Good day, and 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 Divison. Please go ahead, sir.
Thank you, Jody. Good morning to everyone on the call. Thank you for joining us to review Alimera's half year results. I hope everyone is safe and 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 risks, Uncertainties and other factors that may cause actual results to differ materially. With that, please advance to Slide 3. Presenting today, we have Gianfranco Nazzi, Chief Executive Officer Mike MacKillan, Chief Financial Officer and Carl Singelbar, 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 him up for a Q and A session.
I would like to pass you over to Gianfran Conacci. Thanks Pablo for the introduction and good morning to everyone on the call. I am pleased to say the business is continuing 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-twenty three class where ILUMETRI has gained market share And start to gain traction in France where we recently launched. Seysara has had a rebound in TRx with modest improvement in market share since we Since we launched TyleZiv 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 driver shortly.
Overall, similar to many of our peers, we continue to be adversely impacted by COVID, particularly in term of And as previously highlighted, there has been a soft Ferrari this 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 reorder of lebrikizma Phase 3 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 for Clasir and with Zoro in France to 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 So let me start with the performance of ILUMETRI, which continue with strong momentum. The slide shows you the market dynamic in the IL-twenty three class in Germany. Here you can see clearly that the anti IL-twenty three are competing very well with the anti IL-seventeen capturing 34% of the market Our physicians believe in the sustainable efficacy and reassuring safety profile. Within the anti IL-twenty three 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 is a compelling product profile and is the first LTIL23 and easy to use as a key attribute. As you can see, Irulumecury 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 €20,000,000 this quarter. Year to date ILUMETRI is now our number one 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 and we are on track on our expectation to have a meaningful contribution by this summer. These are very good trends showing this quarter and they validate the potential of ILUMETRI in Europe. We strongly believe this is due to the profile of the product Adding a quarterly dosing regimen and a cost effective price, which continue to support the growth of the product in the winning class. Now let's take a look at Seysara. Our strategy remains the same to the BISTA TRx And increase market share as a sales rep increase the face to face interaction with physician when we see the normalization from COVID.
As you can see, the 2nd quarter Has continued to rebound in TRx since the start of the year. And 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 It really differentiate 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 assets is making good progress As we focus on increasing our interaction with prescribers that we're 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 Sezari in the U. S. Market and we are now revising our sales, our PTR sales from $50,000,000 to $75,000,000 Due to higher rebate expectation and slower market access, we think this is a very good product with good potential We have an execution plan in place for rebuilding the TRx and the market share in the months to come. Now let's move to Clizirae, 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 have 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 a shorter treatment protocol and once daily application for 5 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 option 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 Assess is making good progress and we should be able to provide more updates in the coming months. Our promotional efforts are on the eye decile prescriber, which should be reinforced the acceleration of the performance of Glycerin. And we will continue to support the launch in the U. S.
As well as prepare the launch in Europe that is expected of the second half of this year. Finally, I would like to welcome Doctor. Karl Ziegeltauer. 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 annual earlier this month. Karl is a recognized industry leader and is bringing with him 3 decades of leadership experience in drug discovery in international markets Like Germany, Japan and the United States, Eli spent almost all of his career via pharmaceutical.
Cara is a great fit for the company and he has the right profile to continue to execute on our R and 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 Carlo to update you on the pipeline.
Thank you, Gianfranco. Very pleased to meet you all, and I look forward to meet you in person in the 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 STARB III Trials as planned, having already received the acceptance of our clinical trial application. We think this is an interesting opportunity and we will update you on how we go to market as this develops.
And finally, following in 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 and the plan is to use as much as possible existing studies, For example, the U. S. Phase 3 to get approval in Europe.
We are already working on preparations For a planned pre submission meeting with regulatory authorities and we'll 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 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-thirty 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 twenty twenty one for the top line results of the 16 week induction phase. The program includes 2 identical Phase 3 studies designed to confirm the safety and efficacy of lebrikizumab Sumab as monotherapy in patients 2012 years, sorry, and older. The co primary end Point for the ADVOCATE 1 and 2 Phase 3 studies are: number 1, the percentage of participant with an Global Assessment Score of 0 or 1 and the reduction of more than 2 points from baseline to week 16. 2nd, the percentage of participants 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 then have in the first half of twenty twenty two, the 52 week maintenance And dosing data that is required for submission, which puts us on track to launch in 2023. Whilst we wait to see the result of the Phase III data, if we can confirm a profile like that We have seen in Phase 2b, we think we have a very competitive product. Our belief is that lebrikizumab We'll 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 Now thinking from a patient perspective, the atopic dermatitis market is expensive, Growing and diverse weather 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-thirteen antibody, it gives Almirall a unique With that, I will pass over to Mike for the financial review.
Yes. Thanks, everyone. I think we've been aware that there was a short outage in the audio. So we'd like to have Carl re present the first half of Slide 20 13, Because I don't think it was heard by the audience. So if we can go back to Slide 13 and just discuss the first two points, which are Thyssery and Winzora.
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 enables 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 Flytiere Smallfield in the U.
S. We have now received approval in DAU and are now preparing for the launch, which we expect in the second half of this year. In parallel, we are preparing the new launch of VINZORA 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. Furthermore, we have lebrikizumab, which we are very excited about this opportunity, and we continue to work with our Partner Eli Lilly on the Phase 3 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. And finally, following from our announcement earlier this month, we have entered into a license and distribution agreement
Great. Thanks, Karl, and thanks for repeating that. As we know, we had a So I'd like to take you through the financials. If we go to Slide 16 now, as Jean Franco 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 percent in the first half of twenty twenty one. In terms of OpEx, SG and 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 125,000,000 We've also had very strong operating cash flow reaching $110,000,000 year to date. This has enabled us to continue to delever, resulting in a very healthy balance sheet As we finish the quarter at 1.4 times net debt to EBITDA ratio. We have recognized some intangible impairments in the first half of twenty twenty one amounting to roughly $100,000,000 relating to Seysara, the U. S.
Legacy portfolio and the Bionase 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 has 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 have now essentially annualized the initial generic impact of Axsome, 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 In terms of the except for the near term potential generic effect on Ephysib in Spain, which will be impacted in late 2022.
It is worth pointing out that the Q2 2020 was Affected by destocking 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 Sales, we registered a strong performance in Europe, driven by the growth of ILUMETRI as well as strong trends for our chiklupoli 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 and here are a couple of things I'd like to pull out for you.
The existing portfolio net sales Increased around $20,000,000 for the first half aided by the Q1 flat to real sale. And as you can see, the growth drivers had good During the year driven by ILUMETRI and Seysara, but the rest of our U. S. Business took a hit of nearly $10,000,000 year to date. On to Slide 20, to continue with our focus on the core business, I've already highlighted the key factors So let me run you through the rest of the P and L.
We continue to invest in our recent product launches with SG and 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 and D, this quarter had lower spend related to COVID delays. We expect R and D spending to pick up during the second half As we will be starting the Phase 3b reimbursement trials for lebrikizumab as well as the large field trials for splicerion. Overall, the core sales increase and flat overall spending led to our core EBITDA increasing 40% from last year, Reaching $126,000,000 for the first half.
The reconciliation at the end of the P and L as the deferred income, which was $10,000,000 year to date And the other income of roughly $1,000,000 for MasterZeneca. On Slide 21, As we continue down the P and 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 $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've talked about the impairment. So I'll 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 1.4 times net debt to EBITDA, which gives us the flexibility in the current environment And also allows us to do additional licensing and M and 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 $250,000,000 convertible bond that matures in December this year. The credit markets for companies with our credit rating remain robust, and 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 $110,000,000 We've had a negative change in working capital, which is mainly related 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. For the U. S. Commercial launch of Tlicerae as well as the upfront costs for the acquisition rights in Europe for Windsor. 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 $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. And finally, To conclude the financials, we are upgrading the core EBITDA guidance to a range of $195,000,000 to $215,000,000 A roughly $5,000,000 increase of the range from our original guidance set in February.
This is aligned with the strong operation performance as the core business continues The revised range is the risk of further COVID impacts, which we will monitor closely to see how the delta variants and other mutations develop. With that, I'll hand it back to Gianfranco to conclude the presentation.
Thanks, Mike. And to wrap up, this has been a strong year to date demonstrated 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.
And 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 midterm potential of our pipeline with important catalyst into 2021. We are focusing on strong execution in Europe 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 opportunity They complement our portfolio and can generate sustainable value for the future boost of our growth. This year, we have made good progresses by acquiring 2 products, WILZORA for deposoriasis and epinacolazole for the onychomycosis.
This product has a clear strategic fit With that, Pablo, I hand back to you for the structure on the Q and A.
Thank you very much, Gianfranco. Jody, back to you for the Q and A, please.
Thank you. 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 €50,000,000 to €75,000,000 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 Kliserie. On Cliserie 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 3rd quarter event and something that we should be getting fairly soon. And 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.
And final question, if I could, just to check and see what sort of marketing spend going forward. You obviously were able to control it and 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 the back to school season. Many thanks.
Thank you, George. So let's I'll start with Mike that is going to answer the first part of the question and then I will jump on the Cliserie and then we are going to have Carla, discuss about Lebri and then we can close on the market spend with Mike.
Mike, please. Yes. Thanks, Joe. So in the U. S, I think between the opportunity for 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 And it's something that we feel we can really be competitive in. I think we'll probably shy away from the multi $1,000,000,000 biologic type deals just because we don't have really the size and strength. So we have to find interesting little bolt on assets that we can add to the U. S.
Business. But 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 Clysire and those 2 will keep our sales force busy for the immediate short term.
On the Claveri assets, you were asking what is the percentage that we have today. So to give you the number today, we had 11% We are planning to double this number by in the next few months by year end. So we are quite confident that the sales cannot take in the second half of the year. Carlo, lebrik?
Yes. On lebrikizumab, what we will receive in the second half of twenty twenty one is the 16 weeks data. And these are mainly the percentage of patients that have a reduction in the IGA Score and the percentage of patients that achieved 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 the next year, including also some information then on dosing. And 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.
Yes. When it comes to the marketing spend, as we advised earlier in the year, we do Marketing spend to continue to increase this year versus last year. We've got plenty of opportunities. And it's not just related to putting more money behind Seysara. That's, of course, one thing that we continue to invest in.
But we'll be launching Klyseri in Europe. We'll be gearing up for the Winzora launch, and we're now starting to look at even some pre marketing activities for lebri. So As we go through the rest of this year and the next year, we'll continue to invest robustly in our SG and 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 and D spend in 2nd half as we will be getting into the lebrikizumab Phase 3b trial. So if you look towards 2022 and we'll give you More update, of course, beginning of next year, we still see robust opportunity to grow sales, but we are going to need to invest In SG and A and R and D to fuel the future pipeline.
And can I ask whether you participated Going for wind levy, we see that that was in license by Sun today for not very big upfront? We
Joe, 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 Casey Aracottla from Goldman Sachs. Please go ahead.
Hello, everyone. Thank you for taking my questions. I have 2, please. First one, as you do a postmortem of Sarah, what have your learnings been, please? Would you say that the lackluster performance that is due to poor product selection?
Or Is it difficulty in making inroads in the competitive U. S. Derm market? And how does how do all these learnings shape your future M and A strategy? That's The first one.
The second one on ILUMETRI. Can you give the sales split between Germany and other regions? And if you could just update us on the geographical expansion plan for the product in Europe. Thank you.
Okay. Thanks, Casey. I think these are both financial questions, so I'll take them. I mean, 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 2 things. 1, of 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 accessrebates I've 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 This is where there is a generic competition. And I think what we've learned from this and what we'll take into future BD and Licensing and M and 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.
And 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 2 or 3 years, we will look to see what we can do in the Nordics depending on reimbursement. And we'll also look to see how we can start rolling ILUMETRI out into the eastern side.
So 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.
Thank you.
Our next question is from Peter Welford from Jefferies. Please go ahead.
Hi. Thanks for taking my questions. I've got 3 or 4 actually, sorry. So firstly, just on lebrikizumab, just following up on Joe's question and trying to be a bit more specific. I guess what we're sort of wrestling with here is that The maintenance endpoint is 36 weeks after the primary endpoint of the induction phase And the maintenance endpoint will is going to be met and the headline data available in the first half of next year.
Then just taking 36 weeks off that time suggests that the induction data for lebrikizumab has to be in the Q3 Just to allow for 36 weeks until the final maintenance data. So I guess, is there going to be a delay in the presentation Of those induction data, do you see you working with Eli Lilly? And perhaps you could tell us who it is who Sorry, who did who controls the press release for the induction data? Is it you or Lily? Or should we are we correct in thinking that those data should coming in the Q3.
Secondly, then just on Cliserie. 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 proportion a meaningful proportion of out of pocket use of the product in your initial launch to date? Thirdly, just on ethinoconazole.
I wonder if you could just, I guess, explain to us how this product do you think is differentiated given You had an onychomycosis product in the past, tibinifene in Europe, but decided to outlicense that. So I guess why now in license this asset, what is it you think that makes this more attractive versus the tibialefine you had in the past from Poland? And then, sorry, fourthly, just on Efesib, I think you said that went generic in Spain late 2022. Is that also true for Tezobel? I guess if we look at the asset of Tezobel line, should we assume that entire line, basis generic
Thank you, Peter. So we'll
start with lebrikizumab. So the ADVOCATE I and II studies design implies an induction phase of 16 weeks. And the top line result, as mentioned, we will present in the second half of this year. And 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 Which brings then to week 52, which includes, as I said, also different dosing schedules. And 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, Carlos. So I can pick up the Clizira one. So Clizira today, we have almost 2,000 TRx Out of the market, it is between 90% to 100%. So that's where our market share is 2%. In terms of commercial, we have 60% 60% 40% ratio, so 60% of the commercial one.
You were asking also about the omnicomicrosis Why we bought this product? I think the 2 products between Jubilair and Ciclopoli, they are complementing very well. Cicropoli is an OTC product, is for the mild onychomycosis, while JUVIA is an Rx product for the most severe one. So the 2 can complement very well. We are very happy with cyclopole performance year to date.
It's growing 16% year on year. And we truly believe that the 2 of them can really Performing a very nice way our portfolio. So Mike, you want to comment?
Yes. So the generic competition does relate to TESOL as well. So 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. So we'll keep updating as we get closer, but we do
And your next question for today is from Alvaro Lindsay 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 what the maybe you can guide us of what the market opportunities is there in China? Thanks.
I can take both. So Cezara, today, we can start with access. So 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%, but not only this, we are working on a very focused action plan started on the segmentation and targeting. We just completed an ATU survey to better understand the physician prescribing behaviors.
And for that, we are going to change and we are going to adapt also our message. So I'm fully confident that the team has been in the hand how to manage and to reverse the performance of Seysara. As I said and as we said at the beginning, COVID truly impacted a lot and us was the second cause. In terms of China, And Carl was mentioning before that we are going to start on the second half of the year our Phase III trial. And the potential in China, Just to give you an idea, it's 13,130,000 of patients with acne.
So we truly believe that the market can be a good one. And in the next few months, we are going to start working on what will be also the perfect go to market model in order to tackle this very important market. Thank you, Alvaro.
Thanks.
Thank you. There are no further questions waiting. So I'll hand the call back to Pablo Diferson for closing. Thank you. [SPEAKER
PABLO DIFFERENTINO:] Thank you, Jody. We are now going to close our Q and A session. And with this, we will complete our conference today. We want to thank you for your participation. You may now disconnect.