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Earnings Call: Q4 2019

Feb 26, 2020

Operator

Welcome to the BONESUPPORT Q4 report 2019. Throughout the call, all participants will be in listen-only mode. Afterwards, there will be a question-and-answer session. Just to remind you, this conference call is being recorded. Today, I am pleased to present CEO Emil Billbäck and CFO Håkan Johansson. Please begin your meeting.

Emil Billbäck
CEO, BONESUPPORT

Thank you very much, operator. Good morning, everyone. Welcome to the BONESUPPORT quarter four 2019 result call. I'm Emil Billbäck, the CEO of BONESUPPORT, and with me here today also is Håkan Johansson, our CFO. We will take around 25 minutes today to lead you through the presentation of the fourth quarter results. We will open the line for questions and answers. Before starting the presentation, I would like to draw your attention to the disclaimer covering the forward-looking statements that we'll make today, and they can be read on slide two of the presentation. Operator, if you would please help me to go to slide three, we will start the presentation. I would like to begin this presentation with some highlights of the figures that we released in this morning's report.

Overall, quarter four sales were SEK 46 million. Sales-wise, this is the best quarter ever in BONESUPPORT's history and represents a growth of 100% over quarter four 2018. For the full year, sales were SEK 156 million, corresponding to an increase of 61%. 2019 was the first full year of the execution of the new strategy. Sorry, I misread, it's SEK 155 million. 2019 was the first full year of the execution of our new strategy. During the year, we established and fine-tuned our organization, streamlined our priorities, and widened our customer base while making major changes to our commercial platform. Overall, our performance during this year is a confirmation that the strategy that we launched in 2018 is taking the company in the right direction.

Segment Europe and rest of the world grew with 21% in the quarter, reaching SEK 23 million. We had expected a slightly higher growth in Europe, we had a high quarter four variability with two major accounts. The growth of antibiotic-eluting products on a full year basis was 45%, in segment North America, we also saw a continued progress, with sales reaching SEK 23 million, which is up 26% sequentially versus quarter three. We have now seen strong sales growth during four consecutive quarters since we terminated the contract with our former distributor, Zimmer Biomet. With regards to earnings, we delivered a strong gross margin of 89% in the quarter. Moving to the operational highlights.

In the period, the results of the CERTiFy study were published in one of the most respected journals in the field of orthopedic surgery, The Journal of Bone and Joint Surgery. The study showed that CERAMENT BVF is as good as autograft. I will come back to more details regarding this later in the presentation. In the quarter, there was a decision by the French Ministry of Health to fully fund a clinical study on CERAMENT G and V in comparison with the current standard of care. We are thrilled to see the strong interest in the CERAMENT platform also in France. In the quarter, we saw the first orders from hospitals in the U.S. within the HealthTrust contract. This contract went into effect on December first, and we saw the first orders come just before Christmas. More on all of these topics later in the presentation.

Slide four, please. I would like to provide you with some more details regarding our quarterly development. This slide shows sales in the last 12 months, with the dark blue part of the bar representing Europe and the rest of the world, and the light blue part of the bar and the purple part is displaying sales in the U.S. Since October 2018, we have a network of independent distributors, and I'm pleased that five quarters after going independent, we're basically back at the same sales levels as before the termination of the contract with the previous distributor. The chart also confirms the steady growth in Europe and rest of the world, with an accelerating trend since the introduction of the new strategy in mid-2018. I think this gives a good confirmation that the business is on the right track.

Our antibiotic-eluting products grew with 45% in 2019. These products are now 5 x bigger in sales than the sales we have of CERAMENT BVF. The CERAMENT BVF, which is the base product, is anyhow continuing to grow and increase in value. The clinical utility of local antibiotic treatment is demonstrated in numerous clinical studies and is also a strong positive force in the fight against antibiotic resistance. Next slide, please. Focusing a bit more on the details on segment Europe and rest of the world. With a growing base of clinical data and the publication of the results from the CERTiFy study, we are experiencing strong acceptance of CERAMENT in favor of other treatment modalities, especially autograft. Total sales grew with 21%, and antibiotic-eluting products grew with 23%.

These figures are lower than we aim to achieve and are attributed to a slowdown in Sweden and Germany related to two specific accounts. Historically, customer sales concentration has been very high, as university clinics and specialist clinics are always the first to try new breakthrough therapies. We are working on expanding our sales network and address previously under-established area. This will broaden the customer base and indications where CERAMENT is used and make us less dependent on a few large customers. In some of our European territories, the top 10 accounts represent as much as between 50% and 70%. Again, high sales concentration. Furthermore, the recruitment of salespeople in Germany has taken longer than expected due to a very strong European labor market.

At the end of quarter four, we were 25 people in sales functions in Europe, and this is in accordance with the target that we communicated in mid-2018. We have now our own sales organization with good coverage in Germany, the U.K., Switzerland, Sweden, and Denmark. We have also started to make, and we will continue to make, changes in several of the indirect markets, also called the distributor markets. As an example, we appointed a new distributor in Ireland in the quarter, and we are scrutinizing our distribution model in a few of the European key markets. While this could lead to some short-term disruption, we are confident of the value that this will generate for our long-term growth and also for reaching our total sales potential. In the quarter, the CONVICTION study was initiated by the French CRI-OAc Network.

This is a healthcare network operating within osteomyelitis, which is the same as chronic bone infections. The purpose of this group is to improve the results of managing bone and joint infections. The study that has been granted is randomized. It's a controlled, multicenter study to evaluate the effectiveness of CERAMENT G in the treatment of chronic bone infection. The French Ministry of Health is funding the study, which will include 200 patients. BONESUPPORT will provide a research grant, which will cover part of the product cost for the study. If successful, this type of investigator-led and government-funded research could provide strong support in the further commercialization of CERAMENT and could also improve chances of obtaining special national reimbursement. Next page, please.

Returning to the progress that has been made in North America, sales in the quarter were SEK 23 million, which is up 26% sequentially. In the quarter, we saw first sales come through with member hospitals under the HealthTrust contract. HealthTrust is one of the most well-renowned medical organizations in the U.S. and gives us access to more than 1,600 affiliated hospitals. The contract went into effect on December 1st and is very important in terms of market access for 2020. Our distributor network of some 40 distributors, which together deploy more than 500 sales reps, has been fine-tuned during the year, and as an effect, the geographic as well as indication coverage has been gradually improved.

In our own commercial organization, we now have 24 employees, of which 10 are regional sales managers, working directly with the distributors and the distributor reps to penetrate the market. We have recruited excellent people through the two newly created roles in Northeast U.S., and our commercial team is making great progress on market access and gaining grounds in territories that have previously been underserved. The work and preparation of bringing CERAMENT G to the U.S. market is proceeding according to plan, and we expect to submit the PMA application to the FDA at the end of 2021 after completion of the FORTIFY study. Next slide, please. Before commenting on the CERTiFy study, I would like to reemphasize why the CERTiFy study was initiated.

Successful transplantation of bone was done for the first time in the late 17th century, and autograft from the iliac crest, which is the same as the hip bone, has been the golden standard in the treatment of bone defects for the last 100 years. While this is healing well, autograft has significant drawbacks. Studies have shown that close to 40% of the patients that have undergone an autograft procedure will suffer from long-term pain. Larger meta-analysis of 92 studies, comprising as much as 6,400 patients, autograft was reported to have an overall complication rate of 19%, and up to 47% in a published study experienced problems with activities of daily living, such as bending, such as walking, sleeping, and these problems continued for up to six months after surgery. For surgeons, harvesting autograft adds time in surgery.

It prolongs the anesthesia and requires an extra set of hands at the operating table, which puts further strain on an already stretched healthcare organization. As we said on previous occasion, more than 160,000 autograft procedures are done every year in the top five markets of Europe and U.S. This shows that there's a substantial market potential that can be reached with the right solution and the right evidence, which we believe we have. Next slide, please. The clinical evidence for CERAMENT has already been proven in more than 160 publications. In December, though, was a milestone with the first randomized controlled trial with CERAMENT. This is the CERTiFy study, which was published in the highly recognized The Journal of Bone and Joint Surgery, America.

We have already announced the top-level results, but having the results published in such a highly recognized journal is of substantial value for us in discussions with healthcare providers. CERTiFy is a 135 patients, randomized clinical trial with a non-inferiority design, comparing CERAMENT to autograft, with the main objective to evaluate bone healing through radiographs and the patient-related outcome measures, which is called PROMS. PROMS is a very important efficacy parameters for payers and reimbursement. The study showed that the efficacy of CERAMENT was as good as autograft, with proven bone remodeling. The radiographs in the presentation to the right provides a snapshot of the great results of the study. If you look to the right, you will see the top and the bottom radiographs show two patients with the same fracture type.

This injury of the tibia is very common as a result from a fall, a traffic accident, or injuries from sport, such as football, baseball, basketball, or skiing. The gold standard previously has always been to treat these injuries with autograft. The pictures you see show the tibia, which is the leg bone below the knee, from a preoperative stage to complete healing, going left to right. The top series shows a patient treated with autograft or autologous bone graft taken from the iliac crest, which is the hip. The bottom series show a patient treated with CERAMENT BVF. Both patients had screws and plates for fixation, and this can be seen on the two radiograph pictures to the right. You can see the screws with a strong white color. Immediately after surgery, CERAMENT BVF was visible as a white spot.

Over time, CERAMENT is resorbed fully and completely remodeled into new bone within six months. Both cases, after six months, showed perfect remodeling into new bone, again, proving that CERAMENT is as good as autograft from an efficacy standpoint. Patients with CERAMENT have significantly less postoperative pain and less blood loss and no secondary surgical sites. CERAMENT is indeed the first synthetic bone graft substitute with data from a randomized controlled trial that includes PROMS. PROMS is the only way to evaluate the quality of life that patients have following surgery. This data is specifically important to increase our value evidence for reimbursement purposes and to develop new guidelines, and to set a standard of care for the CERAMENT platform. Finishing on this strong note, I would like to hand over to Håkan to provide the financial update.

Håkan Johansson
CFO, BONESUPPORT

Thank you, Emil. Let us go to slide 10, please. This is a graph that is presenting net sales by quarter as bars and last 12-month net sales as a line. Net sales in the fourth quarter amounted to SEK 46.2 million, compared with SEK 23.1 million in the same period previous year, equaling an increase of 100%. The period showed continued growth in Europe and rest of world, and a continued gradual improvement in the U.S. Net sales for the last 12 months amounted to SEK 155 million, compared to SEK 97 million last year, an increase of 61%.

The segment Europe rest of world increased last twelve months sales with 40%. Last twelve months sales in the segment North America increased with 99%, being a strong confirmation of our strategy to reach the U.S. market more efficiently with a new distributor. America, sales for the period amounted to SEK 23.3 million, compared with SEK 4.2 million previous year. The low level last year were explained by the new distribution structure initiated in the fourth quarter last year. Sequential growth from the previous quarter was 26%. The contribution from the segment was SEK -9.3 million, compared to SEK -17.4 million last year. The reduced loss is related to increased sales.

Sales and marketing expenses in the period amounted to SEK 25.7 million, compared with SEK 15.2 million in the same period last year, and this included cost for sales commissions growing from SEK 1.1 million to SEK 8 million. Next slide, please. In the segment, Europe and Rest of World, sales for the segment increased by 21% compared to a strong fourth quarter last year, and amounted to SEK 22.9 million, compared to SEK 18.9 million previous year. Sales in direct key markets accounted for 84% of the segment sales, and sales of the antibiotic eluting products, CERAMENT G and CERAMENT V, continued to perform well and increased by 23% compared to the fourth quarter last year. The contribution from the segment was -SEK 0.5 million, compared to SEK 3.9 million last year.

The improved contribution is an effect of increased sales and gross profits. Sales and marketing expenses decreased by -0.5 million compared to the corresponding period last year, amounted to SEK 19.3 million, compared to SEK 19.9 million last year. The previous year was charged with large recruitment costs related to the expansion of the sales organization. The current period was affected by a couple of vacant positions in Germany that was open during a part of the quarter. Next slide, please. Net sales continue to show a sequential quarterly growth with a slightly lower set growth in Europe and Rest of World for the period.

As you see from the table, gross margin continues to show improvement, with positive effects from increasing U.S. sales, having higher gross margin than in Europe, Rest of World, but also from a favorable product mix with a strong growth in the antibiotic eluting products, CERAMENT G and CERAMENT V. The operating loss in the fourth quarter is impacted by a few short-term variances, like marketing activities that were delayed from the third quarter and impact in the fourth quarter with SEK 2.3 million, and cost for the share saving programs, with effect from the updated participants in the 2019 program, as well as favorable development of the share price. BONESUPPORT remain well-funded to realize the commercial strategy and to reach profitability and positive cash flow.

The working capital facility of SEK 60 million signed with SEB is adding headroom in our ability to pursue the continued growth strategy. Next slide, please. Total expenses in the last quarter is up with SEK 12.6 million, compared with the same period last year, as a result of increasing sales commission in the U.S., but also the commercial investments initiated in 2018. Selling expenses in the quarter was, as already mentioned, impacted by temporary variances in marketing with SEK 2.3 million. R&D remain on a stable level, ensuring execution within our clinical studies and research activities, and administrative expenses have stabilized on a reduced level from the fourth quarter last year, however, impacted in the period by already mentioned cost for the share savings programs. With this, I hand over back to Emil.

Emil Billbäck
CEO, BONESUPPORT

Thank you, Håkan. If we could go to slide 16, operator, we will start to round off this presentation. Since the introduction of the strategy, the updated strategy that we launched in mid 2018, the business has adopted a stronger commercial discipline and a commercial decisiveness. We are now cementing the platform for our accelerated growth journey. Our market access in the U.S. has improved significantly. With the new U.S. commercial platform, we are now able to pursue the full potential of CERAMENT in the U.S. with better coverage of indications, states, metropolitan regions, and GPOs. In Europe, our expanded sales organization will continue to grow sales by a combination of better geographic reach and increased penetration of important indications such as trauma. We now have good geographic coverage in the U.K., Germany, and the Nordics.

With our new salespeople on board, we expect to increase the rate of new customers, and we're also looking to starting a revitalization of our distributor markets. In our mission to create a paradigm shift in the treatment standard of care, solid evidence is a key lever. With the publication of CERTiFy, we believe that benefits of CERAMENT will gain further recognition, and furthermore, the health economic data is needed to gain trust by payers and reimbursement systems. The positive health economic data presented last year shows very large savings when using CERAMENT, which makes us confident about our future outlook, even in a healthcare environment with increasing economic scrutiny. The work and preparation of bringing CERAMENT G to the U.S. market is proceeding according to plan, and recruitment to the FORTIFY study is progressing well.

We expect to submit a Premarket Approval application to the FDA at the end of 2021. All in all, we have delivered what we promised ahead of 2019, and with high confidence in our target of an annual growth of 40% going forward. We are funded to reach profitability, and I'm confident that we can deliver significant shareholder value on the journey ahead. Slide 17, please. The slide 17, you can see the calendar of value-generating milestones, many of which I have mentioned already in this presentation. With that, we conclude this presentation and open up the call for questions.

Operator

Ladies and gentlemen, if you have a question for the speakers, please press zero and one on your telephone keypad now. We've received a first question from Rickard Anderkrans, ABG Sundal Collier. Your line is now open. Please go ahead.

Rickard Anderkrans
Equity Research Analyst, ABG Sundal Collier

Good morning, and thank you for taking my questions. First of all, I would like to get if you could add some information on in terms of the new account rate in Europe and sort of where we are today and where you want to go going forward in terms of existing customer accounts and broadening that base going forward.

Emil Billbäck
CEO, BONESUPPORT

Yeah, I will try. Thank you, Rickard, to answer that, without disclosing information that we have decided not to share. Historically, in Germany, when you introduce also a new innovation and breakthrough therapy like this, you will need to get acceptance first by the bigger university clinics. The sales in Germany is to around 50% made up of the top 10 clinics. The recruitment of the new sales reps had the objective of broadening, taking the experiences from these university clinics and which is very positive, and also rolling it out on a much broader scope, both geographically and indication-wise. The recruitment has been significantly slower and more difficult than we would have hoped for. Also the uptake of new accounts, hence, has been slightly slower than we anticipated.

This is shown also in quarter four, where growth rates were slightly below what we expected, as there's been a bit of variation with one of the big customers. If you have a few really big customers, of course, the slightest variation in purchasing behavior will have an impact. We believe that this impact, or this, let's say, vulnerability or dependency, will reduce significantly over time as the new salespeople get up and running.

Rickard Anderkrans
Equity Research Analyst, ABG Sundal Collier

Perfect. Thank you. Could you also, in terms of the new strategy to revitalize the distributor organization, do you have any more information to provide the market as of now, in terms of which markets you are prioritizing, or will that be sort of a drip feed as the new contracts are signed, or how should we think about that?

Emil Billbäck
CEO, BONESUPPORT

Of course, I cannot speak about topics that have not been already engaged in discussions with the principals. I think everyone has seen also in our previous quarterly reports that sales growth has been very strong in our direct markets, which shows that with a structured and decisive effort, CERAMENT is able to quickly penetrate the market and replace existing therapies. It has also been clear that a very big part of our sales, over 84%, has been made up of the direct markets, which geographically doesn't represent the same amount of the population. We are targeting the big European markets to make sure that we have distributors that live up to the same promotion standard that we have on the direct markets, because a therapy and innovation such as CERAMENT simply deserves that.

Rickard Anderkrans
Equity Research Analyst, ABG Sundal Collier

Excellent. Just a final question on North America as well. I noticed that there seems to be 10 new distributors on board in the U.S. from the previous quarter. How many distributor sales reps do you have on board in the U.S. approximately as of now? Are you able to comment on the mix of old CERAMENT accounts versus new accounts in the U.S. for the quarter?

Emil Billbäck
CEO, BONESUPPORT

We have around 40 distributors in the U.S., and these 40 distributors have access to about 500 sales reps. We have then 10 regional managers spread across U.S., north to south and west to east, that are working every day, both with the physicians and surgeons directly and with the distributor reps. a constant fluctuation of distributor reps, so we train them and provide coaching and education on which clinical studies to use at what time. What I told the market by the Q3 presentation was that our customer base was about 50% new accounts and 50% of historical accounts that have been buying from Zimmer Biomet.

We have decided not to release new data until we will have a capital markets day later this year. The proportion of new accounts is constantly rising.

Håkan Johansson
CFO, BONESUPPORT

Excellent. Thank you very much for taking my questions.

Operator

The next question is from Kristofer Liljeberg, Carnegie. Your line is now open. Please go ahead.

Kristofer Liljeberg
Head of Research, Carnegie

Yeah, thank you. Can you hear me?

Emil Billbäck
CEO, BONESUPPORT

Absolutely.

Kristofer Liljeberg
Head of Research, Carnegie

Just one thing. I have a few questions, but just to follow up on this, your last statement there, that the new accounts becoming proportionally larger. Is that true also considering that, you know, some larger previous Zimmer accounts should have been out of inventories now in the fourth quarter? I guess you would see, higher volumes from there.

Emil Billbäck
CEO, BONESUPPORT

Yes, you're right, Kristofer. There are two things. One is that accounts that previously bought from Zimmer Biomet are eventually running out of their inventory, and then they come to us. That gives us accounts that we call heritage accounts, because they have also bought product from Zimmer Biomet in the past. The new accounts mostly come from where we have won GPOs, where Zimmer Biomet before was underrepresented. When we win these accounts, it give access to hospitals, which previously had not tried CERAMENT, and those are mainly the new accounts. The new accounts are growing slightly quicker than the heritage accounts.

Kristofer Liljeberg
Head of Research, Carnegie

Okay, great. I wonder, maybe starting or continuing with the U.S., seems to be, you know, very good momentum, the new GPO contracts, et cetera. You see anything that would slow down this sequential growth in North America in the near term? Anything we should think about?

Emil Billbäck
CEO, BONESUPPORT

I think what having done this exercise a few times before of going independent, it's, it goes in waves. Basically what happens is we, you set out to win new accounts, which happens when you win a GPO. Whenever you win a GPO, there's a frantic activity to get to those hospitals that are under the GPO, and many of them will then try the products and maybe buy one or two products to put on the shelf. The work that has to follow is that the salespeople then have to work with these accounts to establish the therapy. It will not be a straight line, that's for sure. It will be more of a staircase.

You win an account, you establish the account, and once you've established the account, you can go on and win new accounts. I don't see anything that would stop our long-term progress in the U.S., but I think that in gradual waves, we will continue to drive our market share. I think, of course, when CERAMENT G will come to the U.S. market, I think it will be a big staircase, a big leap forward.

Kristofer Liljeberg
Head of Research, Carnegie

With the HealthTrust GPO contract, where you had sales in Q4, you know, how much of the full potential was seen already in this quarter?

Emil Billbäck
CEO, BONESUPPORT

Sorry, I didn't hear you. How much of what?

Kristofer Liljeberg
Head of Research, Carnegie

Of the GPO contract that you received in Q4. You said you had some first sales from that in just before Christmas. Was that, you know, was that the full effect, what you could expect in the near term, that you have already had now in the fourth quarter? Would you see additional positive impact in the coming quarters?

Emil Billbäck
CEO, BONESUPPORT

We decided to mention this because usually when you win a GPO, it takes around four months to see the first sales. In this case, it went exceptionally fast, much faster than anticipated. When it comes to the HealthTrust penetration, we are pleased that the first hospitals have already started to order, and I think to fully penetrate such a contract is probably a three-year project.

Kristofer Liljeberg
Head of Research, Carnegie

Okay. Thank you. Moving to Europe, I'm a bit surprised to see the sequentially slower growth in Europe, particularly as fourth quarter was not very strong. Of course, we all know about that it has taken longer for you to increase the sales force. That's not something new. Now the growth was some 20% year-over-year. It has been more like 40% in previous quarter. You also talked about some, you know, volatility among some customers. Could you give some more details what's happening in Europe and whether we should expect growth picking up more towards the 40% growth rate in 2020?

Emil Billbäck
CEO, BONESUPPORT

I will be happy to do so. We will not comment on what levels to expect for Europe, because we don't give that kind of guidance. The shortfall that we saw in quarter four, which led to a slightly lower growth rate, as you said, of 20%, 21%, was mainly related to two major accounts, one in Germany and one in Sweden. Both these accounts are among the absolute bigger ones that we have. The customer sales concentration is very high in Germany, around 50% of sales is made with the top 10 customers, and in Sweden, that number is even about 70%.

In Germany, it's one of our biggest hospitals that have had significant structural problems, and they have diverted the patients to surrounding hospitals. In the surrounding hospitals, we are not part of the treatment protocol as we are in this hospital that have closed down their operations. We have redirected some of our sales resources to make sure that the surrounding hospitals are quick now also to approve CERAMENT and get it into their treatment protocol. Every surgical department follows a certain protocol, and if you're not on that protocol, unfortunately, you will not be part of the surgery. This was a bit unexpected, to be honest.

This was one of our bigger and more loyal customers, we see that the disruption has nothing to do with CERAMENT, but that we have been heavily influenced by it. In Sweden, we've had a similar situation rather, where we were a victim of our own incredibly strong sales growth, where several clinicians, treating physicians, used the product to such an extent that the central administration wanted to have a full review, both clinically and financially, and we are in the middle of that review. I have a very strong confidence in our documentation and in the benefits of CERAMENT, I expect that in a couple of months, this will be resolved, and that the positive results from the surgeons actually treating the patients will also influence the central administration decision power.

Kristofer Liljeberg
Head of Research, Carnegie

Thank you very much. That's very helpful. A final question relates to cost, both when it comes to the selling cost line, what type of expansions are you planning for the sales force in both North America and Europe? Also R&D costs, should they continue to be stable now? You talked about the new trial in France, but that being financed by not yourself. With the U.S. trial, if you would have some additional cost models as that, you know, will end, and if you have some costs for preparation, the file, et cetera, to FDA. Thank you.

Emil Billbäck
CEO, BONESUPPORT

Well, Håkan, I believe that in the, in our quarter report, we are showing a table with the specified numbers for the eight previous quarters. With the comments being made in today's presentation on a few short-term variances, I will say that that's a table that is giving quite a good indication on our running cost levels and what can be assumed in the nearest future.

Kristofer Liljeberg
Head of Research, Carnegie

Okay. You mean the increase, the trend you have seen, that type of increase will continue. Is that what you say?

Emil Billbäck
CEO, BONESUPPORT

What you see in the table is that there is a not slowdown in cost increase. We made substantial investments in our commercial platform, initiated in 2018 and impacting in 2019 numbers. What you will see from that table is that that's a trend that is slowing down and stabilizing.

Kristofer Liljeberg
Head of Research, Carnegie

Okay. Thank you.

Operator

The next question is from Frank Gregory, Trinity Delta. Your line is now open. Please go ahead.

Frank Gregory
Senior Analyst, Trinity Delta

Thank you. Good morning, gentlemen. Can I ask about the CONVICTION study? From what you've said so far, it looks that this could be as big as CERTiFy and FORTIFY. First, is that right? Can you give some more indication of what the timings will be? If there's 200 patients, that will take some time to recruit and do all the data. Are we looking 2-3 years before we get results? Finally, on that, you mentioned that you're given a grant, but that implied that you're not covering the whole cost of that. Does that mean that you're going to get some margin contribution from participating in this study?

Emil Billbäck
CEO, BONESUPPORT

Thank you, Frank. Very good questions, as always. The first is the CONVICTION study. Could it be as big as FORTIFY and CERTiFy? The answer is yes. Any orthopedic study with more than 100 patients is a big study. This one is 200 patients, so it will be one of the biggest studies made on CERAMENT. The time I cannot speak about because this is an investigational initiated study. The study is not initiated by us. It's initiated by the French Ministry of Health after having read the very positive results of CERAMENT from clinical studies in the U.K. and Germany. They concluded that CERAMENT most likely has a significant positive outcome on the treatment of bone infections and contacted us to do this study.

The product is CERAMENT is approved and registered in all European countries with a CE mark, but the reimbursement can vary country by country. This study is very important to do to get commercial acceptance, but also reimbursement potentially for France. We decided to give a grant to the specific clinics that will do the study to partly give a little bit of discount on the products, but there are also more parts of this. We will also train them, we will educate them, we will support them with printed material and so on. This will be viewed as a clinical cost and not erode our margin. Finally, the length of the study is very difficult to predict as it's investigator initiated.

What I can say is that this is a very strong network of clinics that are working together to fight bone infections. Recruiting patients here should be faster and easier than recruiting trauma patients. Trauma patients only show up when there's been an accident, while bone infections is a more long-term condition. While this study is as big as FORTIFY and CERTIFY, I do expect the recruitment time and finalization time to be significantly shorter.

Frank Gregory
Senior Analyst, Trinity Delta

Okay, thank you very much for that.

Operator

There are currently no further questions. As a reminder, if you would like to ask a question, please press zero and one on your telephone keypad. We do have a follow-up question from Frank Gregory, Trinity Delta. Your line is now open. Please go ahead.

Frank Gregory
Senior Analyst, Trinity Delta

Apologies. I meant to ask another question, and I completely forgot. A lot of them have been answered by you, previously, but the one where you mentioned difficulty in recruiting sales rep because it's such a tight labor market, does that mean that you're vulnerable to losing some of your people to competitors? Or are you now with such strong clinical data that the people that you have are actually very happy and keen to keep with you?

Emil Billbäck
CEO, BONESUPPORT

Yeah. I think overall, our organization is very happy and I think has a very strong sense of mission. I think for many, it's also great to feel that we work with a product that concretely can show with evidence that we're helping patients to a better life. That's definitely a factor. Of course, we've tried to find people that have previous experience from having worked with sales or having had a previous clinical experience, and there are many companies to choose from. Before we have properly introduced ourselves, we are just one out of many companies, and I think that's the difficult part. Once people have started to work with us, I feel that there is a very strong loyalty and cohesiveness and affinity to the overall mission and journey that we have.

Operator

There are currently no further questions, so I hand back to the speakers for closing remarks.

Emil Billbäck
CEO, BONESUPPORT

I would like to thank everyone for making the time this morning to listen to our presentation on the Q4 and full year results. We believe we have presented yet another confirming quarter and results showing that BONESUPPORT is on the right path, and we look forward to staying in touch and continuously support you and give you update on our progress. Thank you very much.

Operator

Ladies and gentlemen, thank you for your attendance. This call has been concluded. You may disconnect.

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