Episurf Medical AB (publ) (STO:EPIS.B)
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May 5, 2026, 12:20 PM CET
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Earnings Call: Q4 2023

Feb 9, 2024

Pål Ryfors
CEO, Episurf Medical

Hello, my name is Pål Ryfors. I am the CEO of Episurf Medical, and I'm here to provide you with an update of our Q4 2023 results. As usual, I will refer to a set of slides, so please try to have those in front of you while listening to this. On the second slide, in the introduction, I just again want to reiterate that we are now in a growth phase. In our OUS markets, meaning our markets outside of the U.S., we continued on our growth path despite a major restructuring of the sales force. We improved on all key ratios. We're charging better. We have a higher run rate with individual surgeons, and we're growing our surgeon base. In the United States, we could see everything we wanted to see during the fourth quarter.

We have a quick turnaround, meaning that the time from scan upload to approved order is really, really short. We have a high acceptance ratio, meaning that the number of scans turning into an implant for us is at levels we've never seen before in any country, and the pricing is satisfactory, and we're charging really well in the United States. We are really happy about the start in the United States. From about Labor Day, when the first case was approved, we did about one per week, which is definitely not a bad start in the United States. You have to remember that we're starting from scratch. We do not only do the first surgeries. It's the first customer. It's the first VAC approval. It's the first everything for us. This is not an add-on product for us.

It's the start of a long journey in the United States, and the start is really promising. The restructuring program is completed. We are expecting a lower cost base, fully visible in 2024. You don't really see the effect of this in the Q4 2023 results, but you will see it from the first quarter of 2024 and onwards. In this entire process, we have secured strong coverage in our key regions, and I would like to highlight, of course, the United States, Germany, India. We are working to establish ourselves in Spain, Portugal, and we are also eyeing opportunities in Latin America. Other key markets which will grow in importance to us are the U.K., Poland, etc., where we have good representation.

Episurf, in 2024 and onwards, is focusing much more on distributor and agent sales as opposed to before when we had a higher share of direct reps. On slide number three, talking about some highlights from the fourth quarter last year, gross order intake grew to about SEK 3.1 million, up 41%, and net sales grew to SEK 3 million, up 67%. The customer base in the full year grew 37%, so in line with previous growth. And the loss for the period amounted to SEK 21.9 million, which is SEK 1.8 million better than the same period last year. Cash at the end of the year amounted to SEK 57.9 million.

If you look at the key events during the fourth quarter, I would like, again, to highlight the one surgery per week in the United States, a new commercial setup, OUS, and the 510(k) application for the Episealer MTP System, which is now in the process with the FDA. On the right-hand side of this slide, you see a very clear graphical illustration of the change in 2023 compared to the previous years when you look at the number of surgeries performed and also in the numbers on the right-hand side, the financial effect of this. The gross order intake on a 12-month basis grew to over SEK 11 million, up 56%. You can clearly see that this is a new territory compared to where we've been before, and we're just getting started.

Essentially, the absolute majority of this is generated in our OUS markets, so the room for growth is significant. The customer base continued to grow. On slide four, you see that the growth in the fourth quarter amounted to 26%. You have to remember that during the last two quarters of the year, we went through the major restructuring, and it's quite natural that the new acquisition of customers is at a slightly lower level during a process like that. But we did grow despite this, and we also managed to take care of our existing customers. I'm really proud of how the organization has handled this process, which is not always a nice process. We had to say goodbye to many appreciated colleagues, but nevertheless, now we're through it, and I think we did it in a pretty good way.

On slide five, again, you see the growth in gross order intake, and you can clearly see that we are now in a phase of growth with several quarters behind us with stable growth. As I mentioned, the majority of this is derived from our OUS markets, so we should definitely continue with our ambitious growth plans in our OUS markets and then add the U.S. market to that. Why that is so interesting, you can see on slide number six, 93% of our customers are still outside of the U.S., and the U.S. market is by far our largest commercial opportunity. As I mentioned on one of the first slides, the characteristics in the market, and by that I mean the turnaround time, the pricing, the acceptance ratio, all key ratios are better than they are in other markets.

So again, this is an excellent opportunity for us, and I think we are on the right path here. We have, on slide number seven, significant addressable markets available to us already in 2024. You all know that long-term, we have even bigger opportunities once we've had additional products in additional markets. But already in 2024, we estimate that about or just over $1 billion of total addressable market is available to us. We've played with scenario analysis several times, and in a scenario with 1,200 customers divided in various regions, as allocated on the slide, with a run rate between seven and 10 and over 10,000 cases performed annually, that equates to $41 million of revenues.

Regardless of the timing of this, the point here is that the commercial opportunities for us over time, they are significant, and we need to continue on a strategy to establish our technology globally. Regardless of the type of product or the market, we have a big job to do. Another highlight from the last weeks includes the first presentation on a clinical congress with 10-year data from the use of the Episealer. I've been in this job now for many years, and new insights are coming to me still, which I think is good. But one thing I reflect a lot upon is the difference between our markets, if you compare the OUS markets and the products we have in those markets, compared to the United States. In the United States, we are entering a commercially established market with a significantly better product than the competition.

That is at least what we're aiming at. But again, it's a commercially established segment with existing pricing. The treatment alternative, as a concept, is well known to surgeons, and it's a new, cool product, but it's not a new way of treating patients, necessarily. All the commercial benefits that come with that are available to us, so we love the segment. But when comparing to our OUS market, it's evident that in our OUS market, we've been climbing a scientific Mount Everest. Surgeons are not using these kinds of implants, and they're happy to try, but they want to see data. And if you give them data for a few years, they definitely ask for more. But we have now done this for many, many years, and we are now in a position to show them the first 10-year data. And now we're getting and becoming respected for real.

This is highly satisfactory. We think we are the outstanding alternative for these patients and definitely within this product category, which is a small product category in the sense that there are not many competitors, and we are definitely not only a pioneer but also a leader in this segment. And seeing surgeons on stage talking about the 10-year results on important meetings, such as this one in Antwerp last week, it's highly satisfactory. Slide number 10. We don't have any updates for you today regarding the 510(k) submission for the Episealer MTP System. We receive a lot of questions about this, and we receive a lot of questions about our process related to the regulated FDA process and response times that are given by the FDA.

We have always said that our aim is to have the product cleared and on the market in the United States during 2024, and that is what we will stick to when it comes to communication. We also know that going into a process like this, it involves a lot of back and forth with the FDA, a lot of information exchanges. So we will not communicate at every point in time during that process. But as long as we feel that we're sticking to our overall timetable, which is 2024, you will not hear that much from us on this topic. So the strategy, in summary, the Episealer Patellofemoral System is now on the market, and we need to continue to generate cases, generate revenues, and grow the business in the United States.

The Episealer MTP System, which is an excellent commercial opportunity for us once available, is with the FDA and undergoing the review process. Episealer Knee and Episealer Talus are in commercial phase in our OUS markets, and we're continuing on the path we are on. As I've shown you today, we now have several quarters of stable growth behind us, and we just need to continue to do what we're doing with a slightly modified commercial setup. The Episealer Knee for the U.S. market, we've been transparent with the fact that patient recruitment has been slow, but we do see opportunities with a growing presence in the United States to have more motivated sites and surgeons on board.

We will expand the group of surgeons and group of clinics involved in the trial when we think is reasonable, and we will have more cases performed than we did see a slight uptick last year. It's a long-term project for us and slightly deprioritized if you compare it to the four categories above on this slide. Wrapping up with the list of shareholders as of December 31st on slide number 12, and I'm happy to be still in the top 10, and I believe in this company both in the short, mid, and long term. With that, I would like to say thank you very much for your attention, and I hope to see you soon again. Thank you.

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