Alkello A S Stock

Hello, everyone, and welcome to this presentation of ALK's Q2 and first half year 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. With me today are CEO, Peter Halling; and CFO, Claus Steensen Solje. Peter and Claus will walk you through the quarterly highlights, markets, product trends and financials. After a brief strategy update, we will turn to the full year outlook. And as usual, we will end the call with a Q&A session.

First, I'll hand you over to Peter to the highlights on Slide 3. Please go ahead, Peter.

Thank you, Per, and thank you all for taking the time to listen to this call. ALK sustained strong sales momentum in Q2 with double-digit sales growth across all regions, driven mainly by tablets and anaphylaxis products. Revenue grew by 18% in local currencies to close to DKK 1.8 billion and EBIT increased by 19%. The EBIT margin was unchanged at 25% as gross margin improvements were offset by continued investments in product launches, commercial infrastructure, R&D, AI, and other areas.

Tablet sales again exceeded DKK 1 billion and were up 22%. The tablets with the new pediatric indications for ACARIZAX and ITULAZAX continued to perform well and were increasingly contributing to the inflow of new patients across key markets. We continue to see pediatric indications as a key growth driver for ALK for many years to come. There are still many opportunities in this space.

In China, the local Phase III trial of ACARIZAX is rapidly approaching the finishing line with results expected in Q4 this year. If these are positive, we expect to see an important opportunity opening in China, which is the world's largest house dust mite market. And if approved, ACARIZAX could be launched in 2028. On neffy, we made further progress with market access and launches. We have seen good progress with our total anaphylaxis business in Germany, and we are off to a promising start with neffy in Canada.

I'll be back to this shortly, but I'll mention revenue contribution from neffy in the quarter was still relatively modest and came primarily from Germany and the U.S. This reflects the early stages of the launches and particularly the situation in the U.K. where prolonged formulary approvals and administrative processes continue to impact the full rollout of neffy. The ongoing reform of the U.K. health care system is impacting the pace of market access progress. But nevertheless, we remain very confident in the opportunity in the U.K.

In June, we presented detailed data from our successful Phase II peanut tablet trial at the JACI Congress in Istanbul. The congress was attended by more than 7,000 health care professionals, and we saw strong interest from the scientific community in our progress. Feedback on our peanut trial results was very encouraging, and we still expect to initiate Phase III development before the end of '26 and planning is progressing well, including conversations both with EMA in Europe and FDA in the U.S.

Based on the momentum for tablets, we are updating the revenue outlook. The update also reflects greater transparency on pricing and rebates after Germany passed new legislation, increasing the mandatory rebate on prescription drugs from 7% to 15.5%. This change will take effect from 1st of January '27. It is not expected to have any impact in '26, and we remain confident in the strong growth outlook in Germany and globally for the years to come.

Germany is ALK's largest market, and it accounted for approximately 25% of global revenue in 2025. Hence, we're working hard to mitigate the financial effects of the rebate increase next year. The new scheme came as no surprise, although the size of the increase was slightly higher than what we had indicated earlier. Germany has had changing rebate policies over the past many years, and we had expected the rebate increase earlier.

Consequently, ALK has been preparing for a situation like this and will be implementing initiatives to counter the impact. While not all details are yet in place, including potential exemptions from the rebate increase, it is, however, obvious that health care providers cannot and should not benefit twice from the rebates, and we'll, therefore, seek to carefully rebalance our existing rebates -- sorry, agreements and contracts with the health care providers.

The rebate increase does not change ALK's long-term financial ambitions, and we still target more than 10% growth in the years ahead. Our business platform and market positions are robust and Germany remains an important growth market for ALK. We will continue to execute on our strategy and push forward for strong results in the coming years. Earlier today, we announced the appointment of Jacob Glenting as the new Head of R&D. Jacob joined ALK in 2007 and has worked extensively in the interface between commercial and science. He has been a key architect in several of ALK's strategic developments, including the partnerships with Torii, Abbott, Genexine, and Aravive.

He has been deeply involved in the pediatric expansion and strategy development. Few people know our patients better than Jacob. His background in R&D and with a PhD in vaccines and immunology makes him an ideal leader to drive our innovation efforts. Jacob and the team will do so under the Allergy+ strategy and secure a strong bridge to ALK's commercial operations, including our long-term targets. His job will be to balance core business growth with expanding in existing and new adjacent allergy areas, through our own pipeline, partnerships, and business development and licensing.

Now I'll hand it over to you, Claus, for the regional trends on Slide 4.

Thank you so much, Peter. So let's look at the sales. All sales regions delivered double-digit growth in Q2 and Europe continued to lead the development. European revenue was up 19% in local currencies, driven particularly by tablets and anaphylaxis products. The performance was sustained. Q2 sales growth was identical to growth in Q1.

Tablet sales was up 27%, mainly on higher volumes linked to the strong inflow of new patients during the '25, '26 initiation season. The new pediatric and adolescent indications for ACARIZAX and ITULAZAX remain strong contributors to growth, whereas the contribution from GRAZAX was more modest. Tablet sales grew strongly in most markets in Central and Western Europe, including Germany and France. High sales growth, although from a lower base, was also achieved in Eastern European markets such as Poland, Slovakia and the Czech Republic as well as the U.K., where ACARIZAX and ITULAZAX obtained general reimbursement for adults use last year.

I can add that just a few days ago, ACARIZAX and ITULAZAX for pediatric use received a positive endorsement from NICE in the U.K. Of other positive news, I can tell that in Sweden, the government recently introduced a new national allergy strategy calling for more preventive, effective, and equal allergy care throughout the country. We expect these new guidelines, once implemented regionally, will support more patient in treatments with AIT.

Combined SCIT and SLIT drops sales in Europe increased by 4%, with SCIT growth coming from both venom and non-venom subsegments in Central Europe. Sales of SLIT drops, primarily marketed in France, regained some momentum in Q2 after a weak start to the year.

Sales of anaphylaxis and other products in Europe increased by 28%. Growth for our anaphylaxis products alone was 30%, which also became a key driver behind the 20% market growth in Europe. Our Jext auto-injector continued to benefit from tender wins, strong commercial execution, as well as intermittent competition supply issues in certain markets. And the overperformance by Jext more than made up for the slow uptake of EURONEFFY in the U.K., as mentioned earlier by Peter.

Revenue in North America increased by 13% in local currencies based on continued double-digit growth in both the U.S. and Canada. Canadian tablet sales remained an important growth contributor, reflecting an increasing number of customer touch points and solid demand, particularly for the tree tablet ITULAZAX, which again was boosted by the pediatric indication.

Tablet sales in North America were up 17% with double-digit growth in both Canada and the U.S. SCIT sales was flat, while revenue for anaphylaxis and other products increased by 22%. The increase was linked in part to the cost compensation from ARS Pharma related to the co-promotion of neffy, as well as sales of PREPEN diagnostics and other products. In international markets, revenue grew by 18%, mirroring increasing product shipments to China and Japan. SCIT shipments to China increased compared to last year, when shipments was impacted by the renewal of ALK's import license. In-market sales growth temporarily slowed down during the transition to our new partner, Genexine, but a new sales setup is now in place and in-market sales are expected to pick up in the second half year.

Tablet revenue returned to growth and was up 9% in international market. Japan delivered double-digit growth from product shipments and royalties. Supply from our Japanese partner's new API manufacturing facility for the CEDACURE tablet has reached the market, and in-market sales of both CEDACURE and MITICURE accelerated in Q2. We remain confident that ALK's revenue from Japan will pick up further in the second half year as planned.

Now let's continue to Slide 5 with the product lines. Global tablet sales grew by 22% to just over DKK 1 billion. Sales exceeded the DKK 1 billion mark for the second consecutive quarter, well supported by the pediatric rollout. Europe led the way with 27% tablet growth, followed by North America with 17% growth, and international markets with 9%.

Combined SCIT and SLIT drops sales were up 7% to DKK 515 million, mainly driven by the ramp-up of SCIT shipments to China. Sales of anaphylaxis and other products increased by 26% to DKK 267 million. Sales were boosted by Jext with a growing, but still modest, contribution from neffy.

Now let's turn to Slide 6 and the half year financials. Half year revenue increased by 18% in local currencies to DKK 3.6 billion on double-digit growth across all sales regions and product lines. The gross profit of DKK 2.4 billion yielded a gross margin of 68%, up from 66% last year due to higher sales volumes, production efficiencies, and changes to the sales mix with a higher proportion of ALK branded products with higher margins.

Capacity costs increased by 22% in local currencies to DKK 1.4 billion, driven by significant investment in current and future growth drivers, including product launches, commercial infrastructure, and R&D, not least the peanut and ALK014 programs. Sales and marketing costs increased 25%. 6 percentage points of this increase was due to the U.S. neffy co-promotion cost and the marketing fee to our Chinese partners.

These items had very limited impact on our numbers last year. The operating profit improved by 20% in local currencies to more than DKK 1 billion. The EBIT margin was unchanged at 28% as progress on the gross margin was offset by a slightly higher capacity cost-to-revenue ratio, which we had guided for.

The net profit was DKK 776 million, up from DKK 617 million a year ago. Free cash flow improved to DKK 889 million, driven by higher earnings and changes to working capital, including timing of payables and lower CapEx investments. Free cash flow was higher than expected, which is also why we have notched the full year assumption for free cash flow up. The net debt-to-EBITDA ratio remained negative at 0.6. All in all, another strong quarter and solid financial position with high growth and margin resilience despite extra allocation of funds and resources to growth initiatives.

Now let's continue to Slide 7 for the execution of the Allergy+ strategy. Over to you, Peter.

Thanks, Claus. Let me now take you through some of the Allergy+ initiatives that we have lined up for the near future. Starting with respiratory allergy. The pediatric tablet rollout continues to perform really well and increasingly contributes to the tablet growth. By the end of Q2, the house dust mite tablet was launched in 22 markets, including North America, and the tree pollen tablet in 13.

Key performance indicators remain strong. We had around 4,500 prescribers in our direct served markets that have now prescribed at least one of the two tablets to children. Around 20% of these doctors have not prescribed any ALK tablets before. This indicates that we are expanding our prescriber base in existing markets. Our current focus is, first and foremost, on increasing depth and sustaining prescriber adoption, although we also continue to work on prescriber expansion.

As mentioned earlier, the local Phase III trial of ACARIZAX in China will complete in Q4, followed by an anticipated filing in '27 and potential approval in '28. In Japan, the GRAZAX Phase III trial continues towards completion in '27, with a potential filing the same year. Additional life cycle management activities are expected to follow in the years ahead, aimed at further building the value proposition of our core business. The commercialization of neffy or EURONEFFY in Europe for anaphylaxis continues.

A few days ago, the 2 milligram version was launched in the key Canadian market, bringing the number of markets where the product is available up to 10. The 1 milligram version for younger children was approved across Europe, including the U.K., while approvals of the 1 milligram version are pending in Canada and other markets.

Market access processes -- sorry, market access processes are ongoing in several places, and we are planning many additional launches over the next half year, allowing us to start building a more sizable neffy business in the years ahead. As mentioned in my opening remarks, we made good progress with market access in Canada, both with the public health care providers and the commercial plans.

And the initial launch feedback looks promising, even though still early days. We've also seen good progress with our total anaphylaxis business in Germany. Since the beginning of '25, we have doubled our market share, which is now close to 50%, driven by both Jext and EURONEFFY. This happened in the context of the market growing approximately 20% in '26.

We have been able to grow EURONEFFY sales during the period and maintain a sound market share even during the recent peak season. Jext has also benefited from tender wins, which is a major part of the German market. Finally, on food allergy and new disease areas. In just a few months, we plan to initiate the pivotal Phase III trial with the peanut tablet. Preparations are well advanced.

We have initiated a positive and constructive dialogue with the relevant authorities on the Phase III plans. And, subject to their final feedback, we expect to go live by the end of the year and include patients from both sides of the Atlantic. Moreover, as part of our broader food allergy portfolio strategy, we are also seeing positive progress with ALK014, a biologic drug candidate targeting the key mediator of allergic reactions. We expect to enter clinical development in '27. This program may be applied to food allergy as well as many other IgE-mediated allergic diseases.

In the beginning of next year, we also expect to see interim data from ARS's Phase 2b trial with neffy that is asserting rapid relief of acute flares associated with chronic spontaneous urticaria, a potentially very interesting add-on to ALK's product portfolio. So, all in all, work continues to strengthen existing revenue streams and build new ones. We look forward to sharing progress on these and other initiatives.

Now I'll hand it back to you, Claus, and the full year outlook on Slide 8.

Thanks, Peter. We decided to raise the lower end of the revenue outlook range. We now expect revenue to grow by 14% to 16% in local currencies, up from the previous outlook of 13% to 16% growth. The EBIT margin is still expected at around 26%. This clarification reflects the continued strong momentum for tablet sales, particularly in Europe, combined with lower risk related to price and rebate adjustments after it became clear that the German rebate increase will not take effect until next year. We expect volume-driven revenue growth across sales regions and product groups.

Tablet sales are expected to grow by double digits across regions, with children and adolescents projected to account for a growing share of the sales. Combined SCIT and SLIT drop sales are anticipated to grow by single digits, while sales of anaphylaxis and other products are expected to grow by low double digits. As usual, the timing of shipments to China and Japan may cause quarterly fluctuations. The gross margin is now expected to be slightly higher than last year due to positive volume and mix effects, although these will be partly offset by growth in lower-margin partner-related revenue.

Capacity costs are still projected to increase as we continue to reinvest scale benefits into strategic initiatives. Disciplined capital allocations and careful prioritizations remain key to us. We now expect free cash flow to further improve and exceed more than DKK 1 billion, partly driven by optimized CapEx investments. So, to sum up, the business momentum remains strong. We expect to continue our trajectory of double-digit organic revenue growth for the eighth consecutive year with an EBIT margin slightly above our long-term financial ambitions.

So, with this, I hand it back to you, Per, and Slide 9.

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

[Operator Instructions] Our first question today comes from Ben Jackson from Jefferies.

I guess, first of all, can we talk a little bit more about early thoughts into 2027? And I guess more of the focus here is this kind of cryptic messaging that you're giving around the potential for 2027 mitigation of those German rebates. I guess it's probably a little bit about contract-like flexibility with contracting, inflation adjustments, maybe even this idea about how you construct clinical trials. So any thoughts on -- or more detail on that mitigation? And then, perhaps more broadly, how we should be thinking about the top line build into next year? It's early, but it's useful for us.

And then secondly, if I could just ask for a little bit more color on the dynamics around neffy, please, particularly just a bit of commentary about how Canada has initially gone, where you are at with market share in Germany now versus when we last caught up. And then the outlook, and when we should see U.K. becoming a bit more meaningful here given the headwinds that are currently there to slow down the initial launch?

Thanks, Ben. Appreciate it. So let me start out, and then Claus and Per can jump in and supplement. So, first on '27. As you know, we are not guiding specifically on a given year, but I'll give you some high-level thoughts around where we're heading and specifically around how we see the German market. I think, overall, we continue to see Germany as a key growth driver for ALK going forward.

It has been a strong contributor to our double-digit growth in the past years, and we expect that to continue going forward. As you also know, we've been talking about the German rebate and the expectation that it would go up in the past years. And we have all along been planning for how to tackle it.

Obviously, there is a commission now coming in place in Germany. And they have been tasked with the fact that the 15.5% rebate, what would potentially be allowed for exemptions to that rebate. So, we are attacking it from a couple of fronts. One is, if we look at the rebate as it is constructed and potentially with the exemptions, it may be that we can actually use the number of clinical trials with German patients to lower the rebate.

Currently, we don't know whether that is going to be included, but this is part of the discussions in the committee. Moreover, there has been less clear discussions around manufacturing in Germany, R&D in Germany, et cetera. But what it tells us is that there will be levers going forward that may allow a company like ALK to lower the amount we pay in the rebate. The other part of the rebate is that, basically, the way it works in the German system is that we pay a rebate directly to the German health authorities.

As part of that, they send it directly to the insurers. We also have direct contracts with the insurers coming from the other angle, where we are also negotiating a certain amount of rebates. Now, what we are expecting is that this type of double-paying a rebate from two angles is obviously something that we will look into and something we feel can be negotiated with the German insurers, and that can also help us mitigate the rebate.

Thirdly, on an internal front, we've known this for a while that the rebate would come one day, and now it's in '27. First and foremost, it gives us more clarity. We know where we stand, and we also know how to approach it. That means that we have been looking at what are the initiatives that we may or may not continue with in which form. And that allows us to make clear choices quickly and implement them.

And then, finally, I'll say, do remember that ALK has been growing above our long-term targets. That has allowed us to also invest ahead of the curve. And that means that we have been able to make commercial investments quicker than what we've done or been able to do based on our earlier projections. And that allows us also to invest in markets like Germany, and we've been doing that for a period of time. And that also gives us a strong basis going forward.

For instance, the TAV -- so, basically, the move from unregistered products to registered products is ending towards the end of this year, meaning that prescribers and patients will need to transition from unregistered to registered products. That gives ALK a strong opportunity with our portfolio to capture some of that business going forward. So, that also gives us opportunities we haven't had in the past when we look into '27.

So, just to give you an idea of how are we actually intending to mitigate some of this and how do we look at the market going forward in Germany. Last comment on Germany. We see this as a core market in Europe. We look at this market as a market with a lot of growth potential going forward. The rebate will only come once. It might be changed going forward one way or the other, but German remains, as it has been, a key country in ALK's portfolio.

So, hopefully, that gave you a little bit of flavor on that one, Ben. Then on neffy, you asked about whether we could comment a little more on Canada, Germany, and the U.K. I can start out, and then I think you guys just jump in. I think it's early days in Canada. But what we are encouraged about is that some of the market access challenges that you could potentially see in a market like Canada, which is, to some extent, similar to the U.S., we've not been facing.

We found a way to mitigate some of this with patient programs. And that also means that it's an easier flow. And from the patient standpoint, when you acquire or when you get a neffy, you don't experience some of the same market access issues you've seen in the U.S. with rejections. So, we have a clear flow-through. That has been positive, and that's something we've seen also with the pull-through from the wholesalers into the pharmacies. So, overall, a good start. But do remember that we are basically, more or less, 3 or 4 weeks into the launch, but a good start.

Germany, I think, it's a very good example of a market where you have less market access restrictions. It's a market where we've seen, when neffy can flow freely in, it has a pretty solid adoption rate. Now, why are we then stalling a bit? It's twofold. One is, part of the German market is a tender market. And there, we've been very pleased to see that our focus on neffy and our focus on the anaphylaxis portfolio, including Jext, have enabled us to also win tenders in Germany, and that has given us a stronger portfolio and a stronger overall business.

The other part of it is that, normally, in Germany, you also see peak seasons typically in advance of the summer. And that's where we were interested in seeing whether neffy would maintain its market share, and it has been maintaining its market share.

This is typically where you see a lot of the auto-renewals. So, that's also been a positive driver in Germany. Now, we're also realistic around the German market. A fair portion of the German market is still general practitioners that prescribe auto-injectors. And there, we need the guidelines to come in place.

That means update of guidelines. So, basically, neffy or a nasal device is on par with the auto-injectors also from a guideline standpoint, and it takes time. This brings us, obviously, to the U.K. And on the U.K. market, we must admit that we had not anticipated the complexity of a health care system which is under reform.

As Claus also said at the call, and we also said earlier today, we remain very optimistic around the market. There is no doubt that it is a very well-received product. In the U.K., patients, patients are organization, doctors, and even authorities are positive around it. Now, our challenge is not only getting on the formularies but also having the budgets in place and then getting updated on the lists on the local hospitals. That has taken longer than what we had expected, and it's been complicated by the fact that we are moving from 42 regions to 26 regions in the U.K., and we have had downsizing and also cost-budget reforms on top of it.

That has slowed the progress. But it doesn't take away from the fact that the U.K. remains one of the biggest markets for anaphylaxis products, and we believe neffy has a very strong place in that market going forward. It's a matter of time. Claus, Per, anything to add? I hope that gave you some insights.

Our next question comes from Thomas Bowers from SEB.

A few questions from me here. So, maybe just kick off with the peanut project. So, you mentioned a positive dialogue with the regulators. So, should I understand this to be a dialogue with the FDA and EMA? And maybe are there any early conclusions on the TD versus ED endpoints that you have at this point already? And what are, sort of, the remaining gating factors before you can start the study here in the fourth quarter?

And then, second question, just on the full year guidance. So, right now, with a super strong Q2 number here, you implied, sort of, to reach the middle of your updated growth guidance, you imply 13% for H2.

So, what actually prevents you from raising the upper end of guidance today? Is it primarily the uncertainty for the initiation season? Or is it mostly the timing of shipments to international markets? And then, maybe just lastly, just on pediatrics. So, can you give us a little bit more color on where you actually are with the pediatric rollout for ACARIZAX and ITULAZAX? So, I know it's probably still a bit early, but where are we, sort of, percentage-wise of the total prescriptions? I remember ACARIZAX being around those 30% to 40% of prescriptions in Europe or Germany. So, are we getting, sort of, close to that number, or is it still far off?

Thanks, Thomas. Let me kick it off quickly. I'll hand it over to Per. And for the full year guidance, Claus, maybe you can also comment on the peds, and we can jump in as needed. So, on the peanut Phase III, yes, we have had meetings both with the FDA and EMA. And I think we've had a very constructive dialogue with both. What we're really happy about is that they have confirmed that they also think that we have had solid Phase II data.

So, we are confident moving into Phase III. We still need to submit and have final approval for the trial designs before we can move into it, but we remain optimistic around going into Phase III towards the end of the year. So, all in all, good dialogue, but we need to finalize it. Per, you want to comment a bit further on the peanut?

Sure. As to the exact trial design, it is still too early to conclude, as we are still negotiating the details here. Once we have the trial protocol approved by the authorities, we will communicate to the market, and that is expected to happen later this year, and then we initiate the study also later this year. But it's a little bit too premature to have detailed discussions about the trial design before the authorities have approved it. So, that's where we are on that one. Claus?

Full year guidance.

Thank you. Full year guidance. Thanks, Thomas, for the question. And you're right that we had a strong first half with the 18% growth. And we are, of course, looking into now a half year where we are then mathematically expecting somewhere between 11% to 15% growth in the second half in local currencies. I think it's important to state that we still expect a very strong underlying business momentum to continue. So, that's basically not the case, and we are not looking into anything related to the underlying business here. I think there are three things that are worth noticing.

First of all -- please bear in mind that we are up against some tough comparisons versus the second half of last year, where our revenue grew by 18%, especially tablets and Jext in Europe. So, this is the comparison we are up against. And then, you are right that you mentioned it yourself, we have key swing factors for second half, is always the timing of shipments to international markets, Japan, and China. And those could be a swing factor, and we would like to get a little bit further into the second year before we start to conclude on that.

And then, thirdly, our initiation season. We are actually coming out of, as you know, two good initiation seasons back in both '24 and '25 that are also fueling our growth this year. And this is, of course, good, and it will continue to do so. We are expecting a nice initiation season. We still can only look at the early signals from the spring, and that's looking good. But we also have to be a bit cautious here, and we find it prudent to wait until we understand how this initiation season starts one, two months from now.

So, when we know more about that, then we will, of course, as soon as we can see something, report it out. But for now, we believe it's the right thing just to wait a few more months to see where the second half is going. I hope that puts some flavor on that.

Claus, you also want to comment on the peds.

Yes, I can do that on the peds. We are very satisfied with what we are seeing. We have said that a few quarters, actually. We are right now in 22 markets for ACARIZAX and 13 markets for ITULAZAX. We are seeing that the children are taking a larger and larger share of our share growth. And if you look at it from a new patient point of view, then we can see that we are approaching 30% of new patients being children.

We have said at some point in time that we would like to get up to 50%. So, we are approaching that very well and as expected. So, very nice development, and we can only say that we continue to see positive trends in that, and as expected, and very positive. So, that's good.

Our next question comes from Jesper Ingildsen from DNB Carnegie.

Three questions. So, first, on the gross margin, you delivered a strong gross margin again in Q2. Just help us understanding the phasing in the second half. So, now you're guiding for a slightly higher than last year gross margin. But considering normal, sort of, like seasonality, I assume that it will have to improve from Q2, but just help us square that compared to the full year expectation.

I understand, obviously, there's a bit more partners mix, perhaps, in the second half, but is there anything else you could help us better understand that dynamic? Then, on the international market tablet sales, you saw very strong growth here in Q2, again, helped by always new manufacturing facilities being up and running. Just help us understand what the expectations are for growth here into the second half.

You were alluding to some of the shipments you normally have, but this seems to be, like, very strong in Q2. Could we get any flavor on the underlying demand in Japan and what potentially the efforts of Shionogi would potentially add to that acceleration once they finally get the confirmation for the takeover of Torii?

And then, maybe just finally, on capital allocation. Anything new you can share there? What's your current view, particularly, sort of, on BD? Are you still, sort of, like looking for smaller bolt-ons? Or what are you particularly looking at in the market right now? And what would require you to -- what would trigger you to start looking at distributing some of this excess capital to investors?

Thanks, Jesper. So, I'll let Claus kick it off with the gross margin. I can talk about the international tablets. We can talk jointly around the capital allocation. Claus will talk mainly on the CapEx. I'll talk about the BD. So, Claus?

Yes. Thanks, Jesper, for the question here. You are right that our gross margin is actually higher than what we had expected at this point in time. Remember, when we guided last year, we had actually expected higher shipments to both China and Japan, but also higher partner sales, as such, over the year. Thereby, we actually said that you should expect to see this one to two percentage point down on the gross margin this year. Now, we have changed the guidance for that. Now, we are looking at slightly higher compared to last year, and that is very much driven both by that our manufacturing colleagues are doing a very good job.

We are looking into good scrap. We are following the efficiencies in the manufacturing sites, but also that we are now seeing delayed shipments into China and Japan, and that will impact that. The in-market, I think it's important to mention, is actually continuing in both China and Japan very well. Peter will cover the in-market sales also in Japan. But from a gross margin perspective, then, it's the shipments that are postponing it a bit to the second half of the year.

And that's why we also say, where we are now, then, we expect more to have visibility in the second half on the gross margin, and we will end this around -- yes, a little bit better than what we did last year.

And then, when we look into the second half of the year, we are seeing higher tablet sales in Europe also, and this will also bring up the gross margin there. So, we should expect full year a little bit better than what we did last year. And this is, of course, a quite significant upgrade compared to when we were six months ago guiding for the full year.

And I think, Jesper, on the tablets for international markets, particularly Japan, we continue to see a really strong underlying demand in Japan. The in-market sales continue well, both with MITICURE but also CEDACURE. And especially as more API becomes available, it's a matter of meeting that demand. So, I think we expect this to continue. And there, it's really important that we have the full supply chain in order where we can make the shipments on a timely and also to a larger extent that we've done in the past, in order to meet that demand. So, we look positively at Japan and the in-market growth.

Secondly, on the partnership with Torii and, soon, Shionogi, I think it's important to say Shionogi has still not fully vested the MA -- so, the marketing authorization -- that they currently have. And that also means that there is a split between the Torii business and Shionogi. We are talking to Shionogi, but we are talking to Shionogi outside of the business we have with Torii.

So, this is obviously always a little more of a difficult position to be in, but it's a natural position when you see some of these takeovers. So, we are waiting until we have full flow in order to have a communication and discussion around the Japanese market in particular. But that doesn't prevent us from discussing what we can do with this partnership and how we can work together going forward. And I will say we are really excited about both the partnership we have with Torii, but certainly also with the opportunity we have ahead with Shionogi. It's an interesting partner. So, I think I'll leave it there. And maybe, Claus, if you talk about the general capital allocation, I could talk about the BD part.

I will do that. So, Jesper, you're right that we are, of course, seeing some opportunities because we are increasing the free cash flow that you have been seeing. We have already explicitly stated that we will be disciplined about our capital allocation. So, we are sure that we ensure both sufficient flexibility to deliver on our growth ambition while we also generate attractive shareholder returns. You can also see in today's report that we are generating increasing free cash flow.

We are even guiding a bit higher than what we did at the last quarter. So, this is also moving in the right direction. We will continue to allocate capital in the order we have said earlier. First, investments in organic growth, including the R&D area. Second, business development and licensing activities. Peter can comment on that. And then, thirdly, cash distribution to shareholders via dividends and/or share buyback programs.

And that's, of course, also why we resumed here our dividend payouts earlier this year. And there's no doubt that we will continue also to focus on that. So, this is the -- sorry, the disciplined capital allocation we are following. And number two of those was BD activities, Peter, that we're looking at.

Yes. I mean, we don't have anything specific to comment on. I said it before, but I also think you need to look at it in the context of we believe we can do more on the BD side, but we want to do it for the right opportunities. And we're going to do it with, as Claus said, a disciplined approach, but also with regard to our long-term financial targets, including EBIT and including what we said in terms of how we're going to allocate to the R&D function.

So, we continue to monitor the market. We continue to look for opportunities globally. But especially, we'd like to find something that could also be relevant for the U.S. market. So, we continue to work on that angle. And I promise you, if and when we find something, then we will make sure to communicate it based on what we can do there. So, I think it's as close as we get to that one. I hope that gave you some answers, Jesper.

Yes. But we're still talking, sort of, like, mostly bolt-on BD rather than transformational -- or how are you looking at that at this point in time?

We are not looking at -- it depends on how you define transformational, but we are not looking at changing this company fundamentally in any way.

Our next question comes from Peter Hugreffe from Nordea Markets.

So, Claus, I'm sorry, I would like to go back on the implicit second half because you very kindly answered so much questions around the top line. But I guess an implicit 3% to 8% growth on EBIT maybe warrants some explanation of what will take you to 3%, because right now, at least, I fail to see that. So, could you help us with some building blocks around that? And then, just a small follow-up on -- just on the capital allocation. So, can I just understand: when is it enough in terms of piling cash?

Now it's DKK 1.7 billion. I'm just curious to understand when is it that you, kind of, see -- and I respect your dividend payment. And then, just finally, the hire of Jacob Glenting, congratulations on that. Can you just, kind of, in addition to just, you can say, what you mentioned on the strategy -- I mean, are you going back to a bit more, kind of, ALK classic? Or what is it that we are -- we should expect with this mix?

Thanks, Peter. I'll let Claus answer on the second half and the margin growth. Again, on the capital allocation, we can split it. "When is enough enough?" I like that phrasing. And then, obviously, I'll talk to Jacob as well. So, Claus, do you want to kick it off?

Yes. I can do the full year. And thanks, Peter, for the questions. And you're, of course, right -- before, I only touched upon the top line. If you look at the bottom line and the EBIT there, then we continue to have that very nice growth, 20% for the half year. As we stated, we are still guiding this around 26% -- how can that then be? What is it for building blocks that we are then, kind of, invested into, with sales doing good and gross margin also improving?

There are a few things that are important to notice. First of all, we continue to invest into both the children launches and especially the neffy launches. These two are great opportunities for the company in the long run, and we will make sure that we keep investing into that. That also means that if we find, you can say, pockets of money where we can actually see that we can invest even further into secure the organic growth over the many years to come, then we would like to do that.

And if we get those opportunities, for example, with some extra investment opportunities and money, then we would like to do it. And then, also on the R&D part, here, we have, of course, the peanut, as we just talked about before. Here, we are doing everything we can to speed it up as much as possible. The positive -- the dialogue with the FDA and EMA is positive.

And that also means that we feel confident that it's the right thing to do to invest as much as we can into the peanut trial as fast as possible. Of course, we should not do it with head on our arms, but when we can see it makes sense, then we do it. And besides that, then, we're also starting up to invest into ALK014, our own anti-IgE. So, we have some big bets: two commercial, two R&D, where we have an opportunity in the second half of this year to increase the investments.

And this is the building blocks to keep the 26% EBIT margin. Should I just add also on the -- just high level on the -- when it's enough enough, it's a good one. I think we will steal that one. Of course, there is no right or wrong answer on that one.

But we are, of course, also debating internally when is enough enough. As Peter alluded before, and he can add a little bit more again maybe on the BD. But of course, we would like to make sure that we have opportunities, also financially, that if there is anything we find, then we can actually quite fast react on it.

And that means that where we are right now, we would like to keep that flexibility. But it also means that if we do not find anything, then, as we have said before, we do not want to be a bank, and then we will continue, one, with the dividend -- that's the plan. And then, share buyback could be an opportunity. Right now, there are no plans; and, of course, we would inform you about it. But that could be an option if we can see that there are no BD opportunities out there that we would like to spend our cash on. But we will come back to that as soon as we know something concrete.

Yes. Thanks, Claus. I think on the BD side and also on Jacob as new Head of R&D -- I think on the BD side, we will continue to explore the opportunity space. It's important for us to say that when you look at -- when we outlined Allergy+, we know that in the respiratory area, we have a really strong base. We also have a high market share, which limits some of the moves one could envision there. But when we look at some of the other areas, the first one being anaphylaxis, it was clear we could do something on the BD side.

We did it. And I think we had a really good deal with neffy coming in at a very low price, paid off more or less immediately. And now, it's about if we can get this executed, which we believe we can. Then, we have food, and we also have potentially new areas, the example being the CSU with neffy.

But in the food space and also to supplement some of the other spaces, there might be options out there that could help us, as example.

So, we'd like to strengthen this because the thinking and the strategy is a global play opportunity to become a strong number one or number two, with ambition of always being number one, and then with a portfolio, meaning more than one product. So, for instance, in food, currently, we have peanut. And there is an example whether we should do something ourselves internally or if we want to add externally, as examples.

It all boils down to price opportunities, et cetera, and timing. So, that's also why we need to work through some of these things. And it will, by the way, be an ongoing discussion internally. So, ideally, we can meet the investors' needs on all ends. Then, on Jacob, first and foremost, I'm also very pleased, and thank you for noting it, that we found Jacob. Jacob has gone through an extensive process against external candidates, and he came out on top. And, as I also stated, it's because Jacob brings the right type of expertise, both from 25 years in the field, PhD, and R&D background, in a strong combination with an understanding of ALK and what we do and what we need going forward.

You asked whether this was, kind of, back to basics. I don't think ALK had ever left the basics, but I think we look at it as an opportunity with Jacob to strengthen the partnership side, but also to really build a stronger bridge between R&D and commercial and continue to strengthen our position, both in the respiratory space but also in some of these new spaces.

And Jacob brings that expertise. And then, do remember, Jacob has an organization of close to 400 people that are all experts and the subject matter experts, and who have been vital in our success so far. And luckily, I believe all of them are continuing with ALK on top of it.

So, I really feel we have a strong foundation, but Jacob brings something else to the table. And I think he brings that combination that will allow ALK to scale and further build, and become and stay the number one leader in this space. So, super pleased. And hopefully, you will see it soon as well, Peter. So, I hope that, kind of, wraps up the questions.

Our next question comes from Sushila Hernandez from Van Lanschot Kempen.

On neffy, what could the CSU opportunity mean for ALK? And if you opted in after the Phase IIb data, what kind of investments are you looking at?

Thanks, Sushila. So, neffy CSU, as I heard it -- neffy and the Phase IIb. So, ARS is currently conducting the trials. We expect to have the readout in Q1 now. The reason for the slight delay is, basically, when you run the trial, you want, unfortunately, to see at least three incidents from a patient. And luckily, we cannot decide when that happens for each of the patients. So, we need to have the patients to wait for that. So, that is currently being conducted. By the way, part of it is being conducted in Germany. So, we are obviously excited around the trial and the trial results.

Now, in terms of the investments coming from it -- it's too early to say. But we will obviously, together with ARS, depending on the outcome and also the research we've done, figure out how to scale this. Basically, as it stands, this is an ARS investment, with us having the commercial rights outside of the U.S., but we are closely involved. If it turns out and if the business case look as promising as we've seen so far, then we'll obviously work hard to ensure we have the funds in order to commercialize the product as fast as possible. But that will depend also on what are the asks are from the European authorities, authorities in Canada, U.K., and other markets.

So, that remains to be seen. So, first and foremost, we're waiting on the trial outcome. But we are sharing ARS's optimism about the potential. I will say, though, that -- do remember -- there's a difference between what you pay in the U.S. and what you pay outside of the U.S. So, I think the potential outside of the U.S. cannot exactly be 1:1 with what you see in the U.S. Nevertheless, a very exciting product and potential for the future. Did that answer, Sushila?

That's clear. Thank you.

Showing no further questions, I'd like to turn the floor back over to management for closing remarks.

Thank you very much, and thank you all for the good questions. Before we end the call, let me just draw your attention to a few upcoming investor events and roadshows across our three continents. We certainly hope to see you at one of these events. Please also note that we will release our Q3 report on the 17th of November. It was previously planned for the 18th of November. With this, we will end today's session and wish you all a pleasant day. Goodbye. Thank you.

Ladies and gentlemen, with that, we'll conclude today's conference call.

Hello, 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.

Thank 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.

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 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.

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 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.

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% 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.

Thank 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 Instructions]

The first question will come from Thomas Bowers with SEB.

Three 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?

Thank 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.

Yes. 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.

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. 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.

The next question will come from Benjamin Jackson with Jefferies.

Two 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.

Thanks, 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.

The next question will come from Jesper Ingildsen with DNB.

I 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.

Sure. 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.

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

Also 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?

Yes. 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?

Yes. So the discontinuation rates in the Phase II study, is there a difference between the age groups? Could you provide more color?

I will have to -- do you know, Per, if I actually don't know how much...

We 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 Instructions]

The next question will come from Peter Hugreffe Ankersen with Nordea.

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? 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.

Thanks, Peter. Claus?

Thanks 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.

And 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.

Can I ask the other way around?

You can try.

Yes, 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?

It'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?

Thanks, 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.

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

Thank 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.

Dear shareholders, welcome to the Annual General Meeting of ALK. Thank you for taking the time to be with us, both those of you who are here in Horsholm and those who are following via the webcast. I am Anders Hedegaard. I'm Chair of ALK's Board. I'm sorry, I failed to mention that initially. Anyway, the Board has been looking forward to telling you about our development and how we see the future.

We also look forward to have a dialogue with you insofar as you have any questions or comments that you wish to put to us. But before we get to that point, there are some formalities that need to be dealt with. According to the Articles of Association, it's the Board that appoints the Chair of the General Meeting. And once again, we have asked Mr. Niels Kornerup from law firm Bech-Bruun to act in that capacity. You have the floor.

Thank you very much for appointing me Chair of the AGM of ALK-Abello. I hope we'll have a good AGM and a good debate. My first task is to ensure that the AGM has been legally convened and is competent for the transaction of the business of the agenda. Prior to the AGM, I made sure that the notice convening the AGM complies with the legislation and the Articles of Association. And I want to ask if anybody disagrees with me. Otherwise, I will add this to the minutes. It's legally been convened.

Before we started, at the entrance point, we could see there are 74 people here, 39 have voting rights and the rest are invited guests, et cetera. Before we started, I saw that 87% of the votes are represented after deduction of treasury shares, and that makes up 77% of the share capital. The Board has received some proxies and postal votes, which make up 99% of the represented capital with voting rights and 99% of the votes. The final numbers will appear from the minutes of this AGM.

At previous AGMs, we have gone through the Danish Companies Act, and that requires a complete record of the voting, which would be necessary for each vote and each decision unless the AGM decides not to make use of that complete record. We have looked away from that requirement in previous years, and I look at people do you -- if you agree with me to do the same again this year. Thank you.

The people who want the floor, I ask you to contact me with your access card or something else with your name, and then I will give you the floor. And I ask the people come up here to speak from the rostrum. The agenda is on the screen now and has also been sent out. We start with Item 1, report on the activities of the company. Item 2, approval of the annual report and resolution to discharge the Board of Directors and the Board of Management.

Item 3, resolution on allocation of profits. Item 4, adoption of remuneration report for 2025. Item 5, adoption of the remuneration to the Board for the present year. Item 6, election of the Chair of the Board. Election of the Vice Chairs, Item 7. Item 8, election of other members of the Board of Directors. And then Item 9, appointment of auditor. Item 10 is a proposal from the Board of Directors. There's only one. That's an update of the remuneration policy.

And then we finish with Item 8, any other business. With that, we are ready to dive into the agenda proper. And as usual, here in ALK, we'll cover items 1 to 4 as one. And we'll also have the debate for items 1 to 4 as one. So now we have to have the report of the activities, approval of the annual report, resolution of allocation of profits and remuneration report for '25. And with that, I give the floor to the Chairman of the Board, Anders Hedegaard.

Thank you. Now before I get too deeply into the year 2025, which in itself was an impressive year, I think it's worthwhile to dwell a little on ALK's development in recent years. It's been nothing short of impressive. and provided us with strong growth. In 2018, revenue was below DKK 3 billion and the operating profit was negative. Today, we have revenue upwards of DKK 6 billion and an operating profit of almost DKK 1.7 billion.

And this represents an annual revenue growth rate of 12% and an EBIT margin that went from minus 3% to plus 26%. 2025, thus became the seventh consecutive year of growth in ALK revenue, and it's not just growth. It represents a fundamental transformation of the company. The impressive numbers are the result of significant investments in research and development, in markets, in production and in products, especially in our tablet portfolio. In other words, we're a fundamentally stronger company today.

We have a well-documented ability to grow. We have improved profitability, and we have created value for shareholders. In fact, our market value at the end of 2025 was almost 5x as high as at the end of 2018. And this brings me to talk a bit more about 2025 because that year, despite several years of strong growth was new and trailblazing for us. It surpassed our expectations at the start of the year. And I'd like to focus on 3 milestones.

First of all, we reached 0.5 million new patients, which means that 3.1 million people were treated with an ALK product in 2025. That's important. The rise in new patients is a good indicator of future growth. The second milestone is revenue growth. It came to 15% in local currencies and gave us revenue of DKK 6.3 billion. It's the first time we have passed the DKK 6 billion mark, and it was more than we expected at the beginning of the year when the target was growth between 9% and 13%.

And the third milestone is earnings. EBIT increased by as much as 53% and the EBIT margin, as I mentioned, ended at 26% compared to 20% the year before. This meant that we achieved our long-term ambition of a profit margin of 25%. It's a milestone we've been working towards since 2020 when the margin was as low as 4%. And this is a level that we wish to maintain until 2028, while we continue to invest in growth.

Against this backdrop and our solid position in general, the Board proposes to resume paying dividend to shareholders, a total of DKK 355 million for 2025 or DKK 1.6 per share. I'll get back to this later. ALK is present in many parts of the world, and we operate in 3 regions. It's Europe, North America, and then we have what we call international markets.

We have seen double-digit growth in all regions this year, and we see broad and stable progress, which is not driven by one single country or one single product. But Europe remains our largest region. It accounts for 75% of revenue, and this is around DKK 4.5 billion. We grew 18% across the board, including in Germany and France, which are our key markets.

Growth in Europe was mainly contributed by tablets, up 19%, partly from new patients, including children and adolescents, and partly because patients starting treatment previously now make up a larger proportion, and it creates stable growing volume. An important event was that the ACARIZAX tablet against house dust mite and ITULAZAX tablet against tree pollen were approved for children and launched in a number of markets. And this all went far better than we expected.

Another important event was that these 2 tablets were also approved for adoption in the health care system in the U.K., the first allergy tablets ever to achieve this backed with reimbursement. We are continuing our efforts to work to make the tablets more accessible in order for us to help even more patients, including children. The tablets will be our primary growth engine for many years to come.

Injection and drop-based treatments also grew, but on a more modest level in Europe by 3%, partly influenced by the conversion to tablets from the drop-based products. In anaphylaxis, acute life-threatening allergic reactions, Jext was the main growth driver. And neffy, our new adrenal nasal spray, which was launched in Germany last summer, produced its first positive results. In North America, which contributes 16% of revenue, we achieved a sales increase of 19%.

In the U.S.A., we saw the first signs that allergists and pediatricians are starting to prescribe our tablet treatments for children and adolescents. It takes time to build relationships with a wider range of doctors, but we're getting there. We are seeing the first indications of success there. Anaphylaxis and other products grew by 34% in North America, partly thanks to the collaborative effort with our partner, ARS on marketing neffy.

In Canada, there is still strong demand for tablets, and it was supported further by the approval for use in children. In international markets, which account for 13% of revenue, sales grew by 16%. In China, revenue increased as deliveries normalized after the renewal of our import license in late 2024. Partnerships are an important part of our strategy. In China, in the fourth quarter, we transferred the sales and marketing activities for all our products to our new partner, GenSci.

We expect a lot from this cooperation, not least after the launch of our house dust mite tablet. In Japan, the timing of deliveries affected tablet sales, especially in the second half of the year when revenue was slightly down. But our partner, Torii, now part of Shionogi, is seeing strong demand in Japan. So long-term growth prospects remain very good in that country. So in short, 2025 was about good execution and clear priorities.

Gross profit increased to DKK 4.2 billion, and the gross margin rose by 3 percentage points to 67% due to higher volumes, a better sales mix and efficiency improvements in production. In other words, we are seeing clear economies of scale in the business. This gives us room to invest in future growth. Research and development expenses rose by 15%.

Other costs grew significantly less than sales did, which meant that the ratio of total costs to turnover fell to 41%. The excellent operating result meant that we reached a net profit of over DKK 1 billion for the first time ever. For you, our shareholders, it's important for the results to be reflected in the free cash flows. They were positive at DKK 1.4 billion compared to minus DKK 204 million in 2024.

It's this type of cash flow that, together with low debt, allows us to resume paying dividends to shareholders. Our Allergy+ strategy previously launched is now well underway. 2026 is largely about carrying on the good work. But in '25, our focus was clear. We plan to launch tablets for children. And we did this, but it still demands a great deal of commitment across the organization and targeted work with both doctors, patients and authorities in all countries. But the work is bearing fruit.

The biggest part of the increase in treated patients, more than 300,000 came from tablets. And here, children and adolescents now make up a larger proportion of the intake of new patients. Late in the year, more than 4,000 doctors in our direct markets had already prescribed one of our tablets for children. Our partnerships, particularly in Japan, have supported this progress. In '26, we will continue to roll out to children in the markets where we already have a good foothold.

We also expect to launch tablets in new markets, so more allergy sufferers have access to our treatments, including children, adolescents and adults. Within anaphylaxis, we are running the early market rollout of neffy in Europe and in the U.S. And we have collaboration with ARS, which helps extend our reach and our insight into the American allergy market.

The task is clear, neffy has to succeed, and it takes a lot of effort to change the ingrained practice of treating anaphylaxis with needle-based adrenaline pens as was the standard previously. But the potential is great, and the initial feedback bodes well for the establishment of neffy in the long term. In food allergy, our peanut tablet is in Phase II. We hope to be able to publish results from this in the second quarter of this year, and we hope that they will pave the way for a pivotal Phase III study later in '26.

And we are also working with other food allergies, including tree nuts and other new disease areas. Urticaria is one of the allergy-related diseases that we are focusing on. It's a skin disease. It causes great discomfort and new treatment options will be able to make a real difference. In partnership with ARS, we have a program in Phase II, and we look forward with great interest to the clinical results that we expect to see later this year. We also have other strategic priorities in '26 that will hopefully materialize in future.

We're expanding production capacity significantly from around 350 million to 400 million tablets today to upwards of 1 billion after 2030. We are constantly working to improve our infrastructure and our tools, including IT and AI. Finally, we're always looking for opportunities for new partnerships and business development. So overall, we are well on track to achieve our strategic ambitions, and we are on course to help 5 million people a year with allergy by 2030.

Sustainability is an integral part of the way we do business. And we delivered good results in 2025 across our 5 focus areas. The most important thing is the patients. I've mentioned that in 2025, we've treated 3.1 million patients with our products. And even though we are treating more people, we have also reduced our absolute CO2 emissions by 11% since 2022. The goal remains a reduction of 42% by 2030.

Our water consumption has also been reduced by 55% compared to the year before, primarily by the way we rotate crops in our fields that are used for treatment. And we owe you a big thank you to our employees here, but I'll return to that. But it's important to include all parameters, all in the sales, research and development and sustainability. To ensure that executive pay is on a par with comparable Danish companies, the Board of Directors conducts an annual review of the Executive Board remuneration every year.

We look at both the base salary and the total remuneration, and we also assess the balance between fixed, and variable pay to ensure that it falls within the bounds of the remuneration policy and the market standards. It's part of our annual review. And of course, we've also done that in 2025. When we see an increase in remuneration, it's very much because -- in 2025, we firstly looked at our benchmarks and other companies. And there, the base salary for our CEO and our CFO increases by 9%.

And for other members of the Executive Board, we follow the general increase among ALK employees in Denmark. Bonuses and long-term incentives are linked to clear goals, financial targets and sustainability targets. So in 2025, where we have such excellent results, there's also a larger payout of variable remuneration. The full remuneration appears from the remuneration report, which is available on ALK's website. and we'll deal with the Board of Directors under Item 5 in the agenda.

The Board's activity level was high in 2025. We had a total of 10 Board meetings, one of them being a seminar focusing on ALK's growth strategy that was launched in 2024. There were a further 14 meetings in the 3 committees set up by the Board. Throughout the year, we also had a close dialogue with the committees and the executive team. We're also working on other elements of our business development, including capital structure, cybersecurity, AI, international trade and international affairs such as the U.S. and China.

The annual self-evaluation of the Board confirmed that we have a strong commitment and good cooperation in the Board of Directors. And when there are need for adjustments, we make these adjustments. When we look at our ambition towards 2028, our activities reflect that we have a very good company that is run well. And we have an ambition to grow the company with at least 10% towards 2028, and we maintain that ambition. We maintain our EBIT margin of around 25% as our goal.

And if we make more money, we will spend that money on investments in future growth for ALK. In the capital structure, we want the net interest-bearing debt to be at maximum of 2x EBITDA, and we don't want any excess liquidity on the balance sheet. The strong results gave us something specific in 2025, strong cash flows and financial flexibility. At the end of the year, we had a net of DKK 800 million in the bank. That's liquid funds with a deduction of debt.

But financial discipline is at least as important in tailwinds as in headwinds. So we have 3 clear priorities for the liquidity. Our first priority is organic growth. It's about investing where the business needs to grow. both when we look at production capacity, R&D and everything else that's needed to strengthen our market positions. Our second priority is partnerships and business development, commercial collaborations, development of partnerships or acquisitions that can support the strategy.

And our third priority is to give something back to shareholders through dividends and/or share buyback programs. And of course, that's when we judge that we cannot create greater value by investing the money in organic growth or other acquisitions. The point is that the increasing cash flows now give us room to invest and develop the business and also reward our shareholders. On this basis, the Board proposes a dividend of DKK 355 million for 2025.

That's DKK 1.6 per share or about 30% of the net profit for the year. It's an important marker. The dividend reflects our strength right now and the Board's belief that we will continue to create value in the future. In 2025, the ALK share rose by 44%, which means it's more than doubled over the past 2 years. This is significantly better than both the C25 and the global health care stocks that we normally compare ourselves against.

At the end of the year, our market value was around DKK 46 billion, placing ALK among the 20 largest listed companies in Denmark. And we see this as a mark of confidence in our strategy from our shareholders. Finally, I would like to say a few words about our expectations for 2026. We believe in solid growth in revenue and earnings in line with our long-term ambitions. Revenue is expected to grow by 11% to 15% in local currencies, and the EBIT margin is expected to reach around 25%.

Tablet sales are expected to show double-digit growth again due mainly to a larger number of patients, including an increasing proportion of children and adolescents. Sales of anaphylaxis are also expected to see double-digit growth driven especially by our new product, neffy. Injection and drop-based treatments, our legacy products are expected to grow in single digits based on higher volumes in China and better prices in North America, but with moderate growth in Europe, partly due to the switch to tablets that I mentioned earlier.

In contrast to 2025, we expect the gross margin to decline slightly in '26. This is mainly because a larger portion of revenues coming from partner sales where the margin is typically lower. Research and development costs will increase but will remain around 10% of revenue. Sales and marketing costs are also expected to increase. We expect the ratio of capacity costs to revenue to be unchanged in '26.

This is because we reinvest the gains from economies of scale from our existing platforms to ensure long-term growth. Finally, we expect positive cash flow of up to DKK 1 billion and CapEx investments around DKK 500 million. Overall, we enter 2026 in good shape, and we will continue to make progress while investing massively in the future. Now this gives me the chance to say a thank you to everyone at ALK, particularly our employees around the world.

And also thank you to our partners and our customers, of course. They helped make 2025 a year of strong execution and high activity. I'm pleased to see that employee engagement has increased further, and it remains in the top 5% in the international health care industry. This says something about our culture and the will to make ALK a better company.

It's simply about helping people with allergy to live better lives. And that's a goal everyone at ALK works strongly for. With these words, I would like to hand back to the Chair, and I ask you to approve the annual report, the remuneration report and the allocation of profit and to discharge the Board of Directors and the Board of Management from liability.

Thank you. Thank you for the management's report for 2025, the annual report, the remuneration report and also the proposal for distribution of profit. I can inform you that both Board and management have signed the annual report, and there have been no qualifications from the company's auditor. So it's a clean endorsement. I refer you to Page 137 to 140 in the printed version of the annual report.

Also, the auditor has produced a limited assurance report in relation to sustainability, and that also appears in the annual report. As stated, the Board proposes that a total dividend be paid for fiscal 2025 amounting to DKK 355 million or DKK 1.6 per share. And with this, I'd like to open the floor. I had 2 speakers on the list. The first, it represents ATP, one of the major institutional pension funds, Claus Berner. You have the floor, sir.

Thank you. I am Claus Berner Moller. I represent ATP. First of all, I'd like to thank you for the report and the review of the annual report. In 2025, ALK achieved another level of organic growth, 15%, the same as in '24 and an EBIT margin of 25%. That was the target, and it was achieved. It came as high as 26%. The considerable top line growth was contributed, among others, by products in the U.S. and in Europe, where now children can receive the tablets in many cases.

And also, there was considerable growth of 34%, produced primarily by Jext and neffy, and that bodes well for growth in future years. So it's very satisfactory to see the financial performance, in particular, because they have been achieved while also focusing on the long-term value creation. The guidance for next year with organic revenue growth of 11% to 15% and also an EBIT margin that is maintained around 25% is witness of a management that thinks in the long term and is ready to invest in commercial activities, business development and R&D.

The wider pipeline is beginning to take shape. In second quarter this year, we will have the Phase II results for peanut tablets. And it's going to be interesting to see whether we can move on to Phase III. ARS pharma get data from their Phase II study in urticaria later this year, and ALK has the rights to market neffy in the same areas, and that might be an upside in relation to the positive development that we have already seen the first signs of.

When a company grows fast, it's important for the entire organization to be able to hang on and keep in step with the rest of it. In ALK, we have previously seen challenges. So I would like to ask to you about the production setup in this company, 9 production sites, is that the best possible setup? And do you have the right system in place to increase as you have talked about in your forecast? And last, I'd like to say thank you and congratulations to Board and management for the achievements.

Thank you to Claus Berner from ATP. There were a couple of specific questions, and the Chair will now answer.

Well, thank you to Claus. Thank you for showing us so much trust. And I will hand over to our CEO because he will be able to answer your questions concerning the production setup much better than I am.

Thank you also from me to Claus and also thank you to the Chair for allowing me to answer this question. Well, first of all, it's important for us and in ALK's management to make sure that we have a strong and robust production setup. It's a strong focus area, not only for tablets, but for all our facilities. We have a target of doubling tablet production in future. We work together with a partner to ensure that, that happens.

And we are already looking into 2030, where we will be delivering according to plan upwards of 1 billion tablets. The production facilities, well, it's important to say that we are a pharma company. And in a pharma company, we are subject to a number of regulatory requirements that makes it difficult for us to optimize by moving lines about. So every single day, we have to live up to all the standards and requirements that surround us.

So we can -- take an example, the 4 facilities that work with tablet production, which is the biggest part of our product portfolio. We have production facilities in the U.S. and Denmark, the U.K. and Spain, and they are all part of the value chain in relation to tablet production. We are working to make sure that, that works well.

Also by expanding our cooperation with Catalent so that we get a new line in the U.K., but possibly also in some of the -- in another location in Canada, for instance. We really work to ensure high quality, strong production and a production system that makes sure that if we get hikes in production requirements and the things that work as they should.

And the doctors, we are working to make sure that we -- not doctors, sorry, stocks. We are always checking our stock levels. And if all of a sudden, we have a challenge in our value chain, we have a system in place to take account of that. So we are having this in focus. We do everything we can to ensure a stable production and also a growth possibility also in future. Thank you.

And that was a response to ATP from the CEO and the Chairman of the Board. And there's another speaker that has asked for the floor, Mr. Bjorn Hansen. And if anybody else would like the floor, please signal to me while Bjorn makes his way up here.

My name is Bjorn Hansen, and I represent private shareholders, both in Denmark and abroad. Thank you for the report. That was a fine report. It was also nice to hear that the CEO knows what's going on in his company. That's certainly my impression. We all know our Chairman of the Board, Chairman of the AGM. He's probably one of the best one in Denmark.

And you also have -- so you have some very good people here, also a very good Deputy Chairman of the Board. Now my first question, mainly about the audit, but also for you. Artificial intelligence, what does this cost a year for your company? Secondly, how much does IT cost a year? And now markets, maybe the CEO knows this best. I would actually need -- would like to see a few things in Danish.

I don't need 400 pages on climate. But I would like to know a bit about China. I understand there's a partner company, and that's all well and good. As long as we don't leave too much activity out there, I believe firmly in the free trade agreement with India and the EU. Now the production of the tablets, I think it's important that production is in the EU. And I would propose other than that, you start up quickly with production in India after the free trade agreement.

India is a large country, but maybe the area of Punjab would be good. I mean it sounds a bit British, I know, but I think we have good experiences from there. And it would make a good opportunity to enter the Indian market and have production there. I think India could be the source of enormous growth in future also for ALK. And if just one part of thousand would become patients, that would certainly have a large effect on the bottom line for ALK.

But again, I would like to see some text in Danish so that we can understand some numbers about the various markets. And when it comes to markets other than India, I would like to see something in maybe a newsletter. I don't know whether you have any newsletters we could sign up for. It's certainly a while since I've received anything.

But this is a good, stable company. You also do a lot of research, and I assume that most of the research takes place here, but I would like to know for certain. And I would like to ask, do you produce anything here in this area, on this location? Is there any production here? Thank you for the floor and all the best for your future endeavors.

Thank you, Mr. Bjorn Hansen. There were some questions and our CEO, Peter Halling, will answer those questions.

Thank you very much, Mr. Bjorn Hansen. I'll try to answer everything. It's a good test of my knowledge of the company. I think there were about 6 questions, so I'll try to answer them all. Firstly, if we look at AI and also IT. IT, I can give you an overall figure. It's less than 5% of our costs is in administration and part of that is IT. And then, of course, we have continued investments in capacity and part of that is also IT.

We invest about DKK 500 million a year in both physical facilities, but also in IT, cyber infrastructure, including AI. What's important to say about AI is that it's a brand-new world for us. ALK has been on this journey for a number of years with digitalization. We have worked to get the right databases so that we can work with AI. And that means looking at AI now, we have 8 projects that we run internally. It's from R&D to marketing. So we work both with the external part of the world and in research.

We'll use it in our peanut study among other things, and we use AI to analyze data. Last year, we trained more than 1,200 employees in ChatGPT, which most of you know, and we are continuously working to integrate it in our daily work, something that employees appreciate so that they have time and resources to work with this. So AI is also part of our future. And the last thing I want to say about that is AI is changing the world. We fully understand that it has a number of implications.

We have the size we have as a company. So we depend on good partnerships with others. And that means that both our IT department and the rest of the company look at AI daily, both to look for new tools, but also to ensure that the tools available function in our regulatory area because that does set quite clear limits to what we can do. But the short answer is AI is here to stay. And we make sure that our employees are trained for the future use of it.

You asked about China and GenSci, but you also mentioned India. Well, India, we are already in that market. We work with Dr. Reddy's, which is an Indian pharma company. And last year, we launched ACARIZAX in India. It is rolled out now as part of our partner strategy in Asia and the Middle East, where we work with various partners. But we chose Dr. Reddy's India. It's also a very young market, you might say. Both patients and doctors are not that trained in our products, but we have actually had visits from Indian doctors and work with them to help train them so they can help develop the allergy market in India.

So we are starting, it's very small numbers now, single-digit millions last year, Danish kroner. But we think the market has a great deal of potential. As you mentioned, it's a market just as large as the Chinese one, which -- where we now have GenSci as a partner. You asked about free trade. Of course, with the EU-India free trade agreement, which, of course, also includes Denmark, it improves our relationship with India, and we'll continue to work in that direction.

We don't expect to invest any differently because we have an Indian partnership. You asked about newsletters. The way we communicate to the market is through press releases. for instance, when we have new opportunities, new approvals, and we have actually mentioned India in one of them. We also have our quarterly reports. And of course, we are obligated to announce major events such as when we get a readout on our peanut study here expected in May.

You also asked about R&D, where we do it and how. The short response is, it happens not very far away from here across the street, where we have research facilities and we have a very competent researchers. So we invest a lot in research, about 10% of our revenue is spent on research and a lot of it is done here in Denmark.

You also asked about production. Whether we produce in Denmark, actually, that's also across the street from here. We have part of our production and very good employees and colleagues there who work to ensure that we have plenty of product also for our tablets to ensure that we can export from Denmark. So that was the long answer to all the questions, and I hope I answered them all.

Thank you to the CEO for the reply to the question from the shareholder or the 6 questions from the shareholder. Any other requests for the floor? That does not seem to be the case. I will then conclude that we have concluded the debate. I will also ask if the AGM will accept that I find that you have now taken note of the report. You've approved the annual report for 2025.

You have discharged members of Board and Management of their responsibilities, approved the remuneration report for '25 and approved the proposed distribution of profit proposed by the Board. That appears to be the case. Thank you very much. I will make sure that this is entered into the protocol. We have now concluded our discussion and debate in relation to items 1 to 4. We will now embark on Item 5, which is adoption of the remuneration to the Board of Directors for the present year.

The proposal is that the basic fee to the Board and remuneration to members of and the Chair of the Audit Committee remain unchanged in relation to the amounts paid in '25, which means that Board members for the present year, which is '26, will receive a basic fee of DKK 400,000. The Vice Chair of the Board will get DKK 800,000 in remuneration, twice the basic fee. And the Chair of the Board will get DKK 1.2 million, i.e., 3x the basic fee.

It will also appear from the convening notice that the members of the Remuneration and Nomination Committee and the Scientific Committee will receive a remuneration of DKK 100,000, and that corresponds also to the level paid out in '25. The Chair of the Remuneration and Nomination Committee and the Scientific Committee will get DKK 150,000. That is also the same as in '25.

And the Audit Committee, according to the proposal, members will get DKK 140,000 and the Chair of the Audit Committee will get DKK 210,000. Any comments or questions? That doesn't seem to be the case. I take it then that the proposal has been adopted. Now we will vote about -- rather, we are going to deal with Item 6, election of Chair of the Board of Directors. I refer you to the convening notice according to which -- there is a complete outline in Annex 1 of the other positions of Mr. Hedegaard, the current Chair.

And if there are no objections, I take it now that he has been reelected. There are no objections. Congratulations. Item 7 has to do with electing a Vice Chair of the Board of Directors. And here, the proposal is the reelection of the Vice Chair, Lene Skole. You will also find a list in Annex 1 of the convening notice of Lene Skole's other managerial positions, et cetera.

Any other candidates or objections? That doesn't seem to be the case. I find then that Lene Skole has been reelected for a period of 1 year. Congratulations. Next item is Item 8, election of other members of the Board of Directors. And I will now hand over the floor to the Chair, who will explain the candidacies. You have the floor, sir.

Thank you. According to the Articles of Association, the members elected by the AGM are for election every year. You have already reelected the Chair and the Vice Chair. And on behalf of Lene Skole and myself, I would like to thank you for that. The Board also proposes that all other members be reelected. They are Gitte Aabo, Lars Holmqvist, Jesper Hoiland, Bertil Lindmark and Alan Main.

The candidates are presented in the convening notice and in the annual report where you can see their positions, areas of expertise, other directorships, et cetera. We believe the candidates still have the skills needed for the Board to represent the interest of the company and our shareholders. All candidates have international management experience from various industries with particular insights into management and globalization of research-driven companies. We have 7 members elected by the AGM.

Five of them are independent, while Lene Skole and Lars Holmqvist are not independent for corporate governance purposes because they're affiliated with ALK's main shareholders, the Lundbeck Foundation. As I said at last year's AGM, 2025 was the first year in which a new gender balance act took effect. The act contains stricter requirements to ensure that there's a balance between men and women on our Board of Directors. Today, 2 out of the 7 members elected by the AGM are women.

Among the employee-elected members, there are 3 men, 3 women and 1 man. But according to the act, the 2 groups have to be assessed separately. So after today's election, we still do not meet the target laid down by the legislation where there's to be an equal gender distribution at the latest 30th of June this year. The Board of Directors will continue its efforts to achieve an equal gender distribution among the members of the Board.

Among other things, we'll do it by focusing on women to be prioritized when candidates are equally qualified. We'll also strengthen the candidate pipeline and recruitment process when we need to ensure a new candidate pool. Of the agenda, I would like to point out that 4 employee-elected members have been elected for a 4-year period. They are Project Director, Katja Barnkob; Senior QA Manager, Nanna Rassov Carlson; Senior Maintenance supporter, Johan Smedsrud; and Project Director, Lise Lund Maerkedahl.

The employee representatives make an important contribution and participate with all other members of the Board to ensure that the Board makes the right decisions and discuss the right subject matters. And I would like both for myself and for the rest of the Board to thank them warmly for their work. And with that, I hand the floor back to the Chair of the AGM.

I'd like to hear if there are any other candidates in addition to the 4 that we already have. That doesn't seem to be the case. I find then that Gitte Aabo, Lars Holmqvist, Jesper Hoiland, Bertil Lindmark, and Alan Main have all been reelected for a period of 1 year. Congratulations. We've now come to Item 9, appointment of auditor. The proposal is that PwC Statsautoriseret Revisionspartnerselskab be reelected.

It will appear from the convening notice that this election both has to do with audit services and also the production of reports in relation to sustainability reports from the company. I also need to inform you that the proposal is in accordance with the recommendation from the Audit Committee that was produced without any impact from third parties and -- which is not subject to any agreement with a third party, which limits the AGM's election of auditor. Are there any other candidates?

That is not the case. PwC Statsautoriseret Revisionspartnerselskab has been reelected auditor of the company. We've now reached Item 10 on the agenda, proposal from the Board. The only one from the Board this year, and it has to do with an update of the remuneration policy. The proposal is that the remuneration policy be updated to increasingly be in better keeping with practice in the market. This to enable the business to better attract and retain qualified employees.

There is also a proposal to change the threshold values for the short- and long-term incentive program so that the target bonus can account for up to 75% of manager's base salary rather than 50% as before. According to the remuneration policy, the maximum bonus can amount to twice the amount in the target bonus. So the maximum bonus will now be able to go to 150% compared with previous 100%.

I'm not saying that this will automatically happen, but the Board simply wishes it to be possible to assign higher target bonuses. The Board also proposals to remove the possibility of using share options in the long-term incentive programs. In future, the company will only use results dependent attributions of shares. This is the same model as is operated by other Danish companies.

So generally, I will refer you to the report on the remuneration policy situation, which has been available on the company's website before the AGM. Any request for the floor? That doesn't seem to be the case. I take this to mean that you have approved the updated remuneration policy, which will apply for the company going forward.

Thank you very much. I'll make sure this is entered in the protocol, which brings us to the last item on the agenda, which is any other business. Anything is possible here apart from putting forward proposals. Any request for the floor? There is a request for the floor. Mr. Bjorn Hansen has requested the floor. You have the floor, sir.

Just one, I think there are 1 or 2 Swedes in the Board. And when we go to AGMs in Sweden, we get the annual report in Swedish and in English. And we even get it in Finnish in some places. That's a great service, and we would like to see the same here. The information I would like to have is -- I was about to take the microphone home with me, I think. Who has how many shares in the Board of Directors and the Executive Board?

I'm sure some people have shares, and that's good because I really support that. And I would also like to ask for tax purposes, there are many other older Novo Nordisk employees who received shares, and they thought they were tax-free, and they really have to fight for that now. I hope ALK won't end in that situation. I hope if you get shares, they have to be tax-free. I mean the tax should be planned differently. Thank you for the floor.

Thank you, Mr. Bjorn Hansen, and the Chairman of the Board will answer the questions.

I think there were 3 questions there. Firstly, that our annual report is in English. Well, our releases and notices are sent out in both Danish and English. The annual report is only in English. And that's because we are an international company. We are very much focused on the external market. And that's -- it's also a question of cost. Then there's another question, which is about how many shares each of us owns.

It appears from the annual report, I can't say off the cuff who owns how many shares, but it's in the annual report, both for the Board of Directors and for the Board of Management. The shares owned by members of the Board have all been acquired normally from the stock exchange. It's not something that has been paid for or supplied by the company. Now the last part, I have to refer you to next Tuesday when there's a general election here in Denmark. And I certainly understand your thoughts about the tax system.

Thank you very much for the answer. Any other requests for the floor? That doesn't seem to be the case, right? Thus, we have now exhausted the items on the agenda. Thank you for good and orderly meeting. I will now resign as Chair and hand over the meeting to the Chair of the Board.

Thank you. On behalf of the Board, I'd like to thank you for attending today. Thank you to shareholders who have turned up. Thank you for the debate. And of course, also thank you to those who have attended via the webcast. I am deeply grateful that the most competent Chair of AGMs in Denmark made sure with his good and competent management strategy, made sure that we dealt with this within under an hour. Well done. There will now be light refreshments in the foyer. You can meet members of the Board and the executive leadership. We look forward to that, and we look forward to seeing you again next year. Thank you.

Hello, and welcome to the presentation of ALK's Q4 and Full Year 2025 Results. My name is Per Plotnikof, I'm Head of Investor Relations, and thank you all for joining.

On Slide 2, I will present the speakers and agenda for this call. And with me today are CEO, Peter Halling; and CFO, Claus Steensen Solje. Peter and Claus will walk you through the Q4 and full year highlights, market and product trends as well as the full year financial performance. Then we will provide an update on the strategic progress and priorities before presenting our outlook for 2026. As usual, we will end with a Q&A session.

And to get us started, I'll hand you over to Peter on Slide #3. Please go ahead, Peter.

Thank you, Per, and thank you all for joining the call. We delivered a solid performance in the fourth quarter, leading us to end 2025 at the very top end of our latest outlook. So let me start out by highlighting 3 key strategic developments in the quarter.

Firstly, the pediatric rollout of our house dust mite and tree pollen tablets, ACARIZAX and ITULAZAX, provides wider access to prescribers in key markets and continue to perform very well.

Secondly, the European rollout of EURneffy or just neffy continues following our initial launch in Germany in late June, At the end of 2025, EURneffy achieved an 18% value share in Germany. And since then, we have now also launched in the U.K. and by year-end, market access were also in place in Greece, Denmark, Slovenia with launches expected shortly.

While we're still in the early phases, the initial market response to neffy supports the product's long-term potential. At the same time, established clinical practices still favor traditional anaphylaxis treatments, and we'll continue working diligently with the medical communities to drive adoption.

Most recently, we received a positive opinion in late January from the European authorities for the approval of the 1 milligram version of EURneffy for emergency treatment of anaphylaxis in children weighing 15 to 30 kilo.

Thirdly, we continue to make good progress across our existing and newly established partnerships in China, Japan and the U.S., both in terms of execution and preparing additional activities for 2026. These developments will be covered later in the slides.

Now turning to the financials. Revenue in Q4 increased by 17%, driven by strong performance across all geographies and with tablets in Europe and anaphylaxis as key drivers. EBIT increased by 88% with a margin of 22%, as expected, reflecting continued strategic investments in commercial initiatives to support future growth and innovation across markets.

With that, I will now move to the full year picture on Slide 4. 2025 became a landmark year for ALK, and we clearly exceeded our initial expectations for the financial performance. Revenue grew by 15% in local currencies to DKK 6.3 million (sic) [ DKK 6.3 billion ], which is USD 1 billion, driven by double-digit growth across our sales regions. And importantly, we are proud that we also hit our long-standing target of 25% in '25. This is a big achievement for the company, 25% EBIT margin and 26% last year.

So let me highlight 3 full year milestones. The commercial momentum was underpinned by a solid expansion of our patient base. We treated 500,000 patients more in '25 so that a total of 3.1 million patients are now treated with ALK's products. This was made possible not at least through the continued expansion of our tablet business. For example, the rollout of ACARIZAX and ITULAZAX for children helped broaden the patient inflow and adoption across the tablet portfolio.

In anaphylaxis, the main growth driver last year for ALK, but also on top of it, we saw positive contribution for EURneffy, speaking to the portfolio strategy of ALK. And importantly, this is consistent with the strategic direction we have followed since 2024.

Key in executing on Allergy Plus is expanding the addressable market, broadening the patient reach, especially through the pediatric indications, but also leveraging partnerships to help even more patients. As one example, in China, we have successfully transitioned sales and marketing activities to our new partner, GenSci.

And at the same time, we are further strengthening our profitability. EBIT increased by 53% and the EBIT margin improved to 26%, supported by higher sales, improved gross margin and diligent cost control. This also marks the delivery on our 25% in '25 ambition and reinforces our commitment to maintaining an EBIT margin at around 25% while we continue to invest in our continued growth.

Encouraged by this strong momentum, the Board of Directors recommends a dividend payment of DKK 355 million for '25 or 30% of the net profit after tax, in alignment with our capital structure and long-term ambitions.

So on that note, I'll hand it over to you, Claus, for the market review on Slide 5.

Thank you, Peter. First, let's take a look at the performance across our sales regions and then on the different product groups. Let's start with Europe. Europe remained our main region with 71% of group revenue. We saw 14% broad-based growth across the portfolio and geographies, including in our largest markets, Germany and France.

Demand was solid and market conditions were largely stable. Growth was primarily driven by tablets up 19%. Volumes increased especially on a good inflow of new house dust mite patients on ACARIZAX supported by the buildup of patients who had started on grass pollen tablets in prior years.

The new pediatric indications for ACARIZAX and our tree pollen treatment ITULAZAX also added positively to the growth. Overall, ACARIZAX and ITULAZAX were the biggest contributors, while our grass treatment GRAZAX continued to grow steadily.

Performance was particularly strong in Central Europe, including Germany, France and several Eastern European countries, and the U.K. In the U.K., we continued to progress market access for our key tablet products. ACARIZAX and ITULAZAX became the first AIT tablet treatments admitted to the National Health Services or NHS systems with general reimbursement.

This is an important step in what has historically been a low penetrated AIT market. We are now working to extend these approvals to include children while also progressing to make GRAZAX available within the NHS. It is also worth noticing that in contrast to 2024, pricing adjustments had a limited impact in 2025. And this year, tablet sales were only marginally impacted by pan-European trading dynamics among wholesalers.

Combined sales of SCIT and SLIT drops were up modestly by 3%. SLIT drops continue to benefit from a growing prescriber and patient base in France, while SCIT were more muted. In our main SCIT markets, Germany and the Nordics, patient initiations were, to some extent, impacted by patients choosing tablets over SCIT for the indications covered by our tablet portfolio.

Finally, anaphylaxis and other products grew strongly by 34%, driven by Jext on solid execution, tender wins in Southern Europe and competitor supply issues. We also saw a positive although modest contribution from the initial EURneffy introductions in Europe. This growth also underlines the value of having a portfolio approach in anaphylaxis.

Turning to North America. In North America, revenue gained growth in 2025 and increased 19% driven by tablets and anaphylaxis and other products. The U.S. legacy business recovered from last year stagnation and growth was driven by continued adoption among existing allergist prescribers, and to a minor extent, uptake among pediatric prescribers.

Canada sustained a higher growth rate. Here, tablets remain the main product line and the growth reflected a sound underlying demand, supported by the children indication for the house dust mite and tree tablets. The 34% growth in anaphylaxis and other products revenue was driven by cost compensation from ARS Pharma related to the co-promotion of neffy in the U.S. together with higher sales of life science products as we continue to gain customers on our higher-margin solutions.

Let's turn to International markets. In International markets, revenue increased 16%. Tablet revenue growth was 8% with continued positive contribution from smaller markets across the Middle East, Southeast Asia and India, while revenue from Japan was impacted by phasing of shipments, especially in the second half of the year.

In-market demand in Japan remains strong, and our partner, Torii, now part of Shionogi, continue to grow sales by double digit, although capacity constraints still limited its ability to fully meet demand for CEDARCURE tablets. As a new facility has recently become operational, we expect Torii to increasingly be able to supply higher volumes to the market.

China remains the largest SCIT market in the region, and revenue increased as we continue to normalize shipments following the renewal of our import license. In China, in-market sales also continued to grow by double digits, supported by the ongoing expansion of the prescriber base at hospitals.

Now let's turn to a brief update on the product lines on Slide 6. In 2025, tablet sales grew by 17%, reinforcing tablets as our primary revenue stream. Growth was largely driven by the expansion of the patient base, mainly in Europe and Canada with pediatric launches of ACARIZAX and ITULAZAX adding to the momentum, as mentioned earlier.

Overall, the number of new patients starting on tablets increased by well above 10% during the year, which bodes well for the continued solid growth in 2026. SCIT and SLIT drops delivered a 5% sales growth for the year based on resumed shipments to China, offset by the previous mentioned conversion to tablets in Europe.

Finally, anaphylaxis and other product sales increased by 34%, mainly driven by a 58% increase in anaphylaxis sales. This was mainly related to increasing Jext sales although neffy also contributed to that growth.

Now let's turn to Slide 7 for the full year financials. Revenue for 2025 increased by 15% in local currencies to DKK 6.3 billion. It is marking the first time that ALK exceeded DKK 6 billion in annual revenue. It also represents the seventh consecutive year of growth, with results clearly exceeding our initial expectations of a 9% to 13% increase in revenue.

Gross profit increased to DKK 4.2 billion, yielding a gross margin of 67%, up 3 percentage points from last year. The significant and extraordinary improvement came from higher sales volume, a more favorable sales mix and production efficiencies, demonstrating that scale effects are increasingly materializing in the business.

Capacity costs increased by only 6% in local currencies to DKK 2.6 billion. In comparison, capacity costs increased by 9% when excluding the impact of restructuring cost in '24. In line with our plans, R&D expenses increased by R&D -- by 15%, reflecting investments in our pipeline, including the peanut tablet development program, preclinical projects and the Phase III bridging trial with ACARIZAX in China.

Sales and marketing costs increased by 3% and 6% when adjusting for the last year's one-off costs driven by tablet launches and the rollout of neffy, while administrative cost increased modestly. Unlike last year, capacity cost in 2025 did not include any one-off expenses.

Operating profit, EBIT increased to DKK 1.65 billion and the EBIT margin improved to 26%, up by 6 percentage points from last year. This means that we delivered on our important profitability journey and 25% in '25 EBIT margin target, which we officially set back in 2021 when the EBIT margin stood at just 4%.

This expansion of the EBIT margin by more than 20 percentage points has been accomplished at the same time as we have invested significantly in growth, reflecting disciplined prioritization throughout the organization and allocation of resources towards the most impactful growth levers.

Free cash flow was positive at DKK 1.4 billion compared with negative DKK 204 million in 2024. The improvement reflects the higher earnings and an upfront payment from GenSci of DKK 244 million.

In addition, 2024 included a DKK 1 billion license payment to ARS Pharma and DKK 115 million related to the PRE-PEN acquisition. 2025 investments primarily reflect the buildup of capacity for tablet production, upgrades to legacy production, a milestone payment to ARS Pharma related to the first commercial sales of EURneffy and other infrastructure investments.

With this, we conclude our operations review of 2025 and turn to Slide 8 for a closer look at execution of our Allergy Plus strategy. Please go ahead, Peter.

Thanks, Claus. So before diving in to our strategy progress, I would like to address the change in management announced this morning.

Henriette Mersebach will step down from her position as member of the Board of Management and Head of Research & Development. Her departure is by mutual agreement, and this is a strategic leadership decision focused on the long-term needs of the business.

We have appointed Henrik Jacobi, ALK's former Head of R&D, as a Special Adviser to the executive leadership team reporting to me, and we have initiated the search for a new Head of R&D.

I would like to thank Henriette for her contributions over the past 3 years. She and her team secured important regulatory approvals, including for our pediatric treatments, and also advanced our peanut allergy program, among other achievements.

We remain committed to our ambitions in our different therapy areas and in particular, the development in food allergy as well as other disease areas. So now looking at our progress in Allergy Plus.

We entered 2025 with a clear focus on launching our respiratory allergy tablets for children. And we have taken important strides forward. Supported by the children launches, we expanded both our prescriber and patient basis during the year, increasing the number of patients treated with ALK's products by around 0.5 million or 500,000 to an estimated 3.1 million.

The majority of this increase, around 300,000, came from tablets, including children and adolescents. So tablets remain an important driver for growth going forward. We remain on track towards our ambition of helping 5 million people every year by 2030.

Today, the house dust mite tablet, ACARIZAX or ODACTRA in North America is approved for children in 30 countries and launched in 21 of them. Our tree pollen allergy tablet, ITULAZAX or ITULATEK in North America is approved for children and adolescents in 20 countries and launched in 13 when including the very recent launch in Norway just a few days ago.

These rollouts have reshaped our prescriber base. By year-end, more than 4,000 prescribers in our directly served markets had already prescribed one of the 2 tablets to children, and we continue to see strong cross-tablet adoption. In key European markets, more than 90% of pediatric ITULAZAX prescribers also prescribe ACARIZAX. And in Germany, among other countries, pediatricians have emerged as an increasingly important prescriber group.

In the U.S., we expanded our reach in the pediatric segment with the co-promotion agreement with ARS Pharma. In the U.K., the admission of ACARIZAX and ITULAZAX to the NHS with general reimbursement represents an important structural step in a historically underpenetrated AIT market with further work ongoing to extend access locally.

We also made good progress with our 2 new partners, GenSci in China and Shionogi in Japan, following the acquisition of Torii in '25. We see a strong commitment from both partners to further develop both the Chinese and the Japanese allergy market, respectively.

Looking ahead for 2026, our key priorities in the respiratory therapy area will be to maximize the value of the tablet portfolio. This means continuing the rollout to children in the markets where we've already secured access to prescribers. At the same time, we expect to launch tablets for children in additional markets so that adult, adolescents and children all can benefit from our treatments, no matter where they live.

In anaphylaxis, neffy is a strategic enabler of Allergy Plus. In 2025, we have moved into early commercial execution in Europe and in North America. The co-promotion agreement with ARS Pharma in the U.S. is a lever to expand our market reach and build further insights.

For this year, our focus is to succeed with neffy. We expect 2026 to be a buildup year focused on driving market access and initial rollout. In practical terms, that means continue the market-shaping activities across geographies and patient groups and build a clear market position that allows us to move from introduction to broader commercial execution.

We will do this with a combined portfolio approach where we bring together both neffy and Jext to serve different patients and channel needs and to further strengthen our overall footprint in emergency allergy care.

So let's continue to Slide 9. In food allergy, we initiated a Phase II clinical trial of our peanut SLIT tablet, which has received Fast Track Designation from the FDA. We are on track to report Phase II top line results in Q2 this year. Our focus for '26 is to advance the peanut program into progressing it into Phase III, of course, again, subject to positive data coming out of Phase II.

In addition, we progressed preclinical programs in new disease areas, and our partner, ARS Pharma, initiated a Phase IIb trial with neffy acute flares associated with chronic spontaneous urticaria. We also have the rights for this indication in our territories.

And finally, we'll continue to invest in our infrastructure to be able to scale up ALK. This includes investments in tablet production capacity, IT and AI. We'll also continue to explore further business development and partnership opportunities. This could be both commercial stage as well as research stage opportunities.

So in short, 2026 is all about continued execution, and we have a strong foundation. ALK is in a unique position to sustain growth for many years to come to the benefit of an increasing number of patients suffering from severe uncontrolled allergies.

So with this, I'll hand it back over to you, Claus, and the full year outlook on Slide 10.

Thank you, Peter. So for 2026, we expect to continue our trajectory of double-digit revenue growth, while the EBIT margin is planned to remain on par with our long-term earnings ambitions. First, revenue is expected to grow 11% to 15% in local currencies and the EBIT margin is expected at around 25%.

Let me take you through some of the main assumptions. Revenue is expected to grow organically in local currencies across all sales regions and product groups. Growth will predominantly be volume-driven.

The lower end of the range reflects a potential negative impact from price and rebate adjustments, mainly in Europe, and less growth in anophylaxis and SCIT. The upper end assumes stable price and rebate conditions and potentially upsides related to tablet and anaphylaxis sales.

As usual, the timing of product shipments to China and Japan may lead to quarterly fluctuations. Tablet sales are expected to grow by double digits across sales regions, fueled by continued expansion of prescriber and patient bases, naturally with children and adolescent projected to account for a higher share of the sales.

Anaphylaxis and other product sales are expected also to grow by double digit, led by the continued commercialization of neffy. SCIT and SLIT drops revenue is projected to grow by single digits driven by higher SCIT volumes to China, modest volume growth in Europe across SCIT and SLIT drops and improved SCIT pricing in North America.

The gross margin is expected to decrease slightly as the 2025 favorable volume and mix, especially higher tablet sales in Europe, will be offset by growth in partner-related revenue in Japan and China at lower margins as well as increasing neffy sales, which also holds lower margins. Production efficiencies, reduced scrapping and procurement savings are expected to largely compensate for inflation.

Capacity cost to revenue ratio is expected to remain unchanged as we will reinvest the benefits of increased scale into the key strategic growth opportunities. R&D expenses are planned to increase but remain at around 10% of revenue. Sales and marketing expenses are expected to increase while administrative costs are planned to decrease slightly.

Finally, free cash flow is expected to be positive at DKK 800 million to DKK 1 billion. CapEx is projected at around DKK 500 million with a focus on production capacity expansion and IT infrastructure. Potential changes to international tariffs are not expected to material impact growth or earnings given our geographical footprint.

To sum up, we expect 2026 to deliver continued volume-driven organic growth while we keep investing to support our long-term ambitions.

And with this, I would like to hand it back to you, Per, and Slide 11.

Thank you, Claus, and thank you, Peter. And this concludes our presentation, and we will now open up for the Q&A session, and I kindly ask the operator to go ahead, please.

[Operator Instructions] The first question today comes from Thomas Bowers with SEB.

So what level of contribution should we think for the pediatric indication here for your 2026 growth guidance? And given the early launch trajectory, any first stakes here on how we should think about the peak potential here?

And then secondly, can you maybe just add a bit of flavor? You did address this in the prepared remarks, but maybe there's a split here between specialist and pediatricians among those plus 4,000 prescribers. And how does it look like now with the high-volume pediatric prescribers at this point? So any color here will be very helpful to us.

And then lastly, just in regards of the pricing impact or the pricing rebate impact. So I understand that France is mostly a done deal here. So is that part of your sort of midpoint growth guidance? And how should we actually think about the impact when you look at sort of the competitive situation in France?

Is there -- are we looking at potentially even sort of a price parity here on SCIT drops and tablets? So I guess the question here is whether there maybe be some sort of any dynamics that could give you any potential some headwinds or tailwinds in France in the wake of this price adjustments?

Thomas, Peter, I think we caught them all. I'll start out, and I'll have Claus and Per jump in as well. But let me start on the contribution from peds and the peds potential. I know last year that we gave an indication of 1% to 2% from the peds and the 1% on neffy or less than 1% on neffy and then we upgraded. We are not guiding on this. But what we can say is that we expect it to be higher given the continued positive progression of the business.

Then you cut out a little bit. So if I'm not answering 100% correctly on your second question, the specialist versus peds question. I think basically what we are seeing is obviously, as we also mentioned here, with the 4,000 that this is a new development which is positive. I do think that what's important and what we're also learning is where allergists are fully focused on allergies, then do remember pediatricians are treating a multitude of diseases and different types of patients.

So even though that we see a good progression and we talk typically around 25,000 prescribers normally, then with the pediatricians on top, it's not a 1:1. But obviously, we are very positive that this continues and the interest is there because that gives us the future prescriber expansion and allow us to do more for children going forward.

So if I didn't answer completely, then please ask again. And then finally, on the pricing, I'll let Claus talk. I can talk to the last part on the competitive side. We don't really comment on that. But obviously, there is a rebalancing also in the French market, which we believe, is overall putting things more straight, but that's as much as we can say at this stage.

And maybe you want to talk more about the impact?

Yes, I can do that. Thanks, Thomas, for the questions. Related to the pricing and what has been included kind of in our midpoint or in our guidance, then you are right, that the French price decrease that we saw at the end of last year and in the beginning of this year, '26, which was not sustainable, had really big, you can say, impact on us, we have included into the guidance for this year.

So when we are talking about the rebates, especially in the lower part of the guidance, it's, of course, very much the German rebate. It can also be other smaller ones across the world, especially in Europe, but it's, of course, the big one in Germany that can really impact us. So yes, the French price has been included into the guidance.

The next question comes from Benjamin Jackson with Jefferies.

I guess my first one would be on peanut allergy. We're obviously creeping closer to the top line results in the study. So what should we expect from you in terms of the communication around this? Are you going to provide us with any details at the time of the headline?

And also what are you looking for beyond just the actual signal seeking in this study? Are you trying to meet an internal bar to take it forward? Or it's just simply a good -- a signal enough for you to continue exploring that? So that's my first question.

The second one, just to back off that, obviously, respiratory tablet has been a bit tricky in the U.S. given the dynamics there. So how should we be thinking about a potential food allergy tablet in the U.S. and where -- and what can be done to better establish that market there?

And then third and finally, I imagine quite a short answer, but is there any kind of more commentary you can provide about the potential for neffy and CSU in your regions? Obviously, your partner has been quite vocal about how big they see that opportunity. But what are you seeing it for you? Is it something you're willing to get behind and potentially actually fund as well? Obviously, no requirement to, but any thoughts around that would be great.

Perfect. Thanks, Benjamin. Per, if you take the first one on the communication, I'll answer the last 2.

Yes. So thanks, Ben. So on the communication of what to expect from our accounts when we have top line results here later in the second quarter of this year. As we do consider this as material to us, we will be putting out a separate company announcement on the news just to confirm that. And of course, when we look into the data, we will try to give as complete and a meaningful picture as we can once we've gone through the top line results.

And the -- and then, of course, the ultimate aim of this study and the results is to establish a clear proof-of-concept for the peanut tablet and to guide our decisions related to the design of the Phase III study. So that means what exact dose will we be going with, what's the treatment regimen going to be looking like beyond titration schemes, potentially also what will be the treatment duration we see in the maintenance phase, et cetera. So there will be a lot of information.

And obviously, also the safety profile of the drug. Sorry, I forgot that. So there will be a lot of information that we can draw out of this Phase II. And of course, that will inform our Phase III plans that in the best of all worlds, we can initiate at the end of this year and then have results read out maybe in '28 and then with the submission that year and hopefully an approval late '29 and then launch and roll out into the 2030s.

I hope that clarifies that one. Over to you, Peter.

Okay. Thanks, Per. So your question, Benjamin, on respiratory tablets and kind of the comparison with U.S. peanut. I think it's -- first, it's 2 different ways of looking at things. You have to look at the economics for the prescribers behind the products.

And also that today for the tablets, there is an alternative to the treatment, whereas U.S. peanut tablet will both take into account the patient needs, first and foremost, but also looking at how do we make this attractive also to the prescribers.

So -- and then thirdly, on that one, you have to remember that there are really few alternatives and the ones that are in the market are different, both in terms of treatment regimes potentially also from a patient pool, et cetera. So this is a very different way of looking at it.

So rather than looking at the modality or the technology, if you wish, whether it's an injection or whether it's a tablet or not, then look at the patient pool, the prescriber pool, the economics and the op-dosing of the tablets. So I just want to make sure that that's clear.

So that's the U.S. So in other words, to keep it pretty clear, we believe that the tablet potential for the allergists or with the allergists is quite intact and it's broad-based and not a subgroup. It's broad-based.

Then you had a question around neffy and CSU. And we also see the numbers, and we're also obviously excited about what we see everybody else get to. I'll just caution because this is a market which is very new and needs to be developed. But what we do see and where we do agree with the analysis out there, that is we do see the patient population, and we do see the need, and I think that's very important.

But there are major differences both between how you treat and use products in the U.S. and in Europe. So emergency room treatment, the cost of an emergency room visit in the U.S. versus Europe, et cetera. So there are some differences and we need to understand that better.

And moreover, and importantly, we need to understand what would the product look like, what's going to be the final profile of the product, how is it going to work with the patients, and what does it -- what kind of impact will it have on the patients. So we need to understand that. And that's going to tell us what's the price points we potentially could get and how many patients can we actually reach.

So we're still doing all of that diligence. But again, boiling it down, potential we see out there, we think it's very interesting and relevant for us, but we also have still a lot of learnings before we can assess how big this is going to be for ALK.

The next question comes from Jesper Ingildsen with DNB Carnegie.

I have a few as well. Maybe also just on peanut, I mean, I'll be interested to hear your sort of like on how you see this -- the recent developments in the space, amongst others, GSK acquiring RAPT Therapeutics, and also Stallergenes taking proportion of the market. If this changes your view on the opportunity?

And then secondly, on the departure of the Head of R&D, maybe just a bit more flavor here. What has led to this departure? And I guess there could be some concerns that's taking place just before the peanut read out here in Q2. But on the other hand, I also understand it's maybe more related to sort of like the longer-term pipeline. So I'd be interested to sort of like get a sense of what specifically with the long-term pipeline are we talking about here in terms of looking for a different profile?

And then maybe lastly on neffy. So you highlighted in your report that you have captured about 18% market share in value in Germany in '25. Just be curious to hear like what you're seeing in terms of the volume terms? And also, have you seen any negative impact on sort of cannibalization on Jext in Germany specifically, but also overall for neffy what kind of growth contribution you expect in '26?

Yes. So thanks, Jesper, for the questions. I think they most likely ended up with me, all of them. So let me start out by commenting on peanut. Obviously, first and foremost, I think it's really good to see the high interest on food allergies or around food allergies.

Specifically on the GSK RAPT, it is obviously a positive thing for us that a company like GSK shows interest in the space and also acquires a biologic like RAPT which is mostly a competitor to Xolair. The price point I cannot comment on, but obviously, more than $2 billion, I think, sends a signal, and this is my personal opinion, sends a signal that they find this market quite interesting. And that's a good sign for us.

Again, I think we've said it all along, we welcome competition. Do remember that it's different pockets and different types of patients that the different products address, the same with DBV. So I think that's important. We think that the DBV progression is a positive when we start seeing building the market, including for toddlers, et cetera. And you also notice when you look at the data that there's actually quite a wide span of data points out there also in terms of efficacy, which we also find interesting.

Then on PALFORZIA, it's been pulled from the market. I don't think it was a secret that initially was struggling, then Stallergenes took over and for whatever reasons that we are not aware of, they've kind of seen that this is not going as planned in the market, and hence, they've chosen to withdraw it. So I don't think there's a lot more we can say around that, except for the fact that we don't believe it's a matter of potential in the market. It's pertaining specifically to PALFORZIA.

So I think that's on the peanut allergy. So -- and the food allergy space. It's a really interesting market, a lot of opportunity, and I think we have more to be done in that space.

Then you asked about Henriette. Again, and just to be very clear, I also said it to the media, I think the key around this is this is a mutual agreement. This is good timing or the best possible timing. There's never a good timing for any of these things. But we are in a good position with our short-term pipeline.

We believe we've made good progression both with the regulatory approvals we've had but also in terms of Allergy Plus, overall peanut, et cetera. We do believe and this was also what we said at the Capital Markets Day that when we look ahead, ALK wants to be present in a broader number of therapy areas, food, anaphylaxis, respiratory, potential new areas like urticaria. And part of that is also going to be partnerships, BD&L.

And this is where we believe that as we have a very strong R&D organization, and we believe we have a solid early-stage pipeline, which we also have a good control of, where Henriette has been a major contributor, we believe that when we look ahead, also into the '30s, there's an opportunity to strengthen some of these activities further.

And this is why we've said this is a good time to look for a profile that may have tried some of these activities in the past and could be a good fit with ALK. So nothing about Henriette's performance otherwise because we are happy where we stand. So I think that's the best answer I can provide you on that one.

Then you asked about the neffy and the 18% value share in Germany. So obviously, like any other market, you see the swings depending on the season. Germany is slightly different than some of the other markets. This is more a venom market, which is in itself positive, where some of the other markets like the U.K., U.S. and Canada are more food allergy markets.

But we have been positive to see that the mix of food and venom in Germany have provided us fairly quickly with that 18% value share. It's around 11%, 12% volume share in the market, and it's mainly been driven by a digital effort, which we also find positive and interesting.

So I hope that answered most of your questions, Jesper.

The next question comes from Sushila Hernandez with Van Lanschot Kempen.

Could you share a bit more about ALK-014? Is it for IgE-mediated food allergies? And also at what stage of pre-clinical development is this asset? When could it potentially go into the clinic? And also maybe connected to the previous question, what kind of profile are you looking for, for your new Head of R&D?

Thanks. So Per, will you jump on the ALK-014?

So the ALK-014 program is an early stage program currently in preclinical development. And we work here with a different modality. So it's a [indiscernible] like antibody protein we work with. So it works upstream in the immune cascade, so to speak. So different modality. It's a biologic, still early stage. But we do expect, if everything goes well, that over the coming 1 to 2 years that this could be progressed into clinical development, if everything works out.

So that's where we are on it. So it's also a different approach compared to our historic programs where they've all been allergen-specific programs. This is allergen agnostic. So here, it's also a molecule that potentially can be used in multiple indications if everything goes well. So right now, we're investigating in food allergy, but we're also investigating in other non-disclosed indications at this stage. More on that later. Super exciting program, but still early.

Yes. Thanks, Sushila. So let me just, again, on Henriette, I think I said most of it when Jesper asked. But the profile we're looking for is someone who have tried more broadly the partnership BD&L space, but also who can complement our broader allergy portfolio.

So basically, you can say, Henriette brought in a lot of experience around the preclinical. We have a lot of good competencies around this. We feel that the organization and R&D in general, could benefit from a profile who has tried some of these other areas.

So nothing dramatic around it in that sense and just a good time for making a potential change. So that's basically the background. Also just a note that Henrik Jacobi will be assisting ALK as a Special Adviser to help us also continue to progress the internal pipeline. So I think we are in a good position.

I hope that answered, Sushila.

Yes. That's clear.

[Operator Instructions] The next question comes from Thomas Bowers with SEB.

So just a quick question on International markets tablet sales. So of course, I understand the phasing, the quarterly phasing here. But how should we look at, at least Q1, Q2? And then how much is actually still dependent on the Shionogi takeover completing, the stand-fill here? So of course, going from a rather weak Q4, are we going to see a bigger number here in Q1? That's the first question.

And then on the gross margin outlook, of course, I understand the mix effect year-over-year. But are you still seeing an underlying improvement here also in '26? And maybe if you can address sort of what magnitude we're looking at here?

And then last question, just on neffy. So to understand the 18% market share here in Germany, that's quite impressive, I think. So first of all, is there any specifics that is driving this? And also in regards to Canada, you're seeing a sort of a delay here. I'm not sure whether you expect this to be coming through here in the first half. But is there sort of a risk here that you will miss the back-to-school season? Or is that mainly the U.S. that is dependent on that compared to Canada?

Thanks, Thomas. Claus will take International markets and the gross margin, and I'll comment on neffy. So Claus?

Yes, I will thank Thomas. Related to the International markets and what we are seeing there from a growth perspective, then you should not expect a significant impact in the first half of '26. I suppose something about what you saw last year in '25 versus here in '26. You should expect the higher growth contribution from the International market shipments, Japan and China, to come in the second half of '26.

So this is where you're going to see the significant impact coming from there. So don't expect -- there will still be shipments, no doubt about that, but don't expect, from a growth perspective, a big impact in the first half. That will come in the second half.

If I then take the gross margin, just to go up a bit in the helicopter then, then yes, we had this 64% -- increase from 64% to 67%, quite significant and extraordinary than what we have normally seen in the gross margin. We aim at getting this 1 percentage point year-on-year improvement, that's in our plans.

But due to the product mix and especially how we have sold tablets and the higher sales of tablets, especially in Q4 than what we had expected, but also this with the quarterly shipments between the International markets there and our partners, then we saw this extraordinary jump in our gross margin.

As we have already said a few times related to the last quarterly announcement, then we should expect us to see a slightly decline here in '26 versus '25. And that is due to the mostly the increased sales of in the partnership. So when we do it with Torii, now Shionogi, and then GenSci in China, and, of course, the increase of our neffy with ARS, that is all coming with lower gross margin. And since that is a higher portion of our total sales, that will impact the gross margin negative.

There's nothing related, you can say, to the underlying gross margin development. That is still positive, and we are still working on yield improvement and scrap reductions and so on, and we expect that to continue. So it is mostly our product mix that is going to impact the gross margin negatively, so to speak, in '26. I hope that explains.

On the neffy question and the market share, obviously, we've been positively surprised about the ability for neffy to win 18% value share in the market. Do remember, I think we also noted before that the German market is typically a smaller market, slightly different also both from a reimbursement and payer perspective than other markets.

But it gives us obviously hopes also because we can see the composition of the prescribers in Germany is with general practitioners, et cetera. So it's not kind of what you would normally expect, which is, in this case, a positive.

When we look at the U.K. and Canada, U.K., it's really about getting in on formularies in all 42 regions. And this is the hard work. We do believe once it's in and it starts, then it's going to be a growth driver for the company. But we don't see this happening as fast as one could hope. It takes time because it's a public process.

Is it an issue with back-to-school? We don't know in that sense, but we have budgetedly conservatively around it. So we don't see the back-to-school being a major issue. But obviously, we'd like to see an uptick and an effect from the back-to-school, but we're not betting everything on it because we're also realistic on that one.

Canada, again, another different -- you have the different provinces in Canada with different health care regimes. Firstly, we need to get the regulatory approval in place. We do expect that to happen here in Q1. And then if we can launch, then we should also be able to get on the back-to-school season in Canada. This is also going to be an interesting one where there seems to be a little more open as to get some penetration in the Canadian market.

So again, a different market than U.K. and Germany. And then lastly, I'll just mentioned that we still are waiting on launching the 1 milligram in Europe, so for smaller children or children between 15 and 30 kg. So that's obviously also something we're looking forward to getting into the market.

What I'm saying, Thomas, is, 2026 is, as we've previously said, a year where we're building up and continue to build up. We benefit from the full portfolio, but we do hope and expect that neffy is going to be an increasing contributor to the business. So I hope that gives you some answers and nuances.

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

Thank you, and thank you all for the good questions. Before we close, I'll just highlight our upcoming events and financial calendar on Slide #12, and we hope to see you in the near future in Copenhagen, London, Paris or in the U.S. As always, you are welcome to contact us if you have additional questions.

And with this, we will end today's session, and thank you all for joining. Goodbye.

Hello, and welcome to this presentation of ALK's Q3 results and full year outlook, and thank you all for joining us.

Let's turn to Slide #2 with the agenda and speakers. My name is Per Plotnikof. I'm Head of Investor Relations. And with me today are CEO, Peter Halling; and CFO, Claus Steensen Solje. We'll first share a couple of quarterly highlights, followed by a closer look at markets, products and financials. We will detail some of our strategic focus areas before we cover the new full year outlook. As usual, we'll end the presentation with a Q&A session.

And to get us started, I'll hand over to Peter and Slide #3. Please go ahead, Peter.

Thank you, Per, and thank you all for joining this call. Q3 was characterized by a strong focus on execution of our key strategic initiatives. The pediatric tablet launches, a new partnership for China and the commercialization of neffy. Market responses to the tablet launches for children are truly encouraging. The rollout of the house dust mite tablet, ACARIZAX for children progressed well and continue to contribute to the inflow of new patients in Q3.

Moreover, ACARIZAX is attracting new prescribers, not at least amongst pediatricians, suggesting that the children indications have the potential to expand ALK 's addressable markets. We also saw encouraging early uptake of the tree tablet ITULAZAX children and adolescents. In China, we entered into a partnership with GenSci, a strong local Chinese partner, committed to accelerating the uptake of ALK's house dust mite allergy products. GenSci has already taken over sales and marketing of ALUTARD, our SCIT product and skin prick tests.

The partnership is projected to become margin accretive to ALK's midterm, largely driven by cost savings in China, combined with the income from product supply as well as upfront and milestone payments of up to DKK 1.3 billion. A couple of weeks ago, we introduced EURneffy, the adrenaline spray in the U.K., Europe's and ALK's largest anaphylaxis market. Meanwhile, EURneffy is gaining traction in Germany, our first market entry. The product was launched in July. Other market introductions are imminent, while still very early days, market response so far confirms the product's long-term potential despite long-standing clinical practices favoring traditional anaphylaxis products, which we will need to work carefully with.

Financial results in Q3 were strong with double-digit growth across sales regions and product groups. Revenue grew by 18% and was higher than expected, while earnings were up 41% in local currencies, yielding an EBIT margin of 28%. Based on the Q3 result and the outlook for Q4, especially in Europe, we have adjusted the full year outlook. Revenue is now expected to grow 13% to 15%, while the EBIT margin is expected to increase to approximately 26%.

Now we'll detail all of this later. But first, I'll hand it over to you, Claus, and Slide 4.

Thank you, Peter. So let's take a closer look at our 3 sales regions performance. Our main region, Europe reported 18% growth. The revenue growth was driven by sales of tablets, anaphylaxis products and SLIT drops. Q3 growth was, to a minor extent, positively influenced by some phasing of sales between Q3 and Q4. Tablet sales was up 23% on a broad-based growth across brands and markets. Let me also point out that we did observe that wholesalers carry slightly higher inventories, potentially indicating slightly increasing trading patterns, which is natural in a launch situation like we are in with the children tablets right now.

Growth of the tablet business in Europe was, first and foremost, linked to higher volumes, driven by more patients on treatment, whereas prices and rebate adjustments had a much less impact. Volume growth was powered by new patients with the highest contribution coming from our house dust mite, ACARIZAX and the tree pollen ITULAZAX patients. The children indications for ACARIZAX contributed positively across markets, while the recent launch of ITULAZAX now has started to contribute to the patient inflow, especially in the key German market.

Combined sales of SCIT, SLIT drops were up 7% in Europe. SLIT drops sales continued to benefit from an expansion of patient and prescriber bases in France. SCIT sales picked up temporarily due to one-off changes to patient supply patterns, but the underlying growth was still hampered by fewer patients starting up on our legacy products. Sales of other products grew by 39% in Europe, led by 44% growth in the anaphylaxis portfolio. Sales of Jext auto-injectors were driven by strong commercial execution, including newly won tenders in Southern European markets as a consequence of recent supply issues at our competitor.

Revenue also included a modest contribution from neffy. If we turn to North America, then revenue increased by 20%. The U.S. business continued to bounce back from last year stagnancy, while the Canadian business sustained its growth. Tablet sales in North America grew by 20%. The pediatric indication for ODACTRA continued to drive a higher uptake among allergists and to a minor extent, new pediatric prescribers in the U.S. Growth in Canada was higher, driven by continued demand and volume growth, combined with some destocking at wholesalers.

North American sales of SCIT bulk increased by 1%, while sales of other products were up 41% on higher volumes and better pricing of our life science products. Revenue from other products also included, as planned, a modest cost reimbursement from ARS Pharma related to our co-promotion agreement for neffy in the U.S. Revenue in international markets was up 14% due to the increased SCIT shipment to China. We resumed shipments to China in Q2 after the renewal of ALK's import license, and these continued in Q3, so that SCIT revenue in this region increased by 43%. In-market sales in China continued to grow by double digits.

Tablet revenue in international markets was down 4% after decreasing shipments to minor markets, while revenue from the primary market, Japan, was unchanged. In-market sales in Japan grew by double digits, although capacity constraints still prevented our partner, Torii from fully meeting demand for the CEDARCURE tablets. Torii's new API manufacturing facility is now becoming fully operational, but it will still take some time before the extra capacity flows through the manufacturing cycle.

Now let's turn to a brief update on the product lines on Slide 5. Global tablet revenue was up 17% on solid growth in Europe and North America, predominantly driven by higher volumes. All brands grew by double digits, except for CEDARCURE, which saw modest growth, as I just touched on. Combined revenue from SCIT and SLIT drops increased by 11% after progress in all sales regions. The main growth driver were the resumption of SCIT shipments to China and a very solid growth in SLIT drops in our big market, France. Revenue from other products increased by 42% and the anaphylaxis portfolio was at the front with 68% growth. It did actually very well across markets, and neffy also contributed to growth at this early stage of the commercial rollout.

In conclusion, strong growth in all product lines and in all sales regions in Q3. After these quarterly updates, let's move to the year-to-date results on Slide 6. Revenue for the first 9 months of 2025 exceeded DKK 4.5 billion after 14% growth in local currencies. Growth mainly echo higher sales of tablets and anaphylaxis products. A gross profit of DKK 3 billion yield a gross margin of 67%, a big increase of 3 percentage points. These improvements reflected higher volumes, changes to the sales mix where especially European tablet sales contributed to the positive development.

We also saw good production efficiencies coming through. The gross margin was also indirectly helped by the muted growth in tablet sales in international markets, which holds lower margins as a consequence of the partnership with Torii. In addition, we currently only have a minor contribution from the neffy business, which also holds lower gross margins compared to our European tablets. Capacity costs increased by 5% to DKK 1.8 billion.

At the Q2 earnings call in August, after we upgraded the full year outlook, we said that we plan to take advantage of the higher-than-expected revenue to further invest in various growth initiatives. We started doing so in Q3, where R&D expenses were up 16%, while sales and marketing costs increased 3%. Still, the cost increase was lower than planned, meaning that you should expect higher capacity cost in Q4. I'll come back to that later.

The operating profit, EBIT improved by 44% in local currencies to almost DKK 1.3 billion, raising the EBIT margin from 22% to 28%. The EBIT margin progressed due to higher sales, gross margin improvements and modest increase in capacity cost. Moreover, no one-off costs to optimizations were recognized, opposite to last year, where one-offs amounted to DKK 49 million. Free cash flow almost doubled to DKK 836 million.

Higher earnings offset investment to scale up tablet production, upgrade legacy production and expand the anaphylaxis operation. We continue to use some of the cash generated to repay our debt. Cash flow from financing was minus DKK 736 million. This means our net debt-to-EBITDA ratio right now is down to minus 0.1, i.e., we do not have any debt at this stage. So all in all, a solid set of results, which further solidified ALK's financial position and confirm that we are on track to deliver on our long-term financial targets.

So with this, I would like to hand it back to you, Peter, and Slide 7 for a status on our key strategic initiatives.

Thank you, Claus. Let me start by providing some additional insight into the important launches of our respiratory tablets for children. In September, the house dust mite tablet, ACARIZAX was made available for children in 21 markets, including 14 markets served by ALK and 7 partner markets. The more recent rollout of the tree tablet, ITULAZAX for children and adolescents now covers 11 markets with 2 more launches scheduled for Q4. So far, key indicators continue to perform well across metrics, including new patient interactions with caregivers, doctor visits, sales, prescribers, et cetera.

In September, around 3,000 unique prescribers in markets served directly by ALK were estimated to have prescribed at least one of the two tablets for children. The prescriber base includes new pediatricians, indicating that we are gradually expanding markets. While it is still early days, the market response is encouraging. And if we are capable of sustaining these trends, the pediatric indications will become a very important contributor to ALK's future growth for many years.

Within respiratory allergy, things also progressed in China. In China, we initiated a bridging trial to facilitate the approval of ACARIZAX. Recruitment of around 300 subjects is progressing well, and the trial is set to complete around '26, '27 turn of the year, so around January '27. Subject to approval, ACARIZAX could be launched in Mainland China in '28, where the tablet will be added to the portfolio marketed by our new partner, GenSci. Also a brief update on Japan, where our partner, Torii has become a subsidiary of Shionogi. Shionogi has expressed its commitment to our tablet portfolio and sees it as a core business pillar going forward. The ongoing Phase III trial with GRAZAX in Japan continues as planned.

Now let's move to anaphylaxis and the commercialization of neffy, the nasal spray for emergency treatment of acute allergic reactions, branded EURneffy in Europe. We launched EURneffy in Germany in June and the market -- or the market share has increased steadily since while it is encouraging for longer-term potential of the product, it is still early days. A couple of weeks ago, EURneffy was also introduced in the U.K. So we now cover two of three key markets. The third market is Canada, where the regulatory review is still pending, but progressing as planned.

Additional introductions like in Denmark are imminent and further launches are lined up for '26. In all markets where pricing and reimbursements have been settled, EURneffy has secured a price premium relative to adrenaline auto-injectors. We now also have real-world evidence from the U.S. supporting that neffy's effectiveness is consistent with the one of adrenaline auto-injectors, but neffy has advantages over auto-injectors in the form of user-friendliness, longer shelf life and temperature stability.

Despite these positive achievements, it is most likely or will most likely take some time to secure market access and change long-standing clinical practices, such as automated renewal of prescriptions for traditional anaphylaxis products. That said, we are encouraged by the first indications that we've seen in Germany and the positive feedback we are getting from the medical community to this new treatment. We will build on this positive feedback, work to change the habits and behaviors and furthermore, allocate resources to pursue opportunities in other channels, including airlines and schools to name a few.

Moving to food allergy. The U.S. FDA has granted a Fast Track designation to our peanut development program. This allows ALK to benefit from more frequent interactions with the FDA, and it highlights that the agency acknowledges that food allergy represents a significant unmet medical need. We expect this to support the time line for the program. The ongoing Phase II trial with the peanut tablet in North America is on track to report top line data in the first half of '26, most likely towards Q2. At the same time, the planning for Phase III is ongoing.

So to sum up, then we, in general, see good progress across all disease areas. And with this, I'll hand it back to you, Claus, on Slide 8.

Thank you, Peter. So let's end with the outlook for the year. As Peter said previously, we adjusted the full year outlook slightly. We are now looking at 13% to 15% revenue growth in local currencies versus the previous outlook of 12% to 14% growth. The new outlook is based on a few things: double-digit growth in tablet sales, driven by more patients and prescribers. Single-digit growth in combined SCIT and SLIT drops sales, double-digit growth in sales of other products, particularly anaphylaxis. During the spring, we indicated that the children indications and neffy launches would contribute with around 1 percentage point of the growth in 2025.

Based on what we have seen over the past quarter, we now believe that these 2 items will contribute with 2 to 3 percentage points of the anticipated revenue growth. In parallel, we adjusted the EBIT margin outlook to around 26%, up from the 25% we expected before. This corresponds to an improvement of 6 percentage points, fueled by sales growth, gross margin improvements and the optimizations. Also, we don't expect any one-off this year, opposite to last year, where our one-offs cost totaled DKK 75 million.

The new outlook implies that total revenue is projected to grow by around 13% to 18% in Q4. We expect the strong underlying momentum for tablets to continue into Q4 with a strong inflow of new patients during the ongoing initiation season in Europe. However, please notice that Q4 growth in tablet sales is expected at a slightly lower level than in the first 9 months due to phasing of product shipments to Japan and potentially inventory fluctuation at European wholesalers.

The Q4 EBIT margin is expected to be lower than in the first 9 months, reflecting what I mentioned before. We are increasingly allocating funds to growth initiatives like the children launches, neffy and the Phase II peanut trial. This includes new hires, which will lead to increased capacity costs in Q4. We will obviously carry these costs into 2026, but we will do so without jeopardizing our financial ambitions. A 25% EBIT margin target for the next years is still our expectation. We believe the new outlook for 2025 adequately balances risk and upsides. Hence, we expect 2025 to mark the seventh consecutive year of revenue growth and improved earnings, fully in line with ALK's long-term financial ambitions.

And with this, I would like to hand it back to Per and Slide 9.

Thank you, Claus, and thank you, Peter. And we will now turn to the Q&A session, and I kindly ask the operator to go ahead, please.

[Operator Instructions]

The first question today comes from Thomas Bowers with SEB.

I have 3 questions here. So firstly, just if we look at your new patient starting in '25. So you are stating that it's well above 10% the outlook of tablets in '25. So what if you exclude the impact from the pediatric indications, would you still say that you are still above that 10% of new adults starting for this initiation season?

And then second question, just on gross margin. And of course, now we're looking at 2 percentage points year-over-year. So that's, of course, quite impressive. But how much is -- first of all, how much is structural improvements, so the scrapping -- less scrapping and yields and compared to what you see here from the product mix? And also, how should we think about gross margin improvements in '26? Will this then be flat also because we are facing maybe some headwinds on product mix with Japan, China and neffy here? So any color would be appreciated.

And then my final question here for now. So just on the R&D spend. So first of all, what is driving this extreme back-end loaded R&D spend phasing into today -- well, implied for the Q4 in order to stick to that 10%? And maybe also in regards to your midterm guidance or targets. So going for that 10% in '26, is that still achievable with the quite strong top line performance you have here? Because I guess most additional investment you can plug in is related to sales and marketing. So any color on how you are trying to keep that 25% EBIT would be appreciated.

Thanks, Thomas. This is Peter. So let me just start out with your patient question. And Claus, maybe you can jump in on the gross margin, and we can -- one of us can take the R&D spend as well. So just on the patients on the adults, we expect approximately 10%. Do keep in mind that it's still initiation season. So we're still kind of seeing the intake of patients and obviously learning, but we expect it to be around the 10%.

And then to your first part of the question, yes, we saw, as we also stated, a positive surprise in terms of the intake of children. I think it's important to say that part of the reason for why we have been a bit conservative around this has been we had obviously an assumption that there could be this famous catch-up effect where you see a big inflow with people on waiting. But so far, it has continued, especially with what we've seen on the house dust mite. So that has obviously been positive and driving it upwards. So that's the patient side. On the gross margin?

Yes, Claus here, let me take that one. Thomas, it's a good question. And you're completely right that we are seeing a better gross margin improvement than what we had expected. And that's also why we have been able to lifting the outlook for the EBIT. To your question about what is it actually that are driving it, most of those 2% are actually, if you look at it, coming from the volume mix of products here. So we are simply selling products with a higher margin. And then you can say, so what about the yield and the scrap and variance improvements and so on.

They are also there, but it's important to understand that we also have the inflation increase on our production inputs into the manufacturing area. And actually, as it stands right now, then we expect for this year that the increase in inflation to our manufacturing input is being counterbalanced by the improvements in the variances and the scrap and so on. So these two are actually outweighing each other. And that means that the approximately 2% net that you then see is coming from the product mix, selling more tablets to a higher margin.

If you look into '26 on that one, we are not guiding on '26 right now. That's a bit early. We will do that in February. But I can put a bit more flavor on it. You are right that when we come with improvements, as you can say here, around 2%. Then remember, we have normally said that we would like to increase the gross margin 0.5% to 1% year-on-year. That's how we try to improve the gross margin year-on-year. But of course, with such a significant increase in '25, then there could be some headwind next year. And you're also pointing actually to the right reasons, and that's respectively our partner markets.

So next year, you will see an increase in shipments to Torii for lower-margin products. You will see now our partnership with GenSci that also has a lower margin. And you will also see increase in neffy sales also to a lower margin in '26. So these trees are actually, you can say, a drag on our gross margin. We will still have increased tablet sales. So don't worry. We will also work on lower scrap and improvements in the yield and variances. So we will also have that to counterbalance. But it is a good idea to take those partner markets and partners into consideration when trying to forecast on the gross margin next year.

And I think, again, just repeating our long term is obviously the 25% EBIT, but we are making active choices in investing in the business back to what we also stated during Capital Markets Day. But obviously, we are happy with both where the gross margin is and also the ability to deliver above the 25% on EBIT.

Just to your last question on R&D spend, I can start and also on the sales and marketing and Claus can chip in and Per. But basically, you see the increase due to the trial activity. We just talked about China. We also talked about the continuation of peanut et cetera, and the investments into those, that is naturally increasing. We are preparing for the next phases of the study.

So overall, that is part of driving the cost upwards. We've said long term that we will be between 10% and 15%, but we also said that the 15% is more on the extreme end, we should expect more the 10% to 12% overall. Do remember that with the Phase III trials coming in, then obviously, R&D spend will go up. They are naturally more expensive. So anything to add, Claus?

No, I think it's very right what you're saying. And just to maybe add, besides the Phase III trials that we are starting up next year, and we are already starting to prepare for those even actually before we know the results from the Phase II because we, of course, feel comfortable around that. So we have to start planning and that will then hit the 2026 numbers.

And then you are right, we will also see an increase into the commercial space next year, like we will see in Q4, children launches, neffy and so on. So when you combine both the Phase II and Phase III next year and the extra investments into our 2 very important commercial launches and activities rest of this year and next year, then we feel quite comfortable about the long-term financial EBIT around the 25%. So that is still the plan. I hope that explains Thomas, for all your questions.

Very good. Maybe if I can just ask a follow-up in regards to -- maybe we spill over to the product mix comment. So I'm just curious on Japan. So some very upbeat comments from Shionogi recently. But of course, there's a standstill. So anything we should look into in regards to product mix? Because I guess probably we could see still some low numbers in Japan already from the beginning of the year. So any comments on when that standstill will potentially end?

No. So I think that the short answer there, Thomas, is that we do expect to see growth in Japan. And the facility that Torii is inaugurating is expected to come online. So we actually believe that next year is going to be a good growth year in Japan. But obviously, there is a timing element to it, and that is key for us going forward.

When will the cedar pick up based on the pass-through of the manufacturing of the API. So that is coming. But we do see that things are coming online. Shionogi committed to both the partnership, but certainly also to the market. And hence, we are very positive around the future trajectory in Japan.

The next question comes from Jesper Ingildsen with DNB Carnegie.

I also have 3 questions. Firstly, coming back to the pediatric launch. So you highlight now that you are expecting to see 1 to 2 percentage point contribution from that launch in this year, considering sort of like the momentum we're seeing here and continuous rollout, any flavor you could provide in terms of sort of like what we should expect going into next year? I guess, Thomas' question to some extent in terms of new patient starts alluded a bit to that as well, but just any more -- if you can give any more flavor on that?

And then secondly, on neffy, I think ARS Pharma the other day mentioned that the launch in Germany is off to a strong start. I think they even said the market share capture was 3x higher than what they have seen in the U.S. just in the first few months. If you could give a bit more flavor on that launch and what's potentially driving that faster share gain compared to the U.S. in your view?

And then lastly, on capital allocation, your balance sheet is obviously looking increasingly strong. Just any update on what we should expect there in terms of buybacks, dividends and then just M&A in general. So like what's your view at the moment?

Thanks, Jesper. Let me -- it's Peter. I'll start out with the first 2, and Claus, if you take the capital allocation, then and chip in any time. But just on the first, as you know, we cannot guide on next year. But obviously, we have upgraded what we saw this year on the [ P ] side. This is, as we also stated, driven mainly by ACARIZAX, and we saw the continued influx of patients, obviously, positive. Early on the ITULAZAX initiation season in terms of getting data, we are positive. We have seen a good influx, but I think it's premature to say a lot more on that one at this stage. But I'll just say, overall, we remain positive also due to the fact that we've seen these 3,000 unique or new prescribers coming in. So overall, positive.

But I'll just caution that we still have data coming in, and we need to be a lot wise on that one. So that's as much as we can say. Then neffy and ARS' comment on Germany. It is correct that we've seen a good start in Germany. The game right now is very much around market access. It is very much around securing that we also have an inflow or we make a move into the automated renewals. That is where a lot of the existing market lies. So we need to continue to focus on that. But we are also encouraged not only by the uptake we've seen in Germany and the market share gain we've had so far, smaller volume market, though, but actually also in terms of the mix of the prescribers, both a strong growth with general practitioners, which is not where we send our people physically.

So our online effort and digital effort has worked well, but also in other prescriber groups. So that is obviously a positive. But I'll just again, especially because it's early days and the volumes are a little more up and down in markets -- in smaller markets, I'll also caution that we'll see some swings, obviously. But that being said, ARS and we appreciate the positiveness on their side, then it's absolutely good to see so far. So I'll leave it there. Claus, on the capital allocation.

Yes. Thanks for the question, Jesper. Good question. There's no doubt, as we have also said, then this is a quite unique year for ALK on the cash situation. If you go a few years back, then that was not a big challenge for us related to cash because we didn't have that much. This year, we are guiding for more than DKK 1 billion in free cash flow related, of course, to the much higher sales, the gross margin and the EBIT coming in. So a strong year this time.

Related to how we are going to spend it and how we are looking at it, then we have already communicated around our long-term financial targets and when we had the New Allergy Plus strategy back at our Capital Markets Day that first, we would like to invest into our commercial opportunities, the children, the neffy and so on and then the R&D. We will, of course, also invest into tablet manufacturing and make sure that we invest for the future there. Right now, we have capacity. We are producing 300 million to 400 million tablets every year. We can go up to 800 million, and we need to make sure that we can continue to deliver the millions and soon billions of tablets to the market.

We also have, as we have communicated, activities on the BD, business development part. You saw the neffy collaborations, you saw the China one. There could be some activities there where we would like to invest into. And then when we have looked at all this, then we have also said very clear that we don't want to be a bank. We will not sit with cash on the balance sheet for a long time. So if we are in a situation where we cannot spend our own cash flow coming in, including what we have in the bank already on the things I just mentioned, then we are, of course, looking into dividends, share buybacks or what it will be. But this will be a discussion with the Board, of course, here around the Annual General Assembly, and then we will come back with an answer there. I hope that explains, Jesper.

[Operator Instructions]

The next question comes from Sushila Hernandez with Van Lanschot Kempen.

Just 1 on neffy as well. So you mentioned in Germany that there is a long-standing clinical practice favoring traditional adrenaline products. So what is your strategy to move away from this? And also any color on how this is looking for the U.K. market?

Okay. So I can start on the neffy. Firstly, thanks for the question. Good question. So this is obviously a -- for classical, I'll try to just dial it back. What we are seeing is, obviously, you have a pattern with the prescribers where they are doing automated renewals. So as a patient, you will call down once a year and you'll get your renewal on your adrenaline pen. What we're seeing, obviously, now coming in with a new product is that not only the doctor, but the whole practice needs to be educated and you need to get in the system, including also ensuring that the patient, on the sense, have seen the product. That is part of changing the existing prescription patterns.

Then there's the whole influx of new patients created through patient awareness, a lot of attention from doctors in terms of new products, et cetera. This is where we obviously have a big focus, that is ensuring that there's education, training of doctors, KOLs, et cetera, ensuring that we are present at conferences, et cetera, and also that there's a general awareness in the public. This is back to my comment around the digital effort where we are putting a lot of focus on this.

And then obviously, with the nurses and the other practitioners, this is where our team have an ongoing dialogue with the clinics, and we ensure that both KOLs and others are participating in the training. That goes not only for Germany, that goes for any of the markets we are present in. So that's the answer on neffy. Yes, Per, please jump in.

Maybe add on U.K., which was also part of your question. And as you know, we have launched in U.K. We secured pricing. And now the next step is to make sure that it's also anchored in the local formulary listings. And that is going to be the key focus here over the coming months in the U.K. So before we get a sense of how it fares in the U.K., I mean, we are into next year in reality also now considering that we are moving into the low season, the classical low season for anaphylaxic product in Europe. But here, in the short term, the focus is really on making sure that it's anchored in the local integrated care trust and systems on the formularies.

Did that answer?

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

Thank you, operator, and thank you for your good questions. Before we end the call, I would just like to draw your attention to our Q3 road shows, which brings us to Copenhagen, to Canada, to London, Oslo, et cetera. And we hope certainly to see you around some of these events. As always, you're most welcome to contact either one of us if you have additional questions. And with this, we will end today's session, and we wish you all a good day. Thank you very much.