago that Netherlands is again discussing to impose new restrictions. So we're tossed a little bit between hope and despair. But even in these difficult conditions that we cannot control, because they influence everyone, we seem to be winning market shares stronger than the other companies in orthopedic industry.

[Unknown Analyst]

And just a quick follow-up on that. So would you say in the last one or 2 months, have you seen growth taper off significantly in markets where we've seen a big surge in cases, Germany, U.K., et cetera, or have these sort of more regional initiatives been able to kind of counteract that?

[Emil Billbäck, Chief Executive Officer]

Yes. We saw -- yes, I cannot talk so much about quarter 4 actually, as that will have its own meeting beginning of next year. But what I can say, I mean, it's -- I concur with some of the COOs for a few of the bigger orthopedic companies where they've said, there's not going to be a quarter that just brings back all the surgeries. There's not going to be a swing back of the pendulum quickly. We're going to suffer from reduced capacity and regional outburst and outbreaks and the backlog will have to be taken care of over a long period of time.We see the future slightly more positively than some of our bigger colleagues in the industry because we also have a product that promotes for a one stage procedure with shorter stay in hospital and quicker recovery. So we also see CERAMENT actually to maybe get some tailwind right now, because it is recognized that it's an efficient therapy as well. So to answer your question, yes, difficult to predict about the future, but the activities that we are rolling out seems to, in many cases, compensate for some of the shortfall in volumes. And that's why we also now for quarter 3, showed very strong growth.

[Unknown Analyst]

And just lastly, you already spoke on this a bit. I'm not sure you have that much to add. But could you just clarify based on your latest assessment, what would be the ways -- the potential ways forward in the trauma indication in the U.S.

[Emil Billbäck, Chief Executive Officer]

So I know that many are wondering how is this going to be done and there are different options. And I don't want to tie myself to any specific option, because we want to do this right and we want to do this with great decisiveness. And then we investigate the different options, and then we also discuss that with the authority in charge.The way we should set our mind is that there are good clinical studies on CERAMENT in trauma, Aljawadi and Jahangir that have groups of patients of either 50 or 82, and one could consider that this could be used for the novel application if a proper control group could be created. But we should also think about a scenario where CERAMENT G potentially is already approved on the market and could then a company like us provide safety data, from example, the FORTIFY study to show the safety of the product in such indication and then do piggyback on an existing approval.De Novo will take some time. A potential piggybacking with a 510(k) would, of course, go faster. But all of this is theoretical until we have fully investigated it. What I want to send a message now is that we are determined to do this. We will go after this indication, but we will also come back with a more, let's say, detailed planning when we have done the homework.

[Operator]

Our next question comes from Sten Westerberg from Analysguiden.

[Sten Westerberg]

It’s Sten Westerberg, Analysguiden. Two questions, if I may. First, given the performance of CERAMENT in the North American market, is it possible to shed some more light in which area or cities, particularly well accepted given the situation for non-elective surgery in many U.S. states? Is it, for example, better accepted in the elective surgery area and so on? If you could comment on its clinical use little bit extensively would be really interesting. Finally, looking for some granularity to your sales target growth of 40%. Is it based on pure market share gains or do you foresee rebounce in surgery procedures going forward the next couple of years? And of course, if you, to an extent, would be prepared to discuss market shares at this point in time.

[Emil Billbäck, Chief Executive Officer]

Thank you, Sten. So in the quarter, in the U.S., yes, we have had a very strong performance and we have seen that across all states, but more pronounced in those states that have not had a strong surge of the return of the Delta COVID virus. So sales has been somewhat suppressed in the Southern states -- Texas, Florida, Carolinas, Georgia, Alabamas, so I think that was part of your question. We have -- if you look in general, our sales, it's about 50-50, give or take, made up of elective procedures, and 50% of our sales is procedures that are considered of high priority, either related to immediate trauma or related to ortho oncology for cancer removal, which is considered to be very high on the priority list. So 50-50 is, I think, it's a give or take number to look at it.And when elective surgeries, of course, is significantly reduced and pushed out in time it's half of our sales that is being materially influenced. But then, of course, we're also winning new accounts. So in quarter 3, we have seen the biggest growth in the U.S. with accounts that we have worked on for maybe 6, 8, 9 months. You should also remember that we won the big premier contract. So all of a sudden, we got access to customers that have heard about CERAMENT, that wanted the use CERAMENT, but contractually didn't have the clearance. So there are some doors that have opened for us and we're beginning to scratch that surface now and all of these combined is what you have seen in quarter 3.Then in terms of our growth rate of 40%, this is a combination of growing with existing customers and also adding new customers and also adding new territories -- new geographical territories and potentially even entering also new indications such as what we have, just to announced the subchondral area. And exactly how that's split, I don't want to share, let's say, on a quarterly call. Maybe we will come back to that in a Capital Markets Day, which we are thinking about having something in the beginning of next year. Let's see then if we can share some more data on how the future journey will be constructed by different vectors.

[Operator]

We have a follow-up question from Erik Cassel from ABG.

[Erik Cassel, Analyst]

So a follow-up on the market share gains you're talking about, and this is perhaps hard to answer, of course. But are you seeing those gains coming out of synthetic alternatives? Or is it rather that surgeons are becoming less conservative for some reason than moving away from autograft, for example?

[Emil Billbäck, Chief Executive Officer]

Yes. I think, it's actually a very good question, of course. During the pandemic, we have seen that those hardcore traditional surgeons that used autograft have been less likely to be open-minded to new technologies. So what we have seen, the strong sales growth in quarter 3, mainly in the U.S., and this also explains a little bit maybe why U.S. is so much stronger than Europe, where Europe, there's a high degree of autograft. The market share gains has been in quarter 3, very much on behalf of other synthetic alternatives and even allograft. So we have taken significant market shares from other orthobiologics and bone cement.

[Operator]

There are no further questions at this time. Please go ahead, speakers.

[Emil Billbäck, Chief Executive Officer]

So thank you so much. I would like to thank everyone then for joining our quarter 3 report. I hope we have provided a good view on what has happened in the quarter and also share the background behind the numbers. As you know, you're also always welcome to contact us after these calls, if you would like to have more details. And I wish everyone a great time until we meet again and look forward to the journey ahead. Thank you.