Argenx Se · EURONEXT:ARGX
Argenx — Investor Presentation (March 2024)
27 slides from Argenx's investor presentation, March 2024
Slide 1: Reaching Patients through Immunology Innovation
C O RP O RAT E P RE S E NT AT I ON | M ARC H 2 0 2 4 Reaching Patients through Immunology Innovation
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 … MuSK + C2 + Rn Fc P+ + IL22R + GAR Leading Pipeline-in- Pioneering antibody novel target a-product engineering opportunities biology capabilities 70 CD Creating optionality across and within molecules 3
Slide 4: Continuing to drive transformational outcomes for patients
Continuing to drive transformational outcomes for patients Reaching new gMG Leveraging MG know-how into Maximizing value patients with VYVGART future indications creation and patient impact Alexis, VYVGART Patient 4
Slide 5: Our Innovation Horizons
V Our Innovation Horizons YV GA RT Empasiprubart Op POC established in MMN ARGX-109 $1.2B in gMG revenue in 2023 por Trials in DGF and DM (Anti-IL-6) tunit Immuno log Pip ARGX-213 y CIDP sBLA accepted y I (Anti-FcRn) elin PDUFA June 21, 2024 nn ov e ITP MAA filed atio ARGX-121 ARGX-119 Phase 1b/2a t
Slide 6: VYVGART Opportunity Horizon
V VYVGART Opportunity Horizon YV GA RT Empasiprubart Op POC established in MMN ARGX-109 $1.2B in gMG revenue in 2023 por Trials in DGF and DM (Anti-IL-6) tunit Immuno log Pip ARGX-213 y CIDP sBLA accepted y I (Anti-FcRn) elin PDUFA June 21, 2024 nn ov e ITP MAA filed atio ARGX-121 ARGX-119 Phase 1b/
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 7 *Indications in development
Slide 8: VYVGART is Setting New Expectations in gMG
VYVGART is Setting New Expectations in gMG 45% MSE** Meaningful steroid QoL comparable Enables tapering by Superior to healthy significantly at least cost/benefit population* faster 5mg/day over IVIg*** within first access to 78% treatment 6 months MG-ADL ≤4** * Real world evidence **Source: ADAPT a
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
Slide 10: Maximizing patient impact through our commercial organization
Maximizing patient impact through our commercial organization Generating Disease Awareness Elevating Expectations for Treatment Driving Innovation on Patient Experience Providing Broad and Simple Access Long-term commitment to repeatable, sustainable and comprehensive value creation Caitlin, MG pati
Slide 11: Innovation Builds Autoimmune Market Opportunities
Innovation Builds Autoimmune Market Opportunities Growing Growing VYVGART share MG Market • US: VYVGART Hytrulo J-Code Expanding VYVGART TAM • PFS development • Added to China NRDL Growing VYVGART Share Expanding VYVGART TAM • Seronegative trial • Phase 3b studies and externally 17,000* sponsored re
Slide 12: 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 SET NEW HR: 0.39 P = 0.000039 99% Rollover of eligible
Slide 13: 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 14: 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 15: 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 Chronic Inflammatory Myasthenia Demyelinating Phase 2 Proof of Concept Gravis Polyneuropathy ITP Potential 202
Slide 16: 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 17: Pipeline Horizon
V Pipeline Horizon YV GA RT Empasiprubart Op POC established in MMN ARGX-109 $1.2B in gMG revenue in 2023 por Trials in DGF and DM (Anti-IL-6) tunit Immuno log Pip ARGX-213 y CIDP sBLA accepted y I (Anti-FcRn) elin PDUFA June 21, 2024 nn ov e ITP MAA filed atio ARGX-121 ARGX-119 Phase 1b/2a trials i
Slide 18: 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 18
Slide 19: 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 20: 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 21: 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 21
Slide 22: 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 23: Immunology Innovation Horizon
V Immunology Innovation Horizon YV GA RT Empasiprubart Op POC established in MMN ARGX-109 $1.2B in gMG revenue in 2023 por Trials in DGF and DM (Anti-IL-6) tunit Immuno log Pip ARGX-213 y CIDP sBLA accepted y I (Anti-FcRn) elin PDUFA June 21, 2024 nn ov e ITP MAA filed atio ARGX-121 ARGX-119 Phase 1
Slide 24: Pipeline Growth Driven By Immunology Innovation Program
Pipeline Growth Driven By Immunology Innovation Program Internal External Value Creation CLINICAL DISEASE Value Creation DEVELOPMENT INSIGHT LEO Agomab Efgartigimod Empasiprubart (ARGX-112) (ARGX-114) AbbVie ARGX-119 ARGX-121 LEADING ARGX-118 (ARGX-115) TRANSLATIONAL BIOLOGY LABS ARGX-213 OncoVerity
Slide 25: 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 Approved in Japan as VYVDURA Jan 18, 2024 gMG China decisi
Slide 26: Fourth Quarter 2023 Revenue
Fourth Quarter 2023 Revenue Product Net Sales: 2023 Full Year with $1,191 million and Q4 2023 with $374 million +14% (+45) Product Net Sales by Region +22% 374 (+60) QoQ % 329 (in millions of $) Q4 2023 Q3 2023 +23% Growth (+51) +26% 269 US 326 280 16% (+45) +32% 218 Japan 17 15 15% (+42) 173 EMEA 2
Slide 27: 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 27