Bonesupport Holding AB (publ) (BONEX) Earnings Call Transcript & Summary

May 27, 2020

Nasdaq Stockholm SE Health Care Biotechnology special 25 min

Earnings Call Speaker Segments

Operator

operator
#1

Hello and welcome to the BONESUPPORT conference call. [Operator Instructions] Today, I'm pleased to present Emil Billbäck. Please begin your meeting.

Emil Billbäck

executive
#2

Thank you very much, operator. This is Emil Billbäck. I'm here today also with Håkan 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 lose in about 10 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 3. So in short, the message that we released last night is that we have carried out a direct share issue. The proceeds are SEK 378 million, which corresponds to issuing 10.5 million ordinary shares. The subscription price for these was set at SEK 36, 3, 6, which is a discount of about 2.7%, looking at the weighted average over the last 10 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 sold 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 5. 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, we're more or less back to the same levels of sales that we had at the all-time high under their distributionship. My experience is that, that is pretty fast. Usually, such recuperation of the business, in my view, would take about 2 years, maybe 2.5 years, and it has been done in 1 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 have not only carved back the business but also 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 2020 an approval for CERAMENT G through the De Novo pathway specifically 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, and those we 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 CERAMENT BVF and for the future CERAMENT G. Next slide, please. As a quick reminder that the market that we are addressing with CERAMENT G, the market for infected indications with bone graft, is about USD 100 million. The prevention market is on top of that another bit more than USD 200 million. And specifically, what I would like to draw your attention to on this slide is bullet point #5. 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 McNally's team in Oxford and from Jahangir's team in Manchester, that CERAMENT 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 with that. There has been quite a few sales people recruited over the last 2 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 clinicians 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 8, 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 a 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 BONESUPPORT has, and the years represent the starting year. So starting year in a new territory, year 2, year 3, year 4 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 on sales growth if they follow the pattern or the salespeople we have recruited so far. And what we see after 2 years is that it's almost a linear development of sales so that also the new salespeople follow perfectly the pattern on 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 8, right bottom, there's a box which displays the sales on the top 3 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 poached 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 #1 sales rep has an annual sales of close to SEK 9 million 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 CERAMENT because we haven't reached that peak yet. So we keep pushing on. Next slide, please, Slide 9. A few words regarding the manufacturing process. Of course, we are looking now. We've come to the size of the 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 the niche market specifically only for this prevention is valued in the U.S. and the top European 6 markets at USD 300 million. This product is -- and this development is progressing well as well as the CERAMENT plus demineralized bone matrix. And we are pleased that we have succeeded so well with this capital rise -- so 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&D development can now continue completely undisturbed as we have the proceeds to further invest in our market penetration. If we go 2 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 CERAMENT G in the U.S. In March, we received the breakthrough designation for CERAMENT 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 2020. And the FORTIFY pathway, the PMA pathway continues. But here, we have also flagged 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 million. 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 product. And we are now happy to move to the next chapter for BONESUPPORT to reach its full potential. That concludes my presentation, and we can open up if there is any questions.

Operator

operator
#3

[Operator Instructions] And our first question comes from Rickard Anderkrans from ABG.

Rickard Anderkrans

analyst
#4

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.

Emil Billbäck

executive
#5

Yes. Thank you, Rickard. The -- if you look at a company like BONESUPPORT and where we stand after a few years of commercial activities, one would naturally think that distributor markets will be highly represented. That's what I can 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 CERAMENT, 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 not only in the regions where we have direct people but also in all other great geographies around Europe where the market opportunity is obvious.

Rickard Anderkrans

analyst
#6

All right. All right. Excellent. And just a final question from my side. I'm sorry if you mentioned it during the call, but I noticed the specification and use of proceeds as general corporate and financial redispositions of roughly SEK 75 million. Do you have any further flavor on what that includes? And what sort of falls under those costs or financial -- use of proceeds?

Håkan Johansson

executive
#7

Again, [indiscernible] there is no additional specification behind that number. It's more also now we all know that time lines doesn't always take exceptions. This is just to make sure that we have saved the margins backing up the plans that Emil just went through but then also to cover the fees and the cost to make this capital raise that has been done.

Operator

operator
#8

Our next question comes from Franc Gregori from Trinity Delta.

Francesco Gregori

analyst
#9

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&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?

Emil Billbäck

executive
#10

Thank you for your question, Franc. Well, first of all, I would say I completely agree with you -- your statement regarding the U.S. The market opportunity is huge, but it will require 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 periods, become close to 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. And 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&A, we believe that the CERAMENT [ 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 CERAMENT. 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.

Operator

operator
#11

[Operator Instructions] Okay. As there appears to be no more audio questions, I'll return the conference back to you.

Emil Billbäck

executive
#12

Well, then I 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 goodbye.

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