Methyl Aminolevulinate Hydrochloride

Galderma receives FDA Complete Response Letter with comments isolated to Chemistry, Manufacturing, and Controls items International Chamber of Commerce (ICC) arbitration is complete and the regulatory applications are under review Regulatory filings in other territories are ongoing and remain on track ZUG, Switzerland--(BUSINESS WIRE)-- Galderma, the emerging pure-play dermatology category leader, announced today updates related to the regulatory progress of its pending Biologics License Application (“BLA”) for RelabotulinumtoxinA (QM-1114) to the U.S. Food and Drug Administration (“FDA”). The FDA has issued a Complete Response Letter (“CRL”) to Galderma related to its BLA for RelabotulinumtoxinA for the treatment of moderate-to-severe glabellar lines (frown lines) associated with corrugator and/or procerus muscle activity in adult patients as well as moderate-to-severe lateral canthal lines (crow’s feet) associated with orbicularis oculi muscle activity in adult patients. The CRL points out certain deficiencies isolated to items related to Chemistry, Manufacturing, and Controls (“CMC”) processes. All other aspects of the BLA, including safety and efficacy related parts, did not solicit deficiencies to be addressed. Galderma has already identified changes to the manufacturing process to address feedback. It will also be seeking further guidance through continued open dialogue with the FDA toward resolution of the relevant issues. Further update on the regulatory filing strategy of RelabotulinumtoxinA and broader neuromodulator R&D partnership On September 28, 2023, the International Chamber of Commerce (ICC) issued its award on the arbitration commenced by Galderma in 2021 regarding the regulatory filing strategy for RelabotulinumtoxinA, and as a result, the arbitration is complete. While the award is confidential, the result is that the applications submitted for regulatory review are proceeding according to the initial strategy and Galderma and Ipsen await further feedback from regulators. Galderma remains responsible for development, regulatory filing and strategy, manufacturing, and commercialization. Interactions with regulatory authorities remain the responsibility of Galderma. Regulatory approval submissions and issued certificates will ultimately be in the name of Ipsen. The ICC award has no impact on the ongoing European decentralized procedure for the filing of RelabotulinumtoxinA nor on the commercialization of Galderma’s neuromodulator portfolio. Regulatory submissions in other territories are ongoing and remain on track. Furthermore, in a press release dated July 27, 2023, Ipsen made statements about the purported termination of the Galderma-Ipsen Research and Development (R&D) partnership. Galderma contests those statements and remains committed to resolution with Ipsen. Galderma remains committed to bringing scientific innovation to its healthcare professionals, consumers and patients globally by expanding its neuromodulator portfolio as part of the broadest Injectable Aesthetics portfolio on the market. 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:

ZUG, Switzerland--(BUSINESS WIRE)-- Galderma: 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 ReSURFACETM 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. 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 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: Forward-looking statements Certain statements in this announcement are forward-looking statements, including 2023 financial targets. Forward looking statements are statements that are not historical facts and may be identified by words such as "plans", "targets", "aims", " believes", "expects", "anticipates", "intends", "estimates", "will", "may", "continues", "should" and similar expressions. These forward-looking statements reflect, at the time, Galderma's beliefs, intentions and current targets/aims concerning, among other things, Galderma's results of operations, financial condition, industry, liquidity, prospects, growth and strategies and are subject to change. The estimated financial information is based on management's current expectations and is subject to change. By their nature, forward-looking statements involve a number of risks, uncertainties and assumptions that could cause actual results or events to differ materially from those expressed or implied by the forward-looking statements. These risks, uncertainties and assumptions could adversely affect the outcome and financial consequences of the plans and events described herein. Actual results may differ from those set forth in the forward-looking statements as a result of various factors (including, but not limited to, future global economic conditions, changed market conditions, intense competition in the markets in which Galderma operates, costs of compliance with applicable laws, regulations and standards, diverse political, legal, economic and other conditions affecting the Galderma's markets, and other factors beyond the control of Galderma). Neither Galderma nor its shareholders, directors, officers, employees, advisors, or any other person is under any obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise. You should not place undue reliance on forward-looking statements, which speak of the date of this announcement. Statements contained in this announcement regarding past trends or events should not be taken as a representation that such trends or events will continue in the future. Some of the information presented herein is based on statements by third parties, and no representation or warranty, express or implied, is made as to, and no reliance should be placed on, the fairness, reasonableness, accuracy, completeness or correctness of this information or any other information or opinions contained herein, for any purpose whatsoever. View source version on businesswire.com: Contacts For further information: Christian Marcoux, M.Sc. Chief Communications Officer christian.marcoux@galderma.com +41 76 315 26 50 Sébastien Cros Corporate Communications Director sebastien.cros@galderma.com +41 79 529 59 85 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 jessica.cohen@galderma.com +41 21 642 76 43 Source: Galderma View this news release online at: