Iconovo AB (publ) (STO:ICO)

CMD 2021

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May 26, 2021

Most welcome to the 1st Capital Markets Day of Ekonovo ever. This is, of course, a milestone, and we are very happy to have you with us. We are broadcasting live from Malmo today, and you might be anywhere in the world. So as you probably noticed, ICONOVA has been releasing a Flow of interesting and promising news the last few weeks. So we have a lot to talk about today. I will be your guide through this event. My name is Amanda Termejern, And I run a communications agency called Spronkommenikachon. We are specifically aimed at sustainability and innovation, and those are 2 of the topics We are going to talk about today. And about the speakers, eco nove has a strong management team, And some of them will be presenting here from the studio. And just to get you some insights on their backgrounds, I We'll tell you a little bit about them when I introduce them, since this is a strong team that together has the competence to take into a successful future. And for you viewers, you have shown great interest in this event, and we have received quite a few questions in advance, but But it's not too late for you to pose a question. You can write it in live chat just close to the video window where you are seeing us right now. You can do it any time during the event, but we will gather all the questions and answer as many as we have time for at the end of the event in the open Q and A session. By then, you will have learned a lot about EcoNovo, and I will give you a sneak peek into the agenda for today. So we will begin with CEO, Johan Werborg. He will tell us about the company and the newly released strategy for the next 5 years. Then you will get to know some more about the basis of the company, which is the generic products from CTO, Orest Lastov and Vice President, Business Development, Rogge Lassing. They will also brief us on the innovative inhalation projects, increasing potential earnings for the future. And then we will turn to the new business area, Economo Pharma, presented by Johan Werborg, but also CFO, Anna Gallon. They will also sum up The corporate strategy before we take all of your questions and move into the Q and A session. But first of all, I want to introduce you to someone So please welcome into the studio the new Chairman of the Board, Gunnar Gordermeer. Thank you, Amanda. Nice to have you. And Gunnar, I would like To tell our viewers a little bit about yourself, what is your background and how come you chose to take a seat on the Board of Economo? Pleasure. Well, I've spent close to 40 years in Life Science, primarily then in Biotech and Pharma, Amelio also then building organizations, companies, a lot of marketing and sales strategy and business development. And hopefully, some of this could be sort of an experience that is valuable for Equinovo on the growth journey forward. I was very excited when I got the call from ICONOVO about 18 months ago about joining the Board at ICONOVO. As I started out as a product manager at Astra many years ago, and one of the things that I did was to launch Brick and Hill Torb Heylo. That was a very exciting experience for me and also something that have since then Made me very interested in the inhalation area. I then moved on to Nykomed, A little bit of a company that grow from a Northern European company to a global company. And in that function, I built MarketAxess. I built Business Intelligence and some other group functions. I was also responsible for sales in the rest of the world, including China. And the last thing I did was then to be part of the group that sold Nycomet to Takeda in 2011, Business of about €9,600,000,000 I moved on to Targovax, which is a Migno Collodi Company, where I raised $38,000,000 and also took care of an IPO in the Norwegian market. And I am since then focusing then on board work and part of 3 other companies in Sweden focusing then on Oncology. Thank you. A little about you and so much experience. So welcome into Economo. Thank you very much. And we will get back to you shortly with more questions. But now I want to hand over the stage to the CEO of EcoNovo. He came to the company a year ago, bringing valuable experience in international strategic business development. He has a wide commercial background with experience from Pharma Marketing, Business Establishment and Business Development with strong growth in a listed environment. So please Come into the studio, Johan Berg. Thank you very much, Amanda. And Johan, this past year, you've used your experience to turn Equinor's focus from product innovation to Commercialization. And today, for the first time, you will be expressing Equinor's future in numbers. So please take the stage. Thank you. So I'm very pleased to be here and to welcome you all. IConovo is a company that is -Deeply rooted in inhalation. And we have the bold vision to radically transform inhaled Drug therapy by providing unique devices and tailored dry powder formulations. And today, We would like to take the investor view, and I would like to introduce you to ICONOVO today and the start of this Capital Markets Day. And I want you to get a good view of our business model, how it's scalable and flexible. We also want to go through the platforms and projects. And don't worry, you will have enough time to dig really deep into this today. Well, I want to pay special attention to in the beginning here is the 5 year guidance that we published only a few days ago. So financial targets for 2026. And I also want to delve into the new strategy of Generics, innovation and pharma sales. So to start with, Iconovo develops and out licenses complete inhalation products, and they are all based on our Proprietary platforms, and we have 4 platforms today. We have ICO Cap, we have ICO RES, ICO 1 and ICO Pre. And we create value for you as an investor in this very interesting intersection Between medtech and pharma by addressing enormous global markets around the globe. And We do this with an attractive business model that works as well for innovative products as for generic products. And we by now have a portfolio of projects, and therefore we can offer a quite controlled risk. And of course, we wouldn't be here if we don't have a great customer offering as well. So customers Around the globe, contacts Equinovo, and they want to see us because very few companies around the globe can actually do what we are doing today. The company was founded in 2014 around Device Development and Design. As you have heard, probably a lot of people working in AstraZeneca Today, working in ICONOVO. And Orest Last of whom you will meet today was one of the founders of ICONOVO back in 2014. And they founded the company around device design. Another department that we built around this It's the competence around the powder and the formulation technology. And then we have a third department With analytics so that we can all the time test and make sure that the powder ends up in exactly the right composition And that the inhaler and the powder is working perfectly together. So the Iconova offer is that we develop pharmaceutical formulations optimized to our inhaler platforms, -And we then make an exclusive license agreement for a combination of the platform, which is one of our inhalers, -A drug of the customer's choice and in one of the territories that the customers would like to launch in. And our customer offering is all about reducing the risk and reducing the time to market for Companies around the globe and the way we do this is by an integrated way of developing the pharmaceutical product. So we develop the platform, -The inhaler in parallel to the formulation development. And once we are done with that, we make a technology transfer To the customer here illustrated in blue. And when they take over, they make the pharmacokinetic trials Under registration, trials needed. They make the logistics set up, the production, and eventually, they are the ones who are launching this. So from the launch, Sean, we will receive revenues in terms of royalty. And that is also a key part of the revenue model of ICONOVO. It's quite simple, actually. I mean, in the beginning of collaboration, We will receive a technology access fee, and then we develop the project over a couple of milestones. And then in the end, when the product is launched, we will get our fair share of the profit as a royalty or a profit split. Today, we have a comprehensive product pipeline. This is the latest view on the Pipeline, it has changed quite a lot recent weeks with some new additions. So I will take you through it from the top. But you will get enough time today to really get into these projects. But from the top here, you have the 2 ICO RES projects, which is the one with Amneal and the one with Intas. In the middle, you have the ICO cap project, which is for Altebro and Seebri with B&C Korea. And you have the global partner in Stevanato, which have the global license to market ICOCAP -And also they have production facilities. Towards the end there, you have IKO 1, which is The single use inhalation device that we have primarily for innovative - Pharmaceuticals. There we have Monash University with oxytocin and we have the COVID-nineteen project -Together with immune system regulation. You can look at the bottom there. You see I added -Something that we made public only last Friday. We recently initiated a collaboration with respirators as well, where we will Make a feasibility trial for a or a feasibility study for a COPD drug in ico-one as well. And the last line there you see ICOPRI, which is our very important strategic endeavor -And our aim towards the Ellipta portfolio and the U. S. In 2025. -Quite comprehensive. We will go through it with you. One other thing I would like to lift on this page is just The second column from the right, where you will see that we are entering a very interesting time in Acconovo's Story where we will actually see about 3 of these products entering into clinical trials this year. So we have a board which is you have already met Gunnar, the new chair of the board. I'm very pleased to welcome him to the company. And we have a comprehensive, Wide, very experienced Board with a lot of experience from both retail and pharma industry. I would like to pay a special welcome to Ann Giedno, who is new member of the Board of ICONOVO as well. To the right there, you have the leadership team of whom you will meet several persons today. You will meet Anna. You will meet Orest. You will meet Roger as well. And we have Michael Lorender in Operations and Michael Ekstrom in R and D. Iconovo is a listed company. We are on NASDAQ First North in Sweden, And we did our IPO in April 2018. And today, we have a cash position at the end of Q1 Of SEK 53,000,000. We have a market cap today of around SEK 550,000,000. So I would like to introduce you now to our long term strategy. This is A strategy that we have been working on for a couple of quarters, and it is really the strategy that will propel us into Very successful future, and it maximizes the value that we see that we can get out of the company. So it's a 3 pillared strategy. We have, 1st of all, the generic area, which is an interesting area Which we are established within. It was the strategy that the company was founded around. It is a lower risk area And in area where we can be faster to the market. We have the innovative space, which is really interesting. It's a bit higher risk in those projects that we Launch into here. But the rewards on these innovative projects are enormous. And this is also the area where we see the highest growth potential within this, these three strategy areas. And the 3rd pillar is the pharma sales. And really here, it's all about tapping into capturing the full value of our innovation. So these three sections will kind of act as the menu for today or the agenda for today. So you will See us go through each and every area. A few days ago, we also, for the first time, Gave you some numbers and some expectations that we have on the future. So our 5 year guidance was issued. And our 5 year targets that will come from this long term strategy is that we in 2026 will have reached A SEK 200,000,000 revenue that will come from royalties, milestones and our own Nordic sales in 2026. And a very important signal here as well is that we plan to do this with high profitability, And we are aiming at the 50% operating profitability in 2026. So we come from an historic stable growth where we have grown our company from increasing the number of projects we do. We can receive more royalty payments. What we do now with the new strategy is that we are really building A foundation to capture maximal value from what we know how to do. And This will all start with this strategy and be fully released in 2023 when we plan to launch the first products on the market. So in 2023, We will have global generic royalties and also the start of the first sales revenues from the Nordic region. In 2026, when we reached the SEK 200,000,000, around a third of that As an indication will come from Micronova Pharma. So it's quite substantial part that will come from that. And the rest will come from A mix of royalty and milestone revenue from Amneal, from Intas, from B&C, from Stevinato and ICOPRI projects that we today have Made publicly, known and that what's that's what we are working with. But even when we are here in 2026, I would I'd like to say that we still have a lot of greenfields ahead of us. We will see the next phase of the generic launches starting. All of the things that we will do within the Aiko Pre portfolio basically will come from 25 until 2,030, even beyond. We will also see many of the innovative projects that we are launching today will be launched hopefully in the market in that space. And also when we have built ICONOVO Pharma, leveraged, launched our Products within that, there will be a lot of growth within that company as well. So on top of this $200,000,000 we have defined Two additional areas as upsides. We see a SEK 70,000,000 Swedish Crown's potential revenue upside from the sales of Symbicort in the in U. S. A. So this will happen if generic Symbicort sales is established in the U. S. The other upside Is potential revenue of SEK 100,000,000 from the COVID-nineteen vaccine that we have a collaboration with ISR around. In this area, there are high success rewards, although a lower probability. So a closer look on the U. S. Market will tell you that this is an enormous market as most Markets in the U. S. Are. So Symbicort is a $1,000,000,000 market. Actually, in the U. S, you have the spray version of Symbicort and not the dry powder that we offer. But you saw a growth last year at 23% in this market. May have something to do with the COVID pandemic, still it's a really good growth in the world's biggest market. The other upside we should take a bit closer look at is the COVID-nineteen -Vaccine from ISR. This is a possibility for us to launch an innovative inhaled project A bit earlier, as you know, with COVID, we have to make every effort to put this on the market as soon as possible, and we promise to Make every effort so that ISR can have the best possible timelines to build their caisson. And this could even trigger an earlier profitability point for Aiconovo. The probability Success, as I mentioned, for for all our innovative projects will be somewhat lower than for generic projects. So from An iconovo point of view, we need to build a portfolio of innovative projects so that we can increase the chances for us to success with some projects. When you are developing pharmaceutical products, of course, The risks are there, and we have identified the main risks and most of them are on this page. But we believe that We can balance most of these risks with our business model, with the wide strategic width that we have within our company. And the very important thing that I would like to point out that I put a lot of a lot of emphasis at is that we want to build a great company that people want to work in. It's a knowledge company, and we take pride in developing the individuals who work in ICONOVO. We also gave out some guidance on what we think or what we aim that our company should look like in 2026. We aim to be a company that is still a lean, effective and highly competent organization. We will be around 50 employees. And we see that with a new agreement tempo at around 1 to 3 annual agreements, We will have a project pipeline of around 10 projects, and we see that we can launch 5 products in by 2026. So this generic partnership launches will have triggered also then 5 royalty streams to us. And this is the approximate timeline for this. We will see in 2023 the AIMED launch at Amneal, IQOS generic in the EU. And shortly thereafter or simultaneously, we will launch Iconova Pharma Symbicort Generics in the Nordics. After that, in 2024, Ultibro and Seebri will launch through B&C Korea, And we have a generic Relvar U. S. Launch planned for 2025, 2026. -And you also see Intas with an undisclosed product here being launched in the later part of this period. So many, many things to come. Another very important thing for us at Taikonovo is sustainable development. And we have, -For the first time this year, really made an effort to put clear targets on what we want to achieve within This area. So we have identified 3 areas, good health and well-being, decent work and economic growth and climate action As the 3 target areas where we want to make a difference. And by 2026, I would -I see that we can we will have clear achievements -To show within each and every one of those areas. So to summarize it for you, Our 5 year targets is that we aim to reach 200,000,000 revenue in 2026, and we will do that at the high 50% operating profit. And we see 2 upsides, 70,000,000 in U. S. Symbicort And up to 100,000,000 in the ISR COVID-nineteen vaccine. Thank you. Thank you so much, Johan, for showing us the potential future. And I would like to ask Gunnar to come back here as well to talk to us a little bit. So Gunnar, both you and me and the viewers, we have now listened to you, Juan. So which challenges and opportunities do you see for EcoNovo in the near and long term? Yeah. Well, if I may start with the opportunities, I see a lot of opportunities for Icodovo. We have the people. We have the flexible business model. We have the innovation And we have the newly launched Nordic concept. So the people, I mean, we have very competent innovators and product developers Focusing on an underserved area, I mean, inhalation product in general and respiratory field. So I think that we can do many great things going forward. And I mean, we see the weakness of sort of the past here on the table. And I think that going forward, we will see much more innovation from Equinero. So I think that that's Great opportunity. Then the flexible business model, we have 3 different legs to stand on, both the So the specialty generics, we have the innovative products, we have the Nordic sales. And that means that we both have enormous growth potentials in all of these three areas, But also very de risked business potential. So if something slows down in one area, we can speed up something In another area. So I think that's a strength as well, an opportunity. Then you have innovation. We have seen the free agreements we have now Recently had with Monash ISR, Respiratory, that shows also that part of the business model is very interesting and actually works. So we have now Sort of proof. And going forward, we can see, of course, much more of those kind of more aggressive business development Tune it to materialize, so I think that, that will also boost Equinor further. And last but not least, we have then the Nordic sales, Which I personally believe a lot in. I think that the market is big for inhalation products in Scandinavia, Nordics. And we have, of course, also heritage from Astra, AstraZeneca or Astra Drako. We'd also What we use in Scandinavia, this is very high, and we can capitalize on that. And how about the challenges, a bit shortly? Yes, Shortly. Challenges, I think primarily it's to explain the business model. The both the innovation track and The Nordic sales are quite new to the investors. And I think that we have to explain that in more detail and how that sort of complements then the generic sales. That's great because that's why we're here today. Yeah. Yeah. And Johan, for the first time, you are predicting the future in numbers. Why is this the time? Well, the time is Right now, because I mean, we are we the last half a year, we have made a lot of agreements. So a lot of things have happened. We have been able now to launch this new strategy and made this public. Also, the customers that are Kind of leading the commercialization process. And Neil, they are getting ready with their production and everything. So we think it's the perfect time now to both Explain this complexity and to explain also to the market what this great opportunity may lead to. And Gunnar, can you just tell us a little bit about how should a board work for this company, developing company, Economoevo? Yeah. Well, first of all, I think that we have seen a little bit of change in the board. And I think that, that started by the company realizing that you need to move sort To form an innovative start up to a more sort of commercial setup. And that's reflecting maybe my sort of bringing on myself and Adas into the board. So now we have a large board, and that board also reflects everything that Johan said, I mean, from retail to life science, business development And other skills that you actually need, I mean, for the next part of the growth journey for Equinovo. And this is actually an unusually large board, but there is a purpose then? Yes, I think so. I mean, we have 9 board members to totally today, but I think that we work very well together in From committees and so on, focus on different areas. And we think that all of this competence together can maybe help management Also bringing this company to even greater potential. Even greater potential. That's a good place to lead this Discussion. So thank you so much, gentlemen. And we will get back to you later. But now we will turn our eyes to the technology which Introduce to you, Doctor. Orest Lastov. He is a Chief Technology Officer, the founder and innovator of the technology platforms. He worked more than 15 years for AstraZeneca when they were world leading in developing inhalation technology. Thanks to his broad knowledge spanning from chemistry via physics to mechanical design, Economo today can offer a unique range of inhalators. And together with Orest, you will meet Roagela Singh, Vice President Business Development. He brings more than 30 years of experience in pharma and biotech Into the company, he has actually been the global brand manager for Symbicot, the product which Equinorvo is now following up with a generic version. He has specific experience in the realm of combining drug and device, and this is a unique selling point for Economo. So most welcome, Orest Androorge. Thank you very much. Nice to have you. And Orest, you will introduce It's your generic product range, and there will be something similar to a world premiere, right? Yes, absolutely. Exciting. And Roager, you will tell us about the markets waiting for Konnoros products, and also about an agreement that suddenly doubled the market for your predicted bestseller. Perfect. Yes, I will. Great. So gentlemen, I leave the stage to you. Thanks. So Welcome everybody. And I'm very, very excited to present IQ OPRE to you. It is The most advanced and most innovative product that we have ever developed. It's a device that really reaches far out and has the Potentially to be best in class. It's a device that we developed to be similar to the Ellipta device that It's a major portfolio product portfolio of GlactoSmithKline and that Has a great potential commercial potential that Roger would talk more about. And we have developed it to be Similar in all ways that is required for being approved as a generic version. But we have also added some features That will give us differentiation and some benefits to the users. And those two things are An inhalation feedback and load feedback feature, which means that when you this is what it looks like. So when you load the device, you will get a visual feedback. It's loaded, ready for inhalation. And after inhalation, you get a feedback that you have inhaled in a correct way. And I believe this is a very strong feature That will promote our device over our competitor. One thing that we Had to decide very, very early in the development was which route to take. There are 2 obvious ways to Go when you do a generic device development. 1 is to more or less copy of the original. And this is the route that most of our Most of the competition to us are taking. So they're doing something pretty much identical to the original based on the same technology. And they're using aluminum strip that is in the Ellipta device. But this technology is protected by Six different patents and locks out really pretty much those devices until 2,030. So we decided to take a different route. We have our own technology, which is based on injection molded disc And we have a new technology to open the cavities and disperse the drug, and we have our own patents. So by doing our own technology, Our own inventions, I think we get a great advantage of our competition. Another thing that we have that I think it's very, very important when you develop this kind of product is that we have all the functions, all the capabilities in house. So we have device development. We have formulation development. We know how to do the filling and the heat sealing that you need to do. And we do all of this In concert. So it's a true concurrent product development where everything is done jointly by the same team In the same facilities, in the same labs. And this gives us a much better understanding and much quicker problem solving, Much more innovative solutions, all of that. Many companies doing this kind of development have device development done by 1 partner, Technology firm formulation development by 2nd partner, the heat sealing filling developed by Additional partner and this makes them spend a lot of time on coordination and Bringing those technologies together, we have all this already in house. We start off very aggressively. This is our biggest investment ever. So we developed the device, but we also developed all the formulations required to match all the products in the Ellipta portfolio And which means that we develop 5 different formulations at the same time. And if you combine them, you actually get 7 different products. What we focus on primarily today is the Revar, which we spend most of our time because that's the product First being off patent. So we have already in development formulations required for all the products and the RevPAR products, we have gone The 3rd. And we also already are very happy to show you this because this is the first time we show real results. So those are results from our device with our powder compared to the original Ellipta. And as you see, We have very, very close performance. We are very close to meet the equivalence criteria of the product. But of course, a lot of work remains. We need to do all the different process optimization, all the testing, all is a lot of work remaining, But we are at a very, very good start and a really good position to move on. Roger? Thank you. I'm going to take you through some market understanding, also some of the competition. And the reason we're developing ICOPRI is that we want to target the future largest inhaled generic opportunity that exists, And that is the Lipta portfolio from GSK. The product portfolio had sales of $3,500,000,000 In 2020. And it showed a growth rate of 20%. If you're looking at it, There are at least 3 really big opportunities, which is RELVAR, called Brio in the U. S, TRELEGY and ANURO. And if we want to really capture the full value of this opportunity, we need to go to the U. S. Market as well Because the U. S. Is half of the opportunity. And we saw that was a really good growth rate, and that will continue to grow. And it's expected that in 2025, this will be a portfolio of almost $5,000,000,000 And of course, we can only launch our product once all patents have expired. And we are here looking at A combination product of a substance and also of a device, which means we can only launch it once All patents, valid patents have expired. And as you can see from this table, there will be a lot of Patents on the Ellipta device that will actually stop companies from launching even if substance patents has expired. And the most obvious one, that's RELVAR, which where the substance patents lapse in 2025, but it will still be protected by -Additional device patents for the Lipton device. And we aim to be ready to launch it 2025 in the U. S. It's also important to know that 2025, that's when the patent expire in the U. S. We will only be able to launch in Europe a few years later, but they have some patents that last a bit longer. So here, we're looking at the launch in 2027. And if we're looking at this opportunity, because, Of course, this is a big opportunity, also attracting other competitors. And we can really see 2 categories of competition. One is competition where the device will have the same handling as the Ellipta device. And then there could also be coming Competition from other type of devices have a different handling. If we look at these two categories, We decided to develop a same handling device, which is IQPRI because that will be substitutable at the pharmacy level. So you don't need to have a doctor to prescribe a different product. That will not be the case for the other type of products. We can also see that if it's operating the same way, the patient acceptance will be much higher because they will know how to operate just by looking at it. And we have a dual cavity system as the other in that category. That will also give an advantage in the development because you can develop, for example, if it's a 2 substance Product, we can do one powder for each active substance, so it will be a much easier and lower risk development path. And if we're then looking into the ones that have aiming for the same strategy as we have, We have identified 3 other companies doing it, and that's Vectura, it's Merxin and it's Coelise. Vectura has already partnered with Hikma. So if we're looking forward, that is not a competition for new partnerships to IQONOVO. We don't know the status for Merxin and Coelis because they are private companies. There are no partnership announced. But like I said, they are not on the public market, so we don't know for sure. We have capabilities similar to Vectura. That means that we are developing the device, but we are also doing the formulation. And in this project, we are actually aiming to do a final inhalation product that works. That is not something that Merxin or Coelisk can offer because they are companies that are aiming for Making devices, they don't make formulations. So they need to find a partner to do that and have that potentially a bit more cumbersome development, -As Orest was just describing, how we do it in an integrated fashion. And our big selling point, as I see it, is also that we have A non blister solution. We have designed our own internal design, which will really lower the risk If not removing it completely, for potential infringement to GSK patents. And that would make us a much easier way forward. I also would like to address the opportunity because, as I said, this is the biggest And in 2025, like I said, this is almost €5,000,000,000 and you see that on the pie chart to the left. And here again, U. S. Will be about half of that size and Europe will be 1 third. So there is also a big market outside of U. S. And Europe, which we Tend to focus on. And of course, how big share can our partner get in the future? And given the landscape I've just described and the fact that we aim to be in the 1st wave, we believe it's reasonable To capture a market share of at least 10% to 15%. And if our partner would capture that type of share in the market, If you're looking in the middle part of the graph, we think our partner have the potential to have sales between 700 And, 500,000,000 US dollars, which is a significant opportunity. And here we also expect to get terms similar to what we have for all our current generic collaborations, Which means that a royalty between 5% 10%. So if you then apply those numbers to our potential partner sales, you can see In the table to the right, that our sales is basically can be ranging from 24,000,000 to 70 4,000,000. And this means like from 200,000,000 to 400,000,000 Swedish kronor, and half of that will come out of U. S. And then the last thing, looking a bit about the partnering process because we don't have a partner today, And we're already talking to a lot of interested parties. And of course, these are customers we've been talking to historically as well for a lot of other opportunities. And in parallel, we're doing the development at full speed. And this is what we'll continue doing 2021. And when we have data sufficient enough for our customers to be willing to make an agreement because this is a high investment game for them as well, We will have the data to convince them that we have fixed and have a good product, which is equivalent. And that means that we will have a partnering process running during the first half of twenty twenty two. We aim to do it as quickly as possible. But at least what we're saying is that in the summer of 2022, we should be able to have an agreement in place. And if we're looking at our current development plans, that means that as soon as that agreement is signed, we will be able to go into the 1st pilot trial, Seeing if this is really equivalent in patients as well. And that will then be the end of 2022. And then we will start doing all the pivotal work, Which is required to file a registration file and be ready on time. And we will then work in parallel to support our partners in Process scale up, tech transfer and optimization. And we're looking for a partner that have a size and geographic reach. So we want them to have a big footprint, at least including U. S. And Europe. Of course, the financial terms we are offered will be very important. And ideally, they should also be focused on respiratory because this is a special area, not only for developing the products, but also for running the clinical trials. And of course, we're looking for someone who is willing to take the whole portfolio, so we can take all the products we've talked about to the market with 1 partner. Thanks. And now I think we will move on to IQOS. Orest? Thank you, Roger. So IKEA ReS, my pride and joy. This is the first inhalation device that we developed. It's our most important one, and I call it our flagship. And this inhalation device has brought us So the very, very important Amneal deal and will also be the inhaler 1st on the Nordic market with our own name on. So this is a fantastic product that I'm Very, very proud of. And when we started off developing IQOS, our ambition was to have something that's Equivalent to AstraZeneca's turbohaler. And we wanted to have something that looks Similar and is handled in the same way. So it will be easy to for patients to know exactly how to use it. So it will be truly Exchangeable. So based on that, we developed something that has the same performance, same kind of Features, same kind of formulation, etcetera. But based on our long, long experience from AstraZeneca, Knowing what the limitations and weaknesses of the original Turbohead are, we added some very, very important features, Features that we believe will give us an advantage over the original and definitely a strong advantage over our Generic competition and will also make our patients much more confident in their use. The first thing that What's maybe the most important one? It sounds simple, but it's extremely important for the users. That's the dose counter. When you use this product Every day, you want to know how many doses you have left. And in the Turbohaler, you have an indicator showing, as you can see in the slide, It's somewhere between 81100. That's how accurate it is. So you don't really know how many doses you have left. And you cannot really see That when you have operated that it has counted down because it doesn't really move. We have an accurate Counter, which counts down every single dose. So you know exactly how many doses you have left and you can see Directly that it has counted down. So it's a very, very important feature, and it's something that the patient, clinicians, Healthcare providers has asked for decades, literally for decades. Now they will have that in IQOS. Another thing is indicator providing feedback that you have operated the inhaler correctly. When you use the turbo hailer or the IQOS, you twist back and forth and you inhale. The amount of powder is so tiny that you cannot feel that you have inhaled the powder. You just suck on it And hope for the best, if you may. And that's also something that is deeply troubling For many patients because they want to know, did I do it correctly? Did I receive the dose? And in many cases, they do it And extra time. So they take 1, 2, 3 extra doses just to be sure. And that's really, really bad. So we have a visual indicator showing when you have loaded, it's ready for inhalation. A closed window is ready. Powder is prepared. When you suck on it, you inhale it. You can see a change In the window, it opens up and gives you feedback successfully in Malaysia. You have received the drug. So this is something that would provide Safety, comfort and a lot of improved compliance when using our drugs. So we believe this is would be very, very strong differentiating factor. Also, when we started developing IQOS, we were aware of that what the trend is. The trend is Towards electronics, connectivity, mobile health, etcetera. So eventually, someone would Ask for electronics in IqRS. So we developed it in a very, very modular way. Today, we have The counter and the feedback features as one mechanical unit like in the attic of the device. If a customer would like to have electronics instead, we can easily remove the counter, the mechanical counter and replace it with batteries, display, etcetera, etcetera. And that will give us an electronic version of IQOS. So we are prepared to do it. We have partners that we know are able to We provide this service and it would be able to be combined with apps. It could be General apps or proprietary apps specific for our product. So this is a way of preparing IQOS for the future. Roger? Thank you. I'm going to continue at the same path, but for different products. We're going to look at the competitive situation for Symbicort, so the Amneal project. And this is actually a market where given how long it's been generic, there are very few competitors Who have entered the market. So today, we see you see HALO launched by Orion and Spiromax from Teva. And as you can see from the image, they are not really looking anything like turbohaler. They are operated and handled In a very different way. And we see that as a major and a unique opportunity for launch in IQOS. This is the only truly same handling device inhaler available when it comes to market. If we're looking at it, we have also, on top of that, added features just described by Orest, Which will make our product even better than the originator. And what is also very unique to IQOS is that we have 2 reservoirs, which is a very good way feature to have when you're developing various strengths of a product, Which we are with our Symbicort generic Symbicort, IQOS. And I also would like to take you through the market here. This is still a $3,000,000,000 market. This includes both Symbicort, but also the sales out of generic products because we feel we can Successfully compete with them as well. So it's not only about taking sales from the originator. And Here, what we can see is that U. S. Is about 1 third of the sales. Europe is another third. But what is often forgotten is that there is also a lot of business coming from the rest of the world. Here we have done work with PVC. And looking at it, That a market share of 10% is reasonable given where we are still launching 3rd but with a better product. And then like Johan was saying, U. S. Is an opportunity. It's 1 third of the global market, But it is a spray formulation that is available in the U. S. So it's not a turbo halo we would compete with. So that means that we have looked at that as an upside, But it's still part of the potential. So if we're then looking at how much sales could Amneal potentially make If they are so successful that they can get a 10% market share. And if you're looking at the bar graph in the middle, You can see that Europe is, as we've said for a long time, about USD 100,000,000 opportunity, But there will be another 50,000,000 coming from rest of the world. And if U. S. Also would come true, That would be another €100,000,000 And then it would be all the way up to €250,000,000 And we have communicated here as well that we have a royalty between 5% 10%. And if you look at the table to the right, you can see what that type of sales that I've just described would translate to in royalties to IQNOVA. So for the ex U. S. Territory, where we would compete with Turbohaler, we see there is a royalty potential. So that is royalty income to IQ Novo from 8,000,000 to 16,000,000 U. S. Dollars. So that is roughly 70,000,000 to 140,000,000 Swedish krona. Then on top of that, we can see that if everything works in our favor, the product would be launched in the U. S, That would be another $5,000,000 to $10,000,000 as an upside. And just to give a bit more Flavor to what is happening in the market. I would like to share 2 pieces of information, 1 linked to Europe, 1 Link to U. S. To the left, you see the market shares in EU. And In generic products, usually you lose market share very quickly. But due to the fact that the competition doesn't really have A comparative inhaler, they are eating share. They are also today somewhere in the range that we expect, a bit above 10%. And Turbuz halo still have almost 70% or slightly more than 70% of the market. So there is a lot of business still to Be captured in this market. Also coming back to the uncertainties in the U. S, there is litigation ongoing, as always, for big selling products. AstraZeneca have prepared for a generic launch, and we can see that because They have launched what is called an authorized generic, which means that you have a company launching your own product as a generic offering. We feel that is something they have done because there have been ongoing litigation. The latest we heard was that Stryzheniga was successful in protecting it. But in general, I would like to say, when it comes to patents, that is like a living creature. There are always developments to happen going forward and uncertainties. Here I also would like to say a few words about the process. This is a much more developed opportunity. We have developed the Or finalize the development work for the product that will go into a pilot equivalence trial. And that is being prepared as we speak, and it will run during this year. And if that all look Good and well. We will go into a pivotal trial immediately. So that is a registration trial. And then After that, it's another waiting period because there will be a 12 month period to get a regulatory approval. That is the normal approval time. And that would mean that we can launch in 2023. And we're already working with Amneal on the scale up of manufacturing, So they will have enough volume to sell once we get to the market. And with that, I would like to end The discussion about IQOS and move on to the capsule part. And this is IQOCAP. This is our capsule inhaler. It's got some superior handling features, Mostly connected to its robust design. And here we have can have many various Variations and customizations for our customers. So we could have a transparent cover. And The one that Stefaanato is developing is actually a blue version. And looking at the agreements we have For ICOCAP, we have an agreement with Stevanato Group. They have the license For global manufacture distribution and sale, so we wanted a partner that can help us sell this product on a global scale. We will receive royalty payments on their sales for 20 years. They will pay royalties because we have a patent protected design. And we are continuously supporting Stefano to sell this inhaler to their customers Based on our experience in inhalation. They have made some progress on the regulatory front since we handed this over to them. So they have ensured that we have a CE mark for clinical trials in Europe, and they've also filed something called a class 3 Drug master file in the U. S. With FDA, which is something that a developer later on can refer to That's covering the device part of the registration file. We are expecting to see sales Kind of near term, I would say, but they will probably start coming in at a rather low rate because a lot of that sales will go to clinical trials Of customers to Stefanatoo developing products. And later on, once they launch, we will see larger sales. And it's important to understand that this is a business where they only sell the inhalers. So there is no powder. There is no capsules. It's strict selling this inhaler. And there are competition to separate inhalers. Of course, there are originators. That's Presaler from Novartis, and there is the Handihaler from Boehringer Ingelheim. These products, as I see it, are products Where we want to steal away the market. So from that perspective, they are not like direct competitors. The big direct competitor, That's Ares01 from Plasti Appe or I think it's which is part of Berry. And there is also a company called Presspart, which is currently launching an inhaler called Powder Plus. So these are kind of global competition that we're facing. On top of that, there is a lot of local competition, especially in Latin America, where there is a lot of local suppliers of various capsule inhalers. But the big one, which everybody refers to, is the Plastiap RS-one. So I would like to compare ICOCAP to RS-one rather than all the others. And they are both low resistance devices. So it's very easy to inhale from inhaler. We have the same number of steps, which is an advantage if you're doing a generic product. But then if you look at the outside, we have purposely decided to develop an inhaler With a more robust design. And we have also an integrated outer cover. If you look at RS-one, it's very easy to lose a cover. That cannot happen with ICOCAP. And for a lot of products that are launched in many markets, there is too many RSO1 in the market, Which means that they will be looking for a way to differentiate the product and that can be icocap. This is a smaller market than some other markets because it's just for the inhaler. It's not for the formulation. Now no good numbers, but our estimate is that this market is worth 185,000,000 U. S. Dollars. And what is a bit different to other markets is that it doesn't sell in the U. S. Basically. And Europe is only 1 third And the rest is in Asia and Latin America. And given the situation I just described, We believe that a 12% market share is something that Stevanate should be able to reach a bit more long term because they will have to Get into a lot of different products and different customers. But that still means that if we're looking at potential sales of Stevanato, Looking at the middle part of the slide, they can probably sell something between $20,000,000 25,000,000 And like for most of our generic agreements, we have a royalty rate between 5% 10%. And that means that the potential for this agreement is in the range of 1,000,000 to 2,000,000 U. S. Dollar. And this is only for the inhaler. So we also have an agreement with a company called B&C Korea. And this is for the formulations that will have will be used in the IQOCAP together with inhaler. And this is the license to manufacture, sell and distribute these 2 formulations in icocap. It's for a territory where there lives a tremendous amount of people. And The larger part of that is Korea, Japan, China, Taiwan, Russia Sys and Southeast Asia. There are 2 generic formulation. So the originators would be Ultibro, indacaterol and glucopyroneum and Seebri, Which is a glucoporonium, a mono product. Here we will receive mid single percentage Royalties on sale for 20 years. And B&C, they will actually get the inhaler by buying it from Stevanato. So in a sense, it's a two way royalty stream. And here we look at, given the patent situation, that the first Launch will happen in Asia in 2024. And looking at the market opportunities, this is the addressable market for these two formulations. And Altebro and Sebree is an opportunity of more than 600,000,000 U. S. Dollars, as you can see to the left. The agreement we have with B&C is not covering the majority of the potential. That still sits in Europe. And that's an area or an opportunity we're still talking to various partners about partnering for. But if we focus on the Asian territory, that's about 13% of the total. Again, we aim to be in the 1st wave Generic products, think that it's uncertain. We have some order of entry models that we're using to estimate market shares, and here we feel that 13% to 20% could be reasonable. And that means that we're looking at a potential sales by B and C Of 10 to 16,000,000 U. S. Dollars. And Japan is part of that territory. It would be very important For us, they are successful in Japan because that represents more than half of the opportunity. But assuming that they're successful with that And looking at royalty rate is mid single digit. We have translated that to 4% to 7%. And that would mean that we're looking at a royal potential, so sales to IQR Nova of 400 to 1,100,000 U. S. Dollars. And here, I think it's important to understand that we still have the biggest opportunity left to exploit by finding a partner for Europe. That is covering all our generic projects. And I also know there is some interest about how well do we now cover All the generic opportunities. And we are actually well covered, in particularly If we're looking and including IQPRI, where we, of course, still have to find a partner. But we have our generic Symbicort in IQRS. We have the IQ predevelopment covering the Ellipta. And if we're continuing down this pie chart, We have Bre Sailor covered by IQOCAP. There are 2 big opportunities left, which is basically happening now, and that is A generic opportunity for Seretide and Spiriva. And then there is approximately slightly more than 25% left, where we hope we can find some good potential opportunities to exploit. And with that, thanks for Listening to the part on generics. And we will move into Q and A. Thank you so much. And I don't think we have time for the questions, but you've given us a great deal of answers without us even asking them. So I will actually ask you to continue to the innovation segment of EcoNovo, providing different and more complex challenges than the generic section, but also perhaps even greater opportunities. So once again, Orest and Roger, please tell us more. Thanks. Okay. Thank you. So we move on to the innovative field, which is probably the one that's Growing very rapidly now in our company and it's all around IQOS 1. And I would say that IQOS 1, That's my favorite. It's a really, really cool gadget. It's one dose only. You pull the tab, you inhale and you throw it away. And this is perfect way to inhale drug that is Today, given by injections. So we believe that the IQOS one could ultimately eventually Replace injections. And to be able to do that, we made it really, really low cost. So it's very simple, very cheap to produce. So we can really compete cost wise and address Segments and countries where cost is very, very important. And We accomplished this by having a really simple design. And you can see it to the One side, you fill the drug in the cavity, you seal it with aluminum foil and then you close it. And The really brilliant thing is that it's only one part. So it looks like this when you fill it, you put powder it, you fold it, snap it together. That's it. So it's just one plastic part. It couldn't be any simpler. And there's nothing like it on the market and we are really Unique in providing such a low cost and simplicity. And even though it's very simple, It has some really clever technology inside. And it's based around technology or invention of ours that we call reversed vortex dispersion, Which means that on top, you see this is like fluid dynamic simulation. So red is high velocity. So you have air passing very rapidly on top, Creating a strong, strong vortex that is actually reversed to the direction of the flow. And this strong vortex breaks up The powder and disperses in a small, small particles that can eventually be inhaled. Excuse me. So on this technology, we build this very, very clever device. And since it's a dry powder, It has very clear advantages over injections, which is a liquid. And all injections today are Requires cold storage. And probably you know now in COVID times, the Pfizer vaccine requires minus 80 degrees storage. You can just imagine transporting the drug from the factory to the clinics, all of this handling And keeping minus 80 degrees. Our powder is stable in room temperature. This is what it looks like when you distribute vaccines in rural areas. You use coolers or ice boxes. And you can only imagine that How difficult this is, how expensive, how cumbersome this is and also how do you really control that you have maintained the exact Temperature required to keep the drugs stable. So not only is it very expensive and difficult, but the risk is obvious that When you receive the drug, it has been exposed to heat and it's damaged. And the worst thing is probably if you vaccinate people With damaged drug and they don't get the protection that is intended. Another thing that is very, very Important to address that with IQOS 1, we don't need needles. And needles And up like this in some parts of the world. In Sweden, we have special containers and they go for We'll be taking care of a hazardous waste, but in some countries they end up in the trash, on landfills, etcetera. And then there are scavenged by people Cleaning them in best case and selling them on the black market. This is also a huge problem, huge challenge with injections. With IQ1, no needles, no hazardous waste, no safety issues. So When comparing injections to IQ1, it's obvious a massive advantage with IQ1. It's simple to use. No medical staff is needed. It's much, much lower cost, no cold storage, no hazardous waste And it delivers very, very fast to the lung, which means a very rapid systemic uptake, which you don't get with injection. So the advantages are massive. So this is our way of changing the world. It will take a while, but we will get there. Roger? Thank you. I would like to say a few words about the benefits of inhaled therapy. And when we are now reaching out to innovation companies deciding what customers to talk to, we, of course, need to think about What are the benefits that we are offering within health therapy? And we have expertise, And what we're really good at is getting basically very small compounds, smaller than 5 micrometers Down to the lung, because if you can't get it down to the lung, it doesn't matter. And that is what we are kind of aiming for. And if you can deliver a drug to the lung, you will have a much higher drug concentration in lung, Which is important if that is where the problem exists. Another advantage is that A lot of things that could be swallowed like tablets, they first pass through the liver after being absorbed in the body. And liver is really good at breaking down things. So there is a lot of things like all the proteins that you simply can't take as a drug Or at least we would need to give really high amounts because the liver would destroy them. And that you can avoid by giving the truck to Belang. Another benefit is that once you get it to the lung, I mean, this is a place where oxygen and carbon dioxide is exchanging very quickly. And that also means that a drug coming to the lung will be absorbed very, very quickly Into the system. So if you're looking for a fast onset of action, inhalation is a perfect way of achieving that goal. And of course, if you're looking how we are constructed, once the drug is absorbed In the lung, it will go straight to the heart and from the heart out to the general circulation. So it means that you can treat any other organ as well By getting it absorbed quickly in the lung and then getting it out by the heart pumping it out. And that means that we can achieve the same thing and properties as aiming for when injecting things. And also by giving it through the lung, you can again get it into the circulation and avoiding The absorption of the intestinal, which is very often breaking down a lot of products. So these are the 3 areas where we focus Our attention and what customers could benefit from these advantages. And we've been looking at what type of indications or disease areas where this inhaled innovation could bring value. And when you're targeting the lung, as I said, usually want to separate the wanted effects in the lung From the unwanted systemic side effects. And by giving it to the lung, you can reach that. And that is the traditional reason for Kind of giving it an inhaled drug. So now we're talking about asthma treatment, COPD treatment, where obviously the problems is in the lung. But that could also be pulmonary hypertension, fibrosis. It could be bacterial infections. You could aim for lung cancer, cystic fibrosis, cough. I mean, there are so many opportunities. And we're already having projects In asthma and COPD and also for viral infections. The other one, which you have seen, which has been exploited a bit By insulin, inhaled insulin. But isn't that common today? That's looking for the fast onset of action. And this is really fast. This is as fast as giving an intravenous injection and faster than if you would inject it In your subcutaneous fat because that will take a longer time. And here, there are obvious diseases Where things will have a very rapid onset. So we're talking about migraine. We're talking about something we'll come to later, Postpartum hemorrhage, it can be acute allergic reaction. It can be hypoglycemia in diabetes patients. It can be people taking an overdose We need to reverse it very quickly. It can be epilepsy, myocardial infarction, erectile dysfunction, Parkinson's So you can see I can almost go on forever here. And then the last area where which Orest covered very well, that's, of course, the vaccinations, Where you want to have a stable formulation that can be easily distributed, avoiding all the cold chain environment and also getting rid of a hazardous waste. And the biggest area here is vaccinations. But there are also other areas, but very often the fast onset of action and replacing injections kind of have an overlap In the disease areas. And this is an area where we have a lot of discussions at the moment. And after the Monash University Agreement, we are being contacted very frequently to discuss Using IQOS 1 as a vehicle for delivering innovative drugs. And now we have 3 agreements. 1 is with Monash University for an inhaled oxytocin. That's for postpartum hemorrhage or actually bleeding after giving birth. We have with ISR Immune System Regulation, a company in Stockholm, which is developing an inhaled COVID-nineteen vaccine. And very recently, just last week, we signed with Respiratory Respiratorious in Lund. So a very fellow company Who have a very interesting compound for the treatment of COPD and severe asthma. And Of course, you shouldn't only listen to us. You should listen to our customers regarding why did they decide to go for an inhale innovation. -And the first person to listen to, that's Pete Lambert. He's the director of program management at Monash University, And he gives us his explanation for going into this. Hello. My name is Pete Lambert. I am the Director of Programme Management For the oxytocin program and the coordinator of the Global Health Therapeutic Program Area here at Monash Institute of Pharmaceutical Sciences in Melbourne, Australia. Postpartum hemorrhage or PPH, which is excessive bleeding after the birth after birth is the single greatest direct cause of maternal mortality globally. Annually, it accounts for around 60,000 deaths per year, overwhelmingly in the poorest countries of the world. And many multiples of this number of women will also experience serious maternal morbidities as a consequence of PPH. The tragedy of these numbers is that postpartum hemorrhage is largely preventable with existing medications and health care. Specifically, oxytocin is the first line gold standard therapy for both the prevention and treatment of postpartum hemorrhage. And the World Health Organization recommends that every woman at every birth receive a dose of oxytocin immediately after the delivery of their baby to prevent postpartum hemorrhage. Unfortunately, oxytocin is only available as an injection, which is administered either intramuscularly or intravenously. These injection products require refrigeration in order to maintain quality and also trained and authorized healthcare workers for safe administration. Both of these things can be lacking in resource poor settings in low and middle income countries. The WHO recently published a systematic review of studies looking at the quality of oxytocin found in these settings. And it's estimated that around 40% of oxytocin It's below international standards, largely due to deterioration of the product outside of the cold chain. Inhaled oxytocin aims to overcome these problems By developing a single use, simple to use disposable dry powder oxytocin inhaler. The product would be equally effective To attend international unit dose of intramuscular injection, which is the current standard of care in many low and middle income countries, And will be available at a cost comparable to existing, products in this area. Critically, inhaled oxytocin does not require Storage in the refrigerator, which means it can be delivered by usual, non refrigerated supply chain methods. So with this product, we aim to ensure quality at the point of use by removing the product from the cold chain And enabling task shifting of the administration of oxytocin to all birth attendants in these settings, not just those that are administered, Sorry, that are authorized to administer the injection products. In this way, we aim to bring first line gold standard oxytocin Therapy to all women and most particularly those least served communities, with greatest need for this product. Thank you. So I thank Pete for his explanation why Monash went into this. And I would like to say a few words about the collaboration we have with Monash. Like I said, they have the right to use IQOS 1 For the prevention of bleeding, excessive bleeding after childbirth. And here they are looking at the fast onset of action and also replacing injections. They have a global rights, but they are aiming at resource constrained markets where this is a real issue. We got a technology access fee. This is stepwise. So that would be paid out as we make progress in the project of a total of €900,000 On top of that, we are supporting the work being done by Monash. So we on a continuous basis will do commission development work. And here we also have actually a royalty rate of 5% to 10% over 20 years, and that might look Very big for an innovative project, but it's partly due to the relatively low value of the market. But the exciting thing is that this project will actually go into a clinical trial already this year. And after that, it will be ready for a Phase 3 Trial. So this will actually be given to patients or people, I would say, Because they are not necessarily patients with this trial to see how well it works. And like I said, this is not a very big market, mainly due to the low price. There is a lot of oxytocin used in the world, But the price are very low and the market value is estimated to 75,000,000 U. S. Dollars. Given the aim of this collaboration, we will mainly having the use in Africa and But that is still the majority of the sale. And we think that that I mean, that represents 60% of the opportunity And an estimation, because this will not be adopted by every country that actually have a need for it, might also not be completely relevant in the big cities In these countries, but at least on the country side, we think there will be a penetration of 15% to 20%. That represents for Monash or I think I didn't mention that Monash actually is doing this also in collaboration with J&J. But it is from 7 to 9,000,000 U. S. Dollars. So a lot of this is aiming At making the world a better place, I would say. And of course, then we don't know what will happen if we look at territories outside of Africa and Asia, Because if this would be launched in Europe and U. S, I'm sure it would be launched at a very different price point than what we're looking at here. So the royalty potential here, I said 5% to 10%. That represents for us a royalty income Potential of $340,000 to $900,000, so not that big. But still looking at what we make today, It's a small contribution. And I think more important is that it's a proof of concept that this works. And we have noticed that after this agreement, a lot of companies are lining up outside of our door to start discussing using IQOS One for their innovation solutions. And moving on to ISR, a company based in Stockholm. We will actually listen to Doctor. Ulla Windquist, Who is the professor at Karl Linska, the CEO of the company, why they decided to go for an inhaled solution. My name is Ola Wenqvist. I'm the CEO of ISR Immune Stimulation Regulation, a company working with the immune system. As a professor and senior consultant, I've been interested in developing vaccines. The SARS COVID-two pandemic has really increased the science, the knowledge and understanding of a pandemic Where now we start to realize that the entry of the vaccine could be very useful in the lung. An inhaled vaccine will be delivered to the macrophages in the lung, where there will be a local immune response With the preferred immune response that is going to protect the lung tissue from the entry of the SARS CoV-two virus. So we have been working with creating an inhaled vaccine where we have found a very Interesting solution where you can have a one time dose of an inhaled vaccine that can be administered by yourself. This is a cost effective vaccine where the vaccine is formulated as a powder. So you don't need a cold chain To deliver and provide the vaccine in the 3rd world. We believe that using a very cost effective Inhalation device will actually change how we go about vaccines. You don't need injections. You don't need educated healthcare personnel. You can take your own inhaled dose of vaccine yourself By just one single inhalation breath. This will change for the disease to come, influenza, Different versions of COVID that may come. And by using the local immune system in the lung, We will also be able to decrease the dose and diminish the amount of side effects. So inhalation vaccination is probably here to stay. And we're really looking forward to move forward with this new development in inhalation vaccination. Thank you, Ulla, for those words. Just saying a few more words about the agreement. This is for Immunization to prevent COVID-nineteen injections, so a COVID-nineteen vaccine. ISR have the global rights to use our IQOS one for COVID-nineteen And the variance, with that technology. So they're using a technology of spike protein and an adjuvant. So that is kind of the way of getting a very good result from the vaccination. They also got an option to use this technology With IQOS 1 for various other viruses that have its entrance through the lungs. And here we also have a stepwise technology access fee. It's a total of SEK 9,000,000. We have a contract development, so and I think this is important for this area because there are competitors that have devices. But the companies that we are talking to, they need an inhalation product. They need an inhaler with a powder, and we can help them doing that. And this is also exactly why we have a rather big contract development work because we do the product for ISR. And that is only for Getting into the patients in the first phase. So there might be more business coming from these collaborations. And we also have a royalty of a low single digit percentage over 14 years because, of course, taking a COVID-nineteen vaccine to the market We'll mean a really big investments in the development. So then we could settle with A smaller percentage compared with the generic products where we basically deliver a much larger part of the final value. We are working on this project at high speed, and we really want to succeed. And we're doing everything To move it fast as fast as possible. So we're already looking at accelerated plans, looking at the steps to follow before we're there and knowing if we have success. And we plan to enter Phase 1 clinical trials already second half of this year. And the market opportunity here is very hard to Gicht, because we see the speed that vaccination happens in U. S, in Europe. And that also means that unless there is a need for a booster shot, Which might very well be the case. Then there will be less of a need for this product in Europe or U. S. But this could also be a maintenance area where these fires We'll come back every year, and then we might actually have a market that will continue for years years years. Where we are today with a limited knowledge we have, the and the advantages we have with the inhaled, We are mainly looking at an opportunity in the low middle income countries, but that's still 3,900,000,000 people in the world. And they will have a need very often of having a solution that doesn't need cold chain distribution. We've been looking at Price, we say at least 8 to 10 U. S. Dollars. But it's important to know this is the 2 cheapest ones. This is the Johnson and Johnson with 1 Injection or 2 with AstraZeneca. But we don't know who will price this in the end of the day. And if we compare, for example, with Moderna, They actually have a price around $40 per vaccinated person, Meaning 2 vaccinations. And for Pfizer, they're actually running at 16.25 U. S. Dollar Per shot, meaning for each patient, we're talking about above $30 per vaccination. But even with that kind of now very conservative numbers, we're looking at the market potential of at least €31,000,000,000 to €39,000,000,000 There are a lot of vaccines in development, but there are very few that doesn't require cold chain distribution -Where we can come with a solution. And to our best knowledge, it's only IQONOVO and the Chinese companies That is developing an inhaled COVID-nineteen vaccine. And this is one of the agreements where we have communicated Up to SEK 100,000,000 per year. But as I said, that could go down and that could go up. So it's very hard to predict Where that number will end up. I also would like to say a few words about our latest agreement. This is very new for us as well. Here we will be looking at the treatment for COPD and severe asthma. This is a development Where we will develop an inhalation product for them. It's not a license agreement because we first want to see this more of a feasibility that will work. And we will evaluate what inhaler is best suited. And We have a contract development work, which will run up to SEK 3,000,000. We think and hope we can combine that with a license agreement later on. And here we will develop a product to go into Phase 1. We don't know the market opportunity, and we don't have a license agreement, But we know that the COPD and asthma market is worth €30,000,000,000 and they have a unique mode of action. They're actually relaxing the small airways And they have an anti inflammatory activity, so this could for sure replace or be complementary to the treatments of today. And there are met medical needs, if they can achieve that. Just rounding up, Just to see what is the total market potential for inhaled innovation. And if we're looking at the 3 buckets of targeting the lung, fast odds set of action And replacing injections. Targeting the lung is still the biggest opportunity. Here we estimate, and we're only looking at the 7 major markets. It's not like a global potential, but that's still worth SEK 43,000,000,000 and that is traditional indications as asthma and COPD. The other one is Fast On set of action. And here, the largest one would be your myocardial infection, epilepsy or migraine. So still another €25,000,000,000 And the last one is replacing injections. And here, this is dominated by vaccinations, And it is about 25,000,000,000 U. S. Dollars. So thank you. Thank you so much, Sure, Ger. And I would like to ask you a question. So investors are, of course, always interested in the risk level. So what is the risk level in your innovation segment compared to your generic business area? I mean, for our partners, this has much higher risk. If you're looking at the compound going into Phase 1, the Shanta actually coming to market is about 10% to 14%. So we need a whole portfolio here to make sure that we get some to the market. On the other hand, we know that a lot of the big farmers are aiming for blockbusters. Then we're talking about royalties on something larger than USD 1,000,000,000. So reward are big, the risks are bigger, And we need a portfolio to cover it. But having said that, it's mainly the risk of our partners because we do this As a contract work, which means that we don't invest big money in this development ourselves. Sounds like a good position. And also, I was wondering, you described that you showed us big numbers here on your last slide. So how are you working to turn all these opportunities into projects at EcoNovo? I mean, we have just acquired a big database, and we are launching now a bigger, say, more modern marketing Engine, where we will identify the customers that are active in the areas where we have identified they have the right compounds, And we will make sure that they hear and see IQNOVA. And we are also seeking out all these companies at partnering congresses. So We will make sure that they know that we exist. Lots of active work. Thank you so much. It sounds good. Thank you. And we will leave you for now and see you again in the Q and A session. Thank you. And now we will turn our attention to the new business area called Economo Pharma. CEO, Johan Berborg will re enter the stage, but I also want to introduce to you the CFO, Anna Gallon. She has a long experience from several CFO roles in growing innovation companies, raising funds, doing IPOs and improving cash flow and profitability. And of course, this is all valuable experience when ICONOVO is moving into commercialization. So Welcome, Anna, and welcome back, Johan. Thank you. Thank you. And you will now tell us about the 3rd pillar in ICONOVO strategy, giving you a unique position in the Nordic inhalation product market. So please tell us about it. Thank you so much. Yes, so it's time to talk about the pharma sales, the 3rd pillar of our new strategy. And really, here is the big boom that happened Only I think it's a couple of weeks ago now when we got the license from Amneal to -Cell Icoris generic Symbicort in the Nordic countries. So this means that we will become a pharma company based in the Nordics. So this we do because we want to capture the full value of our innovation, and we will be forming -A Nordics focused franchise for this. So basically, from our point of view, To go from where we are today into becoming a pharma company selling our own generic products -In the Nordics, it's a very natural step up the value chain. For me, we have many in Acronovo have done this before, -And we have the needed experience. We have a board with people who have launched drugs, who have set up companies like ours, And we in the leadership team have this experience as well. So it's a very natural step. As well, it's good to know that there will be No large investments needed, for example, in equipment or facilities to go into selling generics. And we will do this by setting up a separate business because we do not want to defocus So the go to market model for us is quite classic. We will set up Iconova Pharma, Nordics focused business and focus on this big market in the Nordics. The total Aspen COPD inhalation Market is around 4,300,000,000. And where off the Symbicort generic market is SEK 800,000,000. So it's also a it is a market with a very high proportion of high value generics. And it's also a market, Although it's 5 different countries with different systems, it's a cyst it's countries Inhalation Pharma, and we will start this by bringing bringing our own products to the market. But we will also take the opportunity to take in any other special generics within the inhalation field If we see a strategic fit and they are offered. And we will start to set this up quite soon. We will start recruitments in 20 20 2/23 and set up a small organization to do this. In comparison to the rest of Iconovo, this Iconovo Pharma will Become a smaller thing. So in the core of IQONOVO, it looks like this. You have the leadership team and the administrative level. -And where it all happens is the 3 chunks of commercial development, -Pharmaceutical development with formulation and analytical competence, and then you have the device development. So what we're actually adding here It's this smaller organization with 5 to 6 headcounts with a leader with some competence within QA, Equality, Regulatory and Pharma vigilance and of course, finance and logistics. And these are either positions that you can hire or it's very common as well to take In consultants and by this externally. Then we need a project manager, a product manager, Tender management and some sales positions to launch this rather complex product. Another thing that I want to bring to your attention is that this idea of us selling our own pharmaceuticals in the Nordics It's actually serving another purpose as well. So the second purpose of this is that it as it is boosting our sales locally, The idea is that there will be a feedback mechanism to boost the sales from our global partners. From from the partner perspective, when we are invested in the Nordics, they see this as a very positive. We have skin in the game, And it's a very convincing and trust building scenario. And by having our own products in the Nordics, We can also serve the rest of the global territories with, for example, real world data that we develop. Our marketing materials can be used, And we can also use the Nordics as a test base for other applications. For example, as Orest alluded to, digital applications or Other mechanical add ons. So the product portfolio will of course It will start with IQOS generic Symbicort with the license granted from Amneal. But we will then build On future products through back licensing from our partners or when we enter a new agreement, we will simply Make Nordic Hours. So we will do this for the inhalation devices that we aim at the generic segment, which is then IQOS, Ico CAP and Ico PRE projects, but we will also open up to other projects, other products from partner companies. Thank you. I'm going here to talk about our market opportunity for The generic Symbicort, it is probably the first product out for ICONOVA Pharma since we have already agreement In place with Anil for the Nordic market. On the graph in the slide, you see on the left hand axis The market value of the market, and it has decreased over the 4 year period with 15%. This is mainly driven by Norway and Denmark. In Norway, substitution is allowed, driving the price down. And in Denmark, the price level historically has been very high, and now prices has gone down just a little bit. On the right hand axis, we have the market volume, and this has instead increased over the period due to more patients for the products. And Symbicort also have their smart concept therapy, allowing patients To have both a reliever and a controller. The total market value for the Nordics is close to €19,000,000 And we see it as a stable market. There has been few changes in the period, and We don't expect any major changes going forward. The country split is we see that Sweden has over 50% of the market, followed by Denmark, Finland and Norway. And this is a normal pattern for inhalation products, not only for Symbicort. Moving on to the next slide. We here see the market share for the different players. We have the original product Symbicort and we have Do a rest from Teva and BUFOMIX from Orion. The generic versions entered the market in 2014, And they have shown some very different strategy. Orion with Bufomix have chosen the low Price strategy. And they have, during this period, increased rapidly in market share from 19 to 42 percentage, While Dura Resp from Teva has chosen another strategy and seems only to be Interested in maintaining their market share. On the right hand side, we see the price erosion. And this has Gone down only a small amount during the period. And we see here a great opportunity for a 4th player on the market. We have done a country analysis of all the Nordic markets, And we show you here Sweden as an example. Sweden is the largest market, and it's also the home market for Ikanova Pharma, which we see as an advantage. We would use this analysis going forward when doing our Price strategy when entering the market. We have looked at different factors. We have looked at how who are the patients, How many suffer from these diseases? What's the attitude from them towards generics? How does the pharmacies look like? How are they organized? Are you allowed to choose one product I recommend it over now. Is the free pricing? How often does prices change? Are there any discounts? Is substitution allowed? And how does the reimbursement system look like? Taking a closer look at Sweden, we have the total market value of over €45,000,000 And you can see on the dotted line that the price level has actually increased in the last year. And we hope that continues. Moving on to our business case. As said before in the presentation, our goal for 2026 is net sales of SEK 200,000,000. We expect that 1 third of this will come from Iganova Pharma. The total market value is being over SEK 800,000,000. And when our product is fully integrated into the market, we see that we can take a market share of between 15% to 20%. And that would also mean a net sales between SEK 80,000,000 to SEK 100,000,000. We feel that our business case is quite conservative. We have only calculated with the 4% annual price erosion, and we have not calculated with any increases In volume at all. And going forward from now until the expected launch, We are now starting to build Equinova Pharma, and we need to set up several systems. The one that requires most time is the quality management system. We also need a system for a batch traceability, PV database and serialization software. We need to apply for a wholesale distribution authorization, And we need to set up agreements with distributors, with logistic companies, with other suppliers. And there needs to be done a couple of audits before we are approved. In 2022, we start teaming up The organization with the aim to launch in 2023. At the same time, Amneal is working on their hand, And they also aim to do a launch in the rest of the EU countries at the same time. Thank you. Great. Thank you. Thank you so much, Anna and Johan. And I'm a bit curious. I mean, this is not the conventional Path to walk down as a company of your type. So where did the decision come from to become a pharmaceutical company? Well, I think it came from, it was one of those decisions that came over time, of course. But, but With the company becoming more commercial, I entered the company is going more into a scale up phase. We started to discuss our new strategies and of course for me it was very natural to go into Selling our own pharmaceutical products, you may we want to maximize the the the value that we ourselves can get out of our own innovation. And For me, it's very natural to also then sell what you have. And it's as simple as that. This is something that we can do and many others have done before. But why would your partner want to give the Nordic market away to you? Because we are a very trusted partner. And actually, they see a lot of benefit in having us With with skin in the game, with with equal kind of things at stake, that, that that will also Give them confidence that we will do everything we can to get the market as fast into the get the product into the market as fast as possible. And Symbicort will be the first one. And what will make this generic Symbicort to develop with Amneal a success? It will be a success because as Orest said before, it's the only product in the market that actually It's handled in the same way as the Turbohaler. And on top of that, we have added several feedback Differentiating features that the patient will really like. So we think that this is the logic choice -Over the other 3 alternatives in the market. -So same, same, but better? -Definitely better. -Okay. And about Economofarma, beyond Symbicot, how wide is the range of opportunities? Like how many other products could sell in the Nordics? I mean, the total market value for inhalation products is over SEK 4,300,000,000. So there are Great opportunities. We have, of course, the generic Symbicort. We also have the other products that we are developing That could be suitable for the Nordic market. And we have the products from our partners. Okay. Well, thank you so much for this introduction to the future of Please stay on stage because time has come to take a closer look at your finances and also summarize the main takeaways for our viewers today. So stay tuned. Here we see some key figures from our latest interim report for Q1. I just want to mention a couple of things. Our net sales this quarter was slightly higher than the corresponding quarter last year. We will talk more about the net sales In the next slide, we had an operating loss that was affected by high costs. We have seen an increased activity in our projects, and this has demanded a larger organization. We are Currently, 28 employees. And we also have engaged a number of consultants, Both to manage project peaks, but also to build up a quality system to Get Eikon over to follow the regulations in EU and the U. S. Looking at our Cash situation, we had over SEK 53,000,000 end of Q1. It's a good sized cash, It will allow us to manage our ongoing projects. Here we have 2 graphs of our net sales, the first one on the left showing our net sales per quarter. We have a revenue recognition module that allow us to recognize the revenue Once we have delivered a milestone and it also have been approved by the customer, this creates a quite uneven Pattern for our net sales. Looking at the right hand graph instead, this is a moving annual total for the net sales, And it's a bit smoother. In 2018, it was a high number. We had then recently signed both The Amneal and the Inta Steel and giving a high number due to high milestone value in the beginning And also the technology access fee in the start. In the second part of the project, The milestone values were smaller. We also had a very low customer activity for the Symbicot project When it was handed over from Neil to CBC and back. However, at end of last year, We did several project deliveries, and we also had 2 new customers in Monash and B&C Korea Creating an upward movement in the graph. Looking at our shareholders, I want to mention here that we have very strong and stable shareholders. We still have the founders in place. We have large investors in Anda and Fjerda Apfondern and also Landsteiner And Handelsbanken Funde. We also have foreign representation through French Eiffel Investment Group. So we hope this is an attractive opportunity to our investors. Looking at our share, there has been an increased activity in our share over the last year. Our share price right now is around DKK 69, which is up 37% in a year. We have seen an increased number of trades per day and also an increased volume traded per day. End of Q1, we had close to 1300 shareholders to help us out facilitating The daily trades with we have Pencil Bank acting as a market maker. And can also mention that the Free float of the share is 60 8 percent when leaving out our largest shareholders. We hope this is an attractive opportunity to invest in the Aiconovo. Okay. -Thanks. The time has come for me to summarize and to close this Capital Markets Day up. -So I hope really that you have been able to follow. It's been a quite comprehensive day. I recognize that. What we have been aiming to do is to go through our three parts of the new strategy. So We started out with the generic area where we are consolidated and we are active within the asthma and COPD generic areas. Then we went over to the innovative branch, which is the area where we see the biggest growth opportunity for the future with replacing injections, Having the lung as a target organ and aiming for drugs with a rapid onset of action. And then I just told you about the 3rd pillar of our strategy, which is the Nordic Pharma sales. So we will have sales Nordic, inhalation branded generics. We will set this up Using our own products and also open up to other inhaled products. So this strategy will now energize us and we will get going within all of these three areas. And this will propel us into a very bright future where we see that in 2026, we will have reached SEK 200,000,000 In revenue and at the high operating profitability profitability at 50%. And additionally, we see some upsides and we defined the U. S. Opportunity in Symbicort Generics as a SEK 70 SEK 1,000,000 upside. And we identified the inhaled COVID-nineteen vaccine, which we are Developing for ISR as a SEK 100,000,000 opportunity. I showed this picture in the beginning here, and some of you may think that this is a quite complex slide. I hope that we were able to break it down for you a bit. It is comprehensive. And what I can promise you is that next time I show this, I probably have to find another format Because we want to find more products and more projects. So we are a company that It's growing. We're in a in a very interesting phase, and we have an aggressive Vision as well that we want to radically transform inhaled drug therapy, and we believe in breathtaking innovation. So to give you some takeaways from this meeting and some of the reasons why I believe We are creating both customer value and value for you as an investor. We have an attractive customer offering Within this very interesting field, just in between medtech and pharma. And we are acting in a field with high expertise, But with low competition, and we know how to do this. We're a platform company. We have today 4 proprietary platform, Our dear inhalation devices. And if you look at Iconovo today, there is a lower risk In our projects compared to many novel pharma companies, which have to go through Phase 1, 2, 3 trials and then register. And we have a portfolio project today with 6 license agreements, some other agreements that we have been telling you about. And we have also the new 3 parted strategy to unlock further value. Thank you very much. Thank you once again, Johan, and of course, Anna. And now the time has come to gather the management team for this open Q and A session. So we hope that you will let us have just a few moments to rearrange, and then we will start answering your questions. Okay. So now we're gathered here to answer a few Questions from our viewers, and of course, many of them are shareholders. So maybe you could tell us a little bit about What activities are performed in ICONOVO to increase the interest in your share? Oh, I can take that. I mean, Of course, we want to increase the transparency about what we are doing. And we realize that what we have been doing lately, The last year has increased the complexity within our company greatly. So we need to take time and really talk To the market, to you as investors and explain what we're doing. So we do a lot of IR activities and try to be seen as often as is possible. And speaking of the investors and what they're wondering about, We they, of course, are always wondering about the cash. And you told us a bit, Anna, that you have a good amount of cash. But also you've told us today a lot It's happening at Iko Novo, and you are developing an entirely new business area. So how are you doing? Will you need further financing? I could take that as well. We have a good cash position, as we said, 53,000,000 at the end of Q1. So we have enough cash to sustain the current number of projects that we are have ongoing. On the other side, We have so much in front of us and so many things that could be done and bring us value. So if we want to accelerate things, there might be good So if that will happen, then we will inform the market about that then. Mhmm. And we have received a very specific question regarding RELVAR. Among the goals for 2026, you mentioned that RELVAR will hopefully contribute royalty earnings. Relvar is expected to sell for about $1,400,000,000 How much are you counting on earning in royalties? Is this included in your financial goals? And what kind of agreement are you expecting for ICOPRIE? So this was a few questions, but who would like to grab at least some of them? I can start. As I explained previously, 2025, 2026, it will be only from the U. S. So that will be the basis will not be based on a global territory. And that will be the 1st year Our first full year 2026. So it is included, but it is just like the first baby step into much larger income to come. Anyone else who wants to complete or we're done there? They also said what type of agreement. But like I said, we want a portfolio So we want somebody to take the full portfolio. So that means launching RELVA 25, INCRUISE 27, Trelegy 2,030, Anova 2,030. So it's a whole range of launches in that period from 2025 to 2,030. And another question, Amneal's U. S. Launch is based on future events in both the U. S. And European market. What are these events and what is the timeline for U. S. Introduction? When it comes to the timeline, I mean, I don't think We are and know what to tell exactly. And if we're looking at the events, One event is, of course, the successful development that we need to see in the clinic now going forward. And the other one is also like linked to the patent landscape, What's happening in the U. S. And we don't have full insights to how that will develop. And that is a big part of the uncertainty that we don't know when Other generic products will be launched, what time frames, etcetera. So that will be a moving target. Also, how do you estimate expected milestone payments for future agreements? Well, that's There are, I mean, of course, we know approximately the pace of things that are coming in and we know the mix of We can estimate the mix of innovation and then generic deals that we are doing. And for us, developing I mean, developing something for An innovative product or something foreign in a generic product is not very different From our business model point of view, I mean, we develop inhalation products and actually, do that in a very similar way. So we can approximate the number of projects that we can cope with and that we can sustain to be fully success successful. And then we base it on that. I don't know if you have. It's also I mean, it's different if the project involves a formulation or Only someone else is doing the formulation. Actually, for us, it's a bit easier now when we have several projects and we have good activity. When we were a bit smaller company and we only had 1 or 2 contracts, the variance and their uncertainty was bigger. But now when we can kind of average things out, we can with confidence say that this approximately will be The amount of milestone payments that we will get with an increase every year. And was this specifically for ICOPRI as well or? No, it's just generally, yeah. Would you like to add something? I was just thinking, I mean, because every time we make In agreement, we have a full business case where we look at the total value that we capture and we look at the split between ourselves and the partners. So we have a very good understanding how we're sharing the value. And also, if we want to make trade offs between royalties or milestone payments, We can also see what value implications that would have for IQONOVO. And another question that's come in is, It's known to be difficult to introduce generic inhalation treatments in the U. S. A relevant example is ViaTris Symbicort launch. What is your view on the likelihood to release Symbicort and Revar in the U. S. Market compared to the EU? Do you want to take that, Roger? Yes. The U. S. Market, I mean, that requires So much more in terms of risk. But I think a lot of the issues we have seen with some of the products that have been facing issues Has been linked to that in a sense of catty corner or they haven't been able to hit the target spot on Because they are very tight at the FDA. So for example, when we looked at Viator's product, I think they approved it, but it still had a different orientation. When we looked at the clinical trial they did, I think they failed in the first trial, probably because they wanted to do some Savings and didn't really power the study well enough, and then they had to go back and redo it again. So I think it's extremely important To keep an eye on the ball on the FDA requirements and make sure that you meet them. And then I think You're in a very good position to be approved in the U. S. Because you also have to face both like A pharmacokinetic study, but also pharmacodynamic studies, you need to test it in patients. There's many more parameters that you have to meet compared to Europe, where It's enough to have a pharmacokinetic bioequivalence and also they actually accept different types of inhalers as generic -Product to an originator product. -And also, what Further opportunities do you see within generic inhalation products when your Simbicot, Ultibru and Sebree and Ellipta products have been delivered? Beyond 2026 then. Yeah. They want an even sharper, what do you call it? Yeah. They want to see further in the crystal ball. Yeah. I think you mentioned that in your presentation. But beyond 2026, there will be a lot of We mentioned all the things that can go into IQOS PRI that we are aiming at now with our existing Offer. But there will also be some generic I mean, some very up and coming products that are launched Right now, that will go generic in this period beyond 2026, of course, towards 2,030. Yeah. I mean, Novartis has launched a new ICSLABA recently. They have launched a triple product. We could go after that with ICOCAP, Both of them, but of course, they're launching now, so they have 10 years data protection. And also we know that Forster is launching Being a Breezeiler, no, it's called. Next Tailor. Next Tailor, that could also be another opportunity. And then we also haven't really focused that much on the product for cystic fibrosis, where there's a lot of Antibiotics and stuff like that, that is given. So there are also other areas which we can look into for the future. Mhmm. Also, how much capacity and time will the project within innovative treatments demand compared to the larger products, Simpicort, Intas and Ecopre? Yeah, I think that was what I was trying to explain before that. From our point of view, from the inter from our ICONOVO development, it's not That's different. It's for in some respects, it's actually easier for us to develop an innovative formulation and to have good effect with that, since when you are developing a generic drug, you have to hit the perfect window, Bioequivalency. But when you develop an innovative drug, we can focus on just having our great inhalers Perform as good as they do. Maybe, Orest, you Yeah. I think one great challenge for us has been to, In some cases, it dialed down the performance because we exceed the performance of the reference product. So we need to dial it down to Perform less. It's called a luxury problem. Yeah. But it's a difficult problem. And it takes a lot of work to Dial it down and exactly to the right position as the reference. If you have innovative drug, you do the best formulation you possibly can. Sounds like a fun challenge. And I would like to stay with you a little bit, Orest, because in the beginning, we met your new Chairman of the Board. Johan has been the CEO for 1 year, but you were up until then, you were the CEO and you were the founder. So what do you feel? What does it say about your that you come to the point where you're ready to take on a new CEO, a new Chairman of the Board. I think we are in a transition phase. So of course, we were a startup from the beginning. And I think myself and Mats, we are more Start off people. We build like the first building blocks of the company and set it up. But now we are in a more mature phase, scale up, Commercialization phase and that's when I thought it was the best time for me to step down, do What I believe I do best do with develop an invention, making new product and new one which is commercial Experience and experience of leading big organization is the best person to take on the CEO. So you're taking a leap here, you could say? Well, I do I focus on R and D, and I think that's what I do best. And also, we talked from the beginning a little bit about sustainability. We just touched upon it. But I would like to ask you, Like, why was this the right time to start focusing on it? Well, it was The start, I mean, we started with a strategy. And of course, sustainability today is a very it's I believe it has always been In the minds of the people in ICONOVO, but now we just made it concrete, and we've chosen to include it in our company goals, And we have done the 1st annual report with the sustainability reporting. And It felt good to do it now. And then we have big ambitions and we also have big ambitions within sustainability. I mean, and just some examples That we mentioned today is the Monash inhaled oxytocin, where you see a really a direct link to health and well Being the 3 that's area 3 within UN Sustainability Goals and 3.1 is actually Women's health. So, maternity health. So that that goes directly in that pocket, and we can we can make a great Impact there. And by focusing on it, we can have even more impact. And then we took 2 additional areas where we also feel That we have a direct kind of a we have we need to form ourselves and we can really make some imprints there. We can change things. Of course, climate is one of them. That's a huge question we all need to help solving, but what could be your big contributions? Yeah. I mean, we're a small company, but we have a global print. We talk to customers. Roger talked to customers every day from all around the globe. And when we put pressure on them to, when we ask How their sustainability strategy looks like, what they do, what they think. We can propose materials, plastics, Ways of doing things. When we come into the commercialization, we can really be there as a partner for them and and push some of the things that we believe in as well. So we're not producing the things ourselves, which kind of we need to have them act, But we can be very persuasive in our offer and form the offers in a way that makes it Yeah, very attractive for them to choose good solutions. And I have a very specific question concerning your timeline, which is When during 2023 will the generic Symbicort product be launched? When during? 2023. 2023, it's what we say. I mean, it's it's also, it's what we can say. It's it's not us. After we have done the We will support Amneal in every way we can, make sure that every time there is a question, we can be there, we can go there and But we don't really control the process. So exactly when is actually up to them. But 2023 is our common goal. And if any one of your investors are feeling, why are things taking so long launching products? Of course, you have to work on the timing with other people's patents expiring. That's what you'll be talking a little bit about. But I mean, how do you manage this plan? How do you do this timing? Well, how do we do this? I mean, we work backwards from patent expiry, of course, But it's not that easy either. Because if you just look at the patent, it could say 2,032 or 2028 or whatever. But maybe it's a weak patent and companies will will, challenge it and maybe it doesn't hold. So you need to you need to have an assumption on When you think the patents actually will not, be valid or kind of hold up anymore. And and and Orest is the one Who is our IP expert. And there are also ways of extending patents that we, of course, don't know what the Patent owner will do 5 years from now. So it's always a risk and always a gamble. So we're working with a patent So the firm in Lund and they are very good at this and help us to manage this. But This is difficult. And also, it's not only developing and manufacturing Generic version, it has to be approved. You'd have to do clinical trials. It's always a risk with clinical trials because then you Deal with people and everything can happen. And then the registration, it could be delayed because the agency has a backlog and it's 6 months delayed because They have a lot of people on sick leave. I don't know. So things like that happen. It's a very strategic game with many parameters, it sounds like. Yes. So it's Some patents are very some processes are very clear to see. You see that there is a clear timeline. A lot of companies are moving Towards that target like we see with the Ellipta portfolio, for example, or Symbicort, which already lost the patent In EU. So we have a mix of complexity here. And if we look at we've been talking About the pace of you wanted, how many agreements you want to find every year and so on. So if you look at the range of agreements that you have reached now, how happy are you with your portfolio today? You're looking happy. I mean, I'm very happy, but of course, I'm the one that negotiated at least the latter ones. So good job, Ro again. I think we should be very happy. And especially I'm personally very happy that IQOS 1 It's such a hit. So we have free agreements in a short period of time. And I think those agreements will trigger more agreements because now it's More well known, more established, and it's found its place in the industry. So I'm very happy about that. And I am really happy too. And I see the momentum in the company. And, yeah, it's fantastic See, I mean, people are working really hard to do this, of course, but, we are also getting a lot of attention. So we seek business, But we also are sort of by companies in a very unexpected way sometimes. That's a good sign when the phone is ringing. -Yes, it is. So we have something really attractive here. -And Anna, are you also happy? -Yes, of course. And I want to mention that IQOS 1 is also I mean, it's a unique product. There is no competition, almost. Sounds like a good position to be in. And let's end this discussion in a happy place. So thank you so much to all of you. And it's Time for us actually to wrap up this afternoon that we have spent together. I want to thank everyone of you that sent us Question, making this a dynamic and relevant event. And of course, thanks to all the speakers letting us dive into the future opportunities and challenges of EcoNovo. If you want to watch some parts of this event again or you want to download presentations or tell your friends about it, you can go to this exact Website address, where you are now and find everything. As you noticed, Equinovo is a company that sends out a lot of news. So of course, you should go into the website, equinovo.se, and sign up for the newsletter, or you can actually follow the company on LinkedIn. I hope we have given you an informative and inspiring afternoon in Economo's world of breathtaking innovation. Thank you so much for watching us and have a lovely evening.

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