ALK-Abelló A/S (CPH:ALK.B)
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Earnings Call: Q2 2024

Aug 23, 2024

Per Plotnikof
Head of Investor Relations, ALK-Abelló

Hello, everyone, and welcome to this presentation of ALK's Q2 results. Thank you all for joining us, and let's turn to slide number two with an intro to the agenda and the speakers. My name is Per Plotnikof. I'm Head of Investor Relations. With me today are CEO Peter Halling, and CFO Claus Steensen Sørlie . We'll first share a couple of highlights from the quarter, and then we will take a closer look at the markets, product trends, and financials. We'll also provide an update on the Allergy+ strategy implementation before we cover the full year outlook. As usual, we'll end the presentation with a Q&A session, and to get started, I'll now hand you over to Peter on slide number three.

Peter Halling
CEO, ALK-Abelló

Thank you, Per, and thank you all for joining this call. The current performance is strong, and Q2 sales, particularly in Europe, exceeded the forecast that we gave back in May. This will have a positive carryover effect into the second half, which is why we have further upgraded the full year revenue and earnings outlook on 21st of June. Today, based on our current performance and the outlook for the remainder of the year, we have upgraded both our revenue and earnings outlook. We'll come back to this later. Looking at Q2, Q2 revenue was up 21% organically on double-digit growth in all AIT vaccine categories: tablets and injection-based SCIT, and sublingual drops. Tablets stood out with 32% sales growth globally and 35% growth in Europe, but in all fairness, also measured against a weak quarter last year.

Priority number one in recent quarters has been to solidify the momentum in European sales tablets, tablet sales after the difficult first half of 2023, and these efforts are on track. We are pleased that we managed to further build on the momentum in Europe in Q2, and as Claus will elaborate on in a short while, this has been a strong quarter. Based on prudent cost management and capital allocation, we've succeeded in raising the EBIT margin by 10 % points year on year, from 9% to 19%. The EBIT result include 38 million DKK in one-off cost to optimization and reprioritization initiatives, in line with our new Allergy+ strategy. Looking at the strategy, the implementation continues well and is well underway. Allergy+ is where it needs to be.

Focus in Q2 has been on initiatives to extend the respiratory tablets reach to new patients and on initiatives to optimize ALK's business platform, enable scale, and free up resources to support growth and future scale. Now, we are looking into a busy second half, where we expect business activity to be roughly on par with first half. Still, we remain confident that we'll be able to deliver a robust full year growth across all sales regions and all product groups. We'll further detail this in the presentation shortly, but first, I'll hand it over to you, Claus, and the Q2 market trends on slide four.

Claus Steensen Sørlie
CFO, ALK-Abelló

Thank you, Peter. Before going through all our regions and product groups, let's dive into European sales. Our European sales were up 25% on double-digit growth in all product lines. Particularly, sales of tablets and SLIT-drops exceeded expectations. Tablet sales grew by 35% against a soft quarter last year. Growth was driven by higher volumes linked to the robust inflow of new patients in the past year, both in the pollen segments and in the house dust mite segment. Growth was also positively influenced by pricing and rebate adjustments, including the reversal of the 2023 mandatory rebate increase in Germany, which added more than 2% points to growth. In addition, Q2 sales continue to be less influenced by trading patterns at wholesalers than in 2023.

In Germany, Europe's largest AIT market, both tablet sales and SCIT sales grew by high double digits, as we benefited from competitive dynamics and the accelerated market transitions towards evidence-based registered AIT products. Court rulings previously confirmed that private payers may reject reimbursement for non-registered AIT products, and this is now impacting the clinical practice to the benefit of tablets and our SCIT products. This trend is also supported by the recent recommendations from the German Allergist Associations, who published a wide list of registered products recommended to be used for new patients. France, Europe's second largest AIT market, also did well. Both sales of tablets and SCIT drops grew by double digits after higher patient inflow to both existing and new doctors. In France, we have seen a more positive market development emerging recently.

Part of this is likely linked to higher burden of disease and patient activation last year, as well as increased clinical capacity at certain doctor offices, meaning that they are able to treat more patients. We have also seen good effects from our commercial activities, such as medical events, prescriber expansion, and so on. Performance was also good in the Nordic and Benelux countries, where we benefited from the focused sales and marketing initiatives which we developed last year. We have been able to activate more payers and more patients, and we have also broadened the prescriber base and managed to increase the depth with current AIT prescribers. Finally, we continue to work with doctors to extend the initiation season to mitigate conflicts with common respiratory infections and other external factors during winter initiation season.

We saw small improvements outside the main initiation season last year, and the upcoming initiation season will show if we are tracking towards further improvements in this area. Let's now turn to slide five, please, and the regional performance overview for the second quarter. Europe accounted for 65% of total revenue in Q2, while the remainder was evenly split between North America and international market. Total sales in North America grew by 3%, while tablet sales were up 29%, driven in part by volume growth, in part by higher realized selling prices in the U.S. sales of SCIT bulk extracts increased by 4%. It has been impacted by previous loss of a customer, but growth is improving compared to first quarter.

Sales of other products, so our business of diagnostics, PRE-PEN, and life science, fell short of expectations with a 9% decrease, primarily due to PRE-PEN. Revenue from international market was up 32% and positively influenced by timing of product shipments to both China and Japan, the two largest markets in this region. In-market sales in both countries continue to grow by double digits, underpinning the commercial potential in these markets. Now let's turn to the product categories on slide six. Global tablet sales increased by 32% on strong double-digit growth in all sales regions. Tablets accounted for 52% of total revenue in the quarter. Global sales of SCIT and SLIT-drops grew by 16% after robust growth for both SCIT and SLIT-drops in Europe, combined with increasing SCIT shipments to China.

Finally, sales of other products and services, including Jext, increased modestly by 1%. Global Jext sales grew by 17%, as market supply continued to normalize after last year's shortfall in supply. But this progress was offset by a weak performance in other products in North America, especially the PRE-PEN. The integration of the PRE-PEN operation progresses as planned. However, sales continue to be impacted by stocking at wholesalers prior to ALK's acquisition in January. Let's now move on to slide seven and the six months financials. Half-year revenue were up 15% in local currencies to DKK 2.7 billion. Growth was mainly driven by tablet sales, particularly in Europe. A gross profit of close to DKK 1.8 billion yield a gross margin of 64.4%, an improvement of close to 1% point.

This improvement was due to changes in the sales mix, volume growth, improved pricing, product production efficiencies, and the reversal of last year's rebate increase in Germany. In line with our expectations, these factors were partly offset by inflationary pressures on input cost. When including one-off restructuring cost in Q2, total capacity costs were unchanged at DKK 1.2 billion. R&D expenses were down 20% after the completion of last year clinical trials of the respiratory tablets. Sales and marketing expenses were up 7%, while admin costs increased 8%, and this increase was mainly due to cost related to the Allergy+ strategy process. Optimizations and savings contributed to the overall cost development, and it remains a priority to lower the capacity cost to revenue ratio.

The operating profit, EBIT, was DKK 580 million, an improvement of 84% in local currencies and 78% in Danish kroner. The EBIT margin increased from 14% to 21%, and when excluding the DKK 38 million one-off restructuring cost, the underlying margin was 23%, a clear indication that we are moving in the right direction towards the 25% margin target in 2025. Finally, free cash flow improved to plus DKK 272 million, as higher earnings offset changes in working capital and investments, including the PRE-PEN acquisition. So all in all, a good set of results, the best half-year performance so far. I now hand it back to Peter for an update on the Allergy+ strategy on slide eight.

Peter Halling
CEO, ALK-Abelló

Perfect. Thank you, Claus. As you recall, we presented the Allergy+ strategy at a very well-attended Capital Markets Day back in June, and I'd just like to state, on behalf of the entire ALK team, we really thank you for your participation and truly appreciate meeting so many of you out here. Now, to briefly recap, the strategy aims to further strengthen ALK's global leadership in respiratory AIT, establish leading positions in food allergy and anaphylaxis, and on top, pursue new innovations to address unmet adjacent allergic conditions. As a company, we want to provide life-changing solutions for millions of people living with allergy, and by doing so, grow revenue by at least 10% on average until 2028 and beyond, in other words, throughout the strategy period.

We continue to aim for an EBIT margin of around 25% next year, in 2025, after which earnings improvement beyond the 25% margin will be reinvested in initiatives to bolster growth and profitability after 2028. The new strategy has four main pillars, as illustrated here on the slide. We will prioritize and focus our commercial activities and footprint to further strengthen ALK's leadership. Tablets remain key to growth as we extend their reach to new patient groups and increase prescription depth and breadth among healthcare professionals. Now, to help even more people with allergy, we will continue to innovate and expand the R&D pipeline in a meaningful and balanced way. We'll maximize the value of existing core products and diversify the portfolio into allergic diseases with the potential to become new growth levers in the longer run for ALK.

To reduce complexity and maintain our competitiveness, we will continue to optimize operations, adjust the cost base, and reduce structural complexities across the value chain. Further, we'll invest in infrastructure and continue to improve processes to be able to scale and grow the business. Moreover, we'll also explore commercial corporations and innovation partnerships to maximize reach and speed up market adoption of our products. All of this is underpinned by a commitment to cultivate and invest in our people and organization, as well to conducting business in a sustainable way. Slide nine, please. Now, as I said in the beginning, the implementation of the strategy is well underway, and we prioritize initiatives with the largest potential to generate strong returns and the greatest impact for patients and prescribers.

Just a few highlights and examples: A key initiative is to extend the tablet offering to new patient groups, and particularly help children early on with allergies and prevent the disease from impairing their lives. Our regulatory filings for children's use of tablets have now been accepted for review by all authorities in Europe, the U.S., and Canada. Subject to approvals, the house dust mite tablet could become available for children in Europe from late 2024 and in North America in 2025 . Likewise, and subject to approval, the tree tablet could become available for children and adolescents in Europe and Canada in 2025 . The children's approval or the children's approvals are important catalysts for ALK's long-term growth. Launch preparations continue as planned, with particular focus on building disease awareness and mobilizing the allergy community.

In Q2, we started reallocating resources to high-impact markets, particularly in Northern and Central Europe. We're stepping up our presence in markets with sustainable demand for AIT and strong endorsement of evidence-based AIT from regulators, payers, and prescribers. Now, unfortunately, not everything has moved in our way. In China, we withdrew our application for the house dust mite tablet in June. Recent dialogue with the authorities in China has confirmed that additional clinical data in Chinese patients will be required to obtain approval. We're now evaluating the best approach to this market, and we will be adapting our plans and activities to a new launch timeline for the house dust mite tablet. We still work under the assumption that it will be possible to secure a Chinese approval within the strategy period. Moreover, we continue to see progress on the important Japanese market.

Our partner, Torii, is working to increase capacity in the production of active ingredients for the cedar pollen tablet, one or more initiatives to overcome temporary capacity limitations given the high demand in Japan. This capacity is, by the way, expected to come online towards the end of 2025. Now, moving to new product opportunities. The development programs in anaphylaxis and food allergy continue as planned. We have intensified our business development activities, and we're screening new administration forms in anaphylaxis with the aim of establishing a future-proof portfolio of solutions. Finally, we have reorganized parts of our operations. Other initiatives are in the making to enable scale, further reduce complexity, and optimize our cost base. For example, this includes investments in infrastructure, and as previously stated, we expect optimization and prioritization initiatives to free up around DKK 250 million in 2025.

Now, roughly half of these savings will be reinvested in growth initiatives, and roughly half will support our 25 in 25 earnings ambition. We continue to see good progress and are very happy and satisfied with the execution. Finally, we have a comprehensive plan lined up for the second half year, and we have some very important decisions ahead of us. We look forward to keeping you posted on future progress, and with this, let's move on to the full year outlook, and over to you, Claus, on slide ten.

Claus Steensen Sørlie
CFO, ALK-Abelló

Thanks, Peter. As we mentioned early, initially, we have upgraded the full year outlook. We now see 14-16% top line growth this year, versus 12-15% previously. At the same time, we raised the EBIT margin guidance to 19-21% from 18-20% previously. Let me take you through the key assumptions. We expect Europe to lead the way with robust double-digit sales growth, while we project mid to high single-digit growth for North America and international market. Tablets will be key to growth across regions. Combined SCIT or SLIT-drop sales are projected to grow by high single digits, while other products are expected to deliver mid to high single-digit growth. When looking at the second half of 2024 , we expect the strong underlying momentum to continue. Growth is expected to be roughly on par with first half.

There are a few swing factors which may influence the second half of this year. The upcoming high season for new patients initiations. We assume that the initiation season in Europe will be a rather normal one based on our leading indicators. That is significantly better than the poor 2022-2023 season, but not as good as the exceptionally good 2023-2024 season. However, I also need to emphasize that this is still too early for us to be very firm on this assumption. In first half of this year in Europe, we had tailwind from certain competitive dynamics, and we need to see if this persists in second half.

And then finally, we have the usual items, namely phasing of product shipments to Japan and China, which will be impacted by an upcoming renewal of our import license in China, which means we will not be able to ship products during that period. And then finally, beside that, we have tougher comparables for EU tablets. We expect lower tablet growth in US, and we are being cautious regarding the parallel trade patterns in Europe. Moving to earnings, the EBIT outlook is also raised by 1% point to 19%-21% from previous 18%-20%, as a consequence of the revised top-line guidance. In addition to increased sales growth, we continue to see scale benefits, optimization, and lower R&D costs. Guidance includes one-off restructuring cost of around 60 million DKK.

The gross margin is expected to improve by around 1% point, despite inflationary pressure in product supply. The capacity cost to revenue ratio is expected to improve as we capitalize on existing platforms to enhance efficiencies, benefit from optimization efforts, and reduced R&D spend. R&D expenses are still expected to decline to around 10% of the expected revenue, while single-digit increases are assumed for both sales, marketing expenses, and administrative costs. So to sum up, we expect 2024 to mark the sixth consecutive year of revenue growth and improved earnings, fully in line with our long-term financial ambitions. With this, I would like to hand it back to Per on slide 11.

Per Plotnikof
Head of Investor Relations, ALK-Abelló

Thank you, Peter, and thank you, Claus, and this concludes the main part of our presentation, and we will now move to the Q&A session, and I'll kindly ask the operator to go ahead. Thank you.

Operator

Thank you. We will now begin the question and answer session. To ask a question, you may press Star, then One on your touchtone phone. If you are using a speakerphone, please pick up your handset before pressing the keys. If at any time your question has been addressed and you would like to withdraw your question, please press Star, then Two. At this time, we will pause momentarily to assemble our roster. The first question of the day comes from Michael Novod with Nordea. Please go ahead.

Michael Novod
Senior Equity Research Analyst, Nordea Markets

Thank you very much. A couple of questions. So firstly, on the peanut allergy tablet and more around the sort of investments into a larger scale program. So I know there's a lot of tailwinds in 24 that may not repeat in 25, but if you sort of see a new traction in your business and grow sort of beyond the expectations, is there a way that you can accelerate the peanut program with additional funds if you still do 25% EBIT margin, but on a higher sales base, make a broader program, potentially also advance plans within tree nut or adjacent food allergies? Just to get a feeling for how you're willing to invest further, should your financial numbers also look better going forward.

Secondly, on China, could you try to detail a bit more around the scope and size of a potential clinical program in China for the house dust mite tablet, and how this will also be sort of impacting potential costs in the coming years?

Claus Steensen Sørlie
CFO, ALK-Abelló

Okay, great. Thanks, Michael. So let me see if I can answer both. Let me start with the peanut. Obviously, as you know, we are waiting new data, and that is expected second half this year. And depending on that, we'll make choices around do we try to accelerate further? Do we do anything different around the study? As you may recall, we have already said that we would accelerate on the third phase of the study, so that was important to us. So that's already we made a choice to invest further. Future investments depends actually less on how we perform overall, as long as we deliver on what we said from the get-go and our long-term ambition.

But obviously, if something comes up that looks very, very interesting and relevant, we'll make a choice around whether we try to accelerate further. But again, we need to see data first. That's kind of the starting point. So that's the best answer I can give you on that one, and unfortunately, it's a little bit the same on China. We are currently in dialogue with the Chinese authorities. We are in a positive dialogue with the Chinese authorities, and as we also stated, our ambition is to set up a study that meets the expectations of the Chinese authorities and ours. It will not be a full-scale clinical study, that much I can say, but the scope and the size of it depends on the dialogue.

Ideally, and this is also the expectation we operate under, is that that study will be finalized, and we will be able to launch within the strategy period, meaning before end of 2028. That said, in terms of the investments, et cetera, into it, it is embedded in our guidance, so this will not impact at this stage, and that's not the expectation that it will impact our guidance, going forward. So I think those are the best answers I can give you, and jump in, Plotnikof , if anything, to add.

Michael Novod
Senior Equity Research Analyst, Nordea Markets

That's fine. Thanks.

Operator

The next question comes from Martin Parkhøi from SEB. Please go ahead.

Martin Parkhøi
Healthcare Analyst, SEB

Yes, good afternoon. Martin from SEB, and first, about the tablet growth in Europe, you did 21% organic growth overall for the group, and according to my calculations, you did around 11% points of that was coming from, which means more than half was coming from EU tablet growth. But can you maybe split Europe down a little bit, say, okay, how dependent are you on single market, for example, like, like Germany, how much is that actually of the growth in EU? And then I have to talk about the margin again, and maybe that's for Claus, and you would say, because now you have lifted your margin guidance by 2% point in basically two months.

I guess it is driven by the higher top line, so it's difficult to understand that. It's not like that you have got cost savings earlier to reach the 25%. I guess it's because of leverage and top line. So in reality, you must have even more money to invest next year if we're assuming a normal policy and a normal growth in 2025.

Claus Steensen Sørlie
CFO, ALK-Abelló

Thanks, Martin, for the two questions. Let me start by the tablet growth in Europe and try to break a little bit down, and then I will come back to the margin improvements. We are, of course, as you know, not commenting on each of the individual market, but there's no doubt that the usual suspects is, of course, as you know, Germany and the Nordic market. But what we have seen lately over the last quarters is that we start to see a very good broad-based growth across many markets in Europe, and it's actually across those that we see it. So this time, we are not dependent on one or two markets that are actually growing. It's actually across many of them.

And if I have to point to one market, you have followed us for a long time and know that France has been a little bit of a pain point for us over the years, with quite low growth, actually some years zero growth, and we haven't really been able to drive that up. What we have seen the last couple of quarters, and that's also helping us, and that's also part of why we are increasing the guidance, is actually that France has started to show very nice momentum, both within the tablet business but also within the drops business.

There are a few arguments for that, as I said, related to doctors and capacity and so on, and we, of course, also believe some of the initiatives that we have been driving in France and invested into, that this is now starting to pay off, so it both tablets and SLIT drops across many different markets, but also France now adding in together with the other ones.

Martin Parkhøi
Healthcare Analyst, SEB

Parallel trade.

Claus Steensen Sørlie
CFO, ALK-Abelló

Yeah, and then, of course, this time with Europe, it's important just to notice this about the parallel trade, and maybe we'll come and discuss it later, but that's, of course, also helping us across the different markets here, and we are a little bit cautious about how that will impact us in the second half, but then maybe we can come back to that. Then you talk about the margin and the improvements that you're seeing there. You are right that, of course, a big part of that is coming from the top line going down into our bottom line. It is coming a lot from the tablet business. You know, our margins is highest on our tablet business, and we have the infrastructure and the production set up already today related to the tablet business.

So every time we can increase and invest into more tablets, growth on the top line, we have kind of the infrastructure set up to have a large part of that, dropping down into the bottom line and thereby impacting positively the EBIT. So it is coming from there. We are also seeing some improvements in our cost base. As you know, we have the program around the DKK 250 million that will free up next year, but we have, as you know, started some of the layoffs and rounds for people leaving us, and that is, of course, starting also to provide some few savings. But most of the impact on the EBIT is coming from the increased top line and especially the tablets.

Martin Parkhøi
Healthcare Analyst, SEB

... I hope that you-

Operator

The next question comes from Ben Jackson with Jefferies. Please go ahead.

Benjamin Jackson
Equity Research Analyst, Jefferies LLC

Hi. Yes, thank you for the question. It's Ben Jackson from Jefferies. Just to follow up on the China opportunity, is this something now that is more likely to be considered with a partner, and that's the best way forward with that? And then secondly, just on the guidance, I appreciate you've already touched on this, but perhaps if we can just get a little bit more clarity around it. On both, what are your assumptions for this upcoming initiation season? Is the assumption here that this is a more normal season, and if the numbers are continuing being strong and continuing to improve, that actually that's a positive upside on what you're expecting?

And then, secondly, also just a bit more clarity about the parallel trade and how that could impact numbers into the second half? Thank you.

Peter Halling
CEO, ALK-Abelló

Okay. So thanks, Ben. Let me start out, and then, Claus, you can jump in along the way. So if we take China specifically, we've made no decisions yet in terms of how we will move forward. But we have been successful in China. We have a sales organization and a commercial team out there that has done well with a growing business. And obviously, we've been further looking into how we could use that organization to launch ACARIZAX. Currently, and depending on the timing of the study, the timing of when we can launch, we will make choices around how do we best take this to market.

So you still have to be a little bit patient with us as we consider it, but we are looking obviously at our option space in that sense. And do remember that we already have a partnership in China with Grand Pharma on the adrenaline, so that's not necessarily a negative. So all in all, we are not set on anything, but we do have a great team in China who's been doing well. Then on the guidance, and Claus, you can also jump in here, but just a few highlights from my side. So basically, as Claus also said early on, a couple of factors that has helped us and provided more clarity going forward.

We've had some additional tailwind that wasn't expected, and that became clear in terms of the potential clouds on pricing, so Germany, France, some of those places where we always have the risk of changes, it's been clear that it will not impact us this year to the extent that one could fear, so that's a portion. Secondly, on the pollen initiation season, as you recall, a couple of years ago, the season 2022, 2023 was a tough season and extremely tough on the company. That hit us in the beginning of 2023. Now, 2023, 2024 season last year was an extremely strong and solid season that has and is obviously enabling and helping us this year.

Now, what we're looking into, and it's still too early to say due to the delay of data and due to the fact that we are in the midst of the high season in August, September, but the early indications we've had and the leading indicators, and it's still data that we're working on, indicates that it will be what we would call a normal season. Primarily, helping us a bit on both house dust mites and also on the grass side, but maybe a little weaker than what we otherwise see on the tree side. So all in all, it looks like a better season, but just before you take this as that's the way it's gonna end, please bear in mind that we are in the midst of it.

So maybe, Claus, I'll just add one last comment on my side on this. That's the competitive situation in Europe. Again, we've seen that we've gotten some tailwind because other competitors have had a more difficult time supplying, and that has helped us, and it will also help us to a larger extent than we previously forecasted. So that is a reason. This is not necessarily something that's gonna help us into 2025. A lot of things can change around that. So that's obviously always something that we keep an eye on. So maybe, Claus, a few words on the guidance and in addition to what is said in the parallel trade.

Claus Steensen Sørlie
CFO, ALK-Abelló

Yeah, I can do that. Thanks, Peter, and thanks, Ben, for the question. I think Peter covered very well, you know, the season part and also the competitive situation that we have. Besides that, you could mention for the second half of the year, the parallel trade. It is a thing that we, especially during 2023, learned a lot about and how it was impacting our growth at that point in time. Here in 2024, we have seen a less impact of that, actually quite low impact of parallel trade, meaning that we don't see a big effect on the top line from that.

We would expect that impact, a positive impact, you can say, would be less in the second half of the year, and that's why we are a little bit cautious related to that one. Then we also have a few other things that could mention. Please remember last year, when you compare to the second half of the year, this is where we started to see a significant growth in the tablets in Europe. So the comparable for last year in 2023 was very tough compared to this half year. So that's also going to help. And then we have the phasing of China and Japan. That's always a little bit of a, for us, which quarters are impacting.

But remember, we have a license renewal in China in the second half of the year, which means we can't really ship as much product to China in that period until that import license has been renewed. It's not something that is going to impact the underlying business, but our top line expected it will, and that will also have an impact and take a bit down on the sales in second half. So these dynamics is why we believe that the guidance we have now set with the realized 15% is quite fair and accurate for the last remainder part of the year.

Peter Halling
CEO, ALK-Abelló

So and maybe one last thing to just boil it down. Another way of looking at the 15% is, we have a solid underlying volume growth of around 10%, and then the other 5% points came from pricing, competitive dynamics, et cetera. So we believe that the volume growth supports our long-term ambition, and then obviously, we have factors playing in to the mix along the way, ups and downs, positives and negatives. I hope that answers, Ben.

Benjamin Jackson
Equity Research Analyst, Jefferies LLC

Yeah, very useful. Thank you.

Operator

The next question comes from Sushila Hernandez with Bank Van Lanschot Kempen. Please go ahead.

Sushila Hernandez
Equity Research Analyst, Van Lanschot Kempen

Yes, thank you for taking my questions. On the new initiations, I appreciate you already commenting on this, but could you elaborate on the high number of new patients starting treatment over the past year, in particular in Q2, what were the main drivers? And the second question on the PRE-PEN, when do you expect the stocking effect for the PRE-PEN to subside? Thank you.

Peter Halling
CEO, ALK-Abelló

All right. Let me see. So the first question on the high number of patients, then, Per, you had a comment specifically on ACARIZAX, so jump in.

Per Plotnikof
Head of Investor Relations, ALK-Abelló

Yeah. So if we looked into Q2, I mean, we still got a little bit of help on new patient initiations from ACARIZAX, and again, very much linked to France, linked to Central Europe, Germany also. So those were the main drive in Q2, which normally it's more of a low season for new treatment starts, but of course, ACARIZAX treating house dust mite, which is perennial allergy, so a little bit of a different pattern there.

Peter Halling
CEO, ALK-Abelló

Yeah. Good. And then, just on your question around PRE-PEN. So, we've been working with PRE-PEN for years, obviously, and then acquired it late last year. What happened, and that has caught us a bit by surprise, was that there was a lot of stocking and also more stocking at the doctors than what we had initially expected, and that is basically now an inventory that is being worked down outside of the company. We expect that to start normalizing in the second part of the year, but the exact timing is always difficult to estimate. It's a small product, but nevertheless, it's an interesting product for the company, and that's also why we chose to acquire it.

So I think that's the best answer I can provide you on PRE-PEN.

Sushila Hernandez
Equity Research Analyst, Van Lanschot Kempen

Thank you.

Operator

As a reminder, if you would like to ask a question, please press star and one to join the question queue. The next question comes from Peter Sehested with ABG. Please go ahead.

Peter Sehested
Senior Research Analyst, ABG

Yes, thank you for taking my questions. I have two, maybe two and a half. Number one, now that Neffy is on the U.S. market, I guess that product's in-market performance will, at some point in time, shape what you're doing within anaphylaxis. Could you just elaborate a bit on what particularly are you looking for, and what sort of observations are the most important in sort of judging affecting impacting your decision on the anaphylaxis portfolio? Secondly, on children, any learnings? I mean, you were working on markets, preparing the markets, but anything new that you have learned since the Capital Markets Day?

Following on or adding to this, I know we shouldn't be too optimistic on the US and keep estimates down. I think we all have that, but nevertheless, I can still remember a conversation I had with a US physician some years back, where that person said, "You know, as the situation is right now, you guys have no chance, but you come in with something for children that works, you know, that's a total game changer," because, you know, a US parent, irrespectively of what, you know, allergists, they will never, you know, sort of block their children from being cured. So, just your thought on that particular dynamic initiative come through.

And then I have a question on the season, but it might already been asked, but nevertheless, splitting the season into sort of the, you know, the weather impacts and the things that you are doing a normal season, coupled with your activities in the market, which seem to have been better over the past years, would suggest that a normal season coupled with that would give you a better season compared to what you've seen historically. So just your comment on that sort of, you know, way of thinking.

Peter Halling
CEO, ALK-Abelló

Yeah. Thanks, Peter. Let me start out, and I like the fact that you kind of bring us around in all over the company here, and b ut good questions. So let's start out by Neffy. This is the nasal product from ARS Pharma that got a label approval in the U.S. and obviously are intending to go global on the anaphylaxis or in the anaphylaxis market. So, first and foremost, I think that what we've seen is they've done well, they got a good label. Be reminded that we are not present in the U.S. with our anaphylaxis portfolio.

But what I think is important to say is what we are looking for is obviously we're looking for adoption potential. Is this products and not necessarily Neffy, but more broadly coming into the market that can help accelerate the growth of the market. Also, that can help expand the market, not only in the U.S., but across. And then on our side, obviously, would this be products that are enabling us to complement or build synergies with our portfolio. So those are some of the key things. We believe that given our position in the value chain or with the prescribers, that we have something to offer on the sales and marketing side, and also in terms of our setup.

And then final comment on that one, whether we see nasal, film or auto-injectors, we actually believe that the combination of products and new innovation being brought into the market will expand the market, and hence, we actually believe that a lot of these products can coexist together. So all in all, we think it's actually great that U.S. has gotten the nice label for Neffy, and we believe it's gonna be a market expansion. So for us, we continue to observe and make our choices, and then in the coming period, we'll be clear in terms of where we're heading. So that's that one.

Then I think the question on the US, and correct me if I'm wrong, Peter, here, but basically what you were asking, you said, "Okay, so what are you seeing in the US that makes you believe that something could change versus the past?" And you kind of gave a little bit your answer yourself. Tablets, and tablets for children could be something that allergists and pediatricians obviously would find interesting. We agree. I think it's important. I don't think it's simple that all allergists will adapt and go with tablets because we have them for children.

But we do hope that obviously there's gonna be an uptake, and that said, you also have to remember, we have nice growth in the U.S. on the tablet side, but you still have the dilemma for the prescribers around where they make money on the products. Moreover, I think it's important to say not only tablets for children indications on the existing types of allergies we have today, but bear in mind that by the end of the 2020s, we'll have also the peanut tablet, if everything goes well, and that should also be an enabler for the U.S. market, including allergists, because they don't have solutions or solid solutions today. So I think that's what I can say, and I otherwise, correct me if I didn't get your answer right, and then the last one was on weather and the weather patterns and the spread.

I think the best answer is obviously we are working, as you know, to work with doctors, prescribers, and KOLs to expand and enable more people to get in earlier and get treatment year-round, rather than in certain portions of the season, for instance, around August, September, so if we can continue to enable that capacity and build it, then obviously the seasons will be of less importance, but there is a caveat, and the caveat is obviously, if you don't have an extreme, when you don't have the extreme seasons, then people are also less observant of their allergies.

And there's also, obviously, if you have a weak season where people don't get the normal signs of allergy, then obviously there will be less interest in getting treated because it takes time and resources to do so. So that's always the challenge around that piece. So I think the answer is, we're hoping that we'll be less dependent on the weather, but we also realize that's still part of the game for the common, and that's also gonna be part of it for foreseeable future. So I don't know if I got around to all the questions here.

Peter Sehested
Senior Research Analyst, ABG

Yeah, I think you did. So my sort of the season was, you know, since you're performing better in the market with your initiatives, I guess you are potentially more robust to a, what you would call a normal season, meteorologically speaking, I would say.

Peter Halling
CEO, ALK-Abelló

Yes.

Peter Sehested
Senior Research Analyst, ABG

All in all, we should expect you to perform better now under a normal, let's say, meteorological season. That's sort of my point I was getting to.

Peter Halling
CEO, ALK-Abelló

But I think it's, it might be premature. I mean, when we talked about it last time, we said we're putting in initiatives, and we had some last year when the organization worked, and we had early signs. I think it's premature to say that we've successfully expanded capacity, but you're right in the sense that if we are successful, and hopefully we will become more successful, we'll be less dependent on the seasons like in the past. So when you get hit by a virus in the fall or in the early fall, then hopefully we'll be able to still get more patients through than when it's only August, September. So from that standpoint, you're right.

Peter Sehested
Senior Research Analyst, ABG

That was what I was looking for. Thank you very much.

Per Plotnikof
Head of Investor Relations, ALK-Abelló

One more question, and then we'll need to round off for the day. Please go ahead.

Operator

The last question today comes from Jesper Ilsøe with Carnegie. Please go ahead.

Jesper Ilsøe
Research Analyst, DNB Carnegie

Thanks for taking my question. I have one on pricing. So just thanks for the comments on 10% volume growth and 5% price and other things here in H1 2024. Just to understand the sort of pricing dynamics going forward, also considering the price wins you've had here in 2024. So can you just remind us if there are any visible upcoming price decisions expected in the next, say, 12 to 24 months? And also how we should, in general, look and expect the price development to look in the coming years. Is it best to assume sort of a stable price development in the coming years? And in that perspective, just remind us of your latest thoughts about this German rebate staying at the current 24 levels or whether it will return again.

I know it's difficult to predict, but any feedback there will be welcome. Thank you.

Per Plotnikof
Head of Investor Relations, ALK-Abelló

Yeah, absolutely. Claus, jump in.

Claus Steensen Sørlie
CFO, ALK-Abelló

Yeah. Thanks. Thank you, Jesper, for the question. I think you almost answered yourself with the word stable. I also think you can say that's how we see it, and when we are making our plans for this year, next year, then we are planning with a stable pricing environment. Then, of course, what is that? Well, that is that in some markets we will see some, hopefully some price increases on some of our products linked to inflation and so on, and maybe there will be some price decreases in other markets, so going a little bit up and down. But overall, I would say stable.

When you then ask to kind of the bigger swing factors, for example, the German rebates and so on, it could also be a French price increase-decrease or situation. We don't see anything right now coming up, but of course, I'm saying that, you know, with the expectation that it's difficult to forecast what's going to happen. We don't see anything, but of course, we are following it very closely. We know that in Germany they're talking about it. The politicians and authorities are talking about it. They miss some money in their budget, so maybe they will come up with the idea that why do not pharma add more to it? And they know they can implement it quite easy.

But right now, we don't expect it, and if it's coming this year, it will be with a little impact and more impact in 25. So right now, no major pricing impact out there. But of course, we are monitoring, and when we know something or see something, we will let you know. So I think the word stable pricing is probably the best we have for now.

Jesper Ilsøe
Research Analyst, DNB Carnegie

Very clear. Thanks so much.

Operator

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

Per Plotnikof
Head of Investor Relations, ALK-Abelló

Thank you very much, operator, and thank you all for the good question. And before we end the call, please take a look at the slide, slide number 12, with upcoming news and events, and we hope to see you at one of these events. And as always, you are most welcome to contact us if you have additional question. With this, we will end today's session, and we wish you all a good day. Goodbye.

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