Press release

+41 76 315 26 50

Emil Ivanov

Head of Strategy, Investor Relations, and ESG

emil.ivanov@galderma.com

+41 21 642 78 12

Sébastien Cros

Corporate Communications Director

+41 79 529 59 85

Jessica Cohen

Investor Relations and Strategy Director

jessica.cohen@galderma.com

+41 21 642 76 43

02/10/2023

ALASTIN Skincare^® is a range of innovative, clinically tested skin care products that correct, protect, and maintain healthy skin for a lifetime. These unparalleled Procedure Support and Daily Restorative Skincare products are formulated with TriHex Technology^®, a patented combination of key peptides and other synergistic ingredients using the latest technology, and are clinically tested to demonstrate safety and their ability to help reawaken the skin’s youthful regenerating processes.

Galderma launches advanced new serum with ALASTIN Skincare® - C-RADICAL Defense Antioxidant Serum

tyler.king — Tue, 12 Sep 2023 16:10:50 +0000

Galderma launches advanced new serum with ALASTIN Skincare® - C-RADICAL Defense Antioxidant Serum tyler.king Tue, 09/12/2023 - 16:10

ALASTIN adds to its solution serums with a radically new form of Vitamin C for skin that looks smoother and more radiant.

DALLAS – September 14, 2023 – Galderma, the emerging pure-play dermatology category leader, announces the launch of another scientific innovation, C-RADICAL Defense Antioxidant Serum, powered by a proprietary encapsulated Vitamin C (Sodium Ascorbate) and 14 vital antioxidants that provides a new option in antioxidant serums. This cosmetically elegant, non-irritating, scent-free formula is consistent from the first pump to the last.

This clinically proven antioxidant serum helps protect against environmental stressors, combatting free radicals, UV damage, blue light, and pollution while supporting the skin’s ability to conserve elastin for skin that looks smoother, and more radiant.^[1]

In a 12-week clinical study, results showed subject improvement in the appearance of skin’s texture, tone, and luminosity, while helping to reduce the appearance of fine lines, wrinkles, photodamage, and other signs of aging in as early as 8 weeks. In addition, C-RADICAL helps reduce the effects of free radicals in the skin by up to 74%.¹

"The ALASTIN C-RADICAL Defense Antioxidant Serum offers an exceptional combination of benefits, proven by impressive clinical results. With its non-tacky, non-irritating, and scent-free formula, it helps protect against environmental stressors, while also preserving elastin to help deliver a brighter, more radiant-looking complexion. This serum truly marks a significant step forward in skincare innovation from Galderma."

ALAN D. WIDGEROW, MBBCh; MMed; FCS; FACS

CHIEF SCIENIFIC OFFICER, GALDERMA, HEAD OF SKIN SCIENCE CENTER FOR INNOVATION, AND HEAD OF ALASTIN INNOVATION

C-RADICAL Defense Antioxidant Serum addresses an unmet demand among individuals seeking a Vitamin C product that not only helps protect against environmental damage and helps enhance skin's appearance, but also has shown exceptional stability, absorption, and a pleasant user experience.

C-RADICAL Defense Antioxidant Serum ($178) can be purchased from ALASTIN Skincare® aesthetic physicians’ offices. Visit www.alastin.com for more information and to find a physician retailer near you.

About ALASTIN Skincare^®

@AlastinSkincare #AlastinSkincare

About Galderma

For more information: www.galderma.com

Media Contacts

Jeffrey Smith

Head of U.S. Communications

+ 1 (682) 401- 8428

Christian Marcoux, M.Sc.

Chief Communications Officer

+41 76 315 26 50

Sébastien Cros

Corporate Communications Director

+41 79 529 59 85

References

[1] Data on file at ALASTIN Skincare®. Individual results may vary.

14/09/2023

Powered by Peptides: Galderma introduces Cetaphil Healthy Renew, a retinol alternative skincare range

tyler.king — Mon, 11 Sep 2023 15:38:44 +0000

Powered by Peptides: Galderma introduces Cetaphil Healthy Renew, a retinol alternative skincare range tyler.king Mon, 09/11/2023 - 15:38

The Healthy Renew collection helps defend against visible signs of aging while being gentle enough for daily use on sensitive skin.

DALLAS, September 7, 2023 – Galderma, the emerging pure-play dermatology category leader, today announces the launch of another scientific innovation, Cetaphil Healthy Renew, the first-ever healthy aging skincare line in its dermatologist recommended skincare range. Understanding that sensitive skin ages differently, Cetaphil is aiming to support sensitive skin consumers during the aging process with a retinol alternative range formulated with purified peptides to help defend against visible signs of aging.

“Aging skin is a particular point of frustration for my sensitive skin patients due to increased risks of irritation and an already compromised skin barrier. Active ingredients like retinol are especially not well-tolerated, so I’m thrilled to share Cetaphil Healthy Renew with them as a new, gentle, and efficacious option to combat the early signs of aging.”

DR. DENDY ENGELMAN

BOARD-CERTIFIED DERMATOLGIST AND CETAPHIL PARTNER

Sensitive skin consumers have been historically underserved in the aging skin category, with mainstream ingredients such as retinol often being too harsh. After researching more than 300 peptides, Cetaphil selected highly purified botanical glycopeptides as the optimal ingredient for Healthy Renew, replicating the benefits of retinol while being well tolerated.

“Those with sensitive skin have an inherently compromised skin barrier, causing it to age differently than other skin types. This is because the skin experiences recurrent irritation that can affect the skin’s natural collagen and elastin production. The simplified protein chains within the Healthy Renew collection are a gentler option for sensitive skin, don’t require typical adaptation time, and aren’t known to increase sensitivity to the sun. Instead, they help reduce the visible signs of aging with minimal skin disruption.”

MATTHEW MECKFESSEL, PHD

DIRECTOR, MEDICAL AFFAIRS

GALDERMA

Combined with Vitamins B3 and B5 to help hydrate, soothe, and repair the skin’s moisture barrier, Healthy Renew’s formula also includes botanical extracts from Rice lees and Edelweiss to target dullness and uneven skin tone. The dermatologist developed line features the following four products that are all hypoallergenic, fragrance-free, paraben-free, and non-comedogenic:

Healthy Renew Face Serum (Starting at $22.99): Nourishing and quick-absorbing serum visibly improves firmness, texture, and tone while providing 24-hour hydration
Healthy Renew Eye Gel Serum (Starting at $22.99): Lightweight serum targets visible dark circles, fine lines, and signs of fatigue around the eyes, leaving the skin smooth and hydrated for a full 24 hours
Healthy Renew Day Cream SPF 30 (Starting at $19.99): Daily-use moisturizer with broad-spectrum SPF 30 visibly smooths fine lines and offers protection from UV rays and surface free radicals
Healthy Renew Night Cream (Starting at $19.99): Rich cream nourishes skin overnight, reducing the appearance of fine lines and revealing glowing skin by morning

Healthy Renew is now available online and at major retailers. See full list of retailers here: https://www.cetaphil.com/us/where-buy. For more information, consumers can also follow Cetaphil on Instagram (@CetaphilUS) and TikTok (@CetaphilUSA) or visit www.cetaphil.com.

About Cetaphil^®

Seventy-five years ago, a leading pharmacist created the first Cetaphil product – a gentle, yet powerful formula that would clean without stripping and moisturize without clogging. Today, Cetaphil is a dermatologist recommended sensitive skincare brand and is recognized around the world. With the help of leading global skincare experts, they continue to develop innovative skincare technologies for sensitive skin that help restore, protect and maintain skin’s health every day. For more information, visit www.cetaphil.com.

About Galderma

Media Contacts

Jeffrey Smith

Head of U.S. Communications

+ 1 (682) 401- 8428

Christian Marcoux, M.Sc.

Chief Communications Officer

+41 76 315 26 50

Sébastien Cros

Corporate Communications Director

svillanueva@lippetaylor.com

+41 79 529 59 85

Sara Villanueva

Lippe Taylor

12/09/2023

PDF file - Galderma reiterates its commitment to commercialize and continue developing the broadest Injectable Aesthetics portfolio on the market, following Ipsen's recent announcement

Galderma reiterates its commitment to commercialize and continue developing the broadest Injectable Aesthetics portfolio on the market, following Ipsen's recent announcement

Lucie.Tesquier — Sat, 29 Jul 2023 13:54:47 +0000

Galderma reiterates its commitment to commercialize and continue developing the broadest Injectable Aesthetics portfolio on the market, following Ipsen's recent announcement Lucie.Tesquier Sat, 07/29/2023 - 13:54

Zug, Switzerland, July 29, 2023 – On Wednesday July 26, 2023 Ipsen informed Galderma of its intention to terminate the neuromodulator Research and Development (R&D) agreement signed in 2014, citing the retention of its rights and obligations related to its early-stage pipeline. This has no impact on the commercialization of Galderma’s neuromodulator portfolio.

Galderma will continue to commercialize and supply Dysport®/Azzalure® and Alluzience® in territories, where approved and as per the commercial agreements. With its leading brands and services, Galderma remains committed to serving its healthcare professionals, consumers and patients globally.

Furthermore, Galderma is well-positioned to continue to build its neuromodulator pipeline, with proven in-house R&D capabilities in medical aesthetics and neuromodulators, having developed QM-1114 internally (RelabotulinumtoxinA) as well as the world’s largest hyaluronic acid filler range, Restylane®. Galderma will continue its development and commercialization programs in the neuromodulators space. Along with Sculptra®, the first and original injectable poly-L-lactic acid collagen stimulator, Galderma’s offering in neuromodulators and fillers makes for the broadest, unparalleled injectable aesthetics portfolio.

In regards to the ongoing arbitrations with Ipsen, Galderma will continue to pursue every available remedy to enforce its rights. The two International Chamber of Commerce arbitrations commenced by Galderma in July 2021 relate to: (1) the regulatory filing strategy for relabotulinumtoxinA and (2) to differing views relating to which countries form part of Ipsen’s/Galderma’s territories under the agreement. With its purpose of advancing dermatology for every skin story, Galderma will continue to bring premium brands and scientific innovation to its expanding markets across injectable aesthetics, dermatological skincare and therapeutic dermatology.

For further information:

Christian Marcoux, M.Sc.

Chief Communications Officer

christian.marcoux@galderma.com

+41 76 315 26 50

Emil Ivanov

Head of Strategy, Investor Relations, and ESG

emil.ivanov@galderma.com

+41 21 642 78 12

Sébastien Cros

Corporate Communications Director

sebastien.cros@galderma.com

+41 79 529 59 85

Jessica Cohen

Investor Relations and Strategy Director

jessica.cohen@galderma.com

+41 21 642 76 43

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

29/07/2023

Galderma achieves record 2 B USD net sales for a six-month period in H1 2023, as it continues to demonstrate leading execution and innovation capabilities in dermatology

Lucie.Tesquier — Wed, 26 Jul 2023 11:59:18 +0000

Galderma achieves record 2 B USD net sales for a six-month period in H1 2023, as it continues to demonstrate leading execution and innovation capabilities in dermatology Lucie.Tesquier Wed, 07/26/2023 - 11:59

Zug, Switzerland, July 27, 2023

Galderma maintained strong momentum across all product categories reaching 2,003 M USD net sales in H1 2023, up 6.9% year-on-year on a constant currency basis
Growth primarily driven by Dermatological Skincare and Therapeutic Dermatology; Injectable Aesthetics continued to grow driven by double-digit performance in both Neuromodulators and Biostimulators despite softening in the Filler market and a high comparative base for the product category in 2022 following a post-COVID rebound
Delivered significant Core EBITDA margin expansion in H1 2023, with a Core EBITDA of 450 M USD and margin of 22.5% compared to 21.0% for full year 2022
On track to deliver on 2023 full-year revenue and profitability guidance of 6-9% constant currency net sales growth and 200-300 bps Core EBITDA margin expansion versus 2022
Showcased best-in-class innovation capabilities across its leading dermatology portfolio, including positive phase III data for nemolizumab in adult patients with prurigo nodularis, along with FDA approvals and major launches in Injectable Aesthetics and Dermatological Skincare
Private placement of over 1 B USD raised for newly issued shares, with proceeds used to strengthen the balance sheet and further accelerate Galderma’s organic growth momentum

“Galderma sustained its growth momentum in the first half of 2023 driven by a laser focus on commercial execution and by premium positioning in attractive, high growth markets. Galderma continues to demonstrate its commitment to bringing science-based premium products to consumers, patients, and healthcare professionals, with new FDA approvals and new product launches in the first half of 2023. We also shared further positive data that underscores the strength of our differentiated innovation pipeline. I am delighted to see our unique, integrated dermatology strategy go from strength to strength, as we continue to deliver on our ambition to become the leader in dermatology.”

Flemming Ørnskov, M.D., MPH

Chief Executive Officer

Positive commercial and financial momentum

In the first half of 2023, Galderma reached the 2 B USD net sales mark for the period for the first time and delivered the majority of Core EBITDA margin expansion planned by year end, with Core EBITDA of 450 M USD and a 22.5% margin, representing a 10.5% constant currency growth compared to the first half of 2022 and a margin increase of 150 bps versus the full year 2022. The robust Core EBITDA growth was driven by sales growth, including contribution from pricing actions and positive brand mix evolution, savings from the end-to-end transformation program and cost discipline.

With its broad portfolio of leading brands and services, fueled by science-based innovation and focused commercial execution, Galderma is well positioned in a growing dermatology market. Despite the uncertain macroeconomic environment, consumer demand for premium products remained resilient.

After record growth in 2022, following a strong rebound from the COVID-19 pandemic, net sales for the first half of the year were up 6.9% year-on-year on a constant currency basis, ahead of expectations.

Injectable Aesthetics delivered single-digit constant currency growth over the period, from a high comparative base in 2022. While Galderma gained market share across its Injectable Aesthetic portfolio, Neuromodulators and Biostimulators stood out with double-digit constant currency growth for the period. Overall category growth was subdued by the return to typical seasonality following the high 2022 rebound post the COVID-19 crisis, as well as softening in demand for Fillers in some key markets.
Dermatological Skincare continued its growth trajectory, highlighted by the double-digit growth of Cetaphil^® in the International region¹ and the growth of Alastin Skincare^®, including the recent expansion into Mexico.
Therapeutic Dermatology returned to growth following the 2022 loss of exclusivity events in the U.S. Growth was driven by successful yield improvement measures in the U.S. for key brands such as Oracea^®, Aklief^® and Soolantra^®, as well as continued robust performance in International.

Growth for the period benefited from brand mix evolution and price increases across geographies, as a result of Galderma’s differentiated portfolio of premium brands and services and ongoing launches of science-based innovations with meaningful consumer benefits.

From a geographical perspective, net sales growth was primarily driven by Galderma’s larger region, International. There was particularly strong momentum with double-digit growth in fast-growing markets such as China, India and Mexico.

Galderma confirms guidance for the full year, expecting to deliver 6-9% net sales growth on a constant currency basis and 200-300 bps Core EBITDA margin expansion (versus 2022). The margin expansion guidance incorporates significant Core EBITDA generation which is planned to be partially reinvested into nemolizumab costs ahead of its future launch, following positive phase III results in prurigo nodularis and atopic dermatitis.

Earlier in 2023, Galderma raised over 1 B USD for newly issued shares in a private placement round. The investment came from a group consisting of current shareholders, new investors, as well as management, highlighting their confidence in Galderma’s track-record and growth potential. The proceeds of the private placement are being used to strengthen the Company’s balance sheet and to further accelerate its organic growth momentum fueled by its unique integrated dermatology strategy.

Continued pipeline progress and launch of innovative products and tools

In the first half of 2023, Galderma continued to advance innovation, with significant launches and positive data presentations across its leading dermatology portfolio.

Therapeutic Dermatology

Nemolizumab: prurigo nodularis update

Galderma premiered positive data from the phase III OLYMPIA 2 trial at the 2023 American Academy of Dermatology Annual Meeting, showing that nemolizumab monotherapy met all primary and key secondary endpoints and demonstrated significant improvements on itch, skin clearance and sleep disturbance in adult patients with prurigo nodularis. Results showed that:

56 percent of nemolizumab-treated patients achieved a response in itch intensity, as defined by an at least 4-point improvement in peak-pruritus numerical rating scale (PP-NRS) score, compared to 21 percent in the placebo group (p<0.0001)²
38 percent of nemolizumab-treated patients reached treatment success in skin lesions, as defined by an investigator’s global assessment (IGA) score of 0 or 1, compared to 11 percent in the placebo group (p<0.0001)²

In addition, the latest data from the OLYMPIA 2 trial presented at the World Congress of Dermatology (WCD) showcased the rapid onset of action of nemolizumab monotherapy in adult patients with prurigo nodularis. Results showed that:

19.7 percent of patients treated with nemolizumab achieved an itch-free state as early as week 4 after only one dose of nemolizumab³

Aklief

Galderma presented data from the START study, a multicenter, randomized, double-blind, vehicle-controlled split-face study, evaluating the efficacy and safety of trifarotene cream for preventing the risk of atrophic acne scar formation. Topline results demonstrate a statistically significant reduction in total atrophic acne scar count with trifarotene cream vs. vehicle treatment as early as week two, with a progressive and statistically significant difference up to week 24, and a significantly higher proportion of patients achieving Investigator’s Global Assessment (IGA) success.⁴

Injectable Aesthetics

Sculptra^®

Galderma received approval from the FDA for Sculptra for the correction of fine lines and wrinkles in the cheek area. Sculptra is the first and original FDA-approved PLLA collagen stimulator that, when injected into the cheek area, helps stimulate natural collagen production to smooth wrinkles and improve skin quality such as firmness and glow, with results lasting up to two years.

Restylane^®

Galderma received FDA approval for its newest hyaluronic acid filler, Restylane Eyelight^® for the treatment of undereye hollows, also known as dark shadows, in adults over the age of 21. It is the first and only product in the U.S. formulated with NASHA^® Technology for volume loss under the eyes, giving patients natural-looking results.

In addition, Galderma launched a new indication of Restylane Defyne^®, for the treatment of chin retrusion, in China. This is the first approval for a hyaluronic acid injectable for this indication in the Chinese market.

Dermatological Skincare

Cetaphil

Galderma continues to roll out product innovation across its leading dermatologist-recommended brand for sensitive skin, Cetaphil. The latest innovation, Cetaphil Healthy Renew, was launched in Brazil in the first half of the year.

To support users with sensitive skin, Cetaphil unveiled a digital AI skin analysis tool. The comprehensive skin analyzer offers personalized skin assessment scores and skincare regimen recommendations in seconds.

In line with its commitment to supporting consumers with sensitive skin through its ongoing innovation, Galderma’s Sensitive Skincare Faculty, in collaboration with the George Washington University hosted a dedicated symposium at WCD. It detailed the most extensive profiling of sensitive skin ever done, in 10,000 people across five continents.

Alastin Skincare

Galderma launched Alastin Skincare ReSURFACE^TM Skin Polish as the newest product addition to the Alastin Skincare collection of scientifically formulated and clinically tested products. ReSURFACE Skin Polish is designed to sweep away dead skin cells and impurities for instantly smoother and visibly brighter skin and delivers the power of dual-action exfoliation through volcanic minerals and glycolic acid (AHA) in a non-irritating, hydrating formula. It has been clinically proven to help improve tactile roughness and skin dullness within one week of use.

For further information:

Christian Marcoux, M.Sc.

Chief Communications Officer

+41 76 315 26 50

Emil Ivanov

Head of Strategy, Investor Relations, and ESG

emil.ivanov@galderma.com

+41 21 642 78 12

Sébastien Cros

Corporate Communications Director

+41 79 529 59 85

Jessica Cohen

Investor Relations and Strategy Director

jessica.cohen@galderma.com

+41 21 642 76 43

Notes and references:

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

2. Kwatra S. Late breaking abstract presented at the 2023 American Academy of Dermatology (AAD)

3. Stander S, et al. Late breaking abstract presented at WCD 2023

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

About Galderma

27/07/2023

Galderma raises approximately USD 1 billion for newly issued shares in a private placement round

Lucie.Tesquier — Mon, 26 Jun 2023 12:32:23 +0000

Galderma raises approximately USD 1 billion for newly issued shares in a private placement round Lucie.Tesquier Mon, 06/26/2023 - 12:32

Zug, Switzerland – June 26, 2023 – Galderma, the emerging pure-play dermatology category leader, announced today a private placement of approximately USD 1 billion for newly issued shares, from a group consisting of current shareholders, new investors, as well as management. The transaction is expected to close in the coming weeks. Galderma will use the proceeds of the private placement to strengthen its balance sheet and to further accelerate its organic growth momentum fueled by its unique integrated dermatology strategy.

“With our relentless focus on commercial execution and premium positioning in high-growth, attractive markets, we continue to deliver strong performance across our three businesses. We are committed to advancing our differentiated innovation pipeline which includes two disruptive biologics with blockbuster potential for long-term sustainable growth.”

FLEMMING ØRNSKOV, M.D., MPH

CHIEF EXECUTIVE OFFICER

GALDERMA

Galderma continues to perform strongly delivering at the top end of its 2022 revenue guidance with double digit growth and expects continued strong growth momentum in 2023.

“We are delighted to see current and new investors sharing our strong confidence and trust in Galderma’s growth trajectory. This demonstrates the conviction that we all have in Galderma’s track record and bold ambition. Along with our co-investors, we continue to be highly supportive of Galderma’s unique integrated dermatology strategy and management team.”

MICHAEL BAUER

PARTNER, CO-HEAD OF GLOBAL HEALTHCARE SECTOR TEAM

EQT

An Initial Public Offering (IPO) remains the likely next step in Galderma’s ambition to become the leading dermatology company in the world.

About Galderma

Media relations

Christian Marcoux, M.Sc.

Chief Communications Officer

+41 76 315 26 50

Sébastien Cros

Corporate Communications Director

jessica.cohen@galderma.com

+41 79 529 59 85

Investor relations

Emil Ivanov

Head of Strategy, Investor Relations, and ESG

emil.ivanov@galderma.com

+41 21 642 78 12

Jessica Cohen

Investor Relations and Strategy Director

+41 21 642 76 43

26/06/2023

Galderma @ WCD 2023: late-breaking phase III results for nemolizumab monotherapy in prurigo nodularis show a significant proportion of itch-free patients by week 4

Lucie.Tesquier — Mon, 26 Jun 2023 08:34:39 +0000

Galderma @ WCD 2023: late-breaking phase III results for nemolizumab monotherapy in prurigo nodularis show a significant proportion of itch-free patients by week 4 Lucie.Tesquier Mon, 06/26/2023 - 08:34

Latest data from the phase III OLYMPIA 2 trial presented at the World Congress of Dermatology (WCD) showcase rapid onset of action of nemolizumab in adult patients with prurigo nodularis, with 19.7% of patients treated with nemolizumab monotherapy achieving an itch-free state as early as week 4 after only one dose of nemolizumab^[1]
100% of adults with prurigo nodularis have reported intense itching caused by the condition as their top complaint^[2]
Nemolizumab is a first-in-class investigational monoclonal antibody that blocks the signaling of IL-31, widely recognized as the itch cytokine and a central mediator of inflammation and fibrosis in prurigo nodularis

Zug, Switzerland – July 4, 2023 – Galderma presented the latest data from its pivotal phase III OLYMPIA 2 trial at the 25^th World Congress of Dermatology (WCD) in Singapore. The results highlight the rapid onset of action of nemolizumab monotherapy in patients with prurigo nodularis, with significantly more patients receiving the treatment achieving an itch-free state (indicated by a weekly average peak-pruritus numerical rating scale [PP-NRS] score <2) by week 4, vs. placebo (19.7% vs. 2.2%, p<0.0001). These data expand upon those previously reported, namely a fivefold increase in the number of patients who achieved a clinically relevant improvement in itch intensity (PP-NRS reduction ≥ 4 points) at week 4 (41.0% for nemolizumab vs. 7.7% for placebo, p<0.0001).^[1]

The OLYMPIA 2 trial evaluated the efficacy, safety, pharmacokinetics and immunogenicity of nemolizumab compared with placebo in adult patients with moderate to severe prurigo nodularis. Topline data were presented to the scientific community earlier this year at the American Academy of Dermatology (AAD). The study met all primary and secondary endpoints, demonstrating that nemolizumab monotherapy significantly improved itch, skin clearance and sleep disturbance. The rapid onset of action was also highlighted, with patients experiencing improvement in itch, sleep intensity and skin clearance as early as week 4. The safety profile was consistent with the phase II results.^[3]

Galderma also presented the results of two Galderma-sponsored studies on the significant impact of prurigo nodularis and itch on sleep disturbance at WCD. In a retrospective, population-level, matched-cohort study, patients with prurigo nodularis were found to have a significantly increased risk of insomnia at one year and of sleep apnea at 10 years. In a qualitative study designed to understand how patients experience sleep disturbance related to prurigo nodularis, the majority (71%) reported that their sleep disturbance was solely due to itch.^[4],[5]

Nemolizumab is an investigational drug specifically designed to target IL-31 signaling to address the underlying causes of the disease. This includes directly addressing the source of itch, thereby improving quality of life outcomes such as sleep disturbance. Data from OLYMPIA 2, also presented at AAD, showed that nearly four times as many patients treated with nemolizumab achieved a significant and clinically meaningful improvement in sleep disturbance, measured by a 4-point improvement on the sleep disturbance numerical rating scale (SD-NRS; 37.2% for nemolizumab vs. 9.9% for placebo p<0.0001).^[3]

“The itch associated with prurigo nodularis is uniquely intense, causing significant sleep disturbance that substantially reduces quality of life. These data demonstrate once again the massive burden those with prurigo nodularis face, and the extent of nemolizumab’s potential to address it.”

BALDO SCASSELLATI SFORZOLINI, M.D., Ph.D.

GLOBAL HEAD OF R&D

GALDERMA

About prurigo nodularis

Prurigo nodularis is a debilitating chronic skin condition characterized by thick skin nodules covering large body areas and associated with intense itch.^[6],[7],[8] Prurigo nodularis affects an estimated 72 out of every 100,000 adults aged 18 to 64 in the United States. It is more common in middle-aged women and, disproportionately, people of African descent.^[6],[9]

About nemolizumab

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 disease mechanisms in both atopic dermatitis and prurigo nodularis, a debilitating chronic skin condition characterized by thick skin nodules covering large body areas and associated with intense itch. With its unique role in directly stimulating itch-related sensory neurons and contributing to inflammation and barrier dysfunction, IL-31 bridges the gap between the immune and nervous systems while acting directly on the skin’s structural cells.

Nemolizumab is in clinical development for the treatment of atopic dermatitis and prurigo nodularis in many countries around the world. Nemolizumab was granted Breakthrough Therapy designation by the U.S. Food and Drug Administration (FDA) in December 2019 for the treatment of pruritus associated with prurigo nodularis. It was initially developed by Chugai Pharmaceutical Co., Ltd., and subsequently licensed to Galderma in 2016 – worldwide except Japan and Taiwan. In Japan, nemolizumab is approved for the treatment of pruritus associated with atopic dermatitis and is in development for prurigo nodularis.

About the OLYMPIA 2 trial

OLYMPIA 2 was a randomized, double-blind, placebo-controlled phase III clinical trial designed to assess the efficacy and safety of nemolizumab monotherapy compared with placebo in patients aged at least 18 with prurigo nodularis after a 16-week treatment period. The trial also assessed the pharmacokinetics and immunogenicity of nemolizumab compared to placebo. OLYMPIA 2 included 274 patients with moderate-to-severe prurigo nodularis.

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’re in shapes our lives, we are advancing dermatology for every skin story. For further information, please visit www.galderma.com

For further information:

Christian Marcoux, M.Sc.

Chief Communications Officer

rachel.mooney@galderma.com

+41 76 315 26 50

Rachel Mooney

Global Franchise Communications

+41 76 261 64 41

Sébastien Cros

Corporate Communications Director

+41 79 529 59 85

References:

[1] Stander S, et al. Late breaking abstract presented at WCD 2023

[2] Pereira MP, Hoffman V, Weisshaar E, et al. Chronic nodular prurigo: clinical profile and burden. A European cross-sectional study. J Eur Acad Dermatol Venereol. 2020;34(10):2373-2383. doi: 10.1111/jdv.16309

[3] Kwatra SG. Poster presented at AAD 2023

[4] Kwatra SG. Poster presented at WCD 2023

[5] Rodriguez D. Poster presented at WCD 2023

[6] Williams KA, Roh YS, Brown I, et al. Pathophysiology, diagnosis, and pharmacological treatment of prurigo nodu-laris. Expert Rev Clin Pharmacol. 2021;14(1):67-77. doi: 10.1080/17512433.2021.1852080

[7] Elmariah S, Kim B, Berger T, et al. Practical approaches for diagnosis and management of prurigo nodularis: Unit-ed States expert panel consensus. J Am Acad Dermatol. 2021;84(3):747-760. doi: 10.1016/j.jaad.2020.07.025

[8] Whang KA, Mahadevan V, Bakhshi PR, et al. Prevalence of prurigo nodularis in the United States. J Allergy Clin Immunol Pract. 2020;8(9):3240-3241. doi: 10.1016/j.jaip.2020.05.051

[9] Huang AH, Canner JK, Khanna R, Kang S, Kwatra SG. Real-world prevalence of prurigo nodularis and burden of associated diseases. J Invest Dermatol. 2020;140(2):480-483.e4. doi: 10.1016/j.jid.2019.07.697

04/07/2023

WCD 2023: Galderma to present extensive data demonstrating enduring commitment to delivering innovative solutions in dermatology

Lucie.Tesquier — Mon, 26 Jun 2023 08:16:45 +0000

WCD 2023: Galderma to present extensive data demonstrating enduring commitment to delivering innovative solutions in dermatology Lucie.Tesquier Mon, 06/26/2023 - 08:16

Galderma will present 59 abstracts at the 25th World Congress of Dermatology (WCD), demonstrating the strength of its commitment to advancing dermatology
Data from the pivotal phase III OLYMPIA 2 trial will be presented as a late-breaking abstract, demonstrating nemolizumab's rapidity of response in prurigo nodularis in the study[1]
A dedicated acne symposium will feature new phase IV study data, investigating the efficacy and safety of trifarotene cream on acne and the risk of formation of acne scars[2]
A separate symposium from Galderma’s Sensitive Skincare Faculty, in collaboration with the George Washington University, will detail the most extensive profiling of sensitive skin ever done, in 10,000 people across five continents[3]

Zug, Switzerland – June 28, 2023 – Galderma will be presenting 59 abstracts/posters from across its extensive portfolio at the 25th World Congress of Dermatology (WCD), reflecting its unrelenting dedication to delivering innovative solutions to advance dermatology for every skin story. Galderma is the only pure-play dermatology company with more than 40 years of heritage, and its significant presence at the congress underscores its leadership in this space. The WCD will take place in Singapore from July 3-8, 2023.

The latest data from the pivotal phase III OLYMPIA 2 trial will be presented as a late-breaking abstract on Tuesday, July 4, 2023 at 3:30 PM SGT in Room 330. The OLYMPIA 2 results to be presented include the rapidity and efficacy of nemolizumab monotherapy in treating prurigo nodularis in the study, with new data presented on the proportion of patients to achieve an itch-free state.¹

The patient burden of acne-induced scarring will be explored in a dedicated symposium with results from the START study, a multicenter, randomized, double-blind, vehicle-controlled split-face study, evaluating the efficacy and safety of trifarotene cream for preventing the risk of atrophic acne scar formation.² Despite the burden of acne scars – 47% of people with acne-induced scarring report having to adjust their daily lives to some degree and 32.2% report that scarring is more bothersome than the acne itself – there is a lack of published evidence and guidelines for their prevention.[4]^{,[5],[6],[7],[8]} Topline results demonstrate a statistically significant reduction in total atrophic acne scar count with trifarotene cream vs. vehicle treatment as early as week two, with a progressive and statistically significant difference up to week 24, and also a significantly higher proportion of patients achieving Investigator's Global Assessment (IGA) success.² The symposium, entitled ‘New Perspectives on personalized management of acne and acne sequelae’ will take place on Tuesday, July 4, 2023 at 12:45 PM SGT in Room 324-326.

A separate symposium entitled ‘Diversity and inclusion in dermatology: A worldwide profiling of sensitive skin’ will see Galderma’s Sensitive Skincare Faculty, in collaboration with the George Washington University, present information from the most extensive global epidemiological study ever assessing and characterizing sensitive skin worldwide.³ The Galderma Sensitive Skincare Faculty brings together experts from across the globe with a mission to help people with sensitive skin to live better lives by focusing on three key pillars of research, innovation and engagement. 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.³ One of the most unexpected results was that self-declared darker skin tones reported the highest levels of very sensitive skin worldwide compared to fairer skin tones. From a symptom perspective, itching was the symptom experienced by most individuals having sensitive skin.³ The symposium will take place on Wednesday, July 5, 2023 at 12:45 PM SGT in Room 324-326.

“The extent of our presence at the WCD this year – with nearly 60 abstracts/posters being presented – really exemplifies the strength of our dedication and offering in dermatology. We’re looking forward to another opportunity to connect and learn from the community, and to share the latest updates from our innovative, science-based portfolio and scientific activities.”

BALDO SCASSELLATI SFORZOLINI, M.D., Ph.D.

GLOBAL HEAD OF R&D

GALDERMA

Healthcare professionals can also learn more during two other Galderma-sponsored symposia taking place on:

Thursday, July 6, 2023

12:45-2:15 PM SGT

Thinking differently about atopic dermatitis: Is it time to evolve our paradigms?Room 324-326, Level 3

Friday, July 7, 2023

12:45-2:15 PM SGT

What’s on the horizon for prurigo nodularis? Navigating new dataRoom 324-326, Level 3

More details on Galderma’s scientific presentations at WCD can be found here.

About Galderma

For further information:

Christian Marcoux, M.Sc.

Chief Communications Officer

+41 76 315 26 50

Sébastien Cros

Corporate Communications Director

rachel.mooney@galderma.com

+41 79 529 59 85

Rachel Mooney

Global Franchise Communications

+41 76 261 64 41

References:

[1] Stander S, et al. Late breaking abstract presented at WCD 2023

[2] Galderma. START Topline results. Presented at WCD 2023

[3] Galderma. This.Is.Sensitive Topline results. Presented at WCD 2023

[4] Acne Scarring Burden Global Report 2021

[5] Abad-Casintahan F, et al. J Dermatol 2016; 43: 826–828

[6] Zaenglein AL, et al. J Am Acad Dermatol 2016; 74: 945–973

[7] Asai Y, et al. CMAJ 2016; 188: 118–126

[8] Nast A, et al. J Eur Acad Dermatol Venereol 2016; 30: 1261–1268

28/06/2023

Galderma receives FDA approval for its newest hyaluronic acid filler, Restylane® Eyelight™

Lucie.Tesquier — Fri, 02 Jun 2023 14:37:39 +0000

Galderma receives FDA approval for its newest hyaluronic acid filler, Restylane® Eyelight™ Lucie.Tesquier Fri, 06/02/2023 - 14:37

Restylane Eyelight is the first and only product in the U.S. to use NASHA^® Technology to improve the appearance of undereye hollows for up to 18 months¹

DALLAS, TEXAS – June 5, 2023 – Galderma announced today the U.S. Food and Drug Administration (FDA) approved Restylane^®Eyelight for the treatment of undereye hollows, also known as dark shadows, in adults over the age of 21.¹ Restylane Eyelight, an undereye hyaluronic acid (HA) dermal filler, is the first and only product in the U.S. formulated with NASHA^® Technology for volume loss under the eyes, giving patients natural-looking results.¹

“Restylane Eyelight is an exciting new treatment option for patients. Formulated with NASHA Technology, this filler is close to the body’s natural hyaluronic acid with minimal crosslinking and produces a firm gel texture (or ‘supportive gel’) that is resistant to water absorption, which makes Restylane Eyelight a safe, natural-looking solution for volume loss under the eyes.^2-4”

Bill Andriopoulos, Ph.D.

Vice President, Medical Affairs

Galderma U.S.

For millions of Americans, dark circles can make individuals feel older, tired and stressed.⁵ Dr. Carolyn Jacob, a board-certified dermatologist based in Chicago and a lead investigator in the clinical trial of Restylane Eyelight sees firsthand how undereye concerns are top of mind for consumers.

“Many of my patients seek treatment for hollows under the eyes, and topical products such as creams, concealers and undereye masks just aren’t able to solve the problem and provide the long-lasting results they are seeking. I’m pleased to see that Restylane Eyelight offers a safe, effective and natural-looking outcome that enables my patients to achieve their aesthetic undereye goals, with results that last up to 18 months with optimal treatment.^1,6”

Carolyn Jacob

Board Certified Dermatologist & Medical Director

Chicago Cosmetic Surgery and Dermatology

Paid Galderma Consultant

This FDA approval is supported by efficacy and safety data from a randomized, evaluator-blinded, parallel group, no-treatment controlled, multi-center Phase 3 study to evaluate the effectiveness and safety of Restylane Eyelight for correction of volume loss under the eyes.⁶

Lack of volume and volume loss in the undereye region can create shadows and emphasize dark circles, leading to the appearance of tiredness and/or aging.⁷ In the Phase 3 study, 87% of patients* had reduced undereye hollowness at 3 months,⁶^† and Restylane Eyelight was found to be well tolerated under the eyes. At 3 months, 92% of patients* were pleased with their results, and 84% were still pleased through 1 year.⁶ The study also yielded high satisfaction, with 93% of patients* expressing interest in receiving treatment again after 12 months.⁶

Restylane’s legacy with safety continues with this Phase 3 trial where most patients* (87%) did not experience adverse events related to treatment with Restylane Eyelight,⁶ giving patients a new treatment option that is safe and effective for the under eyes.

The most commonly observed side effects for undereye injection are swelling, redness, tenderness, pain, bruising, itching, and lumps or bumps at the injection site.^1,6 Most adverse events were mild in severity (75%) and none were severe. There was no incidence of Tyndall effect (blue discoloration) after treatment with Restylane Eyelight.

^{*Patient=Clinical trial subject}

^{† At least 1-grade improvement on the Galderma Infraorbital hollows scale (GIHS)}

Availability of Restylane Eyelight

Restylane Eyelight will be available in aesthetic practice locations across the country over the next several months. To learn more about Restylane Eyelight and the full Restylane portfolio visit RestylaneUSA.com and follow @RestylaneUSA.

About Galderma’s Restylane Product Portfolio

The FDA approval of Restylane Eyelight adds to Galderma’s growing Restylane product portfolio. With over 65 million treatments worldwide and counting, the Restylane family of HA dermal fillers is the broadest portfolio of dermal fillers in the U.S.^8‡ Please refer to the safety information for the approved uses of the Restylane product portfolio.

^{‡ Based on rheological properties (G' and X strain)}

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 spans 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’re in shapes our lives, we are advancing dermatology for every skin story. For more information, please visit www.galderma.com/us.

To earn exclusive rewards, bonuses and discounts on Galderma's aesthetic treatments, join the ASPIRE Rewards program. To learn more about ASPIRE, visit www.aspirerewards.com.

# # #

Media Relations

Jeffrey Smith

Head of U.S. Communications

+ 1 682 401 8428

Christian Marcoux, M.Sc.

Chief Communications Officer

rachel.mooney@galderma.com

+41 76 315 26 50

Rachel Mooney

Global Franchise Communications

+41 76 261 64 41

IMPORTANT SAFETY INFORMATION

The Restylane family of products are indicated for patients over the age of 21, and includes Restylane®, Restylane-L®, Restylane® Lyft with Lidocaine, Restylane® Silk, Restylane® Kysse, Restylane® Refyne, Restylane® Defyne, Restylane® Contour, and Restylane® Eyelight.

APPROVED USES

Restylane® and Restylane-L® are for mid-to-deep injection into the facial tissue for the correction of moderate to severe facial wrinkles and folds, such as nasolabial folds. Restylane® and Restylane-L® are also indicated for injection into the lips.

Restylane® Lyft with Lidocaine is for deep implantation into the facial tissue for the correction of moderate to severe facial wrinkles and folds, such as nasolabial folds and for cheek augmentation and for the correction of age-related midface contour deficiencies. Restylane® Lyft with Lidocaine is also indicated for injection into the dorsal hand to correct volume loss.

Restylane® Silk is for lip augmentation and for correction of perioral wrinkles.

Restylane® Kysse is for lip augmentation and for correction of upper perioral wrinkles.

Restylane® Refyne is for mid-to-deep injection into the facial tissue for the correction of moderate to severe facial wrinkles and folds, such as nasolabial folds.

Restylane® Defyne is for mid-to-deep injection into the facial tissue for the correction of moderate to severe deep facial wrinkles and folds, such as nasolabial folds. Restylane® Defyne is also indicated for injection into the mid-to deep dermis (subcutaneous and/or supraperiosteal) for augmentation of the chin region to improve the chin profile in patients with mild to moderate chin retrusion.

Restylane® Contour is for cheek augmentation and for the correction of midface contour deficiencies.

Restylane® Eyelight is for the improvement of infraorbital hollowing.

Do not use if you have severe allergies with a history of severe reactions (anaphylaxis), are allergic to lidocaine or gram-positive bacterial proteins used to make hyaluronic acid, prone to bleeding, or have a bleeding disorder. The safety of use while pregnant or breastfeeding has not been studied. Tell your doctor if you have a history of scarring or pigmentation disorders as these side effects can occur with hyaluronic acid fillers. Tell your doctor if you are planning other cosmetic treatments (i.e., lasers and chemical peels) as there is a possible risk of inflammation at the injection site.

Tell your doctor if you’re taking medications that lower your body’s immune response or affect bleeding, such as aspirin or warfarin, as these medications may increase the risk of bruising or bleeding at the gel injection site. Using these products on gel injection sites with skin sores, pimples, rashes, hives, cysts, or infections should be postponed until healing is complete.

The most common side effects are swelling, redness, pain, bruising, headache, tenderness, lump formation, itching at the injection site, and impaired hand function. Delayed-onset inflammation near the site of dermal filler injections is one of the known adverse events associated with dermal fillers, and cases have been reported to occur at the dermal filler treatment site following viral or bacterial illnesses or infections, vaccinations, or dental procedures. Typically, the reported inflammation was responsive to treatment or resolved on its own. Serious but rare side effects include delayed onset infections, recurrence of herpetic eruptions, and superficial necrosis at the injection site. The risk of unintentional injection into a blood vessel is small but can occur and could result in serious complications, which may be permanent including, vision abnormalities, blindness, stroke, temporary scabs, or permanent scarring of the skin. As with all skin injection procedures, there is a risk of infection.

To report a side effect with any Restylane product, please call Galderma Laboratories, L.P at 1-855-425-8722. To learn more about serious but rare side effects and full Important Safety Information, visit www.RestylaneUSA.com.

REFERENCES AND NOTES

Restylane Eyelight. Instructions for Use. Galderma Laboratories, L.P. 2023.
Data on file. MA-34483 Study Report. Galderma Laboratories, L.P. 2021.
Kablik J, Monheit GD, Yu L, et al. Comparative physical properties of hyaluronic acid dermal fillers. Dermatol Surg. 2009 Feb; 35 Suppl 1:302-12.
Data on file. MA-53297 Study Report. Galderma Laboratories, L.P. 2022.
Data on file. Analysis of consumer social media conversation/digital behaviors. Galderma Laboratories, L.P. 2023.
Data on file. 43USTT1904 Clinical Study Report. Galderma Laboratories, L.P. 2022.
Vrcek I, Ozgur O, Nakra T. Infraorbital Dark Circles: A Review of the Pathogenesis, Evaluation and Treatment. J Cutan Aesthet Surg. 2016 Apr-Jun;9(2):65-72.
Data on file. MA-39680 Report. Galderma Laboratories, L.P. 2023.

05/06/2023

Galderma receives FDA approval for Sculptra® for cheek wrinkles

Lucie.Tesquier — Wed, 26 Apr 2023 09:42:20 +0000

Galderma receives FDA approval for Sculptra® for cheek wrinkles Lucie.Tesquier Wed, 04/26/2023 - 09:42

Sculptra^® helps improve skin quality and results can last up to 2 years^1-2

The first and original PLLA collagen stimulator is now approved for the correction of fine lines and wrinkles in the full cheek area^3-4

Dallas, Texas – April 26, 2023 – Galderma announced today that the U.S. Food and Drug Administration (FDA) has approved Sculptra® (injectable poly-L-lactic acid (PLLA-SCA)) for the correction of fine lines and wrinkles in the cheek area.³

Sculptra is the first and original FDA-approved PLLA collagen stimulator that, when injected into the cheek area, helps stimulate natural collagen production to smooth wrinkles and improve skin quality such as firmness and glow, with results lasting up to 2 years.^1-5

Sculptra achieved its primary efficacy endpoint of ≥1-grade improvement in cheek wrinkles at rest and its secondary endpoint of addressing cheek wrinkles when smiling for up to 2 years.^3*

“The long-standing science, safety and efficacy behind Sculptra makes this FDA approval a meaningful milestone for Galderma. With 95% of patients^† still showing improved skin glow two years after treatment when injected into the cheek region,¹ we recognize how much of an impact biostimulators can have on the aging face. This new indication allows for Sculptra to pave the way as a leader in the PLLA collagen stimulator category, and we are excited to see what the future holds for this innovative product.”

Bill Andriopoulos, Ph.D.

Vice President of Medical Affairs at Galderma U.S.

Patients^† showed sustained aesthetic improvement in cheek wrinkles throughout the study with 96% showing improvement at 3 months, 94% showing improvement at 1 year and 94% showing improvement at 2 years.^1,6‡

“Sculptra is a foundational treatment that helps smooth wrinkles and offers the added benefit of improved skin quality – helping to firm sagging skin for a more radiant and glowing appearance.^1-3 My patients will be extremely pleased that they can now receive Sculptra in the broader cheek region to support collagen growth and to make their skin look more refreshed and rejuvenated.^3,5,7”

Sabrina Fabi, MD

Double board-certified dermatologist and dermatologic cosmetic surgeon in California, who served as an investigator in clinical trials of Sculptra for cheek wrinkle treatments

This FDA approval is supported by efficacy and safety data from a randomized, evaluator-blinded, no-treatment controlled, multicenter study to evaluate the effectiveness and safety of Sculptra for correction of cheek wrinkles.

To learn more about Sculptra, visit www.SculptraUSA.com and follow the conversation on Instagram at @SculptraUSA.

*≥1-grade improvement on the Galderma Cheek Wrinkles Scale (GCWS; At rest and Dynamic)

†Patients = clinical trial participants

‡Rating of ‘improved’ or better on the Global Aesthetic Improvement Scale (GAIS)

About Sculptra^®

Sculptra (injectable poly-L-lactic acid (PLLA-SCA)) is indicated for use in people with healthy immune systems for the correction of shallow to deep nasolabial fold contour deficiencies, fine lines and wrinkles in the cheek region, and other facial wrinkles.³

Sculptra is an injectable collagen stimulator containing microparticles of poly-L-lactic acid (PLLA-SCA) which help gradually revitalize the skin’s structural foundation, smoothing wrinkles and improving overall skin quality to provide natural-looking, long-term results for up to 2 years.^1-3,5,7§ Sculptra was first approved for aesthetic use in 2009 in the United States and is currently available in more than 40 countries globally. To learn more about Sculptra products, visit www.SculptraUSA.com.

§Clinical study ended at 96 weeks (2 years)

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 spans 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’re in shapes our lives, we are advancing dermatology for every skin story. For more information, please visit www.galderma.com/us.

To earn exclusive rewards, bonuses and discounts on Galderma's aesthetic treatments, join the ASPIRE Rewards program. To learn more about ASPIRE, visit www.aspirerewards.com.

For further information:

Christian Marcoux, M.Sc.

Chief Communications Officer

+41 76 315 26 50

Jeffrey Smith

Head of U.S. Communications

+1 (682) 401-8428

IMPORTANT SAFETY INFORMATION

Indication: Sculptra® (injectable poly-L-lactic acid (PLLA-SCA)) is indicated for use in people with healthy immune systems for the correction of shallow to deep nasolabial fold contour deficiencies, fine lines and wrinkles in the cheek region, and other facial wrinkles.

Sculptra should not be used by people that are allergic to any ingredient of the product or have a history of keloid formation or hypertrophic scarring. Safety has not been established in patients who are pregnant, lactating, breastfeeding, or under 18 years of age.

Sculptra has unique injection requirements and should only be used by a trained healthcare practitioner. Contour deficiencies should not be overcorrected because they are expected to gradually improve after treatment.

Sculptra should not be injected into the blood vessels as it may cause vascular occlusion, infarction or embolic phenomena. Use at the site of skin sores, cysts, pimples, rashes, hives or infection should be postponed until healing is complete. Sculptra should not be injected into the red area (vermillion) of the lip or in the peri-orbital area.

The most common side effects after initial treatment include injection site swelling, tenderness, redness, pain, bruising, bleeding, itching and lumps. Other side effects may include small lumps under the skin that are sometimes noticeable when pressing on the treated area. Larger lumps, some with delayed onset with or without inflammation or skin discoloration, have also been reported.

Sculptra is available only through a licensed practitioner. Complete Instructions for Use are available at www.SculptraUSA.com.

References:

Data on file. 43USSA1812EXT clinical study report. Fort Worth, TX: Galderma Laboratories, L.P. 2022.

Bohnert K. et al. Randomized, Controlled, Multicentered, Double-Blind Investigation of Injectable Poly-L-Lactic Acid for Improving Skin Quality Dermatol Surg 2019;45:718–724.

Sculptra. Instructions for Use. Galderma Laboratories, L.P. 2023.

Bergeret-Galley C. Comparison of Resorbable Soft Tissue Fillers. Aesthetic Surg J 2004; 24:33-46.

Goldberg D, Guana A, Volk A, Daro- Kaftan EDermatol Surg. 2013;39(6):915-922.

Data on file. 43USSA1812 Clinical study report. Fort Worth, TX: Galderma Laboratories, L.P., 2022.

Fitzgerald R, et al. Aesthet Surg J. 2018;38(suppl_1): S13-S17.

26/04/2023