Argenx Se · EURONEXT:ARGX
Argenx — Q3 2021 Earnings Presentation
20 slides from Argenx's earnings presentation, Oct 28, 2021
Slide 1: Together We Discover
Together We Discover Reaching Patients Through Immunology Innovation Third Quarter 2021 Financial Results October 28, 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: Uniquely Positioned
Zai collaboration BP Indications Kidney Myositis Uniquely Therapeutic Positioned Franchises Skin For exponential expansion ROW CIDP China Heme o efgartigimod indications PV o therapeutic franchises o global markets Global Europe Markets Neuro ITP Japan MG US 3
Slide 4: Depth of MG-ADL Response Demonstrated Across First Two Treatment Cycles in ADAPT
Depth of MG-ADL Response Demonstrated Across First Two Treatment Cycles in ADAPT MG-ADL Responders Who Achieved Minimal Symptom Expression (MG-ADL of 0 or 1) 100 Cycle 1 Cycle 2 Patients Achieving MSE, % 80 59.1% 60 36.8% 44.4% 40 20 0.0% n=26/44 n=7/19 n=16/36 n=0/11 0 Efgartigimod Placebo 4
Slide 5: Promising Value Proposition to MG Patients
Promising Value Proposition to MG Patients 79 % 59 % Response MSE 89% Rate 84 % Responses Duration of response Onset of Action MG-ADL responders MG-ADL responders MG-ADL responders achieved MG-ADL responders experienced during first two cycles within first two weeks of treatment minimal symptom expr
Slide 6: Deep Antibody Pipeline of Differentiated Candidates
Deep Antibody Pipeline of Differentiated Candidates Program Indication Preclinical Phase 1 Phase 2 Phase 3 Registration Update IV MG SC MG Data 1H 2022 IV ITP Data 1H 2022 SC ITP Efgartigimod SC PV SC CIDP SC Myositis SC Bullous Pemphigoid (BP) IV + SC MMN ARGX-117 IV + SC Kidney Diseases + AZA Newl
Slide 7: ITP: Two Registrational ADVANCE Trials Run in Parallel
ITP: Two Registrational ADVANCE 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 re
Slide 8: CIDP: Registrational ADHERE Trial Following GO Decision
CIDP: Registrational ADHERE Trial Following “GO” Decision 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-in period Stage A
Slide 9: Pemphigus: Registrational Trial Focused on Fast Onset and Steroid-sparing
Pemphigus: Registrational Trial Focused on 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 dose Efgartigimod weekly SC M
Slide 10: Bullous Pemphigoid: Expanding the Skin Franchise
Bullous Pemphigoid: Expanding the Skin Franchise Autoimmune Blistering Diseases Pemphigus Pemphigoid Autoantibody Driven DSG1 and DSG3 BP180 and BP230 Convincing Rationale IVIg, PLEX, Immunoadsorption demonstrate role of IgG Unmet Patient Needs Fast-acting, tolerable therapies; ability to taper cort
Slide 11: Myositis: IgG-Mediated Biology
Myositis: IgG-Mediated Biology AChR, MuSK, LRP4 Neuromuscular Disease Myasthenia Gravis autoantibodies comprise ~90% of MG patients + ADAPT Data + Chronic Inflammatory 40% anti-myelinated ADHERE Neuromuscular Disease Demyelinating peripheral nerve IgGs GO/NO-GO Polyneuropathy Autoantibodies characte
Slide 12: C2 is Ideal Point of Intervention within Complement Cascade
C2 is Ideal Point of Intervention within Complement Cascade (Auto)antibodies Microorganisms Classical Lectin Alternative IgG IgM Mannose sugar Foreign surface C1 MBL C3 2 qrs Intact alternative pathway to reduce 3 C4 C2 MASPs CFB CFD infection risk Crossroad of classical & lectin pathways Manageable
Slide 13: Phase 1 Data Support Path Forward and Potential for Individualized Dosing Schedule
Phase 1 Data Support Path Forward and Potential for Individualized Dosing Schedule in Patients Favorable safety & tolerability profile supports advancing to Phase 2 patient trials Consistent PK/PD profile across IV and SC dosing that may enable infrequent dosing Phase 2 trial in multifocal motor neu
Slide 14: Our Pipeline Starts with our Immunology Innovation Program
Our Pipeline Starts with our Immunology Innovation Program CLINICAL DEVELOPMENT LEADING TRANSLATIONAL BIOLOGY LABS ANTIBODY ENGINEERING Internal Value Creation External Value Creation Staten AgomAb First in Class | Unique Design | Multiple Indications ARGX-118 Dualyx (ARGX-116) (ARGX-114) Genor LEO
Slide 15: Third Quarter 2021 Financial Results
Third Quarter 2021 Financial Results Nine Months Ended September 30, (in thousands of $ except for shares and EPS) 2021 2020 Variance Revenue $ 471,255 $ 33,652 $ 437,603 Other operating income 23,327 14,056 9,271 Total operating income 494,582 47,708 446,874 Research and development expenses -413,3
Slide 16: 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 EU gMG accepted for review by FDA MAA filed with EMA and validated PDUFA date of December 17, 2021 China Zai Lab to discuss po
Slide 17: 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 17
Slide 18: Listening to and Learning from MG Community
Listening to and Learning from MG Community 18
Slide 19: Building a Leading Immunology Company
Building a Leading Immunology Company Global launch preparations underway in U.S., Japan and EU Efgartigimod proof-of-concept in 4/4 indications with ambition to be in 15 by 2025 Committed to our Patients and their Communities Growing neuromuscular, hematology and skin commercial franchises Enviable
Slide 20: Together We Discover
Together We Discover Reaching Patients Through Immunology Innovation 20