Almirall SA

MAD:ALM

Earnings Call Transcript 2022-Q2

[Operator]

Good day and thank you for standing by. Welcome to the H1 2022 Financial Results and Business Update Conference Call. At this time, all participants are in a listen-only mode. After the speakers’ presentation, there will be a question-and-answer session. [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.

[Pablo Divasson del Fraile]

Thank you, Sarah. 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 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 risk, 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.

[Gianfranco Nazzi, Chief Executive Officer]

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 the second quarter, showing growth in core net sales of 5% in the first half of the year, within 1% growth reported in quarter one. This shows that we had a nice generation in the second quarter.

As you know, the focus of Almirall is now our core European dermatology portfolio where the performance of the business remain very robust, helped by recently launched product. Thanks to the strong European growth and our confidence in 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-IL23 class. Wynzora is also seeing a strong growth in Europe as we continue to make a 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 3 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 the targeted late 2023 European approval and launch.

And additionally, Seysara China Phase 3 clinical trial is ongoing as we work towards an expected launch in 2024. And with Efinaconazole, we have already submitted the filing for regulatory approval in the quarter, with a launch targeted in 2023.

And finally, we have initiated a Phase I for the anti-IL1RAP and Karl will provide more color on the pipeline data 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 this slide, you can see the market dynamics of the anti-IL-23 class in Germany where this class will lead towards leading market position and more new patients.

On the right side of the chart, Ilumetri continued to perform a strongly, achieving an overall net sales of €31 million in this quarter, a solid continuation with 58% sales growth year-on-year. And new country launches help drive this momentum and we expect further contribution from launches to help 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.

[indiscernible] 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 is gaining strong traction and achieve a very good uptake, particularly in Germany, where we have more than 10% unit market share, which is an excellent result given that we only launched the product nine months ago.

We are seeing great traction with early and sustained customer engagement supporting the product. The European rollout continues well, with recent launches in Netherland, Switzerland and Austria, and further launches are planned for this year and 2023.

Moving now into Wynzora for patient 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 have 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 coming quarters.

Wynzora helps strengthening our position in European psoriasis market as the only company to provide a full range of psoriasis products covering the patient journey.

Let's now dive on our US business on slide number 8. As many of you know, for Almirall, the US 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 product that we are developing with worldwide rights. We want to reassure investor and analyst, 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 market where we are present right now.

In the near term, the US 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, the new product and pipeline opportunities.

For right now, we have important launches in Europe and want to put our effort to ensure the success of this medicine [indiscernible] the underlying business in the US in term of TRx volume are aligned 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 continues 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 prescription having been generated since launch, a good result for a new product launch in a highly generic market. Furthermore, more than 4,000 healthcare professional have prescribed Klisyri since launch, but we continue to receive a very positive feedback and good patient engagement.

We have made progress on the commercial progress, 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 in 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 an all-time high in more normalized environment following pressure from a high deductible season in quarter one.

Seysara continued to make a steady access gain, with a good uptake a 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 differentiated base on the microbiology label. And for 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 two very good products with good potential and we continue to work to be the sustainable platform [indiscernible].

And with that, I will pass over to Karl to update you on the pipeline.

[Karl Ziegelbauer]

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 throughout 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 it is the topic of this slide, we’re very excited about the data from the maintenance phase of the ADvocate 1 and 2 Phase 3 clinical trials. Eight out of ten patients who achieved clinical responses after Lebrikizumab treatment, measured by the EASI-75 score at week 16 maintained skin clearance at one year treatment. Once every two week and once every four week maintenance dosing showed basically identical results, with consistent and durable responses. Additionally, patients treated with lebrikizumab maintained itch relief across the two trials over the one-year period.

These data, together with all the other data from the Phase 3 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 3 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 one year later, which puts us on track for a launch in late 2023, and we continue to work on the pre-launch plan. We look forward to continuing our collaboration with Eli Lilly and advancing our clinical program.

Finally, we are very excited by the prospect of delivering this promising therapy for people living with moderate to severe atopic dermatitis in Europe.

Let us now move to the next slide to discuss the progress we’re 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 US and European markets, we are working on an expansion to the large field indication with a potential launch in late 2024 in the US and 2025 in the EU. This month, we have started the large field label expansion study for the US.

The Phase 3 clinical trials for Seysara in China is ongoing, and we have completed recruitment despite the difficult COVID situation in China.

For Efinaconazole, we have submitted regulatory filing in Germany and Italy under the European decentralized procedure. The German regulatory authority is acting as a 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 1 with our anti-IL1RAP monoclonal antibody in the coming weeks. As a reminder, we in-license 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're making good progress with our pipeline and we’re on track to strengthen our leadership position in medical dermatology.

Let me now hand over to Mike to take us through the financial.

[Mike McClellan]

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 €98.3 million year-to-date, though the comparison to last year is impacted by a product divestment in the first half of 2021 of nearly €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 €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% to 12% of net sales for the full year.

This year, we will have to pay for the Phase 3b reimbursements focused studies for lebrikizumab, the Klisyri large field studies as well as an increase in spending on earlier stage assets, such as the anti-IL1RAP, which we recently in licensed.

Total EBITDA reached €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. We did see an improved operating cash flow in the second quarter, reaching €56 million for the first half, which helps further strengthen our healthy balance sheet as we finish this quarter at 0.9 times 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 US 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 we're 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 US 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 US 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 US dollar.

We expect to end the year with an increase in mid-single digits as the weights of the quarters and the halves 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 halves 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 3b 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 3 was performed by our partner in a similar milestone setup. Finally, we will increase spending on earlier stage assets such as the anti-IL1RAP where we are starting Phase 1 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 €107 million includes about €9 million due to the revaluation of our assets related to the AstraZeneca/Covis Pharma agreement. Overall, we remain confident in our full-year 22 guidance of core net sales growth of mid-single digits and total EBITDA between €190 million and €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 law in Spain and the inability to deduct the US 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 €27.6 million, which resulted in a normalized earnings per share of €0.15 per share.

If we now look at the balance sheet on slide 19, there are quite a few comments provided on the slide. So, I just want to highlight two 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 0.9 times 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 €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-IL1RAP 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.

[Gianfranco Nazzi, Chief Executive Officer]

Thank you, Mike. To wrap up, as you already clear heard from us this morning, we have delivered a strong operational performance as the business continues to perform well and in line with our expectation and which put us on target to achieve our 2022 guidance.

We have continued with a 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 introduction.

We continue to execute on the transformation of the company by focusing on the dermatology business as this year continue to remain 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 supports our medium to long term prospects. Lebrikizumab is one of our most promising and it is one of several new growth drivers in the Almirall playbook over the next few years.

Our focused strategy on medical dermatology space position us well for the near, medium and long term. We 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 offer instruction on the Q&A.

[Pablo Divasson del Fraile]

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

[Operator]

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

[Harry Sephton, Credit Suisse]

I have four questions, please. So, the first one on Seysara. Despite the prescription growth, we saw that sales growth is more than eroded away by rebating. Can you comment on the US 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 means for the cadence of R&D spend over 2022 and into 2023?

I then have two 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 rates that we can expect for the year.

[Gianfranco Nazzi, Chief Executive Officer]

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 it is the second quarter we grow that quite extensively. We had to discount in quarter one the high deductible season, so that's why you didn't see a lot in quarter one 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 all your question. And now I will hand over to Karl.

[Karl Ziegelbauer]

After the Phase 3 program for registration is basically completed and you see now the data readout emerging, we have started with a Phase 3b program specifically to address market access and 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 cyclosporine 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.

[Mike McClellan]

Let me take the two financial questions. So, with SG&A, as I mentioned in the commentary, last year, if you look at the two different halves, we had quite a bit of 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 still holds. We do see a little bit of a currency impact there from the US. 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, it 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 pre-financing. But between the two 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 two 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.

[Operator]

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

[Thibault Boutherin, Morgan Stanley]

Just two further questions please. The first 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, whether any kind of stocking or any positive one-off for this quarter? And I know this quarter it is annualizing at €220 million, how much more room for growth do you see for Ilumetri going forward, considering the competition entirely 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 we think about the commercial potential relative to your other European dermatology franchise, Ciclopoli is €40 million, €60 million, is this a good proxy for how big Efinaconazole could be in the future?

[Gianfranco Nazzi, Chief Executive Officer]

I will start with Ilumetri and then Karl is going to share the Efinaconazole and then I will close on the peak year sales. So, in term of Ilumetri, we are very pleased with the performance. And the good news is also the class, the 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 represented 70%. Last year 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.

In terms of growth versus last year, we think we are going to have the same absolute growth. So, last year, we did €80 million. This year growing €40 million versus the previous year. So that's a good proxy on how we think we are going to close 2022.

Now, Karl?

[Karl Ziegelbauer]

Efinaconazole, that is also sold under the brand name Jublia in different country, is a topical treatment for the treatment of infections of toenails, 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 components of nails and toes, and therefore has the ability to deeply and better penetrate into the tissue, and that might be the reasons why we see this improved efficacy.

[Gianfranco Nazzi, Chief Executive Officer]

In terms of peak year sales, I will not comment on this one. But what I'm very proud and very happy to see is that Efinaconazole is growing, again, to complement our offer to our patient being an OTC product, Ciclopoli. And now, as Karl was mentioning, an Rx product that will be very beneficial for our patients. So, again, our goal is to offer the complete offer to our patients moving from the moderate to the more severe onychomycosis.

[Operator]

And the next question comes from the line of Lucy Cordrington from Jefferies.

[Lucy Cordrington, Jefferies International Ltd.]

I was just wondering if you could take us through the filing considerations for the two and four-weekly regimen for lebri. I assume this is entirely an [indiscernible], but also how important is the potential pricing implications then to start deciding the strategy here.

And then, secondly, I appreciate it’s early, but in terms of what the potential development strategy and timelines could be for your anti-IL1RAP?

[Karl Ziegelbauer]

I think for lebrikizumab, I think our data show that patients who responded after week 15 can be maintained on every two or every four weeks application schedule. And then, we have to see now how this plays out in further discussions with regulators and payers, but certainly we believe it will have a positive impact.

I think your second question on IL1RAP, I think this is a target that has potential utility across a number of autoimmune skin diseases. As this is a core receptor of three different cytokines, IL1 alpha, beta, IL33 and IL36 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 1, 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.

[Operator]

We'll now take the next question. It comes from the line of Guilherme Sampaio from CaixaBank.

[Guilherme Macedo Sampaio, CaixaBank]

The first one on Klisyri potential in the US. How has it been evolving following the [indiscernible]? In terms of prices, [indiscernible] 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 assumptions in your pension funds?

[Gianfranco Nazzi, Chief Executive Officer]

I will start with the Klisyri potential. So, Klisyri potential in the US is mainly linked to three main key pillars. Pillar number one is the assets where you may appreciate that we did some good progress in the last months and now we can count both from Medicare, almost 45%, and commercial life we have an approximately 61% coverage.

The second one is the physician likelihood to prescribe topicals. You know that the physician in the US, dermatology in the US, they made money on the cryotherapy. So, there is a shift, not 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 US.

And the third one is about the large field we were mentioning before. But large field that Karl was mentioning, the clinical trial start, we are expecting result sometime next year and with a launch in the mid of 2024.

So, the moment that we are going to achieve those three critical conditions, I think that we are going to start see some nice uptake from Klisyri in the US.

[Mike McClellan]

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 pre-launch for lebrikizumab, I would expect for something very similar, maybe mid-single digits. A little early to give too much color. We will, 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 pre-launch 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 a 3%. Because it's a very long-lived pension plan in Germany, there's a very huge leverage effect. So that's what's caused the decline in the pension plan, a liability which we include in our net debt to EBITDA ratio.

[Guilherme Macedo Sampaio, CaixaBank]

Just to 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 US in Klisyri?

[Gianfranco Nazzi, Chief Executive Officer]

In terms of pricing, you mean?

[Guilherme Macedo Sampaio, CaixaBank]

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 discussions of having €250 million [indiscernible]?

[Gianfranco Nazzi, Chief Executive Officer]

We’re 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 three condition that I was mentioning before. Those are the ones that are going to help to see a shift in term of trajectory in the net sales.

[Operator]

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

[Francisco Ruiz Martín, Exane BNP Paribas]

I have a couple of questions and follow-ups. First one is the impact of the FX. So, if you could give us [indiscernible] in the evolution of US sales and also if they 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 of the cash flow. So could you give us an update on what's the maximum that you spent on lebri in the coming quarters until the approval and if they are going to be booked also on the P&L?

[Mike McClellan]

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 US 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 have 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 $45 million range, but that will go on the balance sheet. What we're seeing in the P&L is the Phase 3b studies for lebrikizumab, which are more reimbursement focused, as well as the Klisyri large field.

[Operator]

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

[Alvaro Lenze]

Maybe returning once again to Klisyri, should we expect until the launch in large field that quarterly revenue should stay within the circa €1 million revenue? Or do you expect the continued growth even before we had to do a 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 a small field setting?

And then, my second question would be on the cost evolution. Of course, you're investing more in R&D and pre-marketing 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 wages in Europe or in the US, and how should these 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 these would be included in the current inflation levels that we're seeing across the board?

[Gianfranco Nazzi, Chief Executive Officer]

I will start with Klisyri, then Mike is going to give you some color on the costs. So, your question about the €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, for sure, to increase the number of these. 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, doctor today is making an average of four prescribing per quarter. And the goal, for sure, is to increase this one. So, the goal is to see a slight uptick in the next quarter, but it 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, we’re 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 relationships that we built with the German dermatologists has helped a lot in term to make this update. So, that's in general what we are expecting. And of course, the large field that we are expecting mid of 2024 is going to give a boost to the sales in the US, in particular, but also in Europe.

[Mike McClellan]

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 pressures so much that it'll 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.

[Operator]

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

[Jaime Escribano, Banco Santander]

A couple of questions from my side. The first one is related to gross margin. If I recall well, you guys did a gross margin of around 67%. It came out 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 in the second half of this year. Maybe you can recall us 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.

[Gianfranco Nazzi, Chief Executive Officer]

In terms of the gross margin, yeah, 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.

[Gianfranco Nazzi, Chief Executive Officer]

Ciclopoli OTC was a little bit weak, as you mentioned, and we think that was related also to the economic cycle. So, their level of willingness to spend from families went a little bit lower and maybe they focus their expenses on a product like – for the post-COVID or the high allergy season that we incurred during quarter two. But nothing to be worried. 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 – we’re going to expect some price gap that are – the one that usually happens. So, 40%. And we are going to see in the next few months this price gap. You may recall that the profitability of those products is not very high. So, at the end, it will not be any big impact in terms of our EBITDA.

[Operator]

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

[Pablo Divasson del Fraile]

Thank you, Sarah. We are now going to close our Q&A session. We want to thank you for your participation of the conference today. Thank you very much.

[Operator]

Thank you.