Almirall, S.A. (ALM) Earnings Call Transcript & Summary

Good day, and thank you for standing by. Welcome to the H1 2022 Financial Results and Business Update Conference Call. [Operator Instructions] Please be advised that today's conference is being recorded. I would now like to hand the conference over to your speaker today, Pablo Divasson, Director of Investor Relations. Please go ahead.

Thank you, Sara. Good morning to everyone on the call. Thank you for joining us to review Almirall's H1 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 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 3. Presenting today, we have Gianfranco Nazzi, Chief Executive Officer; Mike McClellan, Chief Financial Officer; and Karl Ziegelbauer, Chief Scientific Officer. Gianfranco will start with a review of the quarter's business performance and the growth drivers. Karl will provide you with details on the progress of the pipeline before passing to Mike to review the financials. Gianfranco will then make some closing comments before opening up for a Q&A session. I would like to pass you over to our CEO, Gianfranco Nazzi.

Thank you, Pablo. I am pleased to say that we have had a good performance of the business in the second quarter, showing growth in core net sales of 5% in the first half of the year. Within 1% growth reported in quarter 1, this showed that we had a nice acceleration in the second quarter. As you know, the focus of Almirall is in our core European Dermatology portfolio where the performance of the business remained very robust, helped by recently launched product. Thanks to this stronger European growth and our confidence and continued momentum of this core business, we are reiterating our full year 2022 guidance. Let me highlight the performance of our growth drivers. We continue to see excellent momentum from Ilumetri with good contribution from new country launches as well as momentum from the anti-IL-23 class. Wynzora is also seeing strong growth in Europe as we continue to make good progress in rolling this product across other countries. And Klisyri is gaining traction in the country in which it is launched in Europe. We also continue to work hard on the late-stage pipeline to leverage the significant potential there. As you have seen, we announced lebrikizumab Phase III, 52-week top line data, which is very encouraging, and Karl will discuss this later in the presentation. We continue to work with our partner, Eli Lilly, towards a targeted late 2023 European approval and launch. And additionally, Seysara China Phase III clinical trial is ongoing and has worked towards an expected launch in 2024. And with efinaconazole, we already submitted the filing for regulatory approval in the quarter with the launch targeted in 2023. And finally, we are initiating the Phase I for the anti-IL1-RAP, and Karl will provide more color on the pipeline later in the presentation. And with that, let me move now into the details of our growth drivers. I will start with the strong momentum of Ilumetri. Here in the slide, you can see the market dynamics of the anti-IL-23 class in Germany where this class continue to hold the leading market position among new patients. On the right side of the chart, Ilumetri continued to perform strongly, achieving an overall net sales of EUR 31 million in this quarter, a solid continuation with 58% sales growth year-on-year. And new country launches have drive this momentum, and we expect further contribution from launches to have drive growth during the year. We continue to expect the growth in 2022 to be similar to that we've seen in 2021. And with that, I would like to turn our focus next to our recent product launches in Europe, Wynzora and Klisyri. Let's move to Klisyri for the treatment of the actinic keratosis. We are pleased with the progress of the commercial launch of Klisyri in Europe. And the product has gained strong traction and then achieved a very good uptake, particularly in Germany, where we have a more than 10% unit in market share, which is an excellent result given that we only launched the product 9 months ago. We are seeing great traction with early and sustained customer engagement supporting the product. The European rollout continued well with the recent launches in Netherlands, Switzerland and Austria, and further launches are planned for this year in 2023. Moving now into Wynzora for patients with moderate to severe psoriasis. We have seen an excellent traction in the country where the product has been launched with, for example, 7% market share achieved in Germany and 6% in Spain. A total of 49,000 units had been dispensed and sold since its launch, reaching over 17,000 patients. And we are confident that we can have a very nice uptake in this market as well as in additional new countries in the upcoming quarters. Wynzora helps strengthening our position in European psoriasis market as the only company to provide a full range of psoriasis product covering the patient journey. Let's now dive on our U.S. business on Slide #8. As many of you know, for Almirall, the U.S. is an important geographic platform, which provides value and strategic optionality to Almirall in the future. So even though performance has been challenging at times, we want to remain there for future opportunities for a product that we are developing with worldwide rights. We want to reassure investors and analysts, however, that we will be judicious in how we are going to manage this business to ensure that it has a positive EBITDA contribution, and we will do this by operating in niche markets where we are present right now. In the near term, the U.S. is going to remain a small part of our business until we get momentum following the launch of Klisyri large field in late 2024 and thereafter with new product and pipeline opportunities. For right now, we are in important launches in Europe, and we want to put our efforts to ensure the success of this medicine. And with that, the underlying business in the U.S. in terms of TRx volume are in line with our aim to create a sustainable business in the country. Let me now move into Klisyri. We are pleased with the performance as the product continued to make steady gains in TRx and improving market share. The product has gained penetration in the actinic keratosis topical market with over than 41,000 prescriptions having been generated since launch, a good result for a new product launch in a highly generic market. Furthermore, more than 4,000 healthcare professionals have prescribed Klisyri since launch where we continue to receive a very positive feedback and good patient engagement. We have made progress on the commercial coverage, achieving more than 43% in Medicare as 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 as we also work to the large field label expansion, which is expected to be launched in the second half of 2024. Let's take a look now at Seysara. We have seen volume growth year-on-year and prescriber base at an all-time high in more normalized environment following pressure from a high deductible season in quarter 1. Seysara continued to make a steady access gain with a good uptake year-to-date of over 73% of commercial lives. We continue to focus our effort on improving market access and increasing the quality of the coverage through a differentiated base of the microbiology label. In Seysara, we have seen an acceleration of net sales in the second quarter. With both Klisyri and Seysara, there has been a good momentum in the second quarter in TRx volume growth and market share. We think these are the 2 very good products with good potential, and we continue to work to build the sustainable platform around them. And with that, I will pass over to Karl to update you on the pipeline.

Thank you, Gianfranco, and good morning, everyone. Today, I will start with lebrikizumab for atopic dermatitis, our most promising pipeline asset which we are developing in collaboration with our partner, Eli Lilly. Let me reiterate why we are so excited about lebrikizumab. First, lebrikizumab shows a consistent profile across the clinical development program with more than 2,000 patients. We observed consistent efficacy in monotherapy as well as on top of topical corticosteroids in adult and adolescents and across geographies and ethnicity. The safety profile was consistent with prior lebrikizumab studies in atopic dermatitis. Second, for atopic dermatitis, inhibition of IL-13 seems sufficient to control the disease effectively in most of the patients, and we believe lebrikizumab is the best antibody to targeting IL-13, highly potent and with a unique mode of action. Third, and this is the topic of this slide, we're very excited about the data from the maintenance phase of the ADvocate 1 and 2 Phase III clinical trials. 8 out of 10 patients who achieved clinical responses after lebrikizumab treatment, measured by the EASI-75 score at week 16, maintained skin clearance at 1-year treatment. Once every 2-week and once every 4-week maintenance dosing showed basically identical results with consistent and durable responses. Additionally, patients treated with lebrikizumab maintained each relief across the 2 trials over the 1-year period. These data, together with all the other data from the Phase III program of lebrikizumab, makes us confident that lebrikizumab has the potential to be a first-line biologic with less frequent dosing during the maintenance phase. Next slide, please. This slide summarizes the next steps for lebrikizumab. Together with our partner, Eli Lilly, we plan to present the detailed week 52 data from the ADvocate 1 and 2 Phase III studies at an upcoming scientific meeting in the second half of 2022. The submission of a Marketing Authorization Application to the European Medicines Agency is also planned for the second half of this year. We would expect an approval about 1 year later, which puts us on track for a launch in late 2023, and we continue to work on the prelaunch planning. We look forward to continuing our collaboration with Eli Lilly in advancing our clinical program. Finally, we are very excited by the prospect of delivering this promising therapy to people living with moderate to severe atopic dermatitis in Europe. Let us now move to the next slide to discuss the progress we are making in our late-stage pipeline. As you can see on this slide, our late-stage pipeline looks very promising. I already talked about lebrikizumab. After the launch of Klisyri in the U.S. and European markets, we are working on an expansion to the large field indication with a potential launch in late 2024 in the U.S. and 2025 in the EU. This month, we have started the large field label expansion study for the U.S. The Phase III clinical trial for Seysara in China is ongoing, and we have completed recruitment despite the difficult COVID situation in China. For efinaconazole, we have submitted regulatory filings in Germany and Italy under the European decentralized procedure. The German regulatory authority is acting as the Reference Member State. The outcome of this filing is expected to be known in 2023. Finally, we are very excited to report that we are about to initiate the Phase I with our anti-IL1-RAP monoclonal antibody in the coming weeks. As a reminder, we in-licensed exclusive global rights to develop and commercialize this antibody from Ichnos Science end of last year. This antibody, abbreviated as ALM27134, has potential utility across different autoimmune skin diseases. In summary, we are making good progress with our pipeline, and we are on track to strengthen our leadership position in medical dermatology. Let me now hand over to Mike to take you through the financials.

Thanks, Karl. Let's go to Slide 14. As Gianfranco mentioned in the introduction, we have seen a good performance in the first half of the year with core net sales growth of 5.1%, and we are on track with our 2022 guidance. We've seen strong sales growth in Europe from the dermatology portfolio, which has helped drive the overall core net sales increase. We also achieved a core EBITDA of EUR 98.3 million year-to-date, though the comparison of last year is impacted by a product divestment in the first half of 2021 of nearly EUR 15 million. In the first half, we noted a gross margin of 67.7%, broadly in line with what we anticipate for the year. SG&A was EUR 210 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 for the full year. This year, we will have to pay for the Phase IIIb reimbursement-focused studies for lebrikizumab, the Klisyri large field studies as well as an increase in spending on earlier-stage assets such as the anti-IL1-RAP, which we recently in-licensed. Total EBITDA reached EUR 107.6 million, a decline compared to the same period in 2021 due to the heavy investments in SG&A and R&D to support our recent launches and the development of the late-stage pipeline. We did see an improved operating cash flow in the second quarter, reaching EUR 56 million for the first half, which helps further strengthen our healthy balance sheet as we finished this quarter at 0.9x net debt-to-EBITDA ratio. If we go to Slide 15, you can see the dynamics of the core net sales where the European Dermatology business, in particular, has had a very strong performance with 22% increase year-on-year. While there's been a decline in the line Others EU, this was mainly related to the previously mentioned product divestment in 2021. Focusing on our U.S. business, there's been an improvement in the second quarter, though we're still declining versus 2021, and I will provide further details on the next slide. Overall, our portfolio has limited patent expiry risk going forward, outside of Efficib in Spain, which will be impacted in late 2022 and where we are managing the price impact. Let's take a closer look at the Dermatology business on Slide 16. In the first half of the year, we've seen a very strong performance in Europe, driven by the growth of Ilumetri with approximately 58% year-on-year growth as well as strong trends for our Decoderm franchise. Others EU is also benefiting from the launches of Klisyri and Wynzora in key markets. The U.S. business has seen slow but steady progress with improvements quarter-on-quarter. There's been a rebound following a soft first quarter, impacted by higher rebates. We are now seeing progress in TRx and market share for products, including Klisyri and Seysara, as explained by Gianfranco. For Seysara, we have seen an acceleration of net sales in the second quarter. Overall, we see the U.S. as an area of long-term growth potential. But as you see, it's not a significant portion of our business in the near term. In the rest of the world, we've seen growth in the business from a low base, mainly driven by timing of Ciclopoli franchise orders. Now moving on to Slide 17 and the P&L. I've already highlighted the key factors on sales performance, so let me continue with our focus on the core business by running you through the rest of the P&L. In the first half of the year, we achieved a core gross margin of 67.7%, broadly in line with what we anticipate for the year. As we anticipated, SG&A has seen an increase of 4% quarter-on-quarter as we continue to invest in the successful execution of our product launches. SG&A year-to-date has an impact of about 3% due to FX effects, mainly from the U.S. dollar. We expect to end the year with an increase in mid-single digits as the weight of the quarters and the halfs versus last year is slightly different. Last year, in the first half, we were still impacted by COVID restrictions, and you saw an acceleration in the second half. This year, we expect the halfs to be much more evenly weighted. In terms of R&D, there was an acceleration as compared to 2021, which will increase further during the year to a level that we anticipate to be around 11% to 12% of net sales for the full year. There are a few factors that are driving this increase in R&D spend. First is the Phase IIIb reimbursement-focused studies for lebrikizumab in Europe, which are hitting our P&L as compared to the development up to this point, which was funded by milestone payments to our partner. Second, the spend on Klisyri large field studies, which are also shifting on to our P&L as the Phase III was performed by our partner in a similar milestone setup. Finally, we will increase spending on earlier-stage assets such as the anti-IL1-RAP where we are starting Phase I studies. The reconciliation at the end of the P&L reflects the deferred income in the previous years, which has now been fully amortized. Total EBITDA of EUR 107 million includes about EUR 9 million due to the revaluation of our assets related to the AstraZeneca/Covis Pharma agreement. Overall, we remain confident in our full year 2022 guidance of core net sales growth of mid-single digits and total EBITDA between EUR 190 million and EUR 210 million for the full year. On Slide 18, continuing down the P&L, there are not too many line items to explain. However, I'd like to remind you that we are expecting an effective tax rate in the low 30s this year due to the minimum tax flow in Spain and the inability to deduct the U.S. tax losses against the profitable European business. Furthermore, financial expenses have been impacted by the lower share price connected to the equity swap that we have on the balance sheet. Additionally, I'd like to highlight that we finished the half year with a normalized net income of EUR 27.6 million, which resulted in a normalized earnings per share of EUR 0.15 per share. If we now look at the balance sheet on Slide 19, there are quite a few comments provided on the slides. So I just want to highlight 2 of the most important factors. First, 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 following their agreement with AstraZeneca. Second, there was also a slight decrease in financial debt related to the reduction in our pension plans due to an increase in interest rate assumptions. Overall, we have a very healthy balance sheet, finishing the quarter with a leverage of 0.9x net debt to EBITDA and a healthy cash position, which gives us flexibility in the current environment for additional licensing and M&A opportunities. Now let's take a look at the cash flow statement on Slide 20. We delivered operating cash flows of EUR 56 million for the first half, which was mostly generated in the second quarter. We've made key investments in the first half, including the upfront for the anti-IL1-RAP from Ichnos and other milestones. The divestments line here refers to the milestones and royalty collections from AstraZeneca and Covis. These have been classified as investing activities due to the reduced focus in our operations. And finally, there was a decrease in debt related to the regular loan repayments to the European Investment Bank. With that, let me pass it back to Gianfranco to conclude the presentation.

Thank you, Mike. To wrap up, as you already clearly heard from us this morning, we have delivered a strong operational performance as the business continued to perform well and in line with our expectations and which put us on target to achieve our 2022 guidance. We have continued with the strong momentum in Europe, and we will continue to work hard to fulfill the growth trajectory of our recent launches with an expectation of an improving momentum during the year. Furthermore, as detailed by Karl, we are progressing well with our promising innovative late-stage pipeline with exciting development during the year. And we'll be initiating important clinical trials while executing on key market introductions. We continue to execute on the transformation of the company by focusing on the Dermatology business. And this year, we continue to remain busy for our team, not just with extensive European rollout campaigns, but also as we prepare the business with exciting future launches like lebrikizumab, which will support our near-term to long-term sales prospects. Lebrikizumab is one of our most promising assets and will be the one of several new growth drivers in the Almirall playbook over the next few years. Our focused strategy for medical dermatology space position us well for the near, mid and long term. We will continue to execute on our strategy and will continue to strengthen our portfolio by taking advantage of inorganic opportunities as and when they present, given our robust balance sheet and flexible capital structure. Pablo, let me hand back the call to you and now for the instruction on the Q&A.

Thank you, Gianfranco. Sara, back to you for the Q&A, please.

[Operator Instructions] And the first question comes from the line of Harry Sephton from Credit Suisse.

I have 4 questions, please. So the first one on Seysara, despite the prescription growth, we saw that sales growth has more than eroded away by rebating. Can you comment on the U.S. acne market generally on this trend and whether we can expect this trend to continue into the future? Then my second question on lebri. Lilly appears to be less interested in a Dupixent head-to-head study. What do you expect you will do if your partner does not want to invest? And what could this mean for the cadence of R&D spend over 2022 and into 2023? I then have 2 financial questions. Firstly, we saw a material uptick in the SG&A growth in the quarter. Should we anticipate this as the run rate for the rest of the year? And then on financial charges, we also saw this higher in the quarter. We wanted to understand what was driving this and if this is representative of the run rate that we can expect for the year.

Thank you, Harry. I will start with the Seysara question, and then I will move to Karl for the lebri, and Mike is going to close with the financial questions. So in terms of Seysara Rx, I think that you can appreciate that in the second quarter, we grow quite extensively. We had to discount, in quarter 1, the high deductible season. So that's why you didn't see a lot in quarter 1, and in a market that, as you know, is 95% generic. We are confident that with the new microbiology level, we are going to see some positive trends, and especially now we have a campaign, go back to school, that we are thinking that can help us. So that's, in a general way, the Seysara market question. I don't know if I answered to all your questions. And now I will hand over to Karl.

Yes. Thank you. Now after -- now that the Phase III program for registration is basically completed and you see now the data readout emerging, we have started with a Phase IIIb program specifically to address market [ accident ] in pricing in Europe. We have already started end of last year a study that explores lebrikizumab in patients that are not adequately controlled or for which [ titles ] borrowing is not advisable. This study is ongoing, and we're also discussing various options for head-to-head studies and keep you updated as this emerges.

Yes. So let me take the 2 financial questions. So with SG&A, as I mentioned in the commentary, last year, if you look at the 2 different halves, we had quite a bit of an acceleration in the second half because the first half had a lot more COVID restrictions. This year, we don't expect that acceleration. We expect the second half to be in line or maybe even slightly below the first half. So the mid-single-digits guidance we gave earlier in the year for SG&A increase, it still holds. We do see a little bit of a currency impact there from the U.S., but it's also benefiting the sales a little bit, so it washes out at the profit level. In terms of financial charges, if you look into our deck in the appendix, that gives a little bit of detail of what makes that up. In terms of interest expense, we're actually a little bit lower than last year because we did a good job in refinancing. But between the 2 years, you've got a swing in the equity swap. We do have an equity swap with some shares held in a bank. Last year, the share price was going up in the first half, so we saw an income. And this year, the share price has gone down a little bit in the first half when we saw an expense. That's the main swing between the 2 years. Depending on where that equity swap and share price goes, we'll see how that impacts the full year. But overall, interest expense will be slightly down.

And the next question comes from the line of Thibault Boutherin from Morgan Stanley.

Just 2 product questions, please. The first one, on Ilumetri, so another strong quarter. Could you please provide a little bit more color on the split of the contribution between Germany and other countries? Was there any kind of stocking or any positive one-off for this quarter? And now this product is annualizing at EUR 120 million, how much more room for growth do you see for Ilumetri going forward considering the competition in psoriasis is going to increase in the next few months? So second question, efinaconazole, just if you could highlight the key differentiation that this product brings to the market. And when you think about the commercial potential relative to your other European dermatology franchise, Ciclopoli is around EUR 40 million, EUR 50 million, is this a good proxy for how big efinaconazole could be in the future?

Thank you, Thibault. I will start with Ilumetri, and then Karl is going to share with the efinaconazole, and then I will close on the [ PKR ] sales. So in terms of Ilumetri, we are very pleased with the performance, and the good news is also the class IL-23 is growing. To answer to your question, Germany is representing today almost 50%. The good news is that if you look back in 2020, Germany was representing 70%; last year, it was 60%. And this year, we will get close to 50-50. So the good news is that also the other European countries are picking up, and that's a clear guarantee for the future of [ Ilumetri ]. In terms of growth versus last year, we think that we are going to have the same absolute growth. So last year, we did EUR 80 million; this year, growing EUR 40 million versus the previous year. So that's a good proxy on how we think we are going to close the 2022. Now Karl?

Thank you for the question on efinaconazole. I mean efinaconazole, that is also sold under the brand name JUBLIA in different country, is a topical treatment for the treatment of infection of toe nails, which is called onychomycosis. When you look at all the data, it's fair to say that so far, JUBLIA has shown the best efficacy amongst all the topical products to treat this condition. And it might be due to the fact that this compound binds less to keratin, which is the main component of nails and toes and, therefore, has the ability to deeply and better penetrate into this tissue, and that might be the reasons why we see this improved efficacy.

In terms of [ PKR ] sales, I will not comment on this one. But what I'm very proud and very happy to see is that efinaconazole is going again to complement our offer to our patients. Having an OTC product, Ciclopoli and now, as Karl was mentioning, an Rx product, that this will be very beneficial for our patients. So again, our goal is to offer the complete offer to our patients moving from the moderate until to the more severe onychomycosis. Thank you, Thibault.

The next question comes from the line of Lucy Codrington from Jefferies.

I was just wondering if you could take us through the filing considerations for the 2- and 4-weekly regimens for lebri. I assume this is entirely in Almirall's hand, but also how important is the potential pricing implications when you start deciding the strategy here? And then secondly, I appreciate it's early, but in terms of what the potential development strategy and time lines could be for your anti-IL1-RAP?

Karl?

I think first, on lebrikizumab, I think our data show that patients who responded after week 16 can be maintained on every 2 or every 4 weeks application schedule, and then we have to see now how this plays out in further discussions with regular and payers. But certainly, we believe it will have a positive impact. I think your second question on IL1-RAP, I think this is a target that has potential utility across a number of autoimmune skin diseases. As this is a core receptor of 3 different cytokines: IL-1 alpha, beta; IL-33; and IL-36, the alpha, beta and gamma isoforms. Now we believe that with this profile, we can have a better efficacy as, for example, antibodies that just block one cytokine. We are now about to start Phase I. As I mentioned and based on those data, the pharmacokinetics, for example, we will then decide for which indication we do then proof-of-concept studies and how we further develop this compound.

We will now take the next question, it comes from the line of Guilherme Sampaio from CaixaBank.

So 3, if I might. The first one, on Klisyri potential in the U.S., how has this been evolving following the effect that you've been seeing? Now in terms of prices, continues the high level of rebate that you see in other products? Second, in terms of OpEx evolution, if you could provide us some guidance on what are your main thoughts at the moment for 2023. And third, if you could provide a bit more color on the change in the plans in your pension plan?

We start with the Klisyri potential. So Klisyri potential in the U.S. is mainly linked to 3 main key pillars. Pillar #1 is the assets where you may appreciate we did some good progress in the last months. And now we can count both from Medicare, almost 45%; and the commercial lives, we have an approximately 61% coverage. The second one is the physician likelihood to prescribe topical. So you know that the physician in the U.S., dermatology in the U.S., they made money on the cryotherapy. So there is a shift -- not a substitute in the cryotherapy, but to work together with the cryotherapy, and that's something that we are working together with our organization in the U.S. And then the third one is about the large field. We were mentioning before that the large field that Karl was mentioning, the clinical trial start, we are expecting results sometime next year and with a launch in the mid of 2024. So the moment that we are going to achieve those critical condition, I think that we are going to start seeing some nice uptake from Klisyri the U.S.

Yes. So in terms of OpEx, we've guided for this year about mid-single-digit increase. Given the fact that we have more launches to roll out next year and the prelaunch for lebrikizumab, I would expect something very similar, maybe mid-single digits. A little early to give too much color. We'll, of course, give you much more precision on that in February when we do our guidance for 2023. But do expect that kind of a trend probably to continue because of the need to invest in the new launches and the prelaunch for lebrikizumab. In terms of the pension plan, this is simply an actuarial valuation. The interest rates in Europe are starting to tick up. The previous evaluation was done with a 1% discount rate, now it's at 3%. And because it's a very long live pension plan in Germany, there's a very huge leverage effect. So that's what's caused the decline in the pension plan liability, which we include in our net debt-to-EBITDA ratio.

Okay. Just a follow-up on the first one. Just in terms of pricing, was there any change in your views regarding the levels that you might achieve in the U.S. in the Klisyri?

In terms of pricing, you mean? We are working and all that. We are working net to -- sorry? Yes?

No, my question was just -- okay.

No, go ahead. Go ahead, sorry. Guilherme, yes, go ahead.

Yes. No, my question on Klisyri was whether you're seeing any change in potential in terms of pricing compared to what you have embedded in your initial expectations of having EUR 250 million...

Yes, we are working on the gross to net. So we are working to improve it. And our expectation, of course, is to improve it. But as I said before, it's more linked to the 3 conditions that I was mentioning before. Those are the ones that are going to help to see a shift in terms of trajectory in the net sales.

We will now take the next question, and it's coming from the line of Francisco Ruiz from BNP Paribas Exane.

I have a couple of questions from follow-ups. First one is the impact of the FX. So if you could give us the impact in the evolution of U.S. sales and also if you have a positive or negative impact in total OpEx or SG&A? And the second is on the milestones, you commented that you are now including in the P&L instead of the cash flow. So could you give us an update on how many -- what's the milestone that you expect on lebri in the coming quarters until the approval and if they are going to be booked also in the P&L?

Yes. So in terms of the FX, if you look on Slide 17, you can see the changes year-on-year and in constant exchange rate. At the SG&A level, it's about a 3% difference; and at the sales, it's about 1%. At the EBITDA, it's about equal. So there's no real impact overall of the currency, but you do see a little bit in each of the lines. We'll see where the dollar goes. But as our U.S. business is only a small part of our profit, it won't have a major impact on the EBITDA. You just may see some effect in different lines. In terms of milestones, the deals we had with lebrikizumab and Klisyri were based on milestones during the development phase. We paid quite a significant amount. There are some milestones left like the approval milestone of lebrikizumab, which we would expect to pay next year, which is in the USD 45 million range, but that will go on the balance sheet. What we're seeing in the P&L is the Phase IIIb studies for lebrikizumab, which are more reimbursement focused, as well as the Klisyri large field.

We will now take the next question, it comes from the line of Alvaro Lenze from Alantra Equities.

Maybe returning once again to Klisyri. Should we expect until the launch in large field that quarterly revenue should stay within the circa EUR 1 million revenue? Or do you expect continued growth even before we head to the large field? And this would also go for Europe. I don't know if you see the same level of competition from cryotherapy in Europe or whether the launch could provide higher quarterly revenues even in the small field setting. And then my second question would be on the cost evolution. Of course, you're investing more in R&D and premarketing expenses. But maybe if you could give us an indication whether inflation is having a big impact or if you're seeing inflationary pressures maybe in weighted in Europe or in the U.S. and how should this evolve going into 2023? And Mike, I believe you indicated that maybe continuing with a mid-single-digit increase in SG&A could be reasonable for next year, whether this would be including the current inflation levels that we are seeing across the board.

Thank you, Alvaro. I will start with Klisyri, then Mike is going to give you some color on the cost. So your question about the EUR 1 million, for sure, we are working a lot in order to increase the depth of the prescriber. I was mentioning at the beginning that we have today 4,000 prescribers, and the goal is sort of to increase the number of this. Not only that, we also want to increase the number of the prescriber that they are going to do per quarter. So each prescriber today, each doctor today is making an average of 4 prescribing per quarter, and the goal for sure is to increase this one. So the goal is to see a slight uptake in the next quarter, that is going to continue for the future. In terms of Germany, Germany is doing very well. I told you we have 10% market share, and there is also different conditions. Cryotherapy, you were mentioning, is not part of the daily practice for dermatologists in Germany, and that also has an impact. And on top of this, also the long-term and established relationship that we built in the German -- with the German dermatologists help us a lot in terms to make this uptake. So that's, in general, what we are expecting. And of course, the large field that we are expecting mid-2022 -- mid of 2024 is going to be the booster to the sales in the U.S. in particular, but also in Europe. Thank you, Alvaro.

Yes, thanks. And in terms of OpEx, we are seeing some inflationary pressures. I think we talked in the last quarter about some energy costs and other things hitting the gross margin. But we think we can manage it within our guidance for this year. There will be more pressure, of course, next year. So part of that mid-single digits that I mentioned as kind of an expected run rate would include that inflationary impact, including pressure that we could see on wages. It's a little too early to tell and to give exact numbers there, but we will have to balance all of those things within the increases that we'll need to fuel the future business. But so far, we don't think 2022 will be infected by inflation and cost pressure so much that it will take us outside the guidance range. We think we're very comfortable of meeting our profit targets this year. And next year, that's kind of a general guidance. We'll refine that as we get to February. But hopefully, we'll start to see energy prices level out and maybe a little less pressure on inflation in the second half of this year, but too early to tell.

We will now take the next question, it comes from the line of Jaime Escribano from Banco Santander.

So a couple of questions from my side. The first one is related to gross margin. If I recall well, you guided a gross margin of around 67%. It came at around 68% in the quarter. Just to understand, why is this a little bit higher and if this means that in following quarters, we can see something similar or it will return closer to 67%? And then I have a question about a couple of products' performance globally, which came at least a little bit weaker than what I was expecting. And I just wanted to understand what happened there. And a question on Tesavel. Tesavel, if I recall well, is going ex patent second half of this year. Maybe you can recall us how -- what is the status of going ex patent and what should we expect in following quarters and also next year to make sure we model this properly?

Okay. So in terms of the gross margin, yes, we had a nice quarter this quarter, but we still stick by the 67% for the full year. We will see, of course, some of those cost pressures I talked about in terms of energy and some raw materials. But overall, 67% for the full year is a good target still. I'll let Gianfranco talk about Ciclopoli sales.

Yes. Ciclopoli, obviously, was a little bit weak, as you mentioned, and we think that was related also to the economy cycle. So the level of willingness to spend from families went a little bit lower. And maybe they focus their expenses on product like for the post-COVID or the high allergy season that we incurred during quarter 2. But nothing to be worried there. I think that we will see a rebound in the next quarter. For Tesavel, you are absolutely right, there is a patent expiration, and we are going to face and we are going to expect some price cuts that are the one that usually happens, so 40%. And then we are going to see in the next few months this price cut. You may recall that the profitability on those products is not very high. So at the end, it will not be any big impact in terms of our EBITDA. Thank you, Jaime.

I would like to hand back over to Pablo for final remarks.

Thank you, Sara. We are now going to close our Q&A session. We want to thank you for your participation of the conference today. You may now [ disconnect ]. Thank you very much.

Thank you.