ALK-Abelló A/S (ALKB) Earnings Call Transcript

Hello, everyone, and welcome to this presentation of ALK's Q2 results and the revised full year outlook. Thank you all for joining us. Let's turn to Slide #2 with an intro to the agenda and the speakers. My name is Per Plotnikof, I'm Head of Investor Relations. And with me today are CEO, Peter Halling; and CFO, Claus Steensen Solje. We will first be sharing a couple of highlights from Q2 followed by a closer look at market and product trends as well as half year financials. We will then provide an update on recent progresses and on the pediatric agenda, our neffy partnership and other strategic priorities before we present the updated full year outlook. As usual, we will end the presentation with a Q&A session. And to get started, I'll hand over to Peter, Slide 3 for the highlights. Please go ahead, Peter.

Thank you, Per, and thank you all for joining this call. Commercial execution of the key strategic initiatives, including the children launches, was on top of our agenda in Q2. These initiatives started contributing to sales growth in Q2, although they are still all in early stage. The initiatives have come off to a good start and this bodes well for ALK's abilities to deliver sustained profitable growth going forward. In Q2, the ongoing roll out of our ACARIZAX tablet for children with house dust mite tablet is progressing well and have continued to exceed expectations. We also started the launch of ITULAZAX tablet for children and adolescents with tree pollen allergy in European markets and Canada to secure the tablets are available for the coming pollen initiation season. Moreover, we launched the EURneffy adrenaline spray in Germany, the first EU market entry. Additional launches are lined up for the second half year, including the important U.K. market, where EURneffy was recently approved. Across markets, the initial feedback from stakeholders is very encouraging. In the U.S., we entered a co-promotion deal with ARS Pharma, enabling us to establish a new pediatric sales force to promote both neffy and in the future ALK's respiratory tablets. Around 60 salespeople have now been onboarded, trained and are fully deployed in the field. Marketing expansion also continued in other geographies. I'll detail this later. Q2 results exceeded expectations. Back in Q1, we expected revenue growth to soften temporarily due to lower shipments to international markets and destocking at European tablet wholesalers. Instead, we saw over 12% revenue growth driven by adrenaline auto-injectors and an improved momentum for the ACARIZAX tablet in the house dust mite AIT market in Europe. Q2 earnings improved by 41% in local currencies to DKK 375 million, yielding an EBIT margin of 25%. Progress was driven by sales growth, gross margin improvements and last year's optimization and prioritization initiatives, which generated savings of more than DKK 300 million throughout 2025. These savings are allowing us to pursue strategic priorities more vigorously this year without jeopardizing earnings improvements. We also expect the improved sales momentum to continue into the second half year. Consequently, we upgraded the full year outlook last week. We now expect full year revenue to grow by 12% to 14%, while we maintain the EBIT margin outlook as we intend to allocate additional funds to growth initiatives. We remain optimistic about the remainder of the year despite global unrest and turmoil from tariff wars. With this intro, I'll hand it over to you, Claus, and the market trends on Slide 4.

Thank you, Peter. Let's take a closer look at the performance in our sales regions. Our main region, Europe, reported 13% growth. Revenue exceeded our expectations driven by better-than-expected sales of anaphylaxis products and tablets. Tablet sales in Europe increased by 17% on broad-based growth across countries. We saw a reduced impact from price and rebate adjustments meaning that growth was mainly driven by the plus 10% increase in new patients during the 2024-'25 initiation season and growth was reinforced by a steady inflow of new ACARIZAX patients in France, Germany, Eastern Europe and other markets. The new pediatric indication for ACARIZAX contributed positively to revenue growth while the contribution from the new ITULAZAX children approvals was modest, reflecting the early stage of the ongoing launches. Q2 tablet sales growth was similar to Q1, even though the impact from inventory buildups at wholesalers in markets like Germany and France is estimated to have declined in Q2. This highlights the improved momentum for tablets in Europe, and we expect this momentum to continue into the second half year. Combined sales of SCIT and SLIT-drops grew by 1%. SLIT-drops sales continued to increase in France, where SCIT sales fell short of expectations with a modest decrease. This decrease was partly due to fewer new patients and partly due to a reduced impact from price and rebate adjustments compared to previous years. Sales of other products were up by 51% in Europe, led by a 62% growth in the anaphylaxis portfolio. Sales of our adrenaline auto-injector text benefited from strong commercial execution and favorable market dynamics, including supply issues from our competitors. Revenue also included minor EURneffy revenue from pipeline filling ahead of the launch in Germany. Revenue in North America increased by 17%. The U.S. sales continue to bounce back from last year's stagnation as we benefited from a range of initiatives to rebuild growth across product lines. The tablet business in Canada also did well with growth rates exceeding those in the U.S.A. Tablet growth in North America grew by 32%. The new pediatric indication for ODACTRA, our house dust mite tablet in the U.S. led to a higher uptake, especially among allergists and to a minor extent, new pediatric prescribers. The new pediatric indications also contributed to growth in Canada. North America -- North American sales of SCIT bulk increased by 2%, while sales of other products increased by 23%. Moving to international markets. Revenue grew modestly by 1%, reflected easing of product shipments to China. After the recent renewal of ALK's import license, we've assumed SCIT shipment to China in Q2, but shipments as expected, were at a lower level than last year, so SCIT revenue in the region decreased by 20%. But Chinese in-market sales of SCIT continued to grow by double digits based on existing wholesaler inventories. Tablet revenue in international market was up by 9%. The primary market, Japan delivered low double-digit revenue growth from royalties and shipments, although capacity constraints still prevent our partner, Torii from fully meeting demand. We expect Torii to start operations of the new API manufacturing facility in Q3 with a view to roughly doubling capacity and then incrementally increase market supply of CEDARCURE tablets. Now let's turn to the product lines on Slide 5. Tablet revenue was up 16% on good performance in all 3 sales regions. Growth was predominantly driven by higher volumes linked to more patients. Revenue from SCIT and SLIT-drops was down 1%. Performance was impacted by fewer shipments to China and the decline in European SCIT sales. These factors were then partly offset by growing SLIT-drops sales in France and increasing SCIT bulk sales in North America. Global revenue from other products increased by 30% to DKK 250 million. The anaphylaxis portfolio led the way with 56% growth. Jext did very well in Europe, and neffy also contributed, including a minor estimated cost reimbursement from ARS Pharma related to the new co-promotion agreement in the U.S. We also saw a good performance from other products in the U.S., including PRE-PEN and life science products. After these quarterly updates, let's move to the half year results on Slide 6. Revenue was up 12% in local currencies and exceeded DKK 3 billion. Top line growth mainly reflected growth in tablet and Jext sales. The gross profit of DKK 2 billion yielded a gross margin of 66%, an improvement of 2 percentage points. The increased mirrored volume growth, changes to the sales mix and various production efficiencies, partly offset by higher input costs. Capacity costs decreased by 1% in local currencies to DKK 1,167 million, following last year's optimization and privatization initiatives where we downsized operations in certain markets and further adjusted the organization in China. R&D expense grew by 8%, while other capacity cost declined so that the overall capacity cost to revenue ratio decreased by 5 percentage points to 38%. However, please also bear in mind that some phasing of activities contributed to this development. In the second half of the year, we plan to increase our spending linked to the key product launches. The operating profit EBIT was up 46% in local currencies to DKK 844 million, raising the EBIT margin from 21% to 28% the first half year despite a little currency headwind. Progress was driven by higher sales, gross margin improvement and lower capacity costs. No one-off costs to optimization efforts were recognized opposite to last year where one-offs amounted to DKK 38 million. Free cash flow doubled to DKK 546 million as higher earnings offset planned changes in working capital and investments to build up tablet production and upgrade legacy production. Some of the cash generated was used to repay loans, bringing the net debt-to-EBITDA ratio down to 0.1x, highlighting that we have -- that we do not have any debt at this stage. The cash flow also included USD 5 million in milestone payment to ARS Pharma related to the first commercial sales of EURneffy. All in all, the best half year performance so far. So with this, back to you, Peter, and Slide 7, for an update on the strategy execution.

Thanks, Claus. Let me kick off the strategy section by providing some insight into the ongoing launches of our respiratory tablets for children. I'll start with the house dust mite tablet branded ACARIZAX in Europe and ODACTRA in North America. At the end of Q2, the house dust mite tablet for children had been launched in 10 European markets, 2 North American markets served directly by ALK as well as 3 Southeast Asian markets served by our partner, Abbott. Market access processes are well underway in other countries. So additional market launches are planned for the second half year and the rollout continues into 2026. In Q2, we also started to roll out the tree pollen tablet named ITULAZAX, tablet for young children and adolescents aged 5 to 17. This tablet is approved by 17 EU countries and Switzerland, Canada and the U.K., and it's launched in 9 of these markets. Our first goal is to build a solid prescriber base ahead of the main initiation season, which typically starts in late Q3. Over the next 6 to 10 months, we plan to launch ACARIZAX and ITULAZAX in 10 additional EU and non-EU markets, depending on the local market access conclusions. So far, the key indicators continue to exceed expectations. This includes endorsement from key opinion leaders, number of confirmed doctor visits, number of prescribers and the number of patients starting the treatment. In June, more than 2,000 prescribers were estimated to have prescribed the tablets for children in markets served directly by ALK. It is still early days, but the market response is encouraging. We expect to see a steady growth in the patient and prescriber base in the second half year. As the rollout of the 2 key tablets, primarily focused on our existing tablet prescribers, we are also working on mobilizing new prescribers, not at least in the pediatric field and pushing the halo effects from having a complete tablet portfolio, which covers both the common respiratory allergies and is now indicated for all age groups in relevant markets. Attracting more patients and opening the doors to more prescribers is key for our goal to make the pediatric segment an important catalyst for ALK's continued long-term growth. Slide 8, please. If we move to anaphylaxis and our efforts to commercialize EURneffy, the first and only approved nasal spray for emergency treatment of acute allergic reactions. We launched EURneffy in Germany in June, the first market entry since the EU approval. Furthermore, we secured regulatory approval in U.K., currently Europe's and the U.K.'s largest anaphylaxis market that we plan to launch later this year once local market access has been settled. We are also in an ongoing regulatory review in Canada, where we expect an outcome around year-end. Going forward, we see the Germany, the U.K. and Canada as cornerstones for neffy. Market access negotiations progress as planned in the other EU countries and our price premium relative to an auto-injector has so far been secured in Germany and Slovenia, the first 2 markets to settle price and reimbursement. The initial response to our prelaunch and launch activities is very encouraging, and the medical community takes a substantial interest in this new treatment concept. However, I also want to emphasize that we do expect it will take some time to build the sales momentum and change long-standing auto-injector prescription patterns. Our market building activities, including working with key opinion leaders, including guideline authors, presentations at scientific conferences, scientific papers, digital engagement with HCPs, methods to engage new customer groups as well as efforts to activate patients. Besides the U.K., EU and Canada, we also intend to make neffy available in other territories covered by our license agreements with ARS Pharma. We are planning up to 15 additional European launches over the next 6 to 12 months and we are also looking into making the product available in a number of international markets outside of Europe and North America. Moreover, we have applied for approval of a 1 milligram version of the spray in Europe, which will be aimed at small children. In Q2, we entered into an additional agreement with ARS Pharma to co-promote neffy to more than 9,000 U.S. pediatricians. The agreement has allowed us to build a dedicated U.S. pediatric sales force in a balanced way. Balanced way meaning performance-based cost and revenue sharing with ARS. This sales force is now fully deployed in the field and fully focused on delivering results for Q3 and onwards. Slide 9, please. The Q2 report provides a detailed account of the execution of the allergy strategy. So let me just highlight a few additional hotspots starting with the ongoing market expansion in select geographies. As Claus mentioned, our Japanese partner, Torii expects to start operations at a new API manufacturing facility in Q3 with a view of incrementally increasing market supply of CEDARCURE tablets. As announced in May, Torii has been acquired and will become a subsidiary of Shionogi. Consequently, the new owner is in the process of dissolving its current partnership with one of our competitors. The new owner will focus exclusively on ALK's tablets going forward, meaning that all activities going forward are planned, including the Phase III registration starting with ACARIZAX tablet, which is now recruiting patients. We've also seen positive progress in the U.K. where ITULAZAX tablet is about to become accessible through the public NHS system in England, Wales and Northern Ireland following a recent endorsement from the influential NICE Institute. In Q1, ACARIZAX was the first AIT product to be recommended by NICE and we intend to make submissions to extend the tablet's approval to improve the children indication and to make GRAZAX widely available for general reimbursement in the U.K. The tablet's submission to the public health care systems represent a paradigm shift in the market, a market where AIT is significantly underutilized. Our combination of tablets and anaphylaxis products will hopefully lead to sizable synergies. However, building this market remains a long-haul effort. In China, we still expect to initiate the Phase III bridging study for ACARIZAX in Q3, while in the U.S. the new pediatric sales force is medium-term expected to provide attractive synergies for the respiratory tablet portfolio. The new sales force or the addition of new salespeople will also prepare ALK for entry into food allergy. Moving to food allergy. We completed patient recruitment for the Phase II trial of the peanut allergy tablet ahead of trial. 150 subjects were enrolled in this trial, which is expected to report top line data in the first half of 2026. Subsequently, we are planning to move this program into Phase III. And in the wider allergy space, work continues to develop treatments for adjacent disease areas through in-house innovation, licensing deals and partnerships. Our partner, ARS Pharma, is currently recruiting patients for a Phase IIb trial to investigate neffy and its efficacy in acute flares associated with chronic spontaneous urticaria, also known as CSU. The neffy indication would be a very good fit in our portfolio. Our agreement with ARS Pharma grants ALK exclusive rights on this and on any other new indications with the product. So all in all, we are well on track with our strategy, and we look forward to sharing additional progress. With this, I'll hand it back to you, Claus, and the outlook on Slide 10.

Thank you, Peter. Last week, on August 12, we upgraded the full year revenue outlook. We now expect revenue to grow by 12% to 14%, up from the previous outlook of 9% to 13% growth. The upgrade was prompted by better-than-expected performance in Q2 and an improved outlook for the remainder of the year. We see a good momentum for tablets and anaphylaxis products in Europe which will continue into the second half year, supported by solid growth in North American tablet sales. Moreover, the new outlook reflects reduced market risk in Europe for the remainder of 2025 although we believe these are still key risks for next year. The higher-than-expected revenue gives us opportunities to further invest in growth initiatives without jeopardizing our very important 25% in '25 ambition. We will take advantage of these opportunities. Capacity costs will therefore be higher in the second half year than in the first half year, and we still expect the full year EBIT margin to be 25%. Let me take you through some of the key assumptions. We expect full year tablet sales to grow by solid double digits, driven by more patients, including children and adolescents. Children are now expected to contribute with more than 1 percentage point of the total growth. We still expect a reduced impact from pricing and rebate adjustments compared to last year. Combined SCIT and SLIT-drops sales are still projected to grow by single digits. Better uptake of SLIT-drops in France will be partly offset by lower SCIT sales in Europe. Timing of SCIT shipments in China may impact growth in international markets in the second half. Sales of other products are projected to grow by solid double digits driven by the anaphylaxis portfolio. EURneffy related revenue is expected to start contributing to the growth in the second half year, including a minor contribution from a co-promotion deal in the U.S.A. The Trump Administration's new tariff agreements with the EU and other countries are expected to be manageable. In first half year, more than 80% of our revenue in the U.S.A. comes from products that are sourced locally, produced locally and sold in a closed local ecosystem. Hence, our exposure to the new tariffs is expected to be limited. The gross margin is projected to further improve. Higher revenue mix changes and efficiencies will drive the margin upwards, but the improvements will be somewhat offset by higher input costs and the impact of the EURneffy in-licensing deal. R&D expenses are expected to increase by double digit, but will remain at around 10% of the planned revenue. Sales, marketing and administration costs are projected to increase by single digits, while no one-off cost optimizations are planned for. We believe this new outlook adequately balances risk and upside. Hence, we expect 2025 to mark the seventh consecutive year of revenue growth and improved earnings fully in line with our long-term financial targets. With this, I would like to hand it back to Per and Slide 11.

Thank you, Claus, and thank you, Peter. We will now move into the Q&A session, and I kindly ask the operator to go ahead.

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

So 3 questions from my side here. So if we just start with the European tablets growth. So what part of -- how much of this is actually driving the guidance upgrade? You had, I think it was around EUR 50 million or 1 percentage point growth contribution included in the initial guidance. So can you maybe just add a bit of color on the expected full year impact here? And then second question, just moving to Japan. So with the H1 phasing, we have seen, should we still expect a step up here in the second half especially with the supply constraints to be sold in the third quarter and maybe also some impact from Shionogi with the takeover of Torii and divestment of the tablet from Stallergenes. And then last question regarding the U.S. or North America. So a very strong quarter for tablets. That, of course, as you mentioned, some stockpiling in Canada for ODACTRA. But are you also seeing similar, you could say, early traction with the pediatricians as you do in Europe for ODACTRA. I mean, is that the case also for the U.S. market in particular?

Thanks, Thomas. Peter speaking. I'll hand it over to Claus on the tablets in Europe, but just start out by saying it's the majority obviously. But Claus, you want to add a bit more flavor on this, and I'll take Japan and North America.

Yes. I can do that. And I think you actually answered it very well here and very quickly, Peter, because you're right. If you look at the EU tablet, of course, that is, as we have said, that's a big part of the increase in our guidance upgrade. So the midpoint, as you can see, is kind of moved by the 2 percentage points. And a large part of that is the tablets driving that on a company basis. We have seen now that the children launches will be approximately a bit more than 1%, adding to the -- of the total growth coming in. So it is actually a big part of this. It's important to understand, we're only talking about ACARIZAX, the house dust mite where we have included that because we can see in the numbers that is starting to take up the ITULAZAX, the tablet for children, we had not changed our outlook on right now, it's still the plans that we had when we did the Q1 and that remains until we start to see some indications on that one. So related to the upgrade, it's a big part coming from the EU tablet and here by ACARIZAX also for children.

On Japan, the question around Torii capacity and then Shionogi. So the capacity is coming online. As you know, this is a product set up where the APIs need to go through kind of the usual production cycles. So we don't expect a significant contribution yet, but we do expect that this is obviously going to be a step in the right direction. So we haven't added a lot on top. It also needs to start up. But we do expect this will obviously improve the supply situation in Japan going forward, which is very positive as well. Those tablets have been restricted by supplier, and this should alleviate some of that. To your question around Shionogi. Shionogi and Torii are in a grace period, if you wish. So basically in the interim between the full acquisition by Shionogi, which is expected to fall in place in the beginning -- in the early beginning of next year, January, February. This is as much as we know. In between Torii continues as is. And then Shionogi will take over and also do the transition from the existing products to the Torii portfolio, meaning ours. So we expect that to move forward as planned next year. North America, you're right. We are happy with what we've seen. I think it's still premature to say that its ongoing and continued momentum. We are also coming from a low place in terms of the norms. But obviously, we are pleased to see that the allergists in the U.S. and the allergists in Canada and pediatricians are really starting to embrace ODACTRA, especially for children. So all in all, that is obviously positive, but something we hope will be sustained in the coming quarters as well. And then we are hoping going forward that the inclusion of the salespeople that we hired for neffy, also bringing in tablets to the portfolio there can be helping the business on the tablet side. So all in all, a good start in North America, early days, but positive.

Your next question comes from Michael Novod with Nordea.

A few questions from my side as well. So first of all on SCIT and SLIT. You try to sort of give a framework for how you see this business going forward in terms of growth or no growth in SCIT, SLIT, that would be very interesting. And then also on EURneffy, as you said during the prepared remarks, we should remember that this is sort of a gradual launch, but can you try to sort of detail a bit more when you see sort of the strongest traction starting to come, how long time do you believe it takes for sort of convincing prescribers to go for this product compared to Jext and other products? I'll stop with that.

Okay. Thanks, Michael. And let me start out here on both and then Claus and Per can jump in. So I think it's important to say when we look at the SCIT and SLIT and as who you are talking about, when we actually see a cannibalization of injectable sales with the tablets moving forward, there's always a risk. But we have different segments. So a large portion of our SCIT portfolio today is also Venom products and other indications than the traditional major allergies like tree pollen grass and obviously, house dust mite. But in those specific areas, we will see some cannibalization, but we believe it's the right way of moving forward. This is also where we believe we stand strong from a competitive standpoint. In the U.S., like Venom and like many of the other indications where we don't have tablets, we continue to focus on this. And France specifically, you have to know is a different market, the second biggest in Europe, but a different market where the drops are playing a big role. And when we actually see the combination of drops and tablets are working well due to the expansion at the clinics. So the short answer is there will be a very limited or limited effect outside of the major indications and the major ones, we still come from a somewhat lower number. So all in all, we are positive that it's a market expansion game that we're looking at another cannibalization game going forward. Then on the EURneffy and the gradual launch. I think there's 2 ways -- a number of ways are looking at this, but I'll split it for you in this. There's obviously the market expansion in terms of new patients coming in. And there, it will obviously be important to have educated the prescribers in terms of the product, so they understand how it works, et cetera. And that's a key thing, and that is ongoing for us. So that's one aspect. The other aspect is what we would call the switching. So basically, people who are already prescribed on a pen that leads to then switch and some of this is automated. So typically, what you see here in the back-to-school season is that there will be a lot of automatic renewals. And that is where we need to position neffy as the opportunity or option going forward. When will that happen? That's a very good question. I think we are obviously learning from what we're seeing in the U.S., that's a great way of doing it. But it will take some time, and we expect that obviously to start picking up throughout '26. But we are still early days, and we still have a lot to learn. So I'm a little careful in terms of giving you exact viewpoints on that. But we do believe there's a pickup. I can say, we have very encouraging support from the community, including doctors, KOLs, patient organizations, et cetera, around the product stronger than what we've seen otherwise for any other product. But moving from there on to then having the switching happening is still the next step, and that's what we need to see in the coming quarters. So stay tuned, we'll offer more information as we learn. But I think we are off to a decent start there.

Your next question comes from Ben Jackson with Jefferies.

Great. Two from me. Firstly, is it possible just to quantify the tailwinds that you believe that you've got from the competitor supply issues for Jext. And then as we think forward, are you assuming any of this carries through into the second half of the year, either that the competitor supply issues continuing or keeping the market share that you've gained as a result of that? What are the assumptions are built in there? And could it be great? And then secondly, could see that the peanut recruitment was ahead of schedule. Anything to read into this at all? I suspect not, but any additional color that you're hearing would be great. And then also, does this affect any of your financial budgeting with regards to either this year or next year?

Thanks, Ben. Claus will you take a Jext?

I will do that. Thanks, Ben. Thanks for the question. The Jext part, you're right that we were helped here, especially in Q2 by some of our competitors that could not deliver, especially one. And of course, we were capitalizing on that, and we did everything we can to capitalize on that from a business perspective, of course, and also a patient perspective, something like this happens. We, of course, move fast and see what we can do both to patients, but also to take some extra market share and to make the sales out there. I have to say there was already an underlying strong growth uptake in the first half year. So I think that's a positive, but it was now reinforced by this one competitor that could not deliver. Related -- regarding your question about if there's a carryover to second half of the year, Ben, we do not expect that. And the reason is actually that the competitor is now back and starting to deliver already in Q2. So that they should be able to serve some of our patients. Of course, we will still do what we can to maintain some of the patients. But still, since this is a system where basically our patient is going down to the doctor and the prescription is already locked into a certain product then it will just carry it to now the competitive product going forward. But of course, we will do whatever we can to focus on this and see if we can keep the market share. But we don't see anything in second half from this competitor being disrupted.