Galderma:

• Galderma achieved net sales of 3,009 M USD over the first nine months of 2023, up 8.9% year-on-year on a constant currency basis
• Continued pipeline progress with new milestones reached for nemolizumab and RelabotulinumtoxinA
• Galderma is on track to deliver at the upper end of its 2023 net sales guidance of 6-9% constant currency growth, and is in line with its profitability guidance of 200-300 bps core EBITDA margin expansion versus 2022

“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

CHIEF EXECUTIVE OFFICER

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.

Injectable Aesthetics

Despite the high 2022 comparative base, net sales in Injectable Aesthetics saw single-digit growth year-on-year over the first nine months of 2023 on a constant currency basis. While Galderma continued to gain market share across its full Injectable Aesthetics portfolio, Neuromodulators and Biostimulators continued to grow double-digits, more than offsetting the softness in the filler market in some countries. Galderma continues to outpace the market with its leading services, such as its industry-leading healthcare professional education and FACE by Galderma™, a game-changing augmented reality solution launched earlier this year.

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 proceeding 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.

Dermatological Skincare

In Dermatological Skincare, Galderma experienced double-digit net sales growth year-on-year over the first nine months of 2023 on a constant currency basis. Growth, which was ahead of the market, was driven by its two flagship brands Cetaphil and Alastin Skincare.

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.

Therapeutic Dermatology

Continued momentum in Therapeutic Dermatology delivered high single-digit net sales growth year-on-year over the first nine months of 2023 on a constant currency basis, driven by successful yield improvement measures in the U.S., boosting key brands including Differin, Soolantra and Aklief, and continued growth in international markets.

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.

About Galderma

Galderma is the emerging 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 Skincare^® in Dermatological Skincare. For more information: www.galderma.com.

Notes and references:

1. Galderma reports revenue by two geographies: U.S. and International

2. Silverberg J, et al. Nemolizumab improves skin lesions, itch and sleep disturbance in patients with moderate-to-severe atopic dermatitis: Results from two identical phase 3 multinational studies (ARCADIA 1 and ARCADIA 2). Late-breaking abstract presented at EADV 2023.

3. Stander S, et al. Nemolizumab monotherapy improves itch and skin lesions in patients with moderate-to-severe prurigo nodularis: Results from a global phase 3 trial (OLYMPIA 1). Late-breaking abstract presented at EADV 2023.

4. Kwatra SG, et al. Phase 3 trial of nemolizumab in patients with prurigo nodularis. NEJM. 2023; 389: 1579-89. DOI: 10.1056/NEJMoa2301333

5. Galderma. START Topline results. Presented at WCD 2023

Forward-looking statements

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.

View source version on businesswire.com: https://www.businesswire.com/news/home/20231120510393/en/