Hello, and welcome to this presentation of ALK's Q3 results and full-year outlook. Thank you all for joining us.

Let's turn to slide number two with the agenda and speakers. My name is Per Plotnikof.

I'm Head of Investor Relations. With me today are CEO Peter Halling and CFO Claus Steensen Sølje.

We'll first share a couple of quarterly highlights followed by a closer look at markets, products, and financials. We'll detail some of our strategic focus areas before we cover the new full-year outlook.

As usual, we'll end the presentation with a Q&A session. To get us started, I'll hand over to Peter and slide number three.

Please go ahead, Peter.

Thank you, Per. Thank you all for joining this call.

Q3 was characterized by a strong focus on execution of our key strategic initiatives: the pediatric tablet launches, a new partnership for China, and the commercialization of neffy. Market responses to the tablet launches for children are truly encouraging.

The rollout of the house dust mite tablet, ACARIZAX, for children progressed well and continued to contribute to the inflow of new patients in Q3. Moreover, ACARIZAX is attracting new prescribers, not least amongst pediatricians, suggesting that the children indications have the potential to expand ALK's addressable markets.

We also saw encouraging early uptake of the tree tablet, ITULAZAX, for children and adolescents. In China, we entered into a partnership with Grand Pharma, a strong local Chinese partner, committed to accelerating the uptake of ALK's house dust mite allergy products.

Grand Pharma has already taken over sales and marketing of Alutard, our SCIT product, and skin prick tests. The partnership is projected to become margin accretive to ALK mid-term, largely driven by cost savings in China combined with the income from product supply as well as upfront and milestone payments of up to 1.3 billion DKK.

A couple of weeks ago, we introduced EURneffy, the adrenaline spray, in the UK, Europe's and ALK's largest anaphylaxis market. Meanwhile, EURneffy is gaining traction in Germany, our first market entry.

The product was launched in July. Other market introductions are imminent.

While still very early days, market response so far confirms the product's long-term potential despite long-standing clinical practices favoring traditional anaphylaxis products, which we will need to work carefully with. Financial results in Q3 were strong, with double-digit growth across sales regions and product groups.

Revenue grew by 18% and was higher than expected, while earnings were up 41% in local currencies, yielding an EBIT margin of 28%. Based on the Q3 result and the outlook for Q4, especially in Europe, we have adjusted the full-year outlook.

Revenue is now expected to grow 13% to 15%, while the EBIT margin is expected to increase to approximately 26%. Now, we'll detail all of this later, but first, I'll hand it over to you, Claus, and slide four.

Thank you, Peter. Let's take a closer look at our three sales regions' performance.

Our main region, Europe, reported 18% growth. The revenue growth was driven by sales of tablets, anaphylaxis products, and SLIT-drops.

Q3 growth was to a minor extent positively influenced by some phasing of sales between Q3 and Q4. Tablet sales was up 23% on a broad-based growth across brands and markets.

Let me also point out that we did observe that wholesalers carry slightly higher inventories, potentially indicating slightly increasing trading patterns, which is natural in a launch situation like we are in with the children tablets right now. Growth of the tablet business in Europe was first and foremost linked to higher volumes driven by more patients on treatment, whereas prices and rebate adjustments had a much less impact.

Volume growth was powered by new patients with the highest contribution coming from our house dust mite, ACARIZAX, and the tree pollen, ITULAZAX, patients. The children indications for ACARIZAX contributed positively across markets, while the recent launch of ITULAZAX now has started to contribute to the patient inflow, especially in the key German market.

Combined sales of SCIT and SLIT-drops were up 7% in Europe. SLIT-drops sales continued to benefit from an expansion of patient and prescriber bases in France.

SCIT sales picked up temporarily due to one-off changes to patient supply patterns, but the underlying growth was still hampered by fewer patients starting up on our legacy products. Sales of other products grew by 39% in Europe, led by 44% growth in the anaphylaxis portfolio.

Sales of Jext auto-injectors were driven by strong commercial execution, including newly won tenders in Southern European markets as a consequence of recent supply issues at a competitor. Revenue also included a modest contribution from EURneffy.

If we turn to North America, then revenue increased by 20%. The US business continued to bounce back from last year stagnancy, while the Canadian business sustained its growth.

Tablet sales in North America grew by 20%. The pediatric indication for ODACTRA continued to drive a higher uptake among allergists and to a minor extent new pediatric prescribers in the US.

Growth in Canada was higher, driven by continued demand and volume growth, combined with some destocking at wholesalers. North American sales of SCIT bulk increased by 1%, while sales of other products were up 41% on higher volumes and better pricing of our life science products.

Revenue from other products also included, as planned, a modest cost reimbursement from ARS Pharmaceuticals related to our co-promotion agreement for neffy in the US. Revenue in international markets was up 14% due to the increased SCIT shipment to China.

We resumed shipments to China in Q2 after the renewal of ALK's import license, and these continued in Q3 so that SCIT revenue in this region increased by 43%. In-market sales in China continued to grow by double digits.

Tablet revenue in international markets was down 4% after decreasing shipments to minor markets, while revenue from the primary market, Japan, was unchanged. In-market sales in Japan grew by double digits, although capacity constraints still prevented our partner, Torii, from fully meeting demand for the CEDARCURE tablets.

Torii's new API manufacturing facility is now becoming fully operational, but it will still take some time before the extra capacity flows through the manufacturing cycle. Now, let's turn to a brief update on the product lines on slide five.

Global tablet revenue was up 17% on solid growth in Europe and North America, predominantly driven by higher volumes. All brands grew by double digits except for CEDARCURE, which saw modest growth as I just touched on.

Combined revenue from SCIT and SLIT-drops increased by 11% after progress in all sales regions. The main growth driver were the resumption of SCIT shipments to China and the very solid growth in SLIT-drops in our big market, France.

Revenue from other products increased by 42%, and the anaphylaxis portfolio was at the front with 68% growth. Jext did very well across markets, and EURneffy also contributed to growth at this early stage of the commercial rollout.

In conclusion, strong growth in all product lines and in all sales regions in Q3. After these quarterly updates, let's move to the year-to-date results on slide six.

Revenue for the first nine months of 2025 exceeded 4.5 billion Danish kroner after 14% growth in local currencies. Growth mainly echo higher sales of tablets and anaphylaxis products.

A gross profit of 3 billion DKK yield a gross margin of 67%, a big increase of 3 percentage points. This improvements reflected higher volumes, changes to the sales mix, where especially European tablet sales contributed to the positive development.

We also saw good production efficiencies coming through. The gross margin was also indirectly helped by the muted growth in tablet sales in international markets, which holds lower margins as a consequence of the partnership with Torii.

In addition, we currently only have a minor contribution from the EURneffy business, which also holds lower gross margins compared to our European tablets. Capacity cost increased by 5% to 1.8 billion Danish kroner.

At the Q2 earnings call in August, after we upgraded the full-year outlook, we said that we planned to take advantage of the higher-than-expected revenue to further invest in various growth initiatives. We started doing so in Q3, where R&D expenses were up 16%, while sales and marketing cost increased 3%.

Still, the cost increase was lower than planned, meaning that you should expect higher capacity cost in Q4. I'll come back to that later.

The operating profit, EBIT, improved by 44% in local currencies to almost 1.3 billion Danish kroner, raising the EBIT margin from 22% to 28%. The EBIT margin progressed due to higher sales, gross margin improvements, and modest increase in capacity cost.

Moreover, no one-off cost or optimizations were recognized, opposite to last year, where one-offs amounted to 49 million Danish kroner. Free cash flow almost doubled to 836 million Danish kroner.

Higher earnings offset investment to scale up tablet production, upgrade legacy production, and expand the anaphylaxis operation. We continued to use some of the cash generated to repay our debt.

Cash flow from financing was minus 736 million. This means our net debt to EBITDA ratio right now is down to minus 0.1, i.e., we do not have any debt at this stage.

All in all, a solid set of results, which further solidified ALK's financial position and confirmed that we are on track to deliver on our long-term financial targets. With this, I would like to hand it back to you, Peter, and slide seven for a status on our key strategic initiatives.

Thank you, Claus. Let me start by providing some additional insight into the important launches of our respiratory tablets for children.

In September, the house dust mite tablet, ACARIZAX, was made available for children in 21 markets, including 14 markets served by ALK and seven partner markets. The more recent rollout of the tree tablet, ITULAZAX, for children and adolescents now covers 11 markets, with two more launches scheduled for Q4.

Far, key indicators continue to perform well across metrics, including new patients, interactions with caregivers, doctor visits, sales, prescribers, etc. In September, around 3,000 unique prescribers in markets served directly by ALK were estimated to have prescribed at least one of the two tablets for children.

The prescriber base includes new pediatricians, indicating that we're gradually expanding markets. While it is still early days, the market response is encouraging.

If we are capable of sustaining these trends, the pediatric indications will become a very important contributor to ALK's future growth for many years. Within respiratory allergy, things also progressed in China.

In China, we initiated a bridging trial to facilitate the approval of ACARIZAX. Recruitment of around 300 subjects is progressing well, and the trial is set to complete around '26-'27 turn of the year, around January '27.

Subject to approval, ACARIZAX could be launched in mainland China in '28, where the tablet will be added to the portfolio marketed by our new partner, Grand Pharma. Also a brief update on Japan, where our partner, Torii, has become a subsidiary of Shionogi.

Shionogi has expressed its commitment to our tablet portfolio and sees it as a core business pillar going forward. The ongoing Phase 3 trial with GRAZAX in Japan continues as planned.

Now, let's move to anaphylaxis and the commercialization of neffy, the nasal spray for emergency treatment of acute allergic reactions, branded EURneffy in Europe. We launched EURneffy in Germany in June, and the market share has increased steadily since.

While it is encouraging for longer-term potential of the product, it is still early days. A couple of weeks ago, EURneffy was also introduced in the UK.

We now cover two of three key markets. The third market is Canada, where the regulatory review is still pending, but progressing as planned.

Additional introductions like in Denmark are imminent, and further launches are lined up for '26. In all markets where pricing and reimbursements have been settled, EURneffy has secured a price premium relative to adrenaline auto-injectors.

We now also have real-world evidence from the US supporting that neffy's effectiveness is consistent with the one of adrenaline auto-injectors. Neffy has advantages over auto-injectors in the form of user-friendliness, longer shelf life, and temperature stability.

Despite these positive achievements, it will most likely take some time to secure market access and change long-standing clinical practices, such as automated renewal of prescriptions for traditional anaphylaxis products. That said, we are encouraged by the first indications that we've seen in Germany and the positive feedback we're getting from the medical community to this new treatment.

We will build on this positive feedback, work to change the habits and behaviors, and furthermore allocate resources to pursue opportunities in other channels, including airlines and schools, to name a few. Moving to food allergy.

The US FDA has granted a fast track designation to our peanut development program. This allows ALK to benefit from more frequent interactions with the FDA, and it highlights that the agency acknowledges that food allergy represents a significant unmet medical need.

We expect this to support the timeline for the program. The ongoing Phase 2 trial with the peanut tablet in North America is on track to report topline data in the first half of '26, most likely towards Q2.

At the same time, the planning for Phase 3 is ongoing. To sum up, then we, in general, see good progress across all disease areas.

With this, I'll hand it back to you, Claus, and slide eight.

Thank you, Peter. Let's end with the outlook for the year.

As Peter said previously, we adjusted the full-year outlook slightly. We are now looking at 13% to 15% revenue growth in local currencies versus the previous outlook of 12% to 14% growth.

The new outlook is based on a few things: double-digit growth in tablet sales driven by more patients and prescribers; single-digit growth in combined SCIT and SLIT-drops sales; double-digit growth in sales of other products, particular anaphylaxis. During the spring, we indicated that the children indications and neffy launches would contribute with around 1 percentage point of the growth in 2025.

Based on what we have seen over the past quarter, we now believe that these two items will contribute with 2% to 3% percentage points of the anticipated revenue growth. In parallel, we adjusted the EBIT margin outlook to around 26%, up from the 25% we expected before.

This correspond to an improvement of 6 percentage points fueled by sales growth, gross margin improvements, and the optimizations. Also, we don't expect any one-offs this year opposite to last year, where one-offs cost total 75 million DKK.

The new outlook implies that total revenue is projected to grow by around 13% to 18% in Q4. We expect the strong underlying momentum for tablets to continue into Q4 with a strong inflow of new patients during the ongoing initiation season in Europe.

However, please notice that Q4 growth in tablet sales is expected at a slightly lower level than in the first nine months due to phasing of product shipments to Japan and potentially inventory fluctuation at European wholesalers. The Q4 EBIT margin is expected to be lower than in the first nine months, reflecting what I mentioned before.

We are increasingly allocating funds to growth initiatives like the children launches, neffy, and the Phase 2 peanut trial. This includes new hires, which will lead to increase capacity cost in Q4.

We will obviously carry these costs into 2026, but we will do so without jeopardizing our financial ambitions. The 25% EBIT margin target for the next years is still our expectation.

We believe the new outlook for 2025 adequately balances risk and upsides. Hence, we expect 2025 to mark the seventh consecutive year of revenue growth and improved earnings, fully in line with ALK's long-term financial ambitions.

With this, I would like to hand it back to Per and slide nine.

Thank you, Claus, and thank you, Peter. We'll now turn to the Q&A session.

I kindly ask the operator to go ahead, please.

Yes, thank you very much. I have a couple of three questions here.

First, it's just if we look at your new patients starting here in '25. You are stating that it's well above 10% with the tablet in '25.

What if you exclude the impact from the pediatric indications, would you still say that you are still above that 10% of new adults starting for this initiation season? Then second question, just on gross margin, and of course now we're looking at 2 percentage points here year-over-year.

That's of course quite impressive. How much is structural improvements, less scrapping and yields and compared to what you see here from the product mix?

Also, how should we think about gross margin improvements in '26? Will this then be flat or also because we are facing maybe some headwinds on product mix with Japan, China, and neffy here?

Any color would be appreciated. Then my final question here for now, just on the R&D spend.

What is driving this extreme back-end-loaded R&D spend that was implied for the Q4 in order to get to that 10%? Maybe also in regards to your midterm guidance or target, going for that 10% in '26, is that still achievable with quite strong top-line performance that you have here?

Because I guess most additional investments you can plug in is related to sales and marketing. Any color here on how you are trying to keep that 25% EBIT would be appreciated.

Thank you.

Thanks, Thomas. This is Peter.

Let me just start out with your patient question, and Claus, maybe you can jump in on the gross margin, and one of us can take the R&D spend as well. Just on the adults, we expect approximately 10%.

Do keep in mind that it's still initiation season, we're still kind of seeing the intake of patients and obviously learning, but we expect it to be around the 10%. Then to your first part of the question, yes, we saw, as we also stated, a positive surprise in terms of the intake of children.

I think it's important to say that part of the reason for why we have been a bit conservative around this has been we had obviously an assumption that there could be this famous ketchup effect where you see a big inflow with people on waiting, but so far, it has continued, especially with what we've seen on house dust mite. That has obviously been positive and driving it upwards.

That's the patient side. On the gross margin?

Claus here. Let me take that one.

Thomas, it's a good question, and you're completely right that we are seeing a better gross margin improvement than what we had expected. That's also why we have been able to lifting the outlook for the EBIT.

To your question about what is it actually that are driving it, most of those 2% are actually, if you look at it, coming from the volume mix of products here. We're simply selling products with a higher margin.

Then you can say, what about the yield and the scrap and variance improvements and so on? They are also there, but it's important to understand that we also have the inflation increase on our production inputs into the manufacturing area.

Actually, as they stand right now, then we expect for this year that the increase in inflation to our manufacturing input is being counterbalanced by the improvements in the variances and the scrap and so on. These two are actually outweighing each other, and that means that the approximately 2% net that you then see is coming from the product mix, selling more tablets to a higher margin.

If you look into '26 on that one, we are not guiding on '26 right now. That's a bit early.

We will do that in February. I can put a bit more flavor on it.

You're right that when we come with a improvements, as you can say here, around a 2%, then remember we have normally said that we would like to increase the gross margin a 0.5% to 1% year-on-year. That's how we try to improve the gross margin year-on-year.

Of course, with such a significant increase in '25, then there could be some headwind next year. You're also pointing actually to the right reasons, and that's exactly our partner markets.

Next year, you will see an increase in shipments to Torii for lower margin products. You will see now our partnership with Grand Pharma that also has a lower margin, and you will also see increase in EURneffy sales also to a lower margin in '26.

These three are actually, you could say, a drag on our gross margin. We will still have increased tablet sales, don't worry.

We will also work on lower scrap and improvements in the yield and variances. We will also have that to counterbalance, but it is a good idea to take those partner markets and partners into consideration when trying to forecast on the gross margin next year.

I think again, just repeating, our long term is obviously the 25% EBIT, but we are making active choices investing in the business back to what we also stated during Capital Markets Day. Obviously, we are happy with both where the gross margin is and also the ability to deliver above the 25% on EBIT.

Just to your last question on R&D spend, I can start and also on the sales marketing, and Claus can chip in and Per. Basically, you see the increase due to the trial activity.

We just talked about China. We also talked about the continuation of peanut, etc., and the investments into those.

That is naturally increasing. We are preparing for the next phases of the studies.

Overall, that is part of driving the cost upwards. We said long term that we would be between 10% and 15%, but we also said that the 15% is more on the extreme end.

You should expect more the 10% to 12% overall. Do remember that with the Phase 3 trials coming in, then obviously R&D spend will go up.

They are naturally more expensive. Anything to add, Claus?

No, I think it's very right what you're saying, and just to maybe add, besides the Phase 3 trials that we are starting up next year, and we are already starting to prepare for those even actually before we know the results from the Phase 2, because we, of course, feel comfortable about that, we have to start planning, and that will then hit the 2026 numbers. Then you're right.

We will also see an increase into the commercial space next year like we will see here in Q4: children launches, EURneffy, and so on. When you combine both the Phase 2 and Phase 3 next year and the extra investments into our two very important commercial launches and activities rest of this year and next year, then we feel quite comfortable about the long-term financial EBIT around the 25%.

That is still the plan. I hope that explains, Thomas, for all your questions.

Very very good. Thank you.

Maybe I could follow up here in regards to maybe the spillover to the product mix comments. I'm just curious on Japan.

Some very positive comments from Shionogi here recently. Of course, there's the standstill.

Anything we should look into in regards to product mix, because I guess probably we could see still some low numbers in Japan already from the beginning of the year? Have you any comments on when that standstill will potentially end?

I think that the short answer there, Thomas, is that we do expect to see growth in Japan, and the facility that Torii is inaugurating is expected to come live. We actually believe that next year is going to be a good growth year in Japan.

Obviously, there is a timing element to it, and that is key for us going forward. When will the CEDAR pick up based on the pass-through of the manufacturing of the API.

That is coming, but we do see that things are coming online. Shionogi committed to both the partnership, but certainly also to the market, and hence we are very positive around the future trajectory in Japan.

Thanks. Thank you very much.

Thanks. I also have three questions.

Firstly, coming back to the pediatric launch. You highlight now that you are expecting to see 1 to 2 percentage point contribution from that launch in this year.

Considering sort of the momentum you're seeing here and continuous rollout, any flavor you could provide in terms of sort of what we should expect going into next year, I guess Thomas's question to some extent in terms of new patient starts. I know it's a bit to that as well, but if you can give any more flavors on that.

Then secondly on neffy, ARS Pharma the other day mentioned that the launch in Germany is off to a strong start. I think they even said the market share capture was three times higher than what they had seen in the US just in the first few months.

If you could give a bit more flavor on that launch and what's potentially driving that faster share gain compared to the US in your view? Then lastly on capital allocation, the balance sheet is obviously looking increasingly strong.

Just any update on what we should expect there in terms of buybacks, dividends, and then just M&A in general. What's your view at the moment?

Thanks.

Thanks, Jesper. It's Peter.

I'll start out with the first two, and Claus, if you take the capital allocation, then chip in anytime. Just on the first, as we cannot guide on next year.

Obviously, we have upgraded what we saw this year on the peat side. This is, as we also stated, driven mainly by ACARIZAX.

We saw the continued influx of patients, obviously positive. Early on the ITULAZAX initiation season in terms of getting data, we are positive.

We have seen a good influx, but I think it's premature to say a lot more on that one at this stage. I'll just say overall, we remain positive also due to the fact that we've seen these 3,000 unique or new prescribers coming in.

Overall positive. I'll just caution that we still have data coming in, and we need to be a lot wiser on that one.

That's as much as we can say. Then neffy and ARS's comment on Germany.

It is correct that we've seen a good start in Germany. The game right now is very much around market access.

It is very much around securing that we also have an inflow or we make a move into the automated renewals. That is where a lot of the existing market lies.

We need to continue to focus on that. We are also encouraged not only by the uptake we've seen in Germany and the market share gain we've had so far—smaller volume market though—but actually also in terms of the mix of the prescribers, both a strong growth with general practitioners, which is not where we send our people physically.

Our online effort and digital effort has worked well, but also in other prescriber groups. That is obviously a positive.

Again, especially because it's early days and the volumes are a little bit more up and down in smaller markets, I'll also caution that we'll see some swings, obviously. That being said, ARS and we appreciate the positiveness on their side, and it's absolute good to see so far.

I'll leave it there. Claus, on the capital allocation?

Yes, thanks for the question, Jesper. Good question.

There's no doubt, as we have also said, that this is a quite unique year for ALK on the cash situation. If you go a few years back, then that was not a big challenge for us related to cash, because we didn't have that much.

This year, we are guiding for more than a billion in free cash flow, related, of course, to the much higher sales, the gross margin, and the EBIT coming in. Strong year this time.

Related to how we are going to spend it and how we are looking at it, then we have already communicated around our long-term financial targets and when we had the new Allergy+ strategy back at our Capital Markets Day that first we would like to invest into our commercial opportunities: the children, the neffy, and so on, and then the R&D. We will, of course, also invest into tablet manufacturing and make sure that we invest for the future there.

Right now, we have capacity. We are producing 300 to 400 million tablets every year.

We can go up to 800, and we need to make sure that we can continue to deliver the millions and soon billions of tablets to the market. We also have, as we have communicated, activities on the BD, business development part.

You saw the neffy collaboration, you saw the China one. There could be some activities there where we would like to invest into.

Then when we have looked at all this, then we have also said very clearly that we don't want to be a bank. We will not sit with cash on the balance sheet for a long time.

If we are in a situation where we cannot spend our own cash flow coming in, including what we have in the bank already, on the things I just mentioned, then we are, of course, looking into dividends, share buybacks, or whatever it will be. This will be a discussion with the board, of course, here around the annual general assembly, and then we will come back with an answer there.

I hope that explains, Jesper.

Yeah. Thank you.

Yes, thank you for taking my question. Just one on neffy as well.

You mentioned in Germany that there's long-standing clinical practice favoring traditional adrenaline products. What is your strategy to move away from this?

Also any color on how this is looking for the UK market? Thank you.

Okay. I can start on the neffy.

Firstly, thanks for the question. Good question.

I'll try to just dial it back. What we are seeing is obviously you have a pattern with the prescribers where they are doing automated renewal.

As a patient, you will call down once a year and you'll get your renewal on your adrenaline pen. What we're seeing obviously now coming in with a new product is that not only the doctor, but the whole practice needs to be educated and you need to get in the system, including also ensuring that the patient understands, have seen the product.

That is part of changing the existing prescription patterns. Then there's the whole influx of new patients created through patient awareness, a lot of attention from doctors in terms of new products, etc.

This is where we obviously have a big focus. That is ensuring that there's education, training of doctors, KOLs, etc., ensuring that we are present at conferences, etc., and also that there's a general awareness in the public.

This is back to my comment around the digital effort, where we're putting a lot of focus on this. Then obviously with the nurses and the other practitioners, this is where our team have a ongoing dialogue with the clinics and we ensure that both KOLs and others are participating in the training.

That goes not only for Germany, that goes for any of the markets we're present in. That's the answer on neffy.

Per, please jump in.

Maybe add on UK, which was also part of your question. As we've launched in UK.

We've secured pricing, and now the next step is to make sure that it's also anchored in the local formulary listings. That is going to be the key focus here over the coming months in the UK.

Before we get a sense of how it fares in UK, we are into next year in reality, also now considering that we are moving into the low season, the classical low season for anaphylaxis products in Europe. Here in the short term, the focus is really on making sure that it's anchored in the local Integrated Care Trusts and systems on the formularies.

Did that answer?

Thank you. That's clear.

Thank you, operator, and thank you for your good questions. Before we end the call, I'd just like to draw your attention to our Q3 roadshows, which brings us to Copenhagen, to Canada, to London, Oslo, etc.

We hope certainly to see you around some of these events. As always, you're most welcome to contact either one of us if you have additional questions.

With this, we will end today's session, and we wish you all a good day. Thank you very much.