Cosmo N.V. (COPN) Earnings Call Transcript & Summary

Ladies and gentlemen, welcome to the Investor Day 2025 of Cosmo Pharmaceuticals Conference Call and Live Webcast. I am Sandra, the Chorus Call operator. [Operator Instructions] And the conference is being recorded. [Operator Instructions] At this time, it's my pleasure to connect you to the conference room.

Good afternoon, everyone, and welcome to Cosmo's Investor Day. Whether you are joining us in person or online, it's a great pleasure to have you here with us today. My name is Dominika, and I'm the Chief Strategy Officer of Cosmo. And today, aside of welcome and walking you through the agenda, I will be contributing with my colleagues to sharing the strategy of Cosmo and the vision that will guide us going forward. A slide that none of you has ever seen before, I'm sure. A quick reminder that our presentations may contain forward-looking statements which would be subject to risks and uncertainties. So I would like to encourage you to view the disclaimer in full when these materials become available. You may have seen that this morning, we have issued a press release of our 2030 vision and ambition that will guide us going forward. Today, we will be taking you beyond these headlines and offering you a deeper look into the numbers, the way we lead and how we aspire to achieve this vision. To continue creating suspense for a moment longer, let me briefly walk you through the agenda. So we are finding ourselves at the start of the day, where after my welcome, I will be handing over to Giovanni for our opening remarks. Back over to me for more on strategic direction, and I will be also sharing how we are intending to pave the path to leadership on the market. Then my colleagues will be giving you respective deep dives of how that happens in practice. And finally, our CFO, will be giving you an overview of our 5-year financial outlook. Back over to Gio for closing remarks and Q&A. Finally, a last share from me for now. We will be viewing a very short film that captures the essence of Cosmo's identity going forward. So without further ado, let's watch it together. [Presentation]

And with this introduction to an evolved Cosmo, it is my pleasure to welcome Giovanni, our CEO on to stage.

Thank you. Thank you so much, and what an exciting video. It's a great way to start our 2025 Investor Day. And thank you for being here. We have a full house. We oversold tickets, it looks like, so it's good, shows interest about what we've been doing and today, we'll dive deep in many different areas. So it's been a year since I joined Cosmo as the CEO. And the company you're looking at today is a vastly different company than a year ago. And it's not only because we have added new capabilities or because myself and my team learned a lot and also, I would say, grown over the last year, it's because mainly we have applied and seen changes across every single function of the company. And those changes are changes that matter. And one example clearly is, what we have said this morning in our press release, 2030 vision, and we'll dive deep today. You will meet many new talents today presenting to you that were not here last year. And you will hear a very clear and well-defined strategy about the business. And a strategy that create values now and will create value also over the next 5 years. So there is one thing that is very sure here. The company is ready to perform. And we show you today what does it mean through real-life examples, product that are about to hit the market and the way we are thinking of advancing commercial revenues and profitability for the company. So let me start with this slide. This is a new slide. Never seen this before and it's Cosmo on a page, our identity in one page. So now we have a why, we have a what, and we have a where. So, if you look at this, this is going to guide the way we lead the business, the way we work in the company and also the way we communicate with external investors with you. So we, as a mission, the why, we want to empower patients, health care professionals, and partners with life-changing confidence, by innovating at the intersection of science and technology. This is the why and it's a strong one. And if you go at the bottom, you have the way we work together within the company and how we keep ourselves accountable against each other. So those are the values of the company. At the center of this slide, you have the vision, we want to become the most innovative force in life science, through innovation, through execution, and repeating again that cycle. We have the right to do it, and we have also the project to do it. This is Cosmo on a page. It's very exciting. Now let me talk to you about how we are creating value, and this is the, I call it, the Cosmo value stack. And so those are different variables that we have in Cosmo that all of them together create the value of the company. So there are 4 different variables: the attractive setup, the foundational pillars, the strategic clarity, and then also the strong balance sheet that we have. I think the first variable should be well known from you, right? Has been present since years. Make no mistakes. My job at Cosmo was not a turnaround. When I came here last year, the Board asked me to accelerate innovation, to drive execution, narrow the focus on our pipeline, increase top line and EBITDA. And I found the company with a very strong solid foundation, thanks to the 28 years of continued success of Cosmo. Now let me pause and talk about the rest here. I mean, the real changes that happened over the last year are the other 3. The foundational pillars and we'll touch on it. The strategic clarity that we added into the business. And everybody in the team today presenting will present to you what we have been doing and how we see the future moving forward. And then the balance sheet flexibility we have, clearly, is a huge advantage for us in terms of where we are looking at the business organically and also inorganically. I want to spend a few more minutes on the foundational pillars. This is the core of our strength, that enables everything else we do. So we have sharpened our mission. You just saw the amazing video, you saw the Cosmo on a page. The mission that I show you guides the company. We want to build health confidence. Now with that said, also, we have expanded elevated talents in the company over the last 12 months. 50% of my team is new to Cosmo, but not new to transformation. Med tech, AI and pharma acceleration. We are elevating also the performance culture in the company, and we'll talk about this. And the pipeline couldn't be stronger than ever as of today. Full of opportunities, real opportunities, no science projects. So you will be blown away today, I'm pretty sure, to see my team presenting project we've been working on very silently that we want to deliver to you to beat that confidence also with our investor community. Now if I move and I talk about the attractive setup, I think you might remember this slide in last earnings call, but this is a very important slide that needs to be really present every time we talk about Cosmo. So we have a proven business model that innovate, deliver and repeat. Over the last 20-plus years, we have brought EUR 1.2 billion revenue in the company. Very successfully, with not one single blockbuster with the continuous activities of pipeline and success, all organic. This is not a biotech company of maybe 1 day is going to happen. No, it's actually happening constantly again and again. Then if you look at the center, we have a very robust pipeline, 5 different therapeutics area. We are focused, large market opportunity, huge clinical unmet need. Those are real opportunities, commercial opportunities. And then last but not least, we actually amplify our scale not by ourselves, but with the best commercial partner, there are in each of the segments we play. Look at these names, Medtronic, largest medtech company in the world. Takeda, Ferring, Sun. And then on top of this, we have also added the 2 largest tech company in the world who are working with Cosmo on developing new technologies with AI. NVIDIA last year, we are the only medtech company with OEM status for NVIDIA. It means a lot in terms of relationship. And last week, we announced the partnership with Apple with the Apple Vision Pro, and you will be seeing this today as well. Why those company chose Cosmo? Did you ask yourself this question? I did. But the answer is because they trust us. Because we are very uniquely positioned to succeed in what they want to do also through us. We have clinical credibility. We have regulatory speed and we have AI integration that no one else has. Now with that said, those company called Cosmo not a supplier, but a strategic ally, a very important one for them. Now this is a business model that works. We have a robust pipeline, and we have strong partners. From here, we want to scale. Now having the right partners and business model is only part of the equation. A very important part is where do we play? What market we choose? This is a very important part. And you will see from Dominika in the next presentation, the way we are thinking about market selection is very strategic. It's based on data. It's based on opportunity to win. Now let me tell you, those markets here super attractive. Cosmo is so well positioned. Let me start, we have decided to build the business in 4 different verticals. For clarity, right, so Cosmo has 4 different verticals. MedTech AI, Derma, Pharma gastro and CDMO. Let me walk you through one by one. MedTech AI, so let me ask you the fastest growing business in health care is MedTech AI. 39% compound annual rate growth. Worth EUR 162 billion total addressable market. Now the good news here is that Cosmo is not following a trend. We actually set the trend up in 2019 with GI Genius being the first company to get a De Novo application approved in the U.S. and expand year-over-year, you will see with additional technologies. We are one of the few companies who can monetize AI in the market. So with that said, we are in the right market. We have the right partner. We have the right talents to scale. Number two, Derma is a massive opportunity within acne and hair loss. Growing at 10% CAGR, with about $36 billion total addressable market. And consumer demand is increasing because of what, digital health, AI. And you will see today that we are addressing this as well within the portfolio that we have and also the skills we have built within Cosmo, exciting. Last but not least, Pharma and CDMO. We are very different than other normal CDMO. Why? Because we have speed, tech transfer agility, and we have R&D embedded in-house. So this is not a commodity business. This is a very strong strategic lever. Now what excites me even more is when I combine these verticals together, just think about this for a second, the Derma business, the Pharma business and the pipeline benefit so much of the vertical of CDMO in-house. We are taking advantage of this, revenue and also efficiency creation. Then if I think about the AI opportunity we have built with GI Genius and the skills we have in-house and the real data that we have, this now can be applied across the portfolio. Like I will show you today, we will show you today. So I call this not only portfolio diversification. This is multiplying opportunities within this structure. So this is the result of the work we have been doing over the last 12 months and the forward looking that we have in the business. We have issued this release this morning to share with you our vision for 2030, and it is ambitious, but it's based on solid foundation that we have within the company in terms of talents, portfolio and pipeline. So we are looking to increase recurring revenue by 39% over the next 5 years. This is really one of the highest, I would say, opportunity that you have seen -- I mean, you might see across our life science space, difficult to really match. Now the transformative part is going to be also that we want to become more and more profitable. And our CFO will touch base on this how. But we are aiming to increase by 65x EBITDA from the modest level we have today, to what we aspire to be at the end of 2030. This is a very important strategic lever that we want to have. Now with this growth, then you also get margin expansion, which are going to get to 40% from a low single digit of today. This is what happened when you put together mission, culture, talent, strategy and execution. So that's our vision. Now I am sure you guys are thinking, those are great words. Great presentation, I hope, but show me where -- how we get there? That's the next steps, right? This is the next steps. Today, you will see real project that are transforming Cosmo and will transform actually life science in general. So how we approach this? This is a very high-level slide, but it's a segue for my team to show you piece by piece, what we believe is going to happen in the next 5 years. We are accelerating pipeline on the clinical side. I talked about this. You will see, I don't know how to define this breakthrough, groundbreaking activities around MedTech AI. And I want you to think about this not only with the eyes of GI Genius but what this can mean to Cosmo moving forward. And there is also here digital health that you will appreciate today. So our background, our skills in the company are going to be multiplying opportunities. Remember, the portfolio is diversified but also will multiply opportunities. Now we have a strong balance sheet, which is great. We have no debts, which is great, right? So we are always looking at opportunities. The right one will come and has to fit some of the strategic ideas that we have, and Dominika will talk about this. We might pull the trigger and add additional value in the company as well. But this is a clear plan for Cosmo. Now let's move next. And I want to have Dominika walking you through all the strategy assumption that we have in place. And then the team are going to show one by one in terms of growth drivers, how we are heading and get that number that we shared this morning. Thank you so much. Exciting time at Cosmo. Dominika, please.

Thank you, Giovanni, so much for introducing the vision that will drive us going forward and the framework that will get us there. I'm sure you can imagine that since I've joined Cosmo in January, I have been very busy indeed. But one of my key priorities was to make sure that the way how we do business going forward, and the opportunities that we pursue are aligned with delivering strategic clarity and value. And as Gio already mentioned, we will be taking you through -- this presentation today through a deep dive into how we are practically executing on that. So let's start with creating more clarity. Now before I'm going to double down what Gio just mentioned to you around our capabilities and how our divisions are organized, I want to address a trend that I'm sure all of you have been seeing now for a while. The lines of the categories have been blurred. And I think these days, we would be very hard-pressed to find a pharmaceutical company that does not involve technology in their portfolio or in their pipeline. It has become an integral feature to how this industry operates, and we know that this is definitely a trend to stay. Now looking at how we are organized in our divisions. As Gio already mentioned to you, we have strong capability across both Medtech and Pharma. So in MedTech AI, we continue to advance medical devices enabled by AI. In our Dermatology and Gastroenterology division, that is where our acne and androgenetic alopecia, the most common form of hair loss, and colonic diseases products live. And our CDMO manufactures our products as well as the products of our partners. Each one of those divisions innovate in their own right, but also uniquely complements one another. As already mentioned, from our division of MedTech AI, our pioneering knowledge in this space allows us to run this capability throughout the whole portfolio and pipeline, maximizing the value across those divisions. And finally, as you know, our business is currently operating on a business-to-business model which is rooted in strong partnerships with industry household names. Going forward, you will hear us talking a lot about 3 areas of expertise and focus. And those will be gut, skin and AI. Those are the areas where our scientific expertise is the greatest and our ability to make impact equally so. Everything is rooted in the one bold idea that we have already shared with you today, and that is building health confidence, and our aspiration to create holistic solutions rather than mere products. So let's now take a look at why it is worthwhile to occupy the spaces of gut, skin and AI, why it is so pivotal in the future of Cosmo, and why this should matter to you too? Gut is more than just a big market. It is a big human need. Behind the number that you can see on the screen are real people. 1 in 4 still suffers with gastrointestinal diseases. Colorectal cancer is the #2 leading cause of death in cancer. And as the rates of IBD and colonic infections rise, so does the demand for safe and effective treatments. Our capability in AI advanced endoscopy and our science in our pharmaceuticals portfolio, doesn't allow us just to tap into a large market. It helps us catch disease early and improve lives of millions of people. And that is why gut is worth it. Skin health is more than just the category. Behind the number that you can see on this screen are millions of people suffering with the conditions of acne and androgenetic alopecia, the most common form of hair loss. Those conditions deeply impact the confidence and well-being of those patients. The way how we address delivering treatments in those areas is based on scientific rigor and putting patients at the heart of what we do, to deliver innovation that runs skin deep. And that is why it is worthwhile to occupy the space of skin. Finally, to close out with our third area of expertise. Now I won't be telling you why AI is worth it. I'm sure that you all know the reason why. Let me instead tell you what AI means at Cosmo. We have already delivered a paradigm shifting solution in partnership -- in being partnered with Medtronic, in the space of AI advanced endoscopy. And we are not looking to stop there. As my colleagues, Andrea and Nhan will be showing you today, we are working on a whole ecosystem of solutions that are there to enable health care professionals, not replace them. And that is what makes AI so different at Cosmo, and it also makes it practical and real. Now hopefully, with our business focus, our structure, and our areas of expertise clear, we can now move into looking what the framework is that will get us there. In very simple terms, we are guided by the framework that you can see on the screen. It translates to very easy to remember acronym, which we call GRIT. So G for growth potential, R for right to win, I for impact on patients, and T to true to our mission. In reality and in practice, this assessment of opportunities or our current business runs much deeper. We look at unmet need, differentiation, partnerships, financial prospects, growth rates, just to name a few. But I want to give you a flavor that there is a rigorous framework behind how we assess our business and opportunities going forward. On the next slide, you will be seeing a blend of higher and more modest growth rates associated with our assets. But pursuing growth rates that are at a lower rate is still worthwhile when unmet needs are high. Our right to win resides in the expertise of gut, skin and AI. This is where our scientific expertise is the greatest, and this is what gives us our competitive edge. You will see us continuing to focus on great impact on patients with the aspiration to solving great unmet need. So we are not in the space of rare diseases. And finally, we will be guided by our newly shared mission today, building health confidence to ensure that we do not deliver mere products but holistic solutions. Going forward, you will also see us keep a close eye on our growth balance. You will see a strong foundation of organic growth, with inorganic opportunities inserted into the mix, with an eye on sustainable value. So let me share, for the first time with you, how we are paving the path to leadership on the market. Now I'm sure all of you are very much familiar with the GRIT that I am presenting here. So where are the opportunities for growth? Which are our growth drivers? Where are we looking to sustain or maximize our assets? And are there any areas where we are looking to divest? Let's look at the first category. You can see solid tumors and our digital trust placed in the divestment quadrant. The reason being is that those 2 assets are not in alignment of enhancing in any way the focus that we have on gut, skin and AI. So we are divesting on those 2 assets with solid tumors having completed Phase Ia of clinical trial and our digital trust where it has sold mere days ago. So this is our way of creating more clarity and focus in the way how we work. Next up is our CDMO capability. As already mentioned, CDMO remains a strategic pillar since it is manufacturing our own products as well as the products of our partners. We will be looking to sustain this business and maximize opportunities wherever it is feasible. Now let's look at our stars and growth drivers. Within these two circles, you can see in the smaller area, the opportunity for AI advanced endoscopy in terms of target addressable market, where GI Genius resides currently. Today, you will see that because of the fluidity of our AI capability, we have the ability to cross the border into that wider MedTech AI space and Nhan and Andrea will be helping to bring this vision to life. Next up in our portfolio, which focuses on gastrointestinal disease or rather pipeline in this case. For distal ulcerative colitis, we are working on delivering a significant advancement for the treatment of this disease, which would mean addressing both symptoms as well as the cause of this disease. You will be hearing from us soon our advancements on our gastro-pharmaceuticals portfolio. And finally, for bile acid diarrhea, we are looking to take up a complete white space on the market in the absence of available treatments for this disease. For our skin portfolio, you well know that Winlevi is already the #1 topical acne prescription product in the U.S. and we are steadily working towards global expansion for this asset, followed by our great opportunity with androgenetic alopecia, the most common form of hair loss. Our solution looks to address a 30-year drought in a no new developments in prescription products for male hair loss. The market results are in, and Diana will be sharing some very exciting insights with you today. Finally, we are very excited to announce that we are entering the digital health space in our skin therapeutic focus first. And both Andrea and Diana will be walking you through today how we are creating a holistic solution, combining our solution for androgenetic alopecia with an AI digital companion to come. Thank you very much for listening to an outline of Cosmo strategy going forward. You have our commitment that we will be keeping you informed as we make progress. And as our most exciting growth drivers still emerge, I want you to be confident that our new ways of thinking, the rigor and the framework that we are applying will get us there. Now it is my pleasure to hand over to Diana, who will be giving you an update on all things skin. Thank you.

Good afternoon, everybody. It is so nice to see so many familiar faces that have supported us for so long. I am excited today to share with you some really interesting information that we've generated. We've been working very hard in our derm division, and I think you'll be pleased to see the results. So I'm going to talk today about our androgenetic alopecia product, as well as Winlevi, our acne product. Now let's start with Winlevi. Winlevi is the #1 branded prescription product in the United States and has been since 3 months of launch. It is now on track for global expansion. In the U.S., over 1.4 million prescriptions have been written for Winlevi. And in the last year alone, 35 publications have been shared at key derma events, with information on new capabilities with the product in terms of reducing sebum or how it works so well and skin of color. And these exciting publications really set the stage and give information so that this product can be launched in many, many countries over the next years. It's already been launched in 6 countries. Will be launched in 3 countries in the next few months. And by 2027, Winlevi will be available in 40 countries around the world. Now let's talk about androgenic alopecia. I'm happy today to share with you not only the status of our Phase III clinical trials, but importantly, to share some very exciting market research results hot off the press. Our Phase III studies are fully enrolled. There are 2 identical Phase III studies in 1,500 males with mild to moderate AGA and 50 sites across U.S. and Europe. We look forward to announcing this fall, the 6-month safety and efficacy results. And in the first half of next year, the 12-month long-term safety and durability results. Now I'd like to share with you a really brief conversation I had with one of the worldwide key opinion leaders in hair loss. Dr. Maria Hordinsky. She's a dermatologist. She's a past President of the American Hair Research Society, and she is a Board member of the American Academy of Dermatology. Not only this, but she has been a clinical investigator for every product approved for Class IV androgenic alopecia and also was a Phase II and a Phase III investigator in our trials. Let's take a look at the short video. [Presentation]

So I think Dr. Hordinsky's comments are a great segue into sharing our market research results. We've invested in significant amount of research in order to really characterize with a high degree of confidence the U.S. market for androgenetic alopecia. This research was, like I said, it is hot off the press. It was conducted in January to May of this year, by Kline & Company. Kline is an expert advisory firm in the field of the beauty industry. Importantly, we commissioned a very large-scale survey of males with hair loss in the United States. This survey contained 3,004 U.S. males. The size of survey gives us confidence in the results. The size of survey gives us a 95% confidence level with a 1.8% margin of error in that the results can be reflected up towards the total population. So what this means is if 84% of patients, perhaps, say they would try Breezula, that we can be 95% confident with a 1.8% margin of error that, that number is actually somewhere likely between 82% and 86%. Also, Kline conducted a very comprehensive landscape of the current marketplace. Understanding the competitive landscape, the products, the trends and importantly, the importance of the digital channels in this space. And of course, the foundation of this was first qualitative research, not only with consumers but with influencers like barbers and hair stylists, who are some of the first people that patients talk to about their hair loss. And this information served as the very foundation by which we built the large-scale survey. Now let's talk about the size of the market. The U.S. market for androgenetic alopecia in males is absolutely substantial. There's 166 million men in the United States, and 65 million men have androgenetic alopecia according to very recent 2025 sources. Of those 65 million males, 16 million are currently being treated for hair loss. And importantly, 27 million males are currently actively looking for treatment. This makes a 43 million male opportunity for us in the United States alone. Now this market is ready for disruption. As Dominika mentioned, these products that are currently available on the market were launched 30 years ago. So there's been quite a drought for this therapeutic indication. And this market is primed for adoption. For these patients, hair loss is urgent and emotional. Greater than 65% of them express deep concern about their hair loss, saying that it really affects their confidence and their self-perception. 83% of them are very eager to try something new, which is reflecting the drought in the marketplace. These patients are motivated and they are very willing to invest. On average, a hair loss patient is using 1.4 products per patient. And greater than 50% of them are spending from $50 to $150 a month on hair regrowth solutions. This market is also highly responsive to advertising and marketing. An example of that is Nutrafol. Nutrafol is a hair loss supplement that was acquired by Unilever in 2022. Since that time, that business has quadrupled. On the back of Unilever's significant investment in advertising and promotion. This really is evidence of how this market is ready to adopt and take on new products. Now we've identified certain segments that are particularly interesting for clascoterone solution. Millennials, Gen Zs, telehealth users, GLP-1 users, which I'm going to tell you about here shortly. And like I said, those currently being treated or those actively looking for treatment. So let's talk about hair loss and GLP-1 users. These men are highly engaged in hair loss. There's 6 million active male GLP-1 users in the United States. 2.3 million of them are experiencing hair loss and 1.2 million are actively on treatment for hair loss. These men are very digitally active. 70% of them are using digital telehealth in order to get their hair loss treatments. Over 90% of them get their treatments via subscription where the product is repeatedly delivered direct to their door. And when asked about clascoterone solution, 84% said they would be likely or very likely to try our product. Clascoterone has potential to transform the androgenic alopecia marketplace. It will be the first new drug approved by FDA in 30 years. It targets the root cause of hair loss, DHT, and by using a digital-first approach. When asked about clascoterone solution, 86% of treated customers and 84% of those looking for treatment said they would be likely or very likely to use clascoterone. These are some of the highest numbers I've seen in my 37-year career. And I really think this reflects the fact that they can recognize the innovation and that the market is just full of unmet need. Now when asked about what were the most attractive features of our product. They said its efficacy, the fact it would be the first FDA-approved product in 30 years. Its unique mechanism of action and its mild safety profile. Digital and telehealth has emerged as not only a very accepted way of patients getting a hair loss product, but it certainly will be the preferred channel for our product. 42% of hair loss patients have already used telehealth. Over 75% of all patients surveyed said they would use telehealth to buy our product. And over 70% expressed a very high likelihood of using our digital companion. Now Andrea is going to tell you about it more shortly. But what I can tell you is that these patients specifically liked the ability to interact with the hair loss professional right on the application. They also liked the AI-driven progress tracking and the reminders to use the product. Now what we think this means is this leads to much better outcomes for the patients and more loyal customers. This is a very, very large potential in the United States alone. Like I said, this is a transformative product, converting both patients that are using treatment but also the ability to convert patients who are actively looking for treatment and getting them off the fence. This is a lifestyle drug. And our research is showing with a very low price elasticity that this could be priced up to $225 a month. Additionally, we are quite confident in our ability and this product's ability to convert, like I said, both treated and untreated patients. This represents a $20 billion opportunity in the United States alone. So as you can see, we couldn't be more excited about clascoterone solution and its potential. So going back to Dominika's slides, we have a thriving, exciting dermatology business. Winlevi is an $8 billion, EUR 1 billion opportunity and it's on track for global expansion. Our hair loss product, massive opportunity worldwide has very -- we are very confident in the market research results, and we look forward to sharing our Phase III 6-month results with you this fall. So stay tuned. Thank you very much. Now I'd like to invite Andrea to come aboard and talk about our exciting AI capability.

Good afternoon, everybody, and welcome to our Investor Day. As we heard before from Gio, from Diana, from Dominika, AI is really important for our company. And my mission as Chief AI Officer at Cosmo is to make sure that AI becomes the Cosmo strategic engine. So you might be expecting now for me to share with you yet another robotic physician. However, I think that I'm going to show you something much more powerful. Let me start from an example with this image. What do you see? We start from what I call the traditional pharma model. In this model, we build, we develop drugs, we bring them to the market, we sell these drugs to the patient, and then we start again. We move on. However, the patient do not move on. They might go home and they might struggle with the therapy. They might have doubts. They might even doubt that the therapy is working, and they might drop off the therapy before the drug has a time to have an effect. Now imagine this. We believe that in this gap between prescription, a reality, there is a possibility. There is an opportunity to use our AI expertise. We've started with GI Genius, as you will hear after me from Nhan. And GI Genius gave us an incredible opportunity to learn what does it mean to bring AI for real into the health care. We tackle the hard stuff. The regulatory hurdles. How to handle sensitive data? How to design an AI that actually gives the important insight? So what if we could leverage this expertise to revolutionize the model? What if now the patient take the drug, but this time does not go home alone. What if we leverage the possibility of digital, to give a digital companion to our patient. A digital companion that stays with the patient. That answers the doubt. That, as you heard from Diana, it shows the progress. Says to the patient, hey, you are not alone in this. So this is an incredible potential. And let me show you what can be considered our first initial step into this digital world with a short video. [Presentation]

So what you've seen is not just yet another digital application. I believe that this is the proof that a drug can be considered now a digital platform, with the ability to answer the unmet needs that were shown just moments before. An app that can be with the patient facing the important challenge that the patient will face when he's alone. So we will start with hair loss, but this is not limited with the hair loss. All conditions that are chronic, with high emotional content and data reach, will benefit immensely from our AI companion. Now I mentioned data reach because there is another opportunity that these tools unlock. And these are opportunities that turns into this tool into high recurring revenue engine. Why is that? Because, for example, digital companion can be licensed. Data that we gather from patients, from real world, can be shared with our partners. And the diagnostic tools like the one you have seen in the video can be linked to telehealth opportunities to increase the sales of our drugs. I believe this is very exciting. And to go back to what Dominika was showing, this unlocks incredible opportunities. Now I'm really excited to follow up the conversation after. But right now, let me introduce on stage my old friend, Nhan, that will talk you about MedTech AI.

Hello, everybody. Nice to see you here as last year, I was remote. So today, I will drive you through the past, the present and the future of our quest to bring health confidence in patient procedure with AI insights. So I would start from showing you a colonoscopy video. So this is very standard colonoscopy video, I'm sorry for that. And this is what endoscopists are seeing every day. So if you look to a CRC screening colonoscopy, they are seeing maybe 10 patients a day. And if you think about like the colon is about 2 meters then they are inspecting 20 meters of colon every day, which is -- I mean, by the way, it's quite a hard task. And of course, the polyps can be very small and difficult to find behind folds. And so it's really exhausting. So at that time, in 2019, nobody thought it was even possible to do anything about it. And many people tried in several ways. And actually, we introduced it for the first time, the first spark of artificial intelligence in the field by introducing this technology that then Medtronic distributed to the market under the name of GI Genius. I think you -- everybody knows here. So we did this in 2019, and we had to define everything about this product because it didn't exist anything comparable. So we really created the whole ecosystem in this industry for that. But then fast forward to 2021, that year marked really a milestone for global expansion because we got the clearance of FDA with the De Novo, the first De Novo of our artificial intelligence product in gastroenterology. So it was definitely a huge moment. And then at the same time, we also amplified our AI with the characterization feature released in Europe then that is able to -- even to understand if a polyp is precancerous, right? So not only detecting but even guessing if the polyp is precancerous and this has been proven very effective then after its launch in 2021. Then if we started to increase and develop in 2023, we reached 1.5 million patients impacted in 28 countries with our technology, which is an incredible number. And the same year also, we released ColonPRO. ColonPRO is actually the detection system, it's what you've seen already, but was also introducing some quality metrics that are driving quality in procedures. And this was for the first time, AI-driven, of course. And then the same year also, we opened the platform to other applications. So it was a great year. And today, we reached 4 million patients, more than 4 million patients. Just think about the impact of this technology. And the platform that we are bringing now is expanding. It is expanding with 3 elements: the AI module, the intelligent tablet and a new component that you should have been hearing about, which is the GI Genius XR, which is an app for Vision Pro. So let's see all the elements one by one. So first, the module. So GI Genius Module 300 is a game changer in the industry. It's featuring NVIDIA IGX technology and this is really empowering the whole platform, and I'm telling you why. Actually, it's really supercharging partners in releasing products into the platform with no changes. So from the development to production very seamlessly. And because of that, this is accelerating the ecosystem. It's really boosting the ecosystem and also plugging into a community of developers that is, of course, I mean, probably the community of AI developers around the globe. And third, this is cutting-edge technology. So it's really technology jewel. So we can deploy the very latest AI into the patient range, into the endoscopy room. So this is a key technology. So what can we do with that? Well, this is our pipeline. So we definitely started with a CRC screening colonoscopy we've been talking about with ColonPRO, if you remember, launched in 2023. Of course, ColonPRO is the state-of-the-art detection tool, integrating also characterization, even an engine for sizing, is integrating also quality for the endoscopist to monitor several parameters about the procedure. So all good stuff, but we are going beyond that. We are going to upper GI. So probably you've heard about the MDR clearance of certification of Cerebro that is a product of EndoVision. EndoVision is one of our partners in the ecosystem that's received clearance in Europe. And it is about upper GI. So upper GI is a procedure that is very common. It's very frequent. Volumes could be similar to CRC screening colonoscopy. And by the way, it's done with the very same cart. So you have a cart doing colonoscopy. The very same cart is doing also upper GI. So what does it mean? You just would like to maybe do your colonoscopy with ColonPRO and do your upper GI procedure with Cerebro. You can switch with a tap. So you just tap and switch and you do your procedure. And you know what, we can even upgrade the software in pre-existing towers, right? So it's really something that we can transition from doing only colonoscopy to doing also upper GI. And so the software is essentially, let's call it a CAQ. So it's a computer-aided quality, is basically preventing blind spots while doing upper GI procedure. So it's a procedure in the esophagus and the stomach and maybe you could miss something. So the system is detecting landmarks. And actually, it's interacting with the physician to tell if they missed something. And so maybe they go back and expose the mucosa have been left unexposed. And so the procedure can be complete. So this is incredible because we can give confidence to physicians to really carry out a complete procedure and confidence to the patient to receive the same level of care. So this is meeting also our mission here. So moving forward, since we are not stopping with just a generic application for upper GI, we are moving to Barrett's esophagus. So Barrett's esophagus is a condition that is not as prevalent as you would think of colorectal cancer, polyps, but definitely very important also because it connects with the Medtronic portfolio for treating Barrett's esophagus. So what we are doing is to generate -- to develop an AI that is able to detect dysplasia in the Barrett's. So dysplasia is -- it can be really missed and the AI can highlight where the dysplasia is. And so the patients can be routed to treatment. And this is the connection between a diagnostic procedure and a therapeutic procedure. And so we are creating value here. And also, we are preventing those diseases to be missed. Then moving to another example, we are also working in gastrointestinal metaplasia. So gastrointestinal metaplasia is affecting all the upper GI tract and essentially is a condition that is affecting a huge population around the world. I think 1.4 billion patients are suffering of this condition. And this is very present in Asia, but it's present across the globe. And this condition is featuring lesions that could be precancerous. And so if you detect and treat them earlier, you can prevent cancer to happen. So we are also working with CADe and CADx, that means detection and characterization, so detecting lesions and understanding what the lesions are to address and help physicians in the treatment in the -- let's say, in the management of patients with those condition. And also, we are working with an app for esophageal symptoms and even pancreatic cancer. So let's take a look to the second element of the platform, the tablet. So the tablet is an interface that is really creating the missing link between real-time AI, so what happens during the procedure and reporting. So reporting is essentially what happens after the procedure. So why is this the bridge? So the bridge because actually, those are currently disconnected worlds. And we are creating a way to annotate what happens in the procedure while things are happening as easy as it seems. I mean it doesn't exist anything. People are just annotating on a piece of paper. So we are creating a structured way so you can manual annotate things, you can even receive AI feeds and suggested annotations, you can confirm them. So there's an interaction. And then all that is confirmed and sent to the EMR. So this is groundbreaking because actually, it enables an AI companion that is helping physicians in their practice, is reducing the effort and easing up the documentation process because you can document part of the procedure while you are running the procedure, but at the same time, is an interactive component, you are in complete control. So this is basically what the tablet is. And of course, it's enabling an interface also for AI applications. So I also would like to show you an additional feature, which is voice control, advanced voice control that we are featuring now. So if we can switch to the tablet view, yes. Thank you. So this basically is the, let's say, the tablet, as you would see on the tower. As you can see on the right, you have all the types of annotation. This is a free set for colonoscopy. And you can essentially snapshot anything while you are doing the procedure. And then you typically select the annotation we would like to give or AI can even suggest an annotation. What I wanted to highlight is a function to be able to dictate things that could be relevant for that specific snapshot. So we simulate a snapshot and I start dictating. So I'm saying that this is a 3-millimeter polyp in the ascending column that is removed with a cold snare, stop. And this is the result. So it's basically understanding what I'm saying. So it's not only creating a transcription, as you can see, it's also understanding the meaning of what I'm saying and is reconciling this meaning with the annotation set you have on the right. And that annotation set is completely customizable, so we can really create an annotation tool for any procedure provided that we have questions and answers. And all that can be sent to the EMR. So let's make another example because rooms are noisy, maybe you are doing something else, you are chatting with someone else. And so maybe when you start -- when you hit a snapshot -- just generate another snapshot. Thank you. Then you may say, well, today is very warm. I mean -- I'm sorry, today is very warm. And I mean, the air conditioning is like, I don't know, what's going on with the air conditioning. And by the way, it's -- so I'm sorry for that. It just recognized that I was not talking about the polyp and I was just removing everything because it's not giving anything. So this is just -- but then let's do another example, if we can, I'm sorry. And so [Foreign Language] cold snare, stop. So I was talking in Italian, and I finished it in English and the system just understood everything. So it is able to filter out the noise. So can we switch back to the presentation, please? Thank you. So thank you, Antonio. So it's incredible because actually, this is not only for colonoscopy, it's not only a companion for any other application we've seen in the pipeline, but also can go beyond that. I mean it's just applicable to anything. So moving forward, as I just want to cover, this one is very exciting, and I have to have time to cover it. So Vision Pro. So it's just redefining everything. So we have a platform. We have an interactive tablet with a lot of features. We have an ecosystem that is able to create applications. This is generating maybe an AI augmented display. So what if all those contents could be projected around the physician in a digital world, while the physician is still looking at the patient, have everything under control, talking with nurses, doing everything, but being in control, being able to use gestures to control those digital elements. Well, this is what we created, which is exactly that. So let's take a look at how it works. So we have a room. This is an endoscopy room. Now I'm just seeing digital content. So I open up the menu, I open up the application, and I can move the screen around and I can put the screen maybe side-by-side with the physical screen. I mean, I won't be needing any screen anymore because I can't mirror the screen. But look, the screen looks better. There are no glares. The screen can make giants. It can be moved even in position that physically would not be possible. So it's very convenient for configuring your environment around you. I mean, if you're a physician. So this is a very unique feature, and it's real time, no delay, streaming in wireless, so you have no wires and you just can do the procedure and you have your hands to do the procedure. But look, I'm opening what you've seen in the tablet interface that we demoed before. And so you can have the voice activation as well and also doing the annotation, you can do the annotation, pointing with your eyes, making gestures to click and send everything to the EMR. So this is something new. It didn't exist before, and this is just amplifying what we are doing. So it's not a product per se. It's an element of the platform. So I think this is very relevant. And this is the way we are doing things. So we are scaling things up. So we are not only creating. We always would need physicians, by the way. So just to conclude, we have an AI module. We have an intelligent tablet. We have Apple Vision Pro integration. All this is ready to scale beyond GI endoscopy. And what does it mean from a business perspective? It means going from the orange circle to the red circle. This is it. I just would like to hand over to Gio.

Thank you Nhan. Exciting innovation and I'm pretty sure we will have more to talk about. We also have set a demo station after the meeting. So I hope all of you will try to get the Apple Vision Pro and experience yourself the immersive experience that this technology can allow. And like Nhan said, I mean, this is really going beyond endoscopy as any real-time procedure can benefit of this. And we'll talk this later throughout the year, but we're working on a few more things. So I have the honor, and I'm very humble to call on stage a very important key opinion leader in GI worldwide. And he's leading the gastro unit at [ NYUC ] in New York, Professor Department of Medicine, and he's American Board of Internal Medicine. He has a ton of experience with innovation and technology, and he has been in charge for many different committee with the American Society of Gastroenterology. So when we ask him to join us for this meeting to share some of his experience with GI Genius and also the Apple Vision Pro, he immediately said, yes, I want to share this. And this shows the excitement. So please welcome Dr. Professor Seth Gross here on stage.

So we have scripted a few questions. As you see, I can read the question here. So Seth, let's start from -- I mean, you were one of the first to use GI Genius in the U.S. back in 2021. And maybe you can share with the audience here your experience so far, what you like and how it is impacting your practice and your patients?

Yes. So for those of us that perform colonoscopy, and I may be the only one that got excited to see a colonoscopy video clip a little while ago. I remember when I went into practice, one of the senior doctors told me that when you start doing colonoscopy for your patients, you're responsible until they come back. And when I heard that, and it sticks with me today, that's a lot of pressure because we don't want to miss things. And we know that despite all of our efforts, we've come a long way, but there is a chance that we could potentially miss polyps, especially pre-cancerous polyps. So when I heard about artificial intelligence entering endoscopy, starting with colonoscopy, that was really exciting. It made so much sense and it led to myself and my colleagues where I work to implement and bring on GI Genius. And the way I know if something successful where I work is I ask the nurses, because they'll tell me the truth. If I ask the doctors, they'll just say, I'm using it even if they're not using it. But the nurses all told me that the doctors are using this all the time. And the other thing that we were able to do is we're able to look to see if we've seen improvement in what we're doing for colon cancer prevention, which is detecting polyps. And we saw an increase in a key metric. You heard a lot about metrics, but our precancerous polyps detection rate called the adenoma detection rate went up for the physicians that were using GI Genius. And that was also very important to our hospital to show that the investment is worth it. So we've been very happy. I've personally been very excited about AI in endoscopy.

So I think there is an elephant in the room here, and I want to ask this question immediately. So I think AI market penetration in endoscopy in the U.S. is about 6%, 7%, more or less. And GI Genius is the market leader in this space in the U.S. So I think there are about 28,000 towers, colonoscopy towers in the U.S. So how do you see the next 5 years evolution of deploying AI, adopting AI? Do you see a way back or you see an acceleration?

That's a great question. When I think of artificial intelligence, just even taking it even a 30,000-foot view in medicine as a whole, in procedural-based medicine, I would say there's no going back. We're just moving forward with artificial intelligence. And when I think of things over the years, I tell physicians the same thing all the time that artificial intelligence, where it is today in 5 years, 10 years, it's going to be a part of everything that we do. I'm actually using it in my clinic with [indiscernible] for notes. And I was really excited to hear the developments that Cosmo is doing because Cosmo is tackling 2 key areas for artificial intelligence and health care. There's the augment or improved performance, which is making the physician better, which will lead to better patient outcomes. But they also recognize there's a tremendous burden on the physician with electronic paperwork that we have to do. So that audio dictation, that's a game changer. And why is it a game changer for me and the doctors I work with? One, it's going to allow me to take a breath in between these procedures. It's going to allow me to get back to what I used to do when I first went into medicine. When you're a medical student, or a trainee, you get lots of time to talk to your patients. You get a few minutes to engage with them to know them. And these days, we're so busy because we have to get through a very busy day, we're going to be able to get minutes back by having this automation and efficiency improvement in procedural-based medicine.

Thank you. So you know we are about to start a clinical study with the Apple Vision Pro in the U.S. Irving Waxman from Chicago is going to lead this study. So you experienced the Apple Vision Pro a few times already, being part also of the initial prototyping. So can you share here your experience with the technology and how do you see them to be deploying in the market in terms of opportunity at scale?

Yes. I think one of the things that physicians want to have, especially when we're doing procedures is have information at our fingertips. So the first thing that you saw a few moments ago is that it is truly immersive in the sense that we're getting a crisper image. We have the ability to not just do the exam but also do the procedure note while we're working, which is critically important for us just to keep the day moving and also to be very accurate with our reports because at the end of the day, when we look back at care deliver today, it's all based on the notes. It's not based on my memory, right? So we want to have good quality reports, and this will standardize that amongst the providers. And what I envision in terms of a future state is that for physicians, at least in endoscopy, where you heard about endoscopic ultrasound in pancreas cancer because that's how we find it with this ultrasound probe from the stomach. I envision the ability to use the Apple Pro to not only look at what I'm seeing on screen, whether it's an endoscopy image or an ultrasound image, but what if I need to see the MRI image to correlate what I'm doing. So we can have all that information at the tip of our fingers versus having to like leave the procedure zone, go to the computer, relook at the images. So this immersive experience is going to change how we provide care to patients.

So Seth, you saw Nhan presenting all of these variety of very important application that we have about to be in the market and also about to be deployed in the market. So what's your take about the ecosystem that we have built?

So I think what they're doing is, and I'm excited about this, is we have a computer-aided detection in the U.S., which is polyp detection. But there's -- that's just the tip of the iceberg. So if we just focus on colonoscopy for a second, you heard that they talked about these quality metrics. Quality metrics are very important because if we properly inspect the colon, we make sure that the cleanse of the colon is appropriate, that all impacts our outcomes. And sometimes, physicians are not good at recognizing something isn't right. So no one will ever say I do the fastest colonoscopy. No one will ever say that my -- the bowel prep for that patient is bad. And we need that type of feedback so we can improve to offer better care. And what I like what's happening with Cosmo from the colonoscopy point of view, as they're completing the story. They're not just stopping at polyp detection. They're looking at sizing, characterization, how much time we spend, is the bowel prep quality? And then they're taking it a whole step further on the procedure documentation. But then what I was very excited to hear about is the focus on -- you heard about upper GI. So upper GI refers to endoscopy. So flexible tube with the camera goes in your mouth, goes down to your stomach just above your belly button. Many people have had it. We talk more about colonoscopy, but there's a lot happening in endoscopy, and it shouldn't be ignored. And I'm excited to see that Cosmo is focusing on that too. They're working in parallel to deal with our care gaps, our unmet needs. And for endoscopy, people that have heartburn, they don't realize that heartburn in some people could be very dangerous. Some people with heartburn can get an esophagus cancer. I know it's hard to fathom, right, because we all pop Tums every once in a while. But the reality is this could happen, and that's that Barrett's esophagus condition. So if we have the ability to, one, identify Barrett's esophagus. And two, there's a needle in a haystack phenomenon in that area of Barrett's esophagus, which is looking for dysplasia. Dysplasia is precancerous change. If we could find that we stop someone from progressing to esophagus cancer and that's really powerful. And for those patients that don't have that pre-cancerous change in dysplasia but have Barrett's, I could reassure them and tell them there's nothing serious going on. You have a chronic condition that we just need to follow. So they're definitely raising the bar in terms of what we're doing to improve patient outcome.

Last question. So how about competition on AI? What's your take about other companies in this space?

Really great question. There's always going to be other companies and all the things I deal with, there are other companies that have technologies. And what I could say, and what I've known, and what I've used, and what I've seen, is that GI Genius was first to enter endoscopy with artificial intelligence. And what you saw earlier today, is all the things that they are on the verge of implementing, or have implemented, that I could tell you that the competitors only have polyp detection. So they're just entering the market with polyp detection, whereas now we have quality metrics with GI Genius. We're on the verge of going into other organs, like the esophagus and stomach. So they are leaps and bounds ahead from other companies.

Thank you so much. Thank you for coming here, and thank you for the insights.

Good. So I'm happy to introduce the next speaker. We're going to talk about the pharma business and the pipeline of data. Egle, she's going to walk us through the plan.

Thank you so much, Gio. Good afternoon, everyone. It's a real pleasure to be here today. And after so many exciting news we heard, I am here to introduce you and to drive you through some updates in our pharma pipeline. And I would like also, again, to reemphasize, I mean, what you heard many times today that we are really a company that is targeting clear unmet medical needs. I will start with bile acid diarrhea, BAD. This condition affects around 30% of IBSD prevalent patients. So we're talking about around 100 million patients worldwide that are yet largely untreated due to a lack of approved therapies. We are the company that is -- the only company that is at such early stage of the clinical development in this space. So it is really setting us in a clear leadership position in this -- for this treatment. In this year's DDW, in fact, this is the largest congress in gastroenterology, there was highlighted a clear need of targeted therapies in this space. A little bit of update on our clinical progress. We are already started with 2 sites in U.K. There are first patients already screened and one patient started treatment. We got just approval for EU sites and we are starting also our clinical progress also in European sites. Now moving next distal ulcerative colitis. We are developing -- this product is addressing both root of cause and its effects. It's a condition -- we are talking about the condition that has around 1 million patients worldwide. And it's a space where it has not been any innovation since years. We are progressing with our clinical trial here as well. This product now has 14 clinical sites open and we are already at around 15 patients -- 15% of patients enrolled. This product -- why this product is also is different? It has -- this rifamycin enema has a different potential because of its dual mechanism of action. It targets both dysbiosis that is cause of then subsequent inflammation. So this is a real potential innovation both, a potential for new clinical efficient product as well as could bring patient compliance. So moving next to our third pipeline asset, CBD-03-10 for solid tumors. It's just finalizing first part of Phase I clinical trial for advanced refractory solid tumors. It is -- while it's offering a clear clinical -- potential clinical efficacy, yet the oncology is not our core area. So that's why we're actively seeking into strategic options for this product further development and as Dominika mentioned, for potential divestment opportunities. Now moving next. A very quick update on CDMO. It's not just a collateral function of our activities. It's a strategic pillar of our company. We are offering -- what sets apart? We are offering integrated R&D services, short tech transfers and exceptionally fast lead times. This is exactly what leading pharma industry companies is seeking in a partner as Cosmo. We see clear growth opportunity in this area and we are actively seeking and pursuing new business opportunities in this space. And to close, a very important aspect, again, that is an important part that our partners, at leading companies, that trust in Cosmo are seeking for is ESG compliance. Environment, sustainability and governance. We are one of a few out of almost 200 companies that have achieved 3 -- obtained 3 major ISO certifications to show our commitment, the sustainability, quality and efficacy. So to close, we are not just in high unmet medical need markets. we're also building a sustainable business. Thank you. Good, and I will leave the floor to my colleague Svetlana.

Pleased to be here, pleased to talk to you about one of the most exciting part of our company, the financial outlook and our vision. I want to start with the slide once again. As Gio mentioned earlier, you will be seeing it over and over as we remind everyone about our business model. We innovate, we deliver and we repeat, and it's not theoretical. We have done it again and again, generating EUR 1.2 billion in revenues and paying over EUR 150 million to our shareholders to date. Now I want to quickly talk to you about our revenue streams. We generate our revenue 2 ways. Let's chat through the project-based revenues first. We have continuously generated meaningful project-based revenues such as upfronts and milestones that are driven by regulatory, clinical and commercial events. In fact, out of the EUR 1.2 billion that we have generated to date, approximately 1/3 has been generated through project-based. When it comes to this revenue stream, we expect the returns above 4x or higher on the investment that we have put into the programs. On the recurring revenues, we expect a double-digit growth. We generate recurring revenue through 2 ways. One is for all of our products, for all of our partners across all of our divisions, we manufacture the products. We manufacture at a margin. As the projects scale up, as you go through the product growth cycle and life cycle, we continue to generate and grow those revenues. Secondly, we generate royalties for all of our products and all of our partners, we collect the royalty streams. We do that without growing the infrastructure or incurring additional costs, which means that as the products grow, we can grow the EBITDA exponentially. When it comes to our recurring revenues, we expect double-digit growth. Let me show you what I mean. As mentioned previously by every one of my colleagues, our portfolio sits in an attractive, underpenetrated markets that are positioned for sustainable growth in the near term in the next 5 years. For example, our GI Genius is an AI leader in the AI-driven colonoscopy. We have a significant runway in colonoscopy itself, but most importantly, in segments outside of the colonoscopy as explained today by Nhan. Winlevi is going through the global expansion. What that means is as the product continues to grow, and we expect to be in 40 countries by the end of 2027, as mentioned by Diana today, we will generate both the revenues from the supply from producing and manufacturing for Winlevi, but also through the royalties. Lastly, I want to highlight the gastro portfolio. This is something that while not growing significantly, still remains a major market and a major revenue opportunity for Cosmo. Lastly, we have CDMO as a strategic pillar where we have the flexibility to increase or decrease the manufacturing for our products without adding any incremental costs. And when it comes to the future products, digital health is a massive market where we believe we have a strong right to win. And androgenetic alopecia, as explained by Diana earlier, is a fantastic potential across the globe and not just in U.S. alone. We are very selective in where we play. We choose wisely so that we have a right to win. And most importantly, all of those markets are expected to grow significantly in the next 5 years. Now let's see what it means for the numbers. When it comes to the recurring revenues, we believe that we have a solid foundation for not just sustainable but a transformational growth. This year, we have set the guidance for our recurring revenues at EUR 85 million to EUR 90 million with a very low-digit margin of 1 million to 3 million -- or 1% to 3% that is driven by our significant investments into R&D pipeline. This year, we're carrying a Phase III for androgenetic alopecia, two Phase II assets for bile acid diarrhea and distal ulcerative colitis as well as completing the Phase I solid tumors. In parallel, we're developing multiple AI applications, as Nhan mentioned earlier. Now as I said earlier, we expect that those markets will grow. Our vision for 2030 is to grow all those revenues from existing portfolio without adding any new markets from the late-stage pipeline, 23% on a compounded annual growth rate. Or to say differently, we believe that we can deliver EUR 260 million. This is almost triple the growth in 5 years and that's just existing portfolio. That's excluding project-based revenues. So we believe we have a very strong potential to transform the company. Since we have this operational leverage that I mentioned earlier, where we do not need to add any significant investment to our existing operational base, we believe that we could grow our EBITDA to EUR 65 million or to 25% margin versus the low single digits where we are today. Now let's talk about what it means when we lay our late-stage pipeline. When we add the new products from digital health that Andrea talked today about or from clascoterone solution for hair loss that Diana mentioned, we believe that the EUR 260 million can transform to EUR 480 million. I will pause just to let it sink. We believe that we will grow the revenues 39% on a compounded annual growth rate. You can see how the portfolio composition will change where gastro and CDMO will become the minority together with Winlevi with GI Genius and new products driving the majority of the revenues. You can see that the EBITDA is expected to grow to almost EUR 200 million, transforming the margin to 40%. Again, we can do this without building additional infrastructure. All of our products are in high-growth margins with high unmet needs that are underpenetrated and are ready for partnering. We are here to win. Lastly, but also very importantly, I want to mention, once again, come back to our capital allocation strategy. Our capital allocation priorities have not changed. We remain disciplined and shareholder focused. We will continue to invest strategically in R&D in selective markets where we see high returns. We believe that this is one of the best ways that we can deliver value to all of you and any of our future and potential shareholders. We will continue to look for strategic partnerships and licensing so that we can keep the current infrastructure without any additional expenses to once again bring the most value that we can for you and any future investors. We will continue investing into organic business needs where we see fit, for example, into expanding GI Genius beyond just the colonoscopy. We have to date paid over EUR 150 million in returns with dividends to our shareholders. We expect to continue to do so. Every euro that we invest, that we select for R&D or partnerships or manufacturing is carefully measured against those principles. We are driven by shareholder returns. We remain disciplined. We remain focused, and we're very excited about the future. I will now pass it on to Gio to bring us to a close. Thank you.

Well, I'd like to close where I started with the Cosmo value creation formula. I think we talked a lot about the attractive setup, just now also with Svetlana. You experienced the foundational pillars of the company that have evolved. You met many new leaders. You, I guess, touched the culture of high performance team and the aspiration we have and the execution mindset that we have in the business and the team. I hope it was clear. Would be clear in the future also when the delivered results will come. The strategy, in my opinion, is clear, solid. I think you went through many different slides through Dominika presentation on how we select a growth driver. And the gut and skin AI, it's the focus we have, the mission is going to drive the business. And I think this is also another piece that we add to the Cosmo value formula. The balance sheet that you just heard from Svetlana is in a great position, and we are looking forward to the next steps over the next few months to share more and more results as we go through the execution of our plan. So I want to thank my team. This has been a very important meeting for all of us, being the first one. They prepared this meeting very carefully, and I think we have delivered on our commitments to all of you. And I'm looking forward to moving to the Q&A now. We have also underlying potential question. But first, we go to the room here. There will be a couple of microphones and I will try to answer the question, if not myself also if you have specific questions for some of the people and colleagues who presented just let me know.

So first question, Ram.

Thanks very much. Two questions, if I may. One is for Diana. You mentioned in your prepared remarks the -- roughly, I think it was up to $225 per month, potential willingness by patients who might be on a product like Breezula in terms of what they are willing to pay. Can you give us any insights on what that looks like in ex U.S. markets? And what the dynamics potentially might be in those markets if some of the same dynamics apply in terms of willingness to try telehealth approaches and so on and so forth? And then the other question is for Svetlana, if you go back to maybe Slide 84, I think it was. Can you comment on how this EUR 220 million component of the EUR 480 million target revenue in 2030, breaks down in terms of Breezula related and non-Breezula related revenue?

You go first, Diana?

So, Ram, we spent significantly on the U.S. research because we knew it was the going to be the biggest market in the world for clascoterone solution. And we're now evaluating the best way to really get to similar conclusions, right, with similar confidence on the rest of the markets in the world. So I don't have that answer for you today. What I would say is that in the -- as you know, as well as I do, the prices are typically a bit lower outside of the U.S. than they are in the U.S. But I would also comment besides pricing, that there are some other places that we are seeing some digital transformation happening in the marketplace with potential telehealth and digital opportunities. And so we remain bullish over time that we could have a solution also that might enhance the product opportunity from a digital or telehealth perspective.

And if I. -- yes, yes. I just want to add that this is a strategic decision. We want to focus on U.S. first. I think narrow the focus, the market is gigantic. I think it's purposely driven by the opportunity in the U.S. So we're not going to forget about Asia and Europe. But when time will come. I think this is a plan. Things are laid out. We already have some information about those markets. But now we're going to move forward with the U.S. opportunity first.

I will take the second question, Ram. So of the EUR 225 million that are driven by new products, expect that approximately 95% in 2030 is driven by clascoterone solution. I want to say that we are being fairly conservative in our estimates there on what clascoterone can drive, especially given the U.S. market research but we also want to make sure that we leave room to overperform and impress all of you. And less than 5% are driven by the digital AI at that point because, again, it would be still fairly early in this growth cycle. Thank you.

Yes. Could you say your name and company before you ask the question so we can frame it?

Harry Gillis from Berenberg. So I also have some questions on Breezula, if I may. Could you please just talk about some of the conversations you're having with potential partners has interest? From potential partners been increasing as the Phase III readout nears? And in your eyes, what makes an ideal partner? Are you looking at large pharma, pharmacy chains, consumer health, what are you really looking for there? And actually, if I could ask a follow-up on the last question. So thanks for clarifying that 95% of that late-stage revenue is from Breezula. What royalty rate have you assumed in that so we can sort of back that out from end market sales?

You'd like to ask confidential questions though, both of them. I can answer to both. I mean I just can't -- I mean, we know exactly in the U.S. who could be the potential partner. We have also, through the market research came across this research and we have a list of 13 companies that will fit other strategic fit, digital telehealth and also potential pull-through for technology that they already have in the market. We know exactly the names. I'll let you think about it. I'm sure we are potentially very familiar with those names. Regarding the royalties, I think it's going to be a conversation deal. Expect to see upfront payments, important ones with this market size. Expect to see commercial milestone, important ones, with this market size. Expect to see more attractive royalties for Cosmo moving forward. Thank you for the questions.

It's Ben Jackson from Jefferies. Diana, a couple for you, if I may. Firstly, obviously, the results of the survey are quite telling on the positive potential uptake for Breezula, but perhaps could we reframe it? What were the potential pushbacks that you got or highlighted from the survey? Were there any issues that you think you may have to address and overcome to help -- to penetrate that market? And then secondly, could you just add a little bit more color about the potential stay time on these -- on Breezula when it arrives. What are you thinking about how long patients will take this drug and how frequently? And if they were to stop, do you anticipate them coming back? So those kind of dynamics are useful as well.

You're welcome. So it's very interesting because what we found in the survey was that patients already have this very high interest in trying a product. They're very concerned about hair loss. And so we did not get pushbacks in our research. The only hypothetical thing that any patient would say, well, that I think any of us would say about any product, is that as the long as the product is safe and effective, and I'm seeing results, I'm going to keep using it for as long as it's working, right? So they were very interested in actually seeing the clinical results for sure. But when we describe the product, which was the Phase II profile that we saw, they were extremely enthusiastic about it. Now they're very interested in really getting access to products, right? And so this is where the telehealth and the digital piece emerged, so that the doctor no longer is the barrier between them and their treatment. And that's really the beauty of what a direct-to-consumer positioning is for our lifestyle drug. So that when a patient is seeing -- they're doing research, right? And they're seeing our product come up. They can, in the moment, click into a telehealth or digital situation, and right there when they're motivated, receive a prescription, which turns into a subscription that shipped to their house and arrives in the next 1 or 2 days.

Did you also make an assessment of what hair transplants would do to the market, whether that's a viable alternative for patients? Because that's a totally different -- but it's a competitive component?

Well, I've been talking to KOLs for quite a few -- well, for over a decade on hair loss. And certainly, what they say is that patients that can afford a transplant, which can be above $6,000 or $10,000 may go do that. But it's a very small minority of patients. Also, they say that once though a patient gets a hair transplant, they get on a drug like Breezula to maintain the hair transplant itself. So I don't see it as competitive. I actually see this complementary.

Martial Descoutures, ODDO BHF. A follow-up question on Breezula. In your presentation, you highlighted that -- we expect to have a better solution to motivate patients to use it in the future. So what is the definition of a better solution? So at the end, is it possible to have a -- not more data, but your visibility on the efficacy that you expect in the Phase III versus the competitors and maybe the safety profile of the drug?

So of course, we are anxiously awaiting the Phase III results. Certainly, we haven't had any safety warnings because that would normally cover them in a clinical trial, and we feel very confident in the safety of clascoterone. Remember, clascoterone is in Winlevi, and it's been used in over 1.4 million patients. As it relates to the product itself, patients talk about wanting to get access. And I think that's one of the most important things that they talk about when they're talking about what it is that they're looking for. They're looking for a drug that they can get easy access to but that can be very clearly shown to have both the safety and the efficacy. So they're looking for -- in fact, they said specifically, we're looking for education around why the product works, how it would work? As you know, we target the root cause of hair loss. But also that when the product is marketed, that they can see pictures of patients that look like them and the before and after sort of results. And so we feel pretty good that when we're approved, if we're approved, that that's exactly how the product can be marketed in such a way that patients who are already welcoming treatment will receive it, and we'll use it.

Yes. We have one and two -- maybe you were first. We like diversification of question, just by the way.

Stefan Schneider, Vontobel. You focus on the U.S., it's more expensive. You mentioned that. So I was wondering if you have done any analysis, sensitivity analysis on MFN and tariffs? And the discussions that are ongoing for the health care system in the U.S. currently?

Do you want to get this Svetlana? The tariffs.

So at the moment, we have not seen any impact on tariffs on our business. All of our products, even those that are manufactured in Italy, they are finished manufacturing and packaging in U.S. So this has not come up with any of our partners. Whether you're talking about someone like Takeda or someone like Medtronic, or any other partners. When it comes to clascoterone, we expect that it will have a similar impact, right, we will manufacture the actual ingredient in. But the packaging will be completed by a partner because they will be distributing it and all the inserts and so forth. They will be the ones doing the shipping, warehousing and handling once we stop the manufacturing process. So we do not expect tariffs to be an issue at this point.

Thank you. Bob?

Bob Pooler, ValuationLAB. On the GI Genius platform, you're also saying you're going to upper GI. I assume there you need the additional approvals and so on. And just I think for clarification, I think you can use the current stack and basically switch going from upper GI to colonoscopy. So would it also be an assumption that we could see those revenues coming in a lot early because the stacks are already there?

That's a great assumption. Yes, I think we discussed this a few times. The current GI Genius users. As I said, Medtronic is market leader globally, owning 95% of the market, will be immediately jumping on those applications because it's just a simple download and subscription to use those application, Nhan showed the upper GI Barrett's, the upper GI also procedure from Cerebro and the gastric cancer as well. The pipeline that Nhan shows give us 2, 3 years, all of them approved. One of them is approved in Europe, Cerebro and the other are about to get approved in the U.S. So we expect to get meaningful revenue much faster, like you said, because of this, installed base is going to grow anyway in the next 2 or 3 years. So expect that number to be larger.

Then on your new AI-related products there, I really like the companion diagnostic, I think that will increase patient compliance. So you have an interaction, which currently is not there, as you say. Once you go to the pharmacy, you get it, there's no more interaction, and you see the compliance going down. So another products, this is probably something that will just be given together with Breezula. So it's like many apps, it's free for the patient. But on the other apps for other areas, other peers that are developing products there, how do you see that business model there? Is this something where maybe you get revenues on increased compliance or?

Yes. So too early to talk about this, but what Andrea and the team is building for Breezula, first off, it won't be for free. I mean at least for Cosmo, that's an asset that we will license, based on who is going to get also the drug. And I do believe also that they can monetize the app itself as well with some premium features, so which we are working on. With that said, also, we believe that platform will serve us to find opportunities beyond our current product -- within our current product. Think about also acne, very emotional disease, lower the confidence of the people impacted by this disease. So we believe also we can add an additional layer of support for our patients and our partners with this digital companion app. So we have a pipeline. I think today, we wanted to show you what we are building. But as you see, there are opportunities also outside of the portfolio of Cosmo, which we're going to embark over the next few months.

And that's just on my final question then, maybe on when do you expect the results for BAD and the distal ulcerative trials, which you're now investing in?

Well, actually, first, we got to finish the trials. I think the Phase II trial time line is kind of fluid right now as we just open the EMA for the bile acid diarrhea. So we are aiming for next year completion of the trial for bile acid diarrhea and maybe mid of next year for this distal ulcerative colitis. But again, don't quote me on this because we'll give an overview about the time line in the earnings in a few weeks when we get more data consolidated. Any more questions from the room? Otherwise, I don't know if -- no, there is no questions from the phone? Yes, one more Harry?

Harry Gillis from Berenberg again. Just a quick one. I was wondering if you could give any update on the Winlevi filing to the EMA and your level of confidence in resolving that?

Yes, sure. I mean my level of confidence, I'll start from the last, it's very high. With that said, we are following the process very carefully. We expect to get a few more meetings in July and August with EMA that are set by the process and the procedure. So we expect to get an answer sometime in September on the results. So the team with some support of key opinion leaders, European has been working very hard on the answers. I'm confident we have the right -- clinical right to get approved. So that's the way I see it. There is one question from the phone. Yes. So open up.

First question comes from Nicolas Pauillac from Kepler Cheuvreux.

Maybe 2 quick questions from my side. The first one is not going to be very original, but then Breezula again. Could you talk about the time line to commercialization that you guys have in mind because you are showing that it should be coming, let's say, end of Q3 and 12 months, H1 '26. So will you need to have the 12-month data to file or you can go ahead with 6 months? And then, just coming back on the slide on the profitability and the 2030 target. How do you get to the 40% margin with, let's say, just the Breezula sales? Is it that you expect the higher royalties and so that's how you get to the higher overall margin? Is there something more to that?

Yes, I'll answer the first and let Svetlana take the second. Yes, we need to wait 12 months results for efficacy and durability for Breezula for hair loss. Clascoterone, which will come mid of next year and then soon after we're going to file the FDA for the NDA. So we expect to get approved by sometime end of 2027, immediately after start the commercialization. So the number that you saw in our vision are linked to a 2-year sales for the drug. We haven't captured any upfront payment, onetime payment. I just want to make sure. But there will be also that component in the moment we are going to license the product. For the EBITDA, you want to get this?

Yes. So for profitability with new products, it's actually pretty simple. We expect significant royalties from clascoterone. As Diana mentioned, this is a drug that we believe can have a $20 billion peak potential in U.S. alone. Those are the royalties that will be different and higher than what the company has done before because they will be tiered, versus the typical single royalty that is double-digit structure, right? We expect that not only the value will be higher, but it will also be tiered as you reach different thresholds of sales. And lastly, when you think about the small revenue stream that we expect from the digital companions by then, this is a kind of product where you need to invest upfront. But then it's a very little maintenance once the product is on the market. So we expect that to be a very high margin as well. And that together allows us for expected margin of 40% when it comes to EBITDA.

Okay. And maybe if I can just have a quick follow-up question. So in terms of, let's say, sales granularity from this year to 2030, is it fair to assume that, let's say, the core business, with GI Genius, Winlevi and CDMO activity will be pretty much linear in terms of growth, whereas you will have this big bump starting '28, '29, 2030, that comes from Breezula then?

Yes, correct. Correct. I mean now we are all in with execution on pipeline, GI Genius, AI expansion, Winlevi globalization, pharma consolidation and CDMO. So you will hear more about this over the next few weeks. As we wait for the hair loss drug results for the Phase III trial, then we're going to also work very hard on making sure we have the right and the strongest partner to support us with the expansion in the U.S. I think last question, and then we close. I think Ram, one more question.

So this is perhaps deliberately provocative. But if you look at what you expect internally for the cadence of Breezula uptake, is it reasonable to assume that when you think about the time frame within which you expect the hockey stick as it were to occur, this is in a way analogous to what we have historically seen with the uptake pace on the side of the weight loss medications in the United States, given the fact that this is a lifestyle drug and given the sheer size of the market. Can you just maybe give us some qualitative comments on that, please?

Well, first off, I think I want to make sure we go back home with 2 pictures here. The first one is that we have a very strong and growing business without any pipeline in our 5 years plan, right, which is a EUR 250 million -- EUR 260 million, sorry, 25% EBITDA going from EUR 1 million, to EUR 3 million to EUR 4 million, right? So that's the base of Cosmo. That's when I talk about attractive setup, it's this one. That's very important. Now when we add the new products, so we talk about hair loss drug, and we talk about also the digital health, those are huge upside. This morning, I was working with my team. It's a nice cherry on a big cake or nice big cherry on a big cake that will add additional value also to the company future. To answer your question, yes, I think you know what we have seen in the market research, there is a lot of appetite for new solutions for hair loss. I think if you find the right partner with the digital marketing already in place. So that's what we believe is going to be a perfect fit for us. So they don't need to acquire new customer, new consumers, they already have them. And I think this is going to be a much easier, let's say, call it, a faster deployment of the product into the market. With what we have learned is that once you start using the drug, if it works, you stick with the drug. So the market size you saw was for 6 months usage, you can multiply it by 2 for a year. You can multiply it by a number of years based on the number of times that we buy. And I think subscription and delivery is the way to go here, like we said. Well, I want to thank you. This was amazing. Thanks a lot for the engagement for the questions. So we have now a little bit of mingling together in the other room. So there are some drinks and some food. There is also a station with GI Genius, the Apple Vision Pro, the Endoscopy tower. I will recommend you to go and try it out. And thank you so much, and I will be in touch very soon. Thank you.