argenx SE · EURONEXT:ARGX
argenx — H1 2020 Earnings Presentation
21 slides from argenx's earnings presentation, Jul 30, 2020
Slide 1: Half-Year 2020 Financial Results & Second Quarter Business Update
Half-Year 2020 Financial Results & Second Quarter Business Update July 30, 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 Recent Highlights, Including Phase 3 ADAPT Data 2 Efgartigimod: Additional Indications 3 Cusatuzumab and Early Stage Pipeline 4 Launch Preparation 5 Financial Results 6 Q&A 3
Slide 4: Recent Achievements in COVID-19 Environment
Recent Achievements in COVID-19 Environment ✓ Positive topline readout of Phase 3 ADAPT trial ✓ Financing to support first commercial launch and advancement of pipeline ✓ BLA filing remains on track ✓ Opened new trial sites in ITP and CIDP programs ✓ Prepared for start of Phase 1 healthy volunteer t
Slide 5: 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 6: Efgartigimod Showed Robust Benefit For Patients With gMG
Efgartigimod Showed Robust Benefit For Patients With gMG • Statistically significant and clinically Primary endpoint met meaningful improvement in MG-ADL Meaningful patient • Fast and deep responses benefit observed • Potential for individualized dosing Favorable tolerability • Safety & tolerability
Slide 7: ADAPT Data Show Statistically Significant and Clinically Meaningful Improvement in MG-ADL and QMG
ADAPT Data Show Statistically Significant and Clinically Meaningful Improvement in MG-ADL and QMG 7
Slide 8: ADAPT Data Show Fast, Deep and Durable Responses
ADAPT Data Show Fast, Deep and Durable Responses Minimal Symptom Expression Fast Onset of Action Durable Clinical Benefit 40% of efgartigimod patients achieved minimal Of the 44 patients who were efgartigimod Potential for individualized dosing symptom Expression compared to 11% in responders, 84.1%
Slide 9: Repeat Treatment Yielded Equally Strong Benefit
Repeat Treatment Yielded Equally Strong Benefit MG-ADL responders MG-ADL responders (AChR-Ab+ patients, first cycle) (AChR-Ab+, second cycle) 27% of P < 0.0001 36.8% of 80% P < 0.0001 Efgartigimod patients 80% Efgartigimod patients 67.7% P <who 0.0001 responded in the 70.6% not responding to 1st 70%
Slide 10: Developing Highly Differentiated Pipeline
Developing Highly Differentiated Pipeline Positive topline ADAPT data Program Target Indication Preclinical Phase 1 Phase 2 Phase 3 Registration Partner IV FcRn MG BLA SC Bridging MG Bridging Efgartigimod IV ITP IV + SC ITP IV ITP IV PV SC CIDP TBD 5th indication + AZA CD70 Newly diag. AML (unfit) C
Slide 11: Navigating The Impact Of COVID-19
Navigating The Impact Of COVID-19 133 patients remain on ADAPT+ ADVANCE enrolling up to 156 patients Telehealth and remote monitoring Home infusion Decision to expand up to 120-130 patients now in 2021 SC efgartigimod 11
Slide 12: PV: Phase 2 Data Support Advancement to Phase 3 Trial
PV: Phase 2 Data Support Advancement to Phase 3 Trial * At least biweekly efgartigimod + corticosteroids @ 0.25-0.5mg/kg 12
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: Addressable MG Market: Patients Who Need Therapy Beyond Steroids
Addressable MG Market: Patients Who Need Therapy Beyond Steroids 65,000 adult myasthenia gravis patients in 85% U.S. of people with MG progress* to generalized MG within 18 months 55,000 patients have generalized form of myasthenia gravis 36% 20,000 patients require of patients require treatment mor
Slide 18: Hope for people living with myasthenia gravis
Hope for people living with myasthenia gravis Eri Abdiel Railroad inspector and father of six Living with myasthenia gravis “When I was younger, they told me I would never walk again … I was able to beat the odds on that, and I intend to beat the odds on MG.” 18
Slide 19: Half Year 2020 Financial Results
Half Year 2020 Financial Results Six Months Ended June 30, (in thousands of € except for shares and EPS) 2020 2019 Variance Revenue € 22,388 € 43,532 € (21,143) Other operating income 8,729 7,767 961 Total operating income 31,117 51,299 (20,182) Research and development expenses (171,718) (78,304) (
Slide 20: Our Key Priorities
Our Key Priorities 1 File BLA by end of year 2 Commercial preparedness 3 Execute pipeline Expand through Immunology 4 Innovation Program 20
Slide 21: Thank You
4 argenx « hank You TogetherWe | Discover visit argenx.com