Argenx Se · EURONEXT:ARGX
Argenx — Q1 2022 Earnings Presentation
21 slides from Argenx's earnings presentation, May 5, 2022
Slide 1: Together We Discover: First Quarter 2022 Financial Results
Together We Discover Reaching Patients Through Immunology Innovation First Quarter 2022 Financial Results Topline Results: ADVANCE-IV Study in ITP May 5, 2022 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: Catalyst-Filled Start to 2022
Catalyst-Filled Start to 2022 1 US VYVGART® Sales $21.2M in net 1Q product sales 2 Global Launch Japan launch in May Positive ADVANCE - IV data in ITP 3 2 Phase 3 Datasets Positive ADAPT-SC data in gMG - BLA submission by YE 10 efgartigimod indications in clinic by YE 4 Advance Pipeline 2 ARGX-117 i
Slide 4: IgG Autoantibodies Drive ITP
IgG Autoantibodies Drive ITP 1. Accelerate platelet clearance 2. Inhibit platelet production Platelets FcγR Platelets Macrophage VYVGART is Designed to Megakaryocyte Eliminate IgG 3. Induce platelet killing 4. Interfere with platelet function Autoantibodies Platelets Fibrinogen receptor vWF receptor
Slide 5: Primary Immune Thrombocytopenia
Primary Immune Thrombocytopenia LINDA Rare, serious autoimmune disease characterized by low Living with primary ITP platelet counts leading to risk of bruising, bleeding and debilitating fatigue More than 70K patients in the U.S. Treatment goal aims 75% of patients report impaired ability to to achi
Slide 6: ADVANCE-IV Trial Design Based on Key Regulatory Input
ADVANCE-IV Trial Design Based on Key Regulatory Input 131 adult Chronic or Persistent ITP Primary patients End- point 2 weeks screening Patients randomized 2:1 to receive 10mg/kg VYVGART or placebo (24 weeks) Mean platelet count <30x109/L Stable concomitant ITP therapy Fixed weekly dosing Weekly or
Slide 7: Demographics and Baseline Characteristics
Demographics and Baseline Characteristics VYVGART (N=86) Placebo (N=45) Age Mean years (SD) 46.9 (16.6) 51.7 (17.9) Female n (%) 47 (54.7) 24 (53.3) Time since diagnosis Mean years (SD) 10.3 (12.0) 11.1 (13.1) Patients with chronic / persistent ITP n (%) 78 (90.7) / 8 (9.3) 40 (88.9) / 5 (11.1) Plat
Slide 8: % Sustained Platelet Responder
Primary Endpoint Met Clear Separation Between VYVGART and Placebo Primary Endpoint: Statistically Total patient population Significant Improvement over Placebo P = 0.0316 (Platelets ≥50x109 /L in ≥4/6 visits, weeks 19 and 24) LS-Mean Platelet Count Change From Baseline 40 % Sustained Platelet Respon
Slide 9: % of Responders on IWG Score
Per IWG criteria, 51% of VYVGART Patients Showed Real-World Relevant Platelet Count Improvement in Absence of Bleeding Clear Separation Between VYVGART and Placebo International Workgroup (IWG) Criteria Total patient population reflecting real-world treatment goals 60% 51.2% LS-Mean Platelet Count C
Slide 10: VYVGART Showed Fast Onset of Action and Durable Benefit
VYVGART Showed Fast Onset of Action and Durable Benefit Clear Separation Between VYVGART and Placebo Total patient population VYVGART Showed Platelet Count Improvement Compared to Placebo as Early As Week 1 LS-Mean Platelet Count Change From Baseline 40 •1 Fast onset of action •2 Durable platelet co
Slide 11: Difference in Response Rate with 95% CI
Patients Responded Regardless of Age, Severity, Time Since Diagnosis, Prior ITP Treatment or Background Medication Favors Placebo Favors VYVGART Difference in Response Rate with 95% CI 11
Slide 12: VYVGART Showed Robust Benefit for People Living with ITP
VYVGART Showed Robust Benefit for People Living with ITP Key Secondary Endpoints Population VYVGART Placebo P-value Number of Cumulative Weeks of Disease Control Chronic 6.1 weeks 1.5 weeks Number of weeks with platelet counts ≥ 50 x 109/L (Mean +/- SD) (+/- 7.6) (+/- 3.2) 0.0009* Sustained Platelet
Slide 13: VYVGART Demonstrated Favorable Safety Profile
VYVGART Demonstrated Favorable Safety Profile Safety and tolerability profile consistent with previous trials; First chronic dosing Phase 3 trial; Most AEs mild to moderate VYVGART (N=86) Placebo (N=45) Number of patients n (%) n (%) Patients with an Adverse Event (AE) n (%) 80 (93.0) 43 (95.6) Pati
Slide 14: ADVANCE-IV Results Support Path Forward
ADVANCE-IV Phase 3 Results Support Path Forward • Statistically significant and clinically meaningful Primary endpoint met improvement in platelet counts over placebo • Fast and robust platelet count improvement over placebo Meaningful patient benefit observed • Ability for every other week dosing c
Slide 15: First Quarter 2022 Financial Results
First Quarter 2022 Financial Results Three Months ended March 31 (in thousands of $ except for shares and EPS) 2022 2021 Variance Product net sales $ 21,163 $ — $ 21,163 Collaboration revenue 2,249 158,155 (155,906) Other operating income 8,068 20,412 (12,344) Total operating income 31,480 178,567 (
Slide 16: Executing on VYVGART Launch Priorities
Executing on VYVGART Launch Priorities Meeting our stakeholders where they are Empower Patients Best-in-Class Rapid HCP Enable to Demand Better Patient Adoption of Appropriate Support VYVGART Access ~$21.2M 10 mg/kg 1Q 2022 Net Product Sales Intravenous infusion 16
Slide 17: Key Pillars of VYVGART Value-Based Agreement
Key Pillars of VYVGART Value-Based Agreement 4Q 2021 25% Of Covered Lives Affordability Predictability Simplicity 1Q 2022 62% Of Covered Lives Most VYVGART-specific policies are favorable and aligned to label, with prior authorization median of (6) months Seeking broad coverage by end of 2Q 2022 17
Slide 18: Making Strides in Physician Engagement Efforts
Making Strides in Physician Engagement Efforts Peer-to-Peer Marketing Prescriptions Reflective of ADAPT Population 129 Speaker Programs REACHING 600+ Healthcare Providers Most Common Prior Therapies Steroids, IVIg, ISTs, Eculizumab KOLs report they plan to use KOLs report safety profile of VYVGART i
Slide 19: Initial Feedback Highlights MG Community Excitement
Initial Feedback Highlights MG A P P R O X I M AT E LY Community Excitement 380 VYVGART I had such a great PAT I E N T S Yesterday was the first time in 2 years that I was able to response from the first change my baby’s diaper and it dose of my first cycle that was a proud moment for me. I the next
Slide 20: Global gMG Launch Progressing
Global gMG Launch Progressing VYVGART Approved December 17, 2021 United States Japan China (Zai Lab) Middle East (GenPharm) Launch May 9, 2022 Anticipated filing in mid-2022 Europe Anticipated decision Israel (Medison) Canada in 2H 2022 Anticipated filing Global in 2Q 2022 20
Slide 21: ITP is the Second Indication with a Positive Phase 3 Read-out for VYVGART
ITP is the Second Indication with a Positive Phase 3 Read-out for VYVGART LEVERAGE FORMULATIONS ACROSS MULTIPLE INDICATIONS, THERAPEUTIC gMG ITP Pemphigus CIDP Myositis BP Membranous Lupus COVID-19- Sjogren’s FRANCHISES, AND Nephropathy Nephritis mediated Syndrome MOLECULES POTS 4/4 (gMG, ITP, PV, C