Hello, everyone, and welcome to this Presentation of ALK's Q3 Results. Thank you all for joining the call, and let's turn to Slide number 2 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 Solje. We will be sharing a couple of highlights from Q3. We'll take a closer look at markets, product trends and financials. We'll also provide an update on the allergy plus strategy implementation before we turn to the full year outlook. As usual, we will end the presentation with a Q&A session. To get started, I'll hand over to Peter on Slide 3, please.

Thank you, Per, and thank you all for joining this call. Q3 was another solid quarter for ALK. We delivered 18% organic revenue growth across regions and product lines, and we are particularly encouraged by the robust growth rates for tablets, 29% on global scale and 27% in our main market Europe. We solidified the momentum as volumes roughly grew in line with what we saw in the first half, reflecting the past year's strong inflow of new patients. Jext was another source of growth in Q3. Sales of the adrenaline auto-injector rebounded and have now fully recovered from last year's supply shortages. We succeeded in raising the EBIT margin by 10 percentage points year-on-year from 13% to 23%, driven by sales growth, gross margin improvements, resource optimization and general cost savings. These results confirm that we are well on our way to increase revenue and improve earnings as planned in 2024, and we confirm the full year outlook. Now the implementation of our Allergy+ strategy is progressing well. Let me just point out two initiatives. We took important steps to build new revenue streams in the broader allergy space when we a few days ago agreed with ARS Pharma to license the rights to their Neffy nasal spray. Moreover, in China, we are about to finalize the design of the clinical trial to get the regulatory approval of the house dust mite back on track. We have also completed recruitment of patients to the current part of the Phase I/II study with our peanut tablet and expect interim results before the end of the year. We'll further detail this during the presentation, but before, I'll hand it over to you, Claus, and the Q3 market trends on Slide 4.

Thank you, Peter. Let's take a closer look at the performance in our sales regions, where Europe and international markets were key contributors to growth in quarter 3, while growth in North America was soft. Sales in Europe were up 21% on double-digit growth in key markets, Germany, France, the Nordic countries, Benelux, the U.K. and other markets across Europe. Tablet sales grew by 27%. Growth was primarily driven by higher volumes linked to the inflow of new patients in the late 2023, particularly in Northern -- in North, Central and Western Europe. Volume growth was roughly on par with the first half of this year, whereas the contribution from improved pricing, including rebate adjustments, was slightly lower than in the first half year. Trading patterns among wholesalers were still a factor in the marketplace, but these movements had a lower impact than last year. Higher Jext volumes also contributed to growth in Q3, while combined SCIT and SLIT-drop sales increased by 5%, mainly driven by SLIT-drop sales in France. Total sales in North America grew by 3%. Tablet sales were up 13% on higher volumes. Sales of SCIT bulk extracts increased by 4% and remained soft. Sales of other products, so that's diagnostics, PRE-PEN and life science decreased by 4%. Revenue from international markets was up 27% with tablets as the key driver. Tablets revenue increased by 39%, driven by both Japan, Southeast Asia and other minor tablet markets. The growth in shipments to Japan mirrored continued growth in our partners, Torii's in-market sales of tablets. Revenue from SCIT products shipments to China grew by single digits, while Chinese in-market sales of SCIT continued to show double-digit growth. Let's turn to the product lines on Slide 5. Global tablet revenue grew by 29% on double-digit growth in all sales regions. Global revenue from SCIT and SLIT-drops grew modestly by 5% against tough comparisons in Q3 last year, which partly saw high levels of SCIT shipments to China and partly saw an impact from improved pricing and rebate adjustments in Europe. Further to this, Q3 growth this year weakened in Germany due to changes in the product mix, but we expect these changes to be temporary. Global revenue from other products and services, including Jext, increased by 26%. Global Jext sales more than doubled, and sales have now recovered from last year's supply shortages. Oppositely, we saw a weak performance in other products in North America, especially PRE-PEN. The integration of PRE-PEN operation has been completed, but sales continue to perform below expectations. In September, however, a bill was introduced by bipartisan representatives in the house to add initial regulatory verification components to the federal health insurance program, Medicare. This bill could hold a big potential for PRE-PEN, and we will keep you posted on any developments. Now let's move on to Slide 6 and the financial results year-to-date. Nine months revenue was up 16% in local currencies and exceeded DKK 4 billion. That was reflecting a strong momentum for tablets, particularly in Europe. The gross profit of DKK 2.6 billion yield a gross margin of 64.3%, an improvement of more than 1 percentage point. This was due to changes in sales mix, volume growth, improved pricing, production efficiencies and the reversal of last year's repaid increase in Germany. In line with our expectations, these factors were partly offset by higher input costs and minor one-off costs to optimization. Total capacity cost of DKK 1.7 billion were unchanged in local currencies. R&D expenses were down 22% after the completion of last year's comprehensive clinical trials. Sales and marketing expenses were up 8%, where admin cost increased 9%, mainly driven by cost related to the Allergy+ strategy process. Optimizations and cost savings contributed positively and help us lower the capacity cost to revenue ratio by 7 percentage points, as you appreciate from the graph to the right. The operating profit, EBIT, was DKK 886 million, an improvement of 91% in local currencies and 88% in Danish kroner. The EBIT margin increased from 14% to 22%, and the underlying EBIT margin would have exceeded 23% disregarding one-offs, restructuring cost of DKK 49 million, a clear indication that we managed to raise margins steadily towards our '25 and '25 ambition. Finally, free cash flow improved to DKK 425 million as higher earnings clearly offset changes in working capital and investments. All in all, a strong set of results, ALK's best 9-month performance so far. So with that, I would like to hand it back to you, Peter, and the Allergy+ strategy on Slide 8.

Thanks. The implementation of the new Allergy+ strategy progresses as planned, and we are dedicated to deliver on our long-term financial ambitions. As earlier stated a few days ago, we entered into a major in-licensing deal to diversify our product portfolio into adjacent allergic conditions with the potential to become new growth levers for ALK. I'll recap this in a moment, but first, a few snapshots on other priorities. Staying on the subject of new product opportunities, our development program in food allergy continues as planned. Patient recruitment for the second part of our Phase I/II clinical trial in peanut allergy is completed, and the trial is on track to report the next set of results late Q4. Subject to the outcome, we will extend the trial with a third part to explore the tablets efficacy as well. Preparations for the third part has begun so that we have a seamless and fast transition into the next stage. The regulatory processes to secure approvals of tablets for children use in Europe and North America continue. We expect the house dust mite tablet to become available for children late 2024 or early '25. While the tree tablet could become available mid-'25. These are important catalysts for long-term growth. In China, we work to get back on track after we withdrew our application for the house dust mite tablet in June. Based on the dialogue with the authorities, we are about to finalize the design of a clinical trial with 300 Chinese patients. We expect the trial to start in '25 and deliver the clinical data needed to obtain an approval for the tablet in China. Meanwhile, we are adapting our Chinese footprint to the delayed launch time line for the tablet, time line that was originally scheduled for 2025. Finally, the previously announced optimization and prioritization initiatives are gaining good traction, and we continue to reallocate resources to high-impact European markets with the most favorable conditions for AIT. Slide 8, please. Asset. Last weekend, we announced the single largest in-licensing deal in ALK's history. Let me just briefly recap this very important step and our efforts to establish leading positions in anaphylaxis, food allergy and other disease areas to supplement our core business in respiratory allergy. On upfront payment of $145 million, we acquired the rights for parts of the world to Neffy, the first and only approved nasal spray for emergency treatment of acute potentially life-threatening allergic reactions. This product with the potential to transform treatment and significantly expand our markets. Building on this first-mover advantage, we intend to build a substantial business in anaphylaxis in our key markets and beyond, and we start now, approximately three years earlier than originally planned. We also gained exclusive rights to future indications such as acute flares associated with urticaria, currently in Phase II development by ARS Pharma. The deal will contribute to growth from 2025 and onwards and the earnings accretive within a few years. Longer term, we see a highly attractive peak sales potential of up to DKK 3 billion in anaphylaxis alone. And on top of that, will come contributions from new indications such as urticaria. Now the deal also supports ALK's core AIT strategy, including our pediatric ambitions as children and their caregivers are expected to favor needle-free, convenient anaphylaxis treatment. In a longer perspective, Neffy also fits perfectly in with our future product portfolio in food allergy because the frequency of anaphylaxis is particularly high among people with food allergies. So in summary, we are well on track with execution on our strategy. Now over to you, Claus, for the full year outlook.

Thanks, Peter. So on Slide 9, the full year outlook is unchanged. We still expect 14% to 16% top line growth this year, while we continue to see the EBIT margin advanced to 19% to 21%. Europe is still anticipated to lead the way with robust double-digit growth, while single-digit growth is projected for North America and international markets. Growth in European tablet sales is expected to remain strong by mid- to high single-digit sales growth as expected for SCIT and SLIT-drops and other products. Moving to earnings assumptions. We now assume that the gross margin will increase by more than 1 percentage point, while we still expect the capacity cost to revenue ratio to further improve. The outlook for capacity costs includes approximately DKK 60 million in one-off costs to the previous announced optimizations. We may incur additional one-off costs to the revisions of plans and activities in China here in quarter 4, but any such costs will be contained within the current EBIT outlook. A few observations on Q4 results seen in isolation. We should expect higher sales and marketing costs in Q4 to support the upcoming tablet launches for children. In addition, you should expect Q4 revenue growth to be lower than in Q3 and -- Q2 and Q3 of this year. Firstly, we will see fluctuation in shipments to international markets with no SCIT shipments planned for China during the renewal of ALK's import license. And you will also see lower tablet shipments planned for Japan. Secondary, sales growth in North America is expected to continue at a low level, partly due to the soft performance by the legacy products, partly due to a declining impact from recent improvements to average selling prices for tablets in the U.S. In line with what we stated during the quarter 2 call, we expect the 2024 '25 initiation season to be an average good season. This means better than the poor 2022/'23 season, but not as good as the exceptional 2023/'24 season. But please appreciate that this is still early days. We have more insights in February when we published the annual report. So to sum up, we expect 2024 to mark the sixth consecutive year of revenue growth and improved earnings, fully in line with our long-term financial ambitions. And with this, I would like to hand it back to you, Per, on Slide 10.

Thank you, Peter, and thank you, Claus. And this concludes our presentation, and we will now move into the Q&A session. And with this, operator, please go ahead.

[Operator Instructions] And the first question comes from Thomas Bowers with Danske Bank.

A couple of questions from my side here. So kicking off with the gross margin, quite impressive. Of course, you have some one-offs with a little bit of tailwind there, but given that you're seeing this continued momentum in tablet growth and now also with two pediatric indications going live soon here, so of course, a lot of product mix impacts going forward as well. So how should we think about margin improvement -- gross margin improvement going forward? I can see that the consensus is quite strongly focused on that 1 percentage point per year. But would that actually look like an easy-to-beat target for you guys in the next few years? And then just on the Q4, thanks for the additional color, but just on the R&D, what's causing the fluctuation here? And what's going to actually trigger that very significant step up in Q4 in order for you to reach that 10% to sales ratio? And then lastly, just two small questions on neffy, if I may. So I'm just -- when looking at the label, so that, of course, some stuff, I'm looking at in terms of -- sorry, the big concentration level, that was what I was trying to get to. So there's an onset of action when you look at the auto-injectors and then for neffy to reach those numbers, it seems like it takes a little longer. So can you maybe just address what do you think that would means sort of commercially? Is that anything that is relevant or something that could potentially be a problem? And then lastly, just on the royalties you have to pay to ARS Pharma. Is that the same level after the composition of matter, the key patent expires here in '38, '39.

Thanks, Thomas. We had a little bit of hiccup around the Q4 and R&D costs. I think we got the question. Claus will you kick it off with the gross margin.

Well. And yes, hello Thomas. Good to hear you. There was a little bit with Q4 and the R&D I will try to answer ass I heard it but we actually lost few seconds so maybe I’ll have to repeat. And -- so for the gross margin. Then you’re completely right, right now we of course having a good tailwind with the fact tablet sales and with the high margins that we have on the tablets then of course that is also going impact our gross margin. How I would see and how we’re seeing it here is that we would still like to continue to do a 1 percentage point improvement year-on-year. That can be a big fluctuation year-over year, so maybe 1.5 one year little bit less the other year. But I would say in average 1% year-on-year is what we are going for when you look at the different tablets, so that can help us. We also mentioned there are children indication. But also, please remember, we still have kind of a volatile environment out there with price increases and inflation on some of the things we are buying into our production and investing into. So, 1 percentage point is still the best that we would like to guide for now.

And Thomas, we lost you on the Q4 question on R&D. There was a hiccup. Could you just repeat?

So, I think the question was on R&D reasons for a pickup in R&D costs in quarter four.

Yes, okay. I can start with that one. I hope that was the one that you were referring to. You're completely right. When you look at the cost for Q4, then we are seeing increasing costs versus the former quarters. First of all, please take into consideration that our Q4 is always the highest investment quarter. This is where we have the initiation season. This is where we have many things ongoing. So, this is also where year on year you will see that we have the higher increases. You will especially see that in the commercial space. For R&D, we have actually been able to invest earlier. So, simply speed up some of the initiatives we are doing. For example, the Akai Sachs planning that Peter was alluded to in China. Here we have been able to pre-pone some of the costs here into quarter 4 and actually invest a bit ahead of the curve there and start that up a bit earlier than what we had expected. We're actually doing the same with peanut. You have seen that we have now started to preparing for the part three. And this we have also been able to do and we can do that. So, we invest earlier into both the peanut and into the Chinese trial that we are running. All that we can do within our guidance, the full year guidance as we alluded to. But that is what driving up a bit the R&D cost in Q4.

Perfect. So, Thomas two questions, neffy, one on the onset of action and one on the royalties. Just on the onset of action, FDA approved this based on data that showed the profile, the Cmax being similar to what you see with a PEN. And moreover, there have been no changes to the labels. So, we do not hear from KOLs. We have not heard from ARS Pharma or others that this would be a potential issue or concern. So, we don't expect any implications from that angle. It's a very similar product when you talk about the action. On the royalties, just to answer that, royalties will be paid until patent expiry in the late 30s. And thereafter, royalties are no longer following the patent. So, that means that we are not paying the royalties after. So, I think that's the short answer to your last question. I hope that covered.

All right. So, I hope that you can hear us again. We hope that we have been able to reestablish the connection outside. And I would like to proceed with the Q&As, please. Operator, please go ahead.

Yes, thank you. The next question comes from Michael Novard with Nordea.

Yes, thanks a lot. So, I think maybe when Thomas gets back on, you have to repeat your answers. At least I didn't get them at all. But anyway, I'll ask my two questions. So, to the U.S., we've been discussing this for many times. But some of the business is partly sluggish, and the other part is not doing really well. So, what can really be done? I know you're growing tablets by 13%, but it also still comes from a very low base. So, I'm just thinking, what can you do about this and try to change the entire trend in the U.S. market? And then, of course, we're getting close to sort of the first -- or next part of the peanut trial reading out. And maybe can you just remind, will you release anything or can we tease out anything in terms of immune tolerance, signs of that, just to get a feeling of that? Thank you so much.

Thanks, Michael. And I apologize, it was really good questions and answers, especially to Thomas' questions. So, we think so.

If it was done in Russian, I wouldn't understand it.

All right, let me start out by talking about the U.S. You're right, obviously we are not happy overall with the performance. We think, as you also say, we are pleased with the fact that we're still growing nicely on the tablet side, coming from a low level, both in Canada and U.S., but growth continues. We have the important pediatric launches coming up with ODACTRA in the U.S., the house dust mite e, and then ITULAZAX for Canada. So, those will hopefully be enablers. We continue to work on the pediatric segment, but this is basically a journey for the long haul where we need to educate, train, and really bring the pediatricians on board over time, and it takes time. We still have sales with the allergologists, and that's positive, but it's not a growing segment per se due to the way the market is structured, in particular in the U.S. So, that's the challenge. On the other parts of the business, there are a few factors playing in. So, the lower performance on the life science business is partly because we have chosen to discontinue a contract that was a low-margin contract but a fairly high volume. Purposely, we've discontinued that. When we disregard that, we've actually had some good growth, profitable growth, in part of the business. The business that goes into the nuclear pharmacies, where they basically sell to the larger pharmaceutical corporations. So, in that sense, that's positive. On the legacy, the bulk business, this is not a strong growth we are seeing in the market from a volume standpoint. So, that has mainly been driven by prices, and that's going to be an important driver going forward as well from here on. And then on the prepend, we are actually happy about the product. We also think it's quite interesting with the bipartisan bill in the U.S. that could create some momentum down the line. But what we've seen and what we've been negatively surprised about is the stock-up with the doctors and the lack of rebuy this year. We obviously expect and are going to work on getting that back next year. But to boil it down on that part of the question, we are really continuing to have a high focus on getting the tablets right. We are in need to get the approval so we can support it. And in between, we continue to work with the pediatricians and other prescribers to get this moving. But it is a long haul. So, I'll leave it there and then maybe, Per, on the peanut.

Sure. Thank you. So, as we said in the release, we have completed patient recruitment for the second part of the ongoing Phase I-II trial with our peanut tablet. We do expect to report out from the conclusions of this part before the end of the year in December. So, what we are looking at in this part of the study is the safety and tolerability profile of various up-dosing regimes. So, we will use that to make conclusions on those elements, safety, tolerability. We will also use the insights to decide on the doses going forward in the third part, a part that will -- if everything goes well, commence next year, where we also look at the efficacy of the treatment in the patients. So, in the meantime, we have allowed the clinical trial investigators to start screening of patients for this third part. But, of course, the active dosing of patients is subject to conclusions and outcome of the ongoing part right now. So, a lot of data coming out, hopefully.

So, just to be clear, we won't be able to tease anything out regarding any kind of immune tolerance or anything. I know, of course, you are taking blood tests and all that. I just want to be sure whether we are getting anything there or it is only something that you can indicate around safety and tolerability?

So, I mean, we are not investigating efficacy in this study. There are no endpoints on efficacy in this study. This is safety and tolerability. Then we, as you know, as you refer to also, we are, of course, investigating various immunological parameters that will be analyzed afterwards, et cetera. But there are no formal efficacy clinical measurements in this part. That will come in the part that commences next year if everything goes well.

Thank you. Great. Thanks.

Thank you. And the next question comes from Peter Sehested with ABG.

Yes. Thank you for taking my questions. I have a couple. So, I'll just start with two. Just staying on the peanut trial, when that announcement comes out, should we expect that you, in that particular announcement, also disclose whether you will continue or not? So, that's sort of my first question. And then the second question is, I think, more hypothetical. If you were sort of given the option to co-promote Neffy in the U.S., would you consider that to be a strategically attractive opportunity?

Could you repeat the last part, Peter? We just lost you. The last question.

Yes. The last question is this, and it's hypothetical. But if you were given the opportunity to co-promote Neffy in the U.S., would you then consider that to be a strategically important opportunity?

So, let me answer both. It's a little bit the same question or answer. The first one on peanut. We will not and cannot speculate on the outcome of that. When we have the data, we will draw the conclusions on how to proceed. So, I have to leave it at that. Specifically, on ARS and the co-promotion part, the short answer is the same. If there were an interest, we would obviously discuss that with ARS first and then announce whether we would do it both from a strategic standpoint, but also simply from a market sensitivity standpoint. So, I apologize, Peter. I know it's not helping what you're looking for, but we cannot go any further than that. But obviously, maybe to say it more general, we believe Neffy is a great product. It's a great complement to our portfolio. And hence, we see a lot of value in working with ARS.

Okay. I didn't really expect an answer to that. But just getting back to the peanut announcement, it was not to get an answer right now what you believe the outcome will be. It's more like will you, when you announce the outcome of that data, will you at that point in time be able to say we will continue or you will not?

I think the short answer is we will obviously let you know whether we go into a Phase III or not. And that's hopefully also telling you clearly what we believe based on the data. So, the answer, in short, is yes based on whether we move forward or not.

Okay. Good. Thank you.

Thank you. And the next question comes from Benjamin Jackson with Jefferies.

Hi. Great. Thank you for the question, Ben Jackson at Jefferies. Just to follow up on a couple of things there. One is on peanut allergy. I guess this is fairly well implied at this point. But just to be crystal clear, are you anticipating when you say report, that is report to market within 4Q? This isn't something that perhaps is more delayed than we receive with the full year results if things go as you anticipate. And then also along those lines, does the ability to begin screening patients now perhaps move your timelines for the part three results slightly earlier than you previously communicated? And then my second question would be slightly higher level. Around the pediatric launches, specifically in Europe, could you provide more color about the kind of the commercial framework that is being built there? How far along that initial ramp of outreach and activation are you? And I guess what I'm kind of trying to get at there is how much more and how much progress do we need to make along the sales and marketing costs for the next quarter in preparation for the launches? And then also, I guess, how much can you leverage the existing sales force to connect with the physicians in this area? Is this primarily having to activate new pediatricians or is there a fair overlap here with allergists and immunologists that can also be activated? I'll save the rest of the questions, perhaps jump back in the queue.

All right. Thanks, Benjamin. So, yes, we announced that we'll have the data readout this year on the peanuts. So that's the first part of your question. And maybe, Per, on the second part, if you want to add.

Yes, I was a little bit unclear what the question was. I can take that one.

If there's any with our announcement now that we have started screening patients, are we then actually being able to move it ahead? There is no. And that's important to notice. We also say that in our announcement here. There are no news on the data, but it's correct that we have started to prepare for the phase for the part three of this. And I also try to explain. I think it was actually under when we lost the connection. You didn't hear it out there, but we have actually been able to move some cost into Q4 here. So simply speed up some of the things around the peanut trial and thereby invest a bit more here in Q4. Simply so we can start preparing already now for the part three of this before we know the exact outcome of the part two here of the trial. And of course, we are doing that because we are optimistic people. But I have to say, we do not know right now the outcome of those data. But we have been able to invest a bit more faster into it here already starting in Q4.

But obviously, the trials are the trials. You never know how many people, et cetera, the cohorts, et cetera, and the data readout. So this is not to say that should we be positive around the data move forward that this means that we will conclude earlier in the end. Just important to say. So it's still towards the end of the 20th before we have a launch. On the PEAT [ph], we have been preparing. Actually, as we speak, there's a lot of work going on around the launch preparation. The investments will continue into this. Already some of them have happened this year. We continue to invest into next year. It is also included in our long term guidance expectations that we will invest into the PEAT markets. What is important to say is that obviously when we look ahead next year, a lot of this also depends on timing of the initiation season. Remember that it's a three year build up given the fact that you bring in the patients in the first year and then the next year and the third year. They continue as you put in or get in additional patients. So the initiation season next year will be a determining factor for a lot of this. Specifically, the European market we can use and will continue to use our existing commercial channels and team there. They are well established with different types of doctors. Many of the doctors in Europe cover additional areas, including the pediatric area. We are also targeting new prescribers as part of this. So you have specific pediatricians that will be part of it. But we are well positioned to reach out to those as well. So the short answer on that one is we can use the existing infrastructure. We are well established. It is not like in the U.S. where it's a slightly different situation. Canada and Europe are much more alike in that sense.

Thank you.

Thank you. And the next question is from Jesper Ilsoe with Carnegie.

Thanks so much. I'm also trying my luck to ask questions on food allergy and peanuts. But firstly, given the update you provided with screening starting, can you just remind us what you would like to see in the up-dosing regimen trial reading out here late Q4? So basically, what is a good readout when it comes to an up-dosing regimen and sort of be more convenient compared to PALFORZIA? And how important, perhaps, is this trial for the overall program in peanut allergy? And then secondly, just remind us when you actually expect to initiate further trials in other food allergies. Will it be after this Part 2 readout? Or would you like to see efficacy before starting a new trial? So basically, what data points are you waiting for at the moment? Thanks so much.

Thanks, Jesper. Per?

So, I mean, obviously, we are looking for a good safety and tolerability profile of the drug that ultimately will lead to a simple and efficacious drug that is simple both for the patients, safe for the patients, but also simple for the doctors and specialists to administer. And here we are looking at various treatment regimens, various up-dosing schemes, and then we look for the profile here in these patients on this step. And that will, of course, inform the dose levels that we will use in the later efficacy studies where we then go into a more normal clinical design, blinded, placebo-controlled, as you know them, right? And so in this phase here, we are certainly looking for the safety and tolerability profile and hopefully to be able to make a firm conclusion on the dose selection for the next steps.

And then, Jesper, as you know, on the Capital Markets Day, you also said that it's about simplicity, but it's also about obviously securing that there's a viable business model also for the allergologists. So that's obviously also something we are looking at. In terms of other products, it's an ongoing dialogue. We have an ambition of building a food portfolio. The question is how and when we are going to add to it. So I'm not going to speculate in terms of new trials and new assets, et cetera. I'll just state what we said previously. We are continuing to have a focus on building a portfolio and not a single product position.

Thank you. And the next question comes from Sushila Hernandez with Van Lanschot Kempen

Yes, thank you for taking my question. On the house of my clinical trial in China, how long do you expect for recruitment to take for these 300 patients and what would be the duration of this treatment during this trial? Is this 12 months? And the second question, could you share more color on the 2024-25 initiation season? What indicators give you a sense that this will be an average good season? Thank you.

All right, let me take a step. So basically, we're not going to go into the details of the trial. We announced that it's going to be with 300 people. We're going to do the classical updosing schemes, but we are still in dialogue with the Chinese authorities in terms of when and how to conduct it. We do expect that we have all of this finished with an aim of reaching 2028 for timing of approval. So that's China and the house dust mites, all in preparation. Then on the initiation season this year, still early days. We don't have data, as Claus also said during the announcement. We're still waiting on data. We'll have much more data when we get into February. So we don't know about the initiation season yet. What we know from the preliminary data is that based on symptom treatment and medicines, and then obviously initial pollen count, is that it looks like a fairly normal season, maybe slightly lower on tree and slightly higher on house dust mite. And then we are looking at a somewhat normal grass season. I'll just reiterate, this is not confirmed data. This is early indications, and we need to see the initiation data as well. There are a lot of factors playing into this, but this is what we know. So we expect it to be more of a normal season, whereas the '22, '23 season was weak, then the '23, '24 was strong, and this is more like a normal season.

That's clear, thank you.

[Operator Instructions] And we have a follow-up question from Peter Sehested with ABG.

Thank you. Just on the China additional costs that you flagged here from Q4, I guess that we'll have a benefit in savings for 2025, but I guess we should assume that all of that will be plowed back into your marketing activities in Europe. Is that correct? And then just a question after that as well.

Claus?

Yes, I can take that. Peter, you're right. We are flagging that we will see some extraordinary restructuring costs here related to the delay of the launch of our ACARIZAX and the extra trials we are going to do. When we're doing that, we, of course, are also looking at the organization and what we need to have in the affiliate. Right now, we actually have a few hundred people in China building up a good organization with good sales of our current product portfolio. What we will now do is to see some extraordinary restructuring costs here in this Q4, and that we will pay here. That will not have any influence on the next year's numbers, so to speak. It will be a one-time and only here in Q4.

Okay, thank you. And second question actually is a turn back to Monday's call and also a bit to do with Thomas's question early on. I mean, we just look at it at a high level. You can argue that nasal spray has a potential to take the whole market, right? And yet you argue that you continue with Genesis. So my question is this. What segments of the market do you see would like to continue using a pen in Europe? Are you guarding yourself against or hedging the higher time to onset that you have with a pen versus the nasal spray?

We're not guarding this around the onset. It's not something that has been brought up as a concern from neither authorities nor from KOLs and doctors. So we're not too concerned about that. The reason why we continue with both is that we see that the market will be driven, the expansion of the market will be driven primarily by the nasal. And then we know that there's also a need for needle injections. This is a common practice in many markets. It's preferred by some doctors and some hospitals. So that's part of the answer to your question. And also people who have been using or at least been guided to use a needle for years. So we see a clear opportunity for both. We also know that there's a market for anaphylaxis that have been lacking supply. So there's a big need for it. And hence, we see both opportunities. Last thing I'll mention is we also mentioned that Monday Soren did that. He compared it to quite a few other historical segments. So for instance, opioids, where you actually see that both injections and nasal coexist and jointly drive a market expansion. And we also believe that's going to be the case here. And you see the same in other types of similar segments. So we are confident that they can coexist. And we are also confident that there's much more to go for. There's so many patients out there that are not getting treatment today.

And your takeaway from the few comments that we've seen so far from the U.S. market, that it's mainly a conversion of PEN to Neffy?

I didn't get that. Peter, could you repeat?

Yes. I think the initial observations from the U.S. market is that early adopters are patients who are switching from the PENs to the nasal variants.

It's super early to discuss. Right now, Neffy has only been in the market for six weeks or so. And it's a stock up. So I think data is not clear in the U.S. We don't have those insights.

Just a very brief follow up. In terms of the U.K. market, of course, one of the most important. In your assumptions, do you assume that the U.K. will have a relative size in the future as it has now? Or have you assumed something bigger for the U.K.?

You're right. U.K. is an important market. It's one of the biggest markets in Europe for adrenaline auto injectors. It's also going to be important for us. We're not going to dwell on which markets we believe are going to be the biggest, et cetera. But I think I can state without crossing any borders here that this is going to be a very important market for us as well going forward, including for the nasal.

Okay. All right. Thank you very much.

Thank you. Thank you. And this concludes the question and answer session. I would like to return the floor to management for any closing comments.

Thank you. And if you please turn to the last slide. And before we end the call, please take a look at this slide with the upcoming news and events. We have a number of roadshows and meetings lined up. We will be reporting the annual report on the 19th of February. And we hope to see you at one of these events. As always, you are most welcome to contact either one of us if you have additional questions. And with this, we will end today's call. We do apologize for the technical issues we had early on. We hope that we were able to come back in good shape. And in the meantime, thank you and goodbye. We wish you all a good day.