Episurf Medical AB (publ) (STO:EPIS.B)
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Earnings Call: Q4 2022

Feb 17, 2023

Pål Ryfors
CEO, Episurf Medical

Hello everyone. My name is Pål Ryfors. I am the CEO of Episurf Medical. Today, I will present our Q4 2022 numbers, and I will make references to a set of slides, and the page numbers. Let's get going. On slide 2. First of all, I wanna say that we're clearly now entered into a new phase, and the commercial focus is well anchored within our business and with our medical advisors. What I mean with that is that we have had a long period of time, historically with focus on product development and clinical development. It's been back and forth whether we have been really prepared to market our technology. In the last year now, we have really entered into a phase where we have a technology that's ready to be marketed globally, and we have strong support in the medical community for doing so. We clearly feel this within the organization.

COVID is finally behind us. If you followed us for a couple of quarters, you know that I usually start with a slide on COVID-related restrictions, but now we can stop doing that and look forward. Maybe for the last time, I will say that we have to remember the kind of negative effect this has had on our business for the last 36 months. Overall, the development is, in our opinion, very positive, and we are focusing on customer acquisition. I will get back to that topic later in the presentation. We are also focusing on our global strategy and also that I will mention later in the slides. All in all, the team is highly energized and optimistic about the future. On slide number 3, if we've had any emerging commercial business, it's been in the northern parts of Germany.

If you look at our team in Germany North and the number of cases within their region, you can clearly see that over the years we've had a nice growth trajectory up until COVID started, then everything leveled off. We had to manage what we had. We've seen some growth on customer basis, but the volumes at the hospitals for these kind of procedures have been very low. Now we're ready to take the next phase, and we like to see that also in additional regions as we move along. Slide 4 a couple of key highlights from the quarter. The gross order intake amounted to SEK 2.2 million, although still small numbers in absolute numbers, but a 43% growth is encouraging. The quarterly customer base grew by 72% in the fourth quarter. Group net sales up SEK 1.8 million from SEK 1.5 million, and the gross order intake represents orders that will be invoiced in the coming weeks and months.

The loss for the period amounted to SEK 23.7 million, and that is higher than last year, and it's in large explained by the intense phase within our product development activities and also the fact that we have restructured parts of the commercial organization. The cash position at the end of the quarter amounted to SEK 155 million, we have a strong cash position. If I should highlight any key milestones in the quarter, I would like to mention of course, the 510(k) clearance for the Episealer Patellofemoral System. That means that we are now entering into one of the largest market segments out there within orthopedics, namely the osteoarthritis, the knee osteoarthritis market in the U.S.

We also presented our commercial focus areas and our strategies at the company Capital Markets Day in November last year, and I encourage every investor to take a look at the presentations from this event as it lays out our activities for the coming years. On slide 5, we're again focusing on the customer acquisition rate. At the Capital Markets Day, we did show you these numbers up to and including the third quarter last year, and we emphasized that this is a key priority.

Hence, it's highly encouraging to see that we had another quarter with stable growth in a customer base. Over the last 12-month period of time, the average growth rate is 52%. Why this is so important is illustrated on slide number six. On a rolling 12-month basis, we are just above 100 customers, orthopedic surgeons that is who are using our technology. If you apply the current growth rate to these numbers for the next years, you can see that we will end up with a customer base globally of somewhere between 500 and 1,000 surgeons. This is no guidance. These are no exact targets, and we leave a bit of an interval. At the same time, if we're up there, meaning well above 500 customers, we have a commercial business. On the far right-hand side of the slide, you see that if we have 500 customers doing 10 Episealer procedures per year, that will equate to about SEK 170 million of revenues at current pricing.

Hopefully we'll end up higher than that. Again, this illustrates quite well how we are thinking about the future and why it's so important to generate this customer base. And for these orthopedic surgeons, the usage of the Episealer device will increase with experience and as we become more established. Why also we think this is realistic for us is that we are now entering into not only new geographies, we're also adding multiple products. In 2023, in the coming weeks and months, we're targeting the first revenues in the U.S. for our recently cleared patellofemoral system. In 2024, we hope to launch the Episealer MTP system, that is the implant system for the greater toe, also in the U.S. market. In the next years, we are aiming at bringing these products to other geographies in Europe and in Asia.

All in all, if you look ahead a couple of years' time, this company will evolve from a one product company into a company with multiple products in multiple geographies based on a truly groundbreaking technology within the orthopedic industry, that is our individualized technology. Slide 7 to 10 is a quick overview of the product portfolio that we either have in the market now or are developing. The first product is, of course, the Episealer Knee Implant System for the focal lesions in the knee, where we are driving the category creation within orthopedics that doesn't really, hasn't really existed for these kind of products before. The concept has been tested. The results vary quite a lot, and it hasn't really gained the traction that we now hope to achieve with our technology.

Now it works, our results are exceptionally strong, and there is a place for this in the treatment algorithm. The clinical and regulatory barriers are quite high for something like this, and that is what we have been focusing on now for well over 10 years, and we are now seeing that this is the prerequisites for a commercial rollout, they are in place. Similarly, can be said about the Episealer Talus implant. A concept that has been tested in the market with varying results. We think that our truly individualized technology now can enable these kind of procedures in a better way. Surgeons will appreciate this globally. We're creating a category of implants for treating osteochondral lesions in the talus. The Episealer Patellofemoral system, we are targeting osteoarthritis. The clinical indication is osteoarthritis.

This is a totally different market segment than our first Episealer Knee portfolio. This is a market segment for which there are alternative products. There is a degree of competition as the market segment is established. However, we believe with our individualized technology, we will be able to offer the market a very good alternative for these patients. We will, we believe we will be able to capture a good part of this market. The clinical and regulatory barriers are lower, relatively speaking, for entering into the market, but again, some competition on the other end. The same applies to the Episealer MTP system, where we go into the osteoarthritis market, meaning that the clinical indication for this implant system is osteoarthritis. This is an established market segment with no clear winner, and we believe that surgeons will really be attracted by our individualized technology.

For this product, we aim at submitting a 510(k) application in June 2023. As you can see on slide 11, we are now operating on a global scale. In the last 12 months, we've performed surgeries in over 20 countries. If I would highlight anything for 2023, I would like to mention that we are now really looking forward to the opportunities that we have ahead of us in India. We have people on the ground in India. We have a long list of surgeons who we are talking to, and I'm quite excited about our prospects in the Indian market. Australia is a similar situation. We're slightly behind India. We haven't done a case yet in Australia, but we are really focusing on getting a good footprint in in Australia, and investors will see some results from this during 2023. In our traditional home markets in Germany, the Nordic countries, Benelux and U.K., the strategy is slightly refined.

We made some changes to the sales organization, and these markets will continue to be important. We're also having high hopes for the markets, the other markets in Europe such as Poland, Italy, Spain, and Portugal, markets where we expect to take quite big steps during 2023. These expectations, they come from certain changes in the sales organization in these regions. We're now really putting the gear, the foot on the gear in also these markets. The strategy on slide number 12 is summarized as a full commercial focus for the Episealer Knee portfolio in Europe and the rest of the world. The Episealer Knee in the U.S., that is subject to our EPIC-Knee trial, the IDE clinical trial. As you've heard many times, the patient recruitment rate, they are lower than expected. It's been quite a big challenge.

We are still committed to succeed with this trial. We've had patients recruited during the fourth quarter, but we should recognize that this has been slow for us. We're happy to be able to launch the Episealer Patellofemoral System in the U.S. market already in 2023 to partly offset for the shortfall in recruitment we've had in the EPIC-Knee trial. We're actually launching a product on the U.S. market well before we were, we were originally planning for. I think that's a strength as a company that we've managed to develop this product and go for a commercialization so early. We are targeting revenues in the U.S. market, and we hope to see the first revenues during the second quarter for that particular product.

Episealer Talus is also subject to commercialization and certain clinical trials in Europe and rest of the world, that's a very nice addition to our product portfolio in those countries. The Episealer MTP system, we're targeting a 510(k) submission in June at the latest 2023, followed by a commercialization in 2024. There's a lot going on. On slide number 13, we've listed the largest shareholders and about 40% of the company is owned by the largest 10 shareholders. With that, I would like to say thank you very much, and thank you for your interest in Episurf Medical. As a final slide, I remind everyone about the Capital Markets Day that we ran in November.

All presentations by my colleagues and key customers are available on YouTube or on our website, and is well worth a couple of minutes of your time. Until then, thank you very much and have a nice weekend. Bye.

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