Welcome to the BONESUPPORT Audiocast with Teleconference Q4 2021. For the first part of this call, all participants will be in listen-only mode, and afterwards, there will be a questions and answers session. Today, I am pleased to present CEO Emil Billbäck, CFO Håkan Johansson, and CMO Michael Diefenbeck. Gentlemen, you may now begin.
Thank you very much, operator. To clarify, this is the quarter four 2021 call. I'm Emil Billbäck, I'm the CEO, and I'm here with Håkan Johansson. Michael Diefenbeck is not participating today. What we will do is we will over the next 20 minutes provide a presentation on the performance in quarter four of last year and share also the full year results. Then we will open up the line for question and answers. We can go to slide 2, please. Before starting actually the details on the presentation, we would like to draw your attention to disclaimers covering any forward-looking statement that we might make today. Let's go to slide 3, please. I would like to begin this presentation now with some condensed highlights from the report that we released this morning.
Overall, quarter four sales were SEK 61 million, which corresponds to a reported growth of 15% year-over-year. The currency movement in the year has been quite significant, and growth at constant exchange rate was 21%. This is a strong growth with further progress in market share gains, given the impact on market conditions from the resurgence of the pandemic. The EBIT was -SEK 22 million, which is a significant improvement over last year. For the full year, sales were SEK 213 million, which corresponds to a reported growth of 18% year-over-year and +23% at a constant exchange rate. Now, 2020 was a year with very high variability driven by the first pandemic waves.
If we compare our full year, 2021, with the pre-pandemic year, 2019, BONESUPPORT has displayed strength through the volatile times and grew sales with 44%. As you can see, EBIT for the full year landed at -SEK 88 million. From a business operations perspective, we saw the return of regional restrictions and deferrals of non-acute surgeries as Omicron drove high incidence rates and new peaks in the number of hospitalized COVID patients. While the onset of the quarter showed strong sales development, the impact of the resurging pandemic was significant at the end of the quarter. During the quarter, we launched a cannula and guiding tube for use and application of CERAMENT in proximity to joints with minimally invasive procedures. This opened a new segment for us in the U.S. of some 20,000 procedures yearly, mainly in sports medicine.
Injuries in this area are common among athletes, and a quick recovery is of high priority. CERAMENT's properties make it ideal for the treatment of this condition. All in all, we have seen diverse and varying market conditions in the quarter, but with continued strong growth for CERAMENT. Let me go to the next slide and again speak about how the pandemic have impacted the market dynamics. Slide 4, please. The recovery in surgical volumes that we saw during autumn was disrupted as Omicron surged in late November and December, again, making healthcare systems postponing non-critical surgical procedures. CERAMENT sales is, as you know, strongly correlated to the number of surgeries being performed, which in turn has been determined by the pandemic for the last two years. On top of that direct impact, a shortage of staff has added challenges to the surgery volumes.
As an example, some 450,000 people or 3% of the workforce in the U.S. healthcare system left their jobs during the pandemic up until November 2021. Throughout the pandemic, the patient flow has been on a steeper trajectory than the capacity utilization, which has created increased backlogs and queues. As an example of how queues are building up, we can look at the NHS, where there is a graph or a matrix on the bottom left part of the slide. The people in line to receive elective care were 4.5 million in November 2020. By November 2021, that queue had grown to 6 million people. That's a surge of 33% in only one year.
To handle this, the NHS has received an additional GBP 5.4 billion, whereof GBP 1.5 billion is earmarked specifically for elective procedure recovery. The U.K. government has provided extra funding to the NHS by establishing a Build Back Better program to increase elective care activity in the NHS by 30% by 2024-2025 compared to pre-pandemic level. While we continue to see short-term pandemic disruption, the midterm perspective is pointing at strong positive trends in surgical procedures. Sweden, at the bottom right of the slide, with easily accessible and high transparency in data, gives a very similar review for 2021. Surgery productivity in 2020 and 2021 dropped some 20% versus pre-pandemic normal levels of some thousand surgeries a day.
Although the trend during the beginning of the autumn was positive, capacity is far from back at full speed, and queues are still building up. The backlog in Sweden only is 156,000 procedures, which is 30,000 procedures more than we shared these same metrics in the quarter three report. Now let's turn to next slide, and I'll guide you through some of the details of our quarterly performance. Slide 5, please. Despite the strong Omicron impact at the end of quarter four, we reached an all-time high sales. We have gone through the details of this slide at many previous occasions, so let's focus now instead on the trending we see.
On the European side, which is the red and orange bars, we see that the very strong sales trend up until 2019 has been a bit upheld during the last two years by influence of the pandemic. With the latest two to three quarters, though, we see again a growth trajectory despite the effect from the pandemic. In the U.S., growth momentum has been stronger as we continue to expand our market presence through important GPO contract, increased market penetration, and broadening of market segments. All in all, despite pandemic influence and the market conditions that the pandemic has brought with it, we continue to gain market shares, and quarter four was our best quarter ever.
I also have to say that I hope that when we come to quarter three of this year, we will be able to add one color to the U.S. bar, hopefully, potentially representing the first sales of CERAMENT G. Let's turn now to the next slide and transition into the geographic segment details. We'll start with North America on slide 6. We have delivered sales of SEK 35 million, which represent a reported growth of 22% year-over-year and growth above 30% at constant exchange rates. In areas where Omicron has raged through the population, the number of surgeries have been significantly reduced. In other areas that have been less affected, surgeries have almost been back to pre-pandemic levels. After the end of the period, we signed a strategically important distribution agreement extending our market access to the important pediatric market.
The company OrthoPediatrics is a leader in the orthopedic pediatric markets and has annual sales of about $100 million. Since this contract is in effect, they can start to distribute CERAMENT BVF to their network of 250 pediatric hospitals across the U.S. One of our key priorities is, of course, to pursue the CERAMENT G registration in the U.S. In late September, we sent the supplementary De Novo bone infection data to the FDA and have since then been engaged in an interactive review with FDA. What this means that during October and November, the BONESUPPORT and FDA team met almost weekly. By the additional data submitted, the control group now contains data from more than 200 patients. A potential market access grant decision should arrive in this current quarter.
Turning to some other highlights of the quarter in the U.S., in anticipation of pursuing further market opportunities, we're actually expanding our commercial infrastructure with recruitments of two additional regional managers, one in Northern California, because we have split California into North and South, given the vast opportunity. We've also added one regional manager to the Midwest. In total, we have now 12 regional managers in the U.S. In Canada, we are replicating the successful setup in Southern Europe with a hybrid sales model. And as you might remember, CERAMENT G is already approved in Canada. Let's turn to the next slide and look at Europe and rest of the world. In the quarter, we delivered sales of 27 million SEK, which represents a reported growth of 8% and 9% in constant exchange rates.
Sales vary regionally as there were also regionally high levels of hospitalized COVID patients. More and more governments are discussing special funding to address the backlog in elective procedures. As I alluded to earlier, the additional funding in the U.K. was indeed visible with positive effect on sales in the quarter. Several major clinics have also extended their surgical procedures into weekends to reduce the buildup of backlogs. Let's now turn to the next slide and spend a minute on the latest trauma publication on CERAMENT G, showing strong radiologic validation of bone remodeling. Slide 8, please. So this study comprise retrospective data of 51 patients collected from 2015 to 2021. 80% of the patients had open fractures of Gustilo-Anderson IIIB, and 20% had closed fractures. X-rays were performed on these patients regularly over 12 months.
Now, the study concludes a high union rate and, quote, "Good signs of radiological remodeling into trabecular bone," end quote. Now, these findings have already been shown, of course, in clinical studies, clinical practices, preclinical studies, and for other indications. That CERAMENT turns into bone is proven and also widely accepted. This study does, however, provide validating 12-month X-rays specifically for the trauma indication, which is an important piece of data for a future potential regulatory process. The study actually has clear similarities to the data mining that was part of our supplementary submission on De Novo, but this was, as you know, for bone infections. With that, I will hand over to Håkan to run us through the financial details.
Let us go down to slide 10, please. Net sales improved from SEK 53.2 million to SEK 61.4 million, equaling a growth of 15% or 21% in constant exchange rate. The organic growth in the segment North America measured in fixed currencies was SEK 8.6 million or 30%, confirming a continued strong growth trend. The organic growth in Europe and rest of world was SEK 2.4 million or 9%. Changes in currencies had a negative impact in comparison with the Q4 last year or in total SEK 2.7 million, of which SEK 2.5 million relates to a weaker US dollar measured in full-year average in 2021 versus 2020. Next slide, please.
The contribution from the segment North America improved with SEK 3.6 million and was reported to a profit of SEK 3.7 million. The improved contribution relates to increased sales offset by effects from increased costs. Sales and marketing expenses during the quarter amounted to SEK 26.5 million compared with SEK 21.5 million previous year, of which sales commissions to distributors increased with SEK 3 million to SEK 11.4 million. The increase in sales and marketing expenses is mainly due to a higher level of activity. The contribution was also charged with R&D costs related to studies, which decreased from SEK 4.8 million last year to SEK 3.8 million in the 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 remains stable and in line with previous quarters this year.
In Europe and rest of the world, a contribution of SEK 5 million was reported, to be compared with SEK 5.6 million previous year. The slightly lower contribution is explained by a higher level of activity in the period compared with the same period last year, including the setup of a hybrid structure in Southern Europe, but also relating to a lower expense level last year because of the COVID-19 pandemic. Sales and marketing costs increased by SEK 2.1 million compared to the corresponding quarter previous year and amounted to SEK 17.1 million. In Europe and rest of world, a minor decline in gross margin was reported following the market mix during the reported quarter. Next slide, please. In summary, we reported a 21% growth in constant currencies despite continued impact from the pandemic, reaching an all-time high sales of above SEK 61 million.
Gross margin remains stable and in line with previous quarters. It's to be noted that continued growth in the U.S. will have a favorable effect on gross margin. The operating profit was reported to a negative SEK 21.8 million, an improvement with SEK 4.9 million compared with a loss of SEK 26.7 million for the same period previous year. The lower loss included expenses regarding long-term incentive programs, a cost of SEK 4.8 million this year, compared with a cost of SEK 1.8 million previous year, a difference of SEK 3 million. The increased cost was mainly an effect from the first time inclusion of the programs approved at the annual general meeting in May 2021. Profit improvement before the cost for the long-term incentive programs was close to SEK 8 million.
Cash at period end was reported at SEK 206.5 million, remaining with a substantial headroom in funding until we can reach the point of cash flow break-even. Next slide, please. Selling expenses increased with SEK 4.6 million. The higher cost level partially relates to the investments in hybrid markets such as Italy and Spain. The period also contains significant demo kit replenishment, but also increased cost for freights and fees following the sales growth. R&D expenses reported below previous year as FORTIFY-related cost has been phased out during the quarter. Administration remaining on a stable level, excluding effects from the long-term incentive programs, equaling SEK 10 million this year, compared with SEK 10.8 million previous year. With this, I hand back to Emil.
Well, thank you, Håkan. Let me then sum up a bit. As usual, we should be on slide. Which slide are we on?
Fifteen.
15. Good. That's a good slide. We put a timeline so that you can follow the key activities and also upcoming milestones. The closest is the potential De Novo approval for CERAMENT G in the U.S., which is expected in the current quarter. Go to the next slide. That's the final slide of the presentation. Let me summarize. What we have seen now is a quarter which has been very focused on De Novo, of course, also on strategic execution and situational commercial adaptation. At a full year sales growth of 23% in constant currency, we are taking significant market shares. Strengthened by this, and in anticipation of surgical volumes midterm reaching above pre-pandemic levels, we have further invested in our commercial platform.
The most recent steps with the strategic partnership with OrthoPediatrics, two additional regional managers in the U.S., and a hybrid setup in Canada, means that we charge into 2022 with a stronger commercial setup than ever before. As you well know, our most important upcoming task is to enable U.S. market access for CERAMENT G. Through the bone infection De Novo pathway, we hope to achieve market approval in this quarter for the indication bone infection. Data and documentation are being generated to sequentially pursue a broader label in the future with further indications added. Two years of pandemic influence has brought the largest surgical procedure backlog ever in our key markets. The obvious clinical benefits and health economic evidence with CERAMENT is making it an even more attractive solution in addressing the heightened need for outcome-effective orthopedic therapies.
Governments are increasing funding to increase the pace of elective procedures, and as we are moving to a less pandemic influenced reality, we are reiterating our annual sales growth target of 40%. With that, we close our presentation and would like to open up for questions.
Thank you. Ladies and gentlemen, if you have a question for the speakers, please press zero one on your telephone keypad. We have a question from Erik Cassel from ABG Sundal Collier. Please go ahead.
Hi, good morning, Emil and Håkan. I have a couple of questions for you today, and I just want to start off with the cost levels. You talked about going with the hybrid model now in Canada and increasing the amount of regional managers in the U.S. Sort of ramping up sales efforts in North America. Is this in any way conditional on the FDA approval for bone infection or are you doing this either way?
Yeah, thank you, Erik, for your question. The ramp up of resources that you just mentioned, Canada and the two extra regional manager, that decision has already been made and it's being implemented. Out of the two regional managers, one was already recruited in December and the recruitment of a person for the hybrid setup in Canada was also done already at the end of last year. Those have happened independently.
Okay, thank you. What sort of incremental costs does this imply?
Well, we don't break down the cost for individual activities like that. You can see that the cost in quarter four was slightly raised due to partly some of these activities. Overall, it's rather small incremental cost that we're talking about. It's a total of three people that is added.
Okay, thank you. Håkan, you said that cost for replenishing demo kits was substantial this quarter. I guess that's sort of a non-recurring expense. Could you help us in any way with how large that cost was?
The cost for that is somewhere around SEK 1 million, and it will cover the need of demo kits for five to six months.
Okay, very helpful. Thank you, Håkan. Just quickly on the R&D spend run rate now in Q4, is this the level you expect to be at going forward now that FORTIFY is out of the picture?
Well, underlying, we have communicated previously that the level will remain fairly stable after phasing out FORTIFY. What you will see in some quarters is that we will be reaching milestone payments in a few of our clinical studies that will cause some movements. Again, I think that if you take this quarter and also look backwards and adjust for the phasing out of FORTIFY, you would find a fairly stable level, yes.
Okay, thank you. Emil, you said that you're taking significant market share from other treatment options, primarily in the U.S. Would you say that doctors who has been using synthetic grafts are switching to CERAMENT, or is it now more moved from allograft users sort of making the switch?
Yeah, thanks, Erik. Obviously, a good question. In the U.S., we see, as is clear from the numbers, slightly higher growth than what we see in Europe. To a large extent, it is switching from allograft and synthetic grafts. I guess that for an orthopedic surgeon to switch from one synthetic or from allograft into CERAMENT is fairly easy because the procedure doesn't change so much. In Europe, the conversion from autograft to CERAMENT is slightly slower because it also involves changing the technique. U.S., synthetic to synthetic mostly, and in Europe, slightly slower autograft to CERAMENT.
Okay, thank you. Just the last question from me to sort of get a feel for current trading. I mean, it seems to me like the COVID situations in hospitals have improved quite a bit over the last two weeks, just compared to mid-January. The data I have shows that the sort of U.S. room capacity or utilizations is back to sort of early November levels already. So just wondering if you can confirm a fairly quick rebound right now in the numbers you're seeing as well.
Yeah. There is. It depends on if you look at infection rate or hospitalization rate. If you look at hospitalization rate, because usually if you get infected, it takes a few days before you end up in hospital if you have severe symptoms. Our sales to a large extent is a reversed mirror of it. We also see that hospitalization has dropped pretty sharply since the beginning of January. As you said, it's basically on the levels of November and our sales follows a corresponding pattern but opposite.
Okay, very good. Thank you very much, Emil and Håkan. I'll jump back in the queue.
Thank you.
We have a next question from Carl Melzig from SEB. Please go ahead.
Yes. Good morning, and thank you for taking my questions. The first one relates to the financial target. You reiterate the target of 40% sales growth per annum post-COVID or some kind of normalized situation there. I was just thinking, is that based on the assumption that you get the positive decision here on the De Novo application for bone infections? A follow-on question for this. If you assume a worst-case scenario where you don't get the approval, what would you see as a reasonable sales growth target per annum, so say, excluding the CERAMENT G in the U.S., considering that we still have significant elective backlog there? That's my first one. Thanks.
Yeah. Thank you, Carl Melzig. Yeah, I will answer the first question and possibly not the second, but let me explain. The 40% sales growth target was set when we made our five-year plan about three years ago, and it includes an approval for De Novo. If a De Novo approval wouldn't come or would be partially restricted or something else, we would have the opportunity to come back and revisit that target. But as we haven't had any signs that that will be the case, we stick with our previously communicated target until data points arise that will give us reason to revisit it.
Okay.
The way to look at the 40% is not to say that we will grow with 40% for all eternity or the market cap will eventually be bigger than Tesla's, but the way to look at it as is that at least for the next two years, this is a very valid target, given a hopefully potentially positive message from the FDA. Worst-case scenario, I cannot answer actually, because we haven't done that exercise. It all depends on what the message will be from FDA. There are so many different options, of course, everything from a full approval to a full rejection, and then all kinds of scenarios in between. We have actually decided not to dwell further into those different scenarios until we have a better understanding what the outcome can be.
I can assure you, though, that as soon as we have the notification from FDA, we will be able to communicate much clearer what that means to the company.
Okay. Perfect. Fair enough. I just have one additional one. You mentioned a relevant safety stock level, but would you say the situation around possible component shortages have worsened here recently for you guys, or is that still a non-material risk?
Yeah. It's not a risk currently. We have good stock levels and, but we do also see that the disruptions in components everywhere in the world and the disruption in supply chains is probably going on a little bit longer than we first anticipated. We cannot hold for granted that also we would be completely isolated from this in future production. Some products or some components have longer lead times, and they could, of course, be influenced. If that influence would be material. We would communicate it to the market. There's always on products like this short-term disruptions here and there. But to our knowledge, nothing has led to any canceled surgeries or disruption in procedures. So right now we're in good shape.
We keep a very close eye also at our suppliers to guarantee that this continues to be the case.
Okay. Perfect. Thanks a lot. I'll jump back in the queue.
Thank you, Carl.
Thank you. We have a next question from Kristofer Liljeberg from Carnegie. Please go ahead.
Hi, good morning. It's Kristofer from Carnegie. I have four questions. First, on this 40% sales growth target, you said it's very valid for the next two years. Does this mean you expect to grow at least 40% 2022 in isolation? Then a question about your comments about you know the overall market environment, market share gains, et cetera. I wonder a little bit how you see sales being correlated to overall market volumes versus your ability to gain market share by deeper penetration at existing hospitals and the ability to sign new contracts. i.e., how important is those fluctuations in market growth for BONESUPPORT sales?
The third question is if you get this approval now for CERAMENT G, are you planning to expand marketing capabilities significantly, more than what you have done so far? The final question relates to the R&D cost line. Did you include or did you have a FORTIFY cost for the FORTIFY study in the quarter? And if so, how much? Thank you.
Okay. Very good. Yeah, thank you. The first question relates to the growth targets. We have said that we will grow 40% once we get to a more normal post-pandemic state. If the trend continues with the pandemic of reduced restrictions, not only in Sweden but in all key markets, and we see that the healthcare systems is starting to come back at least as close to normal levels, yes, we can confirm 40%. The 40% will be more dependent on the pandemic than anything else right now. In post-pandemic times or where we find some kind of new equilibrium or normal state of being, we can confirm that also for 2022 in isolation.
Could I maybe related to that, since this target was set a few years ago and now we have had the negative impact from the pandemic, assuming there will be catch-up effect, doesn't this mean you should grow a bit above 40% then in the next few years?
I agree. As I said, it's all down to the pandemic. I must admit sitting here a year ago thinking that the autumn of 2021 would indeed have a bit of a rebound and catch up, and I have to admit I was wrong. If the scenario as you depicted it would happen, I think it's also likely that our growth will be even higher than targets. To the market environment, what has happened mainly during the pandemic, and where we see the market share gains is with existing customers or customers that have been won just before the pandemic or during the pandemic. The increase of volume has been bigger with those won customers than the recruitment of new customers.
This is mainly related to restrictions to get into the hospitals and for our salespeople to meet potential new customers during the pandemic. What we're looking forward to now is, with restrictions hopefully starting to be removed, that our salespeople again can be fully productive and effective and again start to visit some of those hospitals around our key markets that yet have not started to try CERAMENT, because there's still a lot of them. With an approval of CERAMENT G in this current quarter, and many of you have also seen, let's say from FDA's web pages, how long time usually they take to answer to such requests. Yes, indeed, the notification should come at the end of February, plus minus one or two weeks, given COVID influence.
We don't have any plans communicated right now to ramp up our efforts further. We have a very well-established commercial structure in the U.S. where the ramp-up is rather getting more attention from the distributor sales rep. They're being paid by commission. I can tell that the distributor reps in the U.S. are very, very eager to see CERAMENT G come into their portfolio. With 12 regional managers, I have absolutely everything I need to go full blast in the U.S. and potentially then spice up the incentives for the distributor reps so that we get maximum attention in front of the customer. It's a variable model, the investment comes more as a commission payment rather than us adding more headcounts. The headcounts is fine for us now.
Finally, on R&D, yes, there were costs in R&D for SEK 45 in quarter four. They were significantly less than one year earlier. It has been a decreasing number since the beginning of 2021. The cost that we saw in quarter four related mainly to closing out some of the study centers and finalizing the report writing, which has to be done. Not material cost, though.
Thank you very much.
Okay. Thank you. We have a next question from Sten Westerberg from Analysguiden. Please go ahead.
Thank you operator for taking my questions. First of all, I wonder if you could discuss in any more detail this interactive review process, what it has consisted of. Is it solely a process for data mining, for coming up with a control group, or have you been asked to complement some data regarding the active component as well? Also follow up on the last question. So we should not assume that given the market opportunity for CERAMENT G, in the case of an approval that you will not incur any launching costs in the coming quarter. Just a clarification on that.
Finally on currencies, I guess there should be quite a swing in the positive direction for you, coming into 2022, with the strengthening of the U.S. dollar. Given current currency rates, what kind of impact do we expect currencies to have on 2022? Thank you.
Thank you, Sten. Yeah. As we said, when we submitted the supplementary De Novo data, we went into an interactive review with FDA, and this was very pleasing to us. I must say, I think I have one of the absolutely sharpest and brightest teams in both regulatory and clinical medical. For us, it was a great relief to be able to get extra air time in front of FDA. It has been also an educational or developing, I should say, process for them. They have never approved a combination product in De Novo, and I'm sure there were a bit of learning on both sides on how to position the results of the extra supplementary data and how to explain them, how to look at the data.
We're talking about some quite sophisticated details. BONESUPPORT has submitted to FDA close to 17,000 data points. It's a very comprehensive submission that we have done. The discussions, mainly in the interactive review, was regarding the comparability of the control group and the treatment group on many different levels, on everything from side effects to biomarkers to efficacy and also X-rays and detailed patient info. This requires both professional interpretations and discussions, and that's what the interactive dialogue has been very much about. You're correct, Sten, when you say that an approval of CERAMENT G and a launch. We would expect then to come.
Well, if the approval would come now in quarter one, we expect a launch that could take place in quarter three, but it wouldn't incur any significant cost in quarter three, quarter two, or for the full year, other than maybe marketing cost, promotion material. The whole sales infrastructure is already in place. Then there's a variable cost on how much is being sold in the U.S. Yes, it's a commission, as we have discussed before, of about 30% to sales. There was a topic also raised on currency and what we could expect for quarter one. I think I leave that over to Håkan to comment on what are the currency effects we've seen in quarter four and potentially quarter one.
Thank you, Emil Billbäck. Yeah, Sten Westerberg, I won't take the risk to speculate on how the currencies will move during 2022. If we look at the current FX ratios compared to the full year averages applied when reporting the Q4, it will definitely take a jump upwards with a much stronger U.S. dollar. That's absolutely correct.
Okay. Thank you so much. That was very helpful.
Thank you. We have a next question from Oscar Bergman from Redeye. Please go ahead.
Hi, guys. Thanks for taking my call. I only have three pretty short questions, and the first one relates to the product that you launched in October. I wonder if you can give some sort of indication for the coming quarters or at least, broadly speaking, some sort of indication of what your expectations are relative to group sales in the longer term.
Yeah, absolutely. The product that launched in quarter four was the guiding tube and the drillable cannula. It gives the opportunity to apply CERAMENT in a, let's say, closed compartment, or if you have to go through the cortical bone, which we couldn't do before. It relates very much to athletes, basketball, for example, and as I mentioned also in my call, it's about 20,000 procedures per year. Yeah, it increases our addressable market, let's say, in the U.S. with about 7%. That's, let's say, if you look at what is the potential of this, I believe that we will penetrate this segment quite well, actually.
Because what you want to have specifically in this area, given the nature of the injury, is an injectable synthetic bone graft that remodels the bone. This is not only top athletes in the U.S. They need to get back quickly. Every day away from a game or practice costs a lot of money. This is also for the average maybe runner that have hurt themselves. They want to get back to a decent life. The properties of the product makes me believe that we will have a strong penetration in this area, and what we've seen so far in the two and a half months that we've sold it would confirm that.
Okay. I assume that the current existing sales channels that you have fits quite well into this new product offering too.
Yeah, it does. It fits very well. The launch of this kit has actually also given us an expanded reach. Some of these orthopedic surgeons working with athlete clubs, they sometimes even have their own physicians staff.
Mm-hmm
Were difficult to access before because there was a limited amount of indications where CERAMENT would fit in. Now all of a sudden, we're right in the bull's eye of a very common and problematic indication, which we have the solution for.
Okay. I was wondering if you can give some color as to how the GPOs have helped drive sales in this quarter and 2021 as a whole.
The GPOs that we won have been one of the major contributors to the strong sales growth of last year. The GPOs has given us access. We have had better success with the GPOs that I must admit I would have imagined and envisioned, and this has given us access. We know that when we get access, and we can compare CERAMENT to either regular bone cement or to allograft or to whatever else the physician might be using before, we know we win those comparisons. Getting market access also means we get sales.
Okay. Thank you. I just have a final question before I can get back into the queue. This hybrid sales model that you're now implementing in Canada, can you give some sort of indication on when that could be up and running and maybe also a brief background to that market?
Yeah, absolutely. The Canadian market is around 30,000 procedures a year, so it's slightly less than one tenth of the U.S. market. It's an attractive market with a well-developed orthopedic surgeon network, good reimbursement. It's a little bit like a mix of British and French system, you could say. We've made a market analysis and concluded that this market could be very attractive to us. We submitted the application for CERAMENT G a couple of years ago.
We got that approved and have now appointed a distributor and decided also that the attractiveness of the market is sufficient for us also to relocate actually one of the persons that have worked in BONESUPPORT for a few years, very skilled, very talented lady, into Canada to set up this hybrid structure. We implemented the hybrid structure in Spain and in Italy. Despite the fact that the pandemic has steered very much of the outcome, we can clearly see that it helps us also to penetrate the market in a very efficient way. We believe that this is a model where maybe our key markets, we have a direct setup. In other markets that are of high interest, we might have a hybrid.
In further outskirts, let's say, of attractiveness, we might work with only distributors.
Thank you. That maybe just one more question before I leave you guys alone. It feels like you're quite confident that you'll be able to launch CERAMENT G in the U.S. without possibly raising more cash. How's the cash position standing in relation to those plans?
Well, I can quickly comment on that and also hand over to Håkan. We have more than plenty of headroom in our cash position. There's no need to raise further funds. Håkan, do you wanna comment on that even?
Again, as also mentioned a few times now, we've established a commercial platform, commercial structure in the U.S., that structure is highly scalable, and that together with the distributors can take on a launch of CERAMENT G without us having to add substantial commercial investments. Again, if we take that into account with a strong gross margin profile in the U.S., a fairly stable cost structure with the exception of the variable commission cost, this has a good chance to give a very good positive impact, not only in terms of sales, but also then profit and cash position.
All right. Okay. Thanks, guys. I'll get back into the queue.
What we can say, Oscar, as you are moving back into the queue is that, would a positive approval come now within the next couple of weeks, we're not gonna hold back. We're gonna go all in to create success in the U.S. market. As Håkan said, if we pay 30% commission and our gross margin currently is around 94%, it will be even higher on the CERAMENT G product. We believe that the product somehow is self-funding as we accelerate penetration. We've taken in a short time a very strong market share in the U.S. with the BVF product. Many physicians are well aware of the concept and understand the mechanisms of the product. gentamicin is a well-known antibiotic, so it's the best of two very good concept combined.
Thank you for adding some more color. Thanks.
Thank you. We have no other questions on the phone for the moment.
Very good. Well, then I would like to say thank you everyone for joining our Q4 results presentation from BONESUPPORT, and I wish everyone a great time until we meet again, which I hope will be very soon. Take care. Bye-bye.
Thank you. Ladies and gentlemen, this concludes today's web conference. Thank you all for your participation. You may now disconnect.