Argenx Se · EURONEXT:ARGX
Argenx — Corporate Update (June 2023)
15 slides from Argenx's corporate update, Jun 21, 2023
Slide 1: VYVGART Hytrulo FDA Approval Call
VYVGART ® Hytrulo (efgartigimod alfa and hyaluronidase-qvfc) FDA Approval Call June 21, 2023
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 or
Slide 3: VYVGART for Generalized Myasthenia Gravis: Now Two FDA-Approved Products
VYVGART for Generalized Myasthenia Gravis NOW TWO FDA-APPROVED PRODUCTS VYVGART and VYVGART Hytrulo are indicated for the treatment of generalized myasthenia gravis (gMG) in adult patients who are anti-acetylcholine receptor (AChR) antibody positive 3
Slide 4: Patient Experience
ANDREA. Living with gMG GENERALIZED MYASTHENIA GRAVIS PATIENT EXPERIENCE gMG is characterized by debilitating muscle weakness and fatigue. Despite taking an average of 2.3 current treatments, 61% of patients have poor well-being according to WHO-5 Index 2.6 Years mean time from symptom expression to
Slide 5: Redefining What 'Well-Controlled' Means for the Patient
Redefining What ‘Well-Controlled’ Means for the Patient We want to transform gMG treatment for patients Achieve minimal symptom expression Reduce reliance on broad immunosuppressants Minimize treatment burden Regain control of their lives, including professionally and socially 5
Slide 6: Phase 3 Bridging Study: Consistent Responses Across IV and SC
Innovative Phase 3 Bridging Study Consistent Responses Across IV and SC MG-ADL RESPONDERS Primary endpoint of noninferiority met [p<0.0001] 69.1% 69.1% n=38/55 n=38/55 VYVGART Hytrulo VYVGART SECONDARY MG-ADL responder: ≥2-point reduction ≥4 consecutive weeks during the first cycle QMG RESPONDERS 65
Slide 7: VYVGART Hytrulo Indication and Dosing
VYVGART® Hytrulo (efgartigimod alfa and hyaluronidase-qvfc) Injection for Subcutaneous Use INDICATION STATEMENT VYVGART Hytrulo is a combination of efgartigimod alfa, a neonatal Fc receptor blocker, and hyaluronidase, an endoglycosidase, indicated for the treatment of generalized myasthenia gravis (
Slide 8: VYVGART Makes Treatment Simple
Chronic autoimmune diseases are complicated VYVGART makes treatment simple Flexibility and Broad HCP Use Best-in-Class Simplicity of Choice for and Adoption Patient Support Access Patients 8
Slide 9: VYVGART Simplifies Treatment of gMG in the Community
VYVGART Simplifies Treatment of gMG in the Community Simple Treatment Predictable Initiation: safety and broad access, tolerability: Choice in HOW no vaccination 18 months and to be treated: requirements over 3000* real IV infusion or SC world patients injection Demonstrated Options for site Efficac
Slide 10: Simplicity of Access: Driving Choice By Value to the Patient
Simplicity of Access: Driving Choice By Value to the Patient ESTABLISHED VALUE TO PATIENTS PARITY PRICING PRODUCT CHOICE BY MARKET Creating a new standard for gMG treatment Annual net price to be similar across IV and SC Patient Payor HCP Flexibility and choice for patients treatment options IV has
Slide 11: My VYVGART Path Personalized Support
My VYVGART Path is Available to Provide Access Support and Education Educate on VYVGART and Resources VYVGART and Hytrulo Information Treatment PERSONALIZED SUPPORT Financial Navigate Assistance Insurance Available Process 11
Slide 12: Reaching gMG Patients Across the Globe
Reaching gMG Patients Across the Globe US VYVGART VYVGART Hytrulo Approved Approved December 2021 June 2023 Global Japan United Kingdom China (Zai Lab) Approved January 2022 Approved March 2023 Expected approval in 2023 Europe Israel (Medison) Canada Approved September 2022 Approved April 2023 Expec
Slide 13: gMG Is Just the Beginning
gMG is just the beginning clinical AMR 8K Pemphigus CIDP Lupus Nephritis 19K 16K 40K BP gMG ITP Myositis 52K 65K 57K 63K ANCA TED Sjogren’s Membranous PC-POTS >500K 105K 100K 330K Nephropathy 80K indications with successful proof-of-concept or Phase 3 data Patient numbers are U.S. prevalence from ar
Slide 14: Empasiprubart for Multifocal Motor Neuropathy: ARDA Study
Empasiprubart for Multifocal Motor Neuropathy Advancing Phase 2 ARDA Study to Cohort 2 A phase 2, randomized, double-blind, placebo-controlled, parallel-group, multicenter study to evaluate the safety and tolerability, efficacy, pharmacokinetics, pharmacodynamics, and immunogenicity of two dose regi
Slide 15: Our Mission Continues…
Co-Creation Empowerment Our mission continues… Innovation Excellence Humility 15