Argenx Se · EURONEXT:ARGX
Argenx — Q3 2020 Earnings Presentation
20 slides from Argenx's earnings presentation, Oct 22, 2020
Slide 1: 3Q 2020 Financial Results & Business Update
3Q 2020 Financial Results & Business Update October 22, 2020
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
Slide 3: Agenda for today
Agenda for today 1 Efgartigimod Update 2 Cusatuzumab, ARGX-117 and Early Stage Pipeline 3 Commercial Update 4 Financial Results 5 Q&A 3
Slide 4: Efgartigimod Provided Statistically Significant Clinical Benefit
Efgartigimod Provided Statistically Significant Clinical Benefit MG-ADL responders QMG responders (AChR-Ab+ patients, cycle 1) (AChR-Ab+ patients, cycle 1) Primary Secondary MG-ADL responder: P < 0.0001 P < 0.0001 QMG responder: ≥2-point improvement ≥3-point improvement for at least four for at leas
Slide 5: ADAPT Data Showed Fast, Deep and Durable Responses
ADAPT Data Showed Fast, Deep and Durable Responses 40% Minimal Symptom Expression Durable Clinical Benefit Potential for Individualized of Efgartigimod Dosing Patients Achieved Minimal Symptom Minimal Symptom Expression Duration of response Expression (AChR Ab+ patients, first cycle) (AChR Ab+ Efgar
Slide 6: Efgartigimod Demonstrated Significant Magnitude Of Benefit
Efgartigimod Demonstrated Significant Magnitude Of Benefit AChr-AB+ Patients, Cycle 1 MG-ADL 14.3% 0.0% Proportion of patients with increasing thresholds 9 20.6% 1.7% of MG-ADL and QMG 8 27.0% 3.3% improvement at week 4* 7 39.7% 8.3% 6 Efgartigimod 55.6% 11.7% 5 Placebo 63.5% 23.3% 4 73.0% 36.7% 3 7
Slide 7: Repeatability of Clinical Benefit in Second Treatment Cycle
Repeatability of Clinical Benefit in Second Treatment Cycle Observed MG-ADL responders Total MG-ADL: Mean change from cycle baseline * p<0.05 ** p<0.01 *** p <0.001 Cycle 1 Cycle 1 Cycle 2 0 100 Mean change f(+/-SE) P < 0.0001 P < 0.0001 -1 -2 % MG-ADL responders 80 70.6% -3 *** 67.7% -4 * ** -5 -6
Slide 8: Overall Population and AChR-Ab Seronegative Treatment Effect (First Cycle)
Overall Population and AChR-Ab Seronegative Treatment Effect (First Cycle) MG-ADL responders Overall population* AChR-Ab- patients Similar results to AChR-Ab+ patients Patient responder analyses P < 0.0001 Efgartigimod (N = 19) Placebo ( N = 19) 67.9% MG-ADL responders 13 (68.4%) 12 (63.2%) QMG resp
Slide 9: Deep Antibody Pipeline Of Differentiated Candidates
Deep Antibody Pipeline Of Differentiated Candidates Program Target Indication Preclinical Phase 1 Phase 2 Phase 3 Registration Partner Next Milestone IV MG BLA BLA to be filed 4Q20 SC MG* Bridging Meet with FDA in 4Q20 Efgartigimod IV ITP Trial ongoing SC FcRn ITP Planning new SC trial SC PV* Ph3 to
Slide 10: ITP Phase 3 ADVANCE: 2 Trials Going Forward
ITP Phase 3 ADVANCE: 2 Trials Going Forward Trial Primary objective N=156 Durable response: * 24 weeks 10mg/kg IV (potential to adjust frequency upon response) sustained platelet count (≥50×109/L) N=156 Patients with primary Durable response: ITP with platelet *SC efgartigimod (ENHANZE®-enabled) sus
Slide 11: Chronic Inflammatory Demyelinating Polyneuropathy: Phase 2 ADHERE Trial
Chronic Inflammatory Demyelinating Polyneuropathy: Phase 2 ADHERE Trial Confirm IgG Document autoantibody efficacy & safety involvement efgartigimod vs placebo Identify patients with active CIDP Treatment period Open-label Placebo-controlled Efficacy analysis based on relapse Screening Run-in period
Slide 12: Efgartigimod Phase 3 Trial in Pemphigus
Efgartigimod Phase 3 Trial in Pemphigus - Focus on Potential to Drive Fast-Onset and Steroid Sparing Concomitant Screening prednisone Randomization (2x1) Primary endpoint is proportion of PV patients achieving CRmin* within 30 Pemphigus vulgaris weeks (PV) and foliaceus (PF) • Prednisone starting do
Slide 13: Cusatuzumab Strategy
Cusatuzumab Strategy Newly diagnosed elderly patients with AML unfit for intensive chemotherapy Phase 2 CULMINATE Trial Phase 1b in Triple Combination Cusatuzumab + Azacitidine Trial in Japan Part 1: Dose selection Cusatuzumab continues to enroll + azacitidine 10 mg/kg 20 mg/kg + venetoclax > 100 pa
Slide 14: ARGX-117: Sweeping Antibody Targeting C2
ARGX-117: Sweeping Antibody Targeting C2 Unique Intervention in Showcase of Antibody Pipeline-in-a-Product Complement Cascade Engineering Capabilities Potential IgG IgM Mannose sugar Sweeping Antibody C1 MASPs MBL qrs MMN C4 Lupus Nephritis C2 CAD Classical C3 convertase Endosome GBS Ischemia CIDP C
Slide 15: Immunology Innovation Program
Immunology Innovation Program Accessing First-in-Class Targets by Collaborating with Leading Research Biologists argenx Academic Institutions & Biotechs Antibody Expertise Disease Biology Expertise Co-creating immunology solutions: building beyond each individual contribution ARGX-112 ARGX-117 ARGX-
Slide 16: Preparing to Bring Efgartigimod to Patients in 2021
Preparing to Bring Efgartigimod to Patients in 2021 Reaching patients, physicians, payors in COVID-19 environment Supply Chain Readiness The Right Team in Place • Global manufacturing scale/flexibility • Commercial leads hired • Building inventory, 3PL selection • Field force of MRLs, TLLs, payor te
Slide 17: A Mystery to Me: A Myasthenia Gravis Docuseries
A Mystery to Me: A Myasthenia Gravis Docuseries
Slide 18: Third Quarter 2020 Financial Results
Third Quarter 2020 Financial Results Nine Months Ended September 30, (in thousands of € except for shares and EPS) 2020 2019 Variance Revenue € 30,062 € 52,264 € (22,202) Other operating income 12,524 8,914 3,610 Total operating income 42,586 61,178 (18,592) Research and development expenses (246,28
Slide 19: Advancing Towards 'argenx 2021' Vision
Advancing Towards ‘argenx 2021’ Vision Commercial franchises argenx 2021: Reaching patients Global expansion across three locations Positive Phase 3 ADAPT data Late-stage pipeline FcRn leadership MG CIDP ITP PV Cusatuzumab strategic alliance Immunology breakthroughs Immunology Innovation Program Str
Slide 20: Thank You
4 argenx « hank You TogetherWe | Discover visit argenx.com