Argenx Se · EURONEXT:ARGX
Argenx — Corporate Update (June 2024)
21 slides from Argenx's corporate update, Jun 24, 2024
Slide 1: VYVGART Hytrulo Now Indicated for CIDP: FDA Approval Call
VYVGART® HYTRULO NOW INDICATED FOR CIDP FDA APPROVAL CALL | JUNE 21, 2024
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: Approval Overview
Approval Overview T I M VAN H AU WE R ME I R E N
Slide 4: VYVGART Hytrulo Now FDA-Approved for CIDP
1958* 1979* 1985* Corticosteroids PLEX IG 2024 • Non-plasma derived biologic therapy for CIDP • Targets FcRn, reducing IgG antibodies, including pathogenic autoantibodies First and only targeted IgG Fc-antibody fragment† VYVGART Hytrulo is a coformulation of efgartigimod alfa and hyaluronidase. By d
Slide 5: Highlights of U.S. Prescribing Information
Highlights of U.S. Prescribing Information INDICATION STATEMENT VYVGART Hytrulo is a neonatal Fc receptor blocker indicated for the treatment of adult patients with chronic inflammatory demyelinating polyneuropathy (CIDP) DOSING AND ADMINISTRATION • Evaluate need to administer age -appropriate vacci
Slide 6: CIDP Patients Need New Options
≤20% achieve remission on current SOC 3 CIDP Patients Need New Options Significant pain, numbness in hands and feet Feelings of isolation and depression report difficulty standing 1 dissatisfied with symptom burden 2 have residual neurological symptoms 4 >50% 80% 88% 6 J A M I L A H 1. Wonink HA et
Slide 7: Clinical Data Review
Clinical Data Review L U C T R U YE N
Slide 8: Innovative ADHERE Study Design
Innovative ADHERE Study Design 8 Patients need to demonstrate disease worsening off-treatment based on INCAT, I-RODS, grip strength Clinical Confirmation Committee Confirm IgG involvement Assess efficacy & safety Run-in period Screening ≤12 WEEKS ≤4 WEEKS VYVGART HYTRULO WEEKLY VYVGART HYTRULO OR PL
Slide 9: Key Data from ADHERE Trial
Key Data from ADHERE Trial 9 2/3 Improved / progressed to Stage B HR: 0.39 P = < 0.0001 61% reduced risk of relapse 9 Consistent response across subgroups STAGE A STAGE B 40% Demonstrated improvement by Week 4 Probability(%) of No Clinical Worsening Time to Improvement
Slide 10: Deep and Clinically Meaningful Improvements in Functional Ability
Patients Experienced Deep and Clinically Meaningful Improvements in Functional Ability *The INCAT disability score1 is a 10-point scale that assesses activ ity limitations of arms and legs; both are scored separately f rom 0–5, with 0 representing no f unctional impairment and 5 representing inabili
Slide 11: ADHERE Trial Safety: Summary of Adverse Events
ADHERE Trial Safety: Summary of Adverse Events 11 AE, adverse event; CIDP, chronic inflammatory demyelinating polyneuropathy; COVID-19, coronavirus disease 2019; PH20, recombinant human hyaluronidase PH20; PYFU, participants years of follow-up; SAE, serious adverse event; SC, subcutaneous; TEAE, tre
Slide 12: Commercial Strategy
Commercial Strategy K AR E N MAS S E Y
Slide 13: Raising Expectations for CIDP Patients
Raising Expectations for CIDP Patients “Every day is your new normal. I had to learn how to continue life - every single day - even though things are going to be different for me.” “ SCOTT- CIDP PATIENT “ 13
Slide 14: Maximizing Impact of VYVGART Hytrulo
Empower Patients to Demand more from their Treatment Provide Best in Class Patient Support Deliver Broad Access Drive Rapid Healthcare Provider Adoption Maximizing Impact of VYVGART Hytrulo 14
Slide 15: 12,000 Adult CIDP Patients in U.S. Not Well-Managed
12,000 Adult CIDP Patients in U.S. Not Well-Managed with Current Treatment Options Diagnosed CIDP Patients Treated CIDP Patients Includes all patients treated on IVIG/SCIG, PLEX, steroids, biologics, other Patients Not Well-Managed on Current Therapy* ~12K ~24K ~41K *This is defined as patients w ho
Slide 16: Activating an Empowered Patient Community
Activating an Empowered Patient Community 16
Slide 17: Driving Rapid Adoption with Neurologists
Driving Rapid Adoption with Neurologists Neurology Landscape Reaching the Right Physicians Leveraging the Strength of ADHERE data Providing Reimbursement Support • Expansion of deeply experienced sales force • Strong relationships with existing VYVGART prescribers • First innovation in 30 years • Co
Slide 18: Securing Broad Access
Securing Broad Access 18 Established price per vial Real World Utilization Data based on ADHERE+ Payor Mix - % of patients covered by VBA Expected annual net revenue per patient of ~$450,000* Average annual out-of-pocket cost to the patient similar to MG Ability to leverage existing established rela
Slide 19: Multidimensional Expansion in CIDP
Filing submitted (VYVDURA) April 2024 Multidimensional Expansion in CIDP Zai Lab announced acceptance of sBLA in China May 2024 Submission filed with EMA June 2024 VYVGART® Hytrulo Approved June 21, 2024 Pre-filled syringe (PFS) filed June 2024 Expected Decisions on Approval 2025 19
Slide 20: Looking Ahead
Looking Ahead T I M VAN H AU WE R ME I R E N
Slide 21: Where Innovation Meets Critical Unmet Need
Where Innovation Meets Critical Unmet Need Patient Science 21