Status Update

May 27, 2020

Thank you very much, operator. This is Emil Bildbeck. I'm here today also with Hakan Johansson, my CFO. And we wanted to give a very quick update on covering the direct share issue that took place last night. And we'll do this in about ten minutes, and then we'll have room if there are any questions to this topic. So next slide, please. You will see that this presentation is covered by the usual disclaimers. Next slide, please. We should now be on Slide three. So in short, the message that we released last night is that we have carried out a direct share issue. The proceeds are $378,000,000, which corresponds to issuing 10,500,000.0 ordinary shares. The subscription price for these was set at SEK 36, SEK 36, which is a discount of about 2.7% looking at the weighted average over the last ten trading days. I think it's fair to say that the direct share issue had a very high interest, and it was oversubscribed with more than 3x. Next slide, please. So really why we did this share issue, I think very few people would be genuinely surprised about this action taking place. We have proven both in Europe and The U. S. That we have a business model that is working and that we have a technology and a value proposition, a solution which is well appreciated by customers. So I find it to be quite logical that we are seeking we sought these funds to be able to scale up the business models that have been proven within limited geographies to roll it out into a stronger market penetration in those geographies, but also go to additional places. In addition, we will make some changes to our manufacturing and supply chain. As you know, the manufacturing process is part of our intellectual property and trade secrets. We do expect that with the coming investments, we will have to increase capacity, and we will also take the opportunity to further increase automatization of our production. Next slide, please. I will cover very shortly what will happen in the different geographies. So we should be on Slide five. And again, I will not cover the background. I believe that we have been very transparent and direct in explaining where we come from and what the current journey is. The journey ahead though for The U. S, definitely there is still a lot of work to be done on the current commercial infrastructure and the new network of independent distributors that we have. We can conclude that the first calendar year after going independent from Zimmer Biomet, were more or less back to the same levels of sales that we had at the all time high under their distribution ship. My experience is that, that is pretty fast. Usually, such a recuperation of the business, in my view, would take about two years, maybe two point five years, and it has been done in one year, which shows the very strong demand in the market. And we have previously also shared that mid last year, about 50% of the customers that we had were new in The U. S. And 50% were heritage customers. So it shows that we don't we haven't we have not only carved back the business growth, we generated quite a lot of new business in territories where we're not present. Then, of course, we're expecting to see in the very late part of twenty twenty an approval for SER-one G through the de novo pathway, for bone infections, which will then provide the first ever synthetic bone graft containing local antibiotics. And finally, we see that wherever we have sophisticated specialist sales efforts, we do have a very strong market conversion. And if we look at The U. S. Map and where we have and we do a heat map, we look at where we have sales, we see that there are several areas that are still significantly underpenetrated. Those both would now like to consider also how do we strengthen our specialist sales even further in areas that holds a very high potential, both for the existing Serument BVF and for the future Serument G. Slide, please. As a quick reminder that the market that we are addressing with Serument G, the market for infected indications with bone grafts is about $100,000,000 The prevention market is, on top of that, another a bit more than $200,000,000 And specifically, what I would like to draw your attention to on this slide is bullet point number five. We should remember that in The U. S, there's a strong financial incentive on top, of course, of wanting the best possible treatment and healing for the patient. There's a strong incentive for both clinics and for treating physicians to make sure that the patient does not come back after a surgery developing an infection. And we have seen in several clinical studies made in Europe, both from McNelly's team in Oxford and from Johan Gyor's team in Manchester that Serument G has exceptional capabilities of eradicating and preventing infections. Next slide, please, shows the ideas we have about the future for Europe. As you can see, everything is building on the existing journey and the existing trajectory. We are looking to see further sales penetration within the key geographies where we have already done significant investments. I will show you on the next slide what I mean by that. There has been quite a few salespeople recruited over the last two years, and we're developing strong tools to make them and their colleagues that have been on their territories for a longer time more productive and reaching not only the university clinics, but using the university clinics also as ambassadors to reach regional hospitals as well. We are going to open up new markets. And specifically, we're looking for markets with a similar market dynamic as those countries and regions where we have created great sales success already. Such examples could be Australia, Middle East, but we see also countries such as Benelux, where there is much more potential, and we'd like to work very close with our partners in that market to make sure we fulfill the full potential there. The distributor markets overall have to be revitalized. And if we look in Southern Europe, countries such as Spain, Italy and France, but also Portugal, Greece, those are countries that have significant challenges with bone infections. And our sales has historically been very small, and this is something that we would like to change because we believe that our products will have great value contribution also on these markets. Slide eight, please. So this is a bit more details. You know, of course, that the direct markets, the few markets where we are direct represent 86% of total sales. So that's quite skewed, and it's very high concentration of sales to those few markets. We need to balance that by getting also more geographies to contribute to the sales success. I would like you to pay attention to the graph in the bottom left. Here, we have adjusted slightly our assumptions, and I have an excellent finance department who have helped me compile numbers so that the blue bars you see here is the incremental sales, the additional sales that we see when we recruit salespeople. And the blue bars is the average of all the sales reps that Bone Support has. And the years represent the starting year. So starting year in a new territory, year two, year three, year four and so on. Below the graph, we have showed the distribution of those 13 new sales reps that we have recruited. I got the question the other day if we constantly have to recruit new salespeople to keep the sales growth at high levels. And I think this chart will show the answer to that question. So the people that we have hired have a very long trajectory in front of them of sales growth if they follow the pattern of the salespeople we have recruited so far. And what we see after two years is that it's almost a linear development of sales. So also the new salespeople follow perfectly the pattern of the historical sales reps, which gives me a very strong confidence that we should continue to work on our investments and the tools to make our salespeople efficient. And that's also why I welcome this infusion of capital that allows our longevity of these investments. To the right on Slide eight, right bottom, there is a box which displays the sales of the top three salespeople that we have in Europe. Of course, I don't want to disclose the name of these people. They will quickly be recruited or polled by competitors. But I must say, I have a very good sales team overall across Europe, very strong individuals. And you can see that the number one sales rep has an annual sales of close to SEK 9,000,000 and a growth last year of more than 50%. So really no signs of saturation. We cannot tell exactly what should the peak sales be of a salesperson of Saramund because we haven't reached that peak yet. So we keep pushing on. Next slide, please. Slide nine. A few words regarding the manufacturing process, of course. We are looking now we've come to the size as a company where it's time also to look over our manufacturing process. And we will go towards more automatization. And we have very good plans already in place for improvements that can be done with the product both to improve the user experience and then also to remove potential variability that will improve our capacity. We believe that these changes also will bring significant savings in material cost and cost of production. On the right side of that slide, you see the key development projects that we are working on. We have a product candidate that would address the market of osteoporosis and osteoporotic fractures. This is a very common indication. And niche market specifically only for this prevention is valued in The U. S. And the top European six markets at $300,000,000 This product is and this development is progressing well as well as the Cerament plus the mineralized bone matrix. And we are pleased that we have succeeded so well with this capital rise sorry, this capital raise because it allows us to continue with these programs without sacrificing or compromising anything. The proceeds from the equity raise will go to commercial investments. So the plans that we had already for R and D development can now continue completely undisturbed as we have the proceeds to further invest in our market penetration. If we go two slides forward, please, we should be on Slide 11. This is the last slide of my presentation. As we have reported before, we're making good progress also in our preparations of launching G in The U. S. In March, we received the breakthrough designation for Surament G, which we're very proud and honored with. In April, we sent in the application with the expectancy on having the approval by late twenty twenty. And the FORTIFY pathway the PMA pathway continues. But here we have also a flag for FDA that we would like to have a conversation in the backdrop, let's say, of the corona pandemic. We would like to have an agreement with FDA what the final steps of this study as well as our path to the PMA market should look like. And there are no news under this point. So the time line, of course, remains intact with our previous expectations. So in short, yesterday, we raised a total of SEK $378,000,000. This shows the tremendous confidence that exists in the market for the story that we are presenting about the future and the journey that we are currently on. It shows also the market appreciation for the great opportunities that exist for our products. And we are now happy to move to the next chapter for Bone Support to reach its full potential. That concludes my presentation, and we can open up if there is any questions. Thank you. And our first question comes from Riccard Andercans from ABG. Please go ahead. Your line is now open. Good morning, and thank you for taking my questions and congrats to the capital raise. Just a quick question in terms of the dynamics on the European and Rest of the World segment. So the current mix of roughly 85% direct sales contribution, is that a level in terms of the split between direct and distribution sales? Is that a level you're happy with and want to maintain? Or do you want to push the distribution part up more? And can you say anything on target levels for that split, I. E, will you want to drive a rapid continued expansion of the direct sales capacity? Or do you I guess you understand where I'm heading with the question. Yes. Thank you, Richard. The if you look at a company like Bone Support and where we stand after a few years of commercial activities, one would naturally think that distributor markets would be high represented. That's what I could say. So direct markets are much higher. And the immediate question is, have we been less successful in distributor markets? Or have we been exceptionally successful in direct markets? I think it's a combination of both. It's a clear sign for me at least that when you have people with strong competence and dedication that promotes Saramind, the market conversion and the move from the previous standard of care of allograft and autograft is very obvious. And that learning we will take with us and shape our future, looking at market per market what has to be done to make sure that we see strong sales growth, only in the regions where we have direct people, but also in all other great geographies around Europe where the market opportunity is obvious. All right. All right. Excellent. Thank you. And just a final question from my side. I'm sorry if you mentioned it during the call, but I noticed the specification in the use of proceeds as general corporate and financial re dispositions of roughly SEK 75,000,000. Do you have any further flavor on what that includes and what sort of falls under those costs or financial use of proceeds? Again, Simon, there is no additional specification behind that number. It's more of, we all know that timelines doesn't always take, etcetera. So this is just to make sure that we have saved the margins backing up the plant that E and M will just went through, but then also to cover fees and the cost to make this capital raise that we've done. All right, excellent. Thank you very much. That's all from my side. Thank you, Richard. Thank you. Our next question comes from Frank Grigori from Trinity Delta. Please go ahead. Your line is now open. Thank you. Good morning, gentlemen. Firstly, can I just say I'm really pleased to see that you are now well funded? My experience is that if you're going to be successful in The U. S, you've got to be ambitious, and that means have funding in place. Half hearted measures simply don't work. Anyway, the question very simply. In manufacturing, the investment that you're going to make, is that going to give you the capacity to address the full potential or will you do it in stages? First automation and then increase the capacity of that automation? Second question is, you've not mentioned M and A at all. Is there anything in your vision that you can see for the longer term that you need to make your current portfolio even better? Is there something which is outside of your sphere at the moment that could improve your marketing and penetration over the medium and longer term? Thank you for your question, Frank. Well, first of all, I would say, completely agree with you, your statement regarding The U. S. The market opportunity is huge, but it will require a structured plan and as well resources to execute those plans. And I truly believe that we have both in place right now. When it comes to the automatization of certain steps in the manufacturing, those will improve the speed of our production, lower the cost and bring capacity at the same time. So they're not mutually exclusive, let's say. Today, let's say, some of the dispensing could in certain period be coming close to a bottleneck. And as we're finding smarter and more efficient ways to do this, we will also increase capacity simultaneously. It comes at very low cost basically. This is these are investments that will pay for themselves very quickly because they will reduce also the manufacturing expenses. When it comes to M and A, we believe that the Saruman concept is very strong. We always get access to the right decision makers. And we can see that also with strong sales uptick in most of the geographies where we're present. But we do have an appetite, of course, to grow both organically and inorganically. But it also requires that we find the right asset that would synergistically fit with Cerment. I don't think we have to do any acquisitions to be very successful on our path. But if the right asset would show up that could boost our speed and acceleration on the journey we're already on, then we would be strike ready. Thank you. Thank you. Okay. As there appear to be no more audio questions, I return the conference back to you. Well then, would like to thank the operator. I would like to thank everyone for calling in to listen to the message we had to give about the direct share issue that took place last night. We are very excited about the journey ahead. We believe now that we have very strong funding to fully execute our plans, and we look forward to keep the market updated and everyone else that would like to follow on this exciting journey. Thank you so much, and