Bonesupport Holding AB (publ) (STO:BONEX)
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May 7, 2026, 5:29 PM CET
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Earnings Call: Q1 2022

May 4, 2022

Emil Billbäck
CEO, BONESUPPORT

Thank you very much, operator, and welcome everyone to BONESUPPORT's Q 1, 2022 Result Call. My name is Emil Billbäck, and, sitting opposite to me here at the desk is Håkan Johansson, our CFO. We will use the next 20 minutes to guide you through the presentation of the first quarter results, and then we will open the line for a question and answer session. Moderator, if you please help me go to slide number two. I hope you recognize that there are some, disclaimers covering forward-looking statements that we might, do today. Let's go to slide number three, please. I would like to begin the presentation with, some condensed highlights from the report that we released this morning.

Overall Q1 sales were SEK 66 million, which corresponds to a reported growth of 48% YoY. Currency movements versus last year have been quite significant, and growth at constant rate was 36%. EBIT was at SEK -16.5 million, which is a SEK 7.3 million profit improvement versus Q1 2021 before the incentive provisions. From a business operations perspective, we have seen a gradual ramp-up of surgeries during the quarter. In certain regions, the ramp-up has been restricted by a shortage of staff as the healthcare system have tried to recover from the Omicron surge that we saw from December 2021 to January 2022. During the quarter, OrthoPediatrics placed the first order with BONESUPPORT and started selling CERAMENT BVF to its network of 250 children's hospitals.

All in all, we have seen diverse and varying market conditions in the quarter, but with continued strong growth for CERAMENT across all markets. The results in the quarter are a confirmation of BONESUPPORT's strong commercial model. With that opening, let's go to the next slide, where hopefully it will be the last time that we will give a COVID update in a quarterly report. I think right now there are many different theories as to if additional waves of COVID will come back and at what time and possibly what kind of severity. But it is clear that a page has been turned and that the healthcare system has adopted and learned to live with the pandemic influence.

There are a couple of market surveys covering how the numbers of surgical procedures have developed in Q1 , 2022 versus last year. The average of these reports would imply a few percent growth in procedures in this quarter versus last year. We saw clearly low volumes in January as an influence of Omicron, and then a rather strong recovery in February and March. The recovery in procedures has been much faster in the U.S. compared to E.U. In Germany, the restrictions have remained at a high level throughout the entire first quarter, with no visible real market recovery. In the U.K., strong and increasing sales have been recorded as extra funding is distributed to increase capacity for surgical procedures.

From the NHS, while we have good availability and transparency in data, you can see that in the green matrix to the left, we can see that the pace at which the backlog was previously increasing has now tapered off. There are also reports from many parts of Europe, and particularly from the US, where orthopedic surgeons are extending the time in the surgical theaters about 2-3 x a week. There are also reports of surgeons working weekends to address the backlog. The headwinds faced by the entire orthopedic community over the most recent two years is likely to turn into tailwinds as the large backlog is being addressed. Now let's turn to the next slide and look at how the recent quarter stands out in accelerated growth trend. Slide five, please.

I trust that most of you recognize the slides, which we have shown at all previous quarterly report presentations. The bar charts show the LTM sales every quarter since Q1 2014. The result of CERAMENT's advancing market positions is visible, with a major jump in sales QoQ in the most recent period. Europe and rest of the world is back on a growth trajectory, showing three consecutive all-time highs. Now, let's turn to the next slide and talk a bit more about what is driving these results. Slide six, please. We start with the U.S. As I mentioned on the update on COVID, January was an Omicron suppressed month, with February and March recovering faster than we and the rest of the industry had anticipated.

Market share gains during the pandemic is now providing strong growth as surgical volumes starts to come back. Sales grew with 64% in the quarter and 18% sequentially over quarter four 2021. The sales team at OrthoPediatrics are fully up and running, and in January they placed the first order. The first procedures in the pediatric hospitals were done the same week that the orders were expedited. We are still in waiting mode for final notification from FDA, and I want to emphasize that waiting mode is not the same as discussion mode or debating mode. During autumn last year, we had a very close dialogue with FDA regarding the supplementary data that we submitted. The interactive review is in fact still open.

Since December, and since early December actually 2021, FDA has not had any further inquiries, but they rather focused their internal work on the final report. I will share some further insight on FDA's workload at later slides. First let's go to Europe and rest of the world, which is on slide seven. Our Europe rest of the world business grew with 28% or 22% in constant exchange rates. The quarter was very much about getting started and again ramping up activities and businesses after the shutdowns that Omicron created. Despite Omicron seemingly causing less symptoms versus previous virus versions, the high transmissibility caused as many COVID patients in hospitals in January as back in April 2020, and it was actually the second highest peak level of hospitalization since the pandemic started.

The plans announced by the government and implemented in U.K. and France to increase surgical capacity are likely to follow suit in several more European countries. In the U.K., we already saw a positive effect on sales in the quarter from these programs, even though capacity is still not at pre-pandemic levels. I would like also to comment on the global supply situation and cost variations in raw materials that we have seen across several industries. BONESUPPORT is not immune to potential disruption or cost increases, but we have long-term contracts with our partners, and we have not had any material influence in the first quarter. Regardless of this, we have executed a price increase of just about 5% in March for our direct markets, which is anticipated to influence all our direct business over the next six months.

Over the next two slides, I'd like to cover a few other events that we would like to share insights on. If you please go to slide eight. Management has decided to transition Switzerland to a distributor service model. The Swiss market is very demanding in terms of having the representative participate at surgery. The expectations on service is very high and frequent visits are required with existing customers and new customers alike. We had previously one sales rep in Switzerland, and as we're expecting to grow further and more into regional hospitals as the pandemic is receding, we need a stronger geographic reach to match the market dynamics. The Swiss market is attractive, but it's not our top priority. We have decided not to go with a hybrid model in this case, but rather a distributor setup.

Next to report on is that we are building continuously resources, data, documentation for the future pursuit of the osteoporosis indications. About six months ago, we reported on favorable outcome in preclinical studies where the combination of zoledronic acid and CERAMENT achieved very strong results. In March of this year, a biomechanical study was published showing the positive results of using CERAMENT to improve anchoring strength in treatment of osteoporotic fractures. There are about 1.25 million osteoporotic femoral fractures a year. Entering in this market, which is our long-term objective, would increase our total accessible market with about $600 million. On the next slide, I have some good news to report on. Slide nine, please. The application for new technology add-on payment takes place in October each year.

Approved devices hold the NTAP status for 2-3 years after the FDA approval. BONESUPPORT submitted updated documentation to CMS in October and received the message on April 18th that NTAP has been granted and that the add-on amount is $4,900. This means that the regular diagnostic related group, DRG, the reimbursement here is increased or extended with $4,900 when CERAMENT is used for one of the indications for which NTAP has been granted. The CERAMENT G NTAP covers 13 DRGs. That means that all the DRGs that we applied for was approved to our great satisfaction. The NTAP becomes effective on October 1st if the prerequisite of market approval from FDA has been given latest July 1st in the same year.

With that short update on the different segments and the additional information, I would like now to hand over to Håkan, who will cover the financials.

Håkan Johansson
CFO, BONESUPPORT

Thank you, Emil. Let us go to slide 11, please. Net sales improved from SEK 44.8 million- SEK 66.3 million, equaling a growth of 48% or 36% in constant exchange rates. The organic growth in the segment North America, measured in fixed currencies, was SEK 11.7 million or 47%, confirming a continued strong growth trend. The organic growth in Europe and rest of world was SEK 4.4 million or 22%. Changes in currencies measured as year-to-date averages in 2022 and 2021 had a positive impact in comparison with the first quarter last year of in total SEK 5.5 million, of which SEK 4.4 million relates to a stronger US dollar. Next slide, please.

The contribution from the segment North America improved with SEK 8.6 million and was reported to a segment profit of SEK 6.6 million. The improved contribution relates to increased sales after effect from increased costs. Sales and marketing expenses during the quarter amounted to SEK 30.1 million compared with SEK 21.6 million previous year, of which sales commissions to distributors increased with SEK 5 million- SEK 12.9 million. The increase in sales and marketing expenses is mainly due to a higher level of activity, but is also including currency effects with SEK 1.7 million. The contribution was also charged by R&D costs related to studies, decreased from SEK 3.7 million last year to SEK 1.9 million this reported quarter.

From the lower graph showing net sales as bars and gross margin as an orange marker, it can be noted that the gross margin remains stable and in line with previous quarters. In Europe and rest of the world, a contribution of SEK 5.6 million was reported to be compared with SEK 2.2 million previous year. The improved contribution explained by the increase in sales. Sales and marketing expenses increased by SEK 1.6 million compared with previous year. The increase is mainly explained by a lower activity level previous year because of the COVID-19 pandemic. From the lower graph, it can be noted that the sales is slightly down compared to Q4 in 2021. This is following normal seasonality as the first and the third quarter is weaker than the second and the fourth quarter.

In Europe and rest of the world, an improved gross margin was reported following the market mix during the reported quarter. Next slide, please. The operating profit was reported to SEK -16.5 million, an improvement with SEK 3.2 million compared with a loss of SEK 90.7 million for the same period previous year. The lower loss included expenses regarding long-term incentive programs, a cost of SEK 3.9 million this year compared with a positive effect of SEK 0.2 million previous year, a difference of SEK 4.1 million. The increased cost was due to regular provisions, approximately SEK 3 million at unchanged circumstances, as well as revaluation following the 8% appreciation in the share price from the end of last year.

The positive effect in the first quarter last year gave the positive effect of SEK 2 million related to the drop in share price last year following the announcement that FDA required additional data and clarifications in our de novo submission. Profit improvement before the cost for the long-term incentive programs was SEK 7.3 million. Cash at period end was reported at SEK 195.6 million and remaining with a substantial headroom in funding until we can reach the point of cash flow breakeven. Next slide, please. Selling expenses increased by SEK 6.3 million, of which SEK 2.5 million relates to currency effects. The higher cost level partially relates to the investments in hybrid markets, Italy and Spain.

The higher cost also relates to a gradual normalization of market activities this year, albeit with regional differences, compared with a lower activity level last year due to COVID restrictions. R&D expenses reported in line with previous year. The phasing out of the FORTIFY study has gradually reduced the quarterly run rate. Administration remaining on a stable level if we exclude the effects from the long-term incentive program, equaling SEK 10.6 million this year compared with SEK 10.1 million previous year. With this, I hand back over to Emil.

Emil Billbäck
CEO, BONESUPPORT

Thank you, Håkan. Let's then go to slide 16. Before wrapping up this quarterly report, if I can make a few comments on our timeline of milestones and significant events. Well, as you are aware, I think all of you, we are in waiting mode for the decision from FDA. The date when the final report was supposed to be received from FDA has passed. That was in Q1 of this year. FDA has published data showing that they were delayed on about 35% on all the de novo applications. FDA has further openly communicated that the reason for the delay is the overwhelmingly many emergency use authorizations that have been sent to the agency related to COVID.

While we are a bit frustrated about the delay of approval on CERAMENT G, we have some full sympathy for the prioritization aligned to save lives of COVID patients and quickly reduce the pandemic burden on the healthcare system. We have anticipated a launch of CERAMENT G in the U.S. in the third quarter and a submission filing for extended indication sometime in the first half of 2023. These timings were connected to getting a potential approval during Q1 . Once we have a clear understanding on the decision timing, we might need to revisit these timings. From final decision to launch, we anticipate around four months.

Finally, on this slide, I will comment also that the SOLARIO study finalization was previously placed in the wrong slot in the timeline, and it was shown at the time of the last patient in. We had accidentally done so, and this has now been corrected. The study is designed for a 12-month follow-up. After the last patient has been included in Q1 2023, the study will be completed in Q1 2024. We have corrected this information, and I would like to emphasize this. There's no further delays on SOLARIO, but just a correction in our reporting, which is now in line with the public record, which it wasn't before.

Let's go now to the last slide of the deck and wrap up some of the findings from the presentation, where I can also give you a bit of outlook into the near-term future. On slide 17, I would say that in short, despite the variable post-pandemic market dynamics, we saw strong commercial acceleration. We have seen strong leverage from the strategic investments done in key markets. In the U.S., for example, growth momentum is very strong, and we continue to drive market penetration within important GPO contracts and with strategic partnerships. Our U.S. distribution model is clearly working. It has shown exceptionally good reach and market access.

With our strong sales team in the Nordics, in the UK and Germany, as well as the investment done in Netherlands, the hybrid set-up market in Southern Europe and the established foothold we have in new markets, we are in better foundation position than ever before to drive market penetration in a post-pandemic environment. As you well know, our most important upcoming task is taking CERAMENT to the US market. This will be done in two steps, through the de novo pathway, which we're waiting now for the final approval. Once we have that, for bone infection, we are looking to secure also market access for broader indications on a broader label. The raised NTAP, the new technology add-on payment for CERAMENT, $4,900 awarded by the CMS, is an important encouragement ahead of our anticipated launch.

With the expanded and solidified customer base, as well as progressive 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. All in all, in a post-pandemic market, we will truly be leveraging the value of our clinical and health economic evidence. At a growth rate of 48% in the quarter, we are continuing to drive traction well above market growth rate, and hence, we are taking strong market shares. Our corporate target is to grow top line with 40% per year. With that, I conclude my presentation and would like to open up for questions.

Operator

Thank you. Ladies and gentlemen, if you have a question for the speakers, please press zero one on your telephone keypad. Thank you. The first question comes from Erik Hultgård from ABG Sundal Collier. Please go ahead.

Erik Hultgård
Healthcare Analyst, ABG Sundal Collier

Hi. Good morning, everyone. You said that the expected price increase that would take full effect in all markets in the coming six months, if I heard you correctly. Just to understand, I mean, the implemented price increase of 5%, that does not come into full effect directly, but rather, like, gradually over Q2 and Q3, right?

Emil Billbäck
CEO, BONESUPPORT

Hi, Erik. Yeah, that is correct. We have communicated to the customers that there will be a price increase. This was sent out in March. The customers without the contract, they receive that price increase immediately. Most of our customers in the direct markets have contract. It will bleed in over the next six months to be fully executed at the end of the year.

Erik Hultgård
Healthcare Analyst, ABG Sundal Collier

Okay. How much of an impact would you say that has on Q2? How large a share of the customers will that take effect on?

Emil Billbäck
CEO, BONESUPPORT

I actually couldn't say, Erik. Apologize for that. I can tell you that by the end of the year, the impact will be on all customers. I think if you estimate maybe a 50% impact, I think you're on the safe side.

Erik Hultgård
Healthcare Analyst, ABG Sundal Collier

Okay. Thank you. What happens to the NTAP if FDA delays the response past the 1st of July? Would that most likely basically postpone the effective date of the NTAP by one year? Or is there a worse implication that I might miss here?

Emil Billbäck
CEO, BONESUPPORT

No, you're correct. I think that is severe enough in a way. If the approval for CERAMENT G has not come by July 1st of this year, we will have to reapply for the NTAP. The earliest that it could then come into effect would be 1st of October 2023. Of course, we're hoping to secure the approval before July 1st, and in such case, the effective date is first of October this year.

Erik Hultgård
Healthcare Analyst, ABG Sundal Collier

Okay. Thank you. I guess this is a hard question, of course, but I know that you speak to industry participants. How likely would you say that it is that you get the answer from FDA before the 1st of July?

Emil Billbäck
CEO, BONESUPPORT

I couldn't say, unfortunately, because if it would be my organization and something we have control over, I could give a firm answer. I don't dare to speculate in how FDA are meeting their commitments. I'm hoping that they are coming now at the very end of the review. As a matter of fact, they have communicated that they are at the very end of the review. We can only try to also assert a certain amount of pressure to secure that we get a final notification before this date. With FDA, as in many times, it's difficult to predict how they respond timing-wise.

Erik Hultgård
Healthcare Analyst, ABG Sundal Collier

Yeah. Understandable. On the order from OrthoPediatrics, would you say that was some sort of, like, first order inventory buildup from their end, or is this more of a recurring number?

Emil Billbäck
CEO, BONESUPPORT

There's a big part of this which is recurring and a part of it is also putting the products for some of these pediatric hospitals that would like it to have at least one or two products on the shelf as well. There will be more orders this year, maybe not to the same size we saw here, but that depends also on how quickly they can turn the products and how effective they will be in their sales. We were very encouraged that immediately after expediting the order, the first procedures started to take place.

Erik Hultgård
Healthcare Analyst, ABG Sundal Collier

Okay, good. Then the last question from me before I jump back in the queue. If you would have had the same run rate as in March, throughout the quarter, where the surgical sort of activity seemed quite normalized, how much better would the quarter have been? I'm just trying to get a feel for the current activity level.

Emil Billbäck
CEO, BONESUPPORT

Okay. Let's see now if I understood your question right. Did you ask if the whole first quarter would have been at the same pace as March, how much stronger would it have been versus what we reported?

Erik Hultgård
Healthcare Analyst, ABG Sundal Collier

Exactly.

Emil Billbäck
CEO, BONESUPPORT

Okay. Well, I cannot disclose, let's say, details like that. March was our best month ever. Clearly the traction is there. January was like many of the other hard-hit pandemic months. That's what I wanted to say. January was similar to those months that you've seen during the outbreak and strong waves of the pandemic. March was the best month ever. If you combine that, you can see that we came out anyhow with a very strong result.

Erik Hultgård
Healthcare Analyst, ABG Sundal Collier

All right. I guess the activity level has continued on a similar level throughout April as well, right?

Emil Billbäck
CEO, BONESUPPORT

Yes, that is correct.

Erik Hultgård
Healthcare Analyst, ABG Sundal Collier

Okay, very good. All from me. Thank you, guys.

Emil Billbäck
CEO, BONESUPPORT

Thank you, Erik.

Operator

Thank you. The next question comes from Hans Boström from Trinity Delta. Please go ahead.

Hans Boström
Analyst, Trinity Delta

Good morning. Two questions, please. First, I would like for you to help us understand how improvement in market growth rate would impact your own sales growth, given that you're growing at such so much higher rate anyway than the market. I'm just wondering whether this, if you say the market growth rate in orthopedic procedures go from 2%-3% to 10%, I would think that there should be a significantly greater impact than the 7% delta. I'm just curious as to how you think market growth rate would impact your own revenue growth rate. Secondly, I'm curious also about your contribution margin development, where the margin, as you disclose it in your report, is still considerably stronger in Europe at 22%.

In Q1 versus 16 in the U.S., if I calculate that correctly, though there has been a stronger improvement in the U.S., but the U.S. has also benefited from the lower R&D expenses. How should we think about this contribution margin in the medium term, is the U.S. to be catching up with Europe or even surpassing it? And what are the levers for that? Thank you very much.

Emil Billbäck
CEO, BONESUPPORT

Yeah, thank you. Thank you very much for your insightful questions. I will address the first one, and Håkan will take over. During the pandemic, we have increased the number of customers. Despite the restrictions from the pandemic, we have converted some very high-value clinics to CERAMENT. During the pandemic, the volume of surgeries at those clinics has still been quite low. Now then that the volumes are starting to pick up, we see the effect with our heritage customers having an increased volume, and we see these new clinics that we have won during the pandemic also ramping up in volume. It becomes a bit of a double kick on the top line.

If we look at the big orthopedic companies that have released their quarterly report just a couple of days ago, we see that they were growing somewhere between 2%-4%. The market survey shows a market growth of about 2%-3%. As you can see, that has translated into a very strong top-line growth for BONESUPPORT. I think needless to say, if the market continues now to experience a tailwind and increases further to 4% or 5%-6%, I think it's likely to believe that BONESUPPORT is gonna be even stronger in growth, given our extended distribution that we have seen over the last 18 months. Håkan, would you like to comment on the margin?

Håkan Johansson
CFO, BONESUPPORT

Sure. Again, the big difference between North America and Europe is that in North America, yes, we have a higher gross margin just south of 94%. But with the distributor set up, we're also paying a commission on all the sales. The commission is roughly around 30% of sales. You could say that on sales, we have a net margin net of the commission of around 64% to be compared with the gross margin level in Europe of just south of 90% and no commission paid. For both North America and Europe, we have largely the organizational structure in place that we need. The cost structure is there.

As we've commented in the report, we've seen a normalization of marketing activities in the quarter. There are still some additional activity levels to add, but largely the cost structure will remain stable. The way you're thinking is that U.S. growth will add the 64% in net contribution to profit. In euro, the sales growth will add roughly 8%-9% to the cost structure. That's the way to reason around that.

Hans Boström
Analyst, Trinity Delta

Just to follow up on that last one, so I understand it correctly, you don't really foresee then much of an expansion of your U.S. footprint in terms of fixed costs for your sales force in the coming year or two.

Håkan Johansson
CFO, BONESUPPORT

Well, that's the beauty of the structure that we have established, that it's so highly scalable through the platform of independent distributor. Largely, we have the foot power that we need also with the launch of CERAMENT G in the US.

Hans Boström
Analyst, Trinity Delta

Okay, that's very clear. On my first question, I mean, obviously, I understand it's quite challenging to provide any guidance on this, but if I understand you correctly, you really have a significant backlog of customers that you would benefit considerably from with an improvement in market growth rate. I'm deducing that we should expect your delta in growth to be higher than any type of increase in market growth rate. Is that a fair understanding?

Emil Billbäck
CEO, BONESUPPORT

Yes, yes. That is indeed a fair understanding. We have seen throughout the entire pandemic that we have outgrown the market growth, which means we have taken significant market shares. We have done that on the merits of the unique value proposition, and that trend continues now that the market is starting to come back. The product is simply better and give better outcome.

Hans Boström
Analyst, Trinity Delta

Okay, great. Thank you very much.

Emil Billbäck
CEO, BONESUPPORT

Thank you.

Operator

Thank you. The next question comes from Sten Westerberg from Analysguiden. Please go ahead.

Sten Westerberg
Equity Research Analyst, Analysguiden

Good morning. I hope you can hear me right now. Yeah, a couple of questions on the de novo situation and the trend. Firstly, I understand that you have made some changes, general changes to the de novo procedures by the FDA during the course of last year, and that these came into effect early this year. Have these changes in any way made your process more complicated? That would be my first question. Secondly, have you disclosed the classification of CERAMENT G as a Class 3, 2 or one product in the de novo procedure? Finally, as for the criterion of not substantially equivalent to marketed product, could you please remind us again, is this primarily based on the one-step procedure or the resorbable qualities of the product?

Any other insight to this criteria would be helpful. Thank you so much.

Emil Billbäck
CEO, BONESUPPORT

Thank you very much, Sten. Yes, there have been changes to the de novo process. Those have been discussed between the industry and the agency, the FDA, for about two years, I think. Some of the first changes were taken to execution beginning of this year. It hasn't influenced our process at all, I would say. Potentially the only influence that we have had is that if the staff at FDA has been disrupted by participating in the meetings with the industry and also presenting the changes to Congress, which has taken time away from an already strained situation. There are no changes in the process that have a direct effect on the application we have for CERAMENT G.

The changes, number one, are not of that nature, and the changes are also being implemented gradually on new applications. The second topic was regarding the classification. Well, clearly, CERAMENT G is an implant with a very sophisticated work mechanism and also includes antibiotic. So there is no doubt that CERAMENT G, by default, becomes a Class 3 product. CERAMENT G becomes a Class 3 product, but the whole purpose with de novo is to share such extensive efficacy and safety data that the product could be considered safe and effective to the extent to fit within a Class 2 category. So that's the purpose. An approval with de novo would take the product into a completely new category.

A new category would be created, which would then be a Class 2. Reduced risk-efficacy ratio. The final question, I have to see if I understood you right, correctly, Sten. You said, what is it that separates the product so much from the market that it is going through these rather detailed processes? It's the fact that it's a biocomposite product that also protects the healing from infection during the recovery period. The antibiotic, in addition to the biocomposite, is of course completely revolutionary and to create an antibiotic elution over more than 30 days. This, of course, is completely different to any other product that is existing on the market. Did I understand your last question correctly?

Otherwise, please, help me, and I will try again.

Sten Westerberg
Equity Research Analyst, Analysguiden

Yes, I think so, actually. I mean, you need to prove not being substantially or not substantially equivalent to marketed products. I guess that answered my question. Which features allows you to claim not being substantially equivalent to marketed products?

Emil Billbäck
CEO, BONESUPPORT

Okay. Yes, of course. If we look at the results of CERAMENT G in the clinical studies, and we compare it to all other treatment methods that is available in the clinical documentation, clearly CERAMENT G accomplishes things that no other product can do. That's why there is nothing to compare with, and that's why we have to go through this rather tedious process with significant documentation and creating a completely new category. If there would be product in the market performing the same way or similar, yeah, then it would be a much easier process. I guess that's the charm and beauty of having breakthrough innovations.

Sten Westerberg
Equity Research Analyst, Analysguiden

Okay. Thank you so much.

Emil Billbäck
CEO, BONESUPPORT

Thank you, Sten.

Operator

Thank you. The next question comes from Oscar Bergman from Redeye. Please go ahead.

Oscar Bergman
Analyst, Redeye

Good morning, guys, and congratulations on the report. I really only have two rather short questions. The first one relates to Italy and Spain, and I wonder if you can elaborate on the contribution to the sales from these hybrid markets. Secondly, you have previously stated that you expect to begin starting to sell CERAMENT G in Q3. But I'm wondering if you have any type of cutoff date for that assumption and when it would be perhaps more reasonably to consider Q4 or even early Q1 next year. Thank you.

Emil Billbäck
CEO, BONESUPPORT

Thank you, Oscar. Yeah, in terms of Italy and Spain, we think these are very attractive markets. As you noted, the hybrid setup was completed mid-last year. We have recruited great talent both in Italy and Spain. As you can imagine, not the perfect time to start building new market penetrations with constant lockdowns. The two people were hired just before the Delta wave came. When the Delta started receding, I proudly announced, "Now it's time to go," and then Omicron came. What we can see is that with a hybrid structure in these rather complex big markets, it's a very strong value proposition because we can own the messaging, we can own the positioning, and we also have a close contact to key opinion leaders and customers.

It's too early to speak about what sales results we have seen, but I can assure you that they are positive to the extent that we have decided for the same model now also in Canada. We see this to be a success model for certain markets of certain size. Again, I cannot release the sales data. Maybe if we see ourselves in a Capital Markets Day later this year, hopefully post an approval, maybe we have the chance of going a little bit more in detail. Once we get the approval, or at least once we get the final notification, hopefully, potentially the approval on CERAMENT G, we need at least four months to ramp up for the launch.

You see, the FDA will most likely have in the final notification some demands on labels and stickers and instruction for use. That means that we haven't started the production of these products until we get the final notification. That would be an expensive process for us. We also have to print material and apply for different systems. That getting into the systems and also contacting previous customer contacts that we have takes a few months. You can count backwards. The minimum for us is four months. If the delay now continues to drag, then we might have to revisit it. We will not do it quarter by quarter, but rather month by month.

All the teams are ready in the BONESUPPORT head office, and the sales team in the U.S. is also ready. We're just waiting for this to happen before the machinery will start.

Oscar Bergman
Analyst, Redeye

All right. Thank you very much. I have a final question before I will get back into the queue. I think one of the other analysts touched on this question as well. OrthoPediatrics, I was wondering if you can say when the first order came from that customer. Perhaps maybe if you can give any sort of guidance as to what to expect in the coming quarters from OrthoPediatrics.

Emil Billbäck
CEO, BONESUPPORT

The first order from OrthoPediatrics, as you saw, was SEK 2.6 million. Not a very big order, I would say. It gives them the product to get started. Starting the same way that we have done with the most important clinics, the most influential clinics. I couldn't give a beat rate here actually, because we have to see how well they penetrate the market. There definitely will be more orders this year. We don't know if it will be another order end of Q2 or beginning of Q3 . I think we will just have to wait and see. We see encouraging market penetration.

As you see from the rest of our US sales, CERAMENT is doing very well on the US market. I don't expect anything else for the pediatric indication. I'm sorry, I cannot give a clear indication of that. We will have to wait until the next quarterly report. We have at least two quarters under the belt.

Oscar Bergman
Analyst, Redeye

All right. Thank you very much. I'll get back in queue.

Emil Billbäck
CEO, BONESUPPORT

Thank you.

Oscar Bergman
Analyst, Redeye

Bye.

Emil Billbäck
CEO, BONESUPPORT

Thank you, Oscar.

Operator

Thank you. Ladies and gentlemen, let me remind you again. If you want to ask a question, please press zero one on your telephone keypad. Thank you. There are no further questions at this time. Dear speakers, back to you.

Emil Billbäck
CEO, BONESUPPORT

Well, thank you very much. I would like then to thank everyone that took the time to join our conference call this morning where we presented our Q1 2022 results. I wish you all a good day, and I wish also that we speak again. I wish that we speak again shortly and definitely before July first. With that, have a good day, everyone. Take care. Bye-bye.

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