Galderma Reports Record Net Sales of Over 3 B USD for the First Nine Months of 2023 With Strong Growth Momentum Across All Product Categories
"We are very pleased with our strong performance, having continued to drive growth and outpace the market, leveraging our truly differentiated integrated dermatology strategy. Galderma has the largest dermatology portfolio in our industry, and innovation remains at the forefront of our priorities to build the leading dermatology platform in the world, with notable updates for the quarter in liquid neuromodulators, the expansion of Alastin Skincare and positive phase III trial results for nemolizumab."
FLEMMING ØRNSKOV, M.D., MPH
Strong commercial performance and innovation across all product categories
Maintaining the growth momentum of H1 2023, Galderma achieved an increase in net sales of 8.9% year-on-year to 3,009 M USD on a constant currency basis in the first nine months of 2023. For the period, net sales growth was strong across all product categories, with balanced contributions across volume, pricing and brand mix.
Internationally, there was particularly strong growth momentum across product categories in fast growing Asian and Latin American markets, including China, India, and Mexico. In the U.S., performance was strong for the quarter, with H1 growth having been impacted by a high comparative base in 2022 for Injectable Aesthetics. Nonetheless, Galderma continued to gain market share in Injectable Aesthetics in the region and took the leading position for fillers and biostimulators combined.1
Reflecting Galderma's consistent performance and progress on deleveraging the business, having fully utilized the proceeds from the private placement of over 1 B USD, all three major rating agencies upgraded Galderma's credit rating.
Based on the strong performance so far, Galderma is on track to deliver at the upper end of its 6-9% net sales constant currency growth range. As for profitability, Galderma confirms its full year guidance of 200-300 bps core EBITDA margin expansion versus 2022.
Galderma continued to showcase its commitment to bringing differentiated products to the market. In 2023, this includes a new indication for Sculptra for the correction of fine lines and wrinkles in the cheek area in the U.S., Restylane Eyelight for undereye hollows in the U.S., multiple Restylane indication introductions in China, and notable progress in advancing Galderma's neuromodulator pipeline. To mark the progress in treatment optimization, and building on its success in neuromodulators, Galderma hosted the first Liquid Live event in October. The event brought together over one hundred of Europe's leading aesthetics practitioners with presentations from renowned experts on key data, the latest market trends and insights to advance the future of neuromodulation in aesthetics. At Liquid Live, Galderma highlighted its plans to launch Alluzience®, the first and only liquid ready-to-use neuromodulator in Europe with rapid onset and effects lasting for up to six months, in 13 new countries.
Galderma also announced progress with RelabotulinumtoxinA regulatory submissions. Following the Complete Response Letter issued by the U.S. Food and Drug Administration, Galderma has already identified changes to the manufacturing process to address feedback and will be sharing path toward resolution of the issues during an upcoming meeting with the agency scheduled in December 2023. Regulatory submissions in other territories are ongoing and remain on track.
On September 28, 2023, the International Chamber of Commerce (ICC) issued its award on the arbitration commenced by Galderma in 2021 regarding the regulatory filing strategy for RelabotulinumtoxinA. While the award is confidential, the result is that the applications submitted for regulatory review are proceeing according to the initial strategy and Galderma and Ipsen await further feedback from regulators.
Furthermore, in a press release issued earlier this year, Ipsen made statements about the purported termination of the Galderma-Ipsen Research and Development (R&D) partnership. Galderma contests those statements and has submitted a request for arbitration with the ICC.
Cetaphil, with a heritage of over 75 years of sensitive skincare leadership, continues to maintain good growth momentum and outpace the market. With especially strong performance in Asia and Latin America, Cetaphil growth was driven by successful e-commerce execution, distribution expansion, and innovation. Innovation in Cetaphil this year has included new product ranges, such as recently launched Healthy Renew, and new solutions, including Cetaphil's digital AI skin analysis tool.
Beyond the broad R&D investments behind Cetaphil, with over 875 clinical studies involving more than 37,000 subjects, Galderma enhanced its engagement on sensitive skin with healthcare professionals and consumers with the launch of Galderma's Sensitive Skincare Faculty. With the objective to raise awareness and develop relevant innovation for sensitive skin, Galderma has organized dedicated medical sessions in 2023, awareness campaigns and, most notably, the most extensive profiling of sensitive skin, covering 10,000 people across five continents.
In the first nine months, growth in Alastin remained robust. Performance was strong in the U.S. across all channels, supported by new innovations, such as ReSURFACE Skin Polish and C-RADICAL Defense Antioxidant serum. As for international expansion, following the successful launch of Alastin Mexico, Galderma announced its launch in the UK in the quarter, as well as direct distribution in Canada, where the product was previously distributed through a partner.
In Therapeutic Dermatology, Galderma had some important milestones in advancing its pipeline with nemolizumab. At the European Academy of Dermatology and Venerology (EADV), Galderma showcased positive data from three pivotal phase III trials for the treatment of atopic dermatitis (AD) and prurigo nodularis (PN) with nemolizumab. Results from the ARCADIA 1 and 2 trials showed that nemolizumab significantly improved skin lesions and itch in adolescent and adult patients with moderate to severe AD, compared to placebo (both administered with background topical corticosteroid therapy or topical calcineurin inhibitors).2 Data from the OLYMPIA 1 trial showed that nemolizumab, as a monotherapy, significantly improved itch and skin lesions in adult patients with moderate to severe PN, compared to placebo, bolstering evidence for nemolizumab's rapid onset of action on itch and reduction of skin lesions in patients with PN.3 In addition, the latest data from the phase III OLYMPIA 2 trial in patients with PN was published by the New England Journal of Medicine, adding to the publication of nemolizumab's phase IIB trial results in the same journal in 2020.4
Beyond nemolizumab, Galderma continued to bring new science and deliver positive data across its Therapeutic Dermatology portfolio. At EADV for example, Galderma presented new data on trifarotene (Aklief) from the phase IV START study showing statistically and clinically significant reduction in the risk of atrophic acne scarring, high patient satisfaction and patient compliance, and data from the phase IV LEAP study in post-inflammatory hyperpigmentation (PIH).5
Beyond the introduction of new products and further innovation, Galderma continued to demonstrate its commitment to dermatologists with notable presence at key industry congresses around the world, providing on-site clinical data presentations, symposia series and booth activities spanning the broadest product portfolio in dermatology across Injectable Aesthetics, Dermatological Skincare and Therapeutic Dermatology.
Notes and references:
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