Good day, welcome to the Almirall's Financial Results and Business Update H1 2021 presentation. Today's conference is being recorded. At this time, I would like to turn the conference over to Pablo Divasson. Please go ahead, sir.
Thank you, Jody. Good morning to everyone on the call. Thank you for joining us to review Almirall's half-year results. I hope everyone is safe and remaining healthy. As usual, you can find the slides to this call in the Investors page of our website at almirall.com. Moving to slide two, I would like to remind you that information presented in this call contains forward-looking statements that involve known and unknown risks, uncertainties, and other factors that may cause actual results to differ materially. With that, please advance to slide three. 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's business performance and the growth drivers. Karl will provide you with details on the pipeline before passing to Mike to review the financials.
Gianfranco will then make the closing comments before opening up for a Q&A session. I would like to pass you over to Gianfranco Nazzi.
Thanks, Pablo, for the introduction. Good morning to everyone on the call. I am pleased to say the business has continued to perform well with a solid performance from the core business and the continuation of the good momentum from our growth drivers. We therefore are upgrading our core EBITDA guidance for 2021. Moving on to the growth drivers. We continue to see strong performance from Ilumetri, with excellent momentum from the anti-IL-23 class, where Ilumetri has gained market share and started to gain traction in France, where we recently launched. SEYSARA has had a rebound in TRx with modest improvement in market share since we launched Klisyri in the U.S. in February. We have been encouraged by good initial data with positive feedback from dermatologists and patients. I will provide further details in the growth drivers shortly.
Overall, similar to many of our peers, we continue to be adversely impacted by COVID, particularly in terms of assessing new patients, and as previously highlighted, there has been a softer outdoor season due to the wet spring in our key geographies. The late-stage pipeline is progressing well, as we continue to work hard in advancing the pipeline to drive the significant potential there. We expect readout of lebrikizumab phase III trial in the second half of this year, and we continue to work with our partner, Eli Lilly, towards the 2023 European launch. Karl will give you more details of the recent European approval of Klisyri and Wynzora in France through the centralized procedure. Lastly, we'll continue to look for opportunistic bolt-on licensing deals to reinforce our core business. A good example is the recent deal for efinaconazole, which we made this quarter.
With that, let me enter into more detail about the growth drivers. Let me start with the performance of Ilumetri, which continued with strong momentum. The slide shows you the market dynamic in the IL-23 class in Germany. Here you can see clearly that the anti-IL-23 are competing very well with the anti-IL-17, capturing 34% of the market share of new patients within the biologics, keeping head-to-head with the IL-17. Our view is the strong uptake of the class is a reflection of physicians' belief in the sustainable efficacy and reassuring safety profile. Within the anti-IL-23 class in Germany, Ilumetri has a strong market share, which has increased to 28% within the class. There are good reasons for this trend.
While competition within the class is strong, Ilumetri has a compelling product profile as the first anti-IL-23 to deliver a dataset with a consistent long-term safety profile through the five years. Very good tolerance, delivery maintained control for psoriasis patients, and easy to use as a key attribute. As you can see here, Ilumetri has had a very good performance with strong quarterly momentum and impressive year-on-year growth, resulting in more than doubling of net sales growth and achieved EUR 20 million this quarter. Year-to-date, Ilumetri is now our number 1 product. We are pleased with the uptake of recent country launches like in Spain, Italy, Austria, and Switzerland, which are starting to increase their contribution to accelerate the overall growth, supported by long-term data confirming the excellent efficacy and safety profile. In Germany, we continue to see strong growth momentum, gaining new patient share.
Since the launch of Ilumetri in France, a key growth market, we continue to see positive initial uptake with a good quarter of solid growth, achieving more than double quarter-on-quarter growth. We are on track on our expectation to have a meaningful contribution by this summer. These are very good trends shown this quarter, and they validate the potential of Ilumetri in Europe. We strongly believe this is due to the profile of the product having a quarterly dosing regimen and a cost-effective price, which continue to support the growth of the product in the winning class. Let's take a look at SEYSARA. Our strategy remains the same to rebuild the TRx and increase market share as the sales rep increase this face-to-face interaction with physicians when we see the normalization from COVID.
As you can see, the second quarter has continued to rebound in TRx since the start of the year. More importantly, we saw an improvement in the market share. 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, as it really differentiates the product from the other older generics that continue to dominate the market. We are focusing our efforts on increasing market share and market access as we continue to increase the commercial coverage plan with several PBMs. Our strategy for access is making good progress as we focus on increasing our interaction with prescribers that were actively prescribing pre-COVID, and we should be able to provide more details in the coming months. As previously communicated, SEYSARA has been heavily impacted by COVID.
This has required us to rethink the potential of SEYSARA in the U.S. market. We have now revised our peak year sales to $50 million-$75 million due to higher rebate expectations and lower market access. We think this is a very good product with good potential. We have an execution plan in place for building the TRx and the market share in the months to come. Let's move to Klisyri, which we launched in the U.S. in February of this year. We are pleased with the initial uptake of the product and given the current environment. The feedback from both dermatologists and patients has been very positive, with comments on the strong immediate benefit for patients by addressing the tolerability limitation of the existing treatments.
We continue to see the product gain penetration on the actinic keratosis topical market, offering a robust product profile, which represents a significant step forward in the treatment of actinic keratosis due to its short treatment protocol and once-daily application for five days, proven efficacy, and good safety profile. Our expectation is that we should be able to gain a good level of market share as dermatologists are seeking new options for treatment of their actinic keratosis patients. We are working hard on our strategy to gain payer coverage to drive safe volume. We are in active discussion with multiple PBMs to increase the commercial coverage in the second half of this year. Access is making good progress, and we should be able to provide more updates in the coming months.
Our promotional efforts are on the eye, the site prescriber, which should reinforce the acceleration of the performance of Klisyri. We will continue to support the launch in the U.S. as well as prepare the launch in Europe that is expected in the second half of this year. Finally, I would like to welcome Dr. Karl Ziegelbauer. As you have seen from our June announcement, we are very pleased to have added to our internationally experienced leadership team with the appointment of Karl as the new Chief Scientific Officer, who started Almirall earlier this month. Karl is a recognized industry leader and is bringing with him three decades of leadership experience in drug discovery in international markets like Germany, Japan, and the United States, and he spent almost all of his career at Bayer Pharmaceutical.
Karl is a great fit for the company. He has the right profile to continue to execute on our R&D strategy to develop the early-stage pipeline with highly innovative medical dermatology products. Karl will utilize his experience in evaluating and scouting out new collaboration with biotechs and academia, as well as the ability to drive the development of our own internal pipeline project. With that, I pass to Karl to update you on the pipeline.
Thank you, Gianfranco. Very pleased to meet you all, and I look forward to meet you in person on the phase III headline readout expected in the second half of this year. I will elaborate on this shortly. For SEYSARA China, we will work towards to start three trials as planned, having already received the acceptance of our clinical trial application. We think this is an interesting opportunity. We will update you on how we go to market as this develops. Finally, following our announcement earlier this month, we have entered into a license and distribution agreement for the topical formulation of efinaconazole in Europe. Efinaconazole is another triazole antifungal compound. The product is already approved in other countries. The plan is to use as much as possible existing studies. For example, the U.S. phase III to get approval in Europe.
We are already working on preparations for a planned pre-submission meeting with regulatory authorities and will keep you updated on the feedback from that meeting. As you can see, we have made excellent 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. With that, I would like to turn next to our most exciting opportunity we have with lebrikizumab in atopic dermatitis. Lebrikizumab is a potentially best-in-class anti-IL-13 antibody, which is currently in phase III development for the treatment of moderate to severe atopic dermatitis. Atopic dermatitis is a disease where there is still a significant unmet medical need.
We are working closely with our partner, Eli Lilly, towards the next catalyst, which we estimate in the second half of 2021 for the top-line results of the 16-week induction phase. The program includes two identical phase III studies designed to confirm the safety and efficacy of lebrikizumab as monotherapy in patients 12 years, sorry, and older. The core primary endpoint for the ADvocate 1 and 2 phase III studies are, number one, the percentage of participant with an Investigator's Global Assessment score of 0 or 1, and a reduction of more than two points from baseline to week 16. Second, the percentage of participant achieving an Eczema Area and Severity Index 75. This means more than 75% reduction from baseline in the EASI score at week 16.
We will have, in the first half of 2022, the 52-week maintenance and dosing data that is required for submission, which puts us on track to launch in 2023. We wait to see the result of the phase III data, if we can confirm a profile like that we have seen in phase II-B, we think we have a very competitive product. Our belief is that lebrikizumab will deliver reliable skin efficacy, superior itch relief, and favorable safety profile. In addition, lebrikizumab may have convenience once-monthly maintenance dosing as another potential competitive advantage, thereby offering patients living with atopic dermatitis access to a truly differentiated therapy with the potential of being best-in-disease therapy. Thinking from a patient perspective, the atopic dermatitis market is expansive, growing, and diverse, where there remains, as mentioned, a large unmet need to provide new options to patients.
The patient numbers with moderate to severe disease are large and growing, and despite the launch of dupilumab, the penetration of biologics is still extremely low. We believe there is a clear need for new and differentiated therapy, and with lebrikizumab in our pipeline, a potentially best-in-class anti-IL-13 antibody, it gives Almirall a unique opportunity to help these patients live a better life. With that, I will pass over to Mike for the financial review.
Thanks, everyone. I think we've been aware that there was a short outage in the audio. We'd like to have Karl re-present the first half of slide 13, because I don't think it was heard by the audience. If we can go back to slide 13 and just discuss the first two points, which are Klisyri, Wynzora.
Thank you, Gianfranco. Pleased to meet you all, and I look forward to meeting you in person in the near future. Here you will see that we have made excellent progress in advancing the pipeline to drive significant potential. The slide is an important one in our view, because it enable you to see how we are moving forward in executing our strategy and transforming our portfolio with innovative products in medical dermatology. Gianfranco has already discussed the successful launch of Klisyri in the U.S. We have now received approval in the EU and are now preparing for the launch, which we expect in the second half of this year. In parallel, we are preparing the EU launch of Wynzora following approval in France.
This will be a decentralized procedure which requires approval country by country, with an expected launch at the end of this year or early next year. We have lebrikizumab, which we are very excited about this opportunity, and we continue to work with our partner, Eli Lilly, on the phase III headline readout expected in the second half of this year. I will elaborate on this shortly. For SEYSARA China, we will work towards the start of phase III trials as planned, having already received the acceptance of our clinical trial application. We think this is an interesting opportunity and will update you on how we go to market as this develops. Finally, following from our announcement earlier this month, we have entered into a license and distribution agreement for the topical formulation of efinaconazole in Europe.
Great. Thanks, Karl, and thanks for repeating that. As we know, we had a slight audio issue. I'd like to take you through the financials. If we go to slide 16 now. As Gianfranco mentioned in the introduction, we've seen a solid first half with healthy growth of the core business. Core net sales increased 8% and core EBITDA increased 40% year-on-year, driven by positive contribution from the growth drivers and a strong EU dermatology performance. The contribution of higher margin products has increased the gross margin ratio to 69.5% in the first half of 2021. In terms of OpEx, SG&A slightly increased as expected, supporting the recent launches, and the overall outcome is a strong growth of our core EBITDA year-to-date at EUR 125 million. We've also had very strong operating cash flow, reaching EUR 110 million year-to-date.
This has enabled us to continue to de-lever, resulting in a very healthy balance sheet as we finish the quarter at 1.4x net debt to EBITDA ratio. We have recognized some intangible impairments in the first half of 2021, amounting to roughly EUR 100 million, relating to SEYSARA, the U.S. legacy portfolio, and the Bioniz option. SEYSARA and the legacy brands have been heavily impacted by COVID, and we've also revised our view in respect to the peak sales and growth potential for SEYSARA, as mentioned by Gianfranco earlier, due to higher expected rebates and co-pay assistance needed to drive the covered portion of the business. Let me now move on to give you more detail behind the numbers. On slide 17, you can see the dynamics of the core business year to date.
The European dermatology business has had a very strong performance, while there's been a slowdown of our other products in the EU as we're seeing a softer allergy season due to the wet spring, in addition to the low cough and cold season we mentioned in Q1. The U.S. business is still seeing a negative impact from COVID, similar to many of our peers, particularly in terms of capturing new patients. As previously communicated, we've now essentially annualized the initial generic impact of Aczone, but we will expect to see additional competitors in the second half, which will erode most of the remaining sales as we move forward. Overall, our portfolio has limited patent expiry risk going forward except for the near-term potential generic effect on Efficib in Spain, which will be impacted in late 2022.
It is worth pointing out that the Q2 2020 was affected by de-stocking following a very strong Q1. While we have seen some improvements, COVID continues to influence the business, and while we continue to monitor the situation regarding future developments, such as the impact of the Delta variant or other mutations, we will have to see how it plays out in the second half. 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 our Ciclopoli franchise. The U.S. business continues to be impacted by COVID, with a slower uptake of new launches and softer demand in some areas. However, we have seen some improvement in recent months. We anticipate COVID to continue to influence the business throughout 2021.
While COVID-related restrictions are already easing in the U.S., we anticipate it will take until the fall to see patients visiting their doctors at a normalized rate. The other U.S. products were also affected by higher rebates and returns in 2021. Moving on to slide 19. If you look at the core sales evolution, here are a couple things I'd like to pull out for you. The existing portfolio net sales increased around EUR 20 million for the first half, aided by the Q1 Flatoril sale. As you can see, the growth drivers had good contribution during the year, driven by Ilumetri and SEYSARA, but the rest of our U.S. business took a hit of nearly EUR 10 million year-to-date. On to slide 20.
To continue with our focus on the core business, I've already highlighted the key factors on sales performance, so let me run you through the rest of the P&L. We continue to invest in our recent product launches, with SG&A increasing in line with our expectations, as we previously guided, especially comparing to 2020, where Q2 had a very low spend due to the COVID lockdowns. While we continue to invest in R&D, this quarter had lower spend related to COVID delays. We expect R&D spending to pick up during the second half, as we will be starting the phase III reimbursement trials for lebrikizumab, as well as the large field trials for Klisyri. Overall, the core sales increase and flat overall spending led to our core EBITDA increasing 40% from last year, reaching EUR 126 million for the first half.
The reconciliation at the end of the P&L adds the deferred income, which was EUR 10 million year to date, and the other income of roughly EUR 1 million from AstraZeneca. On slide 21, as we continue down the P&L, the normalized net income, excluding the impairment impacts, is slightly down versus last year, finishing the first half with a normalized earnings per share of EUR 0.32 per share. If we go on to slide 22, looking at the balance sheet, there are quite a few comments provided on the slide, and I have talked about the impairment, so I will highlight just one of the most important factors for us.
We have a very healthy balance sheet and finished the quarter with a leverage of 1.4x net debt to EBITDA, which gives us the flexibility in the current environment and also allows us to do additional licensing and M&A activity if we see things that can add shareholder value. I'd like also to mention that we're looking at different ways that we could refinance the EUR 250 million convertible bond that matures in December this year. The credit markets for companies with our credit rating remain robust. We're reviewing the best option. We will update you once we have more details, likely to be in Q3 of this year. Slide 23. Let's take a look at the cash flow statement. We delivered a very strong operating cash flow, generating EUR 110 million.
We've had a negative change in working capital, which is mainly related to seasonal increase in accounts receivable that we will see normalize in the rest of the year. We have made key investments in the first half, including the milestone for the U.S. commercial launch of Klisyri, as well as the upfront costs for the acquisition rights in Europe for Wynzora. The divestments listed refer to milestones and royalties collected from AstraZeneca. These have been classified as investing activities due to the reduced focus in our operations. During Q2, we also had the disbursement of the dividend. A gross dividend was paid of EUR 0.19 per share to our shareholders who elected to receive the dividend in cash, while the majority elected the scrip dividend. The 2020 dividend was paid later in the year due to COVID delays.
Finally, to conclude the financials, we are upgrading the core EBITDA guidance to a range of EUR 195 million-EUR 215 million, a roughly EUR 5 million increase of the range from our original guidance set in February. This is aligned with the strong operation performance as the core business continues to perform well, driven by our recently launched products and the European dermatology business. The main swing factor for us ending in the lower part of the revised range is the risk of further COVID impacts, which we will monitor closely to see how the Delta variant and other mutations develop. With that, I'll hand it back to Gianfranco to conclude the presentation.
Thank you, Mike. To wrap up, this has been a strong year-to-date performance, demonstrating good momentum for our European dermatology business and an improving U.S. business. We expect the positive contribution from the key products will continue to improve the core net sales and the core EBITDA. We therefore are upgrading our core EBITDA guidance. As we highlighted in the presentation, we are progressing nicely with our existing innovative pipeline, focusing on unlocking the significant mid-term potential of our pipeline with important catalysts into 2021. We are focusing on strong execution in Europe and preparing the business for these important launches. The growth of the core business will come from the increasing contribution from the current and future launches, where we have low patent exposure.
Additionally, we continue to review opportunity for potential bolt-on and in-licensing opportunities that complement our portfolio and can generate sustainable value for the future boost of our growth. This year, we have made good progresses by acquiring two products, Wynzora for the psoriasis and efinaconazole for the onychomycosis. This product has a clear strategic fit where we'll be able to leverage our existing infrastructure. With that, Pablo, I hand back to you for the introduction on the Q&A.
Thank you very much, Gianfranco. Jovi, back to you for the Q&A, please.
Thank you. Ladies and gentlemen, if you wish to ask a question, please press star one on your telephone keypad and wait for your name to be announced. Your first question for today is from the line of Jo Walton from Credit Suisse. Please go ahead.
Thank you. A few questions, please. On the U.S., now that you've cut your expectation for SEYSARA sales to $50 million-$75 million, I wonder if you could tell us how urgent it is to get another product into that U.S. dermatology business to really justify the marketing support that you need, particularly behind Klisyri. On Klisyri itself, I wonder if you could tell us what level of market access you would be comfortable with by the end of the year, given that you're not happy to give us a level of market access and formulary acceptance at the moment. On lebrikizumab, I wonder if I could push you on when we could get the next set of data.
If we're going to get the 16-week data in the second half of this year and the 52-week data in the first half of next year, presumably the 16-week data is really a third quarter event and something that we should be getting fairly soon. I wonder if you could tell us for lebrikizumab, whether you think we really need to wait for that 12-month data to fully understand the competitive position of the product, because I assume that particularly the monthly dosing is very important to how you think about the pricing. A final question, if I could, just to check and see what sort of marketing spend going forwards. You obviously were able to control it in the first half of this year.
In order to get anywhere close to your peak sales for SEYSARA, do you have to really ramp that up again in 3Q as you go back to school season? Many thanks.
Thanks, Jo. Let's start with Mike, that is going to answer the first part of the question. I will jump on the Klisyri. we are going to have Karl discuss about lebri. we can close on the marketing spend with Mike. Mike, please.
Thanks, Jo. In the U.S., I think between the opportunity for Klisyri and SEYSARA, we still have quite a room to run and to keep our sales forces occupied. We will always, of course, look out into the market to see if there's other things we can add to the portfolio, but it's got to be something that fits in the right spot, and it's something that we feel we can really be competitive in. I think we'll probably shy away from the multi-billion-dollar biologic-type asset deals just because we don't have really the size and strength. We have to find interesting little bolt-on assets that we can add to the U.S. business. I think we've got plenty of room to continue to grow. The U.S. business is profitable, so it's not like we're in a panic situation there.
We just need to make the most out of SEYSARA and Klisyri, and those two will keep our sales force busy for the immediate short term.
Yeah. On the Klisyri asset, you were asking what is the percentage that we have today. To give you the number today, we are at 11%, and we are planning to double this number in the next few months, by year-end. We are quite confident that the sales are going to take in the second half of the year. Karl, Lebri?
Yeah. On lebrikizumab, what we will receive in the second half of 2021 is the 16-week data. This is mainly the percentage of patients that have a reduction in the IGA score and the percentage of patients that will achieve the EASI-75 score. Those patients that are responder continue then on the maintenance part, and those readout will be available in the first half of next year, including also some information then on dosings. Those data are needed actually then to file with regulatory authorities that we will then do with our partner next year to then looking forward to a launch in 2023.
Yeah. When it comes to the marketing spend, as we advised earlier in the year, we do expect marketing spend to continue to increase this year versus last year. We've got plenty of opportunities. It's not just related to putting more money behind SEYSARA. That's of course, one thing that we continue to invest in. We'll be launching Klisyri in Europe. We'll be gearing up for the Wynzora launch, and we're now starting to look at even some pre-marketing activities for Lebri. As we go through the rest of this year and the next year, we'll continue to invest robustly in our SG&A spend because we really see great opportunities in the midterm to drive the product portfolio.
As I mentioned earlier, we'll also see a little bit of uptick in R&D spend in the second half as we will be getting into the lebrikizumab phase III-B trial. If you look towards 2022, and we'll give you more update, of course, beginning next year, we still see robust opportunity to grow sales, but we are going to need to invest in SG&A and R&D to fuel the future pipeline.
Can I ask whether you participated in going for WINLEVI? We see that that was in-licensed by Sun today for not very big upfront.
Jo, we don't comment on assets that other people have licensed, so I can't really answer that one.
Thank you.
Our next question for today is from K.C. Arikatla from Goldman Sachs. Please go ahead.
Hello, everyone. Thank you for taking my questions. I have two, please. First one, as you do a postmortem of SEYSARA, what have your learnings been, please? Would you say that the lackluster performance there is due to poor product selection, or is it difficulty in making inroads in the competitive U.S. derm market? How do all these learnings shape your future M&A strategy? That's the first one. The second one on Ilumetri, can you give the sales split between Germany and other regions? If you could just update us on the geographical expansion plan for the product in Europe. Thank you.
Okay. Thanks, K.C. I think these are both financial questions, so I'll take them. If we look at the postmortem on the initial view of SEYSARA back in 2018 when the acquisition of the Allergan business was made versus what we're seeing in reality now, I would call out two things. One, of course, nobody knew we would have a COVID-type situation that would really impact the access to physicians and patients, especially in a product that was a new launch and really needed to gain new patients. As an acute medication, you need to continually gain new patients. It's not like something that carries over on a patient basis for a long time. I'd say the second is the market access/rebates have hardened quite a bit from that initial view.
What we're seeing in the U.S. market is there is a lot of money being spent in oncology and biologics and in rare diseases, and the payers are squeezing quite hard those classes where there is a generic competition. I think what we've learned from this and what we'll take into future BD and licensing and M&A is that you really have to have something that has an efficacy advantage as well as other advantages and has a very strong profile to get past the payers in the current U.S. market. Because they are seeing a lot of cost pressure, and they're putting it on the places that they can really squeeze hard. Unfortunately, we've seen that in SEYSARA. The second one, when it comes to Ilumetri, Germany is still more than half the sales, but the rest of the countries are starting to pick up pace.
We see as we move forward that we're going to see very good growth in France, Italy, Spain, and we're starting to look at future rollouts. I would say in the next two or three years, we will look to see what we can do in the Nordics, depending on reimbursement. We'll also look to see how we can start rolling Ilumetri out into the eastern side. Lots of potential still, Germany being the main growth driver right now, but we're starting to quickly start to pick up in some of the other markets.
Yeah. Thank you.
As a reminder, if you wish to ask a question, please press star one on your telephone keypad. Our next question is from Peter Welford from Jefferies. Please go ahead.
Hi, thanks for taking my questions. I've got three, or four actually, sorry. Firstly, just on lebrikizumab, just following up on Jo's question and trying to be a bit more specific. I guess what we're sort of wrestling with here is that if the maintenance endpoint is 36 weeks after the primary endpoint of the induction phase, and the maintenance endpoint is going to be met, and headline data available in the first half of next year, just taking 36 weeks off that time suggests that the induction data for lebrikizumab has to be in the third quarter, just to allow for 36 weeks until the final maintenance data. I guess, is there going to be a delay in the presentation or the announcement of those induction data, due to you working with Eli Lilly?
Perhaps you could tell us, who it is who controls the press release for the induction data. Is it you or Lilly? Are we correct in thinking that those data should be coming in the third quarter? Secondly, just on Klisyri. Thanks for giving us the access at the moment. Just curious, if you look at the prescriptions you've seen to date, are most of those, as far as you're aware, from commercial covered lives, or are you seeing a meaningful proportion of out-of-pocket use of the product in your initial launch to date? Thirdly, just on efinaconazole. I wonder if you could just, I guess, explain to us how this product, you think, is differentiated given, I think you had an onychomycosis product in the past, terbinafine, in Europe, but decided to out-license that. I guess why now in-license this asset?
What is it you think that makes this more attractive versus the terbinafine you had in the past from Poland? Sorry, fourthly, just on efinaconazole. I think you said that went generic in Spain late 2022. Is that also true for Tesavel? I guess if we look at the efinaconazole Tesavel line, should we assume that entire line faces generics late 2022? Thank you.
Thank you, Peter. Shall we start with Karl?
Yeah, I can start with lebrikizumab. The ADvocate 1 and 2 studies design implies an induction phase of 16 weeks. The top-line result, as mentioned, we will present in the second half of this year. We will closely align with our partner, Lilly, on everything. We will present and update you as soon as those data are available. After those induction phase, there is a maintenance phase of 36 weeks, which brings then to week 52, which includes, as I said, also different dosing schedules. Once those data are available, again, we will update you as these are the data that are required to submit the trials for regulatory approval.
Thank you, Karl. I can pick up the Klisyri one. Klisyri today, we have almost 2,000 TRXs out of the market. It is between 90 to 100. That's where our market share is 2%. In term of commercial, we have 60/40 ratio. 60% of the commercial one. You were asking also about the onychomycosis and why we bought this product. I think the two product between Jublia and Ciclopoli, they are complementing very well. Ciclopoli is an OTC product, is for the mild onychomycosis, while Jublia is an RX product for the more severe one. The two can complement very well. We are very happy with Ciclopoli performance here today. It's growing 16% year-over-year. We truly believe that the two of them can really perform in a very nice way for our portfolio. Mike, you want to comment?
The generic competition does relate to Tesavel as well. You know that whole product line will face potential generic competition in Spain. I remind you that typically, in Spain when you have a generic, you see a large price decrease, and you have at least the ability to try to continue to drive the volume. We'll keep updating you as we get closer, but we do expect to see that late in 2022.
Your next question for today is from Álvaro Lenze from Alantra Equities. Please go ahead.
Hi, thanks for taking my questions. Most of them have already been answered. I just wanted to know whether is there any read across from the performance of SEYSARA in the U.S. and your potential launch in China, and how do you see the market, and how do you see competition and maybe you can guide us of what the market opportunities is there in China. Thanks.
I can take both. SEYSARA today, we can start with access. Mike was mentioning before about the lack of access. We have a clear plan in order to improve it and to arrive by the year-end at 50%. Today we have 40%. Not only this, we are working on a very focused action plan starting from the segmentation and targeting. We just completed an ATU survey to better understand the physician prescribing behaviors. For that, we are going to change and we are going to adapt also our message. I'm full confident that the team has in the hand how to manage and to revert the performance SEYSARA. As I said, and as we said at the beginning, COVID truly impacted a lot and access was the second cause.
In term of China, Karl was mentioning before that we are going to start on the second half of the year our phase III trial. The potential in China, just to give you an idea, is 13 million of patient with acne. We truly believe that the market can be a good one. In the next few months, we are going to start working on what be also the perfect go-to-market model in order to tackle this very important market. Thank you, Álvaro.
Thanks.
Thank you. There are no further questions waiting, so I'll hand the call back to Pablo Divasson for closing. Thank you.
Thank you, Jody. 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.