Almirall SA

MAD:ALM

Earnings Call Transcript 2021-Q3

[Operator]

Good morning to everyone on the call. Thank you for joining us to review Almirall's Q3 results. I hope everyone is safe remaining healthy. As usual, you can find the slides to this call on the Investors page of our website at almirall.com. Moving to Slide 2, I would like to remind you that information presented in this call contain forward-looking statements that involve known and unknown risk, uncertainties and other factors that make cause actual results to differ materially. With that, please advance to Slide 3. Presenting today, we have Gianfranco Nazzi, Chief Executive Officer; Mike McClellan, Chief Financial Officer; and Karl Ziegelbauer, Chief Scientific Officer. Gianfranco will review the quarter business performance and the growth drivers. Karl will provide you with detail on the pipeline before passing to Mike to review financials. Gianfranco will then make the closing comments before opening up for a Q&A session. I would like to pass you over to our CEO, Gianfranco.

[Gianfranco Nazzi, CEO & Executive Director]

Thanks, Pablo, for the introduction, and good morning to everyone on the call. I am pleased to say that the business is continuing to perform well with a solid performance from the core business and the continuation of a good momentum from our growth drivers and recent launches. Despite the slow July and August impacted by COVID, we have seen a recovery in September, especially in the U.S. We are, therefore, very confident in meeting our upgraded 2021 guidance providing [indiscernible], tightening the core EBITDA range by increasing the base level to EUR 200 million from EUR 195 million. To highlight our growth drivers perform, we continue to see strong performance from Ilumetri with excellent momentum from the anti-IL-23 class, where Ilumetri has gained market share and is gaining traction in France, Spain and Italy, which are the contributing to the overall growth. Seysara has had an improvement in TRx market share year-to-date based on the new macro geology level. Since we launched Klisyri in the U.S., we are receiving positive feedback from dermatologists and patients, and we have seen positive trends in recent weeks with good progress on the coverage. I will provide further details on the growth drivers shortly. But overall, good momentum despite the impact of COVID, particularly in terms of accessing new patients in some geographies. The late-stage pipeline is progressing well. As you have seen, we provided the results of lebrikizumab Phase III data in August, we continue to work with our partner Eli Lily towards the 2023 European launch. Karl will explain more on this later in the presentation as well as the details of the recent European approval and launch of Klisyri in Germany and the U.K. Furthermore, Wynzora has been approved in 7 countries, and we are finally in preparation to launch early next year. We have strong midterm sales growth potential from our innovative pipeline to unlock the huge potential to grow in our core medical dermatology business. And lastly, as you will have seen in September, we issued EUR 300 million in new bonds that we used to repay the EUR 250 million of convertible bonds that come to due date at the end of the year. Mike will run you through details in a simplified capital structure later in the presentation. But as you can see, it has been a busy quarter for us. So let's move now to the performance of our growth drivers, starting with the strong momentum of Ilumetri. As you hope, psoriasis carries a high disease burden, and patients can have a very significant impacted quality of life. Therefore, it is important that [indiscernible] provide longterm control and treatment strategy to reduce the disease burden and improve the quality of life. The slide shows you the market dynamic in the anti-IL-23 class in Germany. Here, you can see clearly the strong uptake in the anti-IL-23 class had increased to 39% market share of the new patient within the biologics. In our view, this is a reflection of physician beliefs in the strong efficacy profile with a key attribute being approved latest last in efficacy with convenient dosing and with no significant safety concerns. Why their is tough competition within the anti-IL-23 class in Germany, Ilumetri has a strong market share, which has increased to 29% with the class and in August has achieved its highest monthly market share. This continued growth momentum is due to Ilumetri adding a compelling product profile with long-term [indiscernible] efficacy, very good tolerance and deliver maintained control for psoriasis patients and easy to use as the key attribute. This superior profile, combined with the quarterly dosing regime will continue to support the grow of the product in the winning class. As you can see, Ilumetri has had a strong performance with sales growing sequentially as the new country launches gain momentum and contribute to the overall growth to achieve a net sales of over EUR 20 million. Despite a softer August due to the seasonality, it resulted in a lower growth of quarter 3 versus quarter 2. The level of seasonality was not as evident last year due to a lower level of net sales. I would like to highlight that in September and October, has seen an acceleration and in particular, October, which has the highest level of net sales of EUR 8.2 million. I have already mentioned the good performance in key markets, Germany, that has continued to drive sales growth. In addition their has been quality momentum and contribution of new contract country launches like France, Spain, Italy, Austria and Switzerland and our latest launch in Portugal, which is really good achievement and validation of the potential of this product. We remain full confident with growth potential going forward with data of September being very encouraging, continued the good momentum of Ilumetri with. With that, I would like to turn next to focus on 2 key [indiscernible] product launches in Europe, Klisyri for the treatment of the actinic keratosis and Wynzora accredited for the treatment of plaque psoriasis. We are very pleased to announce that the U.K. and Germany are the first 2 European countries where Klisyri is available for prescription. The product has been approved for the treatment of the actinic keratosis by the U.K. medicine and health care product regulatory agency and by the European Commission. Klisyri is doing very well in Germany. And for the first month, we have achieved 5,200 prescription and more than half of the wholesaler having already placed order. The route of Klisyri Europe enhances our leadership in the European market, where we believe we are the #1 player for the treatment of actinic keratosis. Market growth is anticipated to be the driver for several factors, including aging population and the rising prevalence of the disease in part due to the environmental factors such as increased sun exposure. It is estimated that approximately 1 in 10 adults in Europe suffered from an actinic keratosis. This is one of the most common diagnosis made by the dermatologists in Europe with a prevalence of approximately 18% of the population and [indiscernible] over the age of 60. In this context, the commercialization of Klisyri is an important addition to dermatologist option to treat actinic keratosis and marks another milestone achieved by Almirall in its mission to bring new and innovative solution for actinic keratosis patients around the world. As launch in general in the U.K., we are on track with the rollout in the rest of the European market. Launch ratings have been positive, given this [indiscernible] option for a short duration and is a good tolerability profile that will significantly improve the actinic keratosis levels of our patients. Now move into another product launch in Europe, Wynzora. Wynzora is the only fixed dose calcipotriene and betamethasone [indiscernible] combination cream been developing user part formulation technology for other patients suffering from mild to moderate psoriasis. This technology are highly tolerated even in sensitive tissue with an important feature of the product. Preparation of the European launch are in the final stages with the loans expected in early 2022, following approval in Spain, U.K., France, Norway, Austria, Denmark and Czech Republic. This is a decentralized procedure, which required approval country by country. The product has a clear strategic fit within our portfolio, providing a full range of psoriasis product that covers the patient journey, strengthening our position in the European psoriasis market. Almirall will be the only pharma company with a full portfolio of psoriasis product, metric, a biologic systemic treatment, [ Seysara ], an overall systemic treatment and Wynzora, a topical product. With key market introduction, 2022 is a very busy year for our teams with the rollout of Klisyri and Wynzora, Two very important growth drivers for Almirall with more to follow in the short to midterm. Now let's take a look at the U.S. product, starting with Klisyri, which we launched in February of this month. We are pleased with the uptake where Klisyri continue to make steady gains month after month. with a positive trend in recent weeks following seasonality in the summer months. We are starting to see better assets after the summer versus the difficulties in accessing physicians due to the COVID-19, which has challenged the uptake of the new product. The product has gained penetration in the actinic keratosis topical market with more than 15,000 prescriptions having been generated since the launch with a market share above 2.5%. Let me remind you that actinic keratosis is the second most common diagnosis made by dermatologists in the U.S. where the existing topical therapies are associated with significant side effects, such as pain, inflammatory reaction, hypopigmentation and scarring. The strategy has always been to generate a lot of user experience and most importantly, is the feed from the dermatologists. Patients are experiencing a strong immediate benefit by addressing the tolerant in limitation of existing treatment. Klisyri offers a good product profile, which represents a significant step forward in the treatment of the actinic keratosis due to a short treatment protocol. [indiscernible] daily application for 5 days proven efficacy and good safety profile. In this context, we believe that Klisyri is well placed within the market where more than 2,000 healthcare profession have been prescribed in Klisyri since the launch and the product has acted to more than 70 million covered lives within the commercial space, where we are targeting more than EUR 100 million by the year-end. This will be a key focus area for our strategy to gain payer coverage to drive sales volume. We are in active discussions with multiple PBMs to increase the commercial coverage to this year. Related to this matter, Medicare Part D is expected in 2022. Access is also making good process -- progress, sorry, as we differentiate Klisyri from what is already available in the market based on efficacy, tolerability and convenience. Promotional efforts are on the higher despite prescribers, which should reinforce the acceleration of the performance of Klisyri. Our expectation is that we should be able to gain a good level of market share as dermatologists are seek for new options to treat the actinic keratosis patient, and we will continue to support the launch in the U.S. Now let's take a look at Seysara. Our strategy remains the same to rebuild the TRx and increase the market share as rapidly increased their face-to-face interaction with physicians on we see normalization from COVID-19. As you can see, the third quarter has continued to make modest gains some gains on the TRx side. We will continue to dedicate resources to further differentiate Seysara based on the microbiology label, which is an important factor that we are able to leverage with physicians and really differentiate the product from the older generics that continue to dominate the market. We are focusing our effort on increasing market access as we continue to increase the commercial coverage plan with several PDLs. We are aiming to exit this year with 54% of access. Our strategy for access is making good progress as we focus on increasing our interaction with prescribers that we're actively prescribing [ pre-COVID ] We think this is a very good product with good profession, and we continue to work hard on our execution plan to rebuild the TRx and market share. With that, I will pass over to Karl to update you on the pipeline.

[Karl Ziegelbauer]

Thank you, Gianfranco. Here, you will see that we have made excellent progress on the pipeline. Firstly, we are very excited having announced the top line readout of the Phase III clinical trial of lebrikizumab, which I want to take you through later in the presentation. Furthermore, can Gianfranco has already discussed the approval of Klisyri in Europe and the successful launch into the U.K. and German market. In parallel, we are preparing the EU launch of Wynzora, which I will elaborate on shortly. For Seysara China, we will work towards the start of the Phase III trial as planned, having already received the acceptance of our clinical trial application. We think this is an interesting opportunity, and we will update on how we go to market as this develops. And finally, efinaconazole in Europe, having already been approved in other countries, the plan is to use as much as possible existing studies for example, the U.S. Phase III data to get approval in Europe. We have -- we are already working towards the pre-submission meeting with regulatory authorities in the coming months and will update you on the feedback from those meetings. Finally, we will initiate the Klysyri [ large ] feed studies this quarter to make it even more competitive product. We expect to have a submission in mid to late 2023. Once we have the large field approved, this will be the second inflection point for growth. will be once we have the large field approved, this will be the second inflection point for growth and will be even more effective in competing with generics such as [indiscernible]. Furthermore, we are looking at additional indications. We will update you when we have a solid plan. As you can see, we are making good progress on the pipeline. And we are on the right track to strengthen our leadership position in medical dermatology, while we continue to look at external opportunity within our key markets which complement our portfolio. We have a strong midterm sales growth potential from our innovative pipeline to unlock the huge potential to growing our core medical dermatology business. With that, I would like to turn the focus on our exciting opportunity we have with lebrikizumab in atopic dermatitis. Atopic dermatitis, it's an immune-mediated chronic skin condition with a significant impact on the well-being and quality of life of patients. Patients with moderate to severe atopic dermatitis have reported -- have a larger impact on quality of life than patients with psoriasis with a condition occurring at any age are typically starting in childhood, and then changes severity over time. Prevalence of atopic dermatitis is very high in pediatric population, and it could be as high as 20% with all rates of severity. The atopic dermatitis market is expensive, growing and diverse -- Despite recent treatment advances, there remains a large unmet need to provide new options to patients that provide effective and well-tolerated treatment options. The patient numbers with moderate to severe disease are large and growing and the penetration of biologics is still extremely low. It is estimated that it should have over 5 million patients suffering with atopic dermatitis in Europe by 2026, of which nearly 4 million will receive treatment. We estimate about 11% to 14% of this population is going to get a new treatment thereby about 1 million of these patients will be treated with new therapeutics modality. This remains a significant market opportunity with high unmet medical need. We expect the market to grow going forward, and we believe lebrikizumab will be an important medicine for patients as there is a clear need for new and differentiated therapies as several currently available treatment options are broad modulators of inflammatory pathway, which can often result in significant side effects for patients. With lebrikizumab in our pipeline, a potentially best-in-class IL-13 antibody, it gives Almirall the unique opportunity to help these patients live a better life. The development schedule remains on track with admission to the EMA expected in 2022 and subsequent approval and release estimated to be obtained in 2023 in the EU. Let me now explain in more detail the significance of the top line results from the 2 monotherapy studies. The Phase III trial is an important milestone in our clinical development program for lebrikizumab, a medicine that we believe has the potential to be best-in-class IL-13 treatment and reaffirms our steadfast commitment to the dermatology community worldwide. ADvocate 1 and ADvocate 2, our ongoing 52-week randomized, double-blind, placebo-controlled parallel group Phase III studies decide to evaluate lebrikizumab as monotherapy in adult and adolescent patients. Adolescent patients means age 12 to less than 18 years of age and weighted at least 40 kilograms, both with moderate to severe atopic dermatitis. The primary efficacy endpoints were assessed at week 16 in the 2 studies and were measured by an investigator global assessment, IGA score of clear or almost clear skin with a reduction of at least 2 points from baseline at [indiscernible] 16 and at least a 75% operator change from baseline in the Eczema Area and Severity Index, EASI score at week 16. The full study results from ADvocate 1 and ADvocate 2 will be disclosed at future scientific congresses in 2022. Data from a Phase III combination studies with topical steroid called [indiscernible] lebrikizumab in patients with atopic dermatitis will be available later this year. These studies are part of the Lebrikizumab Phase III program, which consists of 5 key ongoing global studies, including 2 monotherapy studies and the combination study as well as long-term extension called the joint and adolescent open label trials. The trial is called [ ADor ]. Lebrikizumab has the potential to be best-in-class therapy for treating AD in a class where it has been published that ID is an IL-13-dominant disease. -- lebrikizumab is designed to block block IL-13 signaling, but does not block endogenous IL-13 regulation, which we believe is an important feature as for its known anti-inflammatory properties. Finally, Almirall is studying now various options for Phase III trials for lebrikizumab, and we will communicate it to the market once we have made a decision. With that, I will pass over to Mike to run you through the financials.

[Michael McClellan]

Thanks, Karl. Looking at Slide 18, as Gianfranco in the introduction, we've seen a solid performance with [ core ] growth from the core business through Q3, and we're very confident in meeting our upgraded 2021 guidance with a tightened core EBITDA outlook. We have seen good momentum in Q3 for our recently launched products, including in the U.S. Year-to-date, core net sales increased 6% and core EBITDA increased over 20% year-on-year, driven by positive contribution from growth drivers and a strong EU dermatology performance. In Q3, we saw a gross margin of 67%, which we see as a good proxy for the next few years based on our current mix and the fact that our recently launched products have royalty commitments to our partners. Year-to-date, with the addition of one-offs, divestments and other milestones received during the year, we achieved a core gross margin of 68.5%. In terms of OpEx, SG&A has increased in line with our expectations to support recent launches of criteria in the U.S. and EU markets, the Ilumetri rollout and some normalization of spending post-COVID. The overall outcome is strong growth of our core EBITDA year-to-date of $164 million. We've also seen very strong operating cash flow reaching $161 million year-to-date, resulting in a very healthy balance sheet as we finished the quarter at 1.3x net debt-to-EBITDA ratio. This quarter, we've also successfully completed the issuance of $300 million in senior notes due 2026. I will elaborate on our simplified capital structure later in the presentation. Let me now move on to give you more detail behind these numbers. On Slide 19, here, you can see the dynamics of the core business in the EU and the U.S. markets year-to-date. The European dermatology business has had a very strong performance, while there's also been an increase of our nonderma products compared to 2020. As you can see, the other EU line year-on-year has increased, but this has been influenced by the lateral divestments earlier in this year, offset by lower cough and cold product sales. Moving to our U.S. business, similar to many of our peers, we are still seeing a negative impact from COVID, particularly in terms of capturing new patients. As previously communicated, the generic impact of [ Axon ] has been annualized. However, we expect to see additional competitors by the end of this year, which will erode most of the remaining sales in 2022. Overall, our portfolio has limited patent expiry risk going forward in the near term outside of [indiscernible] in Spain, which will be impacted in late 2022. Additionally, Rest of the World General Medicine has seen a decline year-on-year, mainly driven by [indiscernible] and other products that have higher demand during the pandemic in 2020. While we've seen some improvement in doctor consultations and better patient flow, COVID continues to influence the business, and we will continue to monitor this situation as we move forward. Similarly, we are monitoring interactions between reps and doctors to see how it will evolve. It has been slow for reps getting back to industry positions, which will take a little longer to get back to pre-COVID levels as things start to normal. Spo moving to Slide 20. Looking at the year-to-date dermatology sales. We registered a strong performance in Europe driven by the growth of Ilumetri as well as strong trends for Cyclosporine and our Decoderm franchise. The U.S. business continues to be impacted by COVID with a slower intake of new launches and softer demand in some areas, However, we have seen some improvement in recent months. Most notable is Seysara versus last year, where we will continue to work hard to rebuild the TRx and increase market share. While COVID-related restrictions are easing in the U.S., we anticipate a slow but steady progress of patients visiting their doctors at a normalized rate. The other U.S. products were affected by a returns accrual adjustment in the 2020 numbers. I would also like to highlight the consignment and royalties from authorized generics that are included in the brand sales for '21 and '22, and Consignment income is not a large influencing factor and it's a common strategy for managing patients with little or limited payer coverage. So as we move on to Slide 21. The core net sales evolution. Here are a couple of things I'd like to pull out for you. The existing portfolio net sales increased by around $15 million year-to-date. As you can see, the growth drivers had a good contribution during the year driven by Ilumetri in Europe and Seysara and [ Criteria ] in the U.S. However, the rest of our U.S. business took a hit of nearly $12 million year-on-year. Moving to Slide 22. I've already highlighted the key factors of the sales performance. So let me continue with our focus on the core business by running you through the rest of the P&L. STNA is increasing in line with our expectations as we continue to invest in product launches and especially comparing to the first 9 months of 2020, where there was low spend due to COVID restriction. The percentage of R&D versus net sales is low, but will accelerate as we start to play [indiscernible] large scale studies and prepare for reimbursement-related trials for lebrikizumab. R&D spend will accelerate not only in Q4 but going forward into 2022. Year-to-date, we achieved a gross margin of 68.5%, which benefited from the contribution of a favorable product mix and one-offs.As mentioned earlier, going forward, excluding one-offs, the 67% we saw in Q3 stand-alone is a pretty good proxy for the gross margin in the coming years. Overall, the increase in core sales and the overall spending led to a core EBITDA increasing 20% from last year, reaching $164 million for the 9 months. The reconciliation at the end of the P&L adds to the deferred income, which is $15 million year-to-date and other income of $1 million from AstraZeneca. Slide 23, continuing down the P&L. The normalized net income, excluding the impairment impact results with a slightly down versus last year, finishing the 9 months with a normalized earnings per share of EUR 0.34. The negative net income is affected by the impairments announced at the half year results. If we move on to Slide 24. Taking a look at the balance sheet, there are quite a few comments provided on this slide, so I will discuss -- and I will discuss the high-yield bond issuance shortly. So I'll just highlight one of the most important factors. We have a very healthy balance sheet, and finished the quarter with a leverage of 1.3x EBITDA to net debt, which gives us flexibility in the current environment for additional licensing and potential M&A activity. Slide 25, taking a look at the cash flow statement. We delivered very strong operating cash flow results, generating EUR 161 million, due to strong operating results after adjusting for the impairments, which is also aided by good control of our working capital and net tax refunds. We have made key investments during the year, including the milestone U.S. commercial launch of Klisyri and the upfront costs for the acquisition of European rights of Wynzora. The divestment receipts referred to milestones and royalties collected from AstraZeneca, these have been classified as investing activities due to the reduced focus in our operations. Additionally, we had the disbursement of almost EUR 12 million for a cash dividend in Q2 of EUR 0.19 per share, with some investors choosing the scrip dividend option. On Slide 26, as you may have seen in September, we issued EUR 300 million in new unsecured senior bonds that we will use to repay the EUR 250 million of convertible bonds that come due by the end of the year. The new bonds bear an annual 2.125%, payable semiannually. Additionally, this quarter, we have repaid EUR 150 million of bank loans using existing cash balances. The high level of interest from investors for our bond issuance resulted in orders of multiple times our request, which we see as an acknowledgment of a sign that the investor community recognizes our strong performance and the significant growth prospects of the company in the coming years. We are pleased with the successful outcome, which gives Almirall a simplified capital structure by the end of this year with no risk of future equity dilution. This gives us flexibility and a strong balance sheet to support options for [indiscernible] growth opportunities in the future. Finally, to conclude the financials, we are tightening our core EBITDA guidance to a range of EUR 200 million to EUR 215 million based on our strong results so far in 2021. We aim to end at the top end of the range, but leave some room for continuing COVID uncertainties. This is aligned with the strong operational performance as our core business continues to perform well, driven by recently launched products. We will continue to monitor the COVID impact and see how the possible variants are going to play out. We expect COVID-19 to continue to have some impact, but have a progressive normalization through next year. And with that, I hand it back to Gianfranco to conclude the presentation.

[Gianfranco Nazzi, CEO & Executive Director]

Thank you, Mike. So as you have clearly heard from us this morning, we have delivered a strong operational performance as the core business continued to perform well and in line with our expectations. We are, therefore, confident in meeting our upgraded guidance for 2021 and then tightening the core EBITDA range. This comes as excellent momentum continuing into the quarter 4, where we are confident in Almirall growth drivers will continue their strong growth trajectory as we continue to support the recent launches. Furthermore, as detailed by Karl, we are progressing well with our existing innovative late-stage pipelines as we continue to execute on our transformation of the company by preparing the business for important launches to support the future growth prospects. The coming months will be very busy for us. Our team will be -- the initiation of a very clinical trials in key market introduction. Additionally, on the execution, I am pleased with the performance of our European growth driver, having achieved a record amount of EUR 8.2 million net sales for Ilumetri in October, and continuing its acceleration for Klisyri in Germany, where 5,200 prescriptions have been made in the first month, with more than enough of the whole sellers adding already placed order, and 95% of them already placed preorders. Finally, Almirall is well positioned for the long-term growth by unlocking the value of the late-stage pipeline. This growth will come from the increasing contribution from the Kyorin and future growth drivers as well as opportunistic inorganic growth by leveraging our strong balance sheet and flexible capital structure. With that, Pablo, I hand back to you for the instruction on the Q&A.

[Pablo Divasson del Fraile, Head of IR & Corporate External Communication]

Thank you very much, Gianfranco. Ula, back to you for the Q&A, please.

[Operator]

[Operator Instructions] Your first question is from the line of Matthew Weston from Crédit Suisse.

[Matthew Weston, Managing Director and Co]

Two questions to start with, please. Mike, it's around cost trends, and you highlighted the expected acceleration of R&D into 4Q going into 2022, but also the SG&A spend in 3Q was clearly a surprise to investors. So can you just map out how we should think about total OpEx cost going into next year relative to 3Q spending, so we can understand the balance of R&D and investment in growth drivers? And then the second question is around gross margin. I think you said that the 67% level seen in 3Q was a good guide for next year and the medium term. I previously recall, you discussed improving to 70% as a target. Has that changed? Has that been pushed further, or had I misunderstood previously?

[Michael McClellan]

Yes. So thanks. First of all, I'll take the gross margin first, and then I'll come back to the rest of the costs. What we're seeing of the 67% is a good proxy going forward. Our near term, especially given the growth of Ilumetri and the other products, is products that are heavily weighted with royalties from partners. And in the case of something like Ilumetri, the better we do, the higher that percentage will go up. We do target to get eventually to 70%, but I think it's going to be later out there. It's going to take well into the launch of lebrikizumab to get there. And the difference in why this is kind of shifting is as we've seen that Seysara is not going to be what we originally thought, that was one of the drivers. We're also seeing that the overall mix and the pressure on costs is just going to continue. So 67%, at least in the next 2 to 3 years, is probably a good proxy of what we can do with our existing portfolio. When it comes to the other cost trends, clearly, we are starting to ramp-up the SG&A. We need to invest in the new launches. You're seeing a little bit more of ability to have activity with the physicians and other promotional activities. We are launching Klisyri where we've ramped up France in terms of the Ilumetri launch. As we go into next year, we're going to have spend on Wynzora. We're going to launch Klisyri in more markets. We need to continue to do prelaunch activities for lebrikizumab. So I think we're in a great period of opportunity, and we have a lot of launches in front of us, but it means we're going to have to invest. The same thing on R&D. R&D has been very slow this year, but we will now start to ramp that up. I remind you that lebrikizumab, because it was a partner deal, all of the R&D has been done by Lilly and Dermira before them up until now. But now, we're going to have to start investing in the reimbursement trials for Europe, and they're not going to be inexpensive. We need to give everything we can to this product to make sure that it is as big as success as it is. So if you take a lot of these trends, I think we've confidence in our upgraded guidance for this year. But as we move into next year, we're going to have a limited gross margin opportunity to grow in the next couple of years and pressure on SG&A and R&D. So we'll give you the guidance for 2022 when we get into February. But if you take all those trends into consideration, it's going to be a year or two where we're really going to have heavy investment needs in the next couple of years.

[Operator]

Next Question from the line of Neil Alexander from Deutsche Bank.

[Unknown Analyst]

How is it going? Can you guys hear me?

[Gianfranco Nazzi, CEO & Executive Director]

Yes, as well.

[Unknown Analyst]

Just one question for me. I know you touched base on Ilumetri. I'm just wondering if you can give us an update on the e-rollout in a bit more detail. I know you mentioned France and Portugal as such. It'd be good if we can get a bit more information, more granularity as such and a bit more detail on the progress in the market outside -- any other markets outside Germany.

[Gianfranco Nazzi, CEO & Executive Director]

Thank you, Alexander. I will take it. So Ilumetri, as we said, is doing very well. So we got a record month in October with EUR 8.2 million. Of course, Germany is the main driver with EUR 4.8 million, and then we got a fantastic market share performance on the IL-23 class with a record of 29%. Good news is also that the IL-23 class is growing very well. They reached a market share of 34%. But nevertheless, also across Europe, we are doing quite well. And you were mentioning other countries. For instance: Italy, we sold more than EUR 1 million; Spain, we sold more than EUR 0.5 million; France, we sold more than EUR 600,000; and also in the U.K., with almost EUR 500,000. If you look at the market share across all those different marketing companies is growing quite well. The only difference versus Germany is that in Germany, the IL-23 class is outgrowing the market. And so that's the reason why you will not see the spike that we got in Germany. But we are very pleased with the performance. We have very good feedback from the medical doctor community, and most importantly, for the patients that they're really finding Ilumetri very good drug that answers their unmet needs. So very pleased to see the performance here today, and more to come. Thank you, Alexander.

[Operator]

Your next question comes from the line of Peter Welford from Jefferies.

[Peter James Welford]

I've got a few. First of all, just coming back to the margin. Just curious if you could -- given all the trends you outlined in terms of R&D, SG&A gross margin, and obviously, given also the exceptional, if you like, one-off sort of income that we had in the first quarter of this year in sales, just, I guess, coming back to your comment you made about 2022 and beyond, is there any reason why we shouldn't be assuming that margins are presumably going to decline the EBITDA margin next year? But then, just curious if you can give us some sort of idea. When you think about it, what sort of timeframe we should be thinking about to get back to this year's margin?And sort of, I guess, longer-term trajectory then you think of for the margin, and what sort of EBITDA margin, perhaps longer term, you believe is achievable for Almirall as a business? And then, just probing R&D a little bit more. R&D does -- I appreciate your comments in terms of all the different studies that are ramping up. Is there any way you could give , I guess, some sort of feeling in terms of how you think longer term of how we should think about R&D, perhaps the percentage of sales for your business, given obviously some of the volatility we've seen recently? And then, if you can just answer on lebrikizumab. Is it possible if you can give any timing with regards to when we could see the maintenance results from those studies? And then, could you just then outline with regards to your plans for filing, once those maintenance data are in-house, is that then -- does that trigger you then filing, or rather, some of these other studies that you were mentioning? Are any of these going to be required as part of the regulatory package? And how should we think about the sort of filing timelines for lebrikizumab in Europe?

[Michael McClellan]

Okay. Thanks, Peter. I'll take the first two, and then we'll let Karl answer the lebrikizumab. So in terms of the margin profile, with all those pressures I talked about, I think you're just going to have to expect that the core EBITDA margin is going to be in the low- to mid-20s the next 2, 3 years, and then starting to ramp-up post lebri. We'd still like to target in the outer years hitting towards a 30%, but it's probably going to be quite a few years before we get there because we need that bulk of lebrikizumab sales. So clearly, there is a ton of opportunity in the short term. But because of the gross margin and the need to invest, it's going to be tough to replicate the current year margins, which, of course, were aided by some -- still a little bit of deferred income that we had trailing and some one-offs like product divestments. So before we start hitting back to that upper 20s, it's probably going to be in the 2025 and beyond. Second, when it comes to R&D, historically, we've been in the 10% to 11% of sales. This year has been a little bit lower just because we didn't have a lot of projects in the early part of this year, but it will start to ramp-up. So I would expect, in the next 2 to 3 years, us to probably even go a little bit above that 10% to 11% of sales just because we have that crunch of investment on the Klisyri large field, the lebrikizumab reimbursement studies. We're still doing some life cycle management for some smaller products. And clearly, the company is very interested in innovation. We want to continue to find assets to license in the early stage. We want to continue to really build a leader in medical dermatology going forward. So I would say, R&D is going to become more prominent in the coming years in terms of investment pattern. It will inch up slowly, but we'll probably already start above the historical 10% to 11% in 2022. With that, I'll let Karl take over the lebrikizumab question.

[Karl Ziegelbauer]

Yes. Thanks a lot for your question. I mean, first of all, we're very excited about the results or the first results from the ADvocate 1 and 2, where we saw that 75% skin clearance in more than half of the patients, and we met and achieved the primary and all key secondary endpoints with this study. These were the 16-week data, and now the study is still ongoing with the so-called maintenance phase until week-52. And here, we will see the readout in the first half of next year, followed then by filing to the EU in the second half, and hopefully, approval one year later. We'll also will have still this year the results of the adhere study, the combination with the topical steroids that is forthcoming and will be another data point And as already mentioned, we are currently discussing so-called Phase IIIb studies that we need for market access, specifically in Europe. This is an ongoing discussion taking into consideration the data we already have and as well as forthcoming data, and we'll keep you informed as this develops.

[Operator]

And your next question comes from the line of Alvaro Lenze from Alantra Equities.

[Alvaro Lenze Julia, Research Analyst]

I wanted to have some update on the market size potential of lebrikizumab. And maybe, if you could provide some detail on how do you see the recent developments with other competing plants like JAKs, and whether you could drive some more -- when do you expect to provide more update on the potential peak sales and so on?

[Gianfranco Nazzi, CEO & Executive Director]

Yes. I'll -- thank you, Alvaro. I will start with the potential in peak sales, and then Karl will comment on the JAKs, will comment on the other -- the profile of our other competitor. So let me make you a very simple calculation that can give you an update on how we're building our model. So if you look today in the European market, the patient potential in the topical derma piece are -- we can say, 5.5 million. If you just focus on the severe one, you can arrive to almost 0.5 million. Out of this 0.5 million that are the severe patients, we can say that 40% will go under the biologics, these 200,000. And then the remaining 60% will go into the oral JAKs. So even the class of the biologic that I said is worth almost 200,000 patients, we are going to take 20% market share. That means that we are going to achieve something like 40,000 patients for lebrikizumab. That's where our calculation are coming, and that's where we put our peak sales of EUR 450 million. Again, this is aligned with our Phase II clinical data, and we are waiting for the final results of our Phase III. But let me now like give the chance to Karl to comment on the profile of our competitors.

[Karl Ziegelbauer]

Yes. Thank you, Gianfranco, and thanks for the question. As you know, with respect to the check inhibitors, the European and the U.S. regulatory authorities taking slightly different stance. But independent from that, there is clearly concerns on the safety side of this class of inhibitors, and we'll have to see how this exactly is panning out, being aware that dermatologists are very concerned about safety topics in general. We believe that the biologic, and specifically, with lebrikizumab, with the potential being a best-in-class IL-13 inhibitor, we have a great opportunity based on a compelling combination of efficacy, safety and tolerability, which we believe will be a very competitive profile.

[Operator]

[Operator Instructions] Your next question comes from the line of Thibault Boutherin from Morgan Stanley.

[Thibault Boutherin, Equity Analyst]

It's Thibault from Morgan Stanley. My first question is on Ilumetri. I mean, we are seeing the introduction of a new strong competitor in the IL-17 class with bimekizumab. So just wondering, if you're seeing any change in the market right now in Europe and your view on the evolution of the market share for IL-17 going forward, given that this is quite a sale competitor. That's the first question. And the second one, just on Klisyri. If you could give us just a bit more color on the timing for the inclusion in Medicare Part D and the type of impact you expect for sales growth? Are we going to see a material step change in growth for Klisyri when this happens, or is it more of an incremental type of progress?

[Gianfranco Nazzi, CEO & Executive Director]

Thank you, Thibault. I will take it. So in terms of Ilumetri, we are very confident on our profile, efficacy and safety profile and easy-to-use, and we see several good results across Europe. So as I said, I'm very confident on the future upgrade and growing inside the class of Ilumetri. The class of the IL-17 we saw across Europe, that is the class that is declining in favor of the IL-23. And I think that this will be the trend that is going to continue also for the future. In terms of Klisyri, you were asking about the market access. So we are very pleased to see an increase in market access. In this quarter, we saw a market access of 37%. That accounts for almost 70 million of patient lives. And also, we made some [indiscernible] on Medicare Part D. We got by now 2 million patients on Medicare. That represents almost 3% of the total Medicare class. Our plan, of course, is to continue to work very hard and our strategies mainly focused on gaining access. And the goal is to achieve by year-end, something closer to 50% in terms of market access in the U.S. with almost 100 million patient lives. So that's in a nutshell what we are expecting for Klisyri. In terms of sales, we saw, the last 3 weeks, doing particular as well. We achieved a market share of 2.4 with a weekly patient of 847 in the last week. So we see a nice trend in growing the number of the patients. So we are pretty confident that this trend is going to continue also for the remaining part of the year, and most importantly, for the months to come.

[Operator]

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

[Guilherme Macedo Sampaio, Analyst]

Just a small one, if I may. When you announced the lebrikizumab, you mentioned that the IND sections for EUR 450 million [indiscernible]. You were taking into consideration that, by biologics should have 55% penetration within the new systemic. Now you're dropping this percentage to around 40%, whereas you mentioned in the past that the competition environment has improved, and we've seen some developments across JAKs that back that. What's the main explanation for that?

[Gianfranco Nazzi, CEO & Executive Director]

Thank you, Guilherme. I will take it. So the last estimation was about that the JAKs didn't got -- they got several issues and 70 safety problems in the U.S., while we saw that we have a completely different approach from the European regulatory environment in Europe. So for this reason, we also think that dermatologists, although at the moment, they are scared with the side effect of the JAKs, but in the long term, maybe they will start working, understanding how the JAKs are working. So we said that we are -- we want to be in a very prudent way. And being prudent, we put on the 40%, but still the potential is on the EUR 450 million like we said at the beginning. Maybe Karl, you want to comment something on the side effect profile of the JAKs, or what do you think the dermatologists are going to think about that.

[Karl Ziegelbauer]

I would say, I would echo what you said. I think, at the moment, given the safety profile, there is, of course, concerns as we see from the FDA, basically discussing the whole class with respect to the safety profile. There could be also then situation where the individual dermatologists get used to it, maybe in more severe patients or patients for whatever reason don't like or don't want to biologics, that is always very difficult to predict. And that's why I think market share prediction is more on the conservative side, and makes sense at this stage.

[Operator]

And our last question comes from the line of Jaime Escribano of Banco Santander.

[Jaime Escribano, Equity Analyst]

So a couple of questions from my side. Regarding the pipeline, I remember there was one product for alopecia and on the minocycline, you licensed out one of them, if I -- well, just to have an update on what happened with these 2 products, if you have sold them, or what are your plans from them? And then another question. In terms of the strategy, in the last call, I remember you were talking about taking a decision with a U.S. franchise, whether to make it bigger or even sell it depending on the scale of this franchise going forward. And then also, in terms of strategy, you also mentioned a potential acquisition of a commercial platform in the Nordics or Eastern Europe in order to strengthen the European franchise. And also, finally, the introduction in China. So on these 3 topics, maybe can you give us an update, if you have taken a decision or where -- how should we think about these 3 strategies?

[Michael McClellan]

Thanks, Jaime. Let me answer the first one. I think, you're referring to the finasteride and terbinafine products that were the legacy poly products. We have not launched those products, but we are licensing them out. We do see some small incoming milestone income for this. We found some partners for the finasteride in Eastern Europe as well as a few product -- a few countries within Europe, and the same thing for terbinafine. But these are not going to be significant movers of the company. We're just trying to maximize the value we can get out of them. I'll pass it over to Gianfranco for the strategy question.

[Gianfranco Nazzi, CEO & Executive Director]

Yes. Thank you, Jaime. So in terms of U.S., the strategy is first to fix the foundation of the business. So we are working with our team in order to make a sustainable business for the future. We are not in any discussion about selling the franchise like you were mentioning. The goal today is fixing and making it bigger. And then, we're always looking for some opportunistic opportunities that may arise, but should be in the -- something that we can afford and make this better like something that we take in a [indiscernible] way. In terms of potential expansion in Europe. Yes, you are absolutely right. We said that we want to own the European region. So we are working in order to expand our presence in the Nordics and [indiscernible]. We have a very clever model focusing on biologics. And that will be more exhausted maybe in the month in the months to come. And for China, that's confirm. So we are starting, you may remember, the Phase III clinical trial of Seysara. We are waiting for the first patient in any day soon. And in terms of go-to-market model, depends. So if you're going to have an Seysara, for sure, you need to have some partnership. But we are also working very hard in order to build the portfolio in China. Again, very early days, and I will be more precise in the months to come. Thank you, Jaime.

[Operator]

We now have a question from the line of Matthew Weston from Crédit Suisse.

[Matthew Weston, Managing Director and Co]

It's a big picture question. And you may say I'm fishing too much for 2022 guidance, and that's not really the intention. But I'm aware that after today's call, there's going to be a very strong focus on the cost trends in the medium term. But it also comes on a quarter where revenue missed expectations by maybe 4%. And I know you've laid out the strength in October and the seasonality. But the question is a big picture one about consensus revenue expectations into '22 and '23. I wondered if management, basically, were comfortable with those numbers, or whether or not you felt there was more of a revenue story than the market was giving you credit for, which gave you the confidence in the cost investment that you're making that obviously you've outlined so clearly, Mike. I just don't know whether you can give us any comfort on the top line or maybe even outperformance on the top line to address some of the concerns that will emerge around costs.

[Michael McClellan]

Yes. So Matt, I think that you're probably reading a little bit too much into everything. I think, we had a Q3, which had a normal summer period. I'm not sure the market saw the summer, the normal way we would have seen it. Especially when you look at last year, last year's Q3 was a little bit better, but Q2 was horrible, but some of that was COVID impact. We're not uncomfortable with the consensus revenue out there. We do expect to continue the -- a good trend for the core net sales. We'll remind everyone that we will have the deferred income dropping off completely next years. So keep that in mind. So headline sales will not grow as fast as the core sales, but we should be able to maintain a reasonably similar trend into '22 that you see in 2021 for the core sales. What we do have is the need to invest more. We've got all of these launches and opportunity, and we don't want to start them. And we're coming up 2 years of lower expenses because COVID restricted the activities, not only us, but all of the companies could do. I think you may see that in other companies' trends as well is that you'll get back more to a normalization as we go forward, whereas the last 18 months have been really severely impacted by COVID restrictions in terms of your ability to invest. The R&D situation is unique to us, and it's just because of an inflection point in the way we have to finance our pipeline, particularly as lebrikizumab has been a milestone deal up until now and hasn't really run through our R&D part of our P&L. So I don't think there's necessarily a big revenue issue here. I do think that the product mix and gross margin is probably not what the consensus expects. And there, we do have to expect there'll be some adjustment of that.

[Operator]

We have no further questions. I will now hand the conference back to Pablo Divasson for any closing comments.

[Pablo Divasson del Fraile, Head of IR & Corporate External Communication]

Thank you, Ula. We are now going to close our Q&A session. And with this, we will complete our conference today. We want to thank you for your participation. You may now disconnect.