ALK-B.COALK-B.COCPH
Loading
Per Plotnikof: 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.
Peter Halling: 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.
Claus Solje: 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.
Peter Halling: 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.
Claus Solje: 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.
Per Plotnikof: 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: [Operator Instructions] The first question today comes from Thomas Bowers with SEB.
Thomas Bowers: 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?
Peter Halling: 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?
Claus Solje: 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.
Operator: The next question comes from Benjamin Jackson with Jefferies.
Benjamin Jackson: 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.
Peter Halling: Perfect. Thanks, Benjamin. Per, if you take the first one on the communication, I'll answer the last 2.
Per Plotnikof: 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.
Peter Halling: 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.
Operator: The next question comes from Jesper Ingildsen with DNB Carnegie.
Jesper Ingildsen: 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?
Peter Halling: 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.
Operator: The next question comes from Sushila Hernandez with Van Lanschot Kempen.
Sushila Hernandez: 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?
Peter Halling: Thanks. So Per, will you jump on the ALK-014?
Per Plotnikof: 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.
Peter Halling: 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.
Sushila Hernandez: Yes. That's clear.
Operator: [Operator Instructions] The next question comes from Thomas Bowers with SEB.
Thomas Bowers: 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?
Peter Halling: Thanks, Thomas. Claus will take International markets and the gross margin, and I'll comment on neffy. So Claus?
Claus Solje: 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.
Peter Halling: 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.
Operator: This concludes our question-and-answer session. I would like to turn the conference back over for any closing remarks.
Per Plotnikof: 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.