Argenx Se · EURONEXT:ARGX
Argenx — J.P. Morgan Healthcare Conference 2024
27 slides from Argenx's conference presentation, Jan 8, 2024
Slide 1: The Next Chapter
argenx The Next Chapter J P M O R G A N H E A LT H C A R E C O N F E R E N C E J A N U A R Y 8 , 2 0 2 4 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 Leading Pipeline-in- Pioneering antibody novel target a-product engineering opportunities biology capabilities Creating optionality across and within molecules 3
Slide 4: We are Hearing Transformational Stories with VYVGART
We are Hearing Transformational Stories with VYVGART Mike, VYVGART Patient 4
Slide 5: Our Innovation Horizons
Our Innovation Horizons Empasiprubart POC established in MMN ARGX-109 Trials in DGF and DM $1.2B in gMG revenue in 2023 (Anti-IL-6) ARGX-213 CIDP sBLA submitted (Anti-FcRn) ITP MAA filed ARGX-121 ARGX-119 Phase 1b/2a trials in CMS and ALS 15 indications in development by 2025 ARGX-220 PFS in develop
Slide 6: VYVGART Opportunity Horizon
VYVGART Opportunity Horizon Empasiprubart POC established in MMN ARGX-109 Trials in DGF and DM $1.2B in gMG revenue in 2023 (Anti-IL-6) ARGX-213 CIDP sBLA submitted (Anti-FcRn) ITP MAA filed ARGX-121 ARGX-119 Phase 1b/2a trials in CMS and ALS 15 indications in development by 2025 ARGX-220 PFS in dev
Slide 7: Leadership in FcRn
Leadership in FcRn Unique Pioneering modulation 15 indications FcRn of FcRn by 2025* Generating key Fc fragment and proprietary Transformational data learnings ABDEG™ mutations in gMG and CIDP *Indications in development 7
Slide 8: VYVGART is Setting New Expectations in gMG
VYVGART is Setting New Expectations in gMG 45% MSE Meaningful QoL comparable steroid to healthy tapering by Enables Superior population* at least significantly cost/benefit 5mg/day faster over IVIg*** 78% within first access to MG-ADL ≤4** 6 months treatment * Real world evidence **Source: ADAPT and
Slide 9: Strong Commercial Execution
Strong Commercial Execution G R O W T H E A R L I E R L I N E P A T I E N T S $1.2B* >6,000** Global Product Revenue Global VYVGART Patients 21% 2023 CAGR 55% patients from orals 2023 Performance P R E S C R I B E R E X P A N S I O N B R O A D P A T I E N T A C C E S S >2,300** ~90% Prescribers in t
Slide 10: Innovation Builds Autoimmune Market Opportunities
Innovation Builds Autoimmune Market Opportunities Growing MG Market Growing VYVGART share US: VYVGART Hytrulo J-Code in effect; field force expansion Expanding VYVGART TAM PFS development Addition to China NRDL Expanding VYVGART TAM Growing VYVGART Share Label-enabling trials in broader gMG populati
Slide 11: VYVGART Has Potential to Transform CIDP
VYVGART Has Potential to Transform CIDP Stage A Response rate demonstrates IgG SIGNIFICANT IMPACT ESTABLISHED CIDP AS IgG MEDIATED 67% autoantibodies play significant role in underlying CIDP biology ON CIDP PATIENTS 99% Study Compliance Stage B HR: 0.39 P = 0.000039 99% SET NEW Rollover of eligible
Slide 12: We Aim to Address the Unseen Suffering in CIDP
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, et al.FOR CONFIDENTIAL 2010 INTERNAL USE ONLY. © 2
Slide 13: Transforming the Patient Treatment Experience
Transforming the Patient Treatment Experience Pre-filled Syringe Autoinjector Approved June 2023 Ongoing in clinical trials Industrialization phase Single 30-90s injection Increasingly convenient delivery Exclusive HCP administered Preparing for self-administration FcRn license High concentration fo
Slide 14: This is Just the Beginning
This is Just the Beginning Expected 2024 PoC study readouts Beyond 2024 PoC studies TED Sjogren’s PC-POTS IMNM BP LN MN AAV AMR #14 #15 100K 330K 500K 6K 52K 40K 80K 105K 8K ASyS 11K DM 70K Generalized Chronic Inflammatory Myasthenia Demyelinating Gravis Polyneuropathy ITP Phase 2 Proof of Concept L
Slide 15: Phase Readouts Present Significant Commercial Opportunities
Phase 2 Readouts Present Significant Commercial Opportunities Sjogren’s Syndrome PC-POTS Myositis (IMNM, ASyS, DM) RATIONALE • Anti-Ro/Anti-La AutoAbs • Myositis AutoAbs BIOLOGIC • Passive transfer model evidence • Anti-adrenergic receptor AutoAbs • Passive transfer model evidence (IMNM) • IgG reduc
Slide 16: Pipeline Horizon
Pipeline Horizon Empasiprubart POC established in MMN ARGX-109 Trials in DGF and DM $1.2B in gMG revenue in 2023 (Anti-IL-6) ARGX-213 CIDP sBLA submitted (Anti-FcRn) ITP MAA filed ARGX-121 ARGX-119 Phase 1b/2a trials in CMS and ALS 15 indications in development by 2025 ARGX-220 PFS in development 16
Slide 17: Rewriting Immunology Textbook with Empasiprubart
Rewriting Immunology Textbook with Empasiprubart Pioneering Unique Ongoing complement sweeping development in factor C2 antibody 3 indications Defining MMN as ~80-day half-life supports POC established in MMN auto-IgM mediated favorable dosing disease 17
Slide 18: Empasiprubart has Potential to Transform MMN
Empasiprubart has Potential to Transform MMN HR (95% CI) = 0.09 (0.02; 0.44) 91% reduction in need for IVIg rescue with empasiprubart • 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
Slide 19: MMN Patients are Waiting
MMN Patients are Waiting Patient journey characterized by deep frustration and anxiety “ Clear opportunity for empasiprubart… A D D R E S S A B L E M A R K E T …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. ~10k patients IVIg only treatment
Slide 20: ARGX-119: Enhancing Neuromuscular Junction
ARGX-119: Enhancing Neuromuscular Junction Pioneering Agonistic Initial MuSK biology SIMPLE development in at NMJ Antibody™ CMS and ALS 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 ARGX-119 rescues early neonatal lethality and ARGX-119 preserves NMJ numbers and restores muscle disease relapse in adult DOK7 CMS mice contraction in ALS patient derived NMJs on-a-chip 100 Fidelity (%) 50 mAb Biomaterials, Badu-Mensah et al. 2022; Advanced Therap
Slide 22: Immunology Innovation Horizon
Immunology Innovation Horizon Empasiprubart POC established in MMN ARGX-109 Trials in DGF and DM $1.2B in gMG revenue in 2023 (Anti-IL-6) ARGX-213 CIDP sBLA submitted (Anti-FcRn) ITP MAA filed ARGX-121 ARGX-119 Phase 1b/2a trials in CMS and ALS 15 indications in development by 2025 ARGX-220 PFS in d
Slide 23: Pipeline Growth Driven By Immunology Innovation Program
Pipeline Growth Driven By Immunology Innovation Program 4 IND FILINGS BY END OF 2025 CLINICAL DISEASE Continued Leadership in FcRn DEVELOPMENT INSIGHT ARGX-213 LEADING TRANSLATIONAL BIOLOGY LABS Broad Immune System Targets ARGX-109 ARGX-121 ARGX-220 (Anti-IL-6) ANTIBODY TECHNOLOGY ENGINEERING KNOW-H
Slide 24: Strong Cadence of Milestones in 2024
Strong Cadence of Milestones in 2024 Indication Milestone Timing Decision on approval: Switzerland, Australia, Saudi Arabia, South Korea By Year End gMG VYVGART Seronegative trial initiation By Year End ITP Japan decision on approval 1Q 2024 Japan decision on approval By 1Q 2024 gMG China decision o
Slide 25: On Track To Be Sustainable
On Track To Be Sustainable Q4 2023 Product Net Sales of $374 million Preliminary 2023 Financial Results 374 ($B) 2023 329 Product Net Sales(1) 1.2 21% Cash, cash equivalents and current 3.2 R: 269 financial assets(1) G CA (1) - Preliminary Financials. Unaudited and subject to change. 23 218 20 173 1
Slide 26: 2024 Strategic Priorities
2024 Strategic Priorities Committed to Driving Continued Growth Broaden leadership in 6 Phase 2 data MG market readouts 4 INDs by 2025 Launch CIDP Leading to multiple Advance PFS Phase 3 initiations 26
Slide 27: Thank You
THANK YOU 27