Latest news with #FLEMMINGØRNSKOV
Yahoo
6 days ago
- Business
- Yahoo
Galderma Buys Back Shares Worth CHF 233 Million in the Context of Accelerated Bookbuild Offering
Ad hoc announcement pursuant to Art. 53 LR ZUG, Switzerland, May 28, 2025--(BUSINESS WIRE)--Galderma (SIX: GALD), the pure-play dermatology category leader, today announced that it has agreed to repurchase 2.38 million shares at a price of CHF 97.75 per share for a total consideration of CHF 232.5 million in the context of the accelerated bookbuild offering ("ABO") of Galderma shares by Sunshine SwissCo GmbH ("EQT"), Abu Dhabi Investment Authority and Auba Investment Pte. Ltd. launched yesterday evening. The repurchase was made at the same price per share determined by the bookbuilding offering. The repurchase, which is expected to settle on June 2, is being financed by Galderma's existing liquidity on hand and will not affect the company's ability to deliver on its strategic and financing priorities. The shares will be held in treasury for future use in connection with Galderma's employee participation plans, business development opportunities and/or treasury management. "The repurchase of shares announced today is a testament to the confidence of the Executive Committee and the Board of Directors in the performance fundamentals and the attractive shareholder value creation outlook of Galderma. The participation in the offering reflects our continued focus on disciplined capital allocation, commitment to attractive shareholder returns and our confidence in Galderma's strong cash generation and investment grade balance sheet." FLEMMING ØRNSKOV, M.D., MPH CHIEF EXECUTIVE OFFICER GALDERMA Following the closing of the ABO, the free float in Galderma's shares is expected to increase from 41.8% to 49.8%. About GaldermaGalderma (SIX: GALD) is the pure-play dermatology category leader, present in approximately 90 countries. We deliver an innovative, science-based portfolio of premium flagship brands and services that span the full spectrum of the fast-growing dermatology market through Injectable Aesthetics, Dermatological Skincare and Therapeutic Dermatology. Since our foundation in 1981, we have dedicated our focus and passion to the human body's largest organ – the skin – meeting individual consumer and patient needs with superior outcomes in partnership with healthcare professionals. Because we understand that the skin we are in shapes our lives, we are advancing dermatology for every skin story. For more information: Forward-looking statements Certain statements in this announcement are forward-looking statements. Forward-looking statements are statements that are not historical facts and may be identified by words such as "plans", "targets", "aims", " believes", "expects", "anticipates", "intends", "estimates", "will", "may", "continues", "should" and similar expressions. These forward-looking statements reflect, at the time, Galderma's beliefs, intentions and current targets/ aims concerning, among other things, Galderma's results of operations, financial condition, industry, liquidity, prospects, growth and strategies and are subject to change. The estimated financial information is based on management's current expectations and is subject to change. By their nature, forward-looking statements involve a number of risks, uncertainties and assumptions that could cause actual results or events to differ materially from those expressed or implied by the forward-looking statements. These risks, uncertainties and assumptions could adversely affect the outcome and financial consequences of the plans and events described herein. Actual results may differ from those set forth in the forward-looking statements as a result of various factors (including, but not limited to, future global economic conditions, changed market conditions, intense competition in the markets in which Galderma operates, costs of compliance with applicable laws, regulations and standards, diverse political, legal, economic and other conditions affecting Galderma's markets, and other factors beyond the control of Galderma). Neither Galderma nor any of their respective shareholders (as applicable), directors, officers, employees, advisors, or any other person is under any obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise. You should not place undue reliance on forward-looking statements, which speak of the date of this announcement. Statements contained in this announcement regarding past trends or events should not be taken as a representation that such trends or events will continue in the future. Some of the information presented herein is based on statements by third parties, and no representation or warranty, express or implied, is made as to, and no reliance should be placed on, the fairness, reasonableness, accuracy, completeness or correctness of this information or any other information or opinions contained herein, for any purpose whatsoever. Except as required by applicable law, Galderma has no intention or obligation to update, keep updated or revise this announcement or any parts thereof. View source version on Contacts For further information: Christian Marcoux, Communications +41 76 315 26 50 Richard HarbinsonCorporate Communications +41 76 210 60 62 Emil IvanovHead of Strategy, Investor Relations, and +41 21 642 78 12 Jessica CohenInvestor Relations and Strategy +41 21 642 76 43
Yahoo
6 days ago
- Business
- Yahoo
Galderma Buys Back Shares Worth CHF 233 Million in the Context of Accelerated Bookbuild Offering
Ad hoc announcement pursuant to Art. 53 LR ZUG, Switzerland, May 28, 2025--(BUSINESS WIRE)--Galderma (SIX: GALD), the pure-play dermatology category leader, today announced that it has agreed to repurchase 2.38 million shares at a price of CHF 97.75 per share for a total consideration of CHF 232.5 million in the context of the accelerated bookbuild offering ("ABO") of Galderma shares by Sunshine SwissCo GmbH ("EQT"), Abu Dhabi Investment Authority and Auba Investment Pte. Ltd. launched yesterday evening. The repurchase was made at the same price per share determined by the bookbuilding offering. The repurchase, which is expected to settle on June 2, is being financed by Galderma's existing liquidity on hand and will not affect the company's ability to deliver on its strategic and financing priorities. The shares will be held in treasury for future use in connection with Galderma's employee participation plans, business development opportunities and/or treasury management. "The repurchase of shares announced today is a testament to the confidence of the Executive Committee and the Board of Directors in the performance fundamentals and the attractive shareholder value creation outlook of Galderma. The participation in the offering reflects our continued focus on disciplined capital allocation, commitment to attractive shareholder returns and our confidence in Galderma's strong cash generation and investment grade balance sheet." FLEMMING ØRNSKOV, M.D., MPH CHIEF EXECUTIVE OFFICER GALDERMA Following the closing of the ABO, the free float in Galderma's shares is expected to increase from 41.8% to 49.8%. About GaldermaGalderma (SIX: GALD) is the pure-play dermatology category leader, present in approximately 90 countries. We deliver an innovative, science-based portfolio of premium flagship brands and services that span the full spectrum of the fast-growing dermatology market through Injectable Aesthetics, Dermatological Skincare and Therapeutic Dermatology. Since our foundation in 1981, we have dedicated our focus and passion to the human body's largest organ – the skin – meeting individual consumer and patient needs with superior outcomes in partnership with healthcare professionals. Because we understand that the skin we are in shapes our lives, we are advancing dermatology for every skin story. For more information: Forward-looking statements Certain statements in this announcement are forward-looking statements. Forward-looking statements are statements that are not historical facts and may be identified by words such as "plans", "targets", "aims", " believes", "expects", "anticipates", "intends", "estimates", "will", "may", "continues", "should" and similar expressions. These forward-looking statements reflect, at the time, Galderma's beliefs, intentions and current targets/ aims concerning, among other things, Galderma's results of operations, financial condition, industry, liquidity, prospects, growth and strategies and are subject to change. The estimated financial information is based on management's current expectations and is subject to change. By their nature, forward-looking statements involve a number of risks, uncertainties and assumptions that could cause actual results or events to differ materially from those expressed or implied by the forward-looking statements. These risks, uncertainties and assumptions could adversely affect the outcome and financial consequences of the plans and events described herein. Actual results may differ from those set forth in the forward-looking statements as a result of various factors (including, but not limited to, future global economic conditions, changed market conditions, intense competition in the markets in which Galderma operates, costs of compliance with applicable laws, regulations and standards, diverse political, legal, economic and other conditions affecting Galderma's markets, and other factors beyond the control of Galderma). Neither Galderma nor any of their respective shareholders (as applicable), directors, officers, employees, advisors, or any other person is under any obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise. You should not place undue reliance on forward-looking statements, which speak of the date of this announcement. Statements contained in this announcement regarding past trends or events should not be taken as a representation that such trends or events will continue in the future. Some of the information presented herein is based on statements by third parties, and no representation or warranty, express or implied, is made as to, and no reliance should be placed on, the fairness, reasonableness, accuracy, completeness or correctness of this information or any other information or opinions contained herein, for any purpose whatsoever. Except as required by applicable law, Galderma has no intention or obligation to update, keep updated or revise this announcement or any parts thereof. View source version on Contacts For further information: Christian Marcoux, Communications +41 76 315 26 50 Richard HarbinsonCorporate Communications +41 76 210 60 62 Emil IvanovHead of Strategy, Investor Relations, and +41 21 642 78 12 Jessica CohenInvestor Relations and Strategy +41 21 642 76 43


Business Wire
6 days ago
- Business
- Business Wire
Galderma Buys Back Shares Worth CHF 233 Million in the Context of Accelerated Bookbuild Offering
ZUG, Switzerland--(BUSINESS WIRE)--Galderma (SIX: GALD), the pure-play dermatology category leader, today announced that it has agreed to repurchase 2.38 million shares at a price of CHF 97.75 per share for a total consideration of CHF 232.5 million in the context of the accelerated bookbuild offering ('ABO') of Galderma shares by Sunshine SwissCo GmbH ('EQT'), Abu Dhabi Investment Authority and Auba Investment Pte. Ltd. launched yesterday evening. The repurchase was made at the same price per share determined by the bookbuilding offering. The repurchase, which is expected to settle on June 2, is being financed by Galderma's existing liquidity on hand and will not affect the company's ability to deliver on its strategic and financing priorities. The shares will be held in treasury for future use in connection with Galderma's employee participation plans, business development opportunities and/or treasury management. 'The repurchase of shares announced today is a testament to the confidence of the Executive Committee and the Board of Directors in the performance fundamentals and the attractive shareholder value creation outlook of Galderma. The participation in the offering reflects our continued focus on disciplined capital allocation, commitment to attractive shareholder returns and our confidence in Galderma's strong cash generation and investment grade balance sheet.' FLEMMING ØRNSKOV, M.D., MPH CHIEF EXECUTIVE OFFICER GALDERMA Expand Following the closing of the ABO, the free float in Galderma's shares is expected to increase from 41.8% to 49.8%. About Galderma Galderma (SIX: GALD) is the pure-play dermatology category leader, present in approximately 90 countries. We deliver an innovative, science-based portfolio of premium flagship brands and services that span the full spectrum of the fast-growing dermatology market through Injectable Aesthetics, Dermatological Skincare and Therapeutic Dermatology. Since our foundation in 1981, we have dedicated our focus and passion to the human body's largest organ – the skin – meeting individual consumer and patient needs with superior outcomes in partnership with healthcare professionals. Because we understand that the skin we are in shapes our lives, we are advancing dermatology for every skin story. For more information: Forward-looking statements Certain statements in this announcement are forward-looking statements. Forward-looking statements are statements that are not historical facts and may be identified by words such as "plans", "targets", "aims", " believes", "expects", "anticipates", "intends", "estimates", "will", "may", "continues", "should" and similar expressions. These forward-looking statements reflect, at the time, Galderma's beliefs, intentions and current targets/ aims concerning, among other things, Galderma's results of operations, financial condition, industry, liquidity, prospects, growth and strategies and are subject to change. The estimated financial information is based on management's current expectations and is subject to change. By their nature, forward-looking statements involve a number of risks, uncertainties and assumptions that could cause actual results or events to differ materially from those expressed or implied by the forward-looking statements. These risks, uncertainties and assumptions could adversely affect the outcome and financial consequences of the plans and events described herein. Actual results may differ from those set forth in the forward-looking statements as a result of various factors (including, but not limited to, future global economic conditions, changed market conditions, intense competition in the markets in which Galderma operates, costs of compliance with applicable laws, regulations and standards, diverse political, legal, economic and other conditions affecting Galderma's markets, and other factors beyond the control of Galderma). Neither Galderma nor any of their respective shareholders (as applicable), directors, officers, employees, advisors, or any other person is under any obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise. You should not place undue reliance on forward-looking statements, which speak of the date of this announcement. Statements contained in this announcement regarding past trends or events should not be taken as a representation that such trends or events will continue in the future. Some of the information presented herein is based on statements by third parties, and no representation or warranty, express or implied, is made as to, and no reliance should be placed on, the fairness, reasonableness, accuracy, completeness or correctness of this information or any other information or opinions contained herein, for any purpose whatsoever. Except as required by applicable law, Galderma has no intention or obligation to update, keep updated or revise this announcement or any parts thereof.


Associated Press
06-03-2025
- Business
- Associated Press
Galderma Delivers 2024 Record Net Sales of 4.410 Billion USD, up 9.3% Year-on-Year at Constant Currency1, and Record Core EBITDA of 1.031 Billion USD, While Preparing to Accelerate Its Growth Trajectory Into 2025 and Beyond
ZUG, Switzerland--(BUSINESS WIRE)--Mar 6, 2025-- Galderma Group AG (SIX:GALD), the pure-play dermatology category leader, today announced its financial results for the full year 2024, delivering strong results for another consecutive year while making significant progress with its blockbuster platforms and future growth drivers. Record net sales: Achieved 4,410 million USD in net sales, up 9.3% year-on-year on a constant currency basis 1, with volume-based growth fueled by focused execution and differentiated innovation Broad-based growth: Continued performance across all product categories with constant currency year-on-year growth of 9.6% for Injectable Aesthetics, 10.7% for Dermatological Skincare and 6.1% for Therapeutic Dermatology Focused execution: Continued execution of Galderma's unique growth-focused Integrated Dermatology Strategy, supporting all product categories on a global scale and with omni-channel presence. Moreover, made significant headway with the company's future growth drivers, including Nemluvio ® (nemolizumab) and Relfydess™ (RelabotulinumtoxinA), which received key approvals in the U.S. and Europe, respectively Science and education leadership: Further strengthened its commitment to leadership in dermatology, showcasing its science-based portfolio spanning the full spectrum of the fast-growing dermatology market, with strong progress on its scientific agenda and leading presence at key industry events Record profitability: Delivered 1,031 million USD Core EBITDA 2 for the full year, exceeding the one billion USD mark for the first time in its history. This represents a 23.4% Core EBITDA margin, with a profitability improvement of 30 basis points (up 50 basis points at constant currency) compared to 2023 Deleveraged balance sheet: Reduced leverage 3 to 2.3x at the end of December 2024, along with the issuance of Galderma's first inaugural Swiss bond 2025 full year guidance: Expecting net sales growth of 10-12% at constant currency and Core EBITDA margin of approximately 23% at constant currency, reflecting Galderma's continued growth trajectory and key launches, including required investments, and operating leverage improvements. Confirmed its confidence in Galderma's mid-term guidance 'In 2024, Galderma continued to deliver strong performance while preparing the company for its next phase of growth, following its successful listing on the SIX Swiss Exchange. Our distinctive trajectory is fueled by our growth-focused Integrated Dermatology Strategy, driving the successful execution of our portfolio of premium science-based brands. We continue to increase penetration and share of voice in a market with pockets of softness. Recent key regulatory approvals of new differentiated innovations position Galderma well across all our product platforms – for 2025 and beyond.' FLEMMING ØRNSKOV, M.D., MPH CHIEF EXECUTIVE OFFICER GALDERMA Commercial performance Galderma achieved record net sales of 4,410 million USD for the full year 2024, representing 9.3% year-on-year net sales growth on a constant currency basis. Results were predominantly driven by volume, complemented by favorable mix. Net sales growth was widespread across product categories. All categories grew, with notably strong performance in Injectable Aesthetics and Dermatological Skincare, and Therapeutic Dermatology growth boosted by the launch in the U.S. of Nemluvio. International markets, Galderma's larger geography, continued driving the Group's growth, delivering another year of double-digit performance in highly attractive, largely underpenetrated sectors. They delivered double-digit growth in all three product categories, for the full year and in the fourth quarter of 2024, which was the strongest growth quarter of the year. The double-digit quarterly performance was driven by strong performance of year-end engagement activities across product categories and was aided by a lower 2023 comparative base. Highlights include leadership and market share gains in Neuromodulators, with particularly strong demand in Europe and Latin America. Furthermore, Fillers & Biostimulators achieved robust growth overall, with notable growth in Thailand and the Middle East. Also, Cetaphil ® enjoyed broad-based growth across markets and Alastin ® expanded in its first International markets. Finally, the mature Therapeutic Dermatology portfolio outperformed in International markets, despite genericization and pricing pressures. The U.S. delivered flat year-on-year net sales for the full year 2024. The modest growth in Injectable Aesthetics, Dermatological Skincare and first sales of Nemluvio were offset by the decline in the mature Therapeutic Dermatology portfolio from lower anticipated volumes and ongoing market genericization. In Injectable Aesthetics, the U.S. continued to gain market share across its portfolio. In a softening Injectable Aesthetics market with intensifying promotional activities, growth for the full year was driven by Dysport ® and Sculptra ® (poly-L-lactic acid). In Dermatological Skincare, Cetaphil performed strongly in the fast-expanding e-commerce channel, along with improved Cetaphil execution with Galderma's largest retail partner. Growth was also supported by increasing penetration of Alastin, leveraging synergies from Galderma's leading position in Injectable Aesthetics. Nemluvio recorded first sales of 23 million USD for the full year, tracking ahead of expectations, following the launch mid-August 2024 in prurigo nodularis and mid-December 2024 in atopic dermatitis. For the fourth quarter, the U.S. overall recorded a single digit decline, from the continued impact from constrained consumer spending, compounded by a high comparative base. In addition, Injectable Aesthetics, which continued to gain market share in the U.S. in the fourth quarter, had rebalancing of growth compared to the previous quarter. Furthermore, the anticipated decline of the U.S. Therapeutic Dermatology mature portfolio was not yet offset by the Nemluvio sales ramp-up. Throughout 2024, Galderma made strong progress across its product categories and future growth platforms, driving distinctive innovation and securing key regulatory approvals. Along with the continued execution of its growth-focused Integrated Dermatology Strategy, this will further fuel its growth trajectory in 2025 and beyond. Injectable Aesthetics Injectable Aesthetics net sales for the full year 2024 were 2,299 million USD, with year-on-year growth of 9.6% on a constant currency basis. Both Injectable Aesthetics subcategories performed strongly for the full year 2024, with notable double-digit growth rates of Dysport and Sculptra. Galderma continued its track record of gaining market share across its Injectable Aesthetics portfolio. For the fourth quarter, beyond some market softness, year-on-year growth was impacted by a high comparative base. It was also affected by phasing of growth across subcategories in the second half of the year, rebalancing the sales phasing from the third quarter of the year. Both geographies continued growing for the full year, with market share gains in the U.S. and key International markets. Neuromodulators net sales were 1,285 million USD for the full year, up 11.8% year-on-year at constant currency. Galderma continued to gain market share and outpace the market in Neuromodulators. It saw particularly strong demand from strengthened European leadership and significant outperformance in Latin America, along with notable market share gains in the U.S. and in China. Relfydess (RelabotulinumtoxinA, previously referred to as QM-1114) also recorded its first sales in Europe, with its first launches in the fourth quarter. Fillers and Biostimulators net sales were 1,014 million USD for the full year, up 7.0% year-on-year at constant currency. Fillers sustained growth in Asia Pacific and Latin American markets, while being impacted by softness in other key markets. Biostimulators continued on a strong growth trajectory globally. Progress was supported by the successful Sculptra launch in Thailand and strong demand across key markets, with notable outperformance in the Middle East. The main innovation milestone for Injectable Aesthetics was the successful completion of the European decentralized regulatory procedure for Relfydess, resulting in a positive decision. As of now, Relfydess is approved in 14 European countries, as well as in Australia and the U.K. The first commercial activities began in November 2024 in Germany and Spain and are tracking ahead of expectations. Feedback from healthcare professionals is positive, with an early onset of action from Day 1 and strong anticipation of duration sustained for six months. Relfydess is indicated for the temporary improvement in the appearance of moderate-to-severe glabellar lines (frown lines) at maximum frown and lateral canthal lines (crow's feet) seen at maximum smile. It can be administered alone or in combination, in adult patients under 65 years, when the severity of these lines has an important psychological impact on the patient. Galderma continued to expand the science and innovation fueling its Injectable Aesthetics portfolio. Restylane ® VOLYME™, designed for contouring and volumization of the mid-face region, was launched in China, one of the world's biggest and fastest growing injectable aesthetics markets. Other portfolio expansions included the launch of Restylane SHAYPE™ in Canada and Brazil as the first hyaluronic acid (HA) injectable with bone-mimicking properties using the new NASHA HD™ technology for temporary augmentation of the chin region. This sets the stage for additional market launches. China is also preparing to launch Sculptra in 2025, following approval in 2024. Sculptra is the first proven regenerative biostimulator, with a unique PLLA-SCA™ formulation that helps restore the deep, underlying structure of the skin. Sculptra encourages the remodeling of components of the extracellular matrix, such as elastin and collagen, helping to gradually restore facial volume and the look of fullness to wrinkles and folds over time. Dermatological Skincare Dermatological Skincare net sales for the full year 2024 were 1,331 million USD, up 10.7% on a constant currency basis. Galderma experienced robust growth in both of its flagship Dermatological Skincare brands, Cetaphil and Alastin. In International markets, Cetaphil continued its strong growth trajectory, with notable market share gains in key markets such as Brazil, Canada, China, India, the Philippines, and the U.K. & Ireland, among others. Alastin started to ramp-up outside of the U.S. and is still at the beginning of its international expansion journey. In the U.S., Cetaphil growth was impacted by constrained consumer demand while capturing pockets of growth, especially in e-commerce channels. Cetaphil further benefited from improved execution with Galderma's largest retail partner, while Alastin continued its expansion. Now fully integrated within Galderma's leading dermatology platform, Alastin continued to gain market share and was the fastest growing of the top five professional U.S. skincare brands in 2024. Galderma has also announced a new hub in Miami, Florida, for its U.S. Dermatological Skincare business. This move reflects its commitment to driving innovation and pursuing the next phase of its growth. In 2024, Galderma reached billions of consumers worldwide through engagement with leading healthcare professionals and skinfluencers. E-commerce remained the fastest-growing channel and Cetaphil reached record performances in online sales. The strong e-commerce performance was broad-based: in the U.S., Cetaphil continued its growth momentum at Amazon; in China, growth was boosted by another record-breaking Double-11 performance; and, in select emerging markets, Cetaphil achieved triple-digit e-commerce growth year-on-year. In terms of science and innovation, beyond boosting Cetaphil Restoraderm sales in conjunction with the ramp-up of Nemluvio in the U.S., Galderma ensured a consistent flow of new Cetaphil launches, designed for sensitive skin and tailored to local consumer needs. Launches throughout the year included new innovation, particularly in the face range, as well as continued global expansion of relevant lines. Meanwhile, the previously launched Alastin C-Radical Defense Antioxidant Serum continued its robust market uptake in the U.S., driven by strong clinical differentiation and external recognition, with awards proving its excellence as a top-performing Vitamin C serum. Therapeutic Dermatology Therapeutic Dermatology net sales for the full year 2024 were 780 million USD, up 6.1% year-on-year at constant currency. Growth was driven by International markets and the first sales of Nemluvio in the U.S. Overall, these more than offset the decline in the mature U.S. Therapeutic Dermatology portfolio, with lower anticipated volumes and ongoing market genericization. Nemluvio sales for 2024 reached 23 million USD, all recorded in the U.S. and primarily in the prurigo nodularis indication. In August 2024, Nemluvio was approved for adult patients with prurigo nodularis. Nemluvio is trending at about 30% weekly market share of new-to-brand prescriptions (NBRx), for the period beginning in January to mid-February 2025. Performance was based on the strong activation of healthcare professionals, very positive patient feedback and increasing adoption of Nemluvio in prurigo nodularis in the U.S. In December 2024, the U.S. Food and Drug Administration (FDA) also approved Nemluvio for the treatment of patients 12 years and older with moderate-to-severe atopic dermatitis, in combination with topical corticosteroids (TCSs) and/or topical calcineurin inhibitors (TCIs) when the disease is not adequately controlled with topical prescription therapies. Following the close of the year, the European Commission, the U.K. Medicines and Healthcare products Regulatory Agency, and Swissmedic also approved Nemluvio. Their approval is for subcutaneous use for the treatment of moderate-to-severe atopic dermatitis in patients aged 12 years and older who are candidates for systemic therapy. They also approved subcutaneous use for the treatment of adults with moderate-to-severe prurigo nodularis who are candidates for systemic therapy. Marketing authorization applications for Nemluvio in both prurigo nodularis and atopic dermatitis are currently under review by multiple regulatory authorities across the world. Nemluvio is on a strong launch trajectory, and Galderma reiterated its peak sales guidance of above 2 billion USD. The mature Therapeutic Dermatology portfolio is not expected to be a contributor to growth over the mid-term, as it will continue to be subject to increasing competition and pricing pressures from generics. Expansion opportunities in new markets and patient groups are also being explored. Breakthrough science and industry-leading medical education Galderma reaffirmed its leadership in dermatology. It showcased its innovative, science-based portfolio that spans the full spectrum of the fast-growing dermatology market with strong progress on its scientific agenda and a prominent presence at key industry events. Full results from nemolizumab's phase III ARCADIA 1 and 2 clinical trials in atopic dermatitis were published in The Lancet. These trials evaluated the efficacy and safety of nemolizumab in combination with background TCSs, with or without TCIs, versus placebo in combination with TCSs, with or without TCIs. Participants were adolescent and adult patients with moderate-to-severe atopic dermatitis. The trials met their co-primary and all key secondary endpoints, showing that nemolizumab significantly improved skin lesions, itch and sleep disturbance by week 16 when compared to placebo, with significant itch relief observed as early as week 1. In addition, full results from the phase III OLYMPIA 1 trial evaluating the efficacy and safety of nemolizumab in adults with moderate-to-severe prurigo nodularis have been published in JAMA Dermatology, showing the trial met all primary and key secondary endpoints. Galderma's commitment to market-leading education and services was demonstrated through its presence at major medical congresses, including at the Aesthetic & Anti-Aging Medical World Congress (AMWC), the American Academy of Dermatology (AAD) Annual Meeting, the European Academy of Dermatology and Venereology (EADV) Congress, Vegas Cosmetic Surgery (VCS) and the International Master Course on Aging Science (IMCAS) World Congress. Engagement with healthcare professionals covered the full spectrum of Galderma's portfolio, with a particular focus on showcasing its unparalleled aesthetics portfolio and generating growing appreciation for nemolizumab. For the full year, over 225,000 4 healthcare professionals were reached through education, training and medical awareness activities. These included the Galderma Aesthetic Injector Network (GAIN), the Global Sensitive Skincare Faculty (GSSF), continuous medical education and the aforementioned medical congresses. Galderma also expanded on its global platforms with the launch of its Skin Knowledge and Innovation Network (SKIN), spanning Dermatological Skincare and Therapeutic Dermatology. The program helps healthcare professionals make informed decisions while enhancing their personal development and impact on patients' lives. While welcoming L'Oréal as a new shareholder, Galderma announced that it signed a memorandum of understanding with the Group in August 2024 to work towards a new research and development collaboration. Financial scorecard Galderma delivered 1,031 million USD in Core EBITDA for the full year 2024, surpassing one billion USD for the first time. Core EBITDA year-on-year growth was 12.9% at constant currency, with Core EBITDA growing faster than net sales. The reported Core EBITDA margin was 23.4%, while at constant currency the margin was 23.6%, representing an increase of 30 and 50 basis points, respectively, compared to the 2023 Core EBITDA margin of 23.1%. Core EBITDA margin expansion was driven by ongoing operating leverage and lower-than-anticipated spend on nemolizumab research and development. Total nemolizumab costs related to external Research and Development, Medical and Regulatory, Sales and Marketing, and Distribution for the full year were 226 million USD. Underlying profitability for Galderma, excluding the aforementioned nemolizumab operating expenses, continued to increase driven by the benefits of operating leverage from our Integrated Dermatology Strategy, especially benefiting sales and marketing spend. Improvements on operating expenses offset the impact of pricing pressures on gross margin, especially from a soft trading environment in the U.S. Core net income grew by 138.8%, reflecting three main drivers: 1) strong financial performance on the top- and bottom-line; 2) lower financing expenses, due to Galderma's deleveraging and refinancing activities following the capital structure reset at IPO; and 3) significant improvement of the effective tax rate. Galderma continued to progress on its deleveraging trajectory, with its strong cash generation allowing for early debt repayment. At the end of December 2024, the net debt-to-Core EBITDA leverage ratio was reduced to 2.3x, from 2.6x at the end of June 2024 and 4.9x at the end of December 2023. Over the year, net debt was reduced by 2,277 million USD, down to 2,356 million USD. Given strong financial results for the year and confidence in cash generation, Galderma proceeded to early repayment of gross debt of 256 million USD. The repayment was possible despite 176 million USD paid for three conditional milestones and earn-out obligations during the year. Galderma's interest expense for the full year also benefited from Galderma's deleveraging and refinancing activities, including the capital structure reset at IPO, the early debt repayments and the issuance of an inaugural 500 million CHF bond in August 2024. In 2024, Galderma also made meaningful progress in its Environmental, Social and Governance (ESG) agenda, notably improving front-runner ESG metrics related to emissions, waste and water in its operations. Additionally, the publication of Galderma's ESG 2023 update paved the way for progressive enhancement of its non-financial reporting. Following the record 2024 performance, Galderma's board will propose for approval at the upcoming Annual General Meeting a dividend payment out of reserves from capital contributions of 0.15 CHF (gross) per share 5. Full-year guidance For the full year 2025, Galderma expects net sales growth of 10-12% at constant currency and a Core EBITDA margin of approximately 23% at constant currency. This represents an acceleration of Galderma's growth trajectory and includes the anticipated investments behind its significant launches. As a reminder, while underlying profitability is expected to continue to increase in 2025—driven by operating leverage—this year is expected to incur the highest adverse profit and loss (P&L) impact from investments in nemolizumab. Galderma remains confident in its future and is also reconfirming its previously stated mid-term guidance, with details available in the Appendix along with updated additional modeling metrics. In terms of phasing, year-on-year growth of net sales in the first quarter is expected to be clearly subdued, due to a high comparable base in 2024, some ongoing market softness and the temporary impact from the wildfires in California. The quarterly year-on-year growth is expected to significantly accelerate throughout the rest of the year. It will be fueled by the launch of disruptive innovation, in particular the ramp-up of Nemluvio and Relfydess, and from further geographic and portfolio expansions in International markets. As for Core EBITDA margin phasing, the adverse P&L impact from nemolizumab investments is expected to peak in the first half of the year, with significant expansion of Core EBITDA margin in the second half of the year. Webcast details Galderma will host its financial results call today at 14:00 CET to discuss the full year 2024 results and respond to questions from financial analysts. Investors and the public may access the webcast by registering on the Galderma Investor Relations website at Galderma's Annual Report will be published on March 21, 2025. About Galderma Galderma (SIX: GALD) is the pure-play dermatology category leader, present in approximately 90 countries. We deliver an innovative, science-based portfolio of premium flagship brands and services that span the full spectrum of the fast-growing dermatology market through Injectable Aesthetics, Dermatological Skincare and Therapeutic Dermatology. Since our foundation in 1981, we have dedicated our focus and passion to the human body's largest organ – the skin – meeting individual consumer and patient needs with superior outcomes in partnership with healthcare professionals. Because we understand that the skin we are in shapes our lives, we are advancing dermatology for every skin story. For more information: Appendices Appendix 1: Full year 2024 net sales by product category and geography In million USD Net sales Year-on-year growth FY 2023 FY 2024 Constant currency Reported Group total 4,082 4,410 9.3% 8.0% By product category Injectable Aesthetics 2,128 2,299 9.6% 8.0% Neuromodulators 1,162 1,285 11.8% 10.6% Fillers & Biostimulators 966 1,014 7.0% 5.0% Dermatological Skincare 1,212 1,331 10.7% 9.8% Therapeutic Dermatology 742 780 6.1% 5.1% By geography International 2,271 2,600 16.9% 14.5% U.S. 1,811 1,810 -0.0% -0.0% Appendix 2: Q4 2024 net sales by product category and geography In million USD Net sales Year-on-year growth Q4 2023 Q4 2024 Constant currency Reported Group total 1,072 1,151 9.6% 7.3% By product category Injectable Aesthetics 576 601 6.9% 4.4% Neuromodulators 317 358 15.4% 12.9% Fillers & Biostimulators 259 243 -3.7% -6.1% Dermatological Skincare 312 341 11.0% 9.4% Therapeutic Dermatology 184 208 15.5% 13.0% By geography International 574 686 23.8% 19.4% U.S. 498 465 -6.6% -6.6% Appendix 3: Reconciliation of FY 2024 P&L from IFRS to Core reporting In million USD IFRS - as reported Exceptional & transformation related items Amortization Depreciation Core reporting % Net Sales based on Core reporting Net Sales 4,410 - - - 4,410 Other revenue 30 - - - 30 Cost of goods sold (1,355) - 186 19 (1,150) Gross profit 3,085 - 186 19 3,290 74.6% Research and development (260) - - 2 (258) 5.9% Sales and marketing (1,377) - 1 11 (1,364) 30.9% General and administrative (543) 60 43 30 (411) 9.3% Medical and regulatory (95) - - - (95) 2.1% Distribution (132) - - 1 (130) 3.0% Other income / (expenses) (33) 33 - - - - Operating profit as reported 645 Total adjustments 93 229 64 Core EBITDA 1,031 Appendix 4: Reconciliation of FY 2024 of Core EBITDA to IFRS Net Income In million USD FY 2023 FY 2024 Core EBITDA 942 1,031 % margin 23.1% 23.4% Exceptional and transformation related adjustments (54) (60) Other income / (expenses) (75) (33) Total EBITDA adjustments 6 (130) (93) EBITDA 812 938 % margin 19.9% 21.3% Depreciation (55) (64) Amortization (221) (229) Operating profit 536 645 Net interest expenses incl. VCB revaluation (527) (328) Foreign exchange gain / (loss) on financing activities 2 (7) Income / (loss) before tax 11 310 Income taxes (68) (79) Net income (57) 231 Appendix 5: Reconciliation of FY 2024 from IFRS Net Income to Core Net Income 7 In million USD FY 2023 FY 2024 Net income / (loss) (57) 231 Total EBITDA adjustments 6 130 93 VCB financing revaluation (32) (28) Amortization 221 229 Foreign exchange gain / (loss) on financing activities (2) 7 Income taxes on above items (52) (36) Core Net Income 208 496 Core EPS in USD 8 2.09 Appendix 6: FY 2024 Total Net Indebtedness In million USD Dec 31 2023 Dec 31 2024 Total Indebtedness 9 5,001 2,813 Cash and Cash Equivalents (368) (457) Total Net Indebtedness 4,633 2,356 Appendix 7: Mid-term guidance Mid-term guidance, 2023-2027E CC CAGR 'Teens' defined as numbers greater than 10% and lower than 20% Topline Group net sales 'Low to mid-teens 10 ' CAGR incl. nemolizumab Injectable Aesthetics 'Low to mid-teens 10 ' CAGR Dermatological Skincare 'High single- to low-teens 10 ' CAGR Therapeutic Dermatology 'High-teens 10 ' CAGR incl. nemolizumab Profitability Core EBITDA margin Incl. nemolizumab +300 – 500bps Core EBITDA margin expansion (vs. 2023) by 2027E majority of which delivered in 2026 and 2027 Nemluvio Peak sales (beyond the mid-term period guidance horizon) >2 B USD peak sales Appendix 8: Additional modeling metrics 2024 actuals 2025 Mid-term Non-core adjustments 11 93 M USD ~50 M USD Effective tax rate 12 25.5% 20 - 25% ~20% Core CAPEX 3.3% 3 - 4% of net sales Low to mid-single digit as % of net sales Leverage 2.3x Targeting <2x for the mid-term Net financial expenses 13 328 M USD ~210 - 220 M USD Milestone and earnout payments 176 M USD ~25 M USD Dividends 14 ~17% Ordinary dividend pay-out target of up to 20% Notes and references Constant currency year-on-year growth is defined as the annual growth rate of net sales excluding the impact of exchange rates movements and excluding hyperinflation economies. The impact of changes in foreign exchange rates are excluded by translating all reported revenues during the two periods at average exchange rates in effect during the previous year. Core EBITDA is defined as EBITDA excluding the following items that are deemed exceptional, including acquisition and disposal, integration and carve-out related income and expenses, onerous contracts, business disposal gains and losses, restructuring and reorganization related items, litigation related items, impairment of PPE and software, IPO related incentive plans as well as other income and expense items that management deems exceptional and that are expected to accumulate within the year to be over 1 M USD threshold. These include transformation, carve-out and build-up related project costs as well as post-acquisition related accounting impacts Leverage is defined as Total Net Indebtedness divided by Core EBITDA on a twelve-months rolling basis Single training contact points, one healthcare professional can be trained more than once Dividend-bearing shares are all shares issued except for treasury shares held by Galderma Group AG or its direct or indirect fully owned subsidiaries as of the record date. The dividend will be paid in CHF. The distribution of 0.15 CHF per share is subject to the overall cap of 49.5 million USD converted into CHF two business days prior to the Annual General Meeting divided by the number of outstanding shares. Provided that the proposed dividend payment out of reserves from capital contributions is approved, the payment will be made as of April 29, 2025 to holders of shares on the record date April 28, 2025. The shares will be traded ex-dividend as of April 25, 2025 and, accordingly, the last day on which the shares may be traded with entitlement to receive the dividend will be April 24, 2025. 2023 adjustments include 27 M USD for platform transformation costs, 28 M USD for VCB bonus, 24 M USD litigation and onerous items, 3 M USD for IPO and M&A, 31 M USD for operating FX, 18 M USD on Impairment and Restructuring and Others. 2024 adjustments include 48 M USD for IPO related incentive plans, 4 M USD for VCB bonus, 12 M USD litigation, 9 M USD restructuring, 8 M USD for platform transformation costs, 6 M USD for IPO, 4 M USD for operating FX. Core Net Income is defined as net income / (loss) from continuing operations adjusted for the same items that are treated as exceptional for purposes of defining Core EBITDA, as well as amortization of intangible assets, foreign exchange gains and losses on financing activities. Taxes on the adjustments between IFRS net income and Core Net Income take into account, for each individual item included in the adjustment, the tax rate that will finally be applicable to the item based on the jurisdiction where the adjustment will finally have a tax impact Core EPS is calculated as Core net income divided by the weighted average number of outstanding shares Indebtedness includes financial debt and lease liabilities 'Teens' defined as numbers greater than 10% and lower than 20% Includes assumptions for other income and expenses related to tangible asset impairments, ongoing litigation and onerous items, restructuring charges and others, excluding M&A fees On reported profit before tax Includes interest income and interest expense, excluding FX impact Of reported net income based on prior year results, subject to Board and AGM approval Forward-looking statements Certain statements in this announcement are forward-looking statements. Forward-looking statements are statements that are not historical facts and may be identified by words such as 'plans', 'targets', 'aims', " believes', 'expects', 'anticipates', 'intends', 'estimates', 'will', 'may', 'continues', 'should' and similar expressions. These forward-looking statements reflect, at the time, Galderma's beliefs, intentions and current targets/ aims concerning, among other things, Galderma's results of operations, financial condition, industry, liquidity, prospects, growth and strategies and are subject to change. The estimated financial information is based on management's current expectations and is subject to change. By their nature, forward-looking statements involve a number of risks, uncertainties and assumptions that could cause actual results or events to differ materially from those expressed or implied by the forward-looking statements. These risks, uncertainties and assumptions could adversely affect the outcome and financial consequences of the plans and events described herein. Actual results may differ from those set forth in the forward-looking statements as a result of various factors (including, but not limited to, future global economic conditions, changed market conditions, intense competition in the markets in which Galderma operates, costs of compliance with applicable laws, regulations and standards, diverse political, legal, economic and other conditions affecting Galderma's markets, and other factors beyond the control of Galderma). Neither Galderma nor any of their respective shareholders (as applicable), directors, officers, employees, advisors, or any other person is under any obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise. You should not place undue reliance on forward-looking statements, which speak of the date of this announcement. Statements contained in this announcement regarding past trends or events should not be taken as a representation that such trends or events will continue in the future. Some of the information presented herein is based on statements by third parties, and no representation or warranty, express or implied, is made as to, and no reliance should be placed on, the fairness, reasonableness, accuracy, completeness or correctness of this information or any other information or opinions contained herein, for any purpose whatsoever. Except as required by applicable law, Galderma has no intention or obligation to update, keep updated or revise this announcement or any parts thereof. View source version on CONTACT: Media Christian Marcoux, Chief Communications Officer [email protected] +41 76 315 26 50Sébastien Cros Corporate Communications Director [email protected] +41 79 529 59 85Investors Emil Ivanov Head of Strategy, Investor Relations and ESG [email protected] +41 21 642 78 12Jessica Cohen Investor Relations and Strategy Director [email protected] +41 21 642 76 43 KEYWORD: SWITZERLAND EUROPE INDUSTRY KEYWORD: OTHER HEALTH HEALTH COSMETICS RETAIL PHARMACEUTICAL SOURCE: Galderma Group AG Copyright Business Wire 2025. PUB: 03/06/2025 01:00 AM/DISC: 03/06/2025 01:00 AM
Yahoo
14-02-2025
- Health
- Yahoo
Galderma's Nemluvio® (Nemolizumab) Approved in the European Union for Moderate-to-Severe Atopic Dermatitis and Prurigo Nodularis
Ad hoc announcement pursuant to Art. 53 LR This approval from the European Commission is based on robust results from the phase III OLYMPIA and ARCADIA clinical trial programs, showing that Nemluvio has the potential to address the significant unmet needs of patients with atopic dermatitis and prurigo nodularis1-3 There is a need for new treatment options for atopic dermatitis and prurigo nodularis to effectively relieve the signs and symptoms such as persistent itch, skin lesions and poor sleep quality4-8 Nemluvio is the first approved monoclonal antibody that specifically targets IL-31 receptor alpha, inhibiting the signaling of IL-31, which drives itch and is involved in inflammation and skin barrier dysfunction in both atopic dermatitis and prurigo nodularis, and fibrosis in prurigo nodularis5,8-10 Nemluvio is the first monoclonal antibody in Galderma's portfolio of innovative, science-based products, which span the full spectrum of the fast-growing dermatology market ZUG, Switzerland, February 14, 2025--(BUSINESS WIRE)--Galderma (SWX:GALD) today announced that the European Commission has approved Nemluvio for both moderate-to-severe atopic dermatitis and prurigo nodularis in the European Union (EU). Nemluvio is now approved for subcutaneous use for the treatment of moderate-to-severe atopic dermatitis in patients aged 12 years and older who are candidates for systemic therapy, and for subcutaneous use for the treatment of adults with moderate-to-severe prurigo nodularis who are candidates for systemic therapy.11 "Throughout Galderma's four decades in dermatology we have consistently worked to meet the needs of patients and deliver first-in-class treatment options. This has been exemplified through the clinical and regulatory success achieved with our unique monoclonal antibody, Nemluvio. As the first biologic treatment in our Therapeutic Dermatology portfolio, Nemluvio shows our commitment to advancing dermatology by expanding into new areas of need."FLEMMING ØRNSKOV, M.D., MPHCHIEF EXECUTIVE OFFICERGALDERMA Nemluvio is the first approved monoclonal antibody that specifically targets IL-31 receptor alpha, inhibiting the signaling of IL-31.9 IL-31 is a neuroimmune cytokine that drives itch and is involved in inflammation and skin barrier dysfunction in both atopic dermatitis and prurigo nodularis, and fibrosis in prurigo nodularis.5,8-10 It is also the first and only biologic approved for atopic dermatitis and prurigo nodularis with four-week dosing intervals from the start of treatment.11 This approval is based on results from the phase III ARCADIA and OLYMPIA clinical trial programs, in which Nemluvio significantly improved itch, skin lesions and sleep disturbance, in patients with moderate-to-severe atopic dermatitis and adults with prurigo nodularis, respectively.1-3 Results from the ARCADIA 1 and ARCADIA 2 trials demonstrated that patients treated with Nemluvio, administered subcutaneously every four weeks in combination with background topical corticosteroids, with or without topical calcineurin inhibitors (+TCS/TCI), showed statistically significant improvements on skin clearance in both co-primary endpoints at Week 16, when compared to placebo +TCS/TCI.1 The trials also met all key secondary endpoints, confirming significant responses on itch as early as Week 1 and statistically significant improvements in sleep disturbance.1 Both co-primary endpoints were also met in the OLYMPIA 1 and OLYMPIA 2 clinical trials, where Nemluvio monotherapy demonstrated significant and clinically meaningful improvements on itch and skin lesions at Week 16, when compared to placebo.2,3 The trials met all key secondary endpoints, showing rapid reduction in itch due to prurigo nodularis and sleep disturbance within four weeks of treatment initiation.2,3 Nemluvio was well tolerated in all trials, and its safety profile was generally consistent with earlier data, and between trials.1-3 "Atopic dermatitis and prurigo nodularis can severely impact quality of life due to the associated debilitating symptoms, including chronic itch, skin lesions, poor sleep quality and mental health conditions. With this approval, patients in the EU have a new treatment option, which extensive data has shown can help to safely, quickly, and effectively ease the key symptoms of these diseases and therefore the burden on patients' lives."PROFESSOR DIAMANT THAÇILEAD INVESTIGATOR OF THE ARCADIA STUDIES IN EUROPEUNIVERSITY OF LUBECK, GERMANY "Nemolizumab's benefits have been demonstrated in its comprehensive clinical trial programs in both atopic dermatitis and prurigo nodularis, including the OLYMPIA 1 and 2 studies, which make up the largest completed pivotal program in prurigo nodularis to date. These clinical data, plus its first-in-class mechanism of action and convenient dosing schedule, make it an important new therapeutic solution for dermatologists to support their patients."PROF. SONJA STÄNDERLEAD INVESTIGATOR OF THE OLYMPIA STUDIES IN EUROPEUNIVERSITY HOSPITAL MÜNSTER, GERMANY Nemluvio is also approved by the U.S. Food and Drug Administration for the treatment of atopic dermatitis and prurigo nodularis.12 It is under review for the treatment of both diseases by several additional regulatory authorities around the world, including Canada, Brazil, and South Korea, and via the Access Consortium framework in countries such as Australia, Singapore and Switzerland. Further submissions to other regulatory authorities are ongoing. As previously communicated, peak sales of Nemluvio are expected to reach more than 2 billion USD (expected beyond the 2023-2027 mid-term guidance period). Galderma anticipates Nemluvio to approach 'blockbuster' net sales run-rate by the end of 2027. Media can find more information about atopic dermatitis and prurigo nodularis here. About Nemluvio Nemluvio was initially developed by Chugai Pharmaceutical Co., Ltd. In 2016, Galderma obtained exclusive rights to the development and marketing of nemolizumab worldwide, except in Japan and Taiwan. In Japan, nemolizumab is marketed as Mitchga® and is approved for the treatment of prurigo nodularis, as well as pruritus associated with atopic dermatitis in pediatric, adolescent, and adult patients.13,14 About the ARCADIA clinical trial program1,15,16 The ARCADIA program included two identically designed, pivotal phase III clinical trials, which enrolled more than 1,700 patients – ARCADIA 1 and ARCADIA 2. These global, randomized, multicenter, double-blind, placebo-controlled phase III clinical trials evaluated the efficacy and safety of nemolizumab administered subcutaneously every four weeks compared to placebo (both administered with background topical corticosteroids with or without topical calcineurin inhibitors). The trials were conducted in adolescent and adult patients (12 years and over) with moderate-to-severe atopic dermatitis for an initial treatment phase of 16 weeks. Patients who responded to treatment (defined as patients who achieved an investigator's global assessment score of clear (0) or almost clear (1), or a 75% or greater improvement in the eczema area and severity index score) were then re-randomized to a maintenance treatment phase for up to 48 weeks. About atopic dermatitis Atopic dermatitis is a common, chronic, and flaring inflammatory skin disease, characterized by persistent itch and recurrent skin lesions.5,17,18 It is the most common inflammatory skin disease, impacting almost four times more people than psoriasis.5,19 It affects approximately 10 to 40 million people in the European Union, with up to 66% of adults suffering with a moderate-to-severe form of the condition.20,21 While currently available treatments may improve some signs and symptoms of the disease, many patients do not respond optimally to approved therapies and do not experience itch relief and clear skin to the same degree.5-8 About the OLYMPIA clinical trial program2,3,22,23 The OLYMPIA program included two identically designed, pivotal phase III clinical trials which enrolled 560 patients – OLYMPIA 1 and OLYMPIA 2. This is the largest clinical trial program conducted in prurigo nodularis to date, and the only program to include a long-term extension study. These global, randomized, double-blind, placebo-controlled phase III clinical trials assessed the efficacy and safety of nemolizumab monotherapy compared with placebo in patients at least 18 years of age with moderate-to-severe prurigo nodularis over a 16- or 24-week treatment period for OLYMPIA 2 and OLYMPIA 1, respectively. About prurigo nodularis Prurigo nodularis is a chronic, debilitating, and distinct neuroimmune skin disease characterized by the presence of intense itch and thick skin nodules covering large body areas.24-26 It is estimated to affect between 7-111 people per 100,000 in the European Union depending on the country.27,28 The majority of patients report that the persistent itch negatively impacts their quality of life.29 Furthermore, the intense itch associated with prurigo nodularis results in significant sleep disturbance and further contributes to reduced quality of life.30,31 About Galderma Galderma (SIX: GALD) is the pure-play dermatology category leader, present in approximately 90 countries. We deliver an innovative, science-based portfolio of premium flagship brands and services that span the full spectrum of the fast-growing dermatology market through Injectable Aesthetics, Dermatological Skincare and Therapeutic Dermatology. Since our foundation in 1981, we have dedicated our focus and passion to the human body's largest organ – the skin – meeting individual consumer and patient needs with superior outcomes in partnership with healthcare professionals. Because we understand that the skin we are in shapes our lives, we are advancing dermatology for every skin story. For more information: References Silverberg J, et al. Nemolizumab with concomitant topical therapy in adolescents and adults with moderate-to-severe atopic dermatitis (ARCADIA 1 & 2): results from two replicate double-blinded, randomised controlled phase 3 trials. Lancet. 2024;404(10451):445-460. doi: 10.1016/S0140-6736(24)01203-0 Kwatra SG, et al. Placebo-controlled phase III trial of nemolizumab in patients with prurigo nodularis. N Engl J Med. 2023;389:1579-89. doi: 10.1056/NEJMoa2301333 Ständer S, et al. Nemolizumab in Patients with Moderate-to-Severe Prurigo Nodularis: A Randomized Controlled Phase 3 Trial. JAMA Derm. 2024;160. doi: 10.1001/jamadermatol.2024.4796 Chisolm SS. A Review of the Current Management and Burden of Prurigo Nodularis in the United States. AJMC. 2023; 2023;29(suppl 5):S63-S72. Langan SM, et al. Atopic dermatitis [published correction appears in Lancet. 2020;396(10253):758]. Lancet. 2020;396(10247):345-360. doi:10.1016/S0140- 6736(20)31286-1 Lobefaro F, et al. Atopic Dermatitis: Clinical Aspects and Unmet Needs. Biomedicines. 2022;10:2927. doi:10.3390/biomedicines10112927 Katoh N, Ohya Y, Ikeda M, et al. Clinical practice guidelines for the management of atopic dermatitis 2018. J Dermatol. 2019;46(12):1053-1101. doi:10.1111/1346-8138.15090 Kwatra SG, Misery L, Clibborn C, Steinhoff M. Molecular and cellular mechanisms of itch and pain in atopic dermatitis and implications for novel therapeutics. Clin Transl Immunology. 2022;11(5):e1390. doi:10.1002/cti2.1390 Silverberg JI, et al. Phase 2B randomized study of nemolizumab in adults with moderate-to-severe atopic dermatitis and severe pruritus. J Allergy Clin Immunol. 2020;145(1):173-182. doi:10.1016/ Bewley A, et al. Prurigo Nodularis: A Review of IL-31RA Blockade and Other Potential Treatments. Dermatol Ther (Heidelb). 2022;12(9):2039–2048. doi:10.1007/s13555- 022-00782-2 Nemluvio. EU Summary of Product Characteristics 2025 NEMLUVIO (nemolizumab-ilto) injection 30 mg Prescribing Information. Dallas, TX: Galderma Laboratories, L.P.; August 2024 Chugai Pharmaceutical Co., Ltd. Maruho Obtained Regulatory Approval for Mitchga, the first Antibody Targeting IL-31 for Itching Associated with Atopic Dermatitis. Available online. Accessed February 2025 Chugai Pharmaceutical Co., Ltd. Mitchga Approved for Itching in Pediatric Atopic Dermatitis and Prurigo Nodularis, for its Subcutaneous Injection 30mg Vials. Available online. Accessed February 2025 Efficacy & Safety of Nemolizumab in Subjects With Moderate- to-Severe Atopic Dermatitis (NCT03985943). Available online. Accessed February 2025 Efficacy & Safety of Nemolizumab in Subjects With Moderate- to-Severe Atopic Dermatitis (NCT03989349). Available online. Accessed February 2025 Yang G, et al. Skin Barrier Abnormalities and Immune Dysfunction in Atopic Dermatitis. Int J Mol Sci. 2020;21(8):2867. doi: Ständer S. Atopic dermatitis. N Engl J Med. 2021;384(12):1136-1143. doi:10.1056/NEJMra2023911 Raharja A, et al. Psoriasis: a brief overview. Clin Med (Lond). 2021;21(3):170-173. doi: 10.7861/clinmed.2021-0257 Luger, T, et al. Clinical and Humanistic Burden of Atopic Dermatitis in Europe: Analyses of the National Health and Wellness Survey. Dermatol Ther (Heidelb). 2022;12:949–969. Oisín S, et al. 545 - Prevalence of moderate and severe atopic dermatitis in Ireland: a cross-sectional, real-world study of a secondary care population. BJD. 2024;190(S2):ii43–ii44. An Efficacy and Safety Study of Nemolizumab (CD14152) in Participants With Prurigo Nodularis (NCT04501679). Available online. Accessed February 2025 Study to Assess the Efficacy and Safety of Nemolizumab (CD14152) in Participants With Prurigo Nodularis (PN) (NCT04501666). Available online. Accessed February 2025 Huang AH, et al. Prurigo nodularis: epidemiology and clinical features. J Am Acad Dermatol. 2020;83(6):1559-1565. doi:10.1016/ Pereira MP, et al. European Academy of Dermatology and Venereology European prurigo project: expert consensus on the definition, classification and terminology of chronic prurigo. J Eur Acad Dermatol Venereol. 2018;32(7):1059-1065. doi:10.1111/jdv.14570 Ständer S, et al. IFSI-guideline on chronic prurigo including prurigo nodularis. Itch. 2020;5(4):e42. doi:10.1097/itx.0000000000000042 Ryczek A, et al. Prevalence of Prurigo Nodularis in Poland. Acta Derm Venereol. 2020;100:adv00155. doi: 10.2340/00015555-3518 Ständer, S, et al. Epidemiology of Prurigo Nodularis compared with Psoriasis in Germany: A Claims Database Analysis. Acta Dermato-Venereologica. 2020;100(18):1–6. Todberg T, et al. Treatment and burden of disease in a cohort of patients with prurigo nodularis: a survey-based study. Acta Derm Venereol. 2020;100(8):adv00119. doi:10.2340/00015555-3471 Joel MZ, et al. Risk of itch-induced sleep deprivation and subsequent mental health comorbidities in patients with prurigo nodularis: A population-level analysis using the Health Improvement Network. E-poster presented at EADV 2023. Abstract available online Kwatra SG. Breaking the itch–scratch cycle in prurigo nodularis. N Engl J Med. 2020;382(8):757-758. doi:10.1056/NEJMe1916733 View source version on Contacts For further information: Christian Marcoux, Communications +41 76 315 26 50 Sébastien CrosCorporate Communications +41 79 529 59 85 Emil IvanovHead of Strategy, Investor Relations, and +41 21 642 78 12 Jessica CohenInvestor Relations and Strategy +41 21 642 76 43 Sign in to access your portfolio