Galderma Delivers Strong H1 2022 Results and Continued Innovation Across Its Leading Dermatology Portfolio

(BUSINESS WIRE) -- Galderma:

Continued strong commercial and financial performance in a resilient market

• Galderma delivered continued strong growth across product categories, with net sales up 15% year-on-year on a constant currency basis at 1,914 M USD
• Particularly strong performance of Injectable Aesthetics and Dermo-cosmetics product categories with growth of 32% and 31% on a constant currency basis, respectively
• Volume as a primary growth driver underpins confidence in the resilience and long-term growth fundamentals of the dermatology market

• On track to deliver on 2022 guidance of 12-14% net sales and core EBITDA growth on a constant currency basis

Advancing innovation across its leading dermatology portfolio

• Important clinical milestones achieved, including positive phase III results reinforcing the efficacy and safety of nemolizumab in prurigo nodularis, and positive phase III topline data release of RelabotulinumtoxinA (QM-1114), showing improved glabellar lines (frown) and lateral canthal lines (crow’s feet) with a rapid onset of action and a long duration
• Significant launches across all product categories, including Alluzience^®, the first ready-to-use liquid form of botulinum toxin type A in Europe; Twyneo^®, the first ever tretinoin and benzoyl peroxide combination to treat facial acne; and Epsolay^®, the first and only microencapsulated benzoyl peroxide topical treatment of bumps and blemishes of rosacea

Sustained commercial and financial momentum

In the first half of 2022, the global Injectable Aesthetics and Dermo-cosmetics market segments continued to show robust growth, with the gradual “return to office” post COVID-19. This demonstrates that, despite the global macroeconomic downturn, there is still strong demand for premium products. With its continued commitment to innovation and broad channel exposure, Galderma is well positioned to capitalize on this growing consumer demand.

Net sales growth in the first half of 2022 was driven primarily by strong volume growth in Injectable Aesthetics and Dermo-cosmetics, growing by 32% and 31% year-on-year on a constant currency basis, respectively. This more than offset the anticipated impact of the loss of exclusivity for Epiduo^® Forte and Soolantra^® in the U.S. in Therapeutic Dermatology.

• In Injectable Aesthetics, Galderma continued to grow strongly in an environment of resilient consumer demand. Growth was driven by a balanced contribution across Neuromodulators and Fillers & Biostimulators showing double-digit growth across its key markets and gaining market share.
• In Dermo-cosmetics, Galderma continued to outperform the market, with double-digit growth in eight out of the top 10 markets for the product category. Cetaphil^® continued to deliver strong performance driven by e-commerce and launches in China and the rest of Asia, expansion in India and price and market share gains in the U.S. Alastin Skincare^® continued accelerating its growth trajectory with successful new product launches and synergies with the rest of the portfolio.

• In Therapeutic Dermatology, Galderma navigated the anticipated annualization effect of the U.S. loss of exclusivity of Epiduo^® Forte and Soolantra^® with new launches. Twyneo^® and Epsolay^® launches were executed in the U.S., with positive first results.

From a geographical perspective, net sales growth was balanced across geographies. The U.S. grew 14% year-on-year while International grew 16% year-on-year on a constant currency basis, with accelerated performance in certain markets such as China, India and Brazil. In China, despite COVID-19 related lockdowns in large cities, growth accelerated, reaching double-digit year-on-year figures in both Injectable Aesthetics and Dermo-cosmetics. Given limited exposure to Ukraine and Russia, the conflict had no sizeable direct impact on Galderma’s operations.

Galderma is on track to deliver on its 2022 guidance of 12-14% net sales and core EBITDA year-on-year growth on a constant currency basis. Profitability remains on track despite the inflationary environment as a result of strong underlying volume growth, value-based pricing, and margin improvement behind new product launches with superior consumer benefits.

Strong pipeline momentum and key launches

In the first half of 2022, Galderma continued to invest in innovation to advance its differentiated portfolio for long-term sustainable growth, with significant launches across all product categories and important clinical milestones.

Injectable Aesthetics

Earlier this year, Galderma successfully launched the neuromodulator Alluzience^® in certain European countries as the first ready-to-use liquid form of botulinum toxin type A. Alluzience^® is indicated for use in adult patients as a treatment to temporarily improve the appearance of moderate to severe glabellar lines.

In March 2022, Galderma presented a range of new scientific data on its hyaluronic acid dermal filler range, its first liquid neuromodulator and its original collagen biostimulator at the Aesthetic & Anti-Aging Medicine World Congress (AMWC). Pooled data from two phase III studies (NCT02353871 and NCT02493946) show that Alluzience^® successfully improved glabellar lines regardless of severity with rapid onset and results lasting up to six months.^i,ii Improvements in glabellar line severity, satisfaction and psychological wellbeing were also consistent over several cycles of treatment with Alluzience^®.^{i, ii}

At the IMCAS World Congress, 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.ⁱⁱⁱ

In June 2022, Galderma announced positive topline results from two phase III clinical studies (NCT04249583, NCT04249687) demonstrating that RelabotulinumtoxinA (QM-1114), a novel liquid formulation botulinum toxin A, improves both glabellar (frown) and lateral canthal (crow’s feet) lines with a rapid onset of action and a long duration of up to six months.^{iv, v} Developed by Galderma, RelabotulinumtoxinA is a highly-active, innovative, complex-free and ready-to-use liquid botulinum toxin A with a proprietary strain and manufactured using a state-of-the-art, unique process.^{iv, vi} RelabotulinumtoxinA is designed as a liquid, avoiding the traditional requirement to reconstitute from powder, eliminating variability, errors and risks associated with reconstitution, which is expected to improve the consistency of results.

Dermo-cosmetics

In the first half of 2022, Galderma rolled out Cetaphil’s Optimal Hydration range in Asia, comprising three new products powered by hyaluronic acid and exclusive HydroSensitiv Complex, to hydrate and improve sensitive skin.

Galderma continued to advance Cetaphil’s global initiative aimed at driving innovation with sustainability at its heart and set against four key areas in which the organization can make a difference: reducing environmental impact, formulating with cleaner ingredients, using smarter packaging and serving communities. The latest Cetaphil Gentle Skin Cleanser restage underpins this long-term commitment to supporting a healthier environment and brighter futures for all.

In January 2022, Galderma announced it had completed the acquisition of Alastin, a specialty aesthetics company dedicated to developing innovative and clinically-tested physician-dispensed skincare products, for daily regimens and peri-procedural use. Consumer interest in and acceptance of aesthetic procedures is increasing rapidly, and the addition of Alastin’s synergistic portfolio and expertise in science-based skincare will increase Galderma’s ability to serve the needs of both consumers and professionals.

Following the acquisition of Alastin, Galderma launched two new products from its leading physician-dispensed skincare brand in the first half of 2022:

• ReFORM & RePAIR COMPLEX, an innovative formula with TriHex Technology^® that assists recovery from surgical procedures; and
• HA Immerse Serum^®, a novel hydrating hyaluronic acid formula designed to immerse the skin in moisture on the surface while helping to amplify the skin’s natural ability to create hyaluronic acid.

In February 2022, Galderma sold its Alchemee business to Taro Pharmaceutical Industries Ltd. (NYSE: TARO). The agreement between Galderma and Taro included Alchemee’s business and assets around the world, including the Proactiv^® brand. The sale of Alchemee will allow Galderma to further strengthen its focus on its core, global brands in Dermo-cosmetics.

Therapeutic Dermatology

In June 2022, Galderma announced that the phase III OLYMPIA 2 trial met all primary and key secondary endpoints, with a safety profile consistent with the phase II trial results. Patients with prurigo nodularis treated with nemolizumab monotherapy (without background topical corticosteroids or topical calcineurin inhibitors) showed clinically and statistically significant improvement in both primary endpoints compared to placebo after 16 weeks of treatment:

• 38% of nemolizumab-treated patients reached clearance or almost-clearance of skin lesions when assessed using the investigator’s global assessment (IGA) score, compared to 11% in the placebo group (p<0.0001)
• 56% of nemolizumab-treated patients achieved an at least four-point reduction in itch, as measured by the peak-pruritus numerical rating scale (PP-NRS) score, compared to 21% in the placebo group (p<0.0001)

Nemolizumab is a first-in-class investigational monoclonal antibody directed against the IL-31 receptor alpha that blocks signaling from IL-31. IL-31 plays a key role in multiple diseases, including atopic dermatitis and prurigo nodularis.

In the U.S., Galderma launched Twyneo^®, the first and only tretinoin and benzoyl peroxide combination proven to treat moderate-to-severe acne. Patented microencapsulation technology unites two ingredients that have not been previously combined and enables their controlled release to deliver visible results in as little as two weeks.^{vii, viii} Galderma also launched Epsolay^®, the first and only microencapsulated benzoyl peroxide topical treatment proven to relieve the bumps and blemishes of rosacea.

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 though Injectable Aesthetics, Dermo-cosmetics 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 Dermo-cosmetics. For more information: www.galderma.com.

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 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.

ⁱ Ascher et al. Aesthet Surg J 2020;40:93-104.
ⁱⁱ Kestemont et al. Aesthet Surg J 2021; Sep 2; sjab329.
ⁱⁱⁱ Nikolis A et al. Oral Presentation #114864 to be presented at IMCAS 2022.
^iv Shridharani, S., et al. Treatment of moderate-to-severe glabellar lines with RelabotulinumtoxinA, a new liquid botulinum toxin: Clinical efficacy and safety results from the READY-1 Phase III trial. Poster presented at Vegas Cosmetic Surgery & Aesthetic Dermatology 2022, Las Vegas, NV, June 8-11, 2022.
^v Ibrahim, SF, et al. Treatment of lateral canthal lines with RelabotulinumtoxinA, a new liquid botulinum toxin: Clinical efficacy and safety results from the READY-2 Phase III trial. Poster presented at Vegas Cosmetic Surgery & Aesthetic Dermatology 2022, Las Vegas, NV, June 8-11, 2022.
^vi Liljegren Sundberg, Å and Ståhl, U. Relabotulinum toxin – a novel, high purity BoNT-A1 in liquid formulation. Poster presented at TOXINS, virtual online event, January 16-17, 2021.
^vii Sol-Gel Technologies Ltd. Sol-Gel Technologies announces FDA approval of TWYNEO. Sol-Gel Advanced Topical Therapy. https://ir.sol-gel.com/news-releases/news-release-details/sol-gel-technologies-announces-fda-approval-twyneor.
^viii Galderma Laboratories LP. Clinical Study Report SGT-65-05. 2020, June 5.

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