Almirall, S.A. (OTCPK:LBTSF) Q2 2024 Earnings Conference Call July 22, 2024 4:00 AM ET
Company Participants
Pablo Divasson – Investor Relations
Carlos Gallardo – President & Chief Executive Officer
Karl Ziegelbauer – Chief Scientific Officer
Mike McClellan – Chief Financial Officer
Paolo Cionini – Chief Commercial Officer-Europe & International
Conference Call Participants
Lucy Codrington – Jefferies
Alistair Campbell – Royal Bank of Canada
Guilherme Sampaio – CaixaBank
Francisco Ruiz – BNP Paribas Exane
Alvaro Lenze – Alantra Equities
Jaime Escribano – Banco Santander
Operator
Good day and thank you for standing by. Welcome to the Almirall’s First Half 2024 Financial Results and Business Update Conference Call. At this time, all participants are in listen-only mode. After the speakers’ presentation, there will be a question-and-answer session. [Operator Instructions] Please be advised that this conference is being recorded.
I would now like to hand the conference over to your first speaker today Pablo Divasson. Please go ahead.
Pablo Divasson
Thank you very much, Nadia. Good morning, everyone. Thank you for joining us to review Almirall’s H1 2024 financial results and business update. As usual, you can find the slides we are using today in the Investors section of our website at almirall.com.
Please move to slide number 2. Let me remind you that 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 3. 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 the H1 2024 highlights as well as the update on our biologics growth drivers that are crucial to our ambition of achieving leadership in medical dermatology. Karl will provide you with details on the progress of the pipeline. And Mike will review the financials before Carlos concludes the presentation and we will take your questions.
I would like to invite Carlos Gallardo, our Chairman and CEO to summarize our half year business overview. Please move to slide number 5.
Carlos Gallardo
Thank you, Pablo and good morning to everyone in the call. I am pleased to share with you that we have delivered strong results in the first half of the year. Our biologics continue to be a driving force behind our business momentum. We are pleased with the growth trajectory of our product portfolio.
This balanced performance is a foundation for our leadership in medical dermatology. This year we continue to focus on the execution of the Ebglyss rollout and on advancing our pipeline that as you know is fully dedicated to medical dermatology.
In line with our expectations, our first half 2024 net sales grew 7% and EBITDA grew 3.2% to a total of €104.5 million. Based on this good overall business performance, we are reiterating our full year guidance for the year.
In the first half of the year, our European dermatology portfolio continued to drive our business. Our recently launched products are at the forefront of our portfolio’s performance. Let me give you a few highlights.
Ilumetri, our psoriasis edge biologic continues to deliver solid performance across different regions. It has become a highly successful product in the medical dermatology market and also exemplifies our strong market access and commercial capabilities in the biologics space within dermatology.
Since we launched Wynzora and Klisyri in Europe, we have increased our presence and market share in medical dermatology in the main countries. We have delivered the most notable growth in Spain and Germany.
In terms of Ebglyss, it’s still early days but we are also very encouraged by the strong progress of the sales — of the product sales. We have now launched in Germany, Norway and recently in the UK. More details on Ebglyss later.
Moving to R&D. We are pleased with the significant pipeline progress in the first half of the year. We are excited about the recent FDA approval of Klisyri large field in the US. We expect to launch next month.
We also made very good progress with our early-stage assets which we expect to fit that will fuel our future growth. In March 2024, we announced a license agreement to acquire the rights to an asset that is same that rare dermatological diseases from Eloxx. This technology is an oral read-through inducer addressing nonsense mutations and we are pleased that the Phase I trial started this month.
In February, we successfully licensed the anti-IL21 monoclonal antibody from Novo Nordisk and both our anti-IL-1 RAP monoclonal antibody and anti-IL-2 mutant fusion compounds are in Phase I.
Please move on to slide 7 for an update of our biologics, starting with Ilumetri. On the chart you can see that Ilumetri continues to perform well with a 25% growth year-on-year reaching €52 million in quarter two and reaching over €100 million in the first half of the year.
The anti-IL-23 class leads the area of advanced therapies in the dynamic psoriasis market and Ilumetri continues to show a strong performance within the class.
This is the foundation for Ilumetri’s continued growth in addition to a balanced performance across various geographies. While Germany remains our key market, we continue to see healthy growth in our European countries. New launches are progressing well and drive additional growth.
We also support the brand with new real-world evidence. We recently disclosed the interim results of the POSITIVE study, demonstrating improvement in physical symptoms and overall well-being of patients with moderate to severe psoriasis. All these factors make us confident that we are on track to achieve that €250 million peak sales target we forecasted.
Please move to slide 8 for an update on the Ebglyss launch, our biologic in Europe for atopic dermatitis. The first half performance of Ebglyss demonstrates why we are excited about our progress with Ebglyss. Ebglyss continues its positive performance trajectory. In Q2, it grew 100% quarter-on-quarter, reaching a sales total of €7.2 million and putting our first half 2024 sales close to €11 million.
In the first half of the year, awareness of Ebglyss amongst healthcare professionals has increased significantly. We have secured a double-digit share of the new dynamic market share. As you know, this data captures patients new to the brand including first-time users and switches from other therapies. The data up to May show that Ebglyss has surpassed all other advanced systemics, except for the current standard of care.
In addition, we keep receiving very positive feedback from both dermatologists and their patients in Ebglyss. This is supported by the data showing intention to prescribe by dermatologists. The recent positive NICE recommendation in the UK, highlighting its cost effectiveness further supports our confidence in Ebglyss. We are very pleased with this progress. It’s the result of our investments and our team’s focus on executing Ebglyss launch with actions. All these data points are in line with our expectations and continue to drive our confidence about the potential of Ebglyss.
Please move to slide 9. As you know, Germany is the most important market for biologics in Europe. Looking at Germany give us some valuable insight into the market potential of Ebglyss. The data show that an increasing number of atopic dermatitis patients in Germany are treated with advanced therapies. In 2018, around 4,000 patients were treated with advanced therapeutics, which increased to over 31,000 in 2023.
With a compounded annual growth rate of 50%, this means a market expansion of 8% in just five years. In 2024 this trend continues. And based on previous insights, the biologics market accelerates following the launch of new products. The psoriasis market follow the same dynamic and is a good indicator of how market profit is driven by new therapies. As you will see in the next slide, we are already seeing some of this dynamic with Ebglyss.
You will know that atopic dermatitis is a large and growing market. While we expect to capture a significant share of the advanced therapy segment in AD, there is also a significant opportunity for Ebglyss to contribute to the expansion of the market. Today, only 6% of uncontrolled moderate to severe atopic dermatitis patients in Europe are treated with advanced therapies. It is expected that by 2031 in the EU5, around 400,000 patients will receive advanced therapies.
The number of available treatments is still limited despite patients requiring a wide variety of options. There is still only three mechanisms of action available in Europe. Therefore, we are convinced that Ebglyss has the potential to be a first-line treatment for atopic dermatitis and to deliver significant growth going forward.
Now please move to slide 11 for an overview of the launch map. Here you see the plan for our Ebglyss launches in Europe. We are on track. After launching in Germany at the end of last year, we have launched in Norway last month.
More recently, we launched in the UK and are on track to launch in Denmark, Austria and Spain before the end of the year. We will then roll out Ebglyss in the remaining countries in Europe in 2025. We’ll keep you updated of these launches.
Next please move on to slide 13 for Karl to give us an update on our progress in R&D, both on the pipeline and on the life-cycle management activities.
Karl Ziegelbauer
Thank you, Carlos, and good morning to everyone on the call. Here is an overview of our pipeline. As you can see, we continue to progress well across our early and our late-stage pipeline.
Efinaconazole is currently under regulatory review, and we expect approval in the second half of 2024. Seysara’s regulatory review in China is ongoing and we expect approval before the end of 2024.
In June, we received FDA approval addressing Klisyri’s expansion to large field in the US. We expect launch next month. We are currently running a clinical study to enable the label expansion to large field in Europe, aiming at the launch in 2026. I will provide more details in a moment.
For our anti-IL-1 RAP monoclonal antibody, we have completed Phase I single, and multiple ascending doses in healthy volunteers. Now, pharmacokinetics and safety are explored in patients. This anti-IL-1 RAP monoclonal antibody blood signaling of six members of the IL-1 cytokine superfamily and has potential utility in several autoimmune skin diseases.
The Phase I study assessing our IL-2 mutant Fc-fusion protein was initiated in December 2023. ALM223 is an interleukin-2 mutant fusion protein that activates regulatory T cells. Addressing this mechanism has the potential to treat various autoimmune diseases.
Our anti-IL21 antibody is currently in pharmaceutical development to prepare for Phase II. IL21 is a cytokine involved both in B and T cell biology and hypothesized to play a role in several immune-mediated diseases.
For ZKN-013, our partner, Eloxx, has just started Phase I. This asset is an oral read-through inducer designed to overcome nonsense mutations, rating a premature stop codon leading to defective protein production in cells.
ZKN-013 has potential in several rare indications such as dystrophic epidermolysis bullosa, junctional epidermolysis bullosa and familial adenomatous polyposis. We are pleased with the good progress in both early- and late-stage pipeline as it will contribute to strengthening our leadership role in medical dermatology in the future.
Let’s move to slide 14. Here is an overview of the comprehensive clinical study program to maximize the value of lebrikizumab, we are conducting together with our partner, Eli Lilly.
Atopic dermatitis is a chronic disease that requires chronic treatment. It is therefore, crucial to understand lebrikizumab’s long-term efficacy and safety. Different studies are designed to deliver these data, including the ADlong trial, the extension of the ADvantage study and the extension of the joint study run by our partner, Eli Lilly.
The joint study also explores whether the dosing interval in the maintenance phase might be extended to every eight weeks. The ADhope-1 and 2 studies aim to evaluate the effectiveness of 24-week treatment in improving disease severity, signs and symptoms in different subpopulations with moderate to severe atopic dermatitis.
ADorable-1 and 2 explore lebrikizumab’s benefits in patients with moderate to severe atopic dermatitis between 6 months and less than 18 years of age. These studies are also part of the European pediatric investigational plan and may allow us extending the indication to the pediatric population below 12 years.
Eli Lilly is also exploring the efficacy and safety in patients with skin of color and those having been pre-exposed to dupilumab. Finally, Eli Lilly is exploring lebrikizumab in patients suffering from perineal allergic rhinitis and in patients suffering from chronic rhinosinusitis with nasal polyps. This impressive array of clinical studies show the commitment of both Almirall and Eli Lilly to maximize the value of lebrikizumab.
Please move to the next slide for more information on the Klisyri large field approval in the US. As mentioned earlier, Almirall has received FDA approval for Klisyri large field in June this year. This new approval will change the previous Klisyri dosing for surface area treatment from up to 25 square centimeters to up to 100 square centimeters. This allows clinicians, to treat a larger area of the face or balding scalp to address more extensive manifestations of actinic keratosis. This supplemental new drug application was supported by a multicenter open-label Phase III study, with more than 100 patients in the US. The primary endpoints of the study were the safety and tolerability of applying tirbanibulin to a field of approximately 100 square centimeters, on the face or balding scalp of adult, actinic keratosis patients.
The study showed consistent results with the original pivotal trials conducted on an area of 25 square centimeters, for both local skin reactions and treatment-related adverse events. You might recall that actinic keratosis is the most common precancerous dermatological condition, and the second-most common diagnosis made by dermatologists in the United States. It has a prevalence of between 11% and 25%.
With that, I will hand over to Mike for the financial review.
Mike McClellan
Thank you, Karl for the overview of our exciting R&D work and pipeline progress. As Carlos mentioned, we delivered a solid performance in the first half, with net sales growth of 6.7%. We are pleased to continue the strong growth of the European dermatology portfolio, which helped drive the overall net sales, and this is in line with our ambition to become a leader in medical dermatology.
We’ve also achieved a total EBITDA of €104.5 million in the first half, up 3.2% from last year, benefiting from higher sales growth and offset in part by higher investments in SG&A and R&D. Our gross margin came in at 65.1%, a slight decline versus 2023, due mainly to increased Ilumetri royalties. The gross margin improved in the second quarter versus the first quarter with a better mix.
SG&A in the first half is up 8% to €232 million, due mainly to recent and upcoming Ebglyss launch investments. R&D investment is also up 8%, representing 11.4% of net sales consistent with our annual target. At June 30, we had a net debt-to-EBITDA ratio of 0.4 times.
Please bear in mind, that we had around €75 million of payments in Q1, related to late 2023 milestones.
Let’s move to the details of our sales breakdown on Slide 18. Here you see the net sales dynamics in the first half of the year. The European dermatology business has had a very strong performance, with a 20% increase year-on-year, that I’ll review in detail on the next slide. Our General Medicine and OTC business in Europe displayed a slightly negative performance, due to the comparable in 2023 that includes some minor divestments last year, as well as the ongoing decline of Efficib-Tesavel and lower sales of minor products partially offset by the good performance of Almax in Spain ,and the inclusion of Prometax.
Our US business continued to stabilize in Q2 2024 and I’ll share more details on the next slide. Rest of the world general medicine is stable, as the good performance of Ebastel, offset a tough 2023 comparable, with a discontinued product and the normalization of Imunorix.
Efficib-Tesavel is still adjusting to the decline expected by its patent expiry, but let me remind you that this is the only product we have, which is facing a near-term patent expiry.
Let’s take a closer look at the dermatology business, on the next slide. Our European dermatology segment demonstrated a very strong performance, primarily driven by Ilumetri’s resilient growth, with other growth drivers such as Klisyri and Wynzora, reaping the benefits of new launches in the EU.
After being on the market for six months, Ebglyss sales have reached €10.8 million, which is in line with our expectation and reaffirms our confidence in the product’s growth trajectory. Skilarence had lower sales, due to higher competition and Ciclopoli sales are normalizing as expected. The US business has shown nearly stable results mainly due to Seysara picking up in Q2 2024, while Klisyri sales remained more or less in line with 2023. We expect to accelerate growth of Klisyri with the large field launch later this month.
The US legacy business remains under pressure from ongoing generic erosion related to Cordran and Tazorac but Aczone sales recovered slightly in the second quarter. Rest of the world dermatology sales remained stable due to the income from Seysara China, offsetting the steep decline due to the 2023 license income from Finjuve, in Korea and the supply of Cordran in Japan, which did not repeat.
Now moving to the complete financial statements on Slide 20. Let’s focus on the remainder of the P&L, starting with revisiting some of the items in a little more detail that we mentioned in the financial review highlights. The gross margin made a slight recovery to 65.1% in the half year. We are facing some margin pressure versus 2023 due mainly to reaching higher tiers of royalties from higher sales of Ilumetri. R&D expenses are up from the first half of 2023 landing at 11.4% of sales. We anticipate this figure to land in the full year at the range of 12% of net sales as discussed in the year-end call.
SG&A investments were 8% compared to 2023 and we expect this to keep growing throughout the year, as we continue to roll out Ebglyss in other countries. Financial expenses have been impacted by the interest income from the short-term deposits that we have, as well as the equity swap valuation which benefits from the recent share price increase.
I’d like to remind you that our effective tax rate is affected by the inability to deduct US tax losses against the profitable European business. We expect this to continue from 2024, improve slightly in 2025 and then return to the normal low- to mid-20s range in 2026 and beyond.
Please move to the next slide to take a look at the balance sheet. The key point to highlight on the balance sheet is the impact of the recent investments on intangible assets. This includes a €10 million upfront payment for the Novo Nordisk IL-21 product, a minor upfront payment for Eloxx from the in-licensing deal as well as the Ebglyss milestones and Phase IIIb trial capitalization. The total investment impact has been offset by higher amortization. Importantly, our net debt ratio remains favorable at 0.4 times, despite incurring high levels of cash outflows in the first half, which will be described on the next slide.
Let’s take a look at the cash flow statement on the next slide. We delivered an operating cash flow of €66 million in the first half, a slight improvement versus last year. We are normalizing our working capital due to the stabilization of inventories after the unusually high impact in 2023. The other adjustments are mainly related to net financial income including interest from the short-term deposits and a higher equity swap valuation.
Amongst the investing activities, we had significant cash outflows in the first half, mostly related to 2023 milestones that were paid in the first quarter. In January 2024, we had a €45 million payment for achieving the first EU commercial sale of Ebglyss in December 2023. Additionally, we paid a €20 million milestone related to Ilumetri sales achieving higher targets. The remaining payments include some additional in-licensing payments related to etherna and Eloxx agreements, as well as the milestone for initiation of our Phase I trial paid to Simcere. The divestments line refers to royalties and milestones collections from AstraZeneca/Covis, which are lower in 2023 based on the agreed schedule.
With that, let me pass it back to Carlos to conclude the presentation moving to Slide 24.
Carlos Gallardo
Thank you, Mike and Karl. As you have seen, we have delivered a good operational performance in the first half of the year, which means we are reiterating our full year guidance. This is a crucial step of our returning to achieving leadership in medical dermatology.
We have full confidence that annualized growth will continue throughout the year based on our focus on our key growth drivers. We continue to invest significantly in our key products. Ilumetri is showing good momentum and we anticipate further growth during the year. Its solid performance is laying the foundation to achieve Ilumetri’s peak target sales. We also expect the positive trends of Klisyri and Wynzora to continue as we roll them across additional markets in Europe. We are pleased with the progress of our successful Ebglyss launch in Germany in December. After launching in Norway and the UK, we’re on track to extend our atopic dermatitis patient reach further across Europe. Our commercial teams are preparing the launches in Spain, Denmark and Austria this year and we are getting ready to enter the remaining European markets in 2025.
Our close partnership with the dermatological community remains at the heart of our approach to reach more patients and enable them to benefit from our products. The very positive feedback we received from the medical community and our business performance will help us achieve our ambition of achieving leadership in Medical dermatology.
We are making significant progress with our R&D pipeline. Our promising late-stage programs such as Klisyri large field will be adding value in the near-term and our exciting early-stage assets contribute to securing our future leadership. In line with our long-term view on our business and our ambition, we continue to pursue external pipeline opportunities looking at early and mid-stage assets.
The collaborations and agreements we enter will continue to be based on a strong scientific, strategic and financial rationale. This ensures we continue to grow our impact on patients and the medical community and further cement Almirall’s position as a leader in Medical dermatology.
With this we conclude the presentation. I hand it back to Pablo, for the Q&A session.
Pablo Divasson
Thank you very much, Carlos. Nadia back to you for the Q&A please.
Question-and-Answer Session
Operator
Thank you so much. [Operator Instructions] And now we’re going to take our first question and it comes from the line of Lucy Codrington from Jefferies. Your line is open. Please ask your question.
Lucy Codrington
Hi there. Thank you for taking my questions and just a couple. Can I just clarify on the very comprehensive list of studies ongoing for Ebglyss? Can I just confirm that at present Almirall isn’t participating in the non-dermatological studies that Eli Lilly is running?
And if not, what would lead you to consider participating or opting into those indications? When might that be? And should that be relatively easy to slot in to your existing infrastructure at the moment?
And then related to that just in terms of the ongoing pediatric studies do you view the Peds opportunity to be a material one? And is this already factored in to your current peak sales guide?
And then moving on to Klisyri, just if you could give us some more detail on what the launch for large field entails in the coming months? And what we should think of in terms of how that might inflect in terms of the timeline?
And then finally just on Skilarence, you mentioned the increase in competition there and there’s a decline in the quarter. Do you see any scope for further growth here for Skilarence? Is it more like a maintained level? Or do you expect continued decline? Thank you.
Carlos Gallardo
Thank you, Lucy for the questions. So let me tackle the first couple of questions and maybe Karl, can add more color and then Mike will take the Klisyri and Skilarence questions.
So in terms of the pediatric — the allergic rhinitis study and the chronic rhinosinusitis and nasal polyps study from Lilly, we will have an option to commercialize these indications in Europe. And we will update you on any development here in the future.
Regarding the pediatric expansion, this was always planned for a long time ago. And it’s planned and it was taken into account in the calculation of the peak sales.
Mike McClellan
Yeah, let me take the Klisyri. So what we’re doing to launch Klisyri in the US, we’re actually going to launch a slightly bigger packet size, as we need a little bit more of the product to cover the new 100-square-centimeter area.
So that product will be launching by the end of the month. We’ve got the sales force in next week to train up on the new label. And from 1st of August, we will be out in the market. I would expect sales to pick up, but I don’t think it’s going to be a rapid uptake.
We need to get the word out. We need to get doctors convinced to use Klisyri now for a field therapy instead of a spot therapy. So there’s some work to do there, but we’re very excited about it and we think this will be a key to unlocking some growth in the product.
In terms of Skilarence, Skilarence is an older type product. We only really sell it mainly in two markets; Germany and the Netherlands. And it’s continuing to see some erosion as that middle class of orals is getting squeezed a little bit by the growth of the biologics, which are taking patients a little quicker. So I would expect this to just be a slight decline as we move forward and it’s not a product that we’re promoting actively.
Lucy Codrington
Thank you.
Operator
Thank you. Now we’re going to take our next question, and the question comes from the line of Alistair Campbell from Royal Bank of Canada. Your line is open. Please ask your question.
Alistair Campbell
Great. Thanks very much. Didn’t really have much to ask about, but I just wanted to talk a bit more on the pipeline if possible. First of all I just wanted — it’s not your study, so I’m not sure how much light you might be able to shed. But in terms of the ADapt study, which is in the dupilumab experienced patients my understanding is that so you get in that trial either because you don’t get a response or for other issues like cost or tolerability.
So I wonder if you have a sense of like a baseline of how many patients are actually in the study because they didn’t get a good response to dupilumab. And in terms of the endpoint there, I think it’s EASI-75. What do you think is a single arm study you’d need to show to be convincing that it’s working very well in patients post dupilumab?
And then a broader one just on R&D spending. It seems like a bit of the spend on lebrikizumab might start to at least wind down through 2025 and beyond, but it’s unlikely that maybe your other programs in earlier stage will advance into Phase III by then. So should we be expecting R&D budget retention to maybe ease through 2025, 2026 before accelerating again? Or do you think there’s going to be a kind of steady build there? Thank you.
Karl Ziegelbauer
Thanks Alistair. Maybe I’ll take the question on the ADapt study that is the study Eli Lilly is conducting in moderate to severe atopic dermatitis patients that have been previously treated with dupilumab.
I think from our data, we already have for example on the ADhere and the ADvantage study where there was a small number of patients that have been pre-exposed to dupilumab, we also see already signals that lebrikizumab is active in this patient population.
Now this is more of a former study with about 120 patients and the primary outcome will be EASI-75 as you mentioned. The completion date is planned by December 2024, so we will see some update during this year.
Mike McClellan
Yeah. As you mentioned with the R&D spending, this year we’ve guided towards around 12%. We will in the course of the next couple of years see a little bit decline in the Ebglyss spending. But we are building up our early-stage pipeline as well as our overall R&D capabilities including discovery and all of the value chain. So I think 12% is a good marker in the near -term.
In the longer term it’s really going to depend on the success. As you move things into Phase II and III they get much more expensive. And if we are able to in-license other products in later stage that we don’t currently have in the pipeline, we’ll also see expenses there. So I think just in terms of a general modeling, 12%-ish in the next couple of years is a good benchmark.
Alistair Campbell
Thank you.
Operator
Thank you. Now we’re going to take our next question, and the question comes from the line of Guilherme Sampaio from CaixaBank. Your line is open. Please ask your question.
Guilherme Sampaio
Hello. Thank you for taking my questions. So on Ebglyss, if you could provide a bit more color on how has the market share in dynamic patients evolve versus Q1. So you mentioned there’s an increase. You mentioned that it’s still double digit, but if you could provide a bit more color it would be great.
And second again on Ebglyss, if you could provide a bit more color on the expected contribution from the launches in the second half of the year? Thank you.
Carlos Gallardo
Yes, thank you Guilherme. Can you repeat for your second question?
Guilherme Sampaio
Yes. In terms of the launches that you expect for the second half of the year in terms of contributions to sales expected for Ebglyss.
Carlos Gallardo
Sure Guilherme. Thanks for the question. So in terms of the dynamic market share, we saw a very strong uptake in this market in Germany. And we’ve seen continued acceleration of this market share in up to the last data point that we have that is made. In terms of the launches, I mean, Germany as we’ve mentioned before is the largest market for biologics and in particular for biologics in atopic dermatitis. So it will continue to be the bulk of the sales throughout this year. Also please keep in mind that other countries where we’re launching market access, so getting the product in the formulary so physicians can prescribe them and they’re properly reimbursed takes longer in some countries such as the UK et cetera no? So it will have a contribution, but it will be minor at this point.
Guilherme Sampaio
Okay. Thank you.
Operator
Thank you. Now we’re going to take our next question and the question comes from the line of Francisco Ruiz from BNP Paribas Exane. Your line is open. Please ask your question.
Francisco Ruiz
Hello. Good morning. I have three questions. The first one if you — we have seen a jump in Seysara sales from €9 million to €15 million. Could you explain, I mean the reason for that and what you expect for the full year? Second one is on the milestones. So you could be a little bit more precise on this investment, how much is the milestone regarding to Ebglyss, how much is the milestone from Ilumetri and the rest of acquisitions? And also, what are your expectations for the rest of the year and also for 2025? And the third question is on financial cost. Thanks to the good remuneration of the deposit, you have a very low financial cost. Could we extrapolate this first half for the full year? And what do you expect for the future? Thank you.
Mike McClellan
Yeah. So I think those all three I’ll take. For Seysara, if you look at it there’s the US Seysara which is a slight growth. And then there’s a — in the back pages you see the overall product Seysara. That’s the impact of the China out-licensing I mentioned in the rest of the world. So we had about €3.7 million of milestone income for licensing out the Seysara China. That’s the difference. If you take that out then you’ve just got the slight growth in the US which you see on the US slide. And that’s really because we’ve got slightly better pricing. We’ve really taken more of a value approach than a volume approach in 2024 and it’s paying a little bit of dividends in the year-on-year comparison.
In terms of the milestones, I mentioned in the first half there was €45 million for Ebglyss and there was €20 million for Ilumetri, which was a sales-based milestone that we hit towards the end of last year. If you look at the overall investments that we have this year, it’s close to €90 million already in the first half. We expect that maybe to be at €120 million unless there’s any M&A activity. So there’s a few things in the second half, but much less.
And in terms of the financial cost, it really depends on — we’ve got that small equity swap which was positive this year because of the stock price. So if the stock price continues to go up you could see the same level. But underlying we have about €10 million a year of real interest costs from our debt. We’ve been able to have a little bit of interest income from the deposits. So it will really depend on when we use that money for licensing or M&A and how the share price develops. So anywhere from a minus five to a minus seven or eight is probably reasonable. It could be as low as minus four for the year in terms of financial expense.
Francisco Ruiz
Yeah, very clear. And on the milestones, I know that it will depend on the sales evolution, but on the milestone for 2025, 2026 on Ebglyss and Seysara — or sorry and Ilumetri?
Mike McClellan
Yeah. There are scheduled milestones if we reach certain sales levels, but we haven’t really disclosed those. So we’ll talk about 2025 potential milestones when we give the guidance for 2025 in February.
Francisco Ruiz
Thank you.
Operator
Thank you. Now we’re going to take our next question and the question comes from the line of Alvaro Lenze from Alantra Equities. Your line is open. Please ask your question.
Alvaro Lenze
Hi. Thanks for taking my questions. The first one is on Ebglyss. I don’t know if you can provide the number of the market share on new TRx and what do you think that is coming from? Do you see the feedback from physicians indicating that there are some patients converting from other treatments, whether they are advanced therapies or whether they are from other more simpler technologies or whether it is from just new patients going into biologics and what share you have there?
Second question is going back to Ebglyss on the rhinitis and rhinosinusitis just to understand what the economics of that would be, because I don’t know how easy it is to separate the revenues from selling Ebglyss that would come from atopic dermatitis or from rhinitis, for example. So I don’t know if you are forced to eventually buy the rights for that just to understand how this could work if Lilly could go on selling the product for that indication and you maintaining only the commercialization for atopic dermatitis.
And my last question would be on capital allocation. I mean, close to a year since the capital increase if you could provide an update on what do you think are your priorities if you’re happy with how developments have been or whether you are finding more trouble than you initially expected to deploy the capital, because I see that you have increased significantly your short-term deposits, I would assume that that’s lacking new investment alternatives to deploy the funds. Thank you.
Carlos Gallardo
Thank you Alvaro for the questions. Regarding Ebglyss dynamic market share, as I mentioned before, we see a good progress of this market share. We’re very pleased we are in double-digit situation. Now where are the patients coming from for which it’s a good healthy combination of new patients, so newly diagnostic coming from probably in other therapies where they were not appropriately controlled.
But also I mean the physicians are very eager to try Ebglyss given it’s a very exciting product profile and the great work that our teams have done. So of course, they are trying with new patients and they are also trying it in patients that they were in advanced other products either biologics or orals the JAKs and they want to try it as well. So I would say, it’s a healthy combination between new patients and switched with a predominance of course new patients.
In terms of the economics of the additional indications, Lilly cannot commercialize this indication. So if these indications are commercialized in Europe, it will be done by Almirall.
In terms of the capital increase, I would say that we are very pleased in how we are deploying these funds. I mean, so far we have used the funds for the acquisitions of Prometax and Physiorelax as you know but also in filling our early-stage pipeline with the anti-IL-21 deal with Novo Nordisk and more recently with sale of pharmaceuticals. I think we have a healthy and robust pipeline of opportunities. And so I would say that we are on track and very pleased with we are deploying this capital.
Alvaro Lenze
Okay. Thank you.
Operator
Thank you. There are no further questions for today. I would now like to hand the conference over to your speaker Pablo Divasson for any closing remarks.
Mike McClellan
Excuse me, wait we have.
Operator
My apologies, we just got another question. Are you happy to take?
Mike McClellan
Yes.
Pablo Divasson
Yes. Go ahead please.
Operator
Perfect. Thank you so much. Now we’re going to take another question. And the question comes from the line of Jaime Escribano from Banco Santander. Your line is open. Please ask your question.
Jaime Escribano
Hi. Good morning. Yes, a few questions from my side. So, the first one is regarding the gross margin, which came close to 67% in the quarter. I would like to know how should we think about the gross margin in following quarters, because it was quite low in Q1, but quite high in Q2? So if you can provide some guidance for the year, it would be great.
Then a brief question on Wynzora, which I was expecting to be a small product, but it seems that it’s performing at least better than my estimates. If you can also provide a little bit more color on what your expectations are?
And then on the legacy business, which is declining around 8% in the quarter probably due to Tesavel, but I would like to have a little bit more color on how should we think about the rest of the business, I mean, excluding derma, for example, Prometax what is the contribution that we should expect? And this is pretty much it from my side. Thank you.
Mike McClellan
Okay. Let me take the first question on gross margin. We said in our February call that the gross margin would be around 65%. That’s what we see for that year. We did see a little bit of a mix variation between Q1 and Q2, but it’s kind of evened out than I would expect it to be in that 65% range for the rest of the year. Maybe Wynzora, I will pass over to Paolo?
Carlos Gallardo
Yes Paolo. Thank you, Mike. Paolo Cionini, our Head of Commercial is here as well. So, I think it’s a great opportunity then for him to add a bit more color on Wynzora, but we thought it’s a product that is a great contributor, adds very nicely to our portfolio. And again our strategy to be a leader in medical dermatology means that we want to launch products in the marketplace for all sorts of patients, for all sorts of needs of dermatologists, whether the sales potential is huge such in the case of some of our biologics, also is a little bit more modest such in other cases. But I think that’s what we want to be to offer a portfolio of products that the dermatologists need to treat unmet needs in dermatology and Wynzora is playing a key role here. So — but if Paolo, maybe you can add a bit more color on our expectations and how Wynzora is performing.
Paolo Cionini
Thank you very much Carlos. This is Paolo Cionini Chief Commercial Officer in Almirall. I think Jaime, you’re right, Wynzora as Carlos said, this part of our portfolio what we want to offer is basically one-stop shop in psoriasis together with Ilumetri and Skilarence. We have launched the product successfully in the main countries in Europe and we are very happy with the performance. I think this is due to the efficacy of the product and especially with the formulations that had really outstanding advantages to the patients.
Mike McClellan
Yes. And I’ll take the legacy business. We expect the legacy business to be relatively stable. You do see a year-on-year decline, but there were some minor divestments in early 2023 that we did zero in 2024. So that skews a little bit the growth in that legacy business. You take those out and we’re relatively flat. And I would expect something similar for the rest of the year.
Jaime Escribano
Okay. And maybe if I may can I follow up with another quick question? One on the pipeline, just for my understanding. So from Eli Lilly trials, which of them can you benefit in Europe? So my question basically is in pediatric for example, if they get the indication, this means that you get also the indication for Europe? And then a question on the pipeline — sorry on the guidance for 2024. So you are already making €104 million EBITDA. Do you still maintain the current guidance? Is it because SG&A will increase in the second half of the year and R&D? Or should we think about a review, if things goes well in following quarters? Thank you.
Karl Ziegelbauer
Yes thank you. Happy to answer the question on the clinical studies. So in the studies Lilly is doing for atopic dermatitis, we will of course benefit from the data because it explores lebrikizumab in different kinds of patient populations and settings. Specifically, for the ADorable that is the study in small children six months and less than 18 years as mentioned this is part of the European pediatric investigation or plan. And if positive, this may allow us to extend our label into this very important population for atopic dermatitis.
Mike McClellan
Yes. In terms of the guidance, you’re right, we’re more than halfway to what we’ve guided for the profit. But I remind you that we have additional launches coming up for Ebglyss in particular in the second half, as well as pre-launch in some of the countries that are going to launch early in 2025. So right now, we’re pointing towards the upper end of the guidance that we’ve given and we’d like to land there. If we see when we’re here again in November that things are going well enough to change it then we’ll relook. But right now, we’re very confident that we can make the guidance we’ve given. We’ve had a nice first half and we’d like to see those trends continue.
Jaime Escribano
Perfect. Thank you, very much, Mike.
Operator
Thank you. Dear speakers, there are no further questions. I would now like to hand the conference over to your speaker, Pablo Divasson for any closing remarks.
Pablo Divasson
Thank you very much, Nadia. We are going now to close our Q&A session. With this, we will conclude our conference today. We want to thank you for your participation. You may now disconnect.
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