Per Plotnikof   VP of Corporate Communications, Investor Relations & Strategic Planning and Head of IR

Hello, everyone, and welcome to this presentation of ALK’s full year results and the outlook for ’25, and thank you all for joining us.

Let’s turn to Slide #2 with an introduction 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, Claude Steensenn Solje. We will first be sharing highlights from Q4 and the full year, and then we’ll take a closer look at the market product trends as well as the financials. We’ll also provide an update on the execution of the ALK strategy before we present the outlook. As usual, we will end the presentation with a Q&A session.

And to get us started, I’ll hand you over to Peter and Slide #3 for the Q4 and full year highlights. Please go ahead, Peter.

Peter Halling   President & CEO

Thank you, Per, and thank you all for joining this call. First, a few highlights from Q4. Results were as expected and in line with the full year outlook. Revenue grew by 11% to DKK 1.5 billion. Europe continued to perform very well and delivered double-digit sales growth across all product lines. European tablet sales increased by 32%, as we further solidified market momentum. We estimate that, that number of new patients coming in were basically attributed to starting the tablet treatment in ’24.

’24 initiation season exceeded last year’s number by more than 10%. This should give us some comfort for the growth prospects in ’25, although too early to conclude since the initiation season is still ongoing. North America and international markets didn’t contribute to top line growth in Q4. We knew that in advance and flagged this during the Q3 earnings call and in the Q3 report. Consequently, revenue growth was lower than in Q2 and in Q3. Claus will add a few more words to this later on our call.

Regarding investments, then Q4 is always our largest investment quarter due to the initiation season. But in ’24, we decided to invest even more and speed up strategic initiatives. We increased R&D costs and invested further in both the peanut tablet program and the upcoming ACARIZAX trial in China.

Sales and marketing costs reflected increased activities to support the pediatric launches. Costs also included one-off cost of DKK 26 million related to previously announced optimization initiatives in Europe and the adjustments in China where we reshaped the organization due to the delayed time line for the ACARIZAX launch. We also had additional planned costs related to the neffy deal, including advisory fees. Due to these one-off costs, the Q4 operating margin ended at 14%, which is still in line with our guidance.

Slide 4, please. So let’s move from quarterly variations to the more accurate full year picture. 2024 was a record year for ALK. We delivered on short-term targets and established a new strategic framework for ALK’s long-term development. Revenue was up 15%, driven primarily by European tablet sales. Growth was higher than what we’ve seen in previous years and earnings improved by 65% in local currencies. DKK Result exceeded DKK 1 billion for the very first time. thanks to solid sales growth, margin expansion and efficiencies across the business, a very strong set of results, which Claus will elaborate on later.

Another highlight was the Allergy+ strategy execution, which has started to deliver the desired results. Let me just point out a few things, showing our efforts to unlock further potential in existing markets and expand into new therapy areas with high unmet needs.

Firstly, we are expanding the addressable market in respiratory allergy. We do that when we add new patient groups, particularly children and expand into new relevant segments. Secondly, we took important steps to build new revenue streams in the broader allergy space. We in-licensed the nasal spray neffy, to support our ambitions in anaphylaxis. Moreover, in food allergy, we have good data and readouts from our ongoing clinical development program.

The fast initiation of the strategy implementation and the EBIT optimization was made feasible by our successful execution of the plus DKK 250 million optimization program. 2024 was also a year where ALK calibrated its business platform to focus on high potential growth levers. This is reducing complexity and generating savings, which will partly support earnings and partly be allocated to initiatives with the highest potential to generate strong returns and the greatest benefits for patients and prescribers.

We’ll detail this during the presentation, but first, I’ll hand it over to you, Claus, and the market trends on Slide 5.

Claus Solje   Executive VP, CFO & Member of Management Board

Thanks, Peter. Let’s dive into the performance in our sales regions first. Our main region in Europe stood out as an exceptional contributor to growth. Sales were up 22% with a double-digit growth in most Northern, Central and Western EU markets, including Germany and France. Tablets were the #1 source of growth. European tablet sales increased by 31% as we activated more patients, prescribers, payers and key opinion leaders. Approximately half of the growth came from higher volumes linked to the past year’s inflow of new patients, while improved pricing and rebate adjustments roughly accounted for the other half.

Trading patents among wholesalers were still a factor but these movements had a lower negative impact than in 2023. Sales of our 2 other product lines also grew by double digits in Europe. SCIT and SLIT-drops sales increased by 10%, while sales of other products grew by 32%, driven by the Adrenalin Pemex. ALK consolidated its position as the European market leader.

Revenue in North America was unchanged, and we are not satisfied with this result. It was positive to see tablet sales were up 15%, mainly on higher volumes while the impact from higher average selling prices in the U.S. declined in the second half year. Sales in SCIT bulk extracts were flat, while sales of other products were down 7%. And I’ll come back to this more in a moment.

Revenue in international markets was up 4%. Tablet revenue grew by [indiscernible] fully leading demand. Still, to affirmed Orbit’s position as market leader with growth of 12% in the in-market sales. Revenue from SCIT in China registered a double-digit decline as no shipment was sent to China during the renewal of ALK’s import license and due to some in-market inventory adjustments. The renewal has now been completed, and we have started producing new SCIT products for China that will be shipped from the spring and onwards.

Nevertheless, the in-market sales in China contribute to grow by double digit. Let’s turn to the product lines on Slide 6. We Global tablet revenue was up 24% due to the strong performance in Europe. Global revenue from SCIT and SLIT-drops was up 6%, thanks to higher volumes, improved pricing and rebate adjustments in Europe.

Global revenue from other products increased by 7%. [indiscernible] sales recovered nicely from the 2023 supply challenges. Oppositely, sales of other products were down in North America as we decided to discontinue some high-volume, low-margin contracts on Life Science products. In addition, PRE-PEN sales performed below expectations. We are pleased with the PRE-PEN business, which we acquired in January but the stock off with doctors ahead of the acquisition and the lack of reordering in the first half year came as a surprise to us. We expect to see normalized sales growth this year.

With these updates, let’s move to Slide 7 and the financial results. Revenue was totally up 15% in local currencies and exceeded DKK 5.5 billion for the first time. Gross profit of DKK 3.6 billion yielded gross margin of 64.2%, an improvement of more than 1 percentage point. This improvement was linked to volume growth changes to the sales mix, improved pricing and production efficiencies. In line with our expectations, these factors were partly offset by higher input costs and minor one-off costs to optimizations in product supply. Capacity costs increased by 4% to DKK 2.5 billion.

This figure includes the vast majority of the DKK 75 million in one-off expenses related to optimization initiatives in Europe and China. Without these one-offs, capacity costs would have been flattish mirroring the positive impact from resource optimizations and general cost savings.

Operating profit EBIT was DKK 1.1 billion, an increase of 65% in local currencies and 64% in Danish kroner. It was the first time we exceeded the DKK 1 billion mark in operating profit. The EBIT margin increased from 14% to 20%, and the underlying EBIT margin would have exceeded 21% had it not been for one-off costs.

Finally, free cash flow was negative at minus DKK 204 million. This was a call due to the upfront payment of DKK 1 billion related to the strategic license deal for neffy. Excluding the upfront payment related to the neffy license agreement, free cash flow ended better than expected and increased to DKK 290 million. DKK 70 million, driven by improved earnings, lower CapEx and changes to working capital. The 2 graphs to the right point out 2 important factors in ALK’s earnings journey.

Firstly, we have managed to increase the gross profit by 15% on average in the last 4 years compared to the 12% top line growth in the same period. We remain keen on sustaining this trend although fluctuations may occur from year to year. Secondly, we have managed to contain capacity costs to the capacity cost to revenue ratio is down by 9 percentage points from 54% to 45%. This will remain a key focus area for us. So all in all, a strong set of results that continue this solid traction.

Now back to you, Peter, and the strategy on Slide 8.

Peter Halling   President & CEO

Thanks, Claus. The annual report gives a detailed account of the execution of the Allergy+ strategy. So let me just focus in on a few of the highlights. As a reminder, the strategy builds on ALK’s promise to provide life-changing solutions for the millions of people living with allergies. In 2024, we estimate that around 2.6 million people were treated with ALK products, a net increase of 200,000, and we continue to target 5 million patients yearly by the year 2030.

A major event last year was the approval by 21 countries of our house dust mite tablet ACARIZAX for children use. A similar process for our tree tablet ITULAZAX is progressing so that this tablet could become available for children and adolesents mid-’25. By then, all our major tablet products will be approved for all age groups, and we expect that the complete portfolio for all ages will open doors to even more prescribers. This will become an important catalyst for our long-term growth.

Market expansion continued in Japan, where our partner [indiscernible] is increasing production capacity to meet high demand while also working to bring our grass tablet to the market. The capacity increase is expected to be ready in the second half of ’25, which is slightly earlier than planned for. In China, the country with the highest number of people with house dust mite allergy worldwide, we are expecting to initiate and are conducting initiation trials for ACARIZAX.

Key to deliver the clinical data needed to obtain an approval for the tablet and subject to a successful outcome, we expect a launch around ’28. In India, our partner, Dr. Redis, will launch our house dust mite tablet this year based on the recent regulatory approval. More, we also received very good news from the U.K. where the newly nice recommendation has paved the way for ACARIZAX in the Public National Health Service system. The successful outcome makes ACARIZAX the first AIT tablet eligible for general reimbursement in the NHS system. We hope for a similar outcome for our tree tablet, ITULAZAX which has been submitted for review very recently.

The U.K. is currently one of the few major AIT markets in Europe where ALK’s tablets are authorized without adequate public reimbursement. A key strategic objective is to strengthen the pipeline. In each disease area, our ambition is to build a portfolio of solutions with the potential to establish ALK as a global market leader. And thereby substantially expand our addressable markets. We are continuing to further expand the pipeline, and we are pleased with the progression so far.

A few key events underlining the progression has we entered the single largest enlightening deal in ALK’s history when we acquired the rights for parts of the world to neffy, the first and only approved nasal spray for emergency treatment of acute allergic reactions. A product with the potential to transform treatment and significantly expand markets. Launch preparations are well underway, and we expect to launch in the first European markets this year around summer.

Moreover, the continued development of the next-generation auto-injector Genesis is progressing as planned. With the expanded portfolio, ALK will be the only company in the world offering both needle and needle-free solutions to patients and caregivers. Food allergy, based on the positive Phase I outcome, our trial in peanut allergy advanced into Phase II for dose finding and efficacy, while novel preclinical development projects has begun to take shape.

We also started working more systematically to explore new therapy areas. On that note, we gained exclusive rights to any future new indications for neffy, such as acute flares associated with [indiscernible] are currently in Phase II development.

Finally, as previously mentioned, we implemented a range of optimization and prioritization initiatives to reduce complexity and scale ALK for further growth. For instance, approximately 200 positions were made redundant. We expect these initiatives to generate savings of more than DKK 300 million in ’25. And these savings, which exceeded our original target of DKK 250 million allow us to pursue Allergy+ priorities more rigorously without jeopardizing earnings improvement as well.

Slide 9, please. So let’s cover the [indiscernible] battles for ’25. Obviously, we must keep momentum and continue to grow revenue and earnings by helping more people with allergy immunotherapy and anaphylaxis treatment. Our key objective in this context is to maximize the value of the tablet portfolio and sustain healthy growth in global tablet sales. This is also — sorry, this also means succeeding with the ongoing regulatory filings and launches for tablets in the pediatric space.

We launched ACARIZAX for children in Europe at the turn of the year, and the treatment is now available in 5 markets. This is a result of having achieved the national approvals and reimbursements needed to provide the optimal access to treatment. The initial feedback is very encouraging and it’s good to see a diverse group of doctors, ENTs, pulmonologists, dermatologists, allergists and pediatricians alike among the early adopters.

By our digital channels, we are also working on increasing the disease awareness to support families with allergies and then to take action as no child should be limited by their allergies. These activities are also progressing well. And for instance, we are ranking top 3 on Google searches in the first launch markets, Germany and Denmark.

So overall, we are satisfied and pleased with the progression of the launches in Europe. In parallel, we continue to work on expanding our manufacturing capacity towards 800 million tablets annually before the end of the decade. Important expansion to support the future growth of the tablet business. We’ll continue to expand the wider allergy space, both in food allergy with our peanut tablet and with novel concepts in new areas.

Neffy is a key enabler to our success in the wider allergy space. right now, focus is on securing market access in key EU markets, getting regulatory approvals in the U.K. and Canada, which are both major anaphylaxis markets and then succeeding with our first launches.

We also recently submitted an application to expand the EU approval of neffy to also include small children weighing 15 kg to 30 kg . In parallel, we continue to progress on the Genesis project, developing the new generation of auto injectors.

Finally, we also continue to advance our sustainability agenda. We’ll have a particular focus on laying foundations for our CO2 reductions. Among many other things, this includes installing new efficient equipment in the production facilities to reduce our emissions further and towards 2030, deliver on our 42% reduction target. All in all, a long and comprehensive worksheet follow also with a clear plan and set up to ensure successful execution.

Now with this, I’ll hand it over to you, Claus, and the full year outlook on Slide 11.

Claus Solje   Executive VP, CFO & Member of Management Board

Thanks, Peter. For 2025, we expect to deliver robust revenue and earnings growth. Revenue is projected to increase by 9% to 13% and the EBIT margin is expected to increase by 5 percentage points to around 25%. Let me take you through the key assumptions. Revenue is expected to grow across all sales regions and all product lines. Tablet sales are expected to grow by double digits in all sales regions, fueled by more patients, including more children and adolescents.

Obviously, we do expect a reduced positive impact from pricing and rebate adjustments compared to last year, where these factors accounted for roughly half of the tablet growth in Europe. Consequently, tablet growth in Europe is expected to be lower than last year’s exceptional growth. Combined skin and sleep drop sales are projected to continue last year’s growth trend.

We expect SCIT sales to benefit from higher volumes and market expansions in Europe, supported by improved pricing in North America. And SLIT-drops sales are anticipated to grow in line with the ongoing AIT market expansion in France. On sales of other products is projected to improve compared to last year following the expansion of our Adrenalin portfolio. We expect a neffy spray to contribute to growth from the second half year.

Our gross margin is expected to improve slightly Higher revenue mix changes and efficiencies will drive the margin upwards. But these improvements will be somewhat offset by higher input costs and neffy. Neffy will adversely impact gross margin due to amortizations of the milestone payments, sales royalties and the transfer price of the device.

At R&D expenses are expected to increase but remain at around 10% of the projected revenue. Sales, marketing and administration costs are projected to decrease slightly as cost savings and optimizations offset planned growth investments. Finally, the outlook does not assume any one-off cost for optimization initiatives in 2025.

So to sum up, we expect 2025 to mark the seventh consecutive year of revenue growth and improved earnings, fully in line with our long-term financial ambitions. With this, I would like to hand back to Per and Slide 12.

Per Plotnikof   VP of Corporate Communications, Investor Relations & Strategic Planning and Head of IR

Thank you, Claus, and thank you, Peter. And we will now move to the Q&A session. And please limit yourself to a few questions before rejoining the queue again. And with that, operator, please go ahead.

Operator

[Operator Instructions] The first question today comes from Thomas Bowers with SEB.

Unknown Analyst

So first of all, if we look at the tablet growth in Europe for the fourth quarter, I’m just wondering whether there’s any inventory or any stocking impact that we just need to account for here? And then secondly, in regards to France, you do highlight continued growth momentum also in Q4, and it’s been quite impressive during the quarters in ’24. So can you maybe add a little bit of color on on the relative contribution from France and also whether you see France as having a material impact on the ’25 growth outlook?

And then my last is just a small question here, just on neffy. I know it’s probably a quarter or 2 too early to ask this. But at least the initial indications about pricing, does that sort of reflect your expectations so far?

Peter Halling   President & CEO

Thanks, Thomas. I appreciate the few questions. So Claus, will you comment on the first on the tablet growth?

Claus Solje   Executive VP, CFO & Member of Management Board

Let me do that. It’s a good question, Thomas. Thanks for that, and thanks for listening in here. The tablet growth in Q4 was, as you say, quite significantly high with the 32% in Europe. This is basically driven by a very good underlying volume increase as we have also talked to — but you are right that if you compare to the same quarter last year, then there is a small stocking effect that is worthwhile taking into consideration of around approximately [ DKK 20 million ], and it’s mostly in Germany. So that’s comparing ’24 Q4 to ’23, Q4. So that is something that is helping us a bit on the growth rates towards 32%.

Per Plotnikof   VP of Corporate Communications, Investor Relations & Strategic Planning and Head of IR

And if you take, Thomas, I can comment on France. France had a great year and also, to some extent, a surprisingly strong year to us. The reason was part of the change in France where some of the clinics already now and have been initiating throughout the year and expansion of the clinics, allowing nurses in the clinics to basically take and help the patients to a larger extent than in the past. That has helped us and the business because more patients are coming through in the clinics.

We’ve also seen a good uptick on the tablet side. We do expect that France will continue to grow over all whether it’s material is always for a discussion. But bottom line is France will also be in growth mode in the coming year.

And then finally, the question around neffy, initial indications and price discussions. It’s too early to say. We are in the midst of the discussions, and that will continue for a while. And as soon as we can, we will report any news on terms of the price level. As previously stated, we are still targeting a price that is higher than the current auto injectors.

Operator

The next question comes from Ben Jackson with Jefferies.

Benjamin Jackson   Jefferies

Just 2 quick ones for me. The first, again, on neffy, if I may. Are you able to provide any quantification of how much you think it could contribute in that second half of the year? I think we discussed it previously, but it would be interesting to see if following your initial discussions or following initial physician feedback, you’ve changed these expectations at all?

And perhaps it’s also too early to tell, but have you had any initial engagements with physicians and any feedback that you could report to us upon? We’ve noted through some of our channels that they are already reaching out to patients about the opportunity. And thinking about potential future education. So I’d be interested to see if you have any take on — very early physician feedback there to the data and into the availability.

And then secondly, just on the longer term — well, the midterm strategy numbers, is there a possibility that as we move forward, as things evolve and as the company changes either through the addition of new assets like neffy, that we could reconsider the numbers that you’ve got out there in the midterm aims. Or are they constructed as such would be over 10% and the around 25%, it’s not really something that could be considered even as things change because it’s set up to enable a wide range. Any thoughts around that would be greatly appreciated.

Per Plotnikof   VP of Corporate Communications, Investor Relations & Strategic Planning and Head of IR

Okay. Thanks, Ben. So let me start out with neffy. And Claus chime in any time, right? So first, on the neffy as a growth contributor, we’ve been clear that it’s modest, the contribution we see from neffy, we have guided 9% to 13% in totality, and that includes, obviously, the the impact from neffy and the children launches as well.

Underlying growth remains solid for the business. So I think you can add the numbers yourself on that one. On the physicians, I’ll just say we’ve been very surprised in a positive way by the feedback we’ve gotten from patient organizations, physicians, KOLs and others. There is a clear demand out there for the product. And that’s obviously something that we are positive around now. We need to see pen to paper. There are some very important aspects. One is the enthusiasm. Two is depending on where we end on the price. How would this actually transform into prescriptions, et cetera, out there.

But that being said, I’ll say that so far, so good. We are quite happy with the positive push or the pull we are seeing from the market, especially physicians, but also potential patients and caregivers. So all in all, positive. But let’s see pen to paper, first and foremost.

Maybe on the midterm growth, Claus, you want to add a few words?

Claus Solje   Executive VP, CFO & Member of Management Board

I can. Thanks, Ben, for the questions. Basically our long-term financial targets that you’re asking to around our 10% or above 10% on the top line towards ’28 and our EBIT margin of keeping that hopefully now getting up to the 25% and ’25 and then keep that also in ’26, ’27 and ’28. It’s always difficult to sit here and forecast and it is still our long-term financial targets, and we’re not going to change them during this call. But there are a few things that I could maybe mention in here in the sales of 10%, we are — that is based on organic growth as we see the business today.

And of course, a few things that could kind of talk to from a positive angle that we are focusing on is, of course, as Peter was on the around the neffy, but also the children launches that, of course, is coming. That is very interesting and something that could have a positive momentum.

Then I also think it’s fair to mention that remember that we had to withdraw in China, our launch of a ACARIZAX or postpone it onto the indolent strategy period. So that’s counter a little bit the opposite way. But we still feel comfortable around our long-term top line, around these 10% or above 10% with the potential upsides that are in that.

When it comes to the 25% EBIT margin, then we have basically said that it’s important to us to get to the 25%. We want to make sure that the top line and bottom line are following hand-in-hand, and is also a profitable company also in the longer term. It’s important for us here in the next period from ’25 towards ’28 to invest into these commercial opportunities that we have also investing into our pipeline opportunities and largely also into infrastructure. The company is growing, and we are growing the company quite fast.

So it’s important that we also to make sure we are ready for the future also into the 2030s to actually invest into our infrastructure of the company. So that’s why we would like to make sure that any you can say, 3 financial muscles above the 25% can be used to invest into our business and into the infrastructure of the company. But of course, this is what we plan to do. This is still what we also communicated on the Capital Markets Day, and we still expect to do that. But let’s see where this sense, we, of course, keep an eye on it. And if there’s opportunity to deliver more, then, of course, we will do that. I hope that answerss your question.

Operator

The next question comes from Jesper Ilsoe with Carnegie.

Jesper Ilsoe   Carnegie Investment Bank AB

A couple of questions from is as well. Firstly, on the initiation season. Perhaps you can just I’m not sure I heard you correctly, but you said that it’s a bit better than what you have assumed in your guidance and implies potentially more than 10% growth in new patients. Can you just explain it a bit more again than basically what you are waiting for to be a bit more positive for the initiation season and the signs we’ve seen so far?

And then secondly, on the pediatric launches you’re having here in ’25, of course, will be quite interesting to track and could be a big growth driver. Just help us how you think about the near-term sales of ’25. So what have you assumed in your guidance? And is it fair to assume that you’ve assumed it’s a bit less than 1 percentage point contribution to sales growth. Any extra feedback there would be great.

Peter Halling   President & CEO

Thank you, Jesper. Let me start out with the initiation and then Claus, maybe you can talk pediatric and guidance. Just on the 10%, we expect as being communicated earlier on around or plus the 10%. So all in all, positive but no changes to how we’ve been guiding so far. Again, when we look at the initiation season and it’s important for me to remind all that we are still getting data, January is an important month for us in terms of new patients.

We saw with ITULAZAX and the tree pollen last year already in April, and we’ll be communicating around it that it would most likely be weaker than what we’ve seen in previous year. So that still stands. Secondly, we’ve seen that the grass pollen season is more or less what we would call a normal season, so an average season. That’s still the indication. And then thirdly, we’ve seen the houses dust mite pick up nicely and do well and also be a strong, if you wish, season in that sense.

So all in all, when we look at it, no changes to the guidance. We’ve seen the number of patients coming in on the plus 10%, and we expect this to be what we would call a normal season. And please do take this — please take into account that this is just 1 out of 3 years. We still have the ’22-’23 season affecting us in the ’23-’24 season, a very weak season and an exceptionally strong season. So that’s also what’s playing into it.

So I think that’s the answer on that one. And maybe Claus on the pediatric side?

Claus Solje   Executive VP, CFO & Member of Management Board

Yes, I can do that. Thanks, Jesper for the question. We are, of course, looking very much forward, like you also mentioned to the P launches that is ongoing right now. And as Peter was saying before, then we have now seen it being launched in 5 markets across Europe. And we are actually very happy and satisfied with the progression here and the feedback from doctors and patients and what we are seeing in the market.

You are correct with your statement that we are expecting in our guidance and in our forecast are modest impact from the launches of the pediatricians here, but — and less than 1% is also fair, as you say, this is what we have put into the guidance as stand today. But let’s wait and see over the next few quarters when we get more input from doctors and patients across the European markets.

But right now, we are happy and satisfied with the progression that we see.

Peter Halling   President & CEO

Maybe just to add do remember, this is 1 out of our 3 major tablet products, and it’s still early days. So it will take time.

Jesper Ilsoe   Carnegie Investment Bank AB

If I can just ask one follow-up then. So with the comments you made about the initiation season being normal and grass, but stronger on house dust mite, does this initiation season in any way impact the potential sales for the pediatric launches in Europe in ’25? So how important is it? Because then in that case, the House dust mite launch could be quite strong.

Peter Halling   President & CEO

It’s a good question, Jesper. And hopefully, it’s not hurting things. But I would say — it’s still too early to say whether this will have an impact or not. We’ll know a lot more in the coming quarters. So — but obviously, it’s not negative in that sense.

Operator

[Operator Instructions] Next question comes from Sushila Hernandez with Dan Lancope.

Sushila Hernandez   Kempen & Co

Could you leverage your efforts on building new sales channels in the U.S. among pediatricians? And what initial feedback are you getting on the potential launch of house dust mite tablet? And also for 2025, how do you look at external innovation opportunities? Are you more focused on progressing internal programs?

Peter Halling   President & CEO

Thanks. Let me take the first part on the U.S. side and the U.S. launch. Obviously, we are still in preparation. We expect that this — that the launch will happen in the first half of ’25. So the key there is we are basically expanding into a new channel. It’s a different market compared to Europe. So it’s going to take more time. It’s going to be more education and training. So the impact in the U.S. at this stage will still be — we still expect to be very modest.

That being said, the work we’ve been doing over the past year, ACARIZAX has confirmed that there is a strong interest. But the question is, like with many of the other products, will they put pen to paper. So that’s obviously a key aspect of all of this. So I’d say we still need to learn more around the U.S. I am cautiously optimistic.

But we are still very early days and we need to get the products ready, and then we’ll be able to talk more about are they actually moving on this or is this more kind of initial interest. Second question?

Per Plotnikof   VP of Corporate Communications, Investor Relations & Strategic Planning and Head of IR

Sushila, can you please repeat the second question? You fell out just shortly.

Sushila Hernandez   Kempen & Co

Yes, sure. So for ’25, how do you look at external innovation opportunities? Or are you more focused on progressing internal programs?

Peter Halling   President & CEO

I can start and then, chim in. So basically, as we said last year during the Capital Markets Day, our ambition is to expand our portfolio further and strengthen the pipeline. And that’s going to be a mix of both internal capabilities and projects and then also external. And obviously, shortly after neffy was the first move into this, but neffy was not only on the anaphylaxis side. It also gave us room to move forward with an indication for its carrier. So that’s important.

We still believe there is opportunity and room in the food space. So we talked about 3 tablet, which would be an internal project, but it could also be that we go out and look for external assets to support that part of the growth the same for respiratory or potentially some of the new therapy areas. So that continues to be a focus area for us. It’s also included in the guidance. Claus can talk a little more to it, but we basically set that in our long-term guidance, we are talking 10% to 15% spend on R&D and then obviously depends on whether we invest in one internal asset or external.

Claus, you want to add a few words?

Claus Solje   Executive VP, CFO & Member of Management Board

Maybe just adding that for now in our guidance, you can see that we are spending approximately 10% on R&D versus sales that we’re also guiding for here next year and in ’25 and then we are expecting that depending on how fast we can progress with some of the peanut trials into Phase III and so on, we could go to up to 12%. And then it will depend on, as Peter is saying, how much can we progress our early pipeline initiatives? And what do we find outside, then how will the R&D spend move forward.

But this year around the 10% we have in guidance, probably going up to around 12%, 13% over the next couple of years, and then we will see depending on progress of what we will find internally or externally if that will progress or how it would be.

Operator

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

Per Plotnikof   VP of Corporate Communications, Investor Relations & Strategic Planning and Head of IR

Thank you, and thank you for the good questions. Before we end the call, I’d like I would like to take you to the next 12 months upcoming news flow on Slide #12. Much is obviously centered around the children indications in Europe and North America as well as initiatives to cultivate new tablet markets, China, India, U.K., et cetera. But we also expect first launches on neffy to take place in the second half year, while the Phase II trial in peanut allergy is due to complete in 2026.

And obviously, we’ll keep you updated on these and other events as they progress. Finally, I’d also like to mention that our Q4 roadshow will bring us to Copenhagen tomorrow. And we have additional events lined up in the near-term future in Europe as well as in U.S. As always, you are most welcome to contact us if you have additional questions. And with this, we end today’s session, and we wish you all a good day. Thank you.

Operator

The conference has now concluded. Thank you for attending today’s presentation. You may now disconnect.