Argenx Se · EURONEXT:ARGX
Argenx — JP Morgan Healthcare Conference 2024
27 slides from Argenx's conference presentation, Jan 8, 2024
Slide 1: argenx The Next Chapter
argenx The Next Chapter JP MORGAN HEALTHCARE CONFERENCE JANUARY 8, 2024 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 or
Slide 3: On a Journey to Transform Autoimmunity
On a Journey to Transform Autoimmunity Pioneering novel target biology Leading antibody engineering capabilities Pipeline-in-a-product opportunities Creating optionality across and within molecules 3
Slide 4: We are Hearing Transformational Stories with VYVGART
We are Hearing Transformational Stories with VYVGART 4 Mike, VYVGART Patient
Slide 5: Our Innovation Horizons
PFS in development 15 indications in development by 2025 ITP MAA filed CIDP sBLA submitted ARGX-109 $1.2B in gMG revenue in 2023 (Anti-IL-6) ARGX-213 (Anti-FcRn) ARGX-220 ARGX-121 Empasiprubart POC established in MMN Trials in DGF and DM ARGX-119 Phase 1b/2a trials in CMS and ALS Our Innovation Hori
Slide 6: VYVGART Opportunity Horizon
PFS in development 15 indications in development by 2025 ITP MAA filed CIDP sBLA submitted ARGX-109 $1.2B in gMG revenue in 2023 (Anti-IL-6) ARGX-213 (Anti-FcRn) ARGX-220 ARGX-121 Empasiprubart POC established in MMN Trials in DGF and DM ARGX-119 Phase 1b/2a trials in CMS and ALS VYVGART Opportunity
Slide 7: Leadership in FcRn
Leadership in FcRn Pioneering FcRn Unique modulation of FcRn 15 indications by 2025* Fc fragment and proprietary ABDEG™ mutations Transformational data in gMG and CIDP Generating key learnings *Indications in development 7
Slide 8: VYVGART is Setting New Expectations in gMG
Estimated 4,000 patient years of safety follow-up between clinical trial and real-world experience 45% MSE QoL comparable to healthy population* 78% MG-ADL ≤4** Meaningful steroid tapering by at least 5mg/day within first 6 months Superior cost/benefit over IVIg*** Enables significantly faster acces
Slide 9: Strong Commercial Execution
25% YoY increase >2,300** Prescribers in the US PRESCRIBER EXPANSION Strong Commercial Execution 21% 2023 CAGR $1.2B* Global Product Revenue GROWTH 2023 Performance Favorable payor policies ~90% Access VYVGART after ≤2 Orals BROAD PATIENT ACCESS 55% patients from orals >6,000** Global VYVGART Patien
Slide 10: Innovation Builds Autoimmune Market Opportunities
Innovation Builds Autoimmune Market Opportunities 10 17,000 6,000* Growing MG Market gMG Patients on VYVGART Current VYVGART TAM Expanding VYVGART TAM Growing VYVGART Share US RoW argenx markets (exc. China) Global 31,000 Label-enabling trials in broader gMG populations Phase 3b studies and external
Slide 11: VYVGART Has Potential to Transform CIDP
VYVGART Has Potential to Transform CIDP 11 67% Response rate demonstrates IgG autoantibodies play significant role in underlying CIDP biology HR: 0.39 P = 0.000039 99% Rollover of eligible patients to open-label extension Favorable safety and tolerability profile consistent with previous clinical tr
Slide 12: We Aim to Address the Unseen Suffering in CIDP
CONFIDENTIAL FOR INTERNAL USE ONLY. © 2023 argenx. We Aim to Address the Unseen Suffering in CIDP ≤20% of patients achieve remission on current SOC (CDAS=2)* >50% of patients are dissatisfied with their symptom burden** >42K treated CIDP patients in US & ROW argenx markets (ex-China)*** * Gorson KC,
Slide 13: Transforming the Patient Treatment Experience
Transforming the Patient Treatment Experience 13 Pre-filled Syringe Autoinjector Single 30-90s injection HCP administered Increasingly convenient delivery Preparing for self-administration Approved June 2023 Ongoing in clinical trials Industrialization phase Exclusive FcRn license to ENHANZE® High c
Slide 14: This is Just the Beginning
This is Just the Beginning 14 Generalized Myasthenia Gravis Chronic Inflammatory Demyelinating Polyneuropathy Expected 2024 PoC study readouts ITP Launched 2022 Anticipated approval 2024 Japan submission in review TED 100K IMNM 6K Sjogren’s 330K PC-POTS 500K Beyond 2024 PoC studies BP 52K LN 40K MN
Slide 15: Phase Readouts Present Significant Commercial Opportunities
Phase 2 Readouts Present Significant Commercial Opportunities 15 • Anti-Ro/Anti-La AutoAbs • Passive transfer model evidence • IgG reduction associated with improvement RCT - Phase 2 CRESS/ESSDAI • Steroids/NSISTs • Cholinergic agonists • Artificial tears • Anti-adrenergic receptor AutoAbs • IVIG/PL
Slide 16: Pipeline Horizon
PFS in development 15 indications in development by 2025 ITP MAA filed CIDP sBLA submitted ARGX-109 $1.2B in gMG revenue in 2023 (Anti-IL-6) ARGX-213 (Anti-FcRn) ARGX-220 ARGX-121 Empasiprubart POC established in MMN Trials in DGF and DM ARGX-119 Phase 1b/2a trials in CMS and ALS Pipeline Horizon 16
Slide 17: Rewriting Immunology Textbook with Empasiprubart
Rewriting Immunology Textbook with Empasiprubart Pioneering complement factor C2 Unique sweeping antibody Ongoing development in 3 indications ~80-day half-life supports favorable dosing Defining MMN as POC established in MMN auto-IgM mediated disease 17
Slide 18: Empasiprubart has Potential to Transform MMN
Empasiprubart has Potential to Transform MMN 18 HR (95% CI) = 0.09 (0.02; 0.44) • 94% of treated patients rated their condition improved since starting therapy, including 55% who were much/very much improved 8/9 placebo patients had no change or worsened (Patient Global Impression of Change scale) •
Slide 19: MMN Patients are Waiting
MMN Patients are Waiting Clear opportunity for empasiprubart… …I’m not asking to be able to run and jump like I used to. I just want to be able to stand like I used to. “ ” IVIg only treatment option Patient journey characterized by deep frustration and anxiety …to transform MMN outcomes ADDRESSABLE
Slide 20: ARGX-119: Enhancing Neuromuscular Junction
ARGX-119: Enhancing Neuromuscular Junction Pioneering MuSK biology at NMJ Initial development in CMS and ALS Agonistic SIMPLE Antibody™ Safety and tolerability data from extensive Phase 1 study support advancement into PoC studies 20
Slide 21: CMS and ALS Trials to Start in 2024
CMS and ALS Trials to Start in 2024 21 ARGX-119 rescues early neonatal lethality and disease relapse in adult DOK7 CMS mice Nature, Oury et al. 2021 ARGX-119 preserves NMJ numbers and restores muscle contraction in ALS patient derived NMJs on-a-chip Fidelity (%) Biomaterials, Badu-Mensah et al. 2022
Slide 22: Immunology Innovation Horizon
PFS in development 15 indications in development by 2025 ITP MAA filed CIDP sBLA submitted ARGX-109 $1.2B in gMG revenue in 2023 (Anti-IL-6) ARGX-213 (Anti-FcRn) ARGX-220 ARGX-121 Empasiprubart POC established in MMN Trials in DGF and DM ARGX-119 Phase 1b/2a trials in CMS and ALS Immunology Innovati
Slide 23: Pipeline Growth Driven By Immunology Innovation Program
ARGX-109 (Anti-IL-6) Pipeline Growth Driven By Immunology Innovation Program 23 ARGX-213 ARGX-220 DISEASE INSIGHT ANTIBODY ENGINEERING CLINICAL DEVELOPMENT Continued Leadership in FcRn Broad Immune System Targets ARGX-121 First in class, novel targets 4 IND FILINGS BY END OF 2025 Strong Track Record
Slide 24: Strong Cadence of Milestones in 2024
VYVGART gMG Decision on approval: Switzerland, Australia, Saudi Arabia, South Korea By Year End Seronegative trial initiation By Year End ITP Japan decision on approval 1Q 2024 VYVGART SC gMG Japan decision on approval By 1Q 2024 China decision on approval (Zai Lab) By Year End CIDP U.S. launch, if
Slide 25: Preliminary 2023 Financial Results
Q4 2023 Product Net Sales of $374 million 21 75 131 173 218 269 329 374 2022 Q1 2022 Q2 2022 Q3 2022 Q4 2023 Q1 2023 Q2 2023 Q3 2023 Q4* ($B) 2023 Product Net Sales(1) 1.2 Cash, cash equivalents and current financial assets(1) 3.2 2024 Financial Guidance (1) - Preliminary Financials. Unaudited and s
Slide 26: 2024 Strategic Priorities
6 Leading to multiple 2024 Strategic Priorities Committed to Driving Continued Growth 26 Broaden leadership in MG market Launch CIDP Advance PFS Phase 2 data readouts Phase 3 initiations INDs by 2025 4
Slide 27: THANK YOU
THANK YOU 27