ALK-Abelló A/S (CPH:ALK.B)
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May 6, 2026, 3:32 PM CET
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Earnings Call: Q1 2026

May 4, 2026

Per Plotnikof
Head of Investor Relations, ALK-Abelló

Hello everyone, welcome to this presentation of ALK's Q1 results. Thank you all for joining us. Let's turn to slide number two with an introduction to the speakers and the agenda. My name is Per Plotnikof. I'm Head of Investor Relations, and with me are CEO Peter Halling and CFO Claus Steensen Sølje. Peter and Claus will walk you through the highlights, markets, product trends, and financial. After a strategic update where we'll focus on peanut allergy, our respiratory tablets, and the neffy rollout, we will turn to the full year outlook. As usual, we will end the call with a Q&A session. To get started, I'll hand you over to Peter on slide three. Please go ahead, Peter.

Peter Halling
CEO, ALK-Abelló

Thank you, Per. Thank you all for taking the time to listen in to this call. ALK had a very solid start to the year with revenue and earnings comfortably exceeding the upper end of the full year guidance range. EBIT grew by 22%, yielding a margin of 32% on the back of an 18% revenue growth to DKK 1.8 billion. For the first time ever, ALK's total tablet sales exceeded DKK 1 billion in a single quarter. The results were furthermore supported by an improved gross margin, reflecting some seasonality in the sales mix with a relatively high proportion of European tablet sales, which carry higher margins. As guided, we expect this to somewhat normalize over the year as partner-related revenue increases.

On the strategic side, the pediatric tablets are now marketed in the majority of our key European and North American geographies, and they are increasingly contributing to the inflow of new patients. Anaphylaxis sales also performed well, especially supported by JEXT. It is still early days regarding neffy sales, but we continue to develop market access, and we have secured further regulatory approvals. Starting with the 2 mg approval in Canada, an important market going forward, and the 1 mg version in the EU for younger children, also an important segment. Both we expect to have first launches in the second half of this year. On April 20th, we announced the long-waited phase II results for our peanut allergy tablet. The successful completion of the trial is very encouraging and a first proof of concept of our tablet technology in food allergies.

Based on the strong start of the year, we have upgraded the full year outlook. First, I'll hand it over to you, Claus, for the regional trends on slide four.

Claus Steensen Sølje
CFO, ALK-Abelló

Thanks, Peter. Let's take a closer look at performance in the regions. In Europe, revenue was up 19%. Germany, Europe's largest AIT market, delivered a strong double-digit tablet growth, and tablet sales in France also grew by double digits, maintaining the positive trend of recent years. This partly compensating for lower SLIT-drops revenue in France. We also saw high double-digit growth in several Eastern European countries, and in the U.K., where ACARIZAX and ITULAZAX were admitted to the NHS last year with general reimbursement. In EU, sales of anaphylaxis and other products increased by 47%, with the anaphylaxis portfolio in isolation up 58%. The main driver was JEXT, benefiting from high replacement rates in the U.K. and earlier tender wins in Southern Europe. EURneffy revenue was still modest, as we are building access in many markets, including the U.K.

We still expect to see increasing uptake over the course of the year. Revenue in North America increased by 16% in local currencies, driven by a double-digit growth in both the USA and Canada. This was fueled by a strong demand for tablets in Canada for all brands and age groups. In the USA, revenue benefited from the cost compensation arrangement with ARS Pharma related to the co-promotion of neffy. In international markets, revenue grew by 17% in local currencies. The growth reflected the timing of product shipments to China and Japan. SCIT shipments to China saw a substantial increase compared to Q1 2025, when these were on hold during the renewal of our import license. In Japan, we have been through a period of soft growth due to phasing of shipments, capacity constraints, and the new owner standstill during the completion of the takeover of Torii.

In-market tablet sales recorded by Shionogi grew by double digits, and we may remain comfortable that our full-year tablet revenue growth from international markets will reemerge to double digits, supported by Torii's expansion of API manufacturing capacity. Let's continue on slide five for the product lines. As Peter mentioned, we reached quite an impressive milestone in Q1. We are proud to have reached DKK 1 billion in tablet sales for a quarter for the very first time. In Europe, recent quarters have delivered approximately 20% growth in tablet sales, but Q1 saw 26% growth, mainly driven by higher volumes linked to a continued strong inflow of new patients over the past year. Sales of all tablet brands grew by double digits, and the highest growth contribution came from ITULAZAX and ACARIZAX, increasingly driven by the relatively new indications for children and adolescents.

Tablet sales also grew by 26% in North America, while international markets by contrast saw a 17% decline following fewer product shipments to Japan, partly offset by the double-digit revenue growth in the minor tablet markets of Southeast Asia, the Middle East, and Australia. SCIT and SLIT-drops sales were up 15% to DKK 566 million. SCIT shipments to China resumed after being paused last year, and growth in European SCIT sales was mainly driven by venom products. Conversely, SLIT-drop sales were down in France as mentioned. Sales of anaphylaxis and other products increased by 31% with very strong growth in anaphylaxis-related revenue driven by JEXT auto-injector. neffy also contributed to this growth. Global growth in anaphylaxis alone sales was 84%. Let's turn to slide six for the financials.

Revenue increased by 18% in local currencies to nearly DKK 1.8 billion on double-digit growth across sales regions and product lines. The gross profit of more than DKK 1 billion yield a gross margin of 69%, an improvement of 2 percentage points driven by higher sales volumes, changes to the product mix, and production efficiencies. ALK branded products with higher margins accounted for a fairly high proportion of sales in Q1. However, for the rest of the year, the share of partner-related revenue with lower margins is expected to increase. Capacity cost increased by 23% in local currencies to DKK 658 million after significant investments in current and future growth initiatives, including additional sales resources, as we mentioned during the Q4 earnings call.

The operating profit improved by 22% in local currencies to DKK 570 million, raising the EBIT margin to 32% from 31%. Progress was linked to higher sales and improved gross margin, while the capacity cost to revenue ratio increased slightly to 37% in line with our forecast for 2026. The net profit increased to DKK 437 million. Cash flow from operating activities was DKK 761 million, mainly driven by higher earnings and changes in working capital. Free cash flow was positive at DKK 671 million. All in all, a very strong set of results impacted by operational leverage and some seasonality, supporting a high gross margin versus the full-year guidance.

Now let's turn to slide seven for the peanut allergy results and then to the state of our other strategic initiatives. Please go ahead, Peter.

Peter Halling
CEO, ALK-Abelló

Thanks, Claus. We are very encouraged by the positive results from our phase II ALLIANCE trial of the tablet for treatment of peanut allergy. This is an important milestone, and as I said in the beginning, the first proof of concept for ALK's tablet technology in food allergy. The trial demonstrated clear dose-dependent and statistically significant efficacy across multiple clinical endpoints, and it is the first time ever anybody has demonstrated a convincing treatment effect with AIT in food allergy after just six months of treatment. Obviously, we are also thrilled about efficacy being observed across all age groups from children to adults. Importantly, the treatment was safe and well-tolerated with low discontinuation rates and no treatment-related anaphylaxis or serious adverse events.

Based on these results, we will rapidly advance the peanut tablet into phase III clinical development, which we expect to initiate in the late part of 2026, pending regulatory feedback on the trial design. The FDA's Fast Track designation for the program will hopefully support a constructive dialogue with the agency. Let me just add a quick overview of the unmet needs we are addressing. Peanut allergy is an immune defect where even tiny amounts of peanut protein can trigger dramatic and immediate reactions, including life-threatening anaphylaxis. It typically begins in early childhood and often continues into later life. It is one of the most severe food allergies and a leading cause of anaphylaxis. Today, more than 10 million people in Europe, the U.S., and Canada live with peanut allergy, and over 3 million of them are children and adolescents. Treatment options remain limited.

For some of these patients, sublingual immunotherapy tablets may become a relevant option with the potential to improve quality of life for patients and their families. As part of our broader food allergy portfolio approach, we've also seen positive and encouraging progress on ALK-014. ALK-014 is a biologic candidate targeting the allergic immune response system. This project could potentially enter clinical development in 2027 and may be applied to food allergy as well as other IgE-mediated allergic diseases. In other words, an anti-IgE. Now let's continue to slide eight for a closer look at the execution of other areas of our Allergy+ strategy. Firstly, let me just give you a brief update on our strategic initiatives in the respiratory area and anaphylaxis. Starting with respiratory allergy, the pediatric tablet rollout continues to perform well.

By end of Q1, the house dust mite tablet was launched in 21 markets, including North America, and the tree pollen tablet in 13 markets. Key performance indicators remain strong. More than 4,000 prescribers in our directly served markets have now prescribed at least one or two tablets to children. Around 20% of these doctors have not prescribed any ALK tablets before, which indicates that we're expanding our prescriber base in existing markets. With tablets now launched in the majority of key markets, the focus shifts to increased penetration and sustained prescriber adaption. We also continue to progress our partnerships. In China, ACARIZAX phase III patient recruitment has been completed, with the trial expected to finalize around the turn of the year. In Japan, the GRAZAX phase III trial is progressing towards completion in early 2027.

Let me spend some time on neffy. First, on regulatory progress. In Q1, the European Commission approved the 1 mg version of EURneffy for children aged four years and older, weighing between 15 kg and 30 kg. We expect the first launches from the product in the second half of this year. This was a milestone as EURneffy is the first and only needle-free adrenaline treatment in Europe, now available in two dose strengths. In addition, the 2 mg version was approved in Canada in April, with launches expected just after the summer. Beyond approvals, we are working intensively on market access, going through the grind, so to speak. In the U.K., national approval and pricing was settled last year, but the U.K. is also a market where we need to make sure the product is accessible and reimbursed on a local level.

To actually reach patients, the products needs to be listed among the 42 local formularies across the U.K. We are working through this process systematically, it is expected to continue through most of 2026 and into 2027. While the U.K. represents a large opportunity, the revenue contribution will build gradually from the second half of the year and onwards. An important highlight in the U.K. in Q1 was as new legislation mandating all schools to have readily available adrenaline devices for emergency cases. This legislation maintains or mentions both adrenaline auto-injectors and nasal sprays, such as neffy. In Germany, our first market, neffy is generating revenue and a sound market share has been maintained. Although we are still in the early market-shaping phase, working to change long-standing prescribing habits.

If we look at the U.S., the co-promotion agreement with the ARS is progressing but is also faced with market access hurdles that need to be overcome. More broadly, market access and launch preparation is ongoing in around 17 additional countries. To sum up on neffy, Q1 revenue was modest, as expected, but we do expect an increase in contribution from the second half of 2026 and into 2027 as more markets and regulations come online and are opening up new areas. I'll hand it back to you, Claus, and the full year outlook on slide nine.

Claus Steensen Sølje
CFO, ALK-Abelló

Thanks, Peter. We upgraded the full-year revenue outlook with increased confidence based on the sustained momentum for tablet sales, particularly in Europe, and at the same time we have seen an improved risk picture. We now expect revenue to grow by 13%-16% in local currencies, up from the previous outlook of 11%-15% growth. The EBIT margin outlook is also upgraded and is now expected at around 26%. We are still allocating significant investments to initiatives to bolster long-term growth and profitability. These include commercial investments into tablets, including the children rollout. We are also investing into neffy and expanding the commercial infrastructure in the U.K., Canada, and other markets. Furthermore, we are also advancing our investments into AI. I'd also like to stress that the long-term financial ambitions are currently unchanged. Let me take you through the main assumptions.

We expect volume-driven revenue growth across sales regions and product groups. The lower end of the 13%-16% range reflects macroeconomic uncertainties, including potential negative impact from price and rebate adjustments, even though this has been partially de-risked. It also includes lower growth in SCIT and SLIT-drops sales. The upper end assumes stable price and rebate conditions and potentially upsides for tablet and anaphylaxis sales. As usual, the timing of shipments to international markets may lead to quarterly fluctuations. Tablet sales are expected to grow by double digits. SCIT and SLIT-drops revenue is projected to grow by single digits, while sales of anaphylaxis and other products are expected to grow by low double digits, with an increase in contribution from neffy in the second half year.

The gross margin is now expected to be on par with last year, reflecting the strong tablet momentum in Europe. We still expect a relatively higher growth in partner-related revenue at lower margins in the remainder of the year, primarily from shipments to Japan and China, as well as neffy sales, which also hold lower margins. Capacity costs are projected to increase, but the capacity cost to revenue ratio is expected to be largely unchanged as ALK reinvests the benefit of increased scales into key strategic growth opportunities. To sum up, we expect to continue our trajectory of double-digit organic revenue growth with an EBIT margin which is slightly above our long-term earnings ambitions. Once again, we are very satisfied with the results of Q1 and the current business momentum. With this, I hand it back to you, Per, and slide 10.

Per Plotnikof
Head of Investor Relations, ALK-Abelló

Thank you, Claus, and thank you, Peter. This concludes our presentation, and we will now open up for the Q&A session. Operator, please go ahead.

Operator

Thank you. We will now begin the question and answer session. To ask a question, you may press star, then one on your touch-down phone. If you are using a speakerphone, please pick up your handset before pressing the key. If at any time your question has been addressed and you would like to withdraw your question, please press star, and then two. At this time, we'll pause momentarily to assemble our roster. The first question will come from Thomas Bowers with SEB. Please go ahead.

Thomas Bowers
Analyst, SEB

Yes, thank you very much. Three questions from my table here. just firstly on peanut. Do you believe the high dose that you used in the phase II was optimal given the, you could say the low incidence of adverse events we have observed from that trial? Do you see a scope to push dosing higher into phase III to optimize efficacy or do you think that you already at the current level are close to what you would say at efficacy ceiling? Second question just on remaining risks in regards to the pricing reforms or interim discounts in Germany.

To my understanding, the current proposal is 3.5% discount starting January 2027, you are also still including some risks in 2026 or maybe it's only the macro uncertainties. Is there any uncertainty to timelines here? Also that 3.5%, should we see this as a one-year interim or what's sort of in the planning here? The last question just on ALK-014. First time you've sort of disclosed the target. Should we see this as a potential next generation of Xolair?

Is there anything different with ALK-014 in terms of blocking IgE and also how should we compare this to, for example, ozureprubart from RAPT with the three-month dosing? Anything that can differentiate ALK-014 given that you are a few years behind that? Thank you.

Peter Halling
CEO, ALK-Abelló

Thank you, Thomas. Let me start out just on peanut. I'll have Claus talk about the risks in Germany, and then I'll also comment on ALK-014 in the end. We have been looking obviously at the data and the dosing on the phase II. We believe it's it looks to be at the right range. Could one benefit from higher dose? I think it's it's a matter of looking at dosing and also safety. We feel we are quite in a good place with the current dosing. We do not at this stage, and I'll just underline at this stage, expect to change dosing given the positive results.

What is more important is obviously that we receive good results in only six months. We may benefit from a longer timeline on the phase III trial. I think that's the answer to that one. On the risk, Claus?

Claus Steensen Sølje
CFO, ALK-Abelló

Yeah. Should I just take that? Thanks so much for the question. Let me start by saying that we are only in the beginning of May, right? There could be other pricing risk hitting us during the year that we are not that much aware about at that point in time or this point in time. Let me focus on the German one that you asked too. It is correct that actually last week in the German parliament, they came forward with a suggestion to actually not have any German rebate here for 2026. They let it start from 1st of January of 2027, with 3.5% on top of the 7% that is already there, so 10.5%.

What it also suggested was that that was only going to be for the first half of 2027, and then for the second half of 2027, they didn't really know what to do, but there should more be a percentage that could actually follow something, and that something we don't know what it is. It could, for example, be the price increases or the, or the medical prices in the market. What we are saying right now is that this is still highly uncertain. It's not implemented yet. We do not really know what will happen.

We have heard that there are still voices in the German parliament that believes that the pharma industry are getting off the hook too easy, if I can say it like that, here for 2026, and that there should be something implemented over the second half of the year. We do not know if that is coming, and that's why we are flagging it as a risk and as a potential downside. You are right that right now, it's more suggestion coming from first of January, and then that's it. Whether or not it's a one-year impact, we actually do not know yet. It could be a 2- 3 year. They are not very specific about that.

I will leave it with that.

Peter Halling
CEO, ALK-Abelló

Okay. Thanks, Claus. Just on ALK-014, you asked whether this is a next generation Xolair. I think it's an anti-IgE. Obviously, we are looking at what's in the market, and we're also looking at the data we have available and done in animals. Do remember this is preclinical. We think it's encouraging, and we also think obviously it's encouraging enough that we are considering whether this should move into a phase I. This would be a natural build on in terms of our food allergy portfolio. I promise you, Thomas, we'll be able to disclose more as we progress, but we thought it was important to flag because we know it's a question that has been popping up.

We do have interesting a molecule. It works slightly different than what you see otherwise, but we think it's highly relevant also going forward, not only for food allergy, potentially for more indications given it's a broad anti-IgE. I think I'll leave it at that, and then I'll promise you that we'll come back later in the year when we have a little more clarity in terms of where we stand and when we'll move it forward. If we move it forward, the ambition will be to start it up around year-end and into the new year. That would obviously be a phase I, so focusing in on the safety aspects of the molecule in humans. Good. All right, I hope that answered.

Um, so, uh-

Thomas Bowers
Analyst, SEB

That's great. Thank you. Thank you.

Operator

The next question will come from Benjamin Jackson with Jefferies. Please go ahead.

Benjamin Jackson
Analyst, Jefferies

Brilliant. Thank you for the question. Two topics from me. The first, if I can just follow up on peanut. Hearing what you're saying about the dosing, and you also mentioned, obviously this response is what we're seeing at six months. Perhaps you could comment on what else you think could be done going into a phase III that could perhaps further enhance the results that you're seeing, such as like a longer maintenance or something different in the uptitration phase. Off the back of that, when you're looking at the data that you have in hand now, can you see the response rates improve with time, and therefore there would be reason to dose out for a 12-month period that seems to be more standard, when you look at competitors in this, in this food allergy space?

The second topic, I just wanna touch on M&A a little bit, and potential BD. Generating a lot of cash now, low leverage. Is this becoming a bigger part of your agenda or portfolio decisions going forward? Off the back of that, what should investors expect in terms of the sizing and phenotype of any potential deals that happen? That would be great. Thank you.

Peter Halling
CEO, ALK-Abelló

Thanks, Ben. Peter speaking. I think I ended up with answering both. Yeah.

Claus Steensen Sølje
CFO, ALK-Abelló

Thanks, Ben.

Peter Halling
CEO, ALK-Abelló

No, I think on the peanut, obviously, the breadth and the depth of a phase III is bigger with the, with the prescriber basis, and the population or the cohorts we're putting in. That alone provides us opportunity to optimize further. We obviously learned a number of things in terms of how we can, we can ensure that this is running even better. And that will hopefully help also improve the results, but that remains to be seen. When we look at the maintenance, then we will be looking at something which is likely closer to what you're seeing from others conducting these trials.

We do that because we believe that we'll see even better results than we did in the first part. In terms of the dosing up schemes, et cetera, that's obviously a dialogue also with the FDA in terms of what are their expectations, what are ours. I'll refrain from answering that, but we do obviously think about this also from a prescriber standpoint and from a patient standpoint, so it becomes more efficacious and also easier for all parties involved in terms of running and conducting the trial, but obviously also afterwards where we hope to launch the product. I think we'll do obviously what we can to optimize going forward. The dialogue with the FDA will start hopefully shortly.

Then, as soon as we can, we'll also talk more broadly around how we're conducting and setting up the study design. On the M&A and BD&L, I think that the short answer is we'll announce if, when and if we do more. That being said, yes, we are aware that we're generating cash. We said it all along, this is part of our strategy. We are looking on an ongoing basis, but it's a matter of both price and also relevance for us as a company. I think the good news is, we still have plenty of things to do with our current business, areas to invest in. I'll remind you of what we did at the Capital Markets Day.

Organic growth remains a top priority for the company. Inorganic growth in relevant areas and where we can help expand our portfolio. That can either be in-licensing, it could also be M&A. If something is out there that can help us both from a portfolio standpoint but also from a geographical standpoint, that could be relevant and that we will continue to monitor. I'll promise you as soon as we have something, we will, we'll share it soon and if just to be clear. I cannot get any further into that, but I hope that at least gave you some helping insights.

Benjamin Jackson
Analyst, Jefferies

Yeah, useful. Thank you so much.

Operator

The next question will come from Jesper Ingildsen with DNB. Please go ahead.

Jesper Ingildsen
Analyst, DNB

Yeah, thanks. Yes, thank you. I have a few questions on the food allergy as well, then maybe one on neffy. Just on the ALK-014, you're progressing that into more clinical development. I'm just wondering if you could elaborate a bit sort of, concerning the course related to potentially sort of doing the clinical development around the biologic, such as an anti-IgE. How long you think you'll be able to progress this before having to partner up? I guess especially sort of like in the context of what we've seen in terms of some of the big pharma companies looking at assets in the space, [Technovasi score], for an example just a few weeks ago.

Then on tree nut, I don't see any mentioning of you guys progressing that at this point in time. My understanding was kind of that you were going to progress that on the back of a positive phase II data for peanut. Then lastly, a question on neffy, if we could get an update on the market share you have achieved with that so far. I think it was 18% at the end of 2025. If there's any been any progress. I appreciate Germany is still not the largest market you have the licensing agreement for. I'm just trying to understand why this is still not showing other numbers more material.

Peter Halling
CEO, ALK-Abelló

Sure. Thanks, Jesper. Peter again. Just on ALK-014, do remember this is preclinical. We need to move it, move it forward. When we think about partnerships, et cetera, first and foremost, the key is to ensure we have relevant data that we can take a hard look at and obviously potentially others. I think that would be natural with a phase I. ALK have no intentions of becoming a biologic company as a standalone. That being said, when we have interesting assets in the pipeline and we generate a lot of new knowledge, obviously we also feel it's important for us to take a look at that and progress it.

When we look at trial designs, et cetera, it's not that different from how you would run AIT clinical studies, so we are fairly comfortable around conducting that. The data will tell us whether we believe we need partners or if we can do this on our own. In terms of tree nut is still relevant for the company, obviously we are taking a look at this from a portfolio standpoint and also with the ALK-014, obviously with the peanut trial going into a phase III, we still need to get some feedback from the FDA in terms of what are the expectations for peanut, we can use that to inform us in terms of how should we be looking at something like tree nut.

Bear with us a bit. It's, it's not on purpose, we're leaving it out. It's, it's simply because we need to get through the FDA interactions and kind of get the design on the phase III. That will also inform us on how we should think about peanut potentially, sorry, tree nut potentially. Your question on neffy. Pretty much when we look at Germany, the way we look at it, we will see fluctuations on a monthly basis. We think we've hit a initial plateau. We haven't done a lot to progress market share. What we do like and what we see in the numbers is that we are getting increasing amount of patients on the product overall.

In combination with JEXT, we actually think that our portfolio strategy is working quite well. As we said early on, both Claus and I talked about it, then neffy is expected to go through all the regulatory hurdles, the 1 mg approvals, but also individual in the local markets. Hence, we also believe it becomes more meaningful to talk about the uptake when we get into the later part of 2026, most likely into 2027, depending on the pace. All in all, to conclude, I think we are at a pretty good place initially, but still we are talking low volumes overall, and that's also why we are a little cautious.

Market share remains at a good level, and we are seeing a decent patient uptake. All in all, positive.

Jesper Ingildsen
Analyst, DNB

Thank you.

Operator

The next question will come from Sushila Hernandez with Van Lanschot Kempen. Please go ahead.

Sushila Hernandez
Analyst, Van Lanschot Kempen

Yes, thank you for taking my questions. On the peanut program, is your base case exploring the tablets in 4- 65 year-olds, or is it possible to also go lower? Could you share more color on discontinuation rates in the phase II study? Is there a difference between the age groups? Thank you.

Peter Halling
CEO, ALK-Abelló

Yeah. This is Peter. We are looking at going lower, basically all the way down to one year, to answer your question. Obviously again, depends on the interactions with FDA, but ideally we would. That would be an expansion of the program. You had the second part and you just. Could you repeat, Sushila, on the second part of the question?

Sushila Hernandez
Analyst, Van Lanschot Kempen

Yeah. The discontinuation rates in the phase II study, is there a difference between the age groups? Could you provide more color?

Peter Halling
CEO, ALK-Abelló

Do you know, Per, if I actually don't know.

Per Plotnikof
Head of Investor Relations, ALK-Abelló

We have no further details of this at this stage. This will be presented at a medical. Please remember that the discontinuation levels in general were very low, so we're only talking about a few patients on active treatment and also a few on placebo. It was quite low. It's very difficult to talk meaningfully about discontinuation levels in different age groups. The study is simply too small to do that on a meaningful basis.

Sushila Hernandez
Analyst, Van Lanschot Kempen

Okay, that's clear. Thank you.

Operator

Again, if you have a question, please press star and then one. The next question will come from Peter August Anker with Nordea. Please go ahead.

Peter August Anker
Analyst, Nordea

Yeah, hi, Peter August, Nordea. Thank you for taking my questions. Just a few if I may, maybe for you, Claus, around margins. You're guiding around 25% margin longer term, and now we start seeing 26% and maybe even moving upwards. How should we think about 2026 in terms and beyond in terms of the margin development? Is it just a blip and then you'll come back, or how should we think about that? That's the first thing. Secondly, just I was intrigued around the M&A discussion, so maybe just a little bit more context in terms of are you looking at more transformational deals or just smaller build offs or anything in between?

If you could share any light on that, and then I will spare you for more peanut questions for now.

Peter Halling
CEO, ALK-Abelló

Thanks, Peter. Claus?

Claus Steensen Sølje
CFO, ALK-Abelló

Thanks, Peter. Good to hear from you. You are right that now we have increased to the 26%. Of course, we are not kind of guiding on next year's EBIT margin already now. I think what is interesting to take into consideration is that if you look into next year, we are especially starting the peanut, which is also now peanut phase III trial, so 2027 and 2028. Here we are going to invest significantly into the, to the peanut trials, and that will, you will see an increase there. Depending in all of course also now we talked of ALK-014, where that will go with the preclinical and so on, you could also see increased investments into that.

Overall, the R&D investments will increase. On top of that, then there's no doubt we will continue our commercial investments. Both with the children launches continue to invest into that, but especially next year also the neffy launches across the world. That will be our second parameter also. There's no doubt that next year we will aim for the 25% EBIT margin as we have in our long-term financial targets. That's of course a deliberate decision we are making to make sure that we invest for both top line and bottom line growth in the years to come. I hope that put some flavor to it.

Peter Halling
CEO, ALK-Abelló

Yeah. Peter, as much as I love to talk details around M&A and BD&L, it's difficult to add a lot more flavor. I do think what's important to say though, the way you should think about it, I think we have a company, we still have a number of growth avenues. What we've said all along is when we look across our segments, we think it's relevant to invest in assets that can contribute to a portfolio strategy enabling us to get a strong position globally, including in North America, U.S., Europe, potentially Asia. Ideally, we'll expand.

What we did with the neffy deal was a license deal that gave us a global asset, excluded the U.S. though, and a few other countries, but it actually made a good relevance, or relevant contribution to our portfolio, and that's how we think about it. We obviously also think about it in the food allergy space. If something came up that was relevant in respiratory, we would also be looking at that. We are obviously looking at options. You're also seeing the price points out there and in terms of assets, so it needs to be meaningful for ALK as well. I cannot get more closer than that.

Peter August Anker
Analyst, Nordea

Yeah.

Peter Halling
CEO, ALK-Abelló

It's obviously on the agenda.

Peter August Anker
Analyst, Nordea

Can I ask the other way around then?

Peter Halling
CEO, ALK-Abelló

You can try.

Peter August Anker
Analyst, Nordea

Maybe the answer will be the same. Yeah, exactly. I know. I know. In terms of the cash pile then, because you can say at some point in time, then you will be sitting at, if things goes according to plan, then you'll be sitting at a substantial cash pile. How should we think about that? I mean, at what point in time is it when you start a huge buyback, or is it when you increase the dividend, or how should we think about that in terms of the cash that you'll be piling the coming years, if you live up to your expectations?

Peter Halling
CEO, ALK-Abelló

It's easier for me to talk about how to spend the cash, and Claus likes to talk about how to keep it. Claus, you want to comment?

Claus Steensen Sølje
CFO, ALK-Abelló

Thanks. Thanks, Peter. I think there's no doubt that our... We have said all along that we like to have a disciplined capital allocation. It basically means that if you are looking at our capital structure and how we are looking at this, Peter said it before, we would like to invest into our organic growth. There's no doubt that we will spend as much as we can related to that cash into the commercial opportunities, into the R&D opportunities and so on. On top of that, we also are investing into different areas like in building our manufacturing capacities, where we also right now, for example, can produce up to these 500 million tablets, and we would like to increase to 800 million, up to 1 billion tablets also.

That we are also going to invest into in the years to come. It's correct, we have also said at the Capital Markets Day that we are not a bank. When we have invested sufficiently enough into, you know, top line, organic, into the different facilities, into the BD&L and M&A that Peter is talking to that is difficult to put a number on right now, then if there's anything left, then we would like to return it back to the shareholders. That was what we did this year for the first time, where we now set up a dividend, 30% net profit. Of course, there are other ways of doing that, and you said it yourself, either increase the dividends or looking into share buyback.

That could also be an opportunity, but it's too early to talk about it right now. But we will not pile cash, and we will not be a bank. When we have invested into the future, as we believe is the right thing to do, and if we have concluded there are no BD M&A activities, then we will look into increase the shareholder return. That's the plan.

Peter August Anker
Analyst, Nordea

Much appreciated. Thank you so much.

Peter Halling
CEO, ALK-Abelló

Thanks, Peter.

Peter August Anker
Analyst, Nordea

Thank you so much.

Operator

This will conclude our question and answer session. I would like to turn the conference back over to management for any closing remarks.

Per Plotnikof
Head of Investor Relations, ALK-Abelló

Thank you very much. Thank you all for the good questions. Before we end the call, let me just highlight a few upcoming events on slide 11, and we certainly hope to see you at one of these events. In any case, you are most welcome to get in touch if you have additional questions or comments. With this, we will end today's session. Goodbye, and have a nice day.

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