OssDsign AB (publ) (OSSD) Earnings Call Transcript & Summary

Hello, and welcome to today's webcast with OssDsign, where CEO, Morten Henneveld; and CFO, Anders Svensson, will give a strategy update. [Operator Instructions] And with that said, I hand over to you, guys.

Thank you very much, and a warm good morning to everyone, and thank you for joining us on what is a fantastic day in the history of the company. Today, we want to take you through our new strategy and our new financial goals that was announced late last night. But before we do that, we just want to take the opportunity to walk you through where the company is right now and why we see that this is the right time to accelerate the company. I appreciate that many of you may have heard some of it before, but I think it's important to understand why we are doing it now. Just in case there are any new listeners to OssDsign here, then we operate in the orthobiologic space. We have a strategic focus on spine, and we are solely focused on the U.S. market. It's a very large market, $1.8 billion, and it's growing nicely. It also means that we are a little bit in a sweet spot. Right now, we are benefiting from a number of tailwinds, not least the macro development in the plus 60-year population, which is growing quite rapidly and will do so for many, many years. We're also seeing a surgeon preference shift in the market towards more synthetic solutions given that they are now showing efficacy levels. We are the latest generation, fourth-generation product in the market, and we are seeing a shift towards that. It doesn't carry the risk of disease transmission like allograft does, and efficacy level is actually on par, even higher than the gold standard autograft. And then last but certainly not least, this is an exceptional crowded market. There are a lot of products still in the market that were launched up to 20, 25 years ago who are technically still out there. And what we are seeing is a significant shift away from the older technologies into the latest generation and better-performing products. So we are benefiting from all of those tailwinds. Now what is the problem we are trying to solve? Unfortunately, as we grow, many of us will have back problems. Some will have what's called spinal instability. And there's about 1.5 million of those procedures of -- every year, of which about half of them are what we call fusion procedures. A fusion procedure is a procedure where you use different metalware, screws, rods, cages, but you also use a graft in every single procedure. And at least 20 of them -- 20% of them do not have a successful outcome. So it's a lot of patients every single year that have to undergo revision surgery, which is both painful to them, but also extremely costly to society. In essence, the clinical goal in spine is quite simple. You need to stabilize the spine, and you need to relieve the pain. Now the challenge is that we are somewhat hindered by the natural human biology in the sense that when we're applying the graft, which you do either on the vertebra or you do it inside what's called an interbody cage, the end of the graft or the edges of the graft will touch blood cells. So you're going to have a bleeding environment, and we know that blood cells help stimulate bone growth. But in the middle of the mass or in the void between the vertebra, that's the real clinical challenge. That's a -- what we call an avascular environment, and there was nothing there inherently in the human body that will help you grow bone. This is one of the main reasons you're not getting a successful outcome because you need what's called a bridging bone from end to end and side to side. If you look at how traditional synthetic bone graft work, then they start to grow bone at the edges, and then they grow bone on what we call a creeping bone formation towards the middle. Now the challenge is if they never reach each other in the middle, then you're not going to have a bridging bone, and you're going to have a failed procedure or, alternatively, that it takes so long that you start to see implant loosening, potentially infections because you're not closing the voids, et cetera. What we've seen from the very beginning with Catalyst is that it works in a fundamentally different way in the sense that it grows bone in the middle section, so inside out as fast as it's growing outside in, like a traditional synthetic. This was actually something we tested in the very first preclinical model called the bone model that was used to clear the product in the U.S. And here, you can see that we grew 4x as much bone in the middle section compared to the predicate device, and actually, we grew as much bone almost in the middle as we did at the edges where there were blood cells. And why is that? Well, for many, many years, it's been a holy grail to come up with a synthetic solution that matches that of our human-native bone. Catalyst is doing exactly that. We're no longer just mimicking bone on a macro level. We are actually mimicking the mineral crystals inside the bone. And combined with the fact that we have a 5.8% silicate substitute in the product, that means that we have a potency to trigger what we call dual bone formation pathway, as I discussed before. Essentially, that we are growing bone simultaneously at the edges of the graft and in the center of the graft. And as we will show you here, that is leading to very solid fusion, but also much more rapid fusion than what is otherwise typically observed. In addition to that, the nanoscale structure and the silicate component is providing surgeons with exceptional handling qualities. This is something we've seen and heard from the very, very beginning. It's an often quite overlooked capability in any product because ultimately, if it doesn't work in the hands of the surgeon, if the graft starts to show irrigation, meaning that it washes away, you're not going to have a successful outcome. So this is really also a differentiator in the product and something that we've seen from virtually day 1 when we launched the product some years ago. Now if we move on because we've just talked about how the product works. But of course, we are now at a point where we are proving this in a clinical setting, and we've come a long way in a very short amount of time. But I just want to remind everyone that up until January of '24, we were only commercializing on the very first preclinical study called the Boden model, which you see here on the left. When the product was technically made available towards the end of '21, we immediately started our first inpatient clinical study. 6 months later, we also initiated a prospective multicenter spinal fusion registry, which we call PROPEL, that now has more than 300 patients enrolled in it. And then we followed up with just taking that avascular challenge that I just spoke about and taking that to an extreme, putting it into a muscle pouch in a sheep. So this, of course, has materially changed. And I think it's fair to say you can always discuss when is clinical evidence conclusive. And it probably never will be. We certainly have a philosophy, and it has been a strategic priority from the very first day. But we are seeing a very clear pattern emerging across all of these different studies that we've done to date, and I just want to take you through it. Many of you have probably seen this before. The very first preclinical study we did, the Boden model, showed not only a very high fusion rate of 100%, essentially matching that of the very expensive and somewhat dangerous BMP-2 drugs in the market. More importantly, it shows an incredibly rapid fusion already after 6 weeks. They had a bone formation, which was 2x to the gold-standard autograft, and it was 4x to the other traditional synthetic that we compared against. Moving on to our first inpatient clinical study called TOP FUSION. Here, we came out with, again, very high fusion rate, 93% after 12 months and 100% long-term data after 24 months. But similar to the preclinical study, we saw an exceptional early bone formation and fast progression into fusion to the point where every single patient were either fully fused or partially fused already at a very early time point of 3 months. Same evidence has now been emerging from our spinal fusion registry called PROPEL. We are -- we will be announcing the first 100-patient cohort in the near future, but we have reported and published a number of case reports also on very complex patients, and exactly the same picture is emerging. Complex patients that otherwise were not prone to fusing at all are not only having a very strong clinical outcome. It also happens exceptionally fast, like the case you see on the left-hand side, which was a 3-level surgery with comorbidities and previous failures, and the patient was fully fused at all levels at 6 months. And as we announced here in April, we wanted to take the avascular challenge to an extreme, essentially putting it into a muscle pouch in a sheep, where there is absolutely no chance that you're going to have any help from the body itself of the sheep. And what it showed very, very clearly is that Catalyst, and this is the words of the author, Professor Bill Walsh, stating that this is the first clinically available synthetic bone graft to successfully generate robust functional bone in a challenging avascular environment at such an early time point. The other observation here is we also compared against other products that are also -- also have silicate in them. And as you can see, we had a bone formation, which was 2x to the nearest competitor and 6, 7x to the third product. So I think across all of these, as I said, we have a very clear pattern emerging of a product that is showing a potency which is not observed elsewhere in the market. This has, of course, also translated to a high commercial success, not least the fact that here in May, we hit the magic milestone of having 10,000 patients treated with OssDsign Catalyst. And as you can see, there's been a clear acceleration of 20x actually from the very first milestone we reported back in January '23 of 500 patients. That has, of course, also translated into a very strong sales trajectory. What you see here is a 12-month rolling sales on Catalyst. This is a slide we've shown before also in quarterly reports. So I think many of you have seen it before. What's also worth noting is that we keep running at an exceptional high gross margin around the 95% to 96%. This is well above our very first guidance of 90% and even much above our updated guidance of more than 93%. And what we've seen in particular over the last 3 quarters or so, most notably here in the first quarter report is that the top line acceleration is translating into very clear operating leverage. We are seeing a strong scalability in the business to the point where our best -- our underlying result -- operating result in Q1 was the best ever in the history of the company. If we look a little bit on the market, then this is actually outdated data. We don't tend to provide updates on operational numbers all the time. So this data is back from November '24. We are, of course, way further than what you see here. But we already have approvals in more than 150 centers in the U.S. We have a distributor network, which is an extended arm in the market of about 100. We have full military access, and we also have GPO with Premier that we won last year on absolutely standard market terms. And we often get the question, has it translated into sales? And that we can confirm, it has definitely already translated into sales. But even though we are exceptionally pleased with the progress to date and we are even ahead of our own plan in a number of ways, we still have not even gained access to 10% of the spine orthobiologic market, meaning that there is a 90% untapped potential out there for us to target. And in addition to that, you can only lay the fact that our existing 510(k) clearance in the U.S. actually covers broader indications than just buying. We are also clear for certain pelvis surgeries, for extremity surgeries and even trauma, should we wish to go in there tomorrow. And as you know, we have already started doing some of those cases at a very slow pace. So as you can see from the development we've had so far, we've come an exceptional long way. Not only are we proving that we have a product that is highly differentiated in the market. It works in different ways. It shows a higher level of potency, which is translating into a more rapid fusion. We are treating -- we've treated more than 10,000 patients. We also now are sitting at a clinical repository of 14 publications, either preclinical or clinical, and we have a very large untapped potential ahead of us. So therefore, we feel now is the right time to accelerate the company. And therefore, last night, we launched a new strategy, which we call ScaleToProfit, which is our strategy for '25 to '28, but also with a view beyond that. And if we start with the view right now and beyond that, then the last 3 to 4 years have really been around stabilizing the company. We started a big turnaround process already back in 2020, but the last 3 years has really been around building the orthobiologics business, becoming that U.S.-centric organization that we said we would and also improved gross margin, which as we've also disclosed before, has increased from around 40% back in 2020 to now sitting around 96%. The next 4 years for the company would be all about accelerating and scaling to profitability, and we'll detail that a bit more in a second. After that, once we have more clinical data, et cetera, then clearly, there are expansion opportunities, either more aggressively into adjacent segments and/or geographical expansions into markets outside the U.S. But for the first 4 years, I just want to be very -- the coming 4 years, I want to be very clear, we will remain 100% U.S. focused. So what are the things that we see we're going to invest in, in order to accelerate the company? Well, first and foremost, we have been sitting with virtually the same size of sales team since 2022. So all of the growth acceleration you -- we just showed you is all driven by improved sales force efficiency. So by the end of next year, we want to double that sales force. We are seeing that our sales force are now hitting some sales levels per rep that is highly attractive and highly accretive to the operating leverage and the profitability in the company. At the same time, we are also now in a very fortunate situation that we have created a very large installed customer base. And ultimately, the best salesperson for any product in this industry is someone, a surgeon who has used it clinically. So we want to do a lot more of the surgeons. Last year, we started to bring a lot more surgeons together. This year, actually, we have now had 3 surgeons on podiums presenting to other surgeons. So those are some of the things that we want to do a lot more off so that surgeons can share their clinical success with other surgeons. Then we also want to develop 2 new products and obtain 1 more expanded indication clearance. I'll detail that in a second. We are going to take clinical to the next level during the next 4 years. And then we also want to implement a more scalable and also more cost-efficient production process in the next 4 years. So those are the main growth investment areas that we see. And what that means from a sales point of view is that, as mentioned, we have access to just below 10% of the spine orthobiologics market right now. We are now targeting having access to 30% of that market by 2028. Today, we are doing business in approximately 20 states in the U.S. And during the next 4 years, we want to enter 15 more states. There are some states that we are probably not going to enter at all, and this is the typical ones with a lower population density. We've talked somewhat about expanding into adjacencies. And during the next 4 years, you will definitely see us going more wholehearted into 2 adjacencies. One is the pelvis segment, in particular, the sacroiliac fusions, and also extremities with a focus on foot and ankle. We are somewhat already doing the sacroiliac fusions today because they are done by spine surgeons, so it's the same call point. But before we go wholehearted into extremities, we are preparing for that launch, collecting data, establishing collaborations with key opinion leaders and so on. We cannot, at this point in time, give any clear guidance as to when that happens. That will depend on a number of things. But what we are quite certain about is that it will happen in the next strategy period. When it comes to new products, we are still in a situation where we have one product, which is our -- what's called a putty formulation. During the next 4 years, we will be launching 2 new products. About 20% to 25% of the market is what we call minimal invasive surgery, essentially where you operate through tubes and cannulas. And there's actually not a lot of competitors in the market that have a dedicated MIS product. And we have line of sight to a product based on our putty formulation that we can develop into an MIS-dedicated product, and that product we expect to launch during -- some time during next year. I can tell you we are already somewhat used in some of those cases by using the putty, but we want to have a dedicated product for that specific type of surgery. The second product is what we call a hydrophilic strip. I think the way to think of it is it's a precut, more sponge-like type of formulation. It is something that about 20% to 30% of all lower back surgery is used and some surgeons tend to have a very clear preference for using a strip as opposed to a putty formulation. This is a full-blown development, so this is a product that we expect to launch sometime in '27 to '28. But all of the sales that we'll be generating here will all be incremental because these are cases we are not getting today, even with surgeons where we may have all the other business that they're doing, but because they want to use the strip, we are not getting used in those cases today. In addition to that, as you know, we were the first synthetic bone graft to actually be cleared for -- to get what's called an interbody indication some time ago based on the intrinsic data on the bone graft itself. That was a big indication expansion that we were really looking for. It just came way ahead of time. But there is one more indication clearance that we would like to have, which we expect to get in the next 4 years. Moving on to clinical. As I mentioned, we have come out of the starting block in a very, very fast manner, also much, much faster than what we can see peer companies or competitors were at a similar time point as OssDsign, meaning that we have very substantial, strong, preclinical evidence, not only from the Boden model, but now also from the ovine model that was published in April. We also have our first inpatient clinical evidence in TOP FUSION, again, showing very strong data, fast progression to fusion. And now we are building our real-world clinical evidence. We've published very strong case reports on very tricky patients, and we'll be coming out with a larger cohort story going forward. What we don't have in the company right now is the tip of the iceberg here, which is a larger randomized control level 1 study. So as we look forward and also given the fact that we were able to raise the money that was announced last night, then we see 2 major things to do in the next 4 years. We want to elevate OssDsign into the absolute top tier and actually develop level 1 clinical data. Very few companies in this space actually have this. So it will help us drive differentiation and set us apart from the broader competition. It will be a fairly large study. We are still -- we can't commit to exactly what it would be. But what you see on the right is some approximate numbers. It's going to be a multicenter study, 10 to 20 centers, most likely, and with a fairly large patient and control group population of around 300 to 400. And it will also, of course, be a longer study, around the 5 years. But as this is going on, we are seeing an immense value in the PROPEL registry, also a bigger value than what we originally thought it would have, not least because there is a swing in the market, whereby surgeons and also at the FDA are increasingly looking at real-world data as an add-on to the randomized controlled trial for the sheer fact that in the randomized controlled trial, you have "a perfect patient," and that is very different to the real-world population that we are treating, in particular in the U.S. So as that registry is growing, we will be able to publish more cohort publications, larger cohort publications, but also when it reaches a certain level, you'll be able to do those type of things also on subgroup of patients like complex patients, smokers, diabetics and so on. So we see an immense value in keep building the PROPEL registry in the years to come. And again, the combination of all of this really helps setting OssDsign apart in what is a very crowded market, but also in a market where not that many are investing and can prove clinically differentiation to others, and that is exactly what we're doing as we speak. The last area is around production. Of course, we want to make sure that production is scalable, so it can follow with the growth in the company. But we also feel that we can actually produce smarter than what we're doing right now, not only more scalable, but actually also in a way where we can -- despite the fact that we have an exceptional high gross margin, where we can actually reduce costs even more. As we are doing that, we also need to make sure that we have a certain agility in the company, and that means building a dual-sourcing setup. And of course, as we're doing that, that will be done in the U.S. So we will also be increasing our U.S. footprint. And as we are doing those things anyway, we have a 2-year shelf life right now on the product. We also want to extend that into 3 years. That inevitably means that the risk of scrapping is also reduced. So as we are executing the things that you see here, we've also updated our financial ambition and now -- announced last night that we will deliver sales in excess of SEK 400 million by 2028 and also that we will become EBIT profitable and cash flow positive during the second half of that strategy period. What's also important to note with the directed issue that was announced last night that this is a fully funded plan. So it means that we are now fully capitalized until reaching cash flow positive. But that also means that, by and large, the strategic priorities that we already announced when we did the strategy shift in September '23 remains largely the same. It is 4 very clear priorities. We need to accelerate access and coverage in the U.S. market, including a gradual penetration of the 2 adjacent orthopedic segments that I explained before. We will expand the product portfolio with the 2 products that was shown that we are working on and also get 1 more indication. We are -- will now become very ambitious when it comes to the clinical priority and really go for building that complete repository where we fill out all the boxes in the pyramid and help us set us apart from competition and gain access to a lot more centers over time. And then as I mentioned, we want to make sure that we scale production with an increased footprint. So very much a continuation of what we are already doing, but also with a very clear acceleration in all of those 4 priorities. And of course, we believe that, that, as it has done in the last many years, will translate into even more shareholder value. So I think with that, that was the presentation. Thank you very much for listening to it, and we'll now hand over for Q&A.

[Operator Instructions] And the first question here. Given the strong clinical results and the recent expansion of the Catalyst platform into the U.S. market, what concrete step is OssDsign taking to secure deeper adaptation among major U.S. health care providers and spine surgeons over the next 12 to 24 months? And how will success be measured operationally and commercially?

Okay. I think that's 2 questions. Let me try to answer the first one. I think I actually answered the first question already. There is a little bit of a snowball effect as you're commercializing -- particularly as you're commercializing so quickly. So when you start, you don't have an installed customer base. We have managed to build an installed customer base. So many surgeons are producing clinical results day in and day out. We have to make sure that those surgeons tell that to other surgeons, get on podiums. As you heard me talking about, we've done 3 so far for the first time this year. So those are some of the very concrete things. But also, I would say, just the clinical investments we are doing, those things resonate well. It shows surgeons that we are a very serious company. We put our money where our mouth is, and that is actually helping us differentiating in a very crowded market. To the second question, that's a fairly easy thing. We're not disclosing those numbers, but Anders and I and the rest of the management team are looking at these things on an ongoing basis. We are measuring exactly how much each account is doing, how that develops over time. We are doing it on a surgeon level, but we're also, of course, looking at how many users do we have in each account. So that we have complete transparency on, but it's not willing we are -- something we are willing to share.

Could you explain your confidence level on your updated sales forecast considering that you have not seen the PROPEL registry study results?

Yes. I mean, I think just the fact that we are going out announcing it and doing it together with a direct share issue should give everyone the comfort that those are, of course, numbers that we trust, and we believe that we can deliver as we have demonstrated over the last many, many quarters.

What room is there for a quicker-than-expected positive cash flow during this period? And what is it most dependent on?

I don't think you should expect a quicker-than-envisaged positive cash flow. We believe that we're going to reach profitability somewhere in the second half of this period. And as always happens, cash flow comes slightly after profitability. So that will be towards the end of the period.

Moving into extremities, I assume it requires a new commercial infrastructure. Could you elaborate on this?

Well, I think that's something that we are, of course, considering how to do that. There are many ways to do it. You can do it full blown into a commercial separate entity. Those are different type of sales groups. I've had that in my past with some of the orthopedic giants. But you could also see in a different way that once you're approved in a hospital where you're dealing with the orthopedic spinal surgeons and the neurosurgeons, then they inevitably will also have a foot and ankle department, and you might as well go down there and speak to people. So I think time will tell as we are preparing that launch plan into that segment more wholehearted, those are some of the considerations we'll be doing, but it's premature to guess that right now.

When do you plan to launch into pelvic and foot and ankle? What is the market potential of those 2 submarkets in the U.S. in USD and number of annual procedures?

Yes. So maybe just let me correct. We are doing cases in those segments already. The second case we ever did in the U.S. was actually a foot and ankle case. It is just not -- there's a difference between doing cases and deeming it a strategic priority. So we are doing these sacroiliac cases right now. We're also doing foot and ankle cases right now. The foot and ankle case, depending a little bit on how you define the trauma-related cases in the foot and ankle segment, is somewhere between $60 million and $100 million. So it is, of course, smaller than spine, but it is a good small niche, and it's also an area where we can already see that Catalyst is generating the same strong results as it is in spine. But as I mentioned, we're not committing to any time line. It will depend on a number of things. We are just preparing. So we are ready for when the day arrives.

What is the size today of your sales and marketing team? And how fast will you ramp it up?

Well, as I said, we've been running on 7 regional managers, which means that including sales directors and a VP, we are roughly about 10 people or so, 10, 11 people. We will ramp it up gradually towards the end of '26 as we announced.

Moving on to the last question here. You plan to double the sales force by 2026 and accelerate marketing, but the new financial targets imply annual growth of 30%. I'm having trouble reconciling that. It doesn't really seem like you expect growth to take off immediately. Should you be -- shouldn't you be seeing stronger revenue growth than that?

Well, I think we are announcing what we think is a -- what is an absolute realistic number to the market. So we stand firmly behind that. Can it go faster? Yes, it can. I think one thing people need to understand is that salespeople typically have up to 3-year ramp-up period, right, where the first year, of course, is lower, and then they gradually start to reach their full potential as they approach year 3. So of course, there is a time lag between when you hire them and when you start to have full effect of salespeople. So that's, of course, also baked into the plan.

We actually received one more question here. How is the thinking around getting stand-alone Catalyst used regulatory cleared with the FDA? Is it used stand-alone often today?

Yes. I mean you have a very similar situation like the interbody indication we got, right, which is where, for years and years, products have been used off label by many surgeons. It's not something that we as a manufacturer in any way, of course, can promote. But it is common knowledge that products are also used off label. That also goes to, for instance, stand-alone clearances. We are cleared today one-to-one with autograft, like a number of other products are, but we also know that there is a certain level of off-label usage, where it should be -- where it was being used stand-alone.

That was all the questions we have. So thank you so much for presenting today and answering all questions, and thank you all for tuning in.

Thank you.

Thank you very much.