Galderma Announces Record

Galderma Announces Record 2023 Net Sales of Over 4 B USD and Significant Core EBITDA Margin Expansion

ZUG, Switzerland -- (BUSINESS WIRE) --

Galderma:

Delivered against full year guidance for another consecutive year with strong financial performance

• Galderma achieved net sales      of 4.082 B USD, up 8.5% year-on-year on a constant currency basis¹      in FY 2023, at the higher end of its 6-9% net sales growth 2023 FY      guidance, and surpassed 4 B USD in net sales for the first time

• Positive momentum       across all product categories outperforming fast growing market segments,       with year-on-year net sales growth on a constant currency basis of 6.5%       in Injectable Aesthetics, 12.1% in Dermatological Skincare, and 8.7% in       Therapeutic Dermatology

• Core EBITDA for 2023 was 942      M USD, representing a 23.1% Core EBITDA margin, with 21.4% year-on-year      growth on a constant currency basis. Core EBITDA margin expansion was      significant, up 281 basis points versus prior year on a constant currency      basis in line with its 2023 FY guidance range

Continued commercial execution and pipeline advancements

• In Injectable Aesthetics,      Galderma continued to outpace the market with global share gains in      neuromodulators, fillers and biostimulators. The Company also announced      positive results from two phase IIIb trials investigating      RelabotulinumtoxinA (QM-1114), for the treatment of glabellar lines      (“frown lines”) and lateral canthal lines (“crow’s feet”)

• Dermatological Skincare      flagship brands, Cetaphil and Alastin, drove substantial growth ahead of      the market, with continued geographic and portfolio expansion including      the launch of Cetaphil Healthy Renew, Alastin ReSURFACE Skin Polish and      the C-RADICAL Defense Antioxidant Serum

• In Therapeutic Dermatology,      Galderma made progress to expand its leading portfolio and planned entry      into the fast-growing biologics sub-segment. The Company showcased      positive data from four phase III trials investigating the treatment of      atopic dermatitis and prurigo nodularis with nemolizumab, meeting all      primary and secondary endpoints across trials. On February 14, 2024,      Galderma announced regulatory filing acceptances for nemolizumab in      prurigo nodularis and atopic dermatitis in the U.S. and EU.

2024 guidance

• In 2024, Galderma expects to      deliver 7-10% net sales growth on a constant currency basis and a Core      EBITDA margin in line with 2023 at constant currency, despite      significantly increased investments in nemolizumab

Financial performance

In 2023, for a second year in a row, Galderma delivered at the higher end of its net sales guidance for FY 2023, with 8.5% year-on-year net sales growth on a constant currency basis to 4.082 B USD, driven by volume growth across all product categories and a positive product mix impact in Injectable Aesthetics, complemented with price gains.

• Injectable Aesthetics      delivered 6.5% year-on-year net sales growth on a constant currency basis      driven by double-digit growth in neuromodulators, which saw market share      gains across all key markets. Fillers and biostimulators gained market      share in International markets² and competed for #1 position in      the U.S. despite a soft filler market following normalization from a      post-COVID rebound, with especially strong growth from Sculptra^®.

• Dermatological Skincare      continued to outperform the market, with year-on-year net sales growth of      12.1% on a constant currency basis, driven by Cetaphil^® growth      momentum, with especially strong performance in Asia and Latin America, as      well as continued strong Alastin^® growth, leveraging synergies      with Injectable Aesthetics and supported by new launches.

• Therapeutic Dermatology      recorded net sales growth of 8.7% on a constant currency basis driven by      successful yield improvement measures in the U.S. boosting Differin^®,      Soolantra^® and Aklief^®, and growth in International      markets.

From a geographical perspective, International markets grew 12.3% year-on-year on a constant currency basis, driven by strong performance in China, India, Brazil, UK, and Mexico, with double-digit growth in Injectable Aesthetics and Dermatological Skincare, and mid-single-digit growth in Therapeutic Dermatology despite generic entries. U.S. net sales grew 4.2% year-on-year on a constant currency basis, with double-digit growth in the second half of the year following a high comparable base in Injectable Aesthetics in the first half.

Galderma delivered Core EBITDA of 942 M USD (23.1% margin), representing 21.4% year-on-year growth on a constant currency basis, and a Core EBITDA margin expansion of 202 basis points on a reported basis (281 basis points on a constant currency basis) in line with its guidance range of +200 to +300 basis points versus 2022. 2023 margin expansion was driven by gains from premiumization, structural cost savings, and operating expenses leverage, partially offset by nemolizumab investments.

On 26 June 2023, Galderma announced a private placement of approximately 1 B USD from a group consisting of current shareholders, new investors, as well as management. The proceeds have been used to strengthen the Company’s balance sheet and to further accelerate its organic growth.

In 2024, Galderma expects to deliver 7-10% net sales growth on a constant currency basis. Core EBITDA margin at constant currency is expected to be in line with 2023, despite an expected increase in the company’s investments in 2024 behind nemolizumab’s potential bolstered by its recently announced clinical differentiation and regulatory progress. Galderma expects its underlying profitability (excluding the impact of its investments in nemolizumab) to continue to expand in 2024 as it executes its proven integrated dermatology strategy.

Progressing on a proven integrated strategy and innovation pipeline

Injectable Aesthetics

In 2023, Galderma continued on its above-market growth trajectory, with market share gains in neuromodulators, fillers and biostimulators. The strong momentum is based on continued execution of Galderma’s three strategic pillars, expanding the broadest portfolio in Injectable Aesthetics with leading science and innovation, strengthening commercial execution, and offering market-leading education and services.

Some highlights from 2023 included increasing and deepening the relationship with healthcare professionals globally, with the expansion of the salesforce as well as scaling of the Galderma Aesthetics Injector Network (GAIN) providing leading medical trainings, and amplifying consumer reach through digital activation. The launch and global roll-out is ongoing for FACE by Galderma™, an exclusive augmented reality visualization consultation tool that simulates the results of injectable treatments real-time, as is the scaling of ASPIRE, Galderma’s loyalty program in the U.S for consumers and healthcare professionals. Galderma progressed on leading innovation across its portfolio, with key announcements outlined below.

In 2023, Galderma announced positive results from two phase IIIb trials investigating RelabotulinumtoxinA (QM-1114), for the treatment of frown lines and crow’s feet. Both studies met their primary endpoints, demonstrating significant improvements for both frown lines and crow’s feet, with a rapid onset of action as early as day one and a long duration beyond six months⁴. RelabotulinumtoxinA is a highly active, complex-free, and ready-to-use liquid botulinum toxin A with a proprietary strain and manufactured using a unique state-of-the-art process, with the opportunity to expand Galderma’s neuromodulator portfolio globally. Regulatory approval activities are ongoing for RelabotulinumtoxinA in the U.S., Europe and other markets.

In addition, in neuromodulators, Alluzience’s^® first phase IV study, STAR, showed rapid onset starting on day one, lasting effects up to six months, with 99% of subjects displaying aesthetic improvement at month one and 76% maintaining it up to month six³. At the first Liquid Live event in Dubai, Galderma highlighted its plans to launch Alluzience, the first and only liquid ready-to-use neuromodulator in 13 new countries.

In fillers and biostimulators, Galderma continued to develop innovation for Sculptra, the unique and original PLLA-SCA⁵ collagen stimulator which is celebrating its 25^th anniversary in 2024. In 2023, it received approval by the U.S. Food and Drug Administration (“FDA”) for the correction of fine lines and wrinkles in the cheek area.

The Company also continued to build out its Restylane portfolio with the launch of Restylane Eyelight™ in the U.S., and Restylane SHAYPE™ received approval from Health Canada in 2023 for temporary augmentation of the chin region given its ‘bone-mimicking’ properties using NASHA HD™ technology.

Dermatological Skincare

In 2023, strong growth momentum was driven by Galderma’s two flagship brands in Dermatological Skincare, Cetaphil and Alastin. Both brands outpaced the market, based on differentiated positioning in sensitive skin and peri-procedure skincare respectively as well as part of Galderma integrated dermatology platform, with unique portfolio synergies when executing on Galderma’s strategic pillars.

Cetaphil, with over 75 years of heritage in sensitive skincare, surpassed a record 1 B USD in net sales in 2023. Cetaphil’s portfolio of products continued to evolve to address a wide range of sensitive skin needs. For example, Cetaphil Healthy Renew, the first of its kind, healthy-aging skincare line, was launched in Brazil and the U.S., offering consumers a retinol alternative for sensitive skin, formulated with purified peptides to help defend against visible signs of aging.

Cetaphil also continued to focus on its omnichannel execution, especially in fast-growing markets, with the expansion of its salesforce, retailer distribution, as well as e-commerce and digital engagement. One of the value-adding digital offerings launched in 2023 is the Cetaphil AI Skin Analysis, a comprehensive skin analyzer offering personalized skin assessment scores and skincare regimen recommendations. With a selfie, the digital tool compares the photo to a robust database of 70,000 diverse skin images to create an inclusive, personalized report revealing skin type, skin concerns and proneness to various skin conditions.

In 2023, the growth of Alastin remained strong, especially with increased account penetration in the U.S., based on salesforce expansion, commercial synergies with Injectable Aesthetics, and differentiated innovation. Galderma continued to build out its Alastin portfolio, with new launches such as ReSURFACE Skin Polish^® and C-RADICAL^® Defense Antioxidant Serum. Galderma also initiated targeted international expansion of its Alastin range in the UK and Mexico while gaining direct distribution in Canada.

At the 25th World Congress of Dermatology, the Global Sensitive Skincare Faculty, in collaboration with the George Washington University, presented the results from the most extensive global epidemiological study ever to assess and characterizing sensitive skin worldwide. Including more than 10,000 participants spread across seven countries and five continents, the outcome of the research is a much more diverse and inclusive understanding of global trends and specific nuances of sensitive skin sufferers.

Therapeutic Dermatology

In Therapeutic Dermatology, Galderma continued to execute on Galderma’s three strategic pillars for its portfolio while progressing the development of nemolizumab, a first-in-class investigational monoclonal antibody that blocks the signaling of IL-31, a neuroimmune cytokine responsible for driving multiple disease mechanisms in atopic dermatitis and prurigo nodularis. With its differentiated clinical profile, nemolizumab represents the opportunity to expand on Galderma’s leading Therapeutic Dermatology portfolio and enter into the fast-growing biologics sub-segment.

In 2023, Galderma showcased positive data from four pivotal phase III trials investigating the treatment of atopic dermatitis and prurigo nodularis with nemolizumab. The positive trial results demonstrated that nemolizumab used in monotherapy for the treatment of prurigo nodularis and with topical corticosteroids or topical calcineurin inhibitors for atopic dermatitis showed fast itch relief (as early as Day Two and improving over time, with a significant impact also on sleep and quality of life), lasting skin clearance (significantly improved through Week 16 and beyond), a favorable safety profile and ease of use as the first biologic candidate with once-every-four-week dosing. Additional data also supports the option to reduce to every-eight-week dosing for maintenance in atopic dermatitis. In 2023, results from the OLYMPIA 2 trial in prurigo nodularis were published in The New England Journal of Medicine⁶.

On 14 February 2024, Galderma announced that the FDA accepted its Biologics License Applications (“BLA”) for nemolizumab for the treatment of patients with prurigo nodularis and for adolescents and adults with moderate to severe atopic dermatitis. Nemolizumab was granted FDA Priority Review for prurigo nodularis. In addition, the European Medicines Agency (“EMA") has also accepted the Marketing Authorization Applications (“MAA”) for nemolizumab in prurigo nodularis and atopic dermatitis. Further submissions to regulatory authorities in additional countries are planned in 2024.

Beyond nemolizumab, Galderma continued to deliver positive data across its Therapeutic Dermatology portfolio. In 2023, the Company’s position in acne was strengthened by presenting 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, as well as data from the phase IV LEAP study demonstrating a reduction in post-inflammatory hyperpigmentation.

The Company also continues to bring differentiated innovation to market and in 2023 entered a new acne spot treatment segment with the launch of its science-backed technology behind Benzac and Differin patches in the UK and Italy for the treatment of emerging pimples.

Leadership in education and services

In 2023, Galderma remained true to its commitment to advancing innovation and scientific knowledge in dermatology. Throughout the year, Galderma had a significant presence at major congresses and events, presenting over 50 scientific presentations at the World Congress of Dermatology, contributing to the European Academy of Dermatology and Venereology (EADV), the Aesthetic & Anti-Aging Medical World Congress (AMWC), the American Academy of Dermatology (AAD), and IMCAS World Congress.

The Company also managed to deliver market-leading and differentiated education and services across categories. This included training and engaging with more than 130,000 healthcare professionals through more than 11,000 Galderma Aesthetics Injector Network (GAIN) events and other medical education and awareness programs in 2023.

In 2023, Galderma further consolidated its ESG profile by rolling out a dedicated executive-level ESG oversight and instituting the ESG Council. This Council is chaired by the CEO and includes all members of Galderma’s Executive Committee as well as other relevant senior functional leaders and is responsible of all major decisions related to ESG, including climate-related topics.

About Galderma

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 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: www.galderma.com.

Notes and references:

1. With respect to      period-on-period comparisons, Galderma presents certain financial data on      a constant currency basis, which excludes the translation impact of      exchange rate movements and excluding hyperinflation economies, and which      we refer to as ‘Constant Currency.’ The impact of changes in foreign      exchange rates for the years ended December 31, 2023 and 2022 is excluded      by translating all reported revenues for the periods being compared using      the average exchange rates in effect during the initial year of the      relevant period. The Company believes that this measure facilitates an      understanding of the underlying economic performance of its operations.

2. Galderma reports net sales by      two geographies: U.S. and International markets

3. Galderma data on file:      initial results of the phase IIIb 43QM2106 trial; initial results of the      phase IIIb 43QM2107 trial

4. Hilton et al. Dermatol Surg      2022;48:1198-202

5. Poly-L-Lactic Acid – Sculptra

6. Kwatra SG, et al. Phase 3      trial of nemolizumab in patients with prurigo nodularis. N Engl J Med.      2023;389:1579-89. DOI: 10.1056/NEJMoa2301333

Forward-looking statements

Certain statements in this announcement are forward-looking statements, including 2024 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.