ALK-Abelló A/S (CPH:ALK.B)
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At close: Apr 28, 2026
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CMD 2024

Jun 4, 2024

Per Plotnikof
VP of Corporate Communications, Investor Relations, and Strategic Planning, ALK

Of our recent strategy review with you and present key members of ALK's executive leadership team. We have a program today that covers the key elements of the updated strategy. We have three sessions, each followed with a Q&A session and a break, and we will try to manage time very diligently, including the Q&A sessions. First, we take questions from the room, and then we take questions from online participants. I cannot guarantee that we will be able to cover all questions, but we will make sure to follow up with you afterwards if necessary. The first speaker of today is our President and CEO, Peter Halling, who will give you a rundown on the strategy. Then we'll go into a deep dive on our key markets and growth drivers. Then we will have a Q&A session after that on these two subjects.

Then we'll talk about R&D, then we'll talk about production, and then finally, we'll end up with the numbers, bring you back into the comfort zone, so to speak. So before giving the word to Peter, let me just remind you that today's presentation contains forward-looking statements and that these are, of course, subject to uncertainty, but I am sure you are well aware of that. So with those few words, I'll hand over to President and CEO, Peter Halling. Peter, welcome to the scene.

Peter Halling
President and CEO, ALK

Thank you, Per. Thank you. And on my side and from my side, a big thank you all for joining today, and thank you all for joining online as well. It is with great pleasure that you have an opportunity as new CEO coming in and doing a strategy review together with the organization and the leadership team throughout the days. And we are really excited about presenting our new strategy to all of you today, Allergy+. So what you'll hear and experience in today's work is that we'll take you through the details in a lot of different sessions. We have Søren, Henriette, Christian, Claus, and their teams talking about the implications of the strategy and how we go about it. So without further ado, let's jump into it. ALK in brief, many of you know the company quite well.

ALK is a global specialty pharma company focused on respiratory allergies and associated conditions, ensuring that patients and doctors have access to medicines and treatments in more than 40 markets across the world. We have 2,900 employees that on an everyday basis, work extremely hard to ensure that the products and our treatments are available for more than 2.4 million patients on an every year basis. ALK's history goes more than 100 years back. Since 1923, the company has evolved tremendously from being some of the first ones looking and trying to understand what is allergy, what are allergy, and how does it impact people, and how can we do better? To the mid-1970s, where ALK, as the first company, standardized the extracts and provided the markets with the first standardized products. Since then, ALK has been a rapid development.

More than 20 clinical phase III studies for tablets have been conducted, and today, ALK is a world leader when it comes to tablets and when it comes to AIT, allergy immunotherapy. So just a few highlights: 2006, GRAZAX was launched in the market. GRAZAX, the first grass tablet in Europe and in the world. In 2014, ACARIZAX, house dust mite tablet for patients not only suffering from allergic rhinitis but also asthma. And in 2023, we could celebrate as a company our first 100 years, and we did that in a great way. First quarter, 2024, ALK had its best result in history. So when we think about allergy, what is allergy? Allergy is the most common chronic disease globally.

It has implications on individuals suffering from an allergy and the implications of allergy on an everyday basis, and it has tremendous implications on society. So just a few numbers for you to dwell on: 50% of people suffering from allergy experience poor sleep. 80% of people suffering from allergic rhinitis feels that they are impacted at work, in school, and socially. And if we take the children, 50%, 50% of children with allergic rhinitis risk developing allergic asthma later in life. So big implications. And if we also look at it from society, an untreated patient can cost society up to EUR 5,000 per year. And we're not talking about a few million people with suffering from allergy. Of these, 50 million are eligible for AIT treatment. Impacted by food allergies, and food allergies can have severe consequences.

Just in the U.S. alone, 20 million people are risking anaphylaxis, and anaphylaxis can cause anaphylactic shock, which could be life-threatening. But only 3 million people today in the U.S. are carrying an adrenaline pen, so a lot more to be done there. And then we have the children. Children are often the last ones to be treated, not because we don't want to, but because they are often underdiagnosed. They are often undertreated because it takes time to get products approved for children, and this is something we want to do something about. Implications for the children are severe. I mentioned the 50%. Another way of looking at the number is that childhood allergic rhinitis will increase the risk of developing allergic asthma by 7x.

And as you will hear from Henriette and Peter later on, it has much more in terms of indications and much more in terms of implications of children. I mentioned school, I mentioned that they feel impacted, but it's also clear in the numbers that they are being impeded, impeded in their learning abilities. So when we look at children, it is clear that treatment is imminent and urgent, and this is also why that a lot of pediatricians, a lot of other providers and caregivers want us to take good care of the children.

We also see when children are successfully treated, it is often better than what adults experience, simply due to the fact that we as parents have a focus on bringing our kids to the doctor and ensuring that they take their medicines, and that leads to better adherence, and it leads to much better treatment for the children. Also positively impacting them later in life, meaning that they have less risk of developing some of the worst associated conditions with allergy. So children are at the core, but allergy is still on the rise. So when we look at allergy, allergy is growing in a changing world, and there are a number of macro factors impacting allergy. Allergy is hitting us harder due to climate change. Warmer weather leads to more extreme pollen seasons, but we also see that new allergens are traveling due to the changing climate.

Urbanization, people moving from the countryside to the cities means that they will be exposed to new types of allergens, often more pollution, and also a change in dietary demands or diets. Food allergies are on the rise. All of us are eating more processed food. All of us are exposed to the genetic changes in the environment. All of us see the implications of these changes in terms of more people being exposed or challenged by the allergy. So this is something we need to do something about, and it's very, very, very clear that there's a lot more we can do. So looking at the allergy space and the allergy landscape, it is not only vast, but it is also full of opportunities. Meet needs that we... We have centered our business around the respiratory allergies, and we've been successful in developing this.

There's still more to be done, and we will continue to work on it, as you will see throughout the day. But we also see that food is an interesting area. We are moving into this space. We also see that anaphylaxis is an unmet need. There's much more to be done, many more patients to be helped. And then it's also clear that there's a lot more to be addressed out there. We'll get back into all the details around where to focus and what to do, but point being is that the allergy space is vast, the need is there, and ALK is uniquely positioned to help the people needing treatment. We are a company that is unique in the sense we are there from farm to pharma. When you think about it, ALK is represented along the value chain.

We are into agriculture, growing the pollen, extracting the pollen, standardizing the pollen, creating APIs, scaling up products, ensuring that those products get distributed to doctors and patients around the world so they can get the treatment. We have brilliant researchers that constantly think about the next thing. How do we understand allergy? What kind of products and what kind of solutions are required out there? ALK is in a position that we've proven over the past years, or the past hundred years, as leaders of this industry, and if anyone understands allergy, we're the ones. We do aspire to help millions of people. We want to do a lot more. As a reminder, the 2.4 million people we are treating today is still a drop in the ocean when we think about the potential out there.

But we need to be very clear, and we need to be very disciplined in the way we address these, because it's easy to spend money and time, and resources on a lot of areas, but it requires discipline, prioritization, and focus to ensure you deliver. So ALK wants to deliver through a focus on high revenue growth, a continued focus to increase earnings and cash generation, because we want to liberate funds to invest in the right strategic properties and projects, and that includes solidifying our leaderships in AIT. Further developing our portfolio, so we ensure we have the full coverage. The pediatric launch is a good example of this, and we want to do more of this. We want to build a global position in food and in anaphylaxis. We want to do that because we see clear synergies between our different business segments.

We see a clear need at the doctor with the patient to have solutions like this that are overlapping and are synergistic, so we can do more, and we want to do it. Then, because of our capabilities, because of our understanding of allergy, and because we have a firm belief we can do more, we also believe we are in a position to explore new therapy areas in the space. But we will only enter those areas if they are strategic relevant, and if they are relevant also from a business standpoint. We have clear criteria for how we're going to go about it. If we do that, we'll be in a position to support many more people. Where are we? Well, let's just take a look back at the previous strategy.

ALK was in a completely different place back in 2016 and 2017. Negative margins, challenges around quality, still not the success that we could have hoped for and expected with, with tablets. That journey has been started and has progressed, and it's progressed well. When we look at it today, we are in a position where we have a robust, high-quality manufacturing setup. We are in a place where our commercial teams, our market access organizations, our clinical teams, have ensured that we can provide and deliver evidence-based products to the markets. We have proved our tablet portfolio, not without challenges, and I'll get back to that, but it is progressing. We saw that it is currently more than 50% of our sales today, so significant growth there.

But we also realized that not everything is perfect, and we still have challenges, and we are gonna build on the great foundation we have, but we are also going to address the challenges we have. North America, it is growing, yes, but it's not growing to the extent that we had hoped for and expected. So we want to do more there, and we want to clear it out and make sure we have success in North America. We also said we had an ambition of reaching 25%, and remember, it came from a very low place. In 2023, we had 14% EBIT. This year, we are guiding 17%-19%, so we are still on that journey, delivering on the 25%, but we are confirming that we are going to do what we can to deliver on this.

It is paramount to the company, so we will deliver on this 20 25. But we still need to organize ourselves, reduce the complexity, if we are going to deliver on that level sustainably. So that needs to be tackled. When you are in a growth mode, you add and do a lot, and that means that we have complexities that needs to be addressed. And we also see it when we go out and we benchmark against other companies, global specialty pharma companies. ALK can do more. There's still upside. There's still a lot more we can do, and we need to do it because this company needs to be future, and it needs to be scalable. So what does that mean?

That means that we have pulled together a new strategy, Allergy+, which is building on the foundation and all, all the great achievements in the previous strategy, but also setting the company up to focus in and deliver on its purpose, creating and delivering life-changing solutions for millions of patients. In order to do that, we have clear focus areas, four pillars in the strategy. Focus is about markets and growth. Innovation is around how we create a balanced pipeline that will take this company not only a step forward from where we are, but a leap into the future. It's about optimizing because we realize that ALK cannot compete, ALK cannot progress to the extent we want to unless we continue to optimize, we continue to invest, and we continue to simplify the company, and we want to cultivate-...

We want to cultivate a strong global culture, a culture that's building on the pillars of what we have in terms of strong innovation and strengths of strong aspiration, many great things, but also where we have more focus on delivering on the promises we make, stronger performance as a company, and create discipline in terms of how we're gonna do it. So maybe taking a step further into this to be a little more transparent and clear. So if we take the areas, what is focus about? And just to be clear, you'll hear a lot more in each of the sessions. But if we take focus, it's about sustaining the tablet momentum. We saw it coming back in the fall last year, and it's moving forward, and we're very happy about the result in Q1. We want to sustain that.

We need to launch in key markets, but key markets that are generating the biggest return, so it allows us to scale the business, and it's not only return on profit, but also in terms of the number of patients. And we have, very importantly, launching in the pediatric channel, North America, Europe, both with our three tablets, but also our house dust mite tablets. And then continuing to reallocate and increase investments. You heard about it when I arrived in this. I said, "We need to be clear in terms of our priorities," and we are clear in terms of our priorities. There will be markets that will be invested in, being added resources, and there will also, in some cases, be market that will receive less and other activities that will be closed down.

We'll continue to expand patient access because this is one of the things that makes ALK competitive and very strong. That is our ability to deliver evidence-based, data-driven, clinically proven medicine. And then it's about innovation, building a balanced pipeline. ALK will continue to solidify its leadership in AIT. ALK will also invest in building positions in relevant strategic areas, including food and... And then, as I said early on, we also committed to exploring new therapy areas, but again, we'll do it very diligently, and this is also why you'll hear that we're investing more in our business development to ensure that we have the capabilities to find the right opportunities. And then we're gonna focus on optimizing. We need to future-proof the organization. We need to enable scale for ongoing profitable growth.

So reducing complexity, simplifying the way we work, the way we operate, and support ourselves by a stronger digital infrastructure, because this is one of the areas that is clear coming in from the outside, that ALK could do more on the digital side. And if we do that, we can actually liberate resources, and we can allow people to focus on what they do best, and that is finding solutions for patients. And then it's about optimizing. As I said, A LK has been growing. We have a lot of suppliers, as an example. We have a lot of invoices coming in. We have a lot of things that are not really creating value for the company, and if we clean it up, it's gonna free up resources that we can invest in something better.

Then it's about driving our operational excellence, continuing to invest in tablet production, and Christian will talk about what we do there, but also ensuring that we continue to deliver high-quality products. Then we'll continue to optimize to ensure that we get better gross margins that allows us to continuously free up resources, either for investments or other purposes. Then, as I said, cultivate, it's about strengthening our competitiveness and future-proofing the company, upskilling and investing in our organization, creating a culture that is fit for purpose, but also building on all the great things we already have. Then it is about a global mindset. 99% of ALK's products are sold outside of Denmark, so we need to continue the journey for the company, moving from being a Danish base to more of a global and international company, and we'll continue that journey.

Then we will not stop doing what we always said we wanted to do, and that is we need to focus the sustainability efforts. Two things: one is we've been clear in terms of our targets for CO2 emissions, the 42%. We'll continue that work, but we'll also continue to expand an international inclusion, a diverse work environment. It's important, not because it's the right things, right thing to say, but it's the right thing to do. So we'll continue to focus on this as well. So those are some of the core elements in the strategy. In order to do it, it's about what are the enablers, and I just want to talk about a few of them. I could talk about a lot more, but some of them are really key for us.

I said it a few times, I just want to repeat it. Disciplined allocation of capital and resources. If we do this better, if we structure ourselves in a smarter way, we can liberate a lot more. That is part of the reason for why we firmly believe we can get to 25% and continuously operate at that, but we need to maintain that discipline in the company. Expanding partnerships and also progressing on the business development side. Expanding with partnerships is not only from a commercial front. We are looking at opportunities there, and that will be part of the formula for setting up ALK for future success. But it's also about how we do it on the research side. It's about how we ensure that we continue to work with universities around memory B cells and other exciting areas.

We will continue to do that because ALK needs to be externally focused. That is the core of the company. And then I talked about involving the culture and mindset. That is still fundamental, because ALK also needs to take the steps forward and develop, despite all the good things we do. Embracing AI and digital. I'm sure all of you, you often see that or hear about AI being the new thing, but we are actually quite serious about it. We are serious about going from baby steps on the digital front, moving into actually getting a solid expense system in place. To taking the millions or closer to billions of data points that we have from klarify Universe conducted over the years to the real world. Studies with more than 9,000 patients.

So people are working with AI, and we're looking at how can we actually implement AI more in ALK? And I know Henriette is going to talk about it, and I'm personally quite excited because we are starting to move along. Even though at different paces, we are moving. So if we are to measure and say, "What is this about?" Well, a lot of you, a lot of you out there have taken a leap of faith in this company, invested in the company and believed in the company. So we are committed to continue to deliver shareholder returns, and we believe we will do it the best way by continuing to grow more than 10% in average per year in the strategy period, and will deliver an average of 25% EBIT margin. It can always fluctuate, depending on the activities; it can be above or below.

But if you think about it, I'm not stealing the thunder from Claus, but if you think about it, with a company that grows 10% and a margin that is at 25%, we will be able to generate a lot more free cash flow and a lot more money for investments and investors. And then we are committed to expand our reach. We want to successfully launch in the pediatric channel. That's going to allow us to keep our leading position and expand that position in AIT. We are also gonna take the global position and launch in anaphylaxis. We aim and expect to start the peanut phase III trial throughout the strategy period, and then, as I said, exploring new therapy areas, potentially entering new therapy areas. In order to do it, we need top motivated people.

We need people that wants to be part of the company and that are engaged, and I'm very happy to say we have that today, and we want to continue to do it because they are the fuel and the engine of the company. So what does this mean? Well, let me give you a number. ALK treats 2.4 million patients or reaches 2.4 million patients on an every year basis. It took us from 1923 to 2024 to get there. Now, in the next seven years, we want to double that. We want to ensure that at least 5 million people are being treated on an everyday basis in 2030.

We believe that this is a stop to deliver great shareholder return and hopefully also a lot of inspiration for people in the company and outside of the company. With that, I'll hand it over to the next one in line.

Per Plotnikof
VP of Corporate Communications, Investor Relations, and Strategic Planning, ALK

Thank you very much, Peter. Flo and Jacob have been paramount in also driving change over the past 10, 15 years into, into our commercial activities. Søren, the floor is yours.

Søren Niegel
EVP of Commercial Operations, ALK

Thank you very much, Per, and good afternoon to everyone here in the room and of course, also to all the people following this session online. I have immunotherapy market, also called AIT. I'm going to do that with two of my colleagues. As Per mentioned, Flo [audio distortion] ... So I am one of the dinosaurs of the management team in ALK. ALK has a strong global foothold in AIT. We expect that this position is going to be even further strengthened in the coming years. We have appetite for much more, also when it comes to adjacent therapy areas. Before digging into the field of AIT, I would like to make a few points on those new potential therapy areas for ALK. If you look to the upper right corner of the slide, let's dig into anaphylaxis.

Anaphylaxis is about the same size as the AIT market, but it's undertreated, and we believe that there is a high potential, both seen from a patient perspective and also seen from a monetary perspective. We would like to play a much stronger role in this market going forward, in particular in the medium to long term. Let's go to another adjacent area to our core AIT, and that is food allergy. Let's even zoom in on food AIT. This is a market that is not even existing today. There's only one approved product on the market today. It's very small.

We would like, as a company, to be those that can make that difference for the patients out there, those children, those parents that are on a daily basis fearing that they're going to meet that allergen that they are allergic for, because that has a life-threatening impact on them. This is where we would very much like to make a difference for those people, and we believe we can be that difference to those people. Why do we believe that? As you all know, we have a tablet, it's peanut tablet in phase I right now. It's built on the same technology as we've done for the respiratory tablets, and we believe we can transform that food market in the same way as we've been transforming the respiratory allergy immunotherapy market. Henriette is going to go in depth on the adjacent areas later today.

The unique thing is here, or the beauty is here, that everything we are talking about here, it's all anchored in our unique know-how on molecular and clinical allergy. I'm proud to be part of the commercial team in ALK, but I also work for the company because I have a profound belief in our research and development capabilities. But now I should not be carried away with the future, so let's stay with the present and go into the allergy market as we know today. Allergic rhinitis is one of the biggest chronic diseases in the world. It's up there together with cardiovascular and with diabetes. Approximately 500 people suffering from allergic rhinitis around the world today. It is a DKK 100 billion market. It's primarily symptomatic, antihistamines, corticosteroids. It's almost all over the counter.

Approximately 10% of those 500 million people, they are AIT eligible. What does that mean? It means that they are having moderate to severe symptoms that they cannot keep in control despite the use of symptomatics. And this is where AIT gets into the picture. AIT beats symptomatics on symptom control, and on top of that, AIT is targeting the underlying cause of the disease, meaning that it can put a progress to disease and also prevents other disease from happening, e.g., allergic asthma. Approximately 5 million people in the world are treated with allergy immunotherapy today, so that's only 10% of those that are eligible. So what's happening here? Only 10% of those that are eligible are actually being treated today. There are many reasons behind this.

The short story is, if you look then to the right side of the slide, is that the patient pathway to AIT is very long and it's very cumbersome. Even in a perfect world, it takes somewhere between 7-10 years for an adult to get to the right doctor and get the right treatment. That is in the perfect world. But we are also living in an imperfect world, and we as a company are faced with many, many structural barriers that we put a lot of focus on the last many years. Those barriers being lack of market access or even lack of access in the countries to the treatment, lack of reimbursement, lack of treatment guidelines, lack of doctors' remuneration to actually conduct a proper treatment. Those are things that we have been putting a lot of focus on in the past.

We are g oing to continue to put a lot of focus on that in the future, because we know what works here, and Flora is going to go through a little bit more in depth on that part during the European section. So now I've convinced you that AIT is small. I've convinced you that it's also a bit cumbersome, but the good news is it's growing. It's growing on a global basis. It's growing in North America, it's growing in Europe, it's growing in international markets, in the main countries, Japan and in China. And the growth is driven by SLIT-tablets, mainly our SLIT-tablets. And here comes for me an important message, and that is, you can see if you go to the header, it talks about high barriers to entry. So it's actually pretty difficult, from the outside, to get into the AIT market.

And I think I can say that the risk of brand-specific, generic competition in this field is minute. We don't see this as a risk, and if it's going to be a risk, then the market needs to explode. It's complex to get into this market if you want to go into generic competition. This means that it's a very, very, very strong foothold for us to stay in here. ALK has been the major driver behind the growth of the AIT market the last many years. You can see to the left that we've been able to steadily increase the market share. We are now at around 45% on a global basis, and there's no doubt in my mind that we're going to pass 50% within the next couple of years.

If you then look in the center of the slide, you can see our market shares, value market shares on a regional basis. In all three regions, we are having a strong position, and the value market share is increasing for us, all three regions. Another interesting thing about allergy immunotherapy versus other therapeutic areas is if you look to the right of the slide, you can see the total allergy immunotherapy market split per region. North America is only 20% of the global market. This is very unlike other therapeutic areas, where it's almost always the same size as the rest of the world. For allergy immunotherapy, allergy immunotherapy, that is Europe, where the biggest market is, and we expect also this is going to continue in the years to come. So we've been driving the market growth, and we are also undisputed global market leader in AIT.

We have several competitors that we have the greatest respect for. Most of them are sitting with only local products, or you could say products without any market authorization. That means their ability to scale their current product portfolio is almost impossible. Whereas for ALK, sitting with a fully market-authorized portfolio of products, we can scale our products to all parts of the world. And this is also what's happening. We are the company in the world that has the biggest geographical presence today, and we think that difference is going to be even bigger going forward. Let there be no doubt about that the continued strategy of ALK is to raise the bar even further when it comes to what it takes to get actual registration for allergy immunotherapy products, but also to keep them in the market.

We believe that it's in the interest of both physicians, patients, adults, and of course, children, but society in general, that people actually should know what are actually the documentation behind those medicines that they are taking. This is the position of the company. If you put all these things here together, I will claim that if you believe in the future of AIT, if you believe there's going to be a bright future for AIT in the future, if you believe that it has a prominent place in the treatment of allergy, then you have to believe also in the future of ALK. When it comes to the go-to-market models, we have various models that we're working with. We both work with affiliates, we also work with partnerships.

If you look to the left of the slide, you can see the various archetypes that we are working with, with our affiliates. They differ in the sense that they are working with or we are working with, you could say, relative difference in the capital allocation for these affiliates, but they also differ in terms of the activity split that we're doing with these affiliates. So if you would look at an established market in AIT, then it would be the more classical sales and marketing methodology that we would apply. If you're more in the transformation part, then it's more pilot-based, it is more focused on market access, it's more focused on public affairs. And of course, hopefully, we will be able to eventually to get a transformation market up to an established market.

But again, the capital allocation, the relative capital allocation is very different compared to where the affiliate is, and of course, also the activity mix. When it comes to partners, we are also there working with different models. We have the licensing, like in Japan, where we have a great and a very successful partnership with Torii. We are also working with fostering partnerships, and the difference to licensing is that in principle, we can take those markets back to ALK after some years. This is the case, e.g., for Southeast Asia with Abbott and in India with Dr. Reddy's Laboratories. I said in the beginning that we have appetite for much more, and we have. But it's also important to emphasize that this is really built on a strong foundation of AIT.

This is where we are coming from, and we actually believe if actually we are able to strengthen that position in AIT, we are also making the chance or the likelihood of succeeding in other therapeutic areas much bigger, much bigger, and vice versa. And this is actually why we believe we can get to a leadership position in other areas as well, on top of AIT, being anaphylaxis, being food allergy. And those areas or entering those areas will also re-emphasize our leadership in AIT. Why do we believe in that? Well, first and foremost, the channel is the same. So when we have a focus on respiratory allergies, we have a focus on food, AIT. Countries, also in doctors and pulmonologists. So the work we are doing today, products, we're going to come with the food AIT products.

Second reason is that no company or very few companies, I would say, no company, is actually having a, a unique focus on allergy prescription medicine. This is our leadership aspiration. This is what we, we really would like to aspire for. We want to be leaders in all those therapeutic areas, AIT, anaphylaxis, and in food. With those words... With talking about the children, why we're so passionate. Going to go into the regions. Flo is going to start out with Europe, then Jacob is going to [audio distortion] America. Jacob, the floor is yours.

Jacob Glenting
Senior VP of Global Strategy and Corporate Development, ALK

Everybody in the room, and thanks for your attention on this very important topic. Also into the children segment for ALK, and there are two reasons for that. First one, we in ALK are compelled to help the children living with uncontrolled allergy symptoms. And number two, it's not a trivial expansion from adult into the children space. There are many differentiators when you talk about the pediatric. We actually have identified children as high propensity AIT candidates, and by that we mean that children are more inclined and faster to end on immunotherapy products. We not only have identified them as high propensity candidates for AIT, we claim they are. So what basis do we have from that strong claim? Well, we have one signal. Immunotherapy tablet for children launched, namely MITICURE, called ACARIZAX in Europe or ODACTRA in U.S.

From there, we know that 75% of the children treated today, of the patients treated today are children, 25% adults. If we look at the demographics in Japan, 15% are children. 75% of the population we have on treatment are children. 15%, 25%, 5x more inclined to receive immunotherapy. Nice signal. Two other market dynamics I want to mention. Let's look at the competitors. What do they have of products? They do have marketed products, but the evidence behind, that's heterogeneous. We do have an opportunity there with a full tablet portfolio, with strong clinical evidence, high quality, and convenient treatment. It's not injectables, it's tablets. Second dynamics I want to mention is when you look at the adult segment, that's where we are. You have a patient, and you have a physician. Let's look at the children.

You have a patient, the child, a physician, and a caretaker. That one is important. That's a caretaker that will push the child to receive therapy, push the child to seek treatment, to visit a physician. Dynamics are different as well. Yes, that might not all sound nice, but the children population is low decor. What do we say from ALK? Indeed, smaller than the adult segment, maybe 4x-5x smaller, but when they're high propensity, more inclined, pick up that statement. Well, we saw earlier on talking about the pathway to receiving treatment, 7-10 years, yet we have 6-year-old children on treatment. Children move faster through the referral system, and they are what we define as fast-track patients. What about the symptoms? Are they the same? Yes and no.

The manifestations of allergy is different in children, much of it the same as an adult, but with a higher frequency of comorbidities. For instance, atopic dermatitis, very visual, something that's been taken very serious by caretakers, but asthma as well. Higher comorbidities, and on top of that, a lower level of acceptance of symptoms before you go and seek a doctor. Why is that? Maybe we acquire a certain portion of tolerance to allergy symptoms as we grow up. At least the children seek children earlier. Number three, we know physicians, including pediatricians, they acknowledge allergy as a progressive disease. One allergy, two more allergies, one comorbidity, two more comorbidities. They acknowledge if you treat it early, you may stop the atopic march of allergy. Number four, children, they are very good patients.

They stay on treatment longer than the adult, and they are more compliant to the treatment schedule. If we zoom in on our tablets, we know from real-world evidence that children are 17% more adherent and compliant than adults. That sounds very nice, but do you have all the licenses to be in this area? Ah, there is a few gaps still. Some call this a regulatory schedule. You could also call it a gap analysis. Where do we have the regulatory approvals for which products? Well, right, right now, we have some gaps in ACARIZAX in Europe, North America, for children, at least for the small children. We also have it for ITULAZAX. But as we move towards 2025, we will have filled those gaps, being able to commercialize and market our tablets to children across geographies. With this, we can move into the regions, and I would like to invite Flora to go through Europe. Here you are, Flora.

Flora Beiche-Scholz
EVP of Europe Commercial Operations, ALK

Thank you very much, Jacob. Good. We go into the regional section, and hello and good afternoon to everyone in the room and online. My name is Flora Becher-Stoltz. I'm responsible for commercial operations in region in Europe. Am I standing in the wrong place? I just hear some noise. Good? Okay, thank you very much. Good. So for those of you who have followed our business in Europe, you know that we are in a transformation period. The market is being transformed from not registered name patient products to fully documented, evidence-based AIT, like ALK tablets. And that journey we've been on for some time, and the European market, it has been slowly growing. ALK has been able to expand market share at the same speed. We've got markets that are very well established, primarily the Central and Northern European markets.

We have some growth markets, which are catching up fast, and then we have some transformation markets, which are a little bit further down in the transformation period, but they will also convert towards evidence-based medicine. So Europe is full of opportunities. Now, you can ask yourself how difficult it is in this market transformation to get a patient or an allergic sufferer, they mostly don't like to call themselves patients, to get them with symptoms bothersome enough to warrant AIT treatment in front of a prescriber committed to treat this patient with evidence-based medicine, AIT. The answer is, it can be quite difficult.

I brought this example from Germany just to show you a little bit how we've been working with the different factors in the ecosystem, because in the end, it's not only the patient and the prescriber taking a decision around AIT, it's the whole ecosystem that is influencing the decision. So that's the ecosystem. I will start at one o'clock in the blue circle with the allergic sufferer needing to experience some bothersome symptoms. You could put it down to pollen flight or to a house dust mite, but at least you, as a patient, need to be suffering enough to be actually wanting to do something about your allergy. You may not know it's allergy. You may go on social media, you may go on websites and research what exactly is this.

You may even download an app, one of our apps, k larify, and register your symptoms and go through all the days with high and low pollen flight. Then you can go to a pharmacy, and in a pharmacy, you will get some advice on should you go see a doctor or should you be treated on antihistamines? And that is a little bit the inner circle for the patient. Then if you go to the doctor on the side, then the doctor needs to have some diagnostic opportunities to make sure that he can identify the allergy that this patient is suffering from. There ideally should be some positive experience with AIT, with ALK's portfolio. They need to be cool, strongly behind AIT, evidence-based AIT. There need to be guidelines behind that. And then, obviously, the basics also need to be in place.

The doctor needs to get sufficient remuneration for AIT, and needs to have helping hands, nurses that help him or her to run the practice. Then we go to the outer circle, which is a little bit society and politics. There we would... I start again at 2 o'clock. The patient would need to have general access to reimbursement. There could be patient organizations that are driving certain acceptance in the market of products. There will be, for sure, national drug regulations. There will be something health political institutions are putting a high focus on. There will be the payers themselves that make choices about which AIT should be reimbursed and what not. Then, very famously in Germany, there's also the competent authority, the Paul-Ehrlich-Institut, that have a strong opinion on which product should be in the market and what quality and documentation purposes they should serve.

And then there's guidelines, there's the famous PEI Decree in Germany, and in the end, there's obviously also competitors that are influencing the market and the decision being taken between the prescriber and the patient. And then whatever we can do in order of promotion or in order of offering medical services to the healthcare professionals to drive a decision towards evidence-based AIT. And then everything is in perfect order, and then you think, "Okay, now we've done everything we can." And here I've also introduced one factor that may be a little bit off. The patient normally starts AIT treatment in autumn. They need to be healthy in order to start AIT. If there's a lot of infections, be it on the patient or on the prescriber side, then the ecosystem will not hold. And why is that important?

Some of you may remember that in the season 2022-2023, we had a perfect storm in region Europe. Let me walk you through this slide. You see on the upper graph, you see, depicted the number of patients that are initiated per month. You see here, it's a curve that peaks, that goes down, that peaks, that goes down. Peak is always the month of October. That's the high season for patient initiations. Now, when you look at the graph, then you will see that in autumn 2022, the peak is cut off. This is where a major infection wave hit the countries. If you look at the lower graph, then you see the amount of respiratory infections that are registered in the... In this case, it's Germany.

And then you see that this actually goes to an unusual peak in that season at the end of 2022. So this is where the system so far is not able to administer the same patient care to the allergic sufferers if there is some black swan coming our way. So lessons learned, what can we do to avoid that? We cannot really avoid an infection season, but we can avoid that all patients need to be initiated at the same time. So that can, that peak can be plateaued out a little bit. There could also be more prescribers helping with the patients and putting them on AIT treatment.

And thirdly, something that we also realized is that the visibility of what is really happening in the market is sometimes it's, a little bit, clouded by the data quality, and there we're constantly working on getting better data and getting closer to, what is really happening in the market. So those combinations for 2022, 2023, we are out of that, happy to say. So going forward, what we are planning to do in this transforming European markets. Europe is not homogeneous. It's obviously quite different in their maturity. All the countries are different. But we have some established markets where we have good market access, we have strong advocacy, and the HCPs are ready to treat.

So this is where we will put our efforts into helping with digital consumer communication, into making the awareness specifically for the treatment of children in a broader spectrum known, so to pediatricians or family doctors, whoever may be in contact with children. And then we have some markets that are almost there, but perhaps the prescription depth is not as high and not as many prescribers are ready to treat. So there, we also need to work on making sure that we get appropriate capacities in the market. And then lastly, there are some markets where we're depicting it here as a chain, and there's one broken chain link, and that is the market access or it's the remuneration. So there, our efforts will clearly go into fixing the reimbursement or the market access conditions so that patients have the appropriate access to the right treatment.

Meaning we'll be more stringent in allocating our funds to what makes the most sense in a given market. And with that, in Europe, we're very confident that we really have a lot of opportunities. Short term, by having growth with the pediatric indications, reaching out to the current prescribers. We also have the digital and consumer engagement, and obviously, the market share gain in this evidence-based medicine transformation that's not nearly done. Then if we go to the midterm, then we have the opportunity to involve more doctors into the treatment of children, and obviously, we also are waiting for new assets, adjacent seasonal anaphylaxis, very much looking forward to that. And in the outer years, also new assets in food.

Then we will also see that the transformation in those non-evidence-based markets will have progressed so far that we see a lot of new patients being put on AIT there, also for them to experience what a unique experience AIT can be and how life-changing that can be for patients. With these words and opportunities, Jacob, I will give back to you for opportunities in international markets.

Jacob Glenting
Senior VP of Global Strategy and Corporate Development, ALK

Thank you very much. So international markets is defined as the region outside Europe and North America, but we have decided to focus on 15 markets. We do that not only with affiliate, actually, we use partnership for most of the markets, except China, where we have full control with our own foothold in China. For the rest of the markets, we have reputable partners building on the different partnership models that Søren earlier described, from evergreen agreement with Torii to fostering agreements, where there will be a hand back to ALK after 7-10 years of contract run. We drive right now, the last 5 years, high growth, 45%, and most of it is from tablets. If we look at the species, it would be dominated by two allergens, and that would be house dust mite and cedar.

We are not one-third of ALK's revenue, yet. We are only 15%, but we do drive 1/3 of the share of growth. I will not go through all 15%. I will only take the two big ones, I would say, and give some details on that. Let's start with Japan, where we are really enjoying the nice partnership from our very strong partner, Torii, that has, with great success, commercialized two allergy tablets, namely the MITICURE and CEDARCURE, for house dust mite allergy and cedar allergy, respectively. High prevalences, large population, 30% allergy sensitization of mite, even higher on cedar. 99% of all patients in Japan, they are on tablet, almost all on ALK tablets. Very few on our competitor, Shionogi, that represents Stallergenes with their mite tablet.

If we look at the depth, how deep we are into the prescription level, in Japan, we are roughly half of a very good market floor represents in Germany, so there's still a little way to go. 60% of all volume produced by ALK ends up in Japan. That's substantial. Today, Torii drives sales of more than DKK 1 billion based on two tablets. Will Japan continue to grow? Three factors and three reasons why. We have what we call a driver's license, certifying the Japanese physicians to prescribe tablets. As Torii works with that and grows that, prescriber universe, sales will follow, prescriptions will follow. 22,000 now, every year, going up in number. We also have a call for action from the government in Japan, declaring war against cedar pollinosis. Not only war, they are also mentioning means to fight it. And what means would that be?

That would be immunotherapy as one of them. Who has immunotherapy for cedar allergy? ALK and Torii. Lastly, we have expanded our agreement with Torii to also include the grass tablet, GRAZAX, which is under development. Second market I will go through here is China. I like to say it's the biggest market, but that's only in house dust mite allergy, but still the biggest. It's growing, but it's number five if we take all allergens. I mentioned the 400 in prescriber depth for Japan, 750 for Germany. We are at 40 in China. 70% receiving SLIT therapy, not tablets, drops, not by us, but our competitor, Volvo, a local Chinese company. We have a strong presence, strong organization, enjoying strong growth from one product, that Alutard injectable house dust mite allergens.

We are present in more than 700 hospitals, where we grow a prescriber infrastructure via allergy clinics, and we are awaiting approval of ACARIZAX in China. I can also ask myself, will we continue growing in China? Well, we have 35,000 hospitals we could grow to. We are at 700, so if we can replicate that model, yes, we can grow. Children are also in the center of our prescriber growth and our prescriptions in China, so 90% right now is, of the growth comes from the children and from pediatricians. Last growth driver, expansion of portfolio and obviously our partnership with Grand pharma on the anaphylaxis area. So that conclude region number two on international markets, and we can then move to North America. Thank you. So I'm back again, and I will now talk about region North America.

I started out by saying that the U.S. market, when it comes to AIT, is not the biggest one in the world. But it is still not the whole truth, because part of the truth is also that U.S. is big, of course, and it's actually the biggest allergy immunotherapy market when it comes to patients. There are almost 2 million patients being treated with allergy immunotherapy in the U.S. It's just not our tablets. Approximately 98% or 99% of the patients are being treated by extracts that are actually, you could say, being made as a cocktail by the allergist in the U.S., administered subcutaneously. We are also part of that market in the U.S. and have a fair share of that, approximately 30%. So what is it actually, these extracts? Is it a product? Not really. Not really.

It's done in approximately 6,000 different ways in the U.S. There are 6,000 allergists in the U.S. There's no strict formulary. There's no, you could say, approvals behind this, but there is a medical procedure, and this is what's being used. It is also reimbursed for the patients, and the remuneration goes to the doctor. So that means majority of the value of the AIT market in the U.S. does not sit with the manufacturers, it sits with the doctors. They make quite a lot of money on this. Approximately two-thirds of their practice income is coming from these so-called shot factories. So that is, of course, a very, very, very big part, and there's also a very big difference between, you could say, what they're making versus what we are actually making on these extracts.

So this gives us the classical conflict of interest w hen we are coming with the tablets, when they are not actually making so much money on those, versus the subcutaneous extracts, where they're making a ton of money on this. We have, from the beginning, not been willing to, willing to go up against our customers. The allergists are our customers. They are customers in allergy immunotherapy. They're going to be our customers in anaphylaxis. They're going to be our customers also in food allergy. So from the very beginning, we said, "We're not going to discuss with you whether you're going to continue existing practice. You do what you think is best for your patients, meaning no change." But we did say, and we could see that, is, you're also saying goodbye to a lot of people walking out of the door because they don't want to undergo treatment with the extracts.

They don't want to undergo treatment with subcutaneous immunotherapy. What are you doing with those, dear doctor? Why don't you offer the tablets to those people instead? You're not losing anything because you didn't get them in the first place anyway. We thought that could be a success. We tried it out for a number of years, working intensely with the 6,000 allergists about this. Did we succeed? I think you know. Not to the extent that we had hoped for. We knew that this was going to be a very, very big challenge. We have approximately now 500 allergists that are regular users of the tablets. Those 500 are young and upcoming allergists. We count on them in the long run, so they are still very, very important for us. But the majority of allergists, they didn't buy it. They continue the practice.

It's a little bit like the Ford T syndrome. You can get whatever car you want, whatever color you want, as long as it's going to be an extract cocktail I'm going to deliver to you. So shared decision-making, we did not entirely succeed with, except for those 500. They truly get that this is something you need to decide together with the patient. I'm gonna come back to those 500. So we do have some SLIT-tablet sales in the U.S., even though that is lower than we originally had planned for, and in that niche, we are by far the leaders. We are now almost approaching 100% market share. So once we're going to win in this segment, we're going to win alone because we are more or less the only one there today.

So what do you do with such a big opportunity, but with so big barriers that seems almost impossible for a small company like ALK to cope with? Well, we do this in a very focused way. So when you would look at a specialty pharma company being in the U.S., having a customer group of approximately 6,000 doctors that you would like to visit, you can imagine that gives you a certain size of company. Then you would look at the footprint that we have in the U.S., and there's a big difference. So the amount of resources we have allocated to this is different compared to if this was a fully-fledged operation in specialty pharma. We focus on two prescriber groups, as I alluded to before. We are now, since end of last year, focusing on the [audio distortion] situations. Why since end of last year?

Because now we're gonna get very, very, very close to the point where we have a full portfolio of pediatric indications. The nice thing about the pediatricians in the U.S. is that they're treating more or less, or actually more, eligible AIT patients than the allergists are doing. There's, of course, a difference, is that there are many more pediatricians than there are allergists, so they are less concentrated. But they're treating quite a lot of AIT-eligible patients. What are they doing today? They're using symptomatics or they refer. What are they saying actually to us? They would like to avoid to refer. They would actually like to keep those patients, and this is, of course, where the tablets, they fit very nicely into this one. So once having a full portfolio, we truly actually believe that we can build a presence among the pediatricians.

This is great because building a strong presence with our, our AIT, our tablet portfolio, that's going to help us later on also with the anaphylaxis portfolio and the food AIT portfolio. We are focusing on 2,000 pediatricians. There are approximately 50,000 pediatricians in the U.S. Obviously, once we find a model, we can scale. Once we actually think that this is now up and running with all the academic societies, all those, everything that it takes or that is necessary to scale, we will scale, of course, but right now, we keep at this investment level for the time being. As I said, we still keep focusing on the 500 allergists that are with us, that are speaking our, you could say, the course. We have the same vision on how this market is going to develop.

They're going to be important for us in the future. They are few. That's true. Then we have a third model that we're using. That's the one in the middle. If you look to the right, that's called enterprise selling. Here, we are focusing on doctor groups, quite normal in the U.S. In this case, we are zooming in on pediatricians. These groups, they can be organized per state, they can be regional, they can even be national. Some of them are very, very, very big organizations, meaning that's the executive leadership, it is the medical leadership, it's the market access leadership. It's if the tablets are going to be put in the guidelines, it's also going to be adopted by those doctors in that network or under that ownership. Also here, it's of course going to take time. It will take time.

It will take, most likely, years. What I'm absolutely convinced about when it comes to the U.S., even though I have to say that I'm not so worried about, of course, it is from a low level. Once we're going to succeed with some of the models that we're experimenting with, and of course, some of them will fail, some of them will take time, but once we succeed, then we'll start to scale, and then you should expect more. I would just like to say one thing about the other country. It has a lot to do with the way that we do things here in Europe. It is a growth market for us in ALK. 40 million population, so it's a fairly large country for us. It is predominantly still subcutaneous.

Actually, the extracts that they are using, less or a little bit more than 200, AIT, patients per 100,000 inhabitants, so it's still very low. Lots of potential in, Canada. The good thing is that we are really increasing Canada, and it's the tablets that are making that increase. So in record time, we've actually now obtained a 60% market share in value, not in patients, but in value. And we have also been working a lot with the academic societies, and now we are also number one in the guidelines. So we expect that this is going to continue. So I think you can foresee strong growth coming from Canada. And yes, it's a much smaller country than the U.S., but it's not a small country.

So, we are quite bold when it comes to Canada, also, when we're looking at SLIT-tablets. So that's why we put in the header that we hope we see that this is actually becoming the new Nordic. So that ends the market section. I would just like to go through some of the closing remarks, and then we can go to the Q&A session. So good news. The global AIT market is growing. We've been that major growth driver behind that, or major driver behind that, and we expect this to continue. The beauty is that our pipeline focus, our pipeline assets, that's expected to strengthen our global market position in prescription-based allergy. As I said, we want to claim that space, we want to take that leadership position because we don't see any other companies actually doing that.

The children segment, as Jacob went through, it's close to our hearts. It is really close to our hearts. We are now, as the only company, coming with well-documented products, where we can treat those kids that are in need of a better life. And we think we, we can bring those right solutions. The U.S. AIT market is very, very, very big in patients. Unfortunately, not yet in value for the company. We will steadily unlock this market. It will take time. It will take time, and we're going to do it with a very focused and very financially disciplined approach. International markets, Jacob went through that diverse region with momentum, great growth opportunities. We are just focusing and zooming in on Japan and China, and those two alone will drive a lot of growth. But we haven't talked about the rest. We'll do that some other time.

And then last but not least, Flo went through Europe, where we had great success in recent years. It is under transformation, led by ALK. All the way from the beginning, we were the only company actually driving this change. We didn't even have the doctors with us in the beginning, but slowly, we got also all the doctors behind in doing this change, and look at where we are today. Europe is still holding potential, short, medium, and even also long term for ALK. So I know we are biased, but we really believe in this. Thank you.

Per Plotnikof
VP of Corporate Communications, Investor Relations, and Strategic Planning, ALK

Thank you very much, Søren, and thank you, Jacob and Flora. So, now we'll open up for the first Q&A session. We'll start, and I'll kindly ask the team to come on stage. Session on that after Claus's presentation, so bear with us on that. We will prioritize questions from the room, and then we will also see if there is questions from the online participants afterwards. You can type in your questions on the website, and I'll get a hint here on the screen. So with that, let me try to step down from the stage and see if I can see who was first on this one here. I think you were, Martin, up first. Please go ahead, Martin.

Speaker 14

Actually not, but the rest of Europe. But in reality, we saw last year that a moderate 5% price cut in Germany was enough to cut your EBIT margin by one percentage point. So it seems like you still are rather fragile, and now you also expect to go on towards 2028, and how should we see price performance in that period?

Peter Halling
President and CEO, ALK

Yeah. Good. Let me start out. Firstly, I see... And by the way, it's always interesting when you stand here. You see a lot of the usual suspects immediately raising their hands. But the way we look at Europe, obviously, it is, has a big potential. And obviously, we're pursuing that potential, and that also means that comes with risk. And we know when we look at the strategy there are price cuts. So that's the very short answer. Obviously, we are investing into markets where we see the most potential, but we are also doing it across a number of product ranges. So that also means that when we think about the markets, they will be priced differently, and they will also be impacted differently. So that's gonna be part of it.

Then, when we talk about the overall plan, my proposal there would be that we give Claus a chance to provide a little more detail, and we get into some of that. But, you're absolutely right, on that piece. But that being said, expand our portfolio with new indications at different price levels, and that actually gives us some room, and this is also why we believe it provides solidity.

Speaker 14

I think g ood.

Per Plotnikof
VP of Corporate Communications, Investor Relations, and Strategic Planning, ALK

Yeah. Thank you, Peter. The next question comes from Thomas Bowers from Danske Bank.

Thomas Bowers
Senior Analyst of Healthcare, Danske Bank

Yes, thank you very much. I will kick off with China. So just on the commercial game plan, you highlight, of course, that you are present at 700 hospitals out of 35,000. So should we expect you to enter into sort of a co-promotion or partnering deals to cover the space more, and also in regards to taking too much risk? There was a lot of noise with the adult ACARIZAX approval, and then you got rid of the chamber study. So I'm just wondering on in regards to the pediatric in dication to do more work into to get that on the label as well.

Peter Halling
President and CEO, ALK

Okay, let me start out by question two, and then I think we can also go back to the partnership. So just on the regulatory submission at this stage, we are in a waiting position, obviously, as you are when things are in the regulatory process. So we'll see when we get feedback, and then we'll be able to communicate on that. Then on the partnerships, I think it's important to say, and Jacob, if you wanna step in afterwards, where we've been focusing is on where we could have the biggest impact, the East Coast and the bigger cities. Partnerships is always something that we should explore and look into.

So we are basically agnostic in terms of how we do it, but we look at it in a way where can it create the most value for the company. And maybe, Jacob, you can add a few more-

Jacob Glenting
Senior VP of Global Strategy and Corporate Development, ALK

Yes.

Peter Halling
President and CEO, ALK

things on, on China on that front.

Jacob Glenting
Senior VP of Global Strategy and Corporate Development, ALK

I think I'm through. Thank you.

Peter Halling
President and CEO, ALK

Yeah.

Jacob Glenting
Senior VP of Global Strategy and Corporate Development, ALK

You're right, China is very big. We want to get this right by ourselves, and that's why we start finding a formula and a strong base of clinics that are advocates for SLIT-tablets and the current injection form. Then we expand from there, one step at a time. Eventually, you could ask: Can ALK do China alone? And I think co-promotion would come as a good idea there, but in the long run. So first alone, later on, partnerships.

Per Plotnikof
VP of Corporate Communications, Investor Relations, and Strategic Planning, ALK

Okay. Thank you.

Speaker 15

First, Europe. How does sort of competition stand in terms of Stallergenes Greer? Because that's by far your largest competitor, but it also seems there's been some very significant permanent damage done to them. So is it just a matter of now moving from 45% to 50%, and then you're continuing the journey. U.S., so it seems like you started with a plan A, then it became a plan B, then it's a plan C. What is, what is, what is plan D? Is it also that there is a buffer in your OpEx to secure that you could make a larger commercial push on sort of, commercial?

Peter Halling
President and CEO, ALK

Maybe you can chip in as well. Just a few things. If we take Europe first and the competitive situation, I think Søren said it early on, we have the greatest respect for Stallergenes as possible. Stallergenes and many others are still out there and still building positions in Europe. I think, Søren, you can add more on the competitive perspective there, specifically U.S. Let's get back to that afterwards, but let's start with you, Søren.

Søren Niegel
EVP of Commercial Operations, ALK

Yeah. So, I agree, Michael, we are going to increase market share also in Europe, but we're not necessarily going to take it from Stallergenes. I think they are the game again. So you will see, ALK taking market share, but you're going to see us taking market share from several of those competitors. So, when it comes to the U.S., you are absolutely right that it will be difficult, of course, to bring the commercial success without also upgrading the organization in terms of size. But, we will not do that yet because we simply need to see those signals with those models that we are working with. And of course, now we are really focusing in with pediatric indications on the pediatric situations.

Once we see those signals, then we are going to scale. We don't have to put that into the plans either. So we have growth in our plans, but it's quite modest growth that we have in those plans, I would say. So obviously, we are going to need a lot more money once we can see those signals actually are going to be visible. And obviously, coming, that could actually also to go to do this with partners, also to do de-risk that part a little bit. But we've seen so many, both partners and competitors work with th e U.S. AIT markets, and I'm not here saying then it's us, but we might need some help on the way.

Peter Halling
President and CEO, ALK

M aybe just to add to what you said, Søren, I think it's important to say, what we also stated clearly is, is that as part of the current plan, we wanna see that the U.S. paying off with the expectation of the launches in the pediatric segment, supporting it. So that is embedded in the plan. And secondly, we have invested ahead. You have to remember that ALK set ourselves up for more success in the U.S., so we've actually been investing in the U.S. organization, and now we want to capitalize on, on that. To Søren's point, if we see the success and what we expect and hope, then we will be willing to obviously invest more. But we are conservative around the U.S. It's also conservative in the plan.

Søren Niegel
EVP of Commercial Operations, ALK

Yeah.

Per Plotnikof
VP of Corporate Communications, Investor Relations, and Strategic Planning, ALK

Yeah. Thank you, Michael. We have a question from Peter Sehested from ABG.

Peter Sehested
Equity Analyst, ABG

Yes, thank you very much for taking my question. I have one, actually, I have two. We'll start with number one. You had an ambition of doubling your patient base, but you also have an ambition of tripling, nearly tripling your manufacturing capacity. So either you are overspending and wasting investor resources or... To the second question then.

Peter Halling
President and CEO, ALK

Yeah. It's an excellent question, Peter. So I think what you are talking about, well, the investments made, we're gonna make or are making in our tablet capacity, that capacity, and some of it could help us a lot after 2028. So it sets us up for potential success. We're quite comfortable in terms of where we are and the capacity available. I still think, as a reminder, that the number of patients, given everything you just heard, is not gonna be a walk in the park to develop the market in seven years from the two point. I would be more than pleased and maybe will exceed that number. So I think that's the best answer, but I know you've done the math.

Peter Sehested
Equity Analyst, ABG

My second question is on actually the U.S. and follow-up to Michael's question. What signals should we be looking out for in order sort of to catch up or catch your investment in the U.S. decision ahead of plan? Thank you.

Peter Halling
President and CEO, ALK

Yeah. Søren?

Søren Niegel
EVP of Commercial Operations, ALK

Yeah. And, of course, we started last year, but what we're trying out actually to get up and running. One is, of course, the time to first prescription. We've not been with the pediatricians before, so that obviously takes some time. We need to have the relationship up and running. They need to have the trust in the product, et cetera, et cetera. So that's the first thing. So we're looking, of course, how many actually are we getting to start with using AIT? And here we are more or less actually following the plan. The next one, and that's also important, is that we also need to then see the prescriber depth. And once we get to that number, that's when we can see we can start scaling. Obviously, we are. This is what we are following.

All small figures right now, but of course, very, very important to pick up those signals. And then, as I said, we are, of course, also zooming in on these organizations, these enterprises—that's becoming more and more normal in the U.S. It's a complete different approach in terms of go-to to market. It's more like a 360 approach, where we have all the elements of the company going to those organizations. That's gonna be interesting to see if we could build some good things with those.

It's a little bit difficult in terms of signals, because it's a little bit like in Germany, when we had to work with the evidence-based management. You don't see any signals the first year, there's no signals the second year, and then you start to see something in the third year, and then suddenly in the fifth year, it really takes off. So I don't know whether that answered the question, but that's at least how I would see it.

Peter Sehested
Equity Analyst, ABG

Thank you, Peter.

Speaker 16

... pediatric label expansion. So firstly, just to sort of grasp how potential could model this, both, near term but also long term, there was this, EAACI conference. So can you just touch on upon how the doctors positive example, can we sort of use Japan to, to look at how the uptake will be in the US and Europe, and why or why not? Because when you look at Japan, the uptake was quite fast after the label expansion in 2018, I believe. Then perhaps also touch upon the reimbursement and barriers to uptake in the U.S. and in Europe, for the pediatric label expansion.

Peter Halling
President and CEO, ALK

So maybe, Flora, could you just. I know, both you and all of us joined EAACI, which is, by the way, for the ones not aware, the biggest allergy conference in the world, just held this weekend in Valencia, in Spain. So we shared some some views and some news around pediatric trials and clinical studies.

Flora Beiche-Scholz
EVP of Europe Commercial Operations, ALK

Yeah, we did indeed. And, the data, they are very strong. And I think the reception, when you talk to KOLs and to allergists, treating across Europe, they believe in the data, so that will be sufficient to get a label expansion. And then major markets, you almost immediately get access to the treatment, and the doctors can treat no matter whether it's a child, an adult, or an adolescent. So there's not, not going to be immediate market barriers. Although, a word of caution, we're launching ACARIZAX first. We're launching first in the Northern European markets. You know that this is not the big... So then really be an...

Søren Niegel
EVP of Commercial Operations, ALK

Would love that to, to be the direction for, for Europe and North America. I think it partly will. When we got the children indication, they were really fast in doing prescriber expansion in, in Japan, and they have been excellent at it. I mentioned the driver's license. So they were fast out to the pediatricians with the relevant therapy. But is it a Japanese factor in it also? I think so. Is it something about fewer children per family? Perhaps. Is there something Asian in it? Perhaps. We see similar numbers in China, so there's something Asian about it. There's something about doing prescriber.

Speaker 16

If I could just say one more.

Søren Niegel
EVP of Commercial Operations, ALK

Go ahead, yes sir.

Speaker 16

So, again, just on the pediatricians, there's 4 million already today, as you mentioned, seeking AIT. What is sort of the, the barriers to uptake for this group? Because I guess they are not as disincentivized like, the allergy specialists. So why shouldn't they take your product, basically?

Søren Niegel
EVP of Commercial Operations, ALK

Yeah. That's a very good question. You're right, they don't sit with the same issue because they're not using SCIT at all. So, two factors that we have learned when it comes to penetration, that goes actually across many- and number two, they're very focused on safety. So that's, of course, where our data really gets into the picture, where we can show also a strong data there, and then they need experience. Obviously, they're gonna start out small. They're not gonna take any risk, and they need to feel comfortable before they actually go into increase the use. Yeah.

Per Plotnikof
VP of Corporate Communications, Investor Relations, and Strategic Planning, ALK

Thank you, and I think last, there's one question more, just next to you over there.

Edward Thomason
VP of Equity Research of Life Sciences, Van Lanschot Kempen

Good afternoon, Edward Thomason from Van Lanschot Kempen. Can I just first start off actually on your transformative market? So, update on that.

Peter Halling
President and CEO, ALK

Sure. And maybe Flora, could you share a few words around where are we on NICE and then also in terms of Spain?

Flora Beiche-Scholz
EVP of Europe Commercial Operations, ALK

Yes, I can indeed. Thanks for the question. I think in Spain, we're seeing the early signs that we saw in Germany a couple of years ago with the government publishing a new regulation for allergy immunotherapy. So in three different waves, we will now see that there's requests for documentation, quality, and clinical for first a handful of products that are relevant to the market, venom immunotherapy and peach, and then they move on to the mites and then to all other allergens. So we see that this is actually progressing. We don't really know how long it's going to take, but the first step has been made, and the regulation has been published in Spain.

In the U.K., as you rightly say, there is a lot of support in the clinical environment that will hopefully help us get this first ever product through a NICE appraisal. That would be quite wonderful.

Edward Thomason
VP of Equity Research of Life Sciences, Van Lanschot Kempen

Okay. Thank you. Good luck. And the second question, if I may, just on the AIT market in Europe. So how much of that is the food?

Søren Niegel
EVP of Commercial Operations, ALK

Yeah, today, it's nothing. There's hardly any market today. I think, once we go into mid-2020s, when we're going to launch it, it's going to be a significant increase. It's not so much the number of patients, because that's gonna be relatively lower compared to the respiratory allergies, but we actually do expect a price point that's going to be much higher than that for respiratory allergies.

Edward Thomason
VP of Equity Research of Life Sciences, Van Lanschot Kempen

Okay, and one last quick one, sorry. The discontinuation rate that you pointed to, about 5 in 25 children are actually continuing the treatment. What is in adults?

Peter Halling
President and CEO, ALK

Do you recall the 5 in 25?

Edward Thomason
VP of Equity Research of Life Sciences, Van Lanschot Kempen

What the discontinuation rate is among the adult population?

Peter Halling
President and CEO, ALK

We'll take a look. So maybe just one comment on, on Spain. I think, Flora was absolutely accurate. Just to be clear, we are seeing a lot of products being submitted for registrations, actually, quite a lot more than in Germany. Registered product market is gonna be, long. But the good news is that it is started, and it's progressing, that we're starting to see legislation coming in place. So that gives us hope, and this is a good example of how markets potentially can evolve in the coming, decade.

Per Plotnikof
VP of Corporate Communications, Investor Relations, and Strategic Planning, ALK

Yeah. Thank you. This concludes the first Q&A session of the day. We will have two more, but first we'll have a break, and then we'll address our R&D and our production, and then we'll have another Q&A before rounding off with the financial numbers. Then we will start with R&D. Thank you.

Peter Halling
President and CEO, ALK

Thank you.

Per Plotnikof
VP of Corporate Communications, Investor Relations, and Strategic Planning, ALK

We convene again. I hope we have everybody in, almost. So, welcome back, and it's now a great pleasure of mine to introduce the next speaker, Henriette Mersebach, our Head of R&D, who joined ALK a little more than a year ago and has—Henriette. Henriette, the scene is yours. Please go ahead.

Henriette Mersebach
EVP of Research and Development, ALK

Thank you, Per. Good afternoon, everyone. Good morning to people in the, in the Americas. It's a great pleasure to meet all of you. Henriette Mersebach. I'm the EVP of Research and Development. I've been looking very much forward to speaking to you today about our R&D vision, about our scientific focus, and our ambition to build a pipeline. I joined ALK in 2023 and come from a background in midsize, large pharma, larger pharma. Different therapy areas, different treatment modalities, and I'm gonna make use of all of that here. So I want to start out with a little bit of my impressions now, somewhat new still into the role and my impressions of ALK as a company. So ALK is really, truly a pioneer within molecular and clinical allergy. You've heard this, the amazing tablet portfolio, our stronghold in allergy immunotherapy that Søren has spoken about.

You've also seen it more recently with the discovery of the IgE memory B cell that Peter Sejer will speak to shortly. So clearly, a true pioneer. We also have proven development competencies from running more than 20 phase III studies with the tablet portfolio. So proven competencies that we can actually take assets from research throughout development and out to patient, and this is extremely important in the essence in drug development. And not least do we have a long and successful track record in partnerships. We've heard about some of the commercial partnerships, but we will also speak to some of the more academic partnerships.

But here we've had a long, a long history of partnerships that have actually also helped us contribute to innovation, has helped us evolve as a company, build our expertise, build our competencies, and this is something we'll continue to build on in the future. The way I see it is that we actually stand on a really, really strong foundation, also from an R&D perspective. Some very strong R&D capabilities that I'll speak to more, and this also leaves us with, as we see it, ample opportunities to really make a change, to bring more innovation, and to make a difference to even more patients with allergy. That's what really gets me excited. We've talked about it. There's still a lot to be done. The incidence of allergy is rising. We've heard about climate changes.

We've heard about the increased urbanization. All of this is really contributing to more and more patients on a global setting that's being diagnosed with allergy. In particular, in respiratory allergy, even though so many patients have access to symptomatics, they still face very severe and debilitating symptoms. And there's so much more we need to do here in respiratory. And in ALK, we actually aim to do more than treating symptoms for us, and it's true for the AIT, but it's also true for some of the novel assets that we're looking at. We want to address the underlying allergy, the allergy at its core, and then change the disease trajectory. In food, we've talked about it. It's not as many people, but it's still around 200 people on a global scale.

Here, these are not just one disease, but a range of different food allergies that really are each and every one very life-threatening. Every day, people are going to the emergency room due to food allergy, and yet there are so limited treatments. I mentioned just within allergy immunotherapy, one product approved. We have a few other candidates in a broader food space, but still it's very limited, very insufficient treatments that are available. Anaphylaxis is the third pillar in our strategy in terms of therapy areas. Here. Well, we've had adrenaline available. We've talked about it. We have our own Jext pen. We have adrenaline. It's been available for 100 years, yet this is an area where there's so massive underutilization of the current treatments. So, Peter also spoke to some of the numbers.

We know there's at least 20 million people at risk of anaphylaxis in the U.S., and only 3 million of those are carrying a pen. So why is that? Well, apparently, the current offerings are still too complex. It's not simple for the patients to use. Sometimes it's not even the patients themselves that are using these. So it also has to be simple for someone who is not well treated or well, familiar with the products. And here we actually believe we can make a difference in this area. And then the new adjacent area, we're gonna talk more about what that means, what that means for us in terms of indication. But what we see is really that this is, a natural next step for us to gradually go into another area.

So in closing here on this slide, the unmet need analogy is really evident, and we really mean there's a lot for us to still do within allergy. So in terms of our R&D vision, what does it really entail? Well, it's really about expanding our scientific focus, and in essence, we want to invest into more internal and external innovation to build a more balanced pipeline. And I'm going to put a few more words into it. We have listed here a few four key priorities. First and foremost, it's really about expanding our leadership in respiratory allergy. You've heard from our markets, it's a very strong leadership. We want to build on that stronghold, but then we want to build a more global portfolio within anaphylaxis and within food, and not only in AIT, but actually going beyond that.

Then we want to leverage what we're good at, our pioneering, our research capabilities. We want to leverage what we're good at and actually increase our innovation. But we also need to be honest, we also need to amplify our development speed a bit. Then thirdly, more focus on external innovation. You haven't heard that from us before. That's new, and of course, this will not take center stage. It's not that we expect we won't grow assets ourself, because I don't believe you can be successful with such a model. You need really a strong foundation of research and development capabilities, also to make sure you can further enhance that innovation you may bring in.

But clearly, we want to do more partnerships, bring more assets in, but the assets where we believe we can actually add to the value of the, of the target or the compound. And then lastly, it's about data and, you know, the journey that all of us are on in terms of digital solutions, in terms of artificial intelligence. We've also put in here a number of ambitions, and first and foremost, it's of course, we need simply more clinical pipeline assets. Our pipeline is not rich enough. It's, it's actually looking super fine mid-term, growth-wise, but if we really want to scale ALK and be a greater, bigger company, we need more clinical assets in the, in the pipeline.

But it does matter how you build that pipeline, and we want to be a bit more strategic around what we mean, and that's why we put in the notion like building a balanced pipeline. And I can put my definition on what that means. It's about being intentional in, you know, how many assets you have that are novel targets versus more established targets. It's about early and late-stage development. It's about how many assets you have in your core therapy areas, whether it's respiratory or even food versus more new areas. And, of course, about development risk, development feasibility. Is there an established pathway? Is it just a new area for ALK, but not a new area for the medical community? Is there a regulatory path? And of course, it's all about value, growth potential, et cetera.

All of this we have to factor in when we think about building a pipeline. Then in the end, it's not really enough if you just build a great pipeline. In the end, what matters is really what reaches the patients. And as a doctor, that's really what I care for. So it's about bringing those assets all the way out to patients. So our corporate or our pipeline as it looks today, you have it up here on the slides. As I said before, it very well supports our midterm growth ambition, but again, it comes short if we talk about a greater aspiration, a greater ambition for ALK as a company. I want to put a few more words to the pipeline.

Starting left, we have some very exciting projects in our early research and discovery pipeline. You also see, we are also disclosing that some of those assets are going for food indication as the leading indication right now. But there are also assets that are non-allergen specific, assets that are or targets that are more biology-driven, that can potentially go for a number or range of different indications and then have more potential. So, then in the clinic, we have our peanut tablet. I'll speak a little bit about that later, also today. But that's more or less it in the clinical pipeline. Late-stage development, we have our Genesis, the next generation auto-injector, and then the rest of the activities are mainly centered around respiratory allergy.

It's the GRAZAX development in Japan as part of the [Choi] partnership, and then it's the geographical expansions also, and then it's the pediatric label activities. So if we take our corporate strategic aspiration, as also presented earlier by Peter, and we translate it into more actionable, what does that mean in terms of the pipeline? Again, here in the four pillars, it's very clear we're not stopping our activities within respiratory allergy. This company was founded around respiratory allergy, around allergy immunotherapy, and we are going to maximize this opportunity, and we're going to continue to do life cycle management activities also here. In anaphylaxis, we have talked about it. We are today committing ourselves to a broader portfolio. I'll unfold a little bit what we mean with that. We expect to also have a broader global presence.

I didn't talk so much about it before, but there are several regions in the world where they don't have the access to adequate adrenaline solutions. There are problems around heat stability. We can do something about that. We can bring the next generation best-in-class auto-injector also to other parts of the world. But clearly, there are also a landscape here that's changing, new innovations, new possibilities in terms of administration forms that are coming close. And I think this is a journey we also would like to be part of. In food allergy, clearly, we are making a clear decision to advance our peanut SLIT-tablet program. We're accelerating that program, but we also want to do more. We want to do more than allergy immunotherapy.

Again, it's being mindful of the patients are not the same, all of them, and they need different choices depending on whether they have one or more food allergies, whether they have other comorbidities. So again, we need to be able to provide a range of opportunities, different treatment options, if you want to really play a significant role in such a market. And then it's about progressing into new adjacent therapy areas. Again, as I said, we believe that's a natural step for a company like ALK, if we really want to own allergy and allergic inflammation. We want to give some priority to our research, our research in mast cells, research in IgE memory B cells. We need to understand what that can take us in terms of new innovations, new targets, new possibilities for patients.

And then, as I said, we want to build a pipeline that's more rich, stronger, balanced, but also more diversified, and that entails both internal and external innovation. I'm gonna give a little bit of context to each of those four pillars here, starting with respiratory. And first, take a step back, and really talk about, and Jacob, you also spoke about the children. And this is really about why we, we think it's so important that you address the underlying allergy, and in particular, early in life. Some of these numbers have been mentioned before. Children with atopic dermatitis carry a four-fold increased risk of later in life developing allergic rhinitis. Children with food allergy carry a threefold increased risk of later in life developing allergic rhinitis or allergic asthma.

Children who has allergic rhinitis also carry a seven-fold increased risk of later in life developing asthma. We've spoken about those numbers. We refer to this as what we call the atopic march or the allergic march, and we want to change this. Imagine you can, in fact, reprogram the developing immune system and change that disease trajectory because you intervene this early in life, where you change the, that trajectory for the disease, and there are increasing evidence that that, in fact, can be done. Here are some data from the LEAP study.

It's in fact in infants who were high risk of developing food allergy, and they exposed infants with high doses of allergen to food and could, in fact, reprogram the immune system so that the risk of developing food allergy was much lower in those who were exposed from infancy, from early in life to that particular food allergy or food allergen. So again, this is why we so it, it's so important for us that we go in early, that we treat children, that we not only treat symptoms, but we address the underlying allergy. And that's why we are so excited about also developing our current tablet portfolio, but also future products to be used in children. And clearly, we are quite excited about the pediatric data, and I think, Flor, you were very modest when we spoke about the EAACI Conference.

We had a full house at the symposium and presented the phase III data, and you've seen the results, and they're amazing. With the house dust mite, we completely, you know, spot on with... Likewise, same number, same improvement, and also seen with the tree tablet. So the data are amazing. The safety is great. It's, if anything, better than what we see in adults. Tolerability is really good. So we're quite happy with the data, and the doctors also were quite happy with the presentations, at least that was our take on it. Being biased, of course, as we said. So clearly, we think this is important, and good people are working on all the regulatory activities.

So, you know, we have submitted in the most important markets, and that work is progressing as it should. Again, we are also focusing on lifecycle management. We're just listing GRAZAX here in Japan with our great partner, Torii. But clearly, if possible, if funds allow, we would like to also do more with the tablets in other regions. Bring broader portfolio also to other regions. Again, depending on success, depending on our ability to allocate more funds. And then it's really about generating more evidence, really utilizing the huge data we have in-house and building new insights. Using the data we have to provide evidence for new indications, broader indications. So, it's really about having that complete portfolio backed up by data. And data is really...

Data and AI, I think, is on everyone's minds these days, and, and you also spoke to it. It's certainly also on ALK's agenda very much, and I want to put a few more words to it. We have, especially with the tablet portfolio, we're standing on a wealth of data. Data from more than 20 phase III studies, data from laboratory samples, data from biobanks, more than 100,000 samples in our biobank. Data from a real world, data from the klarify Universe. All of this, we're putting together, of course, as many others, we love data, and we love data mining. We love those new tools. This has really learned us a lot, and in the end, it's really about how you are able to translate data into knowledge, into insights, into new hypotheses.

In our case, also into new discovery of biomarkers, new discovery of IgE memory B cells with use data and machine learning, great computer power for that. So all of this is really about maximizing the value of those data you have. And of course, we also want to do more. For someone like me who have been in drug development for about 20 years, I'm super excited about this because if we can also advance our assets, not only can we find better targets, but we can also accelerate our way to the patients with those assets. We can maximize our ability to succeed with our programs, we can optimize our science, and we can gain efficiency, so it's less costly to try to drive innovation from the lab towards the patients.

So this is really critical for us, that we invest more into our infrastructure, into our computer powers, and into also scaling up people's capabilities, because not everyone is as excited about data that I am. So everyone needs to buy into this, of course. But clearly, this is important, and this is really a landscape in change. Another landscape that's changing, that's within anaphylaxis. You haven't heard us speak so much about anaphylaxis in the previous years, but this is clearly something we find very important with our revised strategy. I've mentioned these numbers. A lot of patients are there at risk of anaphylaxis, and I want to speak a little bit more to what it is, really.

So the most common reason for people to develop a severe allergic reaction or anaphylaxis or even anaphylactic shock, that's due to food allergy. It's due to venom allergy, so a bee sting or a wasp sting, or it's due to drug allergy. So all of these are really at the core of who we are at ALK. We understand those severe allergies. We've worked with those for so many years. Patients start having urticaria. They have angioedema, swelling of the face, swelling of the tongue. They may have gastrointestinal symptom, nausea, vomiting, but then they may have difficulty breathing. They may even have respiratory arrest or cardiovascular symptoms, cardiac arrest. So this is really life-threatening. This is an emergency, and this is serious. But clearly, we believe we can make a difference here.

Before adrenaline has been available for 100 years, and it's really effective. But we could do something about how it's delivered to patients so that it's available also to them, because many patients, again, they don't carry their auto-injector, or they don't know how to use it because they don't use it very frequently. So it has to be really, really simple to use, and it has to, again, also be effective in the given climate zone. That's also important. And it also has to be user-friendly for those that are not necessarily the patient themselves, but people around them. Could be a caregiver or in a kindergarten. So again, we find we have quite a role to play here into this area. We bring experience that we want to leverage, both from our current Jext business, but also about understanding the disease, the underlying causes of anaphylaxis.

We think it really links well. It's synergistic to what we are at ALK. I want to leverage that to bring forward more innovation. So again, we've made a few choices here. We've discontinued our partnership with Windgap because we believe more in our own Genesis, and we want to bring that one forward and give that some more global presence. And then we see this landscape that's changing with more patient-friendly opportunities, also non-injectables. And we're quite excited about this and also want to play a role in that innovation. I'm changing gears now to speak a little bit about food allergy. It's very linked to anaphylaxis. As I said, it's the prime reason and the major reason for people developing anaphylaxis. So again, these two areas are very much linked.

And in food allergy, because of this, there's an enormous high unmet need. And again, it's a life-threatening situation and for many patients, but also not least for the caregivers, that risk of anaphylaxis that is imposed on you on an everyday basis is really burdensome from a quality of life point of view. And yet there's so much more we can do and so little treatments available. And currently there's no treatment options that are curative at all. So again, we have an ambition to build a broader portfolio spearheaded by peanut but not stopping there. A broader portfolio that also introduces other treatment modalities. And how do we plan to go about it? Well, we've put a few words here about how we expect to leverage our current R&D capabilities within drug development.

Again, it's coming again from this very deep biology understanding on the central pathways that are relevant, also in food allergy. It's standing on the shoulders of the world's finest researchers within the clinical and molecular allergology, and then of course, our expertise, our learnings from the SLIT-tablet program. That's gonna take us the first step. Step one is really about establishing presence with the current peanut SLIT-tablet. We've shown it's safe. We've shown this tablet, this technology platform works. It's safe, it's efficacious, it works in children, and it has a unique mode of action because it tackles the underlying allergy and not just treating symptoms. That's step one.

Step two is building a pipeline and then introducing some of the targets you could not see, but could see in our pipeline, in our discovery pipeline, some of the more novel concepts, new mode of actions that we have, biologics as well, into food allergy. So that will take us from only treating targeted allergen-specific peanut allergy into a broader food allergy, non-allergen specific, so allergen-agnostic food allergy, but still going for patients with the highest unmet need. And then the bridge to new indication, that's really about those novel concepts. That's new, those new MOAs, those new targets that have potential to go broader than food, because it's really about treating. It's the underlying biology that we are working on here, those targets that will allow us to then bridge into new indications as well.

I will end on food by putting just a few more points on the peanut program where we are. You've seen our announcement in the spring on the peanut SLIT-tablet. The ALLIANCE study is now the study program has been amended. Now it's a three-part study. We amended the protocol, got acceptance from the authorities also to implement a phase II part into or a phase II design into the program. And that was simply to include also an efficacy readout to accelerate the program, to get some earlier readouts from how the tablet it actually performs. It's a three-part study now. Part one has completed. You saw our announcement on that. Very, very, very safe, tolerable. That's about what you can see. All doses tested were safe and tolerable.

There was no serious adverse events and no events of anaphylaxis. So again, similar to what we had expected, because we know this, this way of treating with allergy immunotherapy so well. So mission accomplished so far. Part two is ongoing and progressing very well. Expect to have data later this year and then move into part three, the efficacy part. So that concludes on food allergy. And now left is really how to go into the new therapy areas. And our approach here has really been a quite extensive mapping on all the allergic inflammation in the outer space of allergy, the broader landscape of allergy. And we've done a careful mapping of that. And of course, this is not all.

There's like hundreds of indications we've been mapping through to understand really what are the remaining unmet needs here, where are the more innovation needed, where do we think there is a match, what's the value potential and all of that? How is the competitive landscape? What was the synergies with our current business and who we are, our capabilities? Where's the position, where we think we can own, where we can make a real difference to patient? That's what it's really been around. So to speak more about our scientific focus. I'm super delighted to invite Peter Sejer to stage. Peter Sejer is our new Head of Global Research and Drug Discovery. Peter, welcome.

Peter Sejer
Head of Global Research and Drug Discovery, ALK

Thank you, Henriette. So, hello, everybody. I think you are brave now. Now, it's the scientist speaking. I would like to, first, in the next five slides, just give you an impression of why we believe we have a reason to play and a reason to win. In drug discovery globally, there is a very clear trend, and that is immunomodulation is taking center stage. This is what you aim for in drug discovery globally. And there we see also three reasons for that. First of all, there's a lot of learnings from biologics. They are very successful in treating inflammatory diseases, and they target a specific immune pathway , like the dupilumab . Secondly, there's also learnings from cancer, where immunomodulation is now really integrated in clinical practice. It's a huge industry.

There's a lot of learnings. And then finally, another reason, there's also a lot of new methodology coming up, in immunology, studying the immune system at a single cell resolution. Super powerful technologies that are evolving as we speak. So how does this affect, allergy? Well, this is one example. This, this is a study we published in February together with the colleagues from McMaster University in Canada. And then, what you see here is that basically, we, we applied the newest, as you can say, the most fancy technologies to clinical trial samples from our, SLIT-tablet programs, the ITULAZAX in this case. And, and what you see here are 90,000 memory B cells.

So each dot here represents data from a cell, and data are the transcriptome of that cell, and for the non-scientist, this is the activity level of the 1,000 most active genes in that cell. This figure is made on the basis of 0.5 TB of data. So there's massive amounts of data that is coming available to us now in the labs. By doing this figure, we could then start to address, okay, so these are memory B cells, are the features where—that are unique to allergy, and where does IgE originate from? And we could identify this cluster marked by the red circle as the originators of IgE, the IgE memory B cell, basically the home of allergy. And this was quite well-received internationally.

It made a lot of also a lot of press because it really helps us understand the allergic disease, mode of action of immunotherapy, but also guides future drug discovery. And there's a lot of parallel innovation going on now with these new techniques. And it also speaks to our legacy of having, you can say, providing scientific leadership in allergy. This is sort of a legacy slide. Peter mentioned it in his presentation that already in the seventies and eighties, we are really setting the global standard for allergy and extracts. This provides safer and better product for patients, yes, but it also teaches us a lot about allergy, and we and get to the discovery of a lot of allergens, like those for the house dust mite, which is now the most prevalent allergy worldwide.

This basically, pioneering continued into the eighties and nineties, where ALK were also the first to use gene technology and genetic engineering in allergen research, making the first recombinant allergens, also leading to the first molecular structure of a recombinant major respiratory allergen. And all of these insights, you can say, were taken further to understand what are the rules, what are the molecular forces that causes allergy, and that's the center graph. And I'm showing it, not to explain it, but just to highlight. This graph was actually shown Saturday at the EAACI meeting by a professor from King's College, even though it's published in 2008, because it explains the basic rules for how we respond to allergens.

That's really important to understand for physicians, because it also explains why you can say if two people have the same level of IgE, why do they respond so differently? Well, if you read the paper, you will know why. So this knowledge, but all this know-how is, of course, put into our tablet development programs. So we have done extensive analysis of these samples with the memory B cells being the best example of that. And this knowledge is, of course, super critical for us to advance our understanding. But it's not enough to have knowledge. You also need to have good partners and collaborators. And in our sort of history of the company, we have been closely affiliated to universities throughout our history.

The last 10 years, we've had 8 major academic collaborations. Just to mention a few, the McMaster collaboration, this was the discovery of the memory B cell, has implications for a lot of range of, of our interactions. We also worked with the La Jolla Institute of Allergy, to evaluate peptide immunotherapy. We have continuously been interested in alternatives to extracts. Are there smarter ways of doing this? And with Imperial College, which, speaking to U.K., is one of the leading, you can say, centers of, of allergy, clinical allergy, also together with us, we have had multiple collaborations on the mode of action of immunotherapy. So how do we do it? The peanut tablet that Henriette mentioned is a good example of how we collaborate with academics.

So initially, we were advisors for the Department of Food here in Copenhagen, to give advice to a project. And together with the global awareness of food allergy and the leap study, we got motivated to start our own research. Then we enhanced, you can say, our involvement with DTU, we became a minor partner. And then learning more, we decided, "Okay, we should make a tablet. We start, you can say, the actual development. And as a consequence of that, we then made collaborations with McMaster and SickKids hospitals, both in Canada, but both also world-renowned centers in food allergy. Really skillful people, teaching us a lot about food allergy very quickly. And then now we're in clinical trials, and we have kept some of these academic affiliations.

We see this path being followed also for our future drug discovery. I mean, going into new indications areas, you find the top labs, you collaborate, you move forward fast. And this is my final slide, and that's just to speak to, again, to the science of this now our scientific DNA, but also to the mode of action of allergen immunotherapy. It's one of the few treatments that actually offers a disease modification, meaning long-term tolerance years after treatment has stopped. There's not a lot of treatments that offers that, and we have studied that for what? 20, 30 years now. So we know a lot about, you can say, what cells are effective. In the immune system, there are T cells and B cells, innate lymphoid cells, and even the epithelium.

So these are the cells forming the inner of the lungs. All the cells are actually affected by treatment. And we also know the mast cells, which are basically also in all organs of the body, also change their response as a consequence of treatment. So you have this systemic change during immunotherapy that we have monitored carefully for many years. So this has made us, I'm proud to say, an internationally recognized center in mode of action of immunotherapy. And we are, as has also been said a few times, really world leaders in clinical and molecular allergy, and we have expert knowledge in a lot of these associated disciplines. So, so we are super excited about the, the Allergy+ indication because we believe that, you can say that we... now we can use our competencies sort of in a broader context. Now I'll hand it back to you, Henriette. Thank you.

Henriette Mersebach
EVP of Research and Development, ALK

Yeah. So ALK is really pioneers within allergology and also both clinically and molecularly. I hope you agree with that now. Our research has really been centered around the core biology, the core pathways of the allergic inflammation. Peter spoken about it. Each of the steps you see on this slide here, from the allergens up top left—we've studied each of those steps in very great details to really understand the mode of action of allergy immunotherapy. And it's the same pathways, same biological system, same cells that are relevant also in the broader range of allergic inflammation, also in the broader range of new adjacent allergic conditions. And that's why we feel we're well positioned to also go broader, to also gradually expand our therapy areas into a broader range of allergic conditions.

We've put a few examples up here. We're happy to speak more about it. Again, I can see, Per, time is running out, so I won't dwell on this, but just again, I hope you're convinced that we know our game here in terms of allergology and allergic inflammation. So just a few closing remarks from me. Our vision really entails that we need to invest more into our internal but also external innovation to really build a more broad but also balanced pipeline. It's again, about reiterating our commitment to respiratory allergy and allergy immunotherapy, but we want to do more. We want to do more in food, we want to do more in anaphylaxis, and that we also want to expand more into new areas, new adjacent areas.

Again, we see quite a range of opportunities. There's significant unmet need, and there's a great potential for us to really make a difference and serve at least double the number of patients in years to come. I look forward to it. Thank you so much.

Per Plotnikof
VP of Corporate Communications, Investor Relations, and Strategic Planning, ALK

Thank you very much, Henriette. Now, you heard about the home of allergy, and you heard about ALK wanting to own allergy. And now it's my true pleasure to introduce you to someone who has considered ALK as the home for... first persons who were part of writing the first study protocol on grass back in the late nineties. Christian will now talk about production. In his senior life, he's become a farmer, and he will talk about our production and scale-up capabilities in the next 15 minutes. Go ahead, Christian.

Christian Houghton
EVP of Product Supply, ALK

Thank you very much for the kind introduction, Per. Container that we use to store the API in. I'll come back to that a little later, so I'll just start up here. ... Naturally occurring allergenic source materials like pollens, house dust mite, and so on, into pharmaceutical allergen products. Doing that is something that require a lot of technical but actually also scientific experience. You have heard about that. This is really something that we have in ALK.

But it also requires a lot of insight and experience within the regulatory framework, and I think this is where our evidence-based agenda comes in. We have a lot of experience also within the regulatory framework in ALK. A few facts about Product Supply. We are about 1,200 people, experienced people, maybe not everybody with 30 years of experience as myself, but still very experienced people across the different sites that we have in our network. And if we start most to the west, in U.S., Post Falls, Idaho, this is where we are making these allergenic source materials that I just talked about. These source materials are used across the other sites in the production network, and if we then move a little to the east in Oklahoma, there we have a smaller site where we're making these so-called vials and diluents.

This is also what we are calling the life cycle business. Then moving a little further up north to the east, this is where we have Port Washington. It's close to New York, and this is where we are making the bottled extracts. Søren's talked to it. We're still in that business, and we're still there with all these many different extracts that we supply to the U.S. doctors mainly. Moving out of U.S. and into Europe, we have the largest production site actually here in Hørsholm, where you are today. This is where we are making the SCIT products, so this is the Alutard and the Aquagen, which is also mainly sold for Europe, but also partly in China. And it's also where we are making the tablet API, except for the cedar API that is coming from Zurich.

The tablets themselves, they are manufactured by Catalent in their site in Swindon, so it's not, let's say, something that we are doing. Then if we move to France, this is where we are making the SLIT drops, the so-called OSIRIS product line, and this is also mainly something that is for France, so it's not something that is sold broadly across the world. Then finally, in Spain, we have a site where we are making the adrenaline auto-injector called Jext, and it's also where we are producing our diagnostics, the skin prick test line, which is, of course, very important in order to diagnose the people before we can put them on treatment. And then finally, we have also packaging and distribution activities there.

Now, all our production sites, they are running under GMP, and they are inspected regularly by the health authorities, but also by our partners. You heard Jacob also talked about the many different partners we have, so we actually have inspections from all of these partners in the sites. Within Product Supply, we have quite a lot of different priorities. Of course, our top priority is first and foremost to safeguard supply and quality, which is our license to operate. But apart from that, we also have some very important projects, and one of them that I'll come back to is the scale-up activities we have on the tablets together with Zurich, but also Catalent. And then we also continue to execute on the product and sites where we did the so-called Project Path that we launched back in 2018.

And then finally, we are preparing to launch the new Genesis auto-injector that also Henriette and Søren have has been speaking to. Apart from that, we are also delivering on the sustainability goals that we have and also continue to drive efficiency through our Manufacturing Excellence program. So this is where we identify a number of incremental improvements that gradually makes us more and more efficient. Good. So then how do we then manufacture these kind of different allergen products? It all starts with allergenic source material. So it all starts in Post Falls, Idaho, where we're making these source materials, and we handle many different type of source materials. Of course, the pollens, it can be from trees, different grasses, and so on, but also various kind of house dust mites that we cultivate and purify ourselves.

Also, venoms for various kind of insects and also different kind of hairs from cats and dogs, especially. Now, this is a very critical step because the quality of these source materials is important for the quality further downstream. So this is also why it's extremely important that we are in control of that step, so we know if there are changes made or anything else, or optimizations, that could have a potential impact further downstream. The second step is about making the allergen extracts, the active substance, and that's something that covers extraction, purification, but also stabilization of the active ingredient, and finally, standardization. And standardization is something that is key to ensure a high batch-to-batch consistency. Peter Sejer talked to it. Peter also trusted in it.

It's something that was established many years ago, but it's still something that is very important in our quality assurance. When you have all that in place, and this is where I think the uniqueness come in, in ALK, that is these two first steps. Downstream, it's further, let's say, traditional manufacturing of tablets, liquids, and so on. And then we have, of course, the final packaging and distribution activities, which is also, I think, quite normal from other pharma companies. Now, within Product Supply, we are highly focused on, of course, making sure that we have a constant high-quality level. This is really, really key for us. We are, of course, also interested in driving efficiency, and I explained we do it through the Manufacturing Excellence program that we have, and of course, safeguard a robust supply. These are the three key things. Now, then...

Comments on why these products are so special. You heard about that there are high entry barriers to this product, but what is it really about? Let me start to explain that all medicinal products, they contain an active substance, and in most cases, that means one specific molecule. In contrast to this, the active substance in an allergen product contains many different molecules because it is the extract made out of the allergenic source materials. And that can be allergens, but it can also be non-allergens and all kinds of molecules actually. And all these different molecules, they are making up the active substance that we call the allergen extract, and is therefore a complex biological substance. So how do we then handle all that complexity?

Well, first of all, through a set of unique manufacturing operations, but also through a set of control mechanisms. So we have a different set of control mechanisms, but the most important one, that is the so-called SQ Standardization procedure. And that's something that we introduced, as explained many years ago, but it has been demonstrated to be extremely robust and efficient in ensuring a high batch-to-batch consistency. So whenever we make a new batch of standardized allergen extract, it has to comply with certain composition and potency requirements. So we measure it up against a reference batch, a so-called in-house reference preparation. And provided the batch in question complies with these criteria, it can be released and used further downstream to make the final product. So in essence, these allergy extracts, they are inherently complex. They can only be released using the in-house reference preparation.

So because of that, it is not possible to make any generic or biosimilar versions of our products. I hope that was clear. Otherwise, you can ask in the break. So going away from that, and let me then turn to the capacity-increasing activities that we have. We have activities actually throughout the supply chain, except for the last part in the packaging and distribution, because we continue to have sufficient capacity there for the next many years. But, we are doing it within the existing manufacturing premises, simply because we don't need to expand. So in Post Falls, we are currently expanding the cultivation and purification capacity of the house dust mite. In Hørsholm, we are expanding the API capacity, and also we are expanding the capacity of both source materials and cedar API.

Catalent are also expanding their capacity, and they are both doing it in their facility in Swindon, but they also established a new facility in Strathroy, Canada, where we will also get capacity from. So I think it demonstrates that Catalent, ALK, so we, we are all fully committed to the capacity expansions that we have. And this is because it holds a lot of value, not only for us, but also for the patients out there. Then we'll come back to this little friend here, because I want to give you some idea about what are we actually talking about when we're talking about scales. This container can hold up to what corresponds to 500,000 or half a million grass tablets. And that turns out to be, I think, 10 million or something like that, Claus, in turno ver approximately.

So it's pretty valuable. So it says something about the scalability. So that's why we are talking about, so there's no need for that. Good. Apart from the capacity, which of course, always important when you are in production, we also need to have our eyes on other things, and one of them is complexity and efficiency. And going back, and it was mentioned, I've been here for many years in ALK, and I was also here in 2010, and I think it's right. You know, I can say these figures are absolutely right. We have worked with, let's say, reducing complexity and improving efficiency through many years. And one of the issues we have had is all the many stockkeeping units. Going back to 2010, we have 10,000 stockkeeping units at ALK.

We have now removed about 75% of that, and it's something that we'll continue to look at in order to take out complexity, not only for product supply, but it's also a matter of something that could affect regulatory affairs, quality, and so on. So this is one agenda point. The other one is scrap. We used to have a very high scrap in ALK, perhaps partly linked to the many stockkeeping units. This is something we have worked with, and we have been able to reduce, so we are now in the high end of the industry benchmark. This is, of course, better because it used to be double if we go back a couple years ago. But still, we want to drive that further down, so we're in the better end of industry benchmark when we're in a distributed period.

So this is also an agenda for us. Then, of course, we are, let's say, benefiting from the higher sales that Søren's team is providing because this gave us obviously some efficiency gains in production. So that's very good. But of course, for the tablets, and I think also Claus can show that a little later... There is really a difference here when it comes to the different products. The tablet is really a profit driver for us, so when they grow, it also helps us in production. And then finally, the manufacturing excellence and quality excellence program that we are running is not only about efficiency, I have to say, it's also about robustness. And I think we need to take these two things into consideration when we talk about production. Efficiency is one thing, robustness is another thing, and quality is a third thing.

We always need to keep those things in a balance. Very good. I would take my closing remarks and say that we have been in this game here for a century. We have a long-term experience with producing these products, standardizing, scale them, and so forth. As you have heard, there's a very high entry barrier. We are working hard together with Catalent to increase the capacity. You can always question is too much, is too little, you know, it's always hard to predict, of course, so many years out, but we're dedicated to do that together with our partners. Then finally, we continue to have high focus on quality. This is our license to operate, and then also continue to drive these improvements to our manufacturing excellence program and quality excellence program. With these words, I think I will stop. I can see I have 34 seconds left, so I think maybe time is coming up.

Per Plotnikof
VP of Corporate Communications, Investor Relations, and Strategic Planning, ALK

Thank you very much, Christian. Don't forget the DKK 10 million on the table there, please. All right, so now we will move to the next Q&A session, which now is on the subject of R&D and on production, and I kindly ask, Peter, Christian, and Henriette, please.

Edward Thomason
VP of Equity Research of Life Sciences, Van Lanschot Kempen

Thank you. Edward Thomason again. Just a question on your pipeline. It looks like there's quite a gap in the pipeline, before and after the peanut allergy. Can you just speak about what the pipeline will look like in 2028? And can we expect any additional product launches before 2028, or are those early-stage assets probably going to be.

Peter Halling
President and CEO, ALK

One of the reasons for why we wanted to do a strategy review was not only myself entering, but also because we knew that we had some gaps in the pipeline we needed to address. We've been very clear in terms of we had the pediatric launches where we finished the clinical trials last year, now we're going into a launch sequence. Then we had the Genesis project that we are now putting in and will hopefully be able to launch towards the end of the strategy period, and then peanut towards 2030 or a little before. So that is... do more. Maybe I'm gonna talk a little bit about what we do internally, but also how we look at it externally in order to fill some of those gaps.

Henriette Mersebach
EVP of Research and Development, ALK

Yeah, but you're absolutely right. We do have a gap in the end of the strategy period, and it's with the current assets we have in the discovery pipeline, we can't really accelerate them fast enough to... If we need to simply fuel the pipeline with also external innovation to really close that gap in the midterm horizon to be able to launch more assets before, because otherwise we are looking into the thirties or at least end in twenty... Before we can bring some of those discoveries to patients.

Peter Halling
President and CEO, ALK

So, so we're doing a couple of things. One is, Henriette... of the pipeline. So we believe with this two-pronged strategy, we'll be able to catch up, but we need to do it in a way where it makes sense strategically for the company, and that's why we wanna invest first into the business development activities, further move forward on the-

Edward Thomason
VP of Equity Research of Life Sciences, Van Lanschot Kempen

And just continuing on that, where's the sweet spot if you are going externally for business development? Is it... You're looking at the discovery phase assets, or is it those early clinical stage assets?

Peter Halling
President and CEO, ALK

It differs, right? So depending on where you're looking.

Henriette Mersebach
EVP of Research and Development, ALK

Yeah.

Peter Halling
President and CEO, ALK

So it might be for some of the new areas, and then jump in.

Henriette Mersebach
EVP of Research and Development, ALK

Yeah, well, it absolutely has to complement what we have in our early discovery, so it differs a little bit by therapy area. So, for certain therapy areas, we're looking more preclinical, but actually phase I/II , as well. But for others, we would also like something that's more close to launch that can run with faster because again, there's we would love to have more also in the end of the strategy.

Edward Thomason
VP of Equity Research of Life Sciences, Van Lanschot Kempen

That's in manufacture and supply. It was a very impressive presentation there, but can you just expand on the regulatory risk, particularly around inspections about your sites? What do you think—how do you view that risk? How should we measure it as an analyst?

Christian Houghton
EVP of Product Supply, ALK

Well, I can say that we have had a very good inspection track record here in the recent years. So I would say, think back and we had a few quality, you could say, issues back in time, that also Peter alluded to in the beginning of his presentations. But those issues are. So I'm not really concerned about that, actually. No.

Edward Thomason
VP of Equity Research of Life Sciences, Van Lanschot Kempen

Thank you very much.

Per Plotnikof
VP of Corporate Communications, Investor Relations, and Strategic Planning, ALK

Thank you, Edward. There's time for one more question, and I think it comes from Thomas Bowers, Danske Bank.

Thomas Bowers
Senior Analyst of Healthcare, Danske Bank

Yes. From my side. So, on the API, you're using one API for GRAZAX, and then one for [audio distortion] correctly, you're using four different parts.

Peter Halling
President and CEO, ALK

Yeah. No, go ahead, Christian.

Christian Houghton
EVP of Product Supply, ALK

Yeah, yeah. So, so you would say for the dust mites, we are using two different active ingredients. But it's, you could say, essentially made out of four different fractions. So we have, you could say, body-

Peter Halling
President and CEO, ALK

What Christian is saying, if you were to change the active ingredient, then you would also have to go through regulatory process again. So require a costly, optimization exercise for us.

Thomas Bowers
Senior Analyst of Healthcare, Danske Bank

Okay. And then I just have a small question on the Genesis project. So, and also in regards to, I presume, a nasal spray product.

Peter Halling
President and CEO, ALK

See what we said from, from the get-go, we wanted to really take a deep dive into the strategy and ensure we were at the right place, and then set up the activities. So that's basically part of, of why, that has caused a delay. And then basically, we're working on the submission, and then, we'll get that submitted. And then that's gonna allow us to hopefully execute fast, but we have to go through the regulatory review, so it's gonna type of, of products. But, I think it was a, a great question, but obviously film, nasal and others as well.

Per Plotnikof
VP of Corporate Communications, Investor Relations, and Strategic Planning, ALK

Thank you very much. Thank you for your good questions. We'll now have a short break. So please be back at 4:15 P.M., and we will move on. Gentlemen, please get seated, and we'll get started again with the final session of the day. It's now my pleasure to introduce you to our CFO, Claus Steensen Sølje, who's been with ALK for actually quite... absolute favorite subject, namely, the numbers. Claus, please go ahead.

Claus Steensen Sølje
CFO, ALK

Thank you so much, Per. I hope you have a little bit of more energy left here for this last topic now, after listening to 2.5 hours of kind of marketing slides. Now we are going to talk about, you know, something I know you love, that I love, and that is, of course, the numbers. Also, hello to all of you out there, a big number of participants here. My job over the next kind of 25 minutes is, of course, to take everything you have heard from my great colleagues and try to combine it into some set of numbers, trying to connect the dots on where we are. And I will start on that treatment very soon. Oh, that was marketing. Oh, I'm not... Sorry. Unique platform, there's no doubt about that.

We have significant potential, and I hope at least my colleagues have convinced you about this along the way here, and I will now try to kind of summarize it into this. I will start by doing it with one slide here. That'll kind of be the theme of what I'm going to talk about during my presentation. The headline is that we are committed to long-term value creation in the company. So everything we do, whether it's in the R&D, whether it's in the manufacturing, whether it's in the commercial, it is about creating long-term value in the company. And this is part of our DNA, and this is what we keep discussing. Try to focus on our roadmap here with four different pillars. One is around being focused on the attractive markets and the products that we have out there.

We have to be razor sharp in where it is that we are focusing within the company. You heard Peter say from the beginning, it's actually not so much the problem for ALK to find things to do. It's about prioritizing into what create value in the end. Second, efficiencies and reducing complexity. You've heard it before. This is something new that we would really like to bring in as part of our, our DNA going forward. You heard Christian talk about the efficiencies in manufacturing. I'll come back to gross margin, but it should be part of our DNA that we always think about how we use our money in the best way. We need to find optimizations along the value chain constantly. But a second part we also need to do is to look into that complexity. Peter also alluded to it. You probably know it, founder's mentality.

We have had a growth period that has been quite fantastic. That is creating complexity within the company, and we all know that complexity then reduce growth, actually even sometimes kills growth. We do not want to end up there, and we need to make sure that we actually reduce it, especially if we want to, and I'm not guiding the market or anything like here, going to be 2x-3x the bigger than what we are today, then we need to scale the company with less complexity. Then number three in our roadmap for long-term value creation, disciplined capital allocation. I, I know the word discipline is a little bit old-fashioned, something my father kept talking about, but in some way I like it. And maybe it is because it's, it's finance a little bit talking, but we have discussed it a lot in the management team.

This is about staying true to the strategy when we talk about capital allocation, staying true to what we want to do. Of course, we will be hit by everything along the way, no doubt about that. Then we need to be agile, and we need to be able to respond to that, quite quickly. But we want to be disciplined in what we are doing and not straying around and jumping all new idea coming in.... And then fourth, about increasing earnings and cash generations. There's no doubt we will continue to focus on that. I'll come back to how we have been doing it. We believe very much still, maybe also getting out of fashion, what do I know? King is cash. No, cash is king or queen. And these days, we also want to focus on that.

We want to drive that agenda from the management team constantly, and everything we do in the management team, we have decided that is, it has to end up with this. So this is our roadmap for the long-term value creation. This now kind of address some of those throughout my presentation, but I'll just start with one thing. In the DNA of ALK, it is that we are a growth company. There's no doubt about that. We want to grow, and we want to continue to grow. We can do that with the existing portfolio, but we would like to grow even more. That's why we want to invest even more into R&D.

But just with the portfolio we have right now, Søren can do wonders because we basically do not have the patent cliff or the challenges, and now with new indications, we can continue on that growth journey. We have been able to do that for the last 20 years. Some years better than others, but we want to continue to do that. No doubt about that. So what about the EBIT? That's our other DNA in what we are doing. We have to admit, that has not been as smooth a sail as we have turned out on the sales path. That has of course, been a bit of a challenge for us.

We have been a little bit impacted by, you know, when can our competitors not deliver to the market, then suddenly our EBIT is doing good, or when did we have milestone from our partners, then again, our EBIT has been doing good. That was why when we created the strategy, the old strategy, we kind of said, "This is not a way to work." That was why the 25 in 25 actually came in, and I still believe it's a very, very good idea to do it. There were two main reasons to why focus on 25 in 25. First of all, was we wanted to show that whatever we do on the top line, we can convert into a stable development in the bottom line. We think we have done that over the last couple of years.

The second was that we wanted to be among our benchmark group when it came to our EBIT margin. So we looked at that point in time, the benchmark, and said, "Where is it we should want to be? If kind of makes sense for us as a specialty pharma." 25% is not a bad place to be. It was approximately, I've talked with many of you about this, it was approximately, it was many years ago. It could be lower and higher, but you know the rule, if you say the same number three times, then it's a target. So suddenly, 25% is our target, and we have decided to stick with that.

So these are the two reasons why, and I actually think it has been very, very healthy for us to drive that mindset throughout the organization, and we will continue to do that. I will come back to that. Last slide on my kind of history lesson. It's, I think, good idea to just look a little bit of where is it actually the growth has been coming from, because when we are kind of forecasting our growth into the future, it will be a little bit the same picture as you see here. If you look at it from a product point of view, to the left for you up here, you can see that 92% of the share of growth in our strategy period came from our tablet vaccines. It will also continue to contribute in the future, in our baseline towards 2028.

Maybe not to the same extent as 92%, but it will be high, and this is where it came from. Actually, the SCIT and SLIT drops, so our drops, especially in France or our injections, they contributed with 0. That can sound a little bit bad. In between years, they actually contributed very nicely, but looking over a period, it's actually not contributed a lot. It is actually either a little bit from the other products, for example, the Jext, the adrenaline, or it's the products that we have in the tablets. Second one is, if you look at it from a geographical point of view, here it's a little bit more spread, which of course is a good thing. Europe, approximately 50% of the share of growth in the last strategy was coming from here.

That's of course also why Flora is here, because we will continue to see this growth going forward. I have noted your question about then what about the risk? I'll come back to that because we are of course seeing, yes, we are a global company, but Europe is our home field, and we'll continue to invest into that. The good thing is that we actually have two other regions that has also contributed quite a bit. You heard it from Søren and Jacob earlier, especially in international market, actually, more than 30% of our share of growth in this period came from there. Of course, our fantastic collaboration with Torii in Japan, but also lately from China. North America, we have said it, we have punished ourselves. We haven't really delivered on the strategy as we have said from the beginning.

But still, if you look at it, then approximately 16% of the share of growth came from there. It's not just Canada, it's also U.S. driving that, and the tablets are growing. It's just not growing fast enough. So looking ahead, where are we then going? What we have said, and we also now have communicated, is in average, we would like to see 10% or above sales in the strategy period towards 2028. It will be the tablets that are going to drive this for us. It's going to be in, it's going to be our pediatric cohorts that are going to drive it, in the strategy period, and we are above the 10%. I just showed you before that the non-tablet portfolio didn't contribute quite a bit.

There, we are a bit more optimistic, maybe not above 10%, but also it is contributing to our growth. If you then look at it from a different regional perspective, where is it that you see it? Well, it is Europe that are going to give us the majority of the growth coming there. It is, of course, linked to the pediatric launches that you are seeing. It's also linked to that market transition with the evidence-based medicine that Flo was talking about we saw in Germany, we are also seeing in other markets out there. We are also going to invest into prescriber expansion, and then as we talked about, we want to be a bit more bold in deciding on where we are going to invest.

If there are markets that cannot live up to our demands on sales growth or profitability, we have agreed with the markets that either you come up with a very good plan for actually coming to a profitability level or sales growth level that can satisfy our internal numbers, or we move investments away from you into some of the markets that actually can. That has also been part of our strategy process to do that, and we have identified those markets. Looking at North America, it will continue to grow. It is also right, as Søren said, we have not put a significant effort in the numbers into the 10% or above towards 2028 coming from U.S.

We have made a strategy where we go in, and we want to see the next 12, 18 months, how can we do with the pediatric products, how we're doing in the market. If we are doing good, I can promise to everybody, then we are going to invest into the market, maybe with a partner. But we want to do it in a cautious step-by-step approach, so we do not go in and invest ahead of the curve and then do not see the results. Then finally, international markets. Torii, Japan, hopefully will continue to grow. Very strong partnership. Hopefully, we'll get an approval in China of ACARIZAX, and then we will continue the quite high growth we are actually seeing there. As I was saying, it's a good growth market for us with the legacy brand.

So of course, we would like to get the new products in there. The patients deserve it for sure. So that's on the sales line. If I then go a little bit down the P&L, just to give you some flavors on how are we thinking about this, then I would like to start, of course, with the gross margin. I hope that besides that, Christian, he is now educated in that there's DKK 10 million in one of those, milk bottoms there he's always carrying around, then we are focusing on the gross margin improvement constantly in our manufacturing setup. We are spending quite an amount of money, on our production facilities, and we need to make sure that we constantly make it, better and better, and cheaper and cheaper.

We have been able to, as you can see, approximately one percentage point on the gross margin year on year in the strategy period. We are not coming out with any guidance on where we would like to end, but it is our firm belief that we should do approximately the same in this strategy period also. Can we do it? Well, if you look to the right up there, there's no doubt that the combination of having tablets with a high gross margin and tablet with a high growth, that's a fantastic combination if you want to improve your gross margin. So that will, of course, help us. But we also want to continue focusing on pricing in Europe, especially, but across. Pricing will also help us.

We can see it is possible when we work long term with the authorities across the different markets to actually increase prices in, in, for our different products. You saw it in Q1, where we said, for example, in Norway, there we have got inflationary price increases on our tablets, quite significant amount of ... We will continue to do that. And then, of course, we will continue to work on our operations performance and constantly, increase the efficiencies in our manufacturing setup. If we then go down and look at the capacity cost, then we have, of course, spent quite an amount of discussions in the, in the leadership team here on making sure that we know our growth runway for the company going forward. When you align on that, then strategic resource allocation is actually not that difficult of an exercise.

So, we spend. Of course, we have the legacy brands earlier. Then it was the tablet vaccines for the adults. Then we are talking a lot about children, and we will repeat that many times, and anaphylaxis is food, and then some of the new therapies that we can look into. That's our growth runway for ALK, and that defines how we are investing, both when it comes from a commercial point of view, but also from an R&D point of view, into this. If you look at the sales and marketing, what we would like to do there, well, of course, as I said before, we are investing into what we call high-potential, profitable growth market. If they're not, we will not invest. We will actually take money away from them and invest into where we believe the future is.

Tablets for children, of course, we will invest into that, where we have the launches coming up. Then, of course, the new sales channels, as Søren once alluded to, we want to invest in where it makes sense, and then new launches coming up, potentially in the end of the strategy period. What we are seeing when it comes to the amounts, we want to see our sales and marketing cost increase year on year in absolute. But we want to, and that's a little bit what we try to show with the snake there, we want the ratio to revenue actually to go down in the strategy period.

We believe we have a business model, we have a platform, we have the people on the ground and the affiliates, so it should be able for us to actually bring the sales and marketing costs down when compared to sales, but absolutely, it has to increase. On R&D, here we actually decided, as also Henriette was talking about, that we want to... Again, we are not guiding here, we want to have a company that are 2x-3x bigger than what we are talking about today. So we can drive a lot of growth with our current portfolio. But if we want to, in the thirties, to be a much, much bigger and significant bigger company than we are today, we need, of course, more pipeline, more investments in there.

So we want to see both the absolute value increase year-over-year, but we also want to see the ratio increase. We have said 10%-15%, and of course, you know that right now we are around these 9%-10%, because now we have finalized the phase III trials. But then after 25%, we would like to go higher. Then if it's 12%, 13%, 14%, 15%, time will tell. But we kind of right now are saying up to 15% could be spent, but of course, we need to have some good things to spend it on, so we are not just going to throw it away. But I'm pretty sure that Henriette will help me finding that, so come up with some good ideas where we can do it. But that, that's the guidance that we are doing right now.

Then before going into the EBIT, coming down to the earnings, I just want to dwell a little bit with this one, because this is something that we in the leadership team have talked a lot about that we need to focus on, especially if we want to take cost out and reinvest into where it makes sense. You saw the DKK 250 million we announced here around Q1, both to invest into the long term, but actually also to make sure that we can increase the EBIT margin. We believe that we need to constantly optimize our business. We need to have a mindset where we constantly look into savings and cost take out, not to just save it for the sake of savings but actually move it into some value-adding things.

That can be everything from commercial, to pipeline, to employees, whatever, but we just need to have that mindset in. The second is we would like to again focus on that complexity. It is, of course, when you have been growing a lot for the last five, six years, there is a tendency that you spend more time on growing the business than actually looking into your infrastructure, looking into your committees, to your decision structure. And there's no doubt that we can also benefit taking a good look at that if we really want to scale up the company. Good example, Peter mentioned it, we are approximately double as many suppliers in ALK as companies that you normally would compare us to.

We have good infrastructure, but there are some IT systems, there are some digital solutions that we need to invest into, so we can decouple the growth of the company with the complexity of the company. If we want to be two times the size, we cannot just continue to grow with the manual solutions that we have. We also need to make sure that's a professional infrastructure, and then we can grow on that. So I just wanted to dwell a bit on that because it's a key point for us and also a key part of the strategy to optimize the business while we are growing. Then EBIT. I know this has been a topic for many in the last 12-14 hours, no doubt about that. I just want to dwell a little bit on history here.

Remember, if you actually go back to 2017, 2018, 2019, we had negative EBIT in ALK. We also had negative cash flow in ALK. It was only actually in 2020 where we actually had the first EBIT in this round, this strategy period here, where we could see that we had positive earnings, the same with the cash flow. Then we have continued that journey along the way towards 2025 and 2025. We have now confirmed that we want to deliver on that, but I also want to remind you, we are still in the first half of 2024, so we still need to, you know, work a little bit to get up there at the end of 2025. And then we have said, for the last three years of the strategy period, so 2026, 2027 and 2028, we would like to maintain our...

things growing in the same speed as our top line, so approximately the 25% EBIT there. That doesn't mean that our profit or our earnings are not going to grow. You have calculated it already, I know that. That if we are going to hit approximately DKK 1 billion in profit this year, then we are going to double that over the next four years to hit approximately DKK 2 billion. So of course, we are going to grow the profitability of the company, but we would like to use that underlying margin improvements that you can also see will be there to invest into commercial activities, into R&D, into infrastructure in those three years, 2026, 2027 and 2028. Then we can discuss on what's then coming after, what are we looking for?

But of course, we are doing this to make sure that after this strategy period, that we have a company that can continue the double-digit growth and can increase the profitability also. Same with the cash flow, just to end on that one, it will be growing. It will be growing quite significantly. Of course, M&A activities, business development, so on, but we will continue to make sure that we have a very sound focus on the cash part. So if you look across these, across margin, well, hopefully, that's our plan, continue to improve, approximately close to 1 percentage point year-on-year throughout the strategy period. The R&D cost ratio, we will allow to grow up to 15%, but it depends on what we have and what we would like to invest in.

So time will tell how fast we go or how fast we go up. Sales and marketing cost ratio will go down a bit like a snake, so depends on which year we are launching what in, but it will go down over the years. And then the EBIT will, over the next one and a half year, continues to go up, EBIT margin, and then will go flat for three years. So we continue to grow our profitability, our profit in line with the top line. Looking at the capital structure then, what is it that we are saying here? First of all, I have to say, I think actually ALK is in a very sound position. We basically have no debt in the company. That's a quite good starting point for us if we would like to be self-financing and actually invest into new areas.

It also means that we got the question today by many, but are you afraid of debt? It's not because we don't want to have any debt, but we have seen many other companies taking significant amount of debt in, and then maybe do not really get a strong return on that. These days, debt are not coming for free, right? It is actually coming. You need to pay back with interest. So we just want to be cautious about this. It also doesn't mean that now we are setting a target of a gearing of two, and then we will run out and go up to two tomorrow. We do not have any plans for that.

We just want to secure that everybody understand if there is an opportunity, then we would like to be able to use debt as a, vehicle, as a tool, but we are also guiding a max for that, what we call a conservative, disciplined, structure. Then what will we then use the money on? We try to make it very clear here over this strategy period until 2028. One thing is investments in organic growth. That's our priority number one. That's what we would like to spend the money on. So commercial, R&D, CapEx, investments into the 800 million tablets, and then business development and licensing activities as number two. This is something we have talked about. It's a bit more on the agenda, what we have seen earlier.

We have concluded that we need to go out and scout and look what's out there, and if we find something, then we would like to also invest into it. Then thirdly, we would, of course, love to make cash distribution to our shareholders. It will come as a priority number three. But I also want to say that we don't want to be a bank. We don't want to sit on the money. So if we do not know in a good way how to spend the money on one or two, then of course, we will discuss with the board. They still need to take the decision on this, and then, of course, we will go into dividend or share buybacks.

That is in our plans, but we would like to prioritize one and two in this strategy period towards 2028, so we build a much stronger and bigger company after 2028. Just a conclusion, kind of the financial aspiration. We are talking about confirming our year this year, and then when we are looking ahead, we are confirming the 25% in EBIT margin, getting up to that in 2025, and then continuing with that. Sales, 10% or above in the strategy period, and then what we call a conservative financial gearing. Last slide for me, just actually saying that we know that the only thing that is clear in our strategy period is that a lot of things will not pan out as we have planned it. That's kind of the only thing we know, and that's okay.

We have made, we believe, a baseline that is ambitious. It's also realistic. We can deliver on it, and we can also deliver on it, even though we get a little bit of a punch from side to side. I think that's a good way of doing it. But just to share a little bit with you, what is it for upsides and downsides that we are also focusing a little bit into. For example, we could potentially see from an upside point of view that we are doing a little bit better with our tablet portfolio in Europe. Right, Flora? Then you could see hopefully that the pediatric coming into the, children doctors across the world will be even better than what we have actually put into our plan, and that's of course, very much something Søren is looking into right now.

Fast-track market transition towards the evidence-based, maybe Spain open up a little bit faster. Maybe some of those markets actually realize it's good to have clinical trials before you actually put your patients on it. And then, of course, something with partnership, licensings. Could we find something that can speed up the top line or something with the activities that we are doing? There are also downsides, of course. There could be some changes to the reimbursement and pricing in European market. That was what you linked to. Now, we actually put even more emphasis into Europe, what will happen? I think it's good to say when we are getting hit by that in Europe, very often it's one times, like we saw in Germany. And then what can counterbalance is, of course, that very often we can actually get price increases also in Europe.

So that can kind of balance a little bit out. And we believe, of course, that we can do some of those measures, but we could be hit. ACARIZAX launch in China, we have not put a substantial amount into our baseline for that, because we want to see what's panned out. But of course, we hope we will get the approval soon. And if Orexo launches, we talk about Genesis, potential partnerships, that could also impact us. And then finally, all the black swans out there, we don't know how it will hit us, the wars and the inflations and so on. That could, of course, also do something with us.

At the end, if I take the starting point in my first slide, we are here to make sure that we can do value creation, short and long term, and we want to continue the journey we have been on. That's very, very key for us. It's very key for the management team. It's a centerpiece of our strategy. Besides this, we need to help many, many important patients, but we believe these two things goes hand in hand. We do it, of course, focusing on the attractive markets out there, razor sharp, focusing on where we want to invest. We want to drive efficiencies, reduce complexity in the company so we can scale. We want to have the capital allocation to support. We want to be disciplined about it. Again, I like that word.

It says something about now we have a plan, and we want to stick to it. And then, of course, we want to continue the high profitability and cash earnings, and then we'll figure out along the way how to spend this money. But we would like to invest into the organic growth, which is already there and should continue also after 2028. And then we would like to see if there's any business development and licenses deals out there, and if not, then of course, we're also looking into cash returns to the shareholders. That's all for me. Per, over to you. Thank you.

Per Plotnikof
VP of Corporate Communications, Investor Relations, and Strategic Planning, ALK

Thank you very much, Claus. And that was the final session of the day, and that means we also move into the final Q&A session. And for that, I kindly ask board of, sorry, I was about to say board of management. On the margin, of course, Claus, and Henriette is next to you, so it's also about, but still you have a flat expectation. Margin. So can you talk a little bit about, you know, of course, a lot of can explain what we would like to spend the money on.

What we have been doing is that we deliberately pick the right range, and that's, of course, because right now we are around the 19%, and we will stay with that for the next couple of years, at least until 2025. That's also because now we have finalized our big thing comes in, then, of course, there could be a change to that. But it's just to say, what have you built into the plan? This is what we have been in for the next couple of years, and then you can count on right now, somewhere around the midpoint in our plans right now, we have put in. If you're going to go to the 15%, it will be in the end of the strategy period as we see it right now. It depends very much on which business activities, business, license activity.

Michael Novod
Managing Director, Nordea Markets

Thank you very, very much, Michael Novod from Nordea. Question to Peter: Could you talk about how you see the approval of omalizumab or XOLAIR in food allergies? Very, very impressive data, generics to XOLAIR in a couple of years.

Per Plotnikof
VP of Corporate Communications, Investor Relations, and Strategic Planning, ALK

So maybe, Henriette, if we give you a mic, you can talk a little bit more about it. Thanks.

Henriette Mersebach
EVP of Research and Development, ALK

Yeah. So you're absolutely right. Omalizumab have been on the market for quite a number of years and got a very attractive label. The potential of omalizumab, as we see it, is that it has the ability to target more than peanut allergy. So anticipate that they will primarily target patients with more than one allergy, so the same patients as we will target with the peanut SLIT-tablet. The benefit is actually that we also, with AIT, will be able to combine those two treatments. But really more that there will be ability also to combine those treatments and actually serve more patients in that.

And again, depends on if you are targeting symptoms or actually also targeting more disease modification. So of course, for us, it's it is a great enabler to have such a big player. If they decide to invest into food, again, we don't know how much they, they really would do this due to the, you know, patent running out, but clearly that would be great.

Speaker 17

The growth trajectory for the tablets, portfolio considerations of period, and that could change your cost structure going forward. Thank you.

Peter Halling
President and CEO, ALK

No. I can answer and then anyone else can join me. And I think the answer is pretty clear. At the current stage, we have a lot of things we need to execute on short- and medium-term, and we also have good ideas for where the pipeline is going to take us, but we still want to see work. We have a company that needs to deliver on the ambition we set out for 25, and we are also starting to invest more in building additional assets into the pipeline. So we felt it was prudent to do it and not go with a seven- or eight-year strategy and bind ourselves.

Per Plotnikof
VP of Corporate Communications, Investor Relations, and Strategic Planning, ALK

Any final questions at this stage? O therwise, I would like to say thank you to the ELT team, and I'll hand the word over to Peter for a closing remark before we end.

Peter Halling
President and CEO, ALK

Excellent. Great day. It's been a lot of hard work, so a big thank you to the team and everyone else involved, but also to all of you for participating. So just a few concluding remarks. I think it's important to state that ALK is about continuing the journey we're on. We have so much more to do. I think that you're all clear by now that the potential in allergies remains substantial. ALK's position is strong, but we also have a lot more to do. We realize it, and this plan is behind it. So we will continue to focus on the pillars of the strategy: focus, innovation, optimization, and cultivation. And by doing that, we'll be able to reach so many more people, children, and patients out there that need our products.

So just a few things to be absolutely clear, this company is committed to creating shareholder value and value for people and patients, globally. We are gonna continue to focus in on strengthening our leadership in AIT. Tablets will be a core driver for the business going forward, and we will invest in markets where we can see that evidence-based products and medicines will have trajectory going forward. We'll continue to innovate. We'll be very clear in terms of we'll have a disciplined approach to capital allocation, including how we build the pipeline. So we are gonna continue to invest in the pipeline, and we're gonna continue to invest in our leadership position, the tablets. We are gonna invest in the close adjacencies, including food and anaphylaxis, and we are also gonna explore, as I've said many times, new therapy areas.

But we realize that we need to do it in a diligent way, so we don't get carried away and spread ourselves too thin. So disciplined is core. Claus alluded to it and said he liked the work. So do I. I think it's important. And then it's about ensuring that we, as a company, continue to optimize, continue to reduce the complexity, so we enable ourselves to scale this company and make it a lot bigger. We've been growing, but we also know that there are many things we can address internally to optimize this company, free up resources, allow employees... in our infrastructure, but also moving away from markets, products, and activities that are not generating the expected return.

And then finally, we'll continue to build on the culture, and we'll continue to pursue on the sustainability agenda we set out, whether focusing in on creating a stronger global organization, diverse and international mindset, but also ensuring that we're delivering on our commitments on the sustainability side. And then we wanna ensure that we have a competitive set up because we know there's a lot more we need to do out there, and we'll focus in on it. So hopefully, you're all pleased with what you see, and hopefully, you all agree that, yes, we've made a lot of progress, and yes, there's still a lot to do. We wanna reach 5 million patients in the next seven years, and we are firm believers that we can do it with this strategy. So with that, I'll say thank you again.

Thank you all for joining here and online, and then, we're looking forward to seeing you all in the coming quarters. Thanks.

Per Plotnikof
VP of Corporate Communications, Investor Relations, and Strategic Planning, ALK

Excellent. Thank you, Peter. And just a final remark from me before we stop this part of the session today. So thank you all for joining both to the 60 people in the room, but also to the 200 people that have been following this webcast throughout the day. Have a bite to eat. We hope to talk to many of you there. If you have follow-up questions, you know our numbers are. We are always open to receive your calls and questions. We will answer as quickly as we can, and with those words, I would also like to say thank you and thank you for all the good questions and dialogue today. Thank you so much.

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