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

Welcome to the presentation of Bonesupport Q3 report. [Operator Instructions] Now, I will hand the conference over to CEO, Emil Billbäck; and CFO, Håkan Johansson. Please go ahead.

Thank you, Operator, and good morning, everyone, and welcome to the Bonesupport Quarter 3, 2023 Result Call. My name is Emil Billbäck, and sitting next to me is Håkan Johansson, our CFO. So, we will use the next 25 minutes to guide you through the presentation of the third quarter results, and then we will open up the line for questions and answers. So, we start by going to Slide 2. And before I start the presentation, I would like to draw all of your attention to the disclaimers covering any forward-looking statements that we will make today. And then let's start the presentation and go to Slide 3. Thank you. So I would like to begin this presentation with some condensed highlights from the report that we released this morning. Overall, quarter 3 sales were SEK 158 million, which corresponds to a reported growth of 87% year-over-year. In constant exchange rate, the growth rate was 76%. The operating result before incentive program was SEK 25 million, which is a profit improvement versus the same period last year of SEK 29 million. Reported EBIT was SEK 50 million, which marks our third consecutive quarter with positive operational result in the first quarter with positive operational cash flow. Let's speak a bit about the highlights of the quarter. And of course, the ongoing launch of CERAMENT G in the U.S. was one of them. We are noticing a strong U.S. approval traction and market penetration, bringing U.S. sales of CERAMENT G to SEK 63 million in the quarter. The use of local antibiotics play an important role in the global antibiotic stewardship program. And in the quarter, further confirming and validating data on CERAMENT G has been presented. In August, the SOLARIO study included a final patient, which means that the study is expected to be closed in quarter 3, 2024. Håkan and I will cover each of these topics in more detail during the presentation. So let's go into the details and go to Slide 4, please. So let's start looking at the sales development. And as you see, this slide is one of the standard charts, displaying the top line trajectory for the business. And the graph shows last 12 months sales in Swedish currency, every quarter since quarter 2, 2016 and split by segments. Quarter 3 displayed the biggest ever quarter-over-quarter growth. And of course, this was boosted by the SEK 63 million contribution from CERAMENT G in the U.S. In Europe and rest of the world, the antibiotic eluting CERAMENT that is CERAMENT G and V combined, grew with 38% in the quarter versus last year, with a noted market share gains on other therapy options, mainly autograft and traditional bone cement. So 1 year after launching CERAMENT G in the U.S., the total global sales in LTM of antibiotic eluting CERAMENT is close to SEK 290 million. It holds a share of the total sales in LTM of 55% and is currently growing at 210%. But let's not go into the details of the U.S. and go to the next slide. So in the U.S., sales were SEK 121 million in the quarter, which corresponds to a reported growth of 115% year-over-year at constant exchange rate growth would have been 102%. Sequentially, growth was 17%, meaning the growth over the numbers, the sales numbers reported in quarter 2. We're starting to see some cannibalization between CERAMENT G and CERAMENT BVF in the U.S. But despite this, CERAMENT BVF in the U.S. grew slightly in the quarter versus the quarter 3, 2022. On the next slide, we will speak a bit more about the details on the CERAMENT G law. So let's go there. So we have previously spoken about the market dynamics for the introduction of a breakthrough orthopedic device and the necessity to get DPO contracts sequentially followed by hospital system approvals and then to get moving on the promotion to surgeons and on clinic level. We earlier on displayed the number of hospital systems where CERAMENT G got approval, as we wanted to give a flavor of the rather fast approval pace, but now I would like to emphasize that a hospital is the facility where a patient is being treated and the hospital system is an administrative and logistic association or a contracted cluster of many hospitals. So a hospital system, which sometimes also is called integrated distribution network has a group of member hospitals. There are about 420 hospital systems in the U.S. and the number of member hospitals vary greatly. As an example, there are more than 200 hospital systems that have only between 1 and 5 member hospitals. And the biggest hospital systems in the U.S. have between 150 to 200 member hospitals. Since the launch of CERAMENT G, we have focused on the most important hospital systems. And in the quarter, we added about 22 hospital systems approval for CERAMENT G, leaving a total of 82 hospital system approvals. These 82 hospital system approvals provide us with a total listing access for CERAMENT G to over 1,000 hospitals. So, we have really only scratched the surface, and we've only started our journey in terms of penetrating the full potential for CERAMENT G in the hospitals to which we now have access. Meanwhile, the pace of securing additional hospital system approvals is continuing. The metric of hospital system approvals was relevant in the very first quarters of the launch to demonstrate that the strong benefits of CERAMENT G also translated into positive approvals. We will not report all these details going forward, but rather focus on sales, which we believe is a good reflection on how many products are actually being used in the market in each quarter. Part of the explanation for the strong market penetration so far is that we can show both superior clinical data and also relevant and positive health economic effect from a one-stage procedure, lower infection rate and reduced amputation rate. This has paved the way for high success rate with private payers. And in the orthopedic clinics where earlier adopters have started to use CERAMENT G, we conclude a positive follow-up on patients treated. The benefits noted and registered are matching what has previously been shown in clinical studies. The early adopters of CERAMENT G are also becoming ambassadors and sharing their successful patient cases with colleagues in the clinic, in the region and at congresses. As previously stated, we are currently putting the last pieces in place to be able to submit our label extension application on open trauma fractures to the FDA during the quarter. Now, let's turn to Europe and Europe on Slide 7. So for the quarter, we saw sales of SEK 37 million, corresponding to a reported growth of 31% year-over-year and 26% growth at constant exchange rates. The third quarter is usually a bit slower in terms of overall surgical volumes in Europe. Staffing issues were expected to exaggerate and slow down the surgical rate even further during the vacation period. In addition, there was again a physician strike in the U.S. sorry, in the U.K., of course, which is one of our largest markets. Despite this, CERAMENT sales developed very well with plus 26% in constant currency. And the year-to-date growth of also 26% in constant currency, represent a development, which is about 5 to 6x higher than the year-to-date market growth for bone graft, testifying to the strong and continuous market share gains for CERAMENT. Looking at some of the highlights, the schedule for conferences and congresses is completely back to normal after COVID. This is important for Bonesupport as we are early on our journey, and congresses are an important way for us to reach new surgeons. The most important European meeting is the European Bone and Joint Infection Society Meeting, was held a few weeks ago. The meeting attracted close to 650 participants, mostly orthopedic surgeons and infection disease specialists. Bonesupport hosted a satellite symposium with a panel debate on the theme limb salvage. With a record 120 participants, it was the most visited symposium of the meeting. At the EPJIS, the European Bone and Joint Infection Society Meeting, several new clinical findings were presented as posters and stage presentations. One of the more important ones were the findings from [ Bernadet Yang et al ], where 125 patients with recurring infection originating mainly from failed prosthetic joint implantations or trauma, were investigated at 2 centers in the U.K. 72 patients had their initial surgery performed with CERAMENT G or V, and patients were then followed up several years later where there were recurrence of infection. And this is, to our knowledge, the largest study of microbiology of recurrent bone and joint infection reported to date. Culture-based diagnostics were used, and the authors conclude that, "treatment of orthopedic infection with local antibiotics was not associated with emergence of antimicrobial resistance". This in adjunct to previous data confirms and validates the benefit of local antibiotic elution as an important tool under the antibiotic stewardship program. The European Bone and Joint Infection Society is also the originator and the facilitator of the SOLARIO trial, a final patient was included in August, which means that the study will close in quarter 3 next year. And with that, I will hand over to more of a deep dive of the numbers to Håkan.

Thank you, Emil. So net sales improved from SEK 84.6 million to SEK 158.2 million, equaling a growth of 87% or 76% in constant exchange rate. Emil has already spoken about the strong performance in the 2 segments and the major drivers behind the sales acceleration. Let me comment on the currency. Changes in currency measured as year-to-date averages in 2023 versus 2022 had a positive impact of in total SEK 9 million, of which SEK 7.5 million relates to a stronger U.S. dollar. The depreciation of the Swedish currency versus other currencies also drives expenses, as you will see on later slides. The contribution from the segment North America improved with SEK 35.3 million and was reported to a regional contribution of SEK 46.5 million. The improved contribution relates to increased sales after effect from increased costs. Sales and marketing expenses during the quarter amounted to SEK 67.6 million compared with SEK 37.7 million previous year, of which sales commission to distributors and fees amounted to SEK 42.2 million compared with SEK 21.1 million in the same period last year. The increase of SEK 8.8 million, excluding sales commissions and fees was driven by currency effect of SEK 1.5 million and the remainder from an increased activity level. As we have announced previously, the U.S. booster positions are up and running, and there's a strong focus on medical education and increased market presence, also contributing to the cost in the quarter. The contribution was also charged by R&D costs related to clinical studies of SEK 0.3 million in the quarter compared to SEK 3.2 million previous year, where previous year included SEK 2.5 million related to ongoing projects. From the lower graph showing net sites as bars and gross margin as the orange marker, it can be noted that the gross margin is remaining strong and reported to 94.6%. In Europe and Rest of the World, a contribution of SEK 9.3 million was reported to be compared with SEK 7.3 million previous year. The improved contribution relates to increased sales after effect from increased costs. Sales and marketing expenses increased with SEK 5.6 million and was driven by field vacancies and an increase in sales representatives. From the lower graph, the orange market, you can see an improved gross margin compared with the previous quarter this year, following an improved product mix with a high sales ratio of antibiotic-eluting products in the quarter. Selling expenses increased with SEK 14.7 million versus last year, of which SEK 1.5 million relates to currency effects and SEK 2.5 million in nonrecurring costs. As we mentioned before, the U.S. booster is up and running, and we continue to see results on top line. In Europe, we have filled vacancies and increased our total euro commercial organization to 31 people. The cost increase in the quarter relates to a ramp-up in activity level at Cores, medical education and, of course, the continued launch program for CERAMENT G in the U.S. As you can see, R&D remains largely in line with previous year and administration remaining on a stable level, excluding effects from the long-term incentive crop with SEK 9 million compared with SEK 11.3 million previous year and SEK 12.2 million in previous quarter. The operating profit was reported to SEK 14.9 million compared with a loss of SEK 13.9 million for the same period previous year, a SEK 28.8 million improvement following a strong sales performance. The profit also includes expense provisions regarding long-term incentive programs amounting to an expense of SEK 9.7 million this year compared with SEK 9.5 million previous year. With a total cost of SEK 9.7 million in the period, only SEK 0.2 million is cash flow impacting in the future. The operating profit improvement before the long-term incentive programs was SEK 29 million, confirming a strong underlying positive trend. For the first time, a positive cash flow from operations was reported, reaching SEK 21 million and yet another confirmation of the strong momentum in the business. And to round off, I would like to pay attention to 2 one-offs reported in the quarter, one related to deferred tax income and 1 relating to a self-correction of EC VATs. With the strong and positive underlying trend in the business and with prudent but realistic assessment of the future, a value has been designed in the balance sheet attributable to the tax losses carried forward as well as other temporary tax differences. The total deferred tax asset has been reported, amounting to SEK 230 million, SEK 13 million posted directly as equity, and SEK 217 million as tax income. Selling expenses in the quarter included SEK 2.5 million regarding a self-correction of EC VAT for earlier years. The background of this cell correction is complicated prerequisites relating to the production process and has been initiated by the company. The self-correction also led to interest expenses of SEK 1.9 million and an exchange rate loss of SEK 0.6 million in the period. And the net cash flow impact from this self-correction totaled SEK 7.1 million. And with this, I hand over back to Emil.

Thank you, Håkan. So we are, of course, pleased to present such strong quarterly results. And we believe that the results are more than confirming the high expectations on what CERAMENT can do to drive improved patient outcome. The journey to reach the full potential for -- Well we're jumping a little bit back and forth? Okay. I was just saying that the journey to reach full potential for CERAMENT within its current market, it's only in its infancy. In addition, there are more and further indications and geographies to eventually be explored. Almost every quarter, there are new data arriving confirming the strong benefits of CERAMENT. This solid foundation of evidence has led to a fast-paced adaptation, especially in the U.S. In the U.S., the number of surgeries is fully back and even above pre-pandemic levels. In Europe, while not yet back on previous levels, we believe that the market dynamics will continue to develop positively. The European surgical backlog is at all-time high, and CERAMENT is in a good position to replace an outdated standard of care. Finally, we would like to inform you that we're planning to hold our Capital Markets Day in late November, in order to provide further details on the development of the Cement journey. And with that, we conclude our presentation and would like to open up for questions and answers.

[Operator Instructions] The next question comes from Erik Cassel from Danske Bank.

Just first off to sort of get it out of the way. There was quite a substantial downtick in BVF in Europe that's seen in the CERAMENT G sales. Just wondering what's the reason behind that, sequentially, that is.

Yes. So I think we're all thrilled to see how strong CERAMENT G and V is performing. And as we've anticipated, there has been a bit of cannibalization in Europe as the surgeons have a stronger preference for the antibiotic eluting product. If you look also at BVF, the numbers are quite small and could vary quarter from quarter depending on if there are orders being placed from distributors or distributor markets and in the distributor markets, many times, BVF is slightly bigger. So there's nothing else than those parameters that have influenced the result.

Okay. Perfect. And then also on the U.S. conversation. I mean, you mentioned that you see conversation for BVF in the U.S. But are we seeing any substantial different pattern playing out in the U.S. compared to the dynamics that we've seen in Europe going forward?

The biggest difference is the very strong acceptance and adaptation driven by not only clinical data but also the health economic data that we have. So if you look at the U.S. sales in the quarter, CERAMENT G is now already bigger than CAMENT-BVS after 1 year only. And I think it shows how quickly the system response, with system, I mean, when you have both the payer of the bill and the clinician, the surgeon joined forces and see that there's a modern treatment that can reduce the recurrence of infection and also have a material impact on the rate of amputations. So what we see in the U.S. is very similar to what we have seen in Europe, but just at a higher pace at a faster pace.

Okay. Good. And I'm wondering on the sales commission levels, 35% in this quarter. When could we expect to see that start coming down, maybe approaching 30% or even lower?

You should start to see that coming down now and going forward. But at what pace, we don't want to speculate in. And here's the reason why the sales of CERAMENT G, I think, has exceeded most analysts' expectations and admittedly also ours. And that means that some of the independent distributors in the U.S. have succeeded significantly and there's a staircase model, so when they do really well, the commission increases slightly. But then every year, they get a new quota, so it's somehow neutralized at the end of the year. But over time, as we gain better and stronger economies of scale and size, the commission should be dropping over time. And then, of course, baked in that same line in the P&L is also GPO fees and freight. And here, there are less economies of sales.

Okay. Perfect. And then just the last one for me. Now that you have positive cash flow and also a pretty good cash position, what are you going to do with the cash flow now from now on? Do you see any organic or inorganic opportunities to deploy that cash?

Yes. Thank you, Erik. Yes, I think if there is one thing with CERAMENT, it's definitely the opportunities that we see for the future. And we're in a strong position. We like to be in a strong position. And I think we need to have more time to discuss what are the opportunities for the future. So, a good opportunity will be at the Capital Markets Day, which we are in the planning on. So that's the next location where you can expect us to talk more about the future direction.

Okay. Perfect. Looking forward to that. Thank you guys.

The next question comes from Mattias Vadsten from SEB.

I have 4, I'll take them one by one. First on CERAMENT G, if I may, running the numbers taking Q3 CERAMENT G sales in the U.S., it's running somewhere around SEK 260 million annualized in sales. This would imply sort of half of the market in Austria Milieu. So we all understand that much sales comes from trauma, of course, diabetic foot and so on. So question is how much of a trigger is really the extended indication application? Are you having potential customers awaiting this approval or customers that want to have the NTAP, for instance, some thoughts here around the dynamics would be great.

Okay. Yes. So, we'll start with that question. Yes, indeed, Mattias, thank you for the questions. CERAMENT G is trending very nicely. We agree. Are there surgeons waiting and holding back using what they believe is best for the patient because of an extended indication? Not. That is not the case. The surgeons will, in every single case, look at what they believe is best for the patient. And we can conclude that in our visits in the U.S., which have been many during this year, we've been in direct contact with surgeons that have had positive experience from CERAMENT G in treating bone infections and they have also started to use it preventively with clear instructions from our side that this is off label and not yet on the IFU, the surgeon make their discretionary decisions. So I can confirm that. To what extent that makes up sales, I don't dare to answer or speculating.

I appreciate the flavor there. And to elaborate on Erik's question on CERAMENT BVF. I mean it increased both Q-on-Q and year-over-year. So do you see the CERAMENT G launch actually helping you here, as brand awareness has improved, that is increased new customers for also the BVF part of the CERAMENT G offering or the cement offering? That's the next one.

Yes. Thank you. That's a good question. I mean, we have access to meticulous data for both the U.S. and European markets. So we can, of course, see much more granularity than what we are sharing with the market from a quarter-to-quarter perspective. And there is a sentence in the CEO comment in the report where I state that we're very pleased to see new customers coming on board customers that are attracted to CERAMENT through CERAMENT G and that have not used CERAMENT BVF before. When these customers come on board, there is also an element of them starting to use not only CERAMENT G, but also CERAMENT BVF. So you're absolutely correct in your conclusion that CERAMENT G has such newsworthiness that it attracts customers that also gives extra flavor and boost to CERAMENT BVF.

And the next one is if you have an understanding of where the market is compared to free dynamic in both regions and for EMEA specifically, if you feel you start to take market shares at a higher rate now compared to a year or 2 ago, given the growth rate here looks quite impressive, given the underlying surgery volume that you speak about? That's the third one.

Yes. So I would say that U.S. surgical volumes in general are above and beyond pre-pandemic levels. There is a strong financial incentive for the hospitals to clear the backlogs. And I haven't seen a number update, but I saw a couple of research institutes predict that this year would be between 5% and 6% even above the pre-pandemic year 2019, that makes sense. When it comes to Europe, it's a little bit more difficult to make a solid conclusion. I think there are some markets that are back and even beyond pre-pandemic levels, while others are still struggling more with the staff shortage that was a consequence of the pandemic. So, if I would take a guess, I would say that Europe, as a cluster is probably still 4% to 5% behind pre-pandemic levels in total surgical volumes, at least the public data available on the backlog would testify to that. And your side question there is, are we taking market shares faster? Yes, we are. The pace of capturing market share has increased. And the simple explanation to that is, some of you might have known us for a few years, but we are still a small player with a breakthrough technology that is transforming standard of care. And we need to have access to the hospitals. We need to have access to the congresses, which is a great forum for us to meet new surgeons. And during the pandemic, we were a rather wing cut in our ability to promote the product. So as the restrictions went away and we kept investing throughout the pandemic. So we came out of the post restrictions with hitting the ground running. So our market share gains have indeed picked up and accelerated.

I appreciate on the flavor there. The last one should be quicker. Can you talk about your production set up a little bit and to the extent there is free capacity to increase production if you're confident there? Just the last one for me.

Yes. So let's say like this, I have the greatest confidence in my team and my organization, hard-working, very talented people that have made it possible, first of all, to carry out and satisfy the need on the product with the strong increase on sales that we see now. So I have equal same level of confidence in my team and the high-quality suppliers that we're working with. Maybe supplies is the wrong word even. It's more partners. We work very integrated and interactively with our partners, and we are transparent with them to communicate also our plans for the future to make sure that they have the ability to raise capacity to satisfy our needs. On top of that, the team is working diligently to build even further safety stock so that we can be flexible to the fluctuations of the market. So with all the knowledge I have today, Mattias, yes, I have full confidence.

The next question comes from Kristofer Liljeberg from Carnegie.

It's Kristofer here. 4 questions from me as well. The first one is if you could comment on the surprisingly limited increase of the working capital this quarter, if there's anything special explaining that?

Well, thank you, Kristofer. And glad it's noted. And again, somehow a supporting factor has been quite some focused and accelerated efforts when it comes to collecting of payments in the U.S. in the background of the direct sales growth we've seen, it's an area where we have had to extend efforts and so on to make sure that we keep our customer base also in line with our commercial conditions and so on. So that's a contributing factor.

Okay. So that's positive to hear. Saying that, do you expect working capital as a percentage of sales to come down here?

I think that's Samau, it's at least not to increase in Samau as any other company with a high growth. So it's an area to really work on and focus on, and we have such a focus. So we expect that this month if not to come down at least to maintain on a stable level.

Okay. But given that if you paid more focus on this quarter, I guess, there's some exceptionally good level in the fourth quarter that we shouldn't see again in Q4, if you…

Yes.

Okay. That's good. Then on the selling cost and R&D, very stable, I would say, quarter-over-quarter. Do you see anything here that would accelerate these costs going into 2024?