7/24/2025

speaker
Operator
Call Operator

Welcome to the Gauderma half-year 2025 financial results call. As customary, the press release along with Gauderma's interim condensed financial statements were published at 7 a.m. Central European Standard Time today and can be consulted on our and for their commitment.

speaker
Flemming Ørnskov
CEO

As we look ahead, I remain fully engaged on taking Gauderma to the next level from category leadership to a true powerhouse in German politics. 2025 is a year of opportunities for us, and I'd be happy to report that we've made progress across our five strategic areas. First, we made strong progress in the first of two years with significant launches across our portfolio. Our two biologics with blockbuster potential, Mluvio and Ralph Vides, have started ahead of expectations. We'll discuss this in more detail later. Second, we maintain our momentum pursuing global opportunities. In H1, we delivered double-digit growth in seven out of our 10 markets. We also achieved important market share gains in injectable aesthetics and dermatological skin care, while Nemluvio reached $131 million in net sales. We continue to strengthen our financial profile. This includes growth in core EBITDA and margin improvements when excluding the P&L impact of Nemolizumab. We also reduced net leverage to 2.1 terms. We repaid $110 million of debt, and we refinanced $1.04 billion of our terminal. Last, but maybe not least, we repurchased shares for 323 million U.S. dollars in the context of accelerated book bill offerings to be held in Treasury. Fourth, we increased our focus on long-term growth. Among the highlights, we recently announced two new clinical trials from Imolizumab, which we'll present later. We also published nine-month data of the first of its kind aesthetic study in medication-driven weight loss. These data confirm the efficacy of Restylane and of Sculptra in improving facial aesthetic appearance for these patients. This is an exciting tailwind to support the growth of our fillers and biostimulatories subcategory. Additionally, we signed a scientific partnership with L'Oreal for a new research project. plan to use our complementary technologies to develop a non-invasive ambulatory imaging approach for extracellular matrix remodeling in the skin. Current methods in this context are invasive or they are suboptimal. There's a need for a portable, cost-effective, and high-resolution imaging solution that enables dynamic and non-invasive evaluation. We're excited to work with L'Oreal on this project. Fifth, our dynamic approach to commercial investments is driving results. We continue to deliver strong growth momentum, navigating market volatility and pockets of softness by leveraging our full portfolio and global geographic reach. Looking at our financial highlights for the period, Galderma continued on a strong growth trajectory, setting us up confidently for 2025 and for the years ahead. On net sales, we delivered a record 2.45 billion U.S. dollars for the first half, representing 12.2% year-on-year growth at constant currency. This growth was predominantly volume-based, with strong performance across product categories and across geography. Core EBITDA growth was also strong for the period and higher than expected in a year of key launches, achieving 555 million US dollars. Our margin of 22.7% reflects the anticipated adverse PLM impact from Nemolizumab. Excluding this impact, our margin continued to improve. For the full year, our guidance reflects both our strong growth trajectory and the investments required to support key launches. As such, we are raising our guidance on net sales to 12% to 14% year-on-year growth at constant currency up from the previous range of 10% to 12%. We're also confirming full-year guidance on core EBITDA margin, expecting at approximately 23% at constant currency. Again, I'm proud of our teams for these strong results and their relentless focus on growth despite an uncertain external environment. Now, let's turn to our performance update, including key highlights by product category. For the first half of the year, Galderma achieved strong top-line growth achieving a record $2.45 billion in net sales, up 12.2% year-on-year at constant currency. For the second quarter, this represented an acceleration to 15.8% year-on-year growth at constant currency, marking a return to double-digit growth. Growth was widespread across product categories and across geographies, as we'll see on the next slides. These results were driven mainly by volume and complemented by favorable mix more than offsetting pricing pressures from the competitive environment. Moving to our product categories and starting with injectable aesthetics, we maintained our strong momentum in both international markets and in the US We continue to gain market share in our two subcategories, driven by focused execution and new product launches. Net sales for the first half of the year were 1.2 billion US dollars, up 9.8% year-on-year, a constant occurrence. For newer modulators, net sales were 707 million US dollars, with year-on-year growth of 14.7% at constant currents. Both geographies reported double-digit growth and continued to gain market share. Dysport continued to perform strongly in top markets globally. Ralph Fidesz, meanwhile, is off to a strong start, now available in 17 markets. Growth in the first half had some positive stocking benefits from its continued rollout. Reception for this innovative neuromodulator which has a truly unique and a differentiated profile, has been very positive. Lastly, neuromodulator growth for the second quarter was slightly subdued following a very strong first quarter with favorable phases. For fillers and biostimulatories, net sales were $534 million for the period, with year-on-year growth of 3.9% at constant curve, Both geographies continued to gain share, with growth mainly driven by strong momentum for Sculptor and the initial uptake of new launches. We continue to observe softness in fillers globally, impacted by lower consumer demand and by aggressive promotional activity from competitors, especially in the US. As a result, the segment has become more sensitive in terms of pricing especially for SKUs, which are perhaps more interchangeable around the mid-base. We continue to focus and to grow our differentiated offering, such as for the lips, for chin, for jawline, and for skin quality. At the same time, we're starting to see healthcare professionals actively advocate for the segment with their patients. That includes explaining the importance of fillers as an integral part of their aesthetic journey. More broadly, we remain focused on opportunities for growth for this segment with select markets and select SKUs continuing to perform well. Biostimulatory growth remains very strong with outstanding performance in international markets. This includes record monthly sales for sculpture in top international markets, as well as first sales from its launch in China and in South Korea. Overall, the growth rate for fillers and biostimulatory in the second quarter was high following a decline in the previous quarter due to a high comparative base in 2020. Overall, in injectable aesthetics, we remain on a strong growth trajectory for 2025 with further acceleration expected next year as we move toward our midterm guidance. Alongside this progress, we continue to demonstrate our commitment to healthcare professionals. This was reflected in another double-digit year-on-year increase in the reach of Gilderma's education and medical awareness initiatives. With the launch of RalphieDev, we're proud to be bringing to market the biggest, yes, the biggest innovation in the field of neuromodulation in the last 20 years. Let me remind you of Valphides' unique features. First, this product is based on a truly innovative and proprietary Rela Botulinum Toxin A-Spray. Second, it was discovered and fully developed in-house. Our internal teams developed a highly potent, complex-free formulation using our own revolutionary pearl technology. Third, It's a holistically differentiated profile offering unique results, which were investigated in over 1,900 patients on a very thorough basis. Fourth, it's also produced in-house in our dedicated state-of-the-art manufacturing facility in Uppsala in Sweden. Introducing a product with this profile is a highly complex process. and our teams have been doing a great job to support its global rollout. Beyond launch plans, we're also working on further global regulatory submissions. This includes refiling in the US, which we are working on towards the end of this year. Overall, we're excited to be pioneering the next generation of neuromodulation with Ralphie Des. We're encouraged to see that market shares this enthusiasm, as we'll see

speaker
Moderator
Meeting Moderator

Next.

speaker
Flemming Ørnskov
CEO

Now launched in 70 markets, the rollout of Ralph Edes is progressing strongly. Local activation events have seen very strong attendance, and sales, while expected to be progressive, are ramping up ahead of our expectations. We also just received positive feedback from the so-called perception study done in Germany and in Spain, the first two markets where we launched in Q4 last year. These findings also reflect what we're starting to hear in an additional launch market. To share some highlights, over 95% of healthcare professionals stated they were willing to continue treating their patients with well-free deaths. Over 90% 55% also stated they were satisfied with a fast onset of Ralphie DES compared to other newer modulators. Last, but maybe not least, a growing share of practices have been reordering Ralphie DES, already reaching 70% in those two early launch markets. You can see some quotes from some renowned healthcare professionals on this slide highlighting Ralphie DES three main differentiating factors. Long duration, with often more than six months observed in practice, as also supported by our Phase IIIb data. Fast onset, with more patients seeing the effects already on day one compared to clinical data. Simple volumetric dosing facilitating the initiation of conversion of healthcare professionals to RalphieDest. With this profile, Ralph Fidesz is helping us further penetrate into existing accounts as well as new ones, where we also leverage the opportunity to promote Galderma's full portfolio. Recent fillers and biostimulator launches are also performing ahead of expectations, helping support growth in this important subcategory. Restylane Shape, our filler with bone-mimicking technology, is now launched in Brazil and is performing remarkably well. Among the highlights in this market, we achieved 6% market share in fillers and are outperforming all recent competitive launches. At three months, we reached about 2.5 times the volume compared to a major recent competitive entry. As part of our market-leading education and training support the launch, we reached over 5,000 healthcare professionals. And similar to Ralph Fidesz, Restylane Shape represents premium innovation with a so-called portfolio effect. As such, the launch also helps us grow the full Restylane portfolio. Meanwhile, Sculptra is on a very strong launch trajectory in China. fast-growing aesthetic market, as well as in South Korea. Reach has been very strong in both markets, including through education and training, as well as consumer activation. Jointly, over 2,900 healthcare professionals were trained and over 150 million media impressions generated. We see a lot of potential for sculpture in these two markets, considering the attractive, regenerative, injectable aesthetics market, and following Thailand's success story. In China alone, sales have been very strong, already growing to be the second, yes, the second largest aesthetic brand for Galderma local. Moving to dermalogical skincare, both Thetaphil and Elastin continue their strong global growth trajectories, with particularly strong performance in e-commerce as well as from new launches. Dermatological skincare net sales for the first half of the year were 790 million U.S. dollars, up 7.7% year-on-year at constant currency. Growth from international markets remained robust with exceptional performance in Asia, especially in India and in China. India has now become Galderma's largest dermatological skincare market outside of the U.S. Overall, in our international geography, Cetaphil outperformed the sector in most of its top markets. In the U.S., Cetaphil grew in e-commerce channels and in select large retailers despite constrained consumer spending. New launches are also performing well. Alastin continues to build on its momentum, with the U.S. growing across channels while also ramping up in international markets. In the US, our physician-first approach is delivering results along with a highly successful launch of our next generation TriHex technology. Dermatological skincare growth overall continues to be driven by holistic execution, especially leveraging its clinically proven portfolio and an advocacy-first marketing We've seen strong activity around the world with too many highlights to cover here. So I'll focus on a few standout examples. We launched CETUS there, a new global advocacy network of healthcare professionals and skin influencers. With thousands of creators, it's set to reach millions, yes, millions of consumers across markets. Strong retail engagement remains a key focus. In India, for example, Cetaphil featured prominently at Flipkart's GlamOp event, where it was named the most scientifically obsessed brand, generating over 20 million views. We're also leveraging celebrity advocacy to support growth. In China, beyond campaigns with renowned actors, Cetaphil partnered with the country's number one live streamer during the 618 shopping festival. As a result of this campaign, Cetaphil sold over 300,000 units in just, yes, just 60 seconds. Similarly, Alastin collaborated with Halle Berry during the U.S. Met Gala and the 25 Cannes Film Festival. Halle Berry prepared for those events using multiple Alastin products. This collaboration generated over 100 million media impressions. Moving to therapeutic dermatology, our accelerated performance was driven by an impressive ramp up in the movie of sales, notably in the second quarter. This was more than upset the decline in the category's mature portfolio, especially in the U.S. Overall, therapeutic dermatology net sales for the first half were $489 million U.S. dollars, up 26.9% year-on-year at constant currency. Of this, 131 million U.S. dollars were recorded by Nemluvio ahead of expectations. Nemluvio's sales were primarily driven by the U.S., the majority still from Brickle and Olaris, with the contribution from atopic dermatitis quickly increasing. Internationally, Nemluvio's launch in Germany in particular remains strong. Nemluvio is off to a great start, and we're excited to continue on that trajectory. At the same time, we're also investing in new clinical trials to fuel further incremental growth opportunities in the long term. Focusing on the U.S., Nemluvio continues to gain market share in both coragulonodularis and atopic dermatitis underpinned by increasing underlying demand and improved market access. Looking at weekly market share in new patient starts or NBRXs, Nimluvio is trending at about 32% in paraclinolaris and about 6% in atopic dermatitis on a rolling six-week average as of the week ending July the 11th. As a reminder, this covers only paid, only paid prescriptions. It does not include products which are provided by Calderma patient services to help bridge until reimbursement is achieved. It is also notable that the majority of all patients who start on Nemluvio are so-called biologic naive patients. This speaks to the unmet need and the differentiation Nemluvio offers with its unique mechanism of action leading to fast and to lasting relief from itch and skin clearance. In terms of access, Nemluvio now has more than 70% commercial corporate lives as a first-line biologic treat. This is a great achievement with Nemluvio now covered as a preferred brand across the four leading major pharmacy benefit managers. Meanwhile, commercial investments are showing results. Healthcare professionals we target lead to nearly two times more new patient initiations on Nemluvio. It's nearly three times more for those we engage and educate with our sales force and with full promotional resources. Our direct-to-consumer advertising is also scoring strongly, above benchmarks on minimal messages, on recall, differentiation, and motivation. It's also translating to a strong call to action for patients to request an alluvial from their healthcare providers. We also continue to deepen our reach in the field, with a Salesforce expansion of 50% in the first half of the year, and we're on track to being fully resourced by the end of this year. On the scientific front, Delderma presented new long-term data on Nemluvio in both atopic dermatitis and in parietal nodularis. These new data reinforced Nemluvio's consistent safety profile and durable clinical efficacy on both skin lesions and itch with prolonged treatment up to two years. Lastly, outside the U.S., Nemluvio's launch in Germany is off to a strong start, global regulatory processes continue to evolve very well. Given this very strong ramble, we anticipate revisiting our peak sales guidance for Nemluvio in due course. Beyond varietal nodularis and atopic dermatitis, we see further opportunity with Nemolizumab, which we see as a pipeline within an asset. As such, I'm proud to present two new potential indications that we're exploring. First, systemic sclerosis, which is a rare potentially fatal autoimmune condition that causes inflammation and fibrosis of the skin and internal organs. This represents a significant opportunity with often drug destination potential. With an estimated 65,000 biologic eligible patients in the US, there's a high unmet medical need with no approved therapy today that addresses the disease There's a strong preclinical evidence supporting the potential of nebulizumab in systemic sclerosis. First, the IL-31 methods for action targets neuroimmune cytokines involved in inflammation and in fibrosis. In addition, a small exploratory open-label study was conducted externally, which showed positive data in each of these three disease areas. We're initiating a phase two proof of concept study across multiple countries. Patient enrollment is expected to start in the second half of the year, and completion of the study is expected in 2028. The second potential indication we selected is chronic pruritus of unknown origin. This is an underdiagnosed condition, often chronic, often debilitating, with itch lasting for more than six weeks without an identified cause. This also represents an attractive opportunity. There's an estimated 120,000 biologic elder patients in the U.S. and EU5 in the U.K., but no disease classification. As such, it represents a market to be developed. Nemolizumab is very well positioned here, with a mechanism of action proven to directly block its signaling. We also have the in-house expertise to successfully design and to execute a relevant trial. We're currently initiating a phase two exploratory proof of concept study in the U.S. Patient enrollment is expected to start in the second half of the year with completion of this study expected in 2026. These new potential indications for Nemolizumab represent an incremental source of growth for Gilderma therapeutic dermatology portfolio beyond the mid-term horizon. It's too early to comment specifically on the potential of these indications but it would be an upside to the current peak sales guidance. Looking at our geographies, both international markets and the US grew double digits in the first half of the year. International, our larger reporting geographies, sustained a strong growth momentum in highly attractive, largely under-penetrated markets. Net sales in India, for example, surpassed 100 million US dollars for the first half. Overall in international markets, projectable aesthetics So double-digit growth and market share gained in both subcategories, with especially strong growth in Brazil, in Canada, in China, in Mexico, and the UK. Dermatological skincare growth, also in the double-digits, was accelerated by outstanding performances in both India and China. The acute and dermatology's modest growth was mainly driven by nemluvial cells in Germany. In the U.S., we delivered strong growth across all product categories, led by strong performance from neuromodulators and from Nimbus. In injectable aesthetics, Calderma continued to gain share in both neuromodulators and fillers and biostimulants. This is despite fillers being impacted by market softness and intensified promotional activities. In dermatologic skin care, Cetaphil made strides in e-commerce, as well as with SEDEC large retailers, despite continued constrained consumer spending. Meanwhile, elastin grew across channels. Diabetic dermatology, hemoglobial cells ramp up, and frugal neuralgias and atopic dermatitis was higher than expected, more than offsetting the anticipated decline from mature products. With this overview complete, I would now like to hand over to Thomas to provide more details on Gilderma's financial. I would also like to take this opportunity to recognize and to thank Thomas for his many, many contributions to Galderma as he will be leaving the company in a year. I'm sure that I speak on behalf of everyone when I wish him success on his next endeavor and say that it's been a real pleasure working with him. He played a key role in setting Galderma up for success and will continue to demonstrate leadership throughout this transition. We are grateful for his commitment to remain in this role through the second quarter of 2026 to ensure a seamless transition to his successor. We will share more in due course. For now, Thomas, over to you.

speaker
Thomas [Surname Unknown]
CFO

Thank you, Flemming. It's been a true pleasure and honor working with you, Flemming, and our highly talented and motivated colleagues. We've been making big strides together in Galderma's journey, which has been the most impactful transformation and growth journey of my career. While I remain super excited about Galderma's trajectory, I've taken the decision after six years at the company to leave in a year's time, knowing that Galderma is in excellent shape in order to pursue another senior executive opportunity externally. As Flemming said, I continue to be solely focused on Galderma's success through Q2 2026. And it's now my pleasure to comment on Galderma's first half financial results and full year guidance, starting with an overview. Here is the financial scorecard for the first half of the year. It shows Galderma delivered record performance, both in terms of top and bottom line growth, as well as through disciplined capital allocation. Fleming just presented the top line growth, so let's now look at the bottom line, as well as cash and balance sheet. Starting with Core EBITDA, we delivered a record $55 million for the first time. This represents year-on-year growth of 9.5% of constant currency while absorbing the cost impact of our significant launches. Core EBITDA margin was 22.7%. We delivered margin ahead of what we expected for the period, given the strong ramp-up of Nemluvio. The margin also benefited from some phasing in research and development costs between the first and second half of the year. Core EBITDA margin at constant currency was 22.8, reflecting minimum foreign exchange impact for the period. Meanwhile, gross margin was impacted by pricing pressures, especially in the US, partially offset by favorable mix. Lastly, core net income continued to grow significantly, achieving $229 million for the period. This was driven by strong core EBITDA growth, lower financing expenses, and a phasing-related improvement of the effective tax rate. As you can see here on this slide, Galderma's underlying profitability, defined as our core EBITDA margin excluding the core EBITDA impact from Nemolizumab, continued to improve. the underlying profitability of 28.9% comes in better than expected for the first half of the year. This level of underlying profitability is not fully representative of what we expect for the full year, especially due to the anticipated impact of U.S. tariffs and the seasonal ramp-up of marketing activities in the second half, as we'll discuss in our full-year guidance section. Next, let's look at the cash generated by the group. Here, this slide is a simple cash bridge. It shows our cash position at the end of June, a key movement in the first half. Let me walk you through the key items. On cash generated from operations, Galderma delivered $555 million for EBITDA, as we've already covered. We also benefited from some tactical factoring of receivables, which we use as a very cost-effective funding source. This shows up as an improvement of networking capital. change in net working capital has typically been between plus and minus 2% of net sales. In the first half of the year, we decided to use factoring opportunistically to partially fund the purchases of treasury shares at highly attractive terms. On interest and taxes, interest payment for the first half of the year was $74 million, benefiting from further deleveraging and refinancing. As for our cash tax and percent of earnings before tax, As you see, the rate is coming down in H1 as we continue to benefit from the use of tax loss carry forwards. CapEx and milestones. Core CapEx came in lower than initially planned due to more precise phasing of project spend, with some now falling into outer years and due to spend efficiency. CapEx as a percentage of sales was also benefited from the higher than expected sales performance. Meanwhile, The last expected milestone payment for Nemulizumab was paid for a total of $23 million. And finally, on financing cash flow and effects, as a testament to the strong cash generation, we repaid some debt early, repurchased shares, and paid our first annual dividend, which we'll cover in more detail on the next slide. As you can see on this slide, we brought net leverage down to 2.1 turns end of june based on our strong financial performance we also took steps to further improve returns for all shareholders first we paid our first annual dividend following approval at the recent agm a gross dividend of 0.15 switch frank cents something per dividend bearing share was distributed out of reserves from capital contributions second we repurchased shares to be held in treasury which we acquired at the set discount to the listed price. In the context of two accelerated book-built offerings by the equity-led consortium of investors, Bell Germa repurchased a total of 2.78 million shares for the amount of 323 million US dollars. These were funded from existing liquidity on hand and topped up by the proceeds from some receivable factoring at very favorable terms, as I mentioned earlier. Now, looking at our debt position, we have made a lot of programs since our IPO by declifting our debt maturity profile, diversifying our funding sources, and significantly bringing down interest costs. In H1, we will pay debt early and refinance a significant part of our term loan for a total of 1.15 billion U.S. dollars. This includes refinancing 1 billion and 40 million U.S. dollars of our term loan. After receiving an investment grade rating by Fitch, we immediately issued two new dual tranche Swiss franc bonds and an inaugural euro bond. This results in further interest cost reduction, representing cash interest expense savings of approximately $16 million per annum. The financial expenses in the cash flow for the first half of the year are slightly lower compared to that compared to what is expected in the second half of the year. This is because you have to account in the second half for the first annual coupon payment of last year's fund. Moving on to guidance, as Flemming already mentioned, we are pleased to update our guidance for the full year, reflecting our strong growth trajectory and investments behind significant launches. We are raising our net sales guidance for 2025 to 12 to 14% year-on-year growth at constant currency from previously 10 to 12. We are also pleased to confirm our core EBITDA margin at approximately 23% at constant currency. The net sales guidance update reflects the strong ramp up of Nimluvio and strong performance in injectable aesthetics. For neuromodulators specifically, We expect the second half to be impacted by stocking dynamics, notably from the ongoing wealth suggest launches and the high comparative base in Latin America. Growth will especially be impacted in the third quarter with a strong reacceleration expected in the fourth quarter. For the full year, we expect low teens, call it 11% to 13% net sales growth for the subcategory, as we remain confident in our ability to outgrow the neuromodulator market globally. Filet and bio stimulators growth is expected to accelerate in the second half of the year compared to the first half for the increasing contribution of new launches and the continued very strong momentum of Sculptra. However, this will mostly come true in Q4 because Q3 growth is against a high comparative base. Overall, considering Sculptra's trajectory, its sales will continue to represent an increasingly bigger share of this subcategory. Dermatological skincare is expected to sustain its growth trajectory globally with expected acceleration mainly in the fourth quarter due to seasonal activations. Finally, therapeutic dermatology is expected to deliver significant growth from the strong ramp-up of Nemluvio. Regarding core EBITDA margin, we expect a slight improvement in the second half of the year, to reach our full year guidance of approximately 23% of constant currency. In terms of underlying profitability, which excludes the core impact of Nemolizumab, we expect a slight decrease in the second half. This reflects the increased seasonal ramp-up of marketing activities, the anticipated impact of US tariffs, as well as R&D spend phasing. As a reminder, we deem our exposure to the currently announced US tariffs to be manageable and their anticipated impact is fully factored in and reflected in our full year guidance. We are confident in our ability to deliver on our guidance, including the capacity to absorb some further tariff impact and some consumer demand related deterioration. Please note that we have also provided additional modeling metrics in the appendix. This concludes the introductory remarks of Galdoma's financial results for the first half of 2025. Before we close the meeting with Flemming's final remarks, I would like to now hand back to the operator to open the call for questions. In the interest of allowing sufficient time for all analysts to be able to ask questions, I would kindly remind analysts to please limit themselves to one question each. Operator, can you please open the line?

speaker
Operator
Call Operator

Thank you. As a reminder, to ask a question, you will need to press star 1 1 on your telephone and wait for your name to be announced. To withdraw your question, please press star 1 1 again. Please stand by while we compile the Q&A roster. We will take our first question, and the question comes from the line of T-Bolt Bothering from Morgan Stanley. Please go ahead. Your line is open.

speaker
Thibault Bothering
Analyst, Morgan Stanley

Thank you very much. Question on Restylane. Now that you have launched in a few markets already, and based on your early data, where does the sort of uptake come from? Do you see a substitution from Dysport in your own portfolio, or is it mostly market share gains from other companies?

speaker
Flemming Ørnskov
CEO

So if I... Sorry, sorry.

speaker
Thibault Bothering
Analyst, Morgan Stanley

Sorry, I meant healthy death, sorry.

speaker
Flemming Ørnskov
CEO

Yes, I'm having to talk about Restylane, but the questions seem to be taking share from other neuromodulators. So let's focus on Ralphie Death. Yeah, so it's lost in 17 countries. We are seeing that we actually continue to see very good growth, particularly for Dysport. The opportunity with Ralphie Death for us is to gain access to accounts where we're not strong today. What we're seeing that with Ralphie Desk, we in several countries gain overall market share. So what we're trying to do is to use Ralphie Desk as a premium product that is targeted key accounts, particularly accounts where we're not present today. Some of these accounts are typically competitive. So net-net, it's taking share away from the competition.

speaker
Operator
Call Operator

Thank you.

speaker
Operator
Call Operator

Thank you. We will take our next question.

speaker
Operator
Call Operator

Your next question comes from the line of Victor Flock from BNP Paribas Exame. Please go ahead. Your line is open. Victor Flock, your line is open.

speaker
Operator
Call Operator

Please ask your question. Can you hear me now? We can hear you. Please proceed.

speaker
Victor Flock
Analyst, BNP Paribas Exame

I apologize. Yes, so a quick follow-on on the on Thibault's question on wealthiness. So historically you've added it to the fact that you were going after a staged launch pointing to ongoing capacity expansion efforts. So I was wondering if you have any updates on those efforts and when we should assume the benefit of additional capacities to kick in. Thank you.

speaker
Flemming Ørnskov
CEO

Yes, I understood the question right, was that we had a subdued launch because of capacity in the manufacturing line. I would say we have ramped up manufacturing really strongly. What we do, and you can see that with all our product launches, and you can see that again in Nemolism Lab in the U.S., where we are only selling through very select pharmacies, we think, and we have very good experience, that what we call a controlled launch with focusing on fewer but high-quality initial accounts for uptakes is better, gaining experience, and then go broader versus going broad from the beginning. So we've had the same rollout strategy for Ralphie Des. And remember here, we also have the additional thing. We want to continue to grow Dysport, or as Allure, as it's called in many places, and Allusion. So for us, it's much more about a controlled rollout, targeting key accounts. The capacity issue is less of an issue for us today. Actually, we're ramping up, we're building up our manufacturing sites, so we're very good. Remember, another huge advantage with Ralph Edessa is we have easier and better access to samples, which is also driving trial and share.

speaker
Operator
Call Operator

Great, thank you.

speaker
Operator
Call Operator

Thank you. We will take our next question. Your next question comes from the line of Jeffrey Melisha from Bank of America Securities. Please go ahead. Your line is open.

speaker
Jeffrey Melisha
Analyst, Bank of America Securities

Good afternoon, everyone. Thank you very much for taking my question. I just wanted to look at capital allocation for a minute. You bought back, obviously, $323 million of shares in the first half and you posted, obviously, a strong free cash flow result, which also led to an improvement of your net to EBITDA ratio at 2.1 times. So how should we think about the capital allocation opportunities in the second half of the year, particularly considering that you have brought capex guidance down or to the lower end of the range? So do you have room here for more buybacks in the near term?

speaker
Flemming Ørnskov
CEO

Yeah, I can maybe start and then I'll pass over to Thomas. You know, we're not signaling whether or not share buyback is something we're going to have in the portfolio of capital allocation. It is one of multiple instruments, so it's business development, so is using cash to continue to pay down debt. I think we've also done a really good job on looking at our term loans and optimizing interest-based payment. So we have a broad application of what is available to us in capital allocation, but Thomas has executed this strategy extremely well with his team. Anything you want to add?

speaker
Thomas [Surname Unknown]
CFO

I think you covered it very well, Jeffrey. I mean, it's testament to the strong cash generation that this business has. And then you can act accordingly and we're pulling all levers available to us, sometimes opportunistically, to maximize value for all shareholders.

speaker
Operator
Call Operator

And that's what we continue to do. Thank you very much.

speaker
Operator
Call Operator

Thank you.

speaker
Operator
Call Operator

We will take our next question. The next question comes from the line of Alistair Campbell from RBC. Please go ahead. Your line is open.

speaker
Alistair Campbell
Analyst, RBC

Yeah, thanks very much. Thanks for taking the question. Obviously, you've talked about tariffs as a potential impact in the second half of the year. And obviously, more generally, companies talk about the ability to potentially pass on price for tariffs. So just thinking about the fillers and biosimilar segments, I mean, broadly, given the market backdrop in the U.S., Do you think it's going to be feasible for the industry to think about price increases, or do you think it could be too tough at this stage? Thank you.

speaker
Flemming Ørnskov
CEO

Yeah, as you have seen from the results, we grow volume and we have taken share. The implicit price implications for broad portfolio with fillers and biostimulatories is, of course, with biostimulatory product, we are in a much better situation. If you look a few years back, The vast majority of that category came from fillers. Now, you know, we are in the situation where it's much more balanced. It's not a one picture fits everything. And it's true that in particular in the U.S., you've seen decline, slowdown in fillers. But as we said, again, it's more the mid-phase, undifferentiated, more price-exposed fillers where the competition is. New fillers, of which we will launch, I think, five or six next year, gives us an opportunity to continue to differentiate and take share. We've shown that with Restylane Shape, for instance, in multiple jurisdictions. Biosimilatory, we see a very significant growth around the globe, and it's a high-priority product. Also, remember, in the background, there's a seismic shift among aesthetic patients. More and more aesthetic patients coming into the clinics have been exposed to GLP-1, so the medication-driven weight loss. is an opportunity. It's still in the early days, but that will always entail that you use a biostimulatory product and will also entail your use of one or two fillers. So we have focused and we've shown that we focus on gaining market share. We focus on shifting to biostimulatory products. And of course, with new introductions of premium fillers that also gives us an opportunity that can offset some of the more price challenges you see in the undifferentiated, you can call it mid-phase filler. So it's a mix, it's changing the mix, it's using new product introductions and it's shifting more to buy stimulatory products. Thomas, anything you wanna add?

speaker
Thomas [Surname Unknown]
CFO

No, I think it's very well summarized. I would only say that even if you look at the U.S., which you're implying a little bit, Alistair, for year-to-date, price for our overall U.S. business has been a net contributor. So we have been growing, and price was also positive. So we're in a good place.

speaker
Alistair Campbell
Analyst, RBC

Thank you. Thanks very much.

speaker
Operator
Call Operator

Thank you. We will take our next question. Your next question comes from the line of James Gordon from J.P. Morgan. Please go ahead. Your line is open.

speaker
Moderator
Meeting Moderator

James Gordon, J.P. Morgan. Thanks for taking the question. My question is about Nemluvio and what the assumptions are within guidance. We're at the top line for this year by two percentage points. That's only very slightly faster growth in H2 than H1, like one percentage point faster. And you've given expectations from almost all the rest of it. So is that assuming then that Nemluvio is going to slow down quite a lot in the second half? And if so, why would that be? Or are you just being conservative? Otherwise, it seems like you would have an even bigger raise if Nemluvio would tree up. Just in terms of what the assumptions are, I haven't seen whether you're still saying that you're only going to break even on Nemluvio 7. Could that now actually happen in 6? How big was the loss in the first half?

speaker
Flemming Ørnskov
CEO

Yeah, so thanks for your question. We're not giving very specific guidance on the flu. I think anyone that's been involved in blockbuster launches knows that we're still in the early phases. We're about six plus months into the atopic dermatitis launch. Remember, there are a few specific things to keep in mind, particularly for the U.S., that when we started the launch, it was in periglinal large. And if you're over 90 kilos, you need a double dose. So when patients are on therapy, that changes and then that, of course, has an impact on the growth. We're seeing very strong ramp up. We're six plus percent already in atopic dermatitis. We've added the field for some of that will only be fully implemented by the end of the year. We've added DTC, which we've just started as well. It looks like I have a very good impact on at our axis. Of course, when competition are seeing that we're gaining so significant share, there's competitive responses. So whether you call that conservative or whether you just say we follow the trajectory and see on a week-to-week basis how things are going and allocate resources appropriately. And then, of course, I think we've been extremely focused. I think it's rather unique for a product at this stage to have over 70% coverage still growing. And we still have great success with getting exemptions in Medicare So there are many things you have. We have very controlled execution through a limited number of specialty pharmacies. We may expand that. So there's still, I could say, mechanics in the launch that we just need all to get right. But I would say the team is doing a phenomenal job. We're very optimistic, but we're not sitting here and giving very specific guidance on what is going to be and what we're going to end the year. I would be surprised if there was any slowdown, but I'm actually quite optimistic that we continue

speaker
Thomas [Surname Unknown]
CFO

roll along and the good news is you can monitor that on the weekly day and from a profitability standpoint you are referring to our some of our comments around midterm guidance where we said we expect break even sometime in in 27 so let's not be overly specific here and not call months what you see is there's a really strong uptake swimming said That, of course, delivers EBITDA and margin. But then also, we are reinvesting some of it because we all know that the steeper we make the launch curve at the beginning, the bigger the area under the curve, the bigger the MTV of such a molecule. And I think that's what we are focused on versus now calling a month or something like that where profitability swings one way or another. We have to really look at the overall value maximization for Galderma, for our shareholders, and bringing it to as many patients in need as possible, and that's what we're focused on.

speaker
Flemming Ørnskov
CEO

It's also important to understand that every investment we make, you know, we've increased the sales force, we've kicked in DTC, we've expanded the DTC. All of these efforts are based on very thorough financial analysis and matrices and ROI analysis. So we take a very structured approach to it.

speaker
Operator
Call Operator

Thank you. We will take our next question.

speaker
Operator
Call Operator

The next question comes from the line of Shan Hammer from Jefferies. Please go ahead. Your line is open.

speaker
Shan Hammer
Analyst, Jefferies

Hi. Thanks for taking my question. So looking at the Nemluvio MBRX shares, it looks like the uptick in atopic derm share is very promising. But PN is perhaps stalled around this low 30 percentage share. So how should we think about MBRX share for PN going forward? And do you have any additional levels to pull or to push higher than this?

speaker
Flemming Ørnskov
CEO

Well, of course, you know, if you look at the hour and the week, you can get different signals. Where I look at is basically the time adjusted rollout in PN and in atopic dermatitis. And I think we stack up extremely well. against all competitors. Remember, there was over a number of weeks that was significant growth in the category of parietal nodularis because Sanofi got access to broader coverage in Medicare. So that created both growth and share for them. But we are north of 30% at this stage. And of course, we've also shifted focus to continue to gain share in atopic dermatitis. So I think in both categories, we progressed really well. I think, as I also mentioned, it's obvious we probably caught some of the competition by surprise, including NPN. So now there's more, you know, counter detailing against us, but we're very, very satisfied with both NPN and in atopic dermatitis. But it's clear, of course, as we now are seeing more and more of the prescription coming from the March Lager, the AD market. We of course also shifted some of the focus on our field organization to AD.

speaker
Operator
Call Operator

Thank you. Thank you. In the interest of time, we have one more question to take. Please stand by.

speaker
Operator
Call Operator

And your final question comes from the line of Shyam Khatadia from Goldman Sachs. Please go ahead. Your line is open.

speaker
Shyam Khatadia
Analyst, Goldman Sachs

Hi, thank you for taking my question. It's on the Nemnubio costs. So I saw you provided some quantification for first half 25. But just wondering what you're thinking about in terms of that cost for the second half. And if you're still expecting full year 25 to have the biggest P&L impact. And if so, is this is a split still considered to be two thirds, one thirds between first half and second half? Thank you.

speaker
Thomas [Surname Unknown]
CFO

Maybe I take that question. Thanks, Shane, for that question. Yes, what we are showing you on that slide is actually the P&L impact, which is the EBITDA. So remember, when you're running strong on sales, then we're not showing you the cost. It's the net of the cost minus the EBITDA or the gross profit that the sales of Nemluvio have produced. So your observation is correct. With that one, compared to previous year, we're running at a pretty good rate because of the help of the top line. So with that in mind, you're correct. We would probably expect for this year's adverse P&L impact, so to speak, to be somewhat in line with the previous year. So it would not be the highest adverse impact In fact, it would more be in line with what you have seen as a previous year when we almost had no sales, you could say. So that's good. And that's because of the strong uptake we're making and the investments behind these uptakes and Salesforce expansion is something explained because a strong uptake doesn't come automatically, right? You have to do something for it. And as to phasing, first half, second half, we said two-thirds, one-third. it'll probably be more around 60-40 first half, second half. That's helpful.

speaker
Operator
Call Operator

Thank you, Thomas. Thank you, Flemming. We'll wrap up with Flemming's comments in a few seconds. Apologies, we couldn't take all the questions on the line. Investor Relations team is available if you want to connect afterwards. Now passing over to Flemming for his closing remarks.

speaker
Flemming Ørnskov
CEO

Yeah, thank you for your time and for your questions. So to summarize, Calderma continued with its strong growth momentum in the year with a lot of opportunities, and they included, we had significant launches, notably with Nemluvio and Ralfades, and as you can see, they're both off to strong starts. We continue to gain market shares. We have a very strengthened financial profile, a shift to long-term growth, including two new clinical trials for Imolizumab, and of course, dynamic commercial investments that we have put in to drive continued growth. Yeah, you saw we delivered a record net sales, $2.45 billion for the first half, growing at about 12.2%, a constant currency. As you saw, our growth was widespread, volume-based, and it was across categories and geographies. We also, and we talked upon that in the last questions, we also delivered $555 million of core EBITDA for the first half. which was a growth of 9.5%, a constant currency, despite all the launches, in particular, the two major ones that we had to fund. And then Corbett's margin was 22.7%, slightly ahead of expectation, which was supported by the strong ramp-up of Nemluvia. I think we also showcased, and thanks for the question here, disciplined capital allocation. We invested in organic growth, of course. We deleveraged net leverage down to 2.1%. And I think we created significant shareholder returns, and we issued a first dividend payment as well as did a share repurchase. And I think based on our strong growth trajectory, we're raising our full-year guidance on net sales to 12% to 14% year-on-year growth at constant currency from the previous guidance of 10% to 12%. And we are confirming our core EBITDA margin of approximately 23% also at constant currency. So as you can see, 25 is an exciting year of opportunities and it sets Galderma up for sustained and sustainable growth in the year and in the years to come. So with these closing remarks, I would like to thank you for joining our call here today.

Disclaimer

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