Arcutis Biotherapeutics, Inc. · NASDAQ:ARQT
Arcutis Biotherapeutics — Corporate Update (September 2020)
36 slides from Arcutis Biotherapeutics's corporate update, Sep 29, 2020
Slide 1: Seborrheic Dermatitis
Exhibit 99.1 Seborrheic Dermatitis September 2020
Slide 2: Legal Disclaimers
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
Slide 3: Seborrheic Dermatitis Phase 2 Data Call
Seborrheic Dermatitis Phase 2 Data Call 3 Copyright ARCUTIS 2020
Slide 4: Frank Watanabe, President & CEO
Frank Watanabe President & CEO 4 Copyright ARCUTIS 2020
Slide 5: Seborrheic Dermatitis (Seb Derm)
Seborrheic Dermatitis (Seb Derm) • Common, chronic inflammatory skin disease • Affects 10M people in the U.S. • Appears as itchy red patches covered by greasy, flaking scales on the scalp, face & chest 5 Copyright ARCUTIS 2020
Slide 6: Negative Impact on Quality of Life (QoL)
Negative Impact on Quality of Life (QoL) Seb derm can have a significant, negative influence on QoL Women Express Particular Psychological Distress Self-Consciousness Oily skin and flakiness in visible areas Limits clothing choices (no black), hairstyle causes psychological distress (due to Rx shamp
Slide 7: Efficacy Benchmarks
Efficacy Benchmarks Total Severity Score Clearance Rate 67% 70% 70% 61% 60% 57% 60% 56% 50% 50% 42% 38% 40% 40% 30% 30% 4 Weeks 4 20% 20% Responders at Responders 10% 10% 0% 0% Clobetasol Propionate Ketoconazole (Nizoral ) Ciclopirox 1% Placebo Ketoconazole 2% Placebo 0.05% (Spray Clobex) 2% Shampoo
Slide 8: Patrick Burnett, Chief Medical Officer
Patrick Burnett, M.D., Ph.D., FAAD Chief Medical Officer 8 Copyright ARCUTIS 2020
Slide 9: Seb Derm Contributing Factors
Seb Derm Contributing Factors Genetic factors Overall health Particular yeast Emotional or Climate that lives on all physical stress, such (usually worse in human skin as lack of sleep cold weather) 9 Copyright ARCUTIS 2020
Slide 10: Limitations of Current Seb Derm Treatments
Limitations of Current Seb Derm Treatments Topical AntiEasy-Fungals to Diagnose No single product appropriate for both scalp and face/body • Often used as first-line therapy • Many patients use 3-5 products • Often ineffective for long-term remission • Time management challenge and Topical steroids
Slide 11: Topical Roflumilast Foam
Topical Roflumilast Foam Roflumilast foam offers a highly differentiated clinical profile Investigated for use as a once More potent (25- to 300-fold) daily, non-steroidal, anti- than the two other FDA- inflammatory topical formulation approved PDE4 inhibitors Selective, highly potent “Leave on” foa
Slide 12: Phase 2 Study of Roflumilast Foam in Seb Derm
Phase 2 Study of Roflumilast Foam in Seb Derm Endpoints 2:1 ARQ-154 foam Primary • IGA success at week 8 Eligibility 0.3% QD Secondary • Diagnosis of at least moderate • Overall assessment of erythema seb derm • Overall assessment of scaling • Aged ≥18 y • WI-NRS • ≤20% BSA Randomize Vehicle Explora
Slide 13: Study Populations
Study Populations ARQ-154 0.3% Vehicle Overall ITT 154 (100%) 72 (100%) 226 (100%) Safety Population 154 (100%) 72 (100%) 226 (100%) mITT* 153 (99.4%) 71 (98.6%) 224 (99.1%) PRU4 125 (81.2%) 59 (81.9%) 184 (81.4%) PRU2 141 (91.6%) 68 (94.4%) 209 (92.5%) * Excludes 2 subjects: One roflumilast subject
Slide 14: Subject Disposition
Subject Disposition ARQ-154 0.3% Vehicle Overall (N=154) (N=72) (N=226) Completed 141 (91.6%) 67 (93.1%) 208 (92.0%) Prematurely discontinued 13 (8.4%) 5 (6.9%) 18 (8.0%) Reason for discontinuation Withdrawal by subject 4 (2.6%) 1 (1.4%) 5 (2.2%) Sponsor decision 0 0 0 PI Decision 0 0 0 Non-complian
Slide 15: Demographics (Safety Population)
Demographics (Safety Population) ARQ-154 0.3% Vehicle Overall (N=154) (N=72) (N=226) Age, mean (yrs) 45.3 44.2 44.9 Gender Male 76 (49.4%) 40 (55.6%) 116 (51.3%) Female 78 (50.6%) 32 (44.4%) 110 (48.7%) Ethnicity Hispanic or Latino 29 (18.8%) 16 (22.2%) 45 (19.9%) Not Hispanic or Latino 125 (81.2%)
Slide 16: Baseline Characteristics (Safety Population)
Baseline Characteristics (Safety Population) ARQ-154 0.3% Vehicle Overall (N=154) (N=72) (N=226) BSA, mean (%) 3.3 3.0 3.2 Baseline IGA (0-4) 3 – Moderate 141 (91.6%) 69 (95.8%) 210 (92.9%) 4 – Severe 13 (8.4%) 3 (4.2%) 16 (7.1%) Baseline Erythema (0-3) 2 – Moderate 135 (87.7%) 66 (91.7%) 201 (88.9%
Slide 17: IGA Success at Each Visit (mITT)
IGA Success at Each Visit (mITT) 74% of Patients Achieved IGA Success 100% 90% p < 0.0001 80% 70% p = 0.0002 60% 50% p = 0.0033 40% 30% Percentage of Patients of Percentage 20% 10% 0% Week 2 Week 4 Week 8 0.3% ARQ-154 Vehicle IGA Success = Clear or Almost Clear with at least a 2-grade improvement fr
Slide 18: WI-NRS 4-pt Response (PRU4 Population)
WI-NRS 4-pt Response (PRU4 Population) 65% of Patients Achieved a WI-NRS 4-pt Response 100% 90% 80% p = 0.0007 70% p = 0.0009 p = 0.0007 60% 50% 40% 30% Percentage of Patients of Percentage 20% 10% 0% Week 2 Week 4 Week 8 0.3% ARQ-154 Vehicle 18 Copyright ARCUTIS 2020 18
Slide 19: Low Rates of Adverse Events (Safety Population)
Low Rates of Adverse Events (Safety Population) ARQ-154 0.3% Vehicle Overall (N=154) (N=72) (N=226) Subjects with any TEAE 37 (24.0%) 13 (18.1%) 50 (22.1%) Subjects with any Tx-Related TEAE 3 (1.9%) 3 (4.2%) 6 (2.7%) Subjects with any SAE 0 0 0 Subjects who discontinued Study 2 (1.3%) 2 (2.8%) 4 (1.
Slide 20: Most Common TEAEs by Preferred Term
Most Common TEAE’s by Preferred Term > 2% in any group ARQ-154 0.3% Vehicle Overall Preferred Term (N=154) (N=72) (N=226) Contact Dermatitis 3 (2%) 2 (3%) 5 (2%) Insomnia 3 (2%) 1 (1%) 4 (2%) Nasopharyngitis 3 (2%) 0 (0%) 3 (1%) 20 Copyright ARCUTIS 2020
Slide 21: Dr. Matthew Zirwas, Investigator in the Trial
Dr. Matthew Zirwas, M.D. Founder of the Bexley Dermatology Research Clinic and Investigator in the Trial 21 Copyright ARCUTIS 2020
Slide 22: Ken Lock, Chief Commercial Officer
Ken Lock Chief Commercial Officer 22 Copyright ARCUTIS 2020
Slide 23: Seb Derm Prevalence
Seb Derm Prevalence Additional opportunities to drive value in Seb Derm: Seb derm patients • Market growth due to educational 10.0M efforts and promotional investment Treated • U.S. patients treated by other 3.2M patients specialties (e.g., PCPs) Rx treated • Ex-US markets topically 2.7M Rx treated
Slide 24: In Derm Offices Volume and Severity In-line with Psoriasis
In Derm Offices the Volume and Severity Is In-line with Psoriasis average number of seborrheic dermatitis 55 patients seen in a Severity of Seborrheic Dermatitis patients typical month 41% 42% 17% Mild Moderate Severe Symptoms Experienced in Each Area From qualitative 36% 33% research and pilot 24%
Slide 25: FDA Approved Seb Derm Treatment Options
FDA Approved Seb Derm Treatment Options Regimens Side Effects Approx List Price LOCOID Solution Burning, itching, irritation, dryness, folliculitis Hydrocortisone Butyrate 0.1% 2-3x/ daily (these reactions are listed in an $65 Approved 1982 approximate decreasing order of occurrence) LOPROX Shampoo
Slide 26: Most Patients Require 2 or More Products
Most Patients Require 2 or More Products Mild Moderate Severe % Patients getting 2 or more Treatments 43% 75% 88% 47% 2 treatments in combination 54% 3 or more 34% 41% treatments in 21% combination 9% Arcutis Quantitative Seb Derm Research August 2020, n=100 Dermatology HCPs 26 CONFIDENTIAL - Do Not
Slide 27: TRx Trends for Approved Therapies
TRx Trends for Approved Therapies 10,000,000 2,000,000 • There are >9M on-label TRx 9,000,000 1,800,000 on an annual basis for FDA 8,000,000 1,600,000 TRx Approved therapies 7,000,000 1,400,000 • Other off-label products 6,000,000 1,200,000 are used (e.g. TCSs, TCIs) 5,000,000 1,000,000 Ciclopirox /
Slide 28: Payor Sentiment
Payor Sentiment Top National Pharmacy Benefit Managers % and Health Plans representing over ~70 80 million formulary lives were surveyed • Seborrheic dermatitis is considered a lower payer management priority compared to Surveyed currently conditions like psoriasis and atopic dermatitis view seborrh
Slide 29: High Interest in Roflumilast Foam
High Interest in Roflumilast Foam Dermatologist Likelihood to Prescribe Roflumilast Foam % 2% % % % 87 11 27 60 Very or Somewhat Likely Very Likely Extremely Likely Extremely likely to Rx It sounds like an attractive option Very, very excited as it is a foam and thus can be Provides another possible
Slide 30: Most Compelling Aspects of Roflumilast Foam
Most Compelling Aspects of Roflumilast Foam Compelling Product Profile Statements (top 2 – very/extremely compelling) Used for long-term management of seb derm 90% Safe to use on all parts of the body: face, scalp, and body 90% Highly favorable tolerability profile (no stinging/burning) 90% Convenie
Slide 31: Pricing of Current Foam Therapies
Pricing of Current Foam Therapies Ranges from ~$365 - $1100 WAC as of September 2020 $1,200 $1,000 $800 $600 $1,113 $992 $400 $785 $829 $829 $200 $366 $0 Finacea 15% Foam Extina 2% Foam Lexette 0.05% Foam Sorilux 0.005% Foam Verdeso 0.05% Foam Enstilar 0.005% Foam (Rosacea) (Seb D) (PsO) (PsO) (AD)
Slide 32: Seb Derm Competitive Pipeline
Seb Derm Competitive Pipeline Development timeline for Seb Derm therapies ARQ-154 Phase IIb trial initiated in seborrheic dermatitis patients 2018 2019 2020 2021 2022 2023 2024 2025 2026 2027 ARQ-154 Omiganan Gel Topline Phase IIb Phase II trial initiated results • 1.75% BID Gel • Facial SD Only • M
Slide 33: ~5 Million Patients Currently Treated Topically by Dermatologists in US
~5 Million Patients Currently Treated Topically by Dermatologists in US US Patient Populations (Millions) Psoriasis Atopic Dermatitis Seborrheic Dermatitis Prevalence 8.6 19.2 10.0 Rx treated 3.5 6.3 2.7 Topically treated 2.5 5.4 2.7 Rx treated in Derm Setting 2.8 1.2 1.8 Rx treated (Topically) in 2
Slide 34: If Approved, Roflumilast Foam
If Approved, Roflumilast Foam: Novel Mechanism Convenience • Will be first treatment in Easy to Diagnose • Will be an easy-to-use, once decades to offer a novel daily, single treatment option for mechanism of action for the both scalp and face/body treatment of seb derm Suitability “Best in Class” •
Slide 35: The Potential of Roflumilast Foam
The Potential of Roflumilast Foam Current Treatments Roflumilast Foam No single product works for scalp, Roflumilast can be used on all body face and body areas, including hair-bearing Most patients need an arsenal of Once-a-day roflumilast offers the products to manage disease convenience of a sing
Slide 36: Thank You
Thank You 36 Copyright ARCUTIS 2020
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