Argenx Se · EURONEXT:ARGX
Argenx — Investor Presentation (November 2023)
25 slides from Argenx's investor presentation, November 2023
Slide 1: Corporate Presentation November 2023
Corporate Presentation November 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: Our mission is to transform severe autoimmunity
Our mission is to transform severe autoimmunity Redefining autoimmune Raising expectations for what diseases as IgG-mediated ‘well-controlled’ means for patients 3
Slide 4: Redefining What 'Well-Controlled' Means for the Patient
Redefining What ‘Well-Controlled’ Means for the Patient We want to transform treatment for patients Minimize treatment burden Achieve broad and sustained responses Regain control of their lives, including professionally and socially 4
Slide 5: VYVGART for Generalized Myasthenia Gravis
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 5
Slide 6: VYVGART Simplifies Treatment of gMG in the Community
VYVGART Simplifies Treatment of gMG in the Community Simple Treatment Initiation: Predictable Safety broad access, and Tolerability: no vaccination Choice in HOW to 18 months and requirements be Treated: over 3000* real IV infusion or SC world patients injection Demonstrated Options for Site Efficac
Slide 7: Consistent Execution + Perpetual Innovation
Driving Sustained Growth Across the Business Consistent Execution + Perpetual Innovation Broaden Reaching More Geographic Pioneer FcRn Class Immunology Patients Expansion of Medicines Pipeline 7
Slide 8: Optimizing Core Launch Strategies
Optimizing Core Launch Strategies Hytrulo launch driven by VYVGART-naïve patients Hytrulo contributing to expansion Reaching Broader Continued shift into $816M gMG Population earlier lines Driving brand loyalty IN COMBINED NET VYVGART First Hytrulo among prescribers & HYTRULO SALES YTD policies publ
Slide 9: Multi-dimensional Expansion to Reach Autoimmune Patients Globally
Multi-dimensional Expansion to Reach Autoimmune Patients Globally Presentations 15 indications by 2025 Sjogren’s Indications Future presentations POTS Myositis Pre-filled syringe BP Pemphigus ITP CIDP gMG Geographies US Japan EMEA UK China Canada Future geographies 9
Slide 10: Innovating on the Patient Experience
Innovating on the Patient Experience Future product presentations providing flexibility in HOW and WHERE patients are treated Single Today 1 30-90 second Effective Safe Injection 2 Second Generation 3 Future Generations Pre-filled Syringe (PFS) Exclusive collaboration Future Future Generations Ongoi
Slide 11: Reaching gMG Patients Across the Globe
Reaching gMG Patients Across the Globe APPROVALS COMPLETE U.S. DEC 2021 JAPAN JAN 2022 EUROPE SEPT 2022 UK MAR 2023 ISRAEL APRIL 2023 CHINA JUNE 2023 CANADA SEPT 2023 APPROVALS COMPLETE U.S. JUNE 2023 APPROVALS PENDING JAPAN BY Q1 2024 EUROPE Q4 2023 CHINA 2024 11
Slide 12: gMG is just the beginning
gMG is just the beginning 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 argenx mark
Slide 13: Advancing Hytrulo in CIDP
Advancing Hytrulo in CIDP Crystal Living With CIDP First Innovation Unlocking New Disease in 30+ Years Biology Insights Potential new IgG shown to play significant role treatment modality in underlying biology of CIDP Bringing Hope to Patients of Largest Global CIDP Trial New Treatment Option New st
Slide 14: ITP ADVANCE-SC Trial
ITP ADVANCE-SC Trial Adult Chronic or Persistent ITP patients Primary Endpoint 2 weeks screening Mean platelet count <30x109/L Patients randomized 2:1 to receive VYVGART Hytrulo or placebo (24 weeks) Stable concomitant ITP Fixed weekly dosing Weekly or q2w dosing based on platelet count thresholds F
Slide 15: Pemphigus ADDRESS Trial
Pemphigus ADDRESS Trial Concomitant Screening prednisone Randomization (2x1) Primary endpoint is proportion of PV Pemphigus vulgaris Prednisone starting patients achieving (PV) and foliaceus (PF) dose 0.5 mg/kg/day CRmin* within 30 weeks with ability to adjust Efgartigimod weekly SC Moderate-to-Seve
Slide 16: Empasiprubart: Opportunity Across Multiple Autoimmune Diseases
Empasiprubart: Opportunity Across Multiple Autoimmune Diseases Proof of Concept Established in MMN Our Path Forward Anti-C2 Sweeping Antibody Enrolling second cohort Topline ARDA results expected from both cohorts in 2024 On track to start proof-of-concept studies No effector function Optimal recycl
Slide 17: ARGX-119: MuSK Agonist with Broad Potential in Neuromuscular Disease
ARGX-119: MuSK Agonist with Broad Potential in Neuromuscular Disease clinical Broaden immunology pipeline First-in-Human Phase 1 Healthy Volunteer Study First-in- Patient Single Ascending Dose Multiple Ascending Dose Congenital Myasthenic 10 dose cohorts Syndrome (CMS) 3 dose cohorts/4 weekly doses
Slide 18: Innovation Ecosystem
Innovation Ecosystem discovery Build out innovation ecosystem 18
Slide 19: Steady Cadence of Upcoming Milestones through 2024
Steady Cadence of Upcoming Milestones through 2024 Planned Commercial Milestones VYVGART gMG Approval in China VYVGART gMG Approval in Canada VYVGART gMG Launches in EU VYVGART Hytrulo gMG Approval in US SC efgartigimod gMG Approval in EU 4Q 2023 SC efgartigimod gMG Approval in Japan By 1Q 2024 VYVG
Slide 20: Our Culture
Co-Creation Empowerment Our Culture Innovation Excellence Humility 20
Slide 21: Breadth and Depth Within Autoimmune Pipeline
Breadth and Depth Within Autoimmune Pipeline Program Indication Preclinical Phase 1 Proof of Concept Registrational Commercial VYVGART gMG (IV) gMG (SC) CIDP Myositis Thyroid Eye Disease ITP (IV) Efgartigimod ITP (SC) COVID-19 Mediated POTS Sjogren's Syndrome Anca Vasculitis Pemphigus Bullous Pemphi
Slide 22: PC-POTS ALPHA Trial
PC-POTS ALPHA Trial 42 patients Total Duration: 24 weeks Endpoints Screening Criteria Co-primary endpoints Randomization (2:1) • MALMO POTS (MaPs) symptom score Prior COVID-19 confirmed by documentation of historical improvement from baseline to week 24 • Compositive Autonomic Symptom Score PCR test
Slide 23: Bullous Pemphigoid BALLAD Trial
Bullous Pemphigoid BALLAD Trial 160 patients Total Duration: 36 weeks Endpoints Bullous Pemphigoid Primary endpoint Randomization (1:1) • Proportion of participants who are in Moderate-to-severe complete remission while receiving disease (Investigator efgartigimod PH20 SC or placebo and have Global
Slide 24: Myositis ALKIVIA Trial
Myositis ALKIVIA Trial Separate Cohorts Phase 2 Phase 3 Screening Phase 2: 24 weeks 90 Patients 150 Patients Proposed Endpoints Stratified for Phase 3: 52 weeks Primary • IMNM Mean Total Improvement Score • Polymyositis (including ASyS) (TIS) Change (ACR/EULAR endorsed) • DM 1000mg efgartigimod SC •
Slide 25: Empasiprubart for Multifocal Motor Neuropathy
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