23 slides from Evolus, Inc. Common Stock's technical presentation, Jan 30, 2023
Slide 1: Jeuveau Extra-Strength Longer Duration Phase II Study First Interim Analysis
Jeuveau® Extra-Strength Longer Duration Phase II Study First Interim Analysis Rui Avelar, MD Chief Medical Officer and Head of R&D
Slide 2: Disclosures: Special Note Regarding Forward-Looking Statements
Disclosures Special Note Regarding Forward-Looking Statements • This presentation contains forward-looking statements as defined under the Private Securities Litigation Reform Act of 1995. All statements other than statements of historical facts contained in this presentation, including statements r
Slide 3: Jeuveau Extra-Strength Phase II Study Glabellar Line Duration
Jeuveau® Extra-Strength Phase II Study Glabellar Line Duration • Objective • Study the safety and duration of effect of prabotulinumtoxinA at an increased dose for the treatment of moderate to severe glabellar lines • Extra-strength formulation • Dose doubled • Hyper-concentrated
Slide 4: Duration Studies: What's Measured?
Duration Studies What’s Measured? • Duration Parameters • Glabellar Line Scale • Global Aesthetic Improvement • Subject Satisfaction
Slide 5: Measuring Duration: Kaplan Meier Plots
Measuring Duration Kaplan Meier Plots
Slide 6: Time Axis Calendar Math
Time Axis Calendar Math Days Weeks Months Hours = Days Days = Weeks Weeks ≠ Months 13 24 7 4 Months Weeks = Months 12 4.345 Months
Slide 7: Glabellar Lines: Study Design
Jeuveau Extra-Strength Phase II Study Glabellar Lines: Study Design • Study Design • Single treatment • Study Population • Multi-center, double blind, • Stable healthy adults, minimum 18 years of age randomized, active controlled • Moderate (GLS=2) to severe (GLS=3) glabellar • 5 sites lines at maxi
Slide 8: Glabellar Lines: Study Design
Jeuveau Extra-Strength Phase II Study Glabellar Lines: Study Design “Extra Strength” Test Formulation • 40U prabotulinum • 8U/0.05mL x 5 injections
Slide 9: Glabellar Lines: Study Objective
Jeuveau Extra-Strength Phase II Study Glabellar Lines: Study Objective • Primary Objective • Duration of effect, time back to baseline by investigatory assessment
Slide 10: Glabellar Lines: Baseline Demographics
Jeuveau Extra-Strength Phase II Study Glabellar Lines: Baseline Demographics PraB E-S 40U OnaB 20U PraB 20U N=51 N=50 N=53 Age in years, mean (range) 46.8 (20,69) 50 (39, 53) 46.8 (39.0, 56.0) Gender Female n (%) 48 (94.1%) 47 (94.0%) 50 (94.3%) Male n (%) 3 (5.9%) 3 (6.0%) 3 (5.7%) Race Asian 0 (0%
Slide 11: Glabellar Lines: Baseline Demographics
Jeuveau Extra-Strength Phase II Study Glabellar Lines: Baseline Demographics PraB E-S 40U OnaB 20U PraB 20U N=51 N=50 N=53 GLS Score at Max Frown by Investigator, n (%) Moderate 15 (29.4%) 14 (28.0%) 18 (34.0%) Severe 36 (70.6%) 36 (72.0%) 35 (66.0%) GLS Score at Max Frown by Subject, n (%) Moderate
Slide 12: Glabellar Line Scale Score: None and Mild as a Responder Definition
Glabellar Line Scale Score None and Mild as a Responder Definition Glabellar Line Scale At Maximum Frown The Importance of Severity Score Baseline Characteristics Description 0 No Lines Responder 1 Mild Lines Non-Responder 1 Pt 2 Moderate Lines 2 Pt 3 Severe Lines
Slide 13: Safety
Safety
Slide 14: Safety – Adverse Events
Jeuveau Extra-Strength Phase II Study Safety – Adverse Events Adverse Event Summary PraB ES 40U OnaB 20U PraB 20U N=51 N=50 N=53 # Events (N=33) All Adverse Events 6 (18.2%) 11 (33.3%) 16 (48.5%) Drug Related Adverse Events 3 2 3 # Subjects with AE’s (N=26) All Adverse Events 6 (11.8%) 10 (20%) 10 (
Slide 15: Safety – Adverse Events
Jeuveau Extra-Strength Phase II Study Safety – Adverse Events Adverse Event Severity • Number of AE’s, 33 events • Mild: 88% Adverse Event Summary PraB ES 40U OnaB 20U PraB 20U • Moderate: 12% N=51 N=50 N=53 • Severe: 0% Severity of AE's Mild 5 (83.3%) 8 (72.7%) 16 (100)%) • Eyelid ptosis Moderate 1
Slide 16: Interim Results: Duration of Effect
Interim Results Duration of Effect
Slide 17: Duration: None or Mild GLS back to Baseline
Jeuveau Extra-Strength Phase II Study Duration: None or Mild GLS back to Baseline None (0) or Mild (1) Glabellar Line Scale Responders Back to Baseline Investigator Assessment Percent of Patients (%) Days From Treatment GLS – Glabellar Line Scale
Slide 18: Duration: GLS Back to Baseline
Jeuveau Extra-Strength Phase II Study Duration: GLS Back to Baseline Return of Glabellar Line Scale Score Back to Baseline Percent of Patients (%) Investigator Assessment Days From Treatment GLS – Glabellar Line Scale
Slide 19: Duration: ≥1 Pt Improvement GLS
Jeuveau Extra-Strength Phase II Study Duration: ≥1 Pt Improvement GLS ≥ 1 Pt or Greater Glabellar Line Scale Responders Duration Investigator Assessment Percent of Patients (%) Days From Treatment GLS – Glabellar Line Scale
Slide 20: Duration: Global Aesthetic Improvement
Jeuveau Extra-Strength Phase II Study Duration: Global Aesthetic Improvement Global Aesthetic Improvement Scale Back to Baseline Investigator Assessment Percent of Patients (%) Days From Treatment
Slide 21: Interim Analysis Summary
Jeuveau Extra-Strength Phase II Study Interim Analysis Summary • Safety • Profile similar across the groups • 88% of AE’s mild, 12% moderate • No serious adverse events • Duration • Multiple parameters demonstrating 6 months (26 weeks) duration • GLS score return to baseline • None or Mild GLS respo
Slide 22: Important Safety Information
Important Safety Information IMPORTANT SAFETY INFORMATION FOR JEUVEAU® (prabotulinumtoxinA-xvfs) JEUVEAU may cause serious side effects that can be life threatening. Get Especially tell your healthcare provider if you: have received any other botulinum toxin product in the past medical help right aw
Slide 23: Evolus
i Evolus www.evolus.com De