Arcutis Biotherapeutics, Inc. · NASDAQ:ARQT
Arcutis Biotherapeutics — Investor Presentation (August 2022)
53 slides from Arcutis Biotherapeutics's investor presentation, Aug 2, 2022
Slide 1: Arcutis Biotherapeutics: Bioscience applied to the skin
Exhibit 99.2 e%® ACUTIS -, ~~ BIOTHERAPEUTICS Bioscience applied to the skin.
Slide 2: Legal Disclaimers
2©Copyright 2022. Arcutis Biotherapeutics, Inc. — Presentation designed for an investor audience. Legal Disclaimers This presentation and the accompanying oral presentation contain “forward-looking” statements that are based on our management’s beliefs and assumptions and on information currently av
Slide 3: 2022: A Transformational Year for Arcutis Continues
3©Copyright 2022. Arcutis Biotherapeutics, Inc. — Presentation designed for an investor audience. 2022: A Transformational Year for Arcutis Continues FDA approval of ZORYVE (roflumilast) in plaque psoriasis and imminent launch is the realization of our efforts to bring meaningful innovation to addre
Slide 4: Our Strategy to Build the Preeminent Immuno-Dermatology Company
4©Copyright 2022. Arcutis Biotherapeutics, Inc. — Presentation designed for an investor audience. Our Strategy to Build the Preeminent Immuno- Dermatology Company FDA = U.S. Food and Drug Administration; IP = intellectual property Developing potential best- in-class and innovative topical dermatolog
Slide 5: Broad and Deep Pipeline
5©Copyright 2022. Arcutis Biotherapeutics, Inc. — Presentation designed for an investor audience. Formulation Preclinical Phase 1 Phase 2 Phase 3 NDA Review Approved Commercial Rights Roflumilast Cream (ARQ-151) Worldwide Worldwide Roflumilast Foam (ARQ-154) Worldwide Worldwide ARQ-252 Cream (JAK1 I
Slide 6: Continued Execution Against Our Four Transformational Catalysts in 2022
6©Copyright 2022. Arcutis Biotherapeutics, Inc. — Presentation designed for an investor audience. Continued Execution Against Our Four Transformational Catalysts in 2022 * Phase 3 topline for INTEGUMENT-1 and -2; INTEGUMENT-PED expected in 2023 Roflumilast Cream Roflumilast Foam Atopic Dermatitis Ph
Slide 7: Topical Roflumilast Opportunity: ~7 million Dermatologist-Treated Patients in the U.S. Alone
7©Copyright 2022. Arcutis Biotherapeutics, Inc. — Presentation designed for an investor audience. Topical Roflumilast Opportunity: ~7 million Dermatologist-Treated Patients in the U.S. Alone Psoriasis Atopic Dermatitis Seborrheic Dermatitis Prevalence ~9M ~26M ~10M Topical Rx treated in Derm setting
Slide 8: ZORYVE - Next Generation PDE4 Inhibitor Approved for Plaque Psoriasis in Ages 12+
8©Copyright 2022. Arcutis Biotherapeutics, Inc. — Presentation designed for an investor audience. ZORYVE (zor-eev) - Next Generation PDE4 Inhibitor Approved for Treatment of Plaque Psoriasis in Ages 12+ PDE4 = phosphodiesterase-4 Uniquely broad label Once-daily treatment in mild, moderate, & severe
Slide 9: Arcutis Enjoys Strong IP Protection
9©Copyright 2022. Arcutis Biotherapeutics, Inc. — Presentation designed for an investor audience. Arcutis Enjoys Strong IP Protection1 1As of 6/1/22; PK = pharmacokinetics; PDE4 = phosphodiesterase 4; JAK = Janus Kinase Roflumilast Patent Protection Expected Until At Least 2037 1 Pending U.S. patent
Slide 10: Plaque Psoriasis - Significant Unmet Needs in Treatment Paradigm
10©Copyright 2022. Arcutis Biotherapeutics, Inc. — Presentation designed for an investor audience. Plaque Psoriasis - Significant Unmet Needs in Treatment Paradigm 1 Skin Insights: Uncovering Psoriasis survey of >500 adults who use topicals, March 2022 ~9M individuals in the U.S. affected Of patient
Slide 11: ZORYVE Cream – FDA-Approved U.S. Label in Psoriasis
11©Copyright 2022. Arcutis Biotherapeutics, Inc. — Presentation designed for an investor audience. ZORYVE Cream – FDA-Approved U.S. Label in Psoriasis WI-NRS: Worst Itch Numeric Rating Scale Once-daily treatment in mild, moderate, & severe plaque psoriasis Indication for ages 12+ Indication for trea
Slide 12: Rapid, Robust Efficacy on IGA Success in Both Phase 3 Plaque Psoriasis Trials
12©Copyright 2022. Arcutis Biotherapeutics, Inc. — Presentation designed for an investor audience. Rapid, Robust Efficacy on IGA Success in Both Phase 3 Plaque Psoriasis Trials IGA = Investigator’s Global Assessment; IGA Success = Clear or Almost Clear with at least a 2-grade improvement from baseli
Slide 13: Significant and Rapid Clearance of Plaques in DERMIS Phase 3 Studies
13©Copyright 2022. Arcutis Biotherapeutics, Inc. — Presentation designed for an investor audience. Significant and Rapid Clearance of Plaques in DERMIS Phase 3 Studies Individual patient results may vary Baseline (Heel) Week 4 Week 8 IGA = 2 IGA = 0 IGA = 0 Demonstrated efficacy in tough-to-treat ar
Slide 14: Efficacy and Safety in Treating Intertriginous Plaques
14©Copyright 2022. Arcutis Biotherapeutics, Inc. — Presentation designed for an investor audience. Demonstrated Efficacy and Favorable Safety and Tolerability in Treating Intertriginous Plaques I-IGA Success = Clear or Almost Clear with at least a 2-grade improvement from baseline 33.7 41.8 57.7 71.
Slide 15: Rapid Reduction of Itch in DERMIS-1 and DERMIS-2
15©Copyright 2022. Arcutis Biotherapeutics, Inc. — Presentation designed for an investor audience. Rapid Reduction of Itch in DERMIS-1 and DERMIS-2 Proportion of patients who achieved a ≥4-point improvement in WI-NRS from baseline score of ≥4 *P <0.001; ** P <0.0001; Evaluated in a subset of the int
Slide 16: New Data Presented at AAD: Consistent Clearance Regardless of Baseline Severity
16©Copyright 2022. Arcutis Biotherapeutics, Inc. — Presentation designed for an investor audience. New Data Presented at AAD: Consistent Clearance Regardless of Baseline Disease Severity IGA Success = Clear or Almost Clear IGA status plus ≥2-grade improvement from baseline. PASI = Psoriasis Area and
Slide 17: ZORYVE – Safe and Very Well-Tolerated
17©Copyright 2022. Arcutis Biotherapeutics, Inc. — Presentation designed for an investor audience. ZORYVE – Safe and Very Well-Tolerated Data are presented for safety population DERMIS-1 and -2 Adverse Reactions Reported in >=1% of Subjects for 8 Weeks [n (%)] ZORYVE (n=576) Vehicle (n=305) Diarrhea
Slide 18: Durability of Response Maintained: Phase 2 Long-Term Data
18©Copyright 2022. Arcutis Biotherapeutics, Inc. — Presentation designed for an investor audience. Durability of Response Maintained: Phase 2 Long-Term Data in Plaque Psoriasis Observed data from ARQ-151-202 study; IGA = Investigator’s Global Assessment; OLE = open label extension 0 10 20 30 40 50 6
Slide 19: ZORYVE: Designed to Simplify the Treatment of Psoriasis
19©Copyright 2022. Arcutis Biotherapeutics, Inc. — Presentation designed for an investor audience. ZORYVE Healthcare Provider Payor Patient ZORYVE: Designed to Simplify the Treatment of Psoriasis
Slide 20: ZORYVE Cream's Label in Psoriasis is Recognition of Our Differentiated Profile
20©Copyright 2022. Arcutis Biotherapeutics, Inc. — Presentation designed for an investor audience. ZORYVE Cream’s Label in Psoriasis is Recognition of Our Differentiated Profile Comparison based on FDA-approved labels for referenced products. No head-to-head trials between these products have been c
Slide 21: ZORYVE - Patient-Friendly Formulation
21©Copyright 2022. Arcutis Biotherapeutics, Inc. — Presentation designed for an investor audience. ZORYVE - Patient-Friendly Formulation That Effectively Delivers Highly Potent PDE4 Once-daily dosing Steroid-free Uniquely featuring HydroARQ Technology • Non-greasy, moisturizing cream • Spreads easil
Slide 22: Patient Dynamics Are Favorable Towards Trial
22©Copyright 2022. Arcutis Biotherapeutics, Inc. — Presentation designed for an investor audience. Patient Dynamics Are Favorable Towards Trial ~2M Psoriasis patients currently Rx treated topically by U.S. dermatologists Rx = prescription Minimal behavioral change required to activate utilization •
Slide 23: Strong Patient Interest and Engagement in Innovation
23©Copyright 2022. Arcutis Biotherapeutics, Inc. — Presentation designed for an investor audience. Strong Patient Interest and Engagement in Innovation 2 in 3 Patients have exhibited psoriasis in intertriginous areas Wish topical treatments were a once daily application 9 in 10 Wish they could use a
Slide 24: Our Access Strategy Remains Unchanged
24©Copyright 2022. Arcutis Biotherapeutics, Inc. — Presentation designed for an investor audience. Our Access Strategy Remains Unchanged: Unlocking Broad, High-Quality Access to ZORYVE Responsible pricing Designed to obtain broad and rapid coverage Reduced prescriber burden Key to maximizing volume
Slide 25: WAC Price of $825 Optimizes for Our Access Objectives
25©Copyright 2022. Arcutis Biotherapeutics, Inc. — Presentation designed for an investor audience. WAC Price of $825 Optimizes for Our Access Objectives, Helps More Patients, & Maximizes Total Franchise Value Topical Roflumilast • Highly innovative • Effective, safe, well-tolerated • Potential 1st l
Slide 26: List Prices of Select Branded Topicals
26©Copyright 2022. Arcutis Biotherapeutics, Inc. — Presentation designed for an investor audience. List Prices of Select Branded Topicals Source: Analysource – 7/15/22 Indicative Payor Controls $1200$400 $800 $1950 $830 = CMS Specialty Tier
Slide 27: Patients Will be Supported via ZORYVE Direct
27©Copyright 2022. Arcutis Biotherapeutics, Inc. — Presentation designed for an investor audience. Patients Will be Supported via ZORYVE Direct 27 For Financially Eligible Patients who are Uninsured or Underinsured, Arcutis Will Also Offer the Arcutis CaresTM Patient Assistance Program *Uninsured pa
Slide 28: ZORYVE Launch Readiness
28©Copyright 2022. Arcutis Biotherapeutics, Inc. — Presentation designed for an investor audience. ZORYVE Launch Readiness Sales force fully hired; detailing begins today Product expected in channel in < 2 weeks Broad sampling program ready to activate ZORYVE Direct patient support active
Slide 29: Strategic Parallels to Oral CGRPs
29©Copyright 2022. Arcutis Biotherapeutics, Inc. — Presentation designed for an investor audience. Strategic Parallels to Oral CGRPs CGRP = calcitonin gene-related peptide Biohaven / Nurtec® Arcutis / Topical Roflumilast Chronic, symptomatic diseases Migraine Psoriasis / Atopic Derm / Seb Derm Large
Slide 30: Significant Opportunity in Underserved, Rapidly Growing Atopic Dermatitis Market
30©Copyright 2022. Arcutis Biotherapeutics, Inc. — Presentation designed for an investor audience. Significant Opportunity in Underserved, Rapidly Growing Atopic Dermatitis (AD) Market 1Source: IQVIA [Biologic = Dupixent; PDE4 = Eucrisa]; TCI = topical calcineurin inhibitor $1.8 $2.7 $3.8 $4.6 $5.9
Slide 31: Atopic Dermatitis: Opportunity for Roflumilast Cream
31©Copyright 2022. Arcutis Biotherapeutics, Inc. — Presentation designed for an investor audience. Atopic Dermatitis: Compelling Opportunity for Roflumilast Cream Very large, established market • ~26 million individuals in U.S. affected • 12% prevalence in children → need for safe/effective therapy
Slide 32: Roflumilast Cream May Address Unmet Needs in Atopic Dermatitis
32©Copyright 2022. Arcutis Biotherapeutics, Inc. — Presentation designed for an investor audience. Roflumilast Cream May Address Unmet Needs in Atopic Dermatitis Validated Target PDE4 inhibition validated in AD Well- tolerated • No application site reaction • A favorable safety profile Simple, easy-
Slide 33: Consistent Evidence of Efficacy Across Endpoints in Phase 2 Proof of Concept
33©Copyright 2022. Arcutis Biotherapeutics, Inc. — Presentation designed for an investor audience. Consistent Evidence of Efficacy Results Across Endpoints in Phase 2 Proof of Concept Data presented for intent-to-treat population.; EASI = eczema area severity index; vIGA-AD = validated investigator’
Slide 34: Roflumilast Cream vs. Current Approved Treatments in Atopic Dermatitis
34©Copyright 2022. Arcutis Biotherapeutics, Inc. — Presentation designed for an investor audience. Roflumilast Cream vs. Current Approved Treatments in Atopic Dermatitis [EASI-75 Responders] 52.3% 59.1% 31.1% 0% 10% 20% 30% 40% 50% 60% 70% Week 4 ARQ-151-212 0.15% ARQ-151 QD 0.05% ARQ-151 QD Vehicle
Slide 35: The Importance of Vehicle in AD Treatment – Restoring the Skin Barrier
35©Copyright 2022. Arcutis Biotherapeutics, Inc. — Presentation designed for an investor audience. The Importance of Vehicle in AD Treatment – Restoring the Skin Barrier Moisturizing Non–lipid-extracting emulsifiers Non-irritating Optimized vehicle formulation may promote treatment adherence and the
Slide 36: Roflumilast Cream Vehicle Comparable to a Leading Commercial Moisturizer
36©Copyright 2022. Arcutis Biotherapeutics, Inc. — Presentation designed for an investor audience. Roflumilast Cream Vehicle Comparable to a Leading Commercial Moisturizer Statistically Significant Improvements in Investigator and Patient-Assessed Moisturizing Properties Mild Eczema Trial Vehicle fo
Slide 37: Favorable Safety and Tolerability Profile in Atopic Dermatitis
37©Copyright 2022. Arcutis Biotherapeutics, Inc. — Presentation designed for an investor audience. Favorable Safety and Tolerability Profile in Atopic Dermatitis • 95% of subjects completed Phase 2 study •Safety and tolerability profile for roflumilast groups similar to vehicle •Treatment-related AE
Slide 38: INTEGUMENT-1 & -2 Phase 3 Atopic Dermatitis Studies
38©Copyright 2022. Arcutis Biotherapeutics, Inc. — Presentation designed for an investor audience. INTEGUMENT-1 & -2 Phase 3 Atopic Derm Studies Endpoints Primary • vIGA-AD success at week 4 Secondary • EASI-75 • WI-NRS (itch) • vIGA-AD = Clear (0) or Almost Clear (1) Safety and tolerability Eligibi
Slide 39: INTEGUMENT Studies Designed for Broad Label in Mild-to-Moderate Atopic Dermatitis
39©Copyright 2022. Arcutis Biotherapeutics, Inc. — Presentation designed for an investor audience. INTEGUMENT Studies Designed for Broad Label in Mild-to-Moderate Atopic Dermatitis IGA Success = Clear or Almost Clear with at least a 2-grade improvement from baseline.; BSA = body surface area; Statis
Slide 40: Roflumilast Foam – Significant, Underappreciated Opportunity
40©Copyright 2022. Arcutis Biotherapeutics, Inc. — Presentation designed for an investor audience. Roflumilast Foam – Significant, Underappreciated Opportunity for Arcutis Seb Derm • As big a market as psoriasis, with no products promoted or in development Scalp • 40% of plaque psoriasis sufferers h
Slide 41: Scalp Psoriasis - Roflumilast Foam May Address Unmet Needs
41©Copyright 2022. Arcutis Biotherapeutics, Inc. — Presentation designed for an investor audience. Scalp Psoriasis - Roflumilast Foam May Address Unmet Needs ~40% of Plaque Psoriasis sufferers have scalp involvement Roflumilast foam ideal for scalp and body psoriasis • Suitable for chronic use • Foa
Slide 42: Scalp Psoriasis - Rapid and Robust Impact on Key Efficacy Measures in Phase 2
42©Copyright 2022. Arcutis Biotherapeutics, Inc. — Presentation designed for an investor audience. 17.4% 41.3% 59.1% 3.1% 5.6% 11.4% 0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100% Week 2 Week 4 Week 8 P e rc e n ta g e o f P a ti e n ts ~ 60% of Patients Achieved S-IGA Success at Week 8 Roflumilast foa
Slide 43: Seborrheic Dermatitis – Significant Unmet Needs in Treatment Paradigm
43©Copyright 2022. Arcutis Biotherapeutics, Inc. — Presentation designed for an investor audience. Seborrheic Dermatitis – Significant Unmet Needs in Treatment Paradigm ~10 million Individuals in the U.S. affected • Itchy red patches covered by greasy / flaking scales on scalp, face and chest •Topic
Slide 44: Roflumilast Foam Could Become Standard of Care in Seborrheic Dermatitis
44©Copyright 2022. Arcutis Biotherapeutics, Inc. — Presentation designed for an investor audience. Roflumilast Foam Could Become Standard of Care in Seborrheic Dermatitis Efficacy data showed meaningful symptomatic improvement The ability to use on all affected areas of the body Safety and tolerabil
Slide 45: Seborrheic Dermatitis: Opportunity Comparable in Size to Psoriasis
45©Copyright 2022. Arcutis Biotherapeutics, Inc. — Presentation designed for an investor audience. Seborrheic Dermatitis: Opportunity Comparable in Size to Psoriasis 1Arcutis Quantitative Seb Derm Research August 2020, n=100 Dermatology HCPs; TRx = prescription Mild Moderate Severe Patients receivin
Slide 46: Patients Require Complex and Onerous Treatment Regimens
46©Copyright 2022. Arcutis Biotherapeutics, Inc. — Presentation designed for an investor audience. Patients Require Complex and Onerous Treatment Regimens 1Harris Poll Seborrheic Dermatitis Survey (n>600 HCPs, n=300 patients) OTC = over the counter; HCP = healthcare professional 1.4 2.1 2.4 Prescrip
Slide 47: STRATUM Phase 3 Trial in Seborrheic Dermatitis
47©Copyright 2022. Arcutis Biotherapeutics, Inc. — Presentation designed for an investor audience. STRATUM Phase 3 Trial in Seborrheic Dermatitis Randomized, Double-blind, Vehicle-controlled Multicenter Study IGA = Investigator’s Global Assessment; IGA Success = Clear or Almost Clear with at least a
Slide 48: Rapid and Robust Results on IGA Success in Pivotal Phase 3 STRATUM Trial
48©Copyright 2022. Arcutis Biotherapeutics, Inc. — Presentation designed for an investor audience. Rapid and Robust Results on IGA Success in Pivotal Phase 3 STRATUM trial 43.2% 73.2% 80.1% 26.6% 47.9% 59.2% 0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100% Week 2 Week 4 Week 8 P e rc e n ta g e o f P a t
Slide 49: Over 50% of Patients Achieved IGA of Clear at Week 8
49©Copyright 2022. Arcutis Biotherapeutics, Inc. — Presentation designed for an investor audience. Over 50% of Patients Achieved IGA of Clear at Week 8 IGA = Investigator’s Global Assessment 16.4% 35.6% 50.7% 6.5% 14.9% 28.2% 0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100% Week 2 Week 4 Week 8 P e rc e
Slide 50: Robust Itch Response in Phase 3
50©Copyright 2022. Arcutis Biotherapeutics, Inc. — Presentation designed for an investor audience. Robust Itch Response in Phase 3 WI-NRS: Worst Itch Numeric Rating Scale; WI-NRS response = 4 point reduction in WI-NRS in patients with WI-NRS > 4 at baseline 32.6% 47.9% 63.6% 15.6% 30.4% 42.3% 0% 10%
Slide 51: Roflumilast Foam Was Well-Tolerated in Phase 3
51©Copyright 2022. Arcutis Biotherapeutics, Inc. — Presentation designed for an investor audience. Roflumilast Foam Was Well-Tolerated in Phase 3 AE: adverse event; SAE: serious adverse event; TEAE: treatment-emergent adverse event Subjects (%) Roflumilast 0.3% (n=304) Vehicle (n=153) Overall (n=457
Slide 52: Most Common Treatment Emergent Adverse Events
52©Copyright 2022. Arcutis Biotherapeutics, Inc. — Presentation designed for an investor audience. Most Common Treatment Emergent Adverse Events (>1.0% in Any Group) *All graded as mild Preferred Term Roflumilast 0.3% (n=304) Vehicle (n=153) Overall (n=457) COVID-19 11 (3.6%) 5 (3.3%) 16 (3.5%) Urin
Slide 53: Advancing Multiple Preclinical Programs in Dermatology
53©Copyright 2022. Arcutis Biotherapeutics, Inc. — Presentation designed for an investor audience. Advancing Multiple Preclinical Programs in Dermatology Candidate Preclinical Program ARQ-252 Cream (JAK1 Inhibitor) • Chronic Hand Eczema • Vitiligo ARQ-255 Suspension (JAK1 Inhibitor) • Alopecia Areat
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