OssDsign AB (publ) (STO:OSSD)
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Earnings Call: Q1 2021

May 12, 2021

Martin Westerlund
Strategy and Operations Manager, Finnwire TAV

Hi, and welcome to the OssDsign webcast. Morten Henneveld, who is the CEO of OssDsign, will be presenting today. My name is Martin Westerlund, and I'm from Finnwire TV. If you have any questions for Morten, you can ask them in the form on our website that is located to the right, and if you're watching this on YouTube, you can find that form in the description. With that said, I'll give Morten the stage.

Morten Henneveld
CEO, OssDsign AB

Good morning, everyone, and welcome to this first quarter of 2021 webcast. My name is Morten Henneveld, and I'm the CEO of OssDsign. Just before we go into the details, this has been an extremely exciting quarter with a number of big events happening for OssDsign, and as always, I'll just start the presentation today, just recapping who OssDsign is and what our history is. And then I'll go into a quick update on the COVID-19 situation, then we'll go through the results, and then, of course, I'll go in and talk much more about the many exciting things that happened during the quarter. As always, when we do this presentation, we have a disclaimer, but maybe just taking a step back, I just want to really make sure that everyone understands who OssDsign is. We are a Swedish company headquartered in Uppsala.

We have a heavy focus on regenerative solutions in everything that we do. We are approximately 50 employees, and we operate in 10 markets globally. For the last many years, we've had more than 50% in terms of CAGR, and we've now sold more than 1,000 implants. But I think more importantly, OssDsign is a company that operates in the orthopedic industry. And we are participating now in two segments, what we call cranio-maxillofacial, or CMF, and now also in orthobiologics. So as we'll talk more about today, we are broadening out the company. But the history of OssDsign is really about surgeons and scientists meeting and applying technologies to solve unmet clinical needs. Since the company was founded in 2011, a lot of things have happened. We started clinical work around 2014, commercialization in 2016.

And then, as you can see, over the last number of years, we've gone direct in the U.S., company IPO'd in 2019. And then, of course, as you know, last year, we did the acquisition of Sirakoss. But before we really go into all the details, I just really want to draw your attention on some key things that happened in the quarter. One is that we had a really strong U.S. momentum. We see momentum picking up, and we see at least some very early signs that things are about to get better in the U.S. We also launched our new strategy called Ascent 25, which means that we now have the framework and the direction ready for the company in the years to come, both where we're going to participate, but also what our priorities are.

And then, very importantly, we announced the rights issue that will start on April the 21st. And that means that we have capital secured to go and execute on the strategy. And we'll come back to that a little bit later. But before we go into the results, I just want to give you an update on the environment which we operate in. The differences in COVID-19 cases and the differences in pace of the vaccine rollout means that we see a very mixed picture across the globe. Sorry. If we start in EMEA or Europe, the UK, we are starting to see some positive signs, and we see gradual opening and also more elective cases happening. But it's also clear that there is an enormous backlog that the healthcare system needs to work through.

Now, this eventually, of course, will also benefit us because there are people waiting, patients waiting for cranioplasty procedures. But it will take time, and it will be a gradual process. Germany and France also gradually improved over the quarter. But as you also know, have started to impose more severe restrictions again in the end of March, at least, and we see some of that carrying over now into April as well. The U.S. is where we've seen most positive progress, driven by an accelerated vaccine rollout. The East Coast continues to perform well. But now we also see other key states, like Texas, for instance, starting to open up, and it is our expectation that this is likely to continue in a slow, steady pace. In Japan, as you probably know, also with the many discussions around the Olympics, things are not really open.

But we remain hopeful that we'll be able to launch in Japan towards the end of Q2. So if we go into the results for the quarter, we reported SEK six million revenue, which on paper equals a minus 23% reported growth. But of course, it is a very different comparison. One, the comparative quarter was before the pandemic, but also it was an all-time high. And last but not least, certainly, we also saw Q1 being very impacted last year by delayed shipments from 2019. So when you cleanse for those effects, the underlying performance was minus 10%, which I think is a very satisfying performance given the very severe restrictions we've seen coming back in Q1, and in particular in Europe, which impacted both the U.K. and Germany and France. But across all geographies, we saw quite a slow start to January and then a gradual pickup.

And March was definitely the best month. And that was the case across all geographies. But as I mentioned before, what we saw was an extremely important development in the U.S. that started to pick up. And the U.S. was actually tracking to reach the best quarter ever. But unfortunately, some delays with one of our suppliers meant that some shipments didn't make it within the quarter. And therefore, the U.S. finished just shy of the all-time high quarter of Q1 2020. But I am very pleased, and I'm very encouraged by this development we're seeing, both in terms of the opening in the U.S. market, but certainly also that we are able to capitalize on that opening. And we remain confident that as soon as we see opening, there will be a need for our products. And we do see all our customers are staying with us.

Very hopeful for the future and the rest of 2021 for the US. Net profit came in at minus SEK 23 million, which was in line with the previous quarter. A number of important events happened during the first quarter. We already talked a little bit to this when we did the Q4 announcement. In January, we published updated post-market surveillance data on our cranial patient-specific implant. So it now covers more than 1,000 patients. It covers all geographies. And it now also spanned across 181 hospitals. And what we saw here was a confirmation that the cranial implant continues to perform at the levels we saw all the way back from the early Kobilinsky study in 2018, meaning an explantation rate around 2% due to infections.

Of course, when we look at the market, as you heard me say before, we see on average anywhere from 17%-15%, or 7%-15% of implants actually being infected out there. So this is clinical outcomes that we are extremely pleased with. It's also clinical outcomes that we actually believe the market should be looking at in terms of what should be expected by patients and by surgeons. Another thing that has happened, which we also alluded to last time, is that we expanded into a new headquarters manufacturing facility in Uppsala, which means that we'll have larger production facilities. We will have areas purpose-built for research and development to drive portfolio innovation. It is, of course, also a more inspiring work environment that will allow us to attract and retain people.

What it means is that we've already taken the steps as we hopefully exit the COVID period during the course of the year to really have prepared the company for further scale and for further growth. We can do that in the facilities that we have. In March, we also launched our new strategy, Ascent 25. The new strategy marks a shift for OssDsign as we move away from being a niche player in the CMF space and now also enter orthobiologics and spine. It's also a strategy that really focuses the company on serving neuro and orthopedic spinal surgeons. We see strong commercial synergies between these segments and will leverage our commercial and our technology platforms to drive further growth and value creation. To achieve this, we've set five clear strategic priorities for the years to come.

The first one is to win in the U.S., disproportionately directing investment towards the U.S. to accelerate surgeon engagement and broadening sales coverage. The second priority is to build the orthobiologics business by investing in strong surgeon ambassadorship, portfolio extensions, and also clinical data. And we confirm that we expect to sell the first product in the second half of 2021. The third priority is a heavy focus on driving portfolio innovation by leveraging not only the former OssDsign technology platform, but now also the technology platform we acquired from Sirakoss. The fourth priority, and we'll go back in a little bit more detail in a second, is really to accelerate our clinical work, our clinical programs.

The fifth, of course, is as we are building more scale into the business, we need to stay very vigilant on a continuous focus on reducing costs and delivery time while at the same time building robustness into the manufacturing. Those are the five priorities and the strategy which you will hear me talk about more also in the future, of course. As we introduced our new strategy, we also presented our plans for rights issue of shares with preferential rights for the company's existing shareholders of approximately 240 million SEK and an allotment option of up to approximately 30 million SEK. The rights issue is fully covered by subscription undertakings and guarantee commitments. I was extremely pleased by the support we have received from existing shareholders, as well as new Swedish and international investors.

With the strong momentum we have, as well as the strategic and the financial foundation now being put in place, I'm very confident about looking into the future and our value creation journey. And I just want to remind everyone here on the call that the subscription period for the rights issue starts on Wednesday, April 21st, and runs until May the 7th. So as we look into the remainder of 2021, we do that with a high degree of confidence and a high degree of excitement on the numerous commercial milestones when we launch our bone graft substitutes in the U.S. and we commence sales in Japan. As I also said before, accelerating clinical programs is one of our most important priorities. And we are already taking the first steps into this.

And very specifically, we will be doing this year two preclinical trials on the bone graft substitute, both on a preclinical for standalone claim, but also to continue to explore the osteoinductive potential we see in that product. We'll also be doing two clinical trials, a TOP FUSION study, it's called, which is the first clinical study that we'll do on the bone graft osteo3. And we'll also be doing a prospective trial on Cranial Plug. And then, as I also said, when we launch the strategy, we plan to set up two registries in the U.S., one for our cranial implant and one for osteo3 bone graft. And then, as we've also discussed a number of times in the past, we are working on a health economic model to also show the society upside of using our Cranial PSI product.

That will continue to work with and expect to update on that later 2021. I think with that, we're looking into a very exciting 2021 for OssDsign. I'm very confident of the building blocks that we're now putting in place, the direction, the capital. But I'm also hopeful about some of the development we're seeing, in particular in the U.S., relative to a gradual opening of society and a gradual opening of more elective procedures so that all our cranioplasty patients can get treated as they're entitled to. I think with that, I would like to thank all of you for listening. I'll hand over to the operator for questions.

Martin Westerlund
Strategy and Operations Manager, Finnwire TAV

Thank you, Morten. Now it's time for the Q&A. If you have any questions for Morten, you can ask them in the form that's on our website. I'll ask them to Morten if time allows. If you're watching this afterwards or that we don't have time to answer your questions, I'll make sure to send them to Morten. The first question is, given the third wave of COVID-19 and the restrictions and postponed surgeries, how many months were you effectively able to sell your products during the quarter in the US and in the EU?

Morten Henneveld
CEO, OssDsign AB

I think it's a difficult question to answer in a binary way because, of course, it is a gradual process. I think what we saw in general is that January was a tougher month due to the very severe restrictions across most geographies, but then we also saw a gradual improvement through the quarter, and as I mentioned, March was the best month in all geographies, but I don't think you can tie it down to a number of months as such.

Martin Westerlund
Strategy and Operations Manager, Finnwire TAV

Thank you for that. And the next question is, you're mentioning the momentum in the U.S. is strong. Can you elaborate on that?

Morten Henneveld
CEO, OssDsign AB

Yeah. I think we are starting to see clearly the impact of a very aggressive and a very accelerated vaccine rollout. And what that means is that some of the areas, I mentioned Texas as an example, some of the states that were previously essentially in lockdown are now starting to open up. We also see some positive signs in other places. And then, of course, we still have places like California that have yet to open up. But I think overall, our take is based on what we see and the progress on vaccines that the U.S. will be gradually opening up now. And we can also see that in our numbers.

Martin Westerlund
Strategy and Operations Manager, Finnwire TAV

Thank you for that answer, and you're talking about the clinical accelerations. Can you give us some more insights on that?

Morten Henneveld
CEO, OssDsign AB

Yeah. I think I mentioned quite clearly here some of the things that we'll be doing. Listen, I think the way to think about this is if you take 2021 as an example, we will be spending somewhere in the area of four times the amount of money on clinical compared to just what we did last year. So I think clinical work and clinical programs and investing in clinical data and outcomes is absolutely profound to what we're trying to do. And I think we have products out there with our Cranial PSI. We need some more data on Cranial Plug, of course.

But also with the preclinical data we had on osteo3 that we acquired from Sirakoss, there are very meaningful data that we need to keep investing and building out so that we can also use that to show to surgeons that using our products will have a significant impact on patients' health.

Martin Westerlund
Strategy and Operations Manager, Finnwire TAV

Thank you, Morten, for that answer. And given that March was the best month during the quarter, how large were the sales during March in relation to the full quarter?

Morten Henneveld
CEO, OssDsign AB

We are not disclosing any specific sales by month right now. But it was, as I said again, it was the best month across all geographies. And I think I'll stay with that answer for now.

Martin Westerlund
Strategy and Operations Manager, Finnwire TAV

Thank you for that answer and now when the capital is secure, what does that mean for OssDsign?

Morten Henneveld
CEO, OssDsign AB

I think it means a lot. It means everything for OssDsign, actually, in a number of ways. Strategically, of course, it means that we've now secured the capital, and as part of that, also had a very clear vote of confidence from both the existing and new shareholder base that we are moving on the right way, and of course, for us, it means that now that we have secured the funding, it means that we can execute on the strategy that we can make the appropriate investment, clinical being one example, so that we can really accelerate and scale the company in the years to come, so in that sense, of course, it's important. Another way, I think it's enormously important, and that's more for the external environment.

And that is that this means that we will not have to go out and fundraise again and again and have that uncertainty in the company. Now we have money. As I said, if we also trigger the allotment option, that if plans are true, of course, and we come out of COVID-19 as expected, that could actually take us to cash flow positive. So I think it's an absolutely profound achievement that we are now securing capital.

Martin Westerlund
Strategy and Operations Manager, Finnwire TAV

Thank you, Morten. Thank you to all of you who have followed this webcast today. I hope that we see each other soon again. Thank you and bye-bye.

Thank you, Robert.

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