Episurf Medical AB (publ) (STO:EPIS.B)
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May 5, 2026, 12:20 PM CET
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Earnings Call: Q1 2023

Apr 28, 2023

Pål Ryfors
CEO, Episurf Medical

Hello, my name is Pål Ryfors. I am the CEO of Episurf Medical, and today I will provide you with an update of our Q1 2023 results. I will refer to a set of slides, so please have those in front of you if possible while listening to this. Starting on slide two, I think it's important to once again emphasize that we are in a new phase. The commercial focus is well anchored within the business and within our community. We're establishing a distribution network in the U.S., and overall, we're definitely moving in the right direction. Customer acquisition looks good. Technology adoption is where we expect it to be, and the global strategy is starting to pay off as we have several years of diligent regulatory work behind us.

The team is highly energized and optimistic about the future, and it certainly applies to myself. A few of the highlights from the 1st quarter of 2023 includes gross order intake of SEK 2.6 million and group net sales of SEK 2.5 million, and these figures grew by 53% and 56% respectively. The numbers are, of course, not yet material enough to make any significant impact on the P&L. However, we believe these are signs that we are, again, as I said, moving in the right direction. The customer base grew by 20% during the quarter, and on a 12-month basis, the same figure amounts to 46%.

The loss for the period increased to SEK 23 million and is mainly explained by the very intense phase we are in within our product development activities, especially highlighting the implant for the greater toe that we are developing. We're also restructuring the sales force and seeing a slight build-out in the sales force, which has required resources during the quarter. Cash at the end of the period amounted to SEK 130 million, we're well-funded in doing this. I will move on to slide number four and look at customer acquisition rate. As you see, it's been a volatile figure over several years. In the last quarters, we've seen steady growth. The 12-month figure of 46% is satisfactory, I will explain why on slide number five. Here we look at a scenario.

This is no guidance or any forecast, but it illustrates a future scenario that we think is doable. Let me give you some details. If you start at our current customer base of about 100 orthopedic surgeons, and you grew this by 50% annually in the coming years. Essentially, we're continuing at the rate we're at at the moment. We end up with about 500 to 1,000 customers, and I understand this is the big numbers game, but we would end up in that interval. Do you think that's doable or not? That's up to each one to decide, but we certainly think it is, given the fact that we are, first of all, growing the existing business. It is already growing.

We're adding new geographies, including the U.S. market, and we're adding new products in, over time, hopefully all geographies that are targeting not only the pre-osteoarthritis cases but also where we have the clinical indication osteoarthritis. We are expanding our target markets quite significantly, and we are already on a growth path. Much of the regulatory work to execute on this has been done. The products are either in the market or close to be launched or at the later stage of the regulatory processes. Hence, we believe that this is a fair calculation example.

The revenue potential in this particular scenario, if you look at the middle part of the table on your right-hand side of the slide, you can see that in a scenario where we have 750 orthopedic surgeons using our products on a 12-month basis, doing on average 10 procedures per year, at current pricing, that would equate to about quarter of a billion Swedish kronors of revenues, which definitely would take us into profitability and represent a proper commercial breakthrough. On the following slides, we summarize the key characteristics of our current and future product portfolio as it looks like right now. I would like to draw your attention to slide number nine, where we provide some details on the, especially the Patellofemoral System and the market that we're targeting.

Of all patients receiving knee replacements, most of them receive a total knee. However, the knee consists of three compartments, the lateral, the medial, and the patellofemoral compartment. Only about 18% or 17% have osteoarthritis in all of these three compartments. 18% actually have osteoarthritis in the patellofemoral compartment. There is a topic of over-treatment in the orthopedic industry today. We've talked to many people in the industry over the years, and we believe that most of us agree that many, many patients could benefit from a smaller implant. The industry has responded to this development over the years. As you see in the red-shaded area of the slide, there are various types of prosthesis for people with isolated osteoarthritis in a specific part of the joint.

However, it stops at a certain level. In the blue-shaded area on the left-hand side of the slide, you see how Episealer and our product offering complements the current offering from the industry. We have been operating in the area of focal lesions, the pre-osteoarthritis cases. We are now also moving into the osteoarthritis cases with the Episealer Patellofemoral System. For anyone to offer a full set of implants for anything from the smaller lesion up to a total knee replacement. We think that the Episealer Patellofemoral portfolio will play an important role in the industry offering in the future as we are truly unique in our space. We are on slide 10 building an distribution network in the U.S. market.

When we met the last time after the Q4 report, I mentioned that we had signed our first distributor in the U.S., and as you can see on the slide, each state represents at least one individual distributor. A lot has happened since, the, you can expect much more in the coming weeks and months. This is the build-out is happening quite rapidly right now. A few words on the greater toe implant from slide 11 and 12 that we are developing. We're developing this for patients suffering from osteoarthritis in the greater toe. On slide 12, let's just talk a little bit about what the competitive landscape looks like today. This is a part of the body that you can always try medical management, but surgeons don't really think it works.

It just buys the patient a little bit of time and might be talking weeks or a few months. In the middle of the slide, you have the existing implants that are out there, and as you can see, they all follow a typical shape. Existing implants, they are not precise, and that's a big reason to why they are motion limiting. At the end, on the right-hand side of the slide, you see fusion, which is an effective pain relief procedure. We're talking about motion, and this simply eliminates motion. There's no joint in the body where fusion was the preferred option, where an effective implant came into the market, successfully, and where the surgeon community then went back to fusion. Everyone wants to avoid it if possible.

There are plenty of drawbacks with anything that you see on the middle and on the left-hand side of the slide. At Episurf Medical, we believe that we will be able to produce an excellent implant, taking account, taking into account full anatomy of the human joints in each case, and hopefully launch this in the U.S. market initially during 2024. Slide 13. We are continuing with the regulatory work, and the commercial platform is expanding. If you look at India, for example, where we had a market we've had our eyes on for many, many years. We have now, in the last weeks and months, have had extensive road shows and launch activities in the country. We're quite excited about India.

Australia, another country I would like to mention, we just signed a new distribution agreement with a firm we have great confidence in. We look forward to the activities in Australia in the coming year. Summarizing the strategy on slide 14, we are continuing with the commercialization for the Episealer Knee portfolio in primarily Europe and the rest of the world, meaning Asia and Middle East in this case. For the U.S. market for that particular product, we are continuing with the IDE clinical trial targeting a PMA process. We have been transparent with the fact that the study recruitment is at a slow pace. However, we have recruited patients during the quarter, and we are determined to continue and succeed with that, although at a longer timetable than originally expected.

However, we actually brought the U.S. launch forward by the development of the Episealer Patellofemoral System, which is now in a commercial phase in initially the U.S. market. Episealer Talus, the strategy for that product reflects and mirrors pretty well what we're doing for Episealer Knee. We're focusing on commercialization and data generation in the studies that are ongoing for this product in Europe. The Episealer MTP system, the timetable for this product is about one year later than for the Episealer Patellofemoral System. We hope to launch this product in the U.S. market mid-2024, following the targeted 510(k) submission mid-2023. The shareholder list on slide 15. Not much has happened during the last quarter. We're grateful for the support from our shareholders. As you can see, the 10 largest own about 40% of the company.

At the bottom, you clearly see that the management is doing its best to buy stock over the years, and we firmly believe in the prospects for this company. Slide number 16, I would like to thank you for your attention and once again remind you about the capital markets day that was held in Stockholm in November. The presentations are available online. If you wanna hear more from me or any details from my colleagues or our customers, please have a look at the website for these excellent presentations. I would like to say thank you very much and see you again soon, I hope. Thank you.

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