5/2/2024

speaker
Hans
CEO

Thank you very much, and welcome to this presentation of part-year report 3 for our part in our fiscal year. As usual, I will comment on the part-year report quite briefly, summarized in the third quarter. I will also say something about the previous emission that we just started last Friday, on Friday before the weekend. I would also like to say a few words about the remaining part of the fiscal year 2023-2024. Now there is barely a quarter left, so this will actually be the orientation for the rest of 2024 and the calendar year 2024. As usual, I have two slides that we always run and say something to those who may not have heard this before. The clinical problem that we address is called peripheral neuropathy. It is about nerve injuries, especially in hands and feet. We work in three areas, diabetes, vibration damage caused by vibrating tools, and we have a number of research collaborations within oncology. We like to talk about our future area, our pipeline, quite simply. Very many are affected by peripheral neuropathy and incredibly many, as you can see, over 500 million are in the risk zone. Problemet är att de som är drabbade av detta de lider mycket på grund av att nervskadorna upptäcks för sent och det i sin tur orsakas av att det finns otillräckliga och väldigt ospecifika kliniska metoder för att diagnostisera den här typen av skador inom vården. Det gäller inte bara Sverige utan det gäller även utomlands. Så det finns ett uttalat behov från vårdsektorn av mer precise and better analysis methods for diagnosing peripheral neuropathy. This is identified much earlier than what can be done today. Our solution to this is a technology that we have developed ourselves under the framework of the University Hospital in Skåne. It is a Swedish product, multi-frequency vibrometry is the name of the technology. In principle, it can be described as that we do We measure the feeling status on the head to early identify and also be able to follow up long-term peripheral injuries in hands and feet. We look at the period from the first to the 31st in the third and also accumulated during our financial year. we landed 2.8% lower compared to the previous year. The headline on this slide, a quarter with expectations and more, says the best about what we ourselves think. We are absolutely not satisfied with this. i den här perioden avslutades kunnat öka vår omsättning 6 kvartal i rad. Så det är lite jack i kurvan, men vi ser det som ett bump in the road, som man säger. Ett hopp i vägen, en liten kulla. Men ingenting som vi är oroliga över långsiktigt. Vi har fortsatt en ackumulerad nettomsättning under räkenskapsåret, som är 19,8 procent bättre än motsvarande period föregående år. Vi har fortsatt god kontroll över bolagets kostnader, våra finanser. Det kommer fortfarande intäkterna från försäljning av instrumentet som vi jobbar med givetvis, men också intäkter från löpande licens- och hyresavtag. And just as it has been now for a period of 3-4 quarters, the income comes in from above all work and environmental medicine, vibration scales in that area, but then increases successively within the area where we invest most right now, and that is diabetes. So about 35% of the income comes from the area of diabetes, but increases successively. And that is what we have actually predicted, but it will happen at a much faster pace. A summary of the quarter on diabetes. For those of you who have been with us before, I have kept these goals to remind everyone of the way we work. The strategy we are working on is to first establish reference clinics on a new market or a new country where we enter, where there are what are called Key Opinion Leaders, which looks like KOL in short. And what it's really about is the people who are relevant in the case of diabetes that other doctors are looking at, both nationally and internationally. It's important for us to hook arms with them so that they become our reference people and also our reference clinics. In short, our ambassadors on one or more markets. After that, we work to find a wider customer base and increase the use and sales of our product. During the quarter, we have also been forced to submit completions to our regulatory application for sales and distribution in China. This means that the time for approval is extended. We are waiting for approval, which we still strongly believe in, before the end of the year, during December 2024. I assume that there is one or two questions about this, and then we will follow up on this at the end, just like Tony was talking about, so we can answer more concretely about this. But I would also like to say that this is really nothing strange in a regulatory process. What has happened, what I have worked on for over 20 years now with medical technology, when you are looking for a CE mark for a product, for example with a German actor who is a regulatory body called TÜV in Germany, which probably many know, It's not strange to be asked for a complete application material. Unfortunately, it takes time, but we still strongly believe that this will pass. No doubt from the company's side at all. The second point is Sten & Diabetes Center Odense. I don't know how many of you know Sten & Diabetes Center, but two words about them. Highly ranked clinics in Europe. They are in Denmark. I think there are seven different places in Denmark. In Odense, we have a collaboration with Specific now. They evaluate our product. We have written a contract that is valid for six months. Their intention is, after completed evaluation, to introduce this clinically in their business. This can be very exciting for us if we go the way we think we want. We have worked for a long time at Steno. This is the result of a long process where we have had contact with Steno before we got to where we are today. We have also, according to the strategy we have, we are going out on new markets, we have to broaden our sales to increase revenue. We were at a congress in the beginning of March in Florence, it's called ATTB and actually it's a small tech fair for new technology in the area, specifically in the area of diabetes. Visitors, comes from all over the world. We had many visitors from the USA. Now we don't have any ongoing activity on the American market, or even a registration process in progress. But a very large interest, a very large interest from many countries in Europe, and also a part from the Middle East. This means that we have a number of leads that we are working on at the moment, both from end customers and potential distributors, But this often takes some time, and we've been actively working on this since we came home from that congress in the middle of March. So it's a lot of excitement that we have in the pipeline when it comes to ATTD. And during the last week we were at the corresponding congress in Västerås. It may not sound as exciting as Florence and an international fair, but a very good meeting. It's diabetic doctors in Sweden, and those who are toning. There were about 400 participants at that congress. I was there myself. We are now starting the follow-up work right here during the day with the contacts we have created. There is interest both from primary care, some health centers, but above all from the clinical care in hospitals. So hopefully more to come, even from that congress. A few words about vibration damage. We raise this so that no one will believe that we have forgotten our roots and where we come from, where we still have the largest sales this year. We have been working for about a month with market activity that is aimed at Swedish company health care, where we work with We are an external company to get new contacts and expand our business health care. We are in the middle of this right now. For those of you who have listened earlier, you may remember that we registered the product at the end of last year in the UK. This in itself means that we have generated an opportunity and we want to investigate where this can possibly take us within corporate healthcare in the UK now that we have a product that is actually cleared and ready to be sold. We have done a basic work during the last one or two months here. There are a number of contacts and we have also found a congress, a medical congress that actually not only turns to the UK but also to Ireland, the Irish market. and corporate health care with actors within these segments. We will participate in the middle of June and it feels very exciting because we believe that it can open up new opportunities. So we are working on corporate health care continuously and it is absolutely not an area that is so open, but we do activities there as well. Our focus for the rest of 2024 and note not only the fiscal year 2023-2024 as the last We still have three geographical main areas with priority. The Nordic region, as we have said, has opened up a bit in Denmark thanks to the Steno. Exciting. We have continued to work in Germany with activities and we are working with our registration, which will be very exciting. When we get it, we will be able to deliver it to China immediately. We are also working towards a scale-up and increased turnover. We are also looking at a broader establishment of more markets than these three geographical areas that have priority. And we are actively seeking to find national partnerships to sell and distribute our product, as we have always said. We have come to a point where we have a number of clinics in Sweden now, among others a few local clinics in Sofiahem, a private actor in Stockholm and also the diabetes reception in Lund. This makes us stand stronger and can be more interesting for partners to sell and distribute our product. Continued activities within business health care and also then the complete screening of diabetes continued in the Nordic countries and Germany, of course. Last but not least, as I said, regulatory approval förbereda produktlanseringen i Kina. Det är också viktigt. Nu börjar vi ha en dialog med vår partner UM Care som går in mer på säljaktiviteter. Vilken typ av material ska vi supplyen om med för att kunna sälja vårt produkt? Det blir en jättespännande fas som vi precis är på väg in i nu. Som ni säkert känner till, vi lanserade en företrädesemission som jag nämnde tidigare i fredags i förra veckan. Vi har en täckningsperiod that runs between the 19th, 4th and 65th. What we offer is a unit that consists of a B-currency and an option that is attached to that currency. The technical cost is 1.50 and at full coverage we can get a maximum of 26.1 million for emission costs. Related to the option, there is further opportunity for almost 40 billion kronor through the attached option and the resolution of that happens in May 2025. If anyone is wondering how we are going to use this liquidity, we will work towards increasing sales. Almost 70% goes to sales and marketing, especially in diabetes, but also a part to oncology and Havs. It is a strategic approach we have chosen when it comes to priorities, that we will keep up the company's business for faster expansion. Both, as I said earlier, broader commitment to export, to focus on finding partners on new markets, but also strengthen ourselves internally, resource-wise within the area of sales. Otherwise it will be difficult to increase sales. So this is in focus for us when it comes to liquidity from emissions. I just want to remind you again that we have a large number of customers who use this product, so we are in an exciting situation. We have talked about this year of breakthrough during 2024. We still believe in this and the countries where we have established so far are the ones you see on the map. But as I said, we are also looking outside these areas and will do it even harder in the fall. A few words at the end. Secured financing. A crucial step to expand is why we choose to implement a pre-emission or new-emission in this situation. We continue to increase the turnover of the company, but we must grow faster. Thank you, that is our focus. The upcoming capital grant will certainly allow us to expand faster, but also to invest in the way that we want to do in order to grow faster. We haven't talked about it, but there are, apart from these conferences that I have mentioned here in ATTD, which is coming back this year, but there is also a possibility in the Middle East, but then it is required that we take a step out of what is called Arab Health, which is held every year in Dubai, where there is a way in, both when it comes to end users, i.e. customers, but also distributors to the Middle East and those markets around there. So a broader commitment to export, we strengthen the resources in sales, And of course, a lot of focus on ensuring regulatory approval in China and being able to start sales. This was my presentation today. With that, Tony, I don't know if there are any questions.

speaker
Tony
Director of Regulatory Affairs

Thank you very much Hans, good presentation as always. We can start by saying that it is good to ask questions now. There are two options here. There is a small icon on the screen called Q&A, Questions and Answers. You can write in your questions there, or you can do it via chat. There is also a chat icon, so you can choose it yourself. Let's see, I can't figure this out. I can only comment on the regulatory process in China. As Hans said, you can never know exactly what will happen and what questions will be asked. At the same time, the process in China has dragged on due to Covid-19. The test institute that has tested the product arrived too late. But we had hoped that we would be able to come to terms with this time, but it has turned out that when this last step comes in, when we are going to get a review from their Chinese authorities, NMPI, then they also have a long way to go, so that's what has happened. But as it is now, we really expect that we will have this done in December this year. The next point is what we are waiting for in June. Then we will get what is called supplementary notice. That is, a statement from NMPI, where they either say that it's fine, it's good, we will get a certificate, or they will request completing tasks. To be realistic, we expect that they will request completing tasks. After that, we have 12 months, but the plan is that within three months, UMKR will be able to respond, so that we will be able to get this certificate of NMPE three months later. So those are the steps we have.

speaker
Hans
CEO

I just want to say one thing, Tony. It might have been obvious, but I don't think it's a misunderstanding. If we were to get more comprehensive questions, as you say, it means no extension after December, necessarily.

speaker
Tony
Director of Regulatory Affairs

Correct? No, it has to do with... I have a dialogue all the time with Young Care about what they think will happen. They have a little idea of where they think NLP will ask the questions, and we have already started to prepare to be able to answer that.

speaker
Hans
CEO

So in the timeline we've talked about, we've also taken a step up.

speaker
Tony
Director of Regulatory Affairs

Is that what we're saying? Absolutely. You might not want to speculate, but if we're lucky, we've seen the forecast in June. But I don't think so. It might be a bit too optimistic. I've got a question from Erik Lundberg. Hans mentioned that you have a lead on a distributor. Can you say something more about that? Which one or which market?

speaker
Hans
CEO

No, we can't. It's the easiest answer. You can't do that. It's as simple as that. We've said this before, both in the press release and in the quarterly reports, that we want to expand, in addition to the three prioritized markets that we work with today. Nothing strange with that, really. ATTD, which we were part of in Florence, is moving from different countries. We've had it on the radar for a few years now. Now it's really time, because this is one of the opportunities to get in touch potential distributors. And we have had a number of people who are interested, with whom we are in dialogue. But you know, everyone who works with businesses, to have a dialogue, it can lead to something positive, but it can also stop. So I can't say anything about it, because it's too premature, the discussions we have with these potential distributors, quite simply.

speaker
Tony
Director of Regulatory Affairs

Ja, det är just vad det är. Det är ju Leeds. Och vi vill inte i förväg gå ut och säga namn, name dropping och så vidare. Det är dels en förhandlingsfråga faktiskt, men också ifall det inte blir någonting så har man öppnat upp någonting.

speaker
Hans
CEO

Om jag får tillägga bara, jag nämnde det här med Odense också. Odense har vi jobbat, jag kommer inte ihåg exakt hur länge vi har haft en dialog med dem, men under en ganska lång period. Där väljer vi ju att inte The dialogue itself is nothing that says that it is a business, but it is first when we have some form of concrete collaboration that we can communicate something about it, just as we have done now with Odense. But this is like, what shall we say, normal operational business that you have discussions all the time with potential customers, new or potential partners in the country. So that's where we are.

speaker
Tony
Director of Regulatory Affairs

Yes, there is another interesting aspect with the word C. Many people talk about it, and it is on high levels here. They talk about the need to change the approach to taking care of diabetic patients, especially with the foot problem. So they use this term called one-stop-shop. This is one of the words we are trying to implement. What we want is for patients to come to the hospital once, and then do all the examinations, and then it should go quickly, and then they should be able to meet the doctor. This saves both the patient's time and their own administrative time at the hospital. So that's something that Modus is working on. And it's essentially the same concept that the endocrinologist in Lund is trying to develop. So with that, I thank you. Thank you very much.

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