LBTSF - Almirall S.A. (LBTSF) Q3 2023 Earnings Call Transcript

2023-11-11 00:59:06 ET

Almirall, S.A. (LBTSF)

Q3 2023 Earnings Conference Call

November 9, 2023, 4:00 AM ET

Company Participants

Pablo Divasson - Director, Investor Relations and Corporate Communications

Carlos Gallardo - Chairman and CEO

Mike McClellan - Chief Financial Officer

Karl Ziegelbauer - Chief Scientific Officer

Paolo Cionini - Chief Commercial Officer, Europe and International

Conference Call Participants

Lucy Codrington - Jefferies

Alistair Campbell - Royal Bank of Canada

Thibault Boutherin - Morgan Stanley

Guilherme Sampaio - CaixaBank

Francisco Ruiz - BNP Paribas Exane

Alvaro Lenze - Alantra Equities

Jaime Escribano - Banco Santander

Pablo de Renteria - Kepler

Presentation

Pablo Divasson

Good morning to everyone on the call. Thank you for joining us to review Almirall’s Nine Months 2023 Results and Business Update. As per usual, you can find the slides to this call on the Investors page of our website at almirall.com.

Please move to slide number two. I would like to remind you that the information presented in this call contains forward-looking statements, which involve known and unknown risks, uncertainties and other factors that may cause actual results to materially differ.

With that, please advance to slide number three. Presenting today, we have Carlos Gallardo, Chairman and Chief Executive Officer; Mike McClellan, Chief Financial Officer; and Karl Ziegelbauer, Chief Scientific Officer. Carlos will start with the highlights, biologics growth drivers and recent launches. Karl will provide you with details on the process of the pipeline, before passing to Mike to review the financials. Carlos will then conclude with closing comments before opening up for a Q&A session.

I would now like to pass it over to Carlos Gallardo, our Chairman and CEO to discuss the highlights. Please move to slide number five.

Carlos Gallardo

Thank you, Pablo, and good morning to everyone in the call. I am pleased to say that Almirall continues to perform well for the first nine months of 2023. The business momentum from our growth drivers remain sold.

Based on the good business performance year-to-date, we are notching up our net sales guidance for full year guidance and we continue to expect to land in the middle of the range for the EBITDA guidance.

The nine-month performance was driven primarily by our European dermatology business with a growth rate of almost 16%, underpinned by Ilumetri and our recently launched products, Wynzora and Klisyri.

Moving to key pipeline highlights. On September 15, the CHMP of the European Medicines Agency issued a positive opinion recommending the marketing authorization of EBGLYSS, which is the brand name for lebrikizumab. Still in our late-stage pipeline, Klisyri large field supplementary NDA in the U.S. was submitted this quarter. The launch is anticipated in the second half of 2024.

For the rest of our portfolio, the Seysara dossier in China was submitted during the third quarter and we are expecting launch in 2024. And for Efinaconazole, the regulatory review is ongoing, and we expect the approval by the second half of 2024. Karl will elaborate on all this in more data.

Regarding the use of the proceeds of the capital increase of June, I am pleased to announce our first deal, the acquisition of the rights of Prometax in Spain, which is a perfect bolt-on for our neurology division in Spain. We are confident on our ability to drive commercial success for Prometax and to create value for the company.

Please move on to the biologics growth drivers update on slide seven. As I mentioned before, last September, the European Medicines Agency, CHMP, issued a positive opinion recommending the marketing authorization of EBGLYSS.

At this stage, we do not expect any delay in Europe related to the FDA CRL in the U.S. We continue working towards our existing time line and to launch the product as expected at the end of the year.

The commercial teams for the initial country launches are already in place and fully prepared for the rollout, in particular in Germany, where we expect a quick turnaround between approval and launch and where we are very pleased with the level of awareness of the product within the dermatology community.

Let’s move to slide eight, please. Let’s now take a closer look at the strong momentum of Ilumetri, our anti-IL-23 biologic for psoriasis in Europe. I would first like to highlight that the anti-IL-23 class continues to maintain its leading market share of new patients amongst biologicals.

As you can see here in the left map, the rollout process in Europe is well underway. We have launched a 200-milligram presentation, the auto-injector and provided new clinical data.

On the right side chart, we see that Ilumetri is performing strongly in the first nine months despite the usual summer softness. It also shows a more balanced growth with the sales contribution of other European countries that now already represent already a 50% with Germany making up the other half.

This demonstrates the good traction of the product in other key European markets where it has been launched. We expect Q4 to resume momentum and we continue to expect full year growth in absolute terms to be comparable to 2022.

Now, let’s move to slide 10 to complete the update on our recent derma launches. Let’s start with Klisyri, where sales grew by 57% for the first nine months. In Europe, the product has seen solid adoption in key markets with expansion in market share. In the U.S., we continue to differentiate Klisyri from what is already available in the market based on efficacy, tolerability and convenience.

As a result, both dermatologists and patients report high overall level of satisfaction and willingness to repeat treatment with Klisyri. We will soon reinforce the franchise with the launch of Klisyri large field, which is anticipated in the second half of 2024 in the U.S. and in 2026 in Europe.

Moving on to -- sorry, moving into Wynzora in Europe. We are pleased with the progress, having achieved sales of around €12 million in the first nine months of the year with solid share in Spain and Germany.

With that, let me pass the word to Karl to cover our pipeline section.

Karl Ziegelbauer

Thank you, Carlos, and good morning from my side. This slide shows you the progress of our pipeline. We continue to advance both our early- and late-stage pipeline. Starting with lebrikizumab, EBGLYSS. As already mentioned, we received a positive CHMP opinion on the marketing approval of EBGLYSS and I will share more details on the regulatory status across Europe on the next slide.

For Klisyri, we have completed the clinical study addressing the expansion to large field in the U.S. and submitted a supplementary NDA in August 2023. We expect launch in the second half of 2024.

For Seysara in China, the Phase 3 clinical study met primary and key secondary endpoint and we submitted a dossier to the Chinese National Medical Products Administration at the end of September 2023. Approval is expected in 2024 in about 12 months to 18 months.

For Efinaconazole, we are under regulatory review. We are facing delays in this regulatory process and expect now approval in the second half of 2024. The Phase 1 of our anti-IL-1RAP monoclonal antibody is ongoing, and we aim to start Phase 1 for our IL-2 mutein fusion protein that we developed in collaboration with Simcere later this year. As you can see, we are making very good progress with both our early- and late-stage pipeline and we are on track to strengthen our leadership position in medical dermatology.

Let’s move to slide 13. On this slide, I would like to share the regulatory status of EBGLYSS across Europe. We already covered the status in the European Union. As a reminder, we received a positive CHMP opinion on September 15th and expect European Commission approval by the end of November 2023.

Regarding the United Kingdom, we submitted a Marketing Authorization Application, MAA, in September 2023. The approval from MHRA is expected by the end of the year following the EC Reliance Procedure.

In Switzerland, we submitted the MAA in June 2023 and the approval is expected by the end of 2024.

In addition to the progress in regulatory, we are extremely excited about the continuous flow of positive clinical data for lebrikizumab and I would like to share a few examples on the following three slides.

Please move to slide 14. We published the results of the ADvantage Phase 3b study at the recent European Academy of Dermatology and Venereology, EADV, Congress. As a reminder, the ADvantage study is a randomized, double-blind, placebo-controlled Phase 3 clinical trial to assess the efficacy and safety of lebrikizumab in combination with topical corticosteroids in adult and adolescent patients with moderate-to-severe atopic dermatitis who are not adequately controlled with cyclosporine A or for whom cyclosporine A is medically not advised.

The study met the primary endpoint at week 16. At week 16, lebrikizumab 250 milligram every two weeks plus TCS significantly improved signs and symptoms of AD measured by the Eczema Area and Severity Index 75%, EASI-75 in 68.4% of patients, while only 40.8% of patients on placebo plus TCS achieved EASI-75.

Consistent benefit was also seen in additional endpoints such as EASI-90, Investigator Global Assessment Score, IGA or Pruritus measured by the Numeric Rating Scale, NRS. The safety profile was consistent with a known safety profile of lebrikizumab.

Another example is shown on slide 15. Additional data presented at the EADV Congress showed sustained depth of response in patients that participated in the Phase 3 monotherapy ADvocate 1 and 2 studies treated with lebrikizumab over 52 weeks.

Deep responses defined as total skin clearance EASI-100 and itch relief of NRS 0 or 1 were achieved in 20% and 31% of patients, respectively, by week 16. This value were either maintained or even improved by week 52. These results suggest that lebrikizumab treatment can potentially allow patients and health care providers to elevate their expected treatment goals in AD beyond EASI-75 response.

A third example is shown on slide 16. At the 43rd Annual Fall Clinical Dermatology Conference held in Las Vegas from October 19th to 22nd, our partner, Eli Lilly, presented the first results of the long-term extension study ADjoin, which represented patients with moderate-to-severe atopic dermatitis who continue treatment with lebrikizumab for up to two years and experienced sustained skin clearance, itch relief and reduced disease severity with monthly maintenance dosing.

ADjoin is a long-term extension of the lebrikizumab monotherapy trials at ADvocate 1 and 2, and the combination study with topical corticosteroids ADhere. Patients taking lebrikizumab who achieved IGA 0, 1 or EASI-75 at week 16 in ADvocate 1 and 2 and ADhere were enrolled in ADjoin.

Patients in the long-term extension trial received either 250-milligram lebrikizumab every two weeks or monthly, after being rolled over from ADvocate 1 or 2 at week 52 or from ADhere at week 16.

As shown in the table, in ADjoin extension following ADvocate 1 and 2, 76% of patients dosed every four weeks and 86% of patients dosed every two weeks maintain clear or almost clear skin IGA 0 or 1 at two years of treatment, 96% of patients dosed every four weeks and 96% of patients dosed every two weeks maintained EASI-75, 83% of patients dosed every four weeks and 82% of patients dosed every two weeks maintained EASI-90, 90% of patients dosed every four weeks and 100% of patients dosed every two weeks maintained clinically meaningful reduction in itch, as measured by a 4-point or large reduction on the itch severity on the Pruritus NRS at two years of treatment.

In ADjoin extension following ADhere, lebrikizumab demonstrated similar results as you can see at the right side of this table. The safety profile of lebrikizumab in ADjoin was consistent with previous lebrikizumab studies in patients with moderate-to-severe atopic dermatitis. These data are very reassuring and give us confident that lebrikizumab has the potential to be a first-line biologic and may support less frequent dosing during the maintenance phase.

In summary, we continue to be extremely excited about lebrikizumab and are confident on the expected approval and launch of lebrikizumab towards year end.

With that, I will hand over to Mike for the financial review.

Mike McClellan

Thank you, Karl. As Carlos mentioned, the first nine months of the year showed solid performance with net sales growth of 6.4%, giving us the confidence to guide to the mid-single-digit sales growth for 2023.

We have seen strong sales growth in Europe from the dermatology portfolio, which has helped drive the overall net sales and a 2% core EBITDA increase year-on-year. We achieved a total EBITDA of €138.2 million in the first nine months of the year, down from the first nine months 2022, mainly due to a lower contribution in other income due to last year’s AstraZeneca/Covis milestones.

For the nine months, our gross margin came in at 64.9%, which is consistent with previous quarters, that was impacted in part by higher royalties, as well as energy costs and inflation, which affected some of our material purchases. This is in line with our full year expectation.

SG&A in the first nine months of 2023 was €316.7 million, as we continue to invest in our newly launched products, as well as some of the pre-marketing ramp-up for EBGLYSS, which will accelerate in the final quarter and grow significantly next year.

R&D investments increased to 11.6% of sales in the first nine months of 2023, compared to 11.3% of net sales that we have reported in the first nine months of 2022. We expect the R&D expenses to accelerate in Q4 to normalize as expected to the full year range of 12% of net sales.

We finished the first nine months of 2023 at 0.2 times net debt-to-EBITDA, which remains highly favorable. The increase from June is mainly explained by the recent Prometax acquisition.

Let’s move to sales breakdown on slide 19. As you can see on slide 19, the dynamics of net sales, the European dermatology business has had a very strong performance with a 15.9% increase year-on-year, which I will expand on in the next slide.

We also had a strong nine-month performance from our general medicine and OTC businesses in the EU, which more than offset the expected decline in Efficib/Tesavel following the patent expiration and price decrease experienced in Q4 2022.

Our U.S. business reported a decrease in nine months 2023 and I will provide more details on the next slide.

Rest of World dermatology sales showed a slight decline, but general medicine is growing, mainly driven by a rebound in Imunorix sales. Overall, it’s important to reiterate that our portfolio has limited patent expiry risk going forward in the midterm, especially now that the Efficib/Tesavel patent has expired.

Let’s take a closer look at dermatology business on the next slide. As you can see on slide 20, we had a very strong performance in Europe driven by the growth of Ilumetri. Other products such as Klisyri and Wynzora are also benefiting in Europe from the initial launches in key markets. Skilarence has declined in 2023 due to a continued shift from oral products to biologics in the psoriasis market.

Focusing on our U.S. business, the market share of Seysara has been stable, although we have seen continued pressure on net revenue due to higher rebates and more consignment sales. Klisyri keeps growing at a good rate and we expect further acceleration coming after the large field approval in the second half of 2024.

As you can see, the legacy business in the U.S. remains under pressure from ongoing generic erosion, mainly related to Aczone and Tazorac and some smaller legacy brands. In the rest of the world, sales are declining slightly due to a lower Cordran Tape supply sales to Japan.

Now, moving on to the full financial statements on slide 21. We have seen the net revenue development in the previous slide, so let’s focus on the rest of the P&L. Gross margin was in line with expectations to 64.9%, given the previously highlighted ongoing pressure of royalties, cost inflation and product mix.

Other income was lower than nine months 2022 due to the milestone income recognized last year, which did not repeat. As most of the revenue related to the Covis agreement was recognized in 2022, we should expect a lower contribution this year and going forward.

R&D expenses are up slightly from 2022, reaching 11.6% of net sales. The increase is mainly driven by the IL-1RAP project and EBGLYSS expenses. As I said earlier, we expect R&D costs to accelerate to the full year level of around 12% of net sales.

SG&A investments grew in the low-single digits compared to nine months 2022, but this will also accelerate in the final quarter as we prepare for the expected launch of EBGLYSS. Financial expenses have been impacted by the share price fluctuations in Q3 linked to the equity swap on the balance sheet, which was a slight positive versus last year.

I would like to remind you that our effective tax rate is affected by the inability to deduct the U.S. tax losses against our profitable European business. The effective tax rate excluding the U.S. losses would be in the high 20%. We do not have any meaningful unusual items in the quarter, and therefore, normalized net income is almost aligned with net income.

Please move to the next slide, so we can look at the balance sheet in detail. On slide 22, the key point to highlight here is the impact of the capital increase and our recent investments. As previously mentioned, we received around €200 million worth of proceeds from the capital increase. A part of this has been allocated to short-term investments and the other part registered as cash equivalents. The increase in cash equivalents has been offset by the first investment as we executed in Q3, the Prometax upfront payment for €45 million. Although we are no longer in a positive cash position, our net debt ratio is highly favorable at 0.2 times.

Let’s take a look at the cash flow statement on the next slide. On slide 23, you can see that we delivered operating cash flows of €50 million in the nine months, lower than last year due to an increase in working capital. This has resulted in an outflow due to higher inventories with certain products requiring higher stock levels due to the launch of EBGLYSS, the continued growth of Ilumetri and some stocking of Klisyri following the financial issues of our partner, which led to us taking over the manufacturing of the product.

We expect the inventory outflow impact to end around €30 million to €40 million for the full year and accounts payable and receivables to normalize more in line with last year’s numbers. The other adjustments are mainly related to the net financial income, including the differences in the value of the equity swap.

Among the investing activities, we made key cash estimates in nine months of 2023, such as the recent Prometax acquisition, the Efficib/Tesavel extension deal, the Physiorelax acquisition earlier in the year and milestone payments related to Ilumetri and Klisyri.

The divestment line here refers to milestones and royalty collections from AstraZeneca/Covis. These have been classified under investing activities due to the reduced focus in our operations and are lower than 2022 based on the agreed schedules.

The short-term deposits I mentioned before are a result of the capital increase in June and will mature by the end of the year and return to the cash line.

Let’s move to back to Carlos now for the conclusions and wrap up.

Carlos Gallardo

Thanks, Mike. So wrapping up, we have delivered a good operational performance in the first nine months of 2023. We expect to land in a mid-single-digit area for sales growth and in the middle of the range for the EBITDA guidance. This is a small upgrade in sales compared to our initial guidance back in February.

Our focused strategy in the medical dermatology space positions us well for the midterm as we continue to execute on the transformation of the company by preparing the business for the launch of EBGLYSS by the end of the year, with commercial teams ready for the launch in the first countries.

We are confident that Almirall’s growth drivers will continue their trajectory throughout the rest of the year, as we continue to support these key products. Ilumetri has demonstrated a strong performance and we expect increasing contributions from the recent country launches. We also expect the positive trends from the rollout of Klisyri and Wynzora in Europe to continue.

Furthermore, as detailed by Karl, we are making good progress with our late-stage pipeline, while at the same time we are strengthening our early-stage pipeline with exciting new assets.

Finally, I would like to remark that we continue to explore other opportunities for early- and mid-stage assets. We will make sure that deals we undertake are underpinned by scientific, strategic and financial rationale.

With this, we conclude this presentation. Pablo, I hand the call back to you.

Pablo Divasson

Thank you, Carlos. And Sandra, back to you for the Q&A, please.

Question-and-Answer Session

Operator

Thank you. [Operator Instructions] We will now take the first question. One moment please. It’s coming from the line of Lucy Codrington from Jefferies. Please go ahead.

Lucy Codrington

Hi, there. Thanks for taking my questions. And just to start with, in terms of the small sales upgrade, I guess, compared to your prior expectations, is that being driven by your dermatology franchise or your non-dermatology franchise or both in terms of their performance so far? And in terms of the potential label for EBGLYSS or lebrikizumab, in terms of the dosing, is it likely that the -- whatever is decided to the maintenance dose will be fixed or is there any scope for a flexible dosing? Just looking at that long-term extension data, although the four weekly is very competitive. There is some reduction versus the twice weekly, at least in the IGA scores. So just whether patients would have the scope to increase based on that. And then, finally, just in terms of the EpimAb deal, could you just talk us through what you were thinking and what the kind of rationale was for that deal and when we might hear next steps for those assets? Thank you.

Carlos Gallardo

Okay. Lucy, thanks for the questions. Mike will take the first question about the net sales and Karl will get back to you with the other two questions. Thank you.

Mike McClellan

Yeah. Thanks, Lucy. So, overall, our dermatology business is pretty much in line with our expectations. We are doing well in many products. We are having a little bit of difficulty in the U.S. So the slight bump up in the guidance to the midrange is really due to the nice performance in the general medicine and OTC business, which is complementing, of course, the dermatology.

I will remind you that Q4 will be a little bit of a tricky comparison because last year in Q4, we did have an €18 million product divestment, we are not going to have anything like that. So the 6.4% will still end up in the midrange, but we do have a tougher comparison in the fourth quarter. I will pass over to Karl for the other two.

Karl Ziegelbauer

Yeah. Thank you, Lucy, for the question. I mean, we submitted the based on the data from ADvocate 1 and 2 and the ADhere study. With respect to the label details, I think, it’s a bit premature to discuss them today. But we will be very happy to walk you through all the details after the approval.

With respect to the EpimAb deal, this is basically giving us access to a technology called Fabs-In-Tandem, how to build bispecific antibody. Bispecific antibody, meaning antibody that can bind to two targets at the same time.

We have a global license for this technology for up to three target pairs and this is part of our discovery effort bringing novel molecules from our own laboratories into clinical development. This is a research stage collaboration, so it will take some time until the first results emerge from that.

Lucy Codrington

Very clear. Thank you.

Operator

Thank you. We will now take the next question from the line of Alistair Campbell from Royal Bank of Canada. Please go ahead.

Alistair Campbell

Good morning, everyone. Thank. Thanks for taking the questions. Just one or two, please. First of all, for Mike. Obviously, the new guidance for this year is probably pointing to an EBITDA margin of a shade under 20%. I just wonder, obviously, you talked about launch costs accelerating next year rightly so because you want to maximize the potential of EBGLYSS. But do you think 2023 will mark the floor for the EBITDA margin and how should we think of that sort of progressing into next year? And then maybe as we think about EBGLYSS launch initially, I wonder if you have done the due diligence you have done in terms of the key European markets. What’s your broad kind of estimate for current Dupixent atopic dermatitis sales in your key European markets? Thank you.

Mike McClellan

Yeah. So let me start with the first one in 2024. We are not giving guidance for 2024 yet, but let me give everybody a few things to color it and then I will pass on to the next question. In 2024, with the launch of EBGLYSS, we are expecting sales to accelerate. So we will see a healthy growth.

Gross margin percentage should remain right around flat at that 65%. So we should be able to keep that pretty much in line. R&D percentage will probably be very similar at 12-ish. Where we will accelerate is in SG&A? We will make sure that we launch this product well and that we take all full advantage of all opportunities there.

We do target to grow EBITDA, but whether or not we can keep the margin flat or there’s just a slight decline, will still be seen. So we will give you an update in February on where we actually will come out with that, but this is now a growth.

I would expect from 2025 and beyond, we will definitely see margin accretion. But given the importance of the launch and uncertain timing as to when we will get into the second and third, fourth markets just because of the price approval and market access, we will really make sure that we set ourselves up for the real accelerated growth in the future.

Alistair Campbell

Thank you.

Carlos Gallardo

Thanks, Mike, and thanks, Alistair, for the question. So for the -- I think for the second question, I think I am going to take advantage that we have Paolo Cionini in the room, that is our Chief Commercial Officer to tackle this question. And I think, Paolo, it’s the first time joining us in this call. So why don’t you very briefly introduce yourself before answering the question? Thank you, Paolo.

Paolo Cionini

Yes. Thank you, Carlos, and thank you, Alistair. Good morning, everybody. My name is Paolo Cionini. I am the Chief Commercial Officer for Almirall and happy to be here with you today. I didn’t understand really the questions -- the second question. Can you repeat it, Alistair?

Alistair Campbell

Yeah. Look, I was really just trying to get a sense of, and obviously, we can see from Sanofi their European sales for Dupixent, but obviously, they don’t split it out between atopic dermatitis and the other indications. So I was just wondering on the market, any sort of market due diligence you have done, what you broadly think that European Dupixent atopic dermatitis market looks like currently in terms of sales?

Paolo Cionini

Yeah. So thank you very much for the questions. I mean, well, the European market in atopic dermatitis is growing and is keeping the pace of that growth, even though we see that, in general, in atopic dermatitis market, there’s factors affecting the access of the patients into the clinics.

So we were expecting maybe a better growth, I would say. But I think that growth is limited by the fact that patients are struggling knowing finding the right access to the clinics. But still we are looking at the market that is really growing amazingly. So there’s still a huge space for patients really to enter into treatment with new products like biologics like Dupixent.

Alistair Campbell

Thank you.

Operator

Thank you. We will now take the next question from the line of Thibault Boutherin from Morgan Stanley. Please go ahead.

Thibault Boutherin

Hello. Thank you for taking my questions. The first one is on Ilumetri. I just like to know if you could comment on where the bulk of the growth is coming from. Is it just growing in line with the Eata [ph] or are you still taking some market share gains across Europe, and if you could comment on, obviously, the competitive dynamics that you are seeing in psoriasis? I mean, the drug is currently annualizing around €170 million and I am just wondering how much more room for growth do you see from here. Obviously asking for formal guidance, but rather a feel of how far we are from the peak sales for this product? And then maybe on Klisyri, the U.S. launch next year. Just wanted to know if you could give us some color of how much of a step change you expect for growth service products from the new indication? Thank you.

Carlos Gallardo

Thank you, Thibault, for the question. So, as I mentioned before, Germany still represents 50% of our sales, but very quickly, the, let’s say, the basket of the rest of the countries are actually catching up and will exceed this current 50% for the other non-German side. We are seeing a growth very close to 40% this year. That is quite in line with the class growth.

So I think that at the beginning of the year, we saw some gains in terms of market share depending on which country you look at, I think, on net average, I would say, again, we are seeing a bit more pressure on -- more lately on our, let’s say, on an ability to gain market share.

But as I mentioned also now, we have launched the 200-milligram that we thought -- we think is going to be very helpful for us to, let’s say, start gaining market share again. We have the auto-injector and also we have just published the interim data on well-being, which is all the positive study that is very novel and exciting data for the products.

So I think the combination of our commercial pressure together with the novelties in the 200-milligram, the auto-injector and the positive data will help us to, let’s say, provide new wins in our pack to regain market share. But again, Paolo is with us. So I think I am sure that Paolo can provide more color on that.

Paolo Cionini

Yes. Carlos, thank you very much. We are just complementing what Carlos was just saying, it’s nice to see that we are keeping the pace in Germany, which is the biggest part of our market. Germany is progressing with this nice 24% growth, looking at IQVIA data lately. But all the other countries are even better than Germany. So that means that in the future, we can see maybe the weight of the other countries taking over the German positions into Ilumetri.

And I would say also that the 200-milligram is really one of the assets that we are really pushing, because I think that 100-milligram, 200-milligram is really a right combination in order to have the right flexibility in treating psoriatic patients in a way that all variances and variability of the disease can be addressed with a nice combination of the 100-milligram, 200-milligram. So a very good asset that we can use in order to strengthen our competitive position in the psoriasis market.

Carlos Gallardo

And perhaps, Mike, you can take the large field.

Mike McClellan

Yeah. So we are expecting to get the approval and launch in the second half of next year and we feel like that’s really going to open up the possibility to really grow the product. We have got good results with the small field in terms of patient acceptance. The doctors definitely like the product as well. But we are competing face-to-face with cryotherapy, which is a medical procedure, which is well reimbursed in the U.S.

So we feel that once we can get to the larger field, then we can get to the field treatment. There is a huge market in terms of volume with 5-FU, which is a product that we feel we have a much better tolerability and safety profile again.

So we think this will unlock the growth. Hard to tell exactly the numbers yet, but we are excited to get that into the market as soon as we have approval and we think it will be a nice inflection point for the product.

Operator

Thank you. We will now take the next question from the line of Guilherme Sampaio from CaixaBank. Please go ahead.

Guilherme Sampaio

Hello. Thank you for taking the questions. So three, if I may. Two on manufacturing. So the first one on Klisyri, you mentioned that you are taking over the manufacturing of Klisyri. In terms of profitability and cash flow generation, what’s the expectation of the changes, especially as the product moves to large field? Second topic on any change plans in lebrikizumab manufacturing strategy following the FDA complete response letter to Lilly? And the third one on peak sales, when would we have the net sales for lebrikizumab peak sales and more color on Klisyri peak sales, please?

Carlos Gallardo

So on -- I would ask you to repeat the first question, Guilherme, thanks for the question. But let me answer the first the EBGLYSS question about manufacturing strategy, we do not plan to change anything about the manufacturing process and we are fully confident on the robustness of the supply chain. And the third question…

Mike McClellan

Peak sale.

Carlos Gallardo

Yeah. The peak sales, yeah. I think that we are not ready yet to provide a -- we provided some time in the past €450 million peak sales. I think that we are not prepared now to provide an update on this peak sales estimate. But can you be so kind, please to repeat the first question?

Mike McClellan

I can take it.

Guilherme Sampaio

Yeah.

Carlos Gallardo

Okay.

M

Yes. We did move the manufacturing. Our previous partner, Athenex went into bankruptcy and they needed to close their manufacturing facility. Luckily, we had already started to ramp up our Reinbek site in Germany as a second source and we recently got the FDA approval for that as well. So we have secured the supply.

In the meantime, we asked them to produce quite a bit of stock so that we could make sure that we bridged over to our own approval. So that’s why you see a little bit of the inflation of the inventory. Going forward, this should give us in the long-term a cost advantage because, yeah, we will be doing it internally within our own Reinbek factory, which is a top class facility in Germany.

So we are looking forward to continuing to grow this product. The Reinbek facility is fully ready to produce the large field, which will be in a very similar packaging, just a larger quantity. So what could have potentially been a very difficult situation for us if we hadn’t been already prepared has turned in to be something that will be an advantage to us in the long-term.

Guilherme Sampaio

Okay. Thank you.

Operator

We will now take the next question from the line of Francisco Ruiz from BNP Paribas Exane. Please go ahead.

Francisco Ruiz

Good morning and Happy Almudena Day for all the people in Madrid. Almost all my questions has been answered, just two clarification. The one in Ilumetri. I don’t know if I heard Mike saying that you expect the same growth in Ilumetri this year than the previous year, but this would mean close to 50% growth. I mean, just to know if this is what you are assuming? The second one, if you could give us some detail on the milestones that will come after the approval of lebrikizumab? Thank you.

Mike McClellan

Yeah. So when Carlos mentioned same growth, he meant the same absolute growth. So last year, in 2022, we saw a roughly €40 million increase from the year before and we are on track to do that again this year. Whether or not we can keep that pace next year, we will see when we give the guidance in February, though, we do expect to still grow significantly that product.

In terms of milestones, we do have an approval milestone of €65 million, that depending on the timing of the approval, will either be paid in December or January. So we will have that, but that’s always been expected and is part of our cash flow plan.

Francisco Ruiz

Okay. Thank you.

Operator

Thank you. We will now take the next question from the line of Alvaro Lenze from Alantra Equities. Please go ahead.

Alvaro Lenze

Hi. Thanks for taking the questions. I just wanted to know or I have seen a quite good performance of Ebastel and Almax in Q3, probably higher than normal for Q3. I just wanted to know if there’s some demand pull-forward from Q4 or whether there’s some changing trends there? Also, you have mentioned that R&D as a percentage of sales should remain stable in 2024 despite the fact that sales should accelerate. So I wanted to know what are the main R&D projects that will be driving this growth? Also, on the M&A priorities, if you could indicate us what sort of assets are you looking for in terms of size and therapeutic indications or type of product where you are looking for more small molecules or biologics? And lastly, if I am not mistaken, I have seen that you have delayed the expected launch of Efinaconazole from late 2023 to second half 2024. I don’t know if you mentioned this at the conference call, if you could explain what has happened there and then what is the reason for the delay? Thank you.

Carlos Gallardo

Thank you, Alvaro, for the question. So, perhaps, Paolo, you can take the first one and the...

Paolo Cionini

Yeah. Absolutely. About Almax and Ebastel. So thank you very much, Alvaro, for the questions. Well, on Almax, I can say that, we are very happy about the performance we are having. In the first part of the year, I think, that we benefit also for some situation in the stocks of our competitors, but now we have the new campaign, the advertisement campaign that we have just launched in September is going quite well and I think that the product is progressing as per our expectations.

In terms of Ebastel, seasonality in terms of allergy was not as expected, I would say. But despite that, I think, that we have delivered as expected, I would say. So in Ebastel, I think, that we are very happy as well.

Carlos Gallardo

Thank you, Paolo. Regarding the R&D costs going forward, Karl, I think, that you are best positioned to answer the question.

Karl Ziegelbauer

Thank you. As I mentioned, we are extremely excited about lebrikizumab and we will continue to explore this molecule together with our partner in Eli Lilly, and considering other indication of further expanding in atopic dermatitis that will be one area where we will invest.

The second, for Klisyri large field, we have now completed the study in the U.S. and submitted a supplementary NDA. We are in the planning stages of a study for the EU that we expect it will start soon.

And then we want to advance our early-stage pipeline for the IL-1RAP monoclonal antibody. We are in Phase 1 and once completed, we will start a proof-of-concept study. So Phase 2a clinical study and we plan to start Phase 1 for the IL-2 mutein Fc later this year that then will be done in 2024.

In addition, we are looking at -- to in-license early-stage asset and we will plan also for further strengthening the early pipeline. With respect to your questions of small versus large molecules, I mean, if I understand it correctly, you are asking what will be our focus. Is that what you asked?

Alvaro Lenze

Yeah. In terms of R&D and also in terms of M&A.

Karl Ziegelbauer

Yeah. I think in terms of R&D our focus is medical dermatology and we focus really of understanding the disease and trying to identify novel ways and mechanism how we can provide better products to patients.

With respect to the modality that we use to address these targets and these unmet medical need, we are agnostic. It can be either a small molecule, it can be also a biologics and we have the ability to basically cover both. It can be also a different modality if turns out to be interesting in addressing an unmet medical need going forward.

Carlos Gallardo

And Alvaro, in terms of M&A beyond R&D, where we are looking into is bolt-on opportunities in Europe, right? So largely in dermatology, but also that depends on the infrastructure we have in the different countries.

If you look in Spain, as you know, we have an important infrastructure in general medicines and OTC as well and also neurology division. So that’s what drove the acquisition of Prometax as it’s a very nice bolt-on for our neurology division in Spain and also a few months ago with the acquisition of Physiorelax, which flagged in nicely as well with the OTC infrastructure in Spain.

So you can expect kind of similar deals. If it’s multi-country, it’s going to be dermatology, if it’s in Spain, it could be dermatology, but also could be in one of these other divisions that I mentioned and with a focus in Europe. We are missing one. Yeah, the Efinaconazole question, yeah. Go ahead, Karl?

Karl Ziegelbauer

Yes. The regulatory process for Efinaconazole is a decentralized process with Germany as the main reference state and then Italy as the second state in contrast to this centralized EMEA process, where you have very kind of standard process and standard time line. The time lines for this decentralized process are less clear and not following such a strict schedule, yeah.

Having said that, we are in the process of answering questions from regulatory authority together with our partner, Kaken, and I think, we are confident that we can bring this product to the market in 2024.

Alvaro Lenze

Okay. Thank you very much.

Operator

Thank you. We will now take the next question from the line of Jaime Escribano from Banco Santander. Please go ahead.

Jaime Escribano

Hi. Good morning. So three questions on my side. The first one on the IL-23 market share chart, which you usually share with us every quarter. I just want to confirm that the market share of IL-23 remains above, if I recall, well above 40%. Just if you can give us some color on that. Second question would be in the new product you acquired rivastigmine, if you are able to give us already a range of sales and EBITDA contribution? And the third one would be a little bit of a follow-up on the guidance for 2024. Just to better understand, Mike, what you said. So if you said topline accelerated -- accelerating from this year, so let’s assume 6%, 7% year-on-year growth in 2024, R&D over sales of 12% and SG&A growing 5%, 6% year-on-year. We end up to an EBITDA of around €190 million, €195 million, which is more or less in line with consensus. My question is, if you find these assumptions reasonable or do you think the EBITDA margin, as you pointed out, could be slightly below 20% in 2024, and as a result, the calculation I made maybe a little bit on -- a little bit too optimistic? Thank you very much.

Carlos Gallardo

Thanks for the question, Jaime. Yeah. On the IL-23 class, we decided to take out the chart because it was focused in Germany and now that we have launched in many other countries. I think it’s important to reflect Ilumetri as a franchise -- European franchise as opposed to focusing exclusively in the market shares in Germany.

But as far as I know, for the first nine years, the market share of the class in Germany is 36%. So it continues to be the leading class in terms of new patients, that’s new patients, Jaime. And the second will be the IL-17 class with a 31% market share for new patients. Paolo, anything to add to that?

Paolo Cionini

No. I think that is a very relevant question. Thank you for the questions, because I think that we are in the right class the IL-23. I think that we are keeping our position -- competitive position in the IL-23 class.

And when we see the class and our positions in the overall biologics market, we see every month, I mean, we are gaining positions. So we gain positions in terms of market share in the biologics class and we keep our positions in terms of IL-23 class.

Mike McClellan

Yeah. Let me take the Prometax. We haven’t given details, but it’s a nice little product in our Spanish business. It doesn’t change the complexion of the business, but it’s a nice little add-on and we will probably give a little bit more flavor in February.

As for 2024, we are not really giving guidance. I’d say of the things you mentioned, the one variable that we still need to really work on is the SG&A and where that level will come in. So the EBITDA numbers you talked about are not impossible, but they will be on the stretched end of things.

So let’s see how the Q4 goes, what we think will be the ramp-up and launch sequence of the different countries into 2024 and we will give you, of course, very solid numbers in our February call.

Jaime Escribano

Okay. Thank you very much.

Operator

Thank you. We will now take the next question from the line of Pablo de Renteria from Kepler. Please go ahead.

Pablo de Renteria

Yeah. Good morning and thanks for the presentation. I just have one question for Karl, if I may. I see that the two-year clinical data of lebrikizumab looks superior to the one-year data. I mean, I don’t know if you could please provide some color on this? Thanks.

Karl Ziegelbauer

Yeah. Thanks for the question. I mean, overall, we are very pleased with the overall profile and the data we are seeing with lebrikizumab. I mean, with respect to long-term studies, it’s very reassuring to see that also in the long-term, we keep the efficacy in actually most of the patients.

With respect to comparisons one year after another, there is a certain variability that we have in the different arms. You also have to look at what is actually the number of patients. So I am not necessarily would read too much into that. I think the important message is that, for the vast majority of patients, we can keep long-term the efficacy, and they are controlled very well.

And this is important, because atopic dermatitis is a chronic disease that requires long-term treatment and we believe with our data that show that we can keep those patients well controlled with an every four-week dosing that this is a very attractive value proposition.

Pablo de Renteria

Okay. Thank you.

Operator

Thank you. There are no further questions at this time. I would now like to turn the conference back to Pablo Divasson for closing remarks.

Pablo Divasson

Thank you very much, Sandra. We are now going to close our Q&A session, and with this, we will conclude our conference today. We want to thank you for your participation. You may now disconnect.

For further details see:

Almirall, S.A. (LBTSF) Q3 2023 Earnings Call Transcript