Good day, and welcome to the Almirall Finance Results and Business Update Q1 2022 presentation. Today's conference is being recorded. At this time, I would like to turn the conference over to Pablo Divason. Please go ahead, sir.
Thank you, Roberto. Good morning to everyone on the call. Thank you for joining us to review Almirall's Q1 results and business update. 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 may cause actual results to differ materially. With that, please advance to slide 3. Presenting today we have Carlos Gallardo Piqué, Chairman and President of the Board of Directors for the introduction. For the presentation and the Q&A, 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. Before I pass to Gianfranco Nazzi, our newly appointed Chairman and President of the Board of Directors would like to make an introduction. I would like to pass you over to Carlos.
Good morning. Thank you, Pablo Divason. Good morning to everyone in the call. I am Carlos Gallardo Piqué, 1 of the members of the founding Gallardo family. I introduced myself a few quarters ago. Last week, as Pablo Divason mentioned, I was appointed President of the Board of Directors. I wanted to take this opportunity to briefly re-introduce myself. To give you a little bit of background, I have 18 years experience in the pharmaceutical industry, both in executive positions and in non-executive positions. In 2014, I was appointed to the board of Almirall as 1 of the family's representatives. I've been already 8 years in the board of Almirall. I am now looking forward to contribute to take Almirall to a leadership position in medical dermatology.
As you are aware, we have a very strong late-stage pipeline in medical dermatology. We have a strong management team in place led by Gianfranco. I'm looking forward to a strong growth trajectory in the coming years and to contribute to take Almirall to the next stage in its development. Let me hand over now to Gianfranco.
Thank you for the introduction, Carlos, and good morning to everyone on the call. I am pleased to say that we have had an encouraging start of the year with a good performance from the core business, showing growth in core net sales of around 2%. The performance of the core business is driven by our recently launched products and the European dermatology portfolio, which I will comment on later in the presentation. Based on the good performance of the business, we are reiterating our full year 2022 guidance. Let me highlight the performance of our growth drivers. We continue to see strong performance from Ilumetri, with excellent momentum from the anti-IL-23 class and good contribution from new country launches.
Since we launched Wynzora in Europe, we have made excellent progress with the rollout, gaining good traction in the countries that we launched, Germany, Spain, and the UK, while approval has been achieved in almost all European countries. With Seysara, we continue to make good progress with increasing market access and coverage. However, we have been impacted by higher rebates, which we expect will normalize during the course of the year. Klisyri is gaining traction in Europe following its launch, and in the US, we are seeing improvement in market share and market access. I will provide further details on the growth drivers shortly. We continue to work hard on the late-stage pipeline to leverage the significant potential there. As you have seen, the phase 3 16-week data on lebrikizumab was provided at the American Academy of Dermatology and at the EADV Congress.
Karl will discuss this later in the presentation. We continue to work with our partner, Eli Lilly, towards a targeted late 2023 European approval. Additionally, Seysara in China phase 3 clinical trial continue and being initiated in Q4 2021. With efinaconazole, we are working towards a regulatory submission in quarter 2 of this year with the launch targeted in 2023. Finally, we are working to start the phase 1 of the anti-IL-1RAP, and Karl will provide more colour on the pipeline later in the presentation. Let's move now to the performance of our growth drivers, starting with the strong momentum of Ilumetri. Here in this slide, you can see the market dynamics of the anti-IL-23 class in Germany, where the new patient market was driven by the anti-IL-23 class, with the anti-TNF losing market share and the anti-IL-17 class struggling somewhat.
As you can see on the right side chart, Ilumetri continued to perform strongly with a solid continuation of sequential quarterly sales growth, achieving an overall net sales of EUR 27 million. New country launches help drive this momentum, and we expect further contribution from new launches to help drive growth during the year. We continue to expect growth in 2022 to be similar to what we've seen in 2021. With that, I would like to turn our focus next to our new recent product launches in Europe, Wynzora and Klisyri. On this slide, let me start with comments on Klisyri for the treatment of the actinic keratosis. We are pleased with the commercial launch of Klisyri in Europe.
The product is doing very well, having achieved a very good uptake, particularly in the German market, as it continued to gain strong traction with early and sustained customer engagement supporting the product launch. Klisyri offers a good profile, which represent a significant step forward in the treatment of the actinic keratosis due to its short treatment protocol, a once daily application for 5 days, proven efficacy and good safety. We continue to progress on the rollout of Klisyri in Europe in the next months. Moving to Wynzora for patients with moderate to severe psoriasis, we have successfully launched this topical cream in Germany, Spain and the UK, where it continued to gain traction. Initial data is very good, and we have already sold 22,000 units in the first month as we successfully execute on the launch of the product.
An extensive European rollout campaign continues as we have achieved approval in almost all European countries, and we are confident that we can have a very nice uptake in these markets. The product is a clear strategic fit within our portfolio as Almirall can now provide a full range of psoriasis products covering the full patient journey, and this also help strengthening our position in the European psoriasis market. Remember that Almirall is the only pharma company with a full portfolio of psoriasis products, a biologic, Ilumetri, an oral systemic treatment, Skilarence, and Wynzora as a topical product. Now, let's take a look at the US product, Klisyri and Seysara. Let me start with Klisyri, which continued to make speedy gains with 3.6% market share.
In March, Klisyri registered its highest TRX volume since its launch, which is a good result for a new product launch in a highly generic market. The product has gained penetration in the actinic keratosis topical market with over 32,000 prescriptions having been generated since launch. We have made progress on increasing the commercial coverage to over 60%, and Medicare coverage has also increased to over 40%. We differentiate Klisyri from what is already available in the market based on efficacy, tolerability, and convenience. We will continue to focus on driving demand and gaining market access. 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. Now, let's take a look at Seysara.
We improved market access and coverage with almost 140 million commercial lives now covered, which equates to almost 73% of the targeted population. In terms of TRX volume, in March, we achieved our highest level since December 2019, which drove our market share to 4.6%. We continue to focus our effort on increasing market access and increase the quality of the coverage. We think this is a very good product with good potential, and we continue to work hard on our execution plan to drive prescription growth and market share by continuing to dedicate resources to further differentiate Seysara based on the microbiology label. With both Aczone and Seysara, there has been good improvement in TRX volume growth and market share.
This has not been translated into net sales growth due to the expensive cost of market access and the higher rebates. We will continue to work to grow the product and expect the rebates to normalize in the coming quarter. With that, I will pass over to Karl to update you on the pipeline.
Thank you, Gianfranco, and good morning to everyone on the call from my side. As you can see on that slide, our late-stage pipeline looks very promising. We are extremely excited that we have announced the detailed week 16 data of 3 pivotal phase 3 clinical trials for lebrikizumab for atopic dermatitis at recent scientific meetings. Furthermore, as Gianfranco has already mentioned, we are launching Klisyri across Europe. We are working on an expansion to large fields with a potential launch in late 2024 in the US and 2025 in the EU. For Seysara in China, the phase 3 trial that we have started end of last year is ongoing. For efinaconazole, a new treatment for onychomycosis, we plan to submit regulatory filings in Q2 2022 as planned.
As you can see, we are making good progress with our late-stage pipeline, and we are on the right track to strengthen our leadership position in medical dermatology. Let me now turn to lebrikizumab for atopic dermatitis, which we are developing with our partner, Eli Lilly. Lebrikizumab is our most promising pipeline asset. End of March, we have hosted an investor call to discuss in detail the week 16 data from the ADvocate 1 and 2 phase III trials. Therefore, today we'll provide a quick recap and focus on the week 16 results of the phase III ADHERE trial, which explored lebrikizumab in combination with topical corticosteroids. Advocate 1 and 2 are 2 phase 3 randomized, double-blinded, placebo-controlled trials exploring the efficacy and safety of lebrikizumab in moderate to severe atopic dermatitis patients.
After 16 weeks, lebrikizumab 250mg every 2 weeks is efficacious in providing clinically meaningful improvements in the signs and symptoms of atopic dermatitis in adult and adolescent patients with moderate to severe atopic dermatitis. For example, in the ADvocate 1 study, 59% of patients treated with lebrikizumab achieved at least 75% skin clearance at week 16, compared to 16% of patients treated with placebo. In the ADvocate 2 study, 51% of patients treated with lebrikizumab achieved at least 75% skin clearance at 16 weeks, compared to 80% of patients taking placebo. Furthermore, in both studies, statistical significance versus placebo was achieved starting at week 4 for IGA, with more than 2-point improvement EASI 90 and pruritus with a numeric rating scale score improving more than 4 points. The safety profile was consistent with previous lebrikizumab studies in AD.
The long-term maintenance of response is being evaluated in the ongoing maintenance period of both trials up to week 52, and we plan to inform you about those results in the coming weeks. Let me now turn to the ADHERE phase III trial. ADHERE is a 16-week randomized double-blinded parallel group global phase III study to evaluate the efficacy and safety of lebrikizumab in combination with topical corticosteroids in adult and adolescent patients with moderate to severe AD. In this study, patients' AD symptoms were inadequately controlled by TCS with or without topical calcineurin inhibitor. The study was designed to be more reflective of clinical practice, and patients were provided with a mild potency TCS and a low potency TCS for use on sensitive skin area, which could be tapered, stopped, or resumed at the patient's discretion.
The primary endpoints were measured at week 16 by an Investigator Global Assessment, IGA score of clear, 0 or almost clear, 1 skin, with a reduction from baseline of more than 2 points. In addition, by at least 75% change in baseline in the Eczema Area and Severity Index, EASI 75 score. The EASI, as a reminder, measures extent and severity of the disease. Furthermore, various secondary endpoints were measured, such as EASI 90, the pruritus numeric rating scale, sleep loss due to pruritus, and the Dermatology Life Quality Index. On the next slide, you see the first set of results. At week 16, 70% of patients taking lebrikizumab plus TCS achieved an EASI 75 response, compared to 42% taking placebo plus TCS.
Differences between patients receiving lebrikizumab in combination with TCS and placebo with TCS were observed as early as 4 weeks for EASI 75. Among patients taking lebrikizumab plus TCS, 41% achieved clear or almost clear skin IGA at 16 weeks, compared to 22% of patients taking placebo plus TCS. Next slide. Patients treated with lebrikizumab plus TCS also achieved statistically significant improvements across key secondary endpoints, including EASI 90, skin clearance and itching, interference of itch on sleep and quality of life measures compared to placebo with TCS. Clinically meaningful differences were observed as early as 4 weeks for itch, interference of itch on sleep and quality of life measures.
Lebrikizumab 250 milligrams every other week, plus TCS improved signs and symptoms of AD, producing statistically significant and clinically meaningful improvements in all primary and major secondary endpoint when compared with placebo plus TCS. The use of combination TCS in this study is consistent with clinical practice in the management of AD. The safety profile was again consistent with previous lebrikizumab AD studies. Now, in summary, the data from the 3 phase 3 studies read out so far confirm that lebrikizumab may potentially offer a compelling combination of efficacy and safety, reinforcing our belief that lebrikizumab has the potential to be the leading treatment option among a new generation of biologics. Our confidence in lebrikizumab follows the strong clinical profile that is emerging.
Primary and key secondary endpoints, including itch, interference of itch and sleep, and quality of life are met at week 16 in 3 pivotal phase 3 trials, Advocate 1 and 2, and ADHERE. We observed a fast onset of action of lebrikizumab, rapidly improving skin and itch symptoms within 4 weeks. We expect to complete the ongoing Advocate 1 and 2 52-week maintenance phase in the next week. We are optimistic that the week 52 results from Advocate 1 and 2 will provide further evidence that lebrikizumab can give the much-needed relief for people who struggle from this chronic lifelong disease. Week 52 maintenance results from Advocate 1 and 2, as well as data from the other ongoing studies in the phase 3 clinical development program, will provide further data about the potential to differentiate with every 4 weeks dosing in the maintenance phase.
We plan regulatory filings with the EMA in the H2 of 2022 and would expect approval about 1 year later in late 2023. With that, I will hand it over to Mike.
Thanks, Karl. Let's go to slide 19. As Gianfranco mentioned in the introduction, we have a good performance in the Q1 with core net sales growth, and we are on track for our 2022 guidance. We have seen good sales growth in Europe, which helped drive overall core net sales increase of 1.6%. We achieved a core EBITDA of EUR 50.3 million though please take into consideration this is a difficult comparison period due to the prior product divestment we had in Q1 of 2021, which amounted to roughly EUR 16 million. In the Q1 , we achieved a gross margin of 66.7%, broadly in line with what we anticipated for the year. SG&A was at EUR 102.9 million as we continue to support our newly launched products.
R&D increased in line with our expectations, which we anticipate to be between 11% and 12% of net sales this year. This year, we will have phase 3B studies for lebrikizumab, reimbursement studies in Europe, the Klisyri large field, as well as an increase in spending on earlier-stage assets, such as the anti-IL-1RAP, which we recently in-licensed. Our total EBITDA landed at EUR 59.6 million, including EUR 9 million other revenue due to the recognition of the AstraZeneca COVID-19 transaction. We finished the quarter with a very healthy balance sheet and 1.1x net debt-to-EBITDA ratio. On slide 20, you can see the dynamics of the core business, where the European dermatology business in particular has had a very strong performance, with more than 30% increase year-on-year.
The decline in the line Others EU mainly relates to the previously mentioned product divestment in Q1 2021. Focusing on our US business, it continues to be impacted by higher rebates and generic competition, which I will detail in the next slide as we discuss the dynamics of the dermatology business. Overall, our portfolio has limited patent expiry risk going forward in the near term outside of Etrivex in Spain, which will be impacted in late 2022, and we are managing the pricing impact. Additionally, Rest of the World General Medicine has seen a small decline year-on-year, mainly driven by Immunorix in Latin America, which had a very high demand during the pandemic and winter months in 2021. Let's take a closer look at the dermatology business on slide 21.
In Q1, we had a very strong performance in Europe, driven by the growth of Ilumetri, as well as strong trends for our Ciclopoli and Decoderm franchises and growth for Skilarence. Other EU also benefit from the initial launches of Klisyri and Wynzora in key markets. Focusing on our US business, it continues to be impacted by higher rebates, as explained by Gianfranco on Klisyri and Seysara slide. Even though there has been progress in TRX and the market share of those products. This pressure has translated across the US dermatology portfolio in terms of lower net sales versus last year, as well as a natural decline of Aczone from generic competition as expected. In the rest of the world, we've seen growth in that business through a low base, mainly driven by the timing of orders in the Ciclopoli franchise.
Now moving on to the P&L on slide 22. Core net sales grew at around 2%, and we're on track to meet our guidance of mid-single digit, which is our current pace if we factor in the product sale in Q1 of last year that I previously mentioned. I've already highlighted the key factors on the sales performance slide, so let me continue with our focus on the core business by running you through the rest of the P&L. For the Q1 , we achieved a core gross margin of 66.7, broadly in line with what we anticipate for the year. As we anticipated, SG&A had a small increase this quarter and will accelerate further during the year as we continue to add investment to fuel the successful execution of our product launches.
In terms of R&D, there was a step up compared to Q1 2021, which will increase further during the year to a level that we anticipate will be between 11%-12% of net sales. There are a few factors that are driving this increase in R&D spend. First, the Phase 3b studies for lebrikizumab, which we have to pay the cost for the reimbursement studies in Europe as compared to the development up to this point, which was funded by milestone payment, payments to our partner. Second, the spend on Klisyri large field, which are also shifting onto our P&L as the Phase 3 was performed by our partner in a similar milestone setup. Finally, we will increase spend on earlier stage assets such as the anti-IL-1RAP that we will submit an IND for in the coming quarter.
The reconciliation at the end of the P&L reflects the deferred income in the previous year, which has now been fully amortized. Total EBITDA of EUR 59.6 million includes EUR 9 million due mainly to the revaluation of our assets related to the Covis-AstraZeneca pharma agreement following the closure of this agreement in Q1. We expect future quarters to revert to amounts similar to the past quarters. Overall, we remain on target with our full year 2022 guidance. Continuing down the P&L on slide 23, there are not too many line items to explain. However, I'd like to comment that we're expecting an effective tax rate in the low 30s% this year due to the minimum tax law in Spain, as we are not able to deduct U.S. tax losses against profitable European business.
I'd like to highlight that we finished the quarter with a normalized net income of EUR 20.5 million, which resulted in a normalized earnings per share of EUR 0.11 per share. On slide 24, if we look at the balance sheet, there are quite a few comments provided on the slide, so I'll only highlight 2 of the most important factors. Some financial assets have been reclassified to accounts receivable following the agreement with Covis to advance certain milestone payments related to the China respiratory business. There was also a slight decline in financial debt due to a scheduled payment of EIB loan that's made every quarter. We now have a very simplified capital structure with no potentially dilutive instruments, and we have a very healthy balance sheet.
We finished the quarter with a leverage of 1.1x net debt to EBITDA and a strong cash position, which gives us flexibility in the current environment for additional licensing and M&A activity. Let's take a look at the cash flow statement on slide 25. Our cash flow from operating activities is down significantly from Q1 2021 due to lower profit before tax impacted by the product sale I previously mentioned, a high outflow of working capital, and the lack of a tax refund receipt in Q1 2022. The negative change in working capital is due to a timing impact on accounts payable and accounts receivable balances, which we expect to normalize in the coming quarters. Tax cash flow turned to a net outflow due to the change in phasing of the refunds of corporate taxes in Spain.
In 2021, we actually received 2 years refunded, once in the Q1 and another in the Q4 , instead of 1 refund per year as we'd seen in previous years. We see this as a phasing impact from the change in how the Spanish government is refunding taxes. We have made key investments during the quarter, including the milestones for the IL-1RAP licensing and the launch of Wynzora in Europe. The divestments referred to in milestones and royalty collections from AstraZeneca and Covis. These have been classified as investing activities due to the reduced focus of this business in our operations. Finally, there is a decrease in debt related to the loan repayments to the European Investment Bank. With that, let me pass it back to Gianfranco to conclude the presentation.
Thanks, Mike. To wrap up, we have had an encouraging start of the year with a good operational performance, which put us on target to achieve our 2022 guidance. We have started this year with strong momentum of Almirall growth drivers, and we'll continue to work hard to fulfill their growth trajectory as we continue to support recent launches with an expectation to further improve during the year. Ilumetri has had a very strong performance, and we expect increasing contribution from new country launches to continue its growth. In addition, I am pleased with the initial performance in Europe of Klisyri and Wynzora, 2 important products for Almirall. Furthermore, as detailed by Karl, we are progressing well with our exciting, innovative late stage pipeline with prominent developments during this year. We'll be initiating important clinical trials while executing on key market introductions.
We continue to execute on the transformation of the company by preparing the business for crucial launches and to support our mid-term growth prospects. This year will be very busy for our team, not just with extensive European rollout campaigns, but also as we prepare the business for exciting future launches like lebrikizumab, which will support our need for long-term sales prospects. Lebrikizumab is 1 of our most promising assets and will be 1 of the several new growth drivers in Almirall playbook over the next few years. Finally, Almirall is also focused on unlocking the value of the early- and late-stage pipeline, which will help drive our future growth prospects. We also continue to look for opportunistic inorganic growth from external opportunities by leveraging, as Mike said, our strong balance sheet and flexible capital structure.
Pablo, with that, let me hand over the call back to you for instruction on the Q&A.
Thank you, Gianfranco. Roberto, back to you for the Q&A, please.
Ladies and gentlemen, we now begin the question and answer session. If you wish to ask a question, please press star and 1 on your telephone.
We have the first question from Jo Walton from Credit Suisse. Please go ahead.
Thank you very much. I've got a few. If we look at the European other sales that went from EUR 17-EUR 24, should we assume that all of that increase was due to the new launches and pipeline filling of Wynzora and Klisyri? I wonder if you could tell us when you would expect to be able to give us individual sales for those. Will they be big enough in terms of in-market sales over the next couple of months? On Klisyri, because you focus so much on the timing of the large field data with the launch in 2025 in Europe, is that when we should look to see a major inflection? Will that drug, you know, be big ahead of that additional data?
On Seysara, could I just ask for a little bit more information on the US? If we look at some other new launches, for example, you know, Winlevi as a different sort of new acne product, we do see that seems to have blown through your level of prescriptions. Just wondering whether there's a concern that doctors just aren't buying into this, and maybe that's why you need higher rebates. Just your level of confidence. On lebrikizumab, I wonder if you could help us. Do you know whether in the baseline, patients who were in the study, there was a decent proportion who may have had comorbidities? Clearly 1 of the issues with lebrikizumab was that it didn't appear to work in asthma.
I wonder if you had asthmatic patients in that database, and maybe that wouldn't be a finding that you would have and that that could, you know, help your, you know, your broader offering there. Many thanks. Oh, and the final financial question. At the Q1 , you did say that you thought your net finance charge would be somewhere and EUR 12-EUR 15 million of. Is that right? 12 to, yes, 12 to 15 million of net finance, unless you could refinance something cheaper. Is that still the run rate we should be looking at for the year? Many thanks.
Thank you, Jo. I will start, and then we'll hand over to Karl for the lebrikizumab and Mike for the finance question. Let me start with the European sales growth. You are absolutely right. The growth momentum is fueled from the launches. Ilumetri is doing very well, but also Wynzora and Klisyri, we start to see very good uptake. In terms of individual sales, we are not giving individual sales. We have just commented last time, you know, the portfolio value, what we are expecting for the different portfolio, and we are very happy to see the uptake of the product following the launch. In terms of Klisyri real-world data in 2025, yes, the real-world data is going to boost the sales and the potential of Klisyri.
Nevertheless, we are very happy with the performance so far, especially in the European market, sorry. In terms of Seysara information in the US, about the rebates. As you know, Seysara is working on a class that is heavily genericized, and the presence of the generics are impacting not only the step-up approach but also, you know, the discussion with the PBMs and insurance company. I think that I answered to your question. If I missed something, let me know. Otherwise, I will pass over to Karl for the lebrikizumab 1.
Yeah. Thanks, Karl. Just, I mean, the question was about inclusion of patients with comorbid asthma. I think in the ADvocate studies, their patients with comorbid type 2 disease, including asthma, were allowed. However, patients with severe uncontrolled asthma are not allowed to be included in the studies. Therefore, only patients with milder asthma or those asthmatics who have been well controlled have been included. As you may know, you know, in the past by Roche, there were actually studies done in asthma, the so-called LAVOLTA I and II trials. Recent further analysis of those trials indicated that the lack of, you know, good activity in those trials might be due to underdosing.
I mean, at that time, 70.5 and 125 milligrams were tested, whereas we test in our studies with Lilly 250 milligrams, and there might be also not the optimal patient population being included.
Yeah. Thanks. Jo, on the financial expense, we had a very small benefit from the increase of the stock price on this equity swap that we have outstanding. I'd say the ballpark of, you know, EUR 12 million-EUR 15 million still holds. You know, it could be influenced a little bit by that equity swap as when the stock price goes up or down, we do recognize that against that line. Nothing major in there.
Just my first question, would it be fair to assume that the difference between the EUR 17 million and the EUR 24 million, that other European dermatology, that EUR 7 million is the initial stocking into the European market of Wynzora and Klisyri?
No. It's a portion of that, but it's not the whole thing. You know, we also had a good momentum from other portions of the business. You know, as soon as Klisyri or Wynzora make the top 6 or 7 products, you'll start to see them in detail in that slide. But it's only EUR 2 million for those 2 products in Q1.
Thank you.
Thank you for your question. The next question from Thibault Boutherin from Morgan Stanley. Please go ahead.
Hello. Hi. Thank you for taking my questions. The first 1 would be on the AstraZeneca and Covis revenue recognition. Could you just come back on the kind of schedule for this? Is there any more to be expected this year? And kind of, you know, quantify broadly how much we could expect in coming years as well. Second question on efinaconazole. Did you get any feedback from your discussion with EMA? Just trying to get some color on your degree of confidence that the filing is going to go through in Q2. Then just a last question on the US business.
You know, given what we are seeing in the numbers, how open are you to potentially exit this region to you know, look at potential strategic consideration here? Or is your plan still to grow your current asset and potentially bolt on to leverage your infrastructure here? Thank you.
Thanks, Thibault. I'll take the first 1 on the Covis-AstraZeneca deal. I need to take you back to the beginning of this transaction in 2020 or 2014. This was considered a business combination, so it's not a matter of, you know, cash equals income. We have to value the value of the overall transaction on an annual basis. The changes in that value or whatever are both through the P&L. As this agreement with Covis and AstraZeneca closed, we also agreed with them to accelerate some of the milestone payments that were due out in the future, particularly in China for the respiratory business. The net of that and all of the new forecasts and everything came to an asset value which allowed us to recognize this EUR 9 million.
I think as I said in my comments, going forward we'll see the usual income of, you know, EUR 2-3 million a quarter. I think for the overall year, we'll probably be slightly above the EUR 10 million that we kind of earmarked for this line. We're also facing, you know, inflation, higher energy costs. Overall, it really doesn't have an impact on our guidance at this point. A little more in this line, a little less in a few others.
Maybe I'll take the question on efinaconazole. Let me just remind you that this is not a central procedure going through EMEA, but a decentralized procedure where we work with the individual European countries. I think at this stage, we are optimistic that we can do the filing with the existing data. As mentioned earlier, we plan to do the first filing in Germany and in other European countries within Q2, as mentioned.
Thank you, Karl, and I will take the last from the US, Thibault. You know that the US business is a difficult 1 in terms of market access. Consider also that our 2 main product, Seysara and Klisyri, are in a class with a heavy presence of generics. For Klisyri, on top of this, you know, the practice in the US is very different from Europe, where we have procedure where the dermatologists are making a lot of money. That said, you know, we are keep focused our effort in order to gain market access to strengthen our position. We resegmented the market, and we are very sure that, you know, with all this measure, we are going to see some good result in the months to come.
In terms of your question about M&A, we are still open and looking. You remember how Mike said that our balance sheet is in a very good order. We are looking for bolt-on niche acquisition. You know, if there will be something in the market that is going to fit our strategy and our go-to-market model, we will look at it very carefully. Thank you, Thibault.
Thank you very much.
Thank you for your question. The next question is from Guilherme Sampaio from CaixaBank BPI. Please go ahead.
Hello. Good morning. Thank you for taking my questions. Guilherme Sampaio from CaixaBank BPI. 3 primarily. The first 1, if you could provide some colour on Ilumetri market share within the IL-23 inhibitors class. The second, Klisyri market share in the US has shown a very good progression last year. But since the beginning of the year, it seems a bit more stalled. As I remember last year, you mentioned over 2.5%. At the beginning of this year, 3.7%, now 3.6%. Any additional colour on this slowdown? In terms of M&A, just to complement in terms of regions, where are you looking at? Something in Europe? Something in the US? If you could complement on this front, it would be good. Thanks.
Thank you, Guilherme. I will take it. In terms of Ilumetri market share on the IL-23 class, you saw the market, the IL-23 is growing very fast. Ilumetri on the new patient is almost 1/3 of this market. The market share goes up and down. The latest 1 was 26%, so I can say that 1/3 is roughly representing properly well our performance in the German market. In terms of the US, the Seysara market share, as you said, was 4.6%. Looking to the week 13 data, it's very close to 5%. Klisyri as well was 3.6%, but looking again to the week 13 data, it's very close to 4%.
As we already commented, we are working very hard in order to gain access from 1 side, but also market share on the other. I'm pleased with the performance, although we need to work very hard in order to go back to the basics and make this happen. In terms of M&A
Our focus in Europe, because we are very present, we are very strong. The market, the M&A in Europe can be much more stronger than what we can have in the US. In the US, as we said before, if we can look for some niche or boutique product while for Europe we are very open to compete with big multinational, large multinational because as we demonstrated with Ilumetri, we can do a lot and we can compete quite well. 2 different type of M&A, but you know, let's look for the right opportunity. Thank you, Guilherme.
Thank you for your question. The next question from Lucy Codrington from Jefferies. Please go ahead.
Hi there. Thanks for taking my questions. First up on lebrikizumab, is your expectation then that it will be primarily used in combination with topical corticosteroids in the real-world setting? Just whether you could comment on the much higher placebo response rate you saw in the ADHERE study compared to the Dupixent combination studies. Secondly, on Klisyri, could you give us your kind of target coverage for that product within the U.S. by the end of the year? Is there any seasonality in prescribing for this product? Then finally on Seysara, just to clarify, did you say that you're expecting the rebates to normalize during the course of the year or actually as early as Q2? Thank you.
Yeah, thank you for the question. I can start with lebrikizumab. I mean, in the Advocate 1 and 2 study, we showed that lebrikizumab shows very strong activity versus placebo. I mean, clinical practice sometimes involves topical corticosteroid and sometimes not. In the ADHERE study, I think what you're referring to with respect to placebo is that we observed that patients who just use topical corticosteroids had a very high percentage of them actually achieved an EASI 75. From our perspective, but we cannot point to a specific reason. However, what is important that we see a very consistent activity of lebrikizumab on top of topical corticosteroid.
The way topical corticosteroid were used in the ADHERE study was trying to reflect the clinical practice that both a medium and a low potency corticosteroid was actually provided by the sponsor and could be used by patients as needed. In contrast to competitor studies where the steroid was not provided and a very strict schedule was prescribed on how the patient should use those topical corticosteroids. That might explain some of those observed difference. As said earlier, there is no specific reason that we observed, and so this is a little bit of speculation at this stage. Thank you, Karl. I will move to the Klisyri 1. You were asking about the coverage. Today we have 60% on the commercial line and 41% on Medicare Part D.
I think that the coverage will represent also what is our target by year-end, so we can increase a little bit. What we want to really achieve is the quality of the coverage, so moving more unrestricted, and that's what we are looking for. You were questioning about the seasonality. You are right. We are moving towards the summer, where we can see the market maybe not growing at the same pace that we saw in the past. Our goal is to continue gaining share on the market, although the market is not going to grow as expected during the winter season. In terms of Seysara, you are asking if we see some normalization of the rebate along the year. The short answer is yes, we are working on this direction.
You saw a rough Q1 , but we are working toward more normalization during the following quarter on the year to come. Thank you, Lucy.
Thanks.
Thank you for your question. The next question is from Jo Walton from Credit Suisse. Please go ahead.
Thank you. Just a couple of follow-ups, please. I wonder if you could tell us a little bit more about the design of your reimbursement and other, you know, phase 3b studies that you're doing. Are you going to be doing a head-to-head with Dupixent? The second 1 is, could you tell us, just remind us, on the FX impact for the group. So your constant currency growth was slightly higher than your actual growth, and that's presumably reflecting the fact that you make a loss in the U.S. Would you expect that to be continuing for the rest of the year, so that unlike other pharma companies who are benefiting from the strength of the dollar versus the euro, this would be a small headwind to you?
Mm-hmm.
Finally, on SG&A, it was flat year-over-year. You say that it's going to grow in the rest of the year. It seems surprising to us that it was flat when you had launches to make. Was there something that you were spending in marketing in the Q1 of last year that you didn't need to repeat so that the underlying investment was higher? It just seems very strange to have no growth in a quarter with strong launches.
Yeah, maybe I'll start with your question on lebrikizumab phase 3b study. We have started end of last year. The first study, that is a study where we explore lebrikizumab in combination with topical corticosteroids in adult and adolescents patients having atopic dermatitis that are not adequately controlled with cyclosporine or for which cyclosporine is medically not advisable. This is a study that is recruiting on track total about 300 patients. The primary endpoint will be the EASI 75 after 16 weeks. This study will allow up to about 20% of patients that have been pre-exposed to biologics. We'll also generate some data in this patient population.
Yeah.
Sorry. With respect to additional studies, including head to head versus standard of care, this is an ongoing discussion with our partner, Eli Lilly, as we're still waiting to see the full data set, including the week 52 maintenance data of the Advocate 1 and 2 trials, as mentioned earlier.
I'll take the other 2. The FX impact, it's not very significant, and we don't expect it to be very significant. You know, we do have the business in the US. We would expect there to be a slight positive due to the strengthening of the dollar by the end of the year. I remind you that Q1 is always the high deductible season, so you don't have necessarily the same, you know, spread of the income throughout the 4 quarters. We'll see. I think we'll see a continued strong dollar that should benefit us a little bit on the top line. It will also have a little bit of a drag with the expenses, but a net, a very small positive. In terms of SG&A, you know, it's just a little bit of timing.
I think by the time we get to the half year, you'll see we'll be progressing versus last year. It's really, you know, quarter by quarter, there's so many activities going on that there's just a slight difference, and I don't think it's an issue. We will see an increase throughout the full year.
Could you give us some help on, you know, higher expenses from, I don't know, energy costs, freight, whatever. Is that something that you will see that's material for you this year?
You know, there'll be EUR a couple million in the cost of goods line. You know, we're keeping a very close eye on it. The Q1 , as everybody's experienced, we've seen energy prices shoot up. We've seen transport prices shoot up, cost of oil. You've seen inflation. We think it's manageable within our guidance, but it'll be, you know, a couple million here and there on different lines.
Thank you very much.
Thank you for your question. I will now hand back the conference over to Pablo Divason.
Thank you, Roberto. We are now going to close our Q&A session. With this, we will complete our conference today. We want to thank you for your participation. You may now disconnect.
That concludes the conference for today. Thank you for participating.