2/20/2026

speaker
Per Plotnikoff
Head of Investor Relations

Hello, and welcome to the presentation of ALK's Q4 and full year 2025 results. My name is Per Plotnikoff. I'm head of investor relations, and thank you all for joining. On slide two, I will present the speakers and agenda for this call. And with me today are CEO Peter Halling and CFO Claus Steensen Sølje. 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 and slide number three. Please go ahead, Peter.

speaker
Peter Halling
Chief Executive Officer

Thank you, Peter. 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 three key strategic developments in the quarter. Firstly, the pediatric rollout of our house dust mite and tree pollen tablets, Acarisax and Etudasax, provides wider access to prescribers in key markets and continue to perform very well. Secondly, the European rollout of Euronefi, or just Nefi, continues following our initial launch in Germany in late June. At the end of 2025, Euronefi achieved an 18% value share in Germany. And since then, we have now also launched in the UK. And by year end, market access was also in place in Greece, Denmark, Slovenia, with launches expected shortly. While we are still in the early phases, the initial market response to Nefi supports the product's long-term potential. At the same time, established clinical practices still favor traditional anaphylaxis treatments, and we will continue working diligently with the medical communities to drive adaption. Most recently, we received a positive opinion in late January from the European authorities for the approval of the one milligram version of your NEFI 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 US, 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 in the Flaxes as key drivers. EBIT increased by 88% with a margin of 22%, as expected, reflecting continuous 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 four. 2025 became a landmark year for ELK, and we clearly exceeded our initial expectations for the financial performance. Revenue grew by 15% in local currencies to 6.3 million DKK, which is 1 billion US dollars, 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 three full-year milestones. The commercial momentum was underpinned by a solid expansion of our patient base. We treated 500,000 patients more in 2025, so that a total of 3.1 million patients are now treated with ALK's products. This was made possible not least through the continued expansion of our tablet business. For example, the rollout of a Carisax and a Tulisax for children helped broaden the patient inflow and adaption 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 Urinefi, 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 AllergyPlus 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, Gensai. 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 355 million Danish kroners for 2025 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 five.

speaker
Claus Steensen Sølje
Chief Financial Officer

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 Akaisax, supported by the build-up of patients who had started on grass pollen tablets in prior years. The new paediatric indications for acai sacs and our tree pollen treatment, etula sacs, also added positively to the growth. Overall, acai sacs and etula sacs were the biggest contributors, while our grass treatment, grass sacs, continued to grow steadily. Performance was particularly strong in Central Europe, including Germany, France and several Eastern European countries and the UK. In the UK, we continued to progress market access for our key tablet products. Akaisax and Etulasax became the first AIT tablet treatments admitted to the National Health Services 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 GRASACs 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 SCID and SlitDrops were up modestly by 3%. SlitDrops continued to benefit from a growing prescriber and patient base in France, while SCID were more muted. In our main SCID markets, Germany and the Nordics, patient initiations were to some extent impacted by patients choosing tablets over SCID for the indications covered by our tablet portfolio. Finally, anaphylaxis and other products grew strongly by 34%, driven by checks on solid execution, tender winds in Southern Europe, and competitor supply issues. We also saw a positive, although modest, contribution from the initial Euronefi introductions in Europe. This growth also underlines the value of having a portfolio approach in anaphylaxis. Turning to North America. In North America, revenue regained growth in 2025 and increased 19% driven by tablets and anaphylaxis and other products. The US legacy business recovered from last year's stagnation and growth was driven by continued adoption among existing allergies prescribers and, to a minor extent, uptake among pediatric prescribers. Canada has sustained a higher growth rate. Here, tablets remain the main product line and the growth afflicted 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 AIS Pharma related to the co-promotion of NEFI in the US, 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 Shinoki, continued to grow sales by double-digit, although capacity constraints still limited its ability to fully meet demand for Cetacure 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 skip 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 six. 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 the pediatric launches of Akai sacs and Etula sacs 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. Skid and slid drops delivered a 5% sales growth for the year based on resumed shipments to China, offset by the previously 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 JEC sales, although NEFI 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 6.3 billion Danish kroner. It is marking the first time that ALK exceeded 6 billion DKK in annual revenue. It also represents the seventh consecutive year of growth, which results clearly exceeding our initial expectations of a 9 to 13% increase in revenue. Gross profit increased to 4.2 billion Danish kroner, yielding a gross margin of 67%, up three 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 increasing materializing in the business. Capacity costs increased by only 6% in local currencies to 2.6 billion Danish kroner. In comparison, capacity costs increased by 9% when excluding the impact of restructuring costs in 2024. In line with our plans, R&D expenses increased by 15%, reflecting investments in our pipeline, including the peanut tablet development program, preclinical projects, and the phase three bridging trial with Akaisax 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 Nefi, while administrative costs increased modestly. Unlike last year, capacity cost in 2025 did not include any one-off expenses. Operating profit, EBIT, increased to 1.65 billion Danish kroner and the EBIT margin improved to 26%, up by six 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 1.4 billion DKK compared with negative 204 million DKK in 2024. The improvement reflects the higher earnings and an upfront payment from Gensai of 244 million DKK. In addition, 2024 included a 1 billion DKK license payment to AIS Pharma and 115 million DKK related to the pre-print acquisition. 2025 investments primarily reflected build-up of capacity for tablet production, upgrades to legacy production, a milestone payment to AIS Pharma related to the first commercial sales of Euronefi 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.

speaker
Peter Halling
Chief Executive Officer

So before diving in to our strategy progress, I would like to address the change in management announced this morning. Henriette Merzenbach will step down from her position as member of the Board of Management and Head of Research and 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, ELK's former head of R&D, as a special advisor 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 three 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 Turbine launches, we expanded both our prescriber and patient basis during the year, increasing the number of patients treated with ALK's products by around half a million, or 500,000, to an estimated 3.1 million. The majority of this increase, around 300,000, came from tablets, including children and adult lessons. So tablets remain an important driver for growth going forward, remain on track towards our ambition of helping 5 million people, every year by 2030. Today, the Hausdorfsmyte tablet Acerisax or Dactra in North America is approved for children in 30 countries and launched in 21 of them. Our tree pollen allergy tablet Etulisax or Etulitex 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 two tablets to children. And we continue to see strong cross-tablet adaption. In key European markets, more than 90% of pediatric etulosax prescribers also prescribe acarosax. And in Germany, among other countries, pediatricians have emerged as an increasingly important prescriber group. In the US, we expanded our reach in the pediatric segment with a co-promotion agreement with ARS Pharma. In the UK, the admission of Acarisax and Etulisax to the NHS with general reimbursement represents an important structural step in a historically undependent traded AIT market, with further work ongoing to extend access locally. We also made good progress with our two new partners, Gensai in China and Shunoki in Japan, following the acquisition of Torii in 2025. 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 have already secured access to prescribers. At the same time, we expect to launch tablets for children in additional markets so that adult, adult lessons and children all can benefit from our treatments no matter where they live. In anaphylaxis, NEFI is a strategic enabler of Allergy+. In 2025, we have moved into early commercial execution in Europe and in North America. The co-promotion agreement with Ares Pharma in the US is a lever to expand our market reach and build further insights. For this year, our focus is to succeed with NEFI. We expect 2026 to be a built-up 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 NEFI and JEXT to serve different patient and channel needs and to further strengthen our overall footprint in emergency allergy care. So let's continue to slide nine. In food allergy, we initiated a phase two clinical trial of our peanut tablet, which has received fast track designation from the FDA. We are on track to report phase two top line results in Q2 this year. Our focus for 2016 is to advance the peanut program into progressing it into phase three. Of course, again, subject to positive data coming out of phase two. In addition, we progress preclinical programs in new disease areas and our partner ARS Pharma initiated a Phase 2b trial with NEFI for 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 ELK. 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 benefits 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.

speaker
Claus Steensen Sølje
Chief Financial Officer

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. For us, revenue is expected to grow 11-15% 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 anaphylaxis and SCID. 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 adolescents 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 NIFI. Skid and slid drops revenue is projected to grow by single digits, driven by higher skid volumes to China, modest volume growth in Europe across skid and slid drops, and improved skid 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 NEFI sales, which also holds lower margins. Production efficiencies, reduced grabbing 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 800 million to 1 billion DKK Cabex is projected at around 500 million DKK with a focus on production capacity, expansion and IT infrastructure. Potentially 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.

speaker
Per Plotnikoff
Head of Investor Relations

Thank you, Klaus, 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.

speaker
Operator
Conference Operator

Thank you. We will now begin the question and answer session. To ask a question, you may press star then 1 on your touchtone phone. If you are using a speakerphone, please pick up your handset before pressing the keys. If at any time your question has been addressed and you would like to withdraw your question, please press star then two. At this time, we will pause momentarily to assemble our roster. The first question today comes from Thomas Bowers with SDV. Please go ahead.

speaker
Thomas Bowers
Analyst, SDV

Yes, thank you very much. I hope you can hear me. I had some sound issues. Am I getting through here?

speaker
Peter Halling
Chief Executive Officer

Somewhat, Thomas. We can hear you.

speaker
Thomas Bowers
Analyst, SDV

Perfect. Great. Thank you very much. So first question, just on what level of contribution should we think for the CDS indications here for your 2026 growth guidance? And given the early launch directory, any first take there 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 your remarks, but maybe there's a split here between specialists and pediatricians among those 4,000 subscribers. And how does it look right now with... 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 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? Are we looking at potentially even sort of a price parity here on the sit drops and tap sets? So I guess the question here is whether there may be any dynamics that could give you any potential competitors, headwinds or tailwinds in France in the wake of this price adjustment. Yeah, thank you.

speaker
Peter Halling
Chief Executive Officer

Thomas, Peter, I think we caught them all. I'll start out, and I'll have Klaus and Peter jump in as well. But let me start on the contribution from PEATS and the PEATS potential. I know last year that we gave an indication of 1% to 2% from the PEATS and the 1% on NEFI, or less than 1% on NEFI. 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 Pete's 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 one-to-one. But obviously, we are very positive that this continues and the interest is there, because that gives us the future prescriber expansion that 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 Klaus 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.

speaker
Claus Steensen Sølje
Chief Financial Officer

Yeah, I can do that. Thanks so much 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, a really big, you could 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.

speaker
Thomas Bowers
Analyst, SDV

That's great. Thank you very much.

speaker
Operator
Conference Operator

The next question comes from Benjamin Jackson with Jeffrey. Please go ahead.

speaker
Benjamin Jackson
Analyst, Jeffrey

Great. Thank you for the question, guys. 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? or beyond just the actual signal-seeking in this study? Are you trying to meet an internal bar to take it forward, or is just simply 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 tablets have 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 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 NEFI and CFU in your regions? Obviously, your partner has been quite but 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. Thank you.

speaker
Peter Halling
Chief Executive Officer

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

speaker
Per Plotnikoff
Head of Investor Relations

Thanks, Ben. So, on the communication of what to expect from our comps 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 the top line results. 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 three study. So that means what exact dose will we be going with what's the treatment regimen going to be looking like, the up titration schemes, potentially also what will be the treatment duration we see in the maintenance phase etc. So there will be a lot of information, obviously also the safety profile of the doctor, sorry I forgot that, So, there will be a lot of information that we can draw out of this phase two. And, of course, that will inform our phase three 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 a 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.

speaker
Peter Halling
Chief Executive Officer

Okay, thanks, Pia. So, your question, Benjamin, on respiratory tablets and kind of the comparison with US peanut. I think it's, first, it's two 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 a US 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, etc. 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 just want to make sure that that's clear. So that's the US. 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 NEFI 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 US and in Europe. So emergency room treatment, the cost of emergency room visit in the US 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 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 can 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.

speaker
Benjamin Jackson
Analyst, Jeffrey

Thank you so much.

speaker
Operator
Conference Operator

The next question comes from Jasper Engelsen with DNB Carnegie. Please go ahead.

speaker
Jasper Engelsen
Analyst, DNB Carnegie

Hi, thanks. I'll take my questions. I have a few as well. Maybe also just on keynote. I'll be interested to hear sort of like on how you see the recent developments in this space amongst others, TSK acquiring RPC through physics and also sterling ends. taking the foreshore off the market if this changes your view and 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. I guess there could be some concerns that's taking place just before the peanut readout here in Q2. But on the other hand, I also understand it's maybe more valid, sort of like, The longer-term pipelines, I'd be interested to 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 Netflix, so you highlighted in your report that you have captured about 18% market share in value in Germany. If you have been at 25, just be curious to hear what you've seen in terms of the volume terms, and also if you've seen any negative impact on cannibalization on checks in Germany specifically, but also overall, what kind of growth contribution you expect in 26. Thanks.

speaker
Peter Halling
Chief Executive Officer

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's 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 SOLER. The price point I cannot comment on, but obviously more than $2 billion, I think, sends a signal, 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. Then 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 Pelforcia, it's been pulled from the market. I don't think it was a secret that initially it was struggling. Then Stella Shen 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 Palforcia. So I think that's on the peanut allergy 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 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 with 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, ELK 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, BDNL. 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 good control of where Henrietta 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 ask about NEFI 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 UK, US, 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 80% 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.

speaker
Jasper Engelsen
Analyst, DNB Carnegie

Yeah, that's perfect. Thank you.

speaker
Operator
Conference Operator

The next question comes from Susila Hernandez with Plan Landsat Jensen. Please go ahead.

speaker
Susila Hernandez
Analyst, Plan Landsat Jensen

Yes, thank you for taking my questions. Could you share a bit more about ALK014? Is it for ID-mediated food energies? um and also at what stage for clinical development is this asset when could it potentially go into the clinic and also maybe connecting to the previous question what kind of profile are you looking for for your new head of r d thank you

speaker
Peter Halling
Chief Executive Officer

Thanks. So, Per, will you jump on the LK014?

speaker
Per Plotnikoff
Head of Investor Relations

So, the LK014 program is an early stage program currently in preclinical development. And we work here with a different modality. So, it's a fusion-like antibody protein we work with. So it works upstream in the immune cascade, so to speak. So different modality. It's a biologic. It's still early stage, but we do expect, if everything goes well, that over the coming one to two 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 nondisclosed indications at this stage. More on that later. Super exciting program, but still early.

speaker
Peter Halling
Chief Executive Officer

Thanks, Ursula. So let me just, again, 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 BDNL 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's 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. I'll also just note that Henrik Jacobi will be assisting ELK as a special advisor to help us also continue to progress the internal pipeline. So I think we are in a good position. I hope that answered, Cecilia.

speaker
Susila Hernandez
Analyst, Plan Landsat Jensen

Thank you. Yes, thank you. That's clear.

speaker
Operator
Conference Operator

As a reminder, if you would like to ask a question, please press star and 1 to join the question queue. The next question comes from Thomas Bowers with SEP. Please go ahead.

speaker
Thomas Bowers
Analyst, SDV

Yes, thank you very much for taking a few follow-ups. So just a quick question on international markets. So I understand the facing, the quarterly facing here, but how should we look at at least Q1, Q2, and how much is actually still dependent on this Yonobi takeover completion, the standstill 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 just on the gross margin outlook, I, of course, understand the mixed 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 NEFI. So, as I said, 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 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? Thank you.

speaker
Peter Halling
Chief Executive Officer

Thanks, Thomas. Klaus will take international markets and the gross margin and I'll comment on EFI. So, Klaus.

speaker
Claus Steensen Sølje
Chief Financial Officer

Yeah, I will thank Thomas. Related to the international markets and what we are seeing there from a gross 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 gross 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 gross perspective a big impact in in the first half that will come in the second half if i then take the gross margin just to to go up a bit in the helicopter then then yes we 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 slight decline here in 26 versus 25. And that is due to the mostly the increased sales in the partnership. So, when we do it with Tony, now Shinogi, and then Gensai in China, and of course, the increase of our Nefi with AIS, that is all coming with a 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.

speaker
Peter Halling
Chief Executive Officer

On the NEFI question and the market share, obviously we've been positively surprised about the ability for NEFI to win an 18% value share in the market. Do remember, I think we also noted it 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, etc. So it's not kind of what you would normally expect, which is in this case a positive. When we look at the UK and Canada, UK, it's really about getting in on formal areas 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 drive 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 budgeted 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 healthcare 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 in on the back-to-school season in Canada. This is also going to be an interesting run where there seems to be a little more openness to get some penetration in the Canadian market. So again, a different market than UK and Germany. And then lastly, I'll just mention that we still are waiting on launching the 1 milligram in Europe. So for... 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 that 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 NEFI is going to be an increasing contributor to the business. So I hope that gives you some answers and nuances.

speaker
Thomas Bowers
Analyst, SDV

That's very helpful. Thank you very much.

speaker
Operator
Conference Operator

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

speaker
Per Plotnikoff
Head of Investor Relations

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 number 12, and we hope to see you in the near future, either 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.

Disclaimer

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