Good morning, everybody, and welcome to this presentation of Chordate's result for the Q2 of 2022. The CEO of Chordate, Anders Weilandt, will present to you, and my name is Joakim Eriksson. I will be your moderator for today. After the presentation, it will follow a small Q&A session, and you're welcome to ask your questions in the field down below or to the right, depending on your device. We will record this session, and it will be available on Chordate's website, Västra Hamnens website and YouTube channel afterwards. With that, I leave the word over to you, Anders. Thank you very much, good morning, everyone, and welcome to this short presentation of the Q2 and the company itself and where we are. I really would like to start with the basic numbers that we have reported in the report. They are as per usual on low levels when it comes to revenue. This is still a very fluctuating matter with this company. I would say in general still affected by the pandemic situation. We have seen activities starting up at various clinics around our markets, but they are still consuming from inventory they had before the pandemic. They are also suffering from organizational and resource matters caused by the pandemic. The revenue and net are very low numbers, and also very difficult to analyze or have any ideas about. Cash flow is, however, a cash flow, and that is slightly higher than the comparable quarter last year. This have resulted in a similar result, slightly lower than before on the EBIT and EBITDA levels. The earnings per share have improved a little bit, but there are also more shares out. That still has to be normalized over time. When we look at the first half year in summary, you can see similar patterns. Really, I don't have a lot of comments on this, unless there would be questions later. Let's quickly repeat for many and also inform about the migraine situation, and the migraine indication is our primary focus nowadays. It's a huge condition, a lot of people affected by it, and it's also very expensive for the society. Many of us have experienced migraine attacks or we know people that does. As usual, this is much more common among women than among men. It begins in early adulthood or even in the adolescent years, and it usually tapers down around the end of the active years in one's life. It can actually hit anyone. There are no understood reasons why an individual gets migraine. You can have twins that where one of the sibling have migraine, severe migraine, and the other one doesn't. We are particularly concerned with the most severe definition of the migraine community, and they are called chronic migraineurs. A chronic migraine is defined as having 15 days of headache per month, where 8 contains migraine events or attacks. The chronic migraine definition is important to understand what we're doing and also scientific side. How many would that be then in the world? It's quite large as a group. It's around 2% of the world population, and it's also so that it's similar in all areas of the world. There are no real differences between various cultures or genomes. It seems like it's evenly spread. In Sweden, that would be somewhat in the neighborhood of 200,000 people that have chronic migraine. The treatment for this is normally drugs, painkillers, onto more advanced specialized drugs such as the CGRP inhibitor family of drugs. It's very costly, as I said, for the society. The cost is distributed normally as 20% for healthcare and medication, and 80% in productivity loss, because you are usually bedridden or incapable of performing your work or continue your studies, whatever you're doing. It's really hitting your life quite severely. The average cost for a chronic migraine patient in Sweden is normally calculated to 120,000 SEK per year. We can take a look at how well the current therapies works. I present here a survey that was done in the US some five-six years ago, where they present that mere 40% of the migraine population are currently happy with their treatment. This is very difficult to treat. It's a constant struggle for the physician together with the patient to find a therapy that actually works. It might work for a number of years, and then it actually stops working, and you lose the effect of your current drug. You have to move on to the next level or the next drug to see if that also works. During the life of a migraine patient, they work together, the physician, doctor, and the patient to find a treatment that works at the current situation. This is, of course, interesting for us as any new treatment option will be met with a high level of interest and curiosity. Might this new thing be something that we can work with? The question here, if there are alternatives to drugs, what we are doing is exactly that. The KOS treatment, the Kinetic Oscillation Stimulation technology is meant as an option to choose or an alternative to drugs. This is what we've been working on for many, many years now, and we're now coming to a situation where we can start to see results relatively soon. The KOS technology is believed to rebalance the autonomic nervous system that is, for many, explained as the cause of a lot of the migraine situation. A lot of this is still unknown and still researched, but the scientific community interested in the neurology field and the migraine in particular are very active, and they present a lot of new findings every year. We mean to deliver proof of this effect that we have developed, and we will see these proof of effect coming out relatively soon. I'll get back to that. The company itself exists to help more migraine patients. That's what we do. We'd like to deliver a tool to put into the toolbox for the neurologists. We like to become an alternative to choose from or to combine with other treatments. The technology is developed and ready, and it's also CE marked, as many of you know. We will prove that this is effective. That is the aim what we are about to do. By doing so, this is a cornerstone of how we as a company deliver return on investment to our investors. This is our house. This is how we have constructed our strategy. It's based on R&D and innovation initially, of course. At the top, it is meant to generate an exit. We are building this to sell the company for our shareholders. This is the common way of delivering return on investment. This is a very, very focused company, with one technology, and it's not really suitable to build, a large company based on that. Our findings and our technology is best valuated when it's added into other portfolios in a global scale. The three pillars of our construction here is scientific evidence, it is IPR patents, and the final proof of concept in market. This is what our three simple things that we are trying to deliver with this strategy. Let's take a look at a few of these. This is our pipeline for building evidence. The most important one is the top one here, the PM007 study, which now are about to deliver its first results. This is a large migraine study. It's already completed. We will, the eighth of September, see the first results from this presentation. We also have a rhinitis study that we are still analyzing, that is coming out later this year. We have two new studies that are about to start. We are preparing for that, very interesting such. They will support the construct of the scientific evidence for migraine effect. The 009 study is a study on, it's a pilot study. It's an open study. This is aimed to study those that have exhausted all other therapy alternatives, including the very famous CGRP inhibitor treatment. Once they are allowed to get reimbursement for CGRP treatment, they have already failed on two-three, or in some markets actually four other alternatives before they can be allowed onto this very expensive CGRP treatment. It's reimbursed somewhere between SEK 60,000-SEK 90,000 per year per patient, so it's considered a very expensive treatment. These patients are normally basically forced to show results within three months of treatment or otherwise the reimbursement will be removed. When that happens, they have really no options left. We are studying that group that basically come out on the other side on CGRP treatment without any effect. We will study an eventual effect from KOS on these patients. If we show no results, there is kind of an equal situation. There is no loss for us if that happens. If we show some effect, it's going to be fantastic because that means that we give some of these patients hope and an alternative that might work. This will be a smashing piece of news if it happens. We can either just have a zero result or we can have positive result. There is nothing else in that study. We are very excited to see this. It's kind of a short, 25, 30 patients. It's run on one very prominent site in London, King's College. We will have results relatively soon. The last one, the 010 study, is also supportive of the migraine ambition here. It's a so-called post-market surveillance study where we study real-life effects on several clinics in several countries. It's about 200 patients, and the follow-up period is long. This study is designed for us to understand what a proper treatment regime should be and how you should actually devise the dosing of this study. We will learn a lot from this, and this is also an open study, so we will publish results as we go with some intervals. This is extremely exciting also because it will demonstrate real clinical life instead of a clinical study, which is always sort of synthetic in its setup. A little bit more on the 007 study. It's completed. It is a double-blind or sham-controlled, placebo-controlled study. We had a fantastic result apparently from the initial interim analysis that were published in 2019. Based on that, we were granted the CE mark, which is stunning in itself. Now, the German part of this and the German study investigators have put together a subgroup analysis of the German population. All in all, 97 patients, probably a few dropouts of that is not a study volume. We are still blinded to this. We don't really know the results yet, due to regulation and how study ethics is handled. This will be presented at a very prominent congress in London the eighth of September, called the Migraine Trust International Symposium. We are super excited to find out what they will present. This will have a great bearing on our short-term, mid-term, and long-term activities. The completed study is still analyzed. Data from the Finnish part, the last four clinics is still collected and compiled, and then it will be data cleaned, so we get the statistical analysis done. This will then result in a manuscript for publication, which will be submitted to prominent magazines in this specific field. Hopefully, we can even present the complete study data towards the end of this year. This still, sorry, remains to be seen, and it's also to a large extent depending on the editorial process at these publications. They are sometimes quite long and thorough. We cannot really predict how long it will take for these magazines to approve this for publication. Once that happen, we can go public with the results. This is the big thing. The zero-zero-seven or double o seven study is really the core of everything we have been aiming to do. The subgroup analysis on the German part will be a major portion of the study group, the population of patients. If that result turns out to be favorable or even good, then of course that has a great meaning for us. We can't help thinking that the scientists here probably wouldn't put it out on a publication at this congress unless there were interesting results. It remains to be seen. Over to a little bit of market, just for information. This is now seeing a little bit of shift in how we handle this. We have still the traditional distributor channel choice in a few markets left, certainly Italy and also Saudi Arabia, and in the Nordics. This has now been enhanced, and we have shifted over to actually retain local market access management in both Saudi Arabia, where we have our own general manager in place to handle all of the Gulf area. We have changed from a distributor situation to a market access consultant situation in Israel, as we recently published, as well as in Germany, and as we have communicated before, also in the U.K. Third, but last but not least, our joint venture partnership in Shanghai that is fully engaged and very active in the registration process of the rhinitis application in China for now. Still a ways to go, but very intense at the moment. These are the three models. That is how we go to market. The business model is based on its technology itself. We protect the business by making the electronic controller only work if you have a purchased code to feed the machine with. Otherwise, it will not perform a treatment routine. Such a machine can on one shift per day, theoretically produce 2000 treatments per year if you work it for eight hours straight. You can also note that the rhinitis treatment is probably one-two treatments per patient in a year, and for the migraine patient is three times more or even more in some cases. At the end of the day, this is a volume business. This is not a matter of selling electronic boxes. This is a matter of having treatments purchased and delivered to patients. Our strategy for the coming years and currently is as before, we are now building on the proof of concept. This is the market access project, very important for us. This will eventually, of course, leads to increased sales numbers. We've need to access the markets, first, and we need to understand the markets, and we also need to generate reimbursement projects to get nearer to a situation where this can be reimbursed from various sources of insurance. We're, as you've seen before here, continue to build on the scientific evidence base, which is very important. All of that is currently focused on the migraine indication. We will continue to get market access through product registrations in China, as well as in the US market with FDA, as we have communicated before. That basically concludes my short presentation, and maybe over to you again, Joakim. Thank you for that presentation, Anders. Let's jump into the Q&A. We have gotten some questions from the audience. First question is, how do you measure placebo with the KOS treatment, and how is the placebo treatment constructed? It is a sham treatment that is operated by the same unit and it's actually randomized inside the machine. You punch in a patient code to which the patient has been randomized and the machine will perform either an active treatment or a placebo or sham treatment. The sham treatment is validated to deliver a non-effect level of treatment. We haven't been able to talk about this before in public, but that means that the patient cannot tell the difference between an active treatment or a non-active treatment. To call it double-blinded, the healthcare personnel that delivers that study treatment shouldn't be able to tell the difference either. The validation of this has been very thorough, and we have used various types of quantifiable methods, including fMRI scanning of the brain to measure activity inside the brain to see the difference where the cutoff is for an active treatment and a non-active treatment. Lacrimation or tear flow has been such an objective measurement to define a threshold or a cutoff where we have non-active and active treatment. All right. Thank you for that. Next question is, did you get the CE marking based on the actual effect for the patients, or was it based merely on the fact that the KOS treatment is safe, not harmful? Well, sorry. In order to get a CE mark or an EC certificate, it's really that what it is, you have to demonstrate efficacy, effect. We didn't see that data. We were blinded to that too, but it was looped outside of the company to our notified body that had the opportunity to study the results at that stage. We can only draw conclusions from outside that if they, in their thorough examination of the effect data, found that there is a plausible and defined effect then that is the foundation for approving a CE mark application. In addition, of course, safety data from the same study to demonstrate that it is also safe for patients. It's a combination of the two, but you can't get a CE mark just based on safety. That is not possible. Yeah, why do you see the invitation to participate at the conference on the eighth of September as a good sign? Well, I mean, this is a subgroup analysis, albeit on a large portion of the total study population. I wouldn't think that any scientist would put their name on something that isn't interesting. Okay. As we are very close to the final results of the entire study, they would in that case have held off until we had the complete data. The logical analysis of this is that they have something to tell, and that it wouldn't be something that is negative. I think that would be strange. We are extremely excited about this. This may be it, basically. We'll see. I also always say science is science, and you quite don't know until you see. The eighth of September, and we will make sure to communicate what's said and shown, so everybody can understand it. This is going to be an interesting day. Another question relating to that is that this sub-analysis, it's still a very large group out of the total patients. How decisive could it be for the full study? What do you say? This will have to be an uneducated guess on my part, but of course, the Finnish patient population will change this result in either direction. I don't have any substance to comment on it, other than that it will probably change the complete data analysis, in either direction. Because you add a new group of patients, they come from a completely different healthcare culture, and they have different methods. It's also different, you know, in a sense that there ought to be some difference between Finnish people and German people. It's very hard to say what kind of impact it will have. Again, back to the decision by these investigators to publish this subgroup data, they must have basically taken that into account and discounted the risk that that effect is negative. We don't know what kind of effect level they see yet. I'm sure they've discussed that. Question relating also to the conference is, do you know yet what time the eighth of September results will be announced? No, not in particular. This is an abstract submitted to the Congress. It's actually also a late-breaking abstract. So the submission was sent in a time window where you can send in late-breaking abstract. That means that they will have to have a news value surpassing the level of regular abstract submitted for presentation. It will be presented as a poster, which is the main form of presentation on these types of congresses. We don't know when the abstract is published. It's also actually published in a sort of an abstract book by a publishing house and a journal. Called the Yes. A different question relating to the financials of the Q2. We saw the operational expenses that they were a bit lower than the Q1. Should we expect this level to be continuing forward or what's your comment on that? Yeah. The Q1 were unusually high compared to other quarters near term. This is more a move toward normality. This level is, I think, more normal for us than the Q1 was. You made some deals there in Israel and Germany and also previously in Great Britain. When you're moving to these kind of contracts instead of working with the distributors as you did before, what can you elaborate a bit on the advantages of this model compared to the other one? Yeah. We are basically gearing up to base everything on the migraine indication and hopefully then good results here coming soon. This have opened up the possibility to work with experts in the market. The rhinitis indication, as I've described before many times, is somewhat a fuzzy market, so there are no real market experts for that specific specialty. When you move over to the migraine headache and the neurology field, you have plenty of extremely talented experts with a lot of experience and also very impressive networks of key opinion leaders. So by doing this, we are seeking a situation where we can work deeper and closer and in more detail with each market through these experts. The big difference is that these people are working on our dime. They are under our contract, and they work under our management. This is like an extension of our marketing, effort and small organization. A distributor per se is basically its own entity. We can only advise and enthuse and try to trigger activities with the distributor, but we can't really direct how they work. This is completely different. This collaboration is much more profound and deep, and it's a joy actually to work with these talented people in these markets. It's only the opening of the market and the opportunity for migraine that have provided us with this opportunity. I'm looking forward to see this develop in all these markets and a few more perhaps. Yeah. You also have an ongoing De Novo application with the FDA. You were supposed to be in talks with them during Q2. How have those talks proceeded? They're ongoing. We've had productive interactions with the authority FDA. It's still in process and we will probably conclude that, as previously said here, early fall. We will learn more. The agency might have other demands on us that we need to assess. It's still ongoing, so we haven't concluded the discussions with the FDA. FDA is, compared to Europe, a completely different thing. We here talk directly to the authority that's also approving an eventual application. That is very different from the European situation where you work through a third party, the notified body, and you're not talking to the medical product agency in Sweden, for instance, Läkemedelsverket or anybody else. You don't discuss things with these kind of authorities. You discuss with their proxies, which are the notified bodies. It's basically talking to the right end of the system when you have discussions with FDA. It's really productive. The coming results now, how do you expect they will impact this application? In a way they will have a great impact. If the results are as good as we hope, that will have a positive, certainly a positive impact on these discussions. It may not be enough or may not be in the right direction, but it will certainly support it. If we have iffy or negative results from this, then of course that will have an impact on these discussions as well. Because then maybe FDA will require us to do further studies that are more specific to the U.S. market. Either way they will have a great impact and hopefully the latter or the first aspect that this will actually be enough. We'll see. We'll see. I don't see any more questions from the audience, so I will make one question more myself and if the audience have any more questions, please write them now. Otherwise, this will be final question and it's regarding what the new studies there with the CGRP failure. Can you elaborate a bit on that study how it's a small study, so when could we expect any results from that? We expect that to be a relatively fast study. We may want to wait until we have the complete picture, but it's also so that as it is an open study and if we see results that are worth publishing, we will do that. If, as I said before, we get any level of positive outcome of this, and then there are a smaller fraction of that population that actually have benefit from our treatment, then of course this is fantastic news both for healthcare and also for these patients. That also might change both the pharma industry and the med tech industry's view on this technology because then it will be an added value with this treatment where we actually can catch a different segment. It's too early to say, but this is a quite smart study actually to do for us now. You don't really have to do it blinded or anything else. It's just measuring if they have any substantial improvement in their conditions. That's enough in order to understand the value of it. We're looking forward to this immensely, basically. Yeah. Thank you for that, Anders. We're looking forward to the study results in September. It's gonna be very exciting to see them. Yes. Thanks for a great presentation and bye. Thank you very much. Thank you all. Bye-bye.
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