Galderma’s Relfydess™ (RelabotulinumtoxinA) Receives Positive Decision for Use in Europe

Ad hoc announcement pursuant to Art. 53 LR

• Relfydess^TM      (RelabotulinumtoxinA) is the first and only ready-to-use liquid      neuromodulator created with PEARL^TM Technology, developed and      manufactured by Galderma^1,2

• This positive decision is      based on results from the phase III READY clinical trial program, which      showed that Relfydess^TM delivered sustained results for six      months, combined with an onset of action as early as day one, for both      frown lines and crow’s feet^3-8

• Galderma is committed to      developing and delivering the broadest portfolio in Injectable Aesthetics

• Once national approvals have      taken place, Relfydess^TM will be the first neuromodulator in      Europe to receive initial approval for two indications – frown lines and      crow’s feet – at the same time

• Relfydess^TM also      received marketing authorization from Australia’s Therapeutic Goods      Administration in June this year

ZUG, Switzerland -- (BUSINESS WIRE) --

Galderma today announced that it has completed its European decentralized procedure (DCP), resulting in a positive decision for Relfydess^TM (RelabotulinumtoxinA – previously referred to as QM1114). Relfydess^TM is indicated for the temporary improvement in the appearance of moderate-to-severe glabellar lines (frown lines) at maximum frown and lateral canthal lines (crow’s feet) seen at maximum smile, alone or in combination, in adult patients under 65 years, when the severity of these lines has an important psychological impact on the patient.⁹ Following the successful completion of the DCP, national approvals in the 16 concerned countries are now under finalization. Relfydess^TM also received a marketing authorization in Australia earlier this year.

Relfydess^TM is developed and manufactured by Galderma. It is the first and only ready-to-use liquid neuromodulator created with PEARL™ Technology that is designed to preserve molecule integrity to deliver a highly active, innovative, complex-free molecule, with up to 39% of patients seeing effects from day one and up to 75% of patients maintaining improvements for six months for frown lines and crow’s feet.^3,4,7,8 It is optimized for simple volumetric dosing, without reconstitution, to increase ease of use and help ensure consistent dose/volume.^1,10

This positive decision, and the previous Therapeutic Goods Administration approval in Australia, were based on results from the phase III READY (RElabotulinumtoxin Aesthetic Development StudY) clinical trial program, which enrolled more than 1,900 participants. Results showed:^3,4,7,8

• Improvement in both frown      lines and crow’s feet versus placebo:

• In READY-1 and       READY-2, treatment with Relfydess^TM demonstrated a 96.3%       none-or-mild responder rate for frown lines and 87.2% for crow’s feet,       after one month, vs 4.5% and 11.9% for placebo, respectively.

• Onset of action as soon as      day one:

• In READY-1 and       READY-2, 39% of patients reported improvements for frown lines and 34%       reported improvements for crow’s feet from day one.

• Sustained results for six      months:

• In READY-1 and       READY-2, up to 75% of patients maintained improvements for six months.

• At month one, up to       96% achieved none-or-mild frown lines and crow’s feet, which was       sustained for six months in almost a quarter of patients.

• Patient satisfaction was      maintained for six months following treatment.

Regulatory applications for Relfydess™ for the treatment of frown lines and crow’s feet will continue to be submitted and assessed by additional authorities globally.

About Relfydess^TM (RelabotulinumtoxinA)

Pioneered by Galderma, Relfydess^TM is the first and only ready-to-use liquid neuromodulator created with PEARL^TM Technology that is designed to preserve molecule integrity.^1,2 PEARL^TM Technology is designed to deliver a highly active, innovative, complex-free molecule, with up to 39% of patients seeing effects from day one and up to 75% of patients maintaining improvements for six months.^1-4,7,8 Relfydess^TM is optimized for simple volumetric dosing, without reconstitution, to increase ease-of-use and help ensure consistent dose/volume every time.^1,10 It was entirely developed and manufactured by Galderma to expand its neuromodulator portfolio as part of the broadest Injectable Aesthetics portfolio on the market.

About the READY clinical trial program

The READY (RElabotulinumtoxin Aesthetic Development StudY) phase III clinical program is composed of four phase III clinical trials which enrolled more than 1,900 participants.^3-6 The READY trials investigated the safety, efficacy, rapidity of onset and/or durability of Relfydess^TM for six months on:

• Frown lines (READY-1).³

• Crow’s feet (READY-2).⁴

• Frown lines and crow’s feet      when treated alone or simultaneously (READY-3).⁵

• Frown lines and crow’s feet      when treated alone or simultaneously with up to four repeated injections      over 52 weeks (READY-4).⁶

About Galderma

Galderma (SIX: GALD) 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 through Injectable Aesthetics, Dermatological Skincare and Therapeutic Dermatology. Since our foundation in 1981, we have dedicated our focus and passion to the human body’s largest organ – the skin – meeting individual consumer and patient needs with superior outcomes in partnership with healthcare professionals. Because we understand that the skin we are in shapes our lives, we are advancing dermatology for every skin story. For more information: www.galderma.com.

References:

1. Sundberg AL and Stahl U.      Relabotulinum toxin - a novel, high purity BoNT-A1 in liquid formulation.      Presented at: TOXINS 2021; Jan 16-17, 2021; virtual meeting

2. Do M, et al. Purification      process of a complex-free highly purified botulinum neurotoxin type A1      (BoNT-A1) - relabotulinumtoxinA. Presented at: TOXINS 2022; July 27-30,      2022; New Orleans, LA

3. Galderma. Data on file.      Clinical Study Report for Protocol 43QM1602: READY-1. Galderma      Laboratories; 2021

4. Galderma. Data on file.      Clinical Study Report for Protocol 43QM1901: READY-2. Galderma      Laboratories; 2021

5. Galderma. Data on file.      Clinical Study Report for Protocol 43QM1902: READY-3. Galderma      Laboratories; 2021

6. Galderma. Data on file.      Clinical Study Report for Protocol 43AM1903: READY-4. Galderma      Laboratories; 2021

7. Shridharani SM, et al.      Efficacy and Safety of RelabotulinumtoxinA, a New Ready-to-Use Liquid      Formulation Botulinum Toxin: Results From the READY-1 Double-Blind,      Randomized, Placebo-Controlled Phase 3 Trial in Glabellar Lines. Aesthetic      Surgery Journal. 2024; sjae131

8. Ablon G, et al. Treatment of      Lateral Canthal Lines with RelabotulinumtoxinA, an Investigational Liquid      Botulinum Toxin: Clinical Efficacy and Safety Results from the READY-2      Phase III Trial. Abstract presented at TOXINS 2024; Jan 17-20, 2024,      Berlin

9. Relfydess^® EU      Summary of Product Characteristics

10. Persson C, et al. Patient and      Investigator Treatment Experience with Ready-to-Use AbobotulinumtoxinA      Solution Versus Powder BotulinumtoxinA for Treatment of Glabellar Lines.      Abstract presented at TOXINS 2024; Jan 17-20, 2024, Berlin