Appreciate it. My name's Ben Jackson. I'm from the European Biopharma team here at Jefferies. I'm joined by the ALK team today. We've got Claus with us and also Per, Head of IR. We're going to jump straight into the questions, I think, but if I hand over to you just to give a brief summary of the business, just for anyone who might be a little bit newer to the name, and then we'll dive right in.
Yeah, thank you so much, Ben, for the invitation, and hello to all of you. Just to the ones that do not really know us, then, of course, ALK is a specialty pharma company that is based within the allergy space. This is where we are and have been for now more than 100 years. We are mostly located in Europe. We have our headquarters in Denmark. We have 70% of our sales in Europe, 15% in North America, and 15% across the world. It is within the allergy space, so it's very much today the respiratory allergy, so what the allergy reunites, so basically everything that is up here that you have. That's the pollen allergies, the grass allergies, the house dust mites, and so on.
We are the company in the world that have the kind of the broadest portfolio of the respiratory allergy vaccines in immunotherapy, where actually we are today covering also now all the age groups, and we can come back to talk about children later. Now we can also actually support children living with allergy for better lives. The earlier treatment paradigm was very much about the whole injection space or drugs, but ALK has over the last 10 years developed our portfolio of tablets, which of course is much better from a convenience point of view, but especially if you're talking about letting go of 60 shots-70 shots over three years, then actually take tablets instead, one tablet a day is much more convenient and actually helps equally good. That's a little bit about us here, I think, as an opening statement.
That's great. Let's start at a group level and then work into the product categories a little bit more. In your Allergy Plus strategy, which is what you announced, I think it was about this time last year now at the Capital Markets Day, you're looking at about 10% top line growth or over 10% top line growth, perhaps. What are the key drivers to that growth that you're seeing going forward? Is there anything you could particularly point to that may enable you to perform significantly above that range?
You're right. We came with our new strategy, Allergy Plus June 24. With that Allergy Plus strategy, we also came with new long-term financial targets, stating that we are going to grow the business more than 10% in CAGR over the years towards 2028, and we are going to reach a margin, EBIT margin of 25% here in 2025, which we have been working on for several years, and we would like to keep that towards 2028. You're right about the 10% on the top line, that is where we would like to aim. There's no doubt that if you look at the growth drivers in the company right now, then of course the tablet vaccines are the ones that are driving it. The next steps that are really adding to it is that we got the children indications.
We have actually been now having the tablet business for grownups, for adults in most markets across the world, 46 markets, and that has been working well. Now here, just before Christmas, we got it for the house dust mite tablet for children and adolescents for children, and then we got it for the Etruscus, the tree pollen tablet here in the spring. That actually means now that we are unlocking now a potential of many more patient groups because we can now, before we were for the grownups, and now we can actually add from children and adults. Remember that if you look at the respiratory allergies, there is probably around 500 million in the world that are suffering from it. There is around 50 million that is suffering from what you call moderate to severe that actually should be in some kind of treatment paradigm from us.
The rest, luckily enough, they can do with antihistamines, they can do with nasal sprays and so on, but the rest should actually be in some kind of immunotherapy. If you look at it today, then there are actually around 100 million children suffering from respiratory allergies. Unlocking that potential is actually going to be one of the growth drivers we have. The second growth driver is, of course, within anaphylaxis. We can talk more about that, but especially our collaboration with AIS Pharma about Nefy is one of the other growth drivers that could add to the top line, and you will see that over the next many, many years.
That makes sense. When we're talking about CGARs, obviously it's interesting to know how you see whether we front weight this, we back weight this, or see it steady. What kind of shape are you looking at growth there, considering that, as you've said, you've got the child indications coming on now, you've got the ARS, the adrenaline that we're going to talk about in a second, and then right at the end of there, we're thinking about moving into food allergy as well. How do you see that shaping up?
I think there's no doubt that if you look at ALK and where we would like to be, we are a growth company and we want to stay a growth company. That means that we want to deliver the 10% or above year- on- year, and we want to be a profitable company at the same time. That's our starting point in this. You're right that we have been able to grow over the last six, seven years, actually more than 10% a year, and we have been able to improve our EBIT margin over the last five years, actually coming from 0% five years ago up to now, hopefully 25% this year. If you look at that top line and the 10% growth, as you say, then we have been able to grow that.
What we would like to sustain is, of course, the plus 10%, adding first with the children indication, then hopefully also adding now the Nefy deal with AIS Pharma, and then move into the food allergy in the end of the strategy period, so when we come to 2029, 2030. We do not have any kind of ambition about growing either faster, sooner, or later. We would like to continue that smooth growth,1 0%+ year- on- year. That is what we are aiming for and continue to do, not just in a few years, but actually on the long-term horizon.
That makes sense. Look, let's dive into the tablets because we're there anyway, and we can come back to a little bit of the financials at the end if we've got time. Look, European tablets, I think, is where a lot of the investor focus is at the moment. It was a driver of multiple guidance upgrades last year. What are the indicators you've had in this year's initiation season that gives you confidence that European tablets are continuing to grow at a good rate?
If you look back in 2022, that was where we had this quite horrible year when you look at the initiation seasons. If you actually look at 2023, it was actually a very strong year, and that was what we saw in the European tablet sales last year. There is no doubt that the European tablet sales, and you're completely right about that, that is our main growth driver. As you said, 70% of our sales is in Europe, 50% of the company sales is actually in tablets. When you combine tablets and Europe, you have the main growth driver and the important part. Last year, we actually were growing these more than 30% in Europe on the growth in tablets, and we could actually see that half of that was volume growth and half of that was some kind of value component.
The value component, price increases, less parallel trade, and these components. The interesting part is actually the volume component because that is very much driven by new patients' initiations coming in. After 2022, where we did not have a strong year, we had a very strong year in 2023. 2024 is what we call a more normal year. A normal year in our world, that is good enough, so to speak. That is good. That is actually, if we want to deliver on our long-term ambition, then that is what we need to do. If you look at the initiation season last year, then it was above these 10% new patients coming in, 10%+, and this is what we need to sustain. We remember we have this very interesting business model where, of course, people stay on treatment for three years.
That means that every three years, basically the patient, they cannot drop off. Every three years, of course, we need to get new patients in and make sure we do that. To have that cycle running, we need more than 10% new patients year on year, and that we delivered on last year, which is good for the next years to come.
Yeah. You touched on pricing, so I'm going to pull you back to it now. What are you expecting for pricing this year? Is there anything that you want to specifically call out with what's going on at the moment?
We're in a situation right now, you're completely right. Last year, as I said, we had a situation where we were in what I call almost a perfect positive storm on the pricing environment. We saw it in Europe, especially. We saw it with the German rebates that we have been impacted by the year before that actually went away last year. We saw it with many price increases in different markets, which we are constantly working on to get, but it takes time, and very often we work two, three years on actually getting those price increases. Last year, actually, several of those kind of came into the same year. We also saw less impact from parallel trade, and we even saw product mix where we sold more tablets in the highest priced markets versus the low priced markets. That helped us a lot.
If you then look at 2025, we came out of a very strong Q1 here with more than 20% tablet growth, which is, of course, very good and where we would like to be. I think it's important to say that that was mostly purely volume growth and then a little bit of stocking. Right now, we actually do not see any price components in 2025. Neither positive or negative, which is good for now. That does not mean that it cannot come. We constantly follow the German rebate situation. We know all politicians are looking into finding some kind of price cuts or rebates. If you look into the next at least in 2025 within the guidance, then we do not really see anything coming.
For the positive, we are constantly working on getting price increases, and I will be the first to let you know if we get one of those.
Sounds good. Look, as you say, one key performance, very strong growth. Again, the focus, I think, a lot for a lot of investors at the moment is these launches for the pediatric indications that you pointed out. How are you anticipating that playing out this year, and what's the initial feedback that you're getting on the launches from what you've seen so far?
If I do right, there's no doubt that we are very eager to help children living with allergy and with the recent approvals we got. We can now see that, as I said before, we have the full space. Basically having the children, the adolescents, and the adults. We got the house dust mite tablet approved for the U.S. market and for Europe and for Canada here just before Christmas. We got the tree pollen tablet for children and adolescents approved here just after here in Q1. That is going to be major growth drivers for us in many years to come. We know that if you, for example, look at Japan, 70% of all patients there, because there we already have children approved, 70% of new patients there, those are actually children.
That has something to do with the fact that we know from research that grownups, it actually takes us seven to 10 years to see a doctor the minute you actually are getting hit by allergy because we're like, no, I can live with that. I take another season, let's wait and see. The minute children actually get impacted by allergy, you have to live with allergy. Normally, the parents take them to the doctor right away, and normally they can start treatment very fast. The other thing that is very important is the children actually, they stay on the treatment for the full period versus sometimes grownups that have a tendency to drop off along the way.
There's no doubt that the children indications that we have now got, and with the more than 100 million children out there in the world suffering from respiratory allergies, this is going to be a growth driver for us for the many, many years to come, also into the 2030s on top of what we do today.
Very clear. Look, we're in the U.S., so I'm going to touch on the U.S. tablets very briefly. I know it's not necessarily a massive focus for you at the moment, but could you just very briefly remind us why U.S. tablets aren't something that a bigger driver is Europe? And then perhaps what we're seeing on a more recent trend basis with regards to this year.
If I do right, it's also a question mark for us why we're not trending better on the tablet business in the U.S. There's no doubt that if you look into the space, then we have a great collaboration with the allergists that are here, and we are selling the extracts, so the injection-based allergies to many of the allergists in the U.S., and we have a good business here for that, and we are having a good collaboration with the allergists. We also have to admit that the setup in the U.S., how it is built today, is that the cash flow is basically following, so the allergists, they are making money on actually seeing the patients as it stands.
That means that it sometimes can be more difficult to get in with the tablet business because there you actually only need to see the patients a few times, and then the patients can actually take the tablets at home. That has been a bit of a challenge in the U.S. to get into that. We have to acknowledge we work a lot with the allergists, and a lot of the allergists have actually changed their prescriber habits to the tablets, but it's not fast enough compared to what we would like to see.
What we have been doing, especially in the last couple of years, is that we have also focused now on the pediatricians in the U.S. because when you talk to them today, they are basically referring the children to the allergist, but with the approval of the children indication, pediatrics for children, then they can actually start to subscribe and actually treat the children that they see in their clinics. What we have been doing now, especially now when we got, for example, the house dust mite approval here before summer, is that we are focusing even more on the pediatricians, and we are actually even hiring people and focusing in on that.
It's too early to conclude if that's going to be the big driver, but there's no doubt after working in the U.S. for many years with the allergists, then opening up an extra sales channel into the pediatrician is, of course, something that we would like to leverage and invest into. If we can see that this is going in the right direction, then we would like to invest even further into that.
Yeah. When we think about actually Europe as well, we also think about your partner, Torii, who is currently undergoing a bit of a manufacturing capacity expansion. Have you got any recent insights to how that is progressing and how that addresses the opportunity? Also, when we consider their recent potential acquisition by Shionogi, is there any insights you can provide there with regards to whether that could accelerate any timelines or benefit the business on your side?
You're right. We have had a standing, very good relationship with Torii in Japan as our partner for now many, many years, and it's actually a great partnership we have. They have a very strong business over there, which also, of course, then helps us, and they treat many patients. They have now, as you said, two things in your question. First, they start with the volume capacity. They have actually had the challenge that they could not deliver to the demand in Japan over the years, especially around the cedar and the house dust mites over there. They have now increased the capacity, and here during the second half of the year, we would actually see a doubling of the API capacity in Japan from Torii.
We have been working very closely with them, and we have now seen that hopefully here at the end of the year, that is also what they have now public to say, they can actually double the capacity in Japan. That, of course, now we need to get it through the whole production chain and with the lead times and everything, and that means that during next year, they should be able to serve many more patients in Japan, which of course is very good. Your second question is very, very interesting also for us, which is Shionogi actually buying Torii from the Japanese tobacco. It is something that we until now see as a very positive thing. We have a great collaboration with Torii, so it is not due to that, but Shionogi is actually a very big company in Japan. They have a very interesting pipeline.
They even have some energy products in their pipeline that we maybe could start to look at to work together around. We have today talked with their senior management in Shionogi, and they are very interested in working with us and collaborate continuously as we did with Torii. There is no doubt that they see this as a potential growth driver in Japan, and they are very interested in hopefully expanding the collaboration. We see this until now. We have to be careful, of course, but with the signals we have seen in the collaborations and the talks we have had with senior management in Shionogi, we see this as a very, very positive thing that have happened and also for the Japanese patients.
Very reassuring on our side as well. Let's switch up the pace a little bit to anaphylaxis then and move on to the Nefy deal, which is obviously this needle-free option for adrenaline to address anaphylactic shocks. Could you remind us what the timeline is for the initial launches of the product and what you see as the cadence of those launches as well?
Yeah, you're right. We have this, we believe it's a very strong collaboration. Our AIS Pharma here in the U.S. that have developed the new nasal adrenaline spray, which was approved by FDA last year. We have a collaboration, so we basically made the license deal where we could now take all markets in the world except U.S., China, Japan, and Australia. We are, of course, working very diligently on this. Europe has been approved, so for now, for us, it's about negotiating the prices, and we are in that process right now. If everything goes well, we will start to see the first market in Europe, and that's Germany, being launched here around summer or just after summer. You will start to see European markets being launched after that as the price negotiation continues. That's the plan.
The two other markets that are very important to us, that's the U.K. and Canada. Right now, we are in regulatory negotiations with both the U.K. authorities and the Canadian authorities. If everything goes well, we should have the Canadian approval here during the autumn and then launch just before Christmas, and the U.K. here after summer, and then hopefully launch that in the autumn also. If everything goes well, as we see it right now, then it's Germany around summer, then U.K., then Canada, and then you'll see a list of countries that we will launch in going forward from there. Very, very exciting to be part of this journey.
Yeah, certainly something to look forward to as well. I guess when we originally spoke about the product, we talked about two things about the opportunity. I think one is the overall growth of the anaphylaxis market as a result of the entry of this, and two is the share that Nefy could take as a result of being the needle-free. Could you talk to us where the confidence comes from for those two points from your side?
Okay. I think when you talk about the whole anaphylaxis space, I think it's very important to understand that when you are with an allergy, it's very important also to focus on that sometimes people actually get those anaphylaxis shocks. Here we're not talking about people feel a little bit dizzy or anything. We're talking about a real risk of dying here. We see that, unfortunately, it is, of course, very, very sad. It's very important that we make sure that everybody that is in the risk of actually getting an anaphylaxis shock, and we are talking about potentially 20 million in Europe and 20 million in the U.S. that are at risk of doing that. We know today that people are not really carrying around with an injection pen, adrenaline pen as it stands today. Very, very few people actually have it.
If they have it, we also know they use it very late because it is actually quite, it could be quite scary if you have not tried it before to actually use an injection, and you have to put it into the muscle, into the thigh, and keep it there. That is the whole injection versus the nasal part as we talk about. Now, of course, if you imagine you have to put a needle like that into a child instead of being able to use a little nasal spray that can do exactly the same. That is, of course, one thing, and that is why we believe that the nasal spray will be transformative within the adrenaline space. The second, and some other arguments are that if you look at the pen market today, then basically the shelf life is very short.
It's not heat stable, so if you put it into a car, you can basically throw it out. It has been in the sun for a long time, where the new products, the Nefy product, it actually has a long shelf life, two and a half years, and it actually also is heat stable. It actually means that you can use it in many more places. You can have it in your boat, your house, your car, your school. You can have it wherever you want to have it, and it's easy to carry around with. I think these arguments are hopefully what will make this a transformative within the whole anaphylaxis space. We believe there's still room for the injectables for a long time. Remember, we also have an injectable, and we hopefully will launch Genesis, the next generation of that here in 2028, 2029.
We will still have that in our portfolio, but there's no doubt in our mind right now that you will see that it will be the other parts, the non-injectable, that will drive the growth in the market and start to take market share. There will still be space for the injectable, but over years, it will be, we believe, the nasal spray that will win.
Yeah, that makes sense. That makes sense. Look, we have to touch on the recent U.S. deal with ARS as well with regards to building out a bit of a pediatrician sales force there. Could you talk to me very briefly about what the rationale was for that and also how the costs can be integrated into this 25% margin? That's probably where we get a lot of questions these days.
Yeah, I can do that. It's very interesting that ARS Pharma, again, has chosen us as a partner. It speaks something about the close collaborations we now have, and we have really started to work closely together on the first deal. Now we kind of made our second deal here that we are very appreciative about them, and we believe they also are. What we have decided together is that we will help them visit all the pediatricians. We have identified around 9,400-9,500 pediatricians that we will take the responsibility over the next four years to actually visit and detail Nefy to those. The deal we have made is that we have actually been out hiring approximately 60 people. We already have them on board since we signed the deal, so it's there.
We have the sales management on board, and we have already started detailing it in the U.S. as we speak. It's a very strong deal for us, you can say, for the, and then I'll come back to the cost part. If you look at it from a strategic point of view, yes, the financials in it are interesting. We'll cover that in a second, but it's actually more the strategic intent that is here very interesting for us. As I talked to you about just a second ago, we would like to spend much more time on the pediatricians in the U.S., and we try to do that with the tablet business. We also have to acknowledge that there are limits to how much feet we can put on the ground and pay for to actually visit those pediatricians out there.
With this deal, we can now, over the next four years, visit 9,400 pediatricians and take responsibility for those. We can build relationship, and then after a certain period of time, we can also talk about our tablet business. That is number two argument why this is interesting because we would like to also take that part when we visit the pediatrician. Number three is remember that if everything goes well, we should hopefully be able to launch the peanut tablet for people with allergic reactions towards peanut at the end of this, so around 2029. That is very interesting because that will also be for the pediatrician, especially for children here in the U.S.
Making this deal with ARS means that we can actually build up over the next many years a strong relationship, hopefully with many thousands of pediatricians detailing Nefy, but then also talking about our tablet business. When peanut comes in some years, we have already laid the ground because we were going to hire some of those people anyway in 2027-2028 to be prepared for the launch of peanut. Now we can actually do that already now as a step into that. Just to answer your question about the finances, you are right that there is a cost-sharing model. Basically, it costs in rounded numbers around $15 million to actually drive this every year, this sales force, and we have a share model. They pay a good part of this, more than half.
That actually means, again, that when you look at the total cost for us, we actually get access to 60 people, to these 9,500 pediatricians for quite low investments over those four years. We are going to make hopefully some sales contribution. We have a model where we get something when we deliver more than a certain market share, and we also get this cost sharing. All that for us is actually booked in the top line. We will get over the next four years something there, and that will help us, and it can in the outer years be very nice for us. The reason to do it is much more the strategic intent than actually the financial numbers.
That makes sense. Look, you touched on peanut allergy, so I think we'll spend the last few minutes there if that's all right. We're expecting the part two of the phase I/II in the first half of 2026. Talk to us a little bit about what would be clinically relevant to see in that study and then also how that translates to what the peanut allergy tablet should look like to be able to be an attractive offering for patients.
Do we want to take the peanut? Mr. Peanut. Yeah, he's our expert on peanut.
So right now, we're running a peanut development program, which is currently in phase II. We had quite a supportive phase I data reading out last year on a couple of occasions. On the back of that, we initiated the phase II study with 125 patients where we look at different doses of the drug up against placebo, and of course, with the intent to see a clear proof of concept of the drug. On the back of that, we will design and finalize the phase III study, which of course will be much larger, but we'll also have selected the dose, the updosing steps, the treatment duration, et cetera. Hopefully on the back of that, we can submit a registration application and get it approved.
Optimally, in order to be successful with the drug, I mean, what we're looking for here in phase II is a clear signal in terms of efficacy that we do see a meaningful responder level with the active patients. Then, of course, we will be looking to optimize that further in phase III. It is going to be the first time we actually see, to put it in layman terms, we see whether the drug will actually work. For us, it is a super important signal. As you say, H1 next year is where we get the proof, and then we take it from there. Super exciting. Peanut allergy, food allergy in general, still being one of the big unsolved mysteries in the broader allergy space.
We are talking about a patient group here that is super sensitive and needs to be taken care of in a very diligent way. Today, they have extremely limited treatment options, and they rely heavily on avoidance and carrying an EpiPen or hopefully a Nefy going forward. There is a real big unmet need for actual treatments that can help take them out of the danger zone so that they are not at risk of essentially dying when exposed to even tiny amounts of peanuts in the world. It is a big focus for us, and it is a big strategic area for us in the hopefully next many years from now.
Yeah, makes sense. Look, with the final question, we've got just 60 seconds to our challenger to answer it. Thoughts on obviously M&A and BD at the moment, given that you've currently done a couple of partnerships, growth going well, what's your thinking around that? Is there more opportunities to explore?
Yeah, there's no doubt about that. We have decided in our allergy plus strategy that BD is a key vehicle for us to actually grow the company. We are in a situation right now where we have no debt. It will be gone here in Q2, even after we invested into the Nefy deal and paid DKK 1 billion in upfront there. We will be in a situation again where we have no debt, and that actually means that we have some financial muscle to actually look into BD activities. We would like to do that both within the kind of commercial space, but also, of course, within the R&D space. I think it's important to say that the BD activities we are doing is something that hopefully should give us a top line or top line very quickly.
That is what we would like to do, and we will continue to focus on that and invest into that over the years to come.
Perfectly timed. Three seconds to spare. Well done. Look, it has been great having you both. Thank you so much for attending. Thank you all for joining us on the fireside chat. If you have got any questions for either myself or the team, please do feel to reach out. Otherwise, see you later in the day for the rest of the fireside. Thank you.