Arcutis Biotherapeutics, Inc. · NASDAQ:ARQT
Arcutis Biotherapeutics — Q3 2023 Earnings Presentation
21 slides from Arcutis Biotherapeutics's earnings presentation, Nov 3, 2023
Slide 1: 3rd Quarter 2023 Financial Results & Business Update
3rd Quarter 2023 Financial Results & Business Update November 3, 2023
Slide 2: Legal Disclaimers
Legal Disclaimers This presentation and the accompanying oral presentation candidates, and our ability to serve those markets; our statements, whether written or oral, that may be made from time contain “forward-looking” statements that are based on our commercialization, marketing and manufacturing
Slide 3: Today's Speakers
Today’s Speakers Frank Watanabe Todd Edwards President & CEO Chief Commercial Officer John Smither Patrick Burnett, MD, PhD, FAAD Chief Financial Officer Chief Medical Officer (interim) ©Copyright 2023. Arcutis Biotherapeutics, Inc. — Presentation designed for an investor audience. 3
Slide 4: Speakers & Agenda: Business Review
Speakers & Agenda Business Review Frank Watanabe President & CEO ©Copyright 2023. Arcutis Biotherapeutics, Inc. — Presentation designed for an investor audience. 4
Slide 5: Q3 Business Updates – Laying the Groundwork for Long-Term Growth
Q3 Business Updates – Laying the Groundwork for Long-Term Growth ZORYVE® (roflumilast) cream 0.3% launch building momentum with ~110,000 TRx launch-to-date; Q3 2023 GTN % in the low 70s Received FDA approval of ZORYVE in plaque psoriasis down to age 6 Submitted sNDA for roflumilast cream 0.15% in at
Slide 6: Topical Roflumilast: Total Patient Opportunity Potential to Grow ~10X
Topical Roflumilast: Total Patient Opportunity Potential to Grow ~10X Total U.S. Topical Roflumilast Addressable Market 14 12 10 U.S. Commercial 6.3 Millions of Patients Patients Only 8 13.1 6 2.9 Addressable Through PCP Partnership 4 1.4 Addressable with 2 1.2 Medicare/ Medicaid Coverage 1.3 0 PsO
Slide 7: Speakers & Agenda: Commercial Update
Speakers & Agenda Commercial Update Todd Edwards Chief Commercial Officer ©Copyright 2023. Arcutis Biotherapeutics, Inc. — Presentation designed for an investor audience. 7
Slide 8: ZORYVE PsO Launch Continues to Strengthen
ZORYVE PsO Launch Continues to Strengthen ~ 110,000 U.S. TRx Launch-to-date 3,000 2,500 2,000 WEEKLY TRX 1,500 Q3 2023 TRx 1,000 500 0 Data Source: ZORYVE – IQVIA SMART Rapid data through week ending 9/29/23 ©Copyright 2023. Arcutis Biotherapeutics, Inc. — Presentation designed for an investor audie
Slide 9: ~80% Commercial Coverage in the U.S.; >90% Lives Covered Without PA
~80% Commercial Coverage in the U.S.; >90% Lives Covered Without PA > 130 > 90% Covered Million Without Covered Commercial PA Lives Total US Commercial Market = 165 million lives Covered Commercial Lives = >130 million Positive Halo Building on Prescriber Confidence with Coverage PA = prior authoriz
Slide 10: Progress Towards Sustained ZORYVE Growth
Progress Towards Sustained ZORYVE Growth Commercial Success Drive Prescriber Patient Engagement Broad, High- Awareness and Use and Positive Experience Quality Access • ~9,000 unique • Refills grew ~50% in Q3 • ~132 million writers since vs. Q2 commercial lives launch covered • ~15% increase in • Liv
Slide 11: Speakers & Agenda: R&D Update
Speakers & Agenda R&D Update Patrick Burnett, MD, PhD, FAAD Chief Medical Officer ©Copyright 2023. Arcutis Biotherapeutics, Inc. — Presentation designed for an investor audience. 11
Slide 12: Clinical and Regulatory Execution Continues
Clinical and Regulatory Execution Continues Key Accomplishments / Milestones Indication Timing FDA Approval of ZORYVE down to the Age of 6 Plaque PsO Filed sNDA for Roflumilast cream down to the Age of 6 Atopic Dermatitis Positive INTEGUMENT-PED topline in Ages 2-5 Atopic Dermatitis Positive INTEGUM
Slide 13: Topical Roflumilast Foam Positioned to Transform Treatment of Seborrheic Dermatitis
Topical Roflumilast Foam Positioned to Transform Treatment of Seborrheic Dermatitis 80% of Patients >50% of Patients Achieved IGA Success at Week 8 Achieved IGA of Clear (IGA = 0) at Week 8 100% p < 0.0001 100% p < 0.0001 90% 90% 80% 80% p < 0.0001 Percentage of Patients Percentage of Patients 70% p
Slide 14: Living With Seborrheic Dermatitis Impacts Multiple Areas of Life
Living With Seborrheic Dermatitis Impacts Multiple Areas of Life 77% 91% 47% “My seborrheic dermatitis Say living with seborrheic Have ever missed work symptoms cause me anxiety” dermatitis negatively impacts because of their their social life and social seborrheic dermatitis interactions symptoms Y
Slide 15: Dynamics Are Favorable For Rapid Adoption
Dynamics Are Favorable For Rapid Adoption Pent-up demand for novel foam offering High patient dissatisfaction with existing treatments Opportunity to leverage positive HCP experience from ZORYVE in psoriasis ©Copyright 2023. Arcutis Biotherapeutics, Inc. — Presentation designed for an investor audie
Slide 16: Durable & Improving Response on EASI-75 in Atopic Dermatitis Long-Term Study
Durable & Improving Response on EASI-75 in Atopic Dermatitis Long-Term Study (INTEGUMENT-OLE) EASI-75 70% 66.2% INTEG-1 & -2 61.5% 64.6% 60% 60.9% % of Patients 50% 42.6% 40% 30% Roflumilast Rollovers Vehicle Rollovers 20% 17.8% 10% 0% 0 4 8 12 16 20 24 28 32 36 40 44 48 52 56 Week of Treatment 75%
Slide 17: Speakers & Agenda: Financial Results
Speakers & Agenda John Smither Chief Financial Officer Financial Results (interim) ©Copyright 2023. Arcutis Biotherapeutics, Inc. — Presentation designed for an investor audience. 17
Slide 18: Strong ZORYVE Net Product Revenue Growth
Strong ZORYVE Net Product Revenue Growth Net Revenues $M • 70% QoQ growth in Q3 8.1 • Driven by GTN % improvement in Q3; average % for the Q in the low 4.8 70s 2.8 • Healthy sequential demand growth continues • Expect further volume growth Q1 '23 Q2 '23 Q3 '23 and GTN improvement in Q4 ©Copyright 20
Slide 19: Q3 2023 Financial Results
Q3 2023 Financial Results GAAP Reported $ Millions, Except Net Loss Per Share Q3 2023 Q3 2022 YoY Change Product Revenues, Net $8.1 0.7 7.4 Other Revenues 30.0 - 30.0 Total Revenues 38.1 - 37.4 Cost of Sales 1.2 0.3 0.9 R&D Expense 26.2 69.7 (43.5) SG&A Expense 47.6 35.5 12.1 Total Operating Expense
Slide 20: Added $100 Million Gross Cash with October Financing
Added $100 Million Gross Cash with October Financing $ Millions, except average shares GAAP Reported Cash Flow & Balance Sheet Data Q3 2023 Cash, Cash Equivalents, and Marketable securities (Sep. 30, 2023) * $228.0 Net cash used in operating activities 44.0 Long-term debt, net (Sep. 30, 2023) 200.8
Slide 21: Thank You Q&A
Thank You Frank Watanabe Todd Edwards President & CEO Chief Commercial Officer Patrick Burnett, MD, PhD, FAAD John Smither Chief Financial Officer Q&A Chief Medical Officer (interim) ©Copyright 2023. Arcutis Biotherapeutics, Inc. All rights reserved. Presentation designed for an investor audience. 2
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