Argenx Se · EURONEXT:ARGX
Argenx — Q1 2021 Earnings Presentation
24 slides from Argenx's earnings presentation, May 2021
Slide 1: Together We Discover: First Quarter 2021 Financial Results
Together We Discover Reaching Patients Through Immunology Innovation First Quarter 2021 Financial Results MAY 2021 1
Slide 2: Forward Looking Statements
Forward Looking Statements This presentation has been prepared by argenx se (“argenx” or the “company”) for informational purposes only and not for any other purpose. Nothing contained in this presentation is, or should ! be construed as, a recommendation, promise or representation by the presenter
Slide 3: Achieving 'argenx 2021' Vision
Achieving ‘argenx 2021’ Vision Commercial franchises argenx 2021: Reaching patients Global expansion FcRn leadership, 4/4 POC MG CIDP ITP PV Late-stage pipeline ARGX-117 pipeline-in-a-product opportunity MMN Cusatuzumab strategic alliance Immunology breakthroughs Immunology Innovation Program Strong
Slide 4: Promising Value Proposition to MG Patients
Promising Value Proposition to MG Patients 78 % 60 % OVER Response Rate 84 % Deep Responses 50 % Supportive of Fast Onset Individualized of Action Dosing MG-ADL responders during first two MG-ADL responders within first two MG-ADL responders achieved minimal Patients likely cycles weeks of treatment
Slide 5: SC Bridging Strategy Leverages Correlation Between Pharmacodynamic and Clinical Effect
SC Bridging Strategy Leverages Correlation Between Pharmacodynamic and Clinical Effect Established association of total IgG and MG-ADL Bridging study (n=50) underway to support following efgartigimod treatment registration of SC efgartigimod • Study designed to demonstrate non- inferiority of PD eff
Slide 6: Efgartigimod: First-in-Class FcRn Antagonist
Efgartigimod: First-in-Class FcRn Antagonist ERI Living with MG • Proof-of-concept in four indications (MG, ITP, PV, CIDP) Patients • IV and SC injection in on drug for development more than • 400+ subjects or patients dosed 2 years CHRIS • Safety profile comparable Living with MG to placebo in ADAP
Slide 7: CIDP: Phase 2/3 ADHERE Trial
Chronic Inflammatory Demyelinating Polyneuropathy: Phase 2/3 ADHERE Trial Assess Confirm IgG autoantibody efficacy & safety involvement efgartigimod vs placebo Treatment period Identify patients with active CIDP Open-label Placebo-controlled Efficacy analysis Stage B based on relapse Screening Run-i
Slide 8: ITP Phase 3 ADVANCE: Two Trials Run in Parallel
ITP Phase 3 ADVANCE: Two Trials Run in Parallel Phase 3, multicenter, randomized, double-blind, placebo-controlled trial N=156 Primary objective 24 weeks 10mg/kg IV efgartigimod Fixed weekly Fixed weekly or Weekly or q2w dosing q2w dosing dosing adjusted according to platelet count Durable response:
Slide 9: Efgartigimod Phase 3 Trial in Pemphigus
Efgartigimod Phase 3 Trial in Pemphigus - Focus on Potential to Drive Fast-Onset and Steroid Sparing Concomitant Screening prednisone Randomization (2x1) Primary endpoint is proportion of PV patients achieving CRmin* within 30 Pemphigus vulgaris weeks (PV) and foliaceus (PF) • Prednisone starting do
Slide 10: Efgartigimod: Broad Pipeline Opportunity
Efgartigimod: Broad Pipeline Opportunity Landscape of Solid Biology Feasible for argenx Franchises & Indications IgG-mediated Severe Rationale: Biotech: Efgartigimod to date achieved proof-of-concept in 4/4 Predominantly Orphan indication, indications; 2/2 in neuromuscular franchise Autoimmune Disea
Slide 11: Reaching Patients Worldwide
Reaching Patients Worldwide + Expand Accelerate Mutual Passion patients we reach + enrollment into global bringing innovative number of indications registrational trials therapies to patients 11
Slide 12: ARGX-117: Broad Opportunity By Targeting C2
ARGX-117: Broad Opportunity By Targeting C2 Unique Phase 1 Healthy Phase 2 Intervention Volunteer Data Indications IgG IgM Mannose sugar Expected Mid-2021 C1 MAS MBL qrs Ps C4 C2 Multifocal Motor Neuropathy C3 convertase SC and IV C3a C3 C3b Formulations Kidney Indications C5 convertase C5a C5 C5-C9
Slide 13: Feasibility: Orphan Potential & Economically Viable Indication Multifocal Motor Neuropathy
Feasibility: Orphan Potential & Economically Viable Indication Unmet need for new therapies that slow down progression of disease and reduce reliance on IVIg MMN Multifocal Motor Prevalence Diagnosis / Treatment Neuropathy Metrics “ALS patient that didn’t die” ~13,000 patients in the US Anti-GM1 IgM
Slide 14: Cusatuzumab Strategy
Cusatuzumab Strategy Newly diagnosed elderly AML patients who are unfit for intensive chemotherapy Phase 2 CULMINATE Trial Phase 1b ELEVATE Trial in Triple Cusatuzumab + Azacitidine 20 mg/kg Combination Go-forward dose selected cusatuzumab + CR CRc azacitidine CR Rates Endosome n=14 n=21 + venetocla
Slide 15: Immunology Innovation Program (IIP)
Core Strategy To Grow Our Pipeline Immunology Innovation Program (IIP) DISCOVERY Optimizing the collision of great minds BIOLOGY TECHNOLOGY Collaborators WHOLLY-OWNED PIPELINE ASSETS COMPANY OUT-LICENSING OR Efgartigimod, CREATION COLLABORATIONS 117, 118, 119 Dualyx Genor (109) Staten (116) Leo (112
Slide 16: Leading Antibody Discovery and Engineering Toolkit
Leading Antibody V-Region Capabilities SIMPLE Discovery and AntibodyTM Platform Engineering Toolkit Fc Engineering to Optimize Antibodies NHANCE® DHS Mutations SC Dosing Optionality ENHANZE® Technology ACT-Ig® POTELLIGENT® SMART-Ig® ABDEGTM 16
Slide 17: Demonstrated Execution Across Business
Demonstrated Execution Across Business MG BLA 5 Global Growing Expanded Building Accepted Efgartigimod Autoimmune Discovery The Right Team Trials Ongoing Pipeline Capabilities 17
Slide 18: First Quarter 2021 Financial Results
First Quarter 2021 Financial Results Three Months Ended March 31, (in thousands of $ except for shares and EPS) 2021 2020 Variance Revenue $ 158,155 $ 21,139 $ 137,017 Other operating income 9,260 4,672 4,588 Total operating income 167,415 25,811 141,604 Research and development expenses (122,328) (
Slide 19: Preparing for a Successful Launch
Preparing for a Successful Launch Physician Payor Building Manufacturing Education Engagement the Team Commitment Reach the 20,000 addressable gMG patients 19
Slide 20: Listening to and Learning from MG Community
Listening to and Learning from MG Community 20
Slide 21: Efgartigimod Regulatory Update
Efgartigimod Regulatory Update United States Global Japan J-MAA for IV efgartigimod for treatment of gMG accepted for review by PMDA BLA for IV efgartigimod for treatment of gMG accepted for review by FDA EU MAA expected to be filed with EMA in second half of 2021 PDUFA date of December 17, 2021 Chi
Slide 22: Myasthenia Gravis Is Just The Beginning
MYASTHENIA GRAVIS Is Just The Beginning Myasthenia Immune Pemphigus Chronic Inflammatory Fifth Sixth Gravis Thrombocytopenia Demyelinating Indication Indication Polyneuropathy Key: NEURO HEME SKIN KIDNEY 22
Slide 23: Strategic Priorities
Building Tomorrow’s Immunology Company Reach gMG patients with efgartigimod Global expansion Strategic Advance clinical development in multiple Priorities Leverage IIP autoimmune indications Rooted in groundbreaking immunology research, growing through collaboration 23
Slide 24: Together We Discover
Together We Discover Reaching Patients Through Immunology Innovation First Quarter 2021 Financial Results MAY 2021 24