Almirall, S.A.

Almirall, S.A.

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Almirall, S.A.US flagOther OTC
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Q2 FY2026 · Earnings Call TranscriptJuly 24, 2026

Operator

Good day, and thank you for standing by. Welcome to the 2026 First Half Earnings Call of Almirall.

Please be advised that today's conference is being recorded. I would now like to hand the conference over to your speaker today, Pablo Divasson, Head of Investor Relations.

Please go ahead.

Operator

Pablo Divasson Fraile

Thank you very much, Sharon, and good morning, everyone. Thank you for joining us for today's quarterly earnings update and review of Almirall's First Half Year Financial Results of 2026.

As always, the slides we are using today are shared in the Investors section of our website at almirall.com. Please move to Slide #2.

Let me remind you that the information presented in this call contains forward-looking statements which involve known and unknown risks, uncertainties and other factors that may cause actual results to materially differ from what we are sharing today. Please move to Slide #3.

Presenting today are Carlos Gallardo, Chairman and Chief Executive Officer; Jon Garay, Chief Financial Officer; and Karl Ziegelbauer, Chief Scientific Officer. Karl will start with the business highlights of the first half of 2026, followed by an update on biologics and the key growth drivers of our medical dermatology portfolio.

Karl will provide you with an update on the pipeline and R&D programs. And then Jon will go through the financials before Carlos concludes the presentation, and we open for questions.

I will hand over to Carlos Gallardo, our Chairman and CEO. Please move to Slide #5.

Pablo Divasson Fraile

Carlos Gallardo Piqué

Thank you, Pablo, and good morning to everyone in the call. Almirall delivered a steady first half of 2026, broadly in line with our expectations and the trajectory set out at the beginning of the year, with performance expected to build progressively through the remainder of the year.

Net sales reached EUR 603 million, with European dermatology once again acting as a primary growth engine. These results remain broadly consistent with recent trends and our full year guidance.

This is why we are reiterating our full year 2026 guidance with growth expected to pick up towards the second half of the year. Turning to products.

Ilumetri delivered steady double-digit growth around EUR 125 million 125 million in the first half and remains firmly on track towards peak sales of over EUR 300 million. Ebglyss generated EUR 84.5 million in the first half, close to doubling year-on-year.

I will provide a bit more context on Ebglyss on the following slides. Among other products, Wynzora continues to lead market share across key regions, while Klisyri delivered stable growth overall.

We remain closely connected to the dermatology community, strengthening our partnership with physicians through ongoing engagement at key platforms such as the 2026 American Academy, Skin Academy and European Academy of Dermatology and Venereology Symposium. On the innovation side, we continue to make progress.

We have several proof-of-concept and Phase II programs advancing, most of which are first or potentially best-in-class. The initiation of Phase II of our anti-IL-21 monoclonal antibody monoclonal antibody marks a key step in our Hidradenitis Suppurativa strategy.

Combined with the IL-1RAP, now we have 2 differentiated assets targeting a disease with significant unmet need. We also signed a strategic research collaboration and licensing agreement with Certest Biotec, adding further depth to our innovation efforts.

Karl will revisit our pipeline updates in greater detail. Please move on to the next slide for an update on our biologics portfolio.

Ilumetri net sales reached EUR 125 million in the first half of the year, marking a steady 10.5% year-on-year increase. Ilumetri continues to demonstrate a solid position in the psoriasis market, maintaining its share within the leading anti-IL-23 class, supported by real-world evidence such as the positive study data presented at the latest AAD and EADV congresses, which continue to highlight meaningful long-term benefits in patients' well-being and disease control.

Moreover, we see additional opportunity to further strengthen the profile of Ilumetri. For that reason, we plan to initiate the EVOLVE study in psoriasis to study the effect of the 200 milligrams dose in biologic-naive patients diagnosed for less than 2 years, further reinforcing Ilumetri's strong and growing long-term clinical evidence base.

Karl will provide additional details on the EVOLVE study. Performance remains consistent, and we, therefore, continue to be firmly on track to deliver over EUR 300 million in peak net sales, even as both the product and the class enter a more mature phase of the growth cycle.

Please move to the next slide for Ebglyss highlights. Since its approval in Germany in December 2023, Ebglyss has rapidly scaled to become our second largest product, underscoring one of the most successful atopic dermatitis launches in recent years.

Second quarter sales reached EUR 43 million, up from around EUR 26 million a year earlier, bringing first half sales to approximately EUR 85 million, close to double the level of the first half of 2025. Despite the positive trajectory of the launch, the performance in the second quarter reflects 2 factors.

First, we must recall that we had a strong performance in the first quarter, which sets a higher base for comparison. Secondly, we experienced some softness in the countries like Germany, where a relatively modest pricing adjustment created a short-term uncertainty, and we may have resulted in some sales shifting from June to July.

In addition, we also experienced temporary minor volatility in certain other countries. Overall, we have not changed our mid- and long-term view on Ebglyss, and we expect the strong clinical profile and continued healthy growth in the AD market to support Ebglyss sales.

While we do not typically like to comment on individual product sales for the year, we are aware that where the consensus is for Ebglyss, and we remain comfortable around that figure. On the clinical side, our collaboration with Lilly continues to support Ebglyss' positioning with extensive lebrikizumab data, including the long 4-year results and the ADorable-1 pediatric data presented at recent scientific meetings.

This week, the EMA admitted the submission of the pediatric indication of Ebglyss. In June, the FDA approved the every 8-week maintenance dosing regimen for Ebglyss in the U.S.

This approval further strengthens Ebglyss profile in atopic dermatitis and supports its long-term competitiveness in the market. We are also conducting the ADhope 2 trial in Europe, which has the potential to support an extension of the dosing interval to every 12 weeks.

I will now hand over to Karl to walk you through our pipeline developments in more detail.

Carlos Gallardo Piqué

Karl Ziegelbauer

Thank you, Carlos, and good morning to everyone on the call. On this slide, I would like to focus on the early and mid-stage pipeline as a source of future value creation and upcoming clinical inflection points.

Today, we have 4 proof-of-concept or Phase II studies ongoing with 2 additional studies planned to start towards the end of this year. During 2025, we advanced 2 important programs into Phase II.

Our anti-IL-1RAP antibody in hidradenitis suppurativa and the IL-2 mutant Fc in alopecia areata. In addition, our partner, Simcere, initiated a Phase II study of IL-2 mutant Fc in atopic dermatitis.

We also recently started a proof-of-concept study for our anti-IL-21 antibody in hidradenitis suppurativa. Looking ahead, we plan to initiate 2 further proof-of-concept studies, IL-2 mutant Fc in SLE with cutaneous manifestation and the anti-IL-1REP antibody in an inflammatory skin disease.

Taken together, this gives us 6 proof-of-concept of Phase II studies with data readouts expected over the next couple of years beginning at the end of 2026. These programs remain early, but they are anchored in well-defined biology and give us a diversified set of potential first or best-in-class opportunities in area of high unmet need.

Next slide. While we advance the clinical pipeline, we're also building the next wave of innovation in dermatology.

Our approach is to focus Almirall's internal capabilities on deep disease understanding and to partner selectively where external technology can provide the most appropriate modality of a -- for a novel therapeutic hypothesis. A recent example is our strategic research collaboration with Certest Biotec, a Spanish biotechnology company with mRNA and lipid nanoparticle discovery and development expertise.

Together, we aim to discover novel treatments for rare dermatological diseases and recurrent cutaneous conditions. The important point is that this is a partner-enabled model.

We access differentiated technology while Almirall retains global rights and leads future development and commercialization. This allows us to broaden our innovation reach while maintaining strategic control over asset that fits our dermatology focus.

Next slide. This slide summarizes our life cycle management activity for products already on the market.

The objective is to support the long-term relevance of our key brands through label expansion, additional clinical evidence and disciplined prioritization of investment. For tirbanibulin, the regulatory process for the larger 100 square centimeter treatment area is ongoing, and we now expect the European approval towards the end of this year.

Together with our partners, Sun Pharma and Eli Lilly, we continue to advance label expansion opportunities and generate additional clinical data for Ilumetri and Ebglyss, respectively. For lebrikizumab, we have filed with the EMA for pediatric label extension to include children from 6 months to 17 years of age and a waiting below 40 kilo with moderate to severe atopic dermatitis with approval expected around mid-2027.

We are also running a Phase III of lebrikizumab in nummular eczema with readout expected in 2029. Additional ongoing clinical studies are summarized in the appendix.

Turning to tildrakizumab. The INSPIRE-I and II studies showed benefit in psoriatic arthritis.

Both trials met the primary endpoint at week 24 and continue to show benefit through week 52. After evaluating the access dynamics and investment required, we have decided not to pursue commercialization of tildrakizumab in psoriatic arthritis in Europe.

We believe that further investment in generating additional data in psoriasis can generate more value for tildrakizumab, and we, therefore, plan to study tildrakizumab in psoriasis patients with short disease duration and high disease burden. Details are shown on the next slide.

EVOLVE PSO is designed to explore the potential benefit of tildrakizumab 200 milligram in biologic-naive adults with moderate to severe plaque psoriasis and short disease duration defined as less than 2 years. In addition, the study will evaluate the potential to maintain high levels of disease control using a dose spacing approach.

We plan to initiate the study around year-end with first readouts are expected in 2029. Strategically, EVOLVE PSO is intended to support a more flexible and patient-centric treatment paradigm.

If successful, it could help reinforce the value proposition of tildrakizumab in psoriasis by maintaining outcomes while potentially reducing treatment burden. With that, I will hand over to Jon for the financial review.

Karl Ziegelbauer

Jon U. Alonso

Thank you, Karl, for the pipeline updates, and good morning, everyone. Net sales for the first half reached EUR 603 million, a 7.5% growth year-on-year and a 10% growth in the last 12 months, which is in line with provided net sales guidance range.

Please note that the second quarter of 2026 included the recently announced divestment of Actithiol, comprising of a EUR 13 million upfront and an additional EUR 1 million revenue recognition out of the remaining payments. As noted, the year is progressing positively with increasing performance expected during the remaining part of the year as indicated in February earnings call.

European Dermatology keeps delivering solid double-digit growth, reinforcing Almirall's path towards leadership in medical dermatology. We will review the details in the coming slides.

EBITDA for the first half came in at EUR 151 million, resulting in a ratio of 25% of our net sales versus 21.7% prior year, representing an improvement by 330 basis points. Gross margin benefited from Actithiol divestment and is expected to normalize in upcoming quarters amid ongoing pressure from higher royalty tiers associated with Ilumetri net sales growth.

Regarding SG&A, investment reflects the timing of our promotional activities during the year, and there will be some pickup in the coming quarters. On R&D expenses, our half year phasing reflects the progress of our trials into Phase II with 4 already ongoing and another 2 set to start shortly.

We closed the first half with a net cash-to-EBITDA ratio of around 0.1 with a strong cash generation in the first half of the year, leaving us with significant financial flexibility. Overall, these results lead us to reiterate our 2026 guidance.

Let's move to the details of our sales breakdown on the next slide. European Dermatology continued to perform positively in the first 6 months with double-digit year-on-year net sales growth.

We will go into more details on the next slide. In General Medicine and OTC, European sales reflect the divestment of Actithiol completed in the second quarter.

Excluding these portfolio moves, the segment remained broadly stable with lower sales in some legacy products largely offset by contributions from products such as Ebastel and Airtal. In the United States, performance declined year-on-year, reflecting continued pressure on the legacy portfolio, which we will discuss on the next slide.

In the rest of the world, overall sales grew strongly, driven by solid dermatology demand. Let me take you through the dermatology performance in more detail on the next slide.

Our European Dermatology business continued to perform well in the first half. Ilumetri delivered robust double-digit growth versus prior year, reaching EUR 125 million.

Ebglyss further increased its contribution to approximately EUR 85 million in the first 6 months of the year. We remain focused on unlocking the full value of the franchise from both the commercial and the R&D side.

Wynzora continued to build market share across core European countries and Klisyri demonstrated stable growth in Europe year-on-year. In the United States, overall performance declined, reflecting continued pressure on the legacy portfolio.

Dollar-euro FX evolution represented a negative impact of minus 6% in our performance year-to-date. Seysara and Klisyri improved the price volume dynamics in the second quarter, while still declining and Axon remain impacted by generic competition.

In the rest of the world, dermatology sales were driven primarily by Finjuve demand in China. Overall, our dermatology franchise continues to show solid underlying performance.

Let's briefly review the remaining elements of the P&L in the next slide. Gross margin reached 64.6% in the first half with the second quarter divestment offsetting royalty impact associated with Ilumetri's growth.

SG&A in the second quarter following an incremental quarter-on-quarter trend as previously announced. We expect that trend to continue in the remaining quarters of 2026 while supporting margin expansion on an annual basis.

R&D percentage of net sales was somewhat lower than our target of 12.5%. Our half year phasing reflects the progress of our trials into Phase II with 4 already ongoing and another 2 set to start shortly.

A full year ratio of approximately 12.5% remains a good proxy, subject to the normal quarterly variability. EBITDA margin reached 25% of net sales, a level aligned with our 2028 ambition, but approximately 2.5 years ahead of schedule.

While this performance benefited from the divestment of a minor non-derma product, portfolio optimization is an integral part of our ongoing business strategy and value creation. This milestone demonstrates the strong position we are building.

Financial expenses continue to reflect the valuation impact of the equity swap in line with the share price evolution during the period. Our effective tax rate continues to normalize, and we continue delivering on this positive trend, driven by the strong increase in the group's overall profitability, which materially reduces the related impact of our U.S.

business at consolidated level. Please move to the next slide to take a look at the balance sheet.

Our balance sheet remained stable throughout the first half of the year. Intangible assets reflect Ebglyss-related R&D capitalization, the development milestone to Simcere for advancing IL-2 mutant fusion protein into Phase II and the access fee linked to the Huaota collaboration, broadly offset by higher amortization.

Our net cash-to-EBITDA ratio stood at around 0.1, providing us with a strong financial flexibility for licensing opportunities and selective bolt-on acquisitions. During the quarter, Moody's upgraded our credit rating to Ba1, validating the strength of our balance sheet and financial performance.

Let's now turn to the cash flow statement. Company generated EUR 17 million cash in the first 6 months of the year compared to a dilution of minus EUR 54 million in the same period last year, representing an improvement by EUR 71 million.

Free cash flow raised to EUR 33 million compared to minus EUR 20 million in the first half of 2025. Let's now go through the different components of our cash flow.

Cash flow from operating activities raised to EUR 132 million, representing more than 2x improvement versus prior year, driven by working capital management alongside higher profitability levels. Cash flow from investing activities reflects the 2025 Ilumetri sales milestone paid in the first quarter, the highest milestone expected this year with the remaining investment-related payments for the year being marginal and the total outflow within the usual limits in absence of new acquisitions.

Cash flow from financing activities reflects the change in the bond interest payment schedule following the recent bond issuance and cancellation of the previous one as well as the dividend paid in the period. With that, thank you very much for your attention, and I hand it over to Carlos for his closing remarks.

Jon U. Alonso

Carlos Gallardo Piqué

Thank you, Jon. To summarize, the first half of 2026 confirms that the business remains solid and on track.

We know where the consensus sits today, and we are comfortable with these figures. Turning to the key drivers.

First, our biologics portfolio continues to give us real momentum in the dermatology market that keeps expanding with Ebglyss scaling across Europe and Ilumetri still growing steadily as it moves through a more mature phase of growth. In parallel, we continue to generate robust life cycle management data that further supports the strong profile of our biologics.

Second, our growing and exciting pipeline now spans immune-mediated skin diseases, rare dermatology and non-melanoma skin cancer with 6 proof-of-concept Phase II programs moving forward and most assets being with potential for best or first-in-class, providing a solid base for sustainable growth without concentration on any single asset. Third, we remain disciplined but active on capital deployment with a strong balance sheet supporting bolt-on M&A and early-stage licensing.

We continue to work towards delivering on our mid- and long-term ambitions, supported by a well-positioned portfolio, a strong and targeted pipeline and strategic positioning in the right dermatology indications. This combination of pipeline depth, financial discipline and execution gives us confidence as we continue to advance Almirall towards leadership in medical dermatology.

With that, we conclude the presentation and turn to Pablo for the Q&A.

Carlos Gallardo Piqué

Pablo Divasson Fraile

Thank you very much, Carlos. Sharon, back to you for the Q&A, please.

Pablo Divasson Fraile

Operator

And your first question comes from the line of Hen Boeg from DB.

Operator

Henrietta Boeg

I've just got a couple. The first one, you mentioned there's a Germany pricing adjustment from July.

It would be good to know a bit of clarity about what effect that's having into H2 and also how this fits into maybe the German drug pricing reform that's taking effect in '27 and how you think that will impact Ebglyss and Ilumetri and maybe whether that's included in your '28 EBITDA margin target of 25%. And then my second question, please, is you didn't reiterate your peak guidance for Ebglyss.

Is there a reason for this? Yes, just a bit more clarity.

Henrietta Boeg

Carlos Gallardo Piqué

I'm not sure about the second question. You're asking us to confirm the peak sales estimate for Ebglyss?

Carlos Gallardo Piqué

Henrietta Boeg

Yes, yes.

Henrietta Boeg

Carlos Gallardo Piqué

Okay. Sure.

Thanks for the question, Hen. So the German pricing reform is certainly not good news for the industry in Europe.

However, there's still a number of clarifications as there are deductions and modifications that now need to be clarified by the German government between now and the end of the year. Once we have clarity on this reform, we will be able to provide further clarity on how we see this impacting the business.

In terms of the peak sales guidance for Elis, yes, we remain very confident on the outlook that we have provided. And so we are very happy to reiterate peak sales above EUR 450 million.

Carlos Gallardo Piqué

Operator

Your next question today comes from the line of Shan Hama from Jefferies.

Operator

Shan Hama

Just 2 from me, please. Are you able to quantify the extent of the planned price decrease for Ebglyss in Germany in July or from July?

And then secondly, can you tell us about some early ordering patterns you're seeing in 3Q for Ebglyss and whether you're expecting a return to acceleration from 3Q despite the typical slowdown during the summer season?

Shan Hama

Carlos Gallardo Piqué

Thank you, Shan, for the questions. If I understood well, you're asking about the price decrease in Germany and Ebglyss this year, it will be from January 1, 2027.

No, is that the question or not?

Carlos Gallardo Piqué

Jon U. Alonso

No. Your question, Shan, if I understood well, you are asking the price reduction for Ebglyss in July, right?

Jon U. Alonso

Shan Hama

Yes, exactly.

Shan Hama

Jon U. Alonso

Yes. So it has been a low single-digit one that it was agreed with the German government at the point of launch of the product.

It has -- is minor, but it has had an impact on the phasing of orders between quarters. So we expect an acceleration in the Q3.

So this is the answer of your first question.

Jon U. Alonso

Carlos Gallardo Piqué

Thank you for -- so sorry, I misunderstood the question. Thank you Jon for your help.

You want to take the number 2 as well?

Carlos Gallardo Piqué

Jon U. Alonso

Yes. Your second question, Shan, was about order pattern in the second half of the year and return to accelerate.

Yes, I mean, we remain confident in the long-term profile of the product. We continue receiving very positive feedback from our key opinion leaders in the market, and we continue having long-term life cycle management.

The market consensus for the products shown at this point in time is in the range of EUR 190 million to EUR 193 million, and we remain comfortable in this ballpark for this year. Just to reiterate that our focus remains firmly on the long-term opportunity.

And as usual, we would encourage all the analysts to have a view on short months more than on quarter-on-quarter phasing. I hope this addresses the answer to your question, Shan.

Jon U. Alonso

Operator

Your next question today comes from the line of Juan Ros Padilla from ODDO BHF.

Operator

Juan Ros Padilla

Two, if I may. First one regarding the PCS guidance.

So after the H1 EBITDA, how should we interpret the guidance of EUR 270 million to EUR 290 million for the year? Are you now maybe more comfortable with the upper half of the range?

And secondly, regarding Ilumetri, we've seen some moderation of the growth in Ilumetri in Q2. Are you still expecting double-digit growth for this year?

And what contribution are you seeing from the 200-milligram presentation?

Juan Ros Padilla

Carlos Gallardo Piqué

Juan, thank you very much for your questions. So at this stage, we are confirming our full year guidance.

Yes, we had a very nice EBITDA in the first half. Not only that, we have already reached the 25% EBITDA ambition that we had set for ourselves in the midterm guidance that we set up and we had set this target for 2028.

So we are very happy to see that we have been able to accelerate our operational leverage agenda. So that's great news.

At this time, we are happy to confirm the full year guidance that we have provided. Ilumetri, perhaps for the details, I'll pass it to John, but let me reiterate that we remain very, very confident with the performance of Ilumetri, both in terms of how the market is growing, IL-23 is firmly established as the winning class.

And within this class, we are able to either to keep or to grow market share. So the underlying dynamics remain extremely positive for Ilumetri.

Jon, do you want to add some more color on Ilumetri?

Carlos Gallardo Piqué

Jon U. Alonso

Just to complement, Juan, that if I remember well, the market consensus is in the ballpark of EUR 260 million, EUR 262 million, similar level as of February earnings call, and the company feels comfortable with that ballpark, although we do not provide guidance per product. On long term, the guidance for the product is to reach peak sales beyond EUR 300 million, and we also reiterate we are comfortable with that peak sales.

But more importantly, Karl has been sharing with us exciting aspects of Ilumetri life cycle management and products. So if it is okay, Juan, I would like to pass the word to Karl to complement our answer.

Jon U. Alonso

Karl Ziegelbauer

Thank you. I mean just to remind everyone, Ilumetri is the only anti-IL-23 with dose flexibility.

And we're seeing, especially on the 200migram where we receive very positive feedback, especially in patients that are overweight or with a high disease burden. And that's why we now start the EVOLVE PSO study to further explore this 200-milligram option in patients with a short disease duration and a high disease burden.

And we will -- we are confident that this adds to the already very solid clinical evidence on Ilumetri will further drive the product.

Karl Ziegelbauer

Operator

And your next question comes from the line of Guilherme Sampaio from Caixa Bank.

Operator

Guilherme Sampaio

So 2, if I may. I'm sorry to insist on the Germany reform, but taking into consideration the accelerated operating leverage that you have been achieving, is there a scenario in your preliminary analysis in which you would not reiterate the 25% margin in 2028 that you've been targeting?

And the second question, you've been guiding for an underlying EBITDA growth acceleration across 2026, and you've been delivering upon it. But you mentioned that you're comfortable with current consensus, which implies a major slowdown in the second half of the year.

So I wanted to confirm both statements. So if you still think that you should have some acceleration or if there's going to be a slowdown and if you could provide some more details regarding this.

Guilherme Sampaio

Carlos Gallardo Piqué

Thanks for your question, Guilherme. Yes, as I mentioned, we're very happy to see our acceleration on the operational leverage agenda that we have established for ourselves.

In addition, we've seen very good progress, and I would say I would as excellent progress in our pipeline with the 6 POCs by end of '26. And that means that we'll have all the data, the data readouts in the next 18 months.

This -- and you were talking about -- asking about the scenario, right? So this opens many scenarios depending on the data, depending on the readouts.

And we will be, of course, first, solving with value maximization for shareholders in mind and secondly, monitoring very closely what this means. And your question on EBITDA for the second half of this year, maybe, John, you want to take it?

Carlos Gallardo Piqué

Jon U. Alonso

Yes. Thank you very much, Carlos.

Thanks a lot, Guilherme, for your question. When you are doing the comparison, first of all, any potential scenario we have had in the first half of the year, including the divestment of a minor derma product was already included in the scenarios we provided for our full year guidance in both net sales and EBITDA, 9% to 12% and EBITDA amount EUR 270 million to EUR 290 million.

Having said that, in the second half of the year, we expect certain acceleration in our R&D investment as our trials progresses, and we expect certain pickup in our SG&A investment following the phasing of our promotional activities. If you remember, what we have always said is that SG&A will be a component -- a key component to the operational leverage that you already see in the P&L as of today but the growth will be materially lower than the growth we are showing in net sales.

In this scenario, in the second half of the year, of course, in order to continue accelerating in the same ratio, we should have a similar divestment to the one we have executed for Actithiol. But from an operational point of view, excluding the divestiture, we continue expecting EBITDA acceleration.

This would be our ambition. And still, we think we are in the ranges we have provided for the full year guidance range for 2026.

Jon U. Alonso

Operator

Your next question today comes from the line of Jaime Escribano from Banco Santander.

Operator

Jaime Escribano

So a couple of questions from my side. The first one more on the competitive landscape in AD.

So today, we heard Sanofi discontinuing amlitelimab. I would like to know your opinion and maybe to summarize which ones do you think are going to be the main competitors going forward?

And the second one for Karl would be how excited you are with the new anti-IL-21 candidate that is passing to Phase II for hidradenitis suppurativa. Maybe if you can elaborate on this candidate versus, for example, the anti-IL-1RAP?

Jaime Escribano

Carlos Gallardo Piqué

Thank you, Jaime, for the questions. So the competitive landscape in AD.

We've always said that the AD market is largely underpenetrated. So only around for probably less than 20% of patients that are eligible for this type of advanced treatments are treated with modern medicines.

So for us, the new entrants, new mechanism of actions coming into this market continue to expand the market, right? Having said so, within the community, it remains firmly convinced that the anti-IL-13 remains the mainstay treatment for first-line in patients, right?

So overall, we believe that IL-13 will continue for the future to become the mainstay and market progression and feedback of physicians, these patients make us very -- continue to deliver very positive signals for us in this market. Karl, do you want to comment maybe on amlitelimab and the IL-21?

Carlos Gallardo Piqué

Karl Ziegelbauer

Yes. I think, yes, we saw the news on amlitelimab this morning.

When these decisions are always based on benefit risk. And we need now to analyze what this could mean on our bispecific antibody where this is only one component.

The other component is an anti-IL-13 mechanism that, as Carlos said, is the key pathogenic driver in AD. Now coming to your second question, we are very excited about the anti-IL-21 antibody.

HS is an indication with very high unmet medical need, but it's also a very complex disease. And that's why we have been searching for mechanism that can address multiple pathways.

The anti-IL-1RAP addresses multiple path more towards to the innate immune system, so the IL-1 alpha beta, the IL-33 and the IL-36 alpha, beta and gamma. And both the anti-IL-1 beta independently as well as an antibody against the IL-36 receptor have shown benefits addressing different aspects of the pathophysiology.

So we believe this combination of those activities when inhibiting the anti-IL-1RAP has a chance for an increased efficacy. IL-21 is a cytokine that is involved both in B and T-cell biology.

So addressing more the adaptive immune system. And again, there is evidence that addressing T-cells and addressing B-cells has impact on the pathophysiology of HS.

And our hypothesis is again that by combining those activity, this may lead to an increased efficacy. We have just started a Phase II kind of proof-of-concept study and expect first results during next year.

Karl Ziegelbauer

Operator

We have one further question in the queue. And the question comes from the line of Joaquin Garcia-Quiros from JB Capital.

Operator

Joaquin Garcia-Quiros

Just regarding the investments, if I remember correctly, you said that you should expect around EUR 70 million for the year. Is that still a good target?

And then what can we expect for next year? And then if you could remind us what could be the potential target markets for hidradenitis suppurativa and alopecia areata and talk a bit on the competition right now that you could have on those fields?

Joaquin Garcia-Quiros

Carlos Gallardo Piqué

Joaquin , thank you much for the questions. John, do you want to take the first one on investments and then Karl the ones on HS and EA.

Carlos Gallardo Piqué

Jon U. Alonso

Thanks a lot, Carlos, and thanks for your question. Joaquin, I understand you refer to investment CapEx.

Should this not be the case, please feel free to speak up, and we also cover ordinary CapEx. In terms of investment CapEx, yes, our guidance for the full year was EUR 70 million to EUR 80 million in absence of new acquisitions.

Our year-to-date basically reflects the payment of our 2025 sales milestone that is the highest we are going to experience this year. And right now, Joaquin, we confirm that range, probably ending to the high to EUR 75 million to EUR 80 million.

It is what we will be finalizing in our investment CapEx. Happy to say that the results we are presenting today, where we are discussing CapEx, they also show the strong cash generation the company has achieved in the first 6 months of the year.

So I am confident we have the enough muscle and power to fund those CapEx and potential new licensing opportunities that may come up in the near future. Hopefully, I have addressed your question.

Otherwise, let me know. Back to Carlos for the other.

Jon U. Alonso

Carlos Gallardo Piqué

And then to Karl.

Carlos Gallardo Piqué

Karl Ziegelbauer

Yes. Thanks for the question.

As I mentioned, HS is an indication with a still very high unmet need and experts we have talked to mention that the currently available treatments are still suboptimal in addressing all the different aspects, specifically the efficacy. The high unmet need is also reflected in the interest and in the pipeline.

We believe we have 2 very differentiated assets that have, as I just mentioned, a chance for an increased efficacy by addressing not a single but multiple other mechanisms. When it comes to the potential commercial opportunities, Evaluate estimate the HS market to be in the range of EUR 5.3 billion in 2030.

And the second, the AA market, alopecia areata is estimated to be in the range of about USD 1.4 billion again from Evaluate Pharma 2030 estimates. This shows that both are significant commercial opportunities.

Karl Ziegelbauer

Operator

I will now hand the call back to Pablo as there are no further questions.

Operator

Pablo Divasson Fraile

Thank you very much, Sharon. If there are no further questions, ladies and gentlemen, this concludes our today's conference call.

Thank you for your participation. You may now disconnect.