Almirall, S.A. (BME:ALM)
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38th Annual J.P Morgan Healthcare Conference

Jan 15, 2020

Antoine Natali
Healthcare Investment Banking, J.P. Morgan

Hi, good morning, everyone. Thanks a lot for joining us today. My name is Antoine Natali. I'm a member of the J.P. Morgan Healthcare Investment Banking team. It is my pleasure to introduce you to our next speaker this morning, Peter Guenter, the CEO of Almirall.

Peter Guenter
CEO, Almirall

Well, thank you very much, and thanks to J.P. Morgan to invite us and give us the opportunity here to present to you the transformation of Almirall. This presentation will also be webcasted and later made available on our website. In the next 20 minutes or so, we are a public company, so this is our disclaimer. In the next 20 minutes or so, what I thought I'm going to share with you is give you a flavor of the work we have been doing with the team over the last two years or so, and hopefully convince you that Almirall today is a quite different company than Almirall back a couple of years ago.

I will shortly or briefly walk you through why we think that being in medical dermatology for a company like Almirall is a good place to be. It's more how you want to be in dermatology than the question, should you be in dermatology? I'll touch briefly upon a couple of innovative launches that we are going through and that, of course, are extremely important to us. I'll finish on our capital allocation and before bringing it to a close. First of all, the transformation is well represented here. Basically, if you take a step back, you go back to October 2017, which was kind of a new setting of the company. There was a profit warning in 2017. The U.S. acquisition that was done a couple of years before turned out to go in the wrong direction.

Then, for me, the new Almirall starts, if you will, with the launch of Skilarence, which was our first launch in psoriasis in Europe, which occurred in October 2017. We made a first in licensing deal for a new mode of action in actinic keratosis, which is a pre-cancerous and very frequent disease in medical dermatology. At that time, tirbanibulin was in phase II. I'll come back in a minute on where the product is now. Very important turning point was the acquisition of the medical dermatology portfolio of Allergan in the U.S. in August 2018, which came with an innovative novel antibiotic for moderate to severe acne, which you see appearing a little bit later, which was then launched a couple of months later in the U.S. called Seysara. I'll come back to that launch in a minute.

We had our first launch of a biologic in Europe, also a very new event to Almirall. This is the license of Sun. We have the European rights on Ilumetri, which is a monoclonal antibody, IL-23p19. I would say perhaps the most important of all happened in February 2019, where we entered into an option deal with Dermira, and to acquire the European rights on lebrikizumab and IL-13 for the treatment of atopic dermatitis. The option deal was constructed in such a way that we had the possibility to look at the phase IIb data and then decide whether we would exercise the option or not.

Of course, when we saw what we thought to be very interesting data, we exercised the option in June 2019, which gives us unrestricted access to this, what we think has best-in-class potential in atopic dermatitis and perhaps beyond for EU. We announced a slate of deals last week, actually. I will come back a little bit more in detail on Bioniz. In the interest of time, I cannot talk too much about the two others, but we're also very excited about it. 23andMe, a company well known to everybody, leveraging its wealth of data in genotyping and phenotyping to also do target discovery and drug design. Actually, we're very happy that we are the first company to which they have outlicensed the rights on an anti-IL-36, and we're very excited by that.

This is a bispecific with lots of promises in dermatology and probably also beyond dermatology. The WuXi deal is also design of bispecific antibodies on undisclosed targets. I will not talk about which target we are talking about. Finally, last week, Lilly announced that they had intended to acquire Dermira, which of course, for us, I think is extremely good news. Number one, it validates the hypothesis that indeed lebrikizumab is a very interesting molecule. Number two, with the power of Lilly behind this brand, in terms of medical affairs, evidence generation, evidence dissemination, life cycle management, et cetera, will of course also be very positive for our development in Europe. This is really what we're trying to do, focus on those launches and building a real pipeline of innovation for severe unmet medical needs in medical dermatology.

In parallel, we look, of course, also at the numbers, right? This is what you see below. Back in 2017, a total EBITDA for the company of EUR 142 million, and here we are, 24 months later, and we are looking at a total EBITDA of EUR 300 million-EUR 310 million. In 24 months, we basically, well, significantly more than doubled the EBITDA. What becomes even more interesting is if you look at core EBITDA. You may remember that in the P&L of Almirall, you have a line, other income, which is basically income that we still receive from a former deal where we divested the respiratory business to AstraZeneca back in 2014. That is finally something that we don't manage.

What we really manage, and where we really would invite you to look at, is what we call the core EBITDA, which is the EBITDA stemming directly from our business. If you look at that number, you see that we have gone from EUR 70 million in 2017 to EUR 245 million-EUR 250 million in 2019. In other words, it's more than a triplication of that core EBITDA. I think this is a nice scene setter for, let's say, what we have been doing in the last two years at Almirall. This comes not by coincidence or by chance. This comes with a team behind and I will not go into all the details, but basically we have a very global, very experienced leadership team. We have actually as many Americans in our team than we have Spaniards in our team.

There is also a Belgian, there is a German. We have recently hired Dr. Koscielny from Celgene, who didn't want to move to BMS with Celgene, we had the opportunity to hire him as a Chief Medical Officer. We have Bhushan here today, Head of R&D. We have Mike, our new CFO, you see that this is a heavyweight team with quite some experience also in big pharma. All this results in really developing Almirall into a real specialty care player in the field of medical dermatology. I guess the key word on this slide is focus. We are talking here about geographical focus. If you look at the right, you see that basically close to 90% of our sales now stem from the U.S. and from Europe, which of course remains our stronghold.

In rest of the world, we have no direct presence, so what you see is basically partnered sales with legacy products of Almirall. If you go to the left part of the slide, you see now that medical dermatology is now close to 50% of our total business, and this share, of course, will continue to increase with the launches that we are currently undergoing and with the future launches that we will have in the coming years, which are all in the field of dermatology. Okay. The rest is some other business in CNS. We have some OTC business in Spain. We have some cardiovascular business in Spain, which is our historical legacy business in Spain. Now, why medical dermatology? Well, if you look at the macro picture of dermatology, medical dermatology, it's a very dynamic market. It's an enormous number of dermatological conditions.

People always think, well, this is acne, perhaps atopic dermatitis and psoriasis, that's it. It's way, way larger than that. What we try to do here is present it in four different buckets. The big-ticket items today in dermatology are psoriasis and increasingly also atopic dermatitis. The third part is there, what I would call the conventional dermatology, like for example, acne and rosacea. The top part of that stack bar is all the rest, and they're things like oncodermatology, rare diseases, is really where we try to focus. The nice thing is actually that with our pipeline building, that we have tried and also succeeded to be present in each of those segments. With our European business in psoriasis, with Skilarence and Ilumetri, we are going to launch lebrikizumab in Europe in 2023.

We have launched Seysara in the acne space in the U.S. We have our AK drug, which is an oncodermatology indication, so with Europe and the U.S., and then, the BNZ-1, on which I will elaborate a little bit more in a minute, for which we have global rights. Of course, you will see more and more with the licensing deals we do, that we try to get global rights, and of course all the proprietary research products that we are managing, of which some will move into the clinical pipeline in 2020. Evidently, are ours, so by definition, we will have global rights for these products. Pipeline, I must say when I came to the company, the pipeline was mainly composed of reformulations. We halted most of these projects. Two were in phase III, so we let them go to the end.

Topical finasteride and topical terbinafine. These products are now under registration in EMA. We consider that they do not fit in our new strategy of Almirall, which is to really focus on high unmet medical need areas and very innovative products. We will out-license these products. What is more exciting is the top part of the slide, where we are trying to build a clinical-stage pipeline with very exciting products. We are talking about here tirbanibulin, lebrikizumab, BNZ-1, and much more to follow in the course of 2020 and 2021. Also very happy with the progress we have made.

If you would take together the peak sales of the launches that are ongoing, SKYRIZI, Ilumetri, and Seysara, and you would combine that with the peak sales of the two top products, tirbanibulin and lebrikizumab, we are looking at combined peak sales of more than EUR 1 billion for a company that does more or less EUR 1 billion. You can see the importance of what we're trying to build here. Let me just focus now on lebrikizumab, because I am not sure that the potential of this drug is sufficiently recognized by observers who look at Almirall. We think that this product has a potential to be best in disease for atopic dermatitis. You see on the right part of the slide, the patient funnel.

It means that the number of patients will probably evolve in the direction of the number of patients you have today for psoriasis. You see the split out between moderate to severe, how many of those are treated, how many of those are considered to be eligible for new systemic treatments, so either antibodies or potentially the oral JAKs when they will come to the market. You see actually that this is going to become a very, very important market in dermatology. The good news is that today there's only one biologic that is marketed, dupilumab of Sanofi. Also good news is that Sanofi has been able, in Europe now, to more or less secure very good market access for dupilumab, so we will not have to open that market access in atopic dermatitis.

We will be able to follow on on what Sanofi has already created with dupilumab. All observers say that the number of atopic dermatitis patients will be at least the same as psoriasis, but even with the burden of disease, that it's probably even more important than the burden of disease in psoriasis. As I mentioned before, we anticipate to launch this early 2023. Now, why are we so excited about the product and why we think that the phase IIb data have been so good? Because the product has a very high affinity and specificity for the IL-13 cytokine. Basically, more and more data show that atopic dermatitis is really an IL-13 dominant disease. This is exactly what we do, is blocking the IL-13 cytokine with a very high degree of affinity and specificity.

Basically, by blocking the IL-13 cytokine, you prevent the heterodimerization of the receptor that you see there. This, the IL-4 alpha and the IL-13Rα1. What is also very original with lebrikizumab is that it allows IL-13 to bind to the IL-13Rα2 receptor, which is postulated to have an anti-inflammatory role by neutralizing the excess of IL-13. This is also an interesting differentiation thread with, for example, tralokinumab, which does inhibit that second receptor. If you look at the Phase IIb data, which are public, which are out there's nothing new here, but I wanted to quickly have a look at it. If you look at pruritus with an every two weeks dose regimen, we see a 70% reduction of the pruritus score.

If you use the product every month, you still see a 47% reduction of the pruritus score. If you look at EASI-90, which is a very high bar to reach in atopic dermatitis, you see that for the every two weeks, 44% EASI-90, and for every month, 36% EASI. If you would make indirect comparison, which I don't like, but you know, since everybody does them, I also do them, you will see that those data compare very favorably with what is out there, either in the clinic, either in clinical development. Safety looks a priori, very reassuring. You see very low data on conjunctivitis or herpes infections. Last slide on lebrikizumab. Really interesting. Since we exercised the option on lebrikizumab, so in June 2019, there's only been good news to the product.

The oral JAK UPA from AbbVie has been launched in the U.S. in rheumatoid arthritis, it's also under development in AD, but they have received a black box warning. It is very reasonable to assume that also in atopic dermatitis, they will have a black box warning. We have initiated phase III, even a little bit ahead of schedule in October 2019. Two potential competitors dropped out of development. There was the IL-17C from Novartis that was stopped in October 2019, and the anti-IL-33 from AnaptysBio that was stopped in November 2019. In the meantime, as I mentioned before, dupilumab working on access and also opening the way for future incumbents in that indication. Sanofi announcing in December 2019, global peak sales for DUPIXENT of EUR 10 billion. Also kind of an external validation of the potential of these products in these therapeutic areas.

Then in December also, tralokinumab hit its primary endpoint, but no details were provided. Perhaps the most important part was, of course, in January, which with the acquisition by Lilly or Dermira, kind of, for us, also a very solid external validation that we made the right choice when we took the option on lebrikizumab. Basically what we've done here, we took again an option, so we de-risk it for us, on a product that is in Phase I/IIa in CTCL. CTCL is a very severe disease in the field of oncodermatology. I'm not going to dwell on all the details in the interest of time, but the burden of disease, the high end medical need.

What this company has is a very innovative platform where they can design peptides which tackle different, or which tackles the signaling of different cytokines with blocking a common receptor. This technology, in the case of BNZ-1, which is their lead product, blocks IL-2, IL-9 and IL-15, and orphan drug designation has been granted by the FDA. The way we are having constructed the deal with Bioniz is as follows. We have the option. We will have the readouts of the clinical data later this year. If we like the data, we will exercise the option. We will have all the global rights on BNZ-1. In parallel, we'll immediately start a broader research collaboration with this company. The idea is that they will bring to us three IND-approved molecules in dermatological conditions, which we will decide, working with their proprietary multi-cytokine inhibition technical platform.

This should give us three additional candidates. What I forgot to say is also that BNZ-1 first indication is CTCL, but there are other indications that will come for this product, amongst others, alopecia areata, which is also a very severe disease in the field of dermatology. Short touch point on the launches. First of all, Ilumetri, our biologic in psoriasis in Europe. You see there actually, the data, the patient data in Germany month after month, and you see that we're actually tracking very, very nicely with the uptake. Just to situate you, the product was launched roughly one year after guselkumab and roughly six months before risankizumab. The three IL-23s. Risankizumab was launched in Germany, about May, June last year. Despite the launch of risankizumab, you see that we continue to gain month after month patients on Ilumetri. Right?

This is certainly a very competitive space, but we think that we have a very good product. The longevity of action, we have four years long-term efficacy data. The product is extremely well-tolerated. It is one injection by quarter, and we think that the IL-23s are going to be the winning class, and that being in that class of the IL-23s, we will continue to grow the product very nicely. Skilarence is the oral drug. You may remember that there was a lot of use of DMF in Holland and in Germany. We basically saturated those markets, and that shows the very nice growth of Skilarence. You should continue to see the product growing in the future, albeit in a more gradual pace, because those two heavy DMF markets, Holland and Germany, we have now market shares in those markets of about 80%-90%.

Of course, much higher in those markets will be difficult. Last but not least, Seysara, our antibiotic in moderate to severe acne. We have a very nice uptake of the TRx. We have already reached a 6% market share in TRx in the U.S. in the broad oral antibiotic market prescribed by dermatologists. We will continue to grow the brand and work hard this year in improving the gross to net ratios by dialing back on the co-pay cards. Capital allocation. Obviously, it's clear that we have created to ourselves lots of opportunities. The ongoing launches, the upcoming launches like tirbanibulin, lebrikizumab. If we exercise the option with Bioniz, it's an orphan drug. This will be a quick development, much more to come into the pipeline.

We have to make sure from a resource allocation standpoint that we fund those opportunities for us to create mid to long-term shareholder value. We will not compromise in making sure that those opportunities are really maximized and sufficiently funded. Number two, obviously, continue to transform the R&D pipeline. We are absolutely not there yet, but we have really made very good progress in the last 12 months, and I have shown you some examples. We intend to secure a stable dividend to our shareholders. We continue to be on the lookout for potentially accretive M&As, because further increasing our critical mass in some businesses and some geographies would also have a very, I would say, virtuous effect on our capabilities to launch the products and to bring them even further with all the opportunities that we have now created.

In closing, I would just say that we think that the strategic transformation at Almirall is now firmly underway. We have a very good momentum for our key growth drivers. European psoriasis franchise, Seysara in the U.S. We have made significant progress across the late-stage pipeline, but also the pre-clinical pipeline, which I haven't showed you today, but also there we have really made a lot of progress. Finally, management remains firmly focused on additional external opportunities to generate sustainable value for our shareholders and future growth process. With that, I thank you very much for your attention. Good morning and welcome to the Q&A session, which I'm willing to take any question.

Antoine Natali
Healthcare Investment Banking, J.P. Morgan

I have a general question on my side with all the recent news on strategic acquisitions that you've announced lately. What do you see as your next key challenges for 2020?

Peter Guenter
CEO, Almirall

Perhaps I'll start and, Bhushan and Mike, please chime in here. I think that in the presentation, I alluded a little bit to it, is that we've created really some very nice opportunities for us to create very significant mid to long-term value. The mistake we should not do is try to be very, very short-term oriented here. Contrary to 2019 it means that you will see some increase in SG&A, for example, for this year. The other thing I alluded a little bit to is the concept of core EBITDA, which is really nicely showcasing the underlying performance of the company, which continues to grow and which will continue to grow. Of course, it's also fair to say that the other income line will not continue to be at the same level as it is today.

I think it's important if you look at our numbers for the coming years that you really focus on top-line sales, on core EBITDA, rather than what you may have been looking at in the past, other income. I know, Mike, if you want to add something.

Mike McClellan
CFO, Almirall

There's some things that are going to happen in 2020 that are expected. Just to remind you, we have seen the launch of a generic of Aczone 7.5% in the U.S. We will see some impact there. As Peter mentioned, SG&A will invest in these new product launches. We were aided a little bit in 2019 by the divestment of the aesthetics business in the U.S., which actually freed up resources. That was part of the reason why we were able to keep the SG&A a little more in check in 2019. The other income will be switching in 2020 from the more milestone-based income you've seen over the last couple of years from AstraZeneca to a pure royalty model. You will see a change in that line.

Peter Guenter
CEO, Almirall

Perhaps one comment I would add is, I've talked to you a lot about the dermatology business. We still have a decent business in Spain, which is very nice, which is very profitable. You may know we have a new government in Spain after lengthy debates and many attempts to have a government. Of course, we don't know what that government would keep as a surprise to pharmaceutical companies in terms of pricing or whatever measures they would take. This is a little bit early to say, but hopefully we'll know more a little bit later.

Speaker 5

I heard a few sort of [audio distortion] , slightly. I'm just wondering how you view that as sort of competitive to, say, Seysara.

Peter Guenter
CEO, Almirall

All right. Yeah.

Speaker 5

Yeah. Whether you view that as competitive to, say, Seysara, and how you sort of are going to go about reducing the couponing going into next year and still retain the sort of nice market share you've got on the scripts.

Peter Guenter
CEO, Almirall

Yeah. I didn't hear the first part of your question because you didn't have the mic, but you're talking about the new topical?

Speaker 5

Yeah.

Peter Guenter
CEO, Almirall

Right. Okay. Yeah. Bhushan, you may want to complete, from all we know, the very vast majority of patients with moderate to severe acne are treated both with an oral and with a topical. If anything, we think this product may take market share in the topical space, we have never seen a new topical negatively impacting the overall oral antibiotic market. The overall oral antibiotic market is a humongous market. It is completely flat, despite the fact that every now and then you would expect that oral antibiotic market may be influenced by some guidelines not to prescribe them too long, et cetera. In reality, we don't see anything of that. Bhushan, anything you want to add?

Bhushan Hardas
Chief Scientific Officer and EVP of Research and Development, Almirall

Yeah. When a dermatologist is going to prescribe oral antibiotic, it is not for its antibiotic activity, but for its anti-inflammatory activity. Our primary efficacy is 12 weeks. There's no competition per se, because the topical is still used as an antibiotic, but Seysara is not prescribed or used as an antibiotic, but as anti-inflammatory. We think there should be no competition at all.

Speaker 5

When do you expect to see the full phase I-B CTCL data for BNZ-1? If you do exercise [audio distortion] how will development responsibilities be handled?

Bhushan Hardas
Chief Scientific Officer and EVP of Research and Development, Almirall

We expect to see the data early next year or late this year. When we see the data, we will know whether we will be able to go to phase III straight up in CTCL. At the same time, we will activate phase II trials in other indications that Peter just talked about, like alopecia areata.

Speaker 5

You'll be handling that development.

Bhushan Hardas
Chief Scientific Officer and EVP of Research and Development, Almirall

Everything is, once we acquire, execute an option, it's our responsibility.

Speaker 5

Apologies if I missed it. The data is from M&A, I guess, you've done the sort of deals earlier stage pipeline. Is there still an interest in sort of later stage product deals at this point?

Peter Guenter
CEO, Almirall

Yeah, absolutely. I think we have to try to do both things at the same time. Building up the pipeline, late-stage assets and licensing, having our proprietary research product move into the clinic. At the same time, being on the lookout of acquiring immediately accretive business in either some key geographies or some key areas. Every now and then there are some assets that are shopped around, if I may say so, and we always take a look at that. We have absolutely the financial power to do those deals, and it would be very beneficial because if we could increase the critical mass of the company to even the further levels in the future, it would actually be helpful to fund even better the innovation agenda. The two go actually hand in hand.

Speaker 5

Think about gross to net in 2020, and how are you going to manage that transition in terms of reducing?

Peter Guenter
CEO, Almirall

For Seysara, we have actually since this week, reduced the generosity of the co-pay card. What you should expect in the next couple of weeks is a decrease of prescriptions. This is actually a good thing, because we will get rid of the non-profitable prescriptions. Once we have a new level of profitable prescriptions, we will start to regrow from that new base, but with very different gross to net assumptions. That's really what we're going to try to achieve in 2020.

Speaker 5

All right. What's the expectation for timelines to the clinic for the 23andMe anti-IL-36?

Bhushan Hardas
Chief Scientific Officer and EVP of Research and Development, Almirall

We will start preclinical trials in about a year for the current. It should be in the clinics late next year, definitely.

Peter Guenter
CEO, Almirall

This is also a very specific antibody. We're really proud with this deal, to be the first one to be a customer of 23andMe and their very exciting things that they do with their databases. We think that the potential clinical applications of that antibody is going to be very interesting. We're very excited by that one.

Speaker 5

Actually, just to follow up on that, 23andMe have a separate collaboration with a CRO called TrialSpark. Is there any thought about patient selection using the genetic profiling through 23andMe in order to recruit patients?

Bhushan Hardas
Chief Scientific Officer and EVP of Research and Development, Almirall

Sure. That is definitely what we are thinking. When we start the clinical trials, that will be one of the ways that we will select the patient, select where the site should be, because then you know where the patients are. Also we know where the site has been, so you may choose a really appropriate site where you really get fast recruitment and better treatment naive patients.

Speaker 5

[Ervan], globally, you highlighted that you're having some issues and that you're taking some mitigating actions. Can you walk us through what you're doing?

Peter Guenter
CEO, Almirall

Actually, Ciclopoli in 2019 was relatively stable. The two reasons for that were, number one, our partner, Menarini, had some new competition in Korea, which they are actually addressing as we speak, and we will see better numbers from that partner business in Korea. The most important part is actually Germany, where we are a market leader in what actually is a large market in onychomycosis in Germany. We continue to be market leader. What we have seen in 2020 is that the overall onychomycosis market stabilized compared to 2019, and that was actually a different given compared to the previous years, where we were looking at a very dynamic onychomycosis market.

We are confident for 2020 that we will again be able to grow Ciclopoli, quite nicely actually, by the mitigating actions, by new actions that we take in Germany to not only defend our market share, but really continue to increase our market share. Moving forward in 2020, you should see, again, a growth for Ciclopoli. Yeah.

Speaker 5

I just want to go back to Seysara. There's some inherent challenges in pulling back on co-pay cards. It's something we saw with [Dermira] and QBREXZA broke their uptake curve, and then you see the opposite with Vusion is able to effectively keep volumes while taking the price. I guess, what are those challenges and how do you plan on addressing them to make sure that Seysara trend is still strong?

Peter Guenter
CEO, Almirall

Yeah. Well, you saw it with QBREXZA, where indeed they had a temporary dip in the prescriptions. Then they started to grow nicely again from that new base. Basically, for us, it's quite clear that if we get rid of these unprofitable prescriptions, well, you will see them disappear. It will have an impact quantitatively on that. It all depends on moving forward or continue to increase your profitable prescriptions, get rid of the non-profitable prescriptions, taking a little bit of a hit by getting rid of those non-profitables. Then you have your new base on which you start to grow.

To me, it would be surprising. Basically what we're going to do is that for non-covered patients, our co-pay card will go up to EUR 125, and that is, of course, a very high amount of patients to tolerate, and we do predict that the vast majority of those non-covered patients will not be ready to pay EUR 125 for the drug, and therefore walk away. These prescriptions will simply disappear. There's no magic bullet to immediately replace them by an increase or an acceleration of the increase of the covered patients. You would need to have an acceleration of the increase of the covered to compensate for the non-covered that will be dropped.

Speaker 5

I'm interested to follow up. You can see it with QBREXZA, but also with AJOVY, there's a flat lining of the scripts once you pull back on the co-pay cards. I guess, how do you prevent the flat lining of scripts? How do you make sure it continues to grow?

Peter Guenter
CEO, Almirall

By gaining market share in the covered segment. Yeah. Today, remember, 6% market share is good, but it's 94% market share that we don't have yet, right? Of course, there's many opportunities for covered prescriptions in that enormous bucket. It's really a matter of continue to gain market share in the covered segment.

Speaker 5

To what extent is the pre-biologic segment of atopic dermatitis or psoriasis in strategy, that area that you're working towards or?

Peter Guenter
CEO, Almirall

Well, in Europe, for example, we have a very nice portfolio in psoriasis now. We have an oral drug, we have a biologic. I didn't dwell on these products. In many countries we also have topical products in psoriasis. If we would have opportunities to build a similar portfolio in atopic dermatitis, with our antibody, with perhaps some kind of topical solution, we would certainly look at that. As you know, there's a lot of oral JAKs who are developed in atopic dermatitis. I'm a little bit dubitative, to be totally honest, on the oral JAKs. They come with baggage on side effects, which makes me believe that the impact of oral JAKs will be reserved to some type of patients. I think dermatologists are a relatively risk-averse population.

I think that really what's going to be the big bulk of the market is going to be the antibodies in atopic dermatitis rather than oral JAKs. Oral JAKs will take a place, but I don't think they will dominate the market. Then, of course, if there would be very good opportunities for, let's say, innovation in atopic dermatitis with a topical formulation, for sure. The issue with topicals is that from a pricing and reimbursement perspective, it's more difficult than a systemic drug. Yeah. Prices for any topical in Europe are low. Typically for topicals you would look at the U.S. market. But even there, the market dynamics for pricing and reimbursement for topicals in the U.S. market have also fundamentally changed. At the end of the day, it depends on the outcomes, what the product would give you.

Well, of course, lebrikizumab, we have to focus on Europe because that's where we have the rights. If there would be a good topical available, we would definitely look at it for Europe, even for the U.S. That's how the market in dermatology really shifts. With topicals, it's difficult to get a decent price. Yeah.

Speaker 5

If you look at the Ilumetri scripts in the U.S., you can see that they've kind of, after being sort of resilient at the beginning, have now started to kind of tail off and lose share to SKYRIZI and so on. Just wondering if you think what the differences are between the U.S. and European landscape and how you can kind of prevent a similar trend.

Peter Guenter
CEO, Almirall

Well, it's rather a question for Sun Pharma, so I will not comment on what Sun Pharma is doing in the U.S. The only thing I can tell you is that, we have seen no deceleration of our capability of getting new patients on Ilumetri, even with the launch of risankizumab. As I told you in my speech, I think that if you would talk to KOLs, I would say that 90% of KOLs would admit that IL-23 is the way to go for the vast majority of psoriasis patients, and that the IL-17s or even the TNF alphas are still the product of choice for PSA patients. In the totality, let's say it's about 30% of patients who have PSA and PSO, right? It means that in 70% of the cases, call it the pure PSO patients, IL-23 is the way to go.

I think that those ships will all rise with the tide. I'm not going to say that we're going to take 60% market share in the IL-23. That market is so big and so dynamic that even with a decent market share, you can really have a very nice revenue coming your way. If I look at the other markets we have launched in Austria, the product is doing well. We are launching now in Spain, our home market, where of course, we also benefit from the, I call it the Almirall effect in Spain. We are opening hospital after hospital or clinic after clinic. That's the way it works in Spain. Again, we see a very nice uptake in the months of November and December with Ilumetri. U.K., like always, a very small market.

Even if you go through NICE, you have to open CCG by CCG. That's exactly what we're doing. Actually, NICE has recognized Ilumetri as the most cost effective of the IL-23s. Of course, we're leveraging that. It's not only Germany. It seems to be a pretty homogeneous performance. We are actually, as we speak, we're talking to the French authorities. We have had a first meeting with the CEPS. We have submitted the file for the Transparency Committee in France. We have some kind of fast route approval for Ilumetri in France, a kind of a cost minimization approach, which would, if everything goes well, allow us to launch the product also in France by probably September this year.

France is a market where if you get to the Transparency Commission, which is the big challenge, it really is a big market for innovation. French doctors still embrace innovation. I think that if you have a good position in Germany, a good position in France, and a good position in Spain for biologics, you can really make a decent living out of it.

Speaker 5

How should we think about bridging to core EBITDA growth for 2020 as other income is lower? I mean, what are the offsetting growth areas?

Peter Guenter
CEO, Almirall

Mike, you want to take it?

Mike McClellan
CFO, Almirall

Yeah. I think we talked a little bit about the factors in the opening. You're going to continue to see the growth of these new launches. You're going to, of course, have a little bit of an offset with the ACZONE generification. We will lose some sales there. You're going to probably see a little bit of a need to invest. It's too early to give you any kind of guidance for 2020, if you take all those things into consideration and you think that the other income is also going to start to dissipate over time, you're going to see that 2020 will potentially have a little bit of pressure on it. In the midterm, we've got great growth profile. I think, at the core EBITDA level, I think we'll manage that as best we can.

The other income is really just an artifact of the history, and you're going to start to see that decline over the coming years.

Speaker 5

Just on the gross margin, because you made some quite nice progress earlier on in the year, you had some of these provisions which sort of offset that. How should we think about the natural run rate of gross margin going into next year with the genericization of ACZONE? Are there any other big sort of drivers, positive or negative, we should think about?

Mike McClellan
CFO, Almirall

Yeah, I think the ACZONE's going to be the biggest impact on the gross margin. Of course, the new launches, the biologics, are a little bit in a better margin shape. Overall, we're looking at trying to keep it relatively steady. Then in the future, as you get out into the midterm with the new products taking more and more of a share, you should start to see an improvement in the gross margin.

Speaker 5

On ACZONE, how do you think about the decline of the generic settlement?

Peter Guenter
CEO, Almirall

This is an authorized generic. We have a settlement with the first filer, Taro. Of course, I cannot disclose the details of that settlement, but we will have some kind of royalty on their net sales, which means that you will see part of that loss of ACZONE compensated in other net sales. Can't really say much more than that. Okay, I'm seeing signs that we should stop, thank you very much for your very good questions. Thank you.

Mike McClellan
CFO, Almirall

Thank you, everyone.

Peter Guenter
CEO, Almirall

Thank you.