ALK-Abello A/S

CSE:ALK B

Earnings Call Analysis

ALK's Q3 Highlights: Strong Growth and Positive Outlook

ALK delivered an impressive Q3, achieving 18% organic revenue growth, primarily fueled by a 29% global increase in tablet sales. The EBIT margin improved significantly from 13% to 23% year-on-year, aided by higher sales and cost efficiencies. The company confirmed a full-year revenue growth outlook of 14% to 16% and an EBIT margin of 19% to 21%. Notably, ALK has ventured into new markets with a major licensing deal for the neffy nasal spray, projected for significant future growth. Key product launches for pediatric with the house dust mite tablet are expected late 2024, positioning ALK for continued long-term success.

Strong Q3 Performance with Significant Growth

ALK delivered impressive results in Q3, achieving an 18% organic revenue growth across various regions and product lines. The key driver was the sales of their tablet products, which surged by 29% globally and 27% in Europe alone. This growth was bolstered by a strong influx of new patients, reflecting well on ALK's marketing efforts and product positioning in the allergy treatment market.

Recovery and Growth in Adrenaline Auto-Injector Sales

Sales of Jext, ALK's adrenaline auto-injector, have fully rebounded, marking a significant recovery from previous supply shortages. This reflects not only ALK's renewed supply chain robustness but also an increased demand for this crucial product, contributing to the overall growth in revenue.

Improvement in Profit Margins

ALK has successfully improved its EBIT margin from 13% to 23% year-on-year, an increase of 10 percentage points. This enhancement is a result of sales growth, improved gross margins, and effective cost management strategies, indicating ALK's commitment to not only increase revenue but also enhance profitability.

Allergy+ Strategy and New Revenue Streams

The company is making progress with its Allergy+ strategy, highlighted by a recent licensing agreement with ARS Pharma for their neffy nasal spray. This product is seen as a transformative addition to ALK's portfolio, potentially expanding the company's market significantly and providing a new revenue stream starting in 2025.

Outlook and Guidance for Future Growth

Despite some challenges, ALK maintains its full-year revenue growth guidance of 14% to 16%, with an EBIT margin expected to advance to between 19% and 21%. Europe is projected to lead this growth, while North American markets are expected to see more modest increases. ALK's gross margin is also anticipated to improve by more than 1 percentage point, reflecting ongoing efficiency optimizations.

Challenges in North America

While ALK's performance in European markets remains strong, growth in North America has been softer, with only a 3% increase reported in sales during Q3. Factors such as pricing pressures and the performance of legacy products are affecting growth. The management has acknowledged these challenges but is optimistic about upcoming pediatric launches that may spark greater growth in this region.

R&D Focus and Upcoming Trials

ALK is on track with its R&D efforts, particularly in the area of food allergy treatments. The company has completed patient recruitment for a Phase I/II study on its peanut allergy tablet, with interim results expected by the end of the year. This reinforces ALK's commitment to innovation in allergy treatments, which could lead to significant market opportunities.

Restructuring Costs and Future Investments

ALK anticipates some one-off restructuring costs in Q4 linked to their expansion efforts and clinical trial preparations in China. However, these costs are expected to be contained within the existing EBIT outlook and should not impact the long-term financial performance negatively.

Earnings Call Transcript 2024-Q3

[Per Plotnikof, executive]

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 #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.

[Peter Halling, executive]

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.

[Claus Solje, executive]

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.

[Peter Halling, executive]

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 party 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 USD 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 3 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.

[Claus Solje, executive]

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, and Slide 10.

[Per Plotnikof, executive]

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]

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

[Thomas Bowers, analyst]

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 expire here in '38, '39.

[Peter Halling, executive]

We actually see it the margins that we have on the going to impact our gross margin. [Technical Difficulty] or the year. But I would say in average 1% year-on-year is what we are going for when you look at tablets [Technical Difficulty] in children in case. But please remember, we still have the environment out there with price increases in [Technical Difficulty] on some of the things we are buying into our production anything to. So one question at this point is the best that we like to guide for now. But [Technical Difficulty] on R&D. There was a hiccup [Technical Difficulty]

So I think the question was R&D [Technical Difficulty] I can start with I hope that was some [Technical Difficulty] when you look at the cost for Q4, then we are seeing increasing cost [Technical Difficulty] more quarters to considerate [Technical Difficulty]. This is we have the initiation. This is where we have many things ongoing, also year-on-year [Technical Difficulty] higher increase, you as [Technical Difficulty] the commercial space.

For R&D, we've actually been able to invest [Technical Difficulty]. We're actually doing the same with peanut. We have started to preparing for the part 3, and [Technical Difficulty] we've been able to do that. So we [Technical Difficulty] full year guidance as we've alluded to, but that is what I think will be the R&D cost in Q4.

So I'll ask two questions on the option and a FDA approved this based on the data profile, the Cmax being similar to what with PRE-PEN. And more, there have been no changes to the label. So as we have [Technical Difficulty] a turn. So we don't expect any implications from that angle. It's a very similar [Technical Difficulty]. On the royalties, just to answer [Technical Difficulty] royalties are no longer following the patent. So that means that we're not paying the royalties after. So I think that [Technical Difficulty]

[Per Plotnikof, executive]

Operator, do you still have the line through?

[Operator]

Yes. You're still on line.

[Per Plotnikof, executive]

Able to reestablish the connection outside. And I would like to proceed with the Q&A, please. Operator, please go ahead.

[Operator]

The next question comes from Michael Novod with Nordea.

[Michael Novod, analyst]

So I think maybe when Thomas gets back on, you have to repeat your answer, at least I didn't get them at all. But anyway, I'll ask my two questions. So to the U.S., we've discussed 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 on 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 the 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?

[Peter Halling, executive]

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

[Michael Novod, analyst]

It was amazing. You could have done it in Russian, I wouldn't understand it.

[Peter Halling, executive]

All right. Let me start out by talking about the U.S. You are right. Obviously, we are not happy overall with the performance. And 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 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 nutritionists 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 a positive.

On the legacy, the bulk business, this is not a strong growth we are seeing on the market -- 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 PRE-PEN, 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 really continue to have a high focus on getting tablets right. We are in need to get the approval so it could 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.

[Per Plotnikof, executive]

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 regimens. 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 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...

[Michael Novod, analyst]

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

[Per Plotnikof, executive]

So I mean, we are not investigating efficacy in this study. There are no end points on efficacy in this study. This is safety and tolerability. Then we -- as you know, as we referred 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.

[Operator]

And the next question comes from Peter Sehested with ABG.

[Peter Sehested, analyst]

Yes. 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 sort of given the option to co-promote neffy in the U.S., would you consider that to be a strategically attractive opportunity?

[Peter Halling, executive]

Can you repeat the last part, Peter, we just lost you on the last question.

[Peter Sehested, analyst]

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?

[Peter Halling, executive]

So let me answer both. It's a little bit the same question. And so 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 there at that. The question 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 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.

[Peter Sehested, analyst]

Yes. Okay. I didn't really expect an answer to that, but nevertheless, just getting back to the peanuts announcement. It was not to get an answer right now once you know the outcome will be, it's more like will you when you announce, the outcome with that data, will you, at that point in time, be able to say, we will continue or you will not?

[Peter Halling, executive]

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.

[Operator]

And the next question comes from Benjamin Jackson with Jefferies.

[Benjamin Jackson, analyst]

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 received 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 time lines for the Part III 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 into 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.

[Peter Halling, executive]

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

[Per Plotnikof, executive]

Yes, I was a little bit unclear what the question was. I can say -- if there's any with our announcement now that we have started screening patients are 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 the phase -- for the Part III of this. And I also tried to explain, I think it was actually on there 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 we 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 III of this before we know the exact outcome of the Part II here of the trial. And of course, we're 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.

[Peter Halling, executive]

But obviously, the trials of the trials you never know how many people said about 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 peak 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. They are 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 peak 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 3-year buildup, 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, Europe, the European market, we can use and we'll continue to use our existing commercial channels and seeing 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 to the attritions that will be part of it, but we are well positioned to reach out to those this year 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.

[Operator]

And the next question is from Jesper Ilsoe with Carnegie.

[Jesper Ilsoe, analyst]

I'm also trying my luck to add a question on food allergy and peanut. So firstly, given the update you provided with screening starting. And 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 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, can you just remind us when you actually expect to initiate further trials in other food allergies? Will it be after this Part II readout? Or would you like to see efficacy before starting in new trials? So basically, what data points will be waiting for at the moment?

[Peter Halling, executive]

Thanks, Jesper. Per?

[Per Plotnikof, executive]

Yes. 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 where up-dosing schemes. And then we look for the profile here in these patients on this step. And that was, 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 stage, we're 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.

[Peter Halling, executive]

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.

[Operator]

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

[Sushila Hernandez, analyst]

On the house dust mite clinical trial in China, how long do you expect for improvement to take for these 300 patients? And what would be the duration of this treatment during this trial? Is it 12 months? And the second question, could you share more color on the 2024, '25 initiation season? And what indicators give you a sense that this will be an average good season?

[Peter Halling, executive]

All right. Let me take that. 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 up-dosing schemes, but we are still in dialogue with Chinese authorities in terms of where and how to conduct it. We do expect that we have all of this finished with a name of reaching 2028 for timing of approval. So that's China and the house dust mite 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. But 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 going 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.

[Operator]

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

[Peter Sehested, analyst]

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

[Claus Solje, executive]

Claus. I can take that. 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 are, of course, 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 cost here in this Q4 and that will be -- will pay here. That will not have any influence on the next year's numbers, so to speak, it will be a onetime and only in Q4.

[Peter Sehested, analyst]

Okay. And second question, actually, is to turn back to the Monday's call and also a bit to do with Thomas' question early on. I mean, we just look at it high level, then you can argue that nasal spray has a potential to take the whole market basically, right? And yet you argued 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? Is that are you guarding yourselves to -- against or hedging the higher time to onset that you have with a pen versus the nasal spray?

[Peter Halling, executive]

We're not guarding this around the onset is 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 would 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 form for years. So we see a clear opportunity for both. We also know 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, Søren, 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 are so many patients out there that are not getting treatment today.

[Peter Sehested, analyst]

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.

[Peter Halling, executive]

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

[Peter Sehested, analyst]

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 to the nasal variant.

[Peter Halling, executive]

It's super early to discuss. Right now, neffy has only been in the market for 6 weeks or so, and it's a stock off. So I think data is not clear in the U.S. We don't have those insights.

[Peter Sehested, analyst]

Perfect. Just a very brief follow-up. In terms of the U.K. market, of course, one of the biggest, 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.?

[Peter Halling, executive]

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.

[Operator]

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

[Per Plotnikof, executive]

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.

[Operator]

Thank you. As mentioned, the conference has now concluded. Thank you for attending today's presentation. You may now disconnect.