Slide 1: Arcutis Biotherapeutics: Bioscience applied to the skin
Exhibit 99.1 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 is the realization of our efforts to bring meaningful innovation to patients with immune-med
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 Continues to Progress
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 ZORYVE (roflumilast cream) Worldwide Worldwide Roflumilast Foam (ARQ-154) Worldwide Worldwide ARQ-252 Cream (JAK1 In
Slide 6: Arcutis Continues to Execute Without Fail
6©Copyright 2022. Arcutis Biotherapeutics, Inc. — Presentation designed for an investor audience. Arcutis Continues to Execute Without Fail *Approved by the FDA for topical treatment of plaque psoriasis, including intertriginous areas, in patients 12 years of age and older; ** Phase 3 topline for IN
Slide 7: Topical Roflumilast Opportunity: ~7 Million Dermatologist-Treated Patients in the U.S.
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 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 9/15/22; PK = pharmacokinetics; PDE4 = phosphodiesterase 4; JAK = Janus Kinase Roflumilast Patent Protection Expected Until At Least 2037 1 Pending U.S. paten
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: Efficacy Comparable to High-Potency Steroids & Vitamin D / Tazarotene Combo
13©Copyright 2022. Arcutis Biotherapeutics, Inc. — Presentation designed for an investor audience. Efficacy at 8 Weeks Comparable to High-Potency Steroids & Vitamin D / Tazarotene Combo IGA Success = Clear or Almost Clear with at least a 2-grade improvement Note: The results of this retrospective po
Slide 14: Significant and Rapid Clearance of Plaques in DERMIS Phase 3 Studies
14©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 15: ZORYVE Delivered Clinically Meaningful Response in 3 out of 4 Patients
15©Copyright 2022. Arcutis Biotherapeutics, Inc. — Presentation designed for an investor audience. ZORYVE Delivered Clinically Meaningful Response in 3 out of 4 Patients % Change in PASI Total Score at Week 8 - Pooled DERMIS Studies PASI-50 72% PASI-75 40% PASI-90 20% C h a n g e f ro m b a se li n
Slide 16: Consistent Clearance Regardless of Baseline Disease Severity
16©Copyright 2022. Arcutis Biotherapeutics, Inc. — Presentation designed for an investor audience. ZORYVE Demonstrates 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 Severi
Slide 17: Efficacy and Tolerability in Treating Intertriginous Plaques
17©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 18: Rapid Reduction of Itch in DERMIS-1 and DERMIS-2
18©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 19: ZORYVE – Safe and Very Well-Tolerated
19©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 20: Durability of Response Maintained: Phase 2 Long-Term Data
20©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 21: ZORYVE: Designed to Simplify the Treatment of Psoriasis
21©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 22: ZORYVE Cream's Label in Psoriasis is Recognition of Our Differentiated Profile
22©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 23: Patient Dynamics Are Favorable Towards Trial
23©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 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: Now Covered by a Top PBM and a Large National Health Plan
25©Copyright 2022. Arcutis Biotherapeutics, Inc. — Presentation designed for an investor audience. Now Covered by a Top Pharmacy Benefit Manager (PBM) and a Large National Health Plan • Formulary Inclusion Effective 11/1 • Differentiated Access, Details Available Soon Unlocking Broad, Quality Covera
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 Are Supported via ZORYVE Direct
27©Copyright 2022. Arcutis Biotherapeutics, Inc. — Presentation designed for an investor audience. Patients Are Supported via ZORYVE Direct 27 For Financially Eligible Patients who are Uninsured or Underinsured, Arcutis Also Offers the Arcutis CaresTM Patient Assistance Program *Uninsured patients a
Slide 28: Atopic Dermatitis: Compelling Opportunity for Roflumilast Cream
28©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 • ~26 million total prescriptions in U.S.1 (~2x of Psoriasis) •
Slide 29: Topical Steroids Remain Standard of Care in Underserved, Rapidly Growing AD Market
29©Copyright 2022. Arcutis Biotherapeutics, Inc. — Presentation designed for an investor audience. Topical Steroids Remain Standard of Care in Underserved, Rapidly Growing AD Market Segment 1Source: IQVIA [Biologic = Dupixent; PDE4 = Eucrisa]; TCI = topical calcineurin inhibitor $4.0 $5.5 $7.1 $8.3
Slide 30: High Unmet Need for New Topical Therapies, Especially for Pediatric Patients
30©Copyright 2022. Arcutis Biotherapeutics, Inc. — Presentation designed for an investor audience. Under 12 years old 12-17 years old 18+ years old Under 12 years old 12-17 years old 18+ years old High Unmet Need for New Topical Therapies, Especially for Pediatric Patients Unmet need with topical th
Slide 31: INTEGUMENT-1 & -2 Phase 3 Atopic Dermatitis Studies
31©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 = Clear (0) or Almost Clear (1) Safety and tolerability Eligibilit
Slide 32: Rapid, Robust Efficacy on IGA Success in Both Phase 3 Atopic Dermatitis Trials
32©Copyright 2022. Arcutis Biotherapeutics, Inc. — Presentation designed for an investor audience. Rapid, Robust Efficacy on IGA Success Observed in Both Phase 3 Atopic Dermatitis Trials vIGA = Validated Investigator’s Global Assessment; IGA Success = Clear or Almost Clear with at least a 2-grade im
Slide 33: Over 40% of Patients Achieved EASI-75 at Week 4
33©Copyright 2022. Arcutis Biotherapeutics, Inc. — Presentation designed for an investor audience. Over 40% of Patients Achieved EASI-75 at Week 4 EASI -75 = 75% improvement from baseline 14.0% 30.6% 43.2% 5.5% 13.2% 22.0% 0% 10% 20% 30% 40% 50% Week 1 Week 2 Week 4 P e rc e n ta g e o f P a ti e n
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] 43% 22% 42% 20% 0% 10% 20% 30% 40% 50% 60% Week 4 Roflumilast Cream Ph 3 0.15% Roflumilast Cream QD Vehicle Q
Slide 35: Robust and Rapid Itch Response Observed in Phase 3
35©Copyright 2022. Arcutis Biotherapeutics, Inc. — Presentation designed for an investor audience. Robust and Rapid Itch Response Observed in Phase 3 WI-NRS: Worst Itch Numeric Rating Scale (only measured in the 12+ year old population in the study); WI-NRS response = 4 point reduction in WI-NRS in
Slide 36: Roflumilast Cream Was Well-Tolerated in Phase 3
36©Copyright 2022. Arcutis Biotherapeutics, Inc. — Presentation designed for an investor audience. Roflumilast Cream Was Well-Tolerated in Phase 3 AE: adverse event; SAE: serious adverse event; TEAE: treatment-emergent adverse event INTEGUMENT-1 INTEGUMENT-2 Subjects (%) Roflumilast 0.15% (n=433) Ve
Slide 37: Most Common Treatment-Emergent Adverse Events
37©Copyright 2022. Arcutis Biotherapeutics, Inc. — Presentation designed for an investor audience. Most Common Treatment-Emergent Adverse Events (≥1.0% in Any Group) INTEGUMENT-1 INTEGUMENT-2 Preferred Term Roflumilast 0.15% (n=433) Vehicle (n=221) Roflumilast 0.15% (n=452) Vehicle (n=230) Headache
Slide 38: Roflumilast Foam – Significant, Underappreciated Opportunity for Arcutis
38©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 39: Scalp Psoriasis - Roflumilast Foam May Address Unmet Needs
39©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 40: ARRECTOR Phase 3 Trial in Scalp & Body Psoriasis
40©Copyright 2022. Arcutis Biotherapeutics, Inc. — Presentation designed for an investor audience. ARRECTOR Phase 3 Trial in Scalp & Body Psoriasis IGA = Investigator’s Global Assessment; IGA Success = Clear or Almost Clear with at least a 2-grade improvement from baseline; WI-NRS: Worst Itch Numeri
Slide 41: Robust Efficacy on Scalp IGA Success in ARRECTOR Trial
41©Copyright 2022. Arcutis Biotherapeutics, Inc. — Presentation designed for an investor audience. Robust Efficacy on Scalp IGA Success in ARRECTOR Trial S-IGA = Scalp Investigator’s Global Assessment; IGA Success = Clear or Almost Clear with at least a 2-grade improvement from baseline ITT Populati
Slide 42: Efficacy on Body IGA Success in ARRECTOR Trial
42©Copyright 2022. Arcutis Biotherapeutics, Inc. — Presentation designed for an investor audience. Demonstrated Efficacy on Body IGA Success in ARRECTOR Trial, Consistent with DERMIS Trials B-IGA = Body Investigator’s Global Assessment; IGA Success = Clear or Almost Clear with at least a 2-grade imp
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: 80% of Patients Achieved IGA Success in Seb Derm Phase 3
48©Copyright 2022. Arcutis Biotherapeutics, Inc. — Presentation designed for an investor audience. 80% of Patients Achieved IGA Success & 50% Completely Clear at 8 Weeks in Seb Derm Phase 3 IGA Success = Clear or Almost Clear with at least a 2-grade improvement from baseline 43.2% 73.2% 80.1% 26.6%
Slide 49: Robust Itch Response in Pivotal Phase 3 STRATUM Trial
49©Copyright 2022. Arcutis Biotherapeutics, Inc. — Presentation designed for an investor audience. Robust Itch Response in Phase 3 in Pivotal Phase 3 STRATUM Trial 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.
Slide 50: Roflumilast Foam Was Well-Tolerated in STRATUM Trial
50©Copyright 2022. Arcutis Biotherapeutics, Inc. — Presentation designed for an investor audience. Roflumilast Foam Was Well-Tolerated in Pivotal Phase 3 STRATUM Trial AE: adverse event; SAE: serious adverse event; TEAE: treatment-emergent adverse event Subjects (%) Roflumilast 0.3% (n=304) Vehicle
Slide 51: Most Common Treatment Emergent Adverse Events in STRATUM Trial
51©Copyright 2022. Arcutis Biotherapeutics, Inc. — Presentation designed for an investor audience. Most Common Treatment Emergent Adverse Events (>1.0% in Any Group) in Pivotal Phase 3 STRATUM Trial *All graded as mild Preferred Term Roflumilast 0.3% (n=304) Vehicle (n=153) Overall (n=457) COVID-19
Slide 52: Advancing Multiple Preclinical Programs in Dermatology
52©Copyright 2022. Arcutis Biotherapeutics, Inc. — Presentation designed for an investor audience. Advancing Multiple Preclinical Programs in Dermatology Candidate Program ARQ-252 Cream (JAK1 Inhibitor) • Chronic Hand Eczema • Vitiligo ARQ-255 Suspension (JAK1 Inhibitor) • Alopecia Areata Other Prec
Slide 53: Alopecia Areata – No Approved Treatments and Significant Unmet Needs
53©Copyright 2022. Arcutis Biotherapeutics, Inc. — Presentation designed for an investor audience. Alopecia Areata (AA) – No Approved Treatments and Significant Unmet Needs Autoimmune, chronic, and relapsing hair loss ranging from scattered patches to complete loss of hair Significant psychosocial i
Slide 54: Barriers to Topical Drug Delivery to the Hair Bulb
54©Copyright 2022. Arcutis Biotherapeutics, Inc. — Presentation designed for an investor audience. Barriers to Topical Drug Delivery to the Hair Bulb AA = alopecia areata Follicle Hair bulb Superficial vascular plexus Epidermis Drug delivery challenge suggested by failure of topical JAKi approach, c
Slide 55: Acquisition of Ducentis – Next Step Towards Preeminent Immuno-Dermatology Company
55©Copyright 2022. Arcutis Biotherapeutics, Inc. — Presentation designed for an investor audience. Acquisition of Ducentis – Next Step Towards Evolution into Preeminent Immuno-Dermatology Company Aligned to the Arcutis Strategy (1) Atopic Derm (AD) is Large Market with High Unmet Need, (2) CD200R is