Argenx Se · EURONEXT:ARGX
Argenx — Investor Presentation (August 2023)
26 slides from Argenx's investor presentation, August 2023
Slide 1: Corporate Presentation August 2023
Corporate Presentation August 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 Crystal Achieve broad and sustained responses Living With CIDP I was the type of woman that would Regain control of their lives, including run first thing in the morning befo
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 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 7: Optimizing Core Launch Strategies
Optimizing Core Launch Strategies VYVGART launched in US, Consistent prescriber Japan, Germany, Italy growth to increase breadth of patients SUBMISSIONS OR APPROVALS IN >2,100 PRESCRIBERS $489M 10+ COUNTRIES UNITED STATES 17,000 addressable IN NET VYVGART SALES YTD Potential to drive gMG patients ea
Slide 8: Consistent Execution + Serial Innovation
Driving Sustained Growth Across the Business Consistent Execution + Serial Innovation Pioneer FcRn Broaden Reaching More Geographic Class of Immunology Patients Expansion Medicines Pipeline 8
Slide 9: Multi-dimensional Expansion to Reach Autoimmune Patients Globally
Multi-dimensional Expansion to Reach Autoimmune Patients Globally Formulations Future Indications Indications Myositis Future BP Presentations Pemphigus Pre-Filled Syringe ITP CIDP gMG Geographies US Japan EMEA UK China Future Geographies 9
Slide 10: Reaching gMG Patients Across the Globe
Reaching gMG Patients Across the Globe Approvals Complete Approvals Pending U.S. DEC 2021 CANADA Q3 2023 JAPAN JAN 2022 EUROPE SEPT 2022 UK MAR 2023 ISRAEL APRIL 2023 CHINA JUNE 2023 Approvals Complete Approvals Pending U.S. JUNE 2023 JAPAN BY Q1 2024 EUROPE Q4 2023 CHINA 2024 10
Slide 11: IgG Autoantibodies Serve as Unifying Biology Rationale for POC Indications
IgG Autoantibodies Serve as Unifying Biology Rationale for POC Indications Contactin1 Ro/SSA DSG-1 Mi-2 THSd7A La/SSB MPO-ANCA ANA PLA2R NF155 GPIIb/IIIa DSG-3 HMGCR DSA BP230 NELL1 Pioneer FcRn PR3-ANCA Class of AChR GPCR Medicines BP180 MuSK LRP4 JO-1 TSHR SRP Immune complexes 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: ADHERE: Opportunity to Transform CIDP Patient Experience
ADHERE: Opportunity to Transform CIDP Patient Experience Stage A 67% - 78% Response rates demonstrate IgG autoantibodies play significant role in underlying CIDP biology Stage B HR: 0.39 P = 0.000039 61% lower risk of relapse based on time to first adjusted INCAT deterioration with VYVGART Hytrulo c
Slide 14: 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 15: 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 16: Positioned for Long-term Franchise Growth
Positioned for Long-term Franchise Growth Hematology Neuromuscular Neurology and Neuromuscular Neuromuscular Dermatology Nephrology Neuromuscular Rheumatology gMG, CIDP, ITP, Sjogren’s, POTS, Pemphigus, Bullous Membranous Myositis, TED, MMN, Anca Vasculitis Pemphigoid, Nephropathy, Lupus CMS, Musk M
Slide 17: Innovation Ecosystem
Innovation Ecosystem discovery Build out innovation ecosystem 17
Slide 18: Steady Cadence of Upcoming Milestones
Steady Cadence of Upcoming Milestones Planned Commercial Milestones VYVGART gMG Approval in China VYVGART gMG Approval in Canada 3Q 2023 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 VYVGART I
Slide 19: Our mission continues…
Co-Creation Empowerment Our mission continues… Innovation Excellence Humility 19
Slide 20: Breadth and Depth Within Autoimmune Pipeline
Breadth and Depth Within Autoimmune Pipeline Program Indication Preclinical Phase 1 Proof of Concept Registrational Commercial VYVGARTT 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 Pemph
Slide 21: ITP ADVANCE-SC Trial
ITP ADVANCE-SC Trial Adult Chronic or Persistent ITP patients Primary End-point 2 weeks screening Mean platelet count <30x109/L Patients randomized 2:1 to receive VYVGART Hytrulo or placebo (24 weeks) Stable concomitant ITP therapy allowed Fixed weekly Weekly or q2w dosing based on platelet count th
Slide 22: Pemphigus ADDRESS Trial: Focus on Fast Onset and Steroid-sparing
Pemphigus ADDRESS Trial: Focus on Fast Onset and Steroid-sparing Concomitant Primary endpoint Screening prednisone Randomization (2x1) is proportion of PV patients Pemphigus Prednisone starting achieving CRmin* vulgaris (PV) and dose 0.5 within 30 weeks foliaceus (PF) mg/kg/day with Efgartigimod wee
Slide 23: 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 Prior COVID-19 confirmed by documentation of score improvement from baseline to week 24 historical PCR test • Compositive Autonomic Symptom Eligi
Slide 24: 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 efgartigimod PH20 SC or placebo and (Investigator Global have
Slide 25: 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 (TIS) • Polymyositis (including Change (ACR/EULAR endorsed) ASyS) 1000mg efgartigimod SC • DM I
Slide 26: 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