ZUG, Switzerland--(뉴스와이어) 2023년 03월 13일 -- Galderma:
Galderma delivered strong performance
· Galderma delivered at the top end of its 2022 revenue guidance with 13.9% year-on-year net sales growth on a constant currency basis at 3,760 M USD and delivered above its 2022 profitability guidance with 14.5% Core EBITDA year-on-year growth on a constant currency basis at 791 M USD
- Sustained growth momentum fueled by continued strong performance in Injectable Aesthetics and Dermatological Skincare with year-on-year net sales growth of 22.3% and 30.7% respectively, on a constant currency basis, primarily driven by volume growth
- Topline growth and margin expansion demonstrate continued strong operating and commercial performance despite a challenging external environment
Significant progress in advancing the R&D pipeline with notable milestones for differentiated biologic entries expected to fuel significant long-term sustainable growth
· Galderma completed three phase III clinical trials studying nemolizumab, a first-in-class investigational monoclonal antibody directed against the IL-31 receptor alpha with a central role in pruritus (itch) and skin inflammation, in the treatment of prurigo nodularis and atopic dermatitis
· Galderma presented positive data from two phase III studies on RelabotulinumtoxinA (QM-1114), a novel liquid formulation botulinumtoxinA for the treatment of glabellar lines (frown) and lateral canthal lines (crow’s feet). As already announced, both studies met their primary endpoints and the results showed both rapid onset of action and long duration of action through to six months
Net sales growth and significant Core EBITDA margin expansion expected in 2023
· In 2023, Galderma expects to deliver 6-9% net sales growth on a constant currency basis, and 200-300 bps Core EBITDA margin expansion (vs 2022). The 2023 Core EBITDA margin expansion guidance includes significant nemolizumab costs
“This has been a year of strong performance for Galderma. We have delivered against our full-year guidance and continued our upward growth trajectory against a backdrop of turbulent macro-economic conditions. We are delivering on our ambition of category leadership in dermatology, through our focus on commercial execution, portfolio and geographic expansion, our innovation pipeline and new product launches. I am pleased with our positive pipeline developments including RelabotulinumtoxinA, our novel liquid formulation botulinum toxin A, and nemolizumab, for the treatment of prurigo nodularis and atopic dermatitis. We look forward to continuing to deliver leading products to address the unmet needs of customers across the globe.”
FLEMMING ØRNSKOV, M.D., MPH
CHIEF EXECUTIVE OFFICER
Financial and commercial update
With its premiumization strategy, Galderma is well positioned to capitalize on growing demand in its attractive, high growth consumer-driven markets. The growing and resilient nature of the dermatology market is underpinned by positive long-term trends and has shown to be recession-proof during periods of macro-economic and geopolitical turbulence.
In 2022, growth was driven by Injectable Aesthetics and Dermatological Skincare, with both product categories outperforming the market with double-digit growth, primarily driven by volume. This demonstrates the continued consumer demand for science-based, premium products in dermatology.
· Injectable Aesthetics outperformed the market with double digit net sales growth and market share gains across the portfolio. Galderma’s net sales in Injectable Aesthetics grew by 22.3% year-on-year on a constant currency basis, driven by strong demand for neuromodulators and the launch of next generation neuromodulator Alluzience in Europe
· Dermatological Skincare strongly outperformed the market, with net sales growth of 30.7% year-on-year on a constant currency basis (year-on-year growth on a constant currency basis of Dermatological Skincare excluding Alastin, consolidated as of FY 2022: +21.3%), fueled by increased consumer demand, new launches, channel expansion and particularly robust e-commerce performance
· Therapeutic Dermatology, Galderma’s smallest product category by net sales, experienced a year-on-year net sales decline as Galderma navigated the anticipated annualization of Epiduo Forte and Soolantra loss of exclusivity in the U.S., increased patient access rebates, and greater competition, with the profit impact partially offset by royalties from authorized generics. This product category continued growing in Asia and Latin America
From a geographical perspective, Galderma’s larger region, International, grew 20.2% year-on-year on a constant currency basis, with particularly strong performance in fast growing markets, such as in China, India, Brazil, Mexico, and the Philippines, with robust growth across all product categories. U.S. grew 6.8% year-on-year on a constant currency basis (+15.2% excluding the impact of loss of exclusivity in Therapeutic Dermatology) primarily driven by volume growth in Injectable Aesthetics and Dermatological Skincare.
Galderma delivered at the top end of its 2022 revenue guidance with 13.9% net sales year-on-year growth on a constant currency basis and exceeded its 2022 profitability guidance, delivering 14.5% Core EBITDA year-on-year growth on a constant currency basis, driven by sales growth, savings from the end-to-end transformation program and cost discipline despite the challenging inflationary environment. Galderma’s ongoing transformation program is delivering a leaner, fit-for-purpose and efficient corporate platform through optimized processes, upgraded systems and tools. In January 2023, Galderma announced the opening of a new Global Capability Center in Spain to centralize its commercial and certain support functions in a cost-efficient manner, which aims to create c.50 jobs in Barcelona in 2023.
Galderma is expanding its manufacturing footprint in response to growing global demand of its products. In October 2022, the Company announced its intention to expand its manufacturing and innovation footprint in the Asia-Pacific region, with support from the Singapore Economic Development Board. In addition, Galderma announced expansion with a new production site in Uppsala, Sweden to meet increasing global demand for its Injectable Aesthetic products.
ESG remains a core focus for Galderma, and it made further significant progress on developing its ESG profile during 2022, with its leadership in ESG emphasized by a reputable external ESG assessment, ranking it among the leading companies in its category.
Continued pipeline momentum and product launches
Throughout 2022, Galderma has continued its investment in scientific innovation. Galderma continues to demonstrate its best-in-class innovation capabilities: inventing, developing and bringing to market innovative dermatological solutions for consumers, patients, and healthcare professionals.
In Therapeutic Dermatology, Galderma celebrated many important achievements - most notably, the completion of three out of four phase III clinical trials studying nemolizumab in the treatment of prurigo nodularis and atopic dermatitis. The results of Galderma’s phase III nemolizumab programs show that nemolizumab, a first-in-class investigational monoclonal antibody directed against the IL-31 receptor alpha with a central role in pruritus (itch) and skin inflammation, has the potential to respond to significant unmet needs of patients with prurigo nodularis and atopic dermatitis.
Prurigo nodularis update
In June 2022, Galderma announced positive data from OLYMPIA 2, the first of two phase III trials, confirming the potential of nemolizumab as monotherapy in prurigo nodularis which was reconfirmed as Breakthrough Therapy by the U.S. Food and Drug Administration (FDA). Patients treated with nemolizumab monotherapy (without background topical corticosteroids or topical calcineurin inhibitors) showed clinically and statistically significant improvement in both primary endpoints of skin lesions and pruritus compared to placebo after 16 weeks of treatment. The trial also met all key secondary endpoints and confirmed early onset of action on itch, skin lesions and sleep disturbance. Nemolizumab demonstrated a favorable benefit-risk balance in this trial.
Galderma is on track to receive the results from its second clinical trial in prurigo nodularis, OLYMPIA 1 and plans to launch in the U.S. in H2 2024.
Atopic dermatitis update
Galderma also recently completed its ARCADIA program, which included two identical, pivotal phase III clinical trials and more than 1,700 patients. The trials evaluated the efficacy and safety of nemolizumab administered subcutaneously every four weeks, compared to placebo, in adolescent and adult patients with moderate to severe atopic dermatitis.
The two-phase III ARCADIA trials met all co-primary endpoints and key secondary endpoints, confirming nemolizumab, in combination with background topical therapy, improved skin lesions, pruritus and sleep disturbance.
Galderma is planning to present the results from these two trials to the scientific community at a congress later in 2023 and is on track to launch in the U.S. in H2 2024.
Acne and rosacea update
In the U.S., Galderma launched Twyneo®, the first and only tretinoin and benzoyl peroxide combination proven to treat moderate-to-severe acne and Epsolay®, the first and only microencapsulated benzoyl peroxide topical treatment proven to relieve the bumps and blemishes of rosacea.
The effectiveness of Galderma’s acne treatments is further demonstrated by sales data from IQVIA. The data, which is based on OTC and prescription treatment sales across 75 countries around the world, confirmed that Galderma’s range of anti-acne products is the number one choice globally. Galderma’s portfolio includes Differin®, Epiduo® Forte, Aklief®, Twyneo®, Actinica® and Benzac®.
Data from the READY-1 and READY-2 phase III studies of RelabotulinumtoxinA (QM-1114) for the treatment of glabellar lines (frown) and lateral canthal lines (crow‘s feet) demonstrated high patient satisfaction and psychological well-being, in addition to previously reported safety and efficacy. Both studies met their primary endpoints, with significantly higher response than placebo after one month for both frown lines and crow’s feet.
· Results showed rapid onset of action, with 39% patients seeing results on Day 1 for frown lines and 34% on Day 1 for crow's feet
· Results also demonstrated long duration of action through to six months
· Treatment was well tolerated, with all treatment-related adverse events mild-to-moderate and non-serious
In October, Galderma announced a new pivotal study with data demonstrating the safety and effectiveness of Sculptra®, the only U.S. FDA-approved PLLA biostimulator, in the correction of cheek wrinkles, an investigational indication.
· The data from its phase III randomized, controlled pivotal study showed long-lasting efficacy out to month 12, with a Galderma Cheek Wrinkle Scales (GCWS at rest) responder rate of 71.6% and improved skin radiance, tightness, and jawline contour (≥ 86%)
· The treatment was considered safe and well tolerated in the study, with mostly mild and transient related adverse events resolving within two weeks
As highlighted at its H1 results in August 2022, Galderma also saw the launch of the neuromodulator, Alluzience®, in certain European countries as the first ready-to-use liquid form of botulinum toxin type A. In addition, Galderma presented phase IV data confirming the effectiveness and natural-looking effects with the Restylane® range of hyaluronic acid fillers, with all patients achieving the aim of their treatment, whether projection or contouring/volumization, with results that were natural-looking with high subject satisfaction.
In 2022, Galderma demonstrated renewed commitment to innovation for consumers with sensitive skin. Galderma’s leading dermatologist-recommended brand, Cetaphil®, marked its 75th anniversary in 2022. Galderma’s latest initiatives, including its We Do Skin. You Do You campaign, aims to establish a new standard in clinical skincare testing to shift the dynamic of the industry, ensuring it is more representative of diverse skin tones. In addition, Galderma completed the rollout of the Cetaphil® Optimal Hydration range in Asia, comprising three new products powered by hyaluronic acid and exclusive HydroSensitivComplex to hydrate and improve sensitive skin.
Following the successful acquisition of Alastin Skincare in January 2022, Galderma has launched further products including most recently, A-LUMINATE BRIGHTENING SERUM®, designed to help reduce the appearance of surface hyperpigmentation without any harsh, irritating ingredients. ALASTIN’s proprietary PATH-3 Technology helps to minimize the recurrence of surface pigmentation and protect against future damage with continued use.
Galderma formed a global Sensitive Skincare Faculty in partnership with the Department of Dermatology at the George Washington University School of Medicine and Health Sciences. The faculty comprises 13 experts from across the world, representing diverse geographies. So far, two grants have been awarded to help people with sensitive skin live better lives.
Notes and references:
 Galderma reports revenue by two geographies: U.S. and International
 Nikolis A et al. Oral Presentation #114864 to be presented at IMCAS 2022.
Galderma 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 though 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. Galderma’s portfolio of flagship brands includes Restylane, Dysport, Azzalure, Alluzience and Sculptra in Injectable Aesthetics; Soolantra, Epiduo, Differin, Aklief, Epsolay, Twyneo, Oracea, Metvix, Benzac and Loceryl in Therapeutic Dermatology; and Cetaphil and Alastin in Dermatological Skincare. For more information: www.galderma.com.
Certain statements in this announcement are forward-looking statements, including 2023 financial targets. 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 the Galderma’s markets, and other factors beyond the control of Galderma). Neither Galderma nor its shareholders, 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.
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