Methyl Aminolevulinate Hydrochloride

At the Liquid Live event in Dubai, the Company gears up for launch of Alluzience® in next wave of countries and presents exciting pipeline update ZUG, Switzerland--(BUSINESS WIRE)-- Galderma, the emerging pure-play dermatology category leader, today hosts the first edition of its Liquid Live event in Dubai as a chance to discuss with clinicians the future of innovation in the field of neuromodulation as well as showcasing the latest neuromodulators from its aesthetics portfolio. This press release features multimedia. View the full release here: Copyrights - Sylvain Granjon To mark the progress in treatment optimization and showcase its commitment to further driving innovation, Galderma has organized the first ever Liquid Live event. This premium experience will convene over one hundred of Europe’s leading aesthetics practitioners to immerse themselves in the future of the neuromodulator field. The Liquid Live event will include presentations from renowned experts on key data, the latest market trends and changes in patient needs, and sharing insights to advance the future of neuromodulation in aesthetics together. A year on from the launch of Alluzience®, the first and only liquid ready-to-use neuromodulator in Europe with rapid onset and effects lasting for up to six months, Galderma is now getting ready to launch the product in 13 new countries1. Indicated for use in adult patients as a treatment to temporarily improve the appearance of moderate to severe glabellar lines, this launch opened a new era of innovation in neuromodulation. As a ready-to-use liquid formulation, it has the potential to improve safety and dosing accuracy compared to existing neuromodulators that require reconstitution, enabling more precision and higher patient satisfaction. “Galderma is the leading innovator in neuromodulators and we are delighted to launch the Liquid Live event as an opportunity to convene leading experts in this field. Alluzience® has a unique pro its launch in 13 new countries is another exciting step in our journey of driving differentiated innovation and expanding our portfolio. Galderma has a strong track record as an innovator in neuromodulation having launched the first liquid neuromodulator, as well as the first neuromodulator with a six-month duration of action, and is committed to further innovation. Liquid Live offers the ideal platform for us to come together as we prepare to launch this unique product more broadly and explore the many possibilities for the future of neuromodulation together.” GERRY MUHLE HEAD OF GLOBAL PRODUCT STRATEGY GALDERMA Galderma is well-positioned to continue to build its category-leading pipeline in injectable aesthetics, with proven in-house R&D capabilities in medical aesthetics. This includes successfully developing RelabotulinumtoxinA internally as well as the world’s largest hyaluronic acid filler range, Restylane®. Along with Sculptra®, the first and original injectable poly-L-lactic acid collagen stimulator, Galderma’s offering in neuromodulators and fillers is the broadest, unparalleled injectable aesthetics portfolio. About Alluzience® Alluzience (abobotulinumtoxinA solution) is the first ready-to-use BoNT-A liquid neuromodulator formulation to be introduced in Europe. Alluzience is indicated for the temporary improvement in the appearance of moderate to severe glabellar lines seen at maximum frown in adult patients under 65 years, when the severity of these lines has an important psychological impact on the patient. It should only be administered by a physician with appropriate qualifications and expertise in this treatment using the required equipment. Dosing and treatment intervals depend on assessment of the individual patient’s response. The treatment interval should be no more frequent than every three months. For more information, please see the Summary of Product Characteristics2. Alluzience is a product under license from Ipsen. Alluzience is a registered trademark of Ipsen. Galderma has an exclusive license from Ipsen to develop, promote and distribute Alluzience in the approved indication in Europe. 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: ---------------- 1 Bulgaria, Croatia, Cyprus, Czech Republic, Estonia, Greece, Hungary, Latvia, Lithuania, Malta, Romania, Slovenia and Slovakia 2 Alluzience Summary of Product Characteristics, 2023 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 Smart Multimedia Gallery Photo Copyrights - Sylvain Granjon Photo Copyrights - Sylvain Granjon Photo Copyrights - Sylvain Granjon Logo View this news release and multimedia online at:

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: