Arcutis Biotherapeutics, Inc. · NASDAQ:ARQT
Arcutis Biotherapeutics — Corporate Update (February 2021)
38 slides from Arcutis Biotherapeutics's corporate update, Feb 1, 2021
Slide 1: DERMIS-1/DERMIS-2 Phase 3 Plaque Psoriasis Topline Data Review
DERMIS-1/DERMIS-2 Phase 3 Plaque Psoriasis Topline Data Review February 2021
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: Agenda and Today's Speakers
AGENDA Frank Watanabe President and CEO Patrick Burnett, M.D., Ph.D., FAAD Chief Medical Officer Ken Lock Chief Commercial Officer Today’s Speakers Copyright ARCUTIS 20213 Mark Lebwohl, MD Professor and Dean for Clinical Therapeutics, Icahn School of Medicine at Mount Sinai
Slide 4: Frank Watanabe, President & CEO
4 Frank Watanabe President & CEO Copyright ARCUTIS 2021
Slide 5: Arcutis Drivers of Value
Arcutis Drivers of Value • Focus on large dermatology markets with significant unmet medical needs • Late-stage pipeline of differentiated products with significant near-term potential • Topical roflumilast could become first-line therapy & transform treatment paradigm • Leading dermatology developm
Slide 6: Our Product Candidates Target Large Markets
1.3M Pts Vitiligo Our Product Candidates Target Large Markets1 1. Source: company estimates Prevalent U.S. Patient (Pts) Populations Pre- RegistrationPhase 1 Phase 2 Phase 3 Stage of Arcutis Clinical Development Mostly Dermatologists Mostly Non-Dermatologists U.S. Prescriber Base Preclinical Plaque
Slide 7: Roflumilast May Address Unmet Needs in Plaque Psoriasis
Roflumilast May Address Unmet Needs in Plaque Psoriasis • Efficacy: – Symptomatic improvements similar to steroid/vitamin D combination, exceeding high-potency steroids or Otezla – Improvement on intertriginous plaques – Impact on itch associated with psoriasis – Rapid onset – Well tolerated • Simpl
Slide 8: Patrick Burnett, Chief Medical Officer
8 Patrick Burnett, M.D., Ph.D., FAAD Chief Medical Officer Copyright ARCUTIS 2021
Slide 9: Significant Unmet Needs in Plaque Psoriasis
Significant Unmet Needs in Plaque Psoriasis • > 90% of US patients treated with topical drugs • Existing topical therapies have numerous shortcomings – Physicians and patients forced to trade off between efficacy and safety/tolerability • Ideal topical: efficacy of high potency steroids, ability to
Slide 10: DERMIS-1/2 Phase 3 Plaque Psoriasis Studies
DERMIS-1/2 Phase 3 Plaque Psoriasis Studies Endpoints Primary • IGA success at week 8 Secondary • PASI-50 and PASI-75 • Intertriginous-IGA (I-IGA) Success • WI-NRS (itch) • Psoriasis Symptom Diary (PSD) Safety and tolerability IGA Success & I-IGA Success = Clear or Almost Clear with at least a 2-gra
Slide 11: Robust Efficacy on IGA Success in Both Phase 3 Studies
Copyright ARCUTIS 2021 CONFIDENTIAL11 Robust Efficacy on IGA Success in Both Phase 3 Studies 11 IGA Success = Clear or Almost Clear with at least a 2-grade improvement from baseline ITT Population 3.3% 19.1% 25.6% 37.5% 2.1% 5.8% 4.7% 6.9% 0% 10% 20% 30% 40% 50% 60% Week 2 Week 4 Week 6 Week 8 Pe rc
Slide 12: DERMIS-1/2 Efficacy
DERMIS-1/2 Efficacy Baseline Week 8 of Treatment Vehicle Topical Roflumilast 0.3% Copyright ARCUTIS 202112 IGA = 3 IGA = 3 IGA = 3 IGA = 3 IGA = 3 IGA = 1 I-IGA = 3 I-IGA = 0 I-IGA = 3 I-IGA = 3
Slide 13: IGA Success Comparable to Combo of High-potency Steroids & Vitamin D / Tazarotene
IGA Success at 8 Weeks Comparable to Combo of High-potency Steroids & Vitamin D / Tazarotene Note: The results of this retrospective post-hoc cross-trial comparison may not be directly comparable, as they are not from a single head-to-head clinical trial. Comparison of IGA Success Rates Across Separ
Slide 14: PASI-75 at Week 8 Surpasses Otezla 16-Week Data
PASI-75 at 8 Weeks Surpasses Otezla 16- Week Data Note: The results of this retrospective post-hoc cross-trial comparison may not be directly comparable, as they are not from a single head-to-head clinical trial. *Otezla® trials were in moderate-to-severe patients 0% 5% 10% 15% 20% 25% 30% 35% 40% 4
Slide 15: IGA Success Comparable to Tapinarof by Earlier Timepoint
IGA Success Comparable to Tapinarof by Earlier Timepoint Comparison of IGA Success Across Separate Topical Psoriasis Clinical Trials 15 Copyright ARCUTIS 2021 CONFIDENTIAL Week 12 Tapinarof Phase 3 Tapinarof Vehicle 0% 5% 10% 15% 20% 25% 30% 35% 40% 45% 50% Week 8 IG A S uc c e ss R a te Roflumilast
Slide 16: Rapid, Robust and Consistent Effect on Itch Across Diseases
Copyright ARCUTIS 2021 CONFIDENTIAL Rapid, Robust and Consistent Effect on Itch Across Diseases 16 0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100% Week 8 Pe rc e nt a g e o f P a tie nt s Seb Derm Ph2 0.3% Roflumilast Foam Vehicle p = 0.0007 WI-NRS response = 4 point reduction in WI-NRS in patients with
Slide 17: Topical Roflumilast Well Tolerated in Phase 3
Topical Roflumilast Well Tolerated in Phase 3 DERMIS-1 DERMIS-2 Roflumilast 0.3% (N=286) Vehicle (N=153) Roflumilast 0.3% (N=290) Vehicle (N=152) Subjects with any TEAE 72 (25.2%) 36 (23.5%) 75 (25.9%) 28 (18.4%) Subjects with any Tx-Related TEAE 7 (2.4%) 3 (2.0%) 16 (5.5%) 8 (5.3%) Subjects with an
Slide 18: Most Common Adverse Events
Most Common Adverse Events (≥2% in Any Group) Copyright ARCUTIS 2021 CONFIDENTIAL18 Hypertension includes synonymous terms (e.g., blood pressure increased) DERMIS-1 DERMIS-2 Subjects, n (%) Preferred Term Roflumilast 0.3% (n=286) Vehicle (n=153) Roflumilast 0.3% (n=290) Vehicle (n=152) Hypertension
Slide 19: Long-Term Data Supports Chronic Use in Plaque Psoriasis
Long-Term Data Supports Chronic Use in Plaque Psoriasis • 73.5% of patients completed 52-64 weeks of treatment – Only 0.9% discontinued due to lack of efficacy – Only 3.9% discontinued due to any adverse event • Efficacy over 52-64 weeks comparable to DERMIS-1/-2 8-week efficacy Copyright ARCUTIS 20
Slide 20: Roflumilast May Address Unmet Needs in Many Other Inflammatory Skin Diseases
Roflumilast May Address Unmet Needs in Many Other Inflammatory Skin Diseases • Dermatologists and patients need topical therapies that: – Provide efficacy as good as or better than current standard-of-care – Do not pose worrisome safety or tolerability issues – Don’t force trade-offs in efficacy and
Slide 21: Topical Roflumilast Efficacy Across Multiple Other Inflammatory Skin Diseases
Topical Roflumilast Efficacy Across Multiple Other Inflammatory Skin Diseases Copyright ARCUTIS 2021 0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100% Week 4 % C FB EASI % CFB 0.15% Roflumilast 0.05% Roflumilast Vehicle p = 0.049 Atopic Dermatitis 0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100% Week 8 Pe rc e
Slide 22: Tofacitinib MACE and Malignancy Data
Tofacitinib MACE and Malignancy Data Post-marketing safety study in 4,362 subjects with Rheumatoid Arthritis 22 Copyright ARCUTIS 2021 CONFIDENTIAL https://investors.pfizer.com/investor-news/press-release-details/2021/Pfizer-Shares-Co-Primary-Endpoint-Results-from-Post-Marketing-Required-Safety-Stud
Slide 23: Consistently Favorable Tolerability Profile Across Indications
of subjects treated with topical roflumilast completed Phase 2 studies Consistently Favorable Tolerability Profile Across Indications In psoriasis, AD, scalp and seb derm programs: • > 2400 individuals already treated with topical roflumilast • Treatment-related AEs rare & balanced across arms • Dis
Slide 24: Mark Lebwohl, MD
24 Mark Lebwohl, MD Professor and Dean for Clinical Therapeutics, Icahn School of Medicine at Mount Sinai Copyright ARCUTIS 2021
Slide 25: Considerations of Topical Steroids
Considerations of Topical Steroids Copyright ARCUTIS 202125 * PHOTOS COURTESY OF DR. MARK LEBWOHL
Slide 26: Striae and Perioral Dermatitis
Striae and Perioral Dermatitis Copyright ARCUTIS 202126 * PHOTOS COURTESY OF DR. MARK LEBWOHL *PHOTOS REPRESENT SIDE EFFECTS FROM USE OF TOPICAL CORTICOSTEROIDS
Slide 27: HPA Suppression & Cushing's Syndrome
HPA Suppression & Cushing’s Syndrome Copyright ARCUTIS 202127 * PHOTOS COURTESY OF DR. MARK LEBWOHL *PHOTOS REPRESENT SIDE EFFECTS FROM USE OF TOPICAL CORTICOSTEROIDS
Slide 28: Telangiectasis and Skin Thinning
Telangiectasis and Skin Thinning Copyright ARCUTIS 202128 * PHOTOS COURTESY OF DR. MARK LEBWOHL *PHOTOS REPRESENT SIDE EFFECTS FROM USE OF TOPICAL CORTICOSTEROIDS
Slide 29: Ken Lock, Chief Commercial Officer
29 Ken Lock Chief Commercial Officer Copyright ARCUTIS 2021
Slide 30: Keys to a Successful Launch
Keys to a Successful Launch Copyright ARCUTIS 202130 Strong Product Profile Large Addressable Population Solid Access & Reimbursement Effective Promotion
Slide 31: Topical Roflumilast Positioned to Have Differentiated and Compelling Profile
Topical Roflumilast Positioned to Have Differentiated and Compelling Profile • Symptomatic improvements comparable to the combo of high-potency steroids and Vitamin D / Retinoid • Significant impact on itch • Ability to use chronically • Little or no application site reaction • Convenient, easy to u
Slide 32: ~5 Million PsO, AD, Seb Derm Patients Rx Topical Treated by Dermatologists in US
~5 Million PsO, AD, Seb Derm Patients Rx Topical Treated by Dermatologists in US 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 Derm Setting 2.0 1.0 1.8 A
Slide 33: Large Pool of Easily Accessible Patients
Large Pool of Easily Accessible Patients • ~ 6M patients currently Rx treated by U.S. dermatologists • Concentrated prescribers create sales force efficiencies – 75 – 80 sales reps required to cover most prescribers • Minimal behavioral change required to activate utilization – Most patients in targ
Slide 34: Psoriasis Landscape: Topical Roflumilast Positioned to Treat the Entire Spectrum
Pr ev a le nc e Topical Therapies Systemic Therapies Psoriasis Landscape: Topical Roflumilast Positioned to Treat the Entire Spectrum 34 Mild – 65% Moderate – 25% Severe – 10% Topical Roflumilast Cream Tapinarof Copyright ARCUTIS 2021
Slide 35: We Intend to Optimize Patient Access to Our Innovative Treatments
We Intend to Optimize Patient Access to Our Innovative Treatments • Seek broad access and reduced prescriber burden to maximize volume opportunity – Highly innovative products at appropriate pricing allow for broad and rapid adoption – Ability for HCP to get drug when prescribed and patient affordab
Slide 36: Target Band for Optimal Access Pricing of Branded Topical Medications
Target Band for Optimal Access Pricing of Branded Topical Medications Source: Analysource – 1/11/21 $1200 $400 $800 Copyright ARCUTIS 202136
Slide 37: Pipeline Could Generate 2030 Sales of ~$3B-$8B in U.S. Market Alone
Pipeline Could Generate 2030 Sales of ~$3B-$8B in U.S. Market Alone U.S. Opportunity Potential 2030 Sales Dermatology market: Topical roflumilast (ARQ-151/154) $1.3-3.7B Plaque & scalp psoriasis 0.5-1.5B Atopic dermatitis 0.4-1.0B Seborrheic dermatitis 0.4-1.2B Topical JAK inhibitor (ARQ-252) 0.5-1.
Slide 38: Thank You
Thank You Copyright ARCUTIS 202138
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