Arcutis Biotherapeutics, Inc. · NASDAQ:ARQT
Arcutis Biotherapeutics — Investor Presentation (October 2023)
38 slides from Arcutis Biotherapeutics's investor presentation, Oct 19, 2023
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 2023. 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: Our Strategy to Build the Preeminent Immuno-Dermatology Company
3©Copyright 2023. 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 4: Recent Business Updates – Laying the Groundwork for Long-Term Growth
4©Copyright 2023. Arcutis Biotherapeutics, Inc. — Presentation designed for an investor audience. Recent Business Updates – Laying the Groundwork for Long-Term Growth TRx = total prescriptions; GTN = gross-to-net; sNDA = supplemental New Drug Application; 1Cash, Restricted Cash, Cash Equivalents, an
Slide 5: Broad and Deep Pipeline Continues to Progress
5©Copyright 2023. 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 (ex-China) Worldwide (ex-China) Roflumilast Foam (ARQ-154) Worldwide (ex-China
Slide 6: Topical Roflumilast: Total Patient Opportunity Potential to Grow ~10X
6©Copyright 2023. Arcutis Biotherapeutics, Inc. — Presentation designed for an investor audience. Topical Roflumilast: Total Patient Opportunity Potential to Grow ~10X PCP = primary care providers 1.3 13.1 1.2 1.4 2.9 6.3 0 2 4 6 8 10 12 14 PsO Seb Derm AD PsO/AD/SD Gov't PCP/Ped Total M ill io ns o
Slide 7: Arcutis Enjoys Strong IP Protection
7©Copyright 2023. Arcutis Biotherapeutics, Inc. — Presentation designed for an investor audience. Arcutis Enjoys Strong IP Protection 1As of 9/31/23; PK = pharmacokinetics; PDE4 = phosphodiesterase 4; JAK = Janus Kinase Roflumilast Patent Protection Expected Until At Least 2037 1 Pending U.S. patent
Slide 8: Plaque Psoriasis - Significant Unmet Needs in Treatment Paradigm
8©Copyright 2023. 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 patients
Slide 9: Rapid, Robust Efficacy on IGA Success in Both Phase 3 DERMIS Trials
9©Copyright 2023. Arcutis Biotherapeutics, Inc. — Presentation designed for an investor audience. Rapid, Robust Efficacy on IGA Success in Both Phase 3 DERMIS Trials in Plaque Psoriasis IGA = Investigator’s Global Assessment; IGA Success = Clear or Almost Clear with at least a 2-grade improvement fr
Slide 10: ZORYVE Delivered Clinically Meaningful Response in 3 out of 4 Patients
10©Copyright 2023. 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 Trials PASI-50 72% PASI-75 40% PASI-90 20% C h a n g e f ro m b a se li n e
Slide 11: Rapid Reduction of Itch in DERMIS-1 and DERMIS-2
11©Copyright 2023. 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 12: ZORYVE PsO Launch Continues to Strengthen
12©Copyright 2023. Arcutis Biotherapeutics, Inc. — Presentation designed for an investor audience. ZORYVE PsO Launch Continues to Strengthen Data Source: ZORYVE – IQVIA SMART Rapid data through week ending 9/29/23 0 500 1,000 1,500 2,000 2,500 3,000 W EE K LY T R X ~ 100,000 TRx Launch-to-date
Slide 13: ~80% Commercial Coverage in the U.S.; >90% Lives Covered Without PA
13©Copyright 2023. Arcutis Biotherapeutics, Inc. — Presentation designed for an investor audience. ~80% Commercial Coverage in the U.S.; >90% Lives Covered Without PA PA = prior authorization; Source: MMIT Positive Halo Building on Prescriber Confidence with Coverage > 130 Million Covered Commercial
Slide 14: Progress Towards Sustained ZORYVE Growth
14©Copyright 2023. Arcutis Biotherapeutics, Inc. — Presentation designed for an investor audience. Progress Towards Sustained ZORYVE Growth Patient Engagement and Positive Experience Broad, High- Quality Access Drive Prescriber Awareness and Use • ~8,500 unique writers since launch • Refills buildin
Slide 15: Atopic Dermatitis: Compelling Opportunity for Roflumilast Cream
15©Copyright 2023. 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 children2 • Need for safe/effective therapy
Slide 16: INTEGUMENT-1 & -2 Phase 3 Atopic Dermatitis Trials
16©Copyright 2023. Arcutis Biotherapeutics, Inc. — Presentation designed for an investor audience. INTEGUMENT-1 & -2 Phase 3 Atopic Derm Trials Endpoints Primary • vIGA-AD success at week 4 Secondary • EASI-75 • WI-NRS (itch) • vIGA = Clear (0) or Almost Clear (1) Safety and tolerability Eligibility
Slide 17: Rapid, Robust Efficacy on IGA Success in Both Phase 3 Atopic Dermatitis Trials
17©Copyright 2023. 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 18: Over 40% of Patients Achieved EASI-75 at Week 4
18©Copyright 2023. 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 19: Roflumilast Cream Was Well-Tolerated in Phase 3 Trials
19©Copyright 2023. Arcutis Biotherapeutics, Inc. — Presentation designed for an investor audience. Roflumilast Cream Was Well-Tolerated in Phase 3 Trials AE: adverse event; SAE: serious adverse event; TEAE: treatment-emergent adverse event INTEGUMENT-1 INTEGUMENT-2 Subjects (%) Roflumilast 0.15% (n=
Slide 20: INTEGUMENT-OLE Phase 3 Atopic Dermatitis Trial
20©Copyright 2023. Arcutis Biotherapeutics, Inc. — Presentation designed for an investor audience. INTEGUMENT-OLE Phase 3 Atopic Dermatitis Trial Endpoints Primary • Occurrence of AEs • Occurrence of SAEs Secondary • vIGA-AD Success • EASI-75 • WI-NRS Safety and tolerability Subjects Included in Int
Slide 21: Long-Term Safety and Tolerability Profile Consistent With INTEGUMENT-1 & -2
21©Copyright 2023. Arcutis Biotherapeutics, Inc. — Presentation designed for an investor audience. Long-Term Safety and Tolerability Profile Consistent With INTEGUMENT-1 & -2 in AD Subjects, n (%) Preferred Term Roflumilast cream 0.15% (N=657) COVID-19 30 (4.6%) Upper respiratory tract infection 21
Slide 22: Durable & Improving Response on IGA Success Over Time
22©Copyright 2023. Arcutis Biotherapeutics, Inc. — Presentation designed for an investor audience. Durable & Improving Response on IGA Success Over Time vIGA-AD success = achievement of IGA=0/1 plus 2-grade improvement from Parent Study Baseline, Observed cases. At Week 4, Roflumilast Rollovers = n
Slide 23: Durable & Improving Response on EASI-75 in INTEGUMENT-OLE Trial
23©Copyright 2023. Arcutis Biotherapeutics, Inc. — Presentation designed for an investor audience. Durable & Improving Response on EASI-75 in INTEGUMENT-OLE Trial 75% EASI improvement from Parent Study Baseline, Observed Cases. At Week 4, Roflumilast Rollovers = n of 439, Vehicle Rollovers = n of 21
Slide 24: First Large Trial to Demonstrate Maintenance Dosing
24©Copyright 2023. Arcutis Biotherapeutics, Inc. — Presentation designed for an investor audience. First Large Trial to Demonstrate Maintenance Dosing • Starting at Week 4 of INTEGUMENT- OLE, participants who achieved vIGA- AD score of clear (0) switched to twice weekly maintenance dosing • Disease
Slide 25: INTEGUMENT-PED Phase 3 Atopic Dermatitis Trial
25©Copyright 2023. Arcutis Biotherapeutics, Inc. — Presentation designed for an investor audience. INTEGUMENT-PED Phase 3 Atopic Dermatitis Trial Endpoints Primary • vIGA-AD success at Week 4 Secondary • EASI-75 at Week 4 • vIGA-AD success at Week 2, Week 1 • vIGA = Clear (0) or Almost Clear (1) at
Slide 26: Rapid, Robust Efficacy on IGA Success, Consistent With INTEGUMENT-1 & -2
26©Copyright 2023. Arcutis Biotherapeutics, Inc. — Presentation designed for an investor audience. Rapid, Robust Efficacy on IGA Success Observed, Consistent With INTEGUMENT-1 & -2 9.4% 21.2% 25.4% 0.9% 6.8% 10.7% 0% 5% 10% 15% 20% 25% 30% 35% Week 1 Week 2 Week 4 P e rc e n ta g e o f P a ti e n ts
Slide 27: ~40% of Patients Achieved EASI-75 at Week 4
27©Copyright 2023. Arcutis Biotherapeutics, Inc. — Presentation designed for an investor audience. ~40% of Patients Achieved EASI-75 at Week 4 EASI -75 = 75% improvement from baseline 19.2% 30.0% 39.4% 5.2% 12.7% 20.6% 0% 5% 10% 15% 20% 25% 30% 35% 40% 45% 50% Week 1 Week 2 Week 4 P e rc e n ta g e
Slide 28: Rapid Response to Treatment With Roflumilast Cream
28©Copyright 2023. Arcutis Biotherapeutics, Inc. — Presentation designed for an investor audience. Rapid Response to Treatment With Roflumilast Cream Individual results may vary Baseline vIGA-AD = 3 Week 1 vIGA-AD = 1 Week 4 vIGA-AD = 1
Slide 29: Roflumilast Foam – Significant, Underappreciated Opportunity for Arcutis
29©Copyright 2023. 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 30: Scalp Psoriasis - Roflumilast Foam May Address Unmet Needs
30©Copyright 2023. 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 31: Robust Efficacy on Scalp IGA Success in Pivotal Phase 3 ARRECTOR Trial
31©Copyright 2023. Arcutis Biotherapeutics, Inc. — Presentation designed for an investor audience. Robust Efficacy on Scalp IGA Success in Pivotal Phase 3 ARRECTOR Trial S-IGA = Scalp Investigator’s Global Assessment; IGA Success = Clear or Almost Clear with at least a 2-grade improvement from basel
Slide 32: Demonstrated Efficacy on Body IGA Success in ARRECTOR Trial
32©Copyright 2023. 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 33: Seborrheic Dermatitis – Significant Unmet Needs in Treatment Paradigm
33©Copyright 2023. 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 •Topi
Slide 34: Seb Derm Patients Require Complex and Onerous Treatment Regimens
34©Copyright 2023. Arcutis Biotherapeutics, Inc. — Presentation designed for an investor audience. Seb Derm 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
Slide 35: 80% of Patients Achieved IGA Success & 50% Completely Clear at 8 Weeks
35©Copyright 2023. 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 36: Alopecia Areata (AA) – Significant Unmet Needs
36©Copyright 2023. Arcutis Biotherapeutics, Inc. — Presentation designed for an investor audience. Alopecia Areata (AA) –Significant Unmet Needs Autoimmune, chronic, and relapsing hair loss ranging from scattered patches to complete loss of hair Significant psychosocial impact on self-esteem, body i
Slide 37: Barriers to Topical Drug Delivery to the Hair Bulb
37©Copyright 2023. 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 38: Acquisition of Ducentis – Next Step Towards Evolution Into Preeminent Immuno-Dermatology Company
38©Copyright 2023. 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
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