ALK-Abelló A/S ($ALKB)
Earnings Call Transcript · May 4, 2026
Highlights from the call
ALK-Abelló A/S reported a strong Q1 2026, with revenue and earnings exceeding the upper end of their guidance. Revenue grew by 18% to DKK 1.8 billion, and EBIT increased by 22% to DKK 570 million, resulting in a 32% EBIT margin. The company achieved a milestone with tablet sales surpassing DKK 1 billion in a single quarter. Management upgraded the full-year revenue growth outlook to 13%-16% from 11%-15% and the EBIT margin to around 26%.
Main topics
- Revenue and Earnings Performance: ALK reported an 18% increase in revenue to DKK 1.8 billion and a 22% increase in EBIT, achieving a 32% margin. This performance was driven by strong tablet sales and an improved gross margin.
- Tablet Sales Milestone: For the first time, ALK's tablet sales exceeded DKK 1 billion in a quarter, with significant growth in Europe and North America. Management noted, 'tablet sales grew by 26% in North America.'
- Peanut Allergy Program: ALK announced positive Phase II results for their peanut allergy tablet, marking the first proof of concept for their tablet technology in food allergies. They plan to advance to Phase III in late 2026.
- Neffy Rollout: Neffy sales are still modest, but regulatory approvals in Canada and the EU are expected to drive growth in H2 2026. Management is focused on market access and expects increasing contributions.
- Regional Performance: Revenue in Europe increased by 19%, with strong growth in Germany and France. North America saw a 16% increase, driven by tablet demand in Canada and the U.S.
Key metrics mentioned
- Revenue: DKK 1.8 billion (+18% YoY)
- EBIT: DKK 570 million (+22% YoY, 32% margin)
- Tablet Sales: DKK 1 billion (First time exceeding DKK 1 billion in a quarter)
- Gross Margin: 69% (Improved by 2 percentage points)
- Net Profit: DKK 437 million (Increased due to higher earnings)
- Free Cash Flow: DKK 671 million (Positive, driven by higher earnings)
ALK-Abelló A/S delivered a robust Q1 2026, driven by strong tablet sales and strategic advancements in their allergy programs. The upgraded guidance reflects management's confidence in sustained growth, particularly in the tablet segment. Key risks include regulatory hurdles for neffy and potential pricing pressures in Germany. Investors should watch for developments in the peanut allergy program and further market access achievements for neffy as potential catalysts.
Earnings Call Speaker Segments
Per Plotnikof
ExecutivesHello, everyone, and welcome to this presentation of ALK's Q1 results. Thank you all for joining us. Let's turn to Slide #2 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 Solje. Peter and Claus will walk you through the highlights, markets, product trends and financial. And after a strategic update, where we'll focus on peanut allergy, our respiratory tablets and the EURneffy rollout, we will turn to the full year outlook. As usual, we will end the call with a Q&A session. And to get started, I'll hand you over to Peter on Slide 3. Please go ahead, Peter.
Peter Halling
ExecutivesThank you, Per. Thank you all for taking the time to listen into 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 be somewhat -- 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-milligram approval in Canada, an important market going forward and the 1-milligram 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 20, we announced the long-waited Phase II results for our peanut allergy tablet. The successful completion of the trial is very encouraging and our 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. All of this will be detailed further during the presentation. But first, I'll hand it over to you, Claus, for the regional trends on Slide 4.
Claus Solje
ExecutivesThanks, 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 is 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 the 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 higher replacement rates in the U.K. and earlier tender wins in Southern Europe. Europe neffy 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 double-digit growth in both the U.S.A. and Canada. This was fueled by strong demand for tablets in Canada for all brands and age groups. In the U.S.A., revenue benefited from the cost compensation arrangement with AIS 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. SLIT 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. But in-market tablet sales recorded by Shionogi grew by double digits, and we 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 5 for the product lines. As Peter mentioned, then 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. SLIT and SLIT-drops sales were up 15% to DKK 566 million. SLIT shipments to China resumed after being paused last year and growth in European SLIT sales was mainly driven by venom products. Conversely, SLIT-drops 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 autoinjector. Neffy also contributed to this growth. Global growth in anaphylaxis alone sales was 84%. Now let's turn to Slide 6 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 yielded 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 costs 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. So now let's turn to Slide 7 for the peanut allergy results and then to the status of other strategic initiatives. Please go ahead, Peter.
Peter Halling
ExecutivesThanks, 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 6 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 '26, 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. Now 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 '27 and may be applied to food allergy as well as other IgE-mediated allergic diseases. So in other words, an anti-IgE. Now let's continue to Slide 8 for a closer look at the execution of other areas of our Allergy+ strategy. So 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 1 or 2 tablets to children. Around 20% of these doctors have not prescribed any ALK tablets before, which indicates that we are expanding our prescriber base in existing markets. With tablets now launched in the majority of key markets, the focus shifts to increase penetration and sustained prescriber adoption. 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 '27. So let me spend some time on neffy. First, on regulatory progress. In Q1, the European Commission approved the 1-milligram version of EURneffy for children aged 4 years and older, weighing between 15 and 30 kilograms. 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 2 dose range. In addition, the 2-milligram 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. So 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, and it is expected to continue through most of '26 and into '27. So 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 markets shaping phase, working to change long-standing prescribing habits. If we look at the U.S., the co-promotion agreement with ARS is progressing, but it's also faced with market access hurdles that needs to be overcome. More broadly, market access and launch preparation is ongoing in around 17 additional countries. So to sum up on neffy. Q1 revenue was modest as expected, but we do expect an increasing contribution from the second half of '26 and into '27 as more markets and regulations come online and are opening up new areas. Now, I'll hand it back to you, Claus, and the full year outlook on Slide 9.
Claus Solje
ExecutivesThanks, 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% to 16% in local currencies, up from the previous outlook of 11% to 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% to 16% range reflects macroeconomic uncertainties, including potential negative impact from price and rebate adjustments, even though this has been partially derisked. 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 increasing 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 benefits of increased scales into key strategic growth opportunities. So 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. So once again, we are very satisfied with the results of Q1 and the current business momentum. With this, I hand back to you, Per and Slide 10.
Per Plotnikof
ExecutivesThank you, Claus, and thank you, Peter. And this concludes our presentation, and we will now open up for the Q&A session. Operator, please go ahead.
Operator
Operator[Operator Instructions] The first question will come from Thomas Bowers with SEB.
Thomas Bowers
AnalystsThree questions from my table here. So just firstly on peanut. You believe the high dose that you used in the Phase II was optimal given the low incidence of adverse events you've observed from that trial. So is the -- do you see a scope to push dosing higher in the Phase III to optimize efficacy? Or do you think that you already at the current level are close to what you could say an efficacy ceiling? And then second question, just on remaining risk in regard to the pricing reforms or interim discounts in Germany. So to my understanding, the current proposal is 3.5% discount starting January '27, but you are also still including some risk in '26 or maybe it's only the macro uncertainties. But is there any uncertainty to time lines there? And also that 3.5%, should we see this as a 1-year interim or what's sort of in the planning here? And then last question just on ALK014. So the first time you sort of disclosed the target. So should we see this as a potential next-generation [ Xolair ]? Is there anything different with 014 in terms of blocking IgE, and also, how should we compare this to, for example, [indiscernible] with the 3-month dosing? So anything that can differentiate ALK014 given that you are a few years behind that?
Peter Halling
ExecutivesThank you, Thomas. Let me start out just on Peanuts. I'll have Claus talk about the risks in Germany, and then I'll also comment on ALK014 in the end. So we have been looking obviously at the data and the dosing on the Phase II. We believe it looks to be the right range. Could one benefit from higher dose? I think it's a matter of looking at dosing and also safety, and we feel we are quite in a good place with the current dosing. So 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 received good results in only 6 months. So we may benefit from a longer time line on the Phase III trial. So I think that's the answer to that one. And then on the risk, Claus.
Claus Solje
ExecutivesYes. Should I just take that? Thanks, Thomas, for the question. Let me start by saying that we are only in the beginning of May, right? So 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 at this point in time. But maybe focusing on the German one that you asked to. It is correct that actually last week, then in the German parliament, they came forward with a suggestion to actually not have any German rebate here for '26, but they start from 1st of January '27 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 '27. And then for the second half of '27, they didn't really know what to do, but it should more be a percentage that could actually follow something. And that's something we don't know what it is. It could, for example, be the price increases 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, and 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 '26 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. But you are right that right now, it's more suggestion coming from 1st of January, and then that's it. Whether or not it's a 1-year impact, we actually do not know yet. It could be a 2 or 3 year. They are not very specific about that. So I'll leave it with that.
Peter Halling
ExecutivesThanks, 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. And 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. So 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. So we do have an interesting 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. So I think I'll leave it at that, and then I 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. And 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 answers.
Operator
OperatorThe next question will come from Benjamin Jackson with Jefferies.
Benjamin Jackson
AnalystsTwo topics for 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've seen at 6 months. But perhaps you could comment on what else you think could be done going into the Phase III that could perhaps further enhance the results that you're seeing, such as like a longer maintenance or something different in the up-titration phase. And then off the back of that, when you're looking at the data that you have hands 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 the food allergy space? And then the second topic, I just want to touch on M&A a little bit and potential BD. Generating a lot of cash now, low leverage. So is this becoming a bigger part of your agenda or portfolio decisions going forward? And then 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.
Peter Halling
ExecutivesThanks, Ben. Peter speaking. I think I ended up with answering both. So no, I think on the peanut, obviously, the breadth and the depth of a Phase III is bigger with the with the prescriber bases and the population or the cohorts we are putting in. That alone provides us opportunity to optimize further. We obviously learned a number of things in terms of how 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've seen from others conducting these trials, and 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 of [ schemes ], et cetera, that's obviously a dialogue also with the FDA in terms of what are their expectations, what are ours. So I 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. So I think we will do obviously what we can to optimize going forward. The dialogue with the FDA will start hopefully shortly. And then as soon as we can, we'll also talk more broadly around how we're conducting and setting up the study design. So on the M&A and BDL, I think the short answer is we'll announce 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. So I'll remind you of what we did at the Capital Markets Day. Organic growth remains a top priority for the company and then 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. But 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. So I'll promise you, as soon as we have something, we will share it soon and if just to be clear. So I cannot get any further into that, but I hope that at least gave you some help in insights.
Operator
OperatorThe next question will come from Jesper Ingildsen with DNB.
Jesper Ingildsen
AnalystsI have a few questions on the food allergy as well and then maybe one on neffy. Just on the ALK-014, so you're progressing that [ into the clinical development ]. I'm just wondering if you could elaborate a bit sort of concerning the cost related to potentially sort of doing the clinical development around the biologic such as anti-IgE? How long you think you will be able to progress this before having to partner up? I guess, especially in the context of what we've seen in terms of some of the big pharma companies looking at assets in the space, [ take Novartis ] for example just a few weeks ago. And then on peanut, I don't see any mention 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 positive Phase II data for peanut. And then lastly, a question on neffy. If we could get an update on the market share you have achieved for that so far. I think it was 18% at the end of '25, [ if there's any progress ]. I appreciate Germany is still not the largest markets you have the license agreement for. I'm just trying to understand why this is still not showing the numbers more materially.
Peter Halling
ExecutivesSure. Thanks, Jesper. Peter again. So just on ALK014, do remember, this is preclinical. We need to move it forward. So 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 Phase I. ALK have no intentions of becoming a biologic company as a stand-alone. But 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. But 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, tree nut is still relevant for the company. But obviously, we are taking a look at this from a portfolio standpoint and also with ALK014. And obviously, with the peanut trial going into Phase III, we still need to get some feedback from the FDA in terms of what are the expectations for peanut, and we can use that to inform us in terms of how should we be looking at something like tree nut. So bear with us a bit. It's not on purpose, we're leaving it out. It's basically 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. Then 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 an initial plateau. We haven't done a lot to progress market share. But what we do like and what we see in the numbers is that we are getting increasing amount of patients on the product overall. And in combination with Jext, we actually think that our portfolio strategy is working quite well. As we said earlier on, both Claus and I talked about it, then neffy is expected to go through all the regulatory hurdles, the 1 milligram approvals, but also individual in the local markets. And hence, we also believe it becomes more meaningful to talk about the uptake when we get into the later part of '26, most likely into '27, depending on the pace. But 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. But market share remains at a good level, and we are seeing a decent patient uptake. So all in all, positive.
Operator
OperatorThe next question will come from Sushila Hernandez with Van Lanschot Kempen.
Sushila Hernandez
AnalystsAlso on the peanut program, is your base case exploring the tablet in 40 to 65-year-olds or is it possible to also go lower? And could you share more color on discontinuation rate in the Phase II study? Is there a difference between the age groups?
Peter Halling
ExecutivesYes. So this is Peter. So we are looking at going lower. So basically all the way down to 1 year to answer your question. Obviously, again, it depends on the interactions with FDA. But ideally, we would. So that would be an expansion of the program. Then you have the second part, and you just -- could you repeat, Sushila, on the second part of the question?
Sushila Hernandez
AnalystsYes. So the discontinuation rates in the Phase II study, is there a difference between the age groups? Could you provide more color?
Peter Halling
ExecutivesI will have to -- do you know, Per, if I actually don't know how much...
Per Plotnikof
ExecutivesWe have no further details of this at this stage. This will be presented at medical. But 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. So it was quite low. So 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.
Operator
Operator[Operator Instructions] The next question will come from Peter Hugreffe Ankersen with Nordea.
Peter Ankersen
AnalystsJust 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? So that's the first thing. And then 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 bolt-ons 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
ExecutivesThanks, Peter. Claus?
Claus Solje
ExecutivesThanks Peter, good to hear from you. You're right that now we have increased to the 26%, and of course, we are not kind of guiding on next year's EBIT margin already now. But I think what is interesting to take into consideration is that if you look into next year, then we are especially starting the peanut, which is also how can a peanut matter, peanut Phase III trials. So '27 and '28, here, we are going to invest significantly into the peanut trials, and that will -- you will see an increase there. Depending, of course, also now we talk about ALK014, where that will go with the preclinical and so on, then you could also see increased investments into that. So 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. So that will be a second parameter also. So there's no doubt that next year, we will aim for the 25% EBIT margin as we have in our long-term financial targets. And 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 puts some flavor to it.
Peter Halling
ExecutivesAnd 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, and the way you should think about it I think we have a company, we still have a number of growth avenues. What we 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, but also potentially Asia. But ideally, we'll expand. What we did with the neffy deal, was a license deal that gave us a global asset, excluding 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. And we obviously also think about it in the food allergy space. And if something came up that was relevant in respiratory, we would also be looking at that. So we are obviously looking at options. You're also seeing the price points out there in terms of assets. So it needs to be meaningful for ALK as well. So I cannot get more closer than that, but it's obviously on the agenda.
Peter Ankersen
AnalystsCan I ask the other way around?
Peter Halling
ExecutivesYou can try.
Peter Ankersen
AnalystsYes, exactly. I know. But just -- so just in terms of the cash pile then because you can say at some point in time, then you will be sitting at -- if things go according to plan, then you'll be sitting at a substantial cash pile. So how should we think about that? I mean at what point of time is that -- 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 be piling in the coming years if you live up to your expectations?
Peter Halling
ExecutivesIt's easier for me to talk about how to spend the cash and Claus likes to talk about how to keep it. So Claus, do you want to comment?
Claus Solje
ExecutivesThanks, Peter. I think there's no doubt that our -- we have said all along that we like to have a disciplined capital allocation. So it basically means that if you're 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. And 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 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. So that we are also going to invest into in the years to come. And then it's correct. We have also said at the Capital Markets Day that we are not a bank. So when we have invested sufficiently enough into top line organic, into the different facilities into the BD 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. But of course, there are other ways of doing that, and you said yourself, either increase the dividends or looking into share buybacks. So 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. So 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 to increase the shareholder return. So that's the plan.
Operator
OperatorThis will conclude our question-and-answer session. I would like to turn the conference back over to management for any closing remarks.
Per Plotnikof
ExecutivesThank you very much. Thank you all for the good questions. And 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. And with this, we will end today's session. Goodbye, and have a nice day.
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