Episurf Medical AB (publ) (STO:EPIS.B)
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May 5, 2026, 12:20 PM CET
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Earnings Call: Q3 2023

Oct 27, 2023

Pål Ryfors
CEO, Episurf Medical

Hello, my name is Pål Ryfors. I am the CEO of Episurf Medical. Today, I will provide you with an update of our Q3 2023 results, and as usual, I will refer to a set of slides, so try to have those in front of you while listening to this. So starting on slide 2 , there are two major things I would like to address. So first of all, we are definitely in a growth phase at the moment. Our OUS business, meaning all of our markets outside of the U.S., are developing very well. We have a significant improvement in essentially all of our key ratios, and we believe we are definitely in a strong positive trend at the moment. Add to that, the enormous potential we see in the U.S. market, and this is starting to look quite interesting.

In the U.S. market, the first cases are done. We have, the pricing is confirmed, and, we have a strong distribution network, and, we are very optimistic about the coming months and quarters in the U.S. market for our first product. The restructuring program, second thing, is ongoing, so we expect a lower cost base from the start of 2024 and onwards, so it will be fully visible for investors from that time. In this process, we have secured excellent coverage of all of our key regions, and I'm quite pleased with the outcome of all of this. Now we're looking forward. On slide 3 , some of the key highlights from the quarter. The Gross Order Intake grew by 67%, and group net sales grew by 86% during the quarter.

Although these are decent growth rates, we would love for the absolute numbers to be higher, and they will be as we move along. The customer base grew by about 40% on a rolling twelve-month basis, which is a very important metric for us, and I will talk more about that in the coming slides. The loss for the period amounted to about SEK 20.8 million, and as I mentioned on previous slide, investors should expect a lower and improved cost base in the coming quarters. Cash at the end of the quarter amounted to SEK 80.7 million, and we expect that cash position to take us all the way through 2024.

So if there are any key highlights I would like to single out from or around the third quarter, it is the start of the U.S. commercial business, with the first surgeries performed, and I will show you a great case on coming slide. It also includes the 510(k) application for the Episealer MTP System, which was a huge milestone for us, and, this is on a short-term basis, I would like to say, our most interesting commercial opportunity, given the characteristics of that market, and we believe we'll have an excellent product to offer to surgeons in the U.S. market during next year.

So on slide 4 , as you can see, the growth in the customer base and also the growth in the gross order intake, these numbers have now been on a steady growth path for quite a few quarters. If you take a little bit of a bigger perspective and look at on the left-hand side of the slide, during the pandemic, the numbers fluctuated a lot, and the volatility was very high. But the important thing is that we have now moved into a more steady growth phase, and we can clearly see that we are adding new customers, and we are increasing the usage with existing customers. Combine that with improved pricing, and it's starting to look quite interesting.

So, on the next slide, the growth in Gross Order Intake is also illustrated by this chart that shows you the growth on a 12-month basis. So you can clearly see again that we are in a steady growth phase right now. Up to the reporting date, the growth is of about 61%, and we now have SEK 11 million on a rolling 12-month basis in Gross Order Intake. And these are numbers that are definitely higher than where we've been before, so slightly new territory for us. But I think the interesting thing with this is that you should think about it as the OUS markets, because if you look at next slide, slide 6 , the absolute majority, essentially all of this, is generated from the OUS markets.

So add to this, the fact that we have now been entering the U.S. market, we have a distribution network established, we have the product cleared, we have VAC approval, and we have strong pricing across the U.S. So adding this market segment to the strong growth we're already seeing in the OUS markets, I think this starts to look quite compelling. So in our OUS markets, we are working in about 20 countries. The growth rates, as I showed, they are strong, and the sales channels are being established in all of our target markets. So on slide 7, the addressable markets that we have available to us already next year amounts to about $1.2 billion. So $700 million in the U.S. market and about $500 million in our OUS markets.

These are markets that are available to us, already this year... Next year. But then you have additional opportunities, as we reach additional clinical or regulatory milestones in more of the mid and long term. So we have enough to do already in the short term, is the point here, and we are on our way. So, we are not giving any guidance or providing any forecast, but, if you look on slide 8, we are giving investors the assumptions to do the math themselves, and it's quite straightforward. So in this particular scenario analysis, we show a scenario where we have about 1,000 customers.

They are on average using the product 7x a year, and this would equate to about 7,000 surgeries, of course, and with targeted pricing of about, it would result in revenues of about $22 million. This, obviously constitutes a commercial breakthrough for us. The usage number, number seven, is that high or low or good or bad? Over the long term, we expect the number to be higher. We expect it to be higher in North America than the other markets, given the characteristics of the various market segments we're in. But for a scenario analysis on a recent, relatively mid-term perspective, the number seven is we think is quite accurate.

So, this is, again, no guidance, no forecast, but it gives you an idea of where this can, where this can go if we continue on the path we're on right now. But it all starts with happy customers and happy patients, of course, and on slide 9 , you see, and you meet one of those. So this is Dr. Gary Levengood, who did the first Episealer Patellofemoral case, not only in the U.S., but also in the world, as this was the first case for us. All in all, this was a huge success, and I can tell you that the case was performed in about 25 minutes, skin- to- skin, so that is extremely impressive.

In an interview we did with Dr. Levengood, you can see on our social media channels, he also used the word reproducible, which I think is really interesting because it illustrates some of the quality industrial aspects of this. That this is a procedure that they can do many of, and if they want to do many in a day, they can do that as well. Again, other things you see on the slide, no fiddle factor, no learning curve. Yeah, the feedback was excellent, and all in all, this was a huge success for us, and we wish the patient happy recovery. So on slide 10 , the next thing in the U.S. market for us is the Episealer MTP System, an implant system targeting individuals suffering from osteoarthritis in the great toe.

Actually, a really big problem in the U.S. medical market, a big unmet medical need. And about 2.5% of anyone above 50 in the U.S. suffers from osteoarthritis in the big toe, and the market opportunity is estimated at about $400 million. The submission went in last Friday to the FDA. The review process has started, and the investors should look out for updates from this process. All of this was, of course, with the 510(k) submission, an excellent milestone for us. So the strategy on slide 11 is largely unchanged. So we are focusing on commercialization in the U.S. market, initially with the Episealer Patellofemoral System, and following in 2024 with the Episealer MTP System.

The Episealer Knee and Episealer Talus products, they are our key products in the OUS markets, and as I mentioned, in those market segments, we are seeing a strong and steady growth in the user base and also in the Gross Order Intake at the moment. The Episealer Knee system for the U.S. market is ongoing, the project is ongoing through the EPIC-Knee study. We have been transparent with the fact that the patient recruitment is slow and much slower than we would have hoped for, but the study is ongoing and represents a great opportunity for us over the long term, but the project has less of a priority these days compared to other key activities, as you see on the slide.

Wrapping up with the shareholders on slide 12, I don't believe there are any major changes on the top 10, and management continues to support and believe in the company. I am the tenth largest shareholder myself. So with that, I would like to say thank you for your attention. Please do not hesitate to reach out to us in any of the channels, or email or call me directly. I'm happy to take any questions. So with that, thank you very much for your attention again, and have a nice day. Bye.

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