Hello and welcome to this presentation and Q&A with CS Medica. With us today we have the full management team. First there will be a presentation and afterwards a Q&A where the management team will answer questions submitted via Stokk.io. There have already been pre-submitted questions on Stokk.io and the Q&A is still open so that you can submit questions live as well. I will now hand over the mic to CS Medica to start the presentation. Your line is now open. Thank you very much and welcome to our webinar regarding our Q4 2023 financial report and our highlights. So I would like to begin just to reframe what is our purpose. We are developing and manufacturing and selling and we are challenging how to treat pain autoimmune disease and stress-related disorders. This is really our purpose. When we look into the market as we see it as of today there are some challenges. You have the pain management autoimmune stress-related disorders are not just growing categories within the healthcare but it's also evolving new research and patient needs and also there's also churn trends. The pharmaceutical industry of course covers most of the pain treatments, but however the trends towards more care models combining drugs with a variety of non-pharmacological intervention gives a new trend towards more natural-based non-side effects to a noticeable trend towards the evidence-based complementary and alternative medicine. So we are working in four areas. We have the skin disease disorders. We have the joint and muscular and the respiratory disorders and the Dermaceuticals. So we provide an alternative evidence-based treatment option using the therapeutic value of the cannabinoids. Our technology and portfolio surpass competitive CBD-infused products as we have legalized registered substance-based medical device with the Cannabidiol under the regulation. Here in Europe we are following the MDR. In the U.K. we're registered with MHRA and in the United States we're registered by FDA, Indian FDA, and TGA in Australia and the Health Ministry of Israel. We have the four of our different categories within pain, skin protection, night, hair and the vet, and the newcomers, upcoming sports category. Solutions and inventions which we have on the market we already by Q4 2023 we have the nine launched products. We have still 13 active in our pipeline. We have 7 products in scope where we utilize the already R&D cuts that we have already incorporated. We have 10 medicines to come and a rate of upcoming dermaceuticals on a idea stage. The vet portfolio and the hair portfolio are on a make-to-order manufacturing strategy. So the highlights we have seen in the Q4 report as of today we secured the patents in Denmark for our CANNASEN Nasal Protect Gel, CANNASEN Wound Gel making advancements in our intellectual property portfolio with now 3 patents. Our CANNASEN® trademark was registered in Australia and goes well hand in hand with the registration with TGA. We received the FDA authorization for commercialization of eight products in the United States as a testament of our quality and safety and efficacy that we can provide in our documentation. We gained the Indian State FDA approval for the two cosmetic products and our subsidiary CANNORDIC India Pvt. Ltd. In China our joint venture with RongShi Medica focused on the Asian market. The delays in the Chinese FDA approval process have addressed by exploring alternative routes. Gitte, you are muted. You just need to unmute yourself. Sorry, sorry. Following Lone's explanation of the activities in this quarter, we are seeing the reflection of all our activities in increased net sales, and also the consolidation are finally reflected in our financial figures where we see a reduction in this quarter in the administration cost of 40%. That means that the operational loss in this quarter compared to last year are reduced from 4.4 to 3.8. But more impressively is the sales where we last quarter in 2022 saw a sale of only 70,000 DKK whereas in this quarter we have raised the sale up to 1.7 million DKK. That is the result of all our initiatives and growth strategies that we have elaborated on this full year of 2022-2023. The result is now finally reflected also in the financials. That is an area that Mikkel later on will dig a little deeper into how we are seeing the sales in the coming quarters as well as the pipeline. We are still struggling with the liquidity in the short term where we have a negative cash credit in the bank at the end of the quarter of DKK -2.2 which we subsequently have finalized with credit lines and loans from family and the two co-founders meaning Lone and me. Besides that we are looking into alternative funding in the short term as well as in the long term. We are trying to figure out ways to get the money out of China. We are still focusing on how to solve the different issues in regard to the approval from the different authorities in China as well as finding alternative routes for our long-term funding as well. We are looking into different options where we also are looking at how we can optimize the circulation of the share in at Spotlight meaning getting more liquidity in the share and more knowledge about our share and performance in general. We are again looking into more solution due to the delay in cash projection and more information about this will follow as soon as we have news through press releases. You are muted. Sorry. Muted. Classic. Thanks a lot for adding in the highlights, Gitte. Yeah, we're happy to see a quarter where we actually execute on all the order intake, all the agreements made in the past, and all those supply chain setups that is actually rolling. Now we're getting products out there primarily within Europe still. It was and it has been a continuous subject to discuss during these web calls. Why don't you sell in Europe? We do, but we do also see high interest coming from outside Europe. So we try to balance that when we do the order intake. I'm happy to see that quite an amount of products actually delivered within Europe in this last quarter, and we can see, yeah, approximately just above 70% is actually Europe territory, and 50% plus are actually recurring customers. That is quite an important part for us to see that not only is the order intake we manage to get the supply chain running we have delivered the products but also customers of ours but also patients testing our products coming back and repurchase again as an extremely crucial factor for this scope of business that we're doing where we need to build up a customer base and we need to build up a patient base which likes the product get the efficacy that they're asking for and coming back for more products. So that's extremely positive. We have an order pipeline growing also for this quarter DKK 0.6 million. And within this quarter by the end of 2023 the order intake was still amounting to DKK 12.2 million. We are now signed up contracts undergoing either sales registrations or licenses within our customers of now plus 25 countries, and 80% of them are within the EU. Yes. You could also say, in regards to the pipeline, that even though a lot of the pipeline from last year was converted into actually net sales where we invoiced, produced, shipped, then you keep filling it up all the time, so we're working short-term and long-term as well, which is why it's important to think not only Europe. Exactly, and we'll come back to that a little bit later when we're looking at the outlook. I'll put a few notes to the current order pipeline and how that looks also after the Q1 2024. But true, true that, yes. Yeah. Which actually also leads me to this slide because we do get a lot of questions in regards to why you're spreading so much why you're working in the U.S. and why you're focusing on Malaysia. Well, first of all, as you can see in terms of our registrations we are able to sell and I know Suzan you will come back to that. You're probably one of the very very busy ones next to Mikkel on that one. When we started it was based on Europe because we're under European MDD moving into MDR. But when we get people or future customers who are approaching us in regards to them having an interest in our products we are not saying no. We might say no if they don't understand our product and they think we are prescription-based or medicine cannabis or anything like that. Or if they wanna dump the prices and not understand where we are. But if they have a need in the market and it matches our purpose to actually deliver improved or alternative treatments to people who have symptoms or or have issues and conditions within our territory which is autoimmune diseases we are not saying no. And as you can see a lot of people in the world have psoriasis a lot have arthritis even pain. You can have pain from sports work doing a wrong anything. So that is our main focus. So when we are contacted from Jordan or if we're contacted from other regions even the U.S. for us we thought the U.S. were in 1 or 1.5 year right Lone? Because that's really really difficult to enter and get FDA approval. But when you work with local people who has an expertise and the match is perfect and the vision is the same then sometimes things speed up. So that is why when you look at the map in regards to Europe and you see where are we registered where are we initiated and where do we wanna start. It's very much based on a pull strategy as well. So as you're saying most of the revenue is based on a customer base that is less than two years old. So of course we haven't had recurring customers or orders coming in when they have really high amount of the MOQ is high to take the order. But we see now they're coming back and they have three or four times orders. So now we see it works. It also the consumers more than 500,000 have the products in their hand. So I think it's very important for you to understand why we launch as we launch and why we have initiated even in Malaysia when you come into it Suzan in a sec. Malaysia was based on a contact but it's also based on the fact that it is one of the most important entry points to Asia as cross-border. So yeah maybe you should talk a little bit about the new strategy for compliance because we have been able to actually have this as a core DNA together with our R&D. But before we go into it I just wanted to wrap up on the operation as well. Because for us it's very very important to be agile. Everybody knows the fact of our financial situation. When you have constrained resources both in terms of people resources but also in terms of financial, it is difficult like a lot of other medtechs to actually expand and scale. A lot of startups have the issue to scale when they want to. We see the impact coming in. We have shifted our focus. We have reflected. We have also learned coming back also to where we are. So over 80% of our revenue as you can see in this quarter comes from Europe. It's the short-term lead to market. We have also revised a lot in regards to our standard operating procedures. We also communicate in an annual report and previous CEO letter that we have onboarded supply chain people. So it has been where we have focused and now we see we have actually reduced the lead time to market by 30%. So we are picking up speed. Now if we had the financial in our back right Gitte then we will probably have a lot more speed. We have reframed the way we of course we communicate but we also reframed our operational performance. We are a very small team doing a lot of the same things as big pharma. We have the compliance. We have the R&D. We work with CMOs. We have audits from notified body. We have go-to-market. But thankfully we we are agile and we're with the new strategy B to B to C we're onboarding a lot of really amazing partners as well with boots on the ground on local markets. So yeah so I think that's why you see a development in the performance as well. And then finally you have all also probably heard we have onboarding a new board members. A new mix of finance legalized input but also international market understanding especially for China which is also helping us as a team to navigate and be even smarter with all the resources or few resources we have. So now Suzan, you have the pleasure to talk about compliance. We are still working to obtain MDR CE Mark and the ISO 13485 with the BSI. We have already planned with BSI about the submission date of the technical file for reclassification and certification of the product. According to MDR for Pain & Arthritis we will submit the technical file August 2024. Wound 2025 January. Nasal was May 2024. Nasal Spray Night January 2025. The Pain Patch and Psoriasis will remain classified as Class I under the MDR and the technical file has been updated with MDR requirements already. As Heidi said our new compliance and market strategy establishes a strong foundation for introducing additional regional products. As Lone mentioned we have registered already eight products under FDA US. Three medical devices Pain Patch and Nasal Spray Night. Two cosmetic products and three VIT products Pain Patch and Pain & Arthritis. We have already registered two cosmetic products in India. Recently our Nasal obtained registration in Malaysia market, a significant step towards penetrating the Asia market. This important approval not only brings the product to the market but we overcome the complex regulatory barriers in Asia with CBD. We are very proud to register this product in Asia in Asia with the. Nasal in Malaysia, we are in. There's also registered in with FDA registration. Yeah the. Yeah. [Foreign language] Sorry. Yes. I think Mikkel you wanna. Yeah, I'll continue with the strategic outlook. So again we exceeded the expectations on the DKK 1.5 million in the last quarter of 2023. And as also stated in the CEO letters lately we are also exceeding the DKK 1.7 million as a turnover in the last quarter which is the Q1 2024. So again we are growing; it's not just a one-off. We have been building up for this pipeline. We've been accelerating the supply chain. We really changed the strategies. We revised. We analyzed how to do things smarter and better. And actually now we see the fruits and actually still keep pushing keep building even though we had the turnover of the DKK 1.7 million in the Q3 2024 and exceeding again in Q1 2024. We still see a current pipeline of DKK 14.4 million. So is that gonna turn into turnover tomorrow? No, it's not because we still need some registrations. We still have partners need of licenses. We still need to do productions. But now we see a steady growth in turnover, and that is very crucial for us. And also in the order pipeline. And again we see even closer collaboration and closer ties between the registration that Suzan does and whatever is supported by external parties as well. And the turnover ending up as sales in countries outside Europe as well. So that's quite important. Yeah, we have quite a focus on countries for registrations in 2024 as you can see. And that is generally based upon interest of customers. So, as Heidi said, again, we don't just go out there and hope to get a registration in Azerbaijan if we don't have a customer in high demand for our products. So this is targeted towards our customer needs. Yeah, we aim to reduce the production lead time and that can be done in many ways. We'll come back to that as soon as we have news on that part. And then for the clinical trials, yeah, again, we have quite an amount finalized last quarter. We have some good things going on for this quarter. And then we have also the target for the Wound gel. I don't wanna deep dive too much in that clinical study, but naturally we need to find applicants to succeed within the study, so that is the aim for this year. Yeah, I don't think there's much more to it on. I think Lone or Gitte, if you have anything to wrap up before questions. Nope. Nope. Then, Anders, I think we just dig into questions right away. Perfect. Let's go directly into the questions and start with the first question here. We are a good part into Q1. Can you provide any information on how Q1 has been for you without putting any numbers on it but just a business update? business update. Yeah. Yeah, maybe just from sales. I can let you know that we've been having quite a busy Q1. That's very good in many ways. We did announce a few press releases on things going on. We did also in the CEO letter tell you guys and let you a little bit know about the turnover which is exceeding the turnover in Q4 2023. That's all I wanna say. I don't wanna put a specific number but we are exceeding the DKK 1.7 million just on the turnover. We had quite a success on the order intake which you guys can know from delivering both turnover and having still high order intake year to date. Yeah. Yeah, just to, as we're working close on go-to-market in that sense, Q1 has been refreshing looking back in 2023 in general. Also, you saw how many things we actually implemented in that year. And that has, that's kind of starting to pick up in Q1. It's no doubt that the pipeline of DKK 14.5 that we had in 2023 by that seeing being converted also gives us an opportunity to focus on something else to build longer term pipelines. So we're having both short and long term which is actually what we see in Q1. And Gitte, maybe you have something to add in regards to anything else on the development but from commercial point of view but also on operational points of view. It's picking up versus what we've seen the last years based on the new strategies implemented. Yes, I can continue on that one. Yeah, we are still consolidating the company and looking into how we can optimize the few people we are and the activities involved to reach our growth level as we are aiming for. But we are still consolidating and on top of that, like I said in the beginning, we are concentrating very much on finding solutions on the short- and long-term funding alternatively to the Chinese funding which is delayed in the money transfer. And again we are aiming for finding solutions that also will optimize the liquidation and circulation of the share. So that is the main focus within my area in this quarter as well as going forward until we have found the perfect solution for the current situation of CS Medica. Then moving on to the next question. It's a bit in the same direction. Can you provide an update on how your pipeline looks for this year? Yeah, I think maybe I already answered that question in the previous answer. Yeah, again, we're looking at a current today order intake of DKK 14.4 million. And that is including the execution on turnover delivered in the past two quarters. So naturally yes, we are picking up. Yes, we are delivering from the order intake coming from second half last year. So that's yeah, it gives us confidence. And we are happy to see this is actually rolling. And we're happy to see happy customers getting new products exciting to launch in the market but also customers coming back reordering even maybe before delivering because they actually managed to have a success on the pre-sales. So just imagine that if you have an order intake first then you need to do the registration, you actually have a 3-4 months production lead time. Those customers they go and they actually visit the pharmacy chains they visit the key opinion leaders and they start the initial pre-booking of sales. And maybe even before delivering products they come back to us with the success, we discuss how to manage and how to succeed on delivering the amount that is actually needed. And maybe that is shifted maybe that's changed a little bit due to success. So we actually have customers coming back reordering even within months which is quite fantastic. So we just need to of course always support these customers and reevaluate how to do things smarter quicker and better. And that's what we are currently doing with the optimized and focused strategy. I think also the sense of, as I mentioned just before, the fact that having a pipeline that is being converted right now also kind of how we work is that then when the order is placed Mikkel he goes in of course and then we look at where is the compliance can we just start production right away or do we need to have Suzan's team on board. So that's kind of the lead time that we work with. But also based on learnings we have of course also optimized the processes but also how we work which also means that it goes faster. The fact that we have also shifted, so for example, I help Mikkel in the go-to-market overall and Suzan on compliance, but the minute that it goes into an actual order that needs to be a production and invoice, then we do short term and long term. That's also how we split to make sure, due to also we've been waiting a long time for financial support, we need to make sure that revenue starts to pick up. We really focus on the resources to say okay fine how can we decrease the artwork timeline how can we decrease the production timeline how can we be smarter how can we make sure that the registration goes faster. Those are the things we also see is happening right now. We also found partners that is able to crack the code on some of these things as well. So Mikkel can continue to fill up the pipeline. So it's kind of a path that is much more fun to work with than the last four 2023 to be honest. True that. Then we are at the last submitted question here. The question is when do you think that the money from China will arrive? That's you, Gitte. Yes, I was just unmuting. That is hard to predict, I would say. We have used a lot of effort try to crack the code of getting money out of China. We have help from foreign affairs in China from Beijing and now also latest with our new board member Jesper Hallé who is focusing exact on this area trying to find ways and help us with these challenges within the Chinese investment agreement and especially focusing on getting the IPR transfer agreement with the DKK 4.9 million out of China which has been in process now since November. So this is our main focus. We are looking into alternative fundings while doing this which should secure the funding especially on the short run. Perfect. That was actually all the questions today, so that finalizes the Q&A. Before we end the webcast, I will just hand over the word for you for any final remarks. Yeah, I would like to just end the webinar with what is the take from today is that now we are start seeing the fruit of the consolidating that we have done within the company. We are seeing that the sales is picking up. And more important, our pipeline of orders is growing and also the compliance part that we have cracked the code how to get forward with the registration. Thank you.
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