ALK-Abello A/S

CSE:ALK B

Earnings Call Analysis

Company Achieves Growth and Expects Continued Revenue Uptick

The company has reported an 8% revenue increase in local currencies, driven by robust tablet sales and double-digit growth in Europe. However, supply issues led to a 4% revenue decline from Jext sales. Operating profit more than doubled to DKK 247 million, benefiting from sales growth and improved gross margins. R&D expenses remain steady, while sales and marketing saw minimal cost increases. The full-year outlook remains unchanged, predicting 8-10% revenue growth in local currencies. Expectations include a 13-15% EBIT margin, an increase from the previous year's 10%, and continued revenue and earnings advancement into 2023.

Introduction of ALK's Q3 Results and Full Year Outlook

ALK's third quarter presentation introduced new CEO Peter Halling and indicated a steady performance with a full year revenue expected to grow by 8% to 10% in local currencies. The company remains confident despite temporary challenges such as the Jext supply issues and mandatory rebates in Germany.

CEO's First Impressions and Strategic Vision

The new CEO expressed confidence in ALK's strong foundation and market-leading position in allergy treatment. His aim is to work with the team to continue transforming the allergy market and create value.

Market Trends and Customer Engagement

Indicators suggest a stronger initiation season this year, with more than 10% increase in new patient initiations in key markets. Engagement through ALK's digital platform, klarify, rose by 40%, indicating higher consumer awareness. However, there's caution over the spread of tablet sales growth across quarters.

Sales Performance Across Product Lines and Regions

Revenue growth was experienced across regions with a notable increase in tablet sales globally and in Europe. Challenges in Jext supply are being resolved, and product sales are expected to normalize in the next month. Sales in Europe were robust, North America showed regulation, and international markets displayed strong growth. SCIT and SLIT-drops sales increased notably by 23% in Q3.

Financial Highlights and Full Year Expectations

ALK achieved a 9% revenue growth, with an operating profit margin improvement due to higher sales, improved gross margin, and a modest increase in capacity costs. The full year outlook remains positive with expected revenue growth and an EBIT margin of 13% to 15%, up from last year.

Strategic Priorities and Operational Focus

Management outlined their commitment to completing and commercializing the tablet portfolio, particularly focusing on North America. The company plans to submit registration applications for tablets targeted at children, expected to be a key growth driver in upcoming years.

Guidance Confirmation and Q4 Outlook

Despite Q3 outcomes, the management maintains the full year outlook, expecting tablet sales growth to be lower in Q4 than Q3 due to seasonality and one-time impacts. However, the mid- to long-term growth prospects remain strong as ALK continues to invest in market-building activities and the potential growth from children's indications appears promising.

Earnings Call Transcript 2023-Q3

[Per Plotnikof, executive]

Hello, everyone, and welcome to this presentation of ALK's Q3 results and the full year outlook. And thank you all for joining us. Let's turn to Slide #2, where I will introduce today's presenters and agenda. My name is Per Plotnikof, I'm Head of Investor Relations. With me today are CFO, Claus Steensen Solje; and our new CEO, Peter Halling. Peter joined ALK 14 days ago on the first of November, welcome on board, Peter.

Today, we will detail the performance in Q3, including market trends and financials. We'll also provide an update on our strategic priorities before we cover the full year outlook. We will end the call with the customary Q&A session. And to get started, I'll hand over to Peter, who will attach a few comments to the highlights of Q3 and make a couple of personal remarks on Slide #3.

[Peter Halling, executive]

Thanks, Per. And thank you all for joining this call. I look forward to working with you and getting to know you in the quarters to come. Now if we turn to the Q3 results, Q3 met our expectations. Revenue was up 8% in local currencies, with growth in all regions. European tablet sales increased by double-digits, mainly driven by a good inflow of new patients in key markets. Moreover, our injectable SCIT products were also a major contributor to growth. Now in contrast, Jext sales declined steeply due to the previously communicated production challenges at our CMO. We expect market supply of this life-saving device to normalize within the coming period. The temporary decline in Jext sales lowered overall revenue approximately by 4% in Q3. Revenue was also impacted by other temporary factors such as the German mandatory rebate and some phasing between quarters. However, the underlying organic growth was around 10%, well in line with ALK's average growth in recent years.

If we look at profit, operating profit EBIT more than doubled to DKK 247 million on sales growth, gross margin improvements and a modest decline in capacity cost. Capacity costs were lower, driven by sales and marketing activities that saw some phasing between Q3 and Q4. Overall, we remain on course to deliver on the full year outlook, which is unchanged. Claus will further detail all this during the presentation. But before we go into the details, let me just make a few personal remarks. As you all appreciate, I hit the [ current ] ground running after a pre-period of extensive homework, I started with ALK just 2 weeks ago. I'm being onboarded in my new role at a very high pace.

Firstly, many of my initial expectations and assumptions have been confirmed. I truly appreciate the effort of the previous management team and the ALK organization. ALK is a company with a strong foundation, history and purpose, and I believe a very talented and passionate organization and not at least, a company with a bright future. On a personal level, I'm humbled, and I'm extremely excited about the opportunity. I'm looking much forward to getting working with the ALK team and our partners to truly transform the allergy market and create value for all. With these said capabilities, ALK is uniquely positioned to transform allergy treatment and expand our market-leading position, thereby helping millions of people suffering from respiratory allergies, supporting caregivers, health care professionals and creating value for our shareholders.

Now as new CEO, I made it clear that our priorities are to keep full focus on building continued momentum in the business and build trust with the markets over the coming quarters. We must embrace the challenges we faced and must resolve in order to progress on our ambitious targets and our strategy. As we work to do so, we'll make the necessary prioritizations while we also secure ALK's long-term position. So with that, I'll hand it over to you, Claus, to take us through Slide 4.

[Claus Solje, executive]

Thank you, Peter, for your reflections. Also a warm welcome from me. I'm very much aligned with your observations, and I'm looking forward to our collaboration. Before we look at the overall sales trends, let's take a deep dive into the European tablet sales, which obviously remains a key focus area after a challenging period. European tablet sales grew by 14% in Q3, that 16% growth on a like-for-like basis is regarding the German rebate increase. The negative impact from the lower-than-expected intake of new patients in the previous innovation season is tailing off. We are benefiting from the initiatives which we developed to improve momentum in the current initiation season. These activities have been centered around Germany and the Nordics, but we also work with other markets to improve market access and mobilize patients.

Leading indicators still point towards stronger initiation season this year, which will lay a stable foundation for growth in 2024. Let me look at a few of these. The number of new patient initiations in key markets during the first 3 quarters exceeded last year's numbers by more than 10%. Since we are currently in the middle of the primary initiation period, it is yet essential to exercise some caution and focus on the continuous -- and continuing this trend. Another leading indicator we use is around the digital klarify universe. Here, we can see that 40% more consumers used our klarify universe to find a doctor, learn about AIT or to take allergy test.

klarify mobilized 670,000 users year-to-date. As we already touched upon at the second quarter, we also saw solid Polyploidys in spring and summer across major markets. And the number of Google searches and the traffic on our klarify platforms indicate that pollen allergy was top of mind among the consumers. Finally, the key AIT markets continue to stabilize from last autumn's unexpected dip in demand, and we are in a good position to capture growth and increase our market share. Looking at the European tablet sales growth of 14% in the third quarter. It is worth to notice that the European tablet sales growth in the second half year may have been slightly front-loaded because we saw some stocking at wholesalers at the end of Q3 in anticipation of a stronger initiation season.

We may also have seen some doctors initiate patient earlier this year following our efforts and Q4 sales will also see an impact of a one-off tax burden in France. Still, despite these quarterly fluctuations, we remain on course to deliver on our target of around 10% growth in European tablet sales in the second half as a whole.

Now let's take a closer look at the global product sales on Slide 5. Global tablet sales increased by 10% on double-digit growth in Europe and North America. Obviously, revenue from Japan was down, reflecting a phasing of product shipments to our Japanese partner, Torii. Revenue from Japan remains subject to continued fluctuations between quarters. Combined SCIT and SLIT-drops sales were up 23% in Q3. We saw a significant increase in product shipments to China, and we continue to see high growth in Europe, driven both by improved pricing and an underlying volume growth. Furthermore, growth was also influenced positively by certain rebate adjustments in Europe. Revenue from other products was down 28%. There are 2 main reasons for that. First, the sales of life science products, such as vials and diluents in the U.S.A. decreased by 7%, but sales of these products are expected to pick up in Q4.

Second, we also saw the anticipated steep decline in sales of Jext [ pins ] in Europe due to the shortages in supply of adrenaline filled cartages from our contract manufacturer. Good news is that supply from this contract manufacturer is improving as we speak, and we expect market supply to normalize within the next month. This is important in order to help patients in need and to position Jext for next year's higher organic replacement rates.

Let's now turn to the market trend on Slide 6. Sales in Europe were up 8%, driven by tablets and SCIT. We did well in Germany, the Nordics and most Central European markets, while sales were unchanged in France. The issues with Jext impacted the performance, especially in the U.K., where adrenaline is our #1 product category. Revenue in North America grew by 2%, following fluctuations in sales of life science products and a relatively soft quarter for SCIT bulk. Tablet sales grew by 26%, equally driven by the U.S.A. and Canada. In the U.S.A., the organization continues to work hard on building new sales channel, channels particularly with pediatricians where Canada continues to deliver solid performance. Finally, revenue in international markets increased by 17% in Q3, driven by shipments into China and growth in the minor overseas tablet markets.

Revenue from Japan was down, as already mentioned. Now let's move on to the 9 months financials on Slide 7. Results in the first 9 months were in line with the full year outlook. Revenue was close to DKK 3.5 billion after 9% growth in local currencies and 70% growth in Danish krone. When -- disregarding the 1-year mandatory rebate increase in Germany, top line growth was 10%. And gross profit of DKK 2.2 billion led to a gross margin of 63%, an improvement of 1 percentage point on a higher sales and efficiencies, partly offset by larger shipments to Torii at lower margins in the first half of the year. The operating profit EBIT of DKK 472 million yield an EBIT margin of 14% and an improvement of 4 percentage points. This improvement was due to higher sales, improved gross margin and only a modest increase in our capacity cost.

If you look at the graph to the right, you will see that the capacity cost to revenue ratio decreased from 54% in Q2 to 49% in Q3. This improvement mainly reflects 2 things: First, we had one-off costs in Q2 associated with the leadership changes, which we highlighted in August. Secondly, we saw some phasing of sales and marketing activities, especially in China between Q3 and Q4, so that sales and marketing costs only increased by 2% year-to-date. Free cash flow was positive at DKK 51 million as planned. Cash flow from operations improved despite continued inventory buildup, but this improvement was offset by planned investments to upscale capacity for tablet production, upgrade legacy production and other investments.

All in all, a good set of results. Now let's move to a brief strategy status on Slide 7, and back to you, Peter.

[Peter Halling, executive]

Thanks, Claus. Good results indeed. The execution of our strategy continues. So let me focus in on the progress on some of the key initiatives, starting out with focus on succeed in North America and complete and commercialize the tablet portfolio. In relation to these work overall progresses to obtain children indications for tablets. Based on the successful Phase III studies in house dust mite and tree tablet, we expect to submit registration applications for the house dust mite tablet, ACARIZAX in Europe around year-end and in the U.S. under the brand name ODACTRA in the first half of '24.

Now subject to approvals, this tablet could become available for children in these regions in '24, '25. Next step is the submissions for the tree tablet. Again, based on the positive Phase III clinical trial with children, we reported on last month, we do expect to submit applications for the tree tablet in Europe under the brand name ITULAZAX and in Canada under the brand name ITULATEK, mid '24, so that this could become available for children in Europe and in Canada in '25.

We expect the children indications to support mid- to long-term growth in Europe and at the same time, strengthen our efforts to unlock the tablet market in the U.S. It is essential that we make the most of these unique opportunities to expand prescriber and patient basis. Planning has been ongoing for a while, market-building activities are underway and efforts will be intensified in the months to come. The potential in children is well known. In Japan, where children constitute the majority of new tablet patients, we've seen good progress. Now speaking of Japan, we continue the discussions with our partner, Torii on the way -- on ways to potentially increase production capacity further for Japanese cedar pollen tablets.

If we then move to consumer engagement and new horizon. I just want to confirm the time plan for the peanut tablet, our first move into food allergy. We still expect interim readouts from the Phase I trial around year-end, and the trial is expected to complete next year. Finally, concerning optimized to excellence, efforts continue to improve efficiency and further automize the portfolio to ensure improved profitability are ongoing. This will allow us to reinvest and further accelerate the business, so very important for the company going forward. As stated earlier, irrespective of the management changes, we will continue to focus and execute on the current strategic priorities, and we'll do our utmost to maintain the business momentum. The new management team is fully committed to driving sustained top line growth, and we will continue to expand our core business in respiratory allergies and will enter the broader allergy field as an example, in peanut through the food allergy space.

We are equally committed to improving profitability to generate attractive returns for shareholders. Moreover, higher earnings will also enable us to continue investing and sustaining and possibly accelerating ALK's long-term growth. So in conclusion, the strategic direction is unchanged and management will, of course, ensure full focus on maintaining the positive business momentum and make the necessary prioritizations to support both our long-term, but also our short-term growth and ambitions. Now Claus will end the presentation with an outlook on Slide 9.

[Claus Solje, executive]

Thanks, Peter. We maintain the full year outlook with increased confidence based on the results year-to-date and the outlook for Q4. Full year revenue is still expected to grow by 8% to 10% in local currencies. This equals 9% to 11% growth disregarding the rebate increase in Germany. On that note, we remain confident that this rebate increase in our largest market will be reverted by year end in line with the authorities or [ regional ] statements. Full year tablet sales growth is still expected within the previous communicated range, led by double-digit growth in North America and international markets and single-digit growth in Europe. The previous communicated price adjustments in parts of Europe are still pending, and we don't expect them to have a material effect this year. Combined full year sales of SCIT and SLIT-drops are still anticipated to grow by double digits, while sales of other products are projected to decline due to Jext. The impact from the temporary supply shortages will also leave a mark on Jext sales in Q4, although this impact will be somewhat lower than in Q3.

Moving to earnings, the EBIT margin is still expected at 13% to 15%, up from 10% last year based on the following assumptions. The gross margin is expected to increase by approximately 1 percentage point, a minor clarification of the previous statement of up to 1 percentage point. The improvement is due to increasing sales, sales mix and efficiencies, which is partly offset by adverse factors such as the German rebate increase, modest cost inflation and higher shipments to Torii at lower margins.

Second, R&D costs are still planned to decrease to around DKK 600 million, and we continue to expect sales and marketing costs to increase by mid-single digits. When you do your Q4 modeling, please bear in mind that we are up against tough comparisons in Q4 last year Jext sales were extraordinarily high and where we started to benefit from the price increases for SCIT, which have supported this year's growth. Further, Q4 will expectably see an increase in sales and marketing costs relatively to Q3 and Q4 last year.

Finally, we expect Q4 tablet sales growth to be lower than in Q3 for the reasons I mentioned before. To sum up, despite the headwinds from the European tablet sales in the first half year and despite the shortfall of Jext sales in the second half year, we expect to continue our journey with increasing revenues and improved earnings in 2023. We are obviously keen to maintain momentum for 2024 and onwards. And with this, I hand it back to you, Per.

[Per Plotnikof, executive]

Thank you, Claus, and thank you, Peter. And this concludes the main part of our presentation, and we will now move on to the Q&A session. And please limit yourself to a maximum of 1 to 2 questions per round and then rejoin the queue afterwards again. Operator, please go ahead.

[Operator]

[Operator Instructions] And our first question will come from Thomas Bowers of Danske Bank.

[Thomas Bowers, analyst]

Yes. Thank you very much. I will try to limit myself to 2 questions here to begin with. So just on the European tablet growth. Are you able to comment on the contribution from the impact you see from doctors starting therapy earlier compared to the actual increase in demand you see here for the third quarter? And then maybe can you comment a bit on the prescriber base that you made some comments in the report. So how have you managed to convince more doctors. So is this the so-called SCIT hardliners that are now in to a larger degree, moving into our therapy? Or what has actually changed compared to your previous efforts here.

[Peter Halling, executive]

Thank you, Thomas. Nice meeting you. I'll hand over the questions to Claus, who will answer.

[Claus Solje, executive]

Thank you, Peter. It's, of course, difficult to evaluate right now, Thomas, how much the so-called, as you say, skid lovers have been moved. What we have been working on in Europe is this about getting doctors to prescribe earlier in the year. So instead of waiting to the high season here in Q4, October, November and December, then actually starting a bit earlier also, so we avoid that you can say how are patients that are going to the doctor due to the allergy is in some kind of competition with people having the flu or other symptoms coming later in the year. How much exactly that is adding, we don't know. We don't have data for that. But what we can see is that the increase, as we have now been seeing in Europe, of the 14%, some of that is driven by the higher initiations of these 10% compared to what we saw at last year. So there's no doubt that there are more patients coming in there, and we believe that some of this is due to doctors starting to treat patients earlier. Then you have a second question. Thomas?

[Thomas Bowers, analyst]

Yes, it was just in regards to the prescriber base. So have you convinced these SCIT lovers, SCIT hardliners or what has changed with the efforts you've made in Germany in particular?

[Claus Solje, executive]

I would, of course, like to say that we have done that, but we don't have data to support it for now. So I'd rather not go into speculate on that one. But what we can see is that there are more patients that have been mobilized as we also allude to, then via our klarify universe, digital clarify universe in Europe. We can see we have had more than 670,000 people being activated in there. Either looking for a doctor or taking some test on our digital platform. So there's no doubt that this year versus last year, we have mobilized more patients that have been looked, [ forward ] for doctors. So I would rather take it in that direction that it's actually the doctors that have pulled in the patients, it's activation of the patients that have probably been a bigger success for us in Europe this year.

[Operator]

The next question comes from Martin Parkhoi of SEB.

[Martin Parkhoi, analyst]

Yes. Correct. Martin Parkhoi, SEB. Also just 2 questions for now. Just on the wholesale inventory build that you talked about in the third quarter, just to make sure, when you look into fourth quarter, I guess that -- it's not like you're looking at a reversal, but it's just a normalized inventory level at that point. So you just don't expect the impact to be there again. And then the second question is just on Jext, you pointed to yourself with Claus with higher replacement rate next year, but maybe you can talk a little bit about -- so all the low sales this year, you expect that to normalize -- come back next year. So if it's a normalized world, how much do you actually think that Jext will drive your top line next year?

[Peter Halling, executive]

Claus?

[Claus Solje, executive]

Yes. First, thanks, Martin, for the question. Regarding the wholesaler buildup, then you -- it's a bit difficult for us to get the 100% clarity into this. But right now, we expect approximately 2% of the growth here in Q2 coming from that we can see wholesaler move from Q4 into Q3. Our data indicates that it is simply because wholesalers anticipated a higher sales in the second half of the year, which we, of course, also believe with the 10%. Whether or not that will kind of go away or come back, again difficult to evaluate. But I would say that there have been some movements from Q3 -- sorry, from Q4 into Q3.

On your next part about the Jext, it's difficult to forecast, at least we are not guiding on the product specifically how much it will add next year. But with the fact that we should be back here at the end of the year with full manufacturing with our supplier then I could say the normalized business should be there next year. And then you're completely right that next year will be a higher replacement year for us, which will add something to the top line. How much we are not going into right now for next year, but we are expecting that it will help for our overall growth next year.

[Operator]

The next question comes from Jesper Ilsoe of Carnegie.

[Jesper Ilsoe, analyst]

I had a question on the next steps in ALK with the upcoming strategy update and new medium-term targets. So I'm just curious, should we see the base case as you guys providing a strategy and new financial targets in connection with your full year report in February '24 or is that too early because listening to you, Peter, on this call, it seems like you say that the overall strategic direction is unchanged. So in that case, it's 3 months for you as a CEO in ALK enough to give a new strategy update and new targets.

[Peter Halling, executive]

Jesper. Thank you for the question. The short answer is, first and foremost, I've only been here for 2 weeks. So I'm still kind of getting my feet wet in all of this. But bottom line is ALK is building its progress on a strong foundation and the strategic direction remains unchanged. So basically, we are still focused on delivering top line growth, double-digit. We're still focused on delivering on our EBIT targets and we want to use that profitability not only to create value for shareholders, but certainly also to reinvest it in the business for the longer term. As we progress on the strategy and on the targets we set out, we will obviously always as an organization and as management team evaluate whether we can look at different prioritizations or whether we want to do something different. If we feel a need to communicate, we'll do that in due course. So I think that's the best answer I can provide you at this stage.

[Operator]

The next question comes from Cecilia Hernandez [indiscernible].

[Unknown Analyst]

On tablet sales in Europe, just to clarify, you mentioned that you still expect single-digit growth, but Q4 growth is expected to be lower than Q3. Could you elaborate why this is? Are the initiations just moving forward [ just in ] Q3 -- and then the second question, you've mentioned your short-term efforts to mobilize these patients. Could you also elaborate on your long-term initiatives for sustainable tablet sales growth?

[Peter Halling, executive]

Claus, do you want to answer the first part?

[Claus Solje, executive]

Yes, I can do that. You are right. We are still -- first, thank you for the question. It's very relevant. We are still guiding for the 10% for Europe sales growth for the half year despite our 14% growth here in Q3. There are some things that are impacting kind of both quarters First of all, as I said before, we have seen some wholesaler movements on stock level, where we can see some movements between Q4 to Q3. And when we kind of calculated that into it that will not come back in Q4. Then second, we have also had a onetime impact in Q4 from the French tax contribution in where this is a standard tax in France that is there every year for the pharma industry and this is related to 2022, actually, where we have now for '23 been asked to pay more into that by the French authorities. That will hit us as a onetime in Q4, and it's approximately also 1 percentage point a bit more than maybe 1 percentage point there.

Then third, that we are looking into and also learning about is the whole parallel trade situation in Europe. This is still a bit unclear for us how much that are being moved. There are some time lags in between quarters. But there's no doubt that we are seeing an increased impact from parallel trade in Q3, but again, even higher probably in Q4. So we believe all these 3 elements is adding to a lower growth rate in Q4 than what we have seen in Q3, and that's why we maintain the 10% for the second half of the year.

[Peter Halling, executive]

And maybe to your second question, which pertains to the ongoing investments towards securing the long-term growth. As Claus said early on, we are facing sales and marketing growth -- sorry, sales and marketing costs between the quarters this time around. We'll continue to invest in sales and marketing, but I think it's important to state what Claus said early on, and that is that we want to decouple our cost and our EBIT and our investments. So we ensure that we keep momentum and we continue to build both top line and bottom line. So that's going to be a continued focus. And then obviously, will make the necessary prioritizations to support the growth. I think it's key to mention 2 things here. One is we have an opportunity both to build a stronger position in the U.S. given the pediatric trials we've completed. So we continue to invest in the U.S. to build a strong organization there and execute.

And secondly, as we are progressing and as we are getting approvals in China and other regions, we'll continue to invest in order to build the necessary capabilities. But again, important to say that we will decouple things. Anything to add, Claus, Per?

[Claus Solje, executive]

Maybe one second thing could be added, and that's the children indication that we are now getting. That's also, of course, an important part in our strategy to actually build the tablet momentum continuously. So on top of what Peter is mentioning about the geographical expansion then for sure, getting the indications in with the children is very important for us. We can see in Japan, where we already have approved a children indication that 70% to 80% of our initiation, so new patients are children. And that's probably because parents are taking their children to the doctor when they realize they have allergy more than they take themselves. So that will be very important for us to get those approvals and those children indications.

[Operator]

The next question comes from Peter Sehested of ABG.

[Unknown Analyst]

Two questions. The first one is actually pertaining to your strategy about getting doctors to prescribe earlier in the season. We have -- for the past 2 years seen, let's say, a corona-related spike in September. Have you sort of considered this whether this could actually be permanent and potentially disrupt sort of your strategy to get doctors to prescribe earlier. And the second question pertains to your journal in portfolio in the pipeline. Is your decision to progress with this portfolio, the one that you have currently, is that totally independent of whether the naval competitor gets approved in the U.S.

[Peter Halling, executive]

Claus, do you want to start out on the first one?

[Claus Solje, executive]

I can take the first one with how we get doctors to basically prescribe earlier. There has been, you can say, a standard in this industry where the doctors are basically only starting in the last quarter, maybe into September, but then in the last quarter. You also have a point that in the last couple of years, we have seen corona, of course, increasing and spiking at the end of Q3 and into Q4. That's also the reason why we would like doctors to actually start initiating patient earlier in Q3. So we avoid, you can say our patient being impacted by the corona spike or other flu's or infections in Q3 and in the beginning of Q4 when the winter is arriving.

There's no doubt that when we talk with doctors, then they are very prone to that and can understand the argument for it. So we believe it will help us further if we can get mobilized this, it makes sense to them, and we will continue to work on that.

[Peter Halling, executive]

Let me try to answer the second question here. So on adrenaline, overall, anaphylaxis remains and is a big part of our strategy. We have 2 ongoing developments, [ Genesis ] and Windgap and we'll continue to pursue both projects. Obviously, we are monitoring the developments in the market, and we'll continue to look at it in terms of how we combine and create the strongest proposition for anaphylaxis. So looking at it, it remains a strong growth driver for ALK going forward.

[Operator]

The next question is a follow-up from Jesper Ilsoe of Carnegie.

[Jesper Ilsoe, analyst]

A question on Japan. So there's -- as you also mentioned in the Q2 update, there's a lot of stories out about the issue with allergies and their national plan to combat allergy in Japan. Perhaps you can provide a few more comments on what discussions you've had with Torii's since your Q2 update and perhaps also more importantly, how this potentially could impact you in '24 because you mentioned that you would increase supply. And then I think that means additional shipments to Torii, is that a fair assumption? Or is this more a long-term consideration.

[Peter Halling, executive]

Let me start out. Obviously, we have conversations and discussions with Torii. And as I also mentioned early on, we are in discussions in terms of how we capture the potential in Japan with expanded production capacity. So we continue to work with Torii in terms of getting to the right place. Secondly, overall for Japan, we are obviously excited about what we see from the Japanese government. But important to say, we don't know yet how this is going to play out. So a key thing for us is to execute in terms of our relationship with Torii both from a capacity standpoint and also ensuring that they are capable of executing in their market. Claus, do you want to add?

[Claus Solje, executive]

Yes. Maybe I can just add. Yes, per relevant question. I think 2 things that is important to note is the whole initiative from the government is, you can say, a more long-term 1 that will probably -- hopefully, you can say, help us in the longer term together with our partner, Torii. The challenge is right now that we are actually seeing some capacity constraints with the API part of the SEDAR in Japan. So that will not help us. It will also not impact us, we believe, right now, significantly in '24, but it will also not help us. So there will be no extra shipments in '24 related to Torii as expected. The whole initiatives about the government that will be more longer term when that will come, you're completely right, we will have to increase and expand production capacities and so on together with Torii, but it's more in the longer term than it's in the short term.

[Jesper Ilsoe, analyst]

Okay. Very clear. Just one additional question on the tablet sales in Europe. So just -- you previously mentioned these 200,000 patients and that you missed 10,000 patients. Now you say that you have the comparison now versus last year more than 10%. So just curious on some additional numbers on what this 10% means and what we should compare with also considering that you are entering the peak initiation season now. So are you still seeing the same trends here in November as well.

[Peter Halling, executive]

Claus, do you want to comment?

[Claus Solje, executive]

Yes, I can do that. We will not add more to the patient number itself. But what we can see is that if you look at this period, the first 9 months, compared to the same 9 months last year, then we are up more than 10% in new patients. Last year, it was the 200,000, as you mentioned. And this year, we can see more than 10% up on the initiation part. This is, of course, very important for us because those 10 -- more than 10% initiations is, of course, also hopefully continuing in here in Q4. And even more important, it's laying the base for the '24 numbers for the tablet in Europe. So those more than 10% new patients that we have been seeing in Q3 is quite important for us and give us a comfort in our Q4 numbers and also the upcoming guidance for '24.

[Operator]

The next question is a follow-up from Thomas Bowers of Danske Bank.

[Thomas Bowers, analyst]

Yes. Thank you very much for the follow-up here as well. So can you just -- you mentioned adrenaline. So should we still expect [ TX2 ] or Windhgap to be submitted for approval here in '24. That has been, as far as I remember the previous outlook, so to say? And then just on sales and distribution costs related to China. You also mentioned some phasing into Q4, but should we actually be looking maybe at a slightly tilt towards the high end of EBIT margin guidance here because I guess it will be difficult to spend all the money in Q4. So maybe a little bit of color here. And then the last question, just on SCIT is, of course, very impressive numbers here in Q3, but of course, driven by China. So if we sort of adjust for that quarterly phasing, should we still be looking at some 12%, 13%, 14% for the H2 based looking at global sales here.

[Peter Halling, executive]

Thank you, Thomas. Maybe I'll start out by just answering your question on adrenaline. We're still -- we haven't decided, it's undecided in terms of how we approach it. But as it is, we continue the project as planned. So maybe, Claus, you want to comment on the China question.

[Claus Solje, executive]

Yes, I would like to do that, Thomas. Let me start by the sales and marketing cost, as you say, then we have seen some movements between Q3 and Q4. And some of that is rightfully in China. We have, in China, seen a slight impact on our Q3 sales from this anticorruption that has been ongoing in the pharma industry of China, like other pharma companies have been seeing that has been impacting our sales albeit here in Q3 and we'll probably also do that into Q4. It will not -- we do not kind of see it as material, but it is something that will lower a bit our Alutard sales here in the second half of the year compared to what we had expected in the beginning of the year. That's also why we are a bit cautious, of course, on the spending. But if everything goes well, we should be able to invest in Q4 that we now have planned also to keep the momentum into 2024.

With the SCIT part, as you're saying and just to allude on that, the Alutard part in China, we should expect that to be good here in the second half of the year. We are not changing guidance on that. But as I said, with the anticorruption ongoing, then there will be a slight impact on the sales in China on that, but probably not material as we see it today.

[Operator]

The next question is a follow-up from Martin Parkhoi of SEB.

[Martin Parkhoi, analyst]

Martin again from SEB. Just a couple of questions on pricing. Back to the fourth quarter on SCIT, where you raise a flag. But of course, there always was some price impact in the fourth quarter of last year. But can you maybe -- how much that actually impact the fourth quarter of last year? If you look at the price hikes in the fourth quarter last year compared to what we have seen in the 3 quarters so far this year. So are there still some incremental impact in the fourth quarter? And related to that, can you again maybe put a little comment to to what you actually in the first month, months have seen in the SCIT franchise on volumes and, of course, then you, of course, also indirectly say what you've seen on value.

And then second or third question, I lost track myself. On the tablet price increases, which you have talked about for some time now and you still hope -- now you're pushing your hooks into 2024. So if you look at likelihood, are you still -- do you still have the same likelihood or probability of getting these price increases through? Or do you see them -- perceive them as being lower now than you thought a couple of quarters ago?

[Peter Halling, executive]

So maybe -- thank you for the question, Martin. I can start answering the last one. Negotiations are still ongoing, and we are basically awaiting the outcome. So I don't think it's for us to speculate in terms of whether it's going one way or the other. So no changes there. And maybe, Claus, you want to comment on the SCIT questions?

[Claus Solje, executive]

Yes. Let's see if I got your first and second and third in the right order here, but your SCIT question that I understand in Q3 in Europe was quite high. And what is the pricing impact there. It is correct that we have seen a pricing impact in Q3 for the SCIT part of Europe, helping us something we have talked to earlier that it was. That will not help us in Q4 because this was already part of the base in Q4 last year. So this quarter here, we have been held a bit so for the 21% on the SCIT in Q3. There is some percentage points there that have been held by the pricing. Otherwise, I would say it's a mix between value and volume increase on the SCIT part have actually quite a strong Q3 on the SCIT part in Europe here that we saw. Did I answer all of them otherwise please come back.

[Martin Parkhoi, analyst]

Yes. My question was in Q4, so I just [ misunderstood ], I think you answered it. It was just that -- it was -- it is fully into the comparison numbers in Q4. So the price impact was already from the beginning of Q4 last year.

[Claus Solje, executive]

Correct. That's correct.

[Martin Parkhoi, analyst]

And then maybe I can -- while you have you online, and it seems like the second time around, we can actually ask more than 2 questions. So just on the -- on the more than 10% initiation, it's a little bit big number more than 10%. So I guess when you see more, then we are not up to 15%, but it has been more than just 10%.

[Peter Halling, executive]

Go ahead, Claus.

[Claus Solje, executive]

Thanks, Martin, for those extra questions. I would like to stick to a number more than 10%. We are seeing a good momentum, but it is only our Q3. We are seeing it is still only 1 month of our initiation season that we have in Q3. The next 3 months here of Q4 is, of course, the most important one. So it's too early for us to really come out with where we are and where would like to see Q4 also before we kind of give a full year status next time around. But -- so that's why for now, we are sticking to the more than 10%.

[Operator]

[Operator Instructions] Our next question will come from Peter Sehested of ABG.

[Unknown Analyst]

Thank you for taking my follow-up. It actually pertains to your comments regarding investments, potential investments in the U.S. to market, the chosen indication. Now I will provocatively saying that is waste of money because to get to children, you have to circumvent the doctor, I have to go to the parents and to get to the parent, you have to initiate a large marketing campaign that could be very costly. So my question is simply an answer to this provocative question. And furthermore, what does your marketing research say about sort of the decision-making process to get the doctors to prescribe [indiscernible].

[Peter Halling, executive]

Okay. Thank you, Peter. I can start out by answering the first part, and maybe, Claus, you can take the second part of the question. Bottom line is, I think ALK has done some extensive homework in terms of how to approach the U.S. market, and overall, how to approach children indications. And I think our commercial organization are well suited to execute on that piece. Obviously, proof is in the pudding. So we'll need to prove over the coming years that this is the right approach. But there are no changes to the strategy, and we'll still pursue also those parts of the allergy space. So maybe, Claus, you want to comment on the second part.

[Claus Solje, executive]

Yes. I can say -- I think it's a fair challenge, and I think you are right on and we have a history with U.S. in ALK, and I think we should respect that. So you're nailing the question here. I think that you can say the change has been that before when we -- our sales channels was through the allergist -- that turned out to be a very difficult strategy for us with the different structures and paying models in U.S. Now with the children indications and then actually going through the children doctors instead, we believe is the right way to do it. At least we believe that's our window of opportunity now. And that's what we can add, that's what we can do and chase. So that's why we are still believing in the U.S. case there. We have already, of course, interesting things ongoing over there, where we are testing things out. And we believe that we can use that sales channel to get to the children.

Yes, you're correct that going into the U.S. market demands more investments, but we will do it step by step. And when we are unlocking the sales and the doors to the doctors, then we will also invest more and more.

[Unknown Analyst]

My third question, in line the others will probably be something in the vicinity of what sort of investments are we talking about initially and sort of the time line if you're prepared to get that sort of comment at this point in time.

[Peter Halling, executive]

I think it's premature, Peter to answer that. But obviously, as we progress, we'll be happy to talk about it. So I think this is too early to go into that for the coming years.

[Unknown Analyst]

Okay. It was also just sort of -- sort of bake something into the numbers already to be [ conservatively thinking ].

[Peter Halling, executive]

Okay. It's a good test. Thank you.

[Operator]

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

[Per Plotnikof, executive]

Thank you very much, operator. And before we end the call, please have a look at Slide #11. We have a couple of roadshow events lined up and more events will be made available on our Investor site as we go forward. And obviously, we hope to see you at one of those events. In addition, we expect first readouts from the Phase I trial in peanut around year-end, and we will publish the annual report on February 8. As always, you are welcome to call us if you have additional questions. And with this, I will wish you all a good day and end today's session. Goodbye.

[Operator]

The conference has now concluded. Thank you for attending today's presentation, and you may now disconnect.