19 slides from Evolus, Inc. Common Stock's earnings presentation, Nov 7, 2023
Slide 1: Jeuveau Extra-Strength Phase II Trial: Final Top Line Results
Jeuveau Extra-Strength Phase II, Randomized, Double Blind, Active- Controlled, Increasing Dose Trial to Study: Final Top Line Results Dr Rui Avelar, MD Chief Medical Officer and Head of R&D
Slide 2: Jeuveau Extra-Strength Phase II Duration Study: Glabellar Lines
Jeuveau Extra-Strength Phase II Duration Study Glabellar Lines Study the safety and duration of effect of prabotulinum at an increased dose for the treatment of moderate to severe glabellar lines • Dose Doubled • Hyper-concentrated Primary Objective • Duration of effect, time back to baseline by inv
Slide 3: Clinical Investigators
• Dr Sue Ellen Cox Clinical • Dr Steve Fagien • Dr John Joseph Investigators • Dr Joely Kaufman-Janette • Dr Keith Marcus 3
Slide 4: Study Design
Jeuveau Extra-Strength Phase II Duration Study Study Design • Multi-center, double blind, • Study Population randomized, active controlled • Stable healthy adults, min • 5 sites 18 years of age • N=150 • Moderate (GLS=2) to Severe (GLS=3) glabellar lines at • Three arms, randomization 1:1:1 max frow
Slide 5: Baseline Characteristics
Jeuveau Extra-Strength Phase II Duration Study Baseline Characteristics PraB E-S 40U OnaB 20U PraB 20U N=51 N=50 N=53 Age in years, mean (range) 46.8 (20,69) 47 (25, 72) 46.8 (22, 72) 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%) 1 (2%)
Slide 6: Baseline Characteristics
Jeuveau Extra-Strength Phase II Duration Study Baseline Characteristics 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 11 (
Slide 7: Safety – Adverse Events
PraB ES OnaB 20U PraB 20U Adverse Event Summary 40U N=50 N=53 Jeuveau Extra- N=51 Strength Phase II # Events (N=36) Duration Study All Adverse Events 8 (22.2%) 12 (33.3%) 16 (44.4%) Safety – Adverse Events Drug Related Adverse Events 3 2 3 # Subjects with AE’s (N=26) All Adverse Events 7 (13.7%) 11
Slide 8: Safety – Adverse Events Severity
Jeuveau Extra-Strength Phase II Duration Study Safety – Adverse Events Adverse Event Severity PraB ES OnaB 20U PraB 20U • Number of AE’s, 36 Adverse Event Summary 40U N=50 N=53 N=51 events • Mild: 88.9% Severity of AE's • Moderate: 11.1% Mild 7 (87.5%) 9 (75.0%) 16 (100)% • Severe: 0% Moderate 1 (12
Slide 9: Duration: Return to Baseline Kaplan-Meier
Jeuveau Extra-Strength Phase II Duration Study Duration Kaplan-Meier: Return to Baseline Glabellar Lines Scale at Maximum Frown Investigator Assessment PRA 40U vs PRA 20U: HR 1.892, p-value 0.0109 PRA 40U vs ONA 20U: HR 2.38, p-value 0.0002 Prabotulinum ES 40U • 183 [153, 211] days, 26.1 weeks, 6.0
Slide 10: Duration: ≥1 Point Improvement Kaplan-Meier
Jeuveau Extra-Strength Phase II Duration Study Duration Kaplan-Meier: ≥1 Pt Improvement Glabellar Line Scale at Maximum Frown Investigator Assessment PRA 40U vs PRA 20U: HR 1.892, p-value 0.0109 PRA 40U vs ONA 20U: HR 2.38, p-value 0.0002 Prabotulinum ES 40U • 183 [153, 211] days, 26.1 weeks, 6.0 mo
Slide 11: Duration: Global Aesthetic Improvement Return to Baseline
Jeuveau Extra-Strength Phase II Duration Study Duration Kaplan-Meier: Global Aesthetic Improvement Return to Baseline (Improved, Much Improved) Investigator Assessment PRA 40U vs PRA 20U: HR 2.096, p-value 0.0006 PRA 40U vs ONA 20U: HR 2.39, p-value 0.0002 Prabotulinum ES 40U • 184 [153, 212] days,
Slide 12: Efficacy: None or Mild Glabellar Line
Jeuveau Extra-Strength Phase II Duration Study Efficacy: None or Mild Glabellar Line None or Mild Glabellar Line Scale at Maximum Frown Investigator Assessment Subject Assessment No data collected btw Day 2 and Day 30 No data collected btw Day 2 and Day 30 Study Compliance Subjects Completing Study:
Slide 13: The Importance of Baseline Characteristics
The Importance of Baseline Characteristics Glabellar Line Scale At Maximum Frown Severity Score Description Glabellar Line Scale Score at 0 No Lines Maximum Frown None or Mild Glabellar Lines Responder 1 Mild Lines as a Responder Definition 1 Pt 2 Moderate Lines Non-Responder 2 Pt 3 Severe Lines 13
Slide 14: Efficacy: None or Mild Responders, Pra 40U vs Daxi 40U Sakura 1
Jeuveau Extra-Strength Phase II Duration Study Efficacy: None or Mild Glabellar Line Responders None or Mild Glabellar Lines at Maximum Frown Investigator and Subject Assessment Pra 40U vs Daxi 40U Sakura 1 Baseline Demographics Daxibotulinum Sakura 1 61.2% Moderate 1pt change required Prabotulinum
Slide 15: Efficacy: None or Mild Responders, Pra 40U vs Daxi 40U Sakura 2
Jeuveau Extra-Strength Phase II Duration Study Efficacy: None or Mild Glabellar Line Responders None or Mild Glabellar Lines at Maximum Frown Investigator and Subject Assessment Pra 40U vs Daxi 40U Sakura 2 Baseline Demographics Daxibotulinum Sakura 1 63.2% Moderate 1pt change required Prabotulinum
Slide 16: FDA Guidance: Upper Facial Lines Efficacy Endpoints
Guidance for Industry =) Upper Facial Lines: r Developing Botulinum Toxin — Drug Products August 2014 Efficacy Endpoints Success should be defined as achievement of a score of 0 or 1 and a two-grade improvement from the baseline, on both the IA and the SSA scales concurrently, to ensure clinical sig
Slide 17: Efficacy: Glabellar Line Scale Composite Score
Jeuveau Extra-Strength Phase II Duration Study Efficacy: Glabellar Line Scale Composite Score None or Mild at Maximum Frown and ≥ 2-Point Improvement Investigator + Subject Assessment (FDA Composite Score) * * *Daxxify® FDA Prescribing Information (Graph GL1 and GL2) No prabot data collected between
Slide 18: Summary
Jeuveau Extra-Strength Phase II Duration Study Summary Safety • Profile similar across the groups • 88.9% of AE’s mild, 11.1% moderate • No Serious adverse events Duration • Time to return to baseline among multiple parameters was 26 weeks or 6 months 18
Slide 19: Thank you!
Thank you! CVOLUS OFAC IC