Argenx Se · EURONEXT:ARGX
Argenx — Investor Presentation (September 2024)
29 slides from Argenx's investor presentation, September 2024
Slide 1: Reaching Patients through Immunology Innovation
C O R P O R AT E P R E S E N TAT I O N | S E P T E M B E R 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: Our Innovation Playbook
Our Innovation Playbook Best-in-Field Pipeline-in- Novel Disease Antibody a-Product Biology Insights Engineering Development Foundational First-in-Class Differentiated Immune Antibodies Patient Targets Outcomes 3
Slide 4: Innovation has no meaning unless it reaches patients
Innovation has no meaning unless it reaches patients and provides real benefit 4
Slide 5: Our Innovation Horizons
Our Innovation Horizons VY VG AR Empasiprubart TO POC established in MMN ARGX-109 Trials in DGF and DM $478M in gMG ppo (Anti-IL-6) revenue in Q2 2024 Pip rtuni elin ARGX-213 CIDP approved (Anti-FcRn) June 21, 2024 ty e ITP approved ARGX-121 ARGX-119 March 26, 2024 (Anti-IgA) Phase 1b/2a trials in C
Slide 6: Leadership in FcRn
Leadership in FcRn Best-in-Field Pipeline-in- Novel Disease Antibody a-Product Biology Insights Engineering Development Pioneering FcRn Biology Unique Modulation of FcRn Pipeline-in-a-Product Development Foundational First-in-Class Differentiated Patient Immune Targets Antibodies Outcomes FcRn Efgar
Slide 7: Delivering Innovation in gMG and CIDP
Delivering Innovation in gMG and CIDP gMG CIDP Functional Ability (aINCAT) ~50% MSE Rapid, deep, sustained Cumulative Frequency of Stage B Best QoL comparable to improvements achieved Consistent Improvement from Stage A Baseline (n=110) 100 healthy population* across fixed and bi-weekly Responses 90
Slide 8: Maximizing the VYVGART Opportunity
Maximizing the VYVGART Opportunity LAUNCH MOMENTUM CONTINUES 83% YoY Growth >10,000 Patients consistent across regions on treatment globally Pre-Filled Syringe in FDA review Presentation Expansion in new geographies CIDP Approved June 21st Geography Early launch excitement 8
Slide 9: VYVGART Hytrulo is Expanding Opportunity
VYVGART Hytrulo is Expanding Opportunity New Prescribers Earlier Line Patients 3 2,700 $478M >50% Revenues Q2 2024 Neurologists in the US1 New Hytrulo patients from orals 72% 20% 60% Overlap MG & CIDP QoQ Growth Of Hytrulo patients are new to prescribers VYVGART 1.Latest figure shared as of Q1 2024
Slide 10: Reaching Patients Across the Globe
Reaching Patients Across the Globe DECISIONS PENDING FOR 2024 EU US • Available to 82% of gMG population • CIDP approved June 21, 2024 gMG • ITP path forward Australia Japan • Early positive indicators of Switzerland ITP launch Saudi Arabia DECISIONS PENDING FOR 2025 China • VYVGART SC approved for
Slide 11: Transforming the Patient Treatment Experience
Transforming the Patient Treatment Experience Pre-filled Syringe Autoinjector Approved June 2023 Filed June 2024 Industrialization phase Single 30-90s injection Increasingly convenient delivery Exclusive HCP administered Preparing for self-administration FcRn license High concentration formulation w
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** of treated patients report residual neurological >88% symptoms, including muscle weakness, sensory symptoms, pain, and fatigue ***
Slide 13: Early Excitement in CIDP
Early Excitement in CIDP Rapid Execution Early Adoption Prescriber breadth and depth ~20% are new to VYVGART 25% of key target physicians reached in 14 days First payor policies in principle First patients on treatment 13
Slide 14: This is Just the Beginning
This is Just the Beginning Phase 3 studies 2024 PoC studies Beyond 2024 PoC studies sn gMG TED ITP-US Sjogren’s IMNM BP LN MN AMR SSc oMG 100K 57K 330K 6K 52K 40K 80K 8K 60K ... ASyS 11K MG REMAINING READOUTS IN 2024 Launched 2022 DM 80K 70K Myositis Bullous Pemphigoid CIDP Approved June 21, 2024 42
Slide 15: Phase 2 Results Support Path Forward to Phase 3
Phase 2 Results Support Path Forward to Phase 3 Increased response on 60% IgG reductions composite endpoints consistent with other clinical trials (22-34%) IgG Reduction Response observed in 4 and Biomarker out of 5 items Reduction of auto- of CRESS Safe & well Data Correlate to antibodies, immune c
Slide 16: Pipeline Horizon
Pipeline Horizon VY VG AR Empasiprubart TO POC established in MMN ARGX-109 Trials in DGF and DM $478M in gMG revenue in Q2 2024 ppo (Anti-IL-6) Immuno rtuni log Pip ARGX-213 y CIDP approved I (Anti-FcRn) elin June 21, 2024 ty nn ov e ITP approved atio ARGX-121 ARGX-119 March 26, 2024 Phase 1b/2a tri
Slide 17: Rewriting Immunology Textbook with Empasiprubart
Rewriting Immunology Textbook with Empasiprubart Best-in-Field Pipeline-in- Novel Disease Antibody a-Product Biology Insights Engineering Development Unique Positioning MMN Disease Potent C2 Pioneering FcRn Biology Unique Modulation Long of FcRn Half-Life Pipeline-in-a-Product MMN, DGF, DM,Developme
Slide 18: Empasiprubart has Potential to Transform MMN
Empasiprubart has Potential to Transform MMN Cohort 1 Cohort 2 Reduced Reduced risk of IVIG risk of IVIG retreatment retreatment by by 91% 84% HR (95% CI) = 0.16 (0.02 ; 1.54) Empasiprubart Placebo Phase 3 to start in 4Q 2024 18
Slide 19: Empasiprubart Improved Grip Strength in Both Hands
Empasiprubart Improved Grip Strength in Both Hands IVIg Treatment → Clear Fluctuating Effect Grip Strength Grip Strength Change from baseline : mean (+/- SE) Grip Strength Change from baseline : mean (+/- SE) Patients at IVIG best 19
Slide 20: MMN: Opportunity to Build a Market
MMN: Opportunity to Build a Market MMN Today The argenx advantage Innovation Natural History Study to understand real-world experience 10K Engagement with patients More Innovation = More Prescribers, Co-creation Better Outcomes For Patients PATIENTS Deep existing neurology Execution relationships 20
Slide 21: ARGX-119: Enhancing Neuromuscular Junction
ARGX-119: Enhancing Neuromuscular Junction Best-in-Field Pipeline-in- Novel Disease Antibody a-Product Biology Insights Engineering Development CMS, ALS Innovative Endpoint Pioneering MuSK Biology Best-in-Field Antibody Engineering Studies with MScan Foundational First-in-Class Differentiated Patien
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 slows muscle denervation disease relapse in adult DOK7 CMS mice and improves motor function Slowdown of muscle denervation Improving motor system output n=6 animals per group, faint grey and blue lines indicat
Slide 23: Immunology Innovation Horizon
Immunology Innovation Horizon VY VG AR Empasiprubart TO POC established in MMN ARGX-109 Trials in DGF and DM $478M in gMG revenue in Q2 2024 ppo (Anti-IL-6) Immuno rtuni log Pip ARGX-213 y CIDP approved I (Anti-FcRn) June 21, 2024 elin ty nn ov e ITP approved atio ARGX-121 ARGX-119 March 26, 2024 Ph
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 TRANSLATIONAL (ARGX-115) 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 By Year End gMG VYVGART Seronegative trial initiation By Year End ✓ ITP Approved in Japan March 26, 2024 ✓ Approved in Japan as VYVDURA Jan 18, 2024 ✓ gMG China decision on app
Slide 26: Second Quarter 2024 Revenue
Second Quarter 2024 Revenue Product Net Sales: Q2 2024 of $478 million 500 Q2 2024: growth of 78% vs Q2 2023 478 (in millions of $) Q2 2024 Q2 2023 Growth % * 450 US 407 244 67% 398 400 374 Japan 20 13 71% 350 329 EMEA 35 12 210% China supply 14 0 - 300 269 Canada 1 0 - 250 218 Total 478 269 78% 200
Slide 27: Q2 2024 Financial Summary
Q2 2024 Financial Summary Summary P/L Three months ended Six months ended Cash March 30 June 30 (million of $) 2024 2023 2024 2023 Ended second quarter 2024 with cash of $3.1B Cash reflects cash, cash equivalents and current financial assets 2024 Financial Guidance ($B) 2024 Cash burn (1) < 0.5 Comb
Slide 28: 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 28
Slide 29: Vision 2030
Vision 2030 5 New Molecules in Phase 3 10 Labeled Indications 50 K Patients on Treatment COMMITMENT TO OUR TRANSFORMATION MISSION Continuous Pipeline of Leadership in FcRn Disciplined Scaling Innovation 29