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 Plotnikof, I'm Head of Investor Relations and with me today are CEO Peter Halling 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 Neffy 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 and to get started I'll hand over to Peter. Slide three for the highlights. Please go ahead Peter.
Thank you Per.
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-Abelló's ability to deliver sustained, profitable growth going forward. In Q2, the ongoing rollout of our ACARIZAX tablet for children with house dust mite allergy is progressing well and has continued to exceed expectations. We also started the launch of the ITULAZAX 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 EURneffy adrenaline spray in Germany, the first EU market entry.
Additional launches are lined up for the second half year, including the important U.K. market where EURneffy was recently approved. Across markets, the initial feedback from stakeholders is very encouraging. In the U.S., we entered a co-promotion deal with ARS Pharma enabling us to establish a new pediatric sales force to promote both EURneffy and, in the future, ALK-Abelló'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 auto-injectors and an improved momentum for the ACARIZAX tablet in the house dust mite AIT market in Europe.
Q2 earnings improved by 41% in local currencies to DKK 375 million, 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 DKK 300 million throughout 2025. These savings are allowing us to pursue strategic priorities more rigorously this year without jeopardizing earnings. 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. We 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 you, Claus, 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 +10% increase in new patients during the 2024/2025 initiation season, and growth was reinforced by a steady inflow of new ACARIZAX patients in France, Germany, Eastern Europe, and other markets. The new pediatric indication for ACARIZAX contributed positively to revenue growth, while the contribution from the new ITULAZAX 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 buildups 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 SCIT and SLIT-drops grew by 1%. SLIT-drop sales continued to increase in France, whereas SCIT 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 Jext portfolio. Sales of our adrenaline auto-injector benefited from strong commercial execution and favorable market dynamics, including supply issues from our competitors.
Revenue also included minor EURneffy revenue from pipeline filling ahead of the launch in Germany. Revenue in North America increased by 17%. U.S. 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 U.S. Tablet growth in North America grew by 32%. The new pediatric indication for 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 SCIT bulk 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-Abelló's import license.
We resumed SKID shipment to China in Q2, but shipments as expected were at a lower level than last year. SKID revenue in the region decreased by 20%, but Chinese in-market sales of SKID continued to grow by double digits based on existing wholesaler inventories. [TEDWE] revenue in international markets 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 Torii from fully meeting demand. We expect Torii to start operations of the new API manufacturing facility in Q3 with a view to roughly doubling capacity and then incrementally increasing market supply of CEDARCURE tablets. Now let's turn to the product lines on slide 5. 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 were 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 DKK 215 million. The anaphylaxis portfolio led the way with 56% growth. Jext did very well in Europe and Neffy also contributed, including a minor estimated cost reimbursement from ARS Pharma related to the new co-promotion agreement in the U.S. We also saw good performance from other products in the U.S., including P-PEN 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 DKK 3 billion. Top-line growth mainly reflected growth in tablet and Jext sales.
A gross profit of DKK 2 billion yielded a gross margin of 66%, an improvement of 2 percentage points. The increase 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 DKK 1,167 million 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 DKK 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 cost. No one-off cost to optimization efforts were recognized. Opposite to last year, where one-offs amounted to DKK 38 million, free cash flow doubled to DKK 546 million 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 $ million.
in milestone payment to ALK.
Pharma related to the first commercial sales of EURneffy. All in all, the best half year performance so far. With this, back to you, Peter, and slide 7 for an update on the strategy execution.
Thanks Claus. Let me kick off this strategy section by providing some insight into the ongoing launches of our respiratory tablets for start with the house dust mite tablet branded ACARIZAX in Europe and ODACTRA in North America. At the end of Q2, the house dust mite 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 ITULAZAX tablet for young children and adolescents aged five to 17. This tablet is approved by 17 EU countries and Switzerland, Canada, and the U.K. 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 ACARIZAX and ITULAZAX 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 focuses 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 ALK's continued long-term growth. Slide 8 please. If we move to anaphylaxis and our efforts to commercialize EURneffy, the first and only approved nasal spray for emergency treatment of acute allergic reactions. We launched EURneffy in Germany in June, the first market interest since the EU approval. Furthermore, we secured regulatory approval in the U.K., currently Europe's and U.K.'s largest NFL access 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 U.K., and Canada as cornerstones for Neffy market access. Negotiations progress as planned in the other EU countries, and a price premium relative to adrenaline auto-injectors 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 include 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 U.K., EU, and Canada, we also intend to make Neffy available in other territories covered by our license agreements with ARS Pharma. We are planning up to 15 additional European launches over the next six to 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 1 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 Neffy to more than 9,000 U.S. pediatricians.
Their agreement has allowed us to build a dedicated U.S. pediatric sales force in a balanced way. 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 9, please. The Q2 report provides a detailed account of the execution of the ALK strategy, so let me just highlight a few additional hotspots, starting with the ongoing market expansion in select geographies. As Claus Steensen Sølje 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 CEDARCURE 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 III registration started with our GRAZAX tablet which is now recruiting patients. We've also seen positive progress in the U.K. where ITULAZAX 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, ACARIZAX was the first AIT product to be recommended by NICE and we intend to make submissions to extend the tablet's approval, to improve the children indication, and to make GRAZAX widely available for general reimbursement. In the U.K., the tablet submission to the public healthcare systems represents a paradigm shift in the market, a market where AIT 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 ACARIZAX in Q3 while in the U.S., 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 III 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 ARS Pharma is currently recruiting patients for a Phase II-B trial to investigate Neffy and its efficacy in acute flares associated with chronic spontaneous urticaria, also known as CSU. The Neffy 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. 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%.
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 1 percentage point of the total growth. We still expect a reduced impact from pricing and rebate adjustments compared to last year. Combined SCIT and SCIT drop sales are still projected to grow by single digits. A better uptake of SLIT-drops in France will be partly offset by lower SCIT sales in Europe. Timing of SCIT 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. EURneffy 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 U.S.
The Trump administration's new tariff agreements with the EU and other countries are expected to be manageable in first half year. More than 80% of our revenue in the U.S. 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 uneven licensing deal. R&D expenses are expected to increase by double digits but will remain at around 10% of the planned revenue. Sales, marketing and administration costs are predicted to increase by single digits while low one-off cost for optimizations are planful. 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 Claus and thank you Peter. 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 one 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 two. At this time, we will pause momentarily to assemble our roster, and the first question comes from Thomas Schultz Bowers with SEB. Please go ahead.
Yes, thank you very much for that.
Three questions from my side here. If we just start with the European tablets growth, how much of this is actually driving the guidance upgrade you had? I think it was around DKK 50 million or 1% growth contribution included in the initial guidance. Can you maybe just add a bit of color on the expected full year out impact here? Second question, just moving to Japan. With the H1 phasing 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 Shionogi with the table of turbulent and divestment of the captives from Stella. Jens there. Last question regarding the U.S. or North America.
A very strong quarter for Tepid, that of course as you mentioned some stuff hiling in Canada for Dacha, but are you also seeing similar, you can say, early traction with the pediatricians as you do in Europe for Dacha? Is that the case also for the U.S. market in particular? Thank you.
All right, thanks Thomas. Peter speaking. I'd hand it over to Claus on the tablets in Europe, but just start out by saying it's the majority obviously. Claus, you want to add a bit more flavor on this and I'll take Japan and North America.
Yeah, I can do that.
I think you actually answered very well here very quickly, Peter, because you are 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. The midpoint, as you can see, is kind of moved by the 2 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 total growth coming in. It is actually a big part of this. It's important to understand we're only talking about ACARIZAX, so the house dust mites, where we have included that because we can see in the numbers that is starting to take up.
The ITULAZAX or the tree 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 indications on that one. Related to the upgrade, it's a big part coming from the EU tablet and hereby the ACARIZAX also for children.
Great. Thomas, on Japan, the question around Torii capacity and then Shionogi. 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. We don't expect a significant contribution yet. We do expect that this is obviously going to be a step in the right direction. We haven't added a lot on top. It also needs to start up. We do expect that this will obviously improve the supply situation in Japan going forward, which is very positive. As we all know, cedar tablets have been restricted by supply, and this should alleviate some of that. To your question around Shionogi, Shionogi and Torii are in a grace period, if you wish.
Basically, in the interim between the full acquisition by Shionogi, 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 Shionogi will take over and also do the transition from the existing products to the Torii portfolio, meaning ours. 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. Obviously, we are pleased to see that the allergists in the U.S. and the allergists in Canada and pediatricians are really starting to embrace Odactra, especially for children. All in all, that is obviously positive and something we hope will be sustained in the coming quarters as well. We are hoping going forward that the inclusion of the salespeople that we hired for Neffy, also bringing in tablets to the public portfolio there, can be helping the business on the tablet side. All in all, a good start in North America. Early days, but positive.
Thank you.
Your next question comes from Michael Novod with Nordea. Please go ahead.
Thank you very much. A few questions from my side as well. First of all, on SCIT, SLIT-drops, try to sort of give a framework for how you see this business going forward in terms of growth or no growth in SCIT state. That'll be very interesting. Also, on your Neffy, 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 sort of the strongest traction starting to come? How long time do you believe it takes for sort of convincing prescribers to go for this product compared to Jext 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. I think it's important to say when we look at the SCIT 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. A large portion of our SCIT portfolio today is also venom products and other indications than the traditional major allergens like tree pollen, grass, and obviously house dust mites. In those specific areas we will see some cannibalization, but we believe it's 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.
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. The short answer is there will be a very limited or limited effect outside of the major indications and the major ones will still come from somewhat lower number. 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, on your Neffy 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. That's a key thing and that is ongoing for us. That's one aspect. The other aspect is what we would call the switching. Basically, people who are already prescribed on a page that needs to then switch and some of this is automated. 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 Neffy 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 U.S.
That's a great way of doing it, but it will take some time and we expect that obviously to start picking up throughout 2026, but we are still early days and we still have a lot to learn. 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. Stay tuned. We'll offer more information as we learn, but I think we are off to a decent start there.
Okay, great.
Thanks a lot.
Your next question comes from Benjamin Jackson with Jefferies LLC. Please go ahead.
Great.
Thanks for the questions. Two from me. Firstly, is it possible just to quantify the tailwinds that you believe that you've got from the competitive supply issues for Jext? 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 keeping the market share that you've gained as a result of that, what are the assumptions that build in there? It could all be great. 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. Also, does this affect any of your financial budgeting with regards to either this year or next year?
Thank you.
Sure. Thanks. Benjamin Jackson, will you take that? I will do that.
Thanks, Ben.
Thanks for the question.
The Jext 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. 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, we do not expect that.
The reason is actually that the competitors are now back and starting to deliver already here 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. 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, it will just carry to now the competitor's product going forward. 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.
Yeah. On the Pinot question, Per, you want to jump in on this one?
Thanks. Thanks, Ben. It's true that we saw 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, 100 patients, 125 patients. Now we're at 150. Everything else equal, that improves the robustness of the data. We expect, as Peter said, to see the top line results from this Phase II in H1 next year. 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.
Think more towards DKK 10 million 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 great. Thank you very much.
Your next question comes from Sushila Hernandez with Van Lanschot Kempen. Please go ahead.
Yes, thank you for taking my questions. I have a few on Neffy, just to clarify, you do not expect to see already the strong back to school seasonality in Europe? On the peanut allergy Phase II study, could you remind us again what kind of data can we expect in H1? The top line data, and then on the bridging trial in China and China in general, will you be looking for a partner? Thank you.
Sushila, can you please repeat? There was a little bit of a fallout here in the room.
Okay, sure. On Neffy, just to clarify, you do not expect to already see a strong back to school momentum in Europe this year. On the peanut allergy study, could you remind us again what kind of data can we expect in the first half of next year, the top line? On China, will you be looking for a partner here? Could you just remind us of the latest status there? Thank you.
Thanks. Asila, this is Peter. I'll answer on the Neffy back to school. No, we do not expect to see a large implication. It's back to my earlier answer to Michael around the switching and the automated renewals as part of it. On top of it, we are only in Germany here in Europe, and obviously in the U.S. we basically started out in late June into early July. We still have a lot of prescribers to reach. It's different from adrenaline auto-injectors that are in a different situation. I just want to make sure we make that clarification. I'm not answering on behalf of ARS Pharma on this one. This is solely on ALK. Okay. On the data on the peanut Per, you want to comment on this?
Yeah, sure. This is a so-called Phase II safety and efficacy study where we investigate two different doses up against the placebo as well as two different treatment regimens, that is, two different updosing phases. 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 updosing steps, what's the dose that we will bring into Phase III, which, if everything goes well, will be initiated as quickly as possible after the Phase II. Around year term next year if things go well, of course. First and foremost, a clinical signal that the drug works and then being able to select the dose for Phase III.
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 ACARIZAX with the intended approval in the late 2020s for that product. That remains the focus in China. In general, around partnerships around the world, anywhere we are looking to expand and continue growing the business also through partnerships. 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 one. Your next question comes from Jesper Ilsøe with DNB Carnegie. Please go ahead. Thank you.
Two questions from my side, one on Japan and one on Neffy. 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? Also, just some thoughts from your side on the momentum going into 2026 given we know that there will be a supply expansion for CEDARCURE. Should we expect another step up in shipments here in 2026 as well? For Neffy, just perhaps some additional color on the high price premium regarding Germany with more than 100% above the other injectables. 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.
If you just do the very simple math, a higher price should also lead to a higher peak sales potential given similar unchanged volumes. Perspectives on that could be helpful. Thanks so much.
Sure. Claus, you want to take the one on Japan on the shipments, and then I can answer on Neffy?
Yeah, I will 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 2026. We are of course expecting now that they have finalized their API facility and we have also helped them with that and started working on it, that we can start to see increased shipments here in the second half of the year and into 2026 especially. It will not be that significant in Q3, Q4, but we should hopefully start to see more into 1H 2026.
Great.
On Neffy and the prices, 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. 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 Neffy. In terms of the long term implications, that's always difficult to assess. Obviously, if we can keep this and we can also keep volumes, it will be good for the case. It's very early days and we need to see that it's sustainable also longer term.
I think if you can repeat the question in a year's time, then we might be able to give you a little more prec.
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 Per Plotnikof 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. With this, we will end today's session and we wish you all a good day. Goodbye.