Alk-Abello As B Shs New

Hello everyone and welcome to this presentation of ALK's Q2 results and the revised full year outlook. Thank you all for joining us. Let's turn to slide number two with an intro to the agenda and the speakers. My name is Per Plotnikoff, I'm Head of Investor Relations and with me today are CEO Peter Helling and CFO Claus Steensen-Sølje. We'll first be sharing a couple of highlights from Q2, followed by a closer look at market and product trends, as well as half-year financials. We will then provide an update on recent progresses and on the pediatric agenda, our NEFI partnership, and other strategic priorities before we present the updated full year outlook. As usual, we will end the presentation with a Q&A session. To get started, I'll hand over to Peter for slide three for the highlights. Please go ahead, Peter.

Thank you, Per, and thank you all for joining this call. Commercial execution of the key strategic initiatives, including the children launches, was on top of our agenda in Q2. These initiatives started contributing to sales growth in Q2, although they are still all in early stage. The initiatives have come off to a good start, and this bodes well for ALK's ability to deliver sustained profitable growth going forward. In Q2, the ongoing rollout of our Carisax tablet for children with HSDM allergy is progressing well and have continued to exceed expectations. We also started the launch of the Tulisax tablet for children and adolescents with tree pollen allergy in European markets and Canada to secure that tablets are available for the coming pollen initiation season. Moreover, we launched the Euronefi adrenaline spray in Germany, the first EU market entry. Additional launches are lined up for the second half year, including the important UK market, where Euronefi was recently approved. Across markets, the initial feedback from stakeholders is very encouraging. In the US, we entered a co-promotion deal with ARS Pharma, enabling us to establish a new pediatric sales force to promote both NEFI and, in the future, ALK's respiratory tablets. Around 60 salespeople have now been onboarded, trained, and are fully deployed in the field. Market expansion also continued in other geographies. I'll detail this later. Q2 results exceeded expectations. Back in Q1, we expected revenue growth to soften temporarily due to lower shipments to international markets and destocking at European tablet wholesalers. Instead, we saw a 12% revenue growth driven by adrenaline autoinjectors and an improved momentum for the Acarisax tablet in the house dust mite AIT market in Europe. Q2 earnings improved by 41% in local currencies to 375 million Danish kroners, yielding an EBIT margin of 25%. Progress was driven by sales growth, gross margin improvements and last year's optimization and prioritization initiatives, which generated savings of more than 300 million DKK throughout 2025. These savings are allowing us to pursue strategic priorities more rigorously this year without jeopardizing earnings improvements. We also expect the improved sales momentum to continue into the second half year. Consequently, we upgraded the full-year outlook last week. We now expect full-year revenue to grow by 12-14%, while we maintain the EBIT margin outlook as we intend to allocate additional funds to growth initiatives. Remain optimistic about the remainder of the year, despite global unrest and turmoil from tariff wars. With this intro, I'll hand it over to Klaus and the market trends on slide 4.

Thank you, Peter. Let's take a closer look at the performance in our sales regions. Our main region, Europe, reported 13% growth. Revenue exceeded our expectations, driven by better than expected sales of anaphylaxis products and tablets. tablet sales in Europe increased by 17% on broad-based growth across countries. We saw reduced impact from price and rebate adjustments, meaning that growth was mainly driven by the plus 10% increase in new patients during the 2024-25 initiation season, and growth was reinforced by a steady inflow of new Akaisax patients in France, Germany, Eastern Europe, and other markets. The new pediatric indication for Akaisax contributed positively to revenue growth, while the contribution from the new Itulasax children approvals was modest, reflecting the early stage of the ongoing launches. Q2 tablet sales growth was similar to Q1, even though the impact from inventory build-ups at wholesalers in markets like Germany and France is estimated to have declined in Q2. This highlights the improved momentum for tablets in Europe, and we expect this momentum to continue into the second half year. Combined sales of skid and slit drops grew by 1%. Slit drop sales continued to increase in France, whereas skid sales fell short of expectations with a modest decrease. This decrease was partly due to fewer new patients and partly due to a reduced impact from price and rebate adjustments compared to previous years. Sales of other products were up by 51% in Europe, led by a 62% growth in the anaphylaxis portfolio. Sales of our adrenaline auto-injector JEXT benefited from strong commercial execution and favorable market dynamics, including supply issues from our competitors. Revenue also included minor UNEFI revenue from pipeline filling ahead of their launch in Germany. Revenue in North America increased by 17%. The US sales continued to bounce back from last year's stagnation as we benefited from a range of initiatives to rebuild growth across product lines. The tablet business in Canada also did well with growth rates exceeding those in the USA. Tablet growth in North America grew by 32%. The new pediatric indication for Adacta, our house dust mite tablet in the U.S., led to a higher uptake, especially among allergists and, to a minor extent, new pediatric prescribers. The new pediatric indications also contributed to growth in Canada. North American sales of SkidBulk increased by 2%, while sales of other products increased by 23%. Moving to international markets, revenue grew modestly by 1%, reflecting phasing of product shipments to China. After the recent renewal of ALK's import license, we resumed skid shipment to China in Q2, but shipments, as expected, were at a lower level than last year, so skid revenue in the region decreased by 20%. But Chinese in-market sales of skid continue to grow by double digits based on existing wholesaler inventories. Tablet revenue in international market was up by 9%. The primary market, Japan, delivered low double-digit revenue growth from royalties and shipments, although capacity constraints still prevent our partner, Tomei, from fully meeting demand. We expect Tori to start operations of the new API manufacturing facility in Q3 with a view to roughly doubling capacity and then incrementally increase market supply of CETA Cure tablets. Now let's turn to the product lines on slide five. Tablet revenue was up 16% on good performance in all three sales regions. Growth was predominantly driven by higher volumes linked to more patients. Revenue from skid and slit drops was down 1%. Performance was impacted by fewer shipments to China and the decline in European skid sales. These factors was then partly offset by growing slit drop sales in France and increasing skid bulk sales in North America. Global revenue from other products increased by 30% to 215 million Danish kroner. The Anaphylaxis portfolio led the way with 56% growth. JEX did very well in Europe, and NEFI also contributed, including a minor estimated cost reimbursement from AIS Pharma related to the new co-promotion agreement in the US. We also saw good performance from other products in the US, including PPN and life science products. After these quarterly updates, let's move to the half-year results on slide 6. Revenue was up 12% in local currencies and exceeded 3 billion Danish kroner. Topline growth mainly reflected growth in tablet and text sales. A gross profit of 2 billion Danish kroner yielded a gross margin of 66%, an improvement of 2 percentage points. The increased mirrored volume growth changes to the sales mix and various production efficiencies, partly offset by higher input cost. Capacity cost decreased by 1% in local currencies to 1,167 million Danish kroner following last year's optimization and prioritization initiatives, where we downsized operations in certain markets and further adjusted the organization in China. R&D expenses grew by 8%, while other capacity costs declined, so that the overall capacity cost to revenue ratio decreased by 5 percentage points to 38%. However, please also bear in mind that some phasing of activities contributed to this development. In the second half of the year, we plan to increase our spending linked to the key product launches. The operating profit, EBIT, was up 46% in local currencies to $844 million, raising the EBIT margin from 21 to 28 in the first half year, despite a little currency headwind. Progress was driven by higher sales, gross margin improvements and lower capacity costs. No one-off cost to optimization efforts were recognized opposite to last year where one-offs amounted to 38 million Danish kroner. Free cash flow doubled to 546 million Danish kroner as higher earnings offset planned changes in working capital and investments to build up tablet production and upgrade legacy production. Some of the cash generated was used to repay loans, bringing the net debt to EBITDA ratio down to 0.1, highlighting that we do not have any debt at this stage. The cash flow also included 5 million USD in milestone payment to AIS Pharma related to the first commercial sales of Eurodenefi. All in all, the best half-year performance so far. So with this, back to you, Peter, and slide seven for an update on the strategy execution.

Thanks, Klaus. Let me kick off this strategy section by providing some insight into the ongoing launches of our respiratory tablets for children. I'll start with the HowStuffMy tablet, branded AcaraSax in Europe and Odactra in North America. At the end of Q2, the HowStuffMy tablet for children had been launched in 10 European markets, two North American markets served directly by ALK, as well as three Southeast Asian markets served by our partner Abbott. Market access processes are well underway in other countries, so additional market launches are planned for the second half year and the rollout continues into 2026. In Q2, we also started to roll out the tree pollen tablet named Etula Sax, tablet for young children and adolescents aged 5 to 17. This tablet is approved by 17 EU countries and Switzerland, Canada and the UK, and it's launched in nine of these markets. Our first goal is to build a solid prescriber base ahead of the main initiation season, which typically starts in late Q3. Over the next six to 10 months, we plan to launch a Carasax and a Tulasax in 10 additional EU and non-EU markets, depending on the local market access conclusions. So far, the key indicators continue to exceed expectations. This includes endorsement from key opinion leaders, number of confirmed doctor visits, number of prescribers, and the number of patients starting the treatment. In June, more than 2,000 prescribers were estimated to have prescribed the tablets for children in markets served directly by ALK. It is still early days, but the market response is encouraging. We expect to see a steady growth in the patient and prescriber base in the second half year. As the rollout of the two key tablets primarily focus on existing tablet prescribers, we are also working on mobilizing new prescribers, not at least in the pediatric field, and pushing the halo effects from having a complete tablet portfolio, which covers both the common respiratory allergies and is now indicated for all age groups in relevant markets. Attracting more patients and opening the doors to more prescribers is key for our goal to make the pediatric segment an important catalyst for ELK's continued long-term growth. Slide 8, please. If we move to anaphylaxis and our efforts to commercialize Urnafi, the first and only approved nasal spray for emergency treatment of acute allergic reactions. We launched Urnafi in Germany in June, the first market interest since the EU approval. Furthermore, we secured regulatory approval in the UK, currently Europe's and the UK's largest anaphylaxis market, where we plan to launch later this year once local market access has been settled. We are also in an ongoing regulatory review in Canada, where we expect an outcome around year end. Going forward, we see Germany, the UK and Canada as cornerstones for NEFI. Market access negotiations progress as planned in the other EU countries, and a price premium relative to adrenaline autoinjectors has so far been secured in Germany and Slovenia, the first two markets to settle price and reimbursement. The initial response to our pre-launch and launch activities is very encouraging, and the medical community takes a substantial interest in this new treatment concept. However, I also want to emphasize that we do expect it will take some time to build the sales momentum and change long-standing automated prescription patterns. Our market building activities, including working with key opinion leaders, including guideline authors, presentations at scientific congresses, scientific papers, digital engagement with HCPs, methods to engage new customer groups, as well as efforts to activate patients. Besides the UK, EU and Canada, we also intend to make NEVI available in other territories covered by our license agreements with ARS Pharma. We are planning up to 15 additional European launches over the next 6-12 months and we are also looking into making the product available in a number of international markets outside of Europe and North America. Moreover, we have applied for approval of a one milligram version of the spray in Europe, which will be aimed at small children. In Q2, we entered into an additional agreement with ARS Pharma to co-promote NEFI to more than 9,000 US pediatricians. The agreement has allowed us to build a dedicated US pediatric sales force in a balanced way. A balanced way meant in performance-based cost and revenue sharing with ARS. This sales force is now fully deployed in the field and fully focused on delivering results for Q3 and onwards. Slide nine, please. The Q2 report provides a detailed account of the execution of the allergy strategy. So let me just highlight a few additional hotspots, starting with the ongoing market expansion in select geographies. As Carl mentioned, our Japanese partner Torii expects to start operations at a new API manufacturing facility in Q3 with the view of incrementally increasing market supply of Cetacure tablets. As announced in May, Torii has been acquired and will become a subsidiary of Shionogi. Consequently, the new owner is in the process of dissolving its current partnership with one of our competitors. The new owner will focus exclusively on ALK's tablets going forward, meaning that all activities going forward are planned, including the Phase 3 registration study with our GRASX tablet, which is now recruiting patients. We've also seen positive progress in the UK, where TulaTax tablet is about to become accessible through the public NHS system in England, Wales and Northern Ireland, following a recent endorsement from the influential NICE Institute. In Q1, Carasax was the first ART product to be recommended by NICE and we intend to make submissions to extend the tablet's approval to include the children indication and to make Grasax widely available for general reimbursement in the UK. The tablet's submission to the public health care systems represent a paradigm shift in the market. A market where ART is significantly underutilized. Our combination of tablets and anaphylaxis products will hopefully lead to sizable synergies. However, building this market remains a long-haul effort. In China, we still expect to initiate the Phase III bridging study for Acarisaxon Q3, while in the US, new pediatric sales force is, medium term, expected to provide attractive synergies for the respiratory tablet portfolio. The new sales force, or the addition of new salespeople, will also prepare ALK for entry into food allergy. Moving to food allergy, we completed patient recruitment for the Phase II trial of the peanut allergy tablet ahead of target. 150 subjects were enrolled in this trial, which is expected to report top line data in the first half of 2026. Subsequently, we are planning to move this program into phase three. And in the wider allergy space, work continues to develop treatments for adjacent disease areas through in-house innovation, licensing deals, and partnerships. Our partner, ERS Pharma, is currently recruiting patients for a Phase 2b trial to investigate NEFI and its efficacy in acute flares associated with chronic spontaneous urticaria, also known as CSU. The NEFI indication would be a very good fit in our portfolio. Our agreement with ARS Pharma grants ALK exclusive rights on this and on any other new indications with the product. So, all in all, we are well on track with our strategy and we look forward to sharing additional progress. With this, I'll hand it back to you, Claus, and the outlook on slide 10.

Thank you, Peter. Last week, on August 12, we upgraded the full-year revenue outlook. We now expect revenue to grow by 12-14%, up from the previous outlook of 9-13% growth. The upgrade was prompted by better-than-expected performance in Q2 and an improved outlook for the remainder of the year. We see a good momentum for tablets and anaphylaxis products in Europe, which will continue into the second half year, supported by solid growth in North American tablet sales. Moreover, the new outlook reflects reduced market risk in Europe for the remainder of 2025, although we believe these are still key risks for next year. The higher than expected revenue gives us opportunities to further invest in growth initiatives without jeopardizing our very important 25 in 25 ambition. We will take advantage of these opportunities. Capacity cost will therefore be higher in the second half year than in the first half year, and we still expect the full year EBIT margin to be 25%. Let me take you through some of the key assumptions. We expect full-year tablet sales to grow by solid double digits, driven by more patients, including children and adolescents. Children are now expected to contribute with more than one percentage point of the total growth. We still expect a reduced impact from pricing and rebate adjustments compared to last year. Combined skid and slid drop sales are still projected to grow by single digits. A better uptake of slid drops in France will be partly offset by lower skid sales in Europe. Timing of skid shipments to China may impact growth in international markets in the second half. Sales of other products are projected to grow by solid double digits driven by the anaphylaxis portfolio. UNFV-related revenue is expected to start contributing to the growth in the second half year, including a minor contribution from the co-promotion deal in the USA. The Trump administration's new tariffs agreements with the EU and other countries are expected to be manageable. In first half year, more than 80% of our revenue in the USA comes from products that are sourced locally, produced locally and sold in a closed local ecosystem. Hence, our exposure to the new tariffs is expected to be limited. The gross margin is projected to further improve. Higher revenue, mix changes and efficiencies will drive the margin upwards. But the improvements will be somewhat offset by higher input costs and the impact of the UNEFI in-licensing deal. R&D expenses are expected to increase by a double digit, but will remain at around 10% of the planned revenue. Sales, marketing, and administration costs are predicted to increase by a single digit, while no one-off costs for optimizations are planned for. We believe this new outlook 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 our long-term financial targets. With this, I would like to hand it back to Per and slide 11.

Thank you, Klaus, and thank you, Peter. And we will now move into the Q&A session, and I kindly ask the operator to go ahead.

We will now begin the question and answer session. To ask a question, you may press star then 1 on your telephone keypad. 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 2. At this time, we will pause momentarily to assemble our roster. And the first question comes from Thomas Bowers with SEB. Please go ahead.

Yes, thank you very much for that. So three questions from my side here. So if we just start with the European tablet growth. So how much of this is actually driving the guidance upgrade? I think it was around 50 million. or one percentage point growth contribution included in the initial guidance. So can you maybe just add a bit of color on the expected full year out impact here? And then second question, just moving to Japan. So with the H1 facing we've seen, should we still expect a step up here in the second half, especially with the supply constraints to be solved in the third quarter and maybe also some impact from And then last question regarding the U.S. or North America. So a very strong quarter for tablets. That's, of course, as you mentioned, some stockpiling in Canada for Daxa, but are you also seeing similar, you can say, early traction with the pediatricians as you do in Europe for Fort Dachshund. I mean, is that the case also for the U.S. market in particular? Thank you.

All right. Thanks, Thomas. Peter speaking. I'll hand it over to Klaus on the tablets in Europe, but just start out by saying it's the majority, obviously. But, Klaus, you want to add a bit more flavor on this, and I'll take Japan and North America.

Yeah, I can do that. And I think you actually answered very well here very quickly, Peter, because you're right. If you look at the EU tablet, of course, that is, as we have said, that's a big part of the increase in our guidance upgrade. So the midpoint, as you can see, is kind of moved by the two percentage points. And a large part of that is the tablets driving that on a company basis. We have seen now that the... children launches will be approximately or a bit more than 1% adding to the of the total growth coming in. So it is actually a big part of this. It's important to understand we're only talking about a Kaiser success or the house does mites where we have included that because we can see in the numbers that is starting to take up the tulisak so the treat tablet for children we have not changed our outlook on right now it's still the plans that we had in the plan when we did the q1 that we are still left in there until we start to see some some indications on that one so related to the upgrade it's a big part coming from the eu tablet and here by the akai sucks also for children

Then, Thomas, on Japan, the question around Torii capacity and then Shinogi. So, the capacity is coming online. As you know, this is a product setup where the APIs need to go through kind of the usual production cycles. So, we don't expect a significant contribution yet. But we do expect that this is obviously going to be a step in the right direction. So we haven't added a lot on top. It also needs to start up, but we do expect that this will obviously improve the supply situation in Japan going forward, which is very positive as we all know, SIDA tablets have been restricted by supply and this should alleviate some of that. To a question around Shinogi, Then Shinogi and Torii are in a grace period, if you wish. So basically in the interim between the full acquisition by Shinogi, which is expected to fall in place in the early beginning of next year, January, February. This is as much as we know. In between, Torii continues as is. And then Shownogi will take over and also do the transition from the existing products to the Torit portfolio, meaning ours. So we expect that to move forward as planned next year. North America, you're right, we are happy with what we've seen. I think it's still premature to say that it's ongoing and continued momentum. We're also coming from a low place in terms of the numbers. But obviously, we are pleased to see that the allergists in the US and the allergists in Canada and pediatricians are really starting to embrace Odactra, especially for children. So all in all, that is obviously positive and something we hope will be sustained in the coming quarters as well. And then we are hoping going forward that the inclusion of the salespeople that we hired for Neffy, also bringing in tablets to the portfolio there can be helping the business on the tablet side. So all in all, a good start in North America, early days, but positive.

Great, thank you. And your next question comes from Michael Navad with Nordia. Please go ahead.

Thank you very much. A few questions from my side as well. So first of all on the skid slit, I tried to sort of give a framework for how you see this business going forward in terms of growth or no growth in skid slit. That would be very interesting. And then also on your NEFI. As you said during the prepared remarks, we should remember that this is sort of a gradual launch, but can you try to sort of detail a bit more when you see the strongest traction starting to come? How long time do you believe it takes for convincing prescribers to go for this product compared to Jaxt and other products?

I'll start with that. Okay, thanks Mikael. Let me start out here on both and then Claus and Per can jump in. So I think it's important to say when we look at the skid and slit and I assume you are talking about where we actually see a cannibalization of injectable sales with the tablets moving forward. There's always a risk, but we have different segments. So a large portion of our skid portfolio today is also venom products and other indications than the traditional major allergens like tree pollen, grass and obviously house dust mites. But in those specific areas, we will see some cannibalization, but we believe it is the right way of moving forward. This is also where we believe we stand strong from a competitive standpoint. In the others, like venom, and like many of the other indications where we don't have tablets, we continue to focus on this. And France specifically, as you know, is a different market, the second biggest in Europe. but a different market where the drops are playing a big role and where we actually see the combination of drops and tablets working well due to the expansion at the clinics. So the short answer is there will be a very limited or limited effect outside of the major indications and the major ones we still come from a somewhat lower number. So all in all, we are positive that it's a market expansion game that we're looking at and not a cannibalization game going forward. Then on your Navi and the gradual launch, I think there's two ways, a number of ways of looking at this, but I'll split it for you in this. There's obviously the market expansion in terms of new patients coming in. And there it will obviously be important to have educated the prescribers in terms of the product, so they understand how it works, etc. And that's a key thing and that is ongoing for us. So that's one aspect. The other aspect is what we would call the switching. So basically people who are already prescribed on a pen, that needs to then switch and some of this is automated. So typically what you see in the back to school season is that there will be a lot of automatic renewals and that is where we need to position Navi as the opportunity or option going forward. When will that happen? That's a very good question. I think we are obviously learning from what we're seeing in the US. That's a great way of doing it, but it will take some time and we expect that obviously to start picking up throughout 26. But we are still early days and we still have a lot to learn. So I'm a little careful in terms of giving you exact viewpoints on that. But we do believe there's a pickup. I can say we have very encouraging support from the community, including doctors, KOLs, patient organizations, et cetera, around the product. Stronger than what we've seen otherwise for any other product. moving from there on to then having the switching happening is still the next step and that's what we need to see in the coming quarters. So stay tuned. We'll offer more information as we learn, but I think we are off to a decent start there.

Great. Thanks a lot.

And your next question comes from Ben Jackson with Jefferies. Please go ahead.

Great. Thanks for the questions. Two for me. Firstly, is it possible just to quantify the tailwinds that you believe that you've got from the competitor supply issues for JEXT? And then as we think forwards, are you assuming any of this carries through into the second half of the year? Either that's the competitor supply issues continuing or, you know, keeping the market share that you've gained as a result of that? What are the assumptions that are built in there? And it could all be great. And then secondly, good to see that the peanut recruitment was ahead of schedule. Anything to read into this at all? I suspect not, but any additional color that you're hearing would be great. And then also, does this affect any of your financial budgeting with regards to either this year or next year? Thank you.

Thanks, Ben.

Klaus, will you take a text? I will do that. Thanks, Ben. Thanks for the question. The text part, you're right that we were helped here especially in Q2 by some of our competitors that could not deliver especially one. Of course, we were capitalizing on that and we did everything we can to capitalize on that. From a business perspective, of course, and also a patient perspective, when something like this happens, we of course move fast and see what we can do both to help patients, but also to take some extra market share and some extra sales out there. I have to say there was already an underlying strong growth of Jext in the first half year, so I think that's a positive, but it was now reinforced by this one competitor that could not deliver. Regarding your question about if there is a carryover to second half of the year, then we do not expect that. And the reason is actually that the competitors is now back and starting to deliver already in Q2. So they should be able to serve some of their patients. Of course, we will still do what we can to maintain some of the patients. But still, since this is a system where basically a person is going down to the doctor and the prescription is already locked into a certain product, then it will just carry to now the competitor's product going forward. But of course, we will do whatever we can to focus on this and see if we can keep the market share. But we don't see anything in second half from this competitor being disrupted.

Then on the peanut question, Pierre, do you want to jump in on this one?

Thanks, Ben. So, it's true that we saw a good momentum in the patient recruitment here over the recent months, which meant that we could also recruit ahead of our original target. Of course, that gives hopefully good robustness in the data. We had an original target of 125 patients, now we're at 150. So everything else equals that improves the robustness of the data. We expect, as Peter said, to see the top-line results from this Phase 2 in H1 next year, so not too far away from now. Of course, super excited to see the results. On your question on the R&D extra costs related to this, the answer is yes, there is a small increase in R&D as a consequence of these additional patients. But it's nothing real, big numbers, and still will be kept within the guidance of around 10% of the sales. But think more towards 10 million kroner or so in R&D that comes on top because we have these additional patients in. So still a relatively limited impact. Does that answer your question, Ben?

Super clear. Thank you very much.

And your next question comes from Sushila Hernandez with Vanland Shot Kempen. Please go ahead.

Yes, thank you for taking my questions. I have a few. So, Nessie, just to clarify, you did not expect to see already the strong back-to-school seasonality in your Again, what kind of data can we expect in H1 for the top line data? And then on the bridging trial in China and China in general, will you be looking for a partner here? Thank you.

Susila, can you please repeat the question? There was a little bit of a fallout here in the room.

Okay, sure. So on that feed, just to clarify, so you do not expect to already see a strong back-to-school momentum in Europe this year. And then on the peanut allergy study, could you remind us again what kind of data can we expect in the first half of next year, so the top line? And then on China, will you be looking for a partner here? Could you just remind us the latest status there? Thank you.

Thanks, Ursula. This is Peter. I'll answer on the NEFI back to school. No, we do not expect to see a large implication. And it's back to my earlier answer to Michael around the switching and the automated renewals as part of it. And on top of it, we are only in... in Germany, here in Europe, and then obviously in the US. We basically started out in late June into early July, so we still have a lot of prescribers to reach. It's different from ARS that are in a different situation, so I just want to make sure we make that clarification. I'm not answering on behalf of ARS on this one. This is solely on ELK. On the data, on the peanut pair, you want to comment on this?

This is a so-called Phase 2 safety and efficacy study, where we investigate two different doses up against the placebo, as well as two different treatment regimen, i.e. two different up-dosing phases. So, what we are looking for is, of course, to see a clinical signal that our tablet works, and also that we will learn something about what's the number of up-dosing steps, what's the dose that we will bring into phase three, which if everything goes well, will be initiated as quickly as possible after the phase two, so around year turn next year if things go well, of course. But first and foremost, a clinical signal that the drug works, and of course, then being able to select the dose for phase three.

And your question on China, focus for ALK in China is twofold. One is the upcoming initiation season, ensuring that we get the number of patients we need, getting product back to China as planned. And then obviously, secondly, ensuring that we continue setting up the trial for Kerasax with the intended approval in the late 20s for that product. So that remains the focus in China. Then in general around partnerships around the world, anywhere we are looking to expand and continue growing the business also through partnerships. So whatever is best for the business in any country or region, we'll be looking at that as an opportunity.

Okay, thank you. That's clear.

Again, if you have a question, please press star then 1. And your next question comes from Jesper Ilse with D&B Carnegie. Please go ahead.

Thank you. Two questions from my side, one on Japan and one on NEFI. So just going back to sort of the dynamics in H2 and also here in H1, can you just explain why the shipments are increasing so much here in H1? And also on top of that, just some thoughts from your side on sort of the momentum going into 2026, given we know that there will be a supply expansion for Cedar Cure, so should we expect another step up in shipments here in 2026 as well? And then for NEFI, just perhaps some additional color on the high price premium you got in Germany with more than 100% above the other injectables. So just whether this potentially changes how you, I know it's early stage, but changes how you view the sales potential for this product long-term in the EU and in Canada. Because if you just do the very simple math, a higher price would also lead to a higher peak sales potential given similar unchanged volumes. So just perspectives on that could be helpful. Thanks so much.

Sure. So Klaus, you want to take the one on Japan on the shipments and then I can answer on EFI.

Yeah, I would do that. We actually didn't have significant shipments here in the first half of the year to Japan, other than you would normally see in our shipment patterns that are changing, you can say, quarter on quarter, depending on what are they calling, what are we sending out there, and so on. The important thing is, as we said, that we are seeing double-digit in-market growth with them as it stands right now. in 26 year right we of course expecting now that they are have finalized their api facility and we can start we have also helped them with that and start working on it that we can start to see increased shipments here in the second half of the year and into the to 26 especially it will not be that significant in q3 q4 but we should hopefully start to see more into the first half of 26.

Great. And then on Nefi and the prices, I mean, obviously, we are satisfied with the price level in Europe so far. Do remember, there's a number of factors playing into how we set the price for the product. Stability and shelf life are key to the price points. In Europe, double packs as well. And consequently, it's the list price and not necessarily the final and negotiated price coming in. So there's a multitude of factors playing into the price. But we are happy with where the price is and also believe it's the right level for a product like NEFI. Then in terms of the long-term implications, that's always difficult to assess. But obviously, if we can keep this and we can also keep volumes, it will be good for the case. But it's very early days and we need to see that it's sustainable also longer term. So I think if you can repeat the question in a year's time, yes, but then we might be able to give you a little more precise answer.

Are you still there, Jesper? Yeah, I am. It was clear. Thanks so much.

Hope you didn't get too upset with the answers. Good.

Thank you.

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

Thank you very much, and thank you for all the good questions as usual. Before we end the call, I would just like to redirect your attention to the coming Q2 Roadshow, which will take us to Copenhagen, Paris, and London. We will also have additional events lined up in the near future as it appears on this slide. We, of course, hope to see you in one or two of these events. Alternatively, as always, you are most welcome to contact us if you have additional questions. And with this, we will end today's session, and we wish you all a good day. Goodbye.