Hello everyone, and welcome to today's presentation, where we will cover ALK's 2020 results, the outlook for 2021, as well as updating you on our strategy. Please turn to slide number two, where I'll introduce today's presenters and the agenda. My name is Per Plotnikof, I'm head of investor relations, and with me today are CEO Carsten Hellmann and Group CFO Søren Jelert. As you can see, we'll begin with Carsten giving you an overview of the progress we have made with the completion of our three-year strategic transformation. Then Søren will go over last year's performance in detail, covering both quarter four and full-year results, and he will then conclude the performance part of the presentation by sharing the outlook for 2021.
Carsten will then take over and give you an update on our strategic priorities, key initiatives, and financial ambitions for the next phase of ALK's development. Finally, we will end the presentation with a customary Q&A session. With these opening remarks, I'll hand you over to Carsten and slide three, please. Carsten, please go ahead.
Thank you, Per, and thank you all for joining this call. As Per mentioned, 2020 was the final year of ALK's strategic transformation. Three years ago, we embarked on a fix-and-grow mission to create a stronger and more resilient ALK, a company capable of delivering double-digit growth. Our track record shows that throughout those three years, we have overperformed significantly relative to the promises we did make. This slide three gives a quick orientation of where we have come from and where we want to go on our journey towards becoming the go-to allergy company. As you can see, since 2018, we've delivered compound average growth in tablet sales of 37%, which has been a key driver of our overall sales growth. Cumulative earnings were DKK 800 million ahead of plan.
Meanwhile, we also cleaned up past issues, particularly in product supply, and have proven a strong commercial execution, hence established a strong growth foundation. And all of this was achieved despite phasing out many older SCIT and SLIT-drops products, and despite facing an unprecedented global challenge in the form of COVID, without which growth would have been even stronger. We're now entering the next strategic phase where, for the next three years, we aim to sustain growth of 10% or more and increase profitability. We want to expand our global leadership in respiratory allergies and, in parallel, start building businesses with the potential to accelerate growth 5 to 10 years from now. And this includes an entry into food allergy, which I'll talk about later. Looking further beyond, we are also committing to achieving an EBIT margin of 25% in 2025. 25 in 25, that's easy to remember.
But before we look into the future, let me just take a moment to summarize the important work that has got us to the point where we are today. Please look at slide four. The past three years have seen multiple transformation initiatives across ALK, resulting in significant growth and multiple highlights across our four areas of strategic focus. First, the ambition to succeed in North America. Since 2018, we have built a sales infrastructure for the tablets from scratch, established an initial prescriber base, launched a DTC, and pre-COVID continued to grow our legacy business. Even so, financial disincentives still prevent many allergists from prescribing our tablets, and COVID blocked further commercial progress in 2020. On the bright side, tablet volumes continue to grow, and they recovered quickly from the initial impact of COVID.
Meanwhile, our digital consumer engagement strategy is showing promising results as we mobilize more consumers to consult doctors about their allergy via our digital platforms. On tablets more generally, our portfolio now covers the five most common global respiratory allergies and has become the undisputed growth engine of ALK, delivering, as I previously mentioned, 37% in compound and uncompound annual growth since 2018. We have a large-scale clinical development program in place to expand the tablet use further, although, as you will see later, some of the timing has been revised slightly because of COVID. On our next priority, the new Klarify digital platforms that are now available in six markets, where the app has been downloaded close to 600,000 times. These platforms allowed us to engage with hundreds of thousands of people and to mobilize suitable candidates towards AIT treatment.
We have also mapped out a path to the U.S. adrenaline market and forged multiple partnerships to enhance our current and future product range. Finally, our optimization and reallocation efforts have made a real difference to robustness and quality in production, helped greatly by portfolio pruning and our size specialization strategy. Meanwhile, we continue to upgrade documentation for core legacy products, identifying and making efficiency gains, and particularly in manufacturing. We also began a cultural transformation of ALK, and everyone at ALK is rightly proud of what has been achieved for the past three years, and our success now gives us a firm foundation for future growth. I'll say more about that and how that looks like later. For now, let's turn to slide 5 so Søren can walk us through the Q4 and 2020 full-year results.
Thank you, Carsten. We ended 2020 with our best-ever fourth quarter, delivering organic growth of 16%. Tablet sales growth was 55% in what is traditionally the peak season for the AIT treatment initiations, and this supports our thinking behind the 2021 growth outlook, which I shall share shortly. EBITDA was up 33% at DKK 64 million, while operating profits benefited from higher sales, savings, and delayed R&D costs. Overall capacity costs were up 11% in local currencies, and R&D expenses increased by 21% in fourth quarter, although we had planned for more, but COVID continued to hinder recruitment of patients for clinical trials. COVID also continued to impact patients' ability and willingness to visit clinics, especially in North America and some European markets, but the overall impact was less than in previous quarters. Please now turn to slide six for the brief sales and markets review.
As you can see, the European business performed strongly throughout the year. Revenue increased by 17% in fourth quarter, contributing to the full-year growth of 8%. Discontinuations reduced full-year growth by four percentage points as we continued to phase out older SCIT and SLIT drops products in favor of documented registered products. Towards the end of the year, we also saw some general inventory stocking by wholesalers ahead of 2021. Sales increased in most European markets, driven by the tablets, which was up 40%. Jext also contributed to our growth with a 42% increase for the full year. Germany delivered strong double-digit growth, and ALK became the first company to exclusively market registered AIT products for the main allergens. This is important because recently, the federal recommendation was made that registered AIT products should be used for new initiations whenever available.
Now, this recommendation has to be recommended regionally before it takes effect, so it's too early to link it to any change in prescribing habits, but it should still add momentum to the ongoing market shift in favor of evidence-based medicines such as ALK's tablets. In Southern Europe, primarily Spain and Italy, COVID continued to constrain the market, while sales in France were flat, as growth in tablet sales was offset by lower SLIT drop sales. In North America, COVID continued to create challenges, especially in the U.S., where we estimate that the total value of missed sales due to COVID exceeded DKK 100 million . As just one example of how the market was affected, we estimate that around half of U.S. clinics were fully or partially closed in second quarter.
As a result, sales across the region's portfolio were challenged, although we did see a pickup towards the end of the year with encouraging tablet sales in fourth quarter. Full-year revenue was down 10%, while the decline in fourth quarter was down to 2%, reflecting a rise in the underlying demand compared to second and third quarter. Sales in international markets were relatively resilient to COVID, except for minor fluctuations in China, and full-year revenue was up 58%, following fourth quarter revenue growth of 46%. Revenue was boosted by Torii conversion of patients to Cedarcure from legacy products and planned advance stocking ahead of 2021. Now, let's take a closer look at the product categories on slide seven.
As I mentioned earlier, the tablet portfolio performed very strongly, with 55% growth in fourth quarter and full-year growth of 42%, underlining the fact that tablets are the undisputed growth engine of ALK. Sales benefited from various factors, including resilience to the impact of COVID versus alternative treatment options, the ongoing market shift in favor of evidence-based medicines, and the continued strong rollout of Itulazax in Europe, which also created a halo effect, especially for Grazax. Combined SCIT and SLIT drops sales were down 7%, part of which was due to product discontinuations. However, SCIT treatments were also disproportionately affected by COVID since patients were either unable or unwilling to visit clinics. This impact was reduced in fourth quarter, with SCIT and SLIT drop sales down just 2% for the quarter.
Sales of other products declined 1% in fourth quarter and 4% for the full year, as COVID also impacted sales of life science products and Pre-Pen in the U.S. By contrast, Jext in Europe sales were up by 45% in fourth quarter and 42% for the full year. This brings us to slide eight and the full-year P&L. I'll go through this slide briefly because we've already touched on the themes. Full-year organic growth was 8% in local currencies. The gross margin was more or less flat at 58%, reflecting mix and changes cost for quality upgrades and higher shipments to Turkey at lower margins. EBITDA increased 64% to DKK 395 million, corresponding to an EBITDA margin of 11%. Capacity costs were down 1% organically due to COVID. The pandemic delayed a number of clinical activities, which is estimated to DKK 100 million in deferred spend.
It also restricted sales and marketing activities and saw a switch of many planned activities to virtual events. Operational leverage of the commercial platform was an important factor. Finally, free cash flow was DKK +56 million. This was better than expected due to higher earnings and deferral of payments. All in all, a solid performance in a very challenging year. Now, let's move to slide nine and the outlook for 2021. Building on a strong momentum of fourth quarter, we expect growth in all sales regions in 2021. Revenue is predicted to increase by 8%-12% organically in local currencies, with product discontinuations reducing growth by approximately one percentage point, underlining the fact that 2020 was the year with the greatest sales impact from discontinuations.
Our working assumption is that COVID will continue to somewhat impact clinic visits in the first half of the year, especially in the first quarter. Quarterly fluctuations in both sales growth and earnings are therefore likely. We expect European sales to grow by around 10%, while sales in North America are projected to gradually recover from COVID and grow in double digits. Growth in international markets is estimated to temporarily slow to high single digits as growth in Japan becomes more incremental following last year's extraordinary conditions. We currently assume growth in global tablet sales will exceed 20%, while the non-tablet portfolio is projected to deliver single-digit growth. EBITDA will benefit from higher sales and better margins.
The gross margin is projected to increase by 1- 2 percentage points, but EBITDA will also be influenced by a significant increase in R&D expenses, reflecting the level of activities and the deferral of some clinical development activities into 2021 due to the COVID. As a result, R&D costs will increase by approximately DKK 150 million , while sales and marketing costs will gradually normalize as we resume many of the activities that became impossible in 2020 and because of the strong focus on digital engagement activities. EBITDA is therefore expected between DKK 325 million and DKK 425 million . We expect cash flow to be negative at DKK - 200 million to DKK 300 million . We see changes in working capital, including one-off payments of accrued rebates and payments related to taxes for Danish employees. These payments amount to a total of DKK 225 million and were originally scheduled for 2020.
CapEx is projected at DKK 300 million as we continue our program of site specialization and manufacturing efficiencies. All in all, a solid top-line growth and earnings largely on par with last year, although earnings and free cash flow obviously will be impacted by cost and payments originally scheduled for 2020. I now hand you back to Carsten, who will talk you through our strategic priorities for the next few years, starting on slide 10.
Thank you, Søren. With the transformation complete, we are entering the next phase of ALK's development. Top priorities for 2021 to 2023 are to sustain growth and increase profitability. And looking further beyond 2023, we go for 25% EBIT in 2025, what we call 25% in 2025. As you can see from the slide, the strategic framework is unchanged, and the strategy is still anchored in the four focus areas which we established three years ago. We strongly believe that these four priorities are still the most critical to continue delivering future growth. And we are equally convinced that continuity allows us to easily build on the foundations we established and benefit from all the investments we have already made. But clearly, some things have changed.
We made some slight adjustments to the pillars, and we have also included initiatives to accelerate ALK's development in five to ten years from now. These long-term growth opportunities are very exciting and cover establishing a presence in food allergy, expanded position in anaphylaxis, and progressing on our research into new innovative treatments for high-impact allergic conditions. It is also worth noting that they are underpinned by a renewed commitment to our people and planet. This will require us to lead the way, not just scientifically and commercially, but also the way we develop our people and organization, and as well as our approach to sustainability. To support this work further, we conducted a materiality assessment in 2020 to identify areas with the highest impact on our business and stakeholders. A key output from this was our new access to medicine strategy.
You can see more in the annual report and in our sustainability report available on our website. With these opening remarks, let's deep dive into North America on slide 11. We remain committed to succeeding in North America, and in particular in the U.S., despite the long-standing financial disincentives for prescribers, the allergist, and the setback of COVID, both of which have challenged our progress there. Even so, we still believe that there is much more to be done with the assets already at our disposal, and we work hard to grow our tablet sales. Our intent is to build broader, scalable sales channels for the tablets that overcome the barriers we currently face with the financially disincentivized allergists. We see Klarify, our digital platform, as a key tool here for mobilizing patients to seek treatment from doctors who will prescribe ALK products, and by that, I mean the tablets.
But we remain committed to customers of our legacy portfolio and aim to increase the value of these sales too. In the short term, that means that sales growth in North America is 10% or more in 2021. We will also increase patient mobilization via tools like our newly launched Speak to a Doctor telehealth option and digital allergist tests. We'll also seek further pediatric and adolescent indications for our tablets to expand the reach. Please go to slide 12. The allergy tablets remain ALK's undisputed growth engine. We aim to sustain the commercial momentum of these core assets by expanding prescriber depth and breadth in existing and new markets via digital engagement and also through the completion of our large clinical development for pediatric indications and further registrations in new markets.
We will measure our progress by targeting sales growth of 20% or more and maximizing the halo effect that we are seeing from the newly launched Itulazax. Finally, a quick update on our clinical trials. As you can see from the table on the right, the timetables for some of these activities have been slightly updated due to the difficulties of recruiting clinical trial participants under COVID. Slide 13, please, and the next strategic pillar. Over recent years, we have developed a range of digital tools and platforms under the Klarify brand to give consumers easier access to a definitive diagnosis and appropriate treatment. Over the next few years, we will leverage these assets to further engage with and mobilize hundreds of thousands of people with allergy to connect with healthcare professionals, with a target of mobilizing 250,000 people in 2021.
New Horizons is a new term that covers not just business development and partnership opportunities, but also our own R&D work on innovations outside respiratory AIT. The headline activities here are the further expansion of our adrenaline franchise, including work to enter the U.S. We will also research new approaches to the treatment of severe allergic conditions and make an entry into food allergy, where we are preparing a peanut program for clinical development. So let me tell you a little bit more about food allergy on slide 14. One piece of news I'm particularly excited to share is our work to develop and register immune therapy treatments for food allergy.
This is an area of very high unmet medical need, and we feel confident that the scientific knowledge we have accumulated through our work on respiratory allergies over the past 20 years forms a good foundation for developing safe and effective food allergy treatments. This part of work has seen more than 23,000 clinical trial participants and more than 20 phase III trials. In short, we are confident that we are ready to take this next step so we can become the leader in food allergies just as we are in respiratory allergies. Initially, we will be targeting treatments for peanut and then tree nut with an investigational sublingual therapy with the potential to become a mainstream treatment. The commercial potential here is significant. Food allergies are a global problem affecting 2.5% of the population and can be life-threatening.
Four allergens: peanut, tree nut, milk, and egg are responsible for most food allergies in preschool children, but we have prioritized peanut and tree nut because while many people can grow out of milk and egg allergies, peanut and tree nut allergies last a lifetime for many sufferers. With very limited treatment options currently available, we believe this move represents an important step toward fulfilling our promise of becoming the go-to allergy company and helping many more people and many more allergy sufferers beyond our current reach. With that, let's move to slide 15 for the fourth area of focus. Here, ALK will continue its work to ensure regulatory compliance, supply chain robustness, and improve quality and efficiency across operations. Major contributors to these priorities are the ongoing pruning of the portfolio and the work to upgrade processes and documentation for our legacy products.
Both of these things improve standardization and efficiency in manufacturing and contribute towards our improved margins. You will see here that we have set a margin contribution target of 1-2 percentage points in 2021, and we will take further steps to operate facilities to support this work and to meet our further target of zero quality-related interruptions in supply in 2021, another measure of how far we've come in cleaning up and addressing previous issues. We are also leveraging our sales and marketing platforms to drive economic scale. For instance, through the continued rollout of sales initiatives, one which we call RISE. That completes my review of the ongoing strategy, and I'll now hand over to Søren, who will tell you on how this all translates into our financial ambitions.
Thank you, Carsten. Please turn to slide 16. Earlier, I mentioned that our overall ambitions are to sustain organic growth of 10% or more per year and to improve profitability so that we gradually ramp up the EBIT margin to around 25% in 2025. Please bear in mind that we have changed our long-term financial metrics from an EBITDA to EBIT, so it's EBIT that's 25% in 2025. The main assumptions behind this are that we expect to improve the gross margin through higher sales and greater supply chain efficiencies starting in 2021. Secondarily, R&D spend will be extraordinarily high in 2021 and 2022, primarily due to the ongoing pediatric trials.
However, from 2023 and onwards, the R&D spending to revenue will decrease when we complete large-scale development work on the respiratory tablet portfolio, while costs for the work in food allergy and research into new innovations have still been included. We expect to drive down sales and marketing costs relative to revenue as we further leverage the existing platform. And the final assumption, we see CapEx at around DKK 300 million annually as we invest in maintenance optimizations and strategic projects. These projections, as always, do not include any significant revenue from acquisitions, new partnerships, or in-licensing agreements, nor payments related to such activities. With this, I'll hand you back to Carsten and the closing remarks.
Thank you, Søren, and thank you to all for listening in. In essence, this updated strategy for 2021 to 2023 aims at expanding ALK's position as a global leader in respiratory allergy, but are also starting to build a significant presence outside the respiratory niche so that ALK becomes relevant for many more people with allergies. The ultimate aim is to become the allergy company, a global allergy player that helps millions of people to take control of their conditions and their lives. A company capable of generating attractive shareholder returns and achieving specialty pharma margins 25% in 2025 with a sustainable double-digit growth outlook beyond that date. I hope you find that prospect as exciting as we do. And I will now hand you back to Per, who will open things up for a Q&A session. Thank you so much.
Thank you, Carsten, and thank you, Søren. And this concludes the main part of our presentation, and we will now open for the question and answer session. Operator, please go ahead.
Thank you. Ladies and gentlemen, if you have a question for the speakers, please press zero one on your telephone keypad, and you'll enter a queue. After you are announced, please ask your question. So that is zero one to register for a question. We have a question from the line of Thomas Bowers from Danske Bank. Please go ahead.
Yes, thank you very much. Three questions from me here. Just to kick off in regards to Germany, can you add a little bit of color on this fee structure change in 2021 for the AIT product? There seems to be some pressure from payers. Does this basically mean that we could see an end to named patient products in one or two years' timeframe? Do you have any impression on this year that you are seeing now? How much could you potentially get from this EUR 100 million opportunity? Is most of this going to flow into the tablet business? On your 25% margin ambition, previously you had above 25% EBITDA. I'm just wondering, would it be fair to say it reflects close to 30% EBITDA?
Or is there any material change in your rate of depreciation or any general changes that would change the, you would say, 4-5 percentage point delta compared to EBIT? And also, are you looking at possible phase III developments in those? I mean, going into food allergies now, so I guess by 2025, you could see potential phase III trials, at least for the peanut allergy product. So is that already included in your margin guidance that you may have some additional R&D costs for those projects? And then maybe a final question just on adrenaline. So Windgap seems to be active and alive. And then I understand that you sort of have a backup solution. Is that X-Chem that you're looking at, or is there other solutions that you are looking maybe to in-license in order to support your 2024 filing target for the U.S. market? Thank you.
Thank you, Thomas. This is Carsten. And I will start with, I will take three of them, and then I'll hand over to Søren about the EBIT. So if you look at Germany, it's true that this is moving towards registered products, and the insurances are now, I think it's in eight of the regions right now, are sort of pushing forward to this one. We have about EUR 100 million up for grabs in the German market over time. Of course, remember, it's immunotherapy, so it's something that is phasing out. And definitely, we're going for all of it. I'm not sure we're getting it, but we have a very solid plan to try to maximize as much as we can getting into this German market. It's happening as we speak, and we think it's a very positive contributor to our European growth, and it is pretty solid.
If you think about, take the Adrenaline first, Windgap is still alive, and we're still working on that one. What we're doing is, in parallel, we are also having an internal project to make sure that we will have a fully ready product to be filed in the U.S. no later than 2024 on Adrenaline. And whether that's going to be Windgap or ourselves, we don't know yet because, of course, with some development risk on both of them, but we will have a product. We are not standing in 2023 and say, "It didn't work out. It doesn't happen." Something will happen. So both are still kicking and alive, and we're working very hard on both of them, and it's just to hedge our opportunities. We would like to deliver on that one as well.
When you look at the food, the cost for developing the peanut is included in our plan to be very bold and frank on that one. We will not come out suddenly and say, "Oh, you remember we told you two years ago that we have a lot of costs that would be, of course, you should have understood." No, we have that included in our plan.
And that is, of course, primarily because we think we are stronger and more robust, and also our metrics internally are looking better out of the transformation period than we hoped for. So we have room for stuff like that, and this is how we use that room. So this is about delivering on everything else you knew of, and now we add this one within the frame as well. And with that, I will give just to Søren to talk about the EBIT and EBIT.
Yes, thank you, Thomas, for the question. And actually, thank you for bringing it out in the open that we have changed this from EBITDA to EBIT. And it is actually so that we have now solidified the outlook with a 25% EBIT. So you could say underlyingly we would have been 30% EBITDA-wise. So I think hopefully that clarifies it. And I think part of that is, of course, also that we are finishing off our transition strategy now and have a better visibility for the years to come, and especially also with the tablet outlook as we see, and also the R&D costs that we consistently expect that the ratio will go towards the 10%, even though including the food program, as Carsten just talked to before. So it's us actually solidifying the 25% in 2025, and it's EBIT. I hope that clarifies your question.
Yes, that's great. Thank you very much.
Our next question comes from the line of Philippa Gardner from Jefferies. Please go ahead.
Oh, yeah, hi there. I had a question on your guidance for the international market when you talk about sort of incremental growth in Japan. I was just wondering, Torii has given guidance for sort of more than 20% for the two products in terms of sales in Japan. So could you just try and help us understand why your guidance seems to be a little bit more conservative in that region, please? Thank you.
Yes, thank you for the question. It's very well spotted that Torii has been out stating these 20% in-market growth in Japan, and that's very well aligned with what we say. And that is because remember that our sales in Japan consists of what's sold in market and then a delivery royalty. And as we also said, that's exactly why some of the high growth in international markets happened in 2020 as planned because they were ramping up for growth. So that was the stock and deliveries that we got benefited from. Now we move into 2021. Of course, now they have the stock at hand, and that's why our growth is coming down a little bit, but they can still maintain their high in-market double-digit sales growth.
So it's extremely well aligned with what we anticipate, but it's just a balance of how we are including it in our revenue line. And then finally, of course, bear in mind that there has been, as we also have written about, this transition from the legacy Cedarcure into our Cedarcure products. And of course, you cannot twice convert the market from the old to the new products. And that, of course, also positively rubbed up on us in 2020. So there are the two explanations for the Japan developments.
Okay, thank you. Our next question comes from the line of Michael Novod from Nordea Markets. Please go ahead.
Yeah, thanks a lot. It's Michael from Nordea. First of all, congrats with the strategy on food allergies. It's very exciting. Maybe you could sort of elaborate a bit on how you're going to structure these trials. So I guess the peanut one is, first of all, going to be the largest one. But what about when you go into other food allergies like tree nuts? Is it going to be of equal size? And then how many specific indications do you need to run, or can you actually sort of combine sort of in the tree nuts on a larger phase III program?
And then secondly, on the French market, you've been talking about this potential price reform for a while, and you still use it as a factor when giving you a low end of the guidance. How realistic is this, and how will the exact impact be in your base case scenario if it happens on the French business?
Yeah, thank you, Michael. Let's take the French price. It is surreal, but I think I have monthly meetings with authorities, and so does our team in France. So it's most likely not going to happen the first half of this year as we see it right now, but it's still a risk because we are asked to lower the prices. However, we also have a situation where our competitors' allergens have a 60% higher price on exactly the same product in France. And of course, we argue that then they have to come down to our level, which is something that's creating a lot of complications, and that gives buyers some time. We have a good dialogue with them.
We are very involved with both the authorities' business in France, where we have now some new regulations in France that when you invest in R&D, when you invest in facilities and so forth, they leverage actually that into the price discussions, and that is what we have been dealing with the last couple of years. You can say we've been successful managing a delay in the price cuts for good reasons, also for the French authorities, so it is a risk, but I think it's maybe half of what you saw when we had a full effect back then. If you look at the clinical setup of the peanut, it is true that it's most likely that if you wanted to do something, depending on how it exactly looks like, there will be opportunities to run parallel tree nut and peanut if you want to.
But you can also maybe even do a parallel phase II and phase III depending on where we stand at that point in time. This is something that we are working on right now and calculating. And of course, subsequent for that one, we will also look at eggs, and we will also look at other food allergies. But seeing what's happening with Aimmune right now, seeing what's happening with DBV, we are confident that coming out with some sublingual technology, predominantly tablets, and we have secured that, will be a game changer should we have that safety profile and efficacy profile we expect. And if there's something our team here knows about that is setting up clinical trials, as I just alluded to in my presentation, and I think we are pretty well off there, Michael.
Can I just ask a follow-up to that? Two follow-ups, actually. So when you talk about sublingual, it can of course also be different than a tablet. So have you already decided that this is going to be a tablet, or could we see a different sublingual administration than the current tablet forms of your current products? And then also another follow-up on the strategy. Is it going to be all organic, or do you also look into the potential for adding technologies or even companies as part of your strategy?
When I say sublingual, it's because we have not all the stability data on a tablet yet. So we're just having that door open should it turn out against all our expectations that we cannot make a tablet. Then, of course, we shouldn't not do another sort of sublingual technology if that is what we need to do. We don't expect that, but that's why we're saying it that way. If you talk about M&A, the numbers you see and the presentation we just made, as you know, does not include that we do any of add-ons or M&A activities to secure that. However, of course, if something very interesting comes across, we will look at it, but then it will be business case by business case.
We are looking at, you know, also we made a deal with X-Chem in the U.S. looking at small molecule technologies for allergy and asthma treatments and got exclusivity there. We're doing a lot of things along the way, but our objective right now, as we can see that only 1% of people with respiratory allergies are being treated, with that massive potential we see just in our core business, with a very strong opportunity in food allergies coming after 2025, and with what we have at hand, by going more digital, by expanding into more markets, by going into China and just continue to penetrate the U.S. market, can create a profitability of 25% EBIT and more than 10% growth with upside on new technologies. That's what we call hands on the wheel where we drive our own future. Can we do anything to accelerate that?
We will do that, but it's not a part of how we think we should be strong. I think we can be strong organically, and right now, you know we've been talking about this before, we have been looking a lot. We don't see many assets out there with a valuation and then accelerating our journey out there that makes sense to us, but I mean, we have the capabilities. I personally have done a lot of bolt-ons and acquisitions in my career. It can be done if it's out there, but it's not a part of the plan. We don't need that.
Super. Thanks a lot.
We have a question from the line of Jesper Ilsøe from Carnegie. Please go ahead.
Thank you so much. Also a question on Germany from my side, and then I have a follow-up afterwards. Starting with Germany then, so you're now one month into 2021 with these fee structure changes in Germany. So maybe you can just update us on what you've seen in the market so far and also the timelines on these, you said, regional recommendations. So just to say, look at what the step change in the sales curve could be during 2021. So could it boost Q1 2021 sales, or will it not kick in really until, say, the second half? And also what do you include in your guidance for this additional tablet sales opportunity in Germany? So does the other end of the guidance include it all, or is there still some, say, headroom left? Thank you.
Yes, I think it's, of course, we just started in January, and I think it's always nice that you're eager to get the results for first quarter already. That made me smile a little bit, of course. I think we are off to a good start because we have the initiations as we expected, and that we also commented on when we had our last call that that was important. And yet we have now more months that solidifies that. So I think that one is in the book. When it comes to the German case, I think it's too early simply to say what's the speed of conversion going to be. We have worked on this for many years now.
And sometimes I think it's fair to say we've been the one on the white horse driving this change, taking bold moves, discontinuing products ahead of before we knew what the authorities would do. Now there seems to be a good inroad in Germany. Now there seems to have got the message, and they're supporting evidence-based medicine. Will it flush out in quarter one, or will it be quarter one next year? We don't know, but clearly it's going in our direction. And then I think we will be happy to report out once we see what the turn of this will be. I think it's fair to accept also that there will likely be resistance from the current competitors in the market, but it's not something that just came around. It's actually been worked on for years, this one.
So I think also the authorities here can allow themselves to be a little bit stubborn and say, you know, it was coming. Why didn't you plan for upgrading your products like ALK have done? So I think that would be my answer to that one. When it comes to the upsides or the higher end of the range, yes, it is part of that. Can we beat it? I think it very much depends on if this flushes out earlier than what we expect, but it's part of the upside to it. Yes, it is.
Thank you. Then a question to Carsten. Carsten, you mentioned in the annual report that you expect to accelerate growth within 5 to 10 years from the current 10% growth rate. So this is, for me at least, the first time you put in writing that you expect accelerating growth rates beyond 2025. So should we read this just to be certain? Should we read this as the pipeline programs and opportunities you have together could lead to annual growth rates above the current 10% that you target?
Are you a step change versus now, let's say, 11%- 15% in some years, but still a step change? And also which programs should be the main growth driver to reach that ambition? Also potentially some reasoning behind this ambition because over time you will be hit by, say, a bigger and tougher base to grow 10% from, to just any additional growth to that. Thanks.
Yes, I think it's a good question, and it's a very rare question, but I do see actually that the core potential of our core business is still very big for many years to go. So I think there's a number of factors that can allow us to, first of all, have the baseline of 10% growth, which is, of course, the tablet growth where you can see also an entry into China as an opportunity with a sizable opportunity or less sizable or more sizable opportunity. You have the whole child indication, pediatric indication, and so forth. But on top of that, you also have adrenaline, and you also have food. I mean, we have not, when we said the 10% added in food, for example. So if we come out with a product after 2025, that adds on to the growth, and it's a big product.
When you just look at the math, yes, it's true. It's growth over growth, and it suggests that we multiply the company size several times, but that should be our ambition. Our ambition with the potential we have, with the core we have, with the no-excuse culture we have developed right now, is to continue to perform the 10% growth per year and having the profitability of 25%, and then work on everything we can to accelerate that. Because the market of allergy in totality is very big. But instead of talking about what if we got 10% of all patients and then trying to calculate the dollars of that, we know hands on the wheel, we can grow 10% per year at least the next many years, and we have some programs that can accelerate that. So that's the essence of it. It's not really a fantasy land.
It's really a strong execution of what we're doing. I cannot guarantee there will not be a black swan as COVID that gives us a quarter or two setback, but the momentum of the fundamentals, I can't see what that should be. Whether there can be a half a year delay on a clinical trial or a stability trial that delays something on an adrenaline pen or one of the food products, I can't tell you, but it doesn't change the momentum story we are in right now.
Thank you so much.
I remind you that if you would like to ask a question, you will have to press zero one on your telephone keypad now. Our next question comes from the line of Peter Sehested from Handelsbanken. Please go ahead.
Yes, hello. Can you hear me?
Yes, fine. Thank you.
Great. Thank you. Most of the questions have actually been asked, so I have to share a bit here in my notes. But I noticed that on the U.S., you said that you'll still be dedicated to provide your legacy products to the existing customers. And I guess those are essentially the allergists who also prescribe the tablets today. In that comment, should we read that as that going forward, your main strategic objective in the U.S. in order to accelerate tablet growth is essentially to circumvent the allergists by means of the initiatives that you already talked about, i.e., these test things that you ran in the U.K., digitalization, etc., etc. That is question number one. In terms of the gross margin and the overall margin in general, could you give us a bit of the mechanics that will drive the 25% margin in 2025?
I mean, you've already flagged that before, but now it's basically just to sort of get a bit more hands-on. And the reason why I ask is that if you assume that Japan or sales from Cedarcure continue at a relatively high pace, that will negatively influence your margins. But we also know that you have some one-off or, let's say, let's just call them one-off items right now in your COGS in terms of all the sort of the write-off stuff that you have right now to document, etc., etc. And then furthermore, to accelerate growth, we will also expect that you have to put in some more resources within SG&A and R&D.
So essentially, I guess what I'm asking you is that what do you expect your gross margin to be in 2025, and what do you think about R&D and SG&A margins until that period? I will stop for now with those two, and I can get back in with you. Thank you.
Thank you so much. Søren will explain to you that we actually have a plan to reach the 2025, and that's pretty solid. But I'll just go about the U.S. first. We are not having a plan to circumvent the allergist as a strategy. We invite all allergists in the U.S. to prescribe tablets, period. However, we can also see that there is some part of the allergy segment that because of this disincentivized structure they have where they're just making so much money on giving shots, they've been very hesitant to take on the tablets. So of course, we're not waiting for the next 20 years to get those last allergists to convert into tablets. So every allergist in the U.S., and this is getting close to 1,000 now, are of course invited to continue to prescribe tablets, and we will grow that base as well.
However, having said that, we can also see now that there's a lot of dynamics in the U.S. market, both in terms of ear, nose, throat ENT doctors being now. We're calling about 30%-40% of our calls to them right now. They are very susceptible and are prescribing much more tablets than an allergist are doing. We can see these doctors' offices where several specialties are in one setting are also prescribing tablets. And then you have the whole new notion of digital pharmacies, digital prescription doctors, houses, and telemedicine is really rapidly up. But we have now launched that in New York, and we have documented also and demonstrated that we can mobilize customers all digitally to the right doctor who are willing and able to prescribe tablets.
So we're not having a strategy not to go to allergists, but we're not waiting for them to come around. So all allergists are certainly invited to come in, but we can also see other segments. And it's only in a couple of years from now when we had the pediatric indication that you will see that, of course, children's doctors will be a key segment for us as well. So that's it. So with that, I'll give it to you, Søren.
Yes. Thank you, Peter. I think we have luckily for us. I think we have been projecting this and discussing this with the investor communities for some time, and we are faring according to the plan that we have laid out. You asked specifically on the gross margin, and I'm quite certain that I earlier also have stated that at the end of the period, we aim for the late 60s% on the gross margins, and I think there are two drivers of that. First and foremost, it is the economies of scale of the tablets, irrespective of what the impact of Japan is. So that's actually baked into that because the core tablets outside Japan will actually have good gross margins.
In addition to that, part of the reason why we are suppressed margin-wise these days is that we invest in quality upgrades and the site upgrade and structure and modernization of that. And that is still expected to yield out margin points from 2023 and onwards. So you will see the economies of scale will yield year on year at a good steady rate, and then you will have a kicker come 2023 where it'll lift a little quicker, and then we are moving towards the late 60s.
So that's the gross margin piece. I think we've also talked to that we are consistently investing what we need to sustain and fuel the future growth, either being food or anaphylaxis or the current children indications, and that we have quoted around 10% of revenue growth for R&D. When it comes to the SG&A, there we expect around these 32%-33%, whatever you're going to make it, cut off 5% on admins, then you are at your 72% for SG&A for sales and marketing.
27.
27, yeah, sorry. 27, little. But the 27 here, again, the reason why it's maybe not 30 is that actually the Japanese market, for instance, where we have the lower margin, we are not promoting it. So there is an inner logic to why we can be more efficient than normal benchmarks would be. And if you stack those up, that's when you end at the 25% margins. And this is the plan we have had. This is the one we have laid out, and this is the one we're executing against to deliver on the famous 25 % and 2025. I hope that clears the questions.
Yes, thank you. And if I can just throw in a very quick follow-up to Carsten on the U.S. because it really sort of warmed my heart when I saw that you had started the celebrity endorsement in the U.S. And I just want to, could you just add some initial comments or is it too early to comment on the effect of that? Thank you very much.
Definitely. We are going new ways in the U.S., and we are getting our tablets endorsed. To succeed in the U.S. is more than just going to the old traditional allergist and convince them to not make money on their shots. What we have to do is what we call an end-to-end strategy for mobilizing and getting awareness of the tablets. And there we use celebrity endorsement. We are very active on social media. But we are also working now to see if we can establish collaborations with the CVS. Fisher Scientific is now going into the HealthHub s with the testing. We are having Cleared in New York and Chicago, which is an end-to-end digital system with a fully digital pharmacy, fully digital doctors' offices, fully digital call centers where you can call in when you have downloaded the Klarify app. So it's one of the parts.
And yes, if you look at the volume of our tablets in the U.S., that's not so bad. It's still the gross-to-net that creates some sales issues. And then also, I will not use it as an excuse, but it is right now a little bit difficult to see what is the chicken and what is the egg due to COVID in some of the cities right now. However, when I talk to the team and we look at the data, it actually looks pretty good, and we will continue that road. U.S. is really something, a place where I think we can win.
Yes, I fully acknowledge that those billions and zillions from five, 10 years ago are not coming out of the ketchup bottle very quickly, but there are still 27 million untreated people in the U.S. that should have immune therapy, and we should go for those with tablets, and we will. But it will be a journey that will last for the next five to 10 years. And let me just underline that in the plan to 25% and 2025, it does not include that we suddenly have a fantastic gigantic success in the U.S. and crack the nut.
This is still with the plan where we can execute year- over- year and penetrate the market better and better. Should be much better than we think right now. Then, back to the other question about acceleration, then we take the positives of that as well, but that's not what we have in the plans today.
Okay. I think there's time for one more question, Operator. Please go ahead.
We have a question from Dhevish Choi from SEB. Please go ahead.
Thank you for taking my question. Two questions from the left-hand side. Firstly, I would just like to follow up on the food allergy. Could you please give us an indication on the R&D budget exactly for the peanuts towards 2025? And what margin level are you expecting beyond 2025, assuming you exceed in the food allergy? Secondly, we have seen there's an antitrust trial against Mylan on the pricing of EpiPen in the U.S. So what are you seeing in the U.S. market in terms of the supply and the demand? Could you elaborate a bit on what kind of data do you have at the moment with potential partner for Jext?
Okay. Let's start with Jext. Remember that 25% of all initiations on pens come from our key target group, the allergists. So we will go direct with the pen. And in our own modeling, honestly, even if we go in with the lowest possible price, meaning, for example, 20% below any generics, is a very, very good business case for us to do that. And we don't think that we will be anything but a good addition to the U.S. adrenaline market after that. When you look at the food allergy, we are expecting to do a full program as we've done before. Certainly, we are very efficient in doing that since we've been doing it so much. And you should look at a three-digit in millions Danish DKK , which means more than EUR 15 million. But it's also still baked into the plans we presented now.
It's not coming as an extra cost on top of. We can manage that and still not be above 10% in R&D cost to sales. What are the margin going to be beyond 25? You're a long way out, but I would say that, as I've always said, we should be a company that grows 10% in sales with a margin, EBIT margin of 25%. And if we have business cases that solidify, it should be 23% or 22% a year because we can further accelerate or further do something to increase the size of ALK.
We will present that as a business case and explain that. But as a company and as a principle, we should be from 25% in EBIT and 10% growth. And remember, it's not something that you have a big black hole and then we pop up in 2025 with 25% EBIT. We will gradually increase the profitability and having a good profitability already in 2023, growing to 25% in 2025.
Thank you, Carsten, and thank you all very, very much for all these good questions and for joining the call. We are planning a series of virtual roadshow sessions over the next few months, and we do hope that you'll be able to join us in one of these events. Otherwise, as always, please do feel free to contact us, either myself or Søren or Carsten. And with this, we just say thank you all for your attention. Wish you all a very good day and close today's session. Goodbye.