STRATUM Phase 3 Seborrheic Dermatitis Topline Data Presentation June 2022
2©Copyright 2022. Arcutis Biotherapeutics, Inc. All rights reserved. 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 available to management. Forward-looking statements include all statements other than statements of historical fact contained in this presentation, including information concerning our current and future financial performance, business plans and objectives, current and future clinical and preclinical development activities, current and future commercialization activities, timing and success of our ongoing and planned clinical trials and related data, the timing of announcements, updates and results of our clinical trials and related data, our ability to obtain and maintain regulatory approval, the potential therapeutic benefits and economic value of our product candidates, competitive position, industry environment, and potential market opportunities. 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3©Copyright 2022. Arcutis Biotherapeutics, Inc. All rights reserved. Presentation designed for an investor audience. Today’s Speakers Frank Watanabe President & CEO Patrick Burnett, MD, PhD, FAAD Chief Medical Officer Ken Lock Chief Commercial Officer Zoe Diana Draelos, MD, FAAD Principal Investigator & President, Dermatology Consulting Services, PLLC
4©Copyright 2022. Arcutis Biotherapeutics, Inc. All rights reserved. Presentation designed for an investor audience. Arcutis Overview Speakers & Agenda
5©Copyright 2022. Arcutis Biotherapeutics, Inc. All rights reserved. Presentation designed for an investor audience. 2022: A Transformational Year for Arcutis Topical roflumilast offers a differentiated clinical profile, targeting three distinct disease areas each with >2 million topically treated patients today in U.S. Dermatology offices We are increasingly excited about the clinical profile and the underappreciated opportunity of roflumilast foam in seborrheic dermatitis We are progressing our commercial launch preparations in advance of our July PDUFA date for roflumilast cream in plaque psoriasis We remain confident in replicating our track record of Phase 3 success in subsequent pivotal readouts in atopic dermatitis and scalp and body psoriasis later this year
6©Copyright 2022. Arcutis Biotherapeutics, Inc. All rights reserved. Presentation designed for an investor audience. First of Four Potential Transformational Catalysts * Phase 3 topline for INTEGUMENT-1 and -2; INTEGUMENT-PED expected in 2023 Roflumilast Cream Roflumilast Foam Atopic Dermatitis Phase 3 — Topline Data* Seborrheic Dermatitis Phase 3 — Topline Data Scalp Psoriasis Phase 3 — Topline Data Plaque Psoriasis Potential FDA Approval Q4 2022Q3 2022Q2 2022
7©Copyright 2022. Arcutis Biotherapeutics, Inc. All rights reserved. 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 2.0M (mild-moderate-severe) 2.6M (mild-to-moderate) 2.2M (moderate-to-severe) Topically treated outside Derm ~1.2M (mild-moderate-severe) ~4.1M (mild-to-moderate) ~1.0M (moderate-to-severe) Significant incremental opportunity to access the millions of U.S. patients Rx treated by other specialties (e.g., PCPs or pediatricians) via partnership Rx = Prescription; PCP = primary care physician
8©Copyright 2022. Arcutis Biotherapeutics, Inc. All rights reserved. Presentation designed for an investor audience. Topical Roflumilast – A Differentiated & Transformational Clinical Profile Efficacy results on par with steroid / vitamin D combinations Non-steroidal with ability to use chronically, anywhere on the body No boxed warnings anticipated Favorable local tolerability Individuals evaluated with topical roflumilast across clinical programs ~3.5K
9©Copyright 2022. Arcutis Biotherapeutics, Inc. All rights reserved. Presentation designed for an investor audience. Seborrheic Dermatitis Disease State Education Speakers & Agenda Zoe Diana Draelos, MD, FAAD Principal Investigator & President, Dermatology Consulting Services, PLLC
10©Copyright 2022. Arcutis Biotherapeutics, Inc. All rights reserved. Presentation designed for an investor audience. Seborrheic Dermatitis – Significant Unmet Needs in Current Treatment Paradigm
11©Copyright 2022. Arcutis Biotherapeutics, Inc. All rights reserved. Presentation designed for an investor audience. Speakers & Agenda Clinical Results Zoe Diana Draelos, MD, FAAD
12©Copyright 2022. Arcutis Biotherapeutics, Inc. All rights reserved. Presentation designed for an investor audience. STRATUM Phase 3 Trial in Seborrheic Dermatitis IGA = Investigator’s Global Assessment; IGA Success = Clear or Almost Clear with at least a 2-grade improvement from baseline; WI-NRS: Worst Itch Numeric Rating Scale; QD = once a day; BSA = body surface area Endpoints Primary • IGA success at week 8 Secondary • IGA success at week 2 and 4 • IGA score of 0 at week 8 • Overall assessment of erythema/scaling • WI-NRS (itch) Safety and tolerability Eligibility • Diagnosis of at least moderate seborrheic dermatitis (IGA ≥3) • Age 9+ • Up to 20% BSA Roflumilast Foam 0.3% QD Dosing Vehicle QD Dosing 8 weeks dosing 2:1 R an do m iz e N=457 Randomized, Double-blind, Vehicle-controlled Multicenter Study
13©Copyright 2022. Arcutis Biotherapeutics, Inc. All rights reserved. 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 ti e n ts 80% of Patients Achieved IGA Success at Week 8 Roflumilast Foam 0.3% (n=304) Vehicle (n=153) IGA Success = Clear or Almost Clear with at least a 2-grade improvement from baseline p = 0.0006 p < 0.0001 p < 0.0001
14©Copyright 2022. Arcutis Biotherapeutics, Inc. All rights reserved. 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 n ta g e o f P a ti e n ts >50% of Patients Achieved IGA of Clear (IGA = 0) at Week 8 Roflumilast Foam 0.3% (n=304) Vehicle (n=153) p = 0.0047 p < 0.0001 p < 0.0001
15©Copyright 2022. Arcutis Biotherapeutics, Inc. All rights reserved. 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% 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 ~64% of Patients Achieved a WI-NRS Response at Week 8 Roflumilast Foam 0.3% (n=304) Vehicle (n=153) p = 0.0037 p = 0.0029 p = 0.0005
16©Copyright 2022. Arcutis Biotherapeutics, Inc. All rights reserved. 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) Subjects with any TEAE 70 (23.0%) 33 (21.6%) 103 (22.5%) Subjects with any Treatment-Related TEAE 8 (2.6%) 5 (3.3%) 13 (2.8%) Subjects with any SAE 1 (0.3%) 0 1 (0.2%) Treatment-related SAE 0 0 0 Subjects who discontinued Study Drug due to AE 2 (0.7%) 3 (2.0%) 5 (1.1%) Subjects who discontinued Study due to AE 2 (0.7%) 3 (2.0%) 5 (1.1%)
17©Copyright 2022. Arcutis Biotherapeutics, Inc. All rights reserved. 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%) Urinary tract infection 4 (1.3%) 3 (2.0%) 7 (1.5%) Nasopharyngitis 4 (1.3%) 1 (0.7%) 5 (1.1%) Nausea* 5 (1.6%) 0 5 (1.1%) Application site pain 1 (0.3%) 3 (2.0%) 4 (0.9%) Sinusitis 0 2 (1.3%) 2 (0.4%)
18©Copyright 2022. Arcutis Biotherapeutics, Inc. All rights reserved. Presentation designed for an investor audience. Speakers & Agenda Commercial Opportunity
19©Copyright 2022. Arcutis Biotherapeutics, Inc. All rights reserved. Presentation designed for an investor audience. Roflumilast Foam Could Become Standard of Care in Seborrheic Dermatitis Efficacy data showing meaningful symptomatic improvement The ability to use on all affected areas of the body Safety and tolerability data that supports potential for chronic use Simple, easy-to-use, 1x daily foam for scalp Dual Mechanism: Anti-fungal + Anti- inflammatory X
20©Copyright 2022. Arcutis Biotherapeutics, Inc. All rights reserved. Presentation designed for an investor audience. Opportunity Comparable in Size to Psoriasis With No Products Promoted 1Arcutis Quantitative Seb Derm Research August 2020, n=100 Dermatology HCPs; TRx = prescription Mild Moderate Severe Patients receiving a prescription treatment 1st line1 71% 92% 97% 75 Average # of seborrheic dermatitis patients seen in a typical month 10 M 6.9 M 4.1 M 2.2 M Seb Derm U.S. Prevalence Topically TRx- treated Topically TRx-treated by derm Topically TRx-treated by derm (moderate-to-severe)
21©Copyright 2022. Arcutis Biotherapeutics, Inc. All rights reserved. Presentation designed for an investor audience. Patients Are Dissatisfied with Complex and Onerous Treatment Regimens 1Harris Poll Seborrheic Dermatitis Survey (n>600 HCPs, n=300 patients), OTC = over the counter 1.4 2.1 2.4 Prescription treatments OTC treatments Alternative treatments TOTAL 5.9 Treatments Used Per Week1, Mean “I am interested in trying new treatment options.” 9 in 10 AGREE1 Patients ready for new options 9 in 10AGREE1 “I would be more likely to stick with a treatment plan if it meant using fewer treatments.”
22©Copyright 2022. Arcutis Biotherapeutics, Inc. All rights reserved. Presentation designed for an investor audience. Zoe Diana Draelos, MD, FAAD Thank You Q&A