Hello, everyone, thank you all for joining this presentation of ALK Q4 results and the outlook for 2023. Let's turn to slide 2, where I'll introduce today's presenters and the agenda. My name is Per Plotnikof. I'm head of investor relations, with me today are CEO Carsten Hellmann and CFO Søren Jelert. First, we'll bring you up to date on the performance in the fourth quarter and the full year, as well as sales trends and financials. Then we'll provide an update on our strategic priorities with deep dives into North America, China, and the pediatric opportunity before we cover the outlook. As usual, we will end this call with a Q&A session. To get started, I'll hand over to Carsten on slide 3, please.
Thanks, Per. Thank you all for joining us today. Let me take you very briefly through a couple of highlights from Q4. Results were in line with the most recent outlook. Q4 revenue was up 12% on growth in all regions and across all product groups. Reported growth in DKK was 14% and the revenue of DKK 1.25 billion was a new all-time high for a quarter in ALK. Global tablet sales grew by 14% despite a temporary weakening of the important German AIT market, which Søren will cover in a moment. Non-tablet sales increased by 10%, led by SCIT and Jext. One of the key takeaways from Q4 and Q3 and Q4 is that SCIT is well-positioned to contribute to growth going forward.
Operating profit, EBITDA, was up 48% to DKK 201 million, driven by top-line growth and efficiencies. Inflationary pressure on margins and costs were manageable. All in all, a strong finish to the year. Let's move to slide 4 and the full year highlights. 2022 showed organic growth in local currencies of 13% and reported growth in DKK was 15%. EBITDA was up 33% to DKK 708 million, driven by top-line growth, margin expansions, and efficiencies in our business. Our business proved resilient to inflationary pressures and macroeconomic uncertainties. We remain on track to deliver long-term sustainable growth and earnings improvements. Strategic progress, including the ongoing efforts to broaden AIT prescriber bases and tap into the large pool of untreated patients who are eligible for AIT treatment.
In 2022, we estimate that ALK products were used by around 2.4 million patients worldwide, a net increase of 300,000 or 14% from 2021, that was primarily due to new tablet and Jext patients. Despite this progress, we are well aware that we are only touching on the tip of the iceberg and the potential remains huge. We are working harder than ever to spread knowledge about allergy and to educate, promote, and facilitate early access to diagnosis in an AIT treatment. We continue to work on expanding the market, building prescriber and patient platforms through a new channel expansion, digital engagement, disease awareness programs, advocacy for evidence-based medicines, and new business models and other activities.
2022 was the fourth consecutive year of strong top-line growth and earnings improvements. There's still so much more we can do to drive progress. We expect 2023 to become the fifth consecutive years of progress. We expect top-line growth and further earnings expansion, although concessions will be slightly tougher. We will detail all this later. First, I will hand you over to Søren on slide 5.
Thanks, Carsten. Let's take a closer look at the market trends in 2022. Let's first look at Europe, where sales were up 10% in fourth quarter and 9% for the full year. This was despite a weakening of the overall AIT market in Germany in the second half of the year, which Carsten just referred to. We believe this weakening was due to a weak 3 pollen season, which resulted in fewer patient initiations and a wave of respiratory infections, which crowded out patients from clinics. We also saw that some prescribers responded slowly to the phasing out of reimbursement for non-registered products. Overall AIT industry sales declined, and this has also had an effect of lowering our tablet sales in quarter three and quarter four as Germany is our largest tablet market.
Nevertheless, ALK gained additional market share in Germany, which we estimate has grown to around 35%, and we are well-positioned to expand our market leadership in Germany further as new patients move to evidence-based products and the ongoing changes and competitive dynamics in the market take full effect. North America reported growth of 6% in fourth quarter and 12% for the full year. With growth from all product lines. U.S. tablet sales were still weak due to our long-standing market barriers, while Canadian tablet sales did very well. Revenue from international markets were up 36% in Q4 and 39% of full year basis, powered by a strong growth in both tablet shipments to Japan and SCIT shipments to China. Let's take a closer look at the product categories on slide 6.
Growth rates for the tablets portfolio were 14% in fourth quarter and 18% for the full year. All sales regions had double-digit growth, and tablets continued to expand their position as a preferred treatment for moderate to severe respiratory allergies. Combined, SCIT and SLIT drop sales increased 4% in fourth quarter and 3% for the full year. European SCIT sales improved towards the end of the year when sales of venom products recovered from previously unavailability, and sales also benefited from supply issues affecting competitors as well as better pricing. SCIT sales also increased in China and North America. Other products generated growth rates of 37% in fourth quarter and 27% for the full year. This was mainly due to Jext. Jext sales surged 51% in Europe in response to higher demand and supply issues which impacted other manufacturers.
With these solid sales trends, let's turn to the P&L on slide 7. Full year revenue exceeded DKK 4.5 billion, reflecting a 13% growth in local currencies and 15% growth in DKK, while our EBIT margin was up 3 percentage points to 10%. Gross margin improved by 1 percentage points to 62%, reflecting higher sales and improved efficiencies. Gains were somewhat offset by higher shipments to Torii in Japan at lower margins. Furthermore, we had one-off cost of DKK 30 million due to discontinuation of non-strategic products and unplanned facility maintenance. Capacity costs increased 8% in local currencies to DKK 2.3 billion. R&D expenses peaked at DKK 665 million. From 2023, we start to see a slightly lower R&D spend.
Sales and marketing costs were up 8% in local currencies as we continue to support growth initiatives, including the build-up in China, preparations for pediatric launches, digital activities, and medical events and congresses. We also had costs associated with optimizing our footprint, including closing down in Turkey. Despite these cost increases, we managed to further reduce the capacity cost to revenue ratio, as you can see on the second graph. We expect this trend to continue as we increasingly benefit from operational leverage and economies of scale. EBITDA increased by 33% in DKK to DKK 708 million, driven by sales growth, improved gross margins, and scale benefits. Free cash flow was positive of DKK 65 million, mainly reflecting higher earnings, changes to working capital, and higher CapEx investments.
All in all, the best results in ALK's history. We are committed to doing even better. Now let's move to the strategy status on slide eight and back to Carsten.
Thanks, Søren. We made broad-based progress on all our strategic focus areas, except for the tablets in the U.S. We are on track to become more relevant to people with allergy, extend our global leadership in respiratory allergy, and to meet our 2025 financial targets. I'll be detailing North American tablets in a moment, but let me first focus on the two other strategic focus areas. On our consumer engagement and new horizons priority, recruitment of patients for the phase I trial with the peanut tablet is ongoing. Recruitment of adults have taken longer than expected, and actions have been taken to minimize delays. We still expect first readouts in 2023. On the two adrenaline auto-injector projects, development continues towards a planned submission to the U.S. FDA. The exact timing will be determined after feedback from the FDA on our regulatory strategies.
Speaking of adrenaline auto-injectors, our partner in China, Grand Pharma, has recently obtained its first approval to start selling Jext in the Greater Bay Area in China. Our digital engagement activities continue to gain scale and importance. We have built a suite of apps, websites, and tools under the klarify banner, and this digital ecosystem helps patients to shorten and simplify their path to AIT treatment. Last year, more than 700,000 unique users found a doctor using our tools, and users logged more than 1 million entries about their symptoms. We use machine learning and other technologies to profile the users who are most likely to book a medical consultation so that we can tailor and personalize communication to exactly where the person is in relation to the advancement of the allergic disease. Remember, it's all about being more relevant to people with allergy.
Getting a better understanding of triggers that prompt people to take action also help us to improve our dialogue with the healthcare professionals. Moreover, we can now also observe the first signs of high use of ALK's AIT products with the doctors who are connected to our klarify universe. Digital engagement with patients and prescribers is a major competitive advantage. In 2023, we will further expand our tools to take new steps towards a multichannel marketing strategy with a global rollout of a new CRM system. Finally, the optimize for excellence priority efforts are on track to upscale capacity for tablet production and to prepare for the commercial supply of the upcoming adrenaline auto-injectors. We also continued efforts to simplify our production setup and pursued further efficiencies across product supply. Let's move on to slide 9 and deeper into North America.
As you all know, market uptake of tablets in the U.S. have been hindered due to this, the slow adoption by allergists who are financially disincentivized to prescribe our FDA-approved tablet portfolio. To overcome this, we have assessed the business models and recently adjusted the organization to create a platform for long-term success through new prescribers and sales channels. The organization in North America is now structured around three business units. The first unit managed our U.S. legacy business and will continue to target growth within SCIT bulk, diagnostics, and life science products. The second unit handles the marketing and sales of U.S. tablets through three sales channels. The existing allergist business will target region-specific opportunities, mainly in East and West Coast territories, where allergists are supportive of tablets, so that the allergy business will have the opportunity to grow with higher efficiency.
The second one is to build new prescriber groups. We will increasingly focus on pediatricians, estimated to treat 4 million AIT-eligible patients. Pediatricians are now a high flow, have a high flow of younger patients and a good understanding of immunology and allergy. Importantly, though, they are not financially disincentivized to prescribe AIT patients compared to the allergists. Initially, we'll also focus on around 2,000 pediatricians who regularly perform allergy tests and issue prescriptions for these symptomatics. To address the many AIT-eligible patients who look for help outside of the traditional healthcare system, we'll establish a new commercial partnerships with selected innovators such as retail pharmacies, urgent care clinics, and on-demand virtual care providers. Across all three channels, our upcoming pediatric and recent adolescent indications, together with the digital engagement programs, will support sales. The third business unit is Canada.
Canada is well on track to becoming a significant contributor to our global sales growth. Canada is now a fully independent sales and marketing organization, and its capabilities will be expanded. We believe that these changes will strengthen our position in North America, and we continue to target double-digit growth in this region. Please move on to slide 10. China is well on its way to overtaking France and becoming the world's largest market for house dust mite AIT. House dust mite AIT sales are estimated at more than DKK 1 billion, and the market fundamentals are attractive. 100 million people in China are affected by house dust mite allergy, while just half a million receive AIT treatment. To unlock this vast potential, we are ramping up ALK's activities in China.
We now have 133 employees on the ground, after a 64% expansion of the sales force and back office staff in 2022. We also expanded the number of hospital-based clinics using AIT products by 50% to more than 500. We accelerated the efforts to train and educate specialists. As a result of all this, our revenue from China was up 62% in 2022. Our ramp up aims to accelerate the adoption of ALK's existing products and build the market ahead of the launch of the house dust mite tablet. We filed for approval in December, we just received notice that the authorities have accepted our application for review and that we will commence now. Subject to approval, the tablet should be on the market in 2024, 2025.
We have already made ACARIZAX available in a special medical zone in China. The first prescriptions have been issued. We expect to gain valuable insights on prescribers and patients in this pilot zone ahead of the nationwide launch. We continue to invest in China. We see China as an important growth driver, short-term and long-term. We expect double-digit growth in 2023 as well. Slide 11, please. Our two pivotal phase III trials in children are on track for completion in 2023. That's MT-12, the trial in Europe and North America with the house dust mite tablet, and MT-06, the trial in Europe and Canada with the tree tablet. Subject to regulatory approval, the two tablets should be available with pediatric indications in Europe and North America in 2024, 2025. The number of children with uncontrolled respiratory allergies is rising rapidly.
Fortunately, there's a growing acceptance by healthcare professionals that early intervention and controls is crucial to holding the allergies progression to asthma and other comorbidities. These new indications address this need perfectly. Market building activities have started and will be accelerated in 2023. We're especially focused on building a prescriber base among pediatricians. In some countries, for instance, Germany, selected pediatricians are already involved in AIT. We will also increasingly engage with parents and guardians through our digital ecosystem to build awareness and help caregivers understand when they should consult a doctor. From a commercial perspective, this opportunity is competing. Globally, 10 million children are estimated to live with uncontrolled respiratory allergies. Meanwhile, experience tell us that children are fast-track patients needing fewer doctors visits and adults before being referred to specialists. Once there, the waiting time is also shorter than for adults.
Once on treatment, children are much more likely to complete their course of treatment than adults. All of this informs our beliefs, belief that expanded pediatric and adult indications will be key drivers for growing our prescribers and patient bases. Now I will hand it back to Søren and the full year outlook.
Thanks, Carsten. We expect to continue our journey of growth and earnings improvement in 2023. We expect revenue to grow by 7%-11% in local currencies, which equals 8%-12% growth disregarding the 1-year mandatory rebate increase in Germany for all prescription drugs. This rebate increase is expected to lower revenue by around 50 million DKK. We expect all sales regions to deliver growth, and tablets will remain key to growth. Tablet sales are projected to increase by up to 15%. Central Europe, Northern Europe, Japan and North America are expected to lead the way through additional market share gains, expansion of prescriber and patient bases, as well as increasing influence of the market transition in favor of registered products.
As in previous years, some fluctuations in the quarterly tablet sales are anticipated, reflecting current market dynamics and phasing of products supplied to partners. In 2023, we expect to see slightly higher growth in the second half of the year than in the first half of the year. The non-tablet portfolio, mainly SCIT and life science products, will also contribute to growth. Jext sales are expected to decline slightly after the extraordinary demand in 2022. The number of Jext pins expiring in 2023 is lower than last year. 2024 will be the next year with high replacement rates for Jexts. The gross margin will benefit from higher sales and efficiencies, this impact will somewhat be offset by various factors, modest cost inflation, German rebate increases, higher shipments to Torii and changes to the product mix.
The gross margin is expected to increase by up to one percentage point. R&D costs are planned to decline to around DKK 600 million as we start normalizing R&D expenses. Sales and marketing costs are expected to increase. The overall capacity cost to revenue ratio is estimated to further decrease. On this basis, we expect operating profit to further improve. To align guidance with our long-term financial ambitions, we have decided to guide on the EBIT margin. The EBIT margin is expected at 13%-15%, up from 10% in 2022. A margin improvement range between 25%-45%. All in all, good progress, which takes us further towards the 25 and 25 earnings ambitions. With this, I'll hand you back to Per and slide 13.
Thank you, Søren. Thank you, Carsten. This concludes the main part of our presentation, and we will now move to the Q&A session. Operator, please go ahead.
Yes, sir. At this time, if you would like to ask a question, please press the star and 1 keys on your touch tone phone. You may remove yourself from the queue at any time by pressing the pound key. Once again, that is star and 1 to ask a question. Our first question will come from Thomas Bowers with Danske Bank. Your line is open.
Yes, thank you very much, Thomas Bowers from Danske. A couple of questions here from my side. Maybe just kicking off with cost inflation. Can you maybe elaborate a little bit on what you mean by actually, well, a modest impact? Is this sort of a percentage point that you assume in your guidance in addition to what do you normally see sort of underlying levels? I'm primarily of course, referring to potential wage inflation here. Then my second question just on pricing power. I understand that you have been able to raise prices for some products or at least within venom.
Can you maybe give us a little bit of color on the level of that price hike and what's actually if it has any impact on your 23 guidance? Maybe also some color on which countries are you referring to here? Should we expect more during the year? Is there any new, I mean, is this a sort of a consequence of the inflation we have seen that some countries are maybe willing to look at pricing in Europe that could be interesting to get your thoughts on here? My final question just for now. Just in regards to Germany.
Just sort of theoretically here, assuming that one of the top four or five players in Germany starts to experience some product stock-outs, would you actually be able to meet that potential additional demand? Do I actually have sufficient capacity in your SCIT portfolio or you also need to go in and try to convert patients to tablets in that case? Thank you.
I'll start with the pricing in Germany. Søren will take the cost inflation question. I think pricing power. No inflation actually on the contrary, you know that the German government actually mandated a 5% rebate increase in Germany. That's actually why we look at 7%-11% instead of 8%-12% as we quote unquote, normally do in our growth. We have on specific products an opportunity to increase the prices, but it's not a general trend as most of our products, the prices are set by the government, and they're not easing off. No, it's not something that you can expect that we took that in as a big tailwind to our guidance for 2023. Not at all.
For Germany, yes, it's true that you saw one company folded a quarter ago and somebody else has some issues right now. We have the capacity and the willingness to take over as much of the German market as we possibly can, and we are trying as hard as we can. I think we talked about it before when we moved on the trend to make sure that only approved registered products could be the ones that you could initiate a new patient with. Which is now up to 80% of all payers in Germany that has mandated that, which put pressure on our competition. We are very focused on capturing as many market shares as we can, which we are actually.
I think we are up to more than 35% market share in Germany now, which is also a very high number for us compared to what we had in history. I think actually in that respect, even though the market in AIT in general can be oppressed at that price pressure and so forth, the underlying fundamentals for us in Germany is in our favor, and we're doing good, and we can supply. It's not as easy as said. It is really a conversion from a doctor between patients and so forth. Definitely we can, and we will, and we do all possible to win. I think be rest assured of that. With that, will you comment on the cost inflation, Søren?
Yeah. Thank you, Thomas, for the question. It's of course clear that the whole notion around inflation have been building up during 2022. When we provided guidance is of course, also that we gradually have taken this, especially wage inflation into considerations. Actually going back to the third quarter report out already at that point in time, we said that we believe that we will be having a modest wage inflation approach in the company. As such, we have been sticking to that plan. We guesstimate that inflation is probably impacting us by 0.5%, and that's a split on wage and of course also other input costs. Bear in mind also that electricity and gas is now coming down to a reasonable level.
Also remember that we claimed relatively early on that we are hedged on that also. That's why the fluctuations there are in good control. 0.5% on inflation pressure. That's what we are committing to.
Great. Then maybe just to follow up, if I may, just on GEX. You're seeing lower GEX sales next year. Is that primarily due to competitor return or is it due to the expiration of the pins?
Predominantly expiration and some extent, competitors coming back. Mostly 2024 will be a good year. I think that's the way we normally say it here. That's when the next ones expire. I think the big bulk.
Okay, great. Thank you very much. Thank you.
Thank you. Our next question will come from Benjamin Silverstone with ABG Sundal Collier. Your line is open.
Thank you. Hi, Carsten and Søren Jelert, thank you for taking my questions. I have three, if I may. The first one is in regards to the partnerships in the U.S. Just for our understanding, is this something that you see moving the needle, so to speak, in terms of sales in the U.S.? The second one is regarding China. You mentioned that the first approvals for Grand Pharma were in terms of the GEX sales. Wondering if you could just reiterate how you do see that addressable market from the Grand Pharma partnership and also how the uptake is expected to look like here. The last question is regarding dynamics that are currently driving Germany.
If you could just give us some indication of how you see the sales in Germany panning out over the foreseeable future and also speak of the
A little bit about the dynamics driving it, that would be much appreciated. Thank you so much.
Thank you, Benjamin. For the partners in the U.S., I think I see it more like a medium term to long term. This is how to build the new challenge when we now got the adolescents approved in the U.S., and we will get the children approval within a year to a year and a half. This is building up the new challenge all to accommodate that. Of course, it's also to just realize that running around visiting allergists in the Midwest of the U.S. didn't pay off. Now we are just refocusing the resources to maximize the output of our investments. We still see a huge potential in the U.S.
It's a long-term potential, and maybe not all of these partnerships will work out, but we definitely know that we're onto something. To tell you, don't expect that we find a big red bottom in March, and then suddenly you see billions coming in. Definitely we're very committed to succeed in the US as we have said every year. You also know we have tried many things, not that successful compared to our expectations, so far. The need is there. The products are the best in the world if they approve, and the potential is there. We'll keep moving. I think we are also, of course, accumulating learnings, and we're putting all those learnings into play now to not repeat our mistakes.
I think that over the next years you will see results from this and maybe better than we expected, but I'm out of the woods of over-promising, under-delivering on the U.S. Let's just keep the hard work in place. For China, it's a matter of Gran Pharma getting the full approval for the full China and reimbursement. That is the key to a large success. You should think about it this way, that Gran Pharma already today has about 50% market share on adrenaline, which is today a sort of a prepacked syringe or just a syringe, which you have to Thank you much.
Thank you very much, Carsten.
Thank you. Our next question will come from Jesper Ilsøe with Carnegie. Your line is open.
Thank you so much. Firstly, a question on the peanut allergy trial where you were mentioning in the report and here on the call that there has been some slow recruitment among adults. Can you please include some additional details on when you expect the data? I previously recall that you mentioned data before the summer. When should we expect the data now, and why has there been a slow recruitment? Any color you can add there, as well as what mitigating actions you are taking. What does that mean? On top of this, Nestlé has had some issues selling Palforzia and now moving away.
Has this decision and this, market development by, the competitors have made any change to how you view the market potential in peanut allergy? Then I have questions afterwards on top of it.
No. I mean, rest assured that we still believe that peanut is a big opportunity for ALK long term. It's also true, as you say, that, as we have to do a provocation test for peanut to start up the trial, and we have to start with adults, it has proven that getting the adults on the trial was more slower and more difficult than we anticipated. We're doing a lot of things to mitigate that. We are expanding the number of clinics or centers that are going to take on patients. We are also thinking about support from other COOs and others to actually mitigate that and do the best we can to see if we can accelerate.
In all fairness, I would say that we will have still in 2023 the readout, and most like it will be somewhere in Q2, depending on how successful we are with these things. It's not a product problem, it's not an ALK problem, it's simply a problem of recruiting these adults to get into our study. I think that's, I need to be very clear about that. That's unfortunate, but this is what happens once a while in clinical trials. I hate it, more than anybody else because I want things faster than slower, but this is the way it is. Regarding Palforzia, DBV, and competitors, it does not take away any of the opportunity or the view of the market.
It's different concepts, different products, and it might even open some opportunities for us in the near term or whatever to actually see if we can learn more about peanut. In essence, what I'm saying is that the market is intact, the relevance is really there. When we look at the narrative of helping people with allergy, it just fits spot on to what we want to be in ALK. Just think about one simple fact, 30% or more of all children with peanut allergy are homeschooled. Imagine what that does for a family if you just translate that into every other activity. It's really burdensome.
It talks into the respiratory allergies, where we know children that are having that magnitude of allergy get lower grades, lower social life, and having a lower quality of life as one. I think it hasn't changed anything in our overall global timeline for this one, but we just are cautious with this and say, Okay, we see this recruitment of adults is lower, and that just means they will be definitely this year, but most likely not before summer.
Just to understand you there, Carsten, you mentioned that you still expect data in Q2. Does that mean that it has actually not been the part one of the trial that has been delayed, it's only part two of the trial which we...
No, I said H2. H2. I said second half.
H2, okay. Okay. Okay. Cool. I have a question on tablets. Of course, as we also saw in Q3, the growth in Europe due to the weak 3 point season has been slow, and this quarter was only around 5%. Perhaps, I also noted that, of course, you mentioned that you expect higher growth in the second half compared to the first half. When do we actually get some stability on the growth coming back to, say, the normalized 10%+ level in Europe? Is that in Q1? Is it Q2? I know it's difficult to predict, but just help us when we look at quarterly growth rates going forward in Europe. Also just in Japan.
I noticed that the numbers are quite high because of shipments, of course, also underlying strength, but shipments in particular. Is that a high base to grow from in 2023? Just help me understand that Soren has taken the guidance down in Q3. There's been a COVID uptick in Q3, as you also mentioned last quarter, yet you still have very strong Q4 numbers, and you still expect 10% growth or 20% growth in Asia. Just help me understand how to balance this when you look at the growth for 2023.
I can start, and then Søren will take over. In EU, in Europe in 2023, we will grow 10%. It will be skewed towards the second half, as we have said all along. We see no fundamentals on momentum problem for ALK as such. We of course you have to remember that when you look at the percentages, when you take out 5% in Germany in extra rebate, most of that is actually coming from the tablets. It has a relatively high impact on the percentages of the growth. Momentum-wise, it is going to be 10% for the year, and you will see that picking up from Q3 and onwards.
I can just start with Japan, and then Søren can move on to a more detailed question. If the underlying question you're asking is there inventory build-up that does not correspond to what's happening in the market and the in-market sales, the answer is no. Actually, I was myself in Japan just a couple of weeks ago, met with the CEO and the teams out there. Yes, it's true that they had some issues with doctor's visits due to COVID. It looks like that's easing up now, and if I look at their expectations going forward, it's really with very strong in-market sales still.
There's no inflation in our numbers based on filling up inventories over and beyond what you've seen before in Japan, if that's the underlying question you're trying to poke at. I know you wanna add on, Søren.
No, I think basically, I think Carsten Hellmann also spoke to it earlier, right? We believe sort of international markets in this case by growing by plus 20%. Within that, of course, there will be a continued number of shipments and to secure that they have adequate stock levels on both MiSecure and CedarCure. When exactly that stock will come in, we also talked to that during 2022. We don't anticipate a lot of that in Q1, essentially it will come up again. Overall, we see a continued, as Carsten Hellmann said, good in market growth from Torii, sort of added with our shipments during the year. We expect still a very good growth in international markets.
Very clear. Thank you so much for answering my questions.
Thank you. Our next question will come from Peter Welford with Jefferies. Your line is open.
Thanks. Peter Welford from Jefferies. I think this was actually already asked by Jessica, but maybe I could push you a little bit more on the peanut opportunity. You could possibly maybe discuss a little bit more on just a sense of how big you think that could be, you know, maybe low single-digit DKK billion or something along those lines, just to kind of get a specific product about differences then.
A broken line. Are you asking about the peanut potential?
Yes. Yeah.
Let me just start about that. I don't know. It's 2.5% of the world population who has peanut allergies or food allergies. A big portion of those have peanut allergy. It's centered around certain geographies, particularly in the US. If you get it right, and you have the right product with low side effect profiles and easy to administer, it can be very big. It can be very big. I'm a little bit cautious about dreaming up fantasy numbers from 2029 and onwards. I think it's an area of administration, the tablets, which we know very well. It's a profile of a product we try to target that is seems to be possible, very safe, low dosage, not so many up dosings.
also a product that will be easy to administer. If we get this one right with a good safety profile and good efficacy, it will be a very big product in the world because it's a very big problem to the world. For me to put financial numbers on it right now, the only financial numbers I can promise you are that we are investing everything it takes to do it as perfectly and as fast as possible. There's absolutely nothing in our financial about our EBIT aspirations or growth aspirations that are going to delay this one. This is going to be crucial for the long-term future of ALK, as well as the small molecule projects we are working on.
I mean, you can just look at Aimmune's or DBV's projections when they try to raise money, you'll get a better idea what they think the potential is. We are just burnt children here in ALK in terms of, you know, taking the number of patients and multiplying it by average price. Definitely, I can tell you that we are very optimistic about the concept we have developed and that we can do it. If we succeed there, we are also very confident that it's going to be a big product. Of course you have price, things you cannot predict eight years from now. You have penetration, you have market conditions. There are tons of things you can't. I think we're well-positioned to capture at least what any other has said in the market would, what they would capture.
I think we have a good opportunity to do that.
Thank you very much.
Thank you. As a reminder, that is star one to ask a question. Our next question will come from Jacob Mekhael with KBC. Your line is open.
Hi there, thanks for taking my question. I just had a few. On the review process for the house dust mite tablet in China, is there an expected timeline that this should take? Do you expect there to be a delay in the process due to COVID-19? That's the question. On, on peanut allergies, I know that in the U.S., in some cases, you know, you have allergists that do home grow therapies, and they can really go higher and higher on the doses. Do you have a plan in the long term if peanut allergy works, in its current form to try to move towards, a more curative therapy, for example?
I think it's two, maybe different questions. I hear them as what are the timelines for China, and the second one being a more prolonged treatment. To take, of course, the last one first, bear in mind that we had the Reveal study, right? Where the prolonged effect of AIT is definitely seen beyond seven years, and then we stop this real life study. We believe, of course, that the treatment options we do have are having a longer effect. That's the first or your last question. When it comes to China, as we stated in the press release, we expect now that there is a timing towards 2024, whereby the Chinese authorities will look into our submissions, and then shortly after that, we expect to launch.
Of course, without saying, what time they will use, but this is normally the timelines we have seen, in the Chinese, approval patterns, and that's what we've commented on. I hope that clarifies your questions.
Yes. Thank you very much.
Thank you. At this time, we have no further questions in the queue. I would like to turn the call back over to our speakers for any additional or closing remarks.
Thank you all. Thank you all for joining today's call and all the good questions. We have several presentations and meetings lined up in the weeks to come. We certainly hope to see you at one of these events. As always, you are most welcome to call us if you have additional questions. With that, I wish you all a good day and a good weekend, and we will end today's session. Thank you and goodbye.